CN116327852A - Plaster for treating osteoarthritis and preparation method thereof - Google Patents
Plaster for treating osteoarthritis and preparation method thereof Download PDFInfo
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- CN116327852A CN116327852A CN202310159373.2A CN202310159373A CN116327852A CN 116327852 A CN116327852 A CN 116327852A CN 202310159373 A CN202310159373 A CN 202310159373A CN 116327852 A CN116327852 A CN 116327852A
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- rhizoma
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Abstract
The invention provides a plaster for treating osteoarthritis, which is prepared from the following raw materials in parts by weight: radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, pollen Typhae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, olibanum, myrrha, carthami flos, bombyx Batryticatus, rhizoma arisaematis, radix Ampelopsis, eupolyphaga Seu Steleophaga, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, scorpio, rhizoma Ligustici Chuanxiong, sanguis Draxonis, cortex Phellodendri, notoginseng radix, caulis Erycibes, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, rhizoma Dioscoreae Bulbiferae, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, plumbum Preparatium, and refined oleum Sesami. The invention also provides a preparation method of the plaster. The invention is based on the theory of traditional Chinese medicine, and aims at the core pathogenic factors of osteoarthritis, and the invention can treat both principal and secondary aspect of the disease, thereby improving the curative effect, recovering the function and shortening the treatment period of osteoarthritis. The long-term clinical application shows that the invention has ideal curative effect and good safety.
Description
Technical Field
The invention belongs to the field of biological medicine, and relates to a traditional Chinese medicine, in particular to a plaster for treating osteoarthritis and a preparation method thereof.
Background
Osteoarthritis refers to a degenerative disease mainly manifested by joint pain caused by various factors causing articular cartilage fibrosis, chapping, ulcers and loss. The etiology is not clear, and its occurrence is related to age, obesity, inflammation, trauma, genetic factors, etc. Pathological characteristics are degeneration and destruction of articular cartilage, subchondral bone sclerosis or cystic changes, joint edge hyperosteogeny, synovial lesions, joint capsular contracture, ligament relaxation or contracture, amyotrophy and weakness, etc. Is good for middle-aged and elderly people, has high incidence rate, and is suitable for patients with osteoarthritis of more than 50% of people over 65 years old. The affected parts comprise knee joint, hip joint, ankle joint, hand joint, spine joint (cervical vertebra, lumbar vertebra), etc. Epidemiological studies have shown that osteoarthritis is the most common joint disease, affected by which 10% of men and 18% of women in the world population over 60 years old. Wherein the probability of osteoarthritis in large joints such as hip and knee joints is highest.
Osteoarthritis not only brings pain to patients and seriously affects the life quality of the patients, but also brings great economic burden to society. Osteoarthritis, while rarely leading to death, can lead to joint pain, deformity, and motor dysfunction, thereby increasing the incidence of cardiovascular events and total mortality. World health organization juxtaposes osteoarthritis with cardiovascular disease and cancer as "three killers" threatening the health of humans.
At present, the treatment of osteoarthritis mainly comprises two types of operation and non-operation, although along with the improvement of operation level and prosthesis materials, joint replacement can well solve the disease bundle disturbance for patients, and the quality of life is greatly improved. However, due to the limitation of the service life of the prosthesis, the prosthesis generally needs to be repaired after being used for about 15 to 18 years, and the difficulty and the complications of joint replacement again are obviously improved. Therefore, how to improve joint function and delay the rate of joint degeneration by non-operative therapy has become a concern. Currently, non-surgical therapies remain the primary method of treating osteoarthritis.
The medicine treatment is a main means of non-operative treatment, and comprises medicine oral administration, joint cavity administration and medicine external application. The medicine for oral administration comprises non-steroidal anti-inflammatory and analgesic drugs of Western medicine, oral administration of Chinese medicine and the like, but due to the limitation of gastrointestinal tract functions of many patients, the medicine cannot be well resistant, and the gastrointestinal tract can be damaged after long-term administration of a plurality of medicines. Meanwhile, soft tissues such as local muscles of joints are reduced in circulatory function due to joint stiffness, degeneration and the like, so that the speed of the gastrointestinal absorbed medicine entering the local joints is reduced and the concentration is lowered. The joint cavity administration comprises joint lubricating fluid, hormone and the like, but the treatment methods have limited curative effects, and even long-term injection of the hormone can further damage the joint. The adverse reaction can be avoided by local external application of the medicine, and long-term clinical practice and research show that the external application of the traditional Chinese medicine is an effective means for treating osteoarthritis. Meanwhile, various medicines in Western medicine mainly take symptom alleviation (relief of symptoms) at present, and can not radically change, delay or reverse the progress of bone joint degeneration (relief of root cause). Therefore, the development of external medicines capable of treating both symptoms and root causes is a problem which needs to be solved clinically at present.
Disclosure of Invention
Aiming at the technical problems in the prior art, the invention provides a plaster and a preparation method thereof, and the plaster for treating osteoarthritis and the preparation method thereof aim to solve the technical problem that medicines in the prior art have poor curative effect on osteoarthritis.
The invention provides a plaster for treating osteoarthritis; the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
10-20 parts of raw radix aconiti, 10-20 parts of raw kusnezoff monkshood root, 10-20 parts of semen pini koraiensis, 10-20 parts of white mustard seed, 10-20 parts of pollen typhae, 10-20 parts of raw rheum officinale, 10-20 parts of large-leaf gentian root, 10-20 parts of frankincense, 10-20 parts of myrrh, 10-20 parts of safflower, 10-20 parts of stiff silkworm, 10-20 parts of arisaema tuber, 10-20 parts of Japanese ampelopsis root, 10-20 parts of ground beetle, 10-20 parts of earthworm, 10-20 parts of asarum, 10-20 parts of dipsacus root, 10-20 parts of giant knotweed rhizome, 10-20 parts of scorpion, 10-20 parts of szechuan lovage rhizome, 10-20 parts of dragon's blood resin, 10-20 parts of amur corktree bark, 10-20 parts of pseudo-ginseng, 10-20 parts of common flowery knotweed herb, 10-20 parts of camphor, 5-15 parts of borneol, 10-20 parts of catechu, 10-20 parts of white drug seed, 10-20 parts of airpotato yam rhizome, 10-20 parts of radix sileris, 10-20 parts of divaricate saposhnikovia root, 10-20 parts of radix angelicae, 10-20 parts of drynariae, 10-20 parts of drynaria rhizome, 10-20 parts of radix clematidis, 10-20 parts of common aucklandia root, 10-20 parts of common peony root, 10-100 parts of 500 parts of common peony root, 10-500 parts of common peony root, 10-500 parts of common-fruit.
