Traditional Chinese medicine plaster for treating bone symptoms and preparation process thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine ointment preparation, and discloses a traditional Chinese medicine ointment patch for treating bone symptoms and a preparation process. The traditional Chinese medicine plaster for treating bone symptoms is prepared from the following raw materials: rheum officinale, ground beeltle, radix achyranthis bidentatae, radix clematidis, pangolin, monkey bone, schizophragma integrifolium, myrrh, rhizoma cibotii, ligusticum wallichii, pawpaw, uncaria, sargentgloryvine stem, asarum, cinnamon, semen strychni, poria cocos, radix paeoniae alba, radix angelicae, dragon's blood, cottonrose hibiscus leaves, frankincense, vegetable oil and red lead. The traditional Chinese medicine plaster for treating bone symptoms can be used for various muscle strain lesions, can be used for various traumatic injuries, fractures, tendon and vessel contracture and the like, and can also be used for symptoms such as arthritis, scapulohumeral periarthritis, cervical spondylosis and hyperostosis; the traditional Chinese medicine has the effects of promoting blood circulation to remove blood stasis, relieving swelling and pain, relaxing tendons and regulating qi, dispelling cold and wind and promoting reunion of fractured tendons and bones, takes effect quickly and does not cause adverse reaction easily.

Description

Technical Field

[0001] The present application relates to the technical field of preparation of traditional Chinese medicine ointments, and in particular to a traditional Chinese medicine ointment for treating bone diseases and a preparation process thereof. Background Art

[0002] Acute injuries, sprains and chronic pain in the waist and legs are common and frequently-occurring diseases in clinical orthopedics. They not only endanger the patient's health, but also seriously affect daily life. So far, there is no treatment guideline to follow. The conventional Western medicine treatments corresponding to the above symptoms mainly include non-steroidal anti-inflammatory drugs such as ibuprofen and celecoxib. Although they have a certain effect on relieving discomfort symptoms, these drugs may cause damage to the stomach and liver of the user, causing adverse reactions such as nausea, vomiting and diarrhea, and have certain limitations. The non-drug treatments in conventional Western medicine treatments mostly use methods such as wearing a waist brace, resting in bed, and avoiding fatigue, and the effect is also very limited.

[0003] Traditional Chinese medicine believes that the above symptoms are mostly caused by violent injuries, which lead to blood stasis and meridian blockage in the injured area, resulting in muscle tightness and pain in the injured area. At present, the main Chinese medicine treatments for the above symptoms include acupuncture and physiotherapy, plaster application, massage, oral medicine soup and Chinese medicine fumigation treatment. Among the above Chinese medicine treatment methods, the plaster application method has a strong short-term treatment effect and lasting efficacy. The treatment cost is significantly lower under the premise of achieving good treatment effects. Traditional Chinese medicine has a very long history of using Chinese medicine plasters to treat surgical diseases. The treatment range includes various bone injuries, traumas, soft tissue injuries, carbuncles, furuncles, boils, sores, etc., especially for fractures, traumas and soft tissue injuries in various parts. The efficacy is unique. Traditional medications include bone-breaking ointment, cinnamon blood-activating ointment, stasis-removing ointment, bone-setting ointment, etc. The limitations are that the treatment course is long and the effect is slow, resulting in too long a course of treatment, and even causing patients to have adverse reactions such as skin allergies and ulcers.

[0004] In order to better deal with symptoms such as acute traumatic injuries, sprains, and pain in the waist and legs, it is of great practical significance to develop a better Chinese medicine ointment for application treatment. Summary of the invention

[0005] The present application examines the formulas and preparation processes of various Chinese medicine ointments, and develops a Chinese medicine ointment that has good swelling-reducing effect, can repair damaged joints and deep soft tissues, and does not cause irritation to the human body by rationally combining different Chinese medicine raw materials and strictly controlling the dosage of each component according to the relationship between the monarch, minister, assistant and envoy. The present application provides a Chinese medicine ointment for treating bone symptoms and a preparation process.

[0006] In a first aspect, the present application provides a Chinese medicine plaster for treating bone symptoms, wherein the raw materials of the Chinese medicine plaster for treating bone symptoms include medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials include the following raw materials in parts by weight: 2.5-3.5 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, smilax glabra and myrrh, 2-2.5 parts each of Cibotium barometz, Ligusticum chuanxiong, papaya, Uncaria rhynchophylla, Sargentophyllum spatholobi, Asarum, cinnamon bark and Strychnos nux vomica, 1.5-2.2 parts each of Poria cocos, white peony root and Angelica dahurica; the medicinal powder includes the following raw materials in parts by weight: 2.5-3.5 parts each of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense, the amount of vegetable oil used is 450-500 parts by weight, and the amount of red lead used is 160-200 parts by weight.

[0007] Furthermore, the vegetable oil is selected from one of soybean oil, sesame oil, cottonseed oil, peanut oil and rapeseed oil.

[0008] Furthermore, the vegetable oil is selected from soybean oil.

