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

Abstract

The present invention provides a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating chronic ankle sprains, relating to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition for treating chronic ankle sprains 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. The present invention has reasonable compatibility, abundant raw materials, and effective combinations between the prescriptions, so that the whole prescription can achieve the effects of promoting blood circulation, dispersing blood stasis and relieving pain, and nourishing tendons and meridians. It is effectively used to treat chronic ankle sprains, is easy to use, and has good effects. It is an innovation in the treatment of chronic ankle sprains and has good promotion and application value 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, and osteoarthritis after an ankle sprain. Research data shows that 70% of people will suffer an ankle sprain, and the recurrence rate among athletes is as high as 80%. Although most patients can resume activities within 24 hours after the sprain, 3.6% of patients still need to take it for three weeks or even longer to resume full activities. Therefore, the vast majority of ankle sprain patients do not take this disease seriously 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 and mild functional impairments may still exist for six months to two years after the acute onset.

[0003] Chronic ankle sprains often develop from acute injuries. Acute ankle sprains damage surrounding soft tissues such as ligaments, muscles, and tendons, resulting in varying degrees of localized tearing and rupture of small blood vessels. These injuries can lead to acute pathological changes such as congestion, exudation, edema, and bleeding. Lack of timely and effective treatment, or prolonged weight-bearing activity after the sprain, can lead to increased exudation and swelling around the ankle joint. If the exudate is not absorbed promptly, it solidifies and is reorganized by connective tissue, forming a scar. If the injured area is close to bone, calcification may occur, resulting in the common clinical condition myositis ossificans. These localized soft tissue hyperplasia, adhesions, or thickening and organizational degeneration can cause limited ankle motion, swelling, and pain, ultimately developing into a chronic sprain, which is difficult to cure due to its recurring nature.

[0004] Chronic ankle sprains fall under the categories of "injured tendons" and "dislocated tendons" in Traditional Chinese Medicine. After an acute ankle sprain, local tendons and veins are damaged, blood overflows from the veins, blood stagnates, and qi and blood flow stagnates, blocking the meridians. Pain results from this blockage, and limited movement due to pain also slows the flow of qi and blood. If treatment is delayed and the old blood stasis is not removed, the injury will recur over time, depriving the local tendons and veins of nourishment. Wind, cold, and dampness can take advantage of this vulnerability, and internal and external blood stasis can disrupt the muscles and tendons, exacerbating meridian blockage and causing numbness. This condition gathers in the affected ankle, causing swelling and pain, difficulty moving, and prolonged healing, aggravated by cold and dampness. In short, the pathogenesis of this disease is primarily due to qi stagnation and blood stasis, as well as malnutrition of tendons and veins. Treatment should focus on promoting blood circulation and regulating qi, relaxing the meridians and unblocking the collaterals, and nourishing the tendons and veins.

[0005] There are currently many treatments for chronic ankle sprains, including acupuncture, acupotomy, massage, topical application of Chinese herbal preparations, and combined treatments. However, current treatments take a relatively long time, requiring patients to frequently travel to and from the hospital, severely impacting their lives and work. Western medicine treatments primarily include oral nonsteroidal anti-inflammatory analgesics, blockades, immobilization, anchors, and ligament reconstruction. Oral medications have a long course of treatment, are burdensome, and are prone to developing drug resistance, with certain adverse reactions to the patient's gastrointestinal, liver, and kidney functions. Blockades only provide relatively short-term relief from pain and do not address the underlying cause of the disease. Therefore, finding an economically safe, simple, and effective method to promote the recovery of chronic ankle sprains has always been a pressing challenge for the medical community. Summary of the Invention

[0006] In order to solve the technical problems existing in the prior art, the present invention provides a Chinese medicine composition and a Chinese medicine ointment for treating chronic ankle sprains. 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 Sinomenium sinomenium, 15-20 parts of Trachelospermum schrenkiana, 20-30 parts of raw aconite, 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 used in preparing a matrix aqueous 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 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.

[0010] Optionally, the traditional Chinese medicine ointment for treating old ankle sprain is made 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, 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 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.

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

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

[0014] 2) Oil phase preparation: Place petrolatum, palmitic acid, jobab oil, and glyceryl tristearate in a heating container and heat to 70-80°C until completely melted and mixed.

