BACTERIOSTATIC COMPOSITION, PREPARATION METHOD THEREFOR, AND USE THEREOF

Abstract

A bacteriostatic composition, a preparation method therefor and a use thereof are provided. The bacteriostatic composition includes one or more of a fatty acid and/or a salt thereof, one or more of a dicarboxylic acid and/or a salt thereof, one or more of an aromatic alcohol, and one or more of an aromatic acid and/or a salt thereof. The bacteriostatic composition may be made into an aqueous solution, a water-soluble gel, a foam, a spray, an ointment, a powder, a film, a capsule, a suppository, or a tablet, and may be used for inhibiting harmful microorganisms, particularly abnormal flora within the vagina.

Claims

1. A bacteriostatic composition, wherein the bacteriostatic composition comprises: (1) one or more of the fatty acids and/or salts thereof selected from the group consisting of acetic acid, glycolic acid, lactic acid, propionic acid, levulinic acid, butyric acid, isobutyric acid, hydroxybutyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of the ingredients (1) as described, calculated as fatty acid, is in the range of 0.001%-3.00% (w/w); (2) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of the ingredients (2) as described, calculated as dicarboxylic acid, is in the range of 0.05%-5.00% (w/w); (3) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, 2,4-dichlorobenzene methanol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of the ingredients (3) as described is in the range of 0.03%-1.00% (w/w); (4) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of the ingredients (4) as described, calculated as aromatic carboxylic acid, is in the range of 0.03%-1.00% (w/w); the bacteriostatic composition is in a dosage form selected from the group consisting of aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, and tablets.

2. The bacteriostatic composition according to claim 1, wherein the total content of the ingredients (1) as described in the bacteriostatic composition is in the range of 0.001%-2.00% (w/w); and/or the total content of the ingredients (2) as described is in the range of 0.10%-3.50% (w/w); and/or the total content of the ingredients (3) as described is in the range of 0.03%-0.70% (w/w); and/or the total content of the ingredients (4) as described is in the range of 0.03%-0.50% (w/w).

3. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition further comprises one or more of the saccharides selected from the group consisting of glucose, fructose, mannose, galactose, maltose, isomaltose, sucrose, isomaltulose, lactose, lactulose, trehalose, cellobiose, melibiose, gentiobiose, 1-kestose, nystose, 1F-fructofuranosylnystose, isomaltotriose, isomaltotetraose, isomaltopentaose, gentiooligosaccharide, raffinose, panose, maltooligosaccharide, palatinose-oligosaccharide, oligofructose, glucomannan, galactooligosaccharide, dextrin, starch, and glycogen; the total content of which is in the range of 0.01%-20.00% (w/w) or 0.10%-2.00% (w/w).

4. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition further comprises one or more of the amino acids and/or salts thereof selected from the group consisting of L-glutamic acid, glutamine, L-aspartic acid, asparagine, leucine, isoleucine, phenylalanine, valine, proline, threonine, and salts thereof; the total content of which is in the range of 0.10%-6.00% (w/w) or 0.50%-3.00% (w/w).

5. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition as described further comprises one or more of the antibacterial drugs selected from the group consisting of metronidazole, tinidazole, ornidazole, gentamicin, tobramycin, amikacin, sisomicin, netilmicin, ciprofloxacin, ofloxacin, levofloxacin, nifuratel, nifuroxime, furacilin, furazolidone, furantoin, silver sulfadiazine, sodium sulfacetamide, clotrimazole, fluconazole, miconazole, ketoconazole, naftifine, terbinafine, amphotericin B, nystatin, levorin, and natamycin.

6. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition as described is in a dosage form selected from the group consisting of aqueous solutions, water-soluble gels, foams, sprays, or ointments; the pH value of which is in the range of 3.1-4.8, or 3.6-4.6, or 3.8-4.4.

7. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition as described can be a therapeutic product, an active ingredient thereof, and an antiseptic thereof; the therapeutic product form is one of the following group: pharmaceutical products, disinfectants, antibacterial agents, bacteriostatic agents, topical microbicides, flora modulators, microecological modulators, microenvironment modulators, microbial modulators, disposable medical supplies, and the like, or the component of medical devices, the component of pharmaceutical devices, the component of disinfection devices, and the component of devices for vagina use.

8. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition can be used as a non-therapeutic product, an active ingredient thereof, and an antiseptic thereof; the non-therapeutic product form is one of the following group: health care products, hygiene products, personal cleaning and care products, cosmetics, disposable hygiene products, cleaning products, daily necessities, microecological care products, deodorants, lubricants, humectants, lotions, cleaning agents, body care products, antipruritic agents, and refreshing agents, or the components of sanitary napkins, sanitary pads, and tampons.

9. The bacteriostatic composition according to claim 1, wherein the bacteriostatic composition is a vaginal bacteriostatic composition, wherein the vaginal bacteriostatic composition comprises the following ingredients: (1) one or more of the fatty acids and/or salts thereof selected from the group consisting of acetic acid, glycolic acid, lactic acid, propionic acid, levulinic acid, butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of the ingredients (1), calculated as fatty acid, is in the range of 0.001%-2.00% (w/w); (2) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of the ingredients (2), calculated as dicarboxylic acid, is in the range of 0.50%-2.50% (w/w); (3) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, 2,4-dichlorobenzene methanol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of the ingredients (3) is in the range of 0.05%-0.60% (w/w); (4) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of the ingredients (4), calculated as aromatic carboxylic acid, is in the range of 0.05%-0.25% (w/w); the vaginal bacteriostatic composition is in a dosage form selected from the group consisting of aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, and tablets.

10. A method for inhibiting harmful microorganisms, wherein the method includes the steps of using a bacteriostatic composition according to claim 1.

11. The method according to claim 10, wherein the harmful microorganisms refer to one or more of Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, and abnormal flora of skin and/or mucosa.

12. A method for modulating vaginal flora, wherein the method includes the steps of using a vaginal bacteriostatic composition, wherein the vaginal bacteriostatic composition comprises the following ingredients: (1) one or more of the fatty acids and/or salts thereof selected from the group consisting of propionic acid, levulinic acid, butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of 0.001%-2.00% (w/w); and (2) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of 0.50%-2.50% (w/w); wherein the vaginal bacteriostatic composition is in a dosage form selected from the group consisting of aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, and tablets; wherein the method for modulating vaginal flora refers to at least one of the following: inhibiting abnormal vaginal flora, restoring and/or maintaining vaginal lactobacilli.

13. The method according to claim 12, wherein the method is for inhibiting abnormal vaginal flora, wherein the inhibiting abnormal vaginal flora refers to inhibiting one or more of Staphylococcus, Streptococcus, Gardnerella, Escherichia coli, Veillonella parvula, Prevotella, and Mobiluncus.

14. The method according to claim 12, wherein the vaginal bacteriostatic composition further comprises one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, 2,4-dichlorobenzene methanol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of which is in the range of 0.05%-0.60% (w/w).

15. The method according to claim 12, wherein the vaginal bacteriostatic composition further comprises one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of which, calculated as aromatic carboxylic acid, is in the range of 0.05%-0.25% (w/w).

16. The method according to claim 12, wherein the vaginal bacteriostatic composition further comprises one or more of the saccharides selected from the group consisting of glucose, fructose, mannose, galactose, maltose, isomaltose, sucrose, isomaltulose, lactose, lactulose, trehalose, cellobiose, melibiose, gentiobiose, 1-kestose, nystose, 1F-fructofuranosylnystose, isomaltotriose, isomaltotetraose, isomaltopentaose, gentiooligosaccharide, raffinose, panose, maltooligosaccharide, palatinose-oligosaccharide, oligofructose, glucomannan, galactooligosaccharide, dextrin, starch, and glycogen; the total content of which is in the range of 0.01%-20.00% (w/w), or 0.10%-2.00% (w/w).

17. The method according to claim 12, wherein the vaginal bacteriostatic composition further comprises one or more of the amino acids and/or salts thereof selected from the group consisting of L-glutamic acid, glutamine, L-aspartic acid, asparagine, leucine, isoleucine, phenylalanine, valine, proline, threonine, and salts thereof; the total content of which is in the range of 0.10%-6.00% (w/w), or 0.10%-2.00% (w/w).

18. The method according to claim 12, wherein the vaginal bacteriostatic composition further comprises one or more of the estrogens or phytoestrogens selected from the group consisting of diethylstilbestrol, hexoestrol, estradiol, estrone, estriol, nilestriol, ethinyloestradiol, quinestrol, mestranol, promestriene, daidzin, daidzein, glycitein, puerarin, coumestrol, genistein, equol, apigenin, genistin, genisteol, biochanin, coumestrol, formononetin, resveratrol, secoisolariciresinol, and lignan; the total content of which is in the range of 0.001%-1.00% (w/w).

19. The method according to claim 12, wherein the vaginal bacteriostatic composition is used to restore and/or maintain normal vaginal flora, and/or to restore and/or maintain normal vaginal microecology, and/or to restore and/or maintain normal vaginal acidity, and/or to clean and take care of the vagina and/or vulva, and/or to reduce and/or eliminate vaginal pruritus, soreness, dryness, irritation, and dyspareunia, and/or to reduce and/or eliminate abnormal vaginal discharge and unpleasant odor of vaginal discharge.

20. The method according to claim 12, wherein the vaginal bacteriostatic composition is used to prevent and/or treat the imbalance of vaginal flora, bacterial vaginosis, aerobic vaginitis, cytolytic vaginosis, vulvovaginal Candidiasis, and/or atrophic vaginitis.

Description

DESCRIPTION OF THE EMBODIMENTS

[0098] Multiple exemplary embodiments of the present invention are described in detail below. This detailed description should not be considered a limitation to the invention but a more detailed description of certain aspects, features, and embodiments of the invention. It should be understood that the terms in the present invention are intended to describe particular embodiments only, rather than to limit the invention. Furthermore, wherein a range of values is provided in this invention, it should be understood that the upper and lower limits of that range, and each intermediate value between them, are also specifically disclosed. Each smaller range between any stated value or intermediate value in a stated range and any other stated value or intermediate value in that stated range is included in the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

[0099] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All literature cited in the specification is incorporated by reference for the purpose of disclosing and describing the methods and/or materials associated with the literature. In case of conflict with any incorporated literature, this Specification shall prevail. Unless otherwise stated, “%” is a percentage by weight.

[0100] Bacteriostatic agents, commonly used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa such as povidone iodine and chlorhexidine, are mostly broad-spectrum bacteriostatic agents that inhibit not only Escherichia coli, Staphylococcus aureus, and fungi, but also lactic acid bacteria such as lactobacilli. Antiseptics, commonly used in skin care products, cosmetics, bath products, as well as medical products and pharmaceutical products such as chlorobutanol and benzalkonium chloride, usually also have an inhibitory effect on lactic acid bacteria such as lactobacilli. There is a lack of highly selective bacteriostatic agents or bacteriostatic compositions that strongly inhibit harmful bacteria, but weakly inhibit beneficial bacteria such as lactobacilli.

[0101] The prior art (e.g., PCT/CN2017/105296, ZL201080036139, and U.S. Pat. No. 8,765,819) discloses compositions formulated with the combination of low-concentration bacteriostatic agents, such as the low-concentration of phenethyl alcohol, propionic acid and/or salt thereof, and/or benzoic acid and/or salt thereof, which can inhibit Escherichia coli and Staphylococcus aureus, with an inhibition rate against Escherichia coli and Staphylococcus aureus of up to more than 50% and a low inhibition rate against Candida albicans of <50% according to the test methods and judgment criteria of results in the National Standards of the People's Republic of China Hygienic Standard for Disposable Sanitary Products (GB15979-2002).

[0102] Increasing the concentration of the bacteriostatic agent can enhance the bacteriostatic effect against Candida albicans. Studies have shown that an appropriate increase in the concentration of each ingredient in the bacteriostatic combination of “propionic acid and/or salt thereof+benzoic acid and/or salt thereof+phenethyl alcohol” can not only enhance the bacteriostatic effect of the combination of bacteriostatic agents, therefor more effectively inhibit Escherichia coli, Staphylococcus aureus, and the like, but also inhibit Candida albicans by an inhibition rate of more than 50%. However, the higher the concentration of the bacteriostatic agent is, the stronger the inhibition against lactobacilli and other lactic acid bacteria becomes. The experimental example I disclosed in PCT/CN2017/105296 showed that when the concentration of sodium propionate was 0.40% (w/v) or 0.50% (w/v), the growth of lactobacilli was not significantly inhibited; when the concentration of sodium propionate was 0.70% (w/v), the growth of lactobacilli was inhibited. When the concentration of phenethyl alcohol was 0.40% (w/v), the growth of lactobacilli was not significantly inhibited; when the concentration of phenethyl alcohol was 0.50% (w/v), the growth of lactobacilli and acid production was inhibited.

[0103] The inventor has continuously carried out an in-depth study to further develop bacteriostatic compositions that effectively inhibit harmful microorganisms but not beneficial bacteria such as lactobacilli, and that can be used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa, and can be used as antiseptics for skin care products, cosmetics, and bath products, as well as medical products and pharmaceutical products. The inventor has found that the selective combination of appropriate fatty acids and/or salts thereof with dicarboxylic acids, aromatic alcohols, and aromatic carboxylic acids has a synergetic bacteriostatic effect against not only Staphylococcus aureus and Escherichia coli, but also Candida albicans, as well as significantly inhibits the growth of Pseudomonas aeruginosa and Aspergillus niger. The vaginal use of bacteriostatic composition prepared accordingly can result in a significant decrease in abnormal vaginal flora and a significant increase in lactobacilli, thus effectively modulate vaginal flora and vaginal acidity. Therefore, the bacteriostatic composition in the present disclosure can be used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa, and for antisepsis of bath products, skin care products, and cosmetics, as well as medical products, and pharmaceutical products.

[0104] In order to facilitate the accurate understanding of relevant nouns or phrases or expressions or standards mentioned herein, the meanings thereof are hereby clarified and defined as follows:

[0105] “Lactobacillus” refers to the bacteria of the genus Lactobacillus, a kind of gram-positive, rod-shaped, non-spore-forming bacteria capable of producing a large amount of lactic acid as a by-product of glucose metabolism, including hundreds of species and subspecies.

