A compound plaster for promoting blood circulation and relieving pain and its preparation method

Abstract

This invention provides a compound plaster for promoting blood circulation and relieving pain, and its preparation method. It relates to the field of pharmaceutical technology and is made from a variety of medicinal materials, including white-flowered snake, red peony root, peach kernel, centipede, aconite, scorpion, and drynaria, combined with litharge and sesame oil. The optimal ratio was determined through scientific screening, forming a compound system that "dispels wind and unblocks meridians, invigorates blood and removes blood stasis, eliminates dampness and relieves pain, and strengthens the body's resistance." It balances rapid onset of action with consolidation of therapeutic effects while reducing the risk of skin irritation. The preparation method includes raw material pretreatment, 30-day sealed soaking in sesame oil, gradient temperature cooking to remove residue, and forming the plaster. Through long-term soaking and gradient cooking processes, the dissolution rate of effective ingredients is significantly improved. This invention is suitable for relieving pain and limited limb movement caused by bone, joint, and soft tissue diseases such as frozen shoulder, cervical spondylosis, and lumbar muscle strain. It is convenient to use, has definite curative effects, and has good application prospects.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a compound plaster for promoting blood circulation and relieving pain and its preparation method. Background Technology

[0002] With the fast pace of modern life, the proportion of people with unhealthy lifestyles such as prolonged desk work, looking down at electronic devices, and lack of exercise is increasing year by year. Consequently, the incidence of bone, joint, and soft tissue diseases such as frozen shoulder, cervical spondylosis, and lumbar muscle strain is also rising, and showing a trend towards affecting younger people. The core pathogenesis of these diseases is the invasion of external pathogens, blockage of meridians and collaterals, and blood stasis. Clinical manifestations include local pain and limited limb movement, severely impacting patients' daily life and work efficiency.

[0003] Currently, clinical treatment for the above-mentioned diseases mainly involves topical ointments, oral medications, and physical therapy. Among these, topical ointments have become the first choice for most patients with mild symptoms due to their advantages such as ease of use, direct action on the lesion, and minimal systemic side effects.

[0004] However, existing plasters for clearing meridians and activating collaterals generally suffer from problems such as single raw material formulation, low dissolution rate of effective ingredients, poor effect on clearing meridians and activating collaterals, and slow onset of action. They are unable to fundamentally solve the core cause of "meridian blockage and blood stasis" and cannot meet patients' needs for efficient and rapid pain relief. Summary of the Invention

[0005] The purpose of this invention is to provide a canned tonic of *Anoectochilus roxburghii* (a type of orchid), ginseng, and free-range chicken, and its preparation method, in order to overcome the shortcomings of the prior art.

[0006] To achieve the above-mentioned objectives, the technical solution adopted by this invention is as follows: A compound plaster for promoting blood circulation and relieving pain, and its preparation method, comprising the following raw materials: White-flowered snake 1-4 jin, red peony root 1-4 jin, peach kernel 1-4 jin, notopterygium root 1-4 jin, angelica root 1-4 jin, corydalis rhizome 1-4 jin, coptis root 1-4 jin, earthworm 1-4 jin, ground beetle 1-4 jin, centipede 40-80 pieces, aconite root 1-4 jin, aconite root 1-4 jin, whole scorpion 1-4 jin, drynaria rhizome 1-4 jin, saposhnikovia root 1-4 jin, human placenta 1-4 jin, mulberry mistletoe 1-4 jin, papaya 1-4 jin, gentian root 1-4 jin, clematis root 1-4 jin, chuanxiong rhizome 1-4 jin, angelica root 1-4 jin, sophora root 1-4 jin, cnidium fruit 1-4 jin, peony bark 1-4 jin, litharge 16-24 jin, sesame oil 30-60 jin.

[0007] As an improvement, the optimal ratio of raw materials is as follows: 2.5 jin of white-flowered snake, 2.5 jin of red peony root, 2.5 jin of peach kernel, 2.5 jin of notopterygium root, 2.5 jin of angelica root, 2.5 jin of corydalis rhizome, 2.5 jin of coptis root, 2.5 jin of earthworm, 2.5 jin of ground beetle, 60 centipedes, 2.5 jin of aconite root, 2.5 jin of aconite root, 2.5 jin of whole scorpion, 2.5 jin of drynaria rhizome, 2.5 jin of saposhnikovia root, 2.5 jin of human placenta, 2.5 jin of mulberry mistletoe, 2.5 jin of papaya, 2.5 jin of gentian root, 2.5 jin of clematis root, 2.5 jin of chuanxiong rhizome, 2.5 jin of angelica root, 2.5 jin of sophora root, 2.5 jin of cnidium fruit, 2.5 jin of peony bark, 20 jin of litharge, and 45 jin of sesame oil.

