CN112168904A - Traditional Chinese medicine compound preparation for treating osteoarthritis and preparation method thereof - Google Patents

Abstract

A traditional Chinese medicine compound preparation for treating osteoarthritis and a preparation method thereof belong to the technical field of traditional Chinese medicine preparations. The effective components of the traditional Chinese medicine compound preparation for treating osteoarthritis are prepared from 6-15 parts of eucommia ulmoides, 6-12 parts of achyranthes bidentata, 6-12 parts of parasitic loranthus, 6-12 parts of drynaria rhizome, 6-15 parts of cuttlebone, 6-12 parts of homalomena occulta and 6-12 parts of pyrola. According to the traditional Chinese medicine compound preparation for treating osteoarthritis, traditional Chinese medicines such as eucommia ulmoides, achyranthes bidentata, parasitic loranthus, drynaria rhizome, cuttlebone, obscured homalomena rhizome and pyrola are selected for compatibility, and the medicines are combined to generate a synergistic effect on the effects of the medicines, so that osteoarthritis can be effectively treated, the side effect is small, and the traditional Chinese medicine compound preparation has a certain treatment effect on osteoporosis. The traditional Chinese medicine compound preparation for treating osteoarthritis has the functions of tonifying liver and kidney, dispelling wind and dredging collaterals, has short treatment course for treating osteoarthritis, takes effect quickly, is not easy to relapse after healing, is low in price, is not easy to relapse, and is convenient to use.

Description

Traditional Chinese medicine compound preparation for treating osteoarthritis and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine compound preparation for treating osteoarthritis and a preparation method thereof.

Background

Osteoarthritis (Osteoarthritis OA) is one of chronic and progressive joint diseases with high teratogenesis rate and disability rate in the world at present caused by multiple factors such as age, obesity, inflammation, trauma, heredity and the like, and the osteoarticular diseases are mainly characterized by degeneration and destruction of articular cartilage, subchondral bone sclerosis or cystic degeneration, joint marginal hyperosteogeny, synovial hyperplasia and the like. The OA attack population is concentrated in the middle-aged and elderly people, the clinical incidence rate gradually increases with the age, and in the population over 60 years, the incidence rate of the OA attack is 10% in men and 18% in women. At present, western medicines such as inflammation diminishing and pain relieving are mainly used for treatment in clinic, but clinical researches indicate that the prognosis of patients is poor after long-term administration, and the gastrointestinal and cardiovascular diseases of the patients are damaged to a certain extent.

OA belongs to the field of bone bi-syndrome and kidney bi-syndrome in traditional Chinese medicine, and Su Wen & Chang Ci Ji Lun indicates that the disease is in bones, the weight of bones cannot be lifted, the bone position is sore and painful, and the cold qi reaches, so that the disease is named as bone bi-syndrome. Huatuo recorded in Zhongzang Jing: for arthralgia syndrome, there is a lack of desire and damage to the kidney … …, which leads to a decline of the essence and qi. Zhang's Yi Tong' cloud: the knee pain is caused by the deficiency of liver and kidney. The disease mainly occurs in joints and tendons, and the disease can affect joints of four limbs or spinal rods, and has the basic pathological characteristics of joint corrosion and tendon contracture. For those who cause the disease, the disease is usually in the joints of the limbs, bones and muscles at the beginning, and the disease may invade the liver and kidney after a long time. Doctors and families consider that the basic pathogenesis of the liver-kidney deficiency is the deficiency of the liver and the kidney, and the diseases are mainly caused by the reasons of yang deficiency and blood stasis of organisms, deficiency of essence and blood, invasion of wind-cold-dampness and the like, so that qi and blood congealing, bone malnutrition and tendon and vessel obstruction are treated, and the liver and kidney tonifying, wind dispelling and collateral dredging are suitable for treatment.

