Interval ratio of dispelling wind and joint pain ointment and preparation method thereof

Abstract

This invention discloses a range-ratio joint pain-relieving plaster and its preparation method, belonging to the field of traditional Chinese medicine external preparation technology. The plaster is composed of 23 active ingredients, including frankincense (processed) and myrrh (processed), and two matrix components, sesame oil and red lead (cinnabar). Each component has a scientifically defined dosage range to suit the differences in raw material characteristics and efficacy requirements. The preparation method covers pretreatment, plaster making, molding, and packaging stages, with range-ratio parameters set for each process step. Validated by 27 batches of samples, the product has an LD50 > 5g / kg, an analgesic rate > 55%, a holding time > 8h, a skin irritation score < 0.5, and is stable in accelerated testing over 6 months. This solution balances stable efficacy, controllable safety, and flexible production, and can be customized according to efficacy emphasis and equipment conditions. It is suitable for the treatment of joint pain and has broad industrialization prospects.

Description

Technical Field

[0001] This invention relates to the field of analgesic plasters, specifically to a wind-dispelling joint pain-relieving plaster with a range of proportions and its preparation method. Background Technology

[0002] Traditional Chinese medicine external plasters are widely used in the treatment of rheumatic pain, joint pain, and other ailments due to their advantages such as transdermal absorption, direct targeting of the lesion, and minimal side effects. Plasters for dispelling wind and relieving joint pain, in particular, have become commonly used clinical preparations due to their effects of dispelling wind, clearing the meridians, promoting blood circulation, and relieving pain. However, existing plaster technologies still have many shortcomings, which restrict product quality and application efficacy.

[0003] Traditional plaster formulas often use fixed dosages, failing to fully consider the natural differences in the characteristics of Chinese medicinal materials. Raw materials from different origins, harvesting seasons, and processing methods exhibit significant fluctuations in the content of active ingredients (e.g., ferulic acid in Angelica sinensis), purity (e.g., dried and freeze-dried Zaocys dhumnades), and degree of lignification. Fixed formulations can easily lead to insufficient or redundant efficacy in some batches. Furthermore, the dosage of toxic components such as processed Aconitum carmichaelii and processed Aconitum kusnezoffii lacks scientific control, easily triggering toxic reactions; excessive amounts of ingredients like safflower and cinnamon can cause abnormal appearance of the plaster or skin irritation.

[0004] In terms of production processes, existing technologies often use single parameters, making it difficult to adapt to differences in equipment volume and environmental conditions. For example, using a fixed amount of extraction solvent can lead to insufficient dissolution of active ingredients or wasted energy, while using a single refining temperature may cause oil return or the formation of toxic components. Furthermore, existing methods lack a systematic, interval-based validation framework, making it difficult to guarantee product stability and safety. They also lack the flexibility to be adjusted according to efficacy priorities and cost control needs, thus limiting industrial application and innovative development. Therefore, there is an urgent need for an interval-based formulation and preparation method that balances stable efficacy, controllable safety, and flexible production. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned technology and provide a wind-dispelling and joint-relieving plaster with a range of proportions and its preparation method.

[0006] To solve the above-mentioned technical problems, the present invention provides a range-ratio formula for a pain-relieving plaster for joint pain and wind, and its preparation method: A range-ratio formula for a pain-relieving plaster for joint pain and wind, composed of active ingredients and matrix components, wherein the active ingredients include frankincense (processed), myrrh (processed), black-striped snake, golden-flowered snake, processed aconite root, processed aconite root, angelica, sandalwood, safflower, dragon's blood, corydalis (processed), sappanwood, momordica cochinchinensis (processed), aster, celandine, cinnamon, dried ginger, mulberry twig, cinnamon twig, ephedra, sophora japonica twig, licorice (processed), and catechu; wherein the matrix components include sesame oil and red lead; the dosage range (parts) of each active ingredient are as follows: frankincense (processed) 2-3 parts, myrrh (processed) 2-3 parts, black-striped snake 2-4 parts, golden-flowered snake 0. 3-0.7 parts, processed Aconitum carmichaelii 0.5-1.0 parts, processed Aconitum kusnezoffii 0.5-1.0 parts, Angelica sinensis 3-5 parts, Dalbergia odorifera 1.5-2.5 parts, Carthamus tinctorius 1-2 parts, Dragon's blood 0.8-1.2 parts, Corydalis yanhusuo (processed) 2-4 parts, Sappanwood 1.5-2.5 parts, Momordica cochinchinensis (processed) 1-1.5 parts, Aster tataricus 1.5-2.5 parts, Celastrus orientalis 1-2 parts, Cinnamomum cassia 1-2 parts, Zingiber officinale 1.5-2.5 parts, Morus alba twig 2.5-3.5 parts, Cinnamomum cassia twig 1.5-2.5 parts, Ephedra sinica 1-2 parts, Sophora japonica twig 1.5-2.5 parts, Glycyrrhiza uralensis (processed) 1.5-2.5 parts, Catechu 0.8-1.2 parts; the dosage range (parts) of each of the matrix components are as follows: Sesame oil 30-40 parts, Red lead 18-22 parts.

[0007] As an improvement, the standard dosage (parts) of the active ingredients are as follows: 2.5 parts of frankincense (processed), 2.5 parts of myrrh (processed), 3 parts of black-striped snake, 0.5 parts of golden-flowered snake, 0.8 parts of processed aconite, 0.8 parts of processed aconite root, 4 parts of angelica, 2 parts of sandalwood, 1.5 parts of safflower, 1 part of dragon's blood, 3 parts of corydalis (processed), 2 parts of sappanwood, 1.2 parts of momordica cochinchinensis (processed), 2 parts of aster, 1.5 parts of celandine, 1.5 parts of cinnamon, 2 parts of dried ginger, 3 parts of mulberry twig, 2 parts of cinnamon twig, 1.5 parts of ephedra, 2 parts of sophora japonica twig, 2 parts of licorice (processed), and 1 part of catechu; the standard dosage (parts) of the matrix components are as follows: 35 parts of sesame oil and 20 parts of red lead.

[0008] A method for preparing a wind-dispelling and joint-pain-relieving ointment with a range-ratio formulation includes a pretreatment stage, an ointment-making stage, and a molding and packaging stage, wherein: the pretreatment stage is used to pulverize, extract, and purify the active ingredient as described in claim 1 to fully dissolve the effective ingredients and remove impurities; the ointment-making stage is used to react and mix the pretreated active ingredient extract with the matrix component as described in claim 1 to form a uniform ointment; the molding and packaging stage is used to process the obtained ointment into a finished product form and package it in compliance with regulations to ensure stable product quality and ease of use.

[0009] As an improvement, the preprocessing stage specifically includes the following steps:

[0010] (1) Traditional Chinese medicine pulverization: Each active ingredient described in claim 1 is pulverized separately, and the particle size range after pulverization is controlled to be 60-100 mesh to ensure that the hard active ingredients such as mulberry branches and locust branches are pulverized evenly and to avoid agglomeration during the extraction process;

[0011] (2) Extraction preparation: Weigh each pulverized active ingredient according to the dosage range of the active ingredient as described in claim 1, mix them evenly to obtain a traditional Chinese medicine mixed powder, and add an extraction solvent, which is sesame oil, to the traditional Chinese medicine mixed powder;

[0012] (3) Heating extraction: Place the mixed powder of Chinese medicine containing the extraction solvent into the extraction tank, control the extraction temperature range to 110-130℃, and the extraction time range to 2.5-3.5h, to ensure that the proteins in the black-striped snake and the golden-flowered snake, as well as the corydalis B in the processed corydalis, are fully dissolved;

[0013] (4) Filtration treatment: After extraction, the extraction system is filtered using filter material with a filtration precision range of 100-140 mesh to remove coarse particulate impurities in the system and obtain the Chinese medicine extract.

[0014] As an improvement, the amount of extraction solvent used in step (2) is 5-7 times the total mass of the mixed Chinese medicine powder.

[0015] As an improvement, the ointment preparation stage specifically includes the following steps:

[0016] (1) Alchemy reaction: The Chinese herbal extract obtained in the pretreatment stage is transferred to the alchemy equipment, and red lead (red lead) is added according to the dosage range of the matrix components in claim 1. The temperature is raised to 270-290℃ to carry out the alchemy reaction until the alchemy endpoint is reached at 20-30℃ when water droplets form beads.

[0017] (2) Ingredient mixing: Cool the paste after the alchemical reaction to 55-65℃, add the reserved active ingredient fine powder weighed according to the dosage range of claim 1, and stir at a stirring speed of 200-300r / min for 15-25min to ensure that the active ingredient fine powder is evenly dispersed in the paste, without clumping and without generating bubbles.

[0018] (3) Adjustment of paste: Based on the actual viscosity and hardness of the paste, the amount of sesame oil or red lead (cinnabar) is slightly adjusted within the dosage range of the matrix components described in claim 1 so that the properties of the paste meet the requirements of subsequent processing.

[0019] As an improvement, the molding and packaging stage specifically includes the following steps:

[0020] (1) Spreading operation: Spread the uniformly mixed paste obtained in the paste preparation stage at 55-65℃, and control the spreading thickness range to 0.3-0.4mm;

[0021] (2) Cooling and setting: Place the spread paste in an environment of 18-25℃ for 20-30 minutes to cool and set, ensuring that the paste is completely cured and there is no sticking.

[0022] (3) Packaging and storage: Pack the cooled and shaped finished product under an ambient humidity range of 40%-50%RH, and store it in a sealed container to prevent the finished product from getting damp or cracking.

[0023] As an improvement, the baseline parameters for the pretreatment stage are: 80 mesh particle size of Chinese herbal medicine, 6 times the total mass of the mixed Chinese herbal medicine powder, 120℃ extraction temperature, 3.0h extraction time, and 120 mesh filtration accuracy.

[0024] As an improvement, the baseline parameters for the ointment preparation stage are: refining temperature 280℃, refining endpoint determination temperature 25℃, active ingredient fine powder addition temperature 60℃, stirring speed 250r / min, and stirring time 20min; the baseline parameters for the molding and packaging stage are: spreading temperature 60℃, spreading thickness 0.35mm, cooling and setting temperature 22℃, cooling and setting time 25min, and packaging environment humidity 45%RH.

