Traditional Chinese medicine composition for treating cold-dampness arthralgia type knee osteoarthritis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating cold-dampness arthralgia type knee osteoarthritis. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-18 parts of radix paeoniae alba, 24-36 parts of morinda officinalis, 12-18 parts of poria cocos, 8-12 parts of radix saposhnikoviae, 8-12 parts of rhizoma cyperi, 8-12 parts of radix achyranthis bidentatae, 12-18 parts of dendrobe, 8-12 parts of yam rhizome, 8-12 parts of radix clematidis, 8-12 parts of eucommia ulmoides, 16-24 parts of rehmannia, 8-12 parts of liquorice and 12-18 parts of angelica sinensis. The invention further provides a preparation method and application of the traditional Chinese medicine composition. In the formula of the traditional Chinese medicine composition, besides warming yang, dispelling cold, resolving dampness and dredging arthralgia, the traditional Chinese medicine composition also has the effects of nourishing essence and blood, promoting qi circulation and relieving pain, perfectly accords with arthralgia treatment principles of tonifying and strengthening the body resistance and dispelling wind and eliminating dampness, and takes both symptoms and root causes into consideration. Clinical experiments prove that the medicine is used for treating cold-dampness arthralgia type knee osteoarthritis, the medicine effect is obvious, the use is safe, and a new medication choice is provided for clinic.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for treating knee osteoarthritis of cold-damp obstruction type, belonging to the field of traditional Chinese medicine. Background Art

[0002] Knee Osteoarthritis (KOA) is a chronic joint disease characterized by degenerative changes of knee joint cartilage and bone hyperplasia. It is the most common type of osteoarthritis, mainly affecting the structure and function of the knee joint. In the initial stage, most patients with knee osteoarthritis have mild symptoms. If not treated, the condition will gradually worsen. The main symptoms include knee pain, knee joint swelling, knee joint popping, etc. Knee joint stiffness and coldness are also one of the symptoms of knee osteoarthritis, mainly stiffness, aggravated by fatigue, cold exposure or minor trauma, and severe cases will have limited movement. Traditional Chinese medicine classification can be divided into:

[0003] Cold-damp obstruction type: The invasion of cold-damp pathogens into the joint leads to poor blood circulation. It is manifested as heavy and aching joint pain, aggravated by cold, relieved by warmth, restricted joint flexion and extension, pale tongue with white and greasy coating, and slow and moderate pulse.

[0004] Damp-heat accumulation type: The accumulation of damp-heat pathogens in the joint blocks the qi and blood. It can be seen that the joint is red, swollen, hot and painful, with difficulty in movement, accompanied by fever, thirst without desire to drink, red tongue with yellow and greasy coating, and slippery and rapid pulse.

[0005] Blood stasis obstruction type: Mostly due to trauma or long-term illness leading to blood stasis blocking the joint, and the qi and blood circulation is blocked. It is manifested as joint pain like needle pricks, fixed pain location, aggravated at night, joint swelling and deformation, purple and dull tongue or with ecchymosis, and unsmooth pulse.

[0006] Liver and kidney deficiency type: Deficiency of the liver and kidney, and the tendons and bones are not nourished. The main symptoms are dull joint pain, weak waist and knees, aggravated pain after fatigue, pale red tongue, and thready and weak pulse.

[0007] Qi and blood deficiency type: Deficiency of qi and blood, unable to nourish the tendons, bones and joints. It is manifested as joint pain, fatigue, dizziness, insomnia and dreaminess, pale tongue, and thready and weak pulse.

