A traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, its preparation method and application

Abstract

This invention relates to a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The composition of this invention comprises: 4-8 parts of processed Aconitum carmichaelii, 4-8 parts of processed Strychnos nux-vomica, 3-10 parts of Clematis chinensis, 4-8 parts of Ligusticum chuanxiong, 2-6 parts of Carthamus tinctorius, 2-6 parts of Sparganium stoloniferum, 2-6 parts of Curcuma zedoaria, 2-6 parts of Corydalis yanhusuo, 4-8 parts of Notopterygium incisum, and 1-3 parts of Borneol. This traditional Chinese medicine composition exerts its medicinal effect through skin penetration, treating symptoms such as frozen shoulder, rheumatic pain, and joint pain caused by the invasion of wind, cold, dampness, and other pathogenic factors leading to obstruction of qi and blood in the meridians. The preparation method of this invention can dissolve both water-soluble components such as alkaloids and glycosides, as well as fat-soluble components such as lactones and terpenes, resulting in a more comprehensive extraction of the medicinal materials and ensuring the integrity of the medicinal effect. It has core advantages such as rapid onset of action, strong penetration, convenient use, and a dry, non-sticky finish.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, its preparation method, and its application. Background Technology

[0002] Shoulder periarthritis, rheumatic pain, and joint pain caused by cold-dampness and blood stasis all share the pathogenesis of "cold, dampness, stasis, and obstruction." Therefore, the treatment approach in traditional Chinese medicine prescriptions should embody the principles of "warming and resolving cold-dampness, and promoting blood circulation and unblocking the meridians." Topical preparations have the advantage of rapid transdermal absorption and direct targeting of the affected area. By applying and massaging the preparation, drug absorption is promoted while physically releasing fascial adhesions and improving microcirculation.

[0003] Currently, most existing topical medications for treating frozen shoulder, rheumatic pain, and joint pain are plasters, such as the traditional Chinese medicine gel plaster for treating gouty arthritis disclosed in Chinese patent document CN120305373A. These plasters have complex formulations, often containing more than fifteen medicinal ingredients, with intricate manufacturing processes, uncertain dosages of active ingredients, and frequently use highly irritating herbs (such as chili peppers, menthol, and camphor) or bases. This can easily lead to contact dermatitis symptoms at the application site, such as redness, swelling, itching, rashes, and blisters; these symptoms are particularly pronounced in individuals with allergies. To ensure a firm adhesion, many plasters are designed with very strong adhesive, which can severely pull on the skin and hair when changing or removing them, causing significant pain, especially for men with abundant body hair and those with delicate skin.

[0004] In addition, the existing shoulder pain relief liniment is composed of processed aconite root, processed strychnos nux-vomica seed, clematis root, safflower, sparganium rhizome, turmeric rhizome, and borneol. It has the effects of dispelling cold, clearing the meridians, and relieving pain. It is used for shoulder periarthritis caused by cold-dampness and blood stasis, and can also be used as an adjunct treatment for rheumatic pain and joint pain. Although the shoulder pain relief liniment has relatively few ingredients, its detoxification process is insufficient. Summary of the Invention

[0005] This invention addresses the technical problems of existing drugs used to treat frozen shoulder, rheumatic pain, and joint pain, such as large formulations, complex processes, susceptibility to inflammation, discomfort, and inadequate toxicity control. It provides a traditional Chinese medicine composition for treating wind-cold-dampness syndrome, its preparation method, and its application. This traditional Chinese medicine composition exerts its effects through skin penetration, primarily treating symptoms such as frozen shoulder, rheumatic pain, and joint pain caused by the invasion of wind, cold, dampness, and other pathogenic factors leading to obstruction of qi and blood in the meridians.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: A traditional Chinese medicine composition for treating wind-cold-dampness arthralgia is composed of the following traditional Chinese medicines in parts by weight: Prepared aconite root 4-8 parts, prepared strychnos nux-vomica seed 4-8 parts, clematis root 3-10 parts, chuanxiong rhizome 4-8 parts, safflower 2-6 parts, sparganium rhizome 2-6 parts, turmeric rhizome 2-6 parts, corydalis rhizome 2-6 parts, notopterygium root 4-8 parts, borneol 1-3 parts.

[0007] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: Prepared aconite root 6 parts, prepared strychnos nux-vomica seed 6 parts, Clematis chinensis 5 parts, Ligusticum chuanxiong 6 parts, safflower 4 parts, Sparganium stoloniferum 4 parts, Curcuma zedoaria 4 parts, Corydalis yanhusuo 4 parts, Notopterygium incisum 4 parts, borneol 2 parts.

[0008] Preferably, the dosage form of the traditional Chinese medicine composition is a topical preparation.

[0009] More preferably, the dosage form of the traditional Chinese medicine composition is a tincture, ointment, or gel.

[0010] More preferably, the dosage form of the traditional Chinese medicine composition is a tincture.

[0011] A method for preparing a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, wherein when the dosage form of the traditional Chinese medicine composition is a tincture, the method includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well; take borneol, dissolve it in ethanol, add it to the above-mentioned combined solution, and stir well; then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into bottles to obtain a tincture of traditional Chinese medicine composition for treating wind-cold-dampness arthralgia.

[0012] A method for preparing a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, wherein when the dosage form of the traditional Chinese medicine composition is an ointment, the method includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well. Take glyceryl monostearate, stearic acid, white petrolatum, liquid paraffin, and lanolin, heat to 75°C to melt, stir well, and keep warm to form the oil phase. Separately, take glycerol and ethylparaben, add purified water, heat to 75°C, and stir to dissolve to form the aqueous phase. While keeping warm, add the combined concentrated alcohol extract and concentrated water extract to the oil phase while stirring, then add the above-mentioned aqueous phase and continue stirring until emulsification is complete. Stop heating and continue stirring until the temperature drops to 40-45°C. Take borneol, dissolve it in ethanol, add it to the ointment, and stir well. Homogenize the ointment twice through a colloid mill until it is fine and uniform. Fill the ointment into ointment boxes at room temperature and seal to obtain the traditional Chinese medicine composition ointment for treating wind-cold-dampness arthralgia.

