Traditional Chinese medicine composition for treating stiff neck, traditional Chinese medicine ointment and preparation method

Abstract

The invention provides a traditional Chinese medicine composition for treating stiff neck, a traditional Chinese medicine ointment and a preparation method, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10 to 20 parts of fructus gardeniae, 10 to 20 parts of cortex kadsurae radicis, 5 to 15 parts of camphor, 10 to 20 parts of frankincense, 10 to 20 parts of myrrh, 20 to 40 parts of folium hibisci mutabilis, 10 to 20 parts of ground beeltle, 5 to 15 parts of artificial musk and 5 to 15 parts of distillers' grains. The traditional Chinese medicine composition is rich in raw materials, reasonable in compatibility, effective in combination and capable of supporting each other, has the effects of relieving swelling and pain, activating blood and relaxing muscles and tendons, can effectively relieve clinical symptoms of patients with stiff neck, is an innovation of medicines for treating stiff neck, and has good popularization and application value and practical clinical significance.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating stiff neck, a traditional Chinese medicine ointment and a preparation method thereof. Background Art

[0002] Stiff neck is a common clinical disease. The main clinical manifestations are persistent muscle tension, pain, stiffness and difficulty in movement on one side of the neck. With the accelerated pace of life and the increased pressure of daily life and work, the incidence of stiff neck is gradually increasing. Surveys show that the incidence of stiff neck in my country is about 14.6%, and the recurrence rate is as high as 85% within 1 to 5 years after the first attack. Mild symptoms can heal themselves within 4 to 5 days. If left untreated, severe symptoms can last for weeks or even months, with repeated attacks, which has a great impact on the patient's quality of life.

[0003] The main symptoms of stiff neck are tenderness and spasm of the rhomboid and trapezius muscles of the neck, tension and stiffness of the muscles on the affected side, which causes difficulty in neck movement, and cord-like nodules can be felt. There are three main factors for stiff neck: muscle sprain; sleeping in a cool place and getting cold; and neck trauma. Improper sleeping posture, inappropriate pillow height, and long-term hyperextension or hyperflexion of the head and neck lead to muscle traction on one side and disorder of the cervical facet joints, which manifests as spasm of the neck muscles on one side and obvious limitation of movement; accidentally catching cold during sleep or getting too cool in midsummer, which reduces blood supply and causes local metabolic disorders, resulting in protective spasm of the neck muscles, which is mainly manifested as stiff neck muscles and difficulty in movement; the neck suddenly twists and turns under the action of external force, and the muscles contract strongly, causing damage to muscle fibers or ligament tissues.

[0004] Stiff neck belongs to the category of "neck arthralgia" in traditional Chinese medicine. "Suwen·Gukonglun" says: "The neck arthralgia is located between the transverse bones on the shoulders. If it is broken, the arm should be straightened at the elbow and the spine should be moxibustioned." This is the earliest discussion on this disease. "Shangkehuiquan·Xuantaigu" states: "Some people have stiff neck pain due to sprains and loose necks." "Suwen·Bilun" says: "Wind, cold and dampness are mixed together and form arthralgia. If the wind prevails, it is walking arthralgia, if the cold prevails, it is painful arthralgia, and if the dampness prevails, it is fixed arthralgia." Traditional Chinese medicine believes that stiff neck is mainly caused by liver and kidney deficiency or improper sleeping posture, which exposes the neck and shoulders, causing wind, cold and dampness to invade the meridians and tendons, local qi and blood stagnation, and muscle tension, so the treatment principle of stiff neck should be to dispel cold, dredge the meridians, relax the tendons and activate blood circulation.

[0005] There are many treatments for stiff neck at present. There are many methods for treating stiff neck in clinical practice, including local blockade, neck pulling, local acupuncture and physiotherapy, etc., which have achieved certain effects. However, these methods are applied locally. Most patients have more tense local muscles in the neck and back due to neck pain and other reasons. Treatment of the affected area will cause increased pain and affect the efficacy. Some patients even refuse treatment, prolong the treatment cycle or delay treatment. Therefore, exploring safe, simple and efficient methods to promote the recovery of stiff neck has always been a problem that needs to be solved in clinical practice. Summary of the invention

[0006] In order to solve the technical problems existing in the prior art, the embodiments of the present invention provide a Chinese medicine composition, a Chinese medicine ointment and a preparation method for treating stiff neck. The technical scheme is as follows:

[0007] A traditional Chinese medicine composition for treating stiff neck comprises the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworm, 5-15 parts of artificial musk and 5-15 parts of distiller's grains.

