COMPOSITION AND THE USE THEREOF

Abstract

The present invention relates to the pharmaceutical field, particularly to a composition and the use thereof. The composition serves to lower uric acid through the combination of several traditional Chinese medicines of Smilacis Glabra Rhizoma, Cichorii Herba, Plantaginis Herba and Coicis semen. On the basis of the combination of the traditional Chinese medicines described above, the addition of Alismatis Rhizoma is able to improve the effect of lowering uric acid more significantly. Further, on the basis of the combination of the traditional Chinese medicines described above, the addition of tuna was able to improve the effect of lowering uric acid more significantly. A comprehensive analysis of the experimental results described above indicates that the compositions provided in the present invention have a significant effect of lowering uric acid.

Claims

1. A composition, characterized in comprising Smilacis Glabra Rhizoma, Cichorii Herba, Plantaginis Herba and Coicis semen.

2. The composition according to claim 1, characterized in comprising the following components in parts by weight, TABLE-US-00012 Smilacis Glabra Rhizoma 3 to 29 parts Cichorii Herba 3 to 16 parts Plantaginis Herba 3 to 16 parts Coicis semen 3 to 21 parts.

3. The composition according to claim 1, characterized in further comprising Alismatis Rhizoma.

4. The composition according to claim 3, characterized in comprising the following components in parts by weight, TABLE-US-00013 Smilacis Glabra Rhizoma 3 to 29 parts Cichorii Herba 3 to 16 parts Plantaginis Herba 3 to 16 parts Coicis semen 3 to 21 parts Alismatis Rhizoma 1 to 10 parts.

5. The composition according to claim 1, characterized in further comprising tuna.

6. The composition according to claim 5, characterized in comprising the following components in parts by weight, TABLE-US-00014 Smilacis Glabra Rhizoma 3 to 29 parts Cichorii Herba 3 to 16 parts Plantaginis Herba 3 to 16 parts Coicis semen 3 to 21 parts Tuna 0.1 to 5 parts.

7. The composition according to claim 5, characterized in comprising the following components in parts by weight, TABLE-US-00015 Smilacis Glabra Rhizoma 3 to 29 parts Cichorii Herba 3 to 16 parts Plantaginis Herba 3 to 16 parts Coicis semen 3 to 21 parts Alismatis Rhizoma 1 to 10 parts Tuna 0.1 to 5 parts

8. The composition according to claim 1, characterized in further comprising Pueraia Lobata Radix.

9. The composition according to claim 8, characterized in comprising the following components in parts by weight, TABLE-US-00016 Smilacis Glabra Rhizoma 3 to 29 parts Cichorii Herba 3 to 16 parts Plantaginis Herba 3 to 16 parts Coicis semen 3 to 21 parts Alismatis Rhizoma 1 to 10 parts Tuna 0.1 to 5 parts Pueraia Lobata Radix 3 to 11 parts

10. A method for reducing uric acid by administering to a subject in need thereof a composition according to claim 1.

Description

DETAILED DESCRIPTION

[0028] The present invention discloses a composition and the use thereof, which could be implemented with suitable modifications of the process parameters by those skilled in the art in light of the present disclosure. It is of particular note that all the similar alterations and modifications are clear to those skilled in the art and deemed to be included in the present invention. Methods and applications of the present invention have been described by the preferred examples, and it is obvious that those in related art are able to make changes or appropriate alternations and the combinations thereof to the methods and applications described herein to implement and apply the inventive technology without departing from the disclosure, spirit and scope of the present invention.

[0029] The present invention provides a composition and the use thereof. The components and reagents are all commercially available. A variety of dosage forms in terms of pharmaceutics such as oral liquid, capsules, tablets, powders or granules and the like may be produced by conventional formulation process (such as water extraction or alcohol extraction, etc.) without limitations here.

[0030] The description of the disclosed examples enables those skilled in the art to implement or make use of the present invention. Various modifications to these examples will be apparent to those skilled in the art, and the general principles defined herein may be realized in other examples without departing from the spirit or scope of the present invention. Accordingly, the present invention will not be limited to these examples illustrated herein, but consistent with the widest range in accordance with the principles and novel features disclosed herein.

