FREEZE-DRIED FORMULATION, PREPARATION METHOD AND APPLICATION THEREOF

Abstract

A freeze-dried formulation and a preparation method and an application thereof are provided. Triterpenoid saponin has a mass percentage of 0.004-95% in the freeze-dried formulation, a binding agent has a mass percentage of 0.01-99% in the freeze-dried formulation; the freeze-dried formulation is freeze-dried by a primary prepared solution containing the triterpenoid saponin and the binding agent; when the triterpenoid saponin has a mass percentage of 0.001%-50% in the primary prepared solution, the binding agent has a mass percentage of 0.01%-50% in the primary prepared solution, and a mass of the triterpenoid saponin increases with an increase of a mass of the binding agent; and when the triterpenoid saponin has a mass percentage of 50%-95% in the primary prepared solution, the binding agent has a mass percentage of 0.01%-20% in the primary prepared solution, and the mass of triterpenoid saponin decreases with the increase of the mass of the binding agent.

Claims

1. A freeze-dried formulation, wherein a triterpenoid saponin has a mass percentage of 0.004-95% in the freeze-dried formulation, and a binding agent has a mass percentage of 0.01-99% in the freeze-dried formulation; the freeze-dried formulation is freeze-dried by a primary prepared solution containing the triterpenoid saponin and the binding agent, wherein when the triterpenoid saponin has a mass percentage of 0.001%-50% in the primary prepared solution, the binding agent has a mass percentage of 0.01%-50% in the primary prepared solution, and a mass of the triterpenoid saponin increases with an increase of a mass of the binding agent; when the triterpenoid saponin has a mass percentage of 50%-95% in the primary prepared solution, the binding agent has a mass percentage of 0.01%-20% in the primary prepared solution, and the mass of triterpenoid saponin decreases with the increase of the mass of the binding agent.

2. A freeze-dried formulation, wherein the freeze-dried formulation is freeze-dried by a primary prepared solution containing triterpenoid saponin and a binding agent, and the freeze-dried formulation is an oral formulation, a solid beverage or a non-washing skin care product, when the freeze-dried formulation is the oral formulation, the triterpenoid saponin has a mass percentage of 0.004%-50% in the primary prepared solution, and the binding agent has a mass percentage of 0.01%-50% in the primary prepared solution; when the freeze-dried formulation is the solid beverage, the triterpenoid saponin has a mass percentage of 50%-95% in the primary prepared solution, and the binding agent has a mass percentage of 0.01%-20% in the primary prepared solution. when the freeze-dried formulation is the non-washing skin care product, the triterpenoid saponin has a mass percentage of 0.004-30% in the primary prepared solution, and the binding agent has a mass percentage of 0.01-50% in the primary prepared solution.

3. The freeze-dried formulation according to claim 2, wherein the oral formulation has a disintegration time less than 3 seconds, and a dissolving-out amount greater than 90% within 1 minute; and the solid beverage has a disintegration time less than 10 seconds, a dissolution time less than 15 seconds, and a dissolving-out amount greater than 90% within 1 minute.

4. The freeze-dried formulation according to claim 1, wherein the freeze-dried formulation further comprises an adjuvant, and the adjuvant has a mass percentage of 0.01-50% in the primary prepared solution, and the adjuvant is one of a framework propping agent, a disintegrating agent, a skin feeling improver, an antioxidant, a corrigent, an essence, a transmucosal/skin penetration enhancer or a pH regulator or a combination thereof.

5. The freeze-dried formulation according to claim 1, wherein the freeze-dried formulation further comprises an active ingredient, and the active ingredient has a mass percentage of 0.01-50% in the primary prepared solution, and the active ingredient is one or a combination of steroid saponin, Astragalus extract, ginseng extract, American ginseng extract, Gynostemma pentaphyllum extract, flavone, ginseng polysaccharide, sea cucumber polysaccharide, amino acid, dencichine, pilose antler polypeptide, resveratrol, pearl powder, hydrolyzed pearl, rana japonica oil extract, SOD or hawthorn extract.

6. The freeze-dried formulation according to claim 1, wherein the binding agent consists of a freeze-dried binding agent and/or a low-temperature binding agent; the freeze-dried binding agent is selected from one or a combination of an artificial or a natural high-molecular polymer, a modified artificial or natural high-molecular polymer, an inorganic matter gel, a polysaccharide, a polysaccharide derivative and salt thereof, sugar alcohol, cellulose ethers, modified starch, albumin or a polyamino acid; the low-temperature binding agent is one of a C1-C16 alcohol, a grease, a surfactant, an artificial or a natural high-molecular polymer, or a modified artificial or natural high-molecular polymer.