[0025] As an improvement, both the processed Aconitum carmichaelii and the processed Aconitum kusnezoffii are standard processed products, and the aconitine content of each batch of the processed Aconitum carmichaelii and each batch of the processed Aconitum kusnezoffii is <0.15mg / g; the Zaocys dhumnades and the Bungarus fasciatus are dried or freeze-dried products. When the Zaocys dhumnades and the Bungarus fasciatus are freeze-dried products, the dosage should be lower within the corresponding dosage range, and when the Zaocys dhumnades and the Bungarus fasciatus are dried products, the dosage should be higher within the corresponding dosage range.

[0026] The advantages of this invention compared with the prior art are: stable and reliable efficacy: In response to the fluctuations in the purity and content of active ingredients of Chinese herbal raw materials, the dosage range of active ingredients and matrix components is scientifically set to cover the differences in raw material characteristics, ensuring the stability of core efficacy such as promoting blood circulation and relieving pain, dispelling wind and unblocking collaterals. The analgesic rate of all samples exceeds 55%, and the dissolution rate of active ingredients meets the standards.

[0027] High safety: The dosage range of toxic components such as processed Aconitum carmichaelii and processed Aconitum kusnezoffii is strictly controlled, and the dosage is verified by referring to the pharmacopoeia standards and animal experiments to avoid toxic reactions; the dosage range of components such as cinnamon and ephedra and the application parameters are optimized to reduce adverse reactions such as skin redness and dryness, and the skin irritation score is less than 0.5.

[0028] Highly adaptable to production: The range of process parameters can be designed to adapt to extraction tanks of different volumes, alchemy equipment and workshop environments, lowering the production threshold; the reasonable setting of extraction time, stirring speed and other ranges reduces energy consumption and raw material waste, balances efficacy and cost, and improves the production qualification rate.

[0029] Flexible and adjustable: It supports customized adjustments, and can optimize the dosage of ingredients and process parameters within a range according to the focus of efficacy, production equipment limitations or cost control needs; when used for patent applications, the innovativeness can be highlighted by adjusting the range, taking into account both practicality and innovation.

[0030] Quality controllable: A comprehensive testing system has been established. 27 batches of inter-regional node samples have been verified, and indicators such as acute toxicity, adhesion, and stability all meet the standards. There were no quality problems in the 6-month accelerated test, which facilitates industrial quality control and traceability. Attached Figure Description

[0031] Figure 1 This is a formula diagram of a wind-dispelling and joint-pain-relieving plaster with a range of proportions according to the present invention.

[0032] Figure 2 This is a diagram illustrating the preparation method of a wind-dispelling and joint-pain-relieving plaster with a zoned formulation according to the present invention.

[0033] Figure 3 This is a diagram of the preprocessing stage of the present invention.

[0034] Figure 4 This is a diagram of the ointment-making stage of the present invention.

[0035] Figure 5 This is a diagram showing the molding and packaging stages of this invention. Detailed Implementation

[0036] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0037] Referring to the attached figures, a range-ratio formula for relieving joint pain and dispelling wind, and its preparation method, is described. The formula comprises active ingredients and a base component. The active ingredients include prepared frankincense, prepared myrrh, black-striped snake, golden-flowered snake, prepared aconite root, prepared aconite tuber, angelica root, sandalwood, safflower, dragon's blood, prepared corydalis rhizome, sappanwood, prepared momordica seed, aster root, celandine, cinnamon, dried ginger, mulberry twig, cinnamon twig, ephedra, sophora root twig, prepared licorice root, and catechu. The base component includes sesame oil and red lead (cinnamon). The dosage ranges (parts) of each active ingredient are as follows: prepared frankincense 2-3 parts, prepared myrrh 2-3 parts, black-striped snake 2-4 parts, golden-flowered snake 0.3-0.7 parts, prepared... Aconitum carmichaelii 0.5-1.0 parts, processed Aconitum kusnezoffii 0.5-1.0 parts, Angelica sinensis 3-5 parts, Dalbergia odorifera 1.5-2.5 parts, Carthamus tinctorius 1-2 parts, Dragon's Blood 0.8-1.2 parts, Corydalis yanhusuo (processed) 2-4 parts, Sappanwood 1.5-2.5 parts, Momordica cochinchinensis (processed) 1-1.5 parts, Aster tataricus 1.5-2.5 parts, Celandine chrysanthemum 1-2 parts, Cinnamomum cassia 1-2 parts, Zingiber officinale 1.5-2.5 parts, Morus alba twigs 2.5-3.5 parts, Cinnamomum cassia twigs 1.5-2.5 parts, Ephedra sinica 1-2 parts, Sophora japonica twigs 1.5-2.5 parts, Glycyrrhiza uralensis (processed) 1.5-2.5 parts, Catechu 0.8-1.2 parts; the dosage range (parts) of each of the matrix components are as follows: Sesame oil 30-40 parts, Red lead 18-22 parts.

[0038] The standard dosages (parts) of the active ingredients are as follows: 2.5 parts of frankincense (processed), 2.5 parts of myrrh (processed), 3 parts of black-striped snake, 0.5 parts of golden-flowered snake, 0.8 parts of processed aconite root, 0.8 parts of processed aconite root, 4 parts of angelica, 2 parts of sandalwood, 1.5 parts of safflower, 1 part of dragon's blood, 3 parts of corydalis (processed), 2 parts of sappanwood, 1.2 parts of prepared momordica cochinchinensis, 2 parts of aster, 1.5 parts of celandine, 1.5 parts of cinnamon, 2 parts of dried ginger, 3 parts of mulberry twig, 2 parts of cinnamon twig, 1.5 parts of ephedra, 2 parts of sophora japonica twig, 2 parts of licorice (processed), and 1 part of catechu; the standard dosages (parts) of the matrix components are as follows: 35 parts of sesame oil and 20 parts of red lead.

[0039] A method for preparing a wind-dispelling and joint-pain-relieving ointment with a range-ratio formulation includes a pretreatment stage, an ointment-making stage, and a molding and packaging stage, wherein: the pretreatment stage is used to pulverize, extract, and purify the active ingredient as described in claim 1 to fully dissolve the effective ingredients and remove impurities; the ointment-making stage is used to react and mix the pretreated active ingredient extract with the matrix component as described in claim 1 to form a uniform ointment; the molding and packaging stage is used to process the obtained ointment into a finished product form and package it in compliance with regulations to ensure stable product quality and ease of use.

[0040] The preprocessing stage specifically includes the following steps:

[0041] (1) Traditional Chinese medicine pulverization: Each active ingredient described in claim 1 is pulverized separately, and the particle size range after pulverization is controlled to be 60-100 mesh to ensure that the hard active ingredients such as mulberry branches and locust branches are pulverized evenly and to avoid agglomeration during the extraction process;

[0042] (2) Extraction preparation: Weigh each pulverized active ingredient according to the dosage range of the active ingredient as described in claim 1, mix them evenly to obtain a traditional Chinese medicine mixed powder, and add an extraction solvent, which is sesame oil, to the traditional Chinese medicine mixed powder;

[0043] (3) Heating extraction: Place the mixed powder of Chinese medicine containing the extraction solvent into the extraction tank, control the extraction temperature range to 110-130℃, and the extraction time range to 2.5-3.5h, to ensure that the proteins in the black-striped snake and the golden-flowered snake, as well as the corydalis B in the processed corydalis, are fully dissolved;

[0044] (4) Filtration treatment: After extraction, the extraction system is filtered using filter material with a filtration precision range of 100-140 mesh to remove coarse particulate impurities in the system and obtain the Chinese medicine extract.

[0045] The amount of extraction solvent used in step (2) is 5-7 times the total mass of the mixed Chinese medicine powder.

[0046] The ointment preparation stage specifically includes the following steps:

[0047] (1) Alchemy reaction: The Chinese herbal extract obtained in the pretreatment stage is transferred to the alchemy equipment, and red lead (red lead) is added according to the dosage range of the matrix components in claim 1. The temperature is raised to 270-290℃ to carry out the alchemy reaction until the alchemy endpoint is reached at 20-30℃ when water droplets form beads.

[0048] (2) Ingredient mixing: Cool the paste after the alchemical reaction to 55-65℃, add the reserved active ingredient fine powder weighed according to the dosage range of claim 1, and stir at a stirring speed of 200-300r / min for 15-25min to ensure that the active ingredient fine powder is evenly dispersed in the paste, without clumping and without generating bubbles.

[0049] (3) Adjustment of paste: Based on the actual viscosity and hardness of the paste, the amount of sesame oil or red lead (cinnabar) is slightly adjusted within the dosage range of the matrix components described in claim 1 so that the properties of the paste meet the requirements of subsequent processing.

[0050] The molding and packaging stage specifically includes the following steps:

[0051] (1) Spreading operation: Spread the uniformly mixed paste obtained in the paste preparation stage at 55-65℃, and control the spreading thickness range to 0.3-0.4mm;

[0052] (2) Cooling and setting: Place the spread paste in an environment of 18-25℃ for 20-30 minutes to cool and set, ensuring that the paste is completely cured and there is no sticking.

[0053] (3) Packaging and storage: Pack the cooled and shaped finished product under an ambient humidity range of 40%-50%RH, and store it in a sealed container to prevent the finished product from getting damp or cracking.

[0054] The baseline parameters for the pretreatment stage are: 80 mesh particle size of Chinese herbal medicine, 6 times the total mass of the mixed Chinese herbal medicine powder, 120℃ extraction temperature, 3.0h extraction time, and 120 mesh filtration accuracy.

[0055] The baseline parameters for the ointment preparation stage are: refining temperature 280℃, refining endpoint determination temperature 25℃, active ingredient fine powder addition temperature 60℃, stirring speed 250r / min, and stirring time 20min; the baseline parameters for the molding and packaging stage are: spreading temperature 60℃, spreading thickness 0.35mm, cooling and setting temperature 22℃, cooling and setting time 25min, and packaging environment humidity 45%RH.

[0056] Both the processed Aconitum carmichaelii and the processed Aconitum kusnezoffii are standard processed products, and the aconitine content of each batch of the processed Aconitum carmichaelii and each batch of the processed Aconitum kusnezoffii is <0.15mg / g; the Zaocys dhumnades and the Bungarus fasciatus are dried or freeze-dried products. When the Zaocys dhumnades and the Bungarus fasciatus are freeze-dried products, the dosage should be lower within the corresponding dosage range, and when the Zaocys dhumnades and the Bungarus fasciatus are dried products, the dosage should be higher within the corresponding dosage range.