[0031] The present invention is further explained below in combination with the Examples:

Example 1

The Composition

[0032] It is obtained by weighing precisely and mixing 29 g of Smilacis Glabra Rhizoma, 9 g of Cichorii Herba, 3 g of Plantaginis Herba and 12 g of Coicis semen.

Example 2

The Composition

[0033] It is obtained by weighing precisely and mixing 3 g of Smilacis Glabra Rhizoma, 16 g of Cichorii Herba, 9 g of Plantaginis Herba and 21 g of Coicis semen.

Example 3

The Composition

[0034] It is obtained by weighing precisely and mixing 16 g of Smilacis Glabra Rhizoma, 3 g of Cichorii Herba, 16 g of Plantaginis Herba and 3 g of Coicis semen.

[0035] Example 4

The Composition

[0036] It is obtained by weighing precisely and mixing 29 g of Smilacis Glabra Rhizoma, 9 g of Cichorii Herba, 3 g of Plantaginis Herba, 12 g of Coicis semen and 1 g of Alismatis Rhizoma.

[0037] Example 5

The Composition

[0038] It is obtained by weighing precisely and mixing 3 g of Smilacis Glabra Rhizoma, 16 g of Cichorii Herba, 9 g of Plantaginis Herba, 21 g of Coicis semen and 6g of Alismatis Rhizoma.

[0039] Example 6

The Composition

[0040] It is obtained by weighing precisely and mixing 16 g of Smilacis Glabra Rhizoma, 3 g of Cichorii Herba, 16 g of Plantaginis Herba, 3 g of Coicis semen and 10 g of Alismatis Rhizoma.

Example 7

The Composition

[0041] It is obtained by weighing precisely and mixing 29 g of Smilacis Glabra Rhizoma, 9 g of Cichorii Herba, 3 g of Plantaginis Herba, 12 g of Coicis semen and 1 g of Alismatis Rhizoma.

Example 8

The Composition

[0042] It is obtained by weighing precisely and mixing 3 g of Smilacis Glabra Rhizoma, 16 g of Cichorii Herba, 9 g of Plantaginis Herba, 21 g of Coicis semen and 6 g of Alismatis Rhizoma.

Example 9

The Composition

[0043] It is obtained by weighing precisely and mixing 16 g of Smilacis Glabra Rhizoma, 3 g of Cichorii Herba, 16 g of Plantaginis Herba, 3 g of Coicis semen and 10 g of Alismatis Rhizoma.

Example 10

The Composition

[0044] It is obtained by weighing precisely and mixing 29 g of Smilacis Glabra Rhizoma, 9 g of Cichorii Herba, 3 g of Plantaginis Herba, 12 g of Coicis semen, 1 g of Alismatis Rhizoma and 2.5 parts of tuna.

Example 11 The Composition

[0045] It is obtained by weighing precisely and mixin3 g of Smilacis Glabra Rhizoma, 16 g of Cichorii Herba, 9 g of Plantaginis Herba, 21 g of Coicis semen, 6 g of Alismatis Rhizoma and 5 parts of tuna g.

Example 12

The Composition

[0046] It is obtained by weighing precisely and mixing 16 g of Smilacis Glabra Rhizoma, 3 g of Cichorii Herba, 16 g of Plantaginis Herba, 3 g of Coicis semen, 10 g of Alismatis Rhizoma and 0.1 parts of tuna.

Example 13

The Composition

[0047] 20 g of Smilacis Glabra Rhizoma, 15 g of Cichorii Herba, 8 g of Plantaginis Herba, 12 g of Coicis semen, 8 g of Pueraia Lobata Radix, 3 g of Alismatis Rhizoma and 0.5 g of tuna extract were weighed precisely.

[0048] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 30 min at 80 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 50 C. for a duration of 7.0 h. Pepsin was employed in the enzymatic hydrolysis in an amount of 2.5% by weight of the pretreated tuna.

[0049] Next is the inactivation of the enzymes at the temperature of 90 C. for a duration of 13 min.

[0050] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 30% at 0.03 MPa and 74 C. under vacuum and dried.

[0051] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time, which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extractedfor 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 80 C. in a vacuum of 0.03Mpa, and concentrated to a solids content of 24%; the oral liquid products were obtained by canning after the addition of auxiliaries.