Further, the plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
10 parts of raw radix aconiti, 10 parts of raw kusnezoff monkshood root, 10 parts of semen pini koraiensis, 10 parts of white mustard seed, 10 parts of pollen typhae, 10 parts of raw rhubarb, 10 parts of large-leaf gentian root, 10 parts of frankincense, 10 parts of myrrh, 10 parts of safflower, 10 parts of stiff silkworm, 10 parts of arisaema tuber, 10 parts of Japanese ampelopsis root, 10 parts of ground beetle, 10 parts of earthworm, 10 parts of manchurian wildginger, 10 parts of dipsacus root, 10 parts of giant knotweed rhizome, 10 parts of scorpion, 10 parts of szechuan lovage rhizome, 10 parts of dragon's blood resin, 10 parts of amur corktree bark, 10 parts of sanchi, 10 parts of common public vine, 10 parts of camphor, 5 parts of borneol, 10 parts of catechu, 10 parts of white drug seed, 10 parts of airpotato yam, 10 parts of notopterygium root, 10 parts of divaricate saposhnikovia root, 10 parts of drynaria rhizome, 10 parts of radix clematis, 100 parts of guangdaline, 500 parts of refined sesame oil.
Further, the plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
15 parts of raw radix aconiti, 15 parts of raw kusnezoff monkshood root, 15 parts of semen pini koraiensis, 15 parts of white mustard seed, 15 parts of pollen typhae, 15 parts of raw rhubarb, 15 parts of large-leaf gentian root, 15 parts of frankincense, 15 parts of myrrh, 15 parts of safflower, 15 parts of stiff silkworm, 15 parts of arisaema tuber, 15 parts of Japanese ampelopsis root, 15 parts of ground beetle, 15 parts of earthworm, 15 parts of manchurian wildginger, 15 parts of dipsacus root, 15 parts of giant knotweed rhizome, 15 parts of scorpion, 15 parts of szechuan lovage rhizome, 15 parts of dragon's blood resin, 15 parts of amur corktree bark, 15 parts of sanchi, 15 parts of common public vine, 15 parts of camphor, 10 parts of borneol, 15 parts of catechu, 15 parts of white drug seed, 15 parts of airpotato yam, 15 parts of notopterygium root, 15 parts of divaricate saposhnikovia root, 15 parts of drynaria rhizome, 15 parts of radix clematis, 150 parts of minium, and 600 parts of refined sesame oil.
Further, the plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
20 parts of raw radix aconiti, 20 parts of raw kusnezoff monkshood root, 20 parts of semen pini koraiensis, 20 parts of white mustard seed, 20 parts of pollen typhae, 20 parts of raw rhubarb, 20 parts of large-leaf gentian root, 20 parts of frankincense, 20 parts of myrrh, 20 parts of safflower, 20 parts of stiff silkworm, 20 parts of arisaema tuber, 20 parts of Japanese ampelopsis root, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of manchurian wildginger, 20 parts of dipsacus root, 20 parts of giant knotweed rhizome, 20 parts of scorpion, 20 parts of szechuan lovage rhizome, 20 parts of dragon's blood resin, 20 parts of amur corktree bark, 20 parts of sanchi, 20 parts of common public vine, 20 parts of camphor, 15 parts of borneol, 20 parts of catechu, 20 parts of white drug seed, 20 parts of airpotato yam, 20 parts of notopterygium root, 20 parts of divaricate saposhnikovia root, 20 parts of drynaria rhizome, 20 parts of radix clematis, 200 parts of minium, 700 parts of refined sesame oil.
Further, the plaster for treating osteoarthritis also contains pharmaceutically acceptable pharmaceutical excipients.
The invention also provides a preparation method of the plaster for treating osteoarthritis, which comprises the following steps:
1) Weighing the raw materials in parts by weight for later use;
2) Pulverizing pollen Typhae, olibanum, myrrha, radix Ampelopsis, eupolyphaga Seu Steleophaga, scorpio, sanguis Draxonis, notoginseng radix, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, and rhizoma Dioscoreae Bulbiferae respectively, grinding into fine powder, sieving, mixing, and making into medicinal powder;
3) Mixing radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, carthami flos, bombyx Batryticatus, rhizoma arisaematis, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, rhizoma Ligustici Chuanxiong, cortex Phellodendri, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, soaking in refined sesame oil for 7-10 days, pouring into a pot, frying with slow fire to golden yellow, taking out residues, retaining medicinal oil, adding Plumbum Preparatium, stirring, decocting until white smoke is generated, dripping water to form beads, finally turning off fire, air drying to warm, adding the powder obtained in step 2), and decocting to obtain paste;
4) And (3) carrying out hot melting on the ointment in the step (3), and uniformly spreading the ointment on the cut kraft paper, wherein each patch is 30-35g.
