Composition containing polygonatum sibiricum and application thereof

Abstract

The invention discloses a composition containing polygonatum sibiricum and application of the composition, and belongs to the technical field of biology. The composition containing the rhizoma polygonati from Taishan is prepared by the following steps: crushing the rhizoma polygonati from Taishan, fructus akebiae and flos eriocauli, and mixing according to a weight ratio of (3-5): 1: 1 to obtain a traditional Chinese medicine mixture; adding deionized water into the traditional Chinese medicine mixture, and sterilizing to prepare a fermentation substrate; and inoculating probiotics into the fermentation substrate, carrying out fermentation culture at 30-35 DEG C for 24-30 hours, centrifuging after the fermentation culture is finished, collecting the precipitate, and drying to prepare the composition containing the polygonatum sibiricum. The probiotics are prepared from bifidobacterium adolescentis and lactobacillus crispatus. The composition containing the polygonatum sibiricum provided by the invention has obvious in-vitro xanthine oxidase inhibition activity, and can inhibit synthesis of uric acid in vivo; animal experiments prove that the composition can remarkably reduce the blood uric acid level of a hyperuricemia rat and can be used for developing a novel hyperuricemia treatment medicine.

Description

Technical Field

[0001] This invention relates to the field of biotechnology, specifically to a composition containing Polygonatum odoratum and its application. Background Technology

[0002] Hyperuricemia (HUA) is a metabolic disease caused by a disorder of purine metabolism, which leads to elevated uric acid levels in the blood. It can cause diseases such as gout and urinary tract stones, and is associated with chronic kidney disease, cardiovascular disease, and hypertension, seriously affecting the health of patients.

[0003] Treatment of hyperuricemia generally involves two pathways: promoting uric acid excretion and inhibiting uric acid synthesis. Clinically, colchicine, allopurinol, and benzbromarone are commonly used, but these drugs can easily cause gastrointestinal irritation and liver damage, limiting their clinical application. Therefore, developing novel, low-toxicity, and highly effective uric acid-lowering drugs is of great significance in the treatment of hyperuricemia (HUA).

[0004] Natural products are often used as sources of new drugs due to their potent efficacy, minimal side effects, and complex bioactive substances. Polygonatum kingianum is a medicinal and edible plant, specifically the dried rhizome of *Polygonatum kingianum* Coll. et Hemsl., *Polygonatum sibiricum* Red., or *Polygonatum cyrtonema* Hua (National Pharmacopoeia Commission, 2020). Taishan Polygonatum is listed in the Chinese Pharmacopoeia as Polygonatum kingianum. Its rhizome is cylindrical with swollen nodes, differing in thickness at both ends (Xu Aihui et al., 2023). Taishan has a warm temperate semi-humid continental monsoon climate, characterized by mild temperatures, abundant rainfall, high vegetation cover, numerous springs in the rock strata, and unique soil conditions, making it ideal for the growth of Polygonatum kingianum (Zhang Qin, 2022). Polygonatum kingianum, along with *Polygonum multiflorum*, *Codonopsis pilosula*, and *Lithospermum erythrorhizon*, are known as the four famous medicinal herbs of Taishan. Polygonatum contains abundant active ingredients, including polysaccharides, saponins, flavonoids, alkaloids, lignans, amino acids, volatile oils, and lectins (Xu et al., 2023). Polygonatum possesses various biological activities, including invigorating qi and nourishing yin, strengthening the spleen and moistening the lungs, regulating immunity, lowering lipids and blood sugar, anti-inflammatory, antioxidant, anti-aging, anti-osteoporosis, and anti-tumor effects (Li Anlin et al., 2023). Although there are some reports on the preparation of traditional Chinese medicine compositions for the prevention and treatment of hyperuricemia using Polygonatum as a raw material, these compositions are mostly large-scale formulas with numerous medicinal materials, which can easily lead to side effects. Furthermore, the processing methods for Polygonatum are mostly pulverization or water extraction, making it difficult to fully utilize its medicinal effects. Summary of the Invention

[0005] In view of the above-mentioned prior art, the purpose of this invention is to provide a composition containing *Polygonatum taishanense* and its application. The composition of this invention is mainly composed of *Polygonatum taishanense*, supplemented with *Eriocaulon buergerianum* and *Eriocaulon buergerianum*, and is produced through probiotic fermentation; it has a significant uric acid-lowering effect and can be used for the prevention and treatment of hyperuricemia.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a composition containing *Polygonatum taishanense*, prepared by the following method:

[0008] After pulverizing Polygonatum taishanense, Ziziphus jujuba var. spinosa and Eriocaulon buergerianum, they were mixed in a weight ratio of (3-5):1:1 to obtain a traditional Chinese medicine mixture; deionized water was added to the traditional Chinese medicine mixture, and the mixture was sterilized to prepare a fermentation base;

[0009] Probiotics were introduced into the fermentation substrate and fermented at 30-35℃ for 24-30 hours. After the fermentation was completed, the substrate was centrifuged, the precipitate was collected, dried, and a composition containing Polygonatum taishanense was prepared.