[0015] 3) Prepare the aqueous phase: Add propylene glycol, Tween 20, and methyl paraben to water, stir to dissolve, and heat to 70-80°C.

[0016] 4) Mixing and emulsification: Slowly add the water phase to 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°C, add the Chinese medicine extract and azone and stir thoroughly;

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

[0019] Optionally, in 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 form 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 form 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 work together to achieve the effects of unblocking meridians and activating blood circulation, dispersing blood stasis and relieving pain, and nourishing tendons and invigorating veins. 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] Sinomenium sinomenium: Bitter, neutral; slightly toxic. Enters the Liver and Spleen meridians. Dispels wind, promotes blood circulation, promotes dampness, and dredges the meridians. Used for rheumatic pain, joint swelling and pain, and traumatic injuries.

[0027] Trachelospermum officinale: Bitter, slightly cold. Entries the Heart, Liver, and Kidney meridians. Dispels wind and dredges the meridians, cools blood and reduces swelling. Used for rheumatic fever, muscle and vein spasms, soreness of the waist and knees, sore throat, and injuries from falls.

[0028] Raw Radix Aconiti Kusnezoffii: Pungent, bitter, and hot. It enters the Heart, Liver, Kidney, and Spleen meridians. It dispels wind and dampness, warms the meridians, and relieves pain. It is used to treat wind-cold-damp arthritis, joint pain, heart and abdominal pain, and pain caused by cold hernia.

[0029] Artificial Musk: Pungent, warm. Targets the Heart and Spleen meridians. Promotes blood circulation, relieves swelling and relieves pain. Used to treat traumatic injuries, stroke, phlegm-induced syncope, and qi-induced syncope.

[0030] Frankincense: Pungent, bitter, and warm. It 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 pain, muscle spasms, injuries from falls, carbuncles, sores, and chest pain.

[0031] Myrrh: Pungent, bitter, neutral. Enters the Heart, Liver, and Spleen meridians. Dissipates blood stasis, relieves pain, reduces swelling, and promotes tissue regeneration. Used to treat rheumatic pain, traumatic injuries, carbuncles, ulcers, chest pain, heart pain, epigastric pain, and dysmenorrhea and amenorrhea.

[0032] Eupolyphaga sinensis: Salty, cold, slightly toxic. Enters the Liver meridian. Dissolves blood stasis and strengthens tendons and bones. Used for tendon and bone fractures, blood stasis, amenorrhea, and lumps.

[0033] The above 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 Clematis chinensis 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: A semi-liquid mixture of alkanes or saturated hydrocarbons, also known as petrolatum, is derived from the fractionation of petroleum. It possesses excellent lubricity, moisturizing, and occlusive properties, effectively locking in moisture, softening the skin, and promoting drug penetration. Its chemical stability and resistance to deterioration extend the shelf life of ointments and facial creams. Vaseline also forms a protective layer, reducing irritation and enhancing comfort. Furthermore, it can adjust the consistency of the base, improving its spreadability and adhesion.

[0036] Palmitic acid: One of the most widely distributed fatty acids in nature, it appears as white crystals at room temperature and is insoluble in water. It is widely found in various oils and fats as a glyceride. In ointments, it primarily serves as a thickener and stabilizer, enhancing viscosity and consistency, making it easier to apply and less prone to runny. It also has lubricating and moisturizing properties, facilitating the even release and skin absorption of drug ingredients, thereby enhancing efficacy.

[0037] Jojoba oil, a liquid wax extracted from the seeds of the jojoba plant, offers numerous skincare and wellness benefits. Rich in vitamin E and essential fatty acids, it effectively nourishes the skin, restores the skin barrier, and relieves dryness and irritation. Additionally, its anti-inflammatory properties soothe irritation and promote healthy-looking skin, making it an ideal natural ingredient in ointments and creams.

[0038] Glyceryl tristearate: An ester compound formed by glycerol and stearic acid, it exhibits excellent stability and ductility, enhancing drug adhesion and sustained-release properties. Its lubricity and flexibility contribute to increased comfort while also providing a moisturizing effect, promoting drug penetration. Furthermore, its chemical stability and resistance to deterioration extend the shelf life of ointments and rubs, making it suitable for a variety of topical preparations.

