External traditional Chinese medicine composition for treating knee osteoarthritis and preparation method thereof

Abstract

The invention provides an external traditional Chinese medicine composition for treating knee osteoarthritis and a preparation method thereof. The traditional Chinese medicine composition is prepared from Chinese angelica, safflower, pollen typhae, herba schizonepetae, zedoary, radix clematidis, notopterygium root, cortex periplocae, cortex erythrinae, caulis spatholobi, fried szechwan chinaberry fruit, rhizoma smilacis glabrae, salvia miltiorrhiza, pepper, garden balsam stem and prepared kusnezoff monkshood root. The external traditional Chinese medicine composition for treating knee osteoarthritis is reasonable in compatibility of the components, dredges channels and collaterals, activates blood circulation to remove blood stasis, enables qi and blood of tendons and vessels to be smooth, eliminates dampness and coldness, and relieves pain, so that the treatment purpose is achieved.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicines, and relates to an external Chinese medicine composition for treating knee osteoarthritis and a preparation method thereof. Background Art

[0002] Knee osteoarthritis (KOA) is a chronic arthritis disease characterized by degeneration and loss of knee cartilage and regeneration of bone at the joint margin and subchondral bone, which is more common in middle-aged and elderly people.

[0003] Knee osteoarthritis is divided into primary and secondary types. Primary osteoarthritis is caused by degeneration of articular cartilage and chronic damage to the joints. Obesity and genetic factors also have a certain influence. It mostly occurs in middle-aged and elderly people. Secondary osteoarthritis is caused by knee trauma, strain, chronic inflammation, and valgus and valgus deformities of the knee, such as femoral condyle or tibial plateau fractures, patellar fractures or dislocations, articular cartilage damage, meniscus damage, patellar chondromalacia, etc., and mostly occurs in young and middle-aged people.

[0004] Currently, the treatment for knee osteoarthritis mainly includes traditional Chinese medicine oral administration, traditional Chinese medicine external application, acupuncture, manipulation, acupotomy and other traditional Chinese medicine treatment methods as well as Western medicine surgery, oral Western medicine, and joint cavity injection treatment.

[0005] Knee osteoarthritis belongs to the category of "knee arthritis" in traditional Chinese medicine, which is related to "deficiency", "evil", "stasis" and "phlegm". The general pathogenesis of this disease is deficiency in the root and excess in the superficial symptoms, with liver and kidney deficiency as the root and wind, cold, dampness, stasis and phlegm as the superficial symptoms; the liver governs the tendons and the kidney governs the bones. With age, liver and kidney deficiency occurs. Liver deficiency causes blood to fail to nourish the tendons, kidney deficiency causes marrow reduction, and tendons and bones are not nourished. In addition, external wind, cold and dampness invade, and fat people have more phlegm, phlegm and blood stasis are intertwined, blocking the meridians, and qi and blood stasis cause the disease. The pathogenesis mainly includes liver and kidney deficiency, blood stasis, phlegm and blood stasis, and wind, cold and dampness. External treatment of knee osteoarthritis with traditional Chinese medicine includes fumigation and washing with traditional Chinese medicine, external application of traditional Chinese medicine, Chinese medicine staining, Chinese medicine ironing, and Chinese medicine ion introduction.

[0006] There is still a lack of effective treatment methods for knee osteoarthritis in clinical practice. In recent years, with the improvement and development of traditional Chinese medicine preparation technology, the application of traditional Chinese medicine external preparations in the treatment of osteoarthritis has become more and more extensive.

[0007] There is currently no report on the external use of the Chinese medicine composition of the present application to treat knee osteoarthritis. Summary of the invention

[0008] The purpose of the present invention is to overcome the shortcomings of the prior art and provide an external Chinese medicine composition for treating knee osteoarthritis. The Chinese medicine composition has reasonable compatibility, definite efficacy, no side effects and adverse reactions, and has broad application prospects.

[0009] Specifically, the technical objectives of the present invention are achieved through the following technical solutions:

[0010] The invention provides an external Chinese medicine composition for treating knee osteoarthritis. The Chinese medicine composition is prepared from angelica, safflower, pollen, schizonepeta, turmeric, clematis, notopterygium, cortex perillae, cortex pittosporum, millettia reticulata, stir-fried Toosendan fruit, smilax glabra, salvia miltiorrhiza, zanthoxylum bungeana, herba schizonepetae and processed aconitum kusnezoffii.