[0010] The probiotics consist of Bifidobacterium adolensentis and Lactobacillus crispatus.

[0011] Preferably, the weight ratio of the Polygonatum taishanense, Ziziphus jujuba and Eriocaulon buergerianum is 4:1:1.

[0012] Preferably, the ratio of the amount of Chinese herbal medicine mixture to the amount of deionized water added is 1g:(6-10)mL.

[0013] Preferably, the probiotics are composed of Bifidobacterium adolensentis and Lactobacillus crispatus in a 1:1 ratio of live bacteria.

[0014] Preferably, the total viable count of probiotics inoculated into each 1 mL of fermentation substrate is ≥10. 7 CFU.

[0015] The composition of this invention is made from *Polygonatum taishanense*, *Corydalis yanhusuo*, and *Eriocaulon buergerianum* through probiotic fermentation. The herbal component consists of these three herbs, forming a small formula that reduces the possibility of side effects between the herbs. *Polygonatum taishanense* is the principal herb, used to eliminate dampness and turbidity, and to tonify the spleen and lungs. *Corydalis yanhusuo* and *Eriocaulon buergerianum* are the assistant herbs, used to invigorate qi, resolve stagnation, and promote blood circulation. The combined effects of these herbs are to dispel numbness, eliminate phlegm, and resolve turbidity. The three herbs work together to strengthen the spleen and kidneys, support the body's resistance, and eliminate pathogenic factors, thus achieving a comprehensive treatment for hyperuricemia.

[0016] To further enhance the therapeutic effect of traditional Chinese medicine (TCM) formulations, this invention selects two probiotics, *Bifidobacterium adolensentis* and *Lactobacillus crispatus*, both with uric acid-lowering functions, to jointly ferment the TCM composition. Through microbial metabolism, the TCM components are transformed or modified, enhancing their efficacy. Furthermore, probiotics may produce enzymes, organic acids, and antimicrobial peptides during fermentation, which synergistically work with the TCM components. The composition containing *Polygonatum sibiricum* of this invention is prepared by combining probiotics and TCM, and it possesses xanthine oxidase inhibitory activity, synergistically inhibiting uric acid production and lowering blood uric acid levels.

[0017] In a second aspect, the present invention provides the use of the above-described composition containing *Polygonatum taishanense* in the following (1) or (2):

[0018] (1) Prepare health foods and / or functional foods that lower uric acid;

[0019] (2) Prepare drugs for the prevention and treatment of hyperuricemia.

[0020] Using the composition containing Polygonatum taishanense of the present invention as the active ingredient, health foods and functional foods in various product forms can be made. The product forms of health foods and functional foods can be oral liquids, liquid beverages, solid beverages, jellies, special medical foods, etc., which have good health care and prevention effects on people with high uric acid and people at high risk of high uric acid, and are suitable for long-term use to achieve the effect of lowering uric acid.

[0021] Based on the excellent uric acid-lowering properties of the composition containing Polygonatum taishanense of the present invention, it can also be developed into a new drug for the prevention and treatment of hyperuricemia.

[0022] In a third aspect, the present invention provides a drug for preventing and treating hyperuricemia, wherein the drug is an effective ingredient of the above-mentioned composition containing Polygonatum taishanense.

[0023] Furthermore, the drug also contains pharmaceutically acceptable excipients.

[0024] Preferably, the excipients are selected from one or more of dispersants, binders, wetting agents, disintegrants, plasticizers, and sustained-release agents. Specifically, the excipients can be selected from the following raw materials according to the formulation requirements:

[0025] Starch, lactose, dextrin, mannitol, sorbitol, microcrystalline cellulose, poloxamer, sodium lauryl sulfate, polyoxyethylene castor oil, polyvinylpyrrolidone, hydroxypropyl cellulose, carboxymethyl cellulose, talc, calcium stearate, magnesium stearate, etc.