[0013] A method for preparing a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, wherein when the dosage form of the traditional Chinese medicine composition is a gel, the method includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well. Take carbomer, sprinkle it into purified water, and let it stand to fully swell, thus obtaining a gel matrix. Add glycerol and azone to the gel matrix and stir well. While stirring, add triethanolamine and adjust the pH value to 6.5-7.5, which will then form a transparent gel. While stirring, add the combined liquid of the above-mentioned concentrated alcohol extract and concentrated water extract to the gel matrix and stir well. Then take borneol, dissolve it in ethanol, add it to the gel matrix, and stir well to obtain a traditional Chinese medicine composition gel for treating wind-cold-dampness arthralgia.

[0014] The application of a traditional Chinese medicine composition for treating wind-cold-dampness syndrome in the preparation of a medicine for treating frozen shoulder, rheumatic pain, or joint pain.

[0015] The beneficial effects of this invention are: This invention relates to a traditional Chinese medicine composition for treating wind-cold-dampness syndrome. The composition exerts its medicinal effects through skin penetration and is primarily used to relieve local discomfort caused by shoulder and neck pain, muscle strain, and frozen shoulder. Its components include extracts of traditional Chinese medicine that promote blood circulation, remove blood stasis, reduce swelling, and relieve pain. By applying it directly to the affected area, it helps improve local blood circulation and reduce inflammatory reactions. It has the effects of relaxing muscles and tendons, dispelling cold and dampness, and is suitable for stiffness and soreness in the shoulder and neck caused by chronic strain or cold.

[0016] This invention relates to a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia. Its core principles are warming, promoting blood circulation, and relieving pain. The composition employs a rigorous combination of principal, assistant, and adjuvant herbs to target the pathogenesis of "stasis, cold, dampness, and stagnation." Processed aconite and strychnos nux-vomica directly attack the affected area, addressing the root cause of "obstruction." Ligusticum chuanxiong, safflower, and corydalis address the symptom of "pain." The combination of the qi-regulating properties of Ligusticum chuanxiong and corydalis, and the blood-activating properties of safflower and sparganium, ensures that qi and blood flow together, thereby resolving stasis and enhancing the effect of unblocking the meridians. The ingenious use of processed aconite and strychnos nux-vomica, considered "poisonous" herbs, leverages their potent effects to treat chronic and stubborn diseases, embodying the principle that "the disease will not be cured until the medicine is effective." The addition of borneol and notopterygium incisum allows the medicinal power to accurately and deeply act on the meridians and joints.

[0017] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness syndrome of the present invention can dissolve both water-soluble components such as alkaloids and glycosides, as well as fat-soluble components such as lactones and terpenes, resulting in a more comprehensive extraction of the medicinal materials and ensuring the integrity of the efficacy. It has core advantages such as rapid onset of action, strong penetration, convenient use, and a dry, non-sticky finish, making it one of the ideal topical dosage forms for treating localized pain such as arthritis and frozen shoulder. It is particularly suitable for people who seek rapid relief, dislike the stickiness of plasters, or are allergic to plasters. Furthermore, the present invention, through a specific extraction process, promotes the full hydrolysis or transformation of highly toxic components, reducing their toxicity to a safe range.

[0018] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention, based on the physicochemical properties (such as water solubility, alcohol solubility, volatility, and thermal stability) of the effective components contained in each medicinal material and the indications of the prescription (usually used for rheumatic pain, qi stagnation and blood stasis, etc.), adopts a preparation process combining alcohol extraction and water extraction. The prescription contains processed aconite (containing aconitine-like toxic components) and processed strychnine (containing strychnine and other toxic components). Although the toxicity is reduced by processing, it still needs to be further reduced by standardized extraction processes (such as extending the water extraction time) to ensure medication safety. Notopterygium incisum and Ligusticum chuanxiong are rich in volatile active ingredients and are not suitable for long-term decoction. Ethanol percolation is preferred. The preparation method of the present invention maximizes the extraction of various effective components and avoids the loss of heat-sensitive and volatile components.

[0019] The traditional Chinese medicine composition of the present invention for treating wind-cold-dampness arthralgia exerts its medicinal effect through skin penetration. It mainly treats symptoms such as frozen shoulder, rheumatic pain, and joint pain caused by the invasion of wind, cold, dampness, and pathogenic factors, which lead to obstruction of qi and blood in the meridians. Detailed Implementation

[0020] The inventive concept of this invention is as follows: This invention aims to provide a traditional Chinese medicine composition for treating wind-cold-dampness syndrome, its preparation method, and its application. It is made from ten traditional Chinese medicines in a specific ratio (processed aconite, processed strychnos nux-vomica, clematis chinensis, chuanxiong rhizome, safflower, sparganium rhizome, turmeric rhizome, corydalis rhizome, notopterygium root, and borneol). The formulation is characterized by its strong ability to attack pathogenic factors, treating both the root cause and symptoms, regulating qi and blood, using toxic substances to counteract toxicity, and guiding the medicine to the affected area. The process is based on the theory of traditional Chinese medicine properties and modern pharmaceutical principles, employing a group extraction strategy and an integrated process for reducing the toxicity and enhancing the efficacy of potent medicinal materials, including alcohol extraction, water extraction for toxicity reduction, and alcohol precipitation. The traditional Chinese medicine composition of this invention exerts its medicinal effect through skin penetration, mainly used to relieve local discomfort caused by shoulder and neck pain, muscle strain, and frozen shoulder. Its components include traditional Chinese medicine extracts that promote blood circulation, remove blood stasis, reduce swelling, and relieve pain. By directly applying it to the affected area, it helps improve local blood circulation and reduce inflammatory reactions. It has the effects of relaxing muscles and tendons, dispelling cold and dampness, and is suitable for stiffness and soreness of the shoulders and neck caused by chronic strain or cold. The Chinese medicine composition of the present invention: (1) It uses potent drugs such as processed aconite and processed strychnos nux-vomica, which have a strong restraining effect on severe and stubborn pain that is difficult to treat with conventional drugs. Combined with the guiding effect of borneol, the medicinal power can penetrate deep tissues and act on muscles, bones and joints. (2) In view of the problem that the existing shoulder pain relief liniment is not sufficiently detoxified, the present invention promotes the full hydrolysis or transformation of highly toxic components through a specific extraction process, reducing its toxicity to a safe range. (3) The preparation method of the Chinese medicine composition of the present invention can solve the problem of component loss caused by single solvent extraction method, especially taking into account the dissolution of water-soluble components (such as safflower pigment and alkaloid salts) and fat-soluble components (such as tetramethylpyrazine and volatile oils), so as to ensure the full efficacy of the compound preparation. (4) The preparation method of the Chinese medicine composition of the present invention has a clear process flow and clear parameters, which is conducive to large-scale industrial production and the establishment and control of product quality standards.

