A traditional Chinese medicine ointment with the effects of removing blood stasis, reducing swelling and relieving pain and a preparation method thereof

Abstract

The application relates to the medical field, in particular to a traditional Chinese medicine ointment with the effects of removing blood stasis, eliminating swelling and relieving pain and a preparation method thereof. The traditional Chinese medicine ointment is prepared from traditional Chinese medicine fine powder and gel base materials, and the specific proportion is as follows: glycerin:NOVETAC VP20:NOVETAC P55N:ganxushuaolium:EDTA-2NA:azone:EZ-1:deionized water:tartrate acid:BIOGUARD-CTM:NOVEPHIL 520:traditional Chinese medicine fine powder:ice piece:ethanol=22.84:6.49:0.91:0.19:0.02:0.64:0.24:35.04:0.00.24:0.25:17.05:15.65:0.19:0.19. The traditional Chinese medicine ointment is convenient to use, can be used or stopped at any time, is suitable for patients who are not easy to orally take medicine or patients with diseases with no obvious oral medicine effect, has a large drug loading capacity of the gel ointment base, is good in compatibility with water-soluble and fat-soluble drugs, and is very suitable for the medicine characteristics of traditional Chinese medicine with multiple components and large doses.

Description

Technical Field

[0001] This invention relates to the field of medicine, specifically to a traditional Chinese medicine ointment with the effects of removing blood stasis, reducing swelling, and relieving pain, and its preparation method. Background Technology

[0002] With the development of pharmaceutical technology and the emergence of new polymer materials, the combination of modern preparation processes and traditional Chinese medicine has provided a broad platform for the improvement of topical drug formulations.

[0003] We developed a self-formulated herbal formula, Xiaoyu San, which, when mixed with water and honey and applied topically to the affected area, has shown significant efficacy in treating early-stage soft tissue injuries. However, after years of clinical application, this dosage form still has many shortcomings, such as poor dosage control, large dosage, waste of medicinal materials, rapid drying and evaporation of active ingredients during application, limited transdermal absorption, easy staining of clothing, and adverse reactions such as skin allergies, redness, and swelling.

[0004] Therefore, in recent years, through research, gel ointments have been developed to address the characteristics of large drug loading capacity, long-lasting efficacy, few adverse reactions, and simple and convenient use. These gel ointments have been applied in clinical practice and have significantly improved patient satisfaction. Summary of the Invention

[0005] The technical problems to be solved by this invention are: drug loading capacity of the matrix, compatibility, air permeability, adhesion, duration of efficacy and absorption rate, toxic side effects and adverse reactions. The specific solution is to provide a traditional Chinese medicine gel with the effects of removing blood stasis, reducing swelling and relieving pain and its preparation method.

[0006] The technical solution of this invention is as follows: The herbal gel is made from fine powder of Chinese herbs and gel matrix raw materials, with the specific ratio as follows: Glycerin: NOVETAC VP20: NOVETAC P55N: Aluminum hydroxyl: EDTA-2NA: Azone: EZ-1: Deionized water: Tartaric acid: BIOGUARD-CTM: NOVEPHIL520: Fine powder of Chinese herbs: Borneol: Ethanol = 22.84: 6.49: 0.91: 0.19: 0.02: 0.64: ​​0.24: 35.04: 0.24: 0.25: 17.05: 15.65: 0.19: 0.19; The formula for the fine powder of Chinese herbs is as follows: *Ligusticum striatum*, *Artemisia capillaris*, *Polygonum cuspidatum*, *Eupolyphaga sinensis*, *Schizonepeta tenuifolia*, *Cicada slough*, raw rhubarb, *Caesalpinia sappan*, processed *Aconitum carmichaelii*, processed *Aconitum kusnezoffii*, *Scutellaria baicalensis*, dandelion, frankincense, myrrh, raw *Rubia cordifolia*, *Panax notoginseng*, *Angelica sinensis*, *Salvia miltiorrhiza* = 1.5:1.0:1.2:1.0:1.0:0.6:1.0:1.0:1.2:1.2:1.0:1.5:1.2:1.2:1.2:1.0:1.0:1.0.

