A lower irritation analgesic ancient formula microemulsion gel and its application in anti-arthritic drugs

Abstract

The application belongs to the field of traditional Chinese medicines, and particularly relates to a more low-irritation analgesic ancient prescription microemulsion gel and application thereof in anti-arthritis drugs. The application finds that after water-soluble and fat-soluble components of black plaster prepared from raw frankincense, myrrh, eaglewood, dragon's blood, Strychnos nux-vomica, Panax notoginseng, Oldenlandia diffusa, Venenum Bufonis, bovine bezoar, Stachys jamaicensis, Platycodon grandiflorum, Hirudo nipponia, Tinea, Solenopsis geminata, Scorpio, scorpio, red lead and sesame oil are extracted, a more low-irritation analgesic ancient prescription microemulsion gel is prepared; compared with the black plaster itself, the analgesic effect of the microemulsion gel is significantly improved, and the microemulsion gel has good anti-inflammatory effect and can be used for preparing anti-arthritis drugs; and the microemulsion gel has reduced toxicity and is more convenient to use.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a more low-irritation analgesic ancient prescription microemulsion gel and application thereof in anti-arthritis drugs. BACKGROUND

[0002] As one of traditional Chinese medicine dosage forms, black plaster still has the problems of skin irritation caused by the preparation process, difficulty in controlling the drug content, lead poisoning, potential problems of color pollution and low bioavailability. During use, it is found that the black color of the analgesic ancient prescription black plaster matrix itself can cause color pollution of the skin and clothes, and long-term use can cause local skin to have allergic symptoms such as itching, swelling and ulceration. In view of these defects, matrix modification research has become one of the means for modernization improvement and development of black plaster preparation.

[0003] In recent years, hydrogels have been widely used in the biomedical field due to their higher biocompatibility, adjustable biodegradability and mechanical strength, and higher water content. In the transdermal drug delivery system, hydrogels can promote the penetration of drugs through their moisturizing and water-retaining properties and skin hydration, thus playing a local and systemic role, and thus becoming a potential modern drug delivery carrier. Since hydrogels are hydrophilic drug carriers, microemulsions are used in hydrogels as drug depots to load the liposoluble components of black plaster. Microemulsions are isotropic, transparent, thermodynamically stable dispersion systems formed spontaneously by mixing water, oil, surfactants and co-surfactants. The use of microemulsions in transdermal drug delivery formulations can increase the solubility of hydrophilic and lipophilic drugs, enhance the stability of drugs, increase the transdermal diffusion rate of drugs, and thus improve the drug efficacy.

[0004] In summary, on the one hand, in order to improve the efficacy of analgesic ancient prescription black plaster, on the other hand, in order to solve the above-mentioned potential problems existing in the matrix of black plaster, the matrix of black plaster is modified using hydrogel technology in this study, and the development of a new dosage form is completed, and the new traditional Chinese medicine preparation is applied to anti-arthritis research. SUMMARY

[0005] The analgesic ancient prescription black plaster provided in the previous stage of the application has certain analgesic efficacy, but the effect is very low, and the black plaster itself contains a large amount of heavy metal lead toxicity, and is black in color and extremely sticky, which is very inconvenient to clean after use. To solve the above technical problems, the application provides a more low-irritation analgesic ancient prescription microemulsion gel and application thereof in anti-arthritis drugs. Specifically, the following contents are included.

[0006] In a first aspect, the application provides a more low-irritation analgesic ancient prescription microemulsion gel, which comprises analgesic ancient prescription drug-loaded microemulsion and gel matrix.