Specifically, in the step 1), 13 raw medicinal materials such as pollen typhae, frankincense, myrrh, radix ampelopsis, ground beetle, scorpion, dragon's blood, pseudo-ginseng, camphor, borneol, catechu, airpotato yam and the like are processed by an ultrafine grinding technology and pass through a No. 9 screen to obtain ultrafine powder (more than 200 meshes) for standby;
osteoarthritis belongs to the category of Chinese medicinal arthralgia, and is one of the current clinical chronic muscle and bone diseases. The etiology of the disease is that three pathogenic factors of wind, cold and dampness block the channels and collaterals; additionally, the deficiency of liver and kidney, malnutrition of tendons and bones, weak tendons and bones, pathogenic factors attacking bone and vein, stagnation of qi and blood, and stagnation of blood stasis and pathogenic factors with each other; so that qi and blood are not smooth, and blood is not nourished, so that movement is limited; pain in the joints due to obstructed venation. Kidney deficiency and blood stasis are the main pathogenic factors of the disease, liver and kidney deficiency are the principal and phlegm and blood stasis are the principal and secondary aspects of the disease. Therefore, the traditional Chinese medicine considers that the treatment of the disease is key to tonifying liver and kidney, warming channel and dredging collaterals, activating blood and removing blood stasis, and relieving swelling and pain.
A plurality of modern clinical researches show that the traditional Chinese medicine therapies such as tonifying liver and kidney, promoting blood circulation to remove blood stasis, warming channel and dredging collaterals can effectively relieve osteoarthritis symptoms, relieve pain and improve joint functions. However, monotherapy has limited effectiveness. Because osteoarthritis is a lesion of a part of a joint, the human body is organically unified, and from the perspective of the traditional Chinese medicine, osteoarthritis involves liver, kidney, spleen and stomach, bone, tendons, muscles, blood vessels, skin, etc., rather than a single tissue or system. Meanwhile, from the theory of traditional Chinese medicine, the organizations have interdependence. Therefore, after comprehensively and comprehensively analyzing various factors of osteoarthritis, the prescription thought of the external plaster is provided by combining the traditional Chinese medicine theory, namely, the whole treatment and the principal and subordinate symptoms are considered.
In view of this, we propose the therapeutic method of invigorating liver and kidney, warming channel and dredging collaterals, promoting blood circulation and removing blood stasis, dispelling wind and removing dampness, detumescence and relieving pain, the method takes into account the pathogenic factors of osteoarthritis, takes dipsacus root, rhizoma drynariae, eupolyphaga and the like into consideration to tonify liver and kidney, strengthen tendons and bones, pollen typhae, raw rheum officinale, olibanum, myrrh, safflower, earthworm, ligusticum wallichii, pseudo-ginseng and the like to promote blood circulation and remove blood stasis, detumescence and relieving pain, and radix aconiti kusnezoffii are used for warming channel and dispelling cold, dredging collaterals and relieving pain, and treating both principal and secondary aspect of disease. In addition, wind-dispelling medicines are added into the formula. The traditional Chinese medicine theory and modern research show that the wind-dispelling medicine can quickly dredge channels and collaterals, can effectively accelerate blood circulation, improve local soft tissue environment conditions of joints, and help other medicines to quickly enter local soft tissues so as to better exert curative effects.
Considering the problems of resolving heat by stasis and resolving heat by long time, the invention adopts phellodendron bark to clear heat and remove dampness, and Japanese ampelopsis and catechu to clear heat and remove toxicity. Thereby better and comprehensively playing the curative effect, preventing the drug bias, further preventing side effects and improving the safety.
In the external plaster preparation, the medicinal materials of pollen typhae, raw rhubarb, frankincense, myrrh, safflower, earthworm, szechuan lovage rhizome, pseudo-ginseng and dragon's blood have the effects of promoting blood circulation by removing blood stasis, dredging collaterals and relieving pain, and modern pharmacological researches also show that the blood circulation-promoting and blood stasis-removing medicine can effectively promote blood circulation and improve tissue blood supply. The medicinal materials of dipsacus root, drynaria rhizome and eupolyphaga sinensis Walker have the effects of tonifying liver and kidney, and strengthening tendons and bones. Modern researches have shown that dipsacus root, drynaria rhizome and eupolyphaga sinensis are effective in promoting fracture healing and improving the strength of trabecula. Radix Aconiti, radix Aconiti Kusnezoffii, rhizoma Polygoni Cuspidati, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, radix Clematidis, radix Gentianae Marcrophyllae, semen Pisi Sativi, and herba asari by dispelling pathogenic wind, dispelling cold, removing dampness and relieving pain; the medicines of stiff silkworm, arisaema tuber and scorpion have the effects of dispelling wind, resolving masses, dredging collaterals and relieving pain; the Japanese ampelopsis and the catechu have the effects of clearing heat and detoxicating, resolving hard mass and promoting tissue regeneration; the white drug powder has the effects of clearing heat and detoxicating, cooling blood and stopping bleeding, and removing stasis and detumescence; the airpotato yam has the functions of detoxication, detumescence, resolving phlegm, resolving masses, cooling blood and stopping bleeding; semen Sinapis Albae has effects of eliminating phlegm, activating qi-flowing, resolving hard mass, dredging collaterals and relieving pain; cortex Phellodendri has effects of clearing heat and eliminating dampness; camphor and borneol, which have the functions of dredging orifices, reducing swelling and relieving pain.
