Anti-inflammatory and analgesic external composition as well as preparation method, application and gel preparation thereof

Abstract

The invention relates to an anti-inflammatory and analgesic external composition, a preparation method and application thereof and a gel preparation, and belongs to the technical field of external pharmaceutical compositions.The anti-inflammatory and analgesic external composition is prepared from, by weight, 3-8 parts of loxoprofen sodium, 500-1000 parts of fried semen brassicae, 300-500 parts of fructus arctii and 10-30 parts of liquorice. The semen brassicae is warm in nature and pungent in taste, belongs to the lung channel, and has the effects of benefiting qi and removing stasis; the fructus arctii is cold in nature, pungent and bitter in taste, belongs to lung and stomach channels and has the effects of detoxifying and promoting eruption, the fructus arctii and the fructus arctii are cold in nature and warm in nature, mutual in medicine property, pungent and divergent in taste and have the effect of transdermal enhancement of the medicine effect, the liquorice is neutral in nature and sweet in taste, belongs to the heart, lung, spleen and stomach channels and has the effects of relieving spasm and pain and harmonizing all the medicines, and the liquorice, the fructus arctii and the liquorice can synergistically play the effects of stimulating menstrual flow and relieving pain. And with the cooperation of loxoprofen sodium, the synergistic interaction effect is achieved in the aspects of diminishing inflammation and relieving pain.

Description

Technical Field

[0001] The present invention relates to the technical field of topical pharmaceutical compositions, and more particularly to an anti-inflammatory and analgesic topical composition, its preparation method, application and gel preparation. Background Art

[0002] Loxoprofen sodium is a non-steroidal analgesic and anti-inflammatory drug, which is widely used in the clinical treatment of diseases such as rheumatoid arthritis, low back pain, osteoarthritis, etc. Loxoprofen sodium can be transformed into the active metabolite trans-OH after being absorbed through the skin and play its role. The drug concentration is the highest in subcutaneous tissue and skeletal muscle. This characteristic determines that loxoprofen sodium can be used as a good transdermal absorption dosage form. Compared with oral preparations, topical preparations can directly act on the patient's site without passing through the digestive tract and the liver, greatly reducing the systemic exposure of the drug and reducing the occurrence of toxic and side effects, with better safety. Therefore, the topical preparation of loxoprofen sodium is one of the key directions for product development at present.

[0003] The prior art (Qin Rongxin et al., Preparation and quality control of loxoprofen sodium gel [J], Shanxi Medical Journal, November 2008, Vol. 37, No. 11: 1038-1039) discloses a loxoprofen sodium gel with a prescription of 5 g of loxoprofen sodium, 10 g of carbomer 940, 100 g of glycerol, 15 g of laurocapram, an appropriate amount of triethanolamine, 0.1 g of thimerosal, and purified water up to 1000 g. However, this gel uses laurocapram as a penetration enhancer, which can promote local blood circulation, but also has certain toxicity, can cause skin inflammatory reactions, and lead to symptoms such as rashes and itching.

[0004] CN110946846A discloses a loxoprofen sodium cataplasm matrix and a preparation method thereof. The cataplasm matrix comprises 0.5 - 2.0 parts of loxoprofen sodium, 40 - 60 parts of purified water, 5 - 10 parts of a skeleton material, 25 - 45 parts of a humectant, 1 - 10 parts of a tackifier, 1 - 8 parts of a filler, 1 - 5 parts of a surfactant, 0.4 - 2.0 parts of a pH regulator, 0.1 - 2.0 parts of aluminum hydroxide, 0.2 - 1.0 parts of a preservative, 1 part of ethanol and 0.05 - 0.5 parts of disodium edetate. The cataplasm matrix provided by this invention does not contain transdermal penetration enhancers such as N - methylpyrrolidone, cromolyn, azone, etc., and achieves the purpose of an ideal transdermal effect by improving the release behavior of the matrix, reducing the risk of potential harm to the human body caused by organic solvents. CN119185258A discloses a loxoprofen sodium cataplasm and a preparation method thereof. The gel matrix of the loxoprofen sodium cataplasm comprises the following raw materials: 20 - 30 parts of sodium polyacrylate, 5 - 10 parts of acrylic acid grafted starch, 0.5 - 1 part of triethanolamine, 15 - 20 parts of gelatin, 0.5 - 5 parts of disodium edetate, 0.5 - 2.5 parts of a crosslinking agent, 1 - 5 parts of a filler, 25 - 35 parts of a humectant, 0.05 - 1 part of an antibacterial agent, 0.005 - 1 part of an antioxidant and 40 - 50 parts of water. This invention selects a mixture of lecithin and polyethylene glycol - 12 - hydroxystearate as the surfactant, which can promote the transdermal absorption of loxoprofen sodium.