[0008] A traditional Chinese medicine ointment for treating stiff neck is prepared from the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworms, 5-15 parts of artificial musk, 5-15 parts of lees, 18-22 parts of vaseline, 20-22 parts of stearic acid, 3-5 parts of lanolin, 8-12 parts of Span 80, 24-28 parts of glycerin, 3-5 parts of Tween 80, 90-100 parts of water, 3-5 parts of azone and 0.3-0.5 parts of methyl parahydroxybenzoate.

[0009] Optionally, the Chinese medicine ointment is made of the following raw materials in parts by weight: 10 parts of gardenia, 10 parts of bauhinia bark, 5 parts of camphor, 10 parts of frankincense, 10 parts of myrrh, 20 parts of hibiscus leaves, 10 parts of earthworms, 5 parts of artificial musk, 5 parts of lees, 18 parts of vaseline, 20 parts of stearic acid, 3 parts of lanolin, 8 parts of Span 80, 24 parts of glycerin, 3 parts of Tween 80, 90 parts of water, 3 parts of azone, and 0.3 parts of methyl parahydroxybenzoate.

[0010] Optionally, the Chinese medicine ointment is made of the following raw materials in parts by weight: 15 parts of gardenia, 15 parts of bauhinia bark, 10 parts of camphor, 15 parts of frankincense, 15 parts of myrrh, 30 parts of hibiscus leaves, 15 parts of earthworms, 10 parts of artificial musk, 10 parts of lees, 20 parts of vaseline, 21 parts of stearic acid, 4 parts of lanolin, 10 parts of Span 80, 26 parts of glycerin, 4 parts of Tween 80, 95 parts of water, 4 parts of azone, and 0.4 parts of methyl parahydroxybenzoate.

[0011] Optionally, the Chinese medicine ointment is made of the following raw materials in parts by weight: 20 parts of gardenia, 20 parts of bauhinia bark, 15 parts of camphor, 20 parts of frankincense, 20 parts of myrrh, 40 parts of hibiscus leaves, 20 parts of earthworms, 15 parts of artificial musk, 15 parts of lees, 22 parts of vaseline, 22 parts of stearic acid, 5 parts of lanolin, 12 parts of Span 80, 28 parts of glycerin, 5 parts of Tween 80, 100 parts of water, 5 parts of azone, and 0.5 parts of methyl parahydroxybenzoate.

[0012] The method for preparing the Chinese medicine ointment for treating stiff neck comprises the following steps:

[0013] 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse Chinese medicine powder, then extract with alcohol and concentrate into Chinese medicine extract for later use;

[0014] 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 70-75°C, melt them completely and stir them evenly to form an oil phase;

[0015] 3) Preparation of aqueous phase: In another container, add glycerin and methyl parahydroxybenzoate into water, heat to 70-75°C, stir to dissolve, then add the Chinese medicine extract prepared in step 1) and azone, stir evenly to form an aqueous phase;

[0016] 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed;

[0017] 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 15-20 minutes to improve the fineness and stability of the paste;

[0018] 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment.

[0019] Optionally, in the step 1), the alcohol extraction is performed by adding 8-10 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction is performed 2-3 times, each time for 1-3 hours, the filtrate is collected, and reduced pressure is concentrated to an extract with a relative density of 1.20-1.25 at 50-60°C.

[0020] Optionally, in step 4), the stirring speed is controlled at 100-300 rpm, and the stirring time is 30-60 min.

[0021] The application of the traditional Chinese medicine composition in preparing medicine for treating stiff neck.

[0022] The beneficial effects brought about by the technical solution provided by the embodiment of the present invention include at least:

[0023] In the prescription of the present invention:

[0024] Gardenia: bitter, cold. Enters the heart, lung, and triple burner meridians. External use reduces swelling and relieves pain; clears away heat and eliminates restlessness, clears heat and removes dampness, cools blood and detoxifies.

[0025] Bauhinia bark: bitter, neutral. Enters the liver and spleen meridians. Promotes blood circulation, relieves stranguria, and detoxifies. Used for traumatic injuries, rheumatic pain, and abdominal pain caused by blood stasis.