[0039] Propylene glycol is a common organic compound used as a solvent and humectant in ointments. Its excellent solubility and permeability effectively promote the uniform dispersion and skin absorption of drug ingredients. Its moisturizing effect prevents ointments from drying out and enhances user comfort. Furthermore, propylene glycol possesses antimicrobial and stabilizing properties, helping to extend the shelf life of ointments and enhancing drug stability and efficacy.

[0040] Water: Serving as a solvent and matrix component in ointments, it dissolves water-soluble drug ingredients and ensures their uniform dispersion. It regulates the consistency and viscosity of ointments, improving the user experience. Water works synergistically with other matrix components (such as oils and emulsifiers) to form a stable ointment system, enhancing the stability and spreadability of the ointment and promoting drug absorption.

[0041] Azone: A chemically synthesized transdermal absorption enhancer significantly enhances the skin permeability of drug ingredients. Its mechanism of action is to alter the lipid structure of the stratum corneum, reducing skin barrier resistance and thereby improving drug bioavailability. Azone is mild and has minimal skin irritation, making it suitable for a variety of topical preparations and can improve the efficacy and speed of action of ointments and massages.

[0042] Methylparaben: A synthetic compound, a commonly used preservative, exhibits broad-spectrum antibacterial and antifungal properties, effectively inhibiting microbial growth and extending product shelf life. Its chemical properties are stable and effective across a wide pH range. It is widely used in cosmetics, pharmaceuticals, and foods, offering high safety, though dosage must be controlled to avoid potential irritation. Furthermore, its water solubility makes it easy to incorporate into formulations.

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

[0044] The technical solutions of the present invention are 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 here is the amount used in preparing a matrix aqueous 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 herbal medicines: Clean and dry Caulis Sinomenii, Trachelospermi Caulis, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, extract with alcohol, and concentrate into an extract;

[0049] 2) Oil phase preparation: Place petrolatum, palmitic acid, jojoba oil, and glyceryl tristearate in a heating container and heat in a water bath to 70°C until completely melted and mixed.

[0050] 3) Prepare the aqueous phase: Add propylene glycol, Tween 20, and methyl paraben to water, stir to dissolve, and heat to 70°C.

[0051] 4) Mixing and emulsification: Slowly add the water phase to 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 suitable containers 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 form an extract with a relative density of 1.20-1.25 at 45°C.

[0056] Wherein, in the steps 4) and 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 here is the amount used in preparing a matrix aqueous 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 herbal medicines: Clean and dry Caulis Sinomenii, Trachelospermi Caulis, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, extract with alcohol, and concentrate into an extract;

[0061] 2) Oil phase preparation: Place petrolatum, palmitic acid, jobab oil, and glyceryl tristearate in a heating container and heat in a water bath to 75°C until completely melted and mixed.

[0062] 3) Prepare the aqueous phase: Add propylene glycol, Tween 20, and methyl paraben to water, stir to dissolve, and heat to 75°C.

[0063] 4) Mixing and emulsification: Slowly add the water phase to 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 suitable containers 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 form an extract with a relative density of 1.20-1.25 at 45°C.

[0067] Wherein, in the steps 4) and 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 here refers to the amount used in preparing a matrix aqueous 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 herbal medicines: Clean and dry Caulis Sinomenii, Trachelospermi Caulis, Radix Aconiti Kusnezoffii, artificial musk, frankincense, myrrh, and Eupolyphaga sinensis, grind them into coarse powder, extract with alcohol, and concentrate into an extract;

[0072] 2) Oil phase preparation: Place petrolatum, palmitic acid, jobab oil, and glyceryl tristearate in a heating container and heat in a water bath to 80°C until completely melted and mixed.

[0073] 3) Prepare the aqueous phase: Add propylene glycol, Tween 20, and methyl paraben to water, stir to dissolve, and heat to 80°C.

[0074] 4) Mixing and emulsification: Slowly add the water phase to 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 suitable containers 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 form an extract with a relative density of 1.20-1.25 at 45°C.