Example 14

[0052] 8 g of Smilacis Glabra Rhizoma, 15 g of Cichorii Herba, 15 g of Plantaginis Herba, 10 g of Coicis semen, 10 g of Pueraia Lobata Radix, 4 g of Alismatis Rhizoma and 4.0 g of tuna extract were weighed precisely.

[0053] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 25 min at 100 C. as pretreatment, and enzymatic hydrolyzing at a temperature of 60 C. for a duration of 8.0 h. Trypsin was employed in the enzymatic hydrolysis in an amount of 2.0% by weight of the pretreated tuna.

[0054] Next was the inactivation of the enzymes at the temperature of 100 C. for a duration of 14 min.

[0055] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 45% at 0.08 MPa and 66 C. under vacuum and dried.

[0056] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 81 C. in a vacuum of 0.08 Mpa, and concentrated to a solids content of 26%; the capsule products were obtained with the addition of auxiliaries according to the conventional process for producing capsules.

Example 15

[0057] 20 g of Smilacis Glabra Rhizoma, 15 g of Cichorii Herba, 13 g of Plantaginis Herba, 10 g of Coicis semen, 8 g of Pueraia Lobata Radix, 3 g of Alismatis Rhizoma and 0.4 g of tuna extract were weighed precisely.

[0058] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 20 min at 90 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 55 C. for a duration of 6.0 h. Proteolytic enzymes were employed in the enzymatic hydrolysis in an amount of 1.5% by weight of the pretreated tuna.

[0059] Next was the inactivation of the enzymes at the temperature of 95 C. for a duration of 16 min.

[0060] The supernatant was obtained by centrifugation, which is concentrated to a solids content of 35% at 0.05 MPa and 75 C. under vacuum and dried.

[0061] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time, which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 72 C. in a vacuum of 0.05Mpa, and concentrated to a solids content of 28%; the tablet products were obtained with the addition of auxiliaries according to the conventional process for producing tablets.

Example 16

[0062] 18 g of Smilacis Glabra Rhizoma, 13 g of Cichorii Herba, 10 g of Plantaginis Herba, 17 g of Coicis semen, 7 g of Pueraia Lobata Radix, 3 g of Alismatis Rhizoma and 0.3 g of tuna extract were weighed precisely.

[0063] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 15 min at 85 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 52 C. for a duration of 4.0 h. Neutral protease was employed in the enzymatic hydrolysis in an amount of 1.0% by weight of the pretreated tuna.

[0064] Next was the inactivation of the enzymes at the temperature of 98 C. for a duration of 18 min.

[0065] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 40% at 0.04 MPa and 65 C. under vacuum and dried.

[0066] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time, which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 68 C. in a vacuum of 0.04 Mpa, and concentrated to a solids content of 22%; the pill products were obtained with the addition of auxiliaries according to the conventional process for producing pills.

Example 17

[0067] 15 g of Smilacis Glabra Rhizoma, 10 g of Cichorii Herba, 8 g of Plantaginis Herba, 15 g of Coicis semen, 5 g of Pueraia Lobata Radix, 2 g of Alismatis Rhizoma and 1.0 g of tuna extract were weighed precisely.

[0068] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 10 min at 95 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 58 C. for a duration of 5.0 h. Flavourzyme ws employed in the enzymatic hydrolysis in an amount of 0.5% by weight of the pretreated tuna.

[0069] Next was the inactivation of the enzymes at the temperature of 92 C. for a duration of 12 min.

[0070] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 36% at 0.06 MPa and 70 C. under vacuum and dried.

[0071] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time, which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 70 C. in a vacuum of 0.06 Mpa, and concentrated to a solids content of 25%; the pulvis products were obtained with the addition of auxiliaries according to the conventional process for producing pulvis.

Example 18

[0072] 25 g of Smilacis Glabra Rhizoma, 12 g of Cichorii Herba, 12 g of Plantaginis Herba, 15 g of Coicis semen, 6 g of Pueraia Lobata Radix, 3 g of Alismatis Rhizoma and 0.5 g of tuna extract were weighed precisely.