[0008] As an improvement, the preparation method includes the following steps: Step 1: Raw material pretreatment: Weigh the corresponding weight of each raw material. Remove the head and scales of the white flower snake and the legs and wings of the centipede. Crush them into coarse powder. Wash the remaining medicinal materials, remove impurities, dry them, and then cut them into sections or slices for later use. Step 2, Soaking and Extraction: Place all the pretreated medicinal materials except for litharge in the weighed sesame oil, seal and soak for 30 days, stirring once every 7 days during the period to obtain the first mixture; Step 3, Decoction and Removal of Dregs: Place the first mixture obtained in Step 2 in a copper pot and simmer over high heat at 400℃-500℃ for 30-60 minutes, stirring continuously. When the surface of the medicinal material turns dark brown and there is no white core inside, reduce the heat to low at 200℃-250℃ and continue simmering for 10-15 minutes. Then filter to remove the dregs and obtain a clear medicinal liquid. The endpoint of the decoction is determined by dropping a small amount of the liquid into cold water. The liquid floats in the center of the water and coagulates into a round bead that is not sticky and does not disperse. Step 4, Forming the paste: Place the medicinal liquid obtained in Step 3 back into the copper pot and heat it over a low flame at 100℃-150℃. Slowly add the weighed litharge while stirring at a speed of 35-45 rpm. Cook until the paste is thick, can be lifted into threads, and can solidify into a round bead when dropped into cold water. Stop heating and let it cool naturally to 50℃-60℃ to obtain the meridian-activating compound plaster.

[0009] As an improvement, three layers of gauze are used for filtration in step 3.

[0010] As an improvement, in step 4, the cooled plaster is evenly applied to non-woven fabric or medical tape, cut into appropriate sizes, and then sealed and packaged.

[0011] As an improvement, in step 3, the high-heat simmering temperature is 400℃ and the simmering time is 60 minutes, while the low-heat simmering temperature is 200℃ and the simmering time is 15 minutes.

[0012] As an improvement, in step 3, the high-heat simmering temperature is 500℃ and the simmering time is 30 minutes, while the low-heat simmering temperature is 250℃ and the simmering time is 10 minutes.

[0013] As an improvement, in step 3, the high-heat simmering temperature is 450℃ and the simmering time is 45 minutes, while the low-heat simmering temperature is 220℃ and the simmering time is 12 minutes; in step 4, the low-heat heating temperature is 120℃, the stirring speed is 40 rpm, and the natural cooling temperature is 55℃.

[0014] The beneficial effects of this invention are as follows: This invention selects insect-based medicinal materials such as white-flowered snake, centipede, and whole scorpion to dispel wind and unblock the meridians as the principal medicine, combined with blood-activating and stasis-removing medicinal materials such as red peony root, peach kernel, and chuanxiong rhizome, as well as wind-dispelling and dampness-removing medicinal materials such as notopterygium root, angelica root, and clematis root, supplemented with angelica to nourish blood and drynaria root to strengthen bones, forming a compound system of "dispelling wind and unblocking the meridians, activating blood and removing stasis, removing dampness and relieving pain, and strengthening the body's resistance and consolidating the foundation". It not only targets the core pathogenesis of "meridian blockage and blood stasis" to take effect quickly, but also takes into account nourishing the liver and kidneys and strengthening tendons and bones to consolidate the curative effect and prevent the recurrence of bone and joint diseases, thus solving the problem of existing plasters having a single formula and treating the symptoms but not the root cause. The preparation process employs a method of sealing and soaking in sesame oil for 30 days, followed by a gradient temperature cooking process. Sesame oil, as an excellent fat-soluble solvent, can fully dissolve the fat-soluble active ingredients in the medicinal materials. The long-term sealed soaking combined with high-temperature extraction over a strong fire and low-temperature concentration steps can promote the release and enrichment of active ingredients in the medicinal materials, and significantly improve the dissolution rate of active ingredients. Herbs such as Sophora flavescens, Cnidium monnieri, and Coptis chinensis, which clear heat, dry dampness, dispel wind, and relieve itching, can inhibit the drying properties of warm herbs and reduce the risk of skin irritation. Attached Figure Description

[0015] Figure 1 This is a process flow diagram of a compound plaster for promoting blood circulation and relieving pain, and its preparation method, according to the present invention. Detailed Implementation

[0016] The invention will be more readily understood by referring to the following detailed description of preferred embodiments and included examples. Unless otherwise specified, 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 invention pertains. In case of conflict, the definitions in this specification shall prevail.

[0017] As used herein, the terms “prepared from” and “comprising” are synonymous. The terms “comprising,” “including,” “having,” “containing,” or any other variations thereof, as used herein, are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0018] The conjunction "composed of..." excludes any unspecified elements, steps, or components. If used in a claim, this phrase makes the claim closed, excluding materials other than those described, except for conventional impurities associated with them. When the phrase "composed of..." appears in a clause of the body of a claim rather than immediately following it, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0019] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1 to 5” is disclosed, the described range should be interpreted as including the ranges “1 to 4”, “1 to 3”, “1 to 2”, “1 to 2 and 4 to 5”, “1 to 3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0020] The singular form includes the plural objects of discussion unless the context clearly indicates otherwise. "Optional" or "any one" means that the matter or event described thereafter may or may not occur, and the description includes both the possibility that the event occurs and the possibility that the event does not occur.

[0021] Approximate terms used in the specification and claims to modify quantities indicate that the invention is not limited to that specific quantity, but also includes acceptable modifications close to that quantity that do not alter the relevant essential function. Correspondingly, the use of "about," "approximately," etc., to modify a numerical value means that the invention is not limited to that precise value. In some instances, approximate terms may correspond to the precision of the instrument used to measure the value. In this application's specification and claims, scope definitions can be combined and / or interchanged, unless otherwise stated, these scopes include all subscopes contained therein.