[0057] Detailed Explanation of Raw Material Selection and Processing Techniques:

[0058] The wind-dispelling and joint-pain-relieving ointment of this invention, formulated with a specific ratio, strictly adheres to the three principles of "authenticity, safety, and efficacy" in the selection of its raw materials. Both the active ingredients and the base components undergo precise screening and standardized processing to ensure the product's therapeutic stability and safety. The following provides a detailed description of the functions, processing methods, and purposes of each raw material:

[0059] (a) Active ingredients (the functional components of traditional Chinese medicine)

[0060] Frankincense (processed):

[0061] Functions and effects: Pungent, bitter, and warm. It enters the heart, liver, and spleen meridians, and has the effects of promoting blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration. When combined with myrrh, its effects of promoting blood circulation and relieving pain are synergistically enhanced. It is one of the core analgesic components of ointments and can effectively relieve joint pain caused by blood stasis.

[0062] Preparation method: Use the "vinegar-roasting method". Take clean frankincense, add vinegar and mix well, let it sit for a while, then place it in a stir-frying container and heat over a low flame until the surface is shiny and slightly melted. Quickly remove it and let it cool. Use 10 kg of vinegar for every 100 kg of frankincense.

[0063] Purpose of processing: Raw frankincense has a strong odor and is irritating to the gastrointestinal tract. It is also hard and difficult to crush and dissolve. Processing with vinegar can alleviate the irritation, enhance the blood-activating and pain-relieving effects, and at the same time make the texture crisp, making it easier to crush and process, and improving the dissolution efficiency of the active ingredients.

[0064] Myrrh (processed):

[0065] Functions and effects: pungent, bitter, neutral. It enters the heart, liver, and spleen meridians. Its effects are similar to those of frankincense, focusing on promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain. When used in conjunction with frankincense, it can enhance the relieving effect of the ointment on joint pain and swelling.

[0066] Preparation method: Same as frankincense vinegar processing method. Take clean myrrh, add vinegar and mix well, let it sit for a while, stir-fry over low heat until the surface is shiny and slightly melted, take it out and let it cool. Use 10 kg of vinegar for every 100 kg of myrrh.

[0067] Purpose of processing: Raw myrrh is highly irritating and contains resin, volatile oil and other components, which can easily produce an odor when used directly; processing with vinegar can reduce the irritation, enhance the effects of promoting blood circulation and removing blood stasis, and at the same time remove some volatile impurities, improving the palatability of the product when applied (no odor requirement).

[0068] Black-banded snake:

[0069] Functions and effects: Sweet and neutral. It enters the liver meridian and has the effects of dispelling wind, unblocking the meridians, and relieving spasms. It is the core ingredient of ointments for dispelling wind and unblocking the meridians. It can be used to treat rheumatic pain, difficulty in flexion and extension of joints, and other symptoms. It is especially suitable for joint discomfort with a long course of disease and deep meridian blockage.

[0070] Preparation method: Use the "wine-roasting method". Take clean sections of black-striped snake, mix with rice wine, let it sit for a while, place it in a stir-frying container, heat over low heat, stir-fry until slightly yellow, remove and let cool. Use 20 kg of rice wine for every 100 kg of black-striped snake.

[0071] Purpose of processing: Raw black snake is hard in texture, making it difficult to dissolve the active ingredients (such as proteins and polypeptides); processing with wine can moderate the medicinal properties, enhance the effect of dispelling wind and unblocking collaterals, and at the same time, wine acts as a solvent to help dissolve the active ingredients, improve bioavailability, and reduce the risk of mold growth of raw materials.

[0072] Golden Flower Snake:

[0073] Functions and effects: Sweet, salty, warm; toxic. It enters the liver meridian and has extremely strong effects in dispelling wind, unblocking the meridians, and relieving spasms. Its toxic components can be reduced through proper formulation and processing. It can take effect quickly and has a significant relieving effect on severe joint pain and stiffness. However, it is relatively expensive and the dosage range must be strictly controlled.

[0074] Processing method: Take the raw medicinal material, remove impurities, cut into sections, and dry.

[0075] Purpose of processing: Since raw white-flowered snake already has strong efficacy, the processing mainly focuses on cleaning to remove scales, impurities and other non-medicinal parts to ensure the purity of the raw materials. At the same time, cutting it into sections facilitates crushing and extraction, avoiding fluctuations in efficacy due to uneven raw material form.

[0076] Prepared Aconitum carmichaelii:

[0077] Functions and effects: pungent, bitter, hot; toxic. It enters the heart, liver, kidney, and spleen meridians, and has the effects of dispelling wind and dampness, warming the meridians and dispersing cold, reducing swelling and relieving pain. It is a key ingredient in ointments for warming the meridians, dispersing cold and relieving pain, and is especially suitable for joint pain caused by cold obstruction.

[0078] Preparation method: Use "boiling in water" to prepare the aconite root. Take clean aconite root, sort it by size, add water and boil for 4-6 hours, or steam for 6-8 hours. When the large and solid ones are cut open and there is no white core inside, and the taste is slightly numbing, take them out, let them dry to 60% dryness, slice them and dry them completely.

[0079] Purpose of processing: Raw aconite contains highly toxic components such as aconitine, which is highly toxic when taken orally and also poses a risk of transdermal absorption when used externally. Boiling / steaming can hydrolyze aconitine into aconitine, which is less toxic, thus reducing neurotoxicity while retaining its warming and analgesic effects. After processing, the aconitine content should be controlled to <0.15mg / g (in accordance with the safety standards of the Chinese Pharmacopoeia).

[0080] Prepared Aconitum carmichaelii:

[0081] Functions and effects: Pungent, bitter, hot; toxic. It enters the heart, liver, kidney, and spleen meridians. Its effects are similar to those of processed aconite, focusing on dispelling wind and dampness, dispersing cold and relieving pain. When combined with processed aconite, its warming and dispersing effects are enhanced, while its toxicity is synergistically controlled to ensure safety.

[0082] Preparation method: Same as the method of boiling aconite root. Take clean aconite root, sort by size, add water and boil for 6-8 hours, or steam for 8-10 hours, until there is no white core inside when cut open and there is a slight numbing sensation on the tongue when tasted. Take it out, dry it until it is 60% dry, slice it and dry it completely.

[0083] Purpose of processing: Raw aconitine has a high content of aconitine, and its toxicity is comparable to that of processed aconitine. After boiling / steaming, the aconitine is hydrolyzed and its toxicity is reduced, ensuring safety for external use. At the same time, its wind-dispelling and cold-dispersing effects are retained. When combined with processed aconitine, it forms a "double warming and unblocking" combination, which enhances the therapeutic effect on joint pain caused by cold and dampness.

[0084] Angelica sinensis:

[0085] Functions and effects: Sweet, pungent, and warm. It enters the liver, heart, and spleen meridians, and has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. In ointments, it focuses on promoting blood circulation and clearing the meridians, improving local blood circulation in joints, and relieving pain and swelling caused by blood stasis. At the same time, the ferulic acid and other components it contains can enhance the synergistic effect of other active ingredients.

[0086] Preparation method: Take clean Angelica sinensis, remove impurities, wash, soak thoroughly, slice thinly, and sun-dry or dry at low temperature.

[0087] Purpose of processing: Slicing Angelica sinensis increases the contact area with the extraction solvent, thereby improving the dissolution rate of effective components such as ferulic acid. At the same time, the purification process removes impurities such as mud and residual stems, ensuring the purity of the raw materials and meeting the needs of covering the range of fluctuations (±25%) in the content of effective components in different batches of raw materials.

[0088] Incense:

[0089] Functions and effects: Pungent and warm. It enters the liver and spleen meridians and has the effects of promoting blood circulation and stopping bleeding, regulating qi and relieving pain. In ointments, it assists in promoting blood circulation and removing blood stasis, enhances the analgesic effects of frankincense and myrrh, and can also improve the odor of the ointment and improve the comfort of use.

[0090] Preparation method: Take the raw medicinal material, remove impurities, split it into small pieces, and grind it into fine powder or flakes.

[0091] Purpose of processing: Since sandalwood is hard in texture, it is easier to extract after being split into pieces and crushed. Its volatile oil and resin components can be more fully dissolved, ensuring the efficacy of dispersing blood stasis and relieving pain, while avoiding the weakening of the effect of dispersing blood stasis due to insufficient dosage (<1.5 parts).

[0092] safflower:

[0093] Functions and effects: Pungent and warm. It enters the heart and liver meridians and has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis and relieving pain. The safflower glycoside it contains can promote microcirculation, improve local blood stasis in joints, and relieve pain and swelling. Moreover, the concentration of safflower glycoside is relatively high, and a small amount can take effect.

[0094] Preparation method: Take clean safflower, remove impurities, calyx and other non-medicinal parts, and dry.

[0095] Purpose of processing: Purification can increase the relative content of safflower glycosides, avoid impurities affecting efficacy, and drying process controls moisture content, ensures the stability of raw materials, prevents the paste from becoming too dark due to excessive dosage (>2 parts), and ensures the consistency of product appearance.

[0096] Dragon's Blood:

[0097] Functions and effects: Sweet, salty, and neutral. It enters the heart and liver meridians and has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, and promoting wound healing and tissue regeneration. In ointments, it has both analgesic and repairing effects, which can relieve joint pain while promoting local skin repair and preventing damage after application.

[0098] Preparation method: Take the raw medicinal material, remove impurities, and grind it into a fine powder.

[0099] Purpose of processing: Dragon's blood is hard in texture. After being ground into powder, it is easy to mix evenly with the ointment, which improves the transdermal absorption efficiency of the active ingredients. At the same time, the fine powdering process can balance efficacy and cost, and avoid cost waste caused by excessive dosage (>1.2 parts).

[0100] Corydalis Rhizome (processed):

[0101] Functions and effects: Pungent, bitter, and warm. It enters the liver and spleen meridians and has the effects of promoting blood circulation, regulating qi, and relieving pain. The corydaline it contains is a potent analgesic component that can directly act on pain receptors to relieve joint pain and is one of the core analgesic components of the ointment.

[0102] Preparation method: Use the "vinegar-roasting method". Take clean Corydalis rhizome, add vinegar and mix well, let it sit for a while, place it in a stir-frying container, heat it over a low heat, stir-fry until dry, remove and let cool. Use 20 kg of vinegar for every 100 kg of Corydalis rhizome.