[0007] Each medicinal herb is pulverized into a fine powder and passed through a No. 9 sieve for later use.

[0008] Weigh out a certain amount of NOVETAC VP20, NOVETAC P55N, aluminum hydroxyl, and EDTA-2NA according to the prescription ratio, and disperse them in the prescribed amount of glycerin to form a uniform paste-like semi-fluid, which is the glycerin phase.

[0009] After dissolving borneol in 95% ethanol, add azone and EZ-1 and stir until completely homogeneous to form the ethanol phase.

[0010] After the prescribed amount of tartaric acid is completely dissolved in water, BIOGUARD-CTM and NOVEPHIL 520 are added while stirring. After stirring evenly, the fine powder of traditional Chinese medicine is dispersed in the matrix in proportion as the aqueous phase.

[0011] Add the ethanol phase to the aqueous phase under high-speed stirring. After stirring at high speed for 3-5 minutes, pour the mixture into a stirrer. Then add the glycerol phase and stir rapidly for 5 minutes until a viscous colloid is formed. Coat the colloid onto a nonwoven fabric, cure, and cut it into 10cm*14cm sizes to obtain the final product.

[0012] Detailed operation steps: 1) Grind each medicinal material into a fine powder and pass it through a No. 9 sieve for later use; 2) First, add glycerin to the mixing container 1. Weigh a certain amount of NOVETAC VP20, NOVETACP55N, aluminum hydroxyl, and EDTA-2NA according to the prescription ratio, disperse them in the prescription amount of glycerin, turn on medium speed and stir for 10-20 minutes to form a uniform paste-like semi-fluid with no visible powder particles, which is the glycerin phase. 3) In the stirring container 2, dissolve the borneol in 95% ethanol, add azone and EZ-1, and stir until completely homogeneous to form the ethanol phase; 4) In the mixing container 3, after the prescribed amount of tartaric acid is completely dissolved in water, add BIOGUARD-CTM and NOVEPHIL 520 while stirring. After stirring evenly, disperse the fine powder of traditional Chinese medicine in the matrix according to the ratio as the aqueous phase. 5) Add the ethanol phase to the aqueous phase under high-speed stirring. After stirring at high speed for 3-5 minutes, pour the mixture into stirring container 3. Then add the glycerol phase. Vacuum the stirring container 3 until the pressure gauge reads below 0.08 Pa. Then start rapid stirring for 5 minutes until a viscous colloid is formed. 6) Stop stirring, release the vacuum, and open stirring container 3 to discharge the material into the hopper of the dedicated coating machine; 7) Discharge material from the hopper, start the coating and slitting machine, and set the machine coating speed and conveyor belt speed according to the production requirements; 8) After curing for 8-12 hours, cut and package.

[0013] Precautions: 1) The glycerol phase (Part 1) must be thoroughly mixed and there should be no visible lumps. 2) The time from mixing the aqueous phase and the glycerol phase (i.e., step 6) to discharging the material into the hopper should not be too long, and should not exceed half an hour; 3) The coating time for each batch of material should be controlled within 15 minutes; if the time is too long, it may cause difficulties in coating the tail material.

[0014] The beneficial effects of this invention are: (1) It is convenient to use and can be used or discontinued at any time. It is more suitable for patients who cannot take oral medication for various reasons or for diseases where oral medication is not effective. (2) The gel ointment matrix has a large drug loading capacity and good compatibility with water-soluble and fat-soluble drugs, which is very suitable for the characteristics of multi-component and large-dose administration of traditional Chinese medicine. It has no effect on the stability of the main drug, no side effects, no skin irritation or allergic reaction, and leaves no residue on the skin; (3) The breathability of the gel ointment and its good adhesion to the skin allow patients to feel a cool and pleasant sensation without any discomfort; (4) It can be repeatedly peeled off without staining clothes or leaving any residue. It is absorbed by acupoints and meridians, which can clear the meridians and internal organs and have an effect on the whole body. Attached Figure Description