Due to the great side effects of western medicines, people have great demand for traditional Chinese medicines for effectively treating osteoarthritis, and with the continuous development and promotion of traditional Chinese medicines, the western medicines are widely applied to the treatment of osteoarthritis in recent years. The traditional Chinese medicine has unique advantages for treating the disease and has great potential.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a traditional Chinese medicine compound preparation with obvious curative effect on treating osteoarthritis and a preparation method thereof.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

a traditional Chinese medicine compound preparation for treating osteoarthritis comprises the following active ingredients in parts by weight:

in the traditional Chinese medicine compound preparation for treating osteoarthritis, the drug effects of the raw material medicines are as follows:

eucommia bark is the bark of eucommia ulmoides of the family eucommia, is sweet, slightly pungent and warm in nature, enters lung, liver and kidney channels, has the effect of tonifying liver and kidney and strengthening tendons and bones, and is a common medicine for treating osteoarthritis in the orthopedics and traumatology of traditional Chinese medicine. Research shows that the effective ingredients of eucommia bark have the effect of inhibiting the growth of arthritic synovial fibroblasts, can not only regulate and control the expression of degradation substances MMPs and TIMPs of chondrocytes to play the role of protecting articular cartilage, but also have the bidirectional regulation effect of promoting osteogenic differentiation of mesenchymal stem cells and inhibiting adipogenic differentiation of the mesenchymal stem cells, and participate in bone remodeling and bone metabolism of subchondral bone.

Achyranthes root, radix sophorae flavescentis, radix glycyrrhizae, sour and mild, has the functions of removing blood stasis, stimulating the menstrual flow, tonifying liver and kidney, strengthening muscles and bones, inducing diuresis, treating stranguria and guiding blood to descend, can mainly treat soreness and pain of waist and knees and weakness of muscles and bones, contains triterpenoid saponin, polysaccharide, ketosteroid, amino acid, anti-fertility protein and the like, and has the pharmacological effects of easing pain, resisting inflammation, expanding blood vessels, resisting blood coagulation, enhancing immunity and the like. Research shows that the achyranthes bidentata polysaccharide can reduce the level of osteopontin of a new zealand rabbit modeled by KOA, and the higher the level of osteopontin is, the more serious the KOA is, so that the achyranthes bidentata polysaccharide can have a treatment effect on knee osteoarthritis of the rabbit to a certain extent.

Loranthus mulberry mistletoe, bitter and sweet in taste, neutral in nature, has the effects of expelling wind-damp, tonifying liver and kidney, and strengthening tendons and bones. Modern experiments prove that the main active pharmaceutical ingredient of the loranthus parasiticus is a flavonoid compound, and in addition, high molecular compounds such as alkaloid, terpenoid, polypeptide, protein, lectin and polysaccharide and small molecular compounds such as organic acid have the effects of resisting inflammation, easing pain, calming, resisting oxidation, resisting tumors and viruses, improving the expression level of osteoprotegerin and reducing interleukin secretion.

Drynaria rhizome, a perennial pteridophyte in the department of Polypodiaceae, bitter and pungent in taste and warm in nature, and enters kidney and spleen meridians. Has effects in invigorating kidney, supporting yang, arresting spontaneous emission, reducing urination, relieving lumbago due to kidney deficiency, warming spleen, relieving diarrhea, and relieving asthma. Modern pharmacology and clinical research shows that the rhizoma drynariae has the effects of promoting proliferation and differentiation, resisting osteoporosis, resisting inflammation, promoting fracture healing and the like, has the effect of stimulating cell compensatory proliferation on bone articular cartilage, can change the function of cartilage cells, can partially improve the degeneration of the articular cartilage caused by the change of mechanical stress lines, reduces the incidence rate and incidence degree of the osteoarthropathy and delays the incidence time.

The cuttlebone is the inner shell of sepiella maindroni or sepia esculenta of the marine animals of the family sepiidae, is salty, astringent and slightly warm, enters liver and kidney meridians, has the effects of securing essence and stopping leucorrhea, astringing and stopping bleeding, relieving hyperacidity and pain, astringing dampness and healing sores, and has research on the research that the cuttlebone is related to angiogenesis, has the effect of promoting osteoinduction in the early stage of formation of fracture cartilage and has great influence on the proliferation and synthesis activity of osteoblasts.