[0073] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 5 min at 100 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 56 C. for a duration of 9.0 h. Alcalase protease was employed in the enzymatic hydrolysis in an amount of 3.0% by weight of the pretreated tuna.

[0074] Next was the inactivation of the enzymes at the temperature of 94 C. for a duration of 10 min.

[0075] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 42% at 0.07 MPa and 80 C. under vacuum and dried.

[0076] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 65 C. in a vacuum of 0.07 Mpa, and concentrated to a solids content of 30%; the powder products were obtained with the addition of auxiliaries according to the conventional process for producing powder.

Example 19

[0077] 15 g of Smilacis Glabra Rhizoma, 8 g of Cichorii Herba, 10 g of Plantaginis Herba, 18 g of Coicis semen, 8 g of Pueraia Lobata Radix, 4 g of Alismatis Rhizoma and 2.0 g of tuna extract were weighed precisely.

[0078] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 30 min at 80 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 54 C. for a duration of 3.0 h. Protease which is preferably selected from the group consisting of acidic protease, papain, trypsin, proteolytic enzyme, neutral protease, flavourzyme and Alcalase protease was employed in the enzymatic hydrolysis in an amount of 0.5%-3.0% by weight of the pretreated tuna.

[0079] Next was the inactivation of the enzymes at the temperature of 96 C. for a duration of 20 min.

[0080] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 38% at 0.08 MPa and 60 C. under vacuum and dried.

[0081] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time, which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 65 C. in a vacuum of 0.05Mpa, and concentrated to a solids content of 20%; the granule products were obtained with the addition of auxiliaries according to the conventional process for producing granules.

Example 20

The Composition

[0082] 29 g of Smilacis Glabra Rhizoma, 3 g of Cichorii Herba, 3 g of Plantaginis Herba, 3 g of Coicis semen, 1 g of Alismatis Rhizoma, 5 g of tuna extract and 11 g of Pueraia Lobata Radix were weighed precisely.

[0083] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 5 min at 80 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 60 C. for a duration of 3.0 h. Acidic protease was employed in the enzymatic hydrolysis in an amount of 0.5% by weight of the pretreated tuna.

[0084] Next was the inactivation of the enzymes at the temperature of 100 C. for a duration of 10 min

[0085] The supernatant was obtained by centrifugation, which was concentrated to a solids content of 45% at 0.08 MPa and 68 C. under vacuum and dried.

[0086] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 65 C. in a vacuum of 0.08 Mpa, and concentrated to a solids content of 20%; the food products were obtained with the addition of auxiliaries according to the conventional process for producing food.

Example 21

The Composition

[0087] 3 g of Smilacis Glabra Rhizoma, 16 g of Cichorii Herba, 16 g of Plantaginis Herba, 21 g of Coicis semen, 10 g of Alismatis Rhizoma, 0.1 g of tuna extract and 3 g of Pueraia Lobata Radix were weighed precisely.

[0088] The method for the preparation of the tuna extract includes taking and grinding the tuna, heating for 30 min at 100 C. as pretreatment, and enzymatic hydrolyzing at the temperature of 50 C. for a duration of 9.0 h. Papain wass employed in the enzymatic hydrolysis in an amount of 3.0% by weight of the pretreated tuna.

[0089] Next wass the inactivation of the enzymes at the temperature of 90 C. for a duration of 20 min.

[0090] The supernatant wass obtained by centrifugation, which is concentrated to a solids content of 30% at 0.03 MPa and 80 C. under vacuum and dried.

[0091] The raw materials described above were extracted twice, with the addition of water in an amount of 12 times at the first time which was boiling extracted for 1.5 hours, and the addition of water in an amount of 8 times at the second time, which was boiling extracted for 1 hour, followed by the combination of the extracts from the above two extractions; the extracts were filtered at the temperature of 85 C. in a vacuum of 0.03Mpa, and concentrated to a solids content of 30%; the health products were obtained with the addition of auxiliaries according to the conventional process for producing health products.