[0022] Furthermore, the indefinite articles “a” and “an” preceding the elements or components of this invention do not impose any limitation on the quantity (i.e., number of times) of the elements or components. Therefore, “an” or “a” should be interpreted as including one or at least one, and the singular form of an element or component also includes the plural form, unless the quantity clearly refers to the singular form.

[0023] Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.

[0024] The TCM efficacy of each ingredient and its role in plasters: White-flowered snake: dispels wind and unblocks the meridians, calms the nerves and stops spasms; as the principal herb, it is specifically used to treat rheumatic pain and muscle spasms, and can effectively clear blocked meridians and relieve symptoms of numbness and limited mobility in the limbs.

[0025] Red peony root: Clears heat and cools blood, disperses blood stasis and relieves pain; assists the principal herb in dispersing blood stasis and improving local redness, swelling, heat and pain, especially suitable for pain caused by blood stasis.

[0026] Peach kernels: promote blood circulation and remove blood stasis, moisten the intestines and relieve constipation; enhance the blood circulation and remove blood stasis effects of plasters, promote the metabolism and excretion of blood stasis, and relieve meridian blockage.

[0027] Notopterygium root: relieves exterior symptoms and dispels cold, eliminates wind and dampness, and relieves pain; it is especially effective for rheumatic pain in the upper body, such as pain caused by cervical spondylosis and frozen shoulder, and helps to dispel wind and dampness in the meridians.

[0028] Angelica pubescens: dispels wind and dampness, relieves pain and numbness; it is especially effective for rheumatic pain in the lower body, such as pain caused by lumbar muscle strain and lumbar disc herniation. It works synergistically with Notopterygium incisum to cover all areas of pain throughout the body.

[0029] Corydalis: promotes blood circulation, regulates qi, and relieves pain; it is a "good medicine for pain relief" and can alleviate pain caused by various blood stasis and improve the speed of pain relief of plasters.

[0030] Coptis chinensis: Clears heat and dries dampness, drains fire and detoxifies; inhibits the drying properties of warm and hot medicinal materials in plasters, and relieves skin irritation symptoms such as redness, swelling and itching that may occur at the external application site.

[0031] Earthworm: Clears heat and calms wind, unblocks meridians, and promotes diuresis. It enhances the effect of the principal herb in unblocking meridians and activating blood circulation, while also guiding the medicine downwards to help improve symptoms of lower limb numbness and pain.

[0032] Ground beetle: It breaks up blood stasis and promotes the healing of tendons and bones; it is effective for diseases caused by blood stasis and tendon and bone injuries, such as ligament sprains, and accelerates the repair of damaged areas.

[0033] Centipede: It can calm wind and relieve spasms, attack toxins and dissipate nodules, and unblock meridians and relieve pain. When combined with white-flowered snake and whole scorpion, it can enhance the effect of unblocking meridians and activating collaterals, and is suitable for stubborn arthralgia.

[0034] Aconitum carmichaelii and Aconitum kusnezoffii: dispel wind and dampness, warm the meridians and relieve pain; for cold-dampness arthralgia and joint pain, they can dispel cold and dampness in the meridians and relieve pain.

[0035] Whole scorpion: calms wind and relieves spasms, attacks toxins and disperses nodules, unblocks meridians and relieves pain; assists the principal drug in clearing the meridians and enhances the therapeutic effect of the plaster on pain caused by meridian blockage.

[0036] Drynaria fortunei: It tonifies the kidneys and strengthens bones, promotes healing of injuries and relieves pain; it also tonifies the liver and kidneys, strengthens tendons and bones, consolidates therapeutic effects, and prevents recurrence of bone and joint diseases.

[0037] Fangfeng: dispels wind and releases the exterior, eliminates dampness and relieves pain, stops spasms; it also helps to dispel wind evil in the meridians and relieve limb contracture and pain caused by wind evil invasion.

[0038] Human placenta extract: Clears heat and reduces inflammation, stops bleeding and removes blood stasis. Relieves local redness, swelling, heat and pain, especially suitable for pain symptoms caused by blood stasis and heat.

[0039] Mistletoe: dispels wind and dampness, tonifies the liver and kidneys, and strengthens muscles and bones; it takes into account both eliminating pathogens and supporting the body's resistance, and while dispelling wind and dampness, it also tonifies the liver and kidneys and strengthens muscles and bones, making it suitable for long-term use by middle-aged and elderly patients.

[0040] Papaya: It relaxes muscles and tendons, harmonizes the stomach and eliminates dampness; it relieves muscle spasms and improves limited limb movement, and is especially suitable for pain caused by muscle tension.

[0041] Gentiana macrophylla: dispels wind and dampness, unblocks meridians and relieves pain, reduces deficiency heat; suitable for rheumatic arthralgia, red, swollen and hot joint pain, and also has heat-clearing effects, suitable for damp-heat type arthralgia.