[0021] This invention provides a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia, the prescription of which is as follows: it is composed of the following traditional Chinese medicines in parts by weight: Prepared aconite root 4-8 parts, prepared strychnos nux-vomica seed 4-8 parts, clematis root 3-10 parts, chuanxiong rhizome 4-8 parts, safflower 2-6 parts, sparganium rhizome 2-6 parts, turmeric rhizome 2-6 parts, corydalis rhizome 2-6 parts, notopterygium root 4-8 parts, borneol 1-3 parts.

[0022] In this formula, processed aconite root is the principal ingredient, dispelling wind and dampness, warming the meridians and dispersing cold, and numbing and relieving pain. It is a key medicine for treating cold-dampness arthralgia, and its strong warming and dispersing power can penetrate deep into the joints and bones, expelling deeply entrenched wind, cold, and dampness. It is particularly effective for severe pain and limited joint flexion and extension caused by stagnation of cold. Processed strychnos nux-vomica, chuanxiong rhizome, safflower, and clematis root are the assistant ingredients. Chuanxiong rhizome is a "qi-regulating herb in the blood," ascending to the head and eyes and descending to the blood sea. It can both invigorate blood and qi and dispel wind and relieve pain. Its dispersing power can enhance the warming and dispersing effect of the principal ingredient and resolve the qi stagnation problem in "qi stagnation and blood stasis," so that qi and blood flow smoothly and pain stops. Safflower specifically enters the blood, invigorating blood and unblocking the meridians, dispersing blood stasis and relieving pain. When combined with chuanxiong rhizome, it can greatly enhance the blood-invigorating and blood-stasis-removing power of the formula. Clematis root is potent and fast-moving, able to dispel wind and dampness, unblock the meridians, and relieve arthralgia. It is particularly adept at softening bones and implying its powerful ability to facilitate joint movement and relieve contractures. It is an excellent medicine for treating rheumatic pain, assisting the principal medicine in dispelling wind and dampness. Sparganium rhizome and Curcuma rhizome are often used together as essential medicines for breaking up blood stasis and eliminating masses. They are potent and effective, adept at breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain. For conditions with a long course, severe blood stasis, and even local induration and lumps (such as the adhesive phase of severe frozen shoulder), these two medicines can powerfully break up stagnation and unblock meridians. In this formula, they serve as adjuvant medicines, assisting the principal and assistant medicines in attacking stubborn blood stasis. Corydalis rhizome can invigorate blood and promote qi circulation; when qi and blood circulate freely, pain is relieved, and its analgesic effect is very significant. As an adjuvant medicine, it specifically enhances the analgesic efficacy of the entire formula. Notopterygium root relieves exterior symptoms, disperses cold, dispels wind and dampness, and relieves pain. It readily enters the bladder and kidney meridians, and is mainly used to treat wind-cold-dampness pain in the upper body, especially the shoulders, back, and limbs. Borneol has the effects of opening the orifices and refreshing the mind, clearing heat and relieving pain, and guiding the medicine through the skin. In this formula, its cold nature can slightly counteract the warming and drying properties of the other medicines. More importantly, it utilizes its extremely strong penetrating power as a "guide medicine" to lead the effective components of the other medicines through the skin barrier and directly to the depths of the lesion.

[0023] In this invention, the mass fraction of processed aconite can be any value between 4 and 8 parts, such as 4 parts, 5 parts, 6 parts, 7 parts, or 8 parts, preferably 4 parts, 6 parts, or 8 parts, and most preferably 6 parts.

[0024] In this invention, the mass fraction of the prepared nux vomica can be any value between 4 and 8 parts, such as 4 parts, 5 parts, 6 parts, 7 parts, or 8 parts, preferably 4 parts, 6 parts, or 8 parts, and most preferably 6 parts.

[0025] In this invention, the mass fraction of Clematis chinensis can be any value between 3 and 10 parts, such as 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, or 10 parts, preferably 3 parts, 5 parts, or 7 parts, and most preferably 5 parts.

[0026] In this invention, the mass fraction of Ligusticum chuanxiong can be any value between 4 and 8 parts, such as 4 parts, 5 parts, 6 parts, 7 parts, or 8 parts, preferably 4 parts, 6 parts, or 8 parts, and most preferably 6 parts.

[0027] In this invention, the mass fraction of safflower can be any value between 2 and 6 parts, such as 2 parts, 3 parts, 4 parts, 5 parts, or 6 parts, preferably 2 parts, 4 parts, or 6 parts, and most preferably 4 parts.

[0028] In this invention, the mass fraction of the triangular prism can be any value between 2 and 6 parts, such as 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, preferably 2 parts, 4 parts, 6 parts, and most preferably 4 parts.

[0029] In this invention, the mass fraction of Curcuma zedoaria can be any value between 2 and 6 parts, such as 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, preferably 2 parts, 4 parts, 6 parts, and most preferably 4 parts.

[0030] In this invention, the mass fraction of Corydalis can be any value between 2 and 6 parts, such as 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, preferably 2 parts, 4 parts, 6 parts, and most preferably 4 parts.

[0031] In this invention, the mass fraction of Notopterygium root can be any value between 4 and 8 parts, such as 4 parts, 5 parts, 6 parts, 7 parts, or 8 parts, preferably 4 parts, 6 parts, or 8 parts, and most preferably 4 parts.

