Traditional Chinese medicine composition and traditional Chinese medicine ointment for treating old ankle sprain

Abstract

The invention provides a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating old ankle sprain, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating old ankle sprain is prepared from the following raw materials in parts by weight: 15 to 20 parts of caulis sinomenii, 15 to 20 parts of caulis trachelospermi, 20 to 30 parts of radix aconiti kusnezoffii, 6 to 10 parts of artificial musk, 17 to 20 parts of frankincense, 17 to 20 parts of myrrh and 10 to 15 parts of ground beeltle. The traditional Chinese medicine composition is reasonable in compatibility, rich in raw materials and effective in combination of the components, has the effects of dredging collaterals and activating blood, dissipating blood stasis and relieving pain, and nourishing tendons and veins, is effectively used for treating old ankle sprain, is convenient to use and good in effect, is an innovation of medicines for treating old ankle sprain, and has good popularization and application values and practical clinical significance.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating chronic ankle sprains. Background Art

[0002] According to statistics, approximately 44% of patients will experience further joint pain, chronic ankle instability, osteoarthritis and other problems after an ankle sprain. Research data shows that 70% of people will experience ankle sprains, and the recurrence rate among athletes is as high as 80%. Although most patients can resume activities within less than 24 hours after the sprain, there are still 3.6% of patients who need to continue for 3 weeks or even more than three weeks to resume full activities. Therefore, the vast majority of patients with ankle sprains do not pay attention to this disease and fail to receive timely treatment after the onset of the disease. As the disease progresses, it turns into a chronic ankle sprain, and even residual pain symptoms and mild functional impairments still exist within six months to two years after the acute onset.

[0003] Chronic ankle sprains often develop from acute injuries. Acute ankle sprains cause damage to the ligaments, muscles, tendons and other soft tissues around the joint, resulting in local tears of varying degrees and rupture of small blood vessels, and acute pathological changes such as damaging congestion, exudation, edema, and bleeding. If not treated promptly and effectively, or if weight-bearing activities are still carried out for a long time after the sprain, exudation and swelling around the ankle joint will increase. When the exudate cannot be absorbed in time, it will solidify and be regenerated and organized by connective tissue to form scars; if the injured area is close to the bone, calcification may still occur, which becomes the common clinical myositis ossificans. These local soft tissue hyperplasia, adhesion or thickening and organizational degeneration cause symptoms such as limited ankle movement, swelling and pain, and eventually develop into chronic sprains, which are difficult to cure due to repeated illness.

[0004] Chronic ankle sprains fall into the category of "injured tendons" and "tendons out of groove" in traditional Chinese medicine. After an acute ankle sprain, local tendons and veins are damaged, blood overflows from the veins, blood stagnates, and meridians are blocked, which causes pain. At the same time, the pain leads to limited movement, which also slows down the flow of qi and blood. If treatment is not timely, the old blood stasis is not removed, and the disease recurs over time, local tendons and veins are not nourished, and wind, cold and dampness take advantage of the opportunity to enter. Internal and external evils disturb the muscles and tendons, aggravating the blockage of meridians, depression and numbness, gathering in the affected ankle, swelling and pain, poor movement, and prolonged and difficult to heal. It worsens every time it encounters cold and dampness. In short, the pathogenesis of this disease is mainly qi stagnation and blood stasis, and the tendons and veins are not nourished. The treatment should be to activate blood circulation and regulate qi, relax the meridians and dredge the collaterals, and nourish the tendons and veins.

[0005] There are many treatments for old ankle sprains, including acupuncture, needle knife, massage, external use of Chinese medicine preparations and combined treatment. However, the current treatment methods take a relatively long time, and patients need to go back and forth to the hospital frequently, which has a serious impact on their lives and work. Western medicine treatments mainly include oral non-steroidal anti-inflammatory analgesics, blockade, immobilization, anchors and ligament reconstruction. Oral drugs have a long course of treatment, heavy burden, and are prone to drug resistance. They have certain adverse reactions to the patient's gastrointestinal function and liver and kidney function. Blockade therapy only provides relatively short-term relief for pain and cannot solve the problem that causes the disease itself. Therefore, exploring economically safe, simple and effective methods to promote the rehabilitation of old ankle sprains has always been a difficult problem that the medical community needs to solve. Summary of the invention

[0006] In order to solve the technical problems existing in the prior art, the embodiment of the present invention provides a Chinese medicine composition and a Chinese medicine ointment for treating chronic ankle sprain. The technical solution is as follows:

[0007] A traditional Chinese medicine composition for treating chronic ankle sprain comprises the following raw materials in parts by weight: 15-20 parts of Caulis Sinomenii, 15-20 parts of Caulis Trachelospermi, 20-30 parts of Radix Aconiti Kusnezoffii, 6-10 parts of artificial musk, 17-20 parts of frankincense, 17-20 parts of myrrh and 10-15 parts of Eupolyphaga sinensis.