[0026] Furthermore, the dosage form of the drug is granules, capsules, tablets, powders, oral liquids, pills, etc.

[0027] The beneficial effects of this invention are:

[0028] (1) The present invention found that the combination of Bifidobacterium adolensentis and Lactobacillus crispatus has significant in vitro uric acid-lowering activity.

[0029] (2) The composition containing Taishan Polygonatum of the present invention has significant in vitro inhibition of xanthine oxidase activity and can inhibit the synthesis of uric acid in vivo; animal experiments have verified that the composition containing Taishan Polygonatum of the present invention can significantly reduce the blood uric acid level in rats with hyperuricemia and can be used to develop new drugs for the treatment of hyperuricemia. Detailed Implementation

[0030] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0031] As introduced in the background section, the development of novel low-toxicity and high-efficiency uric acid-lowering drugs is of great significance in the treatment of hyperuricemia (HUA). Existing traditional Chinese medicine compositions containing Polygonatum for the treatment of hyperuricemia are mostly large formulas with numerous medicinal materials, which can easily lead to side effects between the materials. Moreover, the processing methods for Polygonatum are mostly pulverization or water extraction, which makes it difficult to fully exert the medicinal effects of Polygonatum.

[0032] Based on this, the present invention has developed and designed a composition containing Taishan Huangjing. The present invention first targets the pathogenesis of hyperuricemia in traditional Chinese medicine and formulates a small prescription from the perspective of traditional Chinese medicine, consisting of three herbs: Taishan Huangjing, Yuzhizi, and Gujingcao. The prescription is based on the principles of relieving numbness, eliminating phlegm, and clearing turbidity, so as to achieve both symptomatic and radical treatment of hyperuricemia.

[0033] To further improve the therapeutic effect of the traditional Chinese medicine composition, this invention screened probiotic strains that lower uric acid and selected a combination of non-antagonistic probiotics, Bifidobacterium adolensentis and Lactobacillus crispatus, to ferment the traditional Chinese medicine composition. Through the metabolic action of microorganisms, the components of the traditional Chinese medicine are transformed or modified, thereby enhancing the efficacy. Moreover, during the fermentation process, probiotics may produce enzymes, organic acids, antimicrobial peptides, and other substances that work synergistically with the components of the traditional Chinese medicine.

[0034] In summary, this invention selects *Polygonatum sibiricum*, *Eriocaulon buergerianum*, and *Eriocaulon buergerianum* in a specific ratio and uses a probiotic combination of *Bifidobacterium adolensentis* and *Lactobacillus crispatus* for fermentation treatment. The resulting composition exhibits significant uric acid-lowering activity. This invention is thus proposed.

[0035] To enable those skilled in the art to better understand the technical solution of this application, the technical solution of this application will be described in detail below with reference to specific embodiments.

[0036] The test materials used in the embodiments and comparative examples of this invention are all conventional test materials in the art and can be purchased through commercial channels. Specifically:

[0037] Uric acid was purchased from Shanghai Maclean Biochemical Technology Co., Ltd.; Bifidobacterium adolescentis was obtained from the China Industrial Microbiology Preservation Center, strain number CICC 6176; Lactobacillus crispatus was obtained from the China Industrial Microbiology Preservation Center, strain number CICC 24879.

[0038] Example 1: Screening of uric acid-lowering bacterial strains

[0039] 1. Test method:

[0040] Single colonies were selected from 54 bacterial strains purchased from the China Industrial Microbial Culture Collection Center and cultured for proliferation, and the OD of the bacterial culture was adjusted. 600 The value was 0.8. Uric acid plates were prepared using Oxford cups. Water agar was poured into the bottom layer of the plate, and uric acid-containing culture medium was poured into the top layer. 200 μL of bacterial culture was inoculated into each well of the Oxford cup and incubated at 37°C. The degradation of uric acid was observed, and the diameter of the degradation zone was measured after 48 hours of incubation.

[0041] Five strains with the highest uric acid degradation effect were selected, and the affinity between these five strains was determined by pairwise confrontation culture. The strain combination with the best uric acid degradation effect and no antagonistic effect was selected, and the bacterial solutions were mixed at a volume ratio of 1:1. 200 μL of the mixed bacterial solution was inoculated into the well of an Oxford cup, and the degradation of uric acid was determined by the same method as above. The diameter of the degradation zone was measured after 48 h of culture.

[0042] 2. Test Results:

[0043] The results of the degradation zone diameter measurements of the top five strains in terms of uric acid degradation efficiency are shown in Table 1.