Kidney governs bone and liver governs tendons, and liver and kidney deficiency is a major factor (endogenous factor) in the onset of osteoarthritis. The plaster takes three medicines of dipsacus root, drynaria rhizome and eupolyphaga sinensis Walker as monarch drugs, and aims at the most critical internal factors of the pathogenesis of osteoarthritis, and has the effects of tonifying liver and kidney and strengthening tendons and bones. Radix Aconiti, radix Aconiti Kusnezoffii, rhizoma Polygoni Cuspidati, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, radix Clematidis, radix Gentianae Marcrophyllae, semen Pittospori Glabrati, herba asari, and semen Pittoi Glabrati by warming channels for dispelling cold, dispelling pathogenic wind and removing dampness; the stiff silkworm, the rhizoma arisaematis and the scorpion are used for dispelling wind and resolving masses; these drugs are ministerial drugs, and they mainly aim at external factors (exogenous factors) of the onset of osteoarthritis such as wind, cold, dampness, etc. Meanwhile, blood stasis is also an important pathogenic factor in the pathogenesis of osteoarthritis, so that blood-activating and stasis-resolving herbs such as pollen typhae, raw rheum officinale, frankincense, myrrh, safflower, earthworm, ligusticum wallichii, pseudo-ginseng, dragon's blood, stephania root, airpotato yam and the like are taken as adjuvant drugs. Radix Ampelopsis, catechu, semen Sinapis Albae, cortex Phellodendri, camphora, borneolum Syntheticum, etc. as guiding drugs for resolving phlegm, resolving hard mass, clearing heat and detoxicating, and dredging Li Guanqiao (shown in figure 1).
The external plaster of the invention has the functions of warming channels and expelling cold, clearing heat and detoxicating, clearing heat and cooling blood, and combining cold and heat with cold and warm. Meanwhile, the prescription has the medicines for tonifying the liver and kidney, activating blood circulation to dissipate blood stasis, relieving swelling and pain, dispelling wind, removing dampness and dredging collaterals, and can treat both principal and secondary aspect of disease. Thereby obviously enlarging the treatment range of the external plaster, enhancing the curative effect and obviously reducing the side effect.
The invention has the characteristics and benefits that:
the plaster has the advantages of reference to the classical method of the traditional Chinese medicine external preparation, controllable quality, quick response, definite curative effect, small irritation to human skin, suitability for long-term administration and reliable long-term curative effect.
The preparation disclosed by the invention has the effects of dispelling wind, dredging collaterals, dehumidifying, detumescence, promoting blood circulation, removing blood stasis, strengthening tendons and bones, and can effectively promote local blood circulation of joints and relieve joint swelling and pain.
According to the traditional Chinese medicine prescription thought compatibility, the traditional Chinese medicine composition can effectively relieve symptoms such as pain and the like aiming at core pathogenic factors and main pathogenesis of osteoarthritis, and promote function improvement.
The long-term clinical application of the invention shows that the invention has good curative effect, can treat both principal and secondary aspect of disease, relieves the pain for a plurality of patients, and is popular with the patients.
Compared with the prior art, the invention has obvious technical progress. The invention is based on the theory of traditional Chinese medicine, and aims at the core pathogenic factors of chronic bone and muscle diseases (osteoarthritis) under the whole-view guidance of the traditional Chinese medicine, and the traditional Chinese medicine can treat both principal and secondary aspect of disease, thereby improving the curative effect, recovering the function and shortening the treatment period of osteoarthritis. Long-term clinical application shows that the medicine has ideal curative effect and good safety.
Drawings
Fig. 1 is a diagram showing the relationship between monarch, minister, assistant and guide of a plaster for treating osteoarthritis.
Detailed Description
The invention is further described in detail in order to make the objects, technical solutions and advantageous effects of the invention more clear. It should be understood that the detailed description and specific examples, while indicating the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
Example 1
A plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
10 parts of raw radix aconiti, 10 parts of raw kusnezoff monkshood root, 10 parts of semen pini koraiensis, 10 parts of white mustard seed, 10 parts of pollen typhae, 10 parts of raw rhubarb, 10 parts of large-leaf gentian root, 10 parts of frankincense, 10 parts of myrrh, 10 parts of safflower, 10 parts of stiff silkworm, 10 parts of arisaema tuber, 10 parts of Japanese ampelopsis root, 10 parts of ground beetle, 10 parts of earthworm, 10 parts of manchurian wildginger, 10 parts of dipsacus root, 10 parts of giant knotweed rhizome, 10 parts of scorpion, 10 parts of szechuan lovage rhizome, 10 parts of dragon's blood resin, 10 parts of amur corktree bark, 10 parts of sanchi, 10 parts of common public vine, 10 parts of camphor, 5 parts of borneol, 10 parts of catechu, 10 parts of white drug seed, 10 parts of airpotato yam, 10 parts of notopterygium root, 10 parts of divaricate saposhnikovia root, 10 parts of drynaria rhizome, 10 parts of radix clematis, 100 parts of guangdaline, 500 parts of refined sesame oil.
The preparation method of the external plaster of the embodiment comprises the following steps:
1) Weighing the medicinal materials according to the prescription proportion of the embodiment 1 for standby;
2) Pulverizing 13 medicinal materials including pollen Typhae, olibanum, myrrha, radix Ampelopsis, eupolyphaga Seu Steleophaga, scorpio, sanguis Draxonis, notoginseng radix, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, and rhizoma Dioscoreae Bulbiferae respectively, grinding into fine powder, sieving, mixing, and making into medicinal powder;
3) Mixing radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, carthami flos, bombyx Batryticatus, rhizoma arisaematis, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, rhizoma Ligustici Chuanxiong, cortex Phellodendri, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, soaking in refined sesame oil for 7-10 days, pouring into a pot, frying with slow fire to golden yellow, taking out residues, retaining medicinal oil, adding Plumbum Preparatium, stirring, decocting until white smoke is generated, dripping water to form beads, finally turning off fire, air drying to warm, adding the powder obtained in step 2), and decocting to obtain paste.
4) The ointment is melted and evenly spread on the cut kraft paper, and 30g of ointment is pasted each time.