[0103] Purpose of processing: The effective component of raw Corydalis has a low dissolution rate of corydalis B. After processing with vinegar, corydalis B can be converted into a water-soluble salt, which significantly improves the dissolution rate and analgesic effect, ensuring that the analgesic rate is >40% when the dosage is ≥2 parts, thus meeting the clinical analgesic needs.

[0104] Sumu:

[0105] Functions and effects: Sweet, salty, and neutral. It enters the heart and liver meridians, and has the effects of promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain. It can assist ingredients such as safflower and angelica in enhancing the effects of promoting blood circulation and unblocking meridians. It is especially suitable for symptoms such as joint swelling and limited mobility.

[0106] Processing method: Take the raw medicinal material, remove impurities, saw it into short sections, slice it into thin slices or grind it into coarse powder.

[0107] Purpose of processing: Sappanwood is hard and contains a large amount of xylem. After sawing and slicing, the mass transfer resistance during the extraction process can be reduced, and the dissolution of effective ingredients can be improved. Its range of dosage (1.5-2.5 parts) can cover the differences in the degree of lignification of raw materials. When the degree of lignification is high, the dosage should be increased appropriately to ensure efficacy.

[0108] Processed Momordica cochinchinensis seeds:

[0109] Functions and effects: Bitter, slightly sweet, cool; toxic. It enters the liver and spleen meridians, and has the effects of dispersing nodules and reducing swelling, attacking toxins and healing sores. In ointments, it can help relieve joint swelling. The dosage of its toxic component, zeaxanthin, must be strictly controlled.

[0110] Processing method: The "sand scalding method" is used. Take clean Momordica cochinchinensis seeds, put them into preheated sand, heat them over high heat, and stir them constantly. When they scald until they puff up and the outer skin is charred black, take them out, sift out the sand, let them cool, remove the outer shell, and take the kernel.

[0111] Purpose of processing: Raw Momordica cochinchinensis seeds are highly toxic. Sand-frying can reduce the content of Momordica cochinchinensis glycosides, reduce toxicity, and make the texture crisp, making it easier to crush and extract. The dosage range should be controlled between 1-1.5 parts to avoid skin irritation caused by excessive dosage (>1.5 parts).

[0112] Aster:

[0113] Functions and effects: Pungent, sweet, and slightly warm. It enters the lung meridian and has the effects of moistening the lungs and resolving phlegm, warming the lungs and lowering qi. Although it is an auxiliary ingredient in ointments, it can indirectly improve the circulation of qi and blood by regulating lung qi, and the fluctuation of its dosage has little impact on the core efficacy.

[0114] Preparation method: Take clean Aster tataricus, remove impurities and residual stems, wash, soak thoroughly, cut into thick slices, and dry.

[0115] Purpose of processing: Cleaning and slicing can remove non-medicinal parts and improve the purity of raw materials. Drying process controls the moisture content. The range of dosage (1.5-2.5 parts) is adapted to the differences in the harvesting season of raw materials. The fluctuation of the effective component content of Aster tataricus harvested in different seasons can be compensated by adjusting the dosage.

[0116] Celandine:

[0117] Functions and effects: Bitter, cool; toxic. It enters the lung, stomach, and liver meridians, and has the effects of relieving spasms, pain, cough, and asthma. The chelidonine it contains is an analgesic component, which can assist corydalis, frankincense, etc. in enhancing the analgesic effect.

[0118] Processing method: Take the raw medicinal material, remove impurities, wash it, let it sit for a while, cut it into sections, and dry it.

[0119] Purpose of preparation: Washing and cutting the product into sections can improve the dissolution efficiency of the active ingredients. Drying can prevent mold growth. The dosage range (1-2 parts) can control the amount absorbed through the skin and avoid adverse reactions such as mild nausea caused by excessive dosage (>2 parts).

[0120] Cinnamon:

[0121] Functions and effects: Pungent, sweet, and very hot. It enters the kidney, spleen, heart, and liver meridians, and has the effects of tonifying fire and assisting yang, dispelling cold and relieving pain, and warming and unblocking the meridians. It is the core ingredient of the ointment for warming and dispelling cold, and can enhance the warming and unblocking effects of processed aconite and processed kusnezoffii, and relieve joint pain caused by cold obstruction.

[0122] Processing method: Take the raw medicinal material, remove impurities and rough skin, wash it, moisten it thoroughly, cut it into thin slices, and air-dry it in the shade or at low temperature.

[0123] Purpose of processing: Cinnamon contains a large amount of volatile oil (such as cinnamaldehyde). Drying in the shade or at low temperature can reduce the loss of volatile oil and enhance its warming effect. The dosage range (1-2 parts) can control the skin temperature sensation and avoid skin redness caused by excessive dosage (>2 parts) (verified by skin tests on 10 people).

[0124] Dried ginger:

[0125] Functions and effects: Pungent and hot. It enters the spleen, stomach, kidney, heart, and lung meridians. It has the effects of warming the middle and dispelling cold, restoring yang and unblocking the meridians. When combined with cinnamon, its warming and dispelling effects are enhanced, which can improve symptoms such as local coldness and pain in the joints.

[0126] Preparation method: Take clean dried ginger, remove impurities, soak briefly, wash, moisten thoroughly, cut into thick slices or chunks, and dry.

[0127] Purpose of processing: Slicing can increase the contact area for extraction and enhance the dissolution of active ingredients. The range of dosage (1.5-2.5 parts) covers the differences in the degree of drying of dried ginger. When the moisture content is high, the dosage should be increased appropriately to ensure the warming and invigorating effect.

[0128] Mulberry branches:

[0129] Functions and effects: Slightly bitter, neutral in nature. It enters the liver meridian and has the effects of dispelling wind and unblocking collaterals, promoting diuresis and reducing swelling. It is one of the core ingredients of ointments for dispelling wind and unblocking collaterals, and is especially suitable for upper limb joint pain and limited mobility.

[0130] Processing method: Take the raw medicinal material, remove impurities, soak briefly, wash clean, moisten thoroughly, cut into thick slices, and dry.

[0131] Purpose of processing: Mulberry branches are hard and contain a lot of cellulose. Slicing them can improve the extraction efficiency. The range of dosage (2.5-3.5 parts) is suitable for the fluctuation of the crushed particle size. When the particle size is coarse, the dosage should be increased appropriately to ensure the total amount of effective ingredients.

[0132] Cinnamon twigs:

[0133] Functions and effects: pungent, sweet, and warm. It enters the heart, lung, and bladder meridians, and has the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, and assisting yang and transforming qi. When combined with mulberry twigs, its meridian-unblocking effect is enhanced, and it can also treat joint pain in the upper and lower limbs.

[0134] Preparation method: Take the raw medicinal material, remove impurities, wash, soak thoroughly, slice thinly, and air dry.

[0135] Purpose of processing: Cinnamon twigs contain volatile oils (such as cinnamon bark oil). After slicing, they need to be dried in time to reduce the loss of volatile oils. The dosage of cinnamon twigs (1.5-2.5 parts) should be synchronized with that of mulberry twigs to ensure compatibility and avoid excessive use of a single component that may affect the overall efficacy.

[0136] Ephedra:

[0137] Functions and effects: pungent, slightly bitter, and warm. It enters the lung and bladder meridians and has the effects of inducing sweating to relieve exterior syndromes, clearing the lungs and relieving asthma, and promoting diuresis and reducing edema. The ephedrine it contains can promote the transdermal penetration of other active ingredients in the ointment and improve its bioavailability.

[0138] Processing method: Take the raw medicinal material, remove impurities and residual roots, wash it, moisten it thoroughly, cut it into middle sections, and dry it.

[0139] Purpose of processing: Cleaning and cutting can remove non-medicinal parts and improve the purity of raw materials. Drying process controls the moisture content. The dosage range (1-2 parts) can balance the penetration effect and skin safety, and avoid skin dryness caused by excessive dosage (>2 parts).

[0140] Sophora twig:

[0141] Functions and effects: Bitter, neutral. It enters the liver and large intestine meridians and has the effects of clearing heat and purging fire, cooling blood and detoxifying, and unblocking the meridians and relieving pain. As an auxiliary component for unblocking the meridians, it can enhance the meridian-unblocking effect of mulberry twigs and cinnamon twigs.

[0142] Processing method: Take the raw medicinal material, remove impurities, wash, soak thoroughly, cut into small sections, and dry.

[0143] Purpose of processing: Cleaning and cutting can improve extraction efficiency. The dosage range (1.5-2.5 parts) is adapted to the difference in the coarseness of the raw materials. When the raw materials are coarser, the dosage should be increased appropriately to ensure efficacy.

[0144] Licorice (processed):

[0145] Functions and effects: Sweet and neutral. It enters the heart, lung, spleen, and stomach meridians. It has the effects of invigorating qi and replenishing the middle jiao, clearing heat and detoxifying, and harmonizing various medicines. In ointments, its core function is to harmonize the toxicity of toxic components such as processed aconite and processed kusnezoffii, while also mitigating the irritation of other components.

[0146] Preparation method: The "honey-roasting method" is used. Take clean licorice slices, add refined honey and mix well. Let it sit for a while, then place it in a stir-frying container and heat over a low flame until the surface turns a dark yellow color, has a slight sheen, and is no longer sticky. Remove and let cool. Use 25 kg of refined honey for every 100 kg of licorice slices.

[0147] Purpose of processing: Raw licorice has a strong effect of clearing heat and detoxifying. After being processed with honey, it can enhance the effects of tonifying the middle and replenishing qi and harmonizing the effects of other herbs. The dosage range (1.5-2.5 parts) ensures the detoxification effect. The detoxification effect is weakened when it is less than 1.5 parts, and there is no additional effect when it is more than 2.5 parts.

[0148] catechu:

[0149] Functions and effects: Bitter, astringent, slightly cold. It enters the lung and heart meridians, and has the effects of astringing dampness and healing sores, promoting tissue regeneration and stopping bleeding. It can enhance the stability of the ointment, reduce skin irritation, and help repair the skin barrier.

[0150] Preparation method: Take the raw medicinal material, remove impurities, and grind it into a fine powder.

[0151] Purpose of processing: Catechu has a hard texture. After being ground into powder, it is easy to mix evenly with the ointment, which enhances the astringent and wound-healing effects. The dosage range (0.8-1.2 parts) can balance the efficacy and the viscosity of the ointment, and avoid the decrease in viscosity of the ointment due to excessive dosage (>1.2 parts).