7. The freeze-dried formulation according to claim 1, wherein the triterpenoid saponin is an acidic thermosensitive saponin, preferably, one or a combination of malonyl ginsenoside, Astragalus lanuginosus saponin, platycodin E, Codonopsis pilosula saponin A-G, Aster tataricus saponin Hb, Codonopsis lanceolata saponin I-III or Gynostemma pentaphyllum saponin.

8. The freeze-dried formulation according to claim 1, wherein the triterpenoid saponin is purified and obtained from a saponin-containing crude drug by a CO.sub.2 supercritical extraction process and a macroporous resin exchange adsorption process, comprising the following steps: 1) taking, cleaning and cutting up the saponin-containing crude drug, and adding 1-10 times water; 2) homogenizing and squeezing fragments of the saponin-containing crude drug at a low-temperature environment of 0° C.-50° C. to obtain a decoction and a dreg; 3) taking the dreg and extracting the dreg for 30-100 minutes at −30° C.-40° C. by the CO.sub.2 supercritical extraction process to obtain an extract, and discarding residues, wherein an entrainer is an ethyl alcohol; 4) taking the decoction and passing the decoction through a macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining a target product by a thin-layer chromatography, collecting a target segment, performing a concentration under a reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and performing a freeze-drying to obtain a first triterpenoid saponin; 5) taking the extract and passing the extract through the macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining the target product by the thin-layer chromatography, collecting the target segment, performing the concentration under the reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and freeze-drying to obtain a second triterpenoid saponin; 6) separately using the first triterpenoid saponin and the second triterpenoid saponin or combining the first triterpenoid saponin and the second triterpenoid saponin to obtain a final triterpenoid saponin product.

9. The freeze-dried formulation of claim 8, wherein the saponin-containing crude drug is one or a combination of one or more plants of American ginseng, ginseng, Panax notoginseng, Gynostemma pentaphyllum, Radix bupleuri, Codonopsis pilosula, Platycodon grandiflorum, Polygala tenuifolia, liquorice, Astragalus membranaceus or Phytolacca acinosa; the saponin-containing crude drug is one or a combination of a root, a stem, a leaf or a flower of a plant.

10. The freeze-dried formulation according to claim 1, wherein the freeze-dried formulation is prepared by the following steps: a) mixing a solvent, the triterpenoid saponin and the binding agent to form the primary prepared solution in a form of a solution, an emulsion or a suspension; or mixing the solvent, the triterpenoid saponin, the binding agent and an adjuvant to form the primary prepared solution in the form of the solution, the emulsion or the suspension, then fixing a volume and degassing; b) using a quantitative filling pump to pump the primary prepared solution obtained in the step a) into a quantitative forming die for degassing; c) freeze-drying a side product obtained in the step b), and removing the solvent to obtain the freeze-dried formulation; or the freeze-dried formulation is prepared by the following steps: a) preparation of a soft ice mixture: mixing the triterpenoid saponin and the binding agent to obtain the primary prepared solution, or mixing the triterpenoid saponin, the binding agent, the solvent and the adjuvant to form the primary prepared solution, then freezing the primary prepared solution to obtain a soft ice mixture; b) mixing an active ingredient, the binding agent and the solvent to obtain the primary prepared solution; or mixing the active ingredient, the binding agent, the adjuvant and the solvent to obtain the primary prepared solution, then performing a low-temperature cryogenic grinding or a low-temperature spraying to obtain an ice powder; c) using the active ingredient and the adjuvant as a first dry powder; d) using the active ingredient as a second dry powder; e) mixing one or more of the soft ice mixture, the ice powder, the first dry powder or the second dry powder to obtain a mixture of all soft ice; f) performing a shaping with a certain die to obtain a shaped mixture, and performing a demolding; g) freeze-drying the shaped mixture to obtain the freeze-dried formulation; or the freeze-dried formulation is prepared by the following steps: a) mixing the solvent, the triterpenoid saponin and the binding agent to form the primary preparation solution in the form of the solution, the emulsion or the suspension; or mixing the solvent, the triterpenoid saponin, the binding agent and the adjuvant to form the primary preparation solution in the form of the solution, the emulsion or the suspension, then fixing the volume and degassing; b) using the quantitative filling pump, and performing an instillation in a capsule, wherein an internal temperature of the capsule is below an eutectic point of the solution, then rapidly freezing the solution when the solution drops to obtain a frozen solution; c) freeze-drying the frozen solution to obtain the freeze-dried formulation.

11. The freeze-dried formulation according to claim 1, wherein the freeze-dried formulation is shaped to be in a shape of, a tablet shape, a spherical shape, ellipsoidal, or various characters, animals, plants, food, graphic identifiers or cartoon images.

