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

Abstract

The invention discloses a traditional Chinese medicine composition for treating gout and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition for treating gout comprises the following raw materials in parts by weight: 1-20 parts of eucommia ulmoides, 1-20 parts of radix achyranthis bidentatae, 1-20 parts of radix angelicae pubescentis, 1-20 parts of corydalis tuber and 1-20 parts of notopterygium root. According to the traditional Chinese medicine composition, eucommia ulmoides and radix achyranthis bidentatae serve as monarch drugs, radix angelicae pubescentis and rhizoma corydalis serve as ministerial drugs, notopterygium root serves as an adjuvant drug, all the drugs are combined, the effects of tonifying liver and kidney, strengthening muscles and bones, dispelling wind, eliminating dampness, promoting blood circulation to arrest pain are achieved, the effects of reducing uric acid, eliminating swelling and relieving pain are achieved, the good treatment effect on gout is achieved, meanwhile, gout recurrence can be prevented, and the traditional Chinese medicine composition is safe and free of side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and particularly relates to a traditional Chinese medicine composition for treating gout, its preparation method and application. Background Technology

[0002] Gout is an acute or chronic inflammation and tissue damage caused by the deposition of monosodium urate crystals in bones, joints, kidneys, and subcutaneous tissues. It is directly related to hyperuricemia caused by purine metabolism disorders and reduced uric acid excretion. Clinically, it manifests as hyperuricemia and urate crystal deposition. Deposition in joints leads to gouty arthritis, while deposition in the kidneys results in urinary tract stones or kidney stones. In severe cases, it can lead to decreased kidney function and eventually gouty nephropathy. Currently, conventional Western medicine treatments for gout include nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids, which are effective in reducing inflammation and pain. Commonly used drugs for lowering uric acid include allopurinol, febuxostat, benzbromarone, and probenecid. While these drugs have some efficacy in treating gout, they have many side effects, and the condition is prone to relapse after discontinuation. Traditional Chinese medicine, with its widely available raw materials and safety profile, is considered an important treatment method. Therefore, it is particularly important to provide a safe and side-effect-free traditional Chinese medicine composition that can lower uric acid, effectively relieve gout symptoms, and prevent gout recurrence. Summary of the Invention

[0003] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating gout, which can effectively lower uric acid, eliminate swelling, and relieve pain, and has a good therapeutic effect on gout. At the same time, it can prevent gout recurrence and is safe and has no side effects.

[0004] Another object of the present invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition.

[0005] Another object of the present invention is to provide the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating gout.

[0006] Another object of the present invention is to provide a medicine for treating gout.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0008] This invention provides a traditional Chinese medicine composition for treating gout, the composition comprising the following raw materials in parts by weight: 1-20 parts of Eucommia ulmoides, 1-20 parts of Achyranthes bidentata, 1-20 parts of Angelica pubescens, 1-20 parts of Corydalis yanhusuo, and 1-20 parts of Notopterygium incisum.

[0009] Preferably, the composition comprises the following raw materials in parts by weight: 2-15 parts of Eucommia ulmoides, 3-16 parts of Achyranthes bidentata, 2-14 parts of Angelica pubescens, 2-14 parts of Corydalis yanhusuo, and 1.5-10 parts of Notopterygium incisum.

[0010] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: weighing each raw material, drying, pulverizing and sieving, mixing, and obtaining the traditional Chinese medicine composition.

[0011] Preferably, the mesh size of the sieve is 80 to 150 mesh.

[0012] The present invention also provides the application of the traditional Chinese medicine composition in the preparation of a medicament for treating gout.

[0013] Preferably, the gout is primary gout.

[0014] The present invention also provides a medicament for treating gout, the medicament comprising the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0015] Preferably, the content of the traditional Chinese medicine composition in the drug is 0.01% to 100%.

[0016] Preferably, the drug dosage form includes decoction, pill, powder, ointment, granule, oral liquid, capsule or tablet.