[0106] “Lactic acid bacteria” is a general term of bacteria capable of metabolizing fermentable carbohydrates to produce a large amount of lactic acid, and refer to bacteria of more than 200 species of 18 genera. Lactobacillus is also a kind of lactic acid bacteria.

[0107] “Normal vaginal flora” refers to a Nugent score of 1-3. The vaginal bacteria are dominated by Lactobacillus species and with a small number of other bacteria. Wherein the “other bacteria” refer to gram-positive cocci such as Staphylococcus and Streptococcus, gram-negative bacilli such as Gardnerella and Escherichia coli, gram-negative cocci such as Veillonella parvula, and obligate anaerobes such as Prevotella and Mobiluncus.

[0108] “Abnormal vaginal flora” refers to a Nugent score of 5-10. The vaginal bacteria are dominated by other bacteria and with a small number of Lactobacillus species. Wherein the “other bacteria” refer to gram-positive cocci such as Staphylococcus and Streptococcus, gram-negative bacilli such as Gardnerella and Escherichia coli, gram-negative cocci such as Veillonella parvula, and obligate anaerobes such as Prevotella and Mobiluncus.

[0109] “Harmful microorganisms” generally refer to various highly pathogenic microorganisms, or various opportunistically pathogenic microorganisms that cause disease when human immunity is weakened, or microorganisms that cause the spoilage of food, pharmaceutical products, cosmetics, and hygiene products, including but not limited to the following group of microorganisms: Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, the abnormal flora of skin and/or mucosa, as well as viruses such as HPV and HIV.

[0110] “Ingredient” refers to various ingredients in the composition, including bacteriostatic agents and other ingredients without bacteriostatic activity.

[0111] “Bacteriostatic agent” refers to various ingredients with bacteriostatic effects, or combinations thereof, not limited to conventional bacteriostatic agents or combinations thereof recognized by those skilled in the art.

[0112] “Inhibition rate” is the inhibition rate of bacteriostatic agents against Escherichia coli, Staphylococcus aureus, Candida albicans, or other microorganisms obtained by referring to the test methods and judgment criteria in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products.

[0113] “Bacteriostatic effect” refers to the inhibition of bacteria, fungi, or other microorganisms by bacteriostatic agents. The strength of inhibition is judged herein based on the inhibition rate, specifically as follows: inhibition rate >50%, indicating “possessing bacteriostatic effect”; inhibition rate >90%, indicating “strong bacteriostatic effect”.

[0114] “Low-concentration bacteriostatic agent” is a relatively low concentration bacteriostatic agent with an inhibition rate of <50% against Candida albicans.

[0115] “High-concentration bacteriostatic agent” is a relatively high concentration bacteriostatic agent with an inhibition rate of >50% against Candida albicans.

[0116] “No difference in inhibition rates” or “no influence on bacteriostatic effect” indicates that the difference between two inhibition rates is <15%.

[0117] “A difference in inhibition rates” or “influence on bacteriostatic effect” indicates that the difference between two inhibition rates is 15-30%.

[0118] “A significant difference in inhibition rates” or “significant influence on bacteriostatic effect” indicates that the difference between two inhibition rates is >30%.

[0119] “Synergistic bacteriostatic effect” refers to the combination of two or more bacteriostatic agents acting against Escherichia coli, Staphylococcus aureus, or Candida albicans, which has an inhibition rate that is more than 15% higher than the sum of the inhibition rates of each bacteriostatic agent acting alone.

Embodiment 1

[0120] This embodiment provides a plurality of exemplary ingredients of the bacteriostatic composition. Unless specifically stated otherwise, exemplary ingredients of the composition, described hereunder, are the following substances:

[0121] Propionic acid CAS: 79-09-4, adipic acid CAS: 124-04-9, phenethyl alcohol (2-phenylethanol) CAS: 60-12-8, butyric acid (n-butyric acid) CAS: 107-92-6, hexanoic acid (n-hexanoic acid) CAS: 142-62-1, pimelic acid CAS: 111-16-0, malic acid (L-hydroxysuccinic acid) CAS: 97-67-6, cinnamic acid (trans-cinnamic acid) CAS: 140-10-3, salicylic acid (2-hydroxybenzoic acid) CAS: 69-72-7, lauric acid (dodecanoic acid) CAS: 143-07-7, valeric acid (n-valeric acid) CAS: 109-52-4, heptanoic acid (enanthic acid) CAS: 111-14-8, caprylic acid (n-caprylic acid) CAS: 124-07-2, nonanoic acid (n-nonanoic acid) CAS: 112-05-0, capric acid (n-capric acid) CAS: 334-48-5, undecylic acid (undecanoic acid) CAS: 112-37-8, cinnamyl alcohol (3-phenyl-2-propen-1-ol) CAS: 104-54-1, succinic acid (butanedioic acid) CAS: 110-15-6, tartaric acid (L-tartaric acid) CAS: 87-69-4, maleic acid (cis-butenedioic acid) CAS: 110-16-7, citric acid CAS: 77-92-9, fumaric acid (trans-butenedioic acid) CAS: 110-17-8, undecylenic acid (10-undecylenic acid) CAS: 112-38-9, glutaric acid CAS: 110-94-1.

Example 1

[0122] Add 1.50 g of adipic acid, 2.00 g of propionic acid, 0.25 g of phenethyl alcohol, 1.00 g of citric acid, and 2.50 g of maltose to 80 g of purified water and stir to dissolve them, then add 2.15 g of xanthan gum, and complement purified water to render a total weight of 100 g. Stir for the xanthan gum to swell into a homogeneous viscous gel, then adjust pH to 3.1 with 1.0 mol/L of sodium hydroxide solution, and sterilize at 115.6° C. for 15 minutes, to obtain the water-soluble gel composition in the present disclosure.

Example 2

[0123] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00001 Adipic acid 1.50 g Propionic acid 1.25 g Cinnamic acid 0.08 g Benzyl alcohol 0.50 g Maltose 1.40 g Xanthan gum 2.50 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 3

[0124] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00002 Pimelic acid 0.50 g Cinnamic acid 0.03 g Phenoxyethanol 1.00 g Butyric acid 0.60 g Xanthan gum 2.15 g Add purified water to reach the total weight of 100 g Adjust pH to 4.4

Example 4

[0125] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00003 Glutaric acid 5.00 g Propionic acid 1.50 g Xanthan gum 2.15 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 5

[0126] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00004 Glutaric acid 3.50 g Salicylic acid 0.05 g Levulinic acid 1.25 g Isomaltulose 1.50 g Xanthan gum 2.15 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 6

[0127] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00005 Pimelic acid 2.50 g P-hydroxybenzoic acid 0.20 g Lactic acid 0.75 g Cinnamyl alcohol 0.03 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 7

[0128] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00006 Adipic acid 0.10 g Benzoic acid 0.25 g Caprylic acid 0.01 g Cinnamyl alcohol 0.05 g Malic acid 0.70 g Xanthan gum 2.15 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 8

[0129] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00007 Benzoic acid 0.25 g Capric acid 0.002 g Succinic acid 0.60 g Palatinose 1.00 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 9

[0130] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00008 Benzoic acid 1.00 g Phenethyl alcohol 0.50 g Add purified water to reach the total weight of 100 g Adjust pH to 4.8

Example 10

[0131] Raw materials were weighed and taken according to the following formula, to prepare 100 g of the composition by basically following the method in example 1.

TABLE-US-00009 Adipic acid 1.50 g Cinnamic acid 0.05 g Lauric acid 0.001 g Phenethyl alcohol 0.70 g Add purified water to reach the total weight of 100 g Adjust pH to 3.8

Example 11

[0132] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00010 Glutaric acid 2.50 g Benzoic acid 0.50 g Hexanoic acid 0.15 g Phenoxyethanol 0.30 g Add purified water to reach the total weight of 100 g Adjust pH to 4.6

Example 12

[0133] Raw materials were weighed and taken according to the following formula, to prepare 100 g of the composition by basically following the method in example 1.

TABLE-US-00011 Pimelic acid 0.05 g Cinnamic acid 0.08 g Phenethyl alcohol 0.60 g Undecylic acid 0.001 g Add purified water to reach the total weight of 100 g Adjust pH to 3.6

Example 13

[0134] Raw materials were weighed and taken according to the following formula, to prepare 100 g of composition by basically following the method in example 1.

TABLE-US-00012 Adipic acid 1.50 g Benzoic acid 0.50 g Propionic acid 0.50 g Cinnamyl alcohol 0.08 g Add purified water to reach the total weight of 100 g Adjust pH to 4.4

Example 14

[0135] Raw materials were weighed and taken according to the following formula, to prepare 100 g of the composition by basically following the method in example 1.

[0136] Adipic acid 1.50 g, benzoic acid 0.20 g, propionic acid 1.25 g;

[0137] Glutamic acid 0.76 g, glutamine 0.34 g, aspartic acid 0.60 g, asparagine 0.98 g, isoleucine 0.31 g, methionine 0.35 g, phenylalanine 0.20 g, valine 0.46 g, leucine 0.78 g, proline 0.89 g;

[0138] Xanthan gum 2.50 g;

[0139] add purified water to reach the total weight of 100 g, and adjust pH to 4.0.

Example 15

[0140] Raw materials were weighed and taken according to the following formula, to prepare 100 g of the composition by basically following the method in example 1.

TABLE-US-00013 Adipic acid 0.50 g P-methoxybenzoic acid 0.25 g Acetic acid 3.00 g Glucose 1.00 g Xanthan gum 2.15 g Add purified water to reach the total weight of 100 g Adjust pH to 3.6

Example 16

[0141] A tablet containing 60 mg of adipic acid, 5 mg of sodium benzoate, 30 mg of propionic acid, and 60 mg of sucrose was prepared basically following the method described in Reference 1.

Example 17

[0142] A vaginal suppository containing 60 mg of adipic acid, 5 mg of sodium benzoate, 30 mg of propionic acid, and 60 mg of maltose was prepared basically following the method described in Reference 3.

Embodiment 2

[0143] This embodiment is used to validate the efficacy of the composition.

In Vitro Experiment I

[0144] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231. The percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 1.

TABLE-US-00014 TABLE 1 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Adipic Benzyl Sodium Inhibition Serial acid acid alcohol benzoate rate number (%) (%) (%) (%) (%) 1 0.50 1.50 — 0.20 61.29 2 0.50 1.50 0.50 0.20 81.52 3 0.50 1.50 0.70 0.20 99.27

[0145] Results:

[0146] 1. It was evident in the result of Group 1 in Table 1 that, when the pH value was 3.8, the solution containing “0.50% propionic acid, 1.50% adipic acid, and 0.20% sodium benzoate” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 61.29%;

[0147] 2. It was evident in the results of Groups 2-3 in Table 1 that, when the pH value was 3.8, the combinations of “0.50% propionic acid, 1.50% adipic acid, and 0.20% sodium benzoate” and benzyl alcohol of two different concentrations (0.50%, 0.70%) respectively, had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 81.52% and 99.27%, respectively.

[0148] In summary, it could be seen from the comparison of experimental results of Groups 2-3 and Group 1 that, when the pH value was 3.8, 0.50% and 0.70% benzyl alcohol respectively affected the bacteriostatic effect of the solution containing “0.50% propionic acid, 1.50% adipic acid, and 0.20% sodium benzoate” against Candida albicans, and could enhance the bacteriostatic effect.

In Vitro Experiment II

[0149] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231. The percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.0. The experimental results are shown in Table 2.

TABLE-US-00015 TABLE 2 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Adipic Phenethyl Benzoic Inhibition Serial acid acid alcohol acid rate number (%) (%) (%) (%) (%) 1 1.50 — 0.35 0.20 15.91 2 1.50 — 0.35 0.25 46.09 3 1.50 1.50 0.35 0.20 67.39 4 1.50 1.50 0.35 0.25 92.17

[0150] Results:

[0151] 1. It was evident in the result of Group 1 in Table 2 that, when the pH value was 4.0, the inhibition rate of the solution containing “1.50% propionic acid, 0.35% phenethyl alcohol, and 0.20% benzoic acid” against Candida albicans was 15.91%;

[0152] 2. It was evident in the result of Group 2 in Table 2 that, when the pH value was 4.0, the inhibition rate of the solution containing “1.50% propionic acid, 0.35% phenethyl alcohol, and 0.25% benzoic acid” against Candida albicans was 46.09%;

[0153] 3. It was evident in the result of Group 3 in Table 2 that, when the pH value was 4.0, the solution containing “1.50% propionic acid, 1.50% adipic acid, 0.35% phenethyl alcohol, and 0.20% benzoic acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 67.39%;

[0154] 4. It was evident in the result of Group 4 in Table 2 that, when the pH value was 4.0, the solution containing “1.50% propionic acid, 1.50% adipic acid, 0.35% phenethyl alcohol, and 0.25% benzoic acid” had a strong bacteriostatic effect against Candida albicans, and the inhibition rate was 92.17%.

[0155] In summary,

[0156] 1. It was evident in the comparison of experimental results of Groups 1 and 2, and the result of Groups 3 and 4 that, when the pH value was 4.0, the increase in the concentration of benzoic acid from 0.20% to 0.25% affected or significantly affected the bacteriostatic effects of the solution containing “1.50% propionic acid and 0.35% phenethyl alcohol” and the solution containing “1.50% propionic acid, 1.50% adipic acid, and 0.35% phenethyl alcohol” against Candida albicans, and enhanced the bacteriostatic effect;

[0157] 2. It was evident in the comparison of experimental results of Groups 1 and 3, and Groups 2 and 4 that, when the pH value was 4.0, 1.50% adipic acid significantly affected the bacteriostatic effect of the solution containing “1.50% propionic acid, 0.35% phenethyl alcohol, and 0.20% benzoic acid” and the solution containing “1.50% propionic acid, 0.35% phenethyl alcohol, and 0.25% benzoic acid” against Candida albicans, and enhanced the bacteriostatic effect.

In Vitro Experiment III

[0158] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 3.