[0011] Specifically, the Chinese medicine composition is made of the following raw materials in parts by weight: 12-18 parts of angelica sinensis, 12-18 parts of safflower, 12-18 parts of pollen cattail, 12-18 parts of schizonepeta tenuifolia, 12-18 parts of turmeric slices, 12-18 parts of clematis, 12-18 parts of notopterygium wilfordii, 12-18 parts of perilla bark, 12-18 parts of pittosporum tobira bark, 12-18 parts of millettia reticulata, 6-10 parts of stir-fried toosendan fruits, 12-18 parts of smilax glabra, 4-8 parts of salvia miltiorrhiza, 6-10 parts of zanthoxylum bungeanum, 25-35 parts of schizonepeta radix and 2-4 parts of processed aconite.

[0012] In a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight:

[0013] 15 parts of Chinese Angelicae Sinensis, 15 parts of Carthamus tinctorius, 15 parts of Pollen Typhae, 15 parts of Schizonepeta tenuifolia, 15 parts of Curcuma longa slices, 15 parts of Radix Clematidis, 15 parts of Notopterygium wilfordii, 15 parts of Cortex Periplocae, 15 parts of Cortex Pittosporum tobira, 15 parts of Caulis Spatholobi, 9 parts of stir-fried Fructus Toosendan, 15 parts of Rhizoma Smilacis Glabrae, 6 parts of Salvia miltiorrhizae, 9 parts of Zanthoxylum bungeanum, 30 parts of Herba sperantopathologicaee radix-spermatorrhizae, and 3 parts of Radix Aconiti Kusnezoffii processed.

[0014] In a preferred embodiment of the present invention, the external Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of angelica sinensis, 12 parts of safflower, 12 parts of pollen cattail, 12 parts of schizonepeta tenuifolia, 12 parts of turmeric slices, 12 parts of clematis, 12 parts of notopterygium wilfordii, 12 parts of perilla bark, 12 parts of pittosporum tobira bark, 12 parts of millettia reticulata, 6 parts of stir-fried toosendan fruits, 12 parts of smilax glabra, 4 parts of salvia miltiorrhiza, 6 parts of zanthoxylum bungeanum, 25 parts of scutellaria baicalensis, and 2 parts of processed aconite.

[0015] In a preferred embodiment of the present invention, the external Chinese medicine composition comprises the following raw materials in parts by weight: 18 parts of angelica, 18 parts of safflower, 18 parts of pollen, 18 parts of schizonepeta, 18 parts of turmeric, 18 parts of clematis, 18 parts of notopterygium, 18 parts of perilla bark, 18 parts of pittosporum tobira, 18 parts of millettia reticulata, 10 parts of stir-fried toosendan fruit, 18 parts of smilax glabra, 8 parts of salvia miltiorrhiza, 10 parts of zanthoxylum bungeanum, 35 parts of schizonepeta tenuifolia, and 4 parts of processed aconite.

[0016] The preparation method of the external Chinese medicine composition for treating knee osteoarthritis of the present invention is as follows: weigh the Chinese medicine raw materials, add 10-12 times the weight of water, soak for 0.5-1.5h, boil over high heat and then continue to decoct over low heat for 0.5-1.5h, and prepare the external preparation according to the conventional method.

[0017] The preparation method of the external Chinese medicine composition for treating knee osteoarthritis of the present invention is as follows: weigh the Chinese medicine raw materials, add 10 times the weight of water, soak for 1.5 hours, and prepare the external preparation according to the conventional method.

[0018] Furthermore, the dosage form of the external preparation is a lotion, a patch, a paste, an ointment, a gel, a film coating or a papule.

[0019] Furthermore, the dosage form of the external preparation is a lotion.

[0020] The invention provides use of an external Chinese medicine composition for treating knee osteoarthritis in preparing a medicine for treating knee osteoarthritis.

[0021] Angelica sinensis is warm in nature, pungent and sweet in taste, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood, regulating menstruation, promoting blood circulation, and relieving pain. It is mainly used for dizziness, fatigue, palpitations caused by blood deficiency; weak qi due to blood deficiency, and abdominal pain due to blood deficiency; scanty menstruation, amenorrhea, dysmenorrhea; traumatic injuries, rheumatic pain, sores, carbuncle, swelling and pain, etc.

[0022] Safflower is warm in nature and pungent in taste. It enters the heart and liver meridians and has the effects of promoting blood circulation, dredge menstruation, dispersing blood stasis and relieving pain. It is mainly used to treat amenorrhea, dysmenorrhea, and lochia retention; chest pain, abdominal pain due to blood stasis, stabbing pain in the chest and flanks; traumatic injuries, swelling and pain of sores, etc.