[0042] Clematis chinensis: dispels wind and dampness, unblocks meridians and relieves pain, and dissolves fish bones stuck in the throat; enhances the effects of plasters in unblocking meridians and relieving pain, and has a significant effect on stubborn arthralgia.

[0043] Chuanxiong (Ligusticum striatum): It invigorates blood and qi, dispels wind and relieves pain; it is a "qi-regulating herb in the blood", which can promote the circulation of qi and blood, enhance the effect of invigorating blood and removing blood stasis, and relieve pain caused by qi stagnation and blood stasis.

[0044] Angelica sinensis: It nourishes and invigorates blood, regulates menstruation and relieves pain; it combines the functions of invigorating and nourishing blood, and prevents the invigoration of blood from damaging the body's vital energy. It is suitable for patients with deficiency of qi and blood accompanied by blood stasis.

[0045] Sophora flavescens: Clears heat and dries dampness, kills parasites, and promotes diuresis; relieves skin itching at the external application site and enhances the skin adaptability of the plaster.

[0046] Cnidium monnieri: warms the kidneys and strengthens yang, dries dampness and kills parasites, dispels wind and relieves itching; further enhances the skin-friendly properties of the plaster and prevents skin allergies.

[0047] Moutan bark: Clears heat and cools blood, promotes blood circulation and removes blood stasis; helps to dissipate blood stasis, while clearing heat and reducing fire, relieving discomfort caused by heat from blood stasis.

[0048] Lithium sibiricum: detoxifies, promotes tissue regeneration, and astringes sores; as a base for plasters, it can both carry effective ingredients and promote drug penetration and absorption, while also promoting tissue regeneration and astringing sores.

[0049] Sesame oil: moisturizes dryness, detoxifies, and promotes tissue regeneration; as a solvent and matrix, it dissolves the effective components of medicinal materials, carries ointments, and protects the skin while reducing irritation. Example 1:

[0050] A compound plaster for promoting blood circulation and relieving pain includes the following ingredients: 1 jin of white-flowered snake, 1 jin of red peony root, 1 jin of peach kernel, 1 jin of notopterygium root, 1 jin of angelica root, 1 jin of corydalis rhizome, 1 jin of coptis root, 1 jin of earthworm, 1 jin of ground beetle, 40 centipedes, 1 jin of aconite root, 1 jin of aconite root, 1 jin of whole scorpion, 1 jin of drynaria rhizome, 1 jin of saposhnikovia root, 1 jin of human placenta, 1 jin of mulberry mistletoe, 1 jin of papaya, 1 jin of gentian root, 1 jin of clematis root, 1 jin of chuanxiong rhizome, 1 jin of angelica root, 1 jin of sophora root, 1 jin of cnidium fruit, 1 jin of peony bark, 16 jin of litharge, and 30 jin of sesame oil.

[0051] The preparation method includes the following steps: Step 1: Raw material pretreatment: Weigh each raw material according to the above weights. Remove the head and scales of the white-flowered snake and crush it into coarse powder. Remove the legs and wings of the centipede and crush it into coarse powder. Wash and dry the remaining medicinal materials and cut them into sections for later use.

[0052] Step 2, Soaking and Extraction: Place the pretreated medicinal materials, excluding litharge, in 30 catties of sesame oil, seal and soak for 30 days, stirring once every 7 days during this period to obtain the first mixture.

[0053] Step 3, Decoction and Removal of Dregs: Place the first mixture in a copper pot, simmer over high heat at 400℃ for 60 minutes, then simmer over low heat at 200℃ for 15 minutes. Filter through three layers of gauze to remove the dregs and obtain the medicinal liquid. Take a small amount of the medicinal liquid and drop it into cold water. If it coagulates into a non-sticky bead, the decoction is considered complete.

[0054] Step 4, Forming the ointment: Keep the medicinal liquid heated at 100℃ over a low flame, slowly add 16 jin of litharge, stir evenly at 35 rpm, and cook until the ointment can be lifted into threads and drop into cold water to solidify into round beads. Stop heating and cool to 50℃, spread it on a 10cm×12cm non-woven fabric, and seal it in packaging. Example 2:

[0055] A compound plaster for promoting blood circulation and relieving pain, comprising the following ingredients: 4 jin of white-flowered snake, 4 jin of red peony root, 4 jin of peach kernel, 4 jin of notopterygium root, 4 jin of angelica root, 4 jin of corydalis rhizome, 4 jin of coptis root, 4 jin of earthworm, 4 jin of ground beetle, 80 centipedes, 4 jin of aconite root, 4 jin of aconite root, 4 jin of whole scorpion, 4 jin of drynaria rhizome, 4 jin of saposhnikovia root, 4 jin of human placenta, 4 jin of mulberry mistletoe, 4 jin of papaya, 4 jin of gentian root, 4 jin of clematis root, 4 jin of chuanxiong rhizome, 4 jin of angelica root, 4 jin of sophora root, 4 jin of cnidium fruit, 4 jin of peony bark, 24 jin of litharge, and 60 jin of sesame oil.

[0056] The preparation method includes the following steps: Step 1: Raw material pretreatment: Weigh each raw material according to the above weights. Remove the head and scales of the white-flowered snake and crush it into coarse powder. Remove the legs and wings of the centipede and crush it into coarse powder. Wash and dry the remaining medicinal materials and slice them for later use.