[0017] Preferably, the excipients include one or more of stabilizers, binders, regulators, cosolvents, preservatives, surfactants, colorants, or sweeteners.

[0018] The beneficial effects of this invention are:

[0019] This invention provides a traditional Chinese medicine composition for treating gout, its preparation method, and its application. The composition uses Eucommia ulmoides and Achyranthes bidentata as the principal herbs, Angelica pubescens and Corydalis yanhusuo as the assistant herbs, and Notopterygium incisum as the adjuvant herb. Eucommia ulmoides and Achyranthes bidentata have the effects of tonifying the liver and kidneys and strengthening tendons and bones. When used together, they not only tonify the liver and kidneys and strengthen tendons and bones, but also dispel blood stasis, promote blood circulation, reduce uric acid production, and promote uric acid excretion. Combined with Angelica pubescens and Corydalis yanhusuo, which have the effects of promoting blood circulation, removing blood stasis, relieving pain, and relieving numbness, this composition can effectively improve the pain and discomfort caused by gout and enhance the analgesic effect. Notopterygium incisum, which has the effects of dispelling wind and cold and promoting joint mobility, assists in the efficacy of other herbs, while also enhancing the effects of lowering uric acid and relieving pain. The combined effects of these herbs tonify the liver and kidneys, strengthen tendons and bones, dispel wind and dampness, promote blood circulation, and relieve pain, achieving the effects of lowering uric acid, eliminating swelling, and relieving pain. This composition has a good therapeutic effect on gout, while also preventing gout recurrence, and is safe with no side effects. Detailed Implementation

[0020] This invention provides a traditional Chinese medicine composition for treating gout, the composition comprising the following raw materials in parts by weight: 1-20 parts of Eucommia ulmoides, 1-20 parts of Achyranthes bidentata, 1-20 parts of Angelica pubescens, 1-20 parts of Corydalis yanhusuo, and 1-20 parts of Notopterygium incisum.

[0021] In this invention, the Eucommia ulmoides is warm in nature and sweet in taste, and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys and strengthening tendons and bones, and is one of the principal herbs in the formula. The weight part of the Eucommia ulmoides is further preferably 2 to 15 parts, more preferably 5 to 13 parts. This invention does not have a special limitation on the source of Eucommia ulmoides, which can be obtained through commercially available purchases.

[0022] In this invention, the Achyranthes bidentata is neutral in nature, bitter and sour in taste, and enters the liver and kidney meridians. It has the effects of tonifying the liver and kidneys, strengthening tendons and bones, removing blood stasis and promoting blood circulation, and guiding blood downwards. It is one of the principal herbs in the formula. The weight of Achyranthes bidentata is further preferably 3 to 16 parts, more preferably 6 to 11 parts. This invention does not have a special limitation on the source of Achyranthes bidentata, which can be obtained through commercially available purchases.

[0023] In this invention, the Angelica pubescens is slightly warm in nature, bitter and pungent in taste, and enters the kidney and bladder meridians. It has the effects of dispelling wind and dampness, dispersing cold and relieving pain, and is one of the auxiliary herbs in the formula. The weight part of the Angelica pubescens is further preferably 2 to 14 parts, more preferably 2.5 to 9.5 parts. This invention does not have a special limitation on the source of Angelica pubescens, which can be obtained through commercially available purchases.

[0024] In this invention, the Corydalis rhizome is warm in nature and bitter in taste, and enters the liver and stomach meridians. It has the effects of promoting blood circulation, removing blood stasis, regulating qi, and relieving pain, and is one of the auxiliary herbs in the formula. The weight part of the Corydalis rhizome is further preferably 2 to 14 parts, more preferably 2 to 10 parts. This invention does not have a special limitation on the source of the Corydalis rhizome, which can be obtained through commercially available purchases.