[0023] Puhuang is mild in nature and sweet in taste. It belongs to the liver and pericardium meridians. Its main effects are to astringe blood, promote blood circulation and remove blood stasis. It has the therapeutic characteristics of stopping bleeding without leaving blood stasis. It can be used for symptoms of blood stasis and pain such as bruises caused by falls, dysmenorrhea, postpartum pain, and dull pain in the abdomen and heart.

[0024] Schizonepeta is pungent in nature and slightly warm in flavor. It can relieve exterior symptoms, dissipate wind, and promote the excretion of rashes. It is used for colds, headaches, measles, rubella, and the initial stage of sores.

[0025] Turmeric slices are pungent, bitter and warm in nature. They enter the spleen and liver meridians. They have the effects of breaking blood and promoting qi, and relieving pain in dysmenorrhea. They can be used clinically to treat diseases such as chest and flank pain, chest pain, heart pain, amenorrhea, and dysmenorrhea. They can also be used to treat shoulder and arm pain caused by rheumatism, swelling and pain caused by falls, and other diseases.

[0026] Clematis chinensis is mild in nature and bitter in taste. It belongs to the bladder meridian. It has the effects of removing rheumatism and unblocking meridians. It is mostly used for rheumatic pain, limb numbness, tendon spasm, and difficulty in flexion and extension.

[0027] Qianghuo, spicy, bitter, warm in nature, enters the bladder and kidney meridians, dispels superficial cold, removes rheumatism, benefits joints, relieves pain, and is used to treat exogenous wind-cold, headache without sweating, oil-printed cold and dampness, edema caused by wind and water, and swelling and toxins in sores.

[0028] Persimmon bark, warm in nature, pungent and bitter in taste. It enters the liver, kidney and heart meridians, promotes diuresis and reduces swelling, eliminates rheumatism, strengthens tendons and bones, and is used for lower limb edema, palpitations and shortness of breath, wind-cold-dampness arthralgia, and soreness of the waist and knees.

[0029] The bark of Pittosporum tobira has the effects of relieving pain, eliminating wind and promoting qi, removing dampness and activating blood circulation. The root bark can treat gastritis, nephritis and rheumatic pain. It can also be applied externally to knife wounds to eliminate rheumatism, dredge meridians and kill insects; it can treat rheumatic pain, dysentery, toothache and scabies.

[0030] Millettia reticulata tastes bitter and sweet, and is warm in nature. It has the effects of promoting blood circulation, relieving pain, and relaxing muscles and tendons.

[0031] Stir-fried Chuanlianzi has the effects of soothing the liver and relieving heat, promoting qi and relieving pain, and killing insects. It is mainly used to treat pain in the abdomen, ribs, hernia pain, abdominal pain caused by worms, and tinea capitis. It tastes bitter and is cold in nature. It enters the liver, stomach, and small intestine meridians.

[0032] Wild Smilax glabra is sweet, light and flat. It enters the liver and stomach meridians. It can detoxify, remove dampness and open up the joints. External application can clear away heat and detoxify, reduce swelling and disperse nodules, and treat redness, swelling and ulceration of carbuncles.

[0033] Salvia miltiorrhiza is bitter in taste and cold in nature. It enters the heart meridian, pericardium meridian and liver meridian. It has the effects of promoting blood circulation and removing blood stasis, eliminating carbuncle with cool water, relieving restlessness and calming the mind. It is mainly used for chest pain, heart pain, abdominal pain, chest and flank pain caused by blood stasis; pain caused by arthritis; restlessness and insomnia; irregular menstruation; swollen and painful sores, etc.

[0034] Zanthoxylum bungeanum is pungent and warm. It enters the spleen meridian, lung meridian, and kidney meridian. It has the effects of warming the middle and relieving pain, killing insects and relieving itching. It is mainly used to treat abdominal pain caused by cold, vomiting and diarrhea caused by cold and dampness, abdominal pain caused by insect accumulation, eczema, and vaginal itching.

[0035] Herba Ligustici Radix Pseudostellariae is pungent in taste and warm in nature. It enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, relaxing muscles and activating blood circulation, dispersing blood stasis and reducing swelling, detoxifying and relieving pain. It is mainly used to treat rheumatism, muscle and bone contracture, cold and damp athlete's foot, lumbar sprain, paralysis, amenorrhea, scrotal eczema, sores, boils and swelling.

[0036] Processed Aconitum carmichaelii is hot in nature and bitter in taste. It enters the heart, liver, kidney and spleen meridians and has the effects of dispelling wind and dampness, warming the meridians and relieving pain. It is commonly used clinically for wind-cold-dampness arthralgia, joint pain, cold pain in the heart and abdomen, pain caused by cold hernia, and anesthesia and pain relief.

