Traditional Chinese medicine composition for treating gout as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating gout. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-18 parts of selaginella moellendorffii, 4-6 parts of rhizoma smilacis glabrae, 4-6 parts of semen plantaginis, 4-6 parts of ginseng, 4-6 parts of radix ophiopogonis and 4-6 parts of schisandra chinensis. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition disclosed by the invention is used for treating gout caused by phlegm stagnation and qi and fluid damage, can achieve a remarkable effect at a low dosage through specific raw material selection and compatibility, and is safer and more effective in clinical use.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating gout, belonging to the field of traditional Chinese medicine. Background Art

[0002] Gout is a metabolic rheumatic disease caused by hyperuricemia, similar to arthralgia and rheumatic arthralgia in Traditional Chinese Medicine (TCM). It is primarily due to liver and kidney deficiency, spleen yang dysfunction, internal dampness and turbidity, phlegm and blood stasis, and stagnation of qi and blood, which eventually transforms into heat. Its natural course includes a period of asymptomatic hyperuricemia, acute attacks, interictal periods, and a chronic tophi stage. Gout patients are often obese, have a phlegm-damp constitution, and are prone to alcoholism and a preference for spicy, greasy, and rich foods. This can damage the spleen and stomach, leading to qi and blood disorders in the internal organs and ultimately the disease.

[0003] Traditional Chinese medicine classifies gout as a "bi syndrome" and believes that its onset is related to factors such as congenital deficiency, postnatal malnutrition, and exogenous evil spirits. The pathogenesis is the combination of damp heat, phlegm, and blood stasis, which leads to poor circulation of qi and blood.

[0004] CN201510187849.9, titled "A Traditional Chinese Medicine for Lowering Uric Acid and Its Preparation Method," discloses a uric acid-lowering traditional Chinese medicine prepared from the following raw materials in the following weight ratios: 20-80% Selaginella chinensis, 10-40% Smilax glabra, and 10-40% Plantago seed. This invention effectively reduces serum uric acid levels in hyperuricemia model animals and levels of inflammatory factors such as nitric oxide, interleukin-8, and prostaglandin-2 in the serum of acute gouty arthritis model animals. Hu Hao, et al., Clinical Observation on the Treatment of Acute Gouty Arthritis of Damp-Heat Accumulation Type with Compound Jiangnan Selaginella Decoction Combined with Western Medicine, Guangxi Journal of Traditional Chinese Medicine, Vol. 48, No. 2, April 2025, disclosed that Compound Jiangnan Selaginella Decoction combined with diclofenac sodium sustained-release capsules can alleviate the patient's clinical symptoms, reduce UA levels, and inhibit inflammatory response. Among them, the drug composition of Compound Jiangnan Selaginella Decoction is: 50g of Jiangnan Selaginella, 20g of Smilax glabra, and 20g of Plantago seed.

[0005] Due to the complex dialectical nature of gout, its course is divided into multiple stages, such as asymptomatic hyperuricemia stage, acute attack stage, intermittent stage, chronic tophi stage, chronic gouty nephropathy stage, etc. The currently reported compound Jiangnan Selaginella decoction has a limited course of treatment for gout and its efficacy is not obvious. Summary of the Invention

[0006] The present invention provides a novel traditional Chinese medicine composition for treating gout, and also provides a preparation method and application of the traditional Chinese medicine composition.

[0007] The present invention provides a traditional Chinese medicine composition for treating gout, which is prepared from the following raw materials in the following weight ratios:

[0008] 12-18 parts of Selaginella chinensis, 4-6 parts of Smilax glabra, 4-6 parts of Plantago seeds, 4-6 parts of Ginseng, 4-6 parts of Ophiopogon japonicus, and 4-6 parts of Schisandra chinensis.

[0009] Preferably, it is prepared from the following raw materials in the following weight ratio:

[0010] 15 parts of Selaginella chinensis, 5 parts of Rhizoma Smilacis Glabrae, 5 parts of Semen Plantaginis, 5 parts of Radix Ginseng, 5 parts of Radix Ophiopogonis, and 5 parts of Fructus Schisandrae Chinensis.

[0011] The Chinese medicine composition of the present invention is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to form a commonly used oral preparation in medicine.

[0012] Wherein, the oral preparations are tablets, capsules, pills, granules, and oral liquids.