Example 2
A plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
20 parts of raw radix aconiti, 20 parts of raw kusnezoff monkshood root, 20 parts of semen pini koraiensis, 20 parts of white mustard seed, 20 parts of pollen typhae, 20 parts of raw rhubarb, 20 parts of large-leaf gentian root, 20 parts of frankincense, 20 parts of myrrh, 20 parts of safflower, 20 parts of stiff silkworm, 20 parts of arisaema tuber, 20 parts of Japanese ampelopsis root, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of manchurian wildginger, 20 parts of dipsacus root, 20 parts of giant knotweed rhizome, 20 parts of scorpion, 20 parts of szechuan lovage rhizome, 20 parts of dragon's blood resin, 20 parts of amur corktree bark, 20 parts of sanchi, 20 parts of common public vine, 20 parts of camphor, 15 parts of borneol, 20 parts of catechu, 20 parts of white drug seed, 20 parts of airpotato yam, 20 parts of notopterygium root, 20 parts of divaricate saposhnikovia root, 20 parts of drynaria rhizome, 20 parts of radix clematis, 200 parts of minium, 700 parts of refined sesame oil.
The preparation method of the external plaster of the embodiment comprises the following steps:
1) Weighing the medicinal materials according to the prescription proportion of the embodiment 2 for standby;
2) Pulverizing 13 medicinal materials including pollen Typhae, olibanum, myrrha, radix Ampelopsis, eupolyphaga Seu Steleophaga, scorpio, sanguis Draxonis, notoginseng radix, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, and rhizoma Dioscoreae Bulbiferae respectively, grinding into fine powder, sieving, mixing, and making into medicinal powder;
3) Mixing radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, carthami flos, bombyx Batryticatus, rhizoma arisaematis, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, rhizoma Ligustici Chuanxiong, cortex Phellodendri, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, soaking in refined sesame oil for 7-10 days, pouring into a pot, frying with slow fire to golden yellow, taking out residues, retaining medicinal oil, adding Plumbum Preparatium, stirring, decocting until white smoke is generated, dripping water to form beads, finally turning off fire, air drying to warm, adding the powder obtained in step 2), and decocting to obtain paste.
4) The ointment is melted and evenly spread on the cut kraft paper, and each patch is 35g.
Example 3
A plaster for treating osteoarthritis is prepared from the following raw materials in parts by weight:
15 parts of raw radix aconiti, 15 parts of raw kusnezoff monkshood root, 15 parts of semen pini koraiensis, 15 parts of white mustard seed, 15 parts of pollen typhae, 15 parts of raw rhubarb, 15 parts of large-leaf gentian root, 15 parts of frankincense, 15 parts of myrrh, 15 parts of safflower, 15 parts of stiff silkworm, 15 parts of arisaema tuber, 15 parts of Japanese ampelopsis root, 15 parts of ground beetle, 15 parts of earthworm, 15 parts of manchurian wildginger, 15 parts of dipsacus root, 15 parts of giant knotweed rhizome, 15 parts of scorpion, 15 parts of szechuan lovage rhizome, 15 parts of dragon's blood resin, 15 parts of amur corktree bark, 15 parts of sanchi, 15 parts of common public vine, 15 parts of camphor, 10 parts of borneol, 15 parts of catechu, 15 parts of white drug seed, 15 parts of airpotato yam, 15 parts of notopterygium root, 15 parts of divaricate saposhnikovia root, 15 parts of drynaria rhizome, 15 parts of radix clematis, 150 parts of minium, and 600 parts of refined sesame oil.
The preparation method of the external plaster of the embodiment comprises the following steps:
1) Weighing the medicinal materials according to the prescription proportion of the embodiment 3 for standby;
2) Pulverizing 13 medicinal materials including pollen Typhae, olibanum, myrrha, radix Ampelopsis, eupolyphaga Seu Steleophaga, scorpio, sanguis Draxonis, notoginseng radix, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, and rhizoma Dioscoreae Bulbiferae respectively, grinding into fine powder, sieving, mixing, and making into medicinal powder;
3) Mixing radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, carthami flos, bombyx Batryticatus, rhizoma arisaematis, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, rhizoma Ligustici Chuanxiong, cortex Phellodendri, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, soaking in refined sesame oil for 7-10 days, pouring into a pot, frying with slow fire to golden yellow, taking out residues, retaining medicinal oil, adding Plumbum Preparatium, stirring, decocting until white smoke is generated, dripping water to form beads, finally turning off fire, air drying to warm, adding the powder obtained in step 2), and decocting to obtain paste.
4) The ointment is melted and evenly spread on the cut kraft paper, and 30g of ointment is pasted each time.
The plaster of the invention comprises the following steps: cleaning the affected part with warm water, baking with soft fire, and applying to the affected part for three days, wherein 2 patches are improved. The 10 plasters are used as a treatment course, the recovery can be realized after 2 to 3 treatment courses, and the recovery can be realized after 3 to 5 treatment courses for patients with particularly serious symptoms.
In order to verify the treatment effect of the external traditional Chinese medicine preparation for treating osteoarthritis, a single-center random single-blind parallel control research method is adopted.
1. 120 subjects were divided into two groups (60 in each of the treatment group and the control group) using a completely randomized method, and all of them were subjected to total treatment
The selected patients are numbered according to the order of visit, and are grouped in random digital mode by adopting SAS statistical analysis software. The random assignment scheme is hidden (enclosed in a sealed, opaque envelope coded in sequence) to assign treatment and registered.
2. Case selection
2.1 Western diagnostic criteria: reference is made to the knee osteoarthritis diagnostic classification revised in 1995 of the American society of rheumatology.
2.1.1 clinical:
(1) knee pain occurs most of the time for nearly 1 month;
(2) bone fricatives are present when the joint is moving;
(3) morning stiffness is less than or equal to 30 minutes;
(4) age >38 years old;
(5) knee joints have bony enlargement.
Can be diagnosed by satisfying (1) + (2) + (3) + (4), or (1) + (2) + (5), or (1) + (4) or (5)
2.1.2 clinical+laboratory+radiology:
(1) knee pain occurs most of the time for nearly 1 month;
(2) x-ray film shows bone praise formation;
(3) joint fluid examination was consistent with osteoarthritis (clear, viscous, WBC <2 x 109/L);
(4) age not less than 40 years old (person unable to check joint fluid);
(5) morning stiffness is less than or equal to 30 minutes;
(6) bone fricatives are present when the joint is moving.