Example 22

[0092] 105 SPF grade SD rats, all of which are male and have a body weight of 20020 (g), provided by Beijing Vital River Laboratory Animal Technology Co., Ltd. (license number: SOCK (Beijing) 2012-0001) were taken. Potassium oxonate, Jinan Chenghuishuangda Chemical Co., Ltd. product with the batch number of 12042001, was prepared with 0.1% CMC-Na into a suspension of a concentration of 0.15 g/ml in an amount for 3 d each time and the stock was stored at 4 C. Allopurinol, Tokyo chemical industry Co. Ltd. product with the batch number of MYRYA-IR, was prepared with 0.1% CMC-Na into a suspension of a concentration of 2.7 g/ml in an amount for 3 d each time and the stock was stored at 4 C. . Uric acid and urea nitrogen test kit were provided by Centronic GmbH company in German, with the batch numbers of UF03121HH6G and UF01121GG66G respectively, and creatinine test kit was provided by Shanghai Lanyi Technology Co. Ltd. with the batch number of R102APA.

[0093] SD rats were adapted for 5 days in the experimental environment, and randomly divided by body weight into normal control group, model group, allopurinol group, Sample 1 (the composition of Chinese herbal medicines and tuna extract prepared in Example 18) high-dose group and low-dose group and Sample 2 (the composition of Chinese herbal medicines prepared in Example 18 excluding tuna extract) high-dose group and low-dose group. According to the clinical dose, the intragastric doses of Samples 1 and 2 were 5 times larger (0.2 ml/100 g) and 30 times larger (1.25 ml/100 g) than the recommended amount for human body for the low-dose groups and high-dose groups, respectively.

[0094] The same volume of drinking water was intragastrically administered to the normal control group every day, and the potassium oxonate was intragastrically administered to each of the rest groups of rats every morning at 1.5 g.Math.kg.sup.1.Math.d.sup.1; the same volume of physiological saline was intragastrically administered to the model group in the afternoon; the allopurinol was intragastrically administered to the allopurinol group at 27 mg.Math.kg.sup.1.Math.d.sup.1 in the afternoon; the samples to be tested of different doses diluted to the same volume were intragastrically administered to the Sample 1 of high-dose and low-dose groups and the Sample 2 of high-dose and low-dose groups in the afternoon.

[0095] Modeling principle: the rats were intragastrically administered with the chemical uricase inhibitor, potassium oxonate to inhibit the uricase activity in the rats, which make the uric acid in their body unable to be decomposed and resulting in an increase of serum uric acid to replicate the hyperuricemia model of rats.

TABLE-US-00006 TABLE 1 Scheme of grouping and administration Modeling Agents/Therapeutic Drugs/Health Food Group Number of Rats Sample 1and 2 Dose Normal Control Group 15 Same volume of drinking water Model Group 15 Potassium Oxonate 1.5 g/kg Model Group + Positive drug 15 Potassium Oxonate + Allopurinol 1.5 g/kg + 27 mg/kg Sample 1 Low-dose 15 Potassium Oxonate + Sample 1 1.5 g/kg + 2.1 ml/kg Sample 1 High-dose 15 Potassium Oxonate + Sample 1 1.5 g/kg + 12.5 ml/kg Sample 2 Low-dose 15 Potassium Oxonate + Sample 2 1.5 g/kg .Math. d + 2.1 ml/kg Sample 2 High-dose 15 Potassium Oxonate + Sample 2 1.5 g/kg + 12.5 ml/kg

[0096] The body weights of the rats were monitored, the blood samples were collected to measure the uric acid, creatinine and urea nitrogen before the experiments and at the 15th day of the administration, and the variance ratio of the serum uric acid levels was measured and calculated.

[0097] Variance ratio of serum uric acid=(serum uric acid levels after the experimentsserum uric acid levels before the experiments)/serum uric acid levels before the experiments100%.

[0098] The data was computed using SPSS 13.0 statistical software by one-way analysis of variance (ANOVA), the differences between two groups were compared by LSD test, and the results were expressed by meanstandard deviation (xs).

[0099] The analysis of variance was preceded by the test of the homogeneity of variance, and F value was calculated, F value <F.sub.0.05 leads to the conclusion that the difference between the means of each group was not significant; if F value F.sub.0.05 and P0.05, the statistical analysis was performed by pairwise comparisons between the means of a plurality of the experimental groups and the control group; the data of non-normality or of heterogeneity of variance were subject to appropriate variable conversion, and the statistical analysis was performed using the data converted which was able to meet the requirement of normality or homogeneity of variance; if the purpose of normality or homogeneity of variance was not achieved after the variable conversion, the rank-sum test was used instead for the statistical analysis.

