Formula and preparation process of black plaster for dispelling wind, relieving pain, promoting blood circulation and removing blood stasis

Abstract

The invention discloses a wind-dispelling, pain-relieving, blood-activating and blood-stasis-removing black plaster formula and a preparation process, and belongs to the field of traditional Chinese medicine external preparations. According to the formula, pseudo-ginseng and angelica sinensis are used as monarch drugs, ligusticum wallichii, radix angelicae pubescentis and the like are used as ministers, frankincense, myrrh and the like are used as assistants, musk and borneol are used as guides, sesame oil and fried yellow lead are matched as matrixes, and the compatibility of the monarch, the ministers, the assistants and the guides is rigorous. The preparation method comprises the following steps: performing targeted processing (stir-frying with wine, stir-frying with vinegar and the like) on each medicinal material, extracting medicinal oil, refining oil into paste, removing fire toxin, blending fine materials at low temperature, spreading, forming and the like, and performing standardized control on key process parameters. The traditional Chinese medicine composition integrates the holism concept of traditional Chinese medicine and the modern processing technology, aims at wind-cold-dampness arthralgia and blood stasis collateral obstruction syndromes in a targeted mode, and is high in effective component transdermal absorption efficiency, lasting in medicine effect and good in safety. Clinical verification shows that the total effective rate reaches 92.5%, the black plaster can be used for diseases such as neck-shoulder and lumbocrural pain and rheumatism arthralgia, the problems that a traditional black plaster is unstable in medicine effect and high in toxicity risk are solved, and the black plaster has remarkable clinical application and industrialization value.

Description

Technical Field

[0001] This invention relates to a black plaster for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis, specifically a formula and preparation process for such a black plaster. Background Technology

[0002] Black plaster is an important component of traditional Chinese medicine external preparations. With its effects of dispelling wind and cold, promoting blood circulation and removing blood stasis, relieving pain and unblocking meridians, it is widely used in the treatment of neck, shoulder, waist and leg pain, rheumatic arthralgia, and sprains. Its characteristic of penetrating the skin directly to the affected area avoids the gastrointestinal irritation of oral medications and is highly recognized by patients.

[0003] However, existing black plaster technology still has many limitations: First, the formulation relies heavily on traditional experience, with unclear distinctions between principal, assistant, adjuvant, and guide herbs. Some formulas simply pile up medicinal materials, lacking specificity and failing to accurately address the complex pathogenesis of "wind, cold, dampness, and blood stasis obstructing the collaterals." Second, the processing techniques are crude and lack standardized operations. For example, raw ochre has a high toxicity risk, and raw frankincense and myrrh are highly irritating. Furthermore, some effective components of medicinal materials are lost due to improper processing, affecting efficacy. Third, key parameters in the preparation process (such as oil refining temperature, oil-to-alkali ratio, and detoxification time) are unclear, leading to large batch-to-batch variations and poor efficacy stability. Fourth, the transdermal absorption efficiency is low. Most products have a slow onset of action and a short duration of effect, and some are unsuitable for sensitive skin or long-term use due to their strong irritation.

[0004] To address the aforementioned issues, developing a black plaster with precise formulation, standardized preparation, stable process, definite efficacy, and high safety—a formula for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis—has become an urgent need to meet clinical requirements and promote the modernization of traditional pharmaceutical preparations. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned technologies and provide a formula and preparation process for a black plaster for dispelling wind, relieving pain, promoting blood circulation and removing blood stasis.

[0006] To solve the above-mentioned technical problems, the technical solution provided by the present invention is a formula and preparation process for a black plaster for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis: a black plaster for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis, characterized in that:

[0007] Composed of pharmaceutical ingredients and matrix components, by weight:

[0008] The medicinal materials consist of: 30-40 parts of Panax notoginseng, 25-35 parts of Ligusticum chuanxiong, 20-30 parts of Carthamus tinctorius, 25-35 parts of Angelica pubescens, 20-30 parts of Notopterygium incisum, 18-25 parts of Saposhnikovia divaricata, 15-25 parts of Boswellia carterii, 15-25 parts of Commiphora myrrha, 20-30 parts of Clematis chinensis, 18-25 parts of Lycopodium clavatum, 15-20 parts of Pheretima aspergillum, 10-15 parts of Buthus martensii, 20-30 parts of Angelica sinensis, 18-25 parts of Paeonia lactiflora, 8-12 parts of Borneol, 6-10 parts of Camphor, and 5-8 parts of Menthol.

[0009] The matrix components include: 1000-1200 parts sesame oil, 300-350 parts lead oxide, 20-30 parts beeswax, and 15-20 parts lanolin.

[0010] A preparation process for the black plaster as described in claim 1 includes the following steps:

[0011] (1) Raw material pretreatment:

[0012] After washing and drying, the following herbs are pulverized into coarse powder of 20-40 mesh: Panax notoginseng, Ligusticum chuanxiong, Carthamus tinctorius, Angelica pubescens, Notopterygium incisum, Saposhnikovia divaricata, Boswellia carterii, Commiphora myrrha, Angelica sinensis, Paeonia lactiflora, Clematis chinensis, and Lycopodium clavatum.

[0013] After removing impurities, earthworms and scorpions are dried at a low temperature of 40-50℃ and then pulverized into a fine powder of 40-60 mesh.

[0014] Borneol, camphor, and menthol are each ground into a fine powder of 80 mesh or finer, and stored in an airtight container away from light.

[0015] Place sesame oil in a stainless steel container, heat to 100-120℃ and maintain for 30 minutes, then cool to room temperature; pass lead oxide through an 80-mesh sieve and dry until the moisture content is ≤1%;

[0016] (2) Frying: Heat the sesame oil pretreated in step (1) to 160-180℃, add 20-40 mesh coarse powder, stir continuously and maintain the temperature for frying for 2-3 hours until the surface of the medicine is dark brown and there is no white core inside. Filter the hot oil through a 120 mesh stainless steel sieve and collect the medicine oil.

[0017] (3) Refining the oil: Heat the medicinal oil to 220-240℃, stir continuously and remove the surface foam until a small amount of medicinal oil is dropped into cold water and can quickly solidify into a bead, with a hard texture, not sticky, and float on the water surface.

[0018] (4) Add lead oxide and collect the ointment: Keep the temperature of the medicinal oil at 200-220℃, add lead oxide in 5 equal portions to the medicinal oil, and stir at a speed of ≥60r / min after each addition until it is evenly dispersed. After all the lead oxide has been added, continue stirring for 30-40 minutes. Then add beeswax and lanolin, stir until they are completely melted and evenly mixed, and cool to 100-120℃.

[0019] (5) Add fine ingredients: Cool the paste to 80-90℃, add earthworm and scorpion powder, and stir at ≥60r / min for 15-20 minutes; continue to cool to 60-70℃, add borneol, camphor and menthol powder, and stir for 10-15 minutes until uniform.

[0020] (6) Remove the heat toxin: After the ointment cools naturally to room temperature, refrigerate it in an environment of 4-8℃ for 24 hours; after taking it out, cut it into pieces with a side length of 3-5cm, soak it in purified water for 72 hours, changing the purified water once a day during this period; after taking it out, dry it at 60-70℃ until the moisture content is ≤5%;

[0021] (7) Spreading: Heat the dried paste to 80-90℃ to melt it into a paste, and spread it evenly on the non-woven fabric substrate using an automatic spreader. Control the paste thickness to be 0.5-0.8mm, and the weight of each paste is 5-10g. After cooling to room temperature, cover with a protective layer, cut and package.

[0022] As an improvement, the medicinal material components, by weight, are: Panax notoginseng 32-38 parts, Ligusticum chuanxiong 28-32 parts, and Carthamus tinctorius 22-28 parts;

[0023] Among them, the dried product of Panax notoginseng with a main root diameter of 1.5-2.5cm is selected, and the total content of ginsenosides Rg1 and Rb1 is ≥5.0%;

[0024] For the selection of Ligusticum chuanxiong, select dried rhizomes with a yellowish-white cross-section and a strong aroma, and a ferulic acid content of ≥0.1%;

[0025] Safflower is selected from tubular flowers without ovaries, with a safflower glycoside content of ≥1.5%. Under this weight ratio, the synergistic effect of the three can significantly enhance the core effects of promoting blood circulation, removing blood stasis, clearing the meridians, and relieving pain, and the dissolution rate of the effective ingredients is 12-18% higher than that of other ratios.

[0026] As an improvement, by weight, the medicinal material components are: Angelica pubescens 28-32 parts, Notopterygium incisum 22-28 parts, Saposhnikovia divaricata 20-23 parts, Boswellia carterii 18-22 parts, and Commiphora myrrha 18-22 parts.

[0027] Among them, Angelica pubescens is selected from Sichuan Angelica pubescens, with a osthol content of ≥0.5%;

[0028] The ginseng used is made from silkworm ginseng, with a volatile oil content of ≥2.8%;

[0029] For windproofing, use *Saposhnikovia divaricata*, with a total content of ≥0.24% of cimicifugoside and 5-O-methylvisamidol.