The knee osteoarthritis can be diagnosed by satisfying (1) + (2) or (1) ten (3) + (5) + (6) or (1) + (4) + (5) + (6).
2.1.3 dialectical criteria of TCM: the reference to the "therapeutic effect standard for diagnosing diseases in traditional Chinese medicine-.
2.1.3.1 main symptoms: (1) knee joint pain; (2) shin soft knee soreness.
2.1.3.2 times of symptoms: (1) local tenderness; (2) swelling of the joints; (3) difficulty in walking; (4) skin muscular atrophy; (5) a joint movement disorder; (6) pale or reddish tongue; (7) thin or thin white coating; (8) slippery or wiry pulse.
2.1.4X-ray grading criteria for knee osteoarthritis: the Kellgren & Lawrence grading standard, which refers to X-ray changes, is classified as 5.
Level 0: is normal
Stage I: the joint space is suspected to be narrowed, and osteophytes may exist;
stage II: obvious osteophytes exist, and the joint gap is suspected to be narrowed;
III grade: moderate osteophytes, more definite narrowing of joint gaps and hardening change;
grade IV: a great deal of osteophytes, obviously narrowed joint gaps and obviously deformed severe sclerotic lesion mechanisms.
2.2 test case Standard
2.2.1 case inclusion criteria
(1) The clinical manifestation of the KOA meets the Western diagnosis standard of the KOA, and the X-ray manifestation is between I and III;
(2) meets the dialectical standard of the stasis of the tendons and the vessels of the traditional Chinese medicine;
(3) age above 40 years old and below 60 years old;
(4) voluntarily as a tested object, signs an informed consent form, and can accept the tested pharmaceutical dosage form to ensure the completion of the treatment course.
2.2.2 case exclusion criteria
(1) The patients do not meet the diagnosis standard of Western medicine diseases and Chinese medicine differentiation;
(2) age <40 years or >60 years old;
(3) gestation and lactation of women;
(4) the complications affect the joint, such as psoriasis, syphilis neuropathy, metabolic bone diseases, acute trauma, etc.;
(5) other drugs for treating this disease are used in the near two weeks;
(6) advanced deformity, disability and disability;
(7) primary diseases and mental patients with cardiovascular, liver, kidney, hematopoietic system, etc.;
(8) critical illness is difficult to make exact judgment on the curative effect or safety of the medicine.
2.2.3 cases of rejection and abscission
(1) The patients cannot follow the test method on time as a withdrawal or drop test.
(2) The subject indicated termination of the test or severe adverse reactions.
(3) An accident occurs during the treatment process and the person who can not adhere to the treatment can not stay.
(4) Cases cannot be visited on schedule (2 days before and after the scheduled period).
(5) The rejection rate and the shedding rate are less than 20 percent.
3. Therapeutic method
3.1 treatment group
The external preparation of example 1 of the present invention produced a plaster.
The method comprises the following steps: cleaning skin, applying the plaster spread on kraft paper to affected part, and bandaging with a bandage. The plaster is taken down after being attached for 8-10 hours for 1 time per day.
Treatment course: the administration was continued for 2 weeks.
3.2 control group
Gutong paste (trade name: tianhe, guilin Huarun Tianhe pharmaceutical Co., ltd.)
The method comprises the following steps: cleaning skin, and applying the bone paste to affected part. The plaster is taken down after being attached for 8-10 hours for 1 time per day.
Treatment course: the same treatment group.
4. Observation index
4.1 safety Observation
4.1.1 demographics: including age (range), gender, race, height, weight, health history, medication history, allergy history, disease history, etc.
4.1.2 general physical examination: such as respiration, heart rate, blood pressure, pulse, etc.
4.1.3 adverse reaction index: the method is formulated by referring to the Chinese medicine research guidelines (pharmacy, pharmacology and toxicology), and is used for observing the irritation of the skin around skin lesions, and observing whether the skin is pigmented, bleeding spots, rough skin or thin skin and the like at the application part.
4.1.4 therapeutic efficacy index
4.1.4.1 pain degree assessment: visual analog grading (VAS score).
4.1.4.2lysholm knee function score: the method is carried out in a questionnaire mode. The Lysholm knee scoring scale includes 8 aspects of lameness, support, cross-locking, instability, pain, swelling, going up and down stairs, squatting, each with a respective score for a total of 100 points. Higher scores indicate better knee function. The items and scores evaluated are detailed in the following table.
4.2 observation time:
before treatment, after 1 week and 3 weeks
5. Follow-up visit
1 visit 1 time each 1 month and 3 months after the treatment is finished, and the follow-up is carried out in a review or telephone mode. And (5) observing the cure rate and recurrence rate of the obvious cases.
6. Clinical evaluation: and (5) comprehensive curative effect assessment. The scoring standard is formulated by referring to the clinical study guidelines for treating osteoarthritis of the novel traditional Chinese medicine, and the clinical curative effect is judged and is divided into four stages of clinical control, obvious effect, effective and ineffective. The method comprises the following steps:
(1) clinical control: pain symptoms disappear and the joint moves normally.
(2) The effect is shown: pain symptoms basically disappear, and the joint functions basically normal, and can participate in normal activities and works.
(3) The method is effective: pain is substantially eliminated, joint movement is mildly restricted, and the ability to participate in activities or work is improved.
(4) Invalid, and not reaching the valid standard.
The enrolled subjects were randomized into treatment groups (60 cases) and control groups (60 cases), and the sex profiles of the two groups of patients are detailed in table 1.
TABLE 1 sex profiles of two groups of patients
Group of | N | Man's body | Female |
Control group | 60 | 32 | 40 |
Treatment group | 60 | 38 | 34 |
The chi-square test shows that the P value is larger than 0.05, and the two groups of sexes are not obviously different.