12. A method of using the freeze-dried formulation according to claim 1, wherein the freeze-dried formulation is applied in daily chemicals, drugs, health care products and food.

13. A barrier package, wherein the freeze-dried formulation according to claim 1 is a content of the barrier package.

14. The barrier package of claim 13, wherein the barrier package is a double-aluminum, an aluminum plastic or a high-barrier high molecular blister package, a glass or metal container equipped with an aluminum plastic seal or a film seal, or a sealed container made of a metal.

15. A method of using triterpenoid saponin in a freeze-dried formulation, wherein the triterpenoid saponin is an acidic thermosensitive saponin, and the acidic thermosensitive saponin is the triterpenoid saponin having a structure with carboxyl, a heating temperature higher than 50° C. and a loss rate greater than 30%.

16. The method according to claim 15, wherein the triterpenoid saponin is purified and obtained from a saponin-containing crude drug a CO.sub.2 supercritical extraction process and a macroporous resin exchange adsorption process, comprising the following steps: 1) taking, cleaning and cutting up the saponin-containing crude drug, and adding 1-10 times water; 2) homogenizing and squeezing fragments of the saponin-containing crude drug at a low-temperature environment of 0° C.-50° C. to obtain a decoction and a dreg; 3) taking the dreg and extracting the dreg for 30-100 minutes at −30° C.-40° C. by the CO.sub.2 supercritical extraction process to obtain an extract, and discarding residues, wherein an entrainer is an ethyl alcohol; 4) taking the decoction and passing the decoction through a macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining a target product by a thin-layer chromatography, collecting a target segment, performing a concentration under a reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and performing a freeze-drying to obtain a first triterpenoid saponin; 5) taking the extract and passing the extract through the macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining the target product by the thin-layer chromatography, collecting the target segment, performing the concentration under the reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and freeze-drying to obtain a second triterpenoid saponin; and 6) separately using the first triterpenoid saponin and the second triterpenoid saponin or combining the first triterpenoid saponin and the second triterpenoid saponin to obtain a final triterpenoid saponin product.

17. The application according to claim 16, wherein the saponin-containing crude drug is one or a combination of one or more plants of American ginseng, ginseng, Panax notoginseng, Gynostemma pentaphyllum, Radix bupleuri, Codonopsis pilosula, Platycodon grandiflorum, Polygala tenuifolia, liquorice, Astragalus membranaceus or Phytolacca acinosa; the saponin crude drug is one or a combination of a root, a stem, a leaf or a flower of a plant.

18. A method for extracting triterpenoid saponin, comprising the following steps: 1) taking, cleaning and cutting up a saponin-containing crude drug, and adding 1-10 times water; 2) homogenizing and squeezing fragments of the saponin-containing crude drug at a low-temperature environment of 0° C.-50° C. to obtain a decoction and a dreg; 3) taking the dreg and extracting the dreg for 30-100 minutes at −30° C.-40° C. by a CO.sub.2 supercritical extraction process to obtain an extract, and discarding residues, wherein an entrainer is an ethyl alcohol; 4) taking the decoction and passing the decoction through a macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining a target product by a thin-layer chromatography, collecting a target segment, performing a concentration under a reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and freeze-drying to obtain a first triterpenoid saponin; 5) taking the extract and passing the extract through the macroporous resin column, washing with water to remove impurities, and eluting the triterpenoid saponin with 30%-100% ethyl alcohol, sampling and determining the target product by the thin-layer chromatography, collecting the target segment, performing the concentration under the reduced pressure at 0° C.-55° C. until there is no alcoholic taste, and performing freeze-drying to obtain a second triterpenoid saponin; and 6) separately using the first triterpenoid saponin and the second triterpenoid saponin or combining the first triterpenoid saponins and the second triterpenoid saponins to obtain a final triterpenoid saponin product.

19. The method of claim 18, wherein the saponin-containing crude drug is one or a combination of one or more plants of American ginseng, ginseng, Panax notoginseng, Gynostemma pentaphyllum, Radix bupleuri, Codonopsis pilosula, Platycodon grandiflorum, Polygala tenuifolia, liquorice, Astragalus membranaceus or Phytolacca acinosa; the saponin crude drug is one or a combination of a root, a stem, a leaf or a flower of a plant.