[0025] In this invention, the notopterygium root is warm in nature, bitter in taste, and enters the bladder and kidney meridians. It has the effects of dispelling external cold, eliminating wind and dampness, and benefiting the joints, and is used as an adjuvant in the formula. The weight of the notopterygium root is further preferably 1.5 to 10 parts, more preferably 3 to 7 parts. This invention does not have a special limitation on the source of the notopterygium root, which can be obtained through commercially available purchases.

[0026] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: weighing each raw material, drying, pulverizing and sieving, mixing, and obtaining the traditional Chinese medicine composition.

[0027] In this invention, the drying and pulverizing methods can be conventionally selected according to actual needs; the mesh size of the sieve is preferably 80-150 mesh, more preferably 100-120 mesh. The pulverized and sieved Chinese herbal powder is then mixed evenly to obtain a Chinese herbal composition.

[0028] The present invention also provides the application of the traditional Chinese medicine composition in the preparation of a medicament for treating gout.

[0029] In this invention, the gout is preferably primary gout. The drug may contain only one active ingredient from the traditional Chinese medicine composition, or it may contain other active ingredients that can treat gout. The traditional Chinese medicine composition of this invention can effectively reduce xanthine oxidase activity and uric acid levels, effectively lower uric acid levels in gout patients, eliminate swelling, relieve pain, and prevent gout recurrence, thus exhibiting good therapeutic effects on gout.

[0030] The present invention also provides a medicament for treating gout, the medicament comprising the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0031] In this invention, the dosage form of the drug is not specifically limited and can be conventionally selected according to actual needs, including but not limited to decoctions, pills, powders, ointments, granules, oral liquids, capsules, or tablets. The excipients can be conventionally selected according to the drug dosage form, including but not limited to one or more of stabilizers, binders, regulators, solubilizers, preservatives, surfactants, colorants, or sweeteners. The content of the traditional Chinese medicine composition in the drug can be conventionally selected according to actual needs; for example, the content of the traditional Chinese medicine composition in this invention can be 0.01% to 100%. The method of administration of the drug in this invention can be conventionally selected according to actual needs, preferably oral or injection; the dosage of the drug can be conventionally selected according to actual needs; for example, the dosage of the drug is 0.01 μg to 10 g / day.

[0032] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0033] Unless otherwise specified, the following embodiments are all conventional methods.

[0034] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0035] Example 1

[0036] A traditional Chinese medicine composition for treating gout:

[0037] Eucommia ulmoides 15 parts, Achyranthes bidentata 16 parts, Angelica pubescens 14 parts, Corydalis yanhusuo 14 parts, Notopterygium incisum 10 parts.

[0038] The preparation method of the traditional Chinese medicine composition is as follows:

[0039] Weigh each raw material according to the above-mentioned weight proportions, dry, pulverize, pass through an 80-mesh sieve, and mix well to obtain a traditional Chinese medicine composition.

[0040] Example 2

[0041] A traditional Chinese medicine composition for treating gout:

[0042] Eucommia ulmoides 2 parts, Achyranthes bidentata 3 parts, Angelica pubescens 2 parts, Corydalis yanhusuo 3 parts, Notopterygium incisum 1.5 parts.

[0043] The preparation method of the traditional Chinese medicine composition is as follows:

[0044] Weigh each raw material according to the above-mentioned weight proportions, dry, pulverize, pass through a 150-mesh sieve, and mix well to obtain a traditional Chinese medicine composition.

[0045] Example 3

[0046] A traditional Chinese medicine composition for treating gout:

[0047] Eucommia ulmoides 13 parts, Achyranthes bidentata 11 parts, Angelica pubescens 9.5 parts, Corydalis yanhusuo 10 parts, Notopterygium incisum 7 parts.

[0048] The preparation method of the traditional Chinese medicine composition is as follows:

[0049] Weigh each raw material according to the above-mentioned weight proportions, dry, pulverize, pass through a 100-mesh sieve, and mix well to obtain a traditional Chinese medicine composition.