[0013] The present invention provides a method for preparing a traditional Chinese medicine composition for treating gout, which is characterized in that it comprises the following steps:

[0014] a. Weigh the APIs of various weight ratios;

[0015] b. Powdering, or boiling with water, filtering, concentrating, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used oral preparation in medicine.

[0016] The present invention provides use of the traditional Chinese medicine composition in preparing medicine for treating gout.

[0017] Wherein, the medicine is a medicine for treating gout in the inter-attack period and / or the chronic tophi lesion period.

[0018] The medicine is used to treat gout caused by internal retention of phlegm and turbidity and damage to qi and body fluid.

[0019] The original formula uses Selaginella chinensis as the main herb, combined with Smilax glabra and Plantago seed. Both Smilax glabra and Plantago seed are classic companion herbs for the treatment of gout and hyperuricemia, and are recommended for gout in the context of damp-heat accumulation according to the Integrated Traditional Chinese and Western Medicine guidelines. Selaginella chinensis is effective in lowering serum uric acid and treating acute gouty arthritis. Smilax glabra is an excellent herb for detoxification, promoting detoxification, dampness removal, and joint relaxation. Plantago seed clears heat and dampness, dissipates dampness, and has diuretic properties, promoting uric acid excretion. The combination of these three herbs can eliminate dampness and turbidity, enhancing efficacy, significantly improving symptoms, and lowering serum uric acid concentrations.

[0020] Along with the progression of the disease, when proceeding from the acute attack period to the interictal period and the chronic tophi pathological period, the spleen and stomach function of ascending the clear and descending the turbid is abnormal, phlegm-dampness is internally generated, depressed and heat-transforming, heat damages qi and fluid, forms the phlegm-dampness stagnation of deficiency and excess mixed, the card of qi and fluid damage, treatment should be to eliminate dampness and eliminate turbidity, and concurrently invigorate qi and yin, and the use of original prescription has larger limitation. Chinese medicine composition of the present invention uses Selaginella chinensis, Rhizoma Smilacis Glabrae, Semen Plantaginis, Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis. Selaginella chinensis and Rhizoma Smilacis Glabrae are monarchs, to eliminate dampness and turbidity, Semen Plantaginis is ministerial medicine, to promote blood circulation and promote menstruation, concurrently eliminate dampness and heat, with ginseng to invigorate the spleen and replenish qi, Radix Ophiopogonis nourishes yin and clears heat, Fructus Schisandrae Chinensis invigorates qi and promotes fluid production, astringes and consolidates, stops sweating and stops diarrhea, the three medicines are used together to have both nourishing yin and replenishing qi, repair the effect of vital energy, and can prevent Selaginella chinensis, Rhizoma Smilacis Glabrae, Semen Plantaginis from attacking too much and causing frequent urination or diarrhea. The combined prescription plays the effect of eliminating dampness and eliminating turbidity and detoxifying, strengthening the body's health to help expel pathogenic factors. During the interictal period and the chronic tophi stage, phlegm and turbidity often stagnate, Qi and body fluids are damaged, and deficiency and excess are mixed. Therefore, the Chinese medicine composition of the present invention uses ginseng, ophiopogon japonicus, and schisandra chinensis as adjuvants, which can not only enhance the body's disease resistance and repair capabilities, strengthen the body's resistance and eliminate pathogenic factors, but also prevent the three herbs in the original prescription from being too purgative.

[0021] The Chinese medicine composition of the present invention treats gout caused by internal retention of phlegm and turbidity and damage to qi and fluid. Through the selection and combination of specific raw materials, it can achieve significant effects at low doses, and is safer and more effective in clinical use. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 Ankle joint swelling of mice on day 5 after MSU injection;

[0023] Figure 2 Effect of Jiangnan Selaginella Tongshu Recipe on serum uric acid content (compared with the model group *P<0.05, **P<0.01; compared with the blank group ## P < 0.01);

[0024] Figure 3 Effect of Jiangnan Selaginella Tongshu Recipe on serum NO content (*P<0.05, **P<0.01 compared with the model group);

[0025] Figure 4 Effects of Jiangnan Selaginella Tongshu Recipe on GOP activity in liver tissue (*P<0.05, **P<0.01 compared with the model group; compared with the blank group # P < 0.05);

[0026] Figure 5 Observation of pathological sections of mouse joint synovial tissue. DETAILED DESCRIPTION