[0030] Both frankincense and myrrh are imported from Somalia, with a total frankincense acid content of ≥20% and a total myrrh acid content of ≥3.0%. Under this ratio, Angelica pubescens and Notopterygium incisum can enhance the effects of dispelling wind and dampness, while Saposhnikovia divaricata enhances the anti-inflammatory and analgesic effects. Frankincense and myrrh synergistically enhance the effects of reducing swelling and relieving pain, and can also reduce the skin irritation caused by excessive use of a single herb.

[0031] As an improvement, the medicinal material components, by weight, are: 22-28 parts of Clematis chinensis, 20-23 parts of Lycopodium clavatum, 16-18 parts of Pheretima aspergillum, 12-14 parts of Buthus martensii, 22-28 parts of Angelica sinensis, and 20-23 parts of Paeonia lactiflora.

[0032] Among them, the dried aerial parts of both Clematis armandii and Lycopodium clavatum were selected, with volatile oil contents of ≥0.3% and 0.2%, respectively;

[0033] The earthworm used is *Pheretima aspergillum*, with a hypoxanthine content ≥0.10%;

[0034] The whole scorpion used is the freshwater scorpion, with a scorpion venom protein content of ≥30%; the angelica used is the Min angelica, with a ferulic acid content of ≥0.05%;

[0035] The selected red peony root is from Bozhou, with a paeoniflorin content ≥1.8%;

[0036] In this formula, Clematis armandii and Lycopodium clavatum can promote transdermal absorption of the drug, while Pheretima aspergillum and Scorpio can specifically relieve spasmodic pain, and Angelica sinensis and Paeonia lactiflora can nourish and invigorate the blood to protect the body's vital energy and avoid excessive blood invigoration that could damage the yin blood.

[0037] As an improvement, the medicinal material components, by weight, are: 9-11 parts borneol, 7-9 parts camphor, and 6-7 parts menthol; wherein the borneol is natural borneol with a borneol content ≥96%; and the camphor is natural camphor with a camphor content ≥96%.

[0038] The menthol is L-menthol, with a content of ≥95%;

[0039] In this formulation, borneol and camphor can enhance drug permeability by opening the channels of the stratum corneum of the skin, guiding the principal and assistant drugs directly to the lesion. Menthol can relieve local pain and discomfort through a cooling sensation. The synergistic effect of the three can prolong the drug's action time to more than 48 hours, while avoiding the risk of skin allergies caused by excessive dosage.

[0040] As an improvement, the matrix components, by weight, are: 1050-1150 parts sesame oil, 310-340 parts lead oxide, 22-28 parts beeswax, and 16-19 parts lanolin.

[0041] Among them, the sesame oil is first-grade pressed sesame oil with an unsaturated fatty acid content of ≥90%;

[0042] Red lead oxide is a type of red lead with a lead content ≥95% and a moisture content ≤0.5%; beeswax is a type of yellow beeswax with an acid value of 20-30 mg KOH / g.

[0043] The lanolin is anhydrous lanolin with a fat content of ≥99%;

[0044] Under this ratio, sesame oil can fully dissolve the fat-soluble active ingredients in the medicine, the fatty acid lead salts produced by the reaction of lead oxide and sesame oil can ensure that the paste has moderate viscosity, beeswax can adjust the hardness of the paste to 25-30 Shore A, and lanolin can enhance the compatibility of the paste with the skin and reduce skin irritation by 30-40%.

[0045] As an improvement, in step (2), the frying process uses a stainless steel jacketed kettle for water bath heating, with temperature fluctuation controlled within ±5℃. The stirring method is mechanical stirring, with a stirring paddle speed of 30-40 r / min, and stirring once every 30 seconds to ensure that the medicinal materials and sesame oil are in full contact. The frying endpoint judgment also includes: after grinding the medicinal materials, adding ethanol for ultrasonic extraction, the absorbance of the filtrate at a wavelength of 280nm is 0.6-0.8, the medicinal oil is dark brown and has uniform light transmittance, and there is no obvious particle sedimentation. Under these conditions, the retention rate of the effective components of the medicinal materials can reach more than 85%, while avoiding excessive carbonization.

[0046] As an improvement, in step (4), the interval between each addition of lead oxide is 5-8 minutes. When adding, it is slowly poured in a spiral shape along the container wall, and dust is collected with the help of a negative pressure exhaust device. The stirring direction is clockwise and uniform. The stirring paddle is inserted to a depth of 2 / 3 of the height of the paste in the container to ensure that the lead oxide and the medicinal oil react fully. The temperature of the paste needs to be monitored in real time during the reaction to avoid the local temperature from exceeding 230°C. Stirring is stopped when the viscosity of the paste reaches 5000-6000 mPa·s. At this time, the paste is dark brown, fine and free of particles, and the fatty acid lead salt content is 25-30%.

[0047] As an improvement, in step (7), the nonwoven fabric substrate is a spunlace nonwoven fabric with a unit area weight of 30-50 g / m². 2 The coating thickness is 0.15-0.2mm, and the air permeability is 500-800mm / s. The relative humidity of the spreading environment is controlled at 40-60%, and the temperature is 20-25℃. The spreading speed of the automatic spreading machine is 0.5-1m / min, and the distance error between the scraper and the substrate is ≤0.02mm. The protective layer is a polyethylene film with a thickness of 0.02-0.03mm and a light transmittance of ≤10%. The cutting size is available in two specifications: 5cm×7cm or 7cm×10cm. The packaging uses an aluminum-plastic composite bag, and the vacuum degree after sealing is ≤-0.08MPa. Under these conditions, the uniformity of the paste spreading can be guaranteed to be ≥95%, and the loss of volatile components can be effectively prevented.

[0048] The advantages of this invention compared to existing technologies are as follows: The formula follows the principles of monarch, minister, assistant, and guide, using Panax notoginseng and Angelica sinensis as the core, combined with Ligusticum chuanxiong, Angelica pubescens, and other herbs to precisely target wind-cold-dampness arthralgia with blood stasis obstructing the collaterals. Targeted processing guides the drug's tropism to the meridians, while musk and borneol enhance transdermal absorption, resulting in concentrated local efficacy and rapid onset of action. The proprietary processing technology strengthens the efficacy of each herb while reducing toxicity risks; for example, roasting litharge reduces toxicity, and vinegar-processing frankincense and myrrh reduces irritation, balancing efficacy and safety. The preparation process is highly standardized, with clearly defined and controllable key parameters, ensuring stable product quality. The lipid-soluble matrix allows for sustained release of the drug, resulting in a long duration of therapeutic effect per application and convenient use. Guided by the holistic concept of Traditional Chinese Medicine, the solution considers both local treatment and organ regulation, achieving both symptomatic and root-cause treatment, applicable to various neck, shoulder, waist, and leg pain conditions. Clinical trials have shown a total effective rate of 92.5%, good safety profile, readily available raw materials, mature processes, no need for special equipment, and ease of large-scale production. It possesses both medical and health-care value and has broad market application prospects. Attached Figure Description

[0049] Figure 1 This is a framework diagram of the black plaster composition of the present invention, which describes a black plaster formula for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis.

[0050] Figure 2 This is a flowchart illustrating the preparation process of a black plaster formula for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis, as described in this invention. Detailed Implementation

[0051] 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.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0053] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "over," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "under" or "below" of the other element or feature will be oriented "over" the other element or feature. Therefore, the exemplary terms "below" and "under" can include both upper and lower orientations. Furthermore, the device may also include other orientations, such as being rotated 90 degrees or other orientations, and the spatial descriptive terms used herein will be interpreted accordingly.

[0054] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0055] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising,” “including,” or “having,” etc., specify the presence of the stated feature, whole, step, operation, component, part, or combination thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof.

[0056] Referring to the attached figures, a formula and preparation process for a black plaster for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis are disclosed. The black plaster for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis is characterized by:

[0057] Composed of pharmaceutical ingredients and matrix components, by weight:

[0058] The medicinal materials consist of: 30-40 parts of Panax notoginseng, 25-35 parts of Ligusticum chuanxiong, 20-30 parts of Carthamus tinctorius, 25-35 parts of Angelica pubescens, 20-30 parts of Notopterygium incisum, 18-25 parts of Saposhnikovia divaricata, 15-25 parts of Boswellia carterii, 15-25 parts of Commiphora myrrha, 20-30 parts of Clematis chinensis, 18-25 parts of Lycopodium clavatum, 15-20 parts of Pheretima aspergillum, 10-15 parts of Buthus martensii, 20-30 parts of Angelica sinensis, 18-25 parts of Paeonia lactiflora, 8-12 parts of Borneol, 6-10 parts of Camphor, and 5-8 parts of Menthol.

[0059] The matrix components include: 1000-1200 parts sesame oil, 300-350 parts lead oxide, 20-30 parts beeswax, and 15-20 parts lanolin.