[0015] Figure 1 This is a simplified process flow diagram of the preparation method. Detailed Implementation

[0016] Example 1: A traditional Chinese medicine gel with the effects of removing blood stasis, reducing swelling, and relieving pain, made from fine powder of traditional Chinese medicine and gel matrix raw materials, with the specific ratio of glycerin:NOVETAC VP20:NOVETAC P55N: aluminum hydroxyacetate:EDTA-2NA: azone:EZ-1:deionized water:tartaric acid:BIOGUARD-CTM:NOVEPHIL 520:fine powder of traditional Chinese medicine:borneol:ethanol = 22.84:6.49:0.91:0.19:0.02:0.64:0.24:35.04:0.24:0.25:17.05:15.65:0.19:0.19; The formula for the fine powder of Chinese herbs is as follows: *Ligusticum striatum*, *Artemisia capillaris*, *Polygonum cuspidatum*, *Eupolyphaga sinensis*, *Schizonepeta tenuifolia*, *Cicada slough*, raw rhubarb, *Caesalpinia sappan*, processed *Aconitum carmichaelii*, processed *Aconitum kusnezoffii*, *Scutellaria baicalensis*, dandelion, frankincense, myrrh, raw *Rubia cordifolia*, *Panax notoginseng*, *Angelica sinensis*, *Salvia miltiorrhiza* = 1.5:1.0:1.2:1.0:1.0:0.6:1.0:1.0:1.2:1.2:1.0:1.5:1.2:1.2:1.2:1.0:1.0:1.0.

[0017] Detailed operation steps: 1) Grind each medicinal herb into a fine powder and pass it through a No. 9 sieve for later use; 2) First, add glycerin to the mixing container 1. Weigh a certain amount of NOVETAC VP20, NOVETACP55N, aluminum hydroxyl, and EDTA-2NA according to the prescription ratio, disperse them in the prescription amount of glycerin, turn on medium speed and stir for 10-20 minutes to form a uniform paste-like semi-fluid with no visible powder particles, which is the glycerin phase. 3) In the stirring container 2, dissolve the borneol in 95% ethanol, add azone and EZ-1, and stir until completely homogeneous to form the ethanol phase; 4) In the mixing container 3, after the prescribed amount of tartaric acid is completely dissolved in water, add BIOGUARD-CTM and NOVEPHIL 520 while stirring. After stirring evenly, disperse the fine powder of traditional Chinese medicine in the matrix according to the ratio as the aqueous phase. 5) Add the ethanol phase to the aqueous phase under high-speed stirring. After stirring at high speed for 3-5 minutes, pour the mixture into stirring container 3. Then add the glycerol phase. Vacuum the stirring container 3 until the pressure gauge reads below 0.08 Pa, then start rapid stirring for 5 minutes until a viscous colloid is formed. 6) Stop stirring, release the vacuum, and open stirring container 3 to discharge the material into the hopper of the dedicated coating machine; 7) Discharge material from the hopper, start the coating and slitting machine, and set the machine coating speed and conveyor belt speed according to the production requirements; 8) After curing for 8-12 hours, cut and package.

[0018] Quality inspection of gel patches: Appearance of the plaster: The plaster has a uniform color, moderate softness, consistent thickness, and suitable consistency. It is free of particles, has few air bubbles, and does not bleed through.

[0019] Ointment content: The ointment content of the Xiaoyu San gel ointment was checked according to the 2020 edition of the Pharmacopoeia. One tablet of the ointment was removed, its cap removed, and its weight accurately measured. The tablet was placed in a beaker, and an appropriate amount of water was added. The mixture was heated to boiling to separate the ointment from the non-woven fabric backing material. The non-woven fabric backing material was removed, washed with water until no ointment residue remained, and then air-dried. It was then placed in an oven at 105℃ for 30 minutes. After drying, it was placed in a desiccator and cooled for 30 minutes. The weight loss was then accurately measured, and the weight was converted to the value per 100 cm³. 2 The content of the ointment. The ointment content is not less than 10g / 100cm³. 2 .