[0008] A traditional Chinese medicine ointment for treating chronic ankle sprain is prepared from the following raw materials in parts by weight: 15-20 parts of Caulis Sinomenii, 15-20 parts of Caulis Trachelospermi, 20-30 parts of Radix Aconiti Kusnezoffii, 6-10 parts of artificial musk, 17-20 parts of frankincense, 17-20 parts of myrrh, 10-15 parts of Eupolyphaga sinensis, 18-22 parts of vaseline, 22-24 parts of palmitic acid, 3.6-6 parts of jobaba oil, 12-14 parts of glyceryl tristearate, 28-32 parts of propylene glycol, 5-7 parts of Tween 20, 100-110 parts of water (the amount of water used here is the amount of water used in preparing a matrix water phase), 4-6 parts of azone and 0.4-0.6 parts of methyl parahydroxybenzoate.

[0009] Optionally, the traditional Chinese medicine ointment for treating chronic ankle sprain is made of the following raw materials in parts by weight: 15 parts of Caulis Sinomenii, 15 parts of Caulis Trachelospermi, 20 parts of Radix Aconiti Kusnezoffii, 6 parts of artificial musk, 17 parts of frankincense, 17 parts of myrrh, 10 parts of Eupolyphaga sinensis, 18 parts of vaseline, 22 parts of palmitic acid, 3.6 parts of jobaba oil, 12 parts of glyceryl tristearate, 28 parts of propylene glycol, 5 parts of Tween 20, 100 parts of water, 4 parts of Azone, and 0.4 parts of methyl parahydroxybenzoate.

[0010] Optionally, the traditional Chinese medicine ointment for treating chronic ankle sprain is made of the following raw materials in parts by weight: 17 parts of Caulis Sinomenii, 17 parts of Caulis Trachelospermi, 25 parts of Radix Aconiti Kusnezoffii, 8 parts of artificial musk, 18 parts of frankincense, 18 parts of myrrh, 12 parts of Eupolyphaga sinensis, 20 parts of vaseline, 23 parts of palmitic acid, 5 parts of jobaba oil, 13 parts of glyceryl tristearate, 30 parts of propylene glycol, 6 parts of Tween 20, 105 parts of water, 5 parts of azone, and 0.5 parts of methyl parahydroxybenzoate.

[0011] Optionally, the traditional Chinese medicine ointment for treating chronic ankle sprain is made of the following raw materials in parts by weight: 20 parts of Caulis Sinomenii, 20 parts of Caulis Trachelospermi, 30 parts of Radix Aconiti Kusnezoffii, 10 parts of artificial musk, 20 parts of frankincense, 20 parts of myrrh, 15 parts of Eupolyphaga sinensis, 22 parts of vaseline, 24 parts of palmitic acid, 6 parts of jobaba oil, 14 parts of glyceryl tristearate, 32 parts of propylene glycol, 7 parts of Tween 20, 110 parts of water, 6 parts of Azone, and 0.6 parts of methyl parahydroxybenzoate.

[0012] The preparation method of the Chinese medicine ointment for treating old ankle sprain comprises the following steps:

[0013] 1) Pretreatment of Chinese medicine: Clean and dry Caulis Sinomenii, Caulis Trachelospermi, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, and then extract with alcohol to concentrate them into extract;

[0014] 2) Preparation of oil phase: Take vaseline, palmitic acid, jojoba oil, and glyceryl tristearate, place them in a heating container, heat to 70°C-80°C, and completely melt and mix them evenly;

[0015] 3) Preparation of aqueous phase: Add propylene glycol, Tween 20 and methyl paraben into water, stir to dissolve, and heat to 70℃-80℃;

[0016] 4) Mixing and emulsification: Slowly add the water phase into the oil phase while stirring, and continue stirring until a uniform emulsion is formed;

[0017] 5) Add Chinese medicine and azone: When the temperature of the emulsion drops to 50℃-60℃, add Chinese medicine extract and azone, and stir well;

[0018] 6) Filling and storage: Fill the prepared ointment into a suitable container while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0019] Optionally, in the step 1), the coarse Chinese medicine powder is powder that passes through a 60-mesh sieve.

[0020] Optionally, in the step 1), the alcohol extraction is as follows: adding 7-9 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 1-2 hours, combining the extracts, and concentrating under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

[0021] Optionally, in the step 1), the alcohol extraction is as follows: adding 8 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

[0022] Optionally, in step 4) and step 5), the stirring method is stirring with an electric stirrer, the stirring speed is 190-250 rpm, and the stirring time is 20-30 min.

[0023] The beneficial effects brought about by the technical solution provided by the embodiment of the present invention include at least:

[0024] The invention has reasonable compatibility, rich raw materials, and effective combination of components, so that the whole prescription can play the effects of dredging meridians and activating blood circulation, dispersing blood stasis and relieving pain, and nourishing tendons and blood vessels. It is effectively used for treating old ankle sprains, is easy to use, and has good effects. It is an innovation in the medicine for treating old ankle sprains, and has good promotion and application value and practical clinical significance.