[0027] Example 1 Preparation of the Chinese medicine composition of the present invention (hereinafter referred to as "Jiangnan Selaginella Pain Relief Recipe") Weigh the raw materials in the following weight ratios:

[0028] Selaginella jiangnanensis 15g, Smilax glabra 5g, Plantago asiatica 5g, Ginseng 5g, Ophiopogon japonicus 5g, Schisandra chinensis 5g,

[0029] The above pieces of medicinal material are extracted three times with 10 times the prescribed amount of water, each time for 1 hour. The extract is concentrated into an extract, and the extract is dried and crushed to obtain a dry paste powder. Take the above dry paste powder and add an appropriate amount of dextrin, mix well, granulate with ethanol, dry, and package.

[0030] Example 2 Preparation of the Chinese medicine composition of the present invention

[0031] Weigh the raw materials: 12 g of Selaginella jiangnanensis, 4 g of Smilax glabra, 4 g of Plantago seed, 4 g of Ginseng, 4 g of Ophiopogon japonicus, and 4 g of Schisandra chinensis, directly grind into powder, and fill into capsules to obtain capsules.

[0032] Example 3 Preparation of the Chinese medicine composition of the present invention

[0033] 18 g of Selaginella jiangnanensis, 6 g of Smilax glabra, 6 g of Plantago seed, 6 g of Ginseng, 6 g of Radix Ophiopogonis, and 6 g of Schisandra chinensis were prepared into granules according to the method described in Example 1.

[0034] Comparative Example 1: Original recipe of Selaginella jiangnanensis (formula disclosed in original patent application number: CN201510187849.9)

[0035] 15g of Selaginella jiangnanensis, 5g of Smilax glabra, and 5g of Plantago seed were prepared according to the method of the embodiment.

[0036] The beneficial effects of the present invention are demonstrated by the following pharmacodynamic tests.

[0037] Test Example 1 Pharmacodynamics test of the drug of the present invention

[0038] 1. Animal grouping and drug administration method:

[0039] SPF male C57 mice (6-8 weeks) were randomly divided into a normal group, a model group, a colchicine group (0.3 mg / kg), and low- and high-dose groups (3.75 g·kg) of the original patented formula (hereinafter referred to as the "original formula", prepared from Selaginella chinensis, Smilax glabra, and Plantago asiatica). -1 , 18.7g·kg -1 ), the patented formula of the present invention (hereinafter referred to as "new formula", raw materials are: Selaginella chinensis, Plantago seed, Radix Ophiopogonis, Smilax glabra, Ginseng, Schisandra chinensis, prepared according to Example 1) low and high dose groups (6.0g·kg -1 , 30.0g·kg -1 ), both groups were given 1 and 5 times of the clinical dose, and the drug-treated group was given oral administration once a day for 15 consecutive days.

[0040] 2. Modeling method:

[0041] An acute gouty arthritis combined with hyperuricemia model was established. Each mouse was intraperitoneally injected with 0.25 g / kg of potassium oxonate solution daily for 15 consecutive days. On the ninth day of modeling, gouty arthritis was induced by intraarticular injection of MSU crystal suspension (25 mg / mL, 50 μL / injection) into the right ankle joint every two days. A control group received the same volume of saline. 48 hours after the last MSU injection, the mice were sacrificed, and samples were collected and frozen for future use.

[0042] 3. Detection indicators

[0043] The right ankle circumference was measured every 24 hours, starting on the day of the first MSU injection. The joint swelling index was calculated as (post-modeling circumference - pre-modeling circumference) / pre-modeling circumference. Joint morphology, synovial tissue pathology, and tissue infiltration were observed using HE staining. Levels of UA, NO, XOD, ROS, AST, ALT, BUN, GSH, SOD, MDA, and LDH in the ankle joint and / or serum were measured.

[0044] 4. Experimental results

[0045] 4.1 Effect of the extract of Selaginella jiangnanensis Tongshufang on ankle swelling in mice

[0046] The symptoms of acute gouty arthritis are redness, swelling, heat and pain, so the degree of joint swelling is used as an indicator to roughly evaluate the inflammation caused by sodium urate. Figure 1 As shown, ankle swelling increased in all groups of mice after MSU compared to the normal group. While the normal group injected with saline showed no significant joint swelling, the swelling increased rapidly in all groups injected with MSU. Within five days of the initial MSU injection, the joint swelling in the model group was significantly higher than that in the normal group. However, the joint swelling in mice receiving the Jiangnan Selaginella compound and colchicine increased slowly. In particular, the ankle swelling in the high-dose Jiangnan Selaginella Pain-Soothing Formula group was significantly lower than that in the model group (P < 0.01), and there was no significant difference between the high-dose group and the colchicine group (P > 0.05).