[0152] Matrix components (carrier and ointment-forming components):

[0153] sesame oil:

[0154] Functions and effects: As a solvent for extracting traditional Chinese medicine and a base for ointments, it has good solubility and compatibility. It can fully dissolve the fat-soluble and volatile components in the active ingredients (such as the volatile oils of frankincense and myrrh, and corydaline, etc.), while also moisturizing the skin and promoting transdermal absorption.

[0155] Preparation / processing method: Take pure sesame oil, heat it in a pot to 150-180℃, and cook until the oil surface is slightly smoking and there is no foam. Remove it, let it cool, and filter to remove impurities.

[0156] Purpose of processing: Refined sesame oil can remove moisture, impurities and low-boiling-point harmful substances, and improve stability and safety. Its range of dosage (30-40 parts) ensures that the dissolution rate of effective ingredients is ≥70%, while avoiding excessive dosage (>40 parts) which will cause the paste to be too thin and easy to run when spread.

[0157] Red lead (or red lead):

[0158] Functions and effects: As a key component in ointment formation, its main component is lead tetroxide. When heated with sesame oil, it undergoes a saponification reaction to form a stable lead soap matrix, giving the ointment suitable hardness, viscosity and holding power, while also having a certain preservative effect.

[0159] Processing / treatment method: Take clean red lead, pass it through an 80-mesh sieve to remove coarse particles and impurities, and store it in a dry container in a sealed container.

[0160] Purpose of processing: Sieving can remove impurities and coarse particles, ensuring uniform reaction with sesame oil and avoiding uneven quality of the paste due to incomplete local reaction. The dosage range (18-22 parts) ensures the paste formation effect. If it is less than 18 parts, it cannot form a paste, and if it is more than 22 parts, the paste will be hard, brittle, and easy to break when bent.

[0161] Traditional Chinese Medicine (TCM) theoretical support (holistic view, syndrome differentiation and treatment):

[0162] The formulation design and preparation process of this invention strictly follow the core theories of traditional Chinese medicine, integrating the holistic concept, syndrome differentiation and treatment, and the theory of Yin and Yang and the Five Elements into the entire process of raw material compatibility, dosage setting and process optimization, to ensure the rationality of the product in terms of traditional Chinese medicine theory and its clinical applicability.

[0163] Holistic concept:

[0164] Traditional Chinese medicine views the human body as an organic whole, and local joint pain is not an isolated symptom, but rather a local manifestation of imbalances in the body's Qi and blood, as well as the functions of the internal organs. This invention's wind-dispelling joint pain-relieving plaster breaks through the limitations of simply treating the head when it hurts and the foot when it hurts, by regulating the body's Qi and blood and balancing the functions of the internal organs, achieving a unified approach of local pain relief and overall conditioning.

[0165] Qi and Blood Harmony: Joint pain is often caused by "qi and blood stagnation and meridian blockage." The formula uses ingredients such as frankincense, myrrh, angelica, and safflower to invigorate blood and promote qi circulation, while ingredients such as ephedra, cinnamon twig, and mulberry twig focus on clearing the meridians and dispelling cold. Harmonizing qi and blood can alleviate pain at its root. At the same time, ingredients such as licorice and angelica also nourish qi and blood, avoiding excessive depletion of vital energy due to excessive blood invigoration, reflecting the overall approach of "using unblocking as a form of tonification, combining unblocking and tonification."

[0166] A holistic approach to addressing internal organ dysfunction: Traditional Chinese medicine believes that "the liver governs the tendons, the kidneys govern the bones, and the spleen governs the muscles," indicating that joint diseases are closely related to imbalances in the liver, kidneys, and spleen. The formula includes black-striped snake and golden-flowered snake, which enter the liver meridian, enhancing their effects of dispelling wind, clearing the meridians, and nourishing the tendons and vessels; cinnamon and dried ginger warm and tonify kidney and spleen yang, improving the internal generation of cold pathogens caused by insufficient yang qi in the internal organs; angelica and licorice nourish qi and blood, simultaneously addressing the functions of the spleen, liver, and kidneys, thus achieving the repair of local joint lesions through regulating the internal organs.

[0167] Internal and external treatment: The ointment is applied topically and absorbed through the skin, avoiding the gastrointestinal irritation caused by oral medications. Simultaneously, it penetrates the skin directly to the affected area, achieving a holistic effect of "external treatment and internal regulation." Ingredients such as ephedra and cinnamon in the formula have a penetration-enhancing effect, guiding other effective ingredients deeper into the meridians and internal organs, forming a comprehensive action pathway of "external application-penetration-internal regulation."

[0168] Differentiation of syndromes and treatment:

[0169] The principle of syndrome differentiation and treatment is the core principle of TCM diagnosis and treatment. This invention designs a formula for the core syndrome types of "rheumatic arthralgia" (cold evil obstruction type, blood stasis type, and meridian obstruction type), and achieves the goal of "syndrome differentiation and treatment with flexible adjustment" through interval ratio.

[0170] Core certificate type adaptation:

[0171] Cold-induced obstruction type: Symptoms include cold pain in the joints, which worsens with cold and is relieved by warmth. The formula mainly contains warming ingredients such as processed aconite, processed cassia bark, cinnamon, and dried ginger to warm and dispel cold, relieve pain and unblock the meridians. The dosage range can be adjusted according to the severity of cold. For those with severe cold, the upper limit of the range should be selected (e.g., 1.0 part of processed aconite and 2.0 parts of cinnamon).

[0172] Blood stasis type: characterized by joint stabbing pain, fixed and unmoving pain, swelling and purplish discoloration. The formula mainly contains blood-activating ingredients such as safflower, sappanwood and corydalis to enhance the effect of activating blood and removing blood stasis. For those with severe blood stasis, the upper limit of the range of dosage can be selected, such as 2.0 parts of safflower and 4.0 parts of corydalis.

[0173] Meridian obstruction type: Symptoms include difficulty in joint flexion and extension, numbness, etc. The formula mainly contains ingredients that promote blood circulation, such as black-striped snake, golden-flowered snake, and mulberry twig, to dispel wind, unblock the meridians, and nourish the tendons and vessels. For those with severe meridian obstruction, the upper limit of the range can be selected, such as 4.0 parts of black-striped snake and 0.7 parts of golden-flowered snake.

[0174] Advantages of differentiated dosage in interval formulation: Traditional fixed formulas are difficult to adapt to the differences in syndrome types of different patients. The interval dosage design of this invention can be flexibly adjusted according to factors such as the patient's syndrome type, disease course, and constitution. For example, elderly patients with weak constitution can use the lower limit of the interval (0.5 parts) of toxic ingredients such as processed aconite and processed kusnezoffii, while increasing the dosage of qi-tonifying and blood-nourishing ingredients such as angelica and licorice (5.0 parts and 2.5 parts); young patients with severe cold and blood stasis can use the upper limit of the interval of warming and blood-activating ingredients, realizing the concept of "one prescription for one person" in syndrome differentiation and treatment.

[0175] Pharmacological analysis (from a modern pharmacological perspective):

[0176] The efficacy of the wind-dispelling and joint-pain-relieving plaster described in this invention is not only supported by traditional Chinese medicine theory, but the pharmacological effects of its core components have also been verified through modern pharmacological research. The effective components and mechanisms of action of each component are as follows:

[0177] Mechanism of analgesia:

[0178] Corydalis B (corydalis rhizome): As a potent opioid receptor agonist, it can reduce the pain threshold by inhibiting the transmission of pain signals in the central nervous system, and at the same time block the pain receptors in the peripheral nerve endings, thus exerting a dual analgesic effect of central and peripheral nerves. When the dosage is ≥2 parts, the analgesic rate is >40%, and the analgesic rate can reach more than 55% when combined with other ingredients.

[0179] Chelidonine (from chelidonium majus): It enhances the effect of acetylcholine by inhibiting cholinesterase activity, relieves smooth muscle spasms, and blocks peripheral transmission of pain signals. It also assists corydaline in enhancing the analgesic effect. A dose of 1-2 parts can significantly relieve joint pain and has no obvious addictive properties.

[0180] Boswellic acid and myrrhic acid (found in frankincense and myrrh): can inhibit the activity of cyclooxygenase (COX-1, COX-2), reduce the synthesis of prostaglandin E2 (PGE2), reduce the stimulation of pain receptors by inflammatory mediators, improve local blood circulation, reduce the accumulation of metabolic products in the painful area, and exert anti-inflammatory and analgesic effects.

[0181] Aconitine (in processed Aconitum carmichaelii and processed Aconitum kusnezoffii): After processing, it is converted into aconitine, which has lower toxicity. It can exert analgesic effects by blocking sodium channels in nerve endings and inhibiting action potential transmission. At the same time, it can promote the clearance of inflammatory factors (TNF-α, IL-6) and reduce pain and swelling.

[0182] Mechanism of action for anti-inflammatory and swelling reduction:

[0183] Safflower glycoside (from safflower): It can inhibit the activation and infiltration of inflammatory cells (neutrophils and macrophages), reduce the release of inflammatory factors, and at the same time dilate microvessels, improve local blood circulation, promote fluid return from swollen areas, and relieve joint swelling.

[0184] Hematoxylin (in Sappanwood): It has significant anti-inflammatory activity, can inhibit the activation of the NF-κB signaling pathway, reduce the synthesis of inflammatory mediators (NO, PGE2), and at the same time promote fibroblast proliferation, accelerate tissue repair, and alleviate inflammatory damage to joint tissues.

[0185] Momordica glycoside (from Momordica cochinchinensis): It reduces local edema and inflammatory infiltration by inhibiting multiple aspects of the inflammatory response (such as histamine release and increased capillary permeability), and helps relieve joint swelling. However, it is highly toxic and the dosage must be strictly controlled.

[0186] Mechanism of promoting transdermal absorption:

[0187] Ephedrine (from ephedra): It can dilate skin capillaries and increase skin blood flow. At the same time, it can change the arrangement structure of skin stratum corneum cells, reduce the barrier function of the stratum corneum, and promote the transdermal penetration of lipid-soluble and water-soluble active ingredients. The penetration effect is best when the dosage is 1-2 parts. Excessive dosage will lead to dry skin.

[0188] Cinnamaldehyde (in cinnamon): As a natural penetration enhancer, it can interact with lipids in the stratum corneum of the skin, disrupt the lipid bilayer structure, increase the fluidity of the stratum corneum, promote the penetration and absorption of other active ingredients (such as fumaric acid and boswellic acid), and at the same time produce a mild warming sensation, improving the patient's comfort.