TABLE-US-00016 TABLE 3 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Adipic Benzyl Sodium Inhibition Serial acid acid alcohol benzoate rate number (%) (%) (%) (%) (%) 1 — 1.35 0.25 0.20 45.12 2 0.50 1.35 0.25 0.20 61.60 3 1.25 1.35 0.25 0.20 89.72 4 1.50 1.35 0.25 0.20 94.42 5 3.00 1.35 0.25 0.20 100.00

[0159] Results:

[0160] 1. It was evident in the result of Group 1 in Table 3 that, when the pH value was 3.8, the inhibition rate of the solution containing “1.35% adipic acid, 0.25% benzyl alcohol, and 0.20% sodium benzoate” against Candida albicans was 45.12%;

[0161] 2. It was evident in the results of Groups 2-5 in Table 3 that, when the pH value was 3.8, the combinations of propionic acid of four different concentrations respectively (0.50%, 1.25%, 1.50%, 3.00%) and “1.35% adipic acid, 0.25% benzyl alcohol, and 0.20% sodium benzoate” had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 61.60%, 89.72%, 94.42%, and 100.00%, respectively.

[0162] In summary, it could be seen from the comparison of experimental results of Groups 2-5 and Group 1 that, when the pH value was 3.8, propionic acid affected or significantly affected the bacteriostatic effect of the solution containing “1.35% adipic acid, 0.25% benzyl alcohol, and 0.20% sodium benzoate” against Candida albicans, and enhanced the bacteriostatic effect. The higher the concentration of propionic acid was, the stronger the bacteriostatic effect against Candida albicans became.

In Vitro Experiment IV

[0163] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.3. The experimental results are shown in Table 4.

TABLE-US-00017 TABLE 4 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Adipic Phenethyl Benzoic Inhibition Serial acid acid alcohol acid rate numbe (%) (%) (%) (%) (%) 1 0.54 1.50 0.30 — 26.05 2 0.54 1.50 0.30 0.50 64.80 3 0.54 1.50 0.30 1.00 100.00

[0164] Results:

[0165] 1. It was evident in the result of Group 1 in Table 4 that when the pH value was 4.3, the inhibition rate of the solution containing “0.54% propionic acid, 1.50% adipic acid, and 0.30% phenethyl alcohol” against Candida albicans was 26.05%;

[0166] 2. It was evident in the results of Groups 2 and 3 in Table 4 that when the pH value was 4.3, the combinations of “0.54% propionic acid, 1.50% adipic acid, and 0.30% phenethyl alcohol” with 0.50% or 1.00% benzoic acid respectively had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 64.80% and 100.00% respectively.

[0167] In summary, when the pH value was 4.3, 0.50% and 1.00% benzoic acid significantly affected the bacteriostatic effect of the solution containing “0.54% propionic acid, 1.50% adipic acid, and 0.30% phenethyl alcohol” against Candida albicans, and enhanced the bacteriostatic effect. The higher the concentration of benzoic acid was, the stronger the bacteriostatic effect against Candida albicans became.

In Vitro Experiment V

[0168] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.6. The experimental results are shown in Table 5.

TABLE-US-00018 TABLE 5 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Adipic Phenethyl Inhibition Serial acid acid alcohol Sodium rate number (%) (%) (%) benzoate (%) 1 — 1.50 0.30 1.18 84.12 2 2.00 1.50 0.30 1.18 100.00

[0169] Results:

[0170] 1. It was evident in the result of Group 1 in Table 5 that when the pH value was 4.6, the solution containing “1.50% adipic acid, 0.30% phenethyl alcohol, and 1.18% sodium benzoate” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 84.12%;

[0171] 2. It was evident from the result of Group 2 in Table 5 that, when the pH value was 4.6, the solution containing “2.00% propionic acid, 1.50% adipic acid, 0.30% phenethyl alcohol, and 1.18% sodium benzoate” had a strong bacteriostatic effect against Candida albicans, and the inhibition rate was 100.00%.

[0172] In summary, it could be seen from the comparison of experimental results of Group 1 and Group 2 that, when the pH value was 4.6, 2.00% propionic acid affected the bacteriostatic effect of the solution containing “1.50% adipic acid, 0.30% phenethyl alcohol, and 1.18% sodium benzoate” against Candida albicans, and enhanced the bacteriostatic effect.

In Vitro Experiment VI

[0173] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 6.

TABLE-US-00019 TABLE 6 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Butyric Hexanoic Adipic Phenethyl Phenoxy- Sodium Inhibition Serial acid acid acid alcohol ethanol benzoate rate number (%) (%) (%) (%) (%) (%) (%) 1 0.88 — — 0.40 — 0.20 71.52 2 — 0.12 — 0.40 — 0.20 70.65 3 0.88 — — — 0.40 0.20 56.75 4 — 0.12 — — 0.40 0.20 35.88 5 0.88 — 1.46 0.40 — 0.20 100.00 6 — 0.12 1.46 0.40 — 0.20 100.00 7 0.88 — 1.46 — 0.40 0.20 100.00 8 — 0.12 1.46 — 0.40 0.20 100.00

[0174] Results:

[0175] 1. It was evident in the results of Groups 1-2 in Table 6 that when the pH value was 3.8, the combinations of “0.20% sodium benzoate and 0.40% phenethyl alcohol” and two fatty acids of different concentrations (0.88% butyric acid, 0.12% hexanoic acid) respectively had a bacteriostatic effect against Candida albicans, and the inhibition rates were 71.52% and 70.65% respectively;

[0176] 2. It was evident in the results of Groups 3-4 in Table 6 that when the pH value was 3.8, the solution containing “0.20% sodium benzoate, 0.40% phenoxyethanol, and 0.88% butyric acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 56.75%; the solution containing “0.20% sodium benzoate, 0.40% phenoxyethanol, and 0.12% hexanoic acid” had an inhibition rate of 35.88% against Candida albicans;

[0177] 3. It was evident in the results of Groups 5-6 in Table 6 that, when the pH value was 3.8, the combinations of “1.46% adipic acid, 0.20% sodium benzoate, and 0.40% phenethyl alcohol” and two fatty acids of different concentrations (0.88% butyric acid, 0.12% hexanoic acid) respectively had a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 100%;

[0178] 4. It was evident in the results of Groups 7-8 in Table 6 that when the pH value was 3.8, the combinations of “1.46% adipic acid, 0.20% sodium benzoate, and 0.40% phenoxyethanol” and two fatty acids of different concentrations (0.88% butyric acid, 0.12% hexanoic acid) respectively had a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 100%.

[0179] In summary,

[0180] 1. It was evident in the comparison of experimental results of Groups 5-6 and Groups 1-2 in Table 6 that, when the pH value was 3.8, 1.46% adipic acid affected the bacteriostatic effect of the solution containing “0.20% sodium benzoate, 0.40% phenethyl alcohol, and 0.88% butyric acid” and the solution containing “0.20% sodium benzoate, 0.40% phenethyl alcohol, and 0.12% hexanoic acid” against Candida albicans respectively, and enhanced the bacteriostatic effect;

[0181] 2. It was evident in the comparison of experimental results of Groups 7-8 and Groups 3-4 in Table 6 that, when the pH value was 3.8, 1.46% adipic acid significantly affected the bacteriostatic effect of the solution containing “0.20% sodium benzoate, 0.40% phenoxyethanol, and 0.88% butyric acid” and the solution containing “0.20% sodium benzoate, 0.40% phenoxyethanol, and 0.12% hexanoic acid” against Candida albicans respectively, and enhanced the bacteriostatic effect.

In Vitro Experiment VII

[0182] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 7.

TABLE-US-00020 TABLE 7 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Phenethyl Serial acid Pimelic Malic alcohol P- Inhibition numb        acid (%) acid (%)     hydroxybenzo    rate (%) 1 2.50 — — 0.06 0.21 62.76 2 2.50 1.60 — 0.06 0.21 94.84 3 2.50 — 1.34 0.06 0.21 65.68 indicates data missing or illegible when filed

[0183] Results:

[0184] 1. It was evident in the result of Group 1 in Table 7 that, when the pH value was 3.8, the solution containing “0.21% p-hydroxybenzoic acid, 0.06% phenethyl alcohol, and 2.50% propionic acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 62.76%;

[0185] 2. It was evident in the result of Group 2 in Table 7 that, when the pH value was 3.8, the combination of 1.60% pimelic acid and “0.21% p-hydroxybenzoic acid, 0.06% phenethyl alcohol, and 2.50% propionic acid” had a strong bacteriostatic effect against Candida albicans, and the inhibition rate was 94.84%;

[0186] 3. It was evident in the result of Group 3 in Table 7 that, when the pH value was 3.8, the combination of 1.34% malic acid and “0.21% p-hydroxybenzoic acid, 0.06% phenethyl alcohol, and 2.50% propionic acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 65.68%;

[0187] In summary, it could be seen from the comparison of experimental results of Groups 1 and 2, and Groups 1 and 3 that, when the pH value was 3.8, 1.60% pimelic acid significantly affected the bacteriostatic effect of the solution containing “0.21% p-hydroxybenzoic acid, 0.06% phenethyl alcohol, and 2.50% propionic acid” against Candida albicans, and enhanced the bacteriostatic effect, while 1.34% malic acid did not affect the bacteriostatic effect of the solution containing “0.21% p-hydroxybenzoic acid, 0.06% phenethyl alcohol, and 2.50% propionic acid” against Candida albicans.

In Vitro Experiment VIII

[0188] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.9. The experimental results are shown in Table 8.

TABLE-US-00021 TABLE 8 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Adipic Butyric Sodium Phenethyl Inhibition Serial acid acid benzoate alcohol rate number (%) (%) (%) (%) (%) 1 1.46 — — — 11.52 2 — 0.60 — — 1.57 3 — — 0.14 — 19.90 4 — — — 0.40 −1.05 5 1.46 0.60 — — 13.61 6 — 0.60 0.14 — 17.80 7 — 0.60 — 0.40 8.90 8 1.46 0.60 0.14 — 27.23 9 1.46 0.60 — 0.40 25.65 10 — 0.60 0.14 0.40 2.62 11 1.46 — 0.14 0.40 42.41 12 1.46 0.60 0.14 0.40 89.53

[0189] Results:

[0190] 1. It was evident in the results of Groups 1-4 in Table 8 that, when the pH value was 3.9, four solutions containing 1.46% adipic acid, 0.60% butyric acid, 0.14% sodium benzoate, and 0.40% phenethyl alcohol respectively had inhibition rates of 11.52%, 1.57%, 19.90%, and −1.05% respectively against Candida albicans;

[0191] 2. It was evident in the result of Group 5 in Table 8 that, when the pH value was 3.9, the solution containing “1.46% adipic acid and 0.60% butyric acid” had an inhibition rate of 13.61% against Candida albicans;

[0192] 3. It was evident in the result of Group 6 in Table 8 that, when the pH value was 3.9, the solution containing “0.60% butyric acid and 0.14% sodium benzoate” had an inhibition rate of 17.80% against Candida albicans;

[0193] 4. It was evident in the result of Group 7 in Table 8 that, when the pH value was 3.9, the solution containing “0.60% butyric acid and 0.40% phenethyl alcohol” had an inhibition rate of 8.90% against Candida albicans;

[0194] 5. It was evident in the result of Group 8 in Table 8 that, when the pH value was 3.9, the solution containing “1.46% adipic acid, 0.60% butyric acid, and 0.14% sodium benzoate” had an inhibition rate of 27.23% against Candida albicans;

[0195] 6. It was evident in the result of Group 9 in Table 8 that, when the pH value was 3.9, the solution containing “1.46% adipic acid, 0.60% butyric acid, and 0.40% phenethyl alcohol” had an inhibition rate of 25.65% against Candida albicans;

[0196] 7. It was evident in the result of Group 10 in Table 8 that, when the pH value was 3.9, the solution containing “0.60% butyric acid, 0.40% phenethyl alcohol, and 0.14% sodium benzoate” had an inhibition rate of 2.62% against Candida albicans;

[0197] 8. It was evident in the result of Group 11 in Table 8 that, when the pH value was 3.9, the solution containing “1.46% adipic acid, 0.14% sodium benzoate, and 0.40% phenethyl alcohol” had an inhibition rate of 42.41% against Candida albicans;

[0198] 9. It was evident in the result of Group 12 in Table 8 that, when the pH value was 3.9, the solution containing “1.46% adipic acid, 0.60% butyric acid, 0.14% sodium benzoate, and 0.40% phenethyl alcohol” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 89.53%;

[0199] In summary, it could be seen that when the pH value was 3.9, the inhibition rate of the combination of 1.46% adipic acid, 0.60% butyric acid, 0.14% sodium benzoate, and 0.40% phenethyl alcohol against Candida albicans was much higher than that of each of the ingredients or the combination of any two or three of these ingredients, indicating the combination of these four ingredients had a synergistic bacteriostatic effect against Candida albicans.

In Vitro Experiment IX

[0200] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.3. The experimental results are shown in Table 9.

TABLE-US-00022 TABLE 9 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Hexanoic Adipic Sodium Phenethyl Inhibition Serial acid acid benzoate alcohol rate number (%) (%) (%) (%) (%) 1 0.18 — — — 2.82 2 — 1.35 — — 5.81 3 — — 0.20 — 6.95 4 — — — 0.30 0.59 5 0.18 1.35 0.20 0.30 58.86 6 0.18 1.35 0.20 — 25.17 7 0.18 1.35 — 0.30 9.33 8 — 1.35 0.20 0.30 15.37 9 0.18 — 0.20 0.30 28.78

[0201] Results:

[0202] 1. It was evident in the results of Groups 1˜4 in Table 9 that, when the pH value was 4.3, the inhibition rates against Candida albicans of four solutions containing 1.35% adipic acid, 0.20% sodium benzoate, 0.18% hexanoic acid, and 0.30% phenethyl alcohol respectively were all <10%;

[0203] 2. It was evident in the result of Group 5 in Table 9 that, when the pH value was 4.3, the solution containing “1.35% adipic acid, 0.20% sodium benzoate, 0.18% hexanoic acid, and 0.30% phenethyl alcohol” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 58.86%;

[0204] 3. It was evident from the results of Groups 6-9 in Table 9 that, when the pH value was 4.3, the combination of any three ingredients selecting from 1.35% adipic acid, 0.20% sodium benzoate, 0.18% hexanoic acid, and 0.30% phenethyl alcohol, had an inhibition rate of less than 50% against Candida albicans.