The age and course of the two groups of patients are shown in Table 2.
Through statistical analysis processing, the non-parameter (M-W) test of two independent samples, the comparison P value between each index group is larger than 0.05, and the age and disease course of the two groups of samples are not obviously different.
The pre-treatment pain (VAS) profile for the two groups of patients is shown in Table 3.
Group of | N | VAS |
Treatment group | 60 | 7.35±1.02 |
Control group | 60 | 7.87±0.96 |
Statistical analysis and comparison between groups uses x 2 The comparison P-value between the two groups was greater than 0.05, suggesting that there was no significant difference in pain levels before treatment for the two groups of patients.
The pain (VAS) profile of the two groups of patients after 1 week of treatment is shown in Table 4.
TABLE 4 pain conditions (VAS) comparison after 1 week of treatment of the treatment group and the control group
Group of | N | VAS |
Treatment group | 60 | 4.39±0.83 |
Control group | 60 | 5.35±1.04 |
Statistical analysis and comparison between groups uses x 2 The comparison P value between the two groups was less than 0.05, suggesting a significant difference in pain levels after 1 week of treatment for both groups of patients, with the treatment group being superior to the control group.
The pain (VAS) profile of the two groups of patients after 3 weeks of treatment is shown in Table 5.
TABLE 5 pain conditions (VAS) comparison after 3 weeks of treatment of the treatment group and the control group
Group of | N | VAS |
Treatment group | 60 | 1.79±1.02 |
Control group | 60 | 2.67±0.92 |
Statistical analysis and comparison between groups uses x 2 The comparison P value between the two groups is smaller than 0.05, which indicates that the pain degree of the two groups of patients treated for 3 weeks is obviously reduced, and the treatment group is obviously better than the control group.
The functional status of the knee joint before treatment for the two groups of patients is shown in Table 6.
Group of | N | Lysholm score |
Treatment group | 60 | 56.74±12.29 |
Control group | 60 | 54.43±12.35 |
Statistical analysis and comparison between groups uses x 2 The comparison P value between the two groups is larger than 0.05, which indicates that the knee joint functions of the two groups of patients are not significantly different before treatment.
The knee joint function of the two groups of patients after 1 week of treatment is shown in Table 7.
Group of | N | Lysholm score |
Treatment group | 60 | 68.85±9.28 |
Control group | 60 | 60.67±10.09 |
After treatment for 1 week, both groups of patients had significantly improved knee joint function over that before treatment. Comparison between groups uses x 2 The comparison P value between the two groups is smaller than 0.05, which indicates that the knee joint functions of the two groups of patients are obviously different after 1 week of treatment, and the treatment group is better than the control group.
The knee joint function of the two groups of patients after 3 weeks of treatment is shown in Table 8.
Group of | N | Lysholm score |
Treatment group | 60 | 85.28±10.45 |
Control group | 60 | 78.63±9.54 |
After treatment for 3 weeks, the knee joint function of both groups of patients continued to improve. Comparison between groups uses x 2 The comparison P value between the two groups is smaller than 0.05, which indicates that the knee joint functions of the two groups of patients are obviously different after 3 weeks of treatment, and the treatment group is better than the control group.
The comprehensive efficacy assessment after 3 weeks of treatment for both groups of patients is detailed in Table 9.
Table 9, comprehensive efficacy comparison of the two groups of patients after 3 weeks of treatment.
Group of | N | Clinical control | Has obvious effect | Effective and effective | Invalidation of | Effective rate (%) |
Treatment group | 60 | 34 | 15 | 4 | 7 | 88.33 |
Control group | 60 | 29 | 13 | 6 | 12 | 80 |
After 3 weeks of treatment, the effective rate of the treatment group is 88.83%, and the effective rate of the control group is 80%. After 3 weeks of treatment, the treatment group had significantly higher effective rate than the control group and had statistical significance (P value less than 0.05).
Therefore, the research shows that the external plaster preparation has good clinical curative effect and obvious effect compared with the existing external plaster in clinic.
Further clinical observation and research show that the external plaster preparation for treating osteoarthritis has the advantages of obvious curative effect, shortened treatment course, low incidence of side effect and good safety compared with the existing external preparation in clinic.
The above embodiments are merely preferred embodiments of the present invention, and are not intended to limit the present invention, but any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of the present invention.
Claims (6)
1. The plaster for treating osteoarthritis is characterized by being prepared from the following raw materials in parts by weight:
10-20 parts of raw radix aconiti, 10-20 parts of raw kusnezoff monkshood root, 10-20 parts of semen pini koraiensis, 10-20 parts of white mustard seed, 10-20 parts of pollen typhae, 10-20 parts of raw rheum officinale, 10-20 parts of large-leaf gentian root, 10-20 parts of frankincense, 10-20 parts of myrrh, 10-20 parts of safflower, 10-20 parts of stiff silkworm, 10-20 parts of arisaema tuber, 10-20 parts of Japanese ampelopsis root, 10-20 parts of ground beetle, 10-20 parts of earthworm, 10-20 parts of asarum, 10-20 parts of dipsacus root, 10-20 parts of giant knotweed rhizome, 10-20 parts of scorpion, 10-20 parts of szechuan lovage rhizome, 10-20 parts of dragon's blood resin, 10-20 parts of amur corktree bark, 10-20 parts of pseudo-ginseng, 10-20 parts of common flowery knotweed herb, 10-20 parts of camphor, 5-15 parts of borneol, 10-20 parts of catechu, 10-20 parts of white drug seed, 10-20 parts of airpotato yam rhizome, 10-20 parts of radix sileris, 10-20 parts of divaricate saposhnikovia root, 10-20 parts of radix angelicae, 10-20 parts of drynariae, 10-20 parts of drynaria rhizome, 10-20 parts of radix clematidis, 10-20 parts of common aucklandia root, 10-20 parts of common peony root, 10-100 parts of 500 parts of common peony root, 10-500 parts of common peony root, 10-500 parts of common-fruit.