[0009] By adopting the above technical scheme, the Chinese medicine plaster in this application is fried with soybean oil, which is mainly composed of a variety of unsaturated fatty acids. At the same time, soybean oil is also rich in vitamin E. On the one hand, it is beneficial to prevent skin inflammation during the application of the Chinese medicine plaster. On the other hand, the soybean oil in the Chinese medicine plaster can moisturize the skin and has a moisturizing effect, which helps to relieve the symptoms of skin dehydration, dryness and cracking. In addition, during the application of the Chinese medicine plaster to the injured part, soybean oil can make the stratum corneum soft and easy to fall off, so that the effective Chinese medicinal ingredients in the Chinese medicine plaster are fully absorbed by the skin, which is beneficial to the recovery of joint injuries and limited mobility.

[0010] Furthermore, the Chinese medicine plaster for treating bone symptoms comprises the following raw materials in parts by weight:

[0011] 3 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, ground ash and myrrh, 2.4 parts each of Cibotium barometz, Ligusticum chuanxiong, papaya, Uncaria rhynchophylla, Sargentophylla dahurica, Asarum, cinnamon bark and Strychnos nux vomica, 2 parts each of Poria cocos, White peony root and Angelica dahurica; 3 parts each of Sanguisorba officinalis, Hibiscus mutabilis leaf and frankincense; 480 parts of vegetable oil and 180 parts of red lead.

[0012] In a second aspect, the present application provides a method for preparing the above-mentioned Chinese medicine plaster for treating bone symptoms, comprising the following steps:

[0013] S1, crushing, sieving and mixing the formulated amounts of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense to obtain a medicinal powder for later use;

[0014] S2, add vegetable oil to a container, heat the oil temperature to 150-180 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, and the frying process lasts for 1-2 hours. After the frying is completed, stop heating, remove the residue, and obtain the medicinal oil;

[0015] S3, taking the medicinal oil prepared in step S2, heating it, maintaining the oil temperature at 285-300° C., until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil;

[0016] S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 270-290° C., adding red lead into the cooked oil, stirring, collecting the paste, and obtaining a plaster lump;

[0017] S5. Immerse the plaster lump obtained in the step S4 in water to perform a heat-removing operation, add the plaster lump after the heat-removing operation into a reaction container and heat it until it melts, cool it to 70-80° C., add the medicinal powder obtained in the step S1 and stir evenly to obtain a mixture, spread the mixture on a plaster cloth, and obtain a Chinese medicine plaster.

[0018] Furthermore, in the step S2, during the blasting process, the frying of the medicinal material is stopped when the outer surface of the medicinal material turns dark brown and the inner part turns brown.

[0019] Furthermore, in step S4, the weight ratio of cooked oil to red lead is 7-9:2-3.

[0020] Furthermore, in step S4, red lead is added to cooked oil and stirred for 0.5-1h to form plaster oil, and then the plaster is collected; during the collection process, the plaster oil is cooled to 180-200°C by evenly sprinkling water into the pot, and then the plaster oil is immersed in cold water to obtain a plaster lump.

[0021] Furthermore, in step S5, during the process of removing fire poison, the plaster ball is soaked in water for a total of 4 weeks; during the soaking process, the water is changed once a day in the first week, and once every 3 days in the remaining time.

[0022] Pharmacological analysis is as follows: among the above-mentioned drugs used in the present invention, Radix Rhei, Eupolyphaga Seu Steleophora, Achyranthes Bidentatae, Radix Clematis, Squama Pangolin, Monkey Bone, Herba Myrrhae, Sanguisorbae, Hibiscus Mutabilis Leaves and Olibanum are used as monarch drugs, and the treatment is mainly based on tonifying the kidney and renewing bones, filling essence and nourishing marrow; Cibotium barometz, Rhizoma Chuanxiong, Chaenomeles sinensis, Rhizoma Uncariae, Caulis Sargentodoxae, Asarum, Cortex Cinnamomi and Semen Strychnos are used as ministerial drugs, and blood circulation and stasis are promoted while tonifying kidney essence, and meridians are dredged; Poria, Radix Paeoniae Alba and Radix Angelicae Dahuricae are used as adjuvant drugs, and blood circulation and analgesia are promoted while strengthening kidney essence, and spleen and stomach qi are protected, so that blood stasis has a source. All the drugs are used together, and it is expected to relieve the local pain of patients with common or frequently-occurring diseases in clinical orthopedics, such as acute traumatic injuries, sprains, and pain in the tendons and bones of waist and legs, and improve the healing effect of bone tissue and cartilage tissue.

[0023] Rhubarb, also known as Huangliang, Huoshen, General, and Shu Rhubarb, is used for constipation due to excess heat, abdominal pain due to accumulation of energy, diarrhea, jaundice due to damp heat, vomiting and bleeding due to blood heat, red eyes, swollen throat, amenorrhea due to blood stasis, injuries due to falls, and external treatment of burns due to water or fire.