[0020] Excipient properties: The excipient properties of the blood-stasis-removing gel ointment were tested according to the 2020 edition of the Pharmacopoeia. One piece of blood-stasis-removing gel ointment was removed, its cap was removed, and it was placed in a constant temperature and humidity chamber. The temperature was set at 37℃ and the relative humidity at 64%. After 30 minutes, it was removed and the ointment was fixed to a flat steel plate with clips. The angle between the steel plate and the horizontal plane was set at 60°. After 24 hours, the experiment showed that there was no dripping of the ointment.

[0021] Heat resistance: Remove one sheet of the stasis gel ointment, remove the cover, place it in an oven at 60℃, remove it after 2 hours, and let it cool. No oil seepage was observed at the non-woven fabric backing, the ointment's form did not change significantly, it remained sticky to the touch, and the surface of the ointment had a glossy appearance.

[0022] Content and determination method of effective ingredients in blood stasis relieving gel ointment: determined according to high performance liquid chromatography (General Rule 0512).

[0023] Chromatographic conditions and system suitability test: C18 column (4.6 mm × 150 mm, 5 μm); mobile phase acetonitrile (A) - gradient elution of 0.2% phosphoric acid water containing 2 mmol / L β-cyclodextrin (B) (0-35 min, 21% A, 79% B; 35-95 min, 21% A → 33% A, 79% B → 67% B); flow rate 1.0 mL / min; column temperature 30℃; injection volume 10 μL; detection wavelength: 350 nm (0-30 min, luteolin determination), 205 nm (30-40 min, asiaticoside determination), 203 nm (40-100 min, ginsenoside Rb1 determination). The theoretical plate number, calculated based on the peaks of luteolin, asiaticoside, and ginsenoside Rb1, should not be less than 4000.

[0024] Preparation of reference solution: Accurately weigh appropriate amounts of luteolin, asiaticoside, and ginsenoside Rb1 reference standards, dissolve and dilute with methanol to prepare a mixed reference stock solution with a mass concentration of 15 μg / mL luteolin, 80 μg / mL asiaticoside, and 40 μg / mL ginsenoside Rb1.

[0025] Preparation of the test solution: Remove one patch of stasis gel ointment, peel off the anti-adhesive layer, cut it into small pieces and place it in an Erlenmeyer flask. Add 50 mL of methanol, weigh the total weight, sonicate at 240 W 40 kHz for 30 min, weigh the total weight, make up the weight with methanol, mix well, filter, and filter the filtrate through a 0.45 μm microporous membrane to obtain the test solution.

[0026] The assay involves precisely pipetting 10 μl each of the reference solution and the test solution into a liquid chromatograph and measuring the results.

[0027] Each patch of blood-stasis-reducing gel ointment shall contain no less than 0.5 mg of luteolin, no less than 3 mg of asiaticoside, and no less than 1.5 mg of ginsenoside Rb1.

[0028] Method for determining the limits of toxic components in blood-stasis-reducing gel ointments: Test for diester alkaloids: Chromatographic conditions and system suitability test: Using octadecylsilane-bonded silica gel as the packing material; acetonitrile as mobile phase A, and 0.2% glacial acetic acid solution (adjusted to pH 6.20 with triethylamine) as mobile phase B, gradient elution was performed according to the specifications in the table below; the detection wavelength was 235 nm. The theoretical plate number, calculated based on the neoacinine peak, should be no less than 2000.