[0205] In summary, it could be seen that the inhibition rate of the combination of 1.35% adipic acid, 0.20% sodium benzoate, 0.18% hexanoic acid, and 0.30% phenethyl alcohol, against Candida albicans was significantly higher than that of the combination of any three of these four ingredients, and also significantly higher than the sum of the inhibition rate of each ingredient, indicating that the combination of these four ingredients had a synergistic bacteriostatic effect against Candida albicans.

In Vitro Experiment X

[0206] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 10.

TABLE-US-00023 TABLE 10 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Serial acid Adipic Cinnamic Phenethyl Salicyclic Inhibition number     acid (%) acid (%) alcohol (%) acid (%) rate (%) 1 1.50 1.50 — 0.45 — 30.96 2 1.50 1.50 0.03 0.45 — 59.04 3 1.50 1.50 0.05 0.45 — 71.19 4 1.50 1.50 0.08 0.45 — 96.38 5 1.50 1.50 0.10 0.45 — 100.00 6 1.50 1.50 — 0.45 0.03 37.40 7 1.50 1.50 — 0.45 0.05 55.58 8 1.50 1.50 — 0.45 0.08 86.96 9 1.50 1.50 — 0.45 0.10 94.81 indicates data missing or illegible when filed

[0207] Results:

[0208] 1. It was evident in the result of Group 1 in Table 10 that, when the pH value was 3.8, the solution containing 1.50% adipic acid, 0.45% phenethyl alcohol, and 1.50% propionic acid had an inhibition rate of 30.96% against Candida albicans;

[0209] 2. It was evident in the results of Groups 2-5 in Table 10 that, when the pH value was 3.8, the solution combining cinnamic acids of four different concentrations (0.03%, 0.05%, 0.08%, 0.10%) respectively with the solution containing “1.50% adipic acid, 0.45% phenethyl alcohol, and 1.50% propionic acid” had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 59.04%, 71.19%, 96.38%, and 100.00% respectively;

[0210] 3. It was evident in the results of Groups 6-9 in Table 10 that, when the pH value was 3.8, the combination of 0.03% salicylic acid with “1.50% adipic acid, 0.45% phenethyl alcohol, and 1.50% propionic acid” had an inhibition rate of 37.40% against Candida albicans, while the combination of salicylic acid of three higher concentrations (0.05%, 0.08%, 0.10%) respectively with “1.50% adipic acid, 0.45% phenethyl alcohol, and 1.50% propionic acid” had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 55.58%, 86.96%, and 94.81%, respectively.

[0211] In summary, it could be seen that 0.03-0.10% cinnamic acid and 0.05-0.10% salicylic acid affected or significantly affected the bacteriostatic effect of the solution containing “1.50% adipic acid, 0.45% phenethyl alcohol, and 1.50% propionic acid”, against Candida albicans. The higher the concentration of cinnamic acid or salicylic acid was, the further enhanced the bacteriostatic effect became.

In Vitro Experiment XI

[0212] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 11.

TABLE-US-00024 TABLE 11 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Undecylic Lauric Adipic Phenethyl Sodium Inhibition Serial acid Undecylenic acid acid alcohol benzoate rate number (%) acid (%) (%) (%) (%) (%) (%) 1 0.001 — 8.04 2 0.002 — 10.01 3 — 0.001 — — — — 11.26 4 — 0.002 — — — — 11.10 5 — — 0.001 — — — 9.25 6 — — 0.002 — — — 10.21 7 — — — 1.50 0.25 0.20 50.02 8 0.001 — — 1.50 0.25 0.20 90.24 9 0.002 — — 1.50 0.25 0.20 100.00 10 — 0.001 — 1.50 0.25 0.20 58.59 11 — 0.002 — 1.50 0.25 0.20 85.27 12 — — 0.001 1.50 0.25 0.20 100.00 13 — — 0.002 1.50 0.25 0.20 100.00

[0213] Results:

[0214] 1. It was evident in the results of Groups 1-6 in Table 11 that, when the pH value was 3.8, each one of 0.001-0.002% undecylic acid, 0.001-0.002% undecylenic acid, or 0.001-0.002% lauric acid respectively had inhibition rates of <15% against Candida albicans;

[0215] 2. It was evident in the result of Group 7 in Table 11 that, when the pH value was 3.8, the solution containing “0.20% sodium benzoate, 0.25% phenethyl alcohol, and 1.50% adipic acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 50.02%;

[0216] 3. It was evident in the results of Groups 8-9 in Table 11 that, when the pH value was 3.8, the combinations of “0.20% sodium benzoate, 0.25% phenethyl alcohol, and 1.50% adipic acid” and undecylic acid of two different concentrations (0.001%, 0.002%) respectively had a strong bacteriostatic effect against Candida albicans, and the inhibition rates were higher than 90%;

[0217] 4. It was evident in the results of Groups 10-11 in Table 11 that, when the pH value was 3.8, the combinations of “0.20% sodium benzoate, 0.25% phenethyl alcohol, and 1.50% adipic acid” and undecylenic acid of two different concentrations (0.001%, 0.002%) respectively had a bacteriostatic effect against Candida albicans, and the inhibition rates were higher than 50%;

[0218] 5. It was evident in the results of Groups 12-13 in Table 11 that, when the pH value was 3.8, the combinations of “0.20% sodium benzoate, 0.25% phenethyl alcohol, and 1.50% adipic acid” and lauric acid of two different concentrations (0.001%, 0.002%) respectively had a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 100%.

[0219] In summary, it could be seen that 0.001-0.002% undecylic acid, 0.002% undecylenic acid, and 0.001-0.002% lauric acid significantly affected the bacteriostatic effect of the solution containing “0.20% sodium benzoate, 0.25% phenethyl alcohol, and 1.50% adipic acid” against Candida albicans respectively, and enhanced the bacteriostatic effect.

In Vitro Experiment XII

[0220] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, and the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w). The experimental results are shown in Tables 12-14.

TABLE-US-00025 TABLE 12 Bacteriostatic Effect of Each One of Different Solutions Against Candida albicans ATCC 10231 Propionic Butyric Valeric Hexanoic Heptanoic Caprylic Nonanoic Capric Undecylic Lauric Sodium Inhibition acid acid acid acid acid acid acid acid acid acid benzoate rate pH (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) 3.6 2.00 — 18.22 3.8 — 2.20 — 3.78 3.8 — — 0.60 — −0.51 3.8 — — — 0.20 — −0.31 3.8 0.07 — 2.31 3.8 — 0.02 — 9.96 3.8 — 0.009 — — — — 17.04 3.8 — 0.002 — — — 6.12 3.8 — 0.001 — — −14.39 3.8 — 0.001 — 10.65 3.8 — 0.25 3.73

TABLE-US-00026 TABLE 13 Bacteriostatic Effect of Solutions Containing Two Different Ingredients Against Candida albicans ATCC 10231 Propionic Butyric Valeric Hexanoic Heptanoic Caprylic Nonanoic Capric Undecylic Lauric Sodium Inhibition acid acid acid acid acid acid acid acid acid acid benzoate rate pH (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) 3.6 2.00 — 0.25 57.20 3.8 — 2.20 — 0.25 66.39 3.8 — — 0.60 — 0.25 70.52 3.8 — 0.20 — 0.25 56.02 3.8 — 0.07 — 0.25 79.51 3.8 — 0.02 — — — — 0.20 59.09 3.8 — 0.009 — — — 0.20 58.85 3.8 — 0.002 — — 0.20 50.55 3.8 — 0.001 — 0.20 61.65 3.8 — 0.001 0.20 73.69

TABLE-US-00027 TABLE 14 Bacteriostatic Effect of Solutions Containing Three Different Ingredients Against Candida albicans ATCC 10231 Propionic Butyric Valeric Hexanoic Heptanoic Caprylic Nonanoic Capric Undecylic Lauric Phenethyl Sodium Inhibitiom acid acid acid acid acid acid acid acid acid acid alcohol benzoate rate pH (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) 3.6 1.11 — 0.40 0.20 55.62 3.8 — 0.88 — 0.40 0.20 61.90 3.8 — — 0.40 — — — — — — — 0.40 0.20 81.89 3.8 — — — 0.15 — — — — — — 0.40 0.20 82.82 3.8 — 0.05 — — — — — 0.40 0.20 75.89 3.8 — 0.02 — — — — 0.40 0.20 88.31 3.8 — 0.005 — — — 0.40 0.20 77.98 3.8 — 0.002 — — 0.40 0.20 82.58 3.8 — 0.001 — 0.40 0.20 96.94 3.8 — 0.001 0.40 0.20 100.00

[0221] Results:

[0222] 1. It was evident in the results in Table 12 that, when the pH value was 3.6-3.8, each one of the ten fatty acids of different concentrations (2.00% propionic acid, 2.20% butyric acid, 0.60% valeric acid, 0.20% hexanoic acid, 0.07% heptanoic acid, 0.02% caprylic acid, 0.009% nonanoic acid, 0.002% capric acid, 0.001% undecylic acid, 0.001% lauric acid) or 0.25% sodium benzoate respectively had inhibition rates of <20% against Candida albicans;

[0223] 2. It was evident in the results in Table 13 that, when the pH value the 3.6-3.8, the combinations of 0.20-0.25% sodium benzoate with each one of the ten fatty acids of different concentrations (2.00% propionic acid, 2.20% butyric acid, 0.60% valeric acid, 0.20% hexanoic acid, 0.07% heptanoic acid, 0.02% caprylic acid, 0.009% nonanoic acid, 0.002% capric acid, 0.001% undecylic acid, 0.001% lauric acid) respectively had a bacteriostatic effect against Candida albicans, and the inhibition rates were >50%, indicating that the combination of these two ingredients had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect;

[0224] 3. It was evident in the results in Table 14 that, when the pH value was 3.6-3.8, the combinations of “0.20% sodium benzoate and 0.40% phenethyl alcohol” with each one of the ten fatty acids of different concentrations (2.00% propionic acid, 2.20% butyric acid, 0.60% valeric acid, 0.20% hexanoic acid, 0.07% heptanoic acid, 0.02% caprylic acid, 0.009% nonanoic acid, 0.002% capric acid, 0.001% undecylic acid, 0.001% lauric acid) respectively had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90%, indicating that the combination of these three ingredients had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect;

In Vitro Experiment XIII

[0225] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 15.

TABLE-US-00028 TABLE 15 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Butyric Valeric Hexanoic Heptanoic Caprylic Capric Undecylic Cinnamyl Inhibition Serial acid acid acid acid acid acid acid Lauric acid alcohol rate number (%) (%) (%) (%) (%) (%) (%) acid (%) (%) (%) (%) 1 2.00 — 12.31 2 — 2.20 — 10.76 3 — — 0.60 — 19.70 4 — 0.20 — 5.27 5 — 0.07 — 8.25 6 — 0.02 — 7.93 7 — 0.005 — 22.00 8 — 0.003 — — 20.00 9 — 0.003 — 20.00 10 — 0.30 7.38 11 2.00 — 0.30 81.66 12 — 2.20 — 0.30 100.00 13 — — 0.60 — 0.30 100.00 14 — 0.20 — 0.30 100.00 15 — 0.07 — 0.30 100.00 16 — 0.02 — 0.30 100.00 17 — 0.005 — — 0.30 98.40 18 — 0.003 — 0.30 54.40 19 — 0.003 0.30 81.60

[0226] Results:

[0227] 1. It was evident in the results of Groups 1-10 in Table 15 that, when the pH value was 3.8, each one of the nine fatty acids of different concentrations (2.00% propionic acid, 2.20% butyric acid, 0.60% valeric acid, 0.20% hexanoic acid, 0.07% heptanoic acid, 0.02% caprylic acid, 0.005% capric acid, 0.003% lauric acid, 0.003% undecylic acid) or 0.30% cinnamyl alcohol respectively had inhibition rates of <25% against Candida albicans;

[0228] 2. It was evident in the results of Groups 11-19 in Table 15 that, when the pH value was 3.8, the combinations of each one of the nine fatty acids of different concentrations (2.00% propionic acid, 2.2% butyric acid, 0.60% valeric acid, 0.20% hexanoic acid, 0.07% heptanoic acid, 0.02% caprylic acid, 0.005% capric acid, 0.003% lauric acid, 0.003% undecylic acid) respectively with 0.30% cinnamyl alcohol had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90%, indicating that the combination of these two ingredients had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

In Vitro Experiment XIV

[0229] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 16.

TABLE-US-00029 TABLE 16 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Butyric Pimelic Phenethyl Inhibition Serial acid acid alcohol rate number (%) (%) (%) (%) 1 1.00 — — 1.22 2 — 1.00 — 2.09 3 — — 0.60 4.98 4 1.00 — 0.60 11.09 5 1.00 1.00 0.60 65.22

[0230] Results:

[0231] 1. It was evident in the results of Groups 1-3 in Table 16 that, when the pH value was 3.8, each one of 1.00% butyric acid, 1.00% pimelic acid, or 0.60% phenethyl alcohol respectively had inhibition rates of <10% against Candida albicans;

[0232] 2. It was evident in the result of Group 4 in Table 16 that, when the pH value was 3.8, the inhibition rate of the solution containing 1.00% butyric acid and 0.60% phenethyl alcohol against Candida albicans was 11.09%;

[0233] 3. It was evident in the result of Group 5 in Table 16 that, when the pH value was 3.8, the solution containing 1.00% butyric acid, 1.00% pimelic acid, and 0.60% phenethyl alcohol had a bacteriostatic effect against Candida albicans, and the inhibition rate was 65.22%.

[0234] In summary, it could be seen that the solution containing 1.00% butyric acid, 1.00% pimelic acid, and 0.60% phenethyl alcohol had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

Experimental Example XV

[0235] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing sodium propionate and dicarboxylic acid or tricarboxylic acid were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.6. The experimental results are shown in Table 17.