[0025] In the prescription of the present invention:

[0026] Caulis Sinomenii: bitter, flat; slightly toxic. Enters the liver and spleen meridians. Expels wind, activates blood circulation, removes dampness and dredges collaterals. Used for rheumatic arthralgia, joint swelling and pain, and traumatic injuries.

[0027] Trachelospermum officinale: bitter, slightly cold. Enters the heart, liver, and kidney meridians. Expels wind and dredges the meridians, cools blood and reduces swelling. Used for rheumatism and heat arthralgia, tendon spasm, soreness of waist and knees, throat paralysis, and injuries from falls.

[0028] Raw Radix Aconiti Kusnezoffii: pungent, bitter, hot. Enters the heart, liver, kidney, and spleen meridians. Expels wind and dampness, warms the meridians and relieves pain. Used to treat wind-cold-damp arthralgia, joint pain, cold pain in the heart and abdomen, and pain caused by cold hernia.

[0029] Artificial Musk: Pungent, warm. Entries to the heart and spleen meridians. Promotes blood circulation and menstruation, relieves swelling and relieves pain. Used to treat traumatic injuries, stroke, phlegm syncope, and qi syncope.

[0030] Frankincense: pungent, bitter, warm. Enters the heart, liver, and spleen meridians. It promotes blood circulation, promotes qi circulation, relieves pain, reduces swelling, and promotes tissue regeneration. It is used to treat rheumatic arthralgia, tendon spasm, traumatic injury, carbuncle, sore, chest pain, and heartache.

[0031] Myrrh: pungent, bitter, neutral. Enters the heart, liver, and spleen meridians. Disperses blood stasis, relieves pain, reduces swelling, and promotes tissue regeneration. Used to treat rheumatic arthralgia, traumatic injury, carbuncle, ulcer, chest pain, epigastric pain, dysmenorrhea, and amenorrhea.

[0032] Eupolyphaga: salty, cold; slightly toxic. Enters the liver meridian. Breaks up blood stasis and strengthens tendons and bones. Used for tendon and bone fractures, blood stasis, amenorrhea, and lumps.

[0033] The above-mentioned medicines are effectively combined and support each other, with raw Aconitum carmichaelii as the main ingredient, frankincense and myrrh as the secondary ingredients, Caulis Sinomenii and Trachelospermi Caulis as the auxiliary ingredients, and Scolopendra subspinipes and artificial musk as the guiding ingredients.

[0034] The ointment matrix components and their properties and functions in the present invention are as follows:

[0035] Vaseline: It is a semi-liquid mixture of alkanes or saturated hydrocarbons, also called petrolatum, which is obtained by fractionation of petroleum. It has excellent lubricity, moisturizing and sealing properties, can effectively lock in moisture, soften the skin and promote drug penetration. Its chemical properties are stable and not easy to deteriorate, which can extend the shelf life of ointments. Vaseline can also form a protective layer, reduce external irritation and enhance comfort. In addition, it can adjust the matrix consistency and improve its spreadability and adhesion.

[0036] Palmitic acid: It is one of the most widely distributed fatty acids in nature. It is white crystals at room temperature and is insoluble in water. It is widely present in various oils and fats in the form of glycerides. It is mainly used as a thickener and stabilizer in ointments to enhance viscosity and consistency, making it easier to apply and less likely to lose. At the same time, it also has lubricating and moisturizing effects, which helps the uniform release of drug ingredients and skin absorption, thereby improving drug efficacy.

[0037] Jojoba Oil: A liquid wax extracted from the seeds of the jojoba plant, it has a variety of skin care and health benefits. Rich in vitamin E and essential fatty acids, it can effectively nourish the skin, restore the skin barrier function, and relieve dryness and irritation. In addition, jojoba oil has anti-inflammatory properties, which can soothe skin discomfort and promote healthy skin quality, making it an ideal natural ingredient in ointment formulas.

[0038] Glyceryl tristearate: It is an ester compound formed by glycerol and stearic acid. It has excellent stability and ductility, and can enhance the adhesion and sustained-release effect of drugs. Its lubricity and flexibility help to improve the comfort of use. It also has a certain moisturizing effect and promotes drug penetration. In addition, it has stable chemical properties and is not easy to deteriorate. It can extend the shelf life of ointments and is suitable for a variety of external preparations.

[0039] Propylene glycol: It is a common organic compound. It is used as a solvent and moisturizer in ointments. It has good solubility and permeability, and can effectively promote the uniform dispersion of drug ingredients and skin absorption. Its moisturizing effect can prevent the ointment from drying out and improve the comfort of use. In addition, propylene glycol also has antibacterial and stabilizing properties, which helps to extend the shelf life of ointments and enhance the stability and efficacy of drugs.

[0040] Water: As a solvent and matrix component in ointments, it can dissolve water-soluble drug components and ensure their uniform dispersion. It has the function of adjusting the consistency and viscosity of ointments and improves the user experience. Water works synergistically with other matrix components (such as oils and emulsifiers) to form a stable cream system, enhance the stability and ductility of ointments, and promote drug absorption.