[0050] Example 4

[0051] A traditional Chinese medicine composition for treating gout:

[0052] Eucommia ulmoides 5 parts, Achyranthes bidentata 6 parts, Angelica pubescens 2.5 parts, Corydalis yanhusuo 2 parts, Notopterygium incisum 3 parts.

[0053] The preparation method of the traditional Chinese medicine composition is as follows:

[0054] Weigh each raw material according to the above-mentioned weight proportions, dry, pulverize, pass through a 120-mesh sieve, and mix well to obtain a traditional Chinese medicine composition.

[0055] Example 5

[0056] A traditional Chinese medicine composition for treating gout:

[0057] Eucommia ulmoides 8 parts, Achyranthes bidentata 9 parts, Angelica pubescens 7 parts, Corydalis yanhusuo 6 parts, Notopterygium incisum 5 parts.

[0058] The preparation method of the traditional Chinese medicine composition is as follows:

[0059] Weigh each raw material according to the above-mentioned weight proportions, dry, pulverize, pass through a 100-mesh sieve, and mix well to obtain a traditional Chinese medicine composition.

[0060] Comparative Examples 1-8

[0061] A traditional Chinese medicine composition, the weight parts of each raw material are shown in Table 1:

[0062] Table 1. Raw material composition of the traditional Chinese medicine compositions in Comparative Examples 1-8

[0063] raw material Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 Comparative Example 7 Comparative Example 8 Eucommia - 8 8 8 8 - 8 8 Achyranthes bidentata 9 - 9 9 9 9 9 9 Angelica pubescens 7 7 - 7 7 7 7 7 Corydalis 6 6 6 - 6 6 - 6 Notopterygium 5 5 5 5 - 5 5 - Poria - - - - - 8 - - Clematis - - - - - - 6 - Huangbai - - - - - - - 5

[0064] Preparation method of traditional Chinese medicine composition: The preparation methods of Comparative Examples 1-8 are the same as those of Example 5, except that the composition of traditional Chinese medicine raw materials in the above-mentioned traditional Chinese medicine compositions is different.

[0065] Experimental Example 1

[0066] 1. Experimental animals: 96 SPF-grade male Kunming mice, weighing 18-22g.

[0067] 2. Drug preparation: Take the traditional Chinese medicine composition of Example 5 and Comparative Examples 1-8 respectively, add it to distilled water to prepare drug suspension, and prepare drug concentration according to 10 mL distilled water / kg mouse body weight.

[0068] 3. Experimental grouping: After 1 week of acclimatization feeding, the mice were randomly divided into 12 groups of 8 mice each, namely control group, model group, positive group (allopurinol), experimental group 1 (Example 5), experimental group 2 (comparative example 1), experimental group 3 (comparative example 2), experimental group 4 (comparative example 3), experimental group 5 (comparative example 4), experimental group 6 (comparative example 5), experimental group 7 (comparative example 6), experimental group 8 (comparative example 7), and experimental group 9 (comparative example 8).

[0069] 4. Experimental Methods: Mice in the positive control group were administered allopurinol 40 mg / kg daily by gavage. Experimental groups 1-9 were administered drug suspensions prepared from the traditional Chinese medicine compositions of Example 5 or Comparative Examples 1-8 daily by gavage, with a dosage of 0.77 g / kg. The control and model groups were administered the same volume of distilled water daily by gavage. Administration was repeated once daily for 7 consecutive days. One hour before the last administration, except for the control group, mice in the other groups were intraperitoneally injected with potassium oxonate 300 mg / kg to induce a mouse model of hyperuricemia. Mice in the control group were injected with an equal volume of physiological saline. One hour after the last administration, blood was collected by enucleation, and serum uric acid (UA) levels and xanthine oxidase (XOD) activities were measured in each group. The results are shown in Table 2.