[0100] In the comparison of the dose groups of the tested samples and the model group, positive results of the animal experiments on the function of the tested samples to reduce uric acid were confirmed by the reduction of serum uric acid value in any dose group with significant differences and the absence of marked increase in serum urea nitrogen and serum creatinine.

[0101] As shown in Table 2, the body weights of the animal gradually increase as the feeding time is prolonged, but no significant difference was observed when comparing the body weights of the animal of each groups after the experiments.

TABLE-US-00007 TABLE 2 The effect of the uric acid reducing health food on the animal body weights (x s) (Unit: g) Before 1 week after 2 weeks after 3 weeks after 4 weeks after Group N Experiments treatment treatment treatment treatment Normal Control Group 15 286 14 326 20 354 24 369 27 392 33 Model Group 15 291 9 330 12 360 19 370 26 400 40 Allopurinol Group 15 290 13 322 20 352 24 366 28 387 29 Sample 1 Low-dose 15 288 14 317 19 344 22 358 23 377 26 Sample 1 High-dose 15 287 12 319 17 344 24 361 29 382 29 Sample 2 Low-dose 15 288 11 318 15 347 20 358 23 380 25 Sample 2 High-dose 15 288 14 316 24* 342 32* 354 36 373 43 Note: Compared with the model groups, *P < 0.05

[0102] As shown in Table 2, animal body weights gradually increase as the feeding time is prolonged, but no significant difference is observed when comparing the animal body weights across the groups after the experiments.

[0103] As seen from Table 3, serum uric acid: the serum uric acid levels in the model groups are all increased significantly (P<0.001) compared to those in the normal control groups, and the serum uric acid levels in Sample 1 of high-dose and low-dose groups and Sample 2 of high-dose and low-dose groups are all decreased significantly (P<0.01 or P<0.001) compared to those in the model groups, wherein the serum uric acid level is decreased by 19% in Sample 1 of low-dose group, by 32% in Sample 1 of high-dose group, by 13% in Sample 2 of low-dose group and by 16% in Sample 2 of high-dose group, with the presence of dose-dependence to a certain degree after the intragastric administration of the same sample. The effects of reducing uric acid have no significant difference when comparing low dose of Sample 1 and Sample 2, while high dose of Sample 1 shows a better effect in lowering uric acid than of Sample 2 with a significant difference (P<0.05).

[0104] Urea nitrogen: the serum urea nitrogen levels in model groups are increased significantly (P<0.01 or P<0.001) compared to those in the normal control groups, and the serum urea nitrogen levels in Sample 1 of high-dose and low-dose groups and Sample 2 of high-dose and low-dose groups are all decreased significantly (P<0.01 or P<0.001) compared to those in the model groups, wherein the serum urea nitrogen level is decreased by 13% in Sample 1 of low-dose group, by 22% in Sample 1 of high-dose group, by 13% in Sample 2 of low-dose group and by 28% in Sample 2 of high-dose group, with the presence of dose-dependence to a certain degree after the intragastric administration of the same sample. There is no significant difference when comparing the same dose of Samples 1 and 2.

[0105] Creatinine: the serum creatinine levels in the model groups have no significant changes (P>0.05) compared to those in the normal control groups, and the serum creatinine levels in Sample 1 of high-dose group and Sample 2 of high-dose and low-dose groups are decreased significantly (P<0.05 or P<0.001) compared to those in the corresponding model group 2, wherein the serum creatinine level is decreased by 16% in Sample 1 of high-dose group, by 6% in Sample 2 of low-dose group and by 17% in Sample 2 of high-dose group, with the presence of dose-dependence to a certain degree after the intragastric administration of the same sample. The effect of reducing creatinine of Sample 2 in low dose is more significant (P<0.01) than that of Sample 1 in low dose.