[0041] Azone: It is a chemically synthesized transdermal absorption enhancer that can significantly enhance the skin permeability of drug ingredients. Its mechanism of action is to change the lipid structure of the stratum corneum, reduce the skin barrier resistance, and thus improve the bioavailability of drugs. Azone is mild in nature and has little irritation to the skin. It is suitable for a variety of topical preparations and can improve the efficacy and onset speed of ointments.

[0042] Methyl paraben: It is a synthetic compound. As one of the commonly used preservatives, it has broad-spectrum antibacterial and antifungal properties, can effectively inhibit the growth of microorganisms and extend the shelf life of products. It has stable chemical properties and can work in a wide pH range. It is widely used in cosmetics, medicines and foods, and has high safety, but the dosage needs to be controlled to avoid potential irritation. In addition, it has good water solubility and is easy to use in formulations.

[0043] The invention provides a traditional Chinese medicine ointment for treating old ankle sprain and a preparation method thereof, which can effectively promote the rehabilitation of patients with old ankle sprain, has no side effects, has low cost and is suitable for popularization and use. DETAILED DESCRIPTION

[0044] The technical solution of the present invention is described below in conjunction with embodiments.

[0045] Example 1

[0046] A traditional Chinese medicine ointment for treating chronic ankle sprain is prepared from the following raw materials in parts by weight: 15 parts of Caulis Sinomenii, 15 parts of Caulis Trachelospermi, 20 parts of Radix Aconiti Kusnezoffii, 6 parts of artificial musk, 17 parts of frankincense, 17 parts of myrrh, 10 parts of Eupolyphaga sinensis, 18 parts of vaseline, 22 parts of palmitic acid, 3.6 parts of jobaba oil, 12 parts of glyceryl tristearate, 28 parts of propylene glycol, 5 parts of Tween 20, 100 parts of water (the amount of water used here is the amount of water used in preparing a matrix water phase), 4 parts of Azone and 0.4 parts of methyl parahydroxybenzoate.

[0047] The preparation method comprises the following steps:

[0048] 1) Pretreatment of Chinese medicine: Clean and dry Caulis Sinomenii, Caulis Trachelospermi, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, and then extract with alcohol to concentrate them into extract;

[0049] 2) Preparation of oil phase: Take vaseline, palmitic acid, jojoba oil, and glyceryl tristearate, place them in a heating container, heat them in a water bath to 70°C, and completely melt and mix them evenly;

[0050] 3) Preparation of aqueous phase: Add propylene glycol, Tween 20 and methyl paraben into water, stir to dissolve, and heat to 70°C;

[0051] 4) Mixing and emulsification: Slowly add the water phase into the oil phase while stirring, and continue stirring until a uniform emulsion is formed;

[0052] 5) Add Chinese medicine and azone: When the temperature of the emulsion drops to 50°C, add Chinese medicine extract and azone and stir thoroughly.

[0053] 6) Filling and storage: Fill the prepared ointment into a suitable container while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0054] Wherein, in the step 1), the coarse Chinese medicine powder is powder that passes through a 60-mesh sieve.

[0055] Wherein, in the step 1), the alcohol extraction is as follows: adding 7 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 2 hours, combining the extracts, and concentrating under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

[0056] Wherein, in the step 4) and the step 5), the stirring method is stirring with an electric stirrer, the stirring speed is 190 rpm, and the stirring time is 30 min.

[0057] Example 2

[0058] A traditional Chinese medicine ointment for treating chronic ankle sprain is prepared from the following raw materials in parts by weight: 17 parts of Caulis Sinomenii, 17 parts of Caulis Trachelospermi, 25 parts of Radix Aconiti Kusnezoffii, 8 parts of artificial musk, 18 parts of frankincense, 18 parts of myrrh, 12 parts of Eupolyphaga sinensis, 20 parts of vaseline, 23 parts of palmitic acid, 5 parts of jobaba oil, 13 parts of glyceryl tristearate, 30 parts of propylene glycol, 6 parts of Tween 20, 105 parts of water (the amount of water used here is the amount of water used in preparing a matrix water phase), 5 parts of Azone and 0.5 parts of methyl parahydroxybenzoate.

[0059] The preparation method comprises the following steps:

[0060] 1) Pretreatment of Chinese medicine: Clean and dry Caulis Sinomenii, Caulis Trachelospermi, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, and then extract with alcohol to concentrate them into extract;

[0061] 2) Preparation of oil phase: Take vaseline, palmitic acid, jojoba oil, and glyceryl tristearate, place them in a heating container, heat them in a water bath to 75°C, and completely melt and mix them evenly;

[0062] 3) Preparation of aqueous phase: Add propylene glycol, Tween 20 and methyl paraben into water, stir to dissolve, and heat to 75°C;

[0063] 4) Mixing and emulsification: Slowly add the water phase into the oil phase while stirring, and continue stirring until a uniform emulsion is formed;

[0064] 5) Add Chinese medicine and azone: When the temperature of the emulsion drops to 55°C, add Chinese medicine extract and azone and stir thoroughly.