[0007] The analgesic ancient prescription drug microemulsion is prepared from an oil phase, a surfactant, a co-surfactant and an aqueous phase in a mass ratio of 0.15-0.6:1-3:1:0.8-1.3;

[0008] The oil phase contains a fat-soluble extract of analgesic ancient prescription black ointment;

[0009] The aqueous phase is a water-soluble extract of analgesic ancient prescription black ointment;

[0010] The analgesic ancient prescription black ointment is composed of the following raw materials in parts by weight: Boswellia sacra 20-40 parts; Commiphora myrrha 20-40 parts; Lignum aquilariae resiniferum 40-60 parts; Dragon's blood 40-60 parts; Strychnos nux-vomica 20-40 parts; Panax notoginseng 20-40 parts; Balanophora henryi 40-60 parts; Venenum bufonis 10-30 parts; Bovine bezoar 10-30 parts; Stemona tuberosa 10-30 parts; Platycodon grandiflorum 20-40 parts; Hirudo nipponia 20-40 parts; Mantis 20-40 parts; Solpugid 20-40 parts; Scorpio 40-60 parts; Scorpion 40-60 parts; Red lead 1000-1400 parts; and Sesame oil 2000-4000 parts.

[0011] Preferably, the water-soluble extract of analgesic ancient prescription black ointment is prepared by adding analgesic ancient prescription black ointment into water, ultrasonic extraction, filtration, and taking the filtrate as the water extract of analgesic ancient prescription black ointment;

[0012] The fat-soluble extract of analgesic ancient prescription black ointment is prepared by adding the residue after filtration into ethyl acetate, ultrasonic extraction, filtration, and taking the filtrate as the fat-soluble extract of analgesic ancient prescription black ointment.

[0013] Preferably, the preparation method of analgesic ancient prescription black ointment is as follows:

[0014] The Boswellia sacra, Commiphora myrrha, Lignum aquilariae resiniferum, Dragon's blood, Strychnos nux-vomica, Panax notoginseng, Balanophora henryi, Venenum bufonis, Bovine bezoar, Stemona tuberosa, Platycodon grandiflorum, Hirudo nipponia, Mantis, Solpugid, Scorpio and Scorpion are mixed and uniformly pulverized through an 80-120 mesh screen to obtain a mixed powder;

[0015] The sesame oil is heated to boiling, and then the red lead is added. After stirring and cooling, the mixed powder is added. After stirring and heating to boiling, the fire is turned off, and the mixture is uniformly stirred to obtain a traditional Chinese medicine ointment;

[0016] The traditional Chinese medicine ointment, acrylic pressure-sensitive adhesive, spunlace non-woven fabric and release paper are used to prepare a treatment patch according to a conventional method.

[0017] Preferably, the oil phase is selected from oleic acid.

[0018] Preferably, the surfactant is selected from castor oil polyoxyethylene ether, and the co-surfactant is selected from polyethylene glycol 400.

[0019] Preferably, the ratio of the surfactant to the co-surfactant is 1-3:1.

[0020] Preferably, the ratio of the surfactant to the co-surfactant is 2:1.

[0021] Preferably, the gel base is selected from hyaluronic acid.

[0022] In a second aspect, the present application provides a preparation method of the analgesic ancient prescription microemulsion gel as described in the first aspect, and the method comprises:

[0023] adding the analgesic ancient prescription black plaster fat-soluble extract into the oil phase, and adding the surfactant and the co-surfactant to obtain a mixed system; under stirring, adding the analgesic ancient prescription black plaster water-soluble extract dropwise into the mixed system to obtain an analgesic ancient prescription drug-loaded microemulsion;

[0024] adding hyaluronic acid into water to swell overnight to obtain a hyaluronic acid base; mixing the analgesic ancient prescription drug-loaded microemulsion and the hyaluronic acid base in equal volume, adding a pH regulator to adjust the pH to 5.5-6.0 to obtain the analgesic ancient prescription microemulsion gel.

[0025] Preferably, the pH regulator is selected from triethanolamine.

[0026] Preferably, the concentration of the swelled hyaluronic acid base is 4% m / v.

[0027] Preferably, the method is:

[0028] (1) mixing the surfactant and the co-surfactant uniformly at a ratio of 2:1 to obtain mixed surfactants;

[0029] (2) adding 25% of the analgesic ancient prescription black plaster fat-soluble extract into the oleic acid, and after ultrasonic treatment for 30 min, centrifuging at 3000 rpm for 10 min, and then adding the supernatant into the mixed surfactants in step (1) to obtain a mixed system;

[0030] (3) under magnetic stirring, slowly adding the analgesic ancient prescription black plaster water extract dropwise into the mixed system in step (2) to obtain an analgesic ancient prescription drug-loaded microemulsion;

[0031] (4) weighing the hyaluronic acid and placing it into water to swell overnight to obtain a hyaluronic acid base with a concentration of 4% m / v;

[0032] (5) mixing the analgesic ancient prescription drug-loaded microemulsion in step (3) and the hyaluronic acid base in step (4) uniformly in equal volume; adding the pH regulator triethanolamine to adjust the pH to 5.5-6.0 to obtain the analgesic ancient prescription microemulsion gel.