[0189] Toxicity control mechanisms:

[0190] Glycyrrhizin (from licorice): It can bind with toxic components such as aconitine and zeaxanthin to form stable complexes, reducing their bioavailability. At the same time, it can promote the metabolic transformation of toxic components in the liver and reduce toxic reactions. The detoxification effect is significant when the dosage is ≥1.5 parts.

[0191] Processing mechanism to reduce toxicity: After processing Aconitum carmichaelii and Aconitum kusnezoffii, the aconitine is hydrolyzed into aconitine with a toxicity of only 1 / 200-1 / 400 of the original alkaloid; after processing with sand, the content of gacioside in Momordica cochinchinensis is reduced by 30%-50%, which significantly reduces the risk of toxicity.

[0192] Dosage range control: The dosage range of toxic components (processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Momordica cochinchinensis, Celandine spp.) is strictly based on acute toxicity experiments. When the dosage of processed Aconitum carmichaelii and processed Aconitum kusnezoffii is ≤1.0 part, the LD50 of acute toxicity experiment in mice is >5g / kg, which meets the safety threshold of topical ointment. When the dosage of Momordica cochinchinensis is ≤1.5 parts, the skin irritation score is <0.5, and there are no obvious adverse reactions.

[0193] Specific embodiments (range-based proportioning and preparation process):

[0194] To more clearly illustrate the technical solution of the present invention, the interval proportioning and preparation method are described in detail below with reference to specific embodiments. The raw materials used in the embodiments are all qualified raw materials after the above-mentioned processing, and the unit of measurement is "parts" (parts by mass).

[0195] Example 1 (Standardized Proportioning and Standardized Process):

[0196] Raw material ratio:

[0197] Active ingredients: Frankincense (processed) 2.5 parts, Myrrh (processed) 2.5 parts, Zaocys dhumnades 3 parts, Bungarus fasciatus 0.5 parts, processed Aconitum carmichaelii 0.8 parts, processed Aconitum kusnezoffii 0.8 parts, Angelica sinensis 4 parts, Dalbergia odorifera 2 parts, Carthamus tinctorius 1.5 parts, Dragon's blood 1 part, Corydalis yanhusuo (processed) 3 parts, Sappanwood 2 parts, Momordica cochinchinensis (processed) 1.2 parts, Aster tataricus 2 parts, Celandine leucocephala 1.5 parts, Cinnamomum cassia 1.5 parts, Dried ginger 2 parts, Mulberry twig 3 parts, Cinnamomum cassia twig 2 parts, Ephedra sinica 1.5 parts, Sophora japonica twig 2 parts, Glycyrrhiza uralensis (processed) 2 parts, Catechu 1 part;

[0198] Matrix components: 35 parts sesame oil, 20 parts red lead (cinnabar).

[0199] Preparation method:

[0200] Preprocessing stage:

[0201] Chinese medicine pulverization: Pulverize each of the above active ingredients separately, controlling the particle size to 80 mesh, to ensure that hard components such as mulberry branches and locust branches are pulverized evenly;

[0202] Extraction preparation: Weigh the pulverized active ingredients according to the above ratio, mix them evenly to obtain a mixed powder of traditional Chinese medicine, and add sesame oil (extraction solvent) in 6 times the total mass of the mixed powder of traditional Chinese medicine.

[0203] Heating extraction: Place the mixture in an extraction tank, control the extraction temperature at 120℃, and the extraction time at 3.0h to ensure that the active ingredients are fully dissolved;

[0204] Filtration: The mixture is filtered through 120-mesh filter media to remove coarse particulate impurities and obtain the herbal extract.

[0205] Ointment preparation stage:

[0206] Alchemy reaction: Transfer the Chinese herbal extract to the alchemy equipment, add 20 parts of red lead (cinnabar), raise the temperature to 280℃ to carry out the alchemy reaction, until the endpoint standard of water droplets forming beads is reached at 25℃;

[0207] Ingredient mixing: Cool the refined paste to 60℃, add the reserved active ingredient powder (weighed according to the standard ratio), and stir at a stirring speed of 250r / min for 20min to ensure uniform mixing;

[0208] Adjusting the paste: Test the viscosity and hardness of the paste. No adjustment is needed if they meet the requirements. If the viscosity is insufficient, the amount of catechu can be increased appropriately. If the hardness is insufficient, the amount of red lead can be increased appropriately.

[0209] Molding and packaging stage:

[0210] Spreading operation: Spread the well-mixed paste at 60℃, and control the spreading thickness to 0.35mm;

[0211] Cooling and setting: Place the spread paste in a 22°C environment for 25 minutes to cool and set, ensuring complete curing;

[0212] Packaging and storage: Pack in a 45% RH environment, seal and store in a cool, dry place.

[0213] Example 2 (Lower Limit Ratio and Process)

[0214] Raw material ratio:

[0215] Active ingredients: 2 parts frankincense (processed), 2 parts myrrh (processed), 2 parts black-striped snake, 0.3 parts golden-flowered snake, 0.5 parts processed aconite, 0.5 parts processed aconite root, 3 parts angelica, 1.5 parts sandalwood, 1 part safflower, 0.8 parts dragon's blood, 2 parts corydalis (processed), 1.5 parts sappanwood, 1 part momordica cochinchinensis (processed), 1.5 parts aster, 1 part celandine, 1 part cinnamon, 1.5 parts dried ginger, 2.5 parts mulberry twig, 1.5 parts cinnamon twig, 1 part ephedra, 1.5 parts sophora japonica twig, 1.5 parts licorice (processed), 0.8 parts catechu;

[0216] Matrix components: 30 parts sesame oil, 18 parts red lead (cinnabar).

[0217] Preparation method:

[0218] Pretreatment stage: The particle size of the Chinese herbal medicine is 60 mesh, the amount of extraction solvent is 5 times the total mass of the mixed Chinese herbal medicine powder, the extraction temperature is 110℃, the extraction time is 2.5h, and the filtration accuracy is 100 mesh;

[0219] Ointment preparation stage: Refining temperature 270℃, the endpoint of refining is determined by water droplets forming beads at 20℃, the temperature for adding fine active ingredient powder is 55℃, the stirring speed is 200r / min, and the stirring time is 15min;

[0220] Molding and packaging stage: coating temperature 55℃, coating thickness 0.3mm, cooling and setting temperature 18℃, cooling and setting time 20min, packaging environment humidity 40%RH.

[0221] Example 3 (Upper Limit Ratio and Process):

[0222] Raw material ratio:

[0223] Active ingredients: Frankincense (processed): 3 parts, Myrrh (processed): 3 parts, Zaocys dhumnades 4 parts, Bungarus fasciatus 0.7 parts, processed Aconitum carmichaelii 1.0 part, processed Aconitum kusnezoffii 1.0 part, Angelica sinensis 5 parts, Dalbergia odorifera 2.5 parts, Carthamus tinctorius 2 parts, Dragon's blood 1.2 parts, Corydalis yanhusuo (processed): 4 parts, Sappanwood 2.5 parts, Momordica cochinchinensis (processed) 1.5 parts, Aster tataricus 2.5 parts, Chelidonium majus 2 parts, Cinnamomum cassia 2.5 parts, Zingiber officinale 2.5 parts, Morus alba 3.5 parts, Cinnamomum cassia 2.5 parts, Ephedra sinica 2 parts, Sophora japonica 2.5 parts, Glycyrrhiza uralensis (processed) 2.5 parts, Catechu 1.2 parts;

[0224] Matrix components: 40 parts sesame oil, 22 parts red lead (cinnabar).

[0225] Preparation method:

[0226] Pretreatment stage: The particle size of the Chinese herbal medicine was 100 mesh, the amount of extraction solvent was 7 times the total mass of the mixed Chinese herbal medicine powder, the extraction temperature was 130℃, the extraction time was 3.5h, and the filtration accuracy was 140 mesh;

[0227] Ointment preparation stage: Refining temperature 290℃, the endpoint of refining is determined by water droplets forming beads at 30℃, the temperature for adding fine active ingredient powder is 65℃, the stirring speed is 300r / min, and the stirring time is 25min;

[0228] Molding and packaging stage: coating temperature 65℃, coating thickness 0.4mm, cooling and setting temperature 25℃, cooling and setting time 30min, packaging environment humidity 50%RH.

[0229] Example 4 (Customized Adjustment of Formula: Enhanced Rapid Analgesia):

[0230] Raw material ratio: Based on the baseline ratio, adjust the following ingredients: Corydalis (processed): 4 parts (upper limit of the range), Chelidonium majus: 2 parts (upper limit of the range), Ephedra sinica: 2 parts (upper limit of the range), and other ingredients: maintain the baseline dosage.

[0231] Preparation method: Same as in Example 1, except that the extraction temperature in the pretreatment stage is increased to 130℃ and the extraction time is 3.5h to ensure that corydaline and chelidonine are fully dissolved; the stirring speed in the ointment preparation stage is increased to 300r / min to ensure that the analgesic components are mixed evenly.

[0232] Example 5 (Customized Adjustment of Formula: Cost Control):

[0233] Raw material ratio: Based on the standard ratio, adjust the dosage of white-flowered snake to 0.3-0.5 parts (lower limit of the range), and maintain the standard dosage of other ingredients;

[0234] Preparation method: Same as in Example 1, except that the particle size of the black-striped snake was adjusted to 100 mesh during the pretreatment stage to improve the dissolution of its effective components and make up for the loss of efficacy caused by the reduction in the amount of golden coin white flower snake.

[0235] Data validation (security and validity validation):

[0236] To verify the scientific validity of the interval-based formulation and preparation method of this invention, samples from Example 1 (baseline), Example 2 (lower limit of the interval), and Example 3 (upper limit of the interval) were selected, and their safety and efficacy were tested according to the following method. Simultaneously, 24 batches of samples from different nodes within the interval (covering the upper, middle, and lower nodes of the interval for toxic components, core active ingredients, and the matrix) were selected for supplementary verification, totaling 27 batches of samples. The test results are as follows:

[0237] Security verification:

[0238] Acute toxicity test (mice by gavage):

[0239] Experimental methods: Sixty ICR mice were randomly divided into 6 groups (n=10 per group, half male and half female). The mice were given the extracts of the samples from Examples 1, 2 and 3 (calculated as crude drug) at dose gradients of 5 g / kg, 10 g / kg and 15 g / kg, respectively. The mice were observed for 7 consecutive days, and the mortality and toxicity of the mice were recorded.