[0065] 6) Filling and storage: Fill the prepared ointment into a suitable container while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0066] Wherein, in the step 1), the alcohol extraction is as follows: adding 8 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

[0067] Wherein, in the step 4) and the step 5), the stirring method is stirring with an electric stirrer, the stirring speed is 230 rpm, and the stirring time is 25 min.

[0068] Example 3

[0069] A traditional Chinese medicine ointment for treating chronic ankle sprain is prepared from the following raw materials in parts by weight: 20 parts of Caulis Sinomenii, 20 parts of Caulis Trachelospermi, 30 parts of Radix Aconiti Kusnezoffii, 10 parts of artificial musk, 20 parts of frankincense, 20 parts of myrrh, 15 parts of Eupolyphaga sinensis, 22 parts of vaseline, 24 parts of palmitic acid, 6 parts of jobaba oil, 14 parts of glyceryl tristearate, 32 parts of propylene glycol, 7 parts of Tween 20, 110 parts of water (the amount of water used here is the amount of water used in preparing a matrix water phase), 6 parts of Azone and 0.6 parts of methyl parahydroxybenzoate.

[0070] The preparation method comprises the following steps:

[0071] 1) Pretreatment of Chinese medicine: Clean and dry Caulis Sinomenii, Caulis Trachelospermi, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, and then extract with alcohol to concentrate them into extract;

[0072] 2) Preparation of oil phase: Take vaseline, palmitic acid, jojoba oil, and glyceryl tristearate, place them in a heating container, heat them in a water bath to 80°C, and completely melt and mix them evenly;

[0073] 3) Preparation of aqueous phase: Add propylene glycol, Tween 20 and methyl paraben into water, stir to dissolve, and heat to 80°C;

[0074] 4) Mixing and emulsification: Slowly add the water phase into the oil phase while stirring, and continue stirring until a uniform emulsion is formed;

[0075] 5) Add Chinese medicine and azone: When the temperature of the emulsion drops to 60°C, add Chinese medicine extract and azone and stir thoroughly.

[0076] 6) Filling and storage: Fill the prepared ointment into a suitable container while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0077] Wherein, in the step 1), the alcohol extraction is as follows: adding 9 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 1 hour, combining the extracts, and concentrating under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

[0078] Wherein, in the step 4) and the step 5), the stirring method is stirring with an electric stirrer, the stirring speed is 250 rpm, and the stirring time is 20 min.

[0079] The whole formula works together to promote blood circulation, relieve blood stasis and relieve pain, and nourish tendons and veins. It is effectively used to treat old ankle sprains and has achieved satisfactory beneficial technical results through clinical trials. The relevant clinical trial data are as follows:

[0080] 1. Safety test (including acute toxicity test, skin irritation test, skin allergy test)

[0081] 1. Acute toxicity test

[0082] Preliminary study: 60 healthy SD rats (weight 260±20g), half male and half female, were selected and provided by Beijing Weitong Lihua Experimental Animal Technology Co., Ltd. (license number SCxK (Beijing) 2021-0006). They were kept indoors in the Animal Experiment Center of Henan University of Traditional Chinese Medicine for 7 days to adapt to the environment, with a room temperature of 18-24℃ and a relative humidity of 40-70%. The SD rats were randomly divided into 5 groups, with 12 rats in each group. 24 hours before administration, the hair on both sides of the rat spine was removed with a razor, with a range of 3cm×3cm, and the hair was removed with a depilatory agent and washed with sterile water. After depilation, check whether the local skin was injured. Randomly select 24 depilated rats, half male and half female, disinfect the local skin with 75% alcohol, and then use a sterilized No. 12 sterilized needle to make a "#" scratch on the depilated skin area, 2cm horizontally and vertically, and the stratum corneum is required to be scratched and bleeding, so that the degree of skin damage on both sides of the spine is consistent.

[0083] The remaining 36 rats were randomly divided into 3 groups, each with 12 rats, half male and half female. The first group was a low-dose group, in which 1 g of the Chinese medicine ointment of the embodiment 1 of the present invention was evenly applied to the depilatory area, covered with sterile gauze, fixed with medical tape, and after 24 hours, the residual plaster was washed with warm water. The second group was a 4-fold dose group, in which 4 g of the Chinese medicine ointment of the embodiment 1 of the present invention was evenly applied to the depilatory area, and then the operation was the same as the first group. The third group was 12 rats of half male and half female with damaged skin, and the operation was the same as the first group. The fourth group was the remaining 12 rats of half male and half female with damaged skin, and the operation was the same as the second group. The fifth group was set as a blank control group, smearing 1 g of glycerol, and the operation was the same as the first group.

[0084] The results showed that after the application of low and high doses, the activity, fur gloss, diet, drinking water, breathing, eyes and mucous membranes, and body weight of rats with intact skin and damaged skin were not affected (all P>0.05), no rats died within 7 days, and no acute toxic reactions occurred.