[0037] The external Chinese medicine composition for treating knee osteoarthritis of the present invention uses angelica, safflower, pollen, and radix scutellariae as main drugs, which can promote blood circulation and remove blood stasis, promote qi and blood circulation and relieve pain; uses schizonepeta, turmeric slices, clematis, notopterygium, cortex odoratissimum, and cortex pyriferum as assistant drugs, which can dispel wind and relieve pain, relax muscles and activate collaterals; uses millettia spatholobi, stir-fried Toosendan fruit, smilax glabra, and salvia miltiorrhiza to promote blood circulation and remove blood stasis and relieve pain; uses Zanthoxylum bungeanum and processed aconite as assistant drugs, which help to harmonize the medicinal properties. The whole prescription has reasonable compatibility, strong skin penetration effect of external use of the medicine, and all the medicines are used together to nourish blood and activate collaterals, relieve numbness and remove blood stasis, relieve swelling and relieve pain, relax muscles and activate blood circulation, and promote joint function, and has a significant therapeutic effect on knee osteoarthritis.

[0038] Animal experiments show that the Chinese medicine composition of the present invention significantly improves the swelling degree and Lequesne score of the knee joints of rats with knee osteoarthritis, and improves the symptoms of knee osteoarthritis. The Chinese medicine composition for external use of the present invention can significantly reduce the severity of knee osteoarthritis, and has significant clinical efficacy.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] (1) The external Chinese medicine composition for treating knee osteoarthritis of the present invention can dredge the meridians, promote blood circulation and remove blood stasis, make the tendons and veins smooth, remove dampness and cold, relieve pain and pain, directly reach the lesion, and achieve the purpose of treatment.

[0041] (2) The Chinese medicine composition for external use of the present invention has the effects of promoting qi and removing blood stasis, reducing swelling and relieving pain, and has a rapid and reliable effect. It can be applied topically, which reduces the side effects of systemic medication and is suitable for further promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 The degree of knee joint swelling in each group on day 0.

[0043] Figure 2 On the 21st day, the degree of knee joint swelling in each group was compared with the model group, *p<0.05, **p<0.01; compared with the Example 1 group, # p<0.05, ## p<0.01.

[0044] Figure 3 Lequesne scores of each group on day 0.

[0045] Figure 4 The Lequesne scores of each group on the 21st day were compared with the model group, *p<0.05, **p<0.01; compared with the Example 1 group, # p<0.05, ## p<0.01. Specific embodiments

[0046] The content of the present invention is further described in detail below through specific implementation methods, but this should not be understood as the scope of the above subject matter of the present invention is limited to the following examples. The following examples are used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. If a person of ordinary skill in the art modifies or replaces the technical solution of the present invention with an equivalent without departing from the essence and scope of the technical solution of the present invention, it still belongs to the scope of protection of the present invention.

[0047] Example 1 Chinese medicine composition ointment of the present invention

[0048] Angelica 15g, safflower 15g, pollen 15g, schizonepeta 15g, turmeric slice 15g, clematis 15g, notopterygium 15g, perilla bark 15g, pittosporum tobira bark 15g, millettia reticulata 15g, stir-fried toosendan fruit 9g, wild yam 15g, salvia miltiorrhiza 6g, zanthoxylum bungeanum 9g, herba schizonepetae 30g, and processed aconite 3g.

[0049] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 10 times the weight of water, soak for 1.5 hours, boil over high heat and then continue to simmer for 1 hour to obtain a decoction, concentrate under vacuum pressure to obtain a medicinal liquid concentrate; add beeswax and yellow vaseline to the concentrate, simmer and stir over low heat, cool into a paste, and obtain an ointment for treating knee osteoarthritis.

[0050] Example 2 Chinese medicine composition ointment of the present invention

[0051] Angelica 18g, safflower 12g, pollen 12g, schizonepeta 18g, turmeric 18g, clematis 18g, notopterygium 12g, angelica root 12g, perilla bark 12g, pittosporum tobira bark 18g, millettia reticulata 12g, stir-fried toosendan fruit 6g, wild yam 18g, salvia miltiorrhiza 8g, zanthoxylum bungeanum 6g, herba spatholobi 25g, and processed aconite 4g.

[0052] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 10 times the weight of water, soak for 1.5 hours, boil over high heat and then continue to simmer for 1 hour to obtain a decoction, concentrate under vacuum pressure to obtain a medicinal liquid concentrate; add beeswax and yellow vaseline to the concentrate, simmer and stir over low heat, cool into a paste, and obtain an ointment for treating knee osteoarthritis.