[0032] In this invention, the mass fraction of borneol can be any value between 1 and 3 parts, such as 1 part, 2 parts, or 3 parts, preferably 2 parts.

[0033] In this invention, the most preferred traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: Prepared aconite root 6 parts, prepared strychnos nux-vomica seed 6 parts, Clematis chinensis 5 parts, Ligusticum chuanxiong 6 parts, safflower 4 parts, Sparganium stoloniferum 4 parts, Curcuma zedoaria 4 parts, Corydalis yanhusuo 4 parts, Notopterygium incisum 4 parts, borneol 2 parts.

[0034] The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is preferably in the form of an external preparation, more preferably such as a tincture, ointment or gel, and most preferably a tincture.

[0035] The preparation methods of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention will be given below in conjunction with different dosage forms. In the following preparation methods, the raw medicinal materials are all weighed according to the mass proportions in the formula.

[0036] When the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is a tincture, the preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 60%-80% ethanol as solvent and soak for 24-72 hours. Then, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract and the percolate, let stand, filter, and recover the ethanol to obtain the concentrated alcohol extract for later use.

[0037] Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃).

[0038] Take the above water extract and slowly add ethanol while stirring to make the alcohol content reach 60-65%. Let it stand for 24 hours, take the supernatant, filter it, wash the precipitate with an appropriate amount of 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract and alcohol precipitate for later use.

[0039] Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the combined solution, and stir well. Then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into vials to obtain the traditional Chinese medicine composition (tincture) for treating wind-cold-dampness arthralgia.

[0040] When the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is an ointment, the preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 60%-80% ethanol as solvent and soak for 24-72 hours. Then, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract and the percolate, let stand, filter, and recover the ethanol to obtain the concentrated alcohol extract for later use.

[0041] Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃).

[0042] Take the above water extract and slowly add ethanol while stirring to make the alcohol content reach 60-65%. Let it stand for 24 hours, take the supernatant, filter it, wash the precipitate with an appropriate amount of 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract and alcohol precipitate for later use.

[0043] Combine the above-mentioned concentrated alcohol extract and concentrated water extract, stir well, and set aside. Take appropriate amounts of glyceryl monostearate, stearic acid, white petrolatum, liquid paraffin, and lanolin, heat to 75°C to melt, stir well, and keep warm to obtain the oil phase. Separately, take appropriate amounts of glycerin and ethylparaben, add an appropriate amount of purified water, heat to 75°C, and stir to dissolve to obtain the aqueous phase. While keeping warm, slowly add the above-mentioned mixed solution (i.e., the combined solution of the concentrated alcohol extract and the concentrated water extract) to the oil phase while stirring, then add the above-mentioned aqueous phase, continuing to stir until emulsification is complete. Stop heating and continue stirring until the temperature drops to 40-45°C. Take borneol, dissolve it in an appropriate amount of ethanol, and slowly add it to the ointment, stirring well. Homogenize the ointment twice using a colloid mill until it is fine and uniform, fill it into the specified ointment box at room temperature, and seal it to obtain the traditional Chinese medicine composition (ointment) for treating wind-cold-dampness arthralgia.

[0044] When the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is a gel, the preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia includes the following steps: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 60%-80% ethanol as solvent. After soaking for 24-72 hours, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract and the percolate, let stand, filter, recover the ethanol, and obtain the concentrated alcohol extract for later use.

[0045] Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃).

[0046] Take the above water extract and slowly add ethanol while stirring to make the alcohol content reach 60-65%. Let it stand for 24 hours, take the supernatant, filter it, wash the precipitate with an appropriate amount of 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract and alcohol precipitate for later use.

[0047] Combine the above-mentioned concentrated alcohol extract and concentrated water extract, stir well, and set aside. Take an appropriate amount of carbomer, sprinkle it into an appropriate amount of purified water, and let it stand to fully swell, obtaining a gel matrix, which is also set aside. Add glycerol and azone to the above gel matrix and stir well. While stirring, slowly add triethanolamine to adjust the pH to 6.5–7.5, immediately forming a transparent gel. While stirring, slowly add the above-mentioned mixed solution (i.e., the combined solution of the concentrated alcohol extract and the concentrated water extract) to the gel matrix and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the above-mentioned ointment, and stir well to obtain the traditional Chinese medicine composition (gel) for treating wind-cold-dampness arthralgia.

[0048] The present invention also provides the application of a traditional Chinese medicine composition for treating wind-cold-dampness syndrome in the preparation of a medicine for treating frozen shoulder, rheumatic pain or joint pain.

[0049] The following examples provide a clearer and more detailed description of the traditional Chinese medicine composition and its preparation method of the present invention, and pharmacodynamic experiments verify the efficacy of the traditional Chinese medicine composition of the present invention in treating joint pain caused by the obstruction of qi and blood in the meridians due to invasion of wind, cold, dampness, and pathogenic factors.

[0050] Example 1: The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 4 parts of processed aconite, 4 parts of processed strychnos nux-vomica, 3 parts of clematis chinensis, 4 parts of chuanxiong rhizome, 2 parts of safflower, 2 parts of sparganium rhizome, 4 parts of turmeric rhizome, 4 parts of corydalis rhizome, 6 parts of notopterygium root, and 2 parts of borneol.

[0051] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal herbs: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 60% ethanol as solvent. After soaking for 24 hours, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain a concentrated alcohol extract for later use. Take five medicinal herbs: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 8 times the amount of water for the first decoction and decoct for 1.5 hours. Add 6 times the amount of water for the second decoction and decoct for 1 hour. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water-extracted extract, slowly add ethanol while stirring to achieve an alcohol content of 65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with an appropriate amount of 65% ethanol, combine the washings with the filtrate, recover the ethanol, and obtain the concentrated water-extract-ethanol-precipitated solution for later use. Combine the above-mentioned concentrated ethanol extract with the concentrated water-extract-ethanol-precipitated solution and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the above combined solution, and stir well. Then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into vials to obtain the traditional Chinese medicine composition (tincture) for treating wind-cold-dampness arthralgia.