[0008] Bajitian Decoction is a classic prescription in "Zhang's Medical Mastery". It consists of 12g of Morinda officinalis, 6g of Acanthopanax gracilistylus, 9g of processed Aconite root, 6g of Dioscorea septemloba, 6g of Achyranthes bidentata, 6g of Dendrobium officinale, 6g of roasted Licorice root, 5g of Saposhnikovia divaricata, 5g of Poria cocos, and 6g of Ginger. Among them: The monarch drug: Morinda officinalis can tonify the kidney yang, strengthen the muscles and bones, and dispel wind-dampness. The minister drugs: Processed Aconite root helps Morinda officinalis warm the kidney yang, disperse cold and relieve pain; Acanthopanax gracilistylus nourishes the liver and kidney, strengthens the muscles and bones, and also dispels wind-dampness, assisting the monarch drug to enhance the effect of strengthening bones and dredging arthralgia. The assistant drugs: Dioscorea septemloba promotes diuresis and removes damp turbidity, dispels wind-dampness, targeting the flow of damp pathogen into the joints. Achyranthes bidentata: Nourishes the liver and kidney, strengthens the muscles and bones, and guides the drugs downward to reach the knees directly. Dendrobium officinale: Nourishes yin and promotes fluid production, assisting in restraining the warmth and dryness of processed Aconite root and Morinda officinalis to prevent damage to yin fluid. Saposhnikovia divaricata: Expels wind and overcomes dampness, dispersing migratory pain in the joints. Poria cocos: Strengthens the spleen and promotes diuresis to eliminate dampness, eradicating the source of damp pathogen generation. The envoy drugs: Roasted Licorice root and Ginger. Roasted Licorice root harmonizes various drugs, relieves spasm and pain, and also restrains the toxicity of processed Aconite root. Ginger warms the middle-jiao and harmonizes the stomach, helps Aconite root disperse cold, and also guides the medicinal power to reach the body surface. It has the effects of tonifying the kidney yang, strengthening the muscles and bones, dispelling wind-dampness, and dispersing cold and relieving pain, and is mainly used for symptoms such as cold arthralgia in the knees, difficulty in walking, etc. Bajitian Decoction is mainly used to treat the liver-kidney deficiency type of knee osteoarthritis. Liver-kidney deficiency, lack of nourishment of the muscles and bones, invasion of wind-cold-damp pathogens taking advantage of the deficiency, blocking the meridians, resulting in joint pain, stiffness, limited movement, soreness and weakness in the waist and knees, dizziness and tinnitus, pale red tongue, thready and weak pulse, etc. (Huang Jianghai, Wang Yafei, Bai Liqun, etc. Clinical Efficacy of Bajitian Decoction in the Treatment of Knee Osteoarthritis [J]. Medical Recapitulate, 2018, 24(04): 816 - 819.)

[0009] Due to the complex traditional Chinese medicine differentiation of knee osteoarthritis, there is currently no relevant report on the treatment of knee osteoarthritis with cold-damp obstruction type. Summary of the Invention

[0010] The present invention provides a traditional Chinese medicine composition for treating knee osteoarthritis with cold-damp obstruction type, and the present invention also provides a preparation method and use of this composition.

[0011] The present invention provides a traditional Chinese medicine composition for treating knee osteoarthritis with cold-damp obstruction type, which is prepared from raw medicinal materials in the following weight ratios:

[0012] 12 - 18 parts of Paeonia lactiflora, 24 - 36 parts of Morinda officinalis, 12 - 18 parts of Poria cocos, 8 - 12 parts of Saposhnikovia divaricata, 8 - 12 parts of Cyperus rotundus, 8 - 12 parts of Achyranthes bidentata, 12 - 18 parts of Dendrobium officinale, 8 - 12 parts of Dioscorea septemloba, 8 - 12 parts of Clematis chinensis, 8 - 12 parts of Eucommia ulmoides, 16 - 24 parts of Rehmannia glutinosa, 8 - 12 parts of Licorice root, 12 - 18 parts of Angelica sinensis.

[0013] Preferably, it is prepared from raw medicinal materials in the following weight ratios:

[0014] 15 parts of Paeonia lactiflora, 30 parts of Morinda officinalis, 15 parts of Poria cocos, 10 parts of Saposhnikovia divaricata, 10 parts of Cyperus rotundus, 10 parts of Achyranthes bidentata, 15 parts of Dendrobium officinale, 10 parts of Dioscorea septemloba, 10 parts of Clematis chinensis, 10 parts of Eucommia ulmoides, 20 parts of Rehmannia glutinosa, 10 parts of Licorice root, 15 parts of Angelica sinensis.

[0015] Among them, the Morinda officinalis is Morinda officinalis processed with salt; the Cyperus rotundus is Cyperus rotundus processed with vinegar; the Achyranthes bidentata is Cyathula officinalis; the Dendrobium is dried Dendrobium; the Eucommia ulmoides is Eucommia ulmoides processed with salt; the Rehmannia glutinosa is prepared Rehmannia glutinosa; the Glycyrrhiza uralensis is roasted Glycyrrhiza uralensis.