[0053] Example 3 Chinese medicine composition ointment of the present invention

[0054] Angelica 18g, safflower 18g, pollen 18g, schizonepeta 12g, turmeric 12g, clematis 18g, notopterygium 12g, perilla bark 15g, pittosporum tobira bark 12g, millettia reticulata 18g, stir-fried toosendan fruit 10g, wild yam 12g, salvia miltiorrhiza 6g, zanthoxylum bungeanum 9g, radix schizonepetae 25g, and processed aconite 4g.

[0055] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 10 times the weight of water, soak for 1.5 hours, boil over high heat and then continue to simmer for 1 hour to obtain a decoction, concentrate under vacuum pressure to obtain a medicinal liquid concentrate; add beeswax and yellow vaseline to the concentrate, simmer and stir over low heat, cool into a paste, and obtain an ointment for treating knee osteoarthritis.

[0056] Example 4 Chinese medicine composition cataplasm of the present invention

[0057] Angelica 12g, safflower 18g, pollen 18g, schizonepeta 18g, turmeric slice 12g, clematis 12g, notopterygium 18g, angelica root 18g, perilla bark 18g, Pittosporum tobira bark 12g, Millettia reticulata 18g, stir-fried Toosendan fruit 10g, Smilax glabra 12g, Salvia miltiorrhiza 4g, Zanthoxylum bungeanum 10g, Herba schizonepetae 35g, and processed Aconitum kusnezoffii 2g.

[0058] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 12 times the weight of water, soak for 1.5 hours, boil over high heat and then continue to simmer for 0.5 hours to obtain a decoction, concentrate under vacuum to obtain a medicinal liquid concentrate; add sorbitol, glycerin and other conventional cataplasm bases to the concentrate, stir well, apply to the support layer, and add a protective layer to obtain a cataplasm for treating knee osteoarthritis.

[0059] Example 5 Chinese medicine composition lotion of the present invention

[0060] Angelica 15g, safflower 15g, pollen 15g, schizonepeta 15g, turmeric slice 15g, clematis 15g, notopterygium 15g, perilla bark 15g, pittosporum tobira bark 15g, millettia reticulata 15g, stir-fried toosendan fruit 9g, wild yam 15g, salvia miltiorrhiza 6g, zanthoxylum bungeanum 9g, herba schizonepetae 30g, and processed aconite 3g.

[0061] The preparation method is as follows: weigh the above Chinese medicinal materials, add 10 times the weight of water, soak for 1.5 hours, boil over high heat and then continue to simmer for 1 hour over low heat to obtain a lotion for treating knee osteoarthritis.

[0062] Example 6 Chinese medicine composition gel of the present invention

[0063] Angelica 15g, safflower 18g, pollen 12g, schizonepeta 15g, turmeric slice 12g, clematis 18g, notopterygium 15g, perilla bark 18g, pittosporum tobira bark 15g, millettia reticulata 12g, stir-fried toosendan fruit 9g, wild yam 15g, salvia miltiorrhiza 4g, zanthoxylum bungeanum 10g, schizonepeta tenuifolia 30g, processed aconite 3g.

[0064] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 10 times the weight of water, soak for 0.15 hours, boil over high heat and then continue to simmer for 1.5 hours to obtain a decoction, and concentrate under vacuum to obtain a medicinal liquid concentrate; add carbomer to glycerin and grind it to moisten it, then add a small amount of distilled water to grind it, move it to a measuring cup, take appropriate amounts of triethanolamine, ethyl hydroxybenzoate, and distilled water to dissolve them, stir into a gel, and then add appropriate amount of distilled water to stir evenly; add the above concentrate, grind evenly to obtain a gel for treating knee osteoarthritis.

[0065] Comparative Example 1

[0066] Astragalus 15g, Rhodiola rosea 15g, Pollen Typhae 15g, Schizonepeta tenuifolia 15g, Curcuma longa 15g, Clematidis 15g, Notopterygium wilfordii 15g, Perennial Croton bark 15g, Pittosporum tobira bark 15g, Millettia reticulata 15g, stir-fried Toosendan fruit 9g, Smilax glabra 15g, Salvia miltiorrhiza 6g, Zanthoxylum bungeanum 9g, Herba schizonepetae 30g, and processed Aconitum kusnezoffii 3g.

[0067] The preparation method is the same as that of Example 1.