TABLE-US-00008 TABLE 3 The effect of intragastric administration of the uric acid lowering health care food for 15 d on the levels of uric acid, urea nitrogen and creatinine in animals (x s) Group N Uric Acid (mol/L) Urea Nitrogen (mol/L) Creatinine (mol/L) Normal Control Group 15 133.8 25.0 5.8 0.8 29.3 3.0 Model Group 14 256.4 41.3*** 6.7 0.6** 31.0 3.3 Allopurinol Group 15 31.8 10.3### 6.2 0.9 27.9 2.2## Sample 1 Low-dose 15 207.8 21.9### 5.8 0.9## 31.5 2.6 Sample 1 High-dose 15 173.2 32.1### 5.2 0.8### 26.1 1.9### Sample 2 Low-dose 15 222.2 19.6## 5.8 1.1## 29.0 2.9# Sample 2 High-dose 15 214.3 41.0###.box-tangle-solidup. 4.8 0.7### 25.8 1.3### Note: The model group compared with the normal control group, **P < 0.01, ***P < 0.001; the health product sample group compared with the model group, #P < 0.05, ##P < 0.01; P < 0.01, Sample 1 of low-dose group compared with Sample 2 of low-dose group; .box-tangle-solidup.P < 0.05, Sample 1 of high-dose group compared with Sample 2 of high-dose group.

[0106] As can be seen from Table 1, 2, and 3, with the oral administration of the tested Sample 1 (the composition of Chinese herbal medicines and tuna extract) and Sample 2 (the composition of Chinese herbal medicines) for 15 d, the serum uric acid levels decreased remarkable (p<0.05) with statistical significance compared to those in the model group, which indicating that the test samples act to lowering uric acid. Also, the effect of lowering uric acid of Sample 1 in high dose was better than that of Sample 2 in high dose exhibiting a significant difference (P<0.05), which suggests that the tested Sample 1 (the composition of Chinese herbal medicines and tuna extract) has a superior effect than the Sample 2 (the composition of Chinese herbal medicines). A composition of the present invention having the function of lowering uric acid enables a variety of components to coordinate with each other in rational combinations by the formulation of Chinese herbal medicines and tuna extract, to achieve the healthcare function of reducing uric acid through multiple ways at multi-levels with significant effect of lowering uric acid.

[0107] Experiments implemented with the compositions prepared in Examples 1 to Example 17, and Example 19 to Example 21 of the present invention give the same or similar results as those with the composition prepared in Example 18, without significant differences (P>0.05).

[0108] A comprehensive analysis of the experimental results described above indicates that the compositions provided in the present invention have a significant effect of lowering uric acid (P<0.05).

Example 23

Comparative Test

[0109] Comparative Examples 1 to 5

[0110] The health food having the function of lowering uric acid provided in Comparative Example 1 of the present invention is prepared from the following components in parts by weight: Coicis semen 18, Cichorii Herba 8, Plantaginis Herba 8 and Pueraia Lobata Radix 8.

[0111] The health food having the function of lowering uric acid provided in Comparative Example 2 of the present invention is prepared from the following components in parts by weight: Coicis semen 18, Motherwort 10, Cichorii Herba 8, Plantaginis Herba 8, Pueraia Lobata Radix 8 and tuna extract 0.1.

[0112] The health food having the function of lowering uric acid provided in Comparative Example 3 of the present invention is prepared from the following components in parts by weight: Coicis semen 18, Cassiae semen 9, Cichorii Herba 8, Plantaginis Herba 8, Pueraia Lobata Radix 8 and tuna extract 0.5.

[0113] The health food having the function of lowering uric acid provided in Comparative Example 4 of the present invention is prepared from the following components in parts by weight: Coicis semen 18, Dioscorea Rhizoma8, Poria 8 and tuna extract 0.5.

[0114] The health food having the function of lowering uric acid provided in Comparative Example 5 of the present invention is prepared from the following components in parts by weight: Papaya 6, Dioscorea Rhizoma 8, Poria 8 and tuna extract 0.5.

[0115] Experimental group: Sample 1the composition prepared in Example 1.