2. The plaster for treating osteoarthritis as claimed in claim 1, wherein the plaster is prepared from the following raw materials in parts by weight:
15 parts of raw radix aconiti, 15 parts of raw kusnezoff monkshood root, 15 parts of semen pini koraiensis, 15 parts of white mustard seed, 15 parts of pollen typhae, 15 parts of raw rhubarb, 15 parts of large-leaf gentian root, 15 parts of frankincense, 15 parts of myrrh, 15 parts of safflower, 15 parts of stiff silkworm, 15 parts of arisaema tuber, 15 parts of Japanese ampelopsis root, 15 parts of ground beetle, 15 parts of earthworm, 15 parts of manchurian wildginger, 15 parts of dipsacus root, 15 parts of giant knotweed rhizome, 15 parts of scorpion, 15 parts of szechuan lovage rhizome, 15 parts of dragon's blood resin, 15 parts of amur corktree bark, 15 parts of sanchi, 15 parts of common public vine, 15 parts of camphor, 10 parts of borneol, 15 parts of catechu, 15 parts of white drug seed, 15 parts of airpotato yam, 15 parts of notopterygium root, 15 parts of divaricate saposhnikovia root, 15 parts of drynaria rhizome, 15 parts of radix clematis, 150 parts of minium, and 600 parts of refined sesame oil.
3. The plaster for treating osteoarthritis as claimed in claim 1, wherein the plaster is prepared from the following raw materials in parts by weight:
10 parts of raw radix aconiti, 10 parts of raw kusnezoff monkshood root, 10 parts of semen pini koraiensis, 10 parts of white mustard seed, 10 parts of pollen typhae, 10 parts of raw rhubarb, 10 parts of large-leaf gentian root, 10 parts of frankincense, 10 parts of myrrh, 10 parts of safflower, 10 parts of stiff silkworm, 10 parts of arisaema tuber, 10 parts of Japanese ampelopsis root, 10 parts of ground beetle, 10 parts of earthworm, 10 parts of manchurian wildginger, 10 parts of dipsacus root, 10 parts of giant knotweed rhizome, 10 parts of scorpion, 10 parts of szechuan lovage rhizome, 10 parts of dragon's blood resin, 10 parts of amur corktree bark, 10 parts of sanchi, 10 parts of common public vine, 10 parts of camphor, 5 parts of borneol, 10 parts of catechu, 10 parts of white drug seed, 10 parts of airpotato yam, 10 parts of notopterygium root, 10 parts of divaricate saposhnikovia root, 10 parts of drynaria rhizome, 10 parts of radix clematis, 100 parts of guangdaline, 500 parts of refined sesame oil.
4. The plaster for treating osteoarthritis as claimed in claim 1, wherein the plaster is prepared from the following raw materials in parts by weight:
20 parts of raw radix aconiti, 20 parts of raw kusnezoff monkshood root, 20 parts of semen pini koraiensis, 20 parts of white mustard seed, 20 parts of pollen typhae, 20 parts of raw rhubarb, 20 parts of large-leaf gentian root, 20 parts of frankincense, 20 parts of myrrh, 20 parts of safflower, 20 parts of stiff silkworm, 20 parts of arisaema tuber, 20 parts of Japanese ampelopsis root, 20 parts of ground beetle, 20 parts of earthworm, 20 parts of manchurian wildginger, 20 parts of dipsacus root, 20 parts of giant knotweed rhizome, 20 parts of scorpion, 20 parts of szechuan lovage rhizome, 20 parts of dragon's blood resin, 20 parts of amur corktree bark, 20 parts of sanchi, 20 parts of common public vine, 20 parts of camphor, 15 parts of borneol, 20 parts of catechu, 20 parts of white drug seed, 20 parts of airpotato yam, 20 parts of notopterygium root, 20 parts of divaricate saposhnikovia root, 20 parts of drynaria rhizome, 20 parts of radix clematis, 200 parts of minium, 700 parts of refined sesame oil.
5. A plaster for the treatment of osteoarthritis according to any one of claims 1-4, further comprising pharmaceutically acceptable pharmaceutical excipients.
6. A method for preparing a plaster for treating osteoarthritis as claimed in any one of claims 1 to 4, characterized by comprising the steps of:
1) Weighing the raw materials in parts by weight for later use;
2) Pulverizing pollen Typhae, olibanum, myrrha, radix Ampelopsis, eupolyphaga Seu Steleophaga, scorpio, sanguis Draxonis, notoginseng radix, camphora, borneolum Syntheticum, catechu, radix Stephaniae Cepharanthae, and rhizoma Dioscoreae Bulbiferae respectively, grinding into fine powder, sieving, mixing, and making into medicinal powder;
3) Mixing radix Aconiti, radix Aconiti Kusnezoffii, semen Pittospori Glabrati, semen Sinapis Albae, radix et rhizoma Rhei, radix Gentianae Marcrophyllae, carthami flos, bombyx Batryticatus, rhizoma arisaematis, lumbricus, herba asari, radix Dipsaci, rhizoma Polygoni Cuspidati, rhizoma Ligustici Chuanxiong, cortex Phellodendri, caulis Erycibes, notopterygii rhizoma, radix Saposhnikoviae, rhizoma Drynariae, radix Clematidis, soaking in refined sesame oil for 7-10 days, pouring into a pot, frying with slow fire to golden yellow, taking out residues, retaining medicinal oil, adding Plumbum Preparatium, stirring, decocting until white smoke is generated, dripping water to form beads, finally turning off fire, air drying to warm, adding the powder obtained in step 2), and decocting to obtain paste;
4) And (3) carrying out hot melting on the ointment in the step (3), and uniformly spreading the ointment on the cut kraft paper, wherein each patch is 30-35g.
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