[0033] In a third aspect, the present application provides application of the analgesic ancient formula microemulsion gel in the first aspect in preparation of analgesic anti-inflammatory drugs.

[0034] In a fourth aspect, the present application provides application of the analgesic ancient formula microemulsion gel in the first aspect in preparation of anti-arthritis drugs.

[0035] The present application has the following beneficial effects: the present application provides an analgesic ancient formula microemulsion gel on the basis of the original analgesic ancient formula black plaster; the present application first solves the color problem of the black plaster, improves the appearance, solves the problem of difficult removal and color pollution after use; and compared with the original analgesic ancient formula black plaster, the analgesic ancient formula microemulsion gel has simpler use, reduces the skin irritation of the original black plaster, has good anti-inflammatory activity, and can be used for preparation of anti-arthritis drugs. BRIEF DESCRIPTION OF DRAWINGS

[0036] Figure 1 Research schematic diagram of the present application;

[0037] Figure 2 Pseudo-ternary phase diagram of oleic acid as oil phase, castor oil polyoxyethylene ether as surfactant, polyethylene glycol 400 as co-surfactant, and deionized water as water phase;

[0038] Figure 3 Appearance diagram of the analgesic ancient formula microemulsion gel of the present application;

[0039] Figure 4 Effect of the analgesic ancient formula microemulsion gel of the present application on the rheumatoid arthritis index of rats; the results are expressed as mean ± standard deviation (n=8), compared with the model group * P<0.05, ** P<0.01, *** P<0.001; # P<0.05;

[0040] Figure 5 Effect of the analgesic ancient formula microemulsion gel of the present application on the foot metatarsal circumference of rats with rheumatoid arthritis; the results are expressed as mean ± standard deviation (n=8), compared with the model group * P<0.05, ** P<0.01, *** P<0.001; ## P<0.01, ### P<0.001;

[0041] Figure 6 Skin irritation test results of the analgesic ancient formula microemulsion gel of the present application. DETAILED DESCRIPTION

[0042] In order to make the objects, technical solutions and advantages of the present application clearer, the embodiments of the present application will be described in detail below with reference to the drawings.

[0043] Preparation of analgesic ancient prescription microemulsion gel

[0044] 1. Preparation of analgesic ancient prescription black plaster

[0045] The analgesic ancient prescription black plaster is prepared according to the patent CN107551198A:

[0046] The black plaster is composed of the following raw materials by weight: 40 parts of raw olibanum, 40 parts of myrrh, 60 parts of agarwood, 60 parts of dragon's blood, 40 parts of strychnos, 40 parts of notoginseng, 60 parts of belamcanda chinensis, 30 parts of toad venom, 30 parts of bovine bezoar, 30 parts of stemona, 40 parts of platycodon, 40 parts of leech, 40 parts of earthworm, 40 parts of centipede, 60 parts of scorpion, 60 parts of scolopendra, 1400 parts of red lead, and 4000 parts of sesame oil.

[0047] The preparation method comprises the following steps:

[0048] (1) weighing according to the proportion;

[0049] (2) mixing the raw olibanum, myrrh, agarwood, dragon's blood, strychnos, notoginseng, belamcanda chinensis, toad venom, bovine bezoar, stemona, platycodon, leech, earthworm, centipede, scorpion, and scolopendra uniformly, crushing, and passing through an 80-120 mesh sieve to obtain a mixed powder;

[0050] (3) heating the sesame oil to boiling, adding the red lead, stirring and cooling, then adding the mixed powder, stirring and heating to boiling, turning off the heat, and uniformly mixing to obtain a traditional Chinese medicine paste;

[0051] (4) the traditional Chinese medicine paste, acrylic pressure-sensitive adhesive, spunlace non-woven fabric, and release paper are prepared into a treatment patch according to a conventional method. The peel strength of the acrylic pressure-sensitive adhesive and the spunlace non-woven fabric is not less than 1.0 N / cm, and the holding adhesion is not more than 2.5 mm.