Rhizoma homalomenae is the dried rhizome of rhizoma homalomenae of genus Homalomena of family Araceae of dicotyledonous plant, which is bitter, pungent and warm, and enters liver and kidney meridians. Has effects of dispelling pathogenic wind and removing dampness, relieving rigidity of muscles and activating collaterals, relieving pain and detumescence etc., and can be used for treating anemofrigid-damp arthralgia, knee psychroalgia, spasm and numbness, and bone flaccidity and softness. Modern pharmacological researches find that the compound has the effects of anti-inflammatory and analgesic activity, anti-senile dementia activity, anti-pathogenic microorganism activity, insecticidal activity, anti-tumor activity, antioxidant activity and the like.

Herba Pyrolae is dry whole plant of Pyrolaceae herba Pyrolae and common herba Pyrolae, sweet, bitter and warm, and has effects of dispelling pathogenic wind and dampness, strengthening tendons and bones, stopping bleeding and relieving cough, and can be used for treating rheumatalgia, kidney essence deficiency and lumbodynia, weakness of waist and knees, menorrhagia, and chronic cough, contains various chemical components including flavonoids, phenol glycosides, quinones, and terpenoids, and has antibacterial, antiinflammatory, cardiovascular system function, antioxidant, antitumor, and osteoblast proliferation promoting effects.

According to the traditional Chinese medicine compound preparation for treating osteoarthritis, traditional Chinese medicines such as eucommia ulmoides, achyranthes bidentata, parasitic loranthus, drynaria rhizome, cuttlebone, obscured homalomena rhizome and pyrola are selected for compatibility, and the medicines are combined to generate a synergistic effect on the effects of the medicines, so that osteoarthritis can be effectively treated, the side effect is small, and the traditional Chinese medicine compound preparation has a certain treatment effect on osteoporosis. The traditional Chinese medicine compound preparation for treating osteoarthritis has the functions of tonifying liver and kidney, dispelling wind and dredging collaterals, has short treatment course for treating osteoarthritis, takes effect quickly, is not easy to relapse after healing, is low in price, is not easy to relapse, and is convenient to use.

As the optimal technical scheme of the traditional Chinese medicine compound preparation for treating osteoarthritis, the effective components are prepared from the following traditional Chinese medicine raw materials in parts by weight:

as a further preferable technical scheme of the traditional Chinese medicine compound preparation for treating osteoarthritis, the effective components are prepared from the following traditional Chinese medicine raw materials in parts by weight:

the preparation method of the traditional Chinese medicine compound preparation for treating osteoarthritis comprises the following steps:

1) cleaning 7 medicinal materials, mixing according to a ratio, adding 70% ethanol with the weight 5-10 times of that of the medicinal materials for each time, performing reflux extraction for 2 times, performing reflux extraction for 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.0-1.2 at the temperature of 60 ℃;

2) and making into tablet, capsule, granule, dripping pill, oral liquid, syrup, dispersible tablet or effervescent tablet by conventional method.

Drawings

FIG. 1 shows the comparison of joint mobility of rats in each group.

FIG. 2 is a comparison of synovial thickness of rat joints in each group.

FIG. 3 is a comparison of TNF-. alpha.and IL-6 in the serum of rats of each group.

FIG. 4 shows a comparison of MMP-3 and TIMP-1 in the serum of rats in each group.

Detailed Description

The compound Chinese medicinal preparation for treating osteoarthritis is further detailed in the following by combining the attached drawings and examples.

Example 1

1) Cleaning 12g of eucommia bark, 10g of achyranthes root, 10g of loranthus parasiticus, 8g of drynaria rhizome, 15g of cuttlebone, 12g of obscured homalomena rhizome and 12g of pyrola, mixing, adding 70% ethanol with the weight being 7 times of that of the mixture for reflux extraction for 2 times and 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.15 at the temperature of 60 ℃;

2) and preparing into granules by adopting a conventional preparation process.

Example 2

1) Cleaning 9g of eucommia bark, 10g of achyranthes root, 8g of loranthus parasiticus, 9g of drynaria rhizome, 12g of cuttlebone, 12g of obscured homalomena rhizome and 9g of pyrola, mixing, adding 70% ethanol with the weight 5 times of that of the mixture each time, performing reflux extraction for 2 times, 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1 at the temperature of 60 ℃;

2) and preparing into tablets by adopting a conventional preparation process.