[0052] Example 2: The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 6 parts of processed aconite, 6 parts of processed strychnos nux-vomica, 5 parts of clematis chinensis, 8 parts of chuanxiong rhizome, 6 parts of safflower, 4 parts of sparganium rhizome, 2 parts of turmeric rhizome, 2 parts of corydalis rhizome, 4 parts of notopterygium root, and 1 part of borneol.

[0053] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal herbs: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 70% ethanol as solvent and soak for 72 hours. Then, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain a concentrated alcohol extract for later use. Take five medicinal herbs: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.5 hours. Add 8 times the amount of water for the second decoction and decoct for 1 hour. Filter the decoction, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water-extracted extract, and slowly add ethanol while stirring to achieve an alcohol content of 60%. Let it stand for 24 hours, take the supernatant, filter it, and wash the precipitate with an appropriate amount of 60% ethanol. Combine the washings and the filtrate, recover the ethanol, and obtain the concentrated water-extracted alcohol-precipitated extract for later use. Combine the above-mentioned concentrated alcohol extract with the concentrated water-extracted alcohol-precipitated extract, stir well, and set aside. Take 4.5g of glyceryl monostearate, 10.0g of stearic acid, 5.0g of white petrolatum, 12.0g of liquid paraffin, and 2.0g of lanolin, heat to 75℃ to melt, stir well, and keep warm to obtain the oil phase. Separately take 10.0g of glycerin and 0.2g of ethylparaben, add an appropriate amount of purified water, heat to 75℃, and stir to dissolve to obtain the aqueous phase. While keeping warm, slowly add the above-mentioned mixed solution to the oil phase while stirring, then add the above-mentioned aqueous phase, and continue stirring until emulsification is complete. Stop heating and continue stirring until the temperature drops to 40-45℃. Take borneol, dissolve it in an appropriate amount of ethanol, and slowly add it to the ointment, stirring well. Homogenize the ointment twice using a colloid mill until it is fine and uniform. Fill the ointment into the specified ointment box at room temperature and seal it to obtain the traditional Chinese medicine composition (ointment) for treating wind-cold-dampness arthralgia.

[0054] Example 3: The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 8 parts of processed aconite, 8 parts of processed strychnos nux-vomica, 7 parts of clematis chinensis, 6 parts of chuanxiong rhizome, 4 parts of safflower, 6 parts of sparganium rhizome, 2 parts of turmeric rhizome, 2 parts of corydalis rhizome, 4 parts of notopterygium root, and 1 part of borneol.

[0055] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal herbs: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 80% ethanol as solvent and soak for 48 hours. Then, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain a concentrated alcohol extract for later use. Take five medicinal herbs: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 12 times the amount of water for the first decoction and decoct for 2 hours. Add 10 times the amount of water for the second decoction and decoct for 1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water-extracted extract, slowly add ethanol while stirring to achieve an alcohol content of 65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with an appropriate amount of 65% ethanol, combine the washings with the filtrate, recover the ethanol, and obtain the concentrated water-extract-ethanol-precipitated solution for later use. Combine the above-mentioned concentrated ethanol extract with the concentrated water-extract-ethanol-precipitated solution and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the above combined solution, and stir well. Then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into vials to obtain the traditional Chinese medicine composition (tincture) for treating wind-cold-dampness arthralgia.

[0056] Example 4: The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 4 parts of processed aconite, 4 parts of processed strychnos nux-vomica, 5 parts of clematis chinensis, 8 parts of chuanxiong rhizome, 6 parts of safflower, 6 parts of sparganium rhizome, 6 parts of turmeric rhizome, 6 parts of corydalis rhizome, 8 parts of notopterygium root, and 3 parts of borneol.

[0057] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 70% ethanol as solvent and soak for 48 hours. Then, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain the concentrated alcohol extract for later use. Take five medicinal materials: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1 hour. Add 8 times the amount of water for the second decoction and decoct for 0.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water extract, slowly add ethanol while stirring to achieve an alcohol content of 60%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with an appropriate amount of 60% ethanol, combine the washings and filtrate, recover the ethanol, and obtain the concentrated water-extract-ethanol-precipitated solution for later use. Combine the above concentrated ethanol extract with the concentrated water-extract-ethanol-precipitated solution, stir well, and set aside. Take 1.0g of carbomer, sprinkle it into an appropriate amount of purified water, let it stand to allow it to swell fully, and obtain the gel matrix for later use. Add 8.0g of glycerol and 2.0g of azone to the above gel matrix and stir well. While stirring, slowly add triethanolamine to adjust the pH to 6.5-7.5, and a transparent gel will form. While stirring, slowly add the above mixed solution to the gel matrix and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the above-mentioned extract, and stir well to obtain the (gel). Example 5: Example 5 is an example of the optimal traditional Chinese medicine composition.

[0058] The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 6 parts of processed aconite, 6 parts of processed strychnos nux-vomica, 5 parts of clematis chinensis, 6 parts of chuanxiong rhizome, 4 parts of safflower, 4 parts of sparganium rhizome, 4 parts of turmeric rhizome, 4 parts of corydalis rhizome, 4 parts of notopterygium root, and 2 parts of borneol.

[0059] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal herbs: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 70% ethanol as solvent. After soaking for 48 hours, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain a concentrated alcohol extract for later use. Take five medicinal herbs: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.5 hours. Add 8 times the amount of water for the second decoction and decoct for 1 hour. Filter the decoction, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water-extracted extract, slowly add ethanol while stirring to achieve an alcohol content of 65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with an appropriate amount of 65% ethanol, combine the washings with the filtrate, recover the ethanol, and obtain the concentrated water-extract-ethanol-precipitated solution for later use. Combine the above-mentioned concentrated ethanol extract with the concentrated water-extract-ethanol-precipitated solution and stir well. Take borneol, dissolve it in an appropriate amount of ethanol, add it to the above combined solution, and stir well. Then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into vials to obtain the traditional Chinese medicine composition (tincture) for treating wind-cold-dampness arthralgia.