[0057] Step 2, Soaking and Extraction: Place the pretreated medicinal materials, excluding litharge, in 60 catties of sesame oil, seal and soak for 30 days, stirring once every 7 days during this period to obtain the first mixture.

[0058] Step 3, Decoction and Removal of Dregs: Place the first mixture in a copper pot, simmer over high heat at 500℃ for 30 minutes, then simmer over low heat at 250℃ for 10 minutes. Filter through three layers of gauze to remove the dregs and obtain the medicinal liquid. Take a small amount of the medicinal liquid and drop it into cold water. If it coagulates into a non-sticky bead, the decoction is considered complete.

[0059] Step 4, Forming the ointment: Keep the medicinal liquid heated at 150℃ over a low flame, slowly add 24 jin of litharge, stir evenly at 45 rpm, and cook until the ointment can be lifted into threads and drop into cold water to solidify into round beads. Stop heating and cool to 60℃, spread it on 12cm×15cm medical tape, and seal the packaging. Example 3:

[0060] A compound plaster for promoting blood circulation and relieving pain, the raw materials are as follows (by weight): 2.5 jin of white-flowered snake, 2.5 jin of red peony root, 2.5 jin of peach kernel, 2.5 jin of notopterygium root, 2.5 jin of angelica root, 2.5 jin of corydalis rhizome, 2.5 jin of coptis root, 2.5 jin of earthworm, 2.5 jin of ground beetle, 60 centipedes, 2.5 jin of aconite root, 2.5 jin of aconite root, 2.5 jin of whole scorpion, 2.5 jin of drynaria rhizome, 2.5 jin of saposhnikovia root, 2.5 jin of human placenta, 2.5 jin of mulberry mistletoe, 2.5 jin of papaya, 2.5 jin of gentian root, 2.5 jin of clematis root, 2.5 jin of chuanxiong rhizome, 2.5 jin of angelica root, 2.5 jin of sophora root, 2.5 jin of cnidium fruit, 2.5 jin of peony bark, 20 jin of litharge, and 45 jin of sesame oil.

[0061] Step 1: Raw material pretreatment: Weigh the raw materials according to the above weights. Remove the head and scales of the white-flowered snake and crush it into coarse powder. Remove the legs and wings of the centipede and crush it into coarse powder. Wash and dry the remaining medicinal materials and cut them into sections for later use.

[0062] Step 2, Soaking and Extraction: Place the pretreated medicinal materials, except for litharge, in 45 catties of sesame oil, seal and soak for 30 days, stirring once every 7 days during this period to obtain the first mixture.

[0063] Step 3, Decoction and Removal of Dregs: Place the first mixture in a copper pot, simmer over high heat at 450℃ for 45 minutes, then simmer over low heat at 220℃ for 12 minutes. Filter through three layers of gauze to remove the dregs and obtain the medicinal liquid. Take a small amount of the medicinal liquid and drop it into cold water. If it coagulates into a non-sticky bead, the decoction is considered complete.

[0064] Step 4, Forming the ointment: Keep the medicinal liquid heated at 120℃, slowly add 20 jin of litharge, stir evenly at 40 rpm, and cook until the ointment can be lifted into threads and drop into cold water to solidify into round beads. Stop heating and cool to 55℃, spread on 11cm×13cm non-woven fabric, and seal in packaging.

[0065] Experiment Example 1: Analgesic Effect of Compound Plaster for Unblocking Meridians and Activating Collaterals I. Experimental Materials: Laboratory animals: 60 SPF-grade Kunming mice, half male and half female, weighing 20-22g, provided by the Laboratory Animal Center, Animal Production License No.: SCXK (Lu) 2025-0001.

[0066] Experimental drugs: the meridian-activating and collateral-regulating compound plaster of the present invention (prepared according to Example 3, batch number: 20250601); commercially available ordinary meridian-activating and collateral-regulating plaster (batch number: 20250315, purchased from a pharmacy); 0.5% glacial acetic acid solution (analytical grade, purchased from a chemical reagent company); physiological saline (medical grade, purchased from a pharmaceutical company).

[0067] Experimental instruments: electronic balance (accuracy 0.1mg, model: FA2004), syringe (1mL, model: 1mL disposable sterile syringe), timer (accuracy 0.01s, model: DT830B), hair removal device (model: HL-600).

[0068] II. Experimental Methods: Grouping: Sixty mice were randomly divided into three groups of 20 mice each: a blank control group, a commercially available plaster group, and the plaster group of this invention. Statistical analysis showed no significant differences in body weight and sex ratio among the groups (P>0.05), indicating comparability.

[0069] Treatment: One day before the experiment, the outer thigh of the right hind leg of each group of mice was shaved using a hair removal device, with a shaved area of ​​approximately 2cm × 2cm, ensuring no skin damage. For the plaster group of this invention and the commercially available plaster group, the corresponding plaster was cut into 1cm × 1cm pieces, applied to the shaved area, and secured with medical tape; the blank control group received sterile gauze of the same size, secured with medical tape. The dosage was 0.1g / mouse, and the application time was 4 hours.