[0026] Camphor: pungent, warm. Enters the heart and spleen meridians. Reduces swelling and relieves pain, clears the meridians, and relieves stagnant qi. Used to treat traumatic injuries, scabies, stubborn ringworms, baldness, and frostbite.

[0027] Frankincense: bitter, slightly cold. Enters the heart, liver, and kidney meridians. Expels wind and dredges the collaterals, cools blood and reduces swelling. Used for rheumatism, heat arthralgia, tendon spasm, back and knee pain, throat paralysis, and injuries from falls.

[0028] 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.

[0029] Hibiscus leaf: pungent, cool. Enters the lung and liver meridians. Reduces swelling and discharges pus, dissipates heat and detoxifies, clears the lungs and cools the blood. Used to treat carbuncle, furuncle, abscess, ear pus, nameless swelling, burns and scalds.

[0030] 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.

[0031] 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.

[0032] Wine lees: sweet, pungent, warm in nature. Enters the stomach, liver, and kidney meridians. Promotes blood circulation and relieves pain, warms the middle and dispels cold. Used for pain caused by injuries, stasis, frostbite, and wind-cold-dampness arthralgia.

[0033] The above medicines are effectively combined and support each other, with hibiscus leaves as the main ingredient, gardenia, bauhinia bark, and myrrh as the secondary ingredients, earthworms, frankincense, myrrh, and distiller's grains as the auxiliary ingredients, and camphor 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] Stearic acid: It is a common fatty acid with carboxylic acid as its chemical property. It is widely found in various oils and fats, among which animal fat has a high content. As an emulsifier and thickener in ointments, it can enhance its stability and consistency and improve the uniformity of the drug. Its lubricity and flexibility help to improve the comfort of use. It also has a certain moisturizing effect and promotes drug penetration. Stearic acid can also adjust the melting point of ointments, enhance skin adhesion and improve efficacy. In addition, it is mild in nature and has little irritation to the skin, and is widely used in topical preparations.

[0037] Lanolin: It is a kind of secreted oil attached to wool. It is a light yellow or brownish yellow ointment that is sticky and greasy. As a matrix component in ointments, it has excellent moisturizing, lubricating and skin affinity, can effectively soften the stratum corneum and promote drug penetration. Its natural oil properties can enhance the ductility and adhesion of ointments and improve the comfort of use. Lanolin also has a certain occlusive property, which can lock in moisture and protect the skin.

[0038] Span 80: Sorbitol fatty acid ester is a compound and a lipophilic nonionic surfactant. As an emulsifier and stabilizer in ointments, it can effectively improve the mixing of oil and water phases and enhance the uniformity and stability of ointments. The surface active properties of Span 80 help disperse and penetrate drug ingredients and improve efficacy. Span 80 can also adjust the viscosity and texture of ointments to improve the user experience.

[0039] Glycerin: It is a simple polyol compound. It is a colorless, odorless, sweet, viscous liquid that is non-toxic. The glycerol backbone is present in lipids called glycerides. As a humectant and solvent in ointments, it has excellent hygroscopicity and lubricity, and can effectively keep the ointment moist and prevent it from drying out. Its permeability helps promote the absorption of drug ingredients and enhances efficacy. Glycerin can also improve the ductility and adhesion of ointments and enhance comfort. Glycerin is mild in nature, non-irritating to the skin, and is widely used in topical preparations, with both stability and compatibility.

[0040] Tween 80: Also known as polysorbate-80, it is a nonionic surfactant and emulsifier. As an emulsifier and solubilizer in ointments, it can effectively improve the mixing of oil and water phases and enhance the dispersibility and stability of drug ingredients. Its surface active properties help improve the permeability and bioavailability of drugs and enhance the efficacy. Tween 80 can also adjust the viscosity and texture of ointments and improve the user experience. Tween 80 has good compatibility with other ingredients and is both safe and stable.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] The invention has abundant raw materials, reasonable compatibility, effective combination, mutual support, and the whole formula has the effects of reducing swelling and relieving pain, promoting blood circulation and relaxing muscles, can effectively alleviate the clinical symptoms of patients with stiff neck, is an innovation in the treatment of stiff neck medicine, and has good promotion and application value and practical clinical significance. DETAILED DESCRIPTION

[0045] The technical solution of the present invention is described below in conjunction with embodiments.