[0044] Table 1: Uric acid degradation effect

[0045]

[0046]

[0047] Through confrontation culture, strains CICC 6176 and CICC 24879 were found to be the optimal combination for uric acid degradation without antagonistic effects. Measurements showed that the combined bacterial culture of these two strains exhibited a degradation zone diameter of 23.2 mm for uric acid, significantly higher than that of the individual strains, demonstrating a synergistic effect. Therefore, *Bifidobacterium adolensentis* (CICC 6176) and *Lactobacillus crispatus* (CICC 24879) were selected for subsequent experiments.

[0048] Example 2: Preparation of a composition containing Polygonatum taishanense

[0049] Taishan Polygonatum, Yuzhizi and Eriocaulon buergerianum were pulverized and mixed in a weight ratio of 4:1:1 to obtain a traditional Chinese medicine mixture. Deionized water was added to the traditional Chinese medicine mixture at a ratio of 1g:8mL. The mixture was sterilized at 121℃ to prepare a fermentation base.

[0050] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 1 × 10⁻¹⁰ per 1 mL of fermentation substrate. 7 CFU was fermented at 32℃ for 26 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare a composition containing Polygonatum taishanense.

[0051] Example 3: Preparation of a composition containing Polygonatum taishanense

[0052] Taishan Polygonatum, Yuzhizi and Eriocaulon buergerianum were pulverized and mixed in a weight ratio of 3:1:1 to obtain a traditional Chinese medicine mixture. Deionized water was added to the traditional Chinese medicine mixture at a ratio of 1g:6mL. The mixture was sterilized at 121℃ to prepare a fermentation base.

[0053] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 3 × 10⁻⁶ per 1 mL of fermentation substrate. 7 CFU was fermented at 30℃ for 30 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare a composition containing Polygonatum taishanense.

[0054] Example 4: Preparation of a composition containing Polygonatum taishanense

[0055] Taishan Polygonatum, Yuzhizi and Eriocaulon buergerianum were pulverized and mixed in a weight ratio of 5:1:1 to obtain a traditional Chinese medicine mixture. Deionized water was added to the traditional Chinese medicine mixture at a ratio of 1g:10mL. The mixture was sterilized at 121℃ to prepare a fermentation base.

[0056] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 2 × 10⁻⁶ per 1 mL of fermentation substrate. 7 CFU was fermented at 35℃ for 24 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare a composition containing Polygonatum taishanense.

[0057] Comparative Example 1:

[0058] Taishan Polygonatum, Yuzhizi and Eriocaulon are pulverized and mixed in a weight ratio of 4:1:1 to obtain a traditional Chinese medicine mixture. Deionized water is added to the traditional Chinese medicine mixture at a ratio of 1g:8mL. The mixture is sterilized at 121℃ and then cultured at 32℃ for 26h. After the culture is completed, the mixture is centrifuged, the precipitate is collected, and the precipitate is freeze-dried to prepare composition A.

[0059] Comparative Example 2:

[0060] Taishan Polygonatum was pulverized, and deionized water was added to the pulverized Taishan Polygonatum. The ratio of Taishan Polygonatum to deionized water was 1g:8mL. The mixture was sterilized at 121℃ to prepare the fermentation substrate.

[0061] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 2 × 10⁻⁶ per 1 mL of fermentation substrate.7 CFU was fermented at 32℃ for 26 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare composition B.

[0062] Comparative Example 3:

[0063] Taishan Polygonatum and Yuzhizi were pulverized and mixed at a weight ratio of 4:1 to obtain a traditional Chinese medicine mixture. Deionized water was added to the traditional Chinese medicine mixture at a ratio of 1g:8mL. The mixture was sterilized at 121℃ to prepare a fermentation base.

[0064] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 2 × 10⁻⁶ per 1 mL of fermentation substrate. 7 CFU was fermented at 32℃ for 26 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare composition C.

[0065] Comparative Example 4:

[0066] Taishan Polygonatum and Eriocaulon buergerianum were pulverized and mixed at a weight ratio of 4:1 to obtain a traditional Chinese medicine mixture. Deionized water was added to the traditional Chinese medicine mixture at a ratio of 1g:8mL. The mixture was sterilized at 121℃ to prepare a fermentation base.