[0070] Pain model establishment: 4 hours after administration, the plaster or gauze on each group of mice was removed, and 0.2 mL of 0.5% glacial acetic acid solution was immediately injected into the peritoneum of each group of mice using a 1 mL syringe to establish a chemical pain model.

[0071] Indicator detection: Immediately after injection of glacial acetic acid, timing was started to observe and record the number of writhing responses that occurred in each group of mice within 15 minutes (writhing response criteria: abdominal contraction, trunk twisting, hind limb extension, and hip elevation).

[0072] Statistical analysis: Data were analyzed using SPSS 26.0 statistical software. Quantitative data were expressed as (x±s). The t-test was used for comparisons between groups, and P<0.05 was considered statistically significant.

[0073] III. Experimental Data and Results: The table below shows the statistical results of the number of writhing responses of mice in each group within 15 minutes: Pain relief rate = (number of writhing movements in the blank control group - number of writhing movements in the experimental group) / number of writhing movements in the blank control group × 100%; compared with the blank control group, *P<0.01; compared with the commercially available plaster group, #P<0.01.

[0074] Experimental results showed that the number of writhing responses in mice in the plaster group of this invention within 15 minutes was significantly less than that in the blank control group and the commercially available plaster group (P < 0.01 for both). The analgesia rate reached 72.8%, which was significantly higher than that in the commercially available plaster group (42.2%). This indicates that the meridian-activating and collateral-activating compound plaster of this invention has a significant analgesic effect, and the analgesic effect is superior to that of similar commercially available plasters.

[0075] IV. Experimental Conclusions The compound plaster for promoting blood circulation and relieving pain of this invention can significantly inhibit the writhing response induced by glacial acetic acid in mice, has a good analgesic effect, and its analgesic activity is superior to that of ordinary plasters for promoting blood circulation and relieving pain in the market. It can quickly relieve pain symptoms and meet patients' needs for efficient pain relief.

[0076] Experiment Example 2: Experiment on the effect of compound plaster for promoting blood circulation and activating collaterals on improving microcirculation I. Experimental Materials: Experimental animals: 45 SPF-grade SD rats, half male and half female, weighing 200-220g, provided by a certain experimental animal center, animal production license number: SCXK (Guangdong) 2025-0002.

[0077] Experimental drugs: the meridian-activating and blood-activating compound plaster of this invention (prepared according to Example 3, batch number: 20250601); commercially available ordinary meridian-activating and blood-activating plaster (batch number: 20250315, purchased from a pharmacy); adrenaline injection (1mg / mL, batch number: 20250210, purchased from a pharmaceutical company); physiological saline (medical grade, purchased from a pharmaceutical company).

[0078] Experimental instruments: microcirculation microscope (model: XDS-1B), image analysis system (model: MIAS-2000), electronic balance (accuracy 0.1mg, model: FA2004), syringe (1mL, model: 1mL disposable sterile syringe), hair removal device (model: HL-600).

[0079] II. Experimental Methods: Animal grouping: Forty-five SD rats were randomly divided into three groups of 15 rats each: a blank control group, a commercially available plaster group, and the plaster group of this invention. Statistical analysis showed no significant differences in body weight and sex ratio among the groups (P>0.05), indicating comparability.

[0080] Establishment of a microcirculatory disorder model: Before the experiment, rats in each group were fasted for 12 hours but allowed free access to water. 0.1 mg / kg of adrenaline was injected into the tail vein of each group of rats using a 1 mL syringe. After injection, the rats were placed in a 4°C refrigerator for 30 minutes to establish a microcirculatory disorder model (simulating the pathological state of "meridian blockage and blood stasis").

[0081] Drug administration: After the model was established, the right ear of each group of rats was shaved using a hair removal device, with a shaved area of ​​approximately 1cm × 1cm, ensuring no skin damage. For the plaster group of this invention and the commercially available plaster group, the corresponding plaster was cut into 0.8cm × 0.8cm pieces and applied to the shaved area of ​​the right ear of the rats, secured with medical tape. For the blank control group, sterile gauze of the same size was applied and secured with medical tape. The dosage was 0.2g / rat, and the application time was 6 hours.

[0082] Index detection: Six hours after drug administration, the plaster or gauze was removed from the rats in each group. The rats were then anesthetized and fixed on the microscope stage. The blood flow velocity of the arteries and veins in the right auricle of the rats and the number of open capillaries were observed using a microcirculation microscope, and quantitative analysis was performed using an image analysis system. The index data were recorded before drug administration, 3 hours after drug administration, and 6 hours after drug administration.

[0083] Statistical analysis: Data were analyzed using SPSS 26.0 statistical software. Quantitative data were expressed as (x±s). The t-test was used for comparisons between groups, and p<0.05 was considered statistically significant. III. Experimental Data and Results: The results of microcirculation indicators in the right auricle of rats in each group are shown in the table below: Compared with the blank control group at the same time point, *P<0.01; compared with the commercially available plaster group at the same time point, #P<0.01.