[0016] The traditional Chinese medicine composition of the present invention takes the crude drug powder of the raw materials, the extract of water or organic solvent as the active ingredient, and is prepared into a pharmaceutically common preparation by adding pharmaceutically acceptable excipients or auxiliary components.

[0017] Among them, the preparation is an oral preparation, including tablets, capsules, pills, granules, and oral liquids.

[0018] The present invention provides a preparation method of the traditional Chinese medicine composition for treating knee osteoarthritis of cold-damp obstruction type, which comprises the following steps:

[0019] a. Weigh the raw materials according to each weight ratio;

[0020] b. Decoct and extract with water, filter, and add pharmaceutically acceptable excipients or auxiliary components to the filtrate to prepare a pharmaceutically common preparation.

[0021] The present invention also provides the use of the traditional Chinese medicine composition in the preparation of drugs for knee osteoarthritis.

[0022] Among them, the drug is a drug for treating knee osteoarthritis of cold-damp obstruction type.

[0023] The Chinese medicine composition of the present invention has the effects of tonifying spleen and kidney, removing dampness and removing arthralgia, dispelling cold and relieving pain. After clinical use in the early stage, it has achieved good curative effect in treating knee osteoarthritis (cold dampness and arthralgia syndrome), and is particularly suitable for patients with joint and whole body cold pain. Among them, Morinda officinalis is one of the four famous southern medicines in my country, which has the effects of tonifying kidney yang, strengthening tendons and bones, and removing rheumatism, and is the main medicine; the minister uses Rehmannia glutinosa to nourish yin and tonify the kidney, replenish essence and benefit marrow, balance the warm and dryness of Morinda officinalis, and realize "double tonification of yin and yang". Eucommia ulmoides is sweet and warm, and after salt processing, it enhances the power of tonifying the kidney, tonifies the liver and kidney, and strengthens tendons and bones. It cooperates with Morinda officinalis to enhance the support force of waist and knees, improve kidney deficiency and weak bones and tonify the kidney. Dendrobium nourishes yin and clears heat, nourishes the stomach and produces body fluid, assists Rehmannia glutinosa to nourish kidney yin, and prevents excessive dryness of warm tonification. White peony root nourishes blood and restrains yin, softens the liver and relieves pain, and is compatible with licorice to relieve the pain of tendon spasm. Angelica sinensis nourishes blood and activates blood circulation, regulates menstruation and relieves pain, improves blood deficiency and blood stasis, and promotes joint qi and blood nourishment. Poria strengthens the spleen and eliminates dampness, while Rehmannia nourishes and hinders the stomach, and eliminates dampness and evil, taking care of both the symptoms and the root cause. Radix Dioscoreae eliminates dampness and removes turbidity, dispels wind and removes numbness, removes dampness and turbidity from the joints, and improves poor flexion and extension. Saposhnikovia dispels wind and overcomes dampness, relieves the symptoms and relieves pain, and relieves pain caused by rheumatism invading the joints. Clematis is pungent, salty and warm, dispels rheumatism, dredges the meridians, and is good at treating joint pain, especially in the lower limbs. Cyperus rotundus is used to soothe the liver and regulate qi, and after being made with vinegar, it enhances the analgesic effect, promotes qi circulation to help blood circulation, and relieves qi stagnation and blood stasis. Rhizoma Cyperi nourishes the liver and kidneys, strengthens the tendons and bones, and promotes blood circulation and dredges the meridians, leading the medicine down to the knees and directly to the affected area. Licorice is used to harmonize the various medicines. The whole prescription has the functions of nourishing the kidney and strengthening the spleen, dispelling wind and dampness, and dispersing cold and relieving pain. In the prescription of the Chinese medicine composition of the present invention, in addition to warming yang and dispelling cold, removing dampness and relieving arthralgia, it also takes into account nourishing essence and blood, promoting qi and relieving pain, perfectly conforming to the treatment principle of arthralgia of tonifying and strengthening the body and removing wind and dampness, and taking into account both the symptoms and the root cause. Clinical experiments have shown that the medicine of the present invention is used to treat cold-damp arthralgia type knee osteoarthritis, has obvious efficacy, is safe to use, and provides a new drug option for clinical use. DETAILED DESCRIPTION

[0024] Example 1 Preparation of the Chinese medicine of the present invention

[0025] Weigh the following raw materials:

[0026] White peony root 15g, salt Morinda officinalis 30g, Poria 15g, Saposhnikovia divaricata 10g, vinegar Cyperus rotundus 10g, Cyathula officinalis 10g, dried Dendrobium 15g, Radix Dioscoreae 10g, Clematidis 10g, salt Eucommia 10g, Rehmannia root 20g, roasted Licorice root 10g, Angelica sinensis 15g;

[0027] It includes the following steps:

[0028] Step 1, prepare medicinal materials: weigh and select equal weight proportions of the main medicinal materials of Pueraria root, Notopterygium root, Bupleurum root, Clematis root, Gastrodia elata, Chuanxiong, Curcuma longa, Astragalus root, Cinnamon twig, White peony root, Millettia spatholobi, and Radix glycyrrhizae by electronic balance, and proportions of the auxiliary material ethylparaben;

[0029] Step 2. Soaking: Put the main medicinal materials prepared in Step 1 into the extraction tank, and add water 10 times the amount of the decoction pieces for soaking for 0.5 h;

[0030] Step 3. Heating and cooking: Pass steam into the interior of the extraction tank in Step 2 through the jacketed pan and heat and cook until it reaches the boiling state, and extract under gentle boiling for 1.5 h;

[0031] Step 4. Filtration and extraction: Filter the medicinal liquid through the extraction tank and then pump it into the storage tank. Add water 8 times the amount of the decoction pieces to the medicinal residues and extract under gentle boiling for 1.5 h; then, filter the medicinal liquid through the extraction tank again and pump it into the storage tank. Add water 8 times the amount of the decoction pieces to the medicinal residues and extract under gentle boiling for 1.5 h in the same way, and obtain the filtrate;

[0032] Step 5. Concentration: Combine the filtrates in the storage tank in Step 4, and slowly pour the filtrate into the concentration tank. When the medicinal liquid rises enough to form a cycle, start heating and cooking the filtrate inside the concentration tank through the jacketed pan and slowly opening the steam valve, and obtain the concentrated liquid;

[0033] Step 6. Centrifugal filtration: Centrifugally filter the concentrated liquid concentrated by the concentration tank in Step 5 through a centrifuge, and obtain the centrifugate;

[0034] Step 7. Mixing and preparation: Put the centrifugate obtained in Step 6 into a mixer, and put the auxiliary materials prepared in Step 1 into the mixer for mixing together. Finally, add water to the mixer and stir evenly to obtain the mixed liquid;

[0035] Step 8. Filling: Fill the mixed liquid obtained in Step 7 through a filling production line;

[0036] Step 9. Packaging: Package the semi-finished products filled in Step 8 through a packaging line.

[0037] Example 2 Preparation of the pharmaceutical granule of the present invention

[0038] Weigh the raw materials of each weight:

[0039] 12 g of white peony root, 24 g of morinda officinalis with salt, 12 g of poria cocos, 8 g of ledebouriella seseloides, 8 g of cyperus rotundus with vinegar, 8 g of cyathula officinalis, 12 g of dendrobium officinale, 8 g of dioscorea septemloba thunb, 8 g of clematis chinensis osbeck, 8 g of eucommia ulmoides with salt, 16 g of prepared rehmannia root, 8 g of roasted licorice root, 12 g of angelica sinensis, add water for decocting, concentrating, adding starch to make granules and sizing to obtain the granule.

[0040] Example 3 Preparation of the pharmaceutical capsule of the present invention

[0041] Weigh the raw materials of each weight:

[0042] 18 g of Radix Paeoniae Alba, 36 g of Morinda officinalis How processed with salt, 18 g of Poria cocos, 12 g of Saposhnikovia divaricata, 12 g of Cyperus rotundus L. processed with vinegar, 12 g of Achyranthes bidentata Blume, 18 g of Dendrobium officinale, 12 g of Dioscorea septemloba Thunb., 12 g of Clematis chinensis Osbeck, 12 g of Eucommia ulmoides Oliv. processed with salt, 24 g of Rehmannia glutinosa Libosch. preparata, 12 g of Glycyrrhiza uralensis Fisch. processed with honey, 18 g of Angelica sinensis. Add water to decoct, concentrate to obtain extract, dry, fill into capsules to obtain the capsule preparation.

[0043] The beneficial effects of the present invention are demonstrated by the following pharmacodynamic experiments.