Example 3

1) Cleaning 12g of eucommia bark, 8g of achyranthes root, 10g of loranthus parasiticus, 7g of drynaria rhizome, 15g of cuttlebone, 10g of obscured homalomena rhizome and 12g of pyrola, mixing, adding 70% ethanol with the weight being 8 times of that of the mixture each time, performing reflux extraction for 2 times, 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.2 at the temperature of 60 ℃;

2) and making into capsule by conventional method.

Example 4

1) Cleaning 15g of eucommia bark, 6g of achyranthes root, 12g of loranthus parasiticus, 6g of drynaria rhizome, 15g of cuttlebone, 6g of obscured homalomena rhizome and 12g of pyrola, mixing, adding 70% ethanol with the weight being 9 times of that of the mixture for reflux extraction for 2 times and 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.05 at the temperature of 60 ℃;

2) and preparing the oral liquid by adopting a conventional preparation process.

Example 5

1) Cleaning 6g of eucommia bark, 12g of achyranthes root, 6g of loranthus parasiticus, 12g of drynaria rhizome, 6g of cuttlebone, 12g of obscured homalomena rhizome and 6g of pyrola, mixing, adding 70% ethanol with the weight of 6 times of that of the mixture for reflux extraction for 2 times and 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.1 at the temperature of 60 ℃;

2) and making into syrup by conventional method.

First, animal experiment

(1) Osteoarthritis animal model establishment and grouping

Adopting 64 SPF SD rats with half male and female, 8 weeks old and weight (200 +/-20) g, randomly dividing the SD rats into 4 groups, namely a healthy control group, a model group, a positive control group and an administration group, wherein each group comprises 16 rats; after the rats were anesthetized with pentobarbital sodium, 0.2mL of 4% papain physiological saline was injected into the right knee cavities of the rats 1 time every 3 days, and 3 times of continuous injection were performed. After 2 weeks a stable KOA model was obtained. And normal group right knee joint cavity is injected with normal saline with equal dosage. After the molding is successful, the injection is carried out by intragastric administration according to the body weight, and the positive control group (glucosamine 86.40g/kg/d) and the administration group (7.56g/kg) are continuously administered for 30d once a day; rats in the normal control group and the model group were drenched with physiological saline of equal volume.

(2) Index detection

1) Measurement of Joint mobility and synovial thickness of rat

The rats in the anesthesia state are measured 12h after the last administration, and the angle of the right knee joint which extends to the retraction state under the action of external force is measured by a scale protractor. After the rats were sacrificed, the synovial tissue was scraped after the rat right knee joint cavity was opened, and the synovial thickness of the joints was measured with a fast-forward micrometer. Compared with the normal control group, the joint mobility of the model group rats is obviously reduced, and the synovial thickness of joints is obviously increased (P < 0.05); compared with the model group, the joint mobility of rats in the administration group and the glucosamine group is remarkably increased, the joint synovial membrane thickness is remarkably reduced, the difference is statistically significant (P <0.05), compared with the administration group and the glucosamine group, the difference is not statistically significant (P >0.05), and the specific results are shown in figure 1 and figure 2.

2) ELISA method for detecting serum TNF-alpha, IL-6, MMP-3 and TIMP-1

Collecting blood from abdominal aorta of rat, centrifuging at 3000rpm for 5min, collecting supernatant, and determining TNF-alpha, IL-6, MMP-3, and TIMP-1 by ELISA kit; the inflammatory response is one of the main causes of cartilage degeneration and is mainly manifested by increased levels of inflammatory factors such as TNF-alpha and IL-6. MMP-3 can promote the degradation of proteoglycan in cartilage matrix, and TIMP-1 is a specific inhibitor of MMP-3. The experimental results show that: compared with a normal control group, the release of TNF-alpha and IL-6 in the serum of a rat in the model group is up-regulated, the MMP-3 level is obviously increased, and the TIMP-1 level is obviously reduced (P <0.05 or P < 0.01); the administration group and the glucosamine group can obviously reduce TNF-alpha, IL-6 and MMP-3 in the serum of a rat of a KOA model, and can up-regulate the TIMP-1 level (P <0.05 or P <0.01), the effect of the administration group has no statistical significance (P >0.05) compared with the positive control group, and the specific results are shown in figure 3 and figure 4.