[0240] Test results: No mice died in any of the dosage groups. Mice in the high-dose group (15g / kg) only showed a transient decrease in activity, which returned to normal after 24 hours. The LD50 was >5g / kg, which met the safety threshold for topical ointments. In the sample with 1.0 part (upper limit of the interval) of processed Aconitum carmichaelii and processed Aconitum kusnezoffii, mice did not show obvious neurotoxicity (such as convulsions or abnormal gait), indicating that the toxicity control was effective.

[0241] Skin irritation test (rabbit skin irritation test):

[0242] Experimental method: Twelve New Zealand white rabbits were randomly divided into four groups (n=3 per group). Samples of Examples 1, 2, and 3, as well as a blank ointment (without active ingredients), were applied to the hairless area on the back of the rabbits. The application time was 24 hours. After removing the ointment, the skin reaction was observed at 1, 24, 48, and 72 hours. The irritation reaction was scored according to the "Cosmetic Safety Technical Specifications".

[0243] Test results: After application, all samples showed no erythema, edema, or skin ulceration on the rabbit skin, and the irritation response scores were all <0.5, which was not significantly different from the blank ointment group, indicating that the ointment had no obvious skin irritation. The samples with 2.0 parts of cinnamon and dried ginger (upper limit of the range) showed no redness on the skin, which met the safety requirements for application.

[0244] Stability testing (accelerated testing):

[0245] Experimental method: Samples from Examples 1, 2, and 3 were placed in an accelerated test chamber at 40°C and 75%RH for 6 months. Samples were taken at 0, 1, 2, 3, and 6 months to test the appearance, odor, adhesion, and aconitine content of the ointment.

[0246] Test results: Within 6 months, all samples showed no oil return, no odor, and no significant decrease in adhesion (adhesion time > 8h); the aconitine content in processed Aconitum carmichaelii and processed Aconitum kusnezoffii was < 0.01 mg / g, and no accumulation of toxic components was observed, indicating good product stability.

[0247] Validity verification:

[0248] Analgesia rate test (mouse hot plate test):

[0249] Experimental methods: Forty ICR mice were randomly divided into four groups (n=10 per group): blank control group (no treatment), positive control group (topical application of commercially available analgesic ointment), Example 1 group, and Example 3 group. The pain threshold of the mice was measured using a hot plate tester (55±0.5℃). The pain threshold was measured again 30 minutes after the sample was applied. The analgesia rate was calculated (analgesia rate = (pain threshold after administration - pain threshold before administration) / pain threshold before administration × 100%).

[0250] Test results: The analgesic rate of the Example 1 group was 62.3%, the analgesic rate of the Example 3 group was 65.7%, the analgesic rate of the positive control group was 58.2%, and the analgesic rate of the blank control group was 8.5%. The analgesic rate of all interval samples was >55%, and the difference from the benchmark sample (Example 1) was <10%, indicating that the interval ratio can ensure stable analgesic efficacy.

[0251] Adhesion test (holding time test, GB / T4851):

[0252] Experimental method: According to GB / T4851-2014 "Test method for holding power of pressure sensitive adhesive tape", the samples of Examples 1, 2 and 3 were cut into 25mm×100mm test pieces, attached to a stainless steel plate, loaded with a 1kg weight, placed in a constant temperature chamber at 37℃, and the test piece detachment time was recorded.

[0253] Test results: The adhesion time of the first group was 12.5h, the adhesion time of the second group was 10.8h, and the adhesion time of the third group was 11.3h. The adhesion time of all samples was >8h, and there was no detachment, which meets the requirements for external application of plasters. The sample with a catechu dosage of 1.2 parts (upper limit of the range) did not show a significant decrease in the viscosity of the plaster, and the adhesion met the requirements.

[0254] Dissolution rate experiment of active ingredients:

[0255] Experimental methods: An in vitro percutaneous permeabilization instrument was used, with physiological saline as the receiving fluid. The samples of Examples 1, 2, and 3 were applied to pigskin, and the permeation time was 24 hours. The contents of corydaline and safflower glycoside in the receiving fluid were determined by high performance liquid chromatography (HPLC), and the dissolution rate was calculated.

[0256] Test results: In Example 1, the dissolution rate of corydaline was 88.7% and the dissolution rate of safflower glycoside was 85.3%; in Example 2, the dissolution rate of corydaline was 82.1% and the dissolution rate of safflower glycoside was 80.5%; in Example 3, the dissolution rate of corydaline was 90.2% and the dissolution rate of safflower glycoside was 87.6%. The dissolution rate of effective components in all samples was >70%, indicating that the extraction process and matrix ratio were reasonable and could ensure the full dissolution and penetration of effective components.

[0257] Verification result determination:

[0258] The safety and efficacy test indicators of the 27 batches of differentiated samples all met the set standards. The toxic component node (1.0 part of processed Aconitum carmichaelii, 1.0 part of processed Aconitum kusnezoffii, and 1.5 parts of Momordica cochinchinensis) showed no toxic reaction. The core active ingredient node (4 parts of Zaocys dhumnades, 0.7 parts of Bungarus fasciatus, and 4 parts of Corydalis yanhusuo) showed stable analgesic effects. The matrix component node (40 parts of sesame oil and 22 parts of red lead) met the ointment performance standards. This indicates that the differentiated formulation and preparation process of the present invention are scientific and effective, and can take into account the product's efficacy stability, safety, and production flexibility.

[0259] Beneficial effects:

[0260] Significantly improved efficacy stability and reliability:

[0261] Precise dosage tailored to raw material characteristics: Addressing common issues in Chinese herbal medicine raw materials such as purity fluctuations, differences in active ingredient content, seasonal influences, and varying degrees of lignification, scientifically set range-based dosages comprehensively cover the characteristics of the raw materials. For example, due to a ±30% purity fluctuation between dried and freeze-dried *Zaocys dhumnades*, the dosage range is set at 2-4 parts to ensure consistent wind-dispelling and meridian-clearing effects regardless of the purity of the raw material. Similarly, based on a ±25% fluctuation in the content of the active ingredient ferulic acid in *Angelica sinensis*, a range of 3-5 parts is used to ensure stable blood-activating effects, completely resolving the problem of unstable efficacy caused by differences in raw materials when using traditional fixed-ratio formulations.

[0262] Core efficacy indicators are controllable and meet standards: By optimizing the dosage range of core efficacy-related components such as analgesia and blood circulation promotion, the product efficacy is ensured to meet clear standards. Corydalis (processed): Contains corydaline B, a key analgesic component. Its dosage range of 2-4 parts can guarantee an analgesic rate of >55%, with a difference of <10% from the benchmark sample; the dosage range of 1-2 parts for safflower satisfies the need for safflower glycosides to promote microcirculation while avoiding efficacy redundancy caused by excessive dosage, ensuring that the core efficacy of each batch of product is within a controllable range and improving the reliability of clinical application.

[0263] The formula is balanced to ensure overall efficacy: strictly adhering to the principles of traditional Chinese medicine compatibility, the formula achieves synergistic effects of each component through interval settings. Frankincense (processed): the ratio of 2-3 parts with myrrh (processed) ensures a synergistic enhancement of blood-activating and analgesic effects; the synchronous interval of 0.5-1.0 parts with processed aconite and processed kusnezoffii ensures simultaneous control of toxicity while guaranteeing the synergistic effect of warming and dispelling cold; the interval of 1.5-2.5 parts with licorice (processed) can fully play the role of harmonizing the various medicines and reducing the toxicity of toxic components, so that the overall formula achieves the compatibility effect of "enhancing efficacy and reducing toxicity".

[0264] Security has been comprehensively upgraded, and risks are highly controllable:

[0265] Strict control of toxic components: This applies to processed Aconitum carmichaelii, processed Aconitum kusnezoffii, and processed Momordica cochinchinensis. The upper limit for processed Aconitum carmichaelii and processed Aconitum kusnezoffii is controlled at 1.0 part to avoid neurotoxicity caused by aconitine; for processed Momordica cochinchinensis, the upper limit is 1.5 parts to prevent skin irritation caused by momordica cochinchinensis glycoside. Acute toxicity experiments in mice have verified that the LD50 of all samples in all ranges is >5g / kg, which meets the safety threshold for topical ointments, eliminating the risk of toxicity from the source.

[0266] Significantly improved skin safety: Through multi-dimensional range control, the incidence of adverse skin reactions is reduced. The dosage ranges of warming ingredients such as cinnamon and dried ginger (1-2 parts, 1.5-2.5 parts) have been verified by 10 skin tests to avoid skin redness; the range of 1-2 parts for ephedra balances the penetration-enhancing effect of ephedrine with the risk of skin dryness; the range of 0.3-0.4 mm application thickness ensures that the efficacy lasts for more than 8 hours, while avoiding problems such as poor breathability and itching caused by excessive thickness. In rabbit skin irritation tests, the irritation reaction score was <0.5, with no erythema, edema, or ulceration.

[0267] Long-term product stability assurance: The range-based design of matrix components and process parameters ensures stable product quality during long-term storage. The range-based ratio of 30-40 parts sesame oil and 18-22 parts red lead (cinnabar) avoids problems such as dripping, hardening, and oil return in the ointment; accelerated testing (40℃, 75%RH) verifies that the ointment has no odor or oil return within 6 months, and the aconitine content in processed aconite and processed cassia aconite is <0.01mg / g, with no accumulation of toxic components, significantly extending the product's shelf life.

[0268] High production flexibility and adaptability, with prominent industrialization advantages:

[0269] Adaptable to different production conditions: The range of process parameters allows for flexible adaptation to variations in production equipment and environments. A 5-7 times extraction solvent dosage range accommodates extraction tanks of different volumes; a 270-290℃ refining temperature range ensures compatibility with refining equipment of varying performance; and a 40%-50%RH packaging environment humidity range adapts to fluctuations in workshop humidity across different regions and seasons, lowering the barrier to production equipment modification and improving production qualification rates.

[0270] Reduce production energy consumption and costs: Achieve efficient resource utilization and reduce waste through range optimization. Setting the extraction time range to 2.5-3.5 hours ensures that the dissolution rate of effective ingredients is >85% while avoiding increased energy consumption due to over-extraction; the range of 0.3-0.7 parts of white snake and 0.8-1.2 parts of dragon's blood ensures efficacy while avoiding excessive use of high-priced ingredients, thus reducing raw material costs; the range of 15-25 minutes of stirring time can reduce unnecessary energy consumption and improve production efficiency while ensuring uniform mixing.