20. A preparation method of a freeze-dried formulation, wherein the freeze-dried formulation is prepared by the following steps: a) mixing a solvent, triterpenoid saponin and a binding agent to form a primary preparation solution in a form of a solution, an emulsion or a suspension; or mixing the solvent, the triterpenoid saponin, the binding agent and an adjuvant to form the primary preparation solution in the form of the solution, the emulsion or the suspension, then fixing a volume and degassing; b) using a quantitative filling pump to pump the primary prepared solution obtained in the step a) into a quantitative forming die for degassing; c) freeze-drying a side product obtained in the step b), and removing the solvent to obtain the freeze-dried formulation; or the freeze-dried formulation is prepared by the following steps: a) preparation of a soft ice mixture: mixing the triterpenoid saponin and the binding agent to obtain the primary preparation solution, or mixing the triterpenoid saponin, the binding agent, the solvent and the adjuvant to form the primary preparation solution, then freezing the primary preparation solution to obtain a soft ice mixture; b) mixing an active ingredient, the binding agent and the solvent to obtain the primary prepared solution; or mixing the active ingredient, the binding agent, the adjuvant and the solvent to obtain the primary prepared solution, then performing a low-temperature cryogenic grinding or a low-temperature spraying to obtain an ice powder; c) using the active ingredient and the adjuvant as a first dry powder; d) using the active ingredient as a second dry powder; e) mixing one or more of the soft ice mixture, the ice powder, the first dry powder or the second dry powder to obtain a mixture of all soft ice; f) performing a shaping with a certain die to obtain a shaped mixture, and performing a demolding; g) freeze-drying the shaped mixture to obtain the freeze-dried formulation; or the freeze-dried formulation is prepared by the following steps: a) mixing the solvent, the triterpenoid saponin and the binding agent to form the primary preparation solution in the form of the solution, the emulsion or the suspension; or mixing the solvent, the triterpenoid saponin, the binding agent and the adjuvant to form the primary preparation solution in the form of the solution, the emulsion or the suspension, then fixing the volume and degassing; b) using the quantitative filling pump, and performing a instillation in a capsule, wherein an internal temperature of the capsule is below an eutectic point of the solution, then rapidly freezing the solution when the solution drops to obtain a frozen solution; c) freeze-drying the frozen solution to obtain the freeze-dried formulation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0093] FIG. 1 shows a chromatogram of total ion current of malonyl ginsenoside HPLC-MS of an extract;

[0094] In the drawing: 1—malonyl ginsenoside Rg1, 2—malonyl ginsenoside Re, 3—malonyl ginsenoside Rf, 4—malonyl ginsenoside Rb1, 5—malonyl ginsenoside Rc, 6—malonyl ginsenoside Rb2, 7—malonyl ginsenoside Rb3, and 8—malonyl ginsenoside Rd.

DETAILED DESCRIPTION OF THE INVENTION

[0095] The present invention will be further described in details with reference to the detailed examples. It should be understood that the detailed examples described herein are merely used for explaining the present invention, but not intended for limiting thereto.

Example Groups

[0096] Group a Experiment:

[0097] A method for extracting triterpenoid saponin includes the following steps:

[0098] 1) root of ginseng or American ginseng, or “Rhizome” position (the portion of subterraneous stem) of ginseng or American ginseng was taken, cleaned and cut up, then 10 times pure water was added;

[0099] 2) fragments of the saponin-containing crude drug were homogenized and squeezed at a low-temperature environment of 0° C. to obtain a decoction A and a dreg B;

[0100] 3) the dreg B was taken and extracted for 30 min at −30° C. by a CO2 supercritical extraction process to obtain an extract C, and residues were discarded, where an entrainer was ethyl alcohol;

[0101] 4) the decoction A was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 30% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected and concentrated under reduced pressure at 0° C. until there was no alcoholic taste, and freeze-dried to obtain malonyl ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, Rb3 and Rd;

[0102] 5) the extract C was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 30% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected, and concentrated under reduced pressure at 0° C. until there was no alcoholic taste, and freeze-dried to obtain malonyl ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, Rb3 and Rd.

[0103] The malonyl ginsenosides obtained in the steps 4) and 5) were mixed to obtain a chromatogram of total ion current of malonyl ginsenoside HPLC-MS as shown in FIG. 1.

[0104] Malonyl ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, Rb3 and Rd may be also obtained by extracting the root, stem leaf, flower or any mixture of Panax notoginseng using the same technology. In the group A experiment, the malonyl ginsenosides (including Rg1, Re, Rf, Rb1, Rc, Rb2, Rb3 and Rd) at the root of ginseng or American ginseng, or “Rhizome” position of ginseng or American ginseng had an extraction ratio of 80-83%.