[0084] Experimental results showed that there were no significant differences in microcirculation indicators among the groups of rats before administration (P>0.05); at 3h and 6h after administration, the micro-arteriovenous blood flow velocity and the number of open capillaries in the plaster group of this invention and the commercially available plaster group were significantly higher than those in the blank control group (P<0.01), and the improvement in indicators in the plaster group of this invention was significantly greater than that in the commercially available plaster group (P<0.01). This indicates that the meridian-clearing and blood-activating compound plaster of this invention can significantly improve the blood flow status of rats with microcirculation disorders, promote capillary opening, and has a good meridian-clearing and blood-activating effect, which is superior to that of similar commercially available plasters.

[0085] IV. Experimental Conclusions: The compound plaster for promoting blood circulation and relieving stagnation of the meridians in this invention can significantly accelerate the blood flow velocity of micro-arteries and veins in rats with microcirculatory disorders, increase the number of open capillaries, effectively improve the pathological state of "meridian blockage and blood stasis", and has a significant effect on promoting blood circulation and relieving stagnation of the meridians, which is superior to ordinary plasters for promoting blood circulation and relieving stagnation of the meridians in the market.

[0086] Experimental Example 3: Product Shelf Life Prediction and Microbial Stability Validation I. Experimental Materials: Laboratory animals: 18 SPF-grade New Zealand rabbits, half male and half female, weighing 2.0-2.5 kg, provided by the Laboratory Animal Center, Animal Production License No.: SCXK (Su) 2025-0003.

[0087] Experimental drugs: the meridian-activating compound plaster of this invention (prepared according to Example 3, batch number: 20250601); physiological saline (medical grade, purchased from a pharmaceutical company); petroleum jelly ointment (batch number: 20250120, purchased from a pharmaceutical company).

[0088] Experimental instruments: electronic balance (accuracy 0.1mg, model: FA2004), hair removal device (model: HL-600), vernier caliper (accuracy 0.01mm, model: 0-150mm), skin irritation reaction rating scale.

[0089] II. Experimental Methods: Animal grouping: Eighteen New Zealand rabbits were randomly divided into three groups of six each: intact skin group, damaged skin group, and blank control group. Statistical analysis showed no significant differences in body weight and sex ratio among the groups (P>0.05), indicating comparability.

[0090] Animal pretreatment: 24 hours before the experiment, hair was removed from both sides of the spine on the back of each group of rabbits using a hair removal device. The left side was the intact skin area, and the right side was the damaged skin area (a "#" mark was made on the hair removal area with a sterile needle, to a depth that allowed for slight bleeding, with an area of ​​3cm × 3cm). Rabbits were observed for 24 hours after hair removal to ensure that the intact skin area was free of damage and inflammation, and that the damaged skin area was free of infection.

[0091] Drug administration: In both the intact skin group and the damaged skin group, the meridian-activating compound plaster of this invention was cut into 2cm×2cm pieces and applied to the intact skin area on the left side and the damaged skin area on the right side of the rabbit's back, respectively, and fixed with medical tape. In the blank control group, sterile gauze of the same size was applied to the corresponding area and fixed with medical tape. The dosage was 0.5g / rabbit, the application time was 24 hours, and the drug was administered once a day for 7 consecutive days.

[0092] Indicator detection: The ointment was removed 24 hours after each administration, and the skin contact site reactions of rabbits in each group were observed and recorded, including erythema, edema, papules, and erosion. The reactions were scored according to the skin irritation reaction scoring criteria (scoring criteria: 0 points = no reaction; 1 point = mild erythema; 2 points = significant erythema and mild edema; 3 points = moderate erythema and moderate edema; 4 points = severe erythema and severe edema, accompanied by papules and erosion). The thickness of the edematous area was measured using calipers, and the degree of edema was calculated. After the experiment, tissue samples from the skin contact sites of rabbits in each group were taken for pathological examination to observe the integrity of the skin tissue and the extent of inflammatory cell infiltration.

[0093] Statistical analysis: Data were analyzed using SPSS 26.0 statistical software. Quantitative data were expressed as (x±s). The t-test was used for comparisons between groups, and P<0.05 was considered statistically significant.

[0094] III. Experimental Results: Skin irritation rating results: During the 7-day continuous administration period, no irritation reactions such as erythema, edema, papules, or erosions appeared at the skin contact sites in the blank control group and the intact skin group, and the skin irritation scores were all 0. In the damaged skin group, mild erythema appeared at the skin contact sites on the 1st and 2nd days after administration, with a score of 1. The mild erythema gradually subsided after the 3rd day, and the skin irritation score returned to 0 on the 4th to 7th day, with no severe reactions such as edema, papules, or erosions.

[0095] Edema test results: The edema of rabbits in the intact skin group and the blank control group was 0 mm; the edema of rabbits in the damaged skin group was (0.12±0.03) mm on the first day of administration, (0.10±0.02) mm on the second day, and 0 mm on the third day and thereafter, and the edema symptoms subsided rapidly.

[0096] Pathological section observation results: After the experiment, the rabbit skin tissue in the blank control group and the intact skin group was intact, with clear epidermal and dermal structures and no inflammatory cell infiltration; the rabbit skin tissue in the damaged skin group was basically repaired, with intact epidermis and only a small number of scattered inflammatory cells in the dermis, with no obvious tissue damage.

[0097] IV. Experimental Conclusions: The meridian-activating compound plaster of this invention is non-irritating to intact rabbit skin, and only produces a slight and transient irritant reaction to damaged skin, which can recover quickly without significant long-term skin damage, indicating that the plaster has good skin safety and is suitable for external use.