[0060] Comparative Example 1: The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention is composed of the following parts by weight of traditional Chinese medicinal materials: 6 parts of processed aconite, 6 parts of processed strychnos nux-vomica, 5 parts of clematis chinensis, 6 parts of chuanxiong rhizome, 4 parts of safflower, 4 parts of sparganium rhizome, 4 parts of turmeric rhizome, 6 parts of corydalis rhizome, 4 parts of notopterygium root, and 1 part of borneol.

[0061] The preparation method of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia of the present invention includes the following steps: All the traditional Chinese medicinal materials used are weighed according to the mass proportions in the prescription. Take four medicinal herbs: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. According to the percolation method under the section on fluid extracts and extracts (General Chapter 0189 in the Chinese Pharmacopoeia), use 80% ethanol as solvent. After soaking for 48 hours, slowly percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the squeezed liquid and the percolate, let stand, filter, and recover the ethanol to obtain a concentrated alcohol extract for later use. Take five medicinal herbs: processed Aconitum carmichaelii, processed Strychnos nux-vomica, Carthamus tinctorius, Sparganium stoloniferum, and Curcuma zedoaria. Add water and decoct twice. Add 10 times the amount of water for the first decoction and decoct for 1.5 hours. Add 8 times the amount of water for the second decoction and decoct for 1 hour. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.15 (60℃). Take the above-mentioned water-extracted extract, and slowly add ethanol while stirring to achieve an alcohol content of 65%. Let it stand for 24 hours, take the supernatant, filter it, and wash the precipitate with an appropriate amount of 65% ethanol. Combine the washings and the filtrate, recover the ethanol, and obtain the concentrated water-extracted alcohol-precipitated extract for later use. Combine the above-mentioned concentrated alcohol extract with the concentrated water-extracted alcohol-precipitated extract, stir well, and set aside. Take 4.5g of glyceryl monostearate, 10.0g of stearic acid, 5.0g of white petrolatum, 12.0g of liquid paraffin, and 2.0g of lanolin, heat to 75℃ to melt, stir well, and keep warm to obtain the oil phase. Separately take 10.0g of glycerin and 0.2g of ethylparaben, add an appropriate amount of purified water, heat to 75℃, and stir to dissolve to obtain the aqueous phase. While keeping warm, slowly add the above-mentioned mixed solution to the oil phase while stirring, then add the above-mentioned aqueous phase, and continue stirring until emulsification is complete. Stop heating and continue stirring until the temperature drops to 40-45℃. Take borneol, dissolve it in an appropriate amount of ethanol, and slowly add it to the ointment, stirring well. Homogenize the ointment twice using a colloid mill until it is fine and uniform. Fill the ointment into the specified ointment box at room temperature and seal it to obtain the traditional Chinese medicine composition (ointment) for treating wind-cold-dampness arthralgia.

[0062] Comparative Example 2: The comparative sample used in this comparison was Jiantongning Liniment, which is manufactured by Xiuzheng Pharmaceutical Group (Hunan) Pharmaceutical Co., Ltd.

[0063] Pharmacodynamic experiments: 1. Experiment on the effect on a rat model of arthritis: Rats were stable-fed for 7 days, with 10 rats randomly selected as the control group and the remaining 100 rats used for modeling. Inflammation was induced on days 1 and 14: 0.1 mL of Freund's complete adjuvant was injected intradermally into the right hind paw of each rat. Except for the normal group, rats were subjected to wind-cold-dampness stimulation: starting from day 1 of inflammation induction, the inflammatory rats were placed in 5 ℃ water at a depth of 2 cm with a wind speed of 5 m / s, and stood in the water for 20 minutes, once a day for 14 consecutive days. After modeling was completed, on day 15 of inflammation induction, 90 rats with successfully established arthritis index (AI) ≥4 were selected and randomly divided into model group, positive control group (0.216 g / kg, musk analgesic aerosol, sprayed twice / day, applied topically), Example 1 group (0.390 g / kg, 0.5 ml / time / day, applied topically), Example 2 group (0.390 g / kg, 0.5 ml / time / day, applied topically), Example 3 group (0.390 g / kg, 0.5 ml / time / day, applied topically), Example 4 group (0.390 g / kg, 0.5 ml / time / day, applied topically), Example 5 group (0.390 g / kg, 0.5 ml / time / day, applied topically), and Comparative Example 1 group (0.390 g / kg, 0.5 ml / time / day, applied topically) and Comparative Example 2 group (0.311 g / kg, 0.5 ml / time / day, applied topically), with 10 rats in each group. Each group was administered the medication according to the dosage form characteristics, once daily for 14 consecutive days. After the last dose, blood samples were collected for testing after an 8-hour fast.

[0064] Testing indicators: 1. General test (1) General morphological observation: Observe the general condition of rats in each group, including weight, coat color, mental status, activity, and mortality.

[0065] (2) Examination of secondary paw edema in rats The water displacement volume of rat paws was measured using the water displacement volume method on days 1, 7, and 14 after inflammatory induction, for a total of three measurements. Changes in paw volume before and after drug administration were compared to determine the degree of inflammation in the rat paws.

[0066] (3) Rats' polyarthritis index score On day 16 post-inflammatory induction, the occurrence and severity of polyarthritis lesions were recorded using the joint score scoring method, with joint scores divided into 5 grades (0-4). Grade 0: No redness or swelling, 0 points; Grade 1: Redness and swelling of the little toe joint, 1 point; Grade 2: Redness and swelling of both the toe joint and the toe area, 2 points; Grade 3: Redness and swelling below the toe joint, 3 points; Grade 4: Redness and swelling of the entire limbs, including the toe joint, 4 points. The cumulative arthritis score of the limbs was the arthritis index of each rat, with a maximum of 16 points. Records were taken once every 7 days, for a total of 3 times.

[0067] (4) Blood was collected from the abdominal aorta and allowed to stand for a period of time until the supernatant was separated. Then, the blood was centrifuged at 3600 r / min for 15 min at 4℃. The serum was collected, aliquoted, and stored at -80℃. The levels of tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) in rat serum were detected by strictly following the instructions of the ELISA kit.

