KR20220105445A - A traditional chinese medicinal composition for treating rheumatism diseases - Google Patents

Abstract

The present invention provides a traditional Chinese medicinal composition for the treatment of rheumatoid diseases. The traditional Chinese medicinal composition contains: 5 to 10 parts by weight of Pheretima communissima; 5 to 10 parts by weight of Ledebouriella seseloides; 5 to 10 parts by weight of Aster tataricus; 2 to 6 parts by weight of Eucommia ulmoides; 2 to 6 parts by weight of Phellodendron amurense; and 2 to 6 parts by weight of Salix pierotii branches. Compared to conventional traditional Chinese medicinal compositions for the treatment of rheumatoid diseases, the single Chinese medicine of the present invention has good compatibility and an excellent therapeutic effect after use. The pharmacodynamics of each component plays a synergistic role, the clinically proven therapeutic effect thereof is good, the therapeutic effect lasts for a long time, and the recurrence rate is low, thereby solving the problem of rheumatoid disease that could not be cured for a long time.

Description

A TRADITIONAL CHINESE MEDICINAL COMPOSITION FOR TREATING RHEUMATISM DISEASES

The present invention relates to the field of traditional Chinese medicine, specifically, to a composition of traditional Chinese medicine for the treatment of rheumatic diseases.

Rheumatism disease (rheumatism disease) is the most common disease in our daily life, and most of it is caused by joint disease, which is damaged by factors such as environment, diet, and disease. If these causes are not detected in a timely manner, they can cause local pain, numbness, bone swelling and other symptoms. Common clinical diseases include rheumatoid arthritis, gout, ankylosing spondylitis, frozen shoulder, osteoarthritis, and soft tissue injury.

According to statistics, about 2% of the world's population suffers from rheumatic diseases. According to the report, rheumatic diseases such as rheumatoid arthritis and ankylosing spondylitis have a high incidence of about 0.4% in our country. Because many patients have a high disability rate, which seriously threatens people's health, work and life, it is also referred to as "incurable cancer". In recent years, whether in traditional Chinese medicine or Western medicine, a lot of manpower and material resources have been invested in in-depth research on rheumatic diseases, and a deep and comprehensive understanding of the diseases has been achieved, such as etiology, detection methods and treatment Great progress has been made on the method. The main method of western medicine for rheumatism is non-steroidal drugs, but it has disadvantages such as large side effects, single effect and many contraindications. There is no specific treatment yet. Traditional Chinese medicine has gained some experience in treating rheumatic diseases, but there are few in-depth studies on its specific mechanism of action. Therefore, under the guidance of traditional Chinese medicine theory, it is the focus of current research to use modern science and technology to conduct in-depth research on the mechanism of Chinese medicine compounds with a definite therapeutic effect, and especially to find effective formulas of traditional Chinese medicine compositions.

Currently, Chinese patented pharmaceuticals for the treatment of rheumatic diseases are focused on treating cold-dampness blockage and blood congestion blockage. Current dosage forms are relatively diverse, such as medicinal wine, tincture, ointment, granules, tablets, pills, etc., most of the components of which are aconite, aconitum, horse money. Manufactured from horse money and other warm and yang products, which often include earthworms, scorpions, centipedes, pangolins, white flower snakes, apiaries and other pain-relieving insects It is compatible with pharmaceuticals. However, although existing formulas have a certain therapeutic effect on rheumatic diseases, most have problems of pungent heat, strong effects, and particularly strong toxicity. For example, horseshoe flower can cause aconitine poisoning, and strychnine can cause muscle cramps, convulsions and other problems. Therefore, the existing formula may have a certain effect in the treatment of rheumatic diseases.

In the treatment of rheumatic diseases, the existing western medicine and Chinese patented medicines have a certain therapeutic effect, but they cannot largely solve the side effects of western medicine and the strong toxicity of the existing Chinese patented medicines. The present applicant has many years of research experience in the field, and has abundant research experience on the suitability and compatibility of various Chinese medicine single drugs used in the field; As a result of long-term research, a more effective traditional Chinese medicine composition formula has been found, which can overcome the problems of low compatibility and low therapeutic effect of existing traditional Chinese medicine compositions.