[0070] Table 2. UA content and XOD activity in mice of each group

[0071] Grouping UA (μmol / L) XOD(U / L) control group 121.68±12.02 7.33±0.64 Model group 212.96±21.66 10.52±0.75 Positive group (allopurinol) 127.91±17.13 7.74±0.73 Experimental Group 1 (Example 5) 143.45±11.51 7.70±0.96 Experimental Group 2 (Comparative Example 1) 182.43±14.30 9.53±0.92 Experimental group 3 (Comparative example 2) 193.64±19.66 9.81±1.03 Experimental group 4 (Comparative example 3) 176.84±14.61 8.66±0.98 Experimental group 5 (Comparative example 4) 183.34±16.32 8.81±1.00 Experimental group 6 (Comparative example 5) 171.00±17.40 8.76±0.86 Experimental group 7 (Comparative example 6) 160.87±15.01 9.25±1.02 Experimental group 8 (Comparative example 7) 167.13±15.59 9.28±0.80 Experimental group 9 (Comparative example 8) 162.61±15.89 8.29±0.82

[0072] As shown in Table 2, compared with the control group, the UA content and XOD activity in the model group were significantly increased, indicating that the hyperuricemia mouse model was successfully established. Compared with the model group, gavage administration of the traditional Chinese medicine composition of Example 5 of this invention significantly reduced the UA content and XOD activity in mice, indicating that the traditional Chinese medicine composition of this invention has a uric acid-lowering effect. A comparison of the results of experimental groups 1-6 shows that omitting any one ingredient in the traditional Chinese medicine composition of this invention significantly reduces its uric acid-lowering ability. A comparison of the results of experimental groups 1 and 7-9 shows that replacing Eucommia ulmoides, Corydalis yanhusuo, or Notopterygium incisum in the traditional Chinese medicine composition of this invention with commonly used traditional Chinese medicine ingredients for treating gout (Poria cocos, Clematis chinensis, or Phellodendron chinense) also reduces its uric acid-lowering efficacy. This demonstrates that the various ingredients in the traditional Chinese medicine composition of this invention work synergistically to achieve a uric acid-lowering effect.

[0073] Using the same experimental methods described above, the effects of the traditional Chinese medicine compositions of Examples 1-4 on UA ​​and XOD in hyperuricemic mice were verified, showing results similar to those of the traditional Chinese medicine composition of Example 5. This indicates that the traditional Chinese medicine compositions of the present invention have the effect of lowering uric acid and can be used to treat gout.

[0074] Experimental Example 2

[0075] 1. General Information: 120 patients with gout, aged 18-70 years, were randomly divided into 4 groups (control group, experimental group 1, experimental group 2, and experimental group 3), with 30 patients in each group. Pregnant and lactating women, patients with severe cardiovascular, liver, or kidney diseases, mental disorders, and patients with drug allergies were excluded.

[0076] 2. Diagnostic criteria: The diagnosis of gout conforms to the diagnostic criteria of the Chinese Rheumatology Society's "Guidelines for the Diagnosis and Treatment of Primary Gout" and the TCM industry standard "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine".

[0077] 3. Treatment methods: The control group received febuxostat tablets orally, 20 mg once daily; experimental groups 1-3 received the traditional Chinese medicine composition prepared in Examples 3-5, 3 g twice daily. Both the control and experimental groups underwent daily dietary management, reducing the intake of purines and high-sugar foods, abstaining from alcohol, and avoiding strenuous exercise. One course of treatment lasted 7 days, with 4 courses of treatment administered.

[0078] 4. Efficacy evaluation criteria: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines":

[0079] (1) Clinical cure: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%;

[0080] (2) Significant effect: The clinical symptoms and signs of TCM are significantly improved, and the syndrome score is reduced by ≥70% and less than 95%;

[0081] (3) Effective: The clinical symptoms and signs of TCM patients have improved, and the syndrome score has decreased by ≥30% and is less than 70%;

[0082] (4) Ineffective: There is no significant improvement in the clinical symptoms and signs of TCM, or even aggravation, and the syndrome score decreases by <30%.