[0044] Experimental Example 1 Clinical Efficacy Observation of the Traditional Chinese Medicine Composition of the Present Invention in the Treatment of Knee Osteoarthritis (Bone Bi)

[0045] 1. Experimental purpose: To preliminarily evaluate the efficacy and safety of the traditional Chinese medicine composition of the present invention.

[0046] 2. Research method: Randomized, double-blind design;

[0047] 3. Number of subjects: Experimental group: 133 subjects; Control group: 131 subjects.

[0048] 4. Inclusion and exclusion criteria:

[0049] 4.1 Inclusion criteria

[0050] Western medicine diagnostic criteria: Refer to the classification criteria for knee osteoarthritis revised by the American Rheumatism Association in 1995; Clinical criteria: ① Knee pain for most of the time in the recent 1 month; ② Bone friction sound; ③ Morning stiffness ≤ 30 min; ④ Age ≥ 38 years old; ⑤ Bony swelling. Those who meet ① + ② + ③ + ④ or ① + ② + ⑤ or ① + ④ + ⑤ can be diagnosed with knee osteoarthritis. Clinical and radiological criteria: ① Knee pain for most of the time in the recent 1 month; ② X-ray shows osteophyte formation; ③ Joint fluid examination conforms to osteoarthritis; ④ Age ≥ 40 years old; ⑤ Morning stiffness ≤ 30 min; ⑥ Bone friction sound. Basis for Western medicine diagnosis: Those who meet ① + ② or ① + ③ + ⑤ + ⑥ or ① + ④ + ⑤ + ⑥ can be diagnosed with knee osteoarthritis.

[0051] 4.2 Traditional Chinese medicine syndrome differentiation criteria: Refer to the diagnostic criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" in 2002; Syndrome type: Cold-dampness obstruction syndrome; Main symptoms: Joint pain, aggravated by cold, soreness and weakness of the waist and knees; Sub-symptoms: Morning stiffness, soreness and swelling, limited flexion and extension, fatigue, soreness of the lower limbs, enlarged and pale tongue, or dull tongue, thin or thin and greasy tongue coating, deep and thready or deep and tight pulse. Basis for traditional Chinese medicine diagnosis: Meeting the main symptom + 1 - 2 of the sub-symptoms + the corresponding tongue and pulse manifestations. Imaging grading refers to the Kellgren Lawrence imaging grading method, and all films are jointly evaluated by orthopedic experts and imaging experts.

[0052] 4.3 Inclusion criteria: Meeting the above diagnostic criteria; Aged 40 - 80 years old, gender not limited; Subjects who voluntarily participate and voluntarily sign a written informed consent form.

[0053] 4.4 Exclusion criteria: Those with bone tumors and infectious arthritis, those with severe underlying diseases, those currently participating in other clinical studies or those who participated in other clinical studies within 3 months.

[0054] 5. Specifications, batch numbers, usage and dosage of the drug of the present invention and the control drug:

[0055] The Morinda officinalis decoction is taken orally, and the composition is as follows: Morinda officinalis 12g, Acanthopanax senticosus 6g, Prepared aconite 9g, Dioscorea septemloba 6g, Achyranthes bidentata 6g, Dendrobium officinale 6g, Prepared licorice 6g, Saposhnikovia divaricata 5g, Poria cocos 5g, Ginger 6g. One dose per day, decocted in water to make 100 ml, taken orally twice a day, morning and evening, continuously administered for 4 weeks, and observed for 2 weeks after administration.

[0056] The drug of the present invention is taken orally, and the composition is as follows: White peony root 15g, Morinda officinalis 30g (salted), Poria cocos 15g, Saposhnikovia divaricata 10g, Cyperus rotundus 10g (vinegar processed), Achyranthes bidentata 10g, Dendrobium officinale 15g, Dioscorea septemloba 10g, Clematis chinensis 10g, Eucommia ulmoides 10g (salted), Rehmannia glutinosa 20g, Prepared licorice 10g, Angelica sinensis 15g. One dose per day, decocted in water to make 100 ml, taken orally twice a day, morning and evening, continuously administered for 4 weeks, and observed for 2 weeks after administration.