[0029] 0-44 21→31 71→69 44-65 31→35 69→65 65-70 35 65 Preparation of reference solutions: Take appropriate amounts of aconitine reference standard, hypoaconitine reference standard and neoaconitine reference standard, accurately weigh them, and add isopropanol-chloroform (1:1) mixed solution to prepare mixed solutions containing 50 μg of aconitine, 0.15 mg of hypoaconitine and 0.15 mg of neoaconitine per 1 ml.

[0030] Preparation of the test solution: Discard one patch of stasis-removing gel ointment, remove the anti-adhesive layer, cut into small pieces and place in an Erlenmeyer flask. Add 3 ml of ammonia test solution, accurately add 50 mL of isopropanol-ethyl acetate (1:1) mixed solution, weigh, sonicate (300 W power, 40 kHz frequency; water temperature below 25°C) for 30 minutes, cool, weigh again, replenish the lost weight with isopropanol-ethyl acetate (1:1) mixed solution, shake well, and filter. Accurately measure 25 mL of the filtrate, recover the solvent to dryness under reduced pressure below 40°C, dissolve the residue in 0.01% hydrochloric acid-methanol solution, transfer to a 5 mL volumetric flask, dilute to the mark, shake well, filter, accurately pipette 10 μL, inject into the liquid chromatograph, determine, and calculate according to the standard curve to obtain the final solution.

[0031] Each patch of this product contains no more than 135 μg of diester-type alkaloids, calculated as the total amount of aconitine, hypoaconitine, and neoaconitine.

[0032] The test results of the gel patch indicate that, based on the above analysis, all indicators of the prepared product meet the design requirements.

[0033] (6) Clinical trials: 1.1 Experimental Cases: Patients with soft tissue injuries or closed fractures were randomly selected and divided into a traditional drug administration group and a gel ointment group, with 100 cases in each group. In the traditional drug administration group, there were 48 males and 52 females; their ages ranged from 11 to 94 years, with a mean age of (58.31±18.24) years; the duration of illness ranged from 1 to 15 days, with a mean duration of (4.91±3.08) hours; there were 11 cases of joint injury, 17 cases of simple soft tissue injury, and 72 cases of soft tissue kidney injury combined with fracture (fracture sites mainly involved lumbar vertebrae, thoracic vertebrae, ribs, femur, humerus, tibia, metatarsals, etc., with 20 other fractures). The gel ointment group consisted of 58 males and 42 females, aged 26-92 years (mean age 63.76±14.77 years), with a disease duration of 1-15 days (mean duration 4.46±2.66 hours). Ten cases involved joint injury, 8 cases involved simple soft tissue injury, and 82 cases involved soft tissue injury combined with fractures (fracture sites mainly included the lumbar and thoracic vertebrae, clavicle, ribs, femur, humerus, and tibia; 16 other fractures were also present). There were no statistically significant differences in general characteristics between the two groups. P (>0.05), making them comparable.

[0034] 1.2 Inclusion and Exclusion Criteria Inclusion Criteria: All patients presented with localized pain and swelling; all were closed, simple fractures; and all patients with arthritis or fractures had radiographic evidence. Exclusion Criteria: Open fractures; complications from other systems; and neurovascular injury.

[0035] 1.3 Methods Traditional Drug Treatment Group: Patients in the traditional drug treatment group received traditional Chinese medicine plaster therapy. An appropriate amount of fine Chinese medicine powder (Xiaoyu San prescription) was mixed with honey, applied to a medicated paper, and then applied to the affected area, avoiding broken skin. The plaster was approximately 10cm × 10cm in size and securely fixed with medical tape. The plaster was changed twice daily. Gel Ointment Group: The gel ointment was directly applied to the affected area, avoiding broken skin. The gel ointment was 10cm × 14cm in size. During treatment, the local skin condition was observed. If any allergic symptoms appeared, the treatment was discontinued immediately. The gel ointment was changed twice daily.

[0036] 1.4 Observation indicators: Observe the degree of improvement in pain and swelling, the improvement in ease of use, and the occurrence of adverse reactions in the two groups after treatment.