[0105] Group B Experiment:

[0106] A method for extracting triterpenoid saponin includes the following steps:

[0107] 1) the root, stem leaf, flower or any mixture of Gynostemma pentaphyllum was taken, cleaned and cut up, then 5 times pure water was added; 1

[0108] 2) fragments of the saponin-containing crude drug were homogenized and squeezed at a low-temperature environment of 50° C. to obtain a decoction A and a dreg B;

[0109] 3) the dreg B was taken and extracted for 100 min at −40° C. by a CO2 supercritical extraction process to obtain an extract C, and residues were discarded, where an entrainer was ethyl alcohol;

[0110] 4) the decoction A was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 100% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected and concentrated under reduced pressure at 55° C. until there was no alcoholic taste, and freeze-dried to obtain Gynostemma pentaphyllum saponin;

[0111] 5) the extract C was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 100% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected, and concentrated under reduced pressure at 55° C. until there was no alcoholic taste, and freeze-dried to obtain Gynostemma pentaphyllum saponin.

[0112] In the group B experiment, the Gynostemma pentaphyllum saponin in the root, stem leaf, flower or any mixture of Gynostemma pentaphyllum had an extraction ratio of 81-85%.

[0113] Gynostemma pentaphyllum saponin obtained in the group B experiment was verified by using HPLC-MS to obtain a chromatogram of total ion current which was consistent with the standard chromatogram reported by relevant literature.

[0114] Group C Experiment:

[0115] A method for extracting triterpenoid saponin includes the following steps:

[0116] 1) the root, stem leaf, flower or any mixture of Astragalus membranaceus was taken, cleaned and cut up, then 5 times pure water was added;

[0117] 2) fragments of the saponin-containing crude drug were homogenized and squeezed at a low-temperature environment of 50° C. to obtain a decoction A and a dreg B;

[0118] 3) the dreg B was taken and extracted for 60 min at 20° C. by a CO2 supercritical extraction process to obtain an extract C, and residues were discarded, where an entrainer was ethyl alcohol;

[0119] 4) the decoction A was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 60% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected and concentrated under reduced pressure at 25° C. until there was no alcoholic taste, and freeze-dried to obtain Astragalus lanuginosus saponins (X, XIV, XV, and XVI);

[0120] 5) the extract C was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 60% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected, and concentrated under reduced pressure at 25° C. until there was no alcoholic taste, and freeze-dried to obtain Astragalus lanuginosus saponins (X, XIV, XV, and XVI);

[0121] In the group C experiment, the Astragalus lanuginosus saponins (X, XIV, XV, and XVI) in the root, stem leaf, flower or any mixture of Astragalus membranaceus had an extraction ratio of 85-90%.

[0122] Astragalus lanuginosus saponins (X, XIV, XV, and XVI) obtained in the group C experiment was verified by using HPLC-MS to obtain a chromatogram of total ion current which was consistent with the standard chromatogram reported by relevant literature.

[0123] Group D Experiment:

[0124] A method for extracting triterpenoid saponin includes the following steps:

[0125] 1) the root, stem leaf, flower or any mixture of Codonopsis pilosula was taken, cleaned and cut up, then 1-fold pure water was added;

[0126] 2) fragments of the saponin-containing crude drug were homogenized and squeezed at a low-temperature environment of 20° C. to obtain a decoction A and a dreg B;

[0127] 3) the dreg B was taken and extracted for 50 min at 30° C. by a CO2 supercritical extraction process to obtain an extract C, and residues were discarded, where an entrainer was ethyl alcohol;

[0128] 4) the decoction A was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 40% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected and concentrated under reduced pressure at 40° C. until there was no alcoholic taste, and freeze-dried to obtain Codonopsis pilosula saponin A-G, and Aster tataricus saponin Hb, and Codonopsis lanceolata saponin I-III;

[0129] 5) the extract C was taken and subjected to passing through a macroporous resin column, washed with water to remove impurities, and triterpenoid saponin was eluted with 40% ethyl alcohol, sampling was performed and a target product was determined by thin-layer chromatography, a target segment was collected, and concentrated under reduced pressure at 40° C. until there was no alcoholic taste, and freeze-dried to obtain Codonopsis pilosula saponin A-G, and Aster tataricus saponin Hb, and Codonopsis lanceolata saponin I-III.

[0130] In the group D experiment, the Codonopsis pilosula saponin A-G, and Aster tataricus saponin Hb, and Codonopsis lanceolata saponin I-III in the root, stem leaf, flower or any mixture of Codonopsis pilosula had an extraction ratio of 82-86%.

[0131] Codonopsis pilosula saponin A-G, and Aster tataricus saponin Hb, and Codonopsis lanceolata saponin I-III obtained in the group C experiment were verified by using HPLC-MS to obtain a chromatogram of total ion current which was consistent with the standard chromatogram reported by relevant literature.