[0078] Wherein, in the steps 4) and 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, dissipate blood stasis and relieve pain, and nourish the tendons and meridians. It is effectively used to treat chronic ankle sprains and has achieved satisfactory beneficial technical results in clinical trials. The relevant clinical trial data are as follows:

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

[0081] 1. Acute toxicity test

[0082] Preliminary study: Sixty healthy Sprague-Dawley rats (weighing 260 ± 20 g), half male and half female, were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd. (License No. SCxK (Beijing) 2021-0006). They were housed for 7 days at the Animal Experimental Center of Henan University of Traditional Chinese Medicine for acclimatization at a room temperature of 18-24°C and a relative humidity of 40-70%. The rats were randomly divided into five groups of 12 rats each. Twenty hours before dosing, the hair on both sides of the rats' spines was shaved with a razor, covering an area of ​​3 cm x 3 cm. The hair was then removed with a depilatory agent and washed with sterile water. After depilation, the skin was inspected for damage. Twenty-four randomly selected, half male and half female, depilated skin was disinfected with 75% alcohol. A sterile 12-gauge needle was then used to create a 2 cm horizontal and vertical scar in the depilated skin area. The scar was intended to damage the stratum corneum and bleed, with the skin damaged to a uniform degree on both sides of the spine.

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

[0084] The results showed that after low-dose and high-dose application, the activity, fur gloss, diet, drinking water, respiration, 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 showed that the finished product was non-toxic.

[0086] 2. Skin irritation test

[0087] Twenty-four healthy Sprague-Dawley rats (weighing 260 ± 20 g, half male and half female) were randomly divided into two groups, 12 rats each. One group had intact skin, while the other had damaged skin. Twenty-four hours before dosing, the hair on both sides of the spinal column on the back of the rats was shaved with a razor, approximately 3 cm × 3 cm on each side. In the damaged skin group, a 2 cm horizontal and vertical scar was made on the skin at the depilated site using a sterile 12-gauge needle. The stratum corneum was damaged and bleeding was observed, ensuring that the skin damage on both sides of the spine was consistent. Both groups of rats were smeared with 1 g of the Chinese herbal ointment of Example 1 of the present invention on the left side of their backs, and 1 g of the control substance (glycerol) was smeared on the right side of their backs. The ointment was covered with sterile gauze and secured with medical tape. After 24 hours, the remaining ointment was washed with warm water, and the skin reaction in the smeared area was observed 1 hour, 24 hours, 48 ​​hours, and 72 hours later. The test results showed that no skin irritation such as edema and erythema occurred after 1 hour, 24 hours, 48 ​​hours, and 72 hours. This confirmed that a single administration of the Chinese herbal ointment of Example 1 of the present invention was non-irritating to both intact and damaged skin of rats.

[0088] 3. Skin allergy test

[0089] Thirty-six healthy SD rats (weighing 260±20g) were randomly divided into three groups: a test group, a positive control group, and a blank control group, with half male and half female. 24h before administration, the hair on both sides of the rats' spines were 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 procedure 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, using the same method as the test group. On the 14th day after the last administration, each rat of the test group was smeared with 0.2 ml of 2,4-dinitrochlorobenzene on the left side of the depilatory area, fixed with the aforementioned method, and sterile gauze and adhesive tape were removed after 6 hours. 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 were respectively treated with 0.2 ml of an ethanol solution of 0.2 ml of 0.1% 2,4-dinitrochlorobenzene using medical vaseline 0.2 g and a mass concentration of 0.1%, and the method was the same as that of the test group. The results showed that allergic reactions such as edema and erythema did not occur in the test group and the blank group skin at the time of observation, 24 hours, 48 ​​hours and 72 hours. The sensitization rate of both groups was 0, and the sensitization rate of the positive control group was 100%. It was confirmed that the Chinese medicine ointment of the embodiment of the present invention 1 had no sensitization to rat skin, and 2,4-dinitrochlorobenzene had extreme sensitization 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 an experimental group of the present invention.

[0094] 1.2 Treatment options

[0095] Patients in the control group were placed in the lateral decubitus position and subjected to one-finger massage and kneading for 3 minutes on tender points around the affected ankle. Plucking and longitudinally pushing the indurated "muscle knot" with fingers, increasing the pressure, were performed for 3 minutes. For patients with lateral ankle injuries, the ankle was inverted, while for patients with medial ankle injuries, the ankle was everted. The thenar eminence was massaged or the tender points were kneaded for 3 minutes. The affected area was rubbed until the skin warmed. The ankle was stretched and rotated in both clockwise and counterclockwise directions 6 times each. Then, the ankle joint space was pressed with both thumbs, and the foot was everted inward and outward once each. This was repeated for 6 sets.