TABLE-US-00030 TABLE 17 Bacteriostatic Effect of Aqueous Solutions Containing Different Ingredients Against Candida albicans ATCC 10231 Sodium Adipic Malic Inhibition Serial propionate acid Succinic acid Tartaric Maleic Citric Fumaric rate number (%) (%) acid (%) (%) acid (%) acid (%) acid (%) acid (%) (%) 1 2.88 — 19.32 2 — 4.38 — 17.87 3 — — 3.54 — 10.14 4 — — — 4.02 — 20.29 5 — — — — 4.50 — — — 8.70 6 — 3.50 — — 18.36 7 — 5.76 — 20.29 8 — 3.50 11.11 9 1.25 4.38 — 72.46 10 1.25 — 3.54 — 10.14 11 1.25 — — 4.02 — 7.73 12 1.25 — — — 4.05 — — — 1.45 13 1.25 — 3.50 — — 9.66 14 1.25 — 5.00 — 7.25 15 1.25 — 3.50 15.94

[0236] Results:

[0237] 1. It was evident in the results of Groups 1-8 in Table 17 that, when the pH value was 3.6, each one of the 2.88% sodium propionate and seven dicarboxylic acids or polybasic carboxylic acids of different concentrations (4.38% adipic acid, 3.54% succinic acid, 4.02% malic acid, 4.50% tartaric acid, 3.50% maleic acid, 5.76% citric acid, 3.50% fumaric acid) respectively had inhibition rates of <25% against Candida albicans;

[0238] 2. It was evident in the result of Group 9 in Table 17 that, when the pH value was 3.6, the solution containing 1.25% sodium propionate and 4.38% adipic acid had a bacteriostatic effect against Candida albicans, and the inhibition rate was 72.46%;

[0239] 3. It was evident in the results of Groups 10-15 in Table 17 that, when the pH value was 3.6, the combinations of 1.25% sodium propionate and each one of the six dicarboxylic acids or polybasic carboxylic acids of different concentrations (3.54% succinic acid, 4.02% malic acid, 4.50% tartaric acid, 3.50% maleic acid, 5.76% citric acid, 3.50% fumaric acid) respectively had inhibition rates of <25% against Candida albicans.

[0240] In summary, it could be seen that the combination of adipic acid and sodium propionate had a synergistic bacteriostatic effect against Candida albicans.

Experimental Example XVI

[0241] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, the combination of citric acid, malic acid, or succinic acid respectively with a basic bacteriostatic solution containing “1.46% (w/w) adipic acid+0.16% (w/w) sodium benzoate+0.62% (w/w) propionic acid+0.35% (w/w) phenethyl alcohol” was studied for the bacteriostatic effect of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of the basic bacteriostatic solution was 3.6. The experimental results are shown in Table 18.

TABLE-US-00031 TABLE 18 Effects of Citric Acid, Malic Acid, and Succinic Acid on the Bacteriostatic Effect Adipic Sodium Propionic Phenethyl Citric Malic Succinic Inhibition Serial acid benzoate acid alcohol acid acid acid rate number (%) (%) (%) (%) (%) (%) (%) (%) 1 1.46 0.16 0.62 0.35 — — — 53.77 2 1.46 0.16 0.62 0.35 1.00 — — 49.25 3 1.46 0.16 0.62 0.35 — 0.70 — 54.77 4 1.46 0.16 0.62 0.35 — — 0.61 53.27

[0242] Results:

[0243] 1. The basic bacteriostatic solution had a bacteriostatic effect against Candida albicans, and the inhibition rate was 53.77%;

[0244] 2. The combinations of basic bacteriostatic solution with 1.00% citric acid, 0.70% malic acid, or 0.61% succinic acid respectively had inhibition rates of 49.25%, 54.77%, and 53.27% against Candida albicans respectively.

[0245] In summary, it could be seen that citric acid, malic acid, or succinic acid did not affect the bacteriostatic effect of the basic bacteriostatic solution containing “1.46% (w/w) adipic acid+0.16% (w/w) sodium benzoate+0.62% (w/w) propionic acid+0.35% (w/w) phenethyl alcohol” against Candida albicans.

In Vitro Experiment XVII

[0246] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 19.

TABLE-US-00032 TABLE 19 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Butyric Valeric Hexanoic Heptanoic Caprylic Nonanoic Capric Adipic Pimelic Inhibition Serial acid acid acid acid acid acid acid acid acid rate number (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) 1 1.32 — 2.86 2 — 0.70 — −3.56 3 — — 0.20 — 10.25 4 — — — 0.12 — 34.00 5 — 0.03 — 15.28 6 — 0.0075 — — — 21.36 7 — 0.005 — — 16.25 8 — 1.50 — 0.30 9 — 2.00 2.41 10 1.32 — 1.50 — 51.28 11 — 0.70 — 1.50 — 71.25 12 — — 0.20 — 1.50 — 50.12 13 — — — 0.12 — — — 1.50 — 70.66 14 — 0.03 — — 1.50 — 62.26 15 — 0.0075 — 1.50 — 58.49 16 — 0.005 1.50 — 97.92 17 1.32 — 2.00 81.33 18 — 0.70 — 2.00 90.26 19 — — 0.20 — 2.00 70.25 20 — — — 0.12 — 2.00 97.14 21 — 0.03 — — — 2.00 80.70 22 — 0.0075 — — 2.00 62.54 23 — 0.005 — 2.00 98.25

[0247] Results:

[0248] 1. It was evident in the results of Groups 1-9 in Table 19 that, when the pH value was 3.8, each one of the seven fatty acids of different concentrations (1.32% butyric acid, 0.70% valeric acid, 0.20% hexanoic acid, 0.12% heptanoic acid, 0.03% caprylic acid, 0.0075% nonanoic acid, 0.005% capric acid) and two dicarboxylic acids of different concentrations (1.50% adipic acid, 2.00% pimelic acid) respectively had inhibition rates of <35% against Candida albicans;

[0249] 2. It was evident in the results of Groups 10-16 in Table 19 that, when the pH value was 3.8, the combinations of each one of the seven fatty acids of different concentrations (1.32% butyric acid, 0.70% valeric acid, 0.20% hexanoic acid, 0.12% heptanoic acid, 0.03% caprylic acid, 0.0075% nonanoic acid, 0.005% capric acid) respectively with 1.50% adipic acid had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90%;

[0250] 3. It was evident in the results of Groups 17-23 in Table 19 that, when the pH value was 3.8, the combinations of each one of the seven fatty acids of different concentrations (1.32% butyric acid, 0.70% valeric acid, 0.20% hexanoic acid, 0.12% heptanoic acid, 0.03% caprylic acid, 0.0075% nonanoic acid, 0.005% capric acid) respectively with 2.00% pimelic acid had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90%.

[0251] In summary, it could be seen that, when the pH value was 3.8, the combinations of each one of the seven fatty acids of different concentrations (1.32% butyric acid, 0.70% valeric acid, 0.20% hexanoic acid, 0.12% heptanoic acid, 0.03% caprylic acid, 0.0075% nonanoic acid, 0.005% capric acid) respectively and 1.50% adipic acid or 2.00% pimelic acid respectively had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

In Vitro Experiment XVIII

[0252] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 6538, and Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 20.

TABLE-US-00033 TABLE 20 Bacteriostatic Effect of Different Solutions Against Escherichia coli, Staphylococcus aureus and Candida albicans Butyr- Hexa- Hepta- Capryl- Nona- Unde- Undecy- ic noic noic ic noic Capric cylic lenic Lauric Pimelic Inhibition rate (%) Seria1 acid acid acid acid acid acid acid acid acid acid Candida Escherichia Staphylococcus number (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) albicans coli aureus 1 3.00 — 55.00 100.00 100.00 2 — 0.45 — 100.00 100.00 100.00 3 — — 0.30 — 100.00 100.00 100.00 4 — — — 0.05 — 100.00 100.00 100.00 5 0.03 — 100.00 100.00 100.00 6 — 0.008 — — — — 100.00 100.00 100.00 7 0.006 — — — 78.49 100.00 100.00 8 — 0.006 — — 71.68 100.00 100.00 9 — 0.006 — 50.28 100.00 100.00 10 — 5.00 52.23 100.00 100.00

[0253] It was evident in the results in Table 20 that, when the pH value was 3.8, each one of the nine fatty acids of different concentrations (3.00% butyric acid, 0.45% hexanoic acid, 0.30% heptanoic acid, 0.05% caprylic acid, 0.03% nonanoic acid, 0.008% capric acid, 0.006% undecylic acid, 0.006% undecylenic acid, 0.006% lauric acid) respectively and 5.00% pimelic acid had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90%, and had a strong bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were 100.00%.

In Vitro Experiment XIX

[0254] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 21.

TABLE-US-00034 TABLE 21 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Pimelic Cinnamyl Sodium Inhibition Serial acid acid alcohol benzoate rate number (%) (%) (%) (%) (%) 1 2.00 1.50 — 0.20 41.25 2 2.00 1.50 0.03 0.20 72.15 3 2.00 1.50 0.05 0.20 84.54 4 2.00 1.50 0.08 0.20 95.21

[0255] Results:

[0256] 1. It was evident in the result of Group 1 in Table 21 that, when the pH value was 3.8, the solution containing 1.50% pimelic acid, 0.20% sodium benzoate, and 2.00% propionic acid had an inhibition rate of 41.25% against Candida albicans;

[0257] 2. It was evident in the results of Groups 2-4 in Table 21 that, when the pH value was 3.8, the combinations of cinnamyl alcohol of 0.03%, 0.05%, or 0.08% respectively with “1.50% pimelic acid, 0.20% sodium benzoate, and 2.00% propionic acid” had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were 50%-90% or >90% respectively.

[0258] In summary, it could be seen that each one of the cinnamyl alcohol of 0.03, 0.05%, or 0.08% significantly affected the bacteriostatic effect of the solution containing “1.50% pimelic acid, 0.20% sodium benzoate, and 2.00% propionic acid” against Candida albicans respectively, and enhanced the bacteriostatic effect.

In Vitro Experiment XX

[0259] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.8. The experimental results are shown in Table 22.

TABLE-US-00035 TABLE 22 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Pimelic Sodium Inhibition Serial acid acid benzoate rate number (%) (%) (%) (%) 1 — 5.00 — 15.42 2 — — 1.18 15.92 3 0.10 — — 2.90 4 0.10 5.00 1.18 61.02

[0260] Results:

[0261] 1. It was evident in the results of Groups 1-3 in Table 22 that, when the pH value was 4.8, each one of 5.00% pimelic acid, 1.18% sodium benzoate, or 0.10% propionic acid respectively had inhibition rates of less than 20% against Candida albicans;

[0262] 2. It was evident in the result of Group 4 in Table 22 that, when the pH value was 4.8, the solution containing “5.00% pimelic acid, 1.18% sodium benzoate, and 0.10% propionic acid” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 61.02%.

[0263] In summary, it could be seen that, when the pH value was 4.8, the solution containing 5.00% pimelic acid, 1.18% sodium benzoate, and 0.10% propionic acid had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

In Vitro Experiment XXI

[0264] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of 20 minutes of action against Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 6538, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.0. The experimental results are shown in Table 23.

TABLE-US-00036 TABLE 23 Bacteriostatic Effect of Different Solutions Against Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 6538 Propionic Butyric Hexanoic Adipic Phenethyl Sodium Inhibition rate (%) Serial acid acid acid acid alcohol benzoate Escherichia Staphylococcus number (%) (%) (%) (%) (%) (%) coli aureus 1 — 0.30 0.06 64.80 80.00 2 0.50 — 0.06 53.43 56.27 3 — 0.45 — 0.06 51.86 77.30 4 — — 0.06 — — 0.06 67.84 68.11 5 0.50 — 0.30 — 50.53 65.95 6 — 0.45 — — 0.30 — 88.24 80.00 7 — — 0.06 — 0.30 — 50.00 72.97 8 0.35 — 0.30 0.045 74.51 83.24 9 — 0.30 — — 0.30 0.045 97.55 98.38 10 — — 0.06 — 0.30 0.045 90.69 97.30 11 0.35 — — 1.50 0.30 0.045 97.06 71.89 12 — 0.30 — 1.50 0.30 0.045 99.02 78.92 13 — — 0.06 1.50 0.30 0.045 99.02 88.65

[0265] Results:

[0266] 1. It was evident in the results of Groups 1˜4 in Table 23 that, when the pH value was 4.0, the combinations of 0.06% sodium benzoate and each one of 0.30% phenethyl alcohol, 0.50% propionic acid, 0.45% butyric acid, or 0.06% hexanoic acid respectively had a bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were higher than 50%;

[0267] 2. It was evident in the results of Groups 5-7 in Table 23 that, when the pH value was 4.0, the combinations of 0.30% phenethyl alcohol and each one of 0.50% propionic acid, 0.45% butyric acid, or 0.06% hexanoic acid respectively had a bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were higher than 50%;

[0268] 3. It was evident in the results of Groups 8-10 in Table 23 that, when the pH value was 4.0, the combination of “0.045% sodium benzoate, 0.30% phenethyl alcohol” and 0.35% propionic acid had a bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were higher than 50%; the combinations of “0.045% sodium benzoate, 0.30% phenethyl alcohol” and 0.30% butyric acid or 0.06% hexanoic acid respectively had a strong bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were higher than 90%;

[0269] 4. It was evident in the results of Groups 11-13 in Table 23 that, when the pH value was 4.0, the combinations of “1.50% adipic acid, 0.045% sodium benzoate, and 0.30% phenethyl alcohol” and each one of the three fatty acids of different concentrations (0.35% propionic acid, 0.30% butyric acid, 0.06% hexanoic acid) respectively had a strong bacteriostatic effect against Escherichia coli, and the inhibition rates were higher than 90%; and had a bacteriostatic effect against Staphylococcus aureus, and the inhibition rates were 50%-90%.

In Vitro Experiment XXII

[0270] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, and the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w). The experimental results are shown in Table 24.