[0047] Table 1 Effects of Jiangnan Selaginella Tongshu Recipe on joint swelling and uric acid concentration in gout mice

[0048]

[0049] Compared with the model group: *P<0.1, **P<0.01

[0050] The test results show that the efficacy of the low dose of the present invention (6.0g·kg-1) is significantly better than that of the high dose of the original prescription (18.7g·kg -1 ), the pharmaceutical raw materials of the present invention exert synergistic effects through specific raw material selection and compatibility.

[0051] Compared with the model group, *P<0.05, **P<0.01.

[0052] 4.2 Effect of Jiangnan Selaginella Tongshu Recipe Extract on Uric Acid Content

[0053] Figure 2 The results showed that compared with the normal group, the uric acid levels of mice in the MSU group were significantly increased (P<0.01), indicating that the model was successfully established. At the same time, compared with the model group, colchicine had no significant effect on lowering uric acid levels; the new formula had the most significant effect on lowering uric acid levels (P<0.01).

[0054] 4.3 Effect of Jiangnan Selaginella Tongshu Recipe Extract on NO Content

[0055] Figure 3 Results showed that compared with the normal group, the serum NO content of mice in the MSU group was significantly increased (P<0.01), indicating an elevated level of inflammation. Compared with the model group, colchicine had the most significant effect in inhibiting NO, followed by the high-dose groups of the new and original formulas (P<0.01).

[0056] 4.4 Effects of Jiangnan Selaginella Tongshu Recipe Extract on Liver Function

[0057] Figure 4 Results showed that compared with the normal group, the GOT content in the liver of the MSU group mice was significantly increased (P<0.05), indicating that the liver function of the mice was abnormal after modeling. At the same time, compared with the model group, both the high-dose and low-dose groups of the new formula inhibited the increase of GOT to a certain extent, indicating a certain liver-protective effect (P<0.05).

[0058] 4.5 Effects of the Jiangnan Selaginella Tongshu Recipe Extract on Pathological Damage to Joint Tissue

[0059] A large number of neutrophils were observed in the joint cavity and synovium of mice in the model group, indicating that MSU could induce leukocyte invasion and thus cause an inflammatory response; however, after treatment with colchicine and the drug-treated group, the number of leukocytes invading the joint cavity decreased and the synovium was relatively intact.

Claims

1. A Chinese medicine composition for treating gout, characterized in that: It is prepared from the following raw materials in the following weight ratio: 12-18 parts of Selaginella chinensis, 4-6 parts of Smilax glabra, 4-6 parts of Plantago seeds, 4-6 parts of Ginseng, 4-6 parts of Ophiopogon japonicus, and 4-6 parts of Schisandra chinensis.

2. The Chinese medicine composition for treating gout according to claim 1, wherein: It is prepared from the following raw materials in the following weight ratio: 15 parts of Selaginella chinensis, 5 parts of Rhizoma Smilacis Glabrae, 5 parts of Semen Plantaginis, 5 parts of Radix Ginseng, 5 parts of Radix Ophiopogonis, and 5 parts of Fructus Schisandrae Chinensis.

3. The Chinese medicine composition for treating gout according to claim 1 or 2, characterized in that: The invention is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used oral preparation in medicine.

4. The Chinese medicine composition for treating gout according to claim 3, characterized in that: The oral preparations are tablets, capsules, pills, granules and oral liquids.

5. A method for preparing the Chinese medicine composition for treating gout according to any one of claims 1 to 4, characterized in that: It includes the following steps: a. Weigh the APIs of various weight ratios; b. Powdering, or boiling with water, filtering, concentrating, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used oral preparation in medicine.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating gout.

7. The use according to claim 6, characterized in that: The medicine is a medicine for treating gout in the interictal period and / or the chronic tophi lesion period.

8. The use according to claim 6, characterized in that: The medicine is used for treating gout caused by internal retention of phlegm and turbidity and damage to qi and body fluid.

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