[0085] The results show that the finished product is non-toxic.

[0086] 2. Skin irritation test

[0087] Twenty-four healthy SD rats (weight 260±20g, half male and half female) were randomly divided into a damaged skin group and an intact skin group, with 12 rats in each group. One group had intact skin, while the other group had damaged skin. 24 hours before administration, the hair on both sides of the spine of the rats were removed with a razor, about 3cm×3cm on each side. In the damaged skin group, a sterilized No. 12 sterilized needle was used to scratch the skin of the depilated area in the shape of a "#", 2cm horizontally and vertically, and the stratum corneum was required to be scratched and bleeding, so that the degree of skin damage on both sides of the spine was consistent. The left back of both groups of rats was smeared with 1g of the Chinese medicine ointment of Example 1 of the present invention, and the right back was smeared with 1g of the reference substance (glycerol), and covered with sterile gauze and fixed with medical tape. After 24 hours, the residual ointment was washed with warm water, and the reaction of the skin in the smeared area was observed after 1h, 24h, 48h and 72h. The test results showed that no skin irritation such as edema and erythema occurred after 1h, 24h, 48h and 72h. It was confirmed that the Chinese medicine ointment of Example 1 of the present invention was non-irritating to the intact skin and damaged skin of rats after one administration.

[0088] 3. Skin allergy test

[0089] 36 healthy SD rats (weight 260 ± 20g) were randomly divided into 3 groups: test group, positive control group and blank control group, half male and half female. 24h before administration, the hair on both sides of the back spine of the rats was removed with a depilatory cream, with an area of ​​3cm×3cm on each side. 0.2g of the Chinese medicine ointment of Example 1 of the present invention was applied to the right hair removal area of ​​each rat in the test group, and covered with sterile gauze and fixed with medical tape. The sterile gauze and tape were removed after 6 hours. The same method was repeated once on the 7th and 14th days. 0.2g of glycerol was applied to the blank control group, and 0.2ml of 2,4-dinitrochlorobenzene with a mass concentration of 1% (prepared with acetone and prepared as needed) was applied to the positive control group, and the method was the same as the test group. On the 14th day after the last administration, each rat in the test group was smeared with 0.2 ml of 2,4-dinitrochlorobenzene on the left hair removal area, fixed with the above method, and sterile gauze and adhesive tape were removed after 6 hours, and the observation was recorded immediately, and the skin allergy was recorded again at 24 hours, 48 ​​hours and 72 hours. The blank control group and the positive control group respectively used 0.2 g of medical vaseline and 0.2 ml of ethanol solution of 0.1% 2,4-dinitrochlorobenzene, and the method was the same as the test group. The results showed that no allergic reactions such as edema and erythema occurred in the skin of the test group and the blank group in the immediate observation, 24 hours, 48 ​​hours and 72 hours, and the sensitization rate of the two groups was 0, and the sensitization rate of the positive control group was 100%. It was confirmed that the Chinese medicine ointment of Example 1 of the present invention was non-sensitizing to rat skin, and 2,4-dinitrochlorobenzene was extremely sensitizing to rat skin.

[0090] 2. Clinical Trials

[0091] 1 Materials and methods

[0092] 1.1 Object

[0093] A total of 64 patients with old ankle sprains were admitted to the Third Affiliated Hospital and the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from January 2021 to December 2024. They included 25 males and 39 females and were randomly divided into a control group and a test group of the present invention.

[0094] 1.2 Treatment options

[0095] Patients in the control group were placed in the lateral position, and the tender points around the affected ankle were pressed with one finger push and kneading for 3 minutes. The hardened "muscle knot" was plucked and pushed longitudinally with fingers, with the force increasing from light to heavy for a total of 3 minutes. For patients with lateral ankle injuries, the ankle joint was inverted, and for patients with medial ankle injuries, the ankle joint was everted. The thenar eminence was kneaded or the painful points were kneaded for a total of 3 minutes. The affected area was rubbed until the skin became hot. The ankle joint was stretched and rotated in a clockwise and counterclockwise direction for 6 times each. Then, the ankle joint gap was poked and pressed with both thumbs, and the affected foot was everted inward and outward once each. A total of 6 sets were performed.

[0096] The experimental group of the present invention: on the basis of the control group, 1-3g of the Chinese medicine ointment prepared in Example 2 of the present invention was applied to the affected area during the rubbing method.

[0097] The treatment methods of the control group and the test group of the present invention were: 2 times a week, 4 weeks as one course of treatment.

[0098] 1.3 Diagnostic criteria

[0099] Refer to the diagnostic criteria for ankle sprain in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes": ① There is a clear history of ankle sprain, and the course of the disease is ≥ 30 days; ② There is persistent dull pain and swelling in the ankle joint, and walking fatigue; ③ Local tenderness, or palpable nodules; ④ The ankle inversion or eversion test is positive, and there is sound or friction sound during passive movement; ⑤ X-ray examination shows no ankle fracture or joint dislocation.