TABLE-US-00009 TABLE 4 Scheme of grouping and administration Modeling Agents/ Therapeutic Drugs/Health Food Sample 1/ Group Number of Rats Comparative Example 1 to 5 Dose Normal Control Group 15 Same Volume of Drinking Water Model Group 15 Potassium Oxonate 1.5 g/kg Model Group + Positive 15 Potassium Oxonate + Allopurinol 1.5 g/kg + 27 mg/kg drug Sample 1 15 Potassium Oxonate + Sample 1 1.5 g/kg + 12.5 ml/kg Comparative Example 1 15 Potassium Oxonate + Comparative Example 1 1.5 g/kg + 12.5 ml/kg Comparative Example 2 15 Potassium Oxonate + Comparative Example 2 1.5 g/kg + 12.5 ml/kg Comparative Example 3 15 Potassium Oxonate + Comparative Example 3 1.5 g/kg + 12.5 ml/kg Comparative Example 4 15 Potassium Oxonate + Comparative Example 4 1.5 g/kg + 12.5 ml/kg Comparative Example 5 15 Potassium Oxonate ++ Comparative Example 5 1.5 g/kg + 12.5 ml/kg

TABLE-US-00010 TABLE 5 The effect of the uric acid reducing health food on animal body weights (x s) (Unit: g) Before 1 week after 2 weeks after 3 weeks after Group N Experiments treatment treatment treatment 4 weeks after treatment Normal Control Group 15 286 14 326 20 354 24 369 27 392 33 Model Group 2 15 291 9 330 12 360 19 370 26 400 40 Allopurinol Group 15 290 13 322 20 352 24 366 28 387 29 Sample 1 15 287 12 319 17 344 24 361 29 382 29 Comparative Example 1 15 292 10 322 17 345 30 365 34 385 40 Comparative Example 2 15 286 12 325 22 355 23 371 29 389 42 Comparative Example 3 15 288 11 325 16 354 24 367 29 387 39 Comparative Example 4 15 290 10 327 15 367 30 373 32 390 35 Comparative Example 5 15 287 13 323 20 362 34 372 36 387 43 Note: Compared with the model groups, * P < 0.05

[0116] As shown in Table 5, the body weights of the animal gradually increase as the feeding time is prolonged, and no significant differences are observed when comparing the animal body weights across the groups at the time of their measurements by weighing every week.

TABLE-US-00011 TABLE 6 The effect of intragastric administration of the uric acid reducing health food for 15 d on the levels of uric acid, urea nitrogen and creatinine in the animals (x s). Group N Uric Acid (mol/L) Urea Nitrogen (mol/L) Creatinine (mol/L) Normal Control Group 15 133.8 25.0 5.8 0.8 29.3 3.0 Model Group 14 256.4 41.3*** 6.7 0.6** 31.0 3.3 Allopurinol Group 15 31.8 10.3### 6.2 0.9 27.9 2.2## Sample 1 15 173.2 32.1### 5.2 0.8### 26.1 1.9### Comparative Example 1 15 253.2 50.1 6.5 0.8 29.1 3.3 Comparative Example 2 15 249.7 45.7 6.3 0.6 32.1 2.9 Comparative Example 3 15 213.4 48.1 6.2 0.7 30.9 3.5 Comparative Example 4 15 225.2 45.7 6.2 1.1 29.5 3.1 Comparative Example 5 15 212..3 51.0 6.1 0.7 29.8 2.3 Note: The model group compared with the normal control group, **P < 0.01, ***P < 0.001; the sample group compared with the model group, #P < 0.05, ##P < 0.01;

[0117] As seen from Table 6, the levels of uric acid, urea nitrogen and creatinine in the Comparative Examples 1 to 5 groups have no significant differences compared with those in the model group, suggesting that the comparative groups do not have the effect of lowering uric acid. However, Sample 1, i.e. the composition prepared in Example 1 of the present invention was able to lower uric acid significantly (P<0.05).

[0118] Experiments implemented using the compositions prepared in Examples 2 to Example 21 of the present invention give the same or similar results as those using the composition prepared in Example 18, without significant differences (P>0.05).

[0119] A comprehensive analysis of the experimental results described above indicates that the compositions provided in the present invention have a significant effect of lowering uric acid (P<0.05).

[0120] The above description gives only the preferred embodiments of the present invention, and it should be noted that for those of ordinary skill in the art, a number of improvements and modifications can be made without departing from the principle of the invention, which are also regarded as falling into the scope claimed in the present invention.