[0037] Because patients have different degrees of disease severity, the efficacy observation indicators are mainly based on subjective evaluation. The improvement of pain and swelling before and after use is compared, and the disappearance, improvement or persistence is judged, and scored as 2 points, 1 point and 0 points respectively.

[0038] The ease of use was assessed using a satisfaction survey, evaluating four aspects: ease of use, patch detachment, cleanliness, and portability. Specific scoring criteria are as follows: ① Ease of use: 0 points for requiring a nurse or doctor, 5 points for not requiring a nurse or doctor; ② Patch detachment: 1 point for detachment within 1 hour, 3 points for detachment within 2 hours, 6 points for detachment within 4 hours, 10 points for detachment after 6 hours; ③ Cleanliness: 0 points for obvious soiling of clothing and skin, 4 points for obvious soiling of clothing or skin, 8 points for slight soiling of clothing or skin, 10 points for no obvious soiling of clothing or skin; ④ Portability: 0 points for very inconvenient to carry, 5 points for relatively convenient to carry, 10 points for very convenient to carry.

[0039] 2.3 Data Processing Independent samples were analyzed using IBM SPSS 26.0 software. T Inspection and weighted data analysis.

[0040] The efficacy evaluation criteria refer to the evaluation criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines".

[0041] In the traditional drug administration group, 90% of patients experienced pain relief, while in the gel / ointment group, 96% of patients experienced pain relief; the difference between the two groups was statistically significant. P <0.05. The percentages of patients whose swelling disappeared in the conventional drug administration group and the gel ointment group were 0% and 4%, respectively; the percentages of patients whose swelling was reduced in the conventional drug administration group and the gel ointment group were 73% and 76%, respectively; and the percentages of patients whose swelling persisted in the conventional drug administration group and the gel ointment group were 27% and 20%, respectively. There was no significant difference between the two groups. P >0.05).

[0042] Table 1. Comparison of therapeutic effects before and after treatment in the two groups. Traditional drug administration group 100 0.90±0.30 0.74±0.44 1.06±0.40 Gel ointment group 100 0.96±0.20 0.84±0.46 1.16±0.32 value <0.05 >0.05 <0.05 Note: Overall score = 0.739 * (0.860 * pain score + 0.860 * pain score) + 0.261 * (0.511 * pain score - 0.511 * pain score) Comparison of pain relief scores after treatment: In the traditional drug administration group (0.90±0.30), the pain improvement score was lower than that in the gel ointment group (0.96±0.20), and the difference between the two groups was statistically significant (P<0.05). The swelling improvement score was slightly lower in the traditional drug administration group (0.74±0.44) than in the gel ointment group (0.84±0.46), but the difference between the two groups was not statistically significant (P>0.05). The overall efficacy score was significantly lower in the traditional drug administration group (1.06±0.40) than in the gel ointment group (1.16±0.32), and the difference between the two groups was statistically significant (P<0.05).

[0043] 2.2 Ease of Use Assessment In terms of ease of use, the traditional drug delivery group required nurses or doctors to apply and mix the ointment, scoring 0 points. The gel ointment group required no medical intervention and patients could apply it themselves, scoring 5 points. The comparison between the two groups was statistically significant (P < 0.05). In terms of detachment, cleanliness, and portability, the gel ointment group scored a perfect 10 points in all three categories, significantly better than the traditional drug delivery group, and the comparison between the two groups was statistically significant (P < 0.05).