[0068] Comparative Example 2

[0069] Angelica 15g, safflower 15g, pollen 15g, saposhnikovia 15g, turmeric 15g, clematis 15g, angelica dahurica 15g, cortex angelicae 15g, eucommia ulmoides 15g, millettia reticulata 15g, stir-fried toosendan fruit 9g, wild smilax glabra 15g, salvia miltiorrhiza 6g, zanthoxylum bungeanum 9g, herba spatholobi 30g, and processed aconite 3g.

[0070] The preparation method is the same as Example 1.

[0071] Comparative Example 3

[0072] 15g of Schizonepeta, 15g of Curcuma longa slices, 15g of Clematidis, 15g of Notopterygium wilfordii, 15g of Perilla frutescens bark, 15g of Pittosporum tobira bark, 15g of Millettia reticulata, 9g of stir-fried Toosendan fruit, 15g of Smilax glabra, 6g of Salvia miltiorrhiza, 9g of Zanthoxylum bungeanum, 30g of Radix Polygoni Multiflori, and 3g of processed Aconitum carmichaelii.

[0073] The preparation method is the same as Example 1.

[0074] Comparative Example 4

[0075] Astragalus 15g, Rhodiola rosea 15g, Pollen Typhae 15g, Schizonepeta tenuifolia 15g, Curcuma longa 15g, Clematidis 15g, Notopterygium wilfordii 15g, Perennial Croton bark 15g, Pittosporum tobira bark 15g, Millettia reticulata 15g, stir-fried Toosendan fruit 9g, Smilax glabra 15g, Salvia miltiorrhiza 6g, Zanthoxylum bungeanum 9g, Herba schizonepetae 30g, and processed Aconitum kusnezoffii 3g.

[0076] The preparation method is the same as Example 5.

[0077] Pharmacodynamics Experiment Study on the Effect of the Chinese Medicine Composition of the Present Invention on Preventing and Treating Knee Osteoarthritis

[0078] 1. Experimental Animals

[0079] 72 SPF male SD rats weighing 180-200 g were randomly divided into a blank group, a model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group.

[0080] 2. Methods

[0081] 2.1 Modeling method and grouping

[0082] Except for the blank group, rats in other groups were anesthetized after 10 days of adaptive feeding and intraperitoneally injected with 3% sodium pentobarbital. A rectangular area of ​​about 2 cm × 3 cm was removed from the knee joint of the rat using a shaver to expose the skin of the experimental site. Except for the blank group, which was injected with normal saline, 0.1 mL / kg 10% papain was injected into the joint cavity of the rats in other groups on the 1st, 3rd, and 5th days. After 3 injections of papain, the rats were driven to run for 1 week using an animal experimental treadmill, and the osteoarthritis model was established for 20 minutes every day. The width of the rat knee joint was measured in the second week after the first injection. One rat in each group was randomly killed and dissected to observe the upper and lower cartilage surfaces of the knee joint, and the gross and histopathological scores were performed. The Lequesne score was performed, and a Lequesne score of 6 was considered a successful model.

[0083] 2.2 Administration

[0084] 15 days after modeling, the administration began, and the knee joints of the Example 1 group, the Example 2 group, the Example 3 group, the Comparative Example 1 group, the Comparative Example 2 group, and the Comparative Example 3 group were smeared with the Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, and Comparative Example 3 ointments per unit area, once a day for 3 consecutive weeks. Press and knead for 5 minutes until the skin becomes flushed and slightly hot, so as to promote effective penetration of the drug.

[0085] 3. Statistical analysis

[0086] SPSS 22.0 software was used to analyze the data. The comparison among multiple groups was performed by one-way analysis of variance, and the comparison between two groups was performed by independent sample T test. P < 0.05 was considered statistically significant.

[0087] 4. Observation indicators

[0088] 4.1 Measurement of knee swelling

[0089] Before modeling, after modeling, and 3 weeks after drug administration, the knee joint diameters of rats in each group were measured with a vernier caliper at 5 time points to calculate the degree of swelling of the rat knee joints.

[0090] The formula is: knee joint swelling degree (%) = [(knee joint diameter - knee joint diameter before modeling) / knee joint diameter before modeling] × 100%.

[0091] 4.2 Lequesne Rating

[0092] Before model establishment, after model establishment and 3 weeks after drug administration, the rats in each group were scored according to the Lequesne scoring standard, including 4 aspects (11 points in total), including: joint swelling degree (2 points), joint activity (3 points), gait change (3 points), and pain in the affected limb (3 points).