[0096] The experimental group of the present invention: on the basis of the control group, 1 to 3 g 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 method of the control group and the experimental group of the present invention was: 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 Treatment of Diseases and Syndromes in Traditional Chinese Medicine": ① There is a clear history of ankle sprain with a course of disease ≥ 30 days; ② There is persistent dull pain and swelling in the ankle joint, and fatigue in walking; ③ Local tenderness, or palpable nodules; ④ The ankle inversion or eversion test is positive, and there is a 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: The affected ankle joint still has slight swelling and pain, but the activity and stability are still acceptable.

[0103] Ineffective: The affected ankle joint 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 of which were effective and 7 were ineffective, with an overall effective rate of 78.12%.

[0108] During the whole treatment process, no obvious adverse reactions and abnormalities were observed. Through 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 Moumou, male, 42 years old, from Kaifeng City, Henan Province

[0112] Careless sprain during exercise 2 years ago, left foot swells, pain can not touch the ground, every time when encountering weather change or being tired, left foot pain attacks repeatedly.Use with Chinese medicine ointment massage of the present invention, symptom namely obviously alleviated after 2 days, continuous application 3 weeks, symptom is 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 movement. After 4 courses of treatment with the Chinese medicine ointment of the present invention, the local swelling and pain symptoms of the ankle joint were significantly relieved and the mobility was significantly improved.

[0116] Example 3:

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

[0118] After ankle sprain 6 months, pain continues to increase the weight of, can not walk for a long time recently. Use with Chinese medicine ointment of the present invention, pain symptoms are obviously alleviated after 1 month, continuous application 2 months, pain symptoms disappear substantially.

[0119] Comparative Example 1

[0120] The present invention can be effectively used to treat old ankle sprains, and has been compared with similar Chinese patent medicines in terms of efficacy. Clinical trials have shown satisfactory beneficial technical effects. 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: 2-3 ml of Huoxue Xiaotong tincture (Lingrui, Henan Lingrui Pharmaceutical Co., Ltd.: 60 ml / bottle) was applied externally to the affected area.

[0126] The experimental group of the present invention: 1-3 g of the traditional 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 experimental group of the present invention was: 7 times a week, and 2 weeks constituted a course of treatment.

[0128] 1.3 Diagnostic criteria

[0129] Refer to the diagnostic criteria for ankle sprain in the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine": ① There is a clear history of ankle sprain with a course of disease ≥ 30 days; ② There is persistent dull pain and swelling in the ankle joint, and fatigue in walking; ③ Local tenderness, or palpable nodules; ④ The ankle inversion or eversion test is positive, and there is a 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: The affected ankle joint still has slight swelling and pain, but the activity and stability are still acceptable.

[0133] Ineffective: The affected ankle joint 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] In the experimental group of the present invention, there were 4 cases with marked effect, 19 cases with effect, 3 cases with ineffectiveness, and the total effective rate was 88.46%; in the control group, there was 1 case with marked effect, 18 cases with effect, 7 cases with ineffectiveness, and the total effective rate was 73.08%.

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

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

Claims

1. A Chinese medicinal ointment for treating old ankle sprain, characterized in that: The invention is prepared from the following raw materials in parts by weight: 15-20 parts of Sinomenium sinomenium, 15-20 parts of Trachelospermum schrenkiana, 20-30 parts of raw aconitum 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, 4-6 parts of azone, and 0.4-0.6 parts of methyl parahydroxybenzoate.

2. 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.

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: 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 part 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: 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.

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

6. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 5, wherein: In the step 1), the coarse Chinese medicine powder is powder that passes through a 60-mesh sieve.

7. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 5, wherein: 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 form an extract with a relative density of 1.20-1.25 at 45°C.

8. The method for preparing the Chinese medicinal ointment for treating old ankle sprain according to claim 7, 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 form 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 5, wherein: In the steps 4) and 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.