[0005] In summary, although the prior art has solved to some extent the safety of loxoprofen sodium gel for transdermal drug use, there is still room for improvement in its efficacy and product stability. Therefore, it is very necessary to develop an external preparation of loxoprofen sodium with better efficacy, stability and safety. Summary of the Invention

[0006] In order to solve the above - mentioned technical problems, the present invention provides an anti - inflammatory and analgesic external composition, a preparation method, an application and a gel preparation thereof. Through the mutual cooperation of stir - fried semen sinapis, fructus arctii and liquorice with loxoprofen sodium, the present invention can promote the transdermal absorption of loxoprofen sodium and play a synergistic effect in anti - inflammatory and analgesic aspects.

[0007] To achieve the above purpose, the present invention adopts the following technical solutions: In the first aspect, the present invention provides an anti - inflammatory and analgesic external composition, comprising the following active components: loxoprofen sodium, stir - fried semen sinapis, fructus arctii and liquorice.

[0008] In the present invention, white mustard seeds are warm in nature, pungent in taste, and belong to the lung meridian, having the effect of promoting qi and dispersing nodules; burdock fruits are cold in nature, pungent and bitter in taste, and belong to the lung and stomach meridians, having the effect of detoxifying and promoting eruption. One is cold and the other is warm, and their medicinal properties counteract each other. They are pungent and dispersing, and have the effect of enhancing the medicinal effect through the skin. Licorice is neutral in nature, sweet in taste, and belongs to the heart, lung, spleen, and stomach meridians, having the effect of relieving spasm and pain and coordinating various medicinal herbs. Moreover, the three herbs work together synergistically to exert the effect of dredging meridians and relieving pain, and cooperate with loxoprofen sodium to play a synergistic effect in anti-inflammatory and analgesic aspects.

[0009] In some embodiments, the anti-inflammatory and analgesic external composition of the present invention comprises the following active ingredients in parts by weight: 3 - 8 parts of loxoprofen sodium, 500 - 1000 parts of stir-fried white mustard seeds, 300 - 500 parts of burdock fruits, and 10 - 30 parts of licorice.

[0010] Preferably, the dosage of loxoprofen sodium is 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or the range values between any two of the above numerical values; Preferably, the dosage of stir-fried white mustard seeds is 500 parts, 550 parts, 600 parts, 650 parts, 700 parts, 750 parts, 800 parts, 850 parts, 900 parts, 950 parts, 1000 parts or the range values between any two of the above numerical values; Preferably, the dosage of burdock fruits is 100 parts, 150 parts, 200 parts, 250 parts, 300 parts, 350 parts, 400 parts, 450 parts, 500 parts or the range values between any two of the above numerical values; Preferably, the dosage of licorice is 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts or the range values between any two of the above numerical values.

[0011] In some embodiments, the anti-inflammatory and analgesic external composition of the present invention comprises the following active ingredients in parts by weight: 5 - 7 parts of loxoprofen sodium, 700 - 800 parts of stir-fried white mustard seeds, 350 - 450 parts of burdock fruits, and 18 - 22 parts of licorice.

[0012] In some embodiments, the anti-inflammatory and analgesic external composition of the present invention comprises the following active ingredients in parts by weight: 6 parts of loxoprofen sodium, 750 parts of stir-fried white mustard seeds, 400 parts of burdock fruits, and 20 parts of licorice.

[0013] In the second aspect, the present invention provides a preparation method of the above anti-inflammatory and analgesic external composition, comprising the following steps: (3) Subject stir-fried white mustard seeds, burdock fruits, and licorice in the formula amount to water extraction, solid-liquid separation, concentrate the filtrate, precipitate with alcohol, obtain the supernatant, and then dry the supernatant to obtain a traditional Chinese medicine extract; (4) Mix the traditional Chinese medicine extract with loxoprofen sodium in the formula amount.

[0014] Preferably, in step (1), the water extraction is carried out by decocting with water, the amount of water used is 8 - 12 times the total weight of stir-fried semen sinapis, fructus arctii and licorice root, the number of decocting times is 1 - 3 times, and the time for each decocting is 0.5 - 2 h.