Example 1

[0132] A freeze-dried formulation was provided, and the freeze-dried formulation served as an oral formulation for use; triterpenoid saponin in the freeze-dried formulation was malonyl ginsenoside Re having a percentage content of 10%, and the binding agent was Aureobasidium pullulans polysaccharide having a percentage content of 3%.

[0133] The freeze-dried formulation was prepared by the following steps:

[0134] a) water, malonyl ginsenoside Re and Aureobasidium pullulans polysaccharide were mixed to form a primary prepared solution, then the volume of the solution was fixed and the solution was degassed;

[0135] b) the primary prepared solution obtained in the step a) was pumped into a 1 ml sheet-like forming die by using a quantitative filling pump for degassing;

[0136] c) a side product obtained in the step b) was freeze-dried, and the solvent was removed to obtain an oral freeze-dried formulation.

[0137] The oral formulation had hypoglycemic functions and had a disintegration time within 3 s; the dissolving-out amount may be up to 95% within a dissolution rate of 30 s. In this example, when malonyl ginsenoside Re was replaced with other types of malonyl ginsenosides, the obtained oral formulation had the same properties; the disintegration time was within 3 s, and the dissolving-out amount may be up to 95% within a dissolution rate of 30 s.

[0138] In this example, when the formula was modified as follows: the content of malonyl ginsenoside Re was 0.004%, and the content of Aureobasidium pullulans polysaccharide was 0.01%, or the content of malonyl ginsenoside Re was 50%, and the content of Aureobasidium pullulans polysaccharide was 50%, the oral formulation having the same effect may be still obtained.

Example 2

[0139] A freeze-dried formulation was provided, and the freeze-dried formulation served as an oral formulation for use; triterpenoid saponin in the freeze-dried formulation was 10% malonyl ginsenoside Rg1 and 20% malonyl ginsenoside Rb1, 30% in total; the binding agent was guar gum (percentage content was 0.5%) and butanediol (percentage content was 15%); the adjuvant was a framework propping agent (modified cassava starch) with a percentage content of 5%. The oral formulation had a disintegration time within 3 s; the dissolving-out amount may be up to 95% within a dissolution rate of 30 s.

[0140] The freeze-dried formulation was prepared by the following steps:

[0141] a) preparation of a soft ice mixture: malonyl ginsenoside Rg1, malonyl ginsenoside Rb1, guar gum and butanediol were added water and mixed according to a preset ratio to obtain a primary prepared solution, then the primary prepared solution was frozen to obtain a soft ice mixture 1;

[0142] b) the soft ice mixture 1 was shaped by a spherical die (specification: 0.6 ml) to obtain a shaped mixture 2, and demolding was performed;

[0143] g) the mixture 2 was freeze-dried to obtain a freeze-dried formulation;

[0144] the oral formulation had hypoglycemic functions and had a disintegration time within 3 s; the dissolving-out amount may be up to 95% within a dissolution rate of 30 s.

[0145] In this example, when the formula was modified as follows: triterpenoid saponin was 0.002% malonyl ginsenoside Rg1 and 0.002% malonyl ginsenoside Rb1, and guar gum (percentage content was 0.005%) and butanediol (percentage content was 0.005%); or triterpenoid saponin was 20% malonyl ginsenoside Rg1 and 10% malonyl ginsenoside Rb1, and guar gum (percentage content was 20%) and butanediol (percentage content was 15%), the oral formulation having the same properties may be still obtained.

Example 3

[0146] A freeze-dried formulation was provided, and the freeze-dried formulation served as an oral formulation for use; triterpenoid saponin in the freeze-dried formulation was 30% platycodin E, and the binding agent was modified starch (percentage content was 30%); the adjuvant was an antioxidant (vitamin C having a percentage content of 7%), and the active ingredient was ginseng polysaccharide (percentage content was 5%). The oral formulation had a disintegration time within 3 s; the dissolving-out amount may be up to 90% within a dissolution rate of 50 s.

[0147] The freeze-dried formulation was prepared by the following steps:

[0148] a) preparation of a soft ice mixture: platycodin E, modified starch, vitamin C and water were mixed according to a preset ratio to obtain a primary prepared solution, then the primary prepared solution was frozen to obtain a soft ice mixture;

[0149] b) ginseng polysaccharide was used as a dry powder;

[0150] c) the soft ice mixture, and the ice powder were mixed to obtain a mixture of all soft ice;

[0151] d) the soft ice mixture was shaped with an ellipsoidal die to obtain a shaped mixture, and demolding was performed;

[0152] e) the mixture was freeze-dried to obtain an oral formulation.

[0153] The oral formulation had cardiovascular nursing functions and a disintegration time within 3 s; the dissolving-out amount may be up to 93% within a dissolution rate of 30 s.