[0024] The Chinese earthworm, whose scientific name is Chinese earthworm, is cold in nature and has the effect of cooling blood, reducing swelling and relieving pain. It is suitable for bruises, falls, and pain in the injured area; it can also promote the activity of bone-forming cells and increase the number of cells. For patients with fractures, pain, and traumatic injuries, the combination of Chinese earthworm with frankincense, myrrh and other medicinal materials can enhance the effects of promoting blood circulation, removing blood stasis, and relieving pain, thereby achieving the effect of tendon repair and bone setting. According to the corresponding experiments, the Chinese earthworm extract and water-extracted alcohol precipitation have the effects of anti-thrombosis and dissolving thrombus, can improve blood rheology, inhibit platelet aggregation and adhesion rate, reduce the number of aggregations, and thus facilitate the recovery of traumatic injuries.

[0025] Achyranthes bidentata nourishes the liver and kidneys, strengthens the tendons and bones, and has a good effect on improving symptoms such as weakness of tendons and bones, and soreness of waist and knees caused by liver and kidney deficiency. It contains a variety of active ingredients, such as triterpenoid saponins and ecdysterone, which can promote bone tissue regeneration and enhance bone health. The ingredients contained in Achyranthes bidentata have anti-inflammatory and analgesic effects, which can reduce the inflammatory response after trauma and relieve pain.

[0026] Clematis root can dispel rheumatism, dredge meridians, eliminate phlegm, and disperse bad habits. It is used for stubborn gout, cold pain in waist and knees, beriberi, malaria, accumulation of masses, tetanus, tonsillitis, and various bone stuck in throat. Clematis root contains active ingredients such as flavonoids, phenols, and alkaloids, which can reduce local inflammatory reactions caused by traumatic injuries, increase pain threshold, and thus relieve pain.

[0027] Pangolin is good at running around and has a dispersing nature. It can invigorate blood circulation, dissipate blood stasis, and clear the meridians. It has a good effect on meridian blockage caused by trauma. It has the effect of reducing swelling and draining pus. It can reduce carbuncle that has not yet become purulent and quickly ulcerate the purulent one. It is often used together with Gleditsia sinensis, frankincense, myrrh, honeysuckle, etc. in clinical practice.

[0028] Monkey bones have the effect of removing wind and dampness, which can improve rheumatic diseases and reduce symptoms such as joint swelling and cold hands and feet caused by rheumatoid arthritis. It helps to expel moisture from the body and relieve loose stools and abdominal distension caused by excessive moisture. Monkey bones can reduce swelling and relieve pain after trauma. It has a certain improvement effect on symptoms such as skin injuries, congestion and swelling.

[0029] Drilling wind can dredge meridians and relieve pain. It is used to treat joint discomfort, limb soreness, heaviness and numbness, and make blood circulation smoother, thereby relieving rheumatic pain, limb joint pain and other symptoms. It has the effect of promoting diuresis and reducing swelling, helps to discharge excess water in the body, improve edema, and has a certain effect on relieving local swelling caused by trauma.

[0030] Myrrh can promote blood circulation, remove blood stasis, reduce swelling and relieve pain, and promote wound healing. It also has varying degrees of inhibitory effects on a variety of pathogenic fungi, helping to prevent wound infection.

[0031] In the present invention, Chuanxiong, a blood-qi medicine, is used. It is pungent and fragrant and can move qi, activate blood circulation and remove blood stasis to stop bleeding, go up to the head to dispel wind, and go down to the blood sea to regulate menstruation. It complements clematis, monkey bone, cinnamon bark, Achyranthes bidentata, and Sanguisorba officinalis, and has analgesic, anti-inflammatory and antioxidant effects.

[0032] Uncaria rhynchophylla, Sargentodoxae cuneata and other Chinese medicine plasters can be used as carriers to promote the transdermal absorption of the above-mentioned drugs, allowing them to act directly on the affected area, enhance local drug concentration, and thus better exert the therapeutic effect of the drugs.

[0033] Cinnamon has anti-inflammatory and analgesic effects, and is mostly used to relieve wind-cold and dampness. When used together with frankincense and myrrh, it can enhance the effects of promoting blood circulation, relieving pain, and reducing swelling. The combination of the above drugs can promote the disappearance of local congestion, edema, and aseptic inflammation, and play a role in promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain.

[0034] In summary, the present invention includes at least one of the following beneficial technical effects:

[0035] The Chinese medicine plaster for treating bone symptoms prepared by the present invention can be used for various muscle strain lesions, such as back pain, neck and shoulder (muscle) pain and other symptoms, can be used for various injuries from falls, fractures, muscle spasms and the like, and can also be used for symptoms such as arthritis, periarthritis of the shoulder, cervical spondylosis, and bone hyperplasia; it has the effects of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, relaxing muscles and regulating qi, dispelling cold and wind, and connecting muscles and bones, and has a quick effect and is not easy to cause adverse reactions. DETAILED DESCRIPTION

[0036] The present application designs a Chinese medicine plaster for treating bone symptoms, the raw materials include medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials include the following raw materials in parts by weight: 2.5-3.5 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, burdock and myrrh, 2-2.5 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae cyrtonema, Asarum, cinnamon bark and Strychnos nux vomica, 1.5-2.2 parts each of Poria cocos, white peony root and Angelica dahurica;

[0037] The medicinal powder comprises the following raw materials in parts by weight: 2.5-3.5 parts each of dragon's blood, hibiscus mutabilis leaves and frankincense;

[0038] The amount of vegetable oil used is 450-500 parts, and the amount of red lead used is 160-200 parts.