[0057] 6. Evaluation criteria

[0058] 6.1 Main efficacy indicators:

[0059] 1) Pain VAS score: 0 points: No pain; 1 - 3 points: Slight pain that the patient can tolerate; 4 - 6 points: The patient has pain and it affects sleep, but can still tolerate; 7 - 10 points: The patient has increasingly intense pain and cannot bear it.

[0060] 2) Hospital for Special Surgery Knee Score (HSS): Evaluate the symptoms and signs of knee osteoarthritis from aspects such as knee joint function, range of motion, muscle strength, joint stability, and pain. The total score is 0 - 100 points, and the higher the score, the better the knee joint function. 100 points means completely normal, and 0 points means the most severe. The HSS pain scores are statistically analyzed before treatment, after treatment, and 2 weeks after treatment. Knee joint HSS score: ≥85 points, excellent; 70 - 84 points, good; 60 - 69 points, medium; ≤59 points, poor.

[0061] 3) TCM symptom score: 2, 4, and 6 points are recorded according to the severity of the symptoms, and 0 points are recorded for no symptoms. The main syndrome types include joint pain, cold joints, morning stiffness, poor flexion and extension, soreness of waist and knees, fatigue, tongue and pulse. Clinical recovery: TCM clinical symptoms and signs disappear, and the syndrome score decreases by ≥95%; marked effect: TCM clinical symptoms and signs are significantly improved, and the syndrome score decreases by ≥70%, <95%; effective: TCM clinical symptoms and signs are improved, and the syndrome score decreases by ≥30%, <70%; ineffective: TCM clinical symptoms and signs are not significantly improved, and the syndrome score decreases by <30%.

[0062] 6.2 Safety indicators:

[0063] Adverse events, skin allergies, and abnormal laboratory values ​​during the study were evaluated, and changes in vital signs, physical examinations, and electrocardiograms were assessed. Safety monitoring began at enrollment, especially liver and kidney function and possible adverse reactions.

[0064] Statistical methods:

[0065] SPSS 22.0 software was used to process the quantitative data. The data were expressed as n(%) and subjected to t test. The count data were expressed as n(%) and subjected to χ2 test. P<0.05 indicated statistically significant differences.

[0066] 7. Results and Conclusions:

[0067] 7.1 Clinical trial results

[0068] A total of 264 patients completed the clinical trial, including 133 in the experimental group and 131 in the control group. There was no statistically significant difference in the pain VAS score, New York Special Surgery Hospital knee score, and TCM symptom score between the experimental group and the control group before the trial (p>0.05). There was no statistically significant difference in the baseline levels of age, gender composition, etc. between the two groups before the trial (p>0.05). There was a statistically significant difference in the pain VAS score, New York Special Surgery Hospital knee score, and TCM symptom score between the experimental group and the control group before and after the trial (P<0.05). There was a statistically significant difference in the pain VAS score, New York Special Surgery Hospital knee score, and TCM symptom score between the experimental group and the control group after the trial (P<0.05). The results are shown in Tables 1 and 2.

[0069] Table 1 Comparison of VAS, HHS and TCM syndrome scores before and after treatment

[0070] time VAS HHS TCM Syndrome Scoring Before treatment 5.77±1.43 38.02±3.68 38.69±3.75 After treatment 1.98±0.81 86.59±4.13 7.37±2.03 P-value ＜0.01 ＜0.01 ＜0.01

[0071] Table 2 Comparison of VAS and HHS and TCM syndrome scores of Morinda officinalis decoction / Chinese medicine composition of the present invention

[0072] time VAS HHS TCM Syndrome Scoring Morinda officinalis soup 2.56±0.50 83.82±5.04 9.90±2.32 Chinese medicine composition of the present invention 1.98±0.81 86.59±4.13 7.37±2.03 P-value ＜0.01 ＜0.01 ＜0.01

[0073] 7.2 Safety indicators:

[0074] Compared with before treatment, there were no statistically significant differences in alanine aminotransferase, aspartate aminotransferase, creatinine, and urea nitrogen in all patients after treatment (P > 0.05). The results are shown in Table 3.

[0075] Table 3 Safety analysis before and after treatment

[0076] time Alanine aminotransferase (U / L) Aspartate aminotransferase (U / L) Creatinine (μmol / L) Before treatment 15.72±3.54 21.28±3.87 53.41±4.69 After treatment 15.32±3.36 20.45±3.41 53.31±4.91 P-value 0.545 0.653 0.674

[0077] 8. Conclusion:

[0078] Both the experimental group and the control group could improve the VAS score, the knee joint score of the Hospital for Special Surgery in New York, and the TCM symptom score. The experimental group was superior to the control group in the pain VAS score, the knee joint score of the Hospital for Special Surgery in New York, and the TCM symptom score.