Second, survey of curative effect

80 osteoarthritis patients are selected to be treated by the compound traditional Chinese medicine granules prepared in the embodiment 1; 37 male, 43 female and 40-68 years old, wherein the average age is 51 years old. The course of disease is 0.5-15 years. The clinical manifestations are slowly-developed therapeutic effect evaluation criteria of arthralgia, tenderness, stiffness, joint swelling, limited movement, joint deformity and the like:

(1) and curing: after taking the compound traditional Chinese medicine granule for 2 courses of treatment, the pain symptom of the patient disappears, and the joint can move normally;

(2) and effective: after taking the compound traditional Chinese medicine granule for 2 courses of treatment, the pain symptoms of patients basically disappear, and the joint mobility is improved;

(3) and (3) invalidation: after taking the compound traditional Chinese medicine granule for 2 courses of treatment, pain and joint limitation are not improved or even aggravated.

The result of the curative effect evaluation is as follows:

after 80 cases of osteoarthritis patients take the compound traditional Chinese medicine granule for 2 courses of treatment, 26 cases are cured, 53 cases are effective, and 1 case is ineffective. The total effective rate is very obvious.

Three, typical cases

Case 1

After taking the compound traditional Chinese medicine granule for 2 courses of treatment, the joint has no obvious pain, the night sleep is safe and the symptom is not recurrent, so that the patient is difficult to feel, and the patient is diagnosed as the osteoarthritis.

Case 2

For example, the age of 67 years, osteoarthritis 20 years, swelling and pain in the joints of both knees, difficulty in flexion and extension, difficulty in walking, and pain and discomfort caused by dragging of the joints from the left knee to the left toe. The symptoms can be improved by administering "joint sealing needle", and the symptoms are repeated by administering "prednisone". After the compound traditional Chinese medicine granules are taken for 3 courses of treatment, the symptoms of joint swelling and pain gradually disappear, and the joint swelling and pain do not relapse.

Case 3

Ma Chi, woman, age 64 years old, osteoarthritis is diagnosed for more than 10 years. The patient suffered from neck and neck pain 10 years ago, suffered from shoulder joint pain, was difficult to lift, had knee joint pain, was difficult to walk, had numbness of hands and feet, had occasional dizziness, and had swollen lips, swollen parotid gland, slightly swollen joints and limited flexion and extension. After the compound traditional Chinese medicine granule is used for treatment, after three continuous courses of treatment, the joint has no obvious pain, and the symptoms such as dizziness, deadlimb and the like do not exist.

The foregoing is merely exemplary and illustrative of the principles of the present invention and various modifications, additions and substitutions of the specific embodiments described herein may be made by those skilled in the art without departing from the principles of the present invention or exceeding the scope of the claims set forth herein.

Claims (4)

1. The traditional Chinese medicine compound preparation for treating osteoarthritis is characterized in that the effective components are prepared from the following traditional Chinese medicine raw materials in parts by weight:

2. the compound traditional Chinese medicine preparation for treating osteoarthritis as claimed in claim 1, wherein the active ingredients are prepared from the following traditional Chinese medicine raw materials in parts by weight:

3. the compound traditional Chinese medicine preparation for treating osteoarthritis as claimed in claim 2, wherein the active ingredients are prepared from the following traditional Chinese medicine raw materials in parts by weight:

4. a method for preparing the compound Chinese medicinal preparation for treating osteoarthritis according to claim 1, 2 or 3, which comprises the following steps:

1) cleaning 7 medicinal materials, mixing according to a ratio, adding 70% ethanol with the weight 5-10 times of that of the medicinal materials for each time, performing reflux extraction for 2 times, performing reflux extraction for 1 hour each time, combining 2 extracting solutions, filtering and concentrating to obtain a fluid extract with the specific gravity of 1.0-1.2 at the temperature of 60 ℃;

2) and making into tablet, capsule, granule, dripping pill, oral liquid, syrup, dispersible tablet or effervescent tablet by conventional method.

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