[0039] The present application also designs a preparation process of the above-mentioned Chinese medicine plaster for treating bone symptoms, which comprises the following steps:

[0040] S1, crushing, sieving and mixing the formulated amounts of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense to obtain a medicinal powder for later use;

[0041] S2, add vegetable oil to a container, heat the oil temperature to 150-180 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, and the frying process lasts for 1-2 hours. After the frying is completed, stop heating, remove the residue, and obtain the medicinal oil;

[0042] S3, taking the medicinal oil prepared in step S2, heating it, maintaining the oil temperature at 285-300° C., until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil;

[0043] S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 270-290° C., adding red lead into the cooked oil, stirring, collecting the paste, and obtaining a plaster lump;

[0044] S5. Immerse the plaster lump obtained in the step S4 in water to perform a heat-removing operation, add the plaster lump after the heat-removing operation into a reaction container and heat it until it melts, cool it to 70-80° C., add the medicinal powder obtained in the step S1 and stir evenly to obtain a mixture, spread the mixture on a plaster cloth, and obtain a Chinese medicine plaster.

[0045] The present application is further described below through specific embodiments.

[0046] Example 1

[0047] The Chinese medicine plaster for treating bone symptoms in Example 1 comprises medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials comprise the following raw materials in parts by weight: 3.5 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, scutellaria baicalensis and myrrh, 2.5 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae cyrtonema, Asarum, cinnamon bark and Strychnos nux vomica, 2.2 parts each of Poria cocos, White Peony Root and Angelica dahurica;

[0048] The medicinal powder comprises the following raw materials in parts by weight: 3.5 parts each of dragon's blood, hibiscus mutabilis leaves and frankincense;

[0049] The vegetable oil used is soybean oil, with a dosage of 450 parts, and the dosage of red lead is 160 parts.

[0050] The preparation process of the Chinese medicine plaster for treating bone symptoms in Example 1 comprises the following steps:

[0051] S1. Grind the prescribed amount of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense, pass through a 100-mesh sieve and mix to obtain a medicinal powder for later use;

[0052] S2, add vegetable oil to a container, heat the oil temperature to 150 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, and fry for 1-2 hours. Stop frying when the outer surface of the medicinal materials turns dark brown and the inside turns brown. Stop heating after the frying is completed, remove the residue, and obtain the medicinal oil;

[0053] S3, taking the medicinal oil prepared in step S2, heating it, maintaining the oil temperature at 285° C., until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil;

[0054] S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 270°C, adding red lead into the cooked oil, controlling the weight ratio of cooked oil to red lead to 8:3, stirring for 0.5h, stopping heating, collecting the paste to obtain plaster oil, then evenly sprinkling water into the pot to cool the plaster oil to 180-200°C, immersing the plaster oil in cold water to obtain a plaster lump;

[0055] S5. Immerse the plaster ball obtained in the step S4 in water to perform a heat-removing operation: soak the plaster ball in water for a total of 4 weeks; during the soaking process, change the water once a day in the first week, and change the water every 3 days in the remaining time; add the plaster ball after the heat-removing toxin into a pot and heat it until it melts, cool it to 70°C, add the medicinal powder obtained in the step S1 and stir evenly to obtain a mixture, spread the mixture on a plaster cloth to obtain a Chinese medicine plaster.

[0056] Example 2

[0057] Example 2 is based on Example 1, except that the raw material ratio is different:

[0058] The Chinese medicine plaster for treating bone symptoms in Example 2 comprises medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials comprise the following raw materials in parts by weight: 3 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, scutellaria baicalensis and myrrh, 2.4 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae cyrtonema, Asarum, cinnamon bark and Strychnos nux vomica, 2 parts each of Poria cocos, White Peony Root and Angelica dahurica;

[0059] The medicinal powder comprises the following raw materials in parts by weight: 3 parts each of dragon's blood, hibiscus mutabilis leaves and frankincense;

[0060] The amount of vegetable oil used is 480 parts, and the amount of red lead used is 180 parts.

[0061] Example 3

[0062] Example 3 is based on Example 1, except that the raw material ratio is different:

[0063] The Chinese medicine plaster for treating bone symptoms in Example 3 comprises raw materials including medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials comprise the following raw materials in parts by weight: 2.5 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, scutellaria baicalensis and myrrh, 2 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae cyrtonema, Asarum, cinnamon bark and Strychnos nux vomica, 1.5 parts each of Poria cocos, White Peony Root and Angelica dahurica;

[0064] The medicinal powder comprises the following raw materials in parts by weight: 2.5 parts each of dragon's blood, hibiscus mutabilis leaves and frankincense;

[0065] The amount of vegetable oil used is 500 parts, and the amount of red lead used is 200 parts.