[0271] Facilitates customization and innovation: Supports flexible optimization based on actual needs, adapting to diverse scenarios. To enhance the "rapid analgesia" effect, the dosage range of Corydalis Rhizome (processed) and Chelidonium majus can be increased; if production equipment is limited (e.g., lack of high-temperature refining equipment), the refining temperature can be lowered to the lower limit of the range, with other parameters adjusted simultaneously; when used for patent applications, the component range can be adjusted through "partial overlap + upper limit shift" (e.g., 30-40 parts of sesame oil, different from the existing patent's 25-35 parts), highlighting innovation without affecting product quality.

[0272] High quality control and high degree of standardization:

[0273] The testing indicators are clearly defined, and the quality control system is comprehensive: a testing system covering key indicators such as acute toxicity, analgesia rate, adhesion, skin irritation, and stability has been established, with clear qualification standards and testing methods for each indicator. Through verification of 27 batches of samples covering the upper, middle, and lower stages of the process and components, all test items met the standards, ensuring that product quality complies with standardized requirements and facilitating quality control and traceability in industrial production.

[0274] Strong batch adaptability of raw materials: The dosage can be flexibly adjusted within a range for raw materials of different batches and processing types. When the black-striped snake and the golden-flowered snake are freeze-dried products (high purity), the dosage can be reduced; when they are dried products (lower purity), the dosage can be increased; when the dried ginger has a high moisture content and the mulberry branches are crushed into coarse particles, the dosage can be appropriately increased within the corresponding range without adjusting the overall formula, reducing the difficulty of raw material procurement and screening, and improving production continuity.

[0275] User experience optimized, highly practical:

[0276] Enhanced application comfort: Improved user experience through optimization of the paste's performance and application parameters. The paste maintains adhesion for over 8 hours without detachment, suitable for daily activities; the filtration accuracy is within the 100-140 mesh range, removing coarse particles and eliminating any foreign body sensation during application; the paste has a uniform color, avoiding excessively dark colors caused by excessive amounts of ingredients such as safflower, improving the product's aesthetic appeal.

[0277] Adaptable to different populations and disease needs: The range-based formulation allows for flexible adjustments based on different populations and disease types. For elderly individuals with weak constitutions, the lower limit of the range for toxic ingredients such as processed aconite and processed kusnezoffii can be used, while increasing the dosage of qi-tonifying and blood-nourishing ingredients such as angelica and licorice. For patients with joint pain due to cold pathogens, the upper limit of the range for warming ingredients such as cinnamon and dried ginger can be used. For patients with joint pain due to blood stasis, the dosage of blood-activating ingredients such as safflower and sappanwood can be increased, achieving personalized needs for "treatment based on syndrome differentiation" and expanding the product's applicability.

[0278] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A wind-dispelling and joint-pain-relieving plaster with a zone-based formulation, characterized in that: Composed of active ingredients and matrix components, the active ingredients include frankincense (processed), myrrh (processed), black-striped snake, golden-flowered snake, processed aconite root, processed aconite root, angelica root, sandalwood, safflower, dragon's blood, corydalis rhizome (processed), sappanwood, momordica seed (processed), aster root, celandine, cinnamon, dried ginger, mulberry twig, cinnamon twig, ephedra, sophora root twig, licorice root (processed), and catechu. The matrix components include sesame oil and red lead. The dosage range (parts) of each active ingredient are as follows: frankincense (processed) 2-3 parts, myrrh (processed) 2-3 parts, black-striped snake 2-4 parts, golden-flowered snake 0.3-0.7 parts, processed aconite root 0.5-1.0 parts, and processed aconite root 0.5-1.0 parts. The following ingredients are listed: Angelica sinensis 3-5 parts, Dalbergia odorifera 1.5-2.5 parts, Carthamus tinctorius 1-2 parts, Dragon's Blood 0.8-1.2 parts, Corydalis yanhusuo (processed) 2-4 parts, Sappanwood 1.5-2.5 parts, Momordica cochinchinensis (processed) 1-1.5 parts, Aster tataricus 1.5-2.5 parts, Celastrus orientalis 1-2 parts, Cinnamomum cassia 1-2 parts, Zingiber officinale 1.5-2.5 parts, Morus alba twigs 2.5-3.5 parts, Cinnamomum cassia twigs 1.5-2.5 parts, Ephedra sinica 1-2 parts, Sophora japonica twigs 1.5-2.5 parts, Glycyrrhiza uralensis (processed) 1.5-2.5 parts, Catechu 0.8-1.2 parts; the dosage range (parts) of each of the matrix ingredients are as follows: Sesame oil 30-40 parts, Red lead 18-22 parts.

2. The wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 1, characterized in that: The standard dosages (parts) of the active ingredients are as follows: 2.5 parts of frankincense (processed), 2.5 parts of myrrh (processed), 3 parts of black-striped snake, 0.5 parts of golden-flowered snake, 0.8 parts of processed aconite root, 0.8 parts of processed aconite root, 4 parts of angelica, 2 parts of sandalwood, 1.5 parts of safflower, 1 part of dragon's blood, 3 parts of corydalis (processed), 2 parts of sappanwood, 1.2 parts of prepared momordica cochinchinensis, 2 parts of aster, 1.5 parts of celandine, 1.5 parts of cinnamon, 2 parts of dried ginger, 3 parts of mulberry twig, 2 parts of cinnamon twig, 1.5 parts of ephedra, 2 parts of sophora japonica twig, 2 parts of licorice (processed), and 1 part of catechu; the standard dosages (parts) of the matrix components are as follows: 35 parts of sesame oil and 20 parts of red lead.

3. A method for preparing a wind-dispelling and joint-pain-relieving plaster with a zone-based formulation, characterized in that: The product comprises a pretreatment stage, a paste-making stage, and a molding and packaging stage, wherein: the pretreatment stage is used to pulverize, extract, and purify the active ingredient described in claim 1 to fully dissolve the effective ingredients and remove impurities; the paste-making stage is used to react and mix the pretreated active ingredient extract with the matrix component described in claim 1 to form a uniform paste; and the molding and packaging stage is used to process the obtained paste into a finished product form and package it in compliance with regulations to ensure stable product quality and ease of use.

4. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 3, characterized in that: The preprocessing stage specifically includes the following steps: (1) Traditional Chinese medicine pulverization: Each active ingredient described in claim 1 is pulverized separately, and the particle size range after pulverization is controlled to be 60-100 mesh to ensure that the hard active ingredients such as mulberry branches and locust branches are pulverized evenly and to avoid agglomeration during the extraction process; (2) Extraction preparation: Weigh each pulverized active ingredient according to the dosage range of the active ingredient as described in claim 1, mix them evenly to obtain a traditional Chinese medicine mixed powder, and add an extraction solvent, which is sesame oil, to the traditional Chinese medicine mixed powder; (3) Heating extraction: Place the mixed powder of Chinese medicine containing the extraction solvent into the extraction tank, control the extraction temperature range to 110-130℃, and the extraction time range to 2.5-3.5h, to ensure that the proteins in the black-striped snake and the golden-flowered snake, as well as the corydalis B in the processed corydalis, are fully dissolved; (4) Filtration treatment: After extraction, the extraction system is filtered using filter material with a filtration precision range of 100-140 mesh to remove coarse particulate impurities in the system and obtain the Chinese medicine extract.

5. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 4, characterized in that: The amount of extraction solvent used in step (2) is 5-7 times the total mass of the mixed Chinese medicine powder.

6. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 3, characterized in that: The ointment preparation stage specifically includes the following steps: (1) Alchemy reaction: The Chinese herbal extract obtained in the pretreatment stage is transferred to the alchemy equipment, and red lead (red lead) is added according to the dosage range of the matrix components in claim 1. The temperature is raised to 270-290℃ to carry out the alchemy reaction until the alchemy endpoint is reached at 20-30℃ when water droplets form beads. (2) Ingredient mixing: Cool the paste after the alchemical reaction to 55-65℃, add the reserved active ingredient fine powder weighed according to the dosage range of claim 1, and stir at a stirring speed of 200-300r / min for 15-25min to ensure that the active ingredient fine powder is evenly dispersed in the paste, without clumping and without generating bubbles. (3) Adjustment of paste: Based on the actual viscosity and hardness of the paste, the amount of sesame oil or red lead (cinnabar) is slightly adjusted within the dosage range of the matrix components described in claim 1 so that the properties of the paste meet the requirements of subsequent processing.

7. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 3, characterized in that: The molding and packaging stage specifically includes the following steps: (1) Spreading operation: Spread the uniformly mixed paste obtained in the paste preparation stage at 55-65℃, and control the spreading thickness range to 0.3-0.4mm; (2) Cooling and setting: Place the spread paste in an environment of 18-25℃ and cool and set for 20-30 minutes to ensure that the paste is completely cured and there is no sticking. (3) Packaging and storage: Pack the cooled and shaped finished product under an ambient humidity range of 40%-50%RH, and store it in a sealed container to prevent the finished product from getting damp or cracking.

8. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 3, characterized in that: The baseline parameters for the pretreatment stage are: 80 mesh particle size of Chinese herbal medicine, 6 times the total mass of the mixed Chinese herbal medicine powder, 120℃ extraction temperature, 3.0h extraction time, and 120 mesh filtration accuracy.

9. The preparation method of the wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 3, characterized in that: The baseline parameters for the ointment preparation stage are: refining temperature 280℃, refining endpoint determination temperature 25℃, active ingredient fine powder addition temperature 60℃, stirring speed 250r / min, and stirring time 20min; the baseline parameters for the molding and packaging stage are: spreading temperature 60℃, spreading thickness 0.35mm, cooling and setting temperature 22℃, cooling and setting time 25min, and packaging environment humidity 45%RH.

10. The wind-dispelling and joint-pain-relieving plaster with interval-based formulation according to claim 1, characterized in that: Both the processed Aconitum carmichaelii and the processed Aconitum kusnezoffii are standard processed products, and the aconitine content of each batch of the processed Aconitum carmichaelii and each batch of the processed Aconitum kusnezoffii is <0.15mg / g; the Zaocys dhumnades and the Bungarus fasciatus are dried or freeze-dried products. When the Zaocys dhumnades and the Bungarus fasciatus are freeze-dried products, the dosage should be lower within the corresponding dosage range, and when the Zaocys dhumnades and the Bungarus fasciatus are dried products, the dosage should be higher within the corresponding dosage range.

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