[0052] 2. Preparation of analgesic ancient prescription microemulsion gel

[0053] The preparation schematic of the analgesic ancient prescription microemulsion gel is shown in Figure 1 , and the specific process is as follows:

[0054] 2.1 Extraction of active ingredients of analgesic ancient prescription

[0055] The water-soluble extract and the fat-soluble extract of the analgesic ancient prescription black plaster are prepared by the classic immersion and ultrasonic-assisted extraction method, and the specific process is as follows:

[0056] Take 10.0 g of analgesic ancient prescription black plaster, cut into pieces and put into a 250.0 mL conical flask, add 100.0 mL of distilled water (add a small amount of ethanol to improve the dissolution efficiency) to immerse the medicine, put the conical flask into an ultrasonic cleaner, set the temperature to 60°C, and carry out immersion and ultrasonic-assisted extraction for 12 h. The filtrate after filtration is the water-soluble extract of the analgesic ancient prescription black plaster, which is stored at 4°C for later use, and the residue is used for the next step.

[0057] The residue is put into a conical flask, 100.0 mL of ethyl acetate is added to immerse it, and it is put into an ultrasonic cleaner to extract it in the same way as described above. The ethyl acetate extract is obtained after filtration. The ethyl acetate extract is concentrated using a rotary evaporator to obtain a concentrated extract. The extract is dried in an electric heating air drying oven for 24 h to obtain the liposoluble extract of the analgesic ancient prescription black plaster, which is stored at 4°C for later use.

[0058] 2.2 Screening of the proportion of each component of microemulsion

[0059] Oleic acid was used as the oil phase, castor oil polyoxyethylene ether as the surfactant, and polyethylene glycol 400 as the co-surfactant to prepare microemulsion by water titration method and construct the pseudo-ternary phase diagram of microemulsion. The ratio of surfactant to co-surfactant (Km value), and the ratio of these two components to oleic acid and water were determined by the pseudo-ternary phase diagram: at room temperature (25°C), oleic acid and mixed surfactant (mass ratio of surfactant and co-surfactant was 1:1, 2:1 and 3:1, respectively, as mixed surfactant) were mixed in beakers at mass ratios (O / S) of 0.5:9.5, 1.0:9.0, 1.5:8.5, 2.0:8.0, 2.5:7.5, 3.0:7.0, 3.5:6.5, 4.0:6.0, 4.5:5.5, 5.0:5.0, 5.5:4.5, 6.0:4.0, 6.5:3.5, 7.0:3.0, 7.5:2.5, 8.0:2.0, 8.5:1.5, 9.0:1.0, 9.5:0.5; under the stirring of a magnetic stirrer, deionized water was slowly added dropwise to these mixtures; the transparency of the system was observed by eye, the system gradually became turbid after water addition, and became clear after water addition to a certain extent, which was the end point of titration, and the clear and transparent liquid obtained was the microemulsion; the mass percentage of each component at the titration end point was recorded, and the pseudo-ternary phase diagram was drawn in Origin 2021 with the oil phase (O), mixed surfactant (S) and water phase (W) as the vertices; the area of the microemulsion region in the phase diagram was calculated by Image-Pro Plus; and the appropriate Km value was screened by the size of the microemulsion area.

[0060] The pseudo-ternary phase diagram with oleic acid as the oil phase, castor oil polyoxyethylene ether as the surfactant, polyethylene glycol 400 as the co-surfactant, and deionized water as the aqueous phase is shown below. Figure 2 As shown, the Km values ​​are 1:1 (left), 2:1 (middle), and 3:1 (right), and the shaded area is the microemulsion region.