[0046] The purpose of the present invention is to provide a Chinese medicine composition, a Chinese medicine ointment and a preparation method for treating stiff neck, which can effectively promote the recovery of patients with stiff neck, has no side effects, has low cost and is suitable for popularization and use.

[0047] The "ointment" of the present invention refers to the drug preparation used for ointment. Ointment is one of the treatment methods of traditional Chinese medicine, that is, rubbing the local area with ointment. It comes from "Fifty-two Disease Prescriptions" and belongs to the external treatment method of traditional Chinese medicine. The purpose of health care or curing diseases is achieved by applying ointments and plasters and massaging them. The basic principle of ointment is to warm and dredge the meridians, regulate qi and blood, improve the function of internal organs, strengthen the body and expel evil, and promote health.

[0048] The technical solution solved by the present invention is a traditional Chinese medicine composition for treating stiff neck, characterized in that it comprises the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworm, 5-15 parts of artificial musk, and 5-15 parts of distiller's grains.

[0049] A traditional Chinese medicine ointment for treating stiff neck is prepared from the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworms, 5-15 parts of artificial musk, 5-15 parts of wine lees, 18-22 parts of vaseline, 20-22 parts of stearic acid, 3-5 parts of lanolin, 8-12 parts of Span 80, 24-28 parts of glycerol, 3-5 parts of Tween 80, 90-100 parts of water (the amount of water used here is the amount of water used in preparing a matrix water phase), 3-5 parts of azone and 0.3-0.5 parts of methyl parahydroxybenzoate.

[0050] Furthermore, the present invention also provides a method for preparing a Chinese medicine ointment for treating stiff neck, comprising the following steps:

[0051] 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse powder, then extract with alcohol and concentrate into extract for later use;

[0052] 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 70-75°C, melt them completely and stir them evenly to form an oil phase;

[0053] 3) Preparation of aqueous phase: In another container, add glycerin and methyl paraben to water, heat to 70-75°C, stir to dissolve, then add Chinese medicine extract and azone, stir evenly to form an aqueous phase;

[0054] 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed;

[0055] 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 15-20 minutes to improve the fineness and stability of the paste;

[0056] 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment.

[0057] In the step 1), the alcohol extraction is to add 8-10 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction 2-3 times, each time for 1-3 hours, collect the filtrate, and concentrate under reduced pressure to form an extract with a relative density of 1.20-1.25 at 50-60°C.

[0058] In the step 4), the stirring speed is controlled at 100-300 rpm, and the stirring time is about 30-60 min.

[0059] The application of the traditional Chinese medicine composition in preparing medicine for treating stiff neck.

[0060] Example 1

[0061] A traditional Chinese medicine ointment for treating stiff neck is prepared from the following raw materials in parts by weight: 10 parts of gardenia, 10 parts of bauhinia bark, 5 parts of camphor, 10 parts of frankincense, 10 parts of myrrh, 20 parts of hibiscus leaves, 10 parts of earthworms, 5 parts of artificial musk, 5 parts of lees, 18 parts of vaseline, 20 parts of stearic acid, 3 parts of lanolin, 8 parts of Span 80, 24 parts of glycerol, 3 parts of Tween 80, 90 parts of water, 3 parts of azone and 0.3 parts of methyl parahydroxybenzoate.

[0062] The preparation method comprises the following steps:

[0063] 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse powder, then extract with alcohol and concentrate into extract for later use;

[0064] 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 70°C, melt them completely and stir them evenly to form an oil phase;

[0065] 3) Preparation of aqueous phase: In another container, add glycerin and methyl paraben to water, heat to 70°C, stir to dissolve, then add Chinese herbal extract and azone, stir evenly to form an aqueous phase;

[0066] 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed;

[0067] 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 15 minutes to improve the fineness and stability of the paste;

[0068] 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment.

[0069] In the step 1), the alcohol extraction is to add 8 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction is performed 3 times, each time for 3 hours, the filtrate is collected, and it is concentrated under reduced pressure to an extract with a relative density of 1.20-1.25 at 50-60°C.

[0070] In the step 4), the stirring speed is controlled at 100 rpm and the stirring time is 60 min.