[0066] Example 4

[0067] Example 4 is based on Example 1, except that the preparation process parameters of the Chinese medicine plaster for treating bone symptoms in Example 4 are different:

[0068] The preparation process of the Chinese medicine plaster for treating bone symptoms in Example 4 comprises the following steps:

[0069] S1. Grind the prescribed amount of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense, pass through a 100-mesh sieve and mix to obtain a medicinal powder for later use;

[0070] S2, add vegetable oil to a container, heat the oil temperature to 180 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, and fry for 1-2 hours. Stop frying when the outer surface of the medicinal materials turns dark brown and the inside turns brown. Stop heating after the frying is completed, remove the residue, and obtain the medicinal oil;

[0071] S3, taking the medicinal oil prepared in step S2, heating it, and maintaining the oil temperature at 300° C. until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil;

[0072] S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 290°C, adding red lead into the cooked oil, controlling the weight ratio of cooked oil to red lead to 8:3, stirring for 1 hour, stopping heating, collecting the paste to obtain plaster oil, then evenly sprinkling water into the pot to cool the plaster oil to 180-200°C, immersing the plaster oil in cold water to obtain a plaster lump;

[0073] S5. Immerse the plaster ball obtained in the step S4 in water to perform a heat-removing operation: soak the plaster ball in water for a total of 4 weeks; during the soaking process, change the water once a day in the first week, and change the water every 3 days in the remaining time; add the plaster ball after the heat-removing toxin into a pot and heat it until it melts, cool it to 80° C., add the medicine powder obtained in the step S1 and stir it evenly to obtain a mixture, spread the mixture on the plaster cloth, and obtain a Chinese medicine plaster.

[0074] Example 5

[0075] Example 5 is based on Example 1, except that the vegetable oil in the raw material of the Chinese medicine plaster for treating bone symptoms in Example 5 is replaced by sesame oil instead of soybean oil.

[0076] Comparative Example 1

[0077] Comparative Example 1 is based on Example 2, except that: the raw materials of the Chinese medicine plaster for treating bone symptoms in Comparative Example 1 do not contain Clematis chinensis and monkey bone. That is, the raw materials of the Chinese medicine plaster for treating bone symptoms in Comparative Example 1 include medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials include the following raw materials in parts by weight: 3 parts each of rhubarb, earthworm, Achyranthes bidentata, pangolin, scutellaria baicalensis and myrrh, 2.4 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae cyrtonema, Asarum, cinnamon bark and Strychnos nux vomica, 2 parts each of Poria cocos, white peony root and Angelica dahurica;

[0078] The medicinal powder comprises the following raw materials in parts by weight: 3 parts each of dragon's blood, hibiscus mutabilis leaves and frankincense;

[0079] The amount of vegetable oil used is 480 parts, and the amount of red lead used is 180 parts.

[0080] Comparative Example 2

[0081] Comparative Example 2 is based on Example 2, except that the raw materials of the Chinese medicine plaster for treating bone symptoms in Comparative Example 2 do not contain Sanguisorba officinalis and papaya. That is, the raw materials of the Chinese medicine plaster for treating bone symptoms in Comparative Example 2 include medicinal materials, medicinal powder, vegetable oil and red lead; the medicinal materials include the following raw materials in parts by weight: 3 parts each of rhubarb, Eupolyphaga sinensis, Achyranthes bidentata, Clematis chinensis, Scaly pangolin, Monkey bone, Dysentery and Myrrh, 2.4 parts each of Cibotium barometz, Chuanxiong, Uncaria rhynchophylla, Sargentophyllum sphaerocephalum, Asarum, Cinnamomum cassia and Strychnos nux vomica, 2 parts each of Poria cocos, White Peony Root and Angelica dahurica;

[0082] The powder includes the following raw materials in parts by weight: 3 parts each of hibiscus leaves and frankincense;

[0083] The amount of vegetable oil used is 480 parts, and the amount of red lead used is 180 parts.

[0084] Comparative Example 3

[0085] Comparative Example 3 is based on Example 2, except that the preparation process parameters of the Chinese medicine plaster for treating bone symptoms in Comparative Example 3 are different:

[0086] The preparation process of the Chinese medicine plaster for treating bone symptoms in Comparative Example 3 comprises the following steps:

[0087] S1. Grind the prescribed amount of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense, pass through a 100-mesh sieve and mix to obtain a medicinal powder for later use;

[0088] S2, add vegetable oil to a container, heat the oil temperature to 190 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, fry for more than 2 hours, fry until the outer surface and the inside of the medicinal materials turn dark brown, stop frying, stop heating after the frying is completed, remove the residue, and obtain the medicinal oil;

[0089] S3, taking the medicinal oil prepared in step S2, heating it, and maintaining the oil temperature at 300° C. until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil;