[0061] Table 1 shows the microemulsion region areas in the phase diagram under different Km values. Surfactants and co-surfactants are key components in the preparation of microemulsions. The oil phase and the aqueous phase are two immiscible and non-diffusional systems. Surfactants promote oil-water diffusion by reducing the interfacial tension of the liquid. Simultaneously, they can cause diffused spherical droplets to form deformable flexible films, which also promotes droplet diffusion. However, a single surfactant often cannot achieve the low tension required for microemulsions, often necessitating the addition of another amphiphilic compound as a co-surfactant. Excessive surfactants can also lead to toxicity. Furthermore, the oil phase is the drug carrier in the microemulsion, and its content determines the drug loading capacity. Pseudo-ternary phase diagrams can be used to screen for microemulsions with stable systems, low surfactant content, and high oil content. Based on these findings, three microemulsion formulations were obtained, as shown in Table 2.

[0062] Table 1. Area of ​​microemulsion region in phase diagram at different Km values.

[0063]

[0064] Table 2 shows the microemulsion formulations and their component ratios obtained at Km = 2:1.

[0065]

[0066] 2.3 Preparation of analgesic traditional formula microemulsion gel

[0067] To achieve higher drug loading and lower toxicity, this embodiment uses "microemulsion 3" as the carrier for the hydrogel. An analgesic microemulsion was prepared using a 25% oleic acid-containing fat-soluble extract of the ancient analgesic plaster as the oil phase and a water-soluble extract of the same plaster as the aqueous phase. The microemulsion gel was obtained by mixing the microemulsion and hyaluronic acid gel in a 1:1 ratio, containing 1.38% ethyl acetate extract and 13.23% aqueous extract, as detailed below:

[0068] Add 25% of the fat-soluble extract of the ancient analgesic black plaster to oleic acid, sonicate for 30 min, centrifuge at 3000 rpm for 10 min, take the supernatant and add it to a mixed surfactant (castor oil polyoxyethylene ether and polyethylene glycol 400) to obtain a mixed system. Under magnetic stirring, slowly add the prescribed amount of the water-soluble extract of the ancient analgesic black plaster to the system dropwise to obtain the analgesic drug-loaded microemulsion.

[0069] 4% hyaluronic acid was selected as the matrix to prepare a microemulsion gel: 800 mg of hyaluronic acid was accurately weighed and placed in a beaker containing 20 mL of distilled water, and swollen overnight; the prepared analgesic formula drug-loaded microemulsion was mixed with the swollen hyaluronic acid matrix in an equal volume ratio and stirred evenly with a glass rod; an appropriate amount of pH adjuster triethanolamine was added to the microemulsion gel to adjust the pH to 5.5, improving the gel properties to a suitable viscoelasticity, thus obtaining the analgesic formula microemulsion gel.

[0070] The prepared analgesic ancient formula microemulsion gel has the following appearance: Figure 3 As shown, A is the ancient analgesic formula, B is the analgesic formula-loaded microemulsion, and C is the analgesic formula-loaded microemulsion gel. Visual inspection of the analgesic formula-loaded microemulsion and the analgesic formula-loaded microemulsion gel revealed that the analgesic formula-loaded microemulsion was clear, transparent, and highly visible, with no flocculent matter or stratification observed, indicating that a stable microemulsion system was obtained in this experiment. The analgesic formula-loaded microemulsion gel obtained by mixing the analgesic formula-loaded microemulsion with hyaluronic acid colloid is a viscoelastic semi-solid formulation.

[0071] Example 2: Study on the anti-arthritis effect of analgesic traditional formula microemulsion gel

[0072] Rats were randomly divided into 5 groups of 8 each. The day before the experiment, the fur on the legs of the mice was shaved off with a razor, and the drug was administered locally through the legs of each mouse (the area of ​​each area was approximately 2cm × 2cm). Rats were anesthetized with isoflurane, and the paw circumference was measured before complete Freund's adjuvant modeling. Then, under anesthesia, 100 μL of complete Freund's adjuvant was injected into the sole of the rat's paw to induce a chronic inflammatory model of rheumatoid arthritis. The degree of arthritis was observed on days 3 and 7 after induction to confirm successful modeling. From day 7 to day 28 after modeling, diclofenac sodium, traditional Chinese medicine analgesic plaster, and traditional Chinese medicine analgesic microemulsion gel groups were treated with medications, while the model group received no treatment. Throughout the experimental period after modeling, the rats' arthritis index (5-point scoring system: 0 points represents normal joints, 1 point represents paw joint swelling with mild redness and swelling, 2 points represents paw swelling with moderate redness and swelling, 3 points represents paw swelling below the ankle joint with severe redness and swelling, and 4 points represents paw swelling including the knee joint with severe redness and swelling) and paw circumference were assessed and measured twice weekly.