[0093] 5. Experimental results analysis

[0094] 5.1 Comparison of knee joint swelling

[0095] Compared with the blank group, the knee joint swelling of the rats in the model group increased significantly; compared with the model group, the knee joint swelling of the rats in Example 1, Example 2, Example 3, and Comparative Example 1-3 groups decreased significantly. Figure 1 , Figure 2 The knee joint swelling degree of rats in Comparative Example 1-3 groups was higher than that in Example 1 group.

[0096] 5.2 Lequesne score comparison

[0097] Compared with the blank group, the Lequesne scores of the rats in the model group were significantly increased; compared with the model group, the Lequesne scores of the rats in Example 1, Example 2, Example 3, and Comparative Examples 1-3 were significantly reduced. Figure 3 , Figure 4 The Lequesne scores of the rats in the comparative examples 1-3 groups were higher than those in the example 1 group.

[0098] The Chinese medicine composition of the present invention significantly improves the swelling degree and Lequesne score of the knee joints of rats with knee osteoarthritis, and improves the symptoms of knee osteoarthritis. The effect of improving the symptoms of knee osteoarthritis in Example 1 is significantly better than that in Comparative Examples 1-3.

[0099] Clinical example: Observation on the therapeutic effect of the Chinese medicine composition of the present invention on knee osteoarthritis

[0100] 1. Materials and Methods

[0101] 1. Clinical data

[0102] A total of 72 patients with knee osteoarthritis who visited our hospital were randomly divided into two groups, trial group 1 and trial group 2, with 36 cases in each group. There was no significant difference in gender, age and disease course between the two groups.

[0103] 2. Diagnostic criteria

[0104] American College of Rheumatology diagnostic criteria for knee osteoarthritis:

[0105] ① Knee joint stiffness accompanied by joint hypertrophy; ② Knee joint pain; ③ Joint pain aggravated during activity, etc.

[0106] Kellgren-Lawrance X-ray grading criteria:

[0107] Grade 0-2 is diagnosed as early knee osteoarthritis, grade 0: normal; grade 1: suspected joint space narrowing and possible lip-like hyperplasia; grade 2: definite osteophytes and possible joint space narrowing; grade 3: moderate multiple osteophytes, definite joint space narrowing, sclerosis and possible bone end deformation; grade 4: large osteophytes, obvious joint space narrowing, severe sclerosis and definite bone end deformation.

[0108] 3. Inclusion criteria

[0109] Meet the above diagnostic criteria; age 40-68 years old; patients are informed and sign consent.

[0110] 4. Exclusion criteria

[0111] ① Severe joint deformity and moderate or above swelling; ② Patients over 65 years old, pregnant or lactating women, and those who are allergic to this drug; ③ Patients who have not received one course of treatment or have not taken the drug as prescribed or have discontinued the drug for various reasons and whose efficacy cannot be determined; ④ Patients with severe diseases of the heart, liver, kidney, hematopoietic system, and mental illness.

[0112] 5. Treatment Methods

[0113] Test group 1: Place both feet in a covered wooden barrel and soak the feet from the ankle to about 1 / 2 of the calf with hot water of Example 5 lotion for about 30 minutes, twice a day, one bag each time.

[0114] Test Group 2: Place both feet in a covered wooden barrel and soak the feet in hot water from the ankle to about 1 / 2 of the calf with the lotion of Comparative Example 4 for about 30 minutes, twice a day, one bag each time.

[0115] 6. Clinical efficacy:

[0116] The severity of knee osteoarthritis was scored according to the severity index of knee osteoarthritis (ISOA) developed by Lequesne, which scored pain, walking ability, and daily life involvement, with a normal score of 0 and a maximum score of 8. A total score of 1-4 was mild, 5-7 was moderate, 8-10 was severe, 11-13 was very severe, and ≥14 was extremely severe.

[0117] The clinical cure standard is that the knee swelling and pain completely disappear, and the patient can walk and go up and down stairs normally; the marked effect standard is that the patient has no knee pain at rest, the swelling completely disappears, there is occasional pain during activities, and the patient can work and live normally; the effective standard is that the patient has occasional knee pain, mild pain during walking, discomfort during going up and down stairs, and slightly limited joint movement; the ineffective standard is that the knee pain at rest and during activities has not been significantly improved, and the swelling has not been reduced. Cure and marked effect rate = (clinical cure + marked effect) cases / total cases × 100%.

[0118] Adverse reactions: observe and record whether the patients in both groups have liver damage, gastrointestinal reactions, and symptoms such as rash during the trial.

[0119] 7. Statistical methods

[0120] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0121] 2. Results

[0122] 1. ISOA Rating Comparison

[0123] After treatment, the ISOA score of group 1 was better than that of group 2. The difference in ISOA score between the two groups after treatment was statistically significant. See Table 1.