[0098] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A compound plaster for promoting blood circulation and relieving pain, and its preparation method, characterized in that, Including the following raw materials: White-flowered snake 1-4 jin, red peony root 1-4 jin, peach kernel 1-4 jin, notopterygium root 1-4 jin, angelica root 1-4 jin, corydalis rhizome 1-4 jin, coptis root 1-4 jin, earthworm 1-4 jin, ground beetle 1-4 jin, centipede 40-80 pieces, aconite root 1-4 jin, aconite root 1-4 jin, whole scorpion 1-4 jin, drynaria rhizome 1-4 jin, saposhnikovia root 1-4 jin, human placenta 1-4 jin, mulberry mistletoe 1-4 jin, papaya 1-4 jin, gentian root 1-4 jin, clematis root 1-4 jin, chuanxiong rhizome 1-4 jin, angelica root 1-4 jin, sophora root 1-4 jin, cnidium fruit 1-4 jin, peony bark 1-4 jin, litharge 16-24 jin, sesame oil 30-60 jin.

2. The compound plaster for promoting blood circulation and relieving pain according to claim 1 and its preparation method, characterized in that, The optimal ratio of raw materials is as follows: 2.5 jin of white-flowered snake, 2.5 jin of red peony root, 2.5 jin of peach kernel, 2.5 jin of notopterygium root, 2.5 jin of angelica root, 2.5 jin of corydalis rhizome, 2.5 jin of coptis root, 2.5 jin of earthworm, 2.5 jin of ground beetle, 60 centipedes, 2.5 jin of aconite root, 2.5 jin of aconite root, 2.5 jin of whole scorpion, 2.5 jin of drynaria rhizome, 2.5 jin of saposhnikovia root, 2.5 jin of human placenta, 2.5 jin of mulberry mistletoe, 2.5 jin of papaya, 2.5 jin of gentian root, 2.5 jin of clematis root, 2.5 jin of chuanxiong rhizome, 2.5 jin of angelica root, 2.5 jin of sophora root, 2.5 jin of cnidium fruit, 2.5 jin of peony bark, 20 jin of litharge, and 45 jin of sesame oil.

3. The compound plaster for promoting blood circulation and relieving pain according to claim 1 and its preparation method, characterized in that, The preparation method includes the following steps: Step 1: Raw material pretreatment: Weigh the corresponding weight of each raw material. Remove the head and scales of the white flower snake and the legs and wings of the centipede. Crush them into coarse powder. Wash the remaining medicinal materials, remove impurities, dry them, and then cut them into sections or slices for later use. Step 2, Soaking and Extraction: Place all the pretreated medicinal materials except for litharge in the weighed sesame oil, seal and soak for 30 days, stirring once every 7 days during the period to obtain the first mixture; Step 3, Decoction and Removal of Dregs: Place the first mixture obtained in Step 2 in a copper pot and simmer over high heat at 400℃-500℃ for 30-60 minutes, stirring continuously. When the surface of the medicinal material turns dark brown and there is no white core inside, reduce the heat to low at 200℃-250℃ and continue simmering for 10-15 minutes. Then filter to remove the dregs and obtain a clear medicinal liquid. The endpoint of the decoction is determined by dropping a small amount of the liquid into cold water. The liquid floats in the center of the water and coagulates into a round bead that is not sticky and does not disperse. Step 4, Forming the paste: Place the medicinal liquid obtained in Step 3 back into the copper pot and heat it over a low flame at 100℃-150℃. Slowly add the weighed litharge while stirring at a speed of 35-45 rpm. Cook until the paste is thick, can be lifted into threads, and can solidify into a round bead when dropped into cold water. Stop heating and let it cool naturally to 50℃-60℃ to obtain the meridian-activating compound plaster.

4. The compound plaster for promoting blood circulation and relieving pain according to claim 3 and its preparation method, characterized in that, In step 3, three layers of gauze are used for filtration.

5. The compound plaster for promoting blood circulation and relieving pain according to claim 3 and its preparation method, characterized in that, In step 4, the cooled plaster is evenly applied onto non-woven fabric or medical tape, cut into appropriate sizes, and then sealed in packaging.

6. The compound plaster for promoting blood circulation and relieving pain according to claim 3 and its preparation method, characterized in that, In step 3, the high-heat simmering temperature is 400℃ and the simmering time is 60 minutes, while the low-heat simmering temperature is 200℃ and the simmering time is 15 minutes.

7. The compound plaster for promoting blood circulation and relieving pain according to claim 3 and its preparation method, characterized in that, In step 3, the high-heat simmering temperature is 500℃ and the simmering time is 30 minutes, while the low-heat simmering temperature is 250℃ and the simmering time is 10 minutes.

8. The compound plaster for promoting blood circulation and relieving pain according to claim 3 and its preparation method, characterized in that, In step 3, the high heat cooking temperature is 450℃ and the cooking time is 45 minutes, while the low heat cooking temperature is 220℃ and the cooking time is 12 minutes. In step 4, the low heat heating temperature is 120℃, the stirring speed is 40 rpm, and the natural cooling temperature is 55℃.

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