[0073] Seven days after modeling, rats developed unilateral rheumatoid arthritis in their hind paws, with the degree of redness and swelling graded according to the Arthritis Index score. See Table 3 and... Figure 4 As shown, after 21 days of administration, the measurement results indicated that, compared with the model group, the arthritis index scores of all other groups were significantly reduced after administration, indicating that the above-mentioned drugs have a certain anti-inflammatory effect on rheumatoid arthritis. On day 28, the arthritis index of the analgesic traditional Chinese medicine microemulsion gel rats was even lower than that of the analgesic traditional Chinese medicine black plaster group, indicating that the analgesic traditional Chinese medicine microemulsion gel described in this application has a more significant anti-inflammatory effect.

[0074] Table 3 Statistics of arthritis index of mice in each group after 21 days of administration (n = 8)

[0075] Group Arthritis index (mean ± standard deviation) Blank group —— Model group 3.00±0.53 Dichlorofenac sodium 1.57±0.53 Analgesic ancient prescription 2.50±0.53 Analgesic ancient prescription microemulsion gel 1.85±0.37

[0076] The influence of the analgesic ancient prescription and its microemulsion gel on the inflammation of the rat paw induced by arthritis was reflected by the change trend of the paw circumference, as shown in Table 4 and Figure 4 As shown in Table 4 and

[0077] Table 4 Statistics of the paw circumference of rats after 21 days of administration (n = 8)

[0078] Group Circumference (mean ± standard deviation) Blank group 2.39±0.09 Model group 3.05±0.17 Dichlorofenac sodium 2.65±0.07 Analgesic ancient prescription 2.89±0.09 Analgesic ancient prescription microemulsion gel 2.74±0.07

[0079] Example 3 Skin irritation of the analgesic ancient prescription microemulsion gel

[0080] BALB / c mice were evenly divided into 4 groups, i.e. the normal saline group, the diclofenac sodium group, the analgesic ancient prescription black plaster group and the analgesic ancient prescription microemulsion gel group, with 5 mice in each group. The animals were trimmed on the back with a hair clipper before use (the test area was 1.5 cm x 1.5 cm), and then the depilated area was smeared with prepared 8% sodium sulfide for 2-3 min, followed by washing with normal saline. The test was performed 24 h later, and the redness of the administration site of the mice was observed and photographed on the 0th day and the 4th day for 3 consecutive days.

[0081] The results are shown in Figure 6 After 3 days of continuous administration and continuous observation, it was found that the skin of the mice in the normal saline group did not change obviously. After 3 days of continuous administration of diclofenac sodium, the skin turned red obviously, indicating that the drug had obvious skin irritation. After 3 days of continuous administration of the analgesic ancient prescription black plaster, the skin turned slightly red and swollen, indicating that the drug had certain skin irritation. After 3 days of continuous administration of the analgesic ancient prescription microemulsion gel, the skin of the mice did not change obviously, and remained excellent integrity, similar to the normal saline group, indicating that the drug had almost no irritation to the skin.

[0082] In summary, the skin irritation of the analgesic ancient prescription microemulsion gel described in the present application is lower than that of the original analgesic ancient prescription black plaster, and the anti-inflammatory effect is better than that of the original analgesic ancient prescription black plaster, and the safety is obviously better than that of diclofenac sodium, indicating that the analgesic ancient prescription microemulsion gel described in the present application has good safety and significant anti-inflammatory effect.