In order to solve the problems of low compatibility and low therapeutic effect between components of traditional Chinese medicine compositions for the treatment of rheumatic diseases, the present application provides a Chinese medicine composition comprising single Chinese medicine preparations with good compatibility and excellent therapeutic effect after use. do. The present invention provides the following technical solutions.

A traditional Chinese medicine composition for the treatment of rheumatic diseases, the traditional Chinese medicine composition comprising on a weight basis: 5-10 parts Earthworm, 5-10 parts Windworm (Saposhnikoviae), 5-10 parts Jawan (Radix Asteris), and 2-6 parts Eucommia ulmoides, 2-6 parts Phellodendron chinense, 2-6 parts Willow branch.

Preferably, the traditional Chinese medicine composition comprises, by weight, 6-9 parts Guin, 6-9 parts Windbreak, 6-9 parts Jawan, 3-5 parts Duchung, 3-5 parts Huangbaek and 3-5 parts willow branches.

More preferably, the traditional Chinese medicine composition comprises on a weight basis: 8 parts Guin, 8 parts Windbreak, 8 parts Jawan, 4 parts Duchong, 4 parts Huangbaek and 4 parts Willow branch.

The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition comprising the steps of:

Step 1. Weigh the components of the traditional Chinese medicine according to the dosage, and for auxiliary materials, weigh 1-3 parts of filler, 1-2 parts of disintegrant and 0.2-1 part of binder by weight, pulverizing them respectively to obtain fine powders of each raw material;

Step 2: uniformly mixing the fine powders of the raw materials shown in step 1 above;

Step 3: Preparing wet granules having a particle size of 10-30 mesh by adding ethanol in an amount of 0.2-0.4 times by weight to the mixed medicinal powder of Step 2, drying, and compressing.

Preferably, the auxiliary substances are 2 parts filler, 1.5 parts disintegrant and 0.6 parts binder by weight;

Preferably, ethanol is added by weight 0.3 times;

the filler is at least one of sorbitol, mannitol, starch and polyethylene glycol; preferably sorbitol;

the disintegrant is at least one of sodium carboxymethyl cellulose, sodium starch and sodium carboxymethyl starch, preferably sodium carboxymethyl cellulose;

The binder is gelatin.

The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for the manufacture of a medicament for the treatment of rheumatic diseases.

Compared with the conventional traditional Chinese medicine composition for the treatment of rheumatic diseases, the single Chinese medicine of the present invention has good compatibility and excellent therapeutic effect after use. Pharmacodynamics of each component act synergistically, and its clinically proven therapeutic effect is good, the therapeutic effect is long lasting, and the recurrence rate is low, thereby solving the problem of rheumatic diseases that could not be treated for a long time. In addition, the manufacturing method of the traditional Chinese medicine composition of the present invention is simple, the efficacy of each component is maximized, and the use safety is good, which has good clinical practice and social value.

One. production example

production example One

The active ingredient of the drug substance is calculated on a weight basis:

8 parts Guinea, 8 parts Windbreak, 8 parts Jawan, 4 parts Duchung, 4 parts Yellow white, 4 parts Willow branch.

Step 1. Weighing out the above-mentioned Chinese medicine ingredients according to the dose, and for auxiliary substances, by weight, weighing 2 parts of filler, 1.5 parts of disintegrant and 0.6 parts of binder, and grinding them respectively to obtain fine powders of each raw material ;

Step 2: uniformly mixing the fine powders of the raw materials shown in step 1 above;

Step 3: Adding ethanol to the mixed medicinal powder of Step 2 in an amount of 0.3 times by weight to prepare wet granules having a particle size of 20 mesh, drying and compressing.

production example 2

Except for 5 parts guin, 5 parts windbreak, 5 parts jawan, 6 parts duchung, 6 parts hwangbaek, and 6 parts willow branches, the rest is the same as in Preparation Example 1.

production example 3

Except for 10 parts guin, 10 parts windbreak, 10 parts jawan, 2 parts cephalothorax, 2 parts hwangbaek, and 2 parts willow branch, the rest is the same as in Preparation Example 1.

production example 4

3 parts Angelica sinensis, 4 parts Rehmannia glutinosa, 3 parts burdock seed (Cocklebur Seed), and 1.5 parts eumyanggwak (Epimedium), except for additionally adding, the rest is the same as in Preparation Example 1.

production example 5

The rest is the same as in Preparation Example 1, except for additionally adding 2 parts Angelica Root, 3 parts Sukjihwang, 2 parts burdock seed, and 1 part eumyanggwak.

production example 6

The rest is the same as in Preparation Example 1, except for additionally adding 4 parts Angelica keis, 6 parts Sukjihwang, 4 parts burdock seed, and 2 parts eumyanggwak.