[0015] Preferably, in step (1), the concentration is carried out by reduced pressure concentration at 50 - 60 °C until the relative density is 1.04 - 1.08.

[0016] Preferably, in step (1), the alcohol precipitation is carried out by adding ethanol to make the concentration of ethanol 60 - 70 v / v %.

[0017] Thirdly, the present invention provides the use of the above anti-inflammatory and analgesic external composition or the anti-inflammatory and analgesic external composition prepared by the above preparation method in the preparation of anti-inflammatory and analgesic drugs.

[0018] In some embodiments, the drug is an external preparation, preferably a gel preparation. Further preferably, the gel preparation includes a gel plaster or a gel patch.

[0019] Fourthly, the present invention provides an anti-inflammatory and analgesic gel preparation, which comprises the above anti-inflammatory and analgesic external composition and pharmaceutically acceptable excipients.

[0020] In some embodiments, the excipients include at least one of a gel matrix, a surfactant, a humectant and a preservative.

[0021] Preferably, the gel matrix in the present invention is a conventional bioadhesive material in the art, including at least one of carbomer 940, sodium carboxymethylcellulose and hydroxypropyl methylcellulose.

[0022] Preferably, the surfactant in the present invention is a conventional surfactant in the art, including at least one of polyethylene glycol 400 and tween 80.

[0023] Preferably, the humectant in the present invention is a conventional humectant in the art, including at least one of glycerol, sorbitol and hyaluronic acid.

[0024] Preferably, the preservative in the present invention is a preservative of surfactants in the art, including at least one of sodium benzoate, glycerol monostearate, glycerol monolaurate, glycerol monooleate, methyl paraben, propyl paraben, sorbic acid and benzoic acid.

[0025] Fifthly, the present invention provides a preparation method of the above anti-inflammatory and analgesic gel preparation, which comprises the following steps: S1. Mix and stir the humectant and the gel matrix to obtain material 1, S2. Stir the anti-inflammatory and analgesic external composition, the surfactant and the preservative evenly to obtain material 2; S3. Mix material 1 and material 2, add water and stir to obtain a gel paste.

[0026] In some embodiments, the anti-inflammatory and analgesic gel preparation is a gel patch. Just place the obtained gel paste on the patch.

[0027] The beneficial effects of the present invention are as follows: (1) In the present invention, white mustard seed is warm in nature, pungent in taste, and belongs to the lung meridian, having the effect of promoting qi and dissipating nodules; burdock fruit is cold in nature, pungent and bitter in taste, and belongs to the lung and stomach meridians, having the effect of detoxifying and promoting eruption. One is cold and the other is warm, and their medicinal properties are mutually restricted. With pungent taste for dispersion, they have the effect of enhancing the drug effect through the skin. Licorice is neutral in nature, sweet in taste, and belongs to the heart, lung, spleen, and stomach meridians, having the effects of relieving spasm and pain and coordinating various drugs. The three cooperate synergistically to play the effect of dredging meridians and relieving pain, and cooperate with loxoprofen sodium to play a synergistic and enhancing effect in anti-inflammatory and analgesic aspects.

[0028] (2) The gel paste provided by the present invention has uniform and delicate color, no irritation to the skin, and good stability.

[0029] (3) The anti-inflammatory and analgesic gel preparation prepared by the present invention has good stability, no irritation to the skin, good safety, and has a better anti-inflammatory and analgesic effect compared with the prior art. Specific Embodiments

[0030] The following description of the embodiments is only used to help understand the method and its core idea of the present invention. It should be noted that for those of ordinary skill in the art in this technical field, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

[0031] Therefore, the present invention will not be limited to these embodiments shown herein, but can be applied to a wider range consistent with the principles and novel features disclosed herein. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0032] As used herein, the singular forms "a", "an" and "the" include plural forms unless the context clearly dictates otherwise.

[0033] All numerical values or expressions related to component amounts, process conditions, etc. used should be understood to be modified by "about" in all cases. When the term "about" refers to a quantity or numerical range, it means that the indicated quantity or numerical range is an approximate value within the experimental variability (or within the statistical experimental error). In this article, the term "about" should have the meaning within 10% of the specified value or range, preferably within 5%.

[0034] All ranges involving the same components or properties include the endpoints, which can be combined independently. Since these ranges are continuous, they include every value between the minimum and maximum values. It should also be understood that any numerical range cited in the present invention is expected to include all sub-ranges within that range.