[0090] S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 300°C, adding red lead into the cooked oil, controlling the weight ratio of cooked oil to red lead to 8:3, stirring for 1 hour, stopping heating, collecting the paste to obtain plaster oil, then evenly sprinkling water into the pot to cool the plaster oil to 180-200°C, immersing the plaster oil in cold water to obtain a plaster lump;

[0091] S5. Immerse the plaster ball obtained in the step S4 in water to perform a heat-removing operation: soak the plaster ball in water for a total of 4 weeks; during the soaking process, change the water once a day in the first week, and change the water every 3 days in the remaining time; add the plaster ball after the heat-removing toxin into a pot and heat it until it melts, cool it to 80° C., add the medicine powder obtained in the step S1 and stir it evenly to obtain a mixture, spread the mixture on the plaster cloth, and obtain a Chinese medicine plaster.

[0092] (1) Rat test

[0093] Test animals: rats, male, 150-200 g; test samples: the mixture obtained in step S5 of Examples 1-5 and Comparative Examples 1-3 (ie, the mixture obtained before spreading).

[0094] Test steps: Remove the hair from the rat's calf, and use an impactor with an impact force of 2kgm / S to strike the outer side of the middle of the rat's calf with an impact area of ​​1cm 2 , hit three times continuously to cause local soft tissue damage, and obtain a rat model; the rats after successful modeling were randomly divided into 2 groups, each with 10 rats, one of which was used as an experimental group to apply the composition of the mixture obtained in step S5 of Example 2 of the present invention once every 12 hours, for a total of 3 times, and the other group was not applied with any medicine. 5 rats in each group were killed 12 hours after the end of the administration, and the remaining 5 rats were killed 72 hours later.

[0095] Among them, the test group took 1cm2 of purple muscle tissue in the center of the impact site, and the other group took the muscle tissue at the corresponding position of the left calf as the model control group, and the muscle tissue at the corresponding position of the right calf as the blank control group. After the muscle tissues were washed with physiological saline, the water was absorbed, and about 200mg was weighed, 2mL of physiological saline was added, and the homogenate was added to the test tube for centrifugation, and the supernatant was taken to measure the content of IL-1β and PGE2. The test results are shown in Table 1.

[0096] Table 1

[0097]

[0098] By analyzing the data in Table 1, it can be seen that the mixture obtained in step S5 in Example 2 of the present invention has obvious anti-inflammatory and analgesic effects, and has clinical feasibility in soft tissue injury (IL-1β is a proinflammatory cytokine produced by macrophages, and PGE2 is also an important cell growth and regulatory factor, which has immunosuppressive and anti-inflammatory effects. After tissue injury, the IL-1β and PGE2 secreted by the damaged tissue increase, and the composition of the present invention can effectively reduce the related factors of damaged cells), analgesia and collateral dredging. The composition is suitable for preparing hot compresses. The prepared hot compresses are easy to carry, simple to operate, and can effectively exert the efficacy of traditional Chinese medicine, and can provide rapid treatment for the injured and sick with soft tissue injuries in different environments.

[0099] (2) Clinical trials

[0100] Case source: The hospital recruited patients with Qi stagnation and blood stasis type knee osteoarthritis (KOA) who were willing to undergo conservative treatment (the main symptoms were: stabbing pain in the joints, difficulty in flexion and extension, and pain that did not subside after rest; the secondary symptom was dark complexion).

[0101] The diagnostic criteria adopt the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition)" issued by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association, which specifically include: 1. Recurrent knee pain in the past month; 2. X-rays (standing or weight-bearing position) show subchondral bone sclerosis, osteophyte formation, narrowing of the joint space, lip-like changes at the edges, and may also be accompanied by osteoporosis; 3. The synovial fluid (at least 2 times) is clear and viscous, with WBC <2000 / mL; 4. Middle-aged and elderly patients (≥50 years old); 5. Morning stiffness ≤30min; 6. Bone friction sound (feeling) during activity. Comprehensive clinical, laboratory and X-ray examinations can be used to diagnose if 1+2 or 1+4+5+6 or 1+3+5+6 of the above conditions are met.

[0102] The grading standard (i.e., arthritis X-ray grading standard) refers to the Kellgren-Lawrence imaging grading standard, see Table 1 for details.

[0103] Table 1

[0104] Grading describe Level 0 No significant change (normal) Level I Mild osteophytes Level II Obvious osteophytes but no involvement of the joint space Level III Moderate narrowing of the joint space Level IV Obvious joint space narrowing, subchondral bone sclerosis and deformity

[0105] Inclusion criteria for cases:

[0106] (1) Patients who meet the above-mentioned Western medical diagnostic criteria are classified as Yang deficiency and blood stasis syndrome by TCM diagnosis;

[0107] (2) Patients who meet the X-ray grading criteria of II-III;

[0108] (3) Patients with unilateral knee disease: if both knees were diagnosed with KOA, this study only included the side with more severe symptoms into the test sample;

[0109] (4) patients aged 50 ≤ ≤ 65 years, regardless of gender;

[0110] (5) Patients who are informed and willing to undergo the trial and follow the doctor's instructions to come to the hospital for treatment.