TABLE-US-00037 TABLE 24 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Butyric Citric Adipic Phenethyl Sodium Inhibition Serial acid acid acid acid alcohol benzoate rate number pH (%) (%) (%) (%) (%) (%) (%) 1 4.0 0.20 0.60 0.06 1.17 0.40 0.20 86.56 2 4.2 0.20 0.60 0.06 1.17 0.40 0.20 66.74 3 4.4 0.20 0.60 0.06 1.17 0.40 0.20 37.61

[0271] Results:

[0272] It was evident in the results of Groups 1-3 in Table 24 that, when the pH value was 4.0 and 4.2 respectively, the solution containing “0.06% citric acid, 1.17% adipic acid, 0.20% propionic acid, 0.60% butyric acid, 0.20% sodium benzoate, and 0.40% phenethyl alcohol” had a bacteriostatic effect against Candida albicans, and the inhibition rates were 86.56% and 66.74% respectively. When the pH value was 4.4, the solution containing these ingredients had an inhibition rate of 37.61% against Candida albicans.

[0273] In summary, it could be seen that the lower the pH value of the solution containing “0.06% citric acid, 1.17% adipic acid, 0.2.0% propionic acid, 0.60% butyric acid, 0.20% sodium benzoate, and 0.40% phenethyl alcohol” was, the stronger the bacteriostatic effect of the solution against Candida albicans became.

In Vitro Experiment XXIII

[0274] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.86. The experimental results are shown in Table 25.

TABLE-US-00038 TABLE 25 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Butyric Adipic Malic Phenethyl Sodium Inhibition Serial Palatinose acid acid acid acid alcohol benzoate Puerarin rate number (%) (%) (%) (%) (%) (%) (%) (%) (%) 1 1.80 0.20 0.45 1.46 0.20 0.30 0.12 — 75.14 2 1.80 0.20 0.45 1.46 0.20 0.30 0.12 0.04 78.45 3 1.80 0.20 0.45 1.46 0.20 0.30 0.12 0.06 76.24

[0275] Results:

[0276] 1. It was evident in the result of Group 1 in Table 25 that, when the pH value was 3.86, the solution containing “1.46% adipic acid, 0.20% malic acid, 0.12% sodium benzoate, 0.20% propionic acid, 0.45% butyric acid, 0.30% phenethyl alcohol, and 1.80% palatinose” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 75.14%;

[0277] 2. It was evident in the result of Group 2 in Table 25 that, when the pH value was 3.86, the solution containing “1.46% adipic acid, 0.20% malic acid, 0.12% sodium benzoate, 0.20% propionic acid, 0.45% butyric acid, 0.30% phenethyl alcohol, 1.80% palatinose, and 0.04% puerarin” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 78.45%;

[0278] 3. It was evident in the result of Group 3 in Table 25 that, when the pH value was 3.86, the solution containing “1.46% adipic acid, 0.20% malic acid, 0.12% sodium benzoate, 0.20% propionic acid, 0.45% butyric acid, 0.30% phenethyl alcohol, 1.80% palatinose, and 0.06% puerarin” had a bacteriostatic effect against Candida albicans, and the inhibition rate was 76.24%.

[0279] In summary, it could be seen that when the pH value of the solution was 3.86, the 0.04% and 0.06% puerarin contained in the solution respectively did not affect the inhibitory effect of the solution against Candida albicans, and did not weaken the bacteriostatic effect.

[0280] Understandably, other estrogens such as diethylstilbestrol, hexoestrol, estradiol, estrone, estriol, nilestriol, ethinyloestradiol, quinestrol, mestranol, and promestriene, and other phytoestrogens such as daidzin, daidzein, glycitein, puerarin, coumestrol, genistein, equol, apigenin, genistin, genisteol, biochanin, coumestrol, formononetin, resveratrol, secoisolariciresinol, and lignan are similar to puerarin in property and action principle. Therefore, it can be inferred that said estrogens and phytoestrogens will not significantly weaken the inhibitory effect of the compositions against Candida albicans.

In Vitro Experiment XXIV

[0281] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Candida albicans ATCC 10231, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 4.0. The experimental results are shown in Table 26.

TABLE-US-00039 TABLE 26 Bacteriostatic Effect of Different Solutions Against Candida albicans ATCC 10231 Propionic Malic Adipic Phenethyl Sodium Glutamic Inhibition Serial acid acid acid alcohol benzoate acid rate number (%) (%) (%) (%) (%) (%) (%) 1 1.67 0.14 1.46 0.40 0.20 0.55 55.23 2 1.67 0.14 1.46 0.40 0.20 — 51.68

[0282] Results:

[0283] It was evident in the comparison of experimental results of Group 1 to Group 2 in Table 26 that, when the pH value was 4.0, 0.55% glutamic acid did not affect the bacteriostatic effect of the solution containing “0.14% malic acid, 1.46% adipic acid, 0.20% sodium benzoate, 1.67% propionic acid, and 0.40% phenethyl alcohol” against Candida albicans.

[0284] Understandably, other appropriate amino acids such as glutamine, L-aspartic acid, asparagine, leucine, isoleucine, phenylalanine, valine, proline, and threonine are similar to glutamic acid in property and action principle. Therefore, it can be inferred that said amino acids will not affect the inhibitory effect of the compositions against Candida albicans.

In Vitro Experiment XXV

[0285] According to the method described in Appendix C of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of 20 minutes of action against Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 6538, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was 3.8. The experimental results are shown in Table 27.

TABLE-US-00040 TABLE 27 Bacteriostatic Effect of Different Solutions Against Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 6538 Adipic Propionic Butyric Valeric Hexanoic Cinnamyl Cinnamic Inhibition rate (%) Serial acid acid acid acid acid alcohol acid Escherichia Staphylococcus number (%) (%) (%) (%) (%) (%) (%) coli aureus 1 1.75 1.50 — 100.00 68.57 2 1.75 — 1.30 — 100.00 90.00 3 1.75 — — 0.50 — 100.00 94.29 4 1.75 — 0.20 — — 100.00 91.43 5 1.75 1.50 — 0.03 — 100.00 100.00 6 1.75 — 1.30 — — 0.03 — 100.00 100.00 7 1.75 — — 0.50 — 0.03 — 100.00 100.00 8 1.75 — 0.20 0.03 — 100.00 100.00 9 1.75 1.50 — 0.03 100.00 100.00 10 1.75 — 1.30 — 0.03 100.00 100.00 11 1.75 — — 0.50 — — 0.03 100.00 100.00 12 1.75 — 0.20 — 0.03 100.00 100.00

[0286] Results:

[0287] 1. It was evident in the results of Groups 1-4 in Table 27 that, when the pH value was 3.8, the combinations of 1.75% adipic acid and each one of 1.50% propionic acid, 1.30% butyric acid, 0.50% valeric acid, or 0.20% hexanoic acid respectively had a strong bacteriostatic effect against Escherichia coli, and the inhibition rates were 100.00%, and had a bacteriostatic effect or a strong bacteriostatic effect against Staphylococcus aureus, and the inhibition rates were 50%-90% or >90%;

[0288] 2. It was evident in the results of Groups 5-8 in Table 27 that, when the pH value was 3.8, the combinations of “0.03% cinnamyl alcohol and 1.75% adipic acid” and each one of 1.50% propionic acid, 1.30% butyric acid, 0.50% valeric acid, and 0.20% hexanoic acid respectively had a strong bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were 100.00%;

[0289] 3. It was evident in the results of Groups 9-12 in Table 27 that, when the pH value was 3.8, the combinations of “0.03% cinnamic acid and 1.75% adipic acid” and each one of 1.50% propionic acid, 1.30% butyric acid, 0.50% valeric acid, or 0.20% hexanoic acid respectively had a strong bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were 100.00%.

In Vitro Experiment XXVI

[0290] Basically by referring to the methods and results determination criteria in Volume IV 1121 Bacteriostatic Effectiveness Testing of the Pharmacopoeia of the People's Republic of China 2020, the bacteriostatic composition was studied for their bacteriostatic effects against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger. The experimental results are shown in Table 28.

TABLE-US-00041 TABLE 28 Antimicrobial Effectiveness Testing of a Composition.sup.1 pH of the Initial composition bacterial count Bacterial count lg value reduced.sup.2 Test bacteria pH (cfu/mL) Day 14 Day 28 Day 14 Day 28 Staphylococcus 4.2 2.8 × 10.sup.5 0 0 5 .sup. NI.sup.3 aureus 4.4 2.4 × 10.sup.5 0 0 5 NI Pseudomonas 4.2 2.1 × 10.sup.5 0 0 5 NI aeruginosa 4.4 2.1 × 10.sup.5 0 0 5 NI Escherichia 4.2 1.5 × 10.sup.5 0 0 5 NI coli 4.4 1.6 × 10.sup.5 0 0 5 NI Candida 4.2 1.1 × 10.sup.5 0 0 5 NI albicans 4.4 1.1 × 10.sup.5 1.1 × 10.sup.4 1.1 × 10.sup.3 1 NI Aspergillus 4.2 1.0 × 10.sup.5 0 0 5 NI niger 4.4 1.0 × 10.sup.5 1.0 × 10.sup.5 1.0 × 10.sup.3 0 NI Note: .sup.1The composition included: 1.50% (w/w) adipic acid, 0.14% (w/w) sodium benzoate, 0.32% (w/w) phenethyl alcohol, 0.54% (w/w) propionic acid, 0.20% (w/w) hexanoic acid, 0.20% (w/w) palatinose, 0.60% (w/w) maltose, 0.0005% (w/w) rose essential oil, and 2.15% (w/w) xanthan gum. .sup.2The difference between the lg value of bacteria count measured at each interval and the lg value of the count of bacteria inoculated in 1 mL (g) of the test sample. .sup.3No increase (NI) is defined as not more than 0.5 lg in the test bacteria count compared to the previous measurement time.

[0291] It was evident in the results in Table 28 that, when the pH value was 4.2, the reduced logarithm of the bacterial concentration was 5 on day 14 relative to day 0, and did not increase on day 28 relative to day 14 for all test bacteria, which met the requirements. It could be seen that the composition with a pH value of 4.2 in the test had an antiseptic effect.

[0292] It should be noted that even if the experimental conditions and methods are identical, the results of the in vitro bacteriostatic experiments, such as inhibition rate, may still differ due to the existence of experimental errors when the experiments are repeated, but such differences are reasonable and are understandable to those skilled in the art. Therefore, if there is any inconsistency between the in vitro experimental data in this disclosure and the data in the previous application documents, the data in this disclosure shall prevail.

[0293] In Vivo Experiment I

[0294] Three groups of gels containing different ingredients respectively were vaginally administered to Cynomolgus Monkeys, 0.5 mL once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH value of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table 29:

TABLE-US-00042 TABLE 29 Effects of Bacteriostatic Gels Containing Different Ingredients on Vaginal Acidity and Vaginal Flora of Cynomolgus Monkeys Pre- Single Three Five administration administration administrations administrations Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.4 pH score pH score pH score B.sup.1 C1406056 5.4 >7 3.8 4-6 3.8 0-3 3.8 0-3 1501042 5.4 >7 4.4 4-6 4.1 0-3 3.8 0-3 C1309138 5.4 >7 4.1 4-6 3.8 0-3 3.8 0-3 C.sup.2 1510080 5.4 >7 3.8 4-6 3.8 0-3 3.8 0-3 1508068 5.4 >7 5.4 >7 3.8 4-6 3.8 4-6 C1405048 5.4 >7 3.8 4-6 3.8 4-6 3.8 4-6 2.sup.3 1508188 5.4 >7 5.4 >7 3.8 0-3 3.8 0-3 1508154 5.4 >7 4.1 4-6 4.1 0-3 3.8 0-3 1512032 5.4 >7 5.4 4-6 5.4 >7 Menstruation / 1501120 5.4 >7 4.4 4-6 3.8 4-6 3.8 0-3 1510080 5.4 >7 4.1 4-6 5.4 4-6 4.4 >7 Note: .sup.1The gel of Group B included 2.50% (w/w) maltose, 0.20% (w/w) isomaltulose, 0.16% (w/w) sodium benzoate, 0.60% (w/w) sodium propionate, 0.35% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.168% (w/w) adipic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.6. .sup.2The gel of Group C included 2.50% (w/w) maltose, 0.20% (w/w) isomaltulose, 0.16% (w/w) sodium benzoate, 0.60% (w/w) sodium propionate, 0.35% (w/w) phenethyl alcohol, 0.61% (w/w) succinic acid, 1.168% (w/w) adipic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.6. .sup.3The gel of Group 2 included 1.15% (w/w) sodium propionate, 0.45% (w/w) phenethyl alcohol, 0.20% (w/w) sodium benzoate, 1.50% (w/w) maltose, 1.00% (w/w) citric acid, and 2.15% (w/w) xanthan gum. with pH value adjusted to 3.6. .sup.4Nugent score refers to the scoring based on the staining, morphology, and quantity of bacteria under microscopic examination of vaginal secretions after smearing and Gram staining, specified as follows: ≥7: Vaginal flora is mainly gram-negative bacilli, and/or negative cocci and positive cocci, with no or few gross gram-positive bacilli; 4-6: Vaginal flora is mainly gram-negative bacilli, and/or negative cocci and positive cocci, with few gross gram-positive bacilli; 0-3: Vaginal flora is normal, with mainly gross gram-positive bacilli.

[0295] Results:

[0296] 1. It was evident in the results of Group B in Table 29 that, after five administrations of the gel that had a pH value of 3.6 and contained “2.50% (w/w) maltose, 0.20% (w/w) isomaltulose, 0.16% (w/w) sodium benzoate, 0.60% (w/w) sodium propionate, 0.35% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.168% (w/w) adipic acid, and 2.15% (w/w) xanthan gum”, the pH values of the vaginal secretions decreased to 3.8 and the Nugent scores of the vaginal flora decreased to 0-3 in all the three Cynomolgus Monkeys;

[0297] 2. It was evident in the results of Group C in Table 29 that, after five administrations of the gel that had a pH value of 3.6 and contained “2.50% (w/w) maltose, 0.20 (w/w) isomaltulose, 0.16% (w/w) sodium benzoate, 0.60% (w/w) sodium propionate, 0.35% (w/w) phenethyl alcohol, 0.61% (w/w) succinic acid, 1.168% (w/w) adipic acid, and 2.15% (w/w) xanthan gum”, the pH values of the vaginal secretions decreased to 3.8 in all the three Cynomolgus Monkeys, and the Nugent scores of the vaginal flora decreased to 0-3 in one Cynomolgus Monkey and to 4-6 in two Cynomolgus Monkeys;

[0298] 3. It was evident in the results of Group 2 in Table 29 that, after five administrations of the gel that had a pH value of 3.6 and contained “1.15% (w/w) sodium propionate, 0.45% (w/w) phenethyl alcohol, 0.20% (w/w) sodium benzoate, 1.50% (w/w) maltose, 1.00% (w/w) citric acid, and 2.15% (w/w) xanthan gum”, the pH values of the vaginal secretions decreased to 3.8 in three of the five Cynomolgus Monkeys and to 4.4 in one Cynomolgus Monkey, and one terminated due to menstruation; and the Nugent scores of the vaginal flora decreased to 0-3 in three Cynomolgus Monkeys, one remained >7, and one terminated due to menstruation.