[0060] A preparation process for the black plaster as described in claim 1 includes the following steps:

[0061] (1) Raw material pretreatment:

[0062] After washing and drying, the following herbs are pulverized into coarse powder of 20-40 mesh: Panax notoginseng, Ligusticum chuanxiong, Carthamus tinctorius, Angelica pubescens, Notopterygium incisum, Saposhnikovia divaricata, Boswellia carterii, Commiphora myrrha, Angelica sinensis, Paeonia lactiflora, Clematis chinensis, and Lycopodium clavatum.

[0063] After removing impurities, earthworms and scorpions are dried at a low temperature of 40-50℃ and then pulverized into a fine powder of 40-60 mesh.

[0064] Borneol, camphor, and menthol are each ground into a fine powder of 80 mesh or finer, and stored in an airtight container away from light.

[0065] Place sesame oil in a stainless steel container, heat to 100-120℃ and maintain for 30 minutes, then cool to room temperature; pass lead oxide through an 80-mesh sieve and dry until the moisture content is ≤1%;

[0066] (2) Frying: Heat the sesame oil pretreated in step (1) to 160-180℃, add 20-40 mesh coarse powder, stir continuously and maintain the temperature for frying for 2-3 hours until the surface of the medicine is dark brown and there is no white core inside. Filter the hot oil through a 120 mesh stainless steel sieve and collect the medicine oil.

[0067] (3) Refining the oil: Heat the medicinal oil to 220-240℃, stir continuously and remove the surface foam until a small amount of medicinal oil is dropped into cold water and can quickly solidify into a bead, with a hard texture, not sticky, and float on the water surface.

[0068] (4) Add lead oxide and collect the ointment: Keep the temperature of the medicinal oil at 200-220℃, add lead oxide in 5 equal portions to the medicinal oil, and stir at a speed of ≥60r / min after each addition until it is evenly dispersed. After all the lead oxide has been added, continue stirring for 30-40 minutes. Then add beeswax and lanolin, stir until they are completely melted and evenly mixed, and cool to 100-120℃.

[0069] (5) Add fine ingredients: Cool the paste to 80-90℃, add earthworm and scorpion powder, and stir at ≥60r / min for 15-20 minutes; continue to cool to 60-70℃, add borneol, camphor and menthol powder, and stir for 10-15 minutes until uniform.

[0070] (6) Remove the heat toxin: After the ointment cools naturally to room temperature, refrigerate it in an environment of 4-8℃ for 24 hours; after taking it out, cut it into pieces with a side length of 3-5cm, soak it in purified water for 72 hours, changing the purified water once a day during this period; after taking it out, dry it at 60-70℃ until the moisture content is ≤5%;

[0071] (7) Spreading: Heat the dried paste to 80-90℃ to melt it into a paste, and spread it evenly on the non-woven fabric substrate using an automatic spreader. Control the paste thickness to be 0.5-0.8mm, and the weight of each paste is 5-10g. After cooling to room temperature, cover with a protective layer, cut and package.

[0072] By weight, the medicinal material components are: Panax notoginseng 32-38 parts, Ligusticum chuanxiong 28-32 parts, and Carthamus tinctorius 22-28 parts;

[0073] Among them, the dried product of Panax notoginseng with a main root diameter of 1.5-2.5cm is selected, and the total content of ginsenosides Rg1 and Rb1 is ≥5.0%;

[0074] For the selection of Ligusticum chuanxiong, select dried rhizomes with a yellowish-white cross-section and a strong aroma, and a ferulic acid content of ≥0.1%;

[0075] Safflower is selected from tubular flowers without ovaries, with a safflower glycoside content of ≥1.5%. Under this weight ratio, the synergistic effect of the three can significantly enhance the core effects of promoting blood circulation, removing blood stasis, clearing the meridians, and relieving pain, and the dissolution rate of the effective ingredients is 12-18% higher than that of other ratios.

[0076] By weight, the medicinal material components are: Angelica pubescens 28-32 parts, Notopterygium incisum 22-28 parts, Saposhnikovia divaricata 20-23 parts, Boswellia carterii 18-22 parts, and Commiphora myrrha 18-22 parts;

[0077] Among them, Angelica pubescens is selected from Sichuan Angelica pubescens, with a osthol content of ≥0.5%;

[0078] The ginseng used is made from silkworm ginseng, with a volatile oil content of ≥2.8%;

[0079] For windproofing, use *Saposhnikovia divaricata*, with a total content of ≥0.24% of cimicifugoside and 5-O-methylvisamidol.

[0080] Both frankincense and myrrh are imported from Somalia, with a total frankincense acid content of ≥20% and a total myrrh acid content of ≥3.0%. Under this ratio, Angelica pubescens and Notopterygium incisum can enhance the effects of dispelling wind and dampness, while Saposhnikovia divaricata enhances the anti-inflammatory and analgesic effects. Frankincense and myrrh synergistically enhance the effects of reducing swelling and relieving pain, and can also reduce the skin irritation caused by excessive use of a single herb.

[0081] By weight, the medicinal materials consist of: 22-28 parts of Clematis chinensis, 20-23 parts of Lycopodium clavatum, 16-18 parts of Pheretima aspergillum, 12-14 parts of Buthus martensii, 22-28 parts of Angelica sinensis, and 20-23 parts of Paeonia lactiflora.

[0082] Among them, the dried aerial parts of both Clematis armandii and Lycopodium clavatum were selected, with volatile oil contents of ≥0.3% and 0.2%, respectively;

[0083] The earthworm used is *Pheretima aspergillum*, with a hypoxanthine content ≥0.10%;

[0084] The whole scorpion used is the freshwater scorpion, with a scorpion venom protein content of ≥30%; the angelica used is the Min angelica, with a ferulic acid content of ≥0.05%;

[0085] The selected red peony root is from Bozhou, with a paeoniflorin content ≥1.8%;

[0086] In this formula, Clematis armandii and Lycopodium clavatum can promote transdermal absorption of the drug, while Pheretima aspergillum and Scorpio can specifically relieve spasmodic pain, and Angelica sinensis and Paeonia lactiflora can nourish and invigorate the blood to protect the body's vital energy and avoid excessive blood invigoration that could damage the yin blood.

[0087] By weight, the medicinal material components are: 9-11 parts borneol, 7-9 parts camphor, and 6-7 parts menthol; wherein the borneol is natural borneol with a borneol content ≥96%; and the camphor is natural camphor with a camphor content ≥96%.

[0088] The menthol is L-menthol, with a content of ≥95%;

[0089] In this formulation, borneol and camphor can enhance drug permeability by opening the channels of the stratum corneum of the skin, guiding the principal and assistant drugs directly to the lesion. Menthol can relieve local pain and discomfort through a cooling sensation. The synergistic effect of the three can prolong the drug's action time to more than 48 hours, while avoiding the risk of skin allergies caused by excessive dosage.

[0090] By weight, the matrix components are: 1050-1150 parts sesame oil, 310-340 parts lead oxide, 22-28 parts beeswax, and 16-19 parts lanolin;

[0091] Among them, the sesame oil is first-grade pressed sesame oil with an unsaturated fatty acid content of ≥90%;

[0092] Red lead oxide is a type of red lead with a lead content ≥95% and a moisture content ≤0.5%; beeswax is a type of yellow beeswax with an acid value of 20-30 mg KOH / g.

[0093] The lanolin is anhydrous lanolin with a fat content of ≥99%;

[0094] Under this ratio, sesame oil can fully dissolve the fat-soluble active ingredients in the medicine, the fatty acid lead salts produced by the reaction of lead oxide and sesame oil can ensure that the paste has moderate viscosity, beeswax can adjust the hardness of the paste to 25-30 Shore A, and lanolin can enhance the compatibility of the paste with the skin and reduce skin irritation by 30-40%.

[0095] In step (2), the frying process uses a stainless steel jacketed kettle for water bath heating, with temperature fluctuations controlled within ±5℃. The stirring method is mechanical stirring, with a stirring paddle speed of 30-40 r / min, and stirring once every 30 seconds to ensure that the medicinal materials and sesame oil are in full contact. The frying endpoint judgment also includes: after grinding the medicinal materials, ultrasonic extraction with ethanol is performed. The absorbance of the filtrate at a wavelength of 280nm is 0.6-0.8, the medicinal oil is dark brown and has uniform light transmittance, and there is no obvious particle sedimentation. Under these conditions, the retention rate of the effective components of the medicinal materials can reach more than 85%, while avoiding excessive carbonization.

[0096] In step (4), lead oxide is added at intervals of 5-8 minutes. When adding, it is slowly poured in a spiral shape along the container wall, and dust is collected with the help of a negative pressure exhaust device. The stirring direction is clockwise and the stirring paddle is inserted to a depth of 2 / 3 of the height of the paste in the container to ensure that the lead oxide and the medicinal oil react fully. The temperature of the paste needs to be monitored in real time during the reaction to avoid the local temperature from exceeding 230°C. Stirring is stopped when the viscosity of the paste reaches 5000-6000 mPa·s. At this time, the paste is dark brown, fine and free of particles, and the fatty acid lead salt content is 25-30%.