[0071] Example 2

[0072] A traditional Chinese medicine ointment for treating stiff neck is prepared from the following raw materials in parts by weight: 15 parts of gardenia, 15 parts of bauhinia bark, 10 parts of camphor, 15 parts of frankincense, 15 parts of myrrh, 30 parts of hibiscus leaves, 15 parts of earthworms, 10 parts of artificial musk, 10 parts of lees, 20 parts of vaseline, 21 parts of stearic acid, 4 parts of lanolin, 10 parts of Span 80, 26 parts of glycerol, 4 parts of Tween 80, 95 parts of water, 4 parts of azone and 0.4 parts of methyl parahydroxybenzoate.

[0073] The preparation method comprises the following steps:

[0074] 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse powder, then extract with alcohol and concentrate into extract for later use;

[0075] 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 73°C, melt them completely and stir them evenly to form an oil phase;

[0076] 3) Preparation of aqueous phase: In another container, add glycerin and methyl paraben to water, heat to 73°C, stir to dissolve, then add Chinese medicine extract and azone, stir evenly to form an aqueous phase;

[0077] 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed;

[0078] 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 18 minutes to improve the fineness and stability of the paste;

[0079] 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment;

[0080] In the step 1), the alcohol extraction is to add 9 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction is performed 2.5 times, each time for 2 hours, the filtrate is collected, and it is concentrated under reduced pressure to an extract with a relative density of 1.20-1.25 at 50-60°C.

[0081] In the step 4), the stirring speed is controlled at 200 rpm and the stirring time is 45 min.

[0082] Example 3

[0083] A traditional Chinese medicine ointment for treating stiff neck is prepared from the following raw materials in parts by weight: 20 parts of gardenia, 20 parts of bauhinia bark, 15 parts of camphor, 20 parts of frankincense, 20 parts of myrrh, 40 parts of hibiscus leaves, 20 parts of earthworms, 15 parts of artificial musk, 15 parts of lees, 22 parts of vaseline, 22 parts of stearic acid, 5 parts of lanolin, 12 parts of Span 80, 28 parts of glycerol, 5 parts of Tween 80, 100 parts of water, 5 parts of azone and 0.5 parts of methyl parahydroxybenzoate.

[0084] The preparation method comprises the following steps:

[0085] 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse powder, then extract with alcohol and concentrate into extract for later use;

[0086] 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 75°C, melt them completely and stir them evenly to form an oil phase;

[0087] 3) Preparation of aqueous phase: In another container, add glycerin and methyl parahydroxybenzoate into water, heat to 75°C, stir to dissolve, then add Chinese herbal extract and azone, stir evenly to form an aqueous phase;

[0088] 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed;

[0089] 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 20 minutes to improve the fineness and stability of the paste;

[0090] 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment;

[0091] In the step 1), the alcohol extraction is to add 10 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction is performed twice, each time for 1 hour, the filtrate is collected, and it is concentrated under reduced pressure to an extract with a relative density of 1.20-1.25 at 50-60°C.

[0092] In the step 4), the stirring speed is controlled at 300 rpm and the stirring time is 30 min.

[0093] The whole formula has the effects of reducing swelling and relieving pain, promoting blood circulation and relaxing muscles. It is effectively used to treat stiff neck and has achieved satisfactory beneficial technical results through clinical trials. The relevant clinical trial data are as follows:

[0094] 1. Safety Test

[0095] Experimental animals: SD rats, half male and half female, weighing 260±20 g, were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd. (License No. 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°C and a relative humidity of 40-70%.

[0096] Skin irritation test: 8 SD rats were selected, and the hair on both sides of their spines were removed with a razor 24 hours before administration. The hair removal range on each side was 3cm×3cm, and the hair was removed with a depilatory agent and washed with sterile water. The test was conducted using the SD rat skin self-control method. The upper left spine area of ​​each SD rat was the intact skin irritation test area, and the upper right spine area was the intact skin blank control area; the lower left spine area was the damaged skin irritation test area, and the lower right spine area was the damaged skin blank control area.

[0097] Intact skin irritation test: The Chinese medicine ointment of Example 1 of the present invention was applied to the skin of the upper left side of the spine of SD rats, and glycerol was applied to the skin of the upper right side of the spine for control. The local edema, erythema, etc. and their recovery were observed at 1h, 24h, 48h and 72h respectively.