[0083] The efficacy calculation formula (nimodipine method) = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%

[0084] 5. Treatment efficacy

[0085] Table 3 Treatment Effects

[0086] Grouping Clinically cured Effective efficient invalid Overall efficiency control group 6 10 10 4 86.67％ Experimental Group 1 (Example 3) 9 13 8 0 100.00％ Experimental Group 2 (Example 4) 8 16 5 1 96.67％ Experimental Group 3 (Example 5) 11 15 4 0 100.00％

[0087] As shown in Table 3, the total effective rate of the traditional Chinese medicine composition for treating gout in this invention reached 96.67%–100%, which is 11.54%–15.38% higher than that of the control group. The proportion of patients with gout who achieved a cure or significant improvement with the traditional Chinese medicine composition reached 73.33%–86.67%, which is 37.50%–62.50% higher than that of the control group (53.33%). This indicates that the traditional Chinese medicine composition of this invention has a good therapeutic effect on gout.

[0088] Typical case:

[0089] Case 1: Mr. Liu, 32 years old, had recurrent gout attacks for 3 years. During an attack, his right ankle and first metatarsophalangeal joint were swollen and painful. After taking the traditional Chinese medicine composition of Example 1 of this invention, his uric acid level dropped to normal after 2 weeks. He continued to take it for 2 weeks and has not relapsed since stopping the medication.

[0090] Case 2: Ms. Chen, 41 years old, has a 7-year history of gout. Improper diet or irregular work and rest will cause repeated attacks, with swelling and pain in multiple joints. After taking the traditional Chinese medicine composition of Example 2 of this invention, her uric acid level dropped to normal after 1 month. She continued to take it for another month and has not relapsed since stopping the medication.

[0091] Case 3: Mr. Liao, 55 years old, has a history of gout for nearly 10 years. He has been taking Western medicine for many years, and his condition is prone to relapse after stopping the medication. When he relapses, he experiences severe pain in his ankle and knee joints. After taking the traditional Chinese medicine composition of Example 5 of this invention, his joint pain was significantly relieved after one week of use. After taking it continuously for one month, his uric acid level dropped to normal. He continued to take it for two months and has not relapsed since stopping the medication.

[0092] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating gout, characterized in that, The composition comprises the following raw materials in parts by weight: 1-20 parts of Eucommia ulmoides, 1-20 parts of Achyranthes bidentata, 1-20 parts of Angelica pubescens, 1-20 parts of Corydalis yanhusuo, and 1-20 parts of Notopterygium incisum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition comprises the following raw materials in parts by weight: 2-15 parts of Eucommia ulmoides, 3-16 parts of Achyranthes bidentata, 2-14 parts of Angelica pubescens, 2-14 parts of Corydalis yanhusuo, and 1.5-10 parts of Notopterygium incisum.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 2, characterized in that, The process includes the following steps: weighing each raw material, drying, pulverizing and sieving, mixing, and obtaining a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The sieve mesh size is 80-150 mesh.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating gout.

6. The application according to claim 5, characterized in that, The gout mentioned is primary gout.

7. A medication for treating gout, characterized in that, The drug comprises the traditional Chinese medicine composition according to any one of claims 1 to 2 and pharmaceutically acceptable excipients.

8. The medicament according to claim 7, characterized in that, In the drug, the content of the traditional Chinese medicine composition is 0.01% to 100%.

9. The drug according to claim 7, characterized in that, The drug dosage forms include decoctions, pills, powders, ointments, granules, oral liquids, capsules, or tablets.

10. The medicament according to claim 7, characterized in that, The excipients include one or more of the following: stabilizers, binders, regulators, cosolvents, preservatives, surfactants, colorants, or sweeteners.