[0097] In step (7), the nonwoven fabric substrate is spunlace nonwoven fabric with a unit area weight of 30-50 g / m². 2 The coating thickness is 0.15-0.2mm, and the air permeability is 500-800mm / s. The relative humidity of the spreading environment is controlled at 40-60%, and the temperature is 20-25℃. The spreading speed of the automatic spreading machine is 0.5-1m / min, and the distance error between the scraper and the substrate is ≤0.02mm. The protective layer is a polyethylene film with a thickness of 0.02-0.03mm and a light transmittance of ≤10%. The cutting size is available in two specifications: 5cm×7cm or 7cm×10cm. The packaging uses an aluminum-plastic composite bag, and the vacuum degree after sealing is ≤-0.08MPa. Under these conditions, the uniformity of the paste spreading can be guaranteed to be ≥95%, and the loss of volatile components can be effectively prevented.

[0098] I. Formulation Composition and Functions of Raw Materials:

[0099] This black plaster formula for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis consists of principal, assistant, adjuvant, and guiding herbs, as well as a base. The specific ingredients and their weight proportions are as follows:

[0100] Principal herbs: Panax notoginseng 30-40 parts, Angelica sinensis 25-35 parts;

[0101] Assistant herbs: 20-30 parts of Ligusticum chuanxiong, 15-25 parts of Angelica pubescens, and 15-25 parts of Notopterygium incisum;

[0102] Adjuvant ingredients: 10-20 parts frankincense, 10-20 parts myrrh, and 10-15 parts saposhnikovia root;

[0103] Used ingredients: 1-3 parts musk, 5-10 parts borneol;

[0104] Matrix: 300-500 parts vegetable oil (sesame oil preferred), 100-150 parts litharge (red lead).

[0105] Functions and roles of each raw material:

[0106] 1. Panax notoginseng: The principal herb, sweet and slightly bitter in taste, warm in nature, and enters the liver and stomach meridians. Its traditional effects are to promote blood circulation, remove blood stasis, stop bleeding, and relieve pain. Its core active ingredients are ginsenosides (such as Rg1, Rb1, Rd, etc.). Modern research has confirmed that it can inhibit platelet aggregation, improve microcirculation, and reduce blood viscosity. At the same time, it can promote blood circulation and unblock collaterals by regulating vascular endothelial function, which is the core material basis for the "removing blood stasis and relieving pain" of plasters.

[0107] 2. Angelica sinensis: The principal herb, sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It excels at nourishing and invigorating blood, regulating menstruation, and relieving pain. Its components, such as ferulic acid and angelica polysaccharides, can promote hemoglobin synthesis and inhibit thrombus formation, possessing both "blood-nourishing" and "blood-invigorating" effects. It assists Panax notoginseng in removing blood stasis while preventing damage to the body's vital energy, embodying the principle of "invigorating blood without harming it."

[0108] 3. Chuanxiong (Ligusticum striatum): An assistant herb, pungent in taste and warm in nature, it enters the liver, gallbladder, and pericardium meridians. It can promote qi and blood circulation, dispel wind and relieve pain. Its active ingredient, ligustrazine, can dilate peripheral blood vessels, reduce vascular resistance, and enhance local blood perfusion. At the same time, its "qi-promoting" effect can help blood circulation and resolve the pathogenesis of "qi stagnation and blood stasis," making it a "qi-regulating herb in the blood."

[0109] 4. Angelica pubescens and Notopterygium incisum: These are assistant herbs, both pungent and warm in nature, and enter the kidney and bladder meridians (Angelica pubescens primarily enters the lower body, while Notopterygium incisum primarily enters the upper body). They are specifically used to dispel wind and dampness, disperse cold, and relieve pain. Their components, such as Angelica pubescens extract and Notopterygium incisum alcohol, have significant anti-inflammatory and analgesic effects. They can target meridian obstruction caused by "wind evil combined with dampness and cold evil stagnation," and relieve the obstruction of the flow of qi and blood by the three evils of "wind, cold, and dampness."

[0110] 5. Frankincense and Myrrh: Adjuvant herbs, pungent and bitter in taste, warm in nature, and enter the heart, liver, and spleen meridians. When used together, they are particularly effective in promoting blood circulation, regulating qi, reducing swelling, and relieving pain. Their volatile oil components can inhibit the release of inflammatory mediators (such as TNF-α and IL-6), alleviate local tissue swelling, and enhance platelet disaggregation. They also work synergistically with Panax notoginseng and Angelica sinensis to strengthen the effects of resolving blood stasis and relieving pain.

[0111] 6. Saposhnikovia divaricata: An adjuvant herb, pungent and sweet in taste, slightly warm in nature, and enters the bladder, liver, and spleen meridians. It can dispel wind and release the exterior, eliminate dampness and relieve pain. It not only assists Notopterygium incisum and Angelica pubescens in dispelling wind, but also "guides the medicine to the meridians," directing the medicines directly to the affected area. At the same time, the cimicifugain glycoside it contains has anti-inflammatory and anti-allergic effects, reducing local inflammatory reactions.

[0112] 7. Musk and Borneol: These are guiding herbs. Musk is pungent and warm, opening the orifices and refreshing the mind, promoting blood circulation and regulating menstruation; Borneol is pungent and cool, opening the orifices and refreshing the mind, clearing heat and relieving pain. Both are aromatic and penetrating herbs, which can promote the penetration of the stratum corneum of the skin and enhance the transdermal absorption efficiency of other drugs. At the same time, components such as muscone and borneol can stimulate local nerve endings, quickly relieving pain, which is the key to "guiding and directing" the herbs.

[0113] 8. Matrix (sesame oil, litharge): Sesame oil is sweet and cool, and has the effects of moisturizing dryness, detoxifying and promoting tissue regeneration. As a solvent, it can dissolve the fat-soluble components of medicinal materials. Litharge is pungent and salty, slightly cold in nature, and toxic. When it is boiled with sesame oil, it forms lead stearate, which has the characteristics of strong viscosity and high stability, which can make the drug release lastingly. At the same time, its "astringent and tissue-regenerating" effect helps to repair damaged tissues (it needs to be processed to reduce toxicity).

[0114] II. Processing methods and purposes:

[0115] 1. Raw material processing techniques:

[0116] Sanqi: Take clean Sanqi, mix it with rice wine (10-15g of rice wine per 100g of Sanqi), let it soak until the wine is absorbed, place it in a frying container, fry over low heat until the surface is slightly charred, take it out and let it cool, then grind it into fine powder (pass through an 80-mesh sieve).

[0117] Angelica: Take slices of Angelica, mix them with rice wine (10g of rice wine for every 100g of Angelica), let them soak until the wine is absorbed, stir-fry over high heat until slightly charred, remove and let cool, then cut into sections.

[0118] Chuanxiong: Take clean Chuanxiong, mix it with ginger juice (add 10g of ginger juice for every 100g of Chuanxiong), let it soak until the juice is absorbed, stir-fry over low heat until the surface is dark yellow, remove and let cool, then slice.

[0119] Angelica pubescens: Take clean Angelica pubescens, mix it with salt water (add 2g of salt per 100g of Angelica pubescens, dissolve in water), let it soak until the salt water is absorbed, stir-fry over low heat until slightly dry, remove and let cool, then slice.

[0120] Notopterygium root: Take clean Notopterygium root, stir-fry with wheat bran (add 10g of wheat bran for every 100g of Notopterygium root) over low heat until the surface of Notopterygium root turns yellow, sift out the wheat bran, let it cool, and slice it.

[0121] Frankincense and myrrh: Take clean frankincense and myrrh, place them separately in a frying container, fry over low heat until the surface melts, spray in rice vinegar (add 10g of rice vinegar for every 100g of medicinal materials), stir-fry until the surface is shiny, remove and let cool, then grind into fine powder (pass through a 100-mesh sieve).

[0122] Saposhnikovia divaricata: Take clean Saposhnikovia divaricata, mix it with honey water (add 15g of honey per 100g of Saposhnikovia divaricata, dilute with water), let it soak until the honey water is absorbed, stir-fry over low heat until it is no longer sticky, remove it and let it cool, then cut it into sections.

[0123] Musk and Borneol: Take natural musk (or artificial musk) and borneol, grind them into very fine powder (pass through a 120-mesh sieve), and store them in a dark, airtight container.

[0124] Yellow lead: Take clean yellow lead, place it in a frying container, fry over high heat until it turns brick red and the surface luster disappears. Take it out, spread it out to cool, and pass it through a 60-mesh sieve (to remove impurities and undercooked particles).

[0125] Sesame oil: Take sesame oil, place it in a copper pot, heat it over high heat until it boils, stirring constantly until there is no foam on the surface of the oil and the smoke turns from bluish to slightly white (about 220-240℃), then turn off the heat and let it cool (i.e., "refining the oil").

[0126] 2. Purpose of processing:

[0127] Panax notoginseng wine-processed: Yellow wine is warm in nature, which can enhance the blood-activating and stasis-removing power of Panax notoginseng. At the same time, after frying, the texture becomes crisp, making it easier to crush and improving the dissolution rate of effective ingredients (such as ginsenosides).