[0098] Acute irritation test of damaged skin: Before applying the ointment, a "#" scratch was made on the skin of the test site of the left lower spine area and the right lower spine area of ​​the back of SD rats with a sterilized No. 12 sterilized needle, requiring the stratum corneum to be scratched and bleeding, and the scratch spacing was about 0.3 cm. The Chinese medicine ointment of Example 1 of the present invention was applied to the skin of the lower left side of the spine, and glycerin was applied to the test area of ​​the lower right side of the spine as a control. Other operations were consistent with the acute irritation test of intact skin.

[0099] Continuous drug administration skin irritation test: The Chinese medicine ointment of Example 1 of the present invention and glycerin were applied on the intact skin and damaged skin of SD rats once every 2 hours for a total of 12 times, and the results were observed and recorded. The presence of edema, erythema, etc. at the application site and its recovery status were observed and recorded at 1h, 24h, 48h and 72h after administration.

[0100] The skin irritation intensity is evaluated based on the skin irritation reaction grade score, and the value of each component at each observation time point and the average integral value of the test animals during the observation period are accurately calculated. At the same time, the irritation intensity is evaluated according to the skin irritation test evaluation table.

[0101] The skin irritation test results are shown in Table 1.

[0102] Table 1 Skin irritation test results

[0103]

[0104] The results showed that 1 hour after applying the drug during the acute irritation test, slight erythema appeared on the intact skin of 2 animals in the test group and on the damaged skin of 3 animals, but no obvious edema occurred; while no erythema or edema was found in all the application sites of the blank control group. The erythema of the intact and damaged skin of the animals in the test group subsided after 24h, 48h and 72h. Therefore, according to the skin irritation reaction grade classification and the skin irritation test evaluation table, it can be known that it is non-irritating.

[0105] 2. Clinical Trials

[0106] 1 Materials and methods

[0107] 1.1 Object

[0108] A total of 78 patients with stiff neck were admitted to the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from November 2021 to October 2024, including 36 males and 42 females. They were randomly divided into a control group and a test group of the present invention.

[0109] 1.2 Treatment options

[0110] Control group① Patients were seated, and the neck was treated with gentle massage while gradually relaxing the neck muscles. The neck was lifted and pulled with the grasping method and the tense muscles were pulled. The head was flexed and extended and rotated left and right in a gradual manner.② Patients were seated, and the neck muscles were relaxed with grasping and kneading methods. The neck was gently rotated. When the neck reached the patient's maximum pain tolerance point, it was stopped for a few seconds and repeated several times. After shaking several times, when the neck was bent forward, the rotation range was quickly increased to the painful side of the patient to perform cervical vertebrae manipulation. The manipulation should be fast and light. The cervical vertebrae manipulation should not be forced to have a snapping sound. Patients with severe pain should not be forced to use the manipulation. ③The patient takes a sitting position and presses the Fengchi, Fengfu, Fengmen, Jianjing, Tianzong, Ashi and other acupoints. Start with the manipulation according to the patient's tolerance and gradually increase the strength from light to heavy. Then use the grasping method to grasp the muscles on both sides of the neck. You can use the one-finger Zen pushing method to move up and down along the bladder meridian on both sides of the neck for treatment. Finally, rubbing and hot compress can be added to the painful area of ​​the neck to promote blood circulation and relieve pain.

[0111] 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.

[0112] The treatment method of the control group and the test group of the present invention: once a day, for a total of 7 days.

[0113] 1.3 Diagnostic criteria

[0114] Refer to the diagnostic criteria established in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". (1) Generally, there is no history of trauma, and it is mostly caused by poor sleeping posture or exposure to wind and cold; (2) Acute onset, pain and soreness on one side of the neck after sleep, which may radiate to the upper limbs or back, and difficulty in movement. The pain on the injured side is aggravated during movement, and in severe cases, the head tilts to the affected side; (3) The affected side often has cervical muscle spasm, tenderness in the sternocleidomastoid muscle, trapezius muscle, rhomboid muscle, and levator scapulae, and lumps and cord-like changes can be felt at the site of muscle tension; (4) Cervical spine X-rays show degenerative changes or no obvious abnormalities.

[0115] 1.4 Criteria for determining efficacy

[0116] Cure: Neck pain, soreness and swelling disappeared, tenderness points basically disappeared, and neck functional activities returned to normal.

[0117] Improvement: Neck pain was relieved and neck movement was improved.

[0118] Uncured: No improvement in symptoms.

[0119] Total effective rate = (number of cured + improved) cases / total number of cases × 100%.