[0111] Exclusion criteria for cases:

[0112] (1) Those who do not meet the above diagnostic criteria and inclusion criteria;

[0113] (2) Those who have received other related treatments that may affect the observation of the treatment effect indicators of this study;

[0114] (3) Patients with bilateral knee disease;

[0115] (4) Patients with inappropriate age;

[0116] (5) Patients with severe liver and kidney dysfunction, cardiovascular disease, and diabetes;

[0117] Case exclusion and dropout criteria:

[0118] (1) The patient's condition changes during treatment and the patient cannot tolerate the treatment;

[0119] (2) patients who do not adhere to the treatment plan and have poor compliance;

[0120] (3) patients who voluntarily withdraw from the trial;

[0121] (4) patients lost to follow-up;

[0122] (5) There is skin damage around the knee joint;

[0123] (6) Those who undergo other related treatments for the disease or change the treatment method during treatment.

[0124] The collected eligible cases were numbered and randomly divided into experimental group, control group 1, control group 2 and control group 3, with 30 cases in each group.

[0125] Observation indicators:

[0126] (1) The VAS scores and knee WOMAC scores of the three groups were statistically analyzed on the 1st, 14th, and 28th days of treatment, and the overall therapeutic effects of the three groups were statistically analyzed before treatment, 2 weeks after treatment, and 4 weeks after treatment.

[0127] (2) On the 1st, 14th, and 28th day, 3 ml of cubital venous blood was collected from the three groups of patients and placed in ordinary glass test tubes. The blood was centrifuged at 4000 r / min for 3 min, and the serum was placed in polystyrene test tubes, which were sealed with stoppers and placed in a -20°C refrigerator for testing. IL-1 and TNF-α were measured.

[0128] The experimental group was treated with oral celecoxib capsules and external application of the Chinese medicine plaster prepared in Example 2, the control group 1 was treated with oral celecoxib capsules and external application of the Chinese medicine plaster for treating bone symptoms prepared in Comparative Example 1, the control group 2 was treated with oral celecoxib capsules and external application of the Chinese medicine plaster for treating bone symptoms prepared in Comparative Example 3, and the control group 3 was treated with oral celecoxib capsules and external application of the Gutong plaster. Each group was treated for 4 weeks.

[0129] The details are as follows:

[0130] Celecoxib capsules: (Pfizer, batch number J20120063, oral administration after meals, 1 capsule each time, once a day);

[0131] Gutong plaster: (Guilin China Resources Tianhe Pharmaceutical Co., Ltd., batch number Z10980134, external use, 1 patch per time, 1 time per day, each time lasting no more than 12 hours);

[0132] The Chinese medicine plaster for treating bone symptoms prepared in Example 2 is applied externally to the painful part of the knee joint once a day for 8 hours each time; the Chinese medicine plasters prepared in Control Examples 1 and 3 are used in the same manner as in Example 2.

[0133] Table 2 shows the VAS scores of each group during the trial: Based on the patient's own feeling, the patient was instructed to draw a point on a 10cm long horizontal line to represent the intensity of pain. The 0 end represents no pain, while the 10 end represents severe pain. 3 points or less means mild pain, which is tolerable; 4-6 points means pain and affects sleep, but is still tolerable; 7-10 points means that the patient's pain is unbearable and affects appetite and sleep. The numbers recorded in Table 2 represent the specific number of people in the corresponding scoring range, with a total of 30 people in each group.

[0134] Table 3 shows the WOMAC scores of the knee joints of each group during the trial: the symptom improvement was evaluated by comparing the score changes before and after treatment. The scoring criteria were normal (0 points), mild symptoms (1 point), moderate symptoms (2 points), severe symptoms (3 points), and very severe symptoms (4 points). The total score was greater than or equal to 0 points and less than or equal to 96 points.

[0135] Table 4 shows the levels of 2IL-1 and TNF-α in the serum of each group during the experiment.

[0136] Table 2

[0137]

[0138] Table 3

[0139] Day 1 Day 14 Day 28 Experimental Group 43.55 25.38 17.57 Control group 1 41.26 32.23 24.82 Control group 2 40.64 31.86 25.56 Control group 3 41.81 32.64 27.42

[0140] Table 4

[0141]

[0142] Statistical analysis: The collected data were processed using SPSS 22.0 statistical analysis software. Quantitative data were expressed as "mean ± standard deviation". Normality test and variance homogeneity test were first performed. Data that met normality and variance homogeneity were tested using t-test, and data that did not meet normal distribution were tested using non-parametric (rank sum) test. When statistical analysis was performed between groups, qualitative data were tested using X-ray diffraction analysis. 2 Test, rank sum test, rank sum test was used for ranked data. Two-sided test was used uniformly, when P>0.05, it was not statistically significant, when P<0.05, it was statistically significant. The results are shown in Table 5.