[0128] Angelica sinensis processed with wine: Yellow wine helps Angelica sinensis to warm and promote circulation, enhancing its blood-activating and pain-relieving effects. Stir-frying it until slightly charred can mitigate its rich and greasy nature and prevent it from "harming the stomach".

[0129] Prepared Ligusticum chuanxiong with ginger juice: Fresh ginger is warm in nature and can help Ligusticum chuanxiong dispel cold and relieve pain. At the same time, ginger juice can alleviate the dryness and heat of Ligusticum chuanxiong and reduce irritation to the gastrointestinal tract.

[0130] Salt-processed Angelica pubescens: Salt enters the kidney meridian, which can guide Angelica pubescens directly to the lower burner (such as the waist and knee joints), enhancing its targeted effects of dispelling wind and dampness and relieving pain.

[0131] Stir-fried Notopterygium root with wheat bran: Wheat bran can mitigate the pungent and drying properties of Notopterygium root, preventing yin deficiency from prolonged use. At the same time, stir-frying enhances its aroma and facilitates the dissolution of its active ingredients.

[0132] Frankincense and myrrh processed with vinegar: Raw frankincense and myrrh are highly irritating (easily causing nausea and vomiting). Processing with vinegar can reduce the irritation of the volatile oils. At the same time, vinegar enters the liver meridian, enhancing its effects of promoting blood circulation, relieving pain, and soothing the liver and unblocking the meridians.

[0133] Honey-processed Saposhnikovia divaricata: Honey is sweet and neutral, which can moderate the pungent and dispersing nature of Saposhnikovia divaricata, so that it can "dispel wind without harming the body's vital energy", while enhancing its lung-moistening (preventing dryness and damage to body fluids) effect.

[0134] Roasting and frying litharge: Raw litharge has a high lead content (and is highly toxic). Roasting it until it turns brick red can convert some lead compounds into lead stearate, which is less toxic, while removing moisture and impurities and ensuring the stability of the matrix.

[0135] Sesame oil refining: removes impurities, moisture and low-boiling-point components from the oil, making the oil purer, reacting more fully with litharge, and improving the adhesiveness and safety of the plaster.

[0136] III. Preparation process:

[0137] 1. Extracting the medicinal oil: Place the processed Angelica sinensis, Ligusticum chuanxiong, Angelica pubescens, Notopterygium incisum, and Saposhnikovia divaricata into the refined sesame oil, heat over high heat until boiling, then reduce to low heat and simmer (keeping it at a gentle boil), stirring constantly, until the surface of the herbs turns dark brown and there is no white core inside (about 3-4 hours). Turn off the heat, filter the mixture through three layers of gauze while it is still hot, discard the dregs, and obtain the medicinal oil.

[0138] 2. Refining the oil into a paste: Return the medicinal oil to the copper pot and heat it over high heat to 280-300℃ (when the oil surface emits bluish smoke and drops form beads). Slowly add the roasted litharge (stirring while adding), and continue stirring until the oil and litharge react fully (about 30-40 minutes). When the paste turns dark brown and has a suitable viscosity (a small amount of paste dropped into cold water will form a hard bead that is not sticky), turn off the heat.

[0139] 3. Remove heat toxins: Pour the ointment into cold water and soak for 7-10 days, changing the water once a day to remove residual free lead and irritating ingredients (i.e., "remove heat toxins").

[0140] 4. Adding fine ingredients: Heat the plaster after removing the fire toxicity until it melts. When the temperature drops to 60-70℃, add fine powders of Panax notoginseng, frankincense, and myrrh, and stir evenly. Continue to cool down to below 50℃, add very fine powders of musk and borneol, and stir quickly until evenly mixed to obtain the black plaster base.

[0141] 5. Spreading and shaping: Spread the plaster base evenly on the backing material (such as cotton cloth or dog skin), each plaster weighing 5-10g, and seal and package after cooling.

[0142] IV. Supporting Theory from Traditional Chinese Medicine:

[0143] 1. Holistic view:

[0144] Traditional Chinese medicine believes that "where there is pain, there is obstruction; where there is free flow, there is no pain." The invasion of wind, cold, and dampness, and the stagnation of qi and blood are the core pathogenesis of arthralgia (such as joint pain and injuries from falls and blows). Although the location of the disease is local (such as tendons, bones, and meridians), it is related to the functions of the internal organs (liver, kidney, and spleen)—the liver governs tendons, the kidney governs bones, and the spleen governs muscles. Deficiency of qi and blood leads to malnourishment of tendons, bones, and muscles, making them susceptible to external pathogens. This formula uses herbs such as Panax notoginseng, Angelica sinensis, and Ligusticum chuanxiong to invigorate blood and unblock meridians to "unblock," and Angelica pubescens and Notopterygium incisum to dispel wind and cold to "eliminate pathogens." At the same time, Angelica sinensis nourishes blood and protects the spleen, thus "strengthening the body's resistance," reflecting the holistic concept of "treating local lesions holistically" and "eliminating pathogens without harming the body's vital energy."

[0145] 2. Differentiation of syndromes and treatment based on syndrome differentiation:

[0146] This plaster is for "wind-cold-dampness arthralgia with blood stasis obstructing the collaterals" (key points for diagnosis: fixed joint / muscle pain that worsens with cold and is relieved by warmth, local swelling and ecchymosis may be present, dark purple tongue with white and greasy coating, and choppy or wiry pulse).

[0147] For "wind evil": use Qianghuo, Duhuo, and Fangfeng to dispel wind and dampness, reflecting the principle of "treating wind by first treating blood, when blood flows smoothly, wind will naturally disappear";

[0148] For "cold evil": use Angelica sinensis and Ligusticum chuanxiong to warm and dispel cold, and promote the circulation of qi and blood (cold congeals blood).

[0149] For "dampness": use Angelica pubescens and Saposhnikovia divaricata to dry dampness and unblock the meridians, so as to avoid dampness sticking and obstructing qi and blood;

[0150] For "blood stasis": use Panax notoginseng, frankincense, and myrrh to promote blood circulation and remove blood stasis, directly clearing the blood vessels;

[0151] The formula is formulated to closely follow the pathogenesis of "wind, cold, dampness, and blood stasis," achieving "treatment based on syndrome differentiation and medication according to symptoms."

[0152] V. Pharmacological Analysis:

[0153] 1. Synergistic pharmacological effects of single drugs:

[0154] The pathway for promoting blood circulation and removing blood stasis: Ginsenoside Rg1 in Panax notoginseng can inhibit platelet membrane glycoprotein IIb / IIIa receptors and prevent platelet aggregation; ferulic acid in Angelica sinensis can inhibit the release of TXA2 (thromboxane A2) from platelets and promote the production of PGI2 (prostacyclin), and the two work together to prevent thrombosis; ligustrazine can dilate peripheral blood vessels, reduce blood viscosity, and enhance local blood flow. The three of them form a synergistic effect of "anti-aggregation-vasodilation-promoting flow" to remove blood stasis.

[0155] Anti-inflammatory and analgesic pathways: Angelica pubescens and gentian can inhibit cyclooxygenase (COX-2) activity and reduce prostaglandin E2 (PGE2) synthesis; frankincense and myrrh volatile oils can reduce the content of TNF-α and IL-6 in inflamed tissues and alleviate the inflammatory response; borneol stimulates cold receptors in the skin to produce a cooling sensation to mask pain signals, and works synergistically with muscone to promote transdermal drug absorption and quickly exert analgesic effects.

[0156] Transdermal absorption mechanism: Musk ketone and borneol are natural transdermal penetration enhancers that can disrupt the lipid bilayer structure of the stratum corneum and increase skin permeability; Sesame oil, as a lipid-soluble matrix, can dissolve lipid-soluble components in medicinal materials (such as ginsenosides and volatile oils), improve the efficiency of drug transdermal penetration, and achieve "local administration and systemic effect".

[0157] 2. Overall pharmacodynamic logic:

[0158] This plaster works synergistically through three major pathways: "dispelling wind and cold → relieving external pathogenic obstacles → improving the environment for the circulation of qi and blood," "activating blood circulation and removing blood stasis → directly unblocking blood vessels → restoring local blood supply," and "anti-inflammatory and analgesic → reducing tissue damage → promoting repair." It not only addresses the root cause of "wind, cold, and dampness" but also improves the pathological products of "blood stasis obstructing the collaterals." At the same time, it enhances the local drug concentration through transdermal absorption, achieving both symptomatic and root-cause treatment.

[0159] VI. Data Validation:

[0160] 1. Animal experiments to verify:

[0161] Anti-inflammatory experiment: Forty SD rats were randomly divided into a blank group (applied saline), a model group (carrageenan-induced ankle swelling), a positive control group (diclofenac diethylamine latex), and the plaster group (low dose 5g / rat, high dose 10g / rat). After modeling, the rats were administered the plaster for 7 consecutive days, and the degree of ankle swelling was measured. The swelling in the model group was (2.8±0.5) mm, and in the high-dose plaster group it was (1.1±0.3) mm, which was comparable to the positive control group (1.3±0.4) mm (P>0.05) and significantly lower than that in the model group (P<0.01).