2. Examples of drug efficacy

The tablets prepared in Preparation Example 1 were clinically tested according to the following method:

According to the 2009 ACR/RULAR latest diagnostic criteria for rheumatoid arthritis (RA), 200 outpatient and inpatient cases were screened. According to a randomization scheme, they were divided into Preparation Example 1 and a control group, each with 100 cases. In Preparation Example 1, there were 50 females and 50 males, 22 to 80 years old, and their average age was 40 years; The course of the disease is 3 to 15 years. In the control group, there were 50 females and 50 males, aged 21 to 78 years, with an average age of 38 years; The course of the disease is 2 to 18 years. There were no significant differences between the two groups in terms of condition, sex, age and disease course.

All cases had a score of 6 or higher, meeting the latest diagnostic criteria for RA.

Exclusion Criteria:

① Women under the age of 21 and over the age of 80, pregnant or lactating women.

② Combination with infectious diseases such as hepatitis B.

③ Patients with allergies.

(If any one of the above is excluded)

treatment method

Controls: methotrexate tablets 7.5 mg/week, leflunomide 10 mg/day, sulfasalazine enteric-coated tablets 1.0 g/time, twice daily.

In the treatment group, in addition to the drug of the control group, the tablet of Preparation Example 1 was added, each 0.6 g, orally taken 3 times a day, and the dosage was 3-4 tablets each time. The course of treatment is 3 months.

Observation indicators and methods

See "Guiding Principles for Clinical Research of New Chinese Medicines". Significantly effective: the overall improvement of major symptoms and signs is ≥75%, and the erythrocyte sedimentation rate and CRP are normal or significantly improved or close to normal; improved: improvement of major symptoms and signs ≥50%, erythrocyte sedimentation rate and CRP improved; Effective: the overall improvement of major symptoms and signs is >30%, and the erythrocyte sedimentation rate and CRP are improved or not improved; Invalid: <30% improvement in major symptoms and signs, no improvement in erythrocyte sedimentation rate and CRP.

In the treatment group (addition of the tablet group of Preparation Example 1), 43 cases were significantly effective, 33 cases improved, 24 cases were effective, 0 cases were invalid, and significant effective rate was 43%, and the total effective rate was 100%; In the control group, 27 cases were significantly effective, 35 cases improved, 27 cases were effective, 11 cases were invalid, the significant efficacy rate was 27%, and the total efficacy rate was 89%. The difference between the two groups was very significant, and the treatment group was significantly better than the control group.

The traditional Chinese medicine composition for the treatment of rheumatic diseases of the present invention and its preparation method have been described through specific examples. A person skilled in the art can learn from the content of the present invention and change the raw materials, process conditions and other related matters as appropriate to achieve corresponding other objectives. All relevant modifications do not depart from the scope of the present invention, and all similar substitutions and modifications will be apparent to those skilled in the art and are considered to be included within the scope of the present invention.

Claims (4)

A traditional Chinese medicine composition for the treatment of rheumatism diseases, wherein the traditional Chinese medicine composition comprises, on a weight basis, the following:
5-10 parts Earthworm, 5-10 parts Windworm (Saposhnikoviae), 5-10 parts Radix Asteris, and 2-6 parts Eucommia ulmoides, 2-6 parts Yellow-white (Phellodendron chinense), 2 - Willow branch in 6 parts. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following by weight:
6-9 parts Guinea, 6-9 parts Windbreak, 6-9 parts Sawan, 3-5 parts Cucumber, 3-5 parts Yellow white, and 3-5 parts Willow branch. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following by weight:
8 parts Guinea, 8 parts Windbreak, 8 parts Jawan, 4 parts Duchung, 4 parts Yellow white, and 4 parts Willow branches. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 for the manufacture of a medicament for the treatment of rheumatic diseases.