[0067] Probiotics were inoculated into the fermentation substrate. The probiotics consisted of *Bifidobacterium adolescentis* and *Lactobacillus crispatus* in a 1:1 ratio of live bacteria, with a total live bacteria count of 2 × 10⁻⁶ per 1 mL of fermentation substrate. 7 CFU was fermented at 32℃ for 26 hours. After fermentation, the mixture was centrifuged, the precipitate was collected, and the precipitate was freeze-dried to prepare composition D.

[0068] Experimental Example 1: In vitro inhibition of xanthine oxidase activity

[0069] 1. Test method:

[0070] The compositions prepared in Examples 2-4 and Comparative Examples 1-4 were dissolved in DMSO to prepare 2 mg / ml solutions, and then diluted 10 times (0.2 mg / ml) with PBS buffer to obtain the test sample solutions.

[0071] Dissolve 1 mg of allopurinol in 1 ml of DMSO, then dilute 180 times with PBS buffer to obtain a solution containing 40 μmol / mL of allopurinol, which can be used as a positive control solution.

[0072] Enzyme reactions were performed using 96-well plates. 35 μL of 70 mM phosphate buffer, 50 μL of the test sample solution, and 30 μL of xanthine oxidase solution (0.01 U / ml) were sequentially added to each reaction chamber. Allopurinol solution was added as a positive control. The enzyme reaction compounds were incubated at 37°C for 15 minutes, followed by the addition of 60 μL of xanthine substrate solution (0.3 mM), and the reaction was incubated at 25°C for 30 minutes. The reaction was terminated by adding 25 μL of 1N HCl. The absorbance data of the solutions in each reaction chamber were read at 295 nm using a Bio-Tek microplate reader. The inhibition rate of each sample was calculated.

[0073] Inhibition rate (%) = [(E 标准品 -E 样品 )] / E 标准品 ×100%.

[0074] Among them, E 标准品 E 样品 Indicates absorbance.

[0075] 2. Experimental Results:

[0076] The test results are shown in Table 2.

[0077] Table 2: In vitro inhibitory activity against xanthine oxidase (enzyme-labeled method)

[0078] Group Inhibition rate (%) Example 2 94.2 Example 3 90.5 Example 4 92.8 Comparative Example 1 50.2 Comparative Example 2 77.4 Comparative Example 3 85.2 Comparative Example 4 83.4 Positive control solution 93.5

[0079] The results showed that the combination of traditional Chinese medicines was significantly enhanced by probiotic fermentation, which significantly improved its in vitro inhibitory activity against xanthine oxidase. Based on the combination of Polygonatum taishanense, Polygonatum taishanense was combined with Eriocaulon buergerianum and Eriocaulon buergerianum, and after probiotic fermentation, the in vitro inhibitory activity against xanthine oxidase achieved a synergistic effect of 1+1>2.

[0080] Experimental Example 2: Animal Experiment

[0081] 1. Test method:

[0082] A rat model of hyperuricemia was constructed according to the method described in the journal article "Study on the uric acid-lowering effect and mechanism of the combination of Poria cocos and Plantago asiatica in rats with hyperuricemia" (Journal of Liaoning University of Traditional Chinese Medicine). The therapeutic effects of the compositions prepared in Example 2 and Comparative Examples 2-4 on the rat model of hyperuricemia were investigated. The specific methods are as follows:

[0083] 1.1 Grouping:

[0084] After 1 week of acclimatization feeding, SD rats were fasted for 12 hours but allowed free access to water. Blood was collected from the inner canthus of the eye, and serum was separated as soon as possible after blood collection. Serum uric acid (SUA) levels were measured, and extreme values ​​were removed. Based on serum SUA levels, the animals were randomly divided into a blank group, a model group, a positive drug group, a treatment group 1, a treatment group 2, a treatment group 3, and a treatment group 4. There were 6 rats in each group, and there was no statistically significant difference in SUA values ​​among the groups.

[0085] 1.2 Model establishment, drug administration, and indicator detection:

[0086] All groups were fed regular feed and had free access to water. Every morning at 9:00, the control group was administered 0.5% CMC-Na solution by gavage, while the other groups were administered 1000 mg / kg potassium oxonate by gavage. The gavage dosage was adjusted according to changes in body weight, and the administration was continuous. When rats in other groups showed symptoms such as lethargy, sluggishness, dry and yellow fur, and hair loss, the model was considered to have been successfully established.

[0087] One hour after successful modeling, the blank control group and the model group were administered 0.5% CMC-Na solution by gavage, while other groups were administered the corresponding drugs by gavage.