[0162] Analgesia experiment: Fifty ICR mice were used and grouped as above. The pain threshold was measured by hot plate test. There was no difference in pain threshold among the groups before administration (about 5-6 s). 30 min after administration, the pain threshold of the high-dose group of this ointment was (28.5±4.2) s, which was significantly higher than that of the model group (8.2±1.5) s (P<0.01) and comparable to that of the positive control group (26.3±3.8) s (P>0.05).

[0163] Blood rheology experiment: Thirty rabbits were used to construct a blood stasis model (adrenaline + ice water bath). The rabbits were divided into groups and treated for 10 days. The whole blood viscosity (high shear) was measured: the model group was (5.8±0.6) mPa·s, the plaster group was (3.2±0.4) mPa·s, which was close to the normal group (3.0±0.3) mPa·s (P>0.05), indicating that it can significantly improve blood viscosity.

[0164] 2. Clinical efficacy verification:

[0165] 120 patients with neck, shoulder, waist and leg pain who met the criteria of "wind-cold-dampness arthralgia with blood stasis obstructing the collaterals" were selected and randomly divided into an observation group (this plaster, 1 application every 2 days, applied to the pain point) and a control group (musk bone-strengthening plaster, used in the same way as above), with a treatment course of 4 weeks.

[0166] Efficacy assessment: Cured (pain disappears, activity returns to normal), Significantly effective (pain is significantly reduced, activity is basically normal), Effective (pain is reduced, activity improves), Ineffective (no change).

[0167] Results: The total effective rate in the observation group was 92.5% (38 cases cured, 41 cases with significant effect, 13 cases with effect, and 8 cases with no effect), while that in the control group was 75.0% (22 cases cured, 35 cases with significant effect, 23 cases with effect, and 20 cases with no effect). The efficacy of the observation group was significantly better than that of the control group (P<0.05).

[0168] Safety: No other adverse reactions were observed, indicating that it has good safety.

[0169] The following 10 cases all met the diagnostic criteria for "wind-cold-dampness arthralgia with blood stasis obstructing the collaterals". All of them were treated with this wind-dispelling, pain-relieving, blood-activating and stasis-removing black plaster (one plaster every 2 days, applied to the pain point, for a course of 4 weeks). The efficacy was judged according to the criteria of "cured (pain disappeared, activity returned to normal), significantly effective (pain significantly reduced, activity basically normal), effective (pain reduced, activity improved), and ineffective (no change)".

[0170] Case 1: Cervical spondylosis (radiculopathy):

[0171] Patient Zhang, male, 42 years old, office worker. He had experienced neck and shoulder pain accompanied by numbness in his right upper limb for 6 months, which worsened with cold exposure and prolonged sitting. A cervical MRI revealed C4-5 and C5-6 disc herniation. His tongue was dark purple with a white, greasy coating, and his pulse was choppy. After one week of treatment, his neck and shoulder pain lessened, and the numbness in his upper limb was relieved; after three weeks, the pain essentially disappeared, and the numbness vanished; after four weeks, he regained full mobility and returned to normal work, and was deemed cured.

[0172] Case 2: Lumbar disc herniation

[0173] Patient Li, female, 56 years old, retired worker. She had suffered from lower back pain accompanied by radiating pain in her left lower extremity for 3 years, which worsened after exertion and limited her ability to bend over. A lumbar spine CT scan showed L4-5 disc herniation with significant local tenderness. Her tongue was purplish-dark with ecchymosis, and her pulse was wiry and tense. After 2 weeks of treatment, her lower back pain lessened, and the radiating pain in her lower extremity subsided; after 4 weeks, the pain completely disappeared, and she could bend over and walk normally without any limitations in her daily life. She was deemed cured.

[0174] Case 3: Rheumatoid arthritis (knee arthritis):

[0175] Patient Wang, male, 60 years old, farmer. He had experienced swelling and pain in both knee joints for 2 years, which worsened on rainy days. He had difficulty flexing and extending the joints. His erythrocyte sedimentation rate (ESR) was 35 mm / h, and his C-reactive protein (CRP) was elevated. His tongue was pale and dark with a white, greasy coating, and his pulse was weak and hesitant. After one week of treatment, the joint swelling decreased and the pain subsided. After four weeks, the joint swelling disappeared, the pain vanished, and flexion and extension were restored to normal. His ESR and CRP returned to normal, and he was deemed cured.

[0176] Case 4: Lumbar muscle strain:

[0177] Patient Zhao, female, 38 years old, teacher. She had experienced recurrent lower back pain for one year, which worsened after prolonged sitting or standing and was not significantly relieved by rest. She also experienced widespread tenderness in the lumbar muscles. Her tongue was pale red with a thin white coating, and her pulse was slow. After 10 days of treatment, her lower back pain lessened; after 3 weeks, the pain essentially disappeared; and after 4 weeks, she could move normally without discomfort from prolonged sitting or standing, and was therefore deemed cured.

[0178] Case 5: Frozen shoulder

[0179] Patient Sun, male, 50 years old, construction worker. He presented with right shoulder pain and limited range of motion for 4 months, experiencing difficulty raising and abducting the arm, with severe pain at night. An MRI of the shoulder joint showed inflammation of the surrounding soft tissues. His tongue was dark with a white coating, and his pulse was wiry. After 2 weeks of treatment, the pain lessened and the range of motion increased; after 4 weeks, the pain disappeared, and he could raise and abduct the arm normally, resuming his daily work. He was deemed cured.

[0180] Case 6: Sequelae of sprains and strains (ankle joint)

[0181] Patient Zhou, female, 28 years old, athlete. One year ago, she sprained her ankle and did not fully recover, leaving residual swelling and pain, which worsened with activity and was significantly aggravated by cold exposure. The local skin color was slightly dark, her tongue was pale and dark with a thin white coating, and her pulse was choppy. After one week of treatment, the swelling decreased and the pain subsided; after three weeks, the swelling disappeared and the pain essentially disappeared; after four weeks, her activity returned to normal, and she had no discomfort, thus being deemed cured.

[0182] Case 7: Ankylosing spondylitis (early stage):

[0183] Patient Wu, male, 33 years old, programmer. He presented with lumbosacral pain and stiffness for 6 months, with significant stiffness upon waking, relieved after one hour of activity. A CT scan of the sacroiliac joint showed mild inflammation. His tongue was dark with a white coating, and his pulse was wiry and tense. After 2 weeks of treatment, the lumbosacral pain lessened, and the duration of stiffness shortened; after 4 weeks, the pain disappeared, there was no morning stiffness, and he could move freely, which was deemed a significant effect (no recurrence during 3 months of follow-up, and normal activity).

[0184] Case 8: Tennis elbow (lateral epicondylitis):

[0185] Patient Zheng, female, 35 years old, chef. She had experienced right elbow pain for 3 months, which worsened when wringing towels or lifting heavy objects. Significant tenderness was present at the lateral epicondyle of the humerus. Her tongue was pale red with a thin white coating, and her pulse was slow. After one week of treatment, the pain lessened; after two weeks, the pain essentially disappeared; and after four weeks, there was no tenderness, and she could perform normal work without discomfort. She was deemed cured.

[0186] Case 9: Sciatica

[0187] Patient Chen, male, 45 years old, driver. He had experienced pain in his right buttock and lower limb along the sciatic nerve distribution area for 2 years, which worsened with coughing and sneezing. He also experienced decreased sensation in his lower limbs, a purplish-dark tongue with a white, greasy coating, and a choppy pulse. After 3 weeks of treatment, the pain lessened and sensation returned; after 4 weeks, the pain completely disappeared, and he was able to drive normally without discomfort. He was deemed cured.

[0188] Case 10: Knee osteoarthritis (degenerative):

[0189] Patient Jia, female, 65 years old, retired cadre. She had suffered from bilateral knee pain for 5 years, experiencing difficulty climbing stairs, with noticeable joint crepitus. X-ray showed narrowing of the joint space. Her tongue was dark with a white coating, and her pulse was thready and wiry. After 2 weeks of treatment, the pain lessened, and climbing stairs improved; after 4 weeks, the pain essentially disappeared, and she could climb stairs and walk normally. This was deemed a significant improvement (good recovery of joint function, no significant discomfort).

[0190] VII. Conclusion:

[0191] This black plaster formula for dispelling wind, relieving pain, promoting blood circulation, and removing blood stasis is based on the holistic concept, syndrome differentiation and treatment, and Yin-Yang and Five Elements theory of Traditional Chinese Medicine. It involves the scientific combination of multiple carefully selected Chinese medicinal herbs, and standardized processing enhances efficacy and reduces toxicity. The preparation process is mature and controllable. Pharmacological studies and clinical trials have shown that this plaster can effectively improve symptoms such as pain and swelling caused by wind-cold-dampness syndrome combined with blood stasis through the synergistic effects of dispelling wind and cold, promoting blood circulation, removing blood stasis, and reducing inflammation and pain. It also demonstrates high safety and significant clinical application value.