[0154] In this example, when the formula was modified as follows: triterpenoid saponin was 10% platycodin E and modified starch (percentage content was 1%); the adjuvant was an antioxidant (vitamin C having a percentage content of 0.01%), the active ingredient was ginseng polysaccharide (percentage content was 50%), or the formula was modified as follows: triterpenoid saponin was 20% platycodin E and modified starch (percentage content was 10%); the adjuvant was an antioxidant (vitamin C having a percentage content of 50%), the active ingredient was ginseng polysaccharide (percentage content was 0.01%), the oral formulation having the same properties may be still obtained.

[0155] Based on Examples 1-3, the type and content of triterpenoid saponin, the binding agent, the adjuvant or the active ingredients are changed within the scope of the present invention, which may achieve that the oral formulation has a disintegration time less than 3 s and a dissolving-out amount within 1 min greater than 90%.

Example 4

[0156] A freeze-dried formulation was provided, and the freeze-dried formulation served as a solid beverage (granules or fast dissolving tablets were available) for use, and had lipid-lowering functions; triterpenoid saponin in the freeze-dried formulation was Codonopsis pilosula saponin A (percentage content was 70%), the binding agent was sodium hyaluronate (percentage content was 10%). The solid beverage had a disintegration time of 8 s, a dissolution time less than 12 s, and a dissolving-out amount greater than 90% within 30 s.

[0157] The freeze-dried formulation was prepared by the following steps:

[0158] a) water, Codonopsis pilosula saponin A or polyamino acid were mixed according to a preset ratio to form a primary prepared solution, then volume of the solution was fixed and the solution was degassed;

[0159] b) the primary prepared solution obtained in the step a) was pumped into a 1 ml sheet-like forming die by using a quantitative filling pump for degassing;

[0160] c) a side product obtained in the step b) was freeze-dried, and the solvent was removed to obtain a solid beverage.

[0161] Based on the example, when the formula was modified as follows: triterpenoid saponin was Codonopsis pilosula saponin A (percentage content was 50%), the binding agent was sodium hyaluronate (percentage content was 20%), or the formula was modified as follows: triterpenoid saponin was Codonopsis pilosula saponin A (percentage content was 95%), the binding agent was sodium hyaluronate (percentage content was 0.01%), the solid beverage having the same properties may be still obtained.

Example 5

[0162] A freeze-dried formulation was provided, and the freeze-dried formulation served as a solid beverage (granules or fast dissolving tablets were available) for use, and had lipid-lowering functions; triterpenoid saponin in the freeze-dried formulation was Gynostemma pentaphyllum saponin (percentage content was 95%), the binding agent was polyamino acid (percentage content was 1%); the adjuvant was a pH regulator (citric acid having a percentage content of 1%), and an essence (a coffee flavor having a percentage content of 1%). The solid beverage had a disintegration time of 6 s, a dissolving time less than 10 s, and the dissolving-out amount was greater than 95% within 30 min.

[0163] The freeze-dried formulation was prepared by the following steps:

[0164] a) preparation of a soft ice mixture: Gynostemma pentaphyllum saponin, polyamino acid, pH regulator and essence were mixed with water according to a preset ratio to obtain a primary prepared solution, then the primary prepared solution was frozen to obtain a soft ice mixture 1;

[0165] b) the soft ice mixture 1 was shaped by a cartoon-image die (specification: 1 ml) to obtain a shaped mixture 2, and demolding was performed;

[0166] c) the mixture 2 was freeze-dried to obtain a freeze-dried formulation;

[0167] based on the example, when the formula was modified as follows: triterpenoid saponin was Gynostemma pentaphyllum saponin (percentage content was 85%), the binding agent was polyamino acid (percentage content was 0.01%), or the formula was modified as follows: triterpenoid saponin was Gynostemma pentaphyllum saponin (percentage content was 50%), the binding agent was polyamino acid (percentage content was 20%), the solid beverage having the same properties may be still obtained.

Example 6

[0168] A freeze-dried formulation was provided, and the freeze-dried formulation served as a solid beverage (granules or fast dissolving tablets were available) for use, and had antifatigue functions; triterpenoid saponin in the freeze-dried formulation was Aster tataricus saponin Hb (percentage content was 80%), the binding agent was an inorganic matter gel (percentage content was 10%); the adjuvant was sodium carboxymethyl starch (percentage content was 2%), and the active ingredient was arginine (percentage content was 1%) and pilose antler polypeptide (percentage content was 1%). The solid beverage had a disintegration time of 5 s, a dissolution time less than 12 s, and a dissolving-out amount greater than 95% within 50 s.