[0124] Table 1 Knee osteoarthritis severity index (ISOA) scores in the two groups

[0125]

[0126] Note: Compared with before treatment, ## p<0.01; compared with test group 2, *p<0.05, **p<0.01.

[0127] 2. Comparison of clinical efficacy

[0128] Table 2 Comparison of clinical efficacy between the two groups

[0129]

[0130] The marked efficacy and total efficacy of test group 1 were better than those of test group 2.

[0131] 3. Adverse reactions

[0132] No adverse reactions such as liver damage, gastrointestinal reactions, and skin rashes occurred in either group of patients.

[0133] The external Chinese medicine composition of the present invention can significantly reduce the severity of knee osteoarthritis and has significant clinical efficacy.

[0134] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine composition for external use for treating knee osteoarthritis, characterized in that: The external Chinese medicine composition comprises the following raw materials in parts by weight: 12-18 parts of angelica sinensis, 12-18 parts of safflower, 12-18 parts of pollen cattail, 12-18 parts of schizonepeta tenuifolia, 12-18 parts of turmeric slices, 12-18 parts of clematis root, 12-18 parts of notopterygium wilfordii, 12-18 parts of perilla bark, 12-18 parts of pittosporum tobira bark, 12-18 parts of millettia reticulata, 6-10 parts of stir-fried toosendan fruits, 12-18 parts of smilax glabra, 4-8 parts of salvia miltiorrhiza, 6-10 parts of zanthoxylum bungeanum, 25-35 parts of radix spatholobi, and 2-4 parts of processed aconite.

2. The external Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The external Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of angelica sinensis, 15 parts of safflower, 15 parts of pollen cattail, 15 parts of schizonepeta tenuifolia, 15 parts of turmeric slices, 15 parts of clematis, 15 parts of notopterygium wilfordii, 15 parts of perilla bark, 15 parts of pittosporum tobira bark, 15 parts of millettia reticulata, 9 parts of stir-fried toosendan fruits, 15 parts of smilax glabra, 6 parts of salvia miltiorrhiza, 9 parts of zanthoxylum bungeanum, 30 parts of scutellaria baicalensis, and 3 parts of processed aconite.

3. The external Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The external Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of angelica sinensis, 12 parts of safflower, 12 parts of pollen cattail, 12 parts of schizonepeta tenuifolia, 12 parts of turmeric slices, 12 parts of clematis root, 12 parts of notopterygium wilfordii, 12 parts of perilla bark, 12 parts of pittosporum tobira bark, 12 parts of millettia reticulata, 6 parts of stir-fried toosendan fruit, 12 parts of smilax glabra, 4 parts of salvia miltiorrhiza, 6 parts of zanthoxylum bungeanum, 25 parts of radix spatholobi, and 2 parts of processed aconite.

4. The external Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The external Chinese medicine composition comprises the following raw materials in parts by weight: 18 parts of angelica sinensis, 18 parts of safflower, 18 parts of pollen cattail, 18 parts of schizonepeta tenuifolia, 18 parts of turmeric slices, 18 parts of clematis root, 18 parts of notopterygium wilfordii, 18 parts of perilla bark, 18 parts of pittosporum tobira bark, 18 parts of millettia reticulata, 10 parts of stir-fried toosendan fruit, 18 parts of smilax glabra, 8 parts of salvia miltiorrhiza, 10 parts of zanthoxylum bungeanum, 35 parts of radix schizonepetae and 4 parts of processed aconite.

5. The external Chinese medicine composition for treating knee osteoarthritis according to any one of claims 1 to 4, characterized in that: The preparation method of the Chinese medicine composition is as follows: weigh the Chinese medicine raw materials, add 10-12 times the weight of water, soak for 0.5-1.5 hours, boil over high heat and then continue to simmer for 0.5-1.5 hours, and prepare an external preparation according to a conventional method.

6. The external Chinese medicine composition for treating knee osteoarthritis according to claim 5, characterized in that: The preparation method of the Chinese medicine composition is as follows: weigh the Chinese medicine raw materials, add 10 times the weight of water, soak for 1.5 hours, and prepare an external preparation according to a conventional method.

7. The external Chinese medicine composition for treating knee osteoarthritis according to any one of claims 1 to 4, characterized in that: The dosage form of the Chinese medicine composition is lotion, patch, paste, ointment, gel, film coating or papule.

8. The external Chinese medicine composition for treating knee osteoarthritis according to claim 7, characterized in that: The dosage form of the Chinese medicine composition is a lotion.

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