[0192] The beneficial effects are as follows:

[0193] I. The formula is scientifically precise, resulting in outstanding targeted therapeutic effects:

[0194] 1. The combination of principal, assistant, adjuvant, and guide herbs is rigorous: Panax notoginseng and Angelica sinensis are used as the principal herbs to firmly grasp the core pathogenesis of "activating blood circulation and removing blood stasis, relieving pain and nourishing blood"; while Ligusticum chuanxiong, Angelica pubescens, and other assistant herbs are used to take into account "dispelling wind and cold, promoting qi and unblocking collaterals". For complex syndromes where wind-cold-dampness and blood stasis coexist, the combination of "eliminating pathogens and supporting the body's resistance" is achieved, avoiding the limitations of efficacy caused by single symptom-based treatment.

[0195] 2. Strong targeting: Through processing methods such as salt-processing and ginger-processing, the drug is guided to the meridian (e.g., salt-processed Angelica pubescens enters the kidney meridian, and ginger-processed Ligusticum chuanxiong enhances its cold-dispelling and targeting effects). Combined with the transdermal penetration-enhancing effects of musk and borneol, the effective ingredients can be precisely applied to the lesion site (e.g., the pain point of neck, shoulder, waist and leg pain), resulting in a high local drug concentration and faster onset of action.

[0196] 3. Mild and Safe Medicinal Properties: The processing method involves using wine to moderate the rich and cloying nature of Angelica sinensis, stir-frying with wheat bran to reduce the pungent and drying nature of Notopterygium incisum, and processing with vinegar to reduce the irritation of frankincense and myrrh. This preserves the efficacy of each herb while avoiding the toxic side effects of raw herbs, making it suitable for long-term external use. II. Optimized Processing Technology, Dual Enhancement of Efficacy and Safety

[0197] 1. Enhanced efficacy: Customized processing schemes are designed for different medicinal materials. For example, wine-processing of Panax notoginseng enhances its blood-activating and stasis-removing power, while vinegar-processing of frankincense and myrrh enhances its analgesic effect. At the same time, the texture of the medicinal materials becomes crisp after stir-frying, which facilitates the dissolution of effective components (such as ginsenosides and volatile oils), greatly improving the efficacy per unit dose.

[0198] 2. Reduced toxicity risk: After being roasted at high temperature, some toxic lead compounds in Huangdan are transformed into a form with high stability and low toxicity. Combined with the "detoxification" process to remove free lead and irritating components, the safety risks of external use are significantly reduced. Musk and borneol are ground into powder separately and added at low temperature to avoid the destruction of their volatile active ingredients (such as muscone and borneol) by high temperature, thus ensuring the efficacy of guiding and directing the medicine.

[0199] 3. Enhance the applicability of medicinal materials: Methods such as honey-processing and wheat bran-frying are used to mitigate the harshness of medicinal materials (e.g., honey-processing of Saposhnikovia divaricata "dispels wind without harming the body's vital energy"), reducing skin irritation and expanding the applicable population, making it more tolerable even for those with weak constitutions or sensitive skin. III. The preparation process is mature and controllable, ensuring stable and reliable product quality.

[0200] 1. High degree of process standardization: Key parameters such as oil refining temperature (220-240℃), oil pill reaction conditions (280-300℃), and detoxification time (7-10 days) are clearly defined, avoiding quality fluctuations caused by "experience-based operation" in the traditional black plaster preparation, and ensuring consistency of efficacy between batches.

[0201] 2. Significant advantages of dosage form: Using refined sesame oil as a fat-soluble matrix, it can fully dissolve the fat-soluble active ingredients in the medicinal materials, forming a stable drug release system, so that the efficacy can be sustained on the affected area (each patch can maintain the effect for 2 days), which is far longer than the effect of ordinary topical preparations; the backing material fits the skin, is convenient to use, and does not affect daily activities.

[0202] 3. Thorough Safety Control: Impurities are removed through multiple filtration processes (three-layer gauze filtration of the medicinal oil, and sieving with litharge), combined with a detoxification process to eliminate residual harmful substances. Clinical trials have shown that only a very small number of people experienced mild skin itching, with no serious adverse reactions. Its external safety is superior to similar preparations. IV. Empowered by Traditional Chinese Medicine Theory, Achieving Both Symptoms and Root Cause Treatment

[0203] 1. Adhering to the holistic concept: It not only treats the symptoms of local pain and swelling, but also improves the malnutrition of muscles and bones from the root by regulating liver and kidney function (such as using Chuanxiong to soothe the liver and Duhuo to tonify the kidney) and taking into account the balance of Qi, blood, Yin and Yang (Qi circulation and blood tonification in synergy), thereby reducing the recurrence of the disease and achieving the unity of "local treatment and overall conditioning".

[0204] 2. Wide applicability: It accurately corresponds to "wind-cold-dampness arthralgia with blood stasis and obstruction of collaterals syndrome", covering a variety of common diseases such as neck, shoulder, waist and leg pain, sequelae of traumatic injuries, and rheumatoid arthritis. There is no need to adjust the formula for a single disease, and it is applicable to a wide range of scenarios.

[0205] 3. Combination of Inheritance and Innovation: Guided by the theory of Yin and Yang and the Five Elements, this formula regulates organ function through "replenishing water to nourish wood" (tonifying the kidneys and soothing the liver). It inherits the essence of traditional black plaster formulations while utilizing modern processing techniques and quality control methods to address the pain points of traditional preparations, such as "unstable efficacy and difficult-to-control toxicity," thus achieving an organic integration of traditional Chinese medicine theory and modern preparation technology. V. High Clinical Application Value and Strong Practicality 1. Definite Efficacy: Pharmacological experiments have confirmed that it can significantly inhibit inflammatory responses (reducing TNF-α and IL-6 levels), improve blood rheology (reducing whole blood viscosity), and enhance analgesic effects (prolonging the pain threshold in mice). Clinical trials have verified a total effective rate of 92.5%, significantly superior to conventional topical preparations, effectively relieving patients' core symptoms such as pain and swelling.

[0206] 2. Convenient to use and with high compliance: The external application method avoids the gastrointestinal irritation of oral medications, making it especially suitable for middle-aged and elderly patients with weak spleen and stomach function; each patch has a uniform weight (5-10g), is easy to use, can be replaced by oneself, and meets daily care needs.

[0207] 3. Great industrialization potential: The raw materials for the formula are readily available, the preparation process does not require special equipment, key parameters can be standardized and controlled, which facilitates large-scale production; the product has high safety, stable efficacy, and both medical and health care value, with broad market application prospects.

[0208] 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 kind of dispelling wind and relieving pain and activating blood and removing blood stasis black plaster, characterized in that: it is composed of medicinal material components and matrix components, and the weight parts are as follows: The medicinal material components include: Sanqi 30-40 parts, Chuanqiong 25-35 parts, Honghua 20-30 parts, Duhuo 25-35 parts, Qianghuo 20-30 parts, Fangfeng 18-25 parts, Ru Xiang 15-25 parts, Mody 15-25 parts, Tougucao 20-30 parts, Shenjincao 18-25 parts, Dilong 15-20 parts, Quanxie 10-15 parts, Danggui 20-30 parts, Chishao 18-25 parts, Bingfen 8-12 parts, Camphor 6-10 parts, Menthol 5-8 parts; The matrix components include: sesame oil 1000-1200 parts, red lead 300-350 parts, beeswax 20-30 parts, lanolin 15-20 parts.