[0044] Table 2 Comparison of ease of use between the two groups Traditional drug administration group 0 5.89±0.65 7.68±1.08 5 Gel ointment group 5 10 10 10 value <0.05 <0.05 <0.05 <0.05 2.3 Adverse Reactions Regarding the incidence of adverse reactions, 5 cases of adverse reactions occurred in the traditional drug administration group, all of which were rashes of varying degrees, with an incidence rate of 5%; no significant adverse reactions were observed in the gel ointment administration group. Both the traditional stasis-reducing powder and the stasis-reducing gel ointment showed significant efficacy in relieving limb swelling and pain in the early stages of trauma and improving pain symptoms. The gel ointment group was superior to the traditional drug administration group (P<0.05). The reduction of swelling was comparable between the two groups. Overall, the gel ointment demonstrated superior efficacy compared to the traditional drug administration and was significantly more convenient to use, with a much lower rate of adverse reactions. In conclusion, the stasis-reducing gel ointment can better relieve limb swelling and pain after trauma, improve functional activities, and enhance quality of life; it is also simple and convenient to use, has few adverse reactions, and high safety, making it worthy of clinical promotion and application.

Claims

1. A traditional Chinese medicine gel-like paste with the effects of removing blood stasis, reducing swelling, and relieving pain, characterized in that, The herbal gel is made from fine powdered Chinese herbs and a gel matrix, with the following specific ratio: glycerin:NOVETAC VP20:NOVETAC P55N: aluminum hydroxyacetate:EDTA-2NA: azone:EZ-1:deionized water:tartaric acid:BIOGUARD-CTM:NOVEPHIL 520:fine powdered Chinese herbs:borneol:ethanol = 22.84:6.49:0.91:0.19:0.02:0.64:0.24:35.04:0.24:0.25:17.05:15.65:0.19:0.19; The formula for the fine powdered Chinese medicinal herbs is as follows: *Ligusticum striatum*, *Artemisia capillaris*, *Polygonum cuspidatum*, *Eupolyphaga sinensis*, *Schizonepeta tenuifolia*, *Cicada slough*, raw rhubarb, *Caesalpinia sappan*, processed *Aconitum carmichaelii*, processed *Aconitum kusnezoffii*, *Scutellaria baicalensis*, dandelion, frankincense, myrrh, raw madder root. Panax notoginseng: Angelica sinensis: Salvia miltiorrhiza = 1.5: 1.0: 1.2: 1.0: 1.0: 0.6: 1.0: 1.0: 1.2: 1.2: 1.0: 1.5: 1.2: 1.2: 1.2: 1.0: 1.0: 1.

0.

2. The method for preparing the traditional Chinese medicine gel with the effects of removing blood stasis, reducing swelling, and relieving pain as described in claim 1, characterized in that, Includes the following steps: 1) Grind each medicinal herb into a fine powder and pass it through a No. 9 sieve for later use; 2) First, add glycerin to the mixing container 1. Weigh a certain amount of NOVETAC VP20, NOVETAC P55N, aluminum hydroxyl, and EDTA-2NA according to the prescription ratio, disperse them in the prescription amount of glycerin, turn on medium speed and stir for 10-20 minutes to form a uniform paste-like semi-fluid with no visible powder particles, which is the glycerin phase. 3) In the stirring container 2, dissolve the borneol in 95% ethanol, add azone and EZ-1, and stir until completely homogeneous to form the ethanol phase; 4) In the mixing container 3, after the prescribed amount of tartaric acid is completely dissolved in water, add BIOGUARD-CTM and NOVEPHIL 520 while stirring. After stirring evenly, disperse the fine powder of traditional Chinese medicine in the matrix according to the ratio as the aqueous phase. 5) Add the ethanol phase to the aqueous phase under high-speed stirring. After stirring at high speed for 3-5 minutes, pour the mixture into stirring container 3. Then add the glycerol phase. Vacuum the stirring container 3 until the pressure gauge reads below 0.08 Pa, then start rapid stirring for 5 minutes until a viscous colloid is formed. 6) Stop stirring, release the vacuum, and open stirring container 3 to discharge the material into the hopper of the dedicated coating machine; 7) Discharge material from the hopper, start the coating and slitting machine, and set the machine coating speed and conveyor belt speed according to the production requirements; 8) After curing for 8-12 hours, cut and package. The time from mixing the aqueous phase and the glycerol phase to discharge should not exceed half an hour, and the coating time should be controlled within 15 minutes.

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