[0035] The term "pharmaceutically acceptable" indicates that the composition is compatible with the other components of the formulation and / or the subject to be treated therewith.

[0036] The present invention does not limit the sources of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are all ordinary commercially available products in the technical field. The solvents involved are all water, and the percentages involved are all mass percentages.

[0037] Example 1 An anti-inflammatory and analgesic topical composition, calculated by weight, consists of the following active components: 6 parts of loxoprofen sodium, 750 parts of stir-fried white mustard seeds, 400 parts of great burdock fruits, and 20 parts of liquorice.

[0038] The preparation method is as follows: (1) Take the formulated amounts of stir-fried white mustard seeds, great burdock fruits, and liquorice, add water and decoct twice. Each time, the amount of water added is 10 times the total weight of stir-fried white mustard seeds, great burdock fruits, and liquorice, and each time the time is 1 h. Filter and combine the filtrates. The filtrate is concentrated under reduced pressure at 60 °C to a relative density of 1.04 - 1.08, add ethanol to make the ethanol concentration 65 v / v %, let stand at room temperature for 24 h to obtain the supernatant, and dry at 50 °C to obtain the Chinese medicine extract; (2) Mix the Chinese medicine extract with the formulated amount of loxoprofen sodium.

[0039] Example 2 An anti-inflammatory and analgesic topical composition, calculated by weight, consists of the following active components: 3 parts of loxoprofen sodium, 500 parts of stir-fried white mustard seeds, 300 parts of great burdock fruits, and 10 parts of liquorice.

[0040] The preparation method is as follows: (2) Take the formulated amounts of stir-fried white mustard seeds, great burdock fruits, and liquorice, add water and decoct once. Each time, the amount of water added is 12 times the total weight of stir-fried white mustard seeds, great burdock fruits, and liquorice, and each time the time is 2 h. Filter and combine the filtrates. The filtrate is concentrated under reduced pressure at 60 °C to a relative density of 1.04 - 1.08, add ethanol to make the ethanol concentration 60 v / v %, let stand at room temperature for 24 h to obtain the supernatant, and dry at 50 °C to obtain the Chinese medicine extract; (2) Mix the Chinese medicine extract with the formulated amount of loxoprofen sodium.

[0041] Example 3 An anti-inflammatory and analgesic external composition, calculated by weight, consists of the following active components: 8 parts of loxoprofen sodium, 1000 parts of stir-fried semen sinapis, 500 parts of arctium fruit, and 30 parts of licorice root.

[0042] The preparation method is as follows: (3) Take the formula amount of stir-fried semen sinapis, arctium fruit, and licorice root, decoct with water 3 times. Each time, the amount of water added is 8 times the total weight of stir-fried semen sinapis, arctium fruit, and licorice root, and each time is for 0.5 h. Filter and combine the filtrates. The filtrate is concentrated under reduced pressure at 60 °C to a relative density of 1.04 - 1.08, add ethanol to make the ethanol concentration 70 v / v %, stand at room temperature for 24 h to obtain the supernatant, and dry at 50 °C to obtain the Chinese medicine extract; (2) Mix the Chinese medicine extract with the formula amount of loxoprofen sodium, and that's it.

[0043] Comparative Example 1 An anti-inflammatory and analgesic external composition, calculated by weight, consists of the following active components: 6 parts of loxoprofen sodium, 750 of stir-fried semen sinapis, and 20 parts of licorice root.

[0044] The preparation method is the same as that of Example 1.

[0045] Comparative Example 2 An anti-inflammatory and analgesic external composition, calculated by weight, consists of the following active components: 6 parts of loxoprofen sodium, 400 parts of arctium fruit, and 20 parts of licorice root.

[0046] The preparation method is the same as that of Example 1.

[0047] Comparative Example 3 An anti-inflammatory and analgesic external composition, calculated by weight, consists of the following active components: 6 parts of loxoprofen sodium, 400 parts of stir-fried semen sinapis, 750 parts of arctium fruit, and 20 parts of licorice root.

[0048] The preparation method is the same as that of Example 1.

[0049] I. Loxoprofen Sodium Gel Patch The anti-inflammatory and analgesic external compositions prepared in Examples 1 - 3 and Comparative Examples 1 - 3 were respectively prepared into loxoprofen sodium gel patches, and were respectively labeled as S1 - S3 and D1 - D3.