[0079] In summary, the experimental results prove that the raw material compatibility of the drug of the present invention conforms to the TCM theory, has strong pertinence in the treatment of knee osteoarthritis of cold-dampness obstruction type, and is safe and effective in clinical use.

Claims

1. A traditional Chinese medicine composition for treating knee osteoarthritis of cold-dampness obstruction type, characterized in that: It is prepared from the following raw medicinal materials in the following weight ratios: 12 - 18 parts of Paeonia lactiflora Pall., 24 - 36 parts of Morinda officinalis How, 12 - 18 parts of Poria cocos (Schw.) Wolf, 8 - 12 parts of Saposhnikovia divaricata (Turcz.) Schischk., 8 - 12 parts of Cyperus rotundus L., 8 - 12 parts of Achyranthes bidentata Blume, 12 - 18 parts of Dendrobium officinale Kimura et Migo, 8 - 12 parts of Dioscorea septemloba Thunb., 8 - 12 parts of Clematis chinensis Osbeck, 8 - 12 parts of Eucommia ulmoides Oliv., 16 - 24 parts of Rehmannia glutinosa Libosch., 8 - 12 parts of Glycyrrhiza uralensis Fisch., 12 - 18 parts of Angelica sinensis (Oliv.) Diels.

2. The traditional Chinese medicine composition for treating knee osteoarthritis of cold-damp obstruction type according to claim 1, wherein: It is prepared from the following raw medicinal materials in the following weight ratios: 15 parts of Paeonia lactiflora Pall., 30 parts of Morinda officinalis How, 15 parts of Poria cocos (Schw.) Wolf, 10 parts of Saposhnikovia divaricata (Turcz.) Schischk., 10 parts of Cyperus rotundus L., 10 parts of Achyranthes bidentata Blume, 15 parts of Dendrobium officinale Kimura et Migo, 10 parts of Dioscorea septemloba Thunb., 10 parts of Clematis chinensis Osbeck, 10 parts of Eucommia ulmoides Oliv., 20 parts of Rehmannia glutinosa Libosch., 10 parts of Glycyrrhiza uralensis Fisch., 15 parts of Angelica sinensis (Oliv.) Diels.

3. The traditional Chinese medicine composition for treating knee osteoarthritis of cold-dampness obstruction type according to claim 1 or 2, wherein: The Morinda officinalis How is Morinda officinalis How processed with salt; the Cyperus rotundus L. is Cyperus rotundus L. processed with vinegar; the Achyranthes bidentata Blume is Cyathula officinalis Kuan; the Dendrobium officinale Kimura et Migo is dried Dendrobium officinale Kimura et Migo; the Eucommia ulmoides Oliv. is Eucommia ulmoides Oliv. processed with salt; the Rehmannia glutinosa Libosch. is prepared Rehmannia glutinosa Libosch.; the Glycyrrhiza uralensis Fisch. is roasted Glycyrrhiza uralensis Fisch.

4. The traditional Chinese medicine composition for treating knee osteoarthritis of cold-damp obstruction type according to any one of claims 1-3, characterized in that: It uses the crude drug powder of the above raw materials, water or organic solvent extract as the active ingredient, and adds pharmaceutically acceptable excipients or auxiliary components to prepare pharmaceutically common preparations.

5. The traditional Chinese medicine composition for treating knee osteoarthritis of cold-damp obstruction type according to claim 4, wherein: The preparation is an oral preparation, including tablets, capsules, pills, granules, oral liquids.

6. A preparation method of the traditional Chinese medicine composition for treating knee osteoarthritis of cold-dampness obstruction type according to any one of claims 1-5, characterized in that: It includes the following steps: a. Weigh the raw medicinal materials in the following weight ratios. b. Add water for decoction extraction, filter, and add pharmaceutically acceptable excipients or auxiliary components to the filtrate to prepare pharmaceutically common preparations.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 - 5 in the preparation of a drug for knee osteoarthritis.

8. The use according to claim 7, wherein: The drug is a drug for treating knee osteoarthritis of the cold - damp obstruction type.