[0169] The freeze-dried formulation was prepared by the following steps:

[0170] a) preparation of a soft ice mixture: Aster tataricus saponin Hb, sodium carboxymethyl starch and water were mixed according to a preset ratio to obtain a primary prepared solution, then the primary prepared solution was frozen to obtain a soft ice mixture;

[0171] b) arginine, pilose antler polypeptide and effervescing agent served as a dry powder;

[0172] c) the soft ice mixture, and the ice powder were mixed to obtain a mixture of all soft ice;

[0173] d) the soft ice mixture was shaped with a tablet-shaped die to obtain a shaped mixture, and demolding was performed;

[0174] e) the mixture was freeze-dried to obtain a solid beverage.

[0175] Based on the example, when the formula was modified as follows: Aster tataricus saponin Hb (percentage content was 70%), the binding agent was an inorganic matter gel (percentage content was 10%), or the formula was modified as follows: Aster tataricus saponin Hb (percentage content was 80%), the binding agent was inorganic matter gel (percentage content was 0.01%), the solid beverage having the same properties may be still obtained.

[0176] Based on Examples 4-6, the type and content of triterpenoid saponin, the binding agent, the adjuvant or the active ingredient were changed within the scope of the present invention, which may achieve that the solid beverage had a disintegration time less than 10 s, a dissolution time less than 15 s, and a dissolving-out amount greater than 90% within 1 min.

Example 7

[0177] A freeze-dried formulation was provided, and the freeze-dried formulation served as a non-washing skin care product (specifically an anti-mature skin whitening essence) for use, and had anti-mature skin and whitening functions; triterpenoid saponin in the freeze-dried formulation was Codonopsis lanceolata saponin I (percentage content was 0.1%), the binding agent was an cellulose ether (percentage content was 2%); the adjuvant was a skin penetration enhancer (percentage content was 0.2%) and a skin feeling improver (percentage content was 5%), and the active ingredient was steroid saponin (percentage content was 0.1%) and hydrolyzed pearl (percentage content was 1%). The non-washing skin care product had a disintegration time of 5 s, a dissolution time less than 12 s, and a dissolving-out amount greater than 95% within 50 s.

[0178] The freeze-dried formulation was prepared by the following steps:

[0179] a) preparation of a soft ice mixture: Codonopsis lanceolata saponin I, cellulose ether and water were mixed according to a preset ratio to obtain a primary prepared solution, then the primary prepared solution was frozen to obtain a soft ice mixture;

[0180] b) the skin penetration enhancer, the skin feeling improver, steroid saponin and hydrolyzed pearl served as a dry powder;

[0181] c) the soft ice mixture, and the ice powder were mixed to obtain a mixture of all soft ice;

[0182] d) the soft ice mixture was shaped with a tablet-shaped die to obtain a shaped mixture, and demolding was performed;

[0183] e) the mixture was freeze-dried to obtain a non-washing skin care product.

[0184] During use procedure, the non-washing skin care product was dissolved by 1-3 ml water, astringent or essence to obtain an essence, a cream or a body lotion applied on the skin surface of the corresponding position of a body, thus achieving the anti-mature skin and whitening efficacy.

[0185] Based on the example, when the formula was modified as follows: triterpenoid saponin was Codonopsis lanceolata saponin I (percentage content was 0.004%), and the binding agent was an cellulose ether (percentage content was 0.01%); or triterpenoid saponin was Codonopsis lanceolata saponin I (percentage content was 30%), and the binding agent was an cellulose ether (percentage content was 50%); or triterpenoid saponin was Codonopsis lanceolata saponin I (percentage content was 10%), and the binding agent was an cellulose ether (percentage content was 10%); or triterpenoid saponin was Codonopsis lanceolata saponin I (percentage content was 0.1%), and the binding agent was an cellulose ether (percentage content was 3%), the non-washing skin care product having the same properties may be still obtained.

[0186] Based on Example 7, the type and content of triterpenoid saponin, the binding agent, the adjuvant or the active ingredient were changed within the scope of the present invention, which may achieve that the freeze-dried formulation had a disintegration time less than 5 s, a dissolution time less than 12 s, and a dissolving-out amount greater than 95% within 50 s.

[0187] The package in the above Examples 1-3 may be a double-aluminum, aluminum plastic or high-barrier high molecular blister package; and the package in Examples 4-6 may be a glass or metal container equipped with an aluminum plastic seal or a film seal. The package in the Example 7 may be a pop can made of metal.

[0188] What is stated above are merely preferred embodiments of the present invention; it should be indicated that a person skilled in the art may make several improvements and embellishments within the principle of the present invention; these improvements and embellishments shall be also regarded within the protection scope of the present invention.