[0120] 2 Results

[0121] In the test group of the present invention, 15 cases were cured, 20 cases were improved, 4 cases were not cured, and the total effective rate was 89.74%; in the control group, 8 cases were cured, 21 cases were improved, 10 cases were not cured, and the total effective rate was 74.36%.

[0122] During the whole treatment process, no obvious adverse reactions and abnormalities were observed. After long-term clinical practice, the application of the Chinese medicine prepared in other embodiments can achieve the same or similar therapeutic effects, which will not be described in detail one by one.

[0123] 3 Typical Cases

[0124] Example 1:

[0125] Guan, male, 22 years old, from Zhoukou City, Henan Province

[0126] Neck stiffness, pain for 3 days, unable to turn, pain mainly concentrated in the right neck muscles, and radiated to the right shoulder and upper back, with the use of the Chinese medicine ointment of the present invention, the symptoms were significantly improved after 2 days, continuous application for 5 days, the symptoms were basically eliminated.

[0127] Example 2:

[0128] Zhang, male, 30 years old, from Shangqiu City, Henan Province

[0129] Neck pain 1 day, the pain is more obvious when turning the head, flexion and extension activities are slightly limited, with the use of Chinese medicine ointment massage of the present invention, the pain symptoms that day promptly significantly improved, after application 2 days, the symptoms basically disappeared.

[0130] Example 3:

[0131] Wang, female, 21 years old, from Sanmenxia City, Henan Province

[0132] Neck pain for 3 days, symptoms are obvious during activities, lighter during the day and heavier at night. Use the Chinese medicine ointment of the present invention, the pain symptoms basically disappear after 5 days, and the activities are completely normal after 1 week of continuous use.

[0133] Comparative Example 1

[0134] The present invention can be effectively used to treat stiff neck, 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:

[0135] 1 Materials and methods

[0136] 1.1 Object

[0137] A total of 72 patients with stiff neck were selected from the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from November 2024 to March 2025, including 25 males and 47 females, according to the inclusion and exclusion criteria. They were randomly divided into a control group and a test group of the present invention.

[0138] 1.2 Treatment options

[0139] Control group: Apply 1-3 ml of Snow Mountain Golden Arhat analgesic film (Tibet Pharmaceutical, Tibet Nordicon Pharmaceutical Co., Ltd.: 30 ml / bottle) to the affected area.

[0140] 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.

[0141] The treatment method of the control group and the test group of the present invention: once a day, for a total of 7 days.

[0142] 1.3 Diagnostic criteria

[0143] Refer to the diagnostic criteria established in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". (1) Generally, there is no history of trauma, and it is mostly caused by poor sleeping posture or exposure to wind and cold; (2) Acute onset, pain and soreness on one side of the neck after sleep, which may radiate to the upper limbs or back, and difficulty in movement. The pain on the injured side is aggravated during movement, and in severe cases, the head tilts to the affected side; (3) The affected side often has cervical muscle spasm, tenderness in the sternocleidomastoid muscle, trapezius muscle, rhomboid muscle, and levator scapulae, and lumps and cord-like changes can be felt at the site of muscle tension; (4) Cervical spine X-rays show degenerative changes or no obvious abnormalities.

[0144] 1.4 Criteria for determining efficacy

[0145] Cure: Neck pain, soreness and swelling disappeared, tenderness points basically disappeared, and neck functional activities returned to normal.

[0146] Improvement: Neck pain was relieved and neck movement was improved.

[0147] Uncured: No improvement in symptoms.

[0148] Total effective rate = (number of cured + improved) cases / total number of cases × 100%.

[0149] 2 Results

[0150] In the test group of the present invention, 11 cases were cured, 19 cases were improved, 6 cases were not cured, and the total effective rate was 83.33%; in the control group, 8 cases were cured, 18 cases were improved, 10 cases were not cured, and the total effective rate was 72.22%.

[0151] The invention has scientific and reasonable compatibility, rich raw materials, easy use and good effect. The whole formula has the effects of reducing swelling and relieving pain, promoting blood circulation and relaxing muscles, can effectively alleviate the clinical symptoms of patients with stiff neck, is an innovation in the treatment of stiff neck medicine, and has good promotion and application value and practical clinical significance.

[0152] 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 stiff neck, characterized in that: The invention comprises the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworm, 5-15 parts of artificial musk and 5-15 parts of distiller's grains.