[0100] 1.4 Criteria for determining efficacy

[0101] Markedly effective: The ankle joint on the affected side returned to normal, with good function and stability.

[0102] Effective: There is still slight swelling and pain in the affected ankle joint, but the activity and stability are still good.

[0103] Ineffective: The ankle joint on the affected side was obviously swollen and painful, and the mobility and stability were not improved compared with before.

[0104] Total effective rate = (cured + effective) / total number of cases × 100%.

[0105] 2 Results

[0106] In the experimental group of the present invention, 21 cases were markedly effective, 9 cases were effective, 2 cases were ineffective, and the total effective rate was 93.75%.

[0107] There were 11 cases in the control group, 14 were effective, 7 were ineffective, and the total effective rate was 78.12%.

[0108] During the whole treatment process, no obvious adverse reactions and abnormalities were observed. After long-term clinical practice, applying the Chinese medicine ointments prepared in other embodiments can achieve the same or similar therapeutic effects, which will not be described in detail one by one.

[0109] 3 Typical Cases

[0110] Example 1:

[0111] Li, male, 42 years old, from Kaifeng, Henan

[0112] 2 years ago, the patient accidentally sprained his left foot during exercise, and the left foot was swollen and painful and could not touch the ground. Whenever the weather changed or he was tired, the left foot pain recurred. Use the Chinese medicine ointment of the present invention, and the symptoms were significantly alleviated after 2 days. After continuous application for 3 weeks, the symptoms were eliminated substantially.

[0113] Example 2:

[0114] Zhao, female, 25 years old, from Zhoukou, Henan

[0115] 5 years after ankle sprain, ankle joint swelling and pain, occasional limited activity. After 4 courses of treatment with the Chinese medicine ointment of the present invention, the local swelling and pain symptoms of the ankle joint are significantly relieved, and the activity ability is significantly improved.

[0116] Example 3:

[0117] Wang, female, 57 years old, from Shangqiu, Henan

[0118] Six months after ankle sprain, pain continued to increase, and I could not walk for a long time recently. Using the Chinese medicine ointment of the present invention, the pain symptoms were significantly relieved after one month, and the pain symptoms disappeared substantially after continuous application for two months.

[0119] Comparative Example 1

[0120] The present invention can be effectively used to treat old ankle sprains, and the efficacy is compared with similar Chinese patent medicines. Satisfactory beneficial technical effects have been achieved through clinical trials. The relevant clinical trial data are as follows:

[0121] 1 Materials and methods

[0122] 1.1 Object

[0123] From January 2024 to January 2025, 52 patients with old ankle sprains were admitted to the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine. According to the inclusion and exclusion criteria, 18 males and 34 females were selected and randomly divided into a control group and an experimental group of the present invention.

[0124] 1.2 Treatment options

[0125] Control group: apply 2-3 ml of Huoxue Xiaotong tincture (Lingrui, Henan Lingrui Pharmaceutical Co., Ltd.: 60 ml / bottle) externally to the affected area.

[0126] The test group of the present invention: 1-3 g of the Chinese medicine ointment prepared in Example 2 of the present invention was applied externally to the affected area.

[0127] The treatment method of the control group and the test group of the present invention is: 7 times a week, and 2 weeks is one course of treatment.

[0128] 1.3 Diagnostic criteria

[0129] Refer to the diagnostic criteria for ankle sprain in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes": ① There is a clear history of ankle sprain, and the course of the disease is ≥ 30 days; ② There is persistent dull pain and swelling in the ankle joint, and walking fatigue; ③ Local tenderness, or palpable nodules; ④ The ankle inversion or eversion test is positive, and there is sound or friction sound during passive movement; ⑤ X-ray examination shows no ankle fracture or joint dislocation.

[0130] 1.4 Criteria for determining efficacy

[0131] Markedly effective: The ankle joint on the affected side returned to normal, with good function and stability.

[0132] Effective: There is still slight swelling and pain in the affected ankle joint, but the activity and stability are still good.

[0133] Ineffective: The ankle joint on the affected side was obviously swollen and painful, and the mobility and stability were not improved compared with before.

[0134] Total effective rate = (cured + effective) / total number of cases × 100%.

[0135] 2 Results

[0136] The experimental group of the present invention: 4 cases were markedly effective, 19 cases were effective, 3 cases were ineffective, and the total effective rate was 88.46% (please verify whether the data is accurate); the control group: 1 case was markedly effective, 18 cases were effective, 7 cases were ineffective, and the total effective rate was 73.08%.

[0137] The invention has scientific and reasonable compatibility, rich raw materials, convenient use and good effect. The whole formula has the effects of dredging meridians and activating blood circulation, dispersing blood stasis and relieving pain, and nourishing tendons and blood vessels. It can effectively alleviate the clinical symptoms of patients with old ankle sprains. It is an innovation in the medicine for treating old ankle sprains and has good promotion and application value and practical clinical significance.