[0068] 2. Mouse tail-flick test Ninety ICR mice, half male and half female, were randomly divided into 10 groups: blank group, positive control group (aspirin enteric-coated tablets 0.26g / kg, administered by gavage, 0.2ml / kg), Example 1 group (0.393g / kg, 0.2ml / time / day, applied topically), Example 2 group (0.393g / kg, 0.2ml / time / day, applied topically), Example 3 group (0.393g / kg, 0.2ml / time / day, applied topically), Example 4 group (0.393g / kg, 0.2ml / time / day, applied topically), and Example 4 group (0.393g / kg, 0.2ml / time / day, applied topically). The treatment regimen consisted of four groups: Group 1 (0.393 g / kg, 0.2 ml / time / day, applied topically), Group 5 (0.393 g / kg, 0.2 ml / time / day, applied topically), and Group 1 (0.393 g / kg, 0.2 ml / time / day, applied topically) and Group 2 (0.412 g / kg, 0.2 ml / time / day, applied topically), with 10 mice in each group. Groups 1-5 were administered the herbal compositions prepared in Examples 1-5, and Groups 1-2 were administered the herbal compositions prepared in Comparative Examples 1-2. Each group was administered the herbal composition according to its dosage form characteristics, once daily for 7 consecutive days. Tail-flicking time was observed 1 hour after the last administration. Mice were placed in the fixed container of a pain meter with their tails exposed. The tip 1 / 3 of the tail was irradiated at a power of 25 W. Pain was measured after the animals calmed down. The time it took for the tail to flick after being heated was taken as the latency period of the pain response.

[0069] Experimental results: 1. Establishment of a rat model of arthritis: (1) General morphological observation: Compared with the control group, the rats in the model group had reduced food intake, dry hair, and reduced activity; after inflammation, redness and swelling appeared on the joints and toes of the sensitized side, reaching its peak at 18 hours and gradually decreasing after 7 days; about 7 days after inflammation, lesions occurred at their peak, with swelling of the joints and toes of the inflammatory side, non-inflammatory side, and both forelimbs, and "arthritis" nodules appeared on the ears and tail, and the weight decreased significantly; no animals died during the experiment.

[0070] (2) Examination of secondary paw edema in rats: Compared with the control group, the paw swelling level of rats in the model group was significantly increased, with statistical difference (P<0.001). Compared with the model group, the paw swelling level of rats in the positive control group was decreased on Day 1, 7, and 14, with statistical difference (P<0.001). The paw swelling level of rats in the Example 2 group was decreased on Day 14, with statistical difference (P<0.05). The paw swelling level of rats in the Example 5 group was decreased on Day 7 and 14, with statistical difference (P<0.001). Compared with the control group 1, the paw swelling level of rats in the Example 4 group was decreased on Day 14, with statistical difference (P<0.05). The paw swelling level of rats in the Example 5 group was decreased on Day 7 and 14, with statistical difference (P<0.001). Compared with the control group 2, the paw swelling level of rats in the Example 5 group was decreased on Day 7 and 14, with statistical difference (P<0.001). See Table 1.

[0071] Table 1. Effects of each group of rats with rheumatic arthritis on paw swelling (mL). (n=10) Compared with the blank group, aaa P < 0.001; compared with the model group, b P<0.05, bb P<0.01, bbb P<0.001; compared with Comparative Example 1, ccc P<0.001; compared with the control group 2, d P<0.05, ddd P<0.001.

[0072] (3) Rats' polyarthritis index score: Compared with the model group, the positive control group showed a significant decrease in arthritis index on Day 7 and 14 (P<0.001), the Example 1 group showed a significant decrease in arthritis index on Day 14 (P<0.05), the Example 2 group showed a significant decrease in arthritis index on Day 14 (P<0.05), and the Example 5 group showed a significant decrease in arthritis index on Day 7 and 14 (P<0.01, P<0.001). Compared with Comparative Example 1, the Example 2 group showed a significant decrease in arthritis index on Day 14 (P<0.05), the Example 5 group showed a significant decrease in arthritis index on Day 7 and 14 (P<0.01, P<0.001), and the Example 5 group showed a significant decrease in arthritis index on Day 7 (P<0.01). (See Table 2).

[0073] Table 2. Effects on the arthritis index (scores) of each group of rats ( (n=10) Compared with the model group, b P<0.05, bbb P<0.001; compared with Comparative Example 1, c P<0.05, ccc P<0.001; compared with the control group 2, dd P<0.01.

[0074] (4) Compared with the blank group, the serum levels of TNF-α and IL-6 in the model group rats were increased, with statistical differences (P<0.01, P<0.001); compared with the model group, the levels of IL-6 in the Example 2 group, the positive control group, and the TNF-α and IL-6 in the Example 5 group were decreased, with statistical differences (P<0.05, P<0.001); compared with the comparative example 1 group, the levels of TNF-α and IL-6 in the Example 5 group were decreased, with statistical differences (P<0.01, P<0.001); compared with the comparative example 2 group, the levels of TNF-α and IL-6 in the Example 5 group were decreased, with statistical differences (P<0.01, P<0.001), as shown in Table 3.

[0075] Table 3. Effects of serum TNF-α and IL-6 levels in each group of rats ( (n=10) Compared with the blank group, aa P<0.01, aaa P < 0.001; compared with the model group, b P<0.05, bbb P<0.001; compared with Comparative Example 1, cc P<0.01, ccc P<0.001; compared with the control group 2, dd P<0.01, ddd P<0.001.

[0076] 2. Mouse tail-flick test: Compared with the blank control group, the positive control group and the Example 5 group could prolong the tail-flicking time of mice, with statistically significant differences (P<0.001); compared with the comparative example 1 group, the Example 5 group could prolong the tail-flicking time of mice, with statistically significant differences (P<0.001); compared with the comparative example 2 group, the Example 5 group could prolong the tail-flicking time of mice, with statistically significant differences (P<0.01), as shown in Table 4.