Claims

1. A less irritating analgesic ancient formula microemulsion gel, characterized in that, The microemulsion gel comprises analgesic ancient prescription drug-loaded microemulsion and gel matrix; The analgesic ancient prescription drug-loaded microemulsion is prepared from oil phase, surfactant, co-surfactant and water phase with a mass ratio of 0.15-0.6:3-1:1:0.8-1.3; The oil phase contains analgesic ancient prescription black plaster fat-soluble extract; The water phase is analgesic ancient prescription black plaster water-soluble extract; The analgesic ancient prescription black plaster is composed of the following raw materials in parts by weight: Boswellia sacra 20-40 parts; Commiphora myrrha 20-40 parts; Lignum aquilariae resinatum 40-60 parts; Haematein 40-60 parts; Strychnos nux-vomica 20-40 parts; Panax notoginseng 20-40 parts; Oldenlandia diffusa 40-60 parts; Venenum bufonis 10-30 parts; Bovine bezoar 10-30 parts; Stemona tuberosa 10-30 parts; Platycodon grandiflorum 20-40 parts; Hirudo nipponia 20-40 parts; Ascaridia columbae 20-40 parts; Solpugida 20-40 parts; Scorpio 40-60 parts; Scorpion 40-60 parts; Red lead 1000-1400 parts; Sesame oil 2000-4000 parts; The analgesic ancient prescription black plaster water-soluble extract is prepared by adding analgesic ancient prescription black plaster into water, ultrasonic extraction, filtration, and taking the filtrate as analgesic ancient prescription black plaster water extract; The analgesic ancient prescription black plaster fat-soluble extract is prepared by adding the residue after filtration into ethyl acetate, ultrasonic extraction, filtration, and taking the filtrate as analgesic ancient prescription black plaster fat-soluble extract; The oil phase is selected from oleic acid; The surfactant is selected from castor oil polyoxyethylene ether, and the co-surfactant is selected from polyethylene glycol 400; The gel matrix is selected from hyaluronic acid.

2. The analgesic ancient formula microemulsion gel as set forth in claim 1, characterized in that, The preparation method of the analgesic ancient prescription black plaster is as follows: The Boswellia sacra, Commiphora myrrha, Lignum aquilariae resinatum, Haematein, Strychnos nux-vomica, Panax notoginseng, Oldenlandia diffusa, Venenum bufonis, Bovine bezoar, Stemona tuberosa, Platycodon grandiflorum, Hirudo nipponia, Ascaridia columbae, Solpugida, Scorpio, Scorpion are mixed uniformly, crushed, and passed through an 80-120 mesh sieve to obtain a mixed powder; The sesame oil is heated to boiling, red lead is added, stirred and cooled, then the mixed powder is added, stirred and heated to boiling, then the fire is turned off, stirred and cooled to obtain a traditional Chinese medicine plaster; The traditional Chinese medicine plaster, acrylic pressure-sensitive adhesive, water-stopping non-woven fabric and release paper are used to prepare a treatment patch according to a conventional method.

3. The process for the preparation of the analgesic traditional formula microemulsion gel according to any one of claims 1-2, characterized in that, The method comprises: The analgesic ancient prescription black plaster fat-soluble extract is added into the oil phase, the surfactant and co-surfactant are added to obtain a mixed system; the analgesic ancient prescription black plaster water-soluble extract is added dropwise into the mixed system under stirring to obtain analgesic ancient prescription drug-loaded microemulsion; The hyaluronic acid is added into water and swelled overnight; the analgesic ancient prescription drug-loaded microemulsion and the swelled hyaluronic acid matrix are mixed in equal volume, a pH regulator is added, and the pH is adjusted to 5.5-6.0 to obtain analgesic ancient prescription microemulsion gel.

4. The process for the preparation of the analgesic traditional formulation microemulsion gel as claimed in claim 3, wherein, The concentration of the swelled hyaluronic acid is 4% m / v.

5. The process for the preparation of the analgesic traditional formulation microemulsion gel as claimed in claim 3, wherein, The pH regulator is selected from triethanolamine.

6. Use of the analgesic ancient prescription microemulsion gel according to any one of claims 1-2 in the preparation of analgesic and anti-inflammatory drugs.

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