2. A preparation process of the black plaster of claim 1, characterized in that: it comprises the following steps: (1) raw material pretreatment: Sanqi, Chuanqiong, Honghua, Duhuo, Qianghuo, Fangfeng, Ru Xiang, Mody, Danggui, Chishao, Tougucao and Shenjincao are sequentially cleaned, dried and then crushed into 20-40 mesh coarse powder; Dilong and Quanxie are dried at 40-50℃ after removing impurities, and then crushed into 40-60 mesh fine powder; Bingfen, Camphor and Menthol are respectively ground into more than 80 mesh fine powder and then sealed and stored in dark; Sesame oil is heated to 100-120℃ in a stainless steel container for 30 minutes and then cooled to room temperature; Red lead is sieved through 80 mesh and then dried to ≤1% moisture content; (2) frying: the pretreated sesame oil in step (1) is heated to 160-180℃, and then 20-40 mesh coarse powder is added, and the temperature is maintained for 2-3 hours with continuous stirring until the surface of the medicinal material is dark brown and the inside is white-free, and then the medicinal oil is collected by filtering through a 120 mesh stainless steel screen while hot; (3) oil refining: the medicinal oil is heated to 220-240℃ with continuous stirring and removal of surface scum until a small amount of medicinal oil dropped into cold water can quickly solidify into beads, the texture is hard and not sticky, and it floats on the water surface; (4) adding red lead and collecting the plaster: the temperature of the medicinal oil is maintained at 200-220℃, and red lead is added into the medicinal oil in five equal portions, each portion is stirred at a speed of ≥60 r / min until it is evenly dispersed, after all the red lead is added, the stirring is continued for 30-40 minutes, and then beeswax and lanolin are added, and the stirring is continued until they are completely melted and uniformly mixed, and then the temperature is cooled to 100-120℃; (5) adding fine powder: the temperature of the plaster is cooled to 80-90℃, and then Dilong and Quanxie fine powder are added, and the stirring is continued at a speed of ≥60 r / min for 15-20 minutes; the temperature is continuously cooled to 60-70℃, and then Bingfen, Camphor and Menthol fine powder are added, and the stirring is continued for 10-15 minutes until they are uniformly mixed; (6) removing fire toxin: after the plaster is naturally cooled to room temperature, it is stored in a 4-8℃ environment for 24 hours; after being taken out, it is cut into blocks with an edge length of 3-5 cm, and then soaked in purified water for 72 hours, and the purified water is replaced once a day during the soaking; after being taken out, it is dried at 60-70℃ until the moisture content is ≤5%. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ (7)Spreading: the dried paste is heated to 80-90℃ to melt into paste, and then is uniformly spread on the non-woven fabric substrate by using an automatic spreading machine, the thickness of the paste is controlled to be 0.5-0.8mm, the weight of each paste is controlled to be 5-10g, and then the paste is cooled to room temperature and is covered with a protective layer, and then is cut and packaged. 3.The wind-eliminating and pain-relieving blood-activating and stasis-dissolving black plaster according to claim 1, characterized in that: in the medicinal material components, the following components are contained by weight: 32-38 parts of notoginseng, 28-32 parts of chuanxiong, and 22-28 parts of safflower; wherein the notoginseng is selected from dry products with taproot diameter of 1.5-2.5cm, and the total content of ginsenoside Rg1 and Rb1 is greater than or equal to 5.0%; the chuanxiong is selected from dry rhizomes with yellow-white cross section and strong aroma, and the content of ferulic acid is greater than or equal to 0.1%; the safflower is selected from tubular flowers without ovaries, and the content of carthamin is greater than or equal to 1.5%, and the synergistic effect of the three components can significantly enhance the core effects of blood-activating and stasis-dissolving, collateral-dredging and pain-stopping, and the dissolution rate of effective components is increased by 12-18% compared with other ratios. 4.The wind-eliminating and pain-relieving blood-activating and stasis-dissolving black plaster according to claim 1, characterized in that: in the medicinal material components, the following components are contained by weight: 28-32 parts of rhizoma lepidii, 22-28 parts of notopterygii, 20-23 parts of saposhnikovia divaricata, 18-22 parts of olibanum, and 18-22 parts of myrrh; wherein the rhizoma lepidii is selected from rhizoma lepidii from Sichuan, and the content of ostruthin is greater than or equal to 0.5%; the notopterygii is selected from notopterygii from Sichuan, and the content of volatile oil is greater than or equal to 2.8%; the saposhnikovia divaricata is selected from saposhnikovia divaricata from Guanxi, and the total content of rhizomastachyol and 5-O-methylvisamminol is greater than or equal to 0.24%; the olibanum and myrrh are both selected from imported products from Somalia, the total content of olibanic acid is greater than or equal to 20%, and the total content of myrrholic acid is greater than or equal to 3.0%; under the above ratio, the rhizoma lepidii and notopterygii can enhance the effects of wind-eliminating and dampness-eliminating, the saposhnikovia divaricata can enhance the effects of anti-inflammation and pain-relieving, the olibanum and myrrh can synergistically enhance the effects of swelling-stopping and pain-relieving, and can reduce the skin irritation caused by high dosage of single medicinal material. 5.The wind-eliminating and pain-relieving blood-activating and stasis-dissolving black plaster according to claim 1, characterized in that: in the medicinal material components, the following components are contained by weight: 22-28 parts of rhizoma bistortae, 20-23 parts of rhizoma valerianae, 16-18 parts of lumbricus, 12-14 parts of scolopendra, 22-28 parts of angelica sinensis, and 20-23 parts of radix paeoniae rubra; wherein the rhizoma bistortae and rhizoma valerianae are both selected from dry aboveground parts, and the contents of volatile oil are greater than or equal to 0.3% and 0.2%, respectively; the lumbricus is selected from lumbricus from Guangdong, and the content of hypoxanthine is greater than or equal to 0.10%; the scolopendra is selected from scolopendra from Qinghai, and the content of scorpion toxin protein is greater than or equal to 30%; the angelica sinensis is selected from angelica sinensis from Min, and the content of ferulic acid is greater than or equal to 0.05%; the radix paeoniae rubra is selected from radix paeoniae rubra from Bo, and the content of paeoniflorin is greater than or equal to 1.8%; under the above ratio, the rhizoma bistortae and rhizoma valerianae can promote the transdermal absorption of the medicinal materials, the lumbricus and scolopendra can specifically relieve spastic pain, and the angelica sinensis and radix paeoniae rubra can nourish blood and activate blood to protect the healthy qi and avoid excessive blood-activating from damaging yin blood. 6.The wind-eliminating and pain-relieving blood-activating and stasis-dissolving black plaster according to claim 1, characterized in that: in the medicinal material components, the following components are contained by weight: 9-11 parts of borneol, 7-9 parts of camphor, and 6-7 parts of menthol; wherein the borneol is natural borneol, and the content of borneol is greater than or equal to 96%; the camphor is natural camphor, and the content of camphor is greater than or equal to 96%. Menthol is L-menthol, content ≥95%; Under this proportion, borneol and camphor can enhance drug permeability by opening the skin keratin layer channel, guide the monarch drug and ministerial drug to the lesion, menthol can relieve local pain and discomfort through the cooling sensation, and the synergistic effect of the three can prolong the drug action time to more than 48 hours, while avoiding the risk of skin allergy caused by excessive dosage.

7. The wind-dissipating and pain-relieving blood-activating and stasis-removing black plaster according to claim 1, characterized in that: In the base component, by weight: sesame oil 1050-1150 parts, red lead 310-340 parts, beeswax 22-28 parts, lanolin 16-19 parts; The sesame oil is first-grade pressed sesame oil, and the content of unsaturated fatty acids is ≥90%; The red lead is red lead, and the lead content is ≥95% and the moisture content is ≤0.5%; the beeswax is yellow beeswax, and the acid value is 20-30 mgKOH / g; The lanolin is anhydrous lanolin, and the fat content is ≥99%; Under this proportion, the sesame oil can fully dissolve the fat-soluble active ingredients in the medicinal materials, the fatty acid lead salt generated by the reaction of red lead and sesame oil can ensure moderate stickiness of the plaster, the beeswax can adjust the hardness of the plaster to 25-30 Shore A, and the lanolin can enhance the compatibility of the plaster with the skin, reducing the skin irritation by 30-40%.

8. The preparation process according to claim 2, characterized in that: In step (2), the frying process uses a stainless steel sandwich pot heated by water bath, and the temperature fluctuation is controlled within ±5℃. The stirring mode is mechanical stirring, and the stirring paddle speed is 30-40 r / min, stirring once every 30 seconds to ensure that the medicinal materials and sesame oil are in full contact. The judgment of the end of frying also includes: after grinding the medicinal materials, adding ethanol for ultrasonic extraction, the absorbance of the filtrate at 280 nm wavelength is 0.6-0.8, the color of the medicinal oil is dark brown, the transparency is uniform, and there is no obvious particle precipitation. Under this condition, the retention rate of active ingredients in medicinal materials can reach more than 85%, while avoiding excessive carbonization.

9. The preparation process according to claim 2, characterized in that: In step (4), the interval time for adding red lead each time is 5-8 minutes, and the red lead is slowly poured along the container wall in a spiral shape when added, and the dust is collected by a negative pressure exhaust device; the stirring direction is clockwise uniform stirring, and the stirring paddle is inserted to a depth of 2 / 3 of the height of the plaster in the container, to ensure that the red lead and medicinal oil react fully; the plaster temperature needs to be monitored in real time during the reaction process to avoid local temperature exceeding 230℃, and the stirring is stopped when the viscosity of the plaster reaches 5000-6000 mPa·s. At this time, the plaster is dark brown, fine and particle-free, and the content of fatty acid lead salt is 25-30%.

10. The preparation process according to claim 2, characterized in that: The non-woven fabric substrate in step (7) is a spunlace non-woven fabric with a unit area weight of 30-50 g / m 2 , a thickness of 0.15-0.2 mm, and an air permeability of 500-800 mm / s; the relative humidity of the spreading environment is controlled at 40-60%, and the temperature is 20-25°C; the spreading speed of the automatic spreading machine is 0.5-1 m / min, and the distance error between the scraper and the substrate is ≤0.02 mm; the protective layer is a polyethylene film with a thickness of 0.02-0.03 mm and a light transmittance of ≤10%; the cutting size is 5 cm×7 cm or 7 cm×10 cm in two specifications; and the packaging is performed by using an aluminum-plastic composite bag, and the vacuum degree after sealing is ≤-0.08 MPa, which can ensure that the spreading uniformity of the paste is ≥95% and effectively prevent the loss of volatile components.

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