[0077] Table 4. Latency of pain response in mice of each group ( (n=10) Compared with the blank group, aaa P<0.001; compared with Comparative Example 1, ccc P<0.001; compared with the control group 2, dd P<0.01.

[0078] The results showed that: (1) Group 5 of Example 5 had significant effects in reducing swelling, reducing inflammation, and relieving pain; Groups 1, 2, 3, and 4 of Example 5 and Groups 1 and 2 of Example 6 had no significant effects in reducing swelling, reducing inflammation, and relieving pain. (2) Group 5 of Example 5 had better effects than Groups 1, 2, 3, and 4 of Example 6; (3) Group 5 of Example 5 had better effects than Groups 1 and 2 of Example 6. Conclusion: The fifth example group can relieve pain, improve paw swelling caused by wind-cold-dampness in rats, and reduce the joint inflammation index and serum TNF-α and IL-6 levels in rats.

[0079] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A traditional Chinese medicine composition for treating wind-cold-damp arthralgia, characterized in that, It is composed of the following Chinese medicinal herbs in parts by weight: Prepared aconite root 4-8 parts, prepared strychnos nux-vomica seed 4-8 parts, clematis root 3-10 parts, chuanxiong rhizome 4-8 parts, safflower 2-6 parts, sparganium rhizome 2-6 parts, turmeric rhizome 2-6 parts, corydalis rhizome 2-6 parts, notopterygium root 4-8 parts, borneol 1-3 parts.

2. The Chinese medicine composition for treating wind-dampness arthralgia according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: Prepared aconite root 6 parts, prepared strychnos nux-vomica seed 6 parts, Clematis chinensis 5 parts, Ligusticum chuanxiong 6 parts, safflower 4 parts, Sparganium stoloniferum 4 parts, Curcuma zedoaria 4 parts, Corydalis yanhusuo 4 parts, Notopterygium incisum 4 parts, borneol 2 parts.

3. The Chinese medicine composition for treating wind-dampness arthralgia of claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is an external application preparation.

4. The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia according to claim 3, characterized in that, The dosage form of the traditional Chinese medicine composition is a tincture, ointment, or gel.

5. The Chinese medicine composition for treating wind-dampness arthralgia of claim 4, characterized in that, The dosage form of the traditional Chinese medicine composition is a tincture.

6. A method for preparing the traditional Chinese medicine composition for treating wind-cold-damp arthralgia according to claim 1, characterized in that, When the dosage form of the traditional Chinese medicine composition is a tincture, the following steps are included: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.

15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well; take borneol, dissolve it in ethanol, add it to the above-mentioned combined solution, and stir well; then add 50% ethanol to adjust the total volume to 1000 mL, stir well, let stand for 24 hours, filter, and fill into bottles to obtain a tincture of traditional Chinese medicine composition for treating wind-cold-dampness arthralgia.

7. A method for preparing the traditional Chinese medicine composition for treating wind-cold-damp arthralgia according to claim 1, characterized in that, When the dosage form of the traditional Chinese medicine composition is an ointment, the following steps are included: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.

15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well. Take glyceryl monostearate, stearic acid, white petrolatum, liquid paraffin, and lanolin, heat to 75°C to melt, stir well, and keep warm to form the oil phase. Separately, take glycerol and ethylparaben, add purified water, heat to 75°C, and stir to dissolve to form the aqueous phase. While keeping warm, add the combined concentrated alcohol extract and concentrated water extract to the oil phase while stirring, then add the above-mentioned aqueous phase and continue stirring until emulsification is complete. Stop heating and continue stirring until the temperature drops to 40-45°C. Take borneol, dissolve it in ethanol, add it to the ointment, and stir well. Homogenize the ointment twice through a colloid mill until it is fine and uniform. Fill the ointment into ointment boxes at room temperature and seal to obtain the traditional Chinese medicine composition ointment for treating wind-cold-dampness arthralgia.

8. A method for preparing the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia as described in claim 1, characterized in that, When the dosage form of the traditional Chinese medicine composition is a gel, the following steps are included: Take four medicinal materials: Ligusticum chuanxiong, Notopterygium incisum, Clematis chinensis, and Corydalis yanhusuo. Grind them into coarse powder. Using the percolation method under the section on fluid extracts and extracts, use 60%-80% ethanol as solvent. After soaking for 24-72 hours, percolate at a rate of 1-3 mL per minute. Collect the percolate, press the residue, combine the extract with the percolate, let it stand, filter, and recover the ethanol to obtain the concentrated alcohol extract. Take five medicinal materials: processed aconite, processed strychnos nux-vomica, safflower, sparganium rhizome, and turmeric rhizome. Add water and decoct twice. For the first decoction, add 8-12 times the amount of water and decoct for 1-2 hours. For the second decoction, add 6-10 times the amount of water and decoct for 0.5-1.5 hours. Filter the two decoctions separately, combine the filtrates, and concentrate to a clear extract with a relative density of 1.10-1.

15. Take the above water extract, add ethanol under stirring to make the alcohol content reach 60-65%, let stand for 24 hours, take the supernatant, filter, wash the precipitate with 60-65% ethanol, combine the washing liquid with the filtrate, recover the ethanol, and obtain the concentrated water extract alcohol precipitate. Combine the above-mentioned concentrated alcohol extract and concentrated water extract, and stir well. Take carbomer, sprinkle it into purified water, and let it stand to fully swell, thus obtaining a gel matrix. Add glycerol and azone to the gel matrix and stir well. While stirring, add triethanolamine and adjust the pH value to 6.5-7.5, which will then form a transparent gel. While stirring, add the combined liquid of the above-mentioned concentrated alcohol extract and concentrated water extract to the gel matrix and stir well. Then take borneol, dissolve it in ethanol, add it to the gel matrix, and stir well to obtain a traditional Chinese medicine composition gel for treating wind-cold-dampness arthralgia.

9. The use of the traditional Chinese medicine composition for treating wind-cold-dampness arthralgia as described in any one of claims 1-5 in the preparation of a medicament for treating frozen shoulder, rheumatic pain, or joint pain.

Images