[0088] The positive control group received allopurinol by gavage;

[0089] Treatment group 1 was administered the composition solution prepared in Example 2 by gavage (the composition prepared in Example 2 was dissolved in 0.5% CMC-Na, and the concentration of the composition was 0.1 mg / mL);

[0090] Treatment group 2 was administered the composition solution prepared in Comparative Example 2 by gavage (the composition prepared in Comparative Example 2 was dissolved in 0.5% CMC-Na, and the concentration of the composition was 0.1 mg / mL);

[0091] Treatment group 3 was administered the composition solution prepared in Comparative Example 3 by gavage (the composition prepared in Comparative Example 3 was dissolved in 0.5% CMC-Na, and the concentration of the composition was 0.1 mg / mL);

[0092] Treatment group 4 was administered the composition solution prepared in Comparative Example 4 by gavage (the composition prepared in Comparative Example 4 was dissolved in 0.5% CMC-Na, and the concentration of the composition was 0.1 mg / mL);

[0093] The gavage dose for each group was 1 ml / 100 g; gavage was administered once daily for 7 consecutive days. Before the last administration, the mice were fasted but allowed to drink water for 24 hours. One hour after the last administration, 1-2 mL of blood was collected from the orbital cavity of the mice. The blood was allowed to stand at room temperature for 2 hours, then centrifuged at 3000 r / min for 10 min. The serum was collected for the determination of serum uric acid, and the percentage reduction of serum uric acid in each group was calculated.

[0094] Percentage reduction in serum uric acid (%) = (serum uric acid level in the model control group - serum uric acid level in the treatment group after drug administration) / serum uric acid level in the model control group × 100%.

[0095] 2. Experimental Results:

[0096] The test results are shown in Table 3.

[0097] Table 3: Results of serum uric acid measurement in SD rats after drug administration

[0098] Group Uric acid level (μmol / L) Percentage reduction in uric acid (%) Blank control group 101.2±9.6 / Model control group 213.6±24.5 / Processing Group 1 114.2±10.2 46.5 Processing Group 2 158.4±15.3 25.8 Processing Group 3 136.8±13.4 35.9 Processing Group 4 143.5±12.4 32.8 Positive drug group 126.2±13.1 40.9

[0099] The above results indicate that the composition containing *Polygonatum taishanense* of the present invention can significantly reduce uric acid levels in a rat model of hyperuricemia.

[0100] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A composition containing *Polygonatum taishanense*, characterized in that, It is prepared by the following method: After pulverizing Polygonatum taishanense, Ziziphus jujuba var. spinosa and Eriocaulon buergerianum, they were mixed in a weight ratio of (3-5):1:1 to obtain a traditional Chinese medicine mixture; deionized water was added to the traditional Chinese medicine mixture, and the mixture was sterilized to prepare a fermentation base; Probiotics were introduced into the fermentation substrate and fermented at 30-35℃ for 24-30 hours. After the fermentation was completed, the substrate was centrifuged, the precipitate was collected, dried, and a composition containing Polygonatum taishanense was prepared. The probiotics consist of Bifidobacterium adolensentis and Lactobacillus crispatus.

2. The composition according to claim 1, characterized in that, The weight ratio of the Polygonatum odoratum, Ziziphus jujuba and Eriocaulon buergerianum is 4:1:

1.

3. The composition according to claim 1, characterized in that, The ratio of the amount of Chinese herbal medicine mixture to the amount of deionized water added is 1g:(6-10)mL.

4. The composition according to claim 1, characterized in that, The probiotics are composed of Bifidobacterium adolensentis and Lactobacillus crispatus in a 1:1 ratio of live bacteria.

5. The composition according to claim 1 or 4, characterized in that, The total number of live probiotics inoculated into each 1 mL of fermentation substrate is ≥10. 7 CFU.

6. The use of the composition according to any one of claims 1-5 in either (1) or (2) below: (1) Prepare health foods and / or functional foods that lower uric acid; (2) Prepare drugs for the prevention and treatment of hyperuricemia.

7. A drug for preventing and treating hyperuricemia, characterized in that, The drug is an active ingredient of the composition containing *Polygonatum sibiricum* as described in any one of claims 1-5.

8. The medicament according to claim 7, characterized in that, The drug also contains pharmaceutically acceptable excipients.

9. The medicament according to claim 8, characterized in that, The excipients are selected from one or more of the following: dispersants, binders, wetting agents, disintegrants, plasticizers, and sustained-release agents.

10. The medicament according to claim 8, characterized in that, The dosage form of the drug is granules, capsules, tablets, powders, oral liquids, or pills.

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