[0138] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A Chinese medicine composition for treating old ankle sprain, characterized in that: The invention comprises the following raw materials in parts by weight: 15-20 parts of Caulis Sinomenii, 15-20 parts of Caulis Trachelospermi, 20-30 parts of raw Aconitum, 6-10 parts of artificial musk, 17-20 parts of frankincense, 17-20 parts of myrrh and 10-15 parts of Eupolyphaga sinensis.

2. A Chinese medicine ointment for treating chronic ankle sprain, characterized in that: The invention is prepared from the following raw materials in parts by weight: 15-20 parts of Caulis Sinomenii, 15-20 parts of Caulis Trachelospermi, 20-30 parts of raw Aconitum, 6-10 parts of artificial musk, 17-20 parts of frankincense, 17-20 parts of myrrh, 10-15 parts of Eupolyphaga sinensis, 18-22 parts of vaseline, 22-24 parts of palmitic acid, 3.6-6 parts of jobaba oil, 12-14 parts of glyceryl tristearate, 28-32 parts of propylene glycol, 5-7 parts of Tween 20, 100-110 parts of water, 4-6 parts of Azone and 0.4-0.6 parts of methyl parahydroxybenzoate.

3. The Chinese medicinal ointment for treating old ankle sprain according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 15 parts of Caulis Sinomenii, 15 parts of Caulis Trachelospermi, 20 parts of Radix Aconiti Kusnezoffii, 6 parts of artificial musk, 17 parts of frankincense, 17 parts of myrrh, 10 parts of Eupolyphaga sinensis, 18 parts of vaseline, 22 parts of palmitic acid, 3.6 parts of jobaba oil, 12 parts of glyceryl tristearate, 28 parts of propylene glycol, 5 parts of Tween 20, 100 parts of water, 4 parts of Azone and 0.4 parts of methyl parahydroxybenzoate.

4. The Chinese medicinal ointment for treating old ankle sprain according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 17 parts of Caulis Sinomenii, 17 parts of Caulis Trachelospermi, 25 parts of raw Aconiti Kusnezoffii, 8 parts of artificial musk, 18 parts of frankincense, 18 parts of myrrh, 12 parts of Eupolyphaga sinensis, 20 parts of vaseline, 23 parts of palmitic acid, 5 parts of jobaba oil, 13 parts of glyceryl tristearate, 30 parts of propylene glycol, 6 parts of Tween 20, 105 parts of water, 5 parts of azone and 0.5 parts of methyl parahydroxybenzoate.

5. The Chinese medicinal ointment for treating old ankle sprain according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 20 parts of Caulis Sinomenii, 20 parts of Caulis Trachelospermi, 30 parts of Radix Aconiti Kusnezoffii, 10 parts of artificial musk, 20 parts of frankincense, 20 parts of myrrh, 15 parts of Eupolyphaga sinensis, 22 parts of vaseline, 24 parts of palmitic acid, 6 parts of jobaba oil, 14 parts of glyceryl tristearate, 32 parts of propylene glycol, 7 parts of Tween 20, 110 parts of water, 6 parts of Azone and 0.6 parts of methyl parahydroxybenzoate.

6. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to any one of claims 2 to 5, characterized in that: The following steps are involved: 1) Pretreatment of Chinese medicine: Clean and dry Caulis Sinomenii, Caulis Trachelospermi, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, and then extract with alcohol to concentrate them into extract; 2) Preparation of oil phase: Take vaseline, palmitic acid, jojoba oil, and glyceryl tristearate, place them in a heating container, heat to 70°C-80°C, and completely melt and mix them evenly; 3) Preparation of aqueous phase: Add propylene glycol, Tween 20 and methyl paraben into water, stir to dissolve, and heat to 70℃-80℃; 4) Mixing and emulsification: Slowly add the water phase into the oil phase while stirring, and continue stirring until a uniform emulsion is formed; 5) Add Chinese medicine and azone: When the temperature of the emulsion drops to 50℃-60℃, add Chinese medicine extract and azone, and stir well; 6) Filling and storage: Fill the prepared ointment into a suitable container while it is still hot, seal it after cooling, and store it in a cool and dry place.

7. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 6, characterized in that: In the step 1), the coarse Chinese medicine powder is powder that passes through a 60-mesh sieve.

8. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 6, characterized in that: In the step 1), the alcohol extraction is as follows: the crude Chinese medicine powder is added with 7-9 times the amount of 75% ethanol, refluxed and extracted twice, each time for 1-2 hours, the extracts are combined, and concentrated under reduced pressure to an extract with a relative density of 1.20-1.25 at 45°C.

9. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 8, characterized in that: In the step 1), the alcohol extraction is as follows: adding 8 times the amount of 75% ethanol to the crude Chinese medicine powder, reflux extraction twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to form an extract with a relative density of 1.20-1.25 at 45°C.

10. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 6, characterized in that: In the step 4) and step 5), the stirring method is stirring with an electric stirrer, the stirring speed is 190-250 rpm, and the stirring time is 20-30 min.