[0299] In summary, it could be seen that all the three groups of gels, which had a pH value of 3.6, had the efficacies of inhibiting abnormal vaginal flora, restoring vaginal acidity, and restoring vaginal lactobacilli. Between the gels of Groups B and C, which both contained adipic acid, and contained either citric acid or succinic acid respectively, Group B had better efficacy than Group C and Group 2, the latter did not contain adipic acid. The gel of Group 2 containing no adipic acid had the weakest efficacy in inhibiting abnormal vaginal flora, in restoring vaginal acidity, and in restoring vaginal lactobacilli among the three groups of gels.

[0300] In Vivo Experiment II

[0301] Three groups of gels containing different ingredients respectively were vaginally administered to Rhesus Monkeys, 0.5 ml once a day, for five consecutive days. Vaginal secretions were collected for the test of pH value and for smear staining and microscopic examination, to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Rhesus Monkeys. The experimental results are shown in Table 30:

TABLE-US-00043 TABLE 30 Effects of Bacteriostatic Gels Containing Different Ingredients on Vaginal Acidity and Vaginal Flora of Rhesus Monkeys Pre- Single Three Five administration administration administrations administrations Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.4 pH score pH score pH score A.sup.1 15208 5.4 >7 5.4 >7 4.1 4-6 5.4 4-6 15196 5.4 >7 3.8 4-6 3.8 0-3 3.8 0-3 16152 5.4 >7 5.4 >7 5.4 4-6 3.8 0-3 16286 5.4 >7 5.4 4-6 3.8 4-6 3.8 0-3 B.sup.2 15176 5.4 >7 5.4 >7 3.8 4-6 5.4 4-6 17036 5.4 >7 5.4 >7 4.1 4-6 4.1 4-6 1310354 5.4 >7 5.4 4-6 3.8 0-3 3.8 0-3 1306108 5.4 >7 3.8 0-3 3.8 0-3 3.8 0-3 1-4± 5.4 >7 5.4 4-6 3.8 0-3 3.8 0-3 C.sup.3 1401040 5.4 >7 5.4 4-6 3.8 0-3 3.8 0-3 1308498 5.4 >7 4.1 4-6 5.4 4-6 4.1 4-6 Note: .sup.1The gel of Group A included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.60% (w/w) butyric acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 4.1. .sup.2The gel of Group B included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.60% (w/w) butyric acid, 0.0010% (w/w) capric acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 4.1. .sup.3The gel of Group C included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.60% (w/w) butyric acid, 0.0015% (w/w) capric acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 4.1. .sup.4Same as Note 4 in in vivo experiment I.

[0302] Results:

[0303] 1. It was evident in the results of Group A that, after five administrations of the gel, which had a pH value of 4.1 and contained “1.31% (w/w) adipic acid, 0.35% (w/w) malic acid, 0.30% (w/w) phenethyl alcohol, 0.12% (w/w) sodium benzoate, and 0.60% (w/w) butyric acid”, as well as 2.00% (w/w) isomaltulose and 2.15% (w/w) xanthan gum, the pH values of vaginal secretions decreased to 3.8 in three of the four Rhesus Monkeys, while their Nugent scores of the vaginal flora decreased to 0-3; the pH value of vaginal secretion remained 5.4 in one Rhesus Monkey, and the Nugent score of vaginal flora decreased to 4-6.

[0304] 2. It was evident in the results of Group B that, after five administrations of the gel, which had a pH value of 4.1 and contained “1.31% (w/w) adipic acid, 0.35% (w/w) malic acid, 0.30% (w/w) phenethyl alcohol, 0.12% (w/w) sodium benzoate, 0.60% (w/w) butyric acid, and 0.0010% (w/w) capric acid”, as well as 2.00% (w/w) isomaltulose and 2.15% (w/w) xanthan gum, the pH values of vaginal secretions decreased to 3.8 in three of the five Rhesus Monkeys, while their Nugent scores of the vaginal flora decreased to 0-3; the pH value decreased to 4.1 in one of the rest, while the Nugent score decreased to 4-6; and the pH value remained 5.4 in another one of the rest, while the Nugent score decreased to 4-6.

[0305] 3. It was evident in the results of Group C that, after five administrations of the gel, which had a pH value of 4.1 and contained “1.31% (w/w) adipic acid, 0.35% (w/w) malic acid, 0.30% (w/w) phenethyl alcohol, 0.12% (w/w) sodium benzoate, 0.60% (w/w) butyric acid, and 0.0015% (w/w) capric acid”, as well as 2.0% (w/w) isomaltulose and 2.15% (w/w) xanthan gum, the pH values of vaginal secretions decreased to 3.8 in one of the two Rhesus Monkeys, while the Nugent score of the vaginal flora decreased to 0-3; and the pH value in another Rhesus Monkeys decreased to 4.1, while the Nugent score decreased to 4-6.

[0306] In summary, it could be seen that the three groups of gels containing 0.60% (w/w) butyric acid, 0.00125% (w/w) capric acid, or 0.0015% (w/w) capric acid respectively in the experiment had the effect of inhibiting abnormal vaginal flora, modulating vaginal flora, restoring vaginal lactobacilli, and restoring vaginal acidity to normal.

[0307] In Vivo Experiment III

[0308] Five groups of gels containing different ingredients respectively were vaginally administered to Cynomolgus Monkeys, 0.5 mL once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table 31:

TABLE-US-00044 TABLE 31 Effects of Bacteriostatic Gels Containing Different Ingredients on Vaginal Acidity and Vaginal Flora of Cynomolgus Monkeys Pre- Single Three Five administration administration administrations administrations Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.6 pH score pH score pH score l.sup.1 175458c 5.4 >7 4.1 >7 4.1 4-6 3.8 4-6 1506228 5.4 >7 5.4 4-6 4.1 4-6 4.1 4-6 1508188 5.4 >7 3.8 4-6 4.1 4-6 3.8 0-3 1504422 5.4 >7 3.8 4-6 4.1 4-6 4.1 0-3 2.sup.2 1300048 5.4 >7 3.8 4-6 3.8 0-3 3.8 0-3 1601022 5.4 >7 3.8 0-3 3.8 0-3 3.8 0-3 3.sup.3 1512032 5.4 >7 5.4 4-6 4.1 4-6 3.8 4-6 1508068 5.4 >7 4.1 0-3 3.8 0-3 4.1 0-3 1502116 5.4 >7 3.8 0-3 3.8 0-3 4.1 0-3 4.sup.4 1512078 5.4 >7 4.1 4-6 3.8 0-3 3.8 0-3 1104018 5.4 >7 3.8 0-3 3.8 0-3 3.8 4-6 5.sup.5 1105022 5.4 >7 3.8 4-6 3.8 0-3 3.8 0-3 1501024 5.4 >7 4.1 4-6 3.8 0-3 3.8 0-3 Note: .sup.1The gel of Group 1 included 0.14% (w/w) sodium benzoate, 0.54% (w/w) propionic acid, 1.46% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.2The gel of Group 2 included 2.00% (w/w) maltose, 0.14% (w/w) sodium benzoate, 0.54% (w/w) propionic acid, 1.46% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.3The gel of Group 3 included 2.0% (w/w) isomaltulose, 0.14% (w/w) sodium benzoate, 0.54% (w/w) propionic acid, 1.46% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.4The gel of Group 4 included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.0015% (w/w) capric acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.9. .sup.5The gel of Group 5 included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.01% (w/w) caprylic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.9. .sup.6Same as Note 4 in in vivo experiment I.

[0309] Results:

[0310] 1. It was evident in the results of Groups 1-3 in Table 31 that all of the ingredients except saccharide of the gels of the three groups are identical. The gel of Group 1 did not contain any saccharide, the gel of Group 2 contained 2.00% (w/w) maltose, and the gel of Group 3 contained 2.00% (w/w) isomaltulose. The gels had the same pH value of 3.8, and all contained “0.14% (w/w) sodium benzoate, 0.54% (w/w) propionic acid, 1.46% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum”.

[0311] After five administrations, the pH values of vaginal secretions decreased to 4.1 or below in all three groups; the Nugent scores of the vaginal flora in Group 1 without saccharide decreased to 4-6 in two of the four Cynomolgus Monkeys, and to 0-3 in the other two Cynomolgus Monkeys; The Nugent scores in Group 2 with maltose decreased to 0-3 in two Cynomolgus Monkeys. The Nugent scores in Group 3 with isomaltulose decreased to 0-3 in two of the three Cynomolgus Monkeys and to 4-6 in the other one Cynomolgus Monkey.

[0312] 2. It was evident in the results of Group 4 in Table 31 that, after five administrations of the gel, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, 0.0015% (w/w) capric acid, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 3.8 in two Cynomolgus Monkeys, and the Nugent score of the vaginal flora decreased to 0-3 in one Cynomolgus Monkey and to 4-6 in another Cynomolgus Monkey.

[0313] 3. It was evident in the results of Group 5 in Table 31 that, after three administrations of the gel, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, 0.01% (w/w) caprylic acid, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 3.8 and the Nugent score of the vaginal flora decreased to 0-3 in two Cynomolgus Monkeys.

[0314] In summary, it could be seen that:

[0315] 1. The gel which had a pH value of 3.8 and contained “1.46% (w/w) adipic acid, 0.35% (w/w) malic acid, 0.54% (w/w) propionic acid, 0.30% (w/w) phenethyl alcohol, and 0.14% (w/w) sodium benzoate” but no saccharide had the efficacy of inhibiting abnormal vaginal flora, restoring vaginal acidity, and restoring vaginal lactobacilli, as shown in the results of Group 1. However, the gel of Group 2 which contains maltose further and the gel of Group 3 which contains isomaltulose further had a faster and stronger effect in restoring vaginal lactobacilli than the gel of Group 1 without saccharide, as shown in the results of Group 2 and Group 3.

[0316] 2. The gels which contained “1.31% (w/w) adipic acid, 0.35% (w/w) malic acid, 0.38% (w/w) propionic acid, 0.30% (w/w) phenethyl alcohol, 0.12% (w/w) sodium benzoate, and 2.0% (w/w) isomaltulose”, as well as 0.0015% (w/w) capric acid or 0.01% (w/w) caprylic acid respectively had the efficacy of inhibiting abnormal vaginal flora, restoring the vaginal acidity, and restoring vaginal lactobacilli, as shown in the results of Group 4 and Group 5.

[0317] In Vivo Experiment IV

[0318] Three groups of gels that contained different ingredients were vaginally administered to Cynomolgus Monkeys, 0.5 ml once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value, and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table 32:

TABLE-US-00045 TABLE 32 Effects of Bacteriostatic Gels Containing Different Ingredients on Vaginal Acidity and Vaginal Flora of Cynomolgus Monkeys Pre- Single Three Five Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.4 pH score pH score pH score 1.sup.1 151674 5.4 >7 5.4 4-6 4.1 4-6 3.8 0-3 2.sup.2 175456c 5.4 >7 4.1 4-6 3.8 4-6 3.8 0-3 1612144 5.4 >7 4.1 4-6 4.1 4-6 4.1 0-3 3.sup.3 1502004 5.4 >7 5.4 >7 5.4 >7 5.4 0-3 1503264 5.4 >7 3.8 4-6 5.4 4-6 5.4 4-6 Note: .sup.1The gel of Group 1 included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.04% (w/w) heptanoic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.9. Note .sup.2The gel of Group 2 included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.10% (w/w) hexanoic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.9. Note .sup.3The gel of Group 3 included 2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.20% (w/w) valeric acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.9. Note .sup.4Same as Note 4 in in vivo experiment I

[0319] Results:

[0320] 1. It was evident in the result of Group 1 in Table 32 that, after five administrations of the gel, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, 0.04% (w/w) heptanoic acid, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretion decreased to 3.8 and the Nugent score of the vaginal flora decreased to 0-3 in Cynomolgus Monkeys.

[0321] 2. It was evident in the results of Group 2 in Table 32 that, after five administrations of the gel, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, 0.10% (w/w) hexanoic acid, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 4.1 or below, and the Nugent scores of the vaginal flora decreased to 0-3 in the two Cynomolgus Monkeys.

[0322] 3. It was evident in the results of Group 3 in Table 32 that, after five administrations of the gel, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, 0.20% (w/w) valeric acid, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions remained 5.4 in the two Cynomolgus Monkeys, and the Nugent scores of the vaginal flora decreased to 0-3 in one Cynomolgus Monkey and to 4-6 in another Cynomolgus Monkey.

[0323] In summary, it could be seen that the three groups of gels, which had a pH value of 3.9 and contained “2.00% (w/w) isomaltulose, 0.12% (w/w) sodium benzoate, 0.38% (w/w) propionic acid, 1.31% (w/w) adipic acid, 0.30% (w/w) phenethyl alcohol, 0.35% (w/w) malic acid, and 2.15% (w/w) xanthan gum”, as well as 0.04% (w/w) heptanoic acid, 0.10% (w/w) hexanoic acid, or 0.20% (w/w) valeric acid respectively had the efficacy of inhibiting abnormal vaginal flora and restoring vaginal lactobacilli. The two groups of gels containing 0.04% (w/w) heptanoic acid or 0.10% (w/w) hexanoic acid respectively also had the efficacy of restoring vaginal acidity.