2. A Chinese medicine ointment for treating stiff neck, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of gardenia, 10-20 parts of bauhinia bark, 5-15 parts of camphor, 10-20 parts of frankincense, 10-20 parts of myrrh, 20-40 parts of hibiscus leaves, 10-20 parts of earthworms, 5-15 parts of artificial musk, 5-15 parts of wine lees, 18-22 parts of vaseline, 20-22 parts of stearic acid, 3-5 parts of lanolin, 8-12 parts of Span 80, 24-28 parts of glycerol, 3-5 parts of Tween 80, 90-100 parts of water, 3-5 parts of azone and 0.3-0.5 parts of methyl parahydroxybenzoate.

3. The Chinese medicinal ointment for treating stiff neck according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10 parts of gardenia, 10 parts of bauhinia bark, 5 parts of camphor, 10 parts of frankincense, 10 parts of myrrh, 20 parts of hibiscus leaves, 10 parts of earthworms, 5 parts of artificial musk, 5 parts of lees, 18 parts of vaseline, 20 parts of stearic acid, 3 parts of lanolin, 8 parts of Span 80, 24 parts of glycerol, 3 parts of Tween 80, 90 parts of water, 3 parts of azone and 0.3 parts of methyl parahydroxybenzoate.

4. The Chinese medicinal ointment for treating stiff neck according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 15 parts of gardenia, 15 parts of bauhinia bark, 10 parts of camphor, 15 parts of frankincense, 15 parts of myrrh, 30 parts of hibiscus leaves, 15 parts of earthworms, 10 parts of artificial musk, 10 parts of lees, 20 parts of vaseline, 21 parts of stearic acid, 4 parts of lanolin, 10 parts of Span 80, 26 parts of glycerol, 4 parts of Tween 80, 95 parts of water, 4 parts of azone and 0.4 parts of methyl parahydroxybenzoate.

5. The Chinese medicinal ointment for treating stiff neck according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 20 parts of gardenia, 20 parts of bauhinia bark, 15 parts of camphor, 20 parts of frankincense, 20 parts of myrrh, 40 parts of hibiscus leaves, 20 parts of earthworms, 15 parts of artificial musk, 15 parts of lees, 22 parts of vaseline, 22 parts of stearic acid, 5 parts of lanolin, 12 parts of Span 80, 28 parts of glycerol, 5 parts of Tween 80, 100 parts of water, 5 parts of azone and 0.5 parts of methyl parahydroxybenzoate.

6. The method for preparing the Chinese medicinal ointment for treating stiff neck according to any one of claims 2 to 5, characterized in that: The following steps are involved: 1) Extraction of Chinese medicine: Clean gardenia, bauhinia bark, camphor, frankincense, myrrh, hibiscus leaf, earthworm, artificial musk, and distiller's grains, crush them into coarse Chinese medicine powder, then extract with alcohol and concentrate into Chinese medicine extract for later use; 2) Preparation of oil phase: Add vaseline, stearic acid, lanolin and Span 80 into a container, heat to 70-75°C, melt them completely and stir them evenly to form an oil phase; 3) Preparation of aqueous phase: In another container, add glycerin and methyl parahydroxybenzoate into water, heat to 70-75°C, stir to dissolve, then add the Chinese medicine extract prepared in step 1) and azone, stir evenly to form an aqueous phase; 4) Emulsification: Slowly add the water phase into the oil phase under stirring and continue stirring until a uniform emulsion is formed; 5) Adjustment and homogenization: Add Tween 80 and continue stirring for 15-20 minutes to improve the fineness and stability of the paste; 6) Filling and packaging: After the paste cools to room temperature, fill it into a suitable packaging container and seal it to obtain the finished Chinese medicine ointment.

7. The method for preparing the Chinese medicinal ointment for treating stiff neck according to claim 6, characterized in that: In the step 1), the alcohol extraction is to add 8-10 times the amount of ethanol to the crude powder of the traditional Chinese medicine, reflux extraction 2-3 times, each time for 1-3 hours, collect the filtrate, and concentrate under reduced pressure to form an extract with a relative density of 1.20-1.25 at 50-60°C.

8. The method for preparing the Chinese medicinal ointment for treating stiff neck according to claim 6, characterized in that: In the step 4), the stirring speed is controlled at 100-300 rpm, and the stirring time is 30-60 min.

9. Use of the Chinese medicine composition according to claim 1 in preparing a medicine for treating stiff neck.

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