[0143] Table 5

[0144]

[0145]

[0146] In summary, the above data analysis shows that according to the VAS scoring standard and the knee joint WOMAC scoring standard, the pain of the patients in the embodiment was significantly relieved after treatment compared with before treatment (P < 0.05). The embodiment has a better pain relief effect than the control group (P < 0.05); the serum IL-1 and TNF-α of the patients in the embodiment after treatment were significantly reduced compared with before treatment (P < 0.05); the serum IL-1 and TNF-α of the embodiment were reduced compared with the control group (P < 0.05); according to the knee joint efficacy judgment standard, the joint function state of the patients in the embodiment was significantly relieved after treatment compared with before treatment (P < 0.05).

[0147] The above description is only an exemplary embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification under the technical concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A Chinese medicine plaster for treating bone symptoms, characterized in that: The raw materials of the Chinese medicine plaster for treating bone symptoms include medicinal materials, medicinal powder, vegetable oil and red lead; The medicinal materials include the following raw materials in parts by weight: 2.5-3.5 parts each of rhubarb, ground beetle, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, ground worm and myrrh, 2-2.5 parts each of Cibotium barometz, Chuanxiong, papaya, Uncaria rhynchophylla, Sargentodoxae, Asarum, Cinnamomum cassia and Strychnos nux vomica, 1.5-2.2 parts each of Poria cocos, White peony root and Angelica dahurica; The medicinal powder comprises the following raw materials in parts by weight: 2.5-3.5 parts each of Dragon's Blood, Hibiscus Leaves and Frankincense, The amount of the vegetable oil is 450-500 parts by weight, and the amount of the red lead is 160-200 parts by weight.

2. The Chinese medicine plaster for treating bone diseases according to claim 1, characterized in that: The vegetable oil is selected from one of soybean oil, sesame oil, cottonseed oil, peanut oil and rapeseed oil.

3. The Chinese medicine plaster for treating bone diseases according to claim 1, characterized in that: The vegetable oil is selected from soybean oil.

4. The Chinese medicine plaster for treating bone diseases according to claim 1, characterized in that: The Chinese medicine plaster for treating bone symptoms comprises the following raw materials in parts by weight: 3 parts each of rhubarb, earthworm, Achyranthes bidentata, Clematis chinensis, pangolin, monkey bone, ground ash and myrrh, 2.4 parts each of Cibotium barometz, Ligusticum chuanxiong, papaya, Uncaria rhynchophylla, Sargentophylla dahurica, Asarum, cinnamon bark and Strychnos nux vomica, 2 parts each of Poria cocos, White peony root and Angelica dahurica; 3 parts each of Sanguisorba officinalis, Hibiscus mutabilis leaf and frankincense; 480 parts of vegetable oil and 180 parts of red lead.

5. A method for preparing the Chinese medicine plaster for treating bone diseases according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1. Grind, sieve and mix the prescribed amount of Sanguisorba officinalis, Hibiscus mutabilis leaves and frankincense to prepare a medicinal powder for later use; S2, add vegetable oil to a container, heat the oil temperature to 150-180 ° C, add the formula amount of medicinal materials to the container for frying, keep the oil temperature constant, and the frying process lasts for 1-2 hours. After the frying is completed, stop heating, remove the residue, and obtain the medicinal oil; S3, taking the medicinal oil prepared in step S2, heating it, maintaining the oil temperature at 285-300° C., until the medicinal oil is observed to drop into cold water and form beads without dispersing, then stopping heating to obtain cooked oil; S4, heating the cooked oil obtained in step S3 to keep the oil temperature at 270-290° C., adding red lead into the cooked oil, stirring, collecting the paste, and obtaining a plaster lump; S5. Immerse the plaster lump obtained in the step S4 in water to perform a heat-removing operation, add the plaster lump after the heat-removing operation into a reaction container and heat it until it melts, cool it to 70-80° C., add the medicinal powder obtained in the step S1 and stir evenly to obtain a mixture, spread the mixture on a plaster cloth, and obtain a Chinese medicine plaster.

6. The method for preparing the Chinese medicine plaster for treating bone diseases according to claim 5, characterized in that: In the step S2, during the blasting process, the frying of the medicinal material is stopped when the outer surface of the medicinal material turns dark brown and the inner part turns brown.

7. The method for preparing the Chinese medicine plaster for treating bone diseases according to claim 5, characterized in that: In step S4, the weight ratio of cooked oil to red lead is 7-9:2-3.

8. The method for preparing the Chinese medicine plaster for treating bone diseases according to claim 5, characterized in that: In step S4, red lead is added to cooked oil and stirred for 0.5-1h to form plaster oil, and then the plaster is collected; during the collection process, the plaster oil is cooled to 180-200°C by evenly sprinkling water into the pot, and then the plaster oil is immersed in cold water to obtain a plaster lump.

9. The method for preparing the Chinese medicine plaster for treating bone diseases according to claim 5, characterized in that: In step S5, during the process of removing fire poison, the plaster ball is soaked in water for a total of 4 weeks; during the soaking process, the water is changed once a day in the first week, and once every 3 days in the remaining time.

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