[0324] In Vivo Experiment V

[0325] Six groups of gels containing different ingredients were vaginally administered to Cynomolgus Monkeys, 0.5 mL once a day, for five consecutive days. The vaginal swabs were collected for the test of pH values and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table 33:

TABLE-US-00046 TABLE 33 Effects of Bacteriostatic Gels Containing Different Ingredients on Vaginal Acidity and Vaginal Flora of Cynomolgus Monkeys Pre- Single Three Five administration administration administrations administrations Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.7 pH score pH score pH score 1356026 5.4 >7 5.4 4-6 5.4 4-6 5.4 0-3 1 1524590 5.4 >7 5.4 >7 5.4 >7 3.8 4-6 1517032 5.4 >7 5.4 >7 5.4 >7 Menstruation / 2- 1235012 5.4 >7 5.4 4-6 5.4 4-6 5.4 4-6 1430426 5.4 >7 4.4 0-3 4.1 0-3 4.1 0-3 3.sup.3 1093752 5.4 >7 3.8 0-3 3.8 0-3 3.8 0-3 1490523 5.4 >7 5.4 >7 4.6 4-6 4.1 0-3 4.sup.4 1205990 5.4 >7 5.4 >7 4.6 4-6 4.6 4-6 1434210 5.4 >7 4.1 0-3 3.8 0-3 3.8 0-3 5.sup.5 1539203 5.4 >7 5.4 >7 5.4 4-6 4.6 4-6 1434420 5.4 >7 5.4 >7 3.8 0-3 3.8 0-3 6.sup.6 1029995 5.4 >7 4.6 >7 3.8 0-3 3.8 0-3 1488275 5.4 >7 5.4 >7 5.4 >7 4.1 4-6 Note: .sup.1The gel of Group 1 included 0.10% (w/w) hexanoic acid, 1.50% (w/w) adipic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.1. .sup.2The gel of Group 2 included 2.00% (w/w) propionic acid, 0.30% (w/w) cinnamyl alcohol, 0.60% (w/w) succinic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.3The gel of Group 3 included 0.02% (w/w) caprylic acid, 0.25% (w/w) benzoic acid, 1.00% (w/w) citric acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.4The gel of Group 4 included 0.20% (w/w) benzoic acid, 0.25% (w/w) benzyl alcohol, 0.001% (w/w) undecylic acid, 1.00% (w/w) malic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.80. .sup.5The gel of Group 5 included 0.20% (w/w) benzoic acid, 0.50% (w/w) propionic acid, 1.50% (w/w) adipic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.6The gel of Group 6 included 1.00% (w/w) pimelic acid, 0.60% (w/w) phenethyl alcohol, 1.25% (w/w) butyric acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.7Same as Note 4 in in vivo experiment I.

[0326] Results:

[0327] 1. It was evident in the results of Group 1 in Table 33 that, after five administrations of the gel, which had a pH value of 3.1 and contained “0.10% (w/w) hexanoic acid, 1.50% (w/w) adipic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the experiment was terminated in one of the three Cynomolgus Monkeys due to menstruation; the pH values of vaginal secretions remained 5.4 in one Cynomolgus Monkey, and decreased to 3.8 in another one; The Nugent scores of the vaginal flora decreased to 4-6 in one Cynomolgus Monkey and decreased to 0-3 in another one;

[0328] 2. It was evident in the results of Group 2 in Table 33 that, after five administrations of the gels, which had a pH value of 3.8 and contained “2.00% (w/w) propionic acid, 0.30% (w/w) cinnamyl alcohol, 0.60% (w/w) succinic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 4.1 in one of the two Cynomolgus Monkeys and remained 5.4 in another one; The Nugent scores of the vaginal flora decreased to 4-6 in one Cynomolgus Monkey and to 0-3 in another one.

[0329] 3. It was evident in the results of Group 3 in Table 33 that, after five administrations of the gel, which had a pH value of 3.8 and contained “0.02% (w/w) caprylic acid, 0.25% (w/w) benzoic acid, 1.00% (w/w) citric acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 3.8 in one of the two Cynomolgus Monkeys and to 4.1 in another, and the Nugent scores of the vaginal flora decreased to 0-3 in the two Cynomolgus Monkeys;

[0330] 4. It was evident in the results of Group 4 in Table 33 that, after five administrations of the gel, which had a pH value of 3.8 and contained“0.20% (w/w) benzoic acid, 0.25% (w/w) benzyl alcohol, 0.001% (w/w) undecylic acid, 1.00% (w/w) malic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 4.6 in one of the two Cynomolgus Monkeys and to 3.8 in another, and the Nugent score of the vaginal flora decreased to 4-6 in one Cynomolgus Monkey and to 0-3 in another;

[0331] 5. It was evident in the results of Group 5 in Table 33 that, after five administrations of the gel, which had a pH value of 3.8 and contained “0.20% (w/w) benzoic acid, 0.50% (w/w) propionic acid, 1.50% (w/w) adipic acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH value of vaginal secretions decreased to 4.6 in one of the two Cynomolgus Monkeys and to 3.8 in another, and the Nugent score of vaginal flora decreased to 4-6 in one Cynomolgus Monkey and to 0-3 in another;

[0332] 6. It was evident in the results of Group 6 in Table 33 that, after five administrations of the gel, which had a pH value of 3.8 and contained “1.00% (w/w) pimelic acid, 0.60% (w/w) phenethyl alcohol, 1.25% (w/w) butyric acid, 2.00% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH value of vaginal secretions decreased to 3.8 in one of the two Cynomolgus Monkeys and to 4.1 in another, and the Nugent score of the vaginal flora decreased to 0-3 in one Cynomolgus Monkey and to 4-6 in another.

[0333] In summary, it could be seen that these 6 gel compositions had the effect of inhibiting abnormal vaginal flora, restoring vaginal acidity, and restoring vaginal lactobacilli.

[0334] In Vivo Experiment VI

[0335] The gels containing adipic acid or fumaric acid were vaginally administered to Cynomolgus Monkeys, 0.5 mL once a day, for five consecutive days, and vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table 34:

TABLE-US-00047 TABLE 34 Effects of Gels Containing Adipic Acid and Fumaric Acid on Vaginal Acidity Pre- Single Three Five Serial Animal Nugent Nugent Nugent Nugent number No. pH score.sup.3 pH score pH score pH score 1.sup.1 1038246 5.4 >7 5.4 >7 5.4 >7 5.4 >7 1421211 5.4 >7 5.4 >7 5.4 >7 5.4 4-6 2.sup.2 1421363 5.4 >7 4.6 4-6 4.4 0-3 4.1 0-3 1102845 5.4 >7 4.4 0-3 4.1 0-3 4.1 0-3 Note: .sup.1The gel of Group 1 included 1.50% (w/w) fumaric acid, 1.00% (w/w) propionic acid, 0.08% (w/w) cinnamic acid, 0.25% (w/w) phenethyl alcohol, 1.40% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.2The gel of Group 2 included1.50% (w/w) adipic acid, 1.00% (w/w) propionic acid, 0.08% (w/w) cinnamic acid, 0.25% (w/w) phenethyl alcohol, 1.40% (w/w) maltose, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.8. .sup.3Same as Note 4 in in vivo experiment I.

[0336] Results:

[0337] 1. It was evident in the results of Group 1 in Table 34 that, after five administrations of the gel, which had a pH value of 3.8 and contained “1.50% (w/w) fumaric acid, 1.00% (w/w) propionic acid, 0.08% (w/w) cinnamic acid, 0.25% (w/w) phenethyl alcohol, 1.40% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions remained 5.4 in two Cynomolgus Monkeys, and the Nugent score of the vaginal flora remained >7 in one Cynomolgus Monkey and decreased to 4-6 in another.

[0338] 2. It was evident from the results of Group 2 in Table 34 that, after five administrations of the gel, which had a pH value of 3.8 and contained “1.50% (w/w) adipic acid, 1.00% (w/w) propionic acid, 0.08% (w/w) cinnamic acid, 0.25% (w/w) phenethyl alcohol, 1.40% (w/w) maltose, and 2.15% (w/w) xanthan gum”, the pH values of vaginal secretions decreased to 4.1 and the Nugent scores of the vaginal flora decreased to 0-3 in both of the two Cynomolgus Monkeys.

[0339] In summary, it could be seen that the gel containing 1.50% (w/w) adipic acid had the effect of inhibiting abnormal vaginal flora, restoring vaginal lactobacilli, and restoring vaginal acidity.

[0340] Clinical Observation I

[0341] The gel A was vaginally administered in 10 patients with bacterial vaginosis (BV) and 5 healthy volunteers, 4.5 g once a day, for 5 consecutive days, and vaginal swabs were collected on the third day of administration (V1) and 3 days after drug discontinuance (V2) for the test of pH value and for smear staining and microscopic examination to observe the effects of the gel on the pH values of vaginal secretions and on the vaginal flora. The experimental results are shown in Table 35:

TABLE-US-00048 TABLE 35 Effects of Gel A on Vaginal Acidity and Vaginal Flora of Patients with BV and Healthy Volunteers Pre-administration V1 V2 Nugent Nugent Nugent Subject pH.sup.2 score.sup.3 pH score pH score Gel Patients 1 4.6-5.4 8 3.8-4.1 8 3.8-4.1 1 A.sup.1 with BV 2 4.6-5.4 8 3.8-4.1 5 3.8-4.1 2 3 4.6-5.4 7 3.8-4.1 2 3.8-4.1 0 4 4.6-5.4 8 4.6-5.4 8 4.6-5.4 6 5 4.6-5.4 8 4.6-5.4 7 3.8-4.1 1 6 4.6-5.4 8 3.8-4.1 5 3.8-4.1 2 7 4.6-5.4 8 3.8-4.1 4 3.8-4.1 1 8 4.6-5.4 8 4.6-5.4 6 3.8-4.1 2 9 4.6-5.4 8 3.8-4.1 3 3.8-4.1 1(VVC) 10 4.6-5.4 7 3.8-4.1 0 3.8-4.1 0 Healthy 1 3.8-4.1 0 3.8-4.1 1 3.8-4.1 1 volunteers 2 3.8-4.1 1 3.8-4.1 2 3.8-4.1 1 3 3.8-4.1 1 3.8-4.1 0 3.8-4.1 0 4 3.8-4.1 2 3.8-4.1 0 3.8-4.1 1 5 3.8-4.1 1 3.8-4.1 1 3.8-4.1 1 Note .sup.1Gel A included 1.46% (w/w) adipic acid, 0.70% (w/w) sodium propionate, 0.14% (w/w) sodium benzoate, 0.32% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.60% (w/w) maltose, 0.20% (w/w) palatinose, 0.0005% (w/w) rose essential oil, and 2.15% (w/w) xanthan gum, with pH value adjusted to 3.70. Note .sup.2pH value was measured using a pH range standard colorimetric card. The colorimetric card has two ranges: 3.8-4.1 indicates normal; 4.6-5.4 indicates abnormal. Note .sup.3Same as Note 7 in in vivo experiment I.

[0342] Results:

[0343] 1. It was evident in the results of BV patients in Table 35 that, after three administrations of the gel, which had a pH value of 3.70 and contained “1.46% (w/w) adipic acid, 0.70% (w/w) sodium propionate, 0.14% (w/w) sodium benzoate, 0.32% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.60% (w/w) maltose, 0.20% (w/w) palatinose, 0.0005% (w/w) rose essential oil, and 2.15% (w/w) xanthan gum”, the pH values decreased to 3.8-4.1 in seven of the ten BV patients, and the Nugent scores of the vaginal flora decreased to 3 or below in three BV patients and to 4-6 in four BV patients.

[0344] After five administrations and an interval of 3 days after drug discontinuance, the pH values decreased to 3.8-4.1 in nine of the ten BV patients, and the Nugent scores of the vaginal flora decreased to lower than 3. In one patient, the pH value remained 4.6-5.4, and the Nugent score decreased to 6.

[0345] 2. It was evident in the results of healthy volunteers in Table 35 that, three administrations of the gel, which had a pH value of 3.70 and contained “1.46% (w/w) adipic acid, 0.70% (w/w) sodium propionate, 0.14% (w/w) sodium benzoate, 0.32% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.60% (w/w) maltose, 0.20% (w/w) palatinose, 0.0005% (w/w) rose essential oil, and 2.15% (w/w) xanthan gum”, did not affect the pH values of vaginal secretions or the vaginal flora in healthy volunteers.

[0346] After five administrations and an interval of 3 days after drug discontinuance, the results showed that the administrations did not affect the pH value of vaginal secretions or the vaginal flora in healthy volunteers.

[0347] In summary, it could be seen in the experiment that, the gel, which had a pH value of 3.70 and contained“1.46% (w/w) adipic acid, 0.70% (w/w) sodium propionate, 0.14% (w/w) sodium benzoate, 0.32% (w/w) phenethyl alcohol, 1.00% (w/w) citric acid, 1.60% (w/w) maltose, 0.20% (w/w) palatinose, 0.0005% (w/w) rose essential oil, and 2.15% (w/w) xanthan gum”, could decrease significantly the abnormal vaginal flora, increase significantly vaginal lactobacilli, and lowered the vaginal pH value in BV patients, but had no effect on the normal pH values of vaginal secretions or normal flora in healthy volunteers, indicating that the gel had the effect of inhibiting abnormal vaginal flora, restoring and/or maintaining vaginal lactobacilli, and restoring and/or maintaining normal vaginal acidity.

REFERENCES

[0348] 1. Fang Liang: Pharmaceutics, People's Medical Publishing House, eighth edition (2016), pages 243-252; [0349] 2. Fang Liang: Pharmaceutics, People's Medical Publishing House, eighth edition (2016), pages 211-228; [0350] 3. Fang Liang: Pharmaceutics, People's Medical Publishing House, eighth edition (2016), pages 234-237; [0351] 4. Fang Liang: Pharmaceutics, People's Medical Publishing House, eighth edition (2016), pages 280-284.

[0352] Although the present invention has been described by referring to exemplary embodiments, it should be understood that the present invention is not limited to the disclosed exemplary embodiments. Various adjustments or variations can be made to the exemplary embodiments of the specification without departing from the scope or spirit of the invention. The scope of the claims is to be based on the broadest interpretation to cover all modifications, equivalent structures, and functions.