[0050] Specifically, the preparation method of the loxoprofen sodium gel patch is as follows: S1. Take 12 g of glycerol and 3.5 g of sodium carboxymethylcellulose, mix and stir to obtain Material 1. S2. Take 50 g of the anti-inflammatory and analgesic external composition, 12 g of polyethylene glycol 400, and 0.2 g of preservative, stir evenly to obtain Material 2; S3. Mix Material 1 and Material 2, add water to 100 g, and stir evenly, and that's it.

[0051] II. Stability of Loxoprofen Sodium Cataplasm Take 5 g of loxoprofen sodium cataplasm and place it in a centrifuge tube. Centrifuge it (centrifuge at 10000 rpm for 5 min), and observe the stability of the cataplasm. The results are shown in Table 1.

[0052] Table 1

[0053] The results show that the cataplasm prepared from the anti-inflammatory and analgesic external composition of the present invention has uniform and delicate paste color and good stability.

[0054] III. Safety of Loxoprofen Sodium Cataplasm Put loxoprofen sodium cataplasm into vacuum pressing bottles respectively (S1 - S3 or D1 - D3). After pressing through the vacuum pressing bottle, place the loxoprofen sodium cataplasm on a blank patch to obtain loxoprofen sodium patch, which are respectively labeled as TS1 - TS3, TD1 - TD3.

[0055] Apply the prepared loxoprofen sodium patches to the wrists of volunteer subjects, 30 in each group, and evaluate skin irritation and skin allergy. The results are shown in Table 2.

[0056] Table 2

[0057] The results show that the cataplasm prepared from the anti-inflammatory and analgesic external composition of the present invention has no irritation to the skin and good safety.

[0058] III. In Vitro Transdermal Test Adopt the modified Franz diffusion cell method, use pig abdominal skin as the barrier, and investigate the transdermal absorption effect of the anti-inflammatory and analgesic external compositions prepared in Examples 1 - 3 and Comparative Examples 1 - 3.

[0059] The specific method is as follows: Fix the washed pig skin on the release port of the Franz diffusion cell respectively. Add pH 7.4 phosphate buffer solution as the release medium in the receiving chamber to keep the inner cortex in close contact with the solution. Apply 3 g of loxoprofen sodium cataplasm on the skin, adjust the water bath to keep the temperature of the outer jacket layer constant at 32 ± 0.5 °C, and the stirring speed is 600 rpm. Absorb 4 ml of the release medium at 0, 1 h, 2 h, 4 h, 6 h, 12 h, and 24 h respectively, and add an equal amount of PBS solution at the same time. Calculate the cumulative absorption percentage. The results are shown in Table 3 below.

[0060] Table 3

[0061] The results showed that for the loxoprofen sodium cataplasm prepared with the anti-inflammatory and analgesic topical composition of Examples 1 - 3 of the present invention, the transdermal absorption rate of loxoprofen sodium reached over 18% in 4 hours, and the transdermal water absorption rate reached over 38% in 24 hours. This indicates that the anti-inflammatory and analgesic topical composition provided by the present invention has a good transdermal absorption effect.

[0062] Comparing the loxoprofen sodium cataplasm prepared with the anti-inflammatory and analgesic topical composition of Comparative Examples 1 - 3, it can be seen that when the composition of the anti-inflammatory and analgesic topical composition is changed, the transdermal absorption effect of loxoprofen sodium shows a decline, indicating that the composition and dosage of stir-fried semen sinapis, fructus arctii, and licorice have an important influence on the transdermal absorption of loxoprofen sodium.

[0063] IV. Evaluation of anti-inflammatory and analgesic effects (1) Rats (weighing 140 - 160 g) were randomly grouped by body weight, with 8 rats in each group, half male and half female. The abdominal hair was removed with depilatory cream, and the area was 2 cm × 2 cm. First, the circumference of the right hind paw of the rats was measured, and then the loxoprofen sodium cataplasm (administration groups TS1 - TS3 and TD1 - TD3) or blank cataplasm (without the anti-inflammatory and analgesic topical composition, blank group) was applied to the abdomen of the rats, and then the rats were fixed on a wooden board to prevent them from scratching off the drug. 0.1 mL of 0.1 wt% carrageenan was injected subcutaneously into the right hind paw of the rats 30 minutes after administration. The circumference of the right hind paw of the rats was measured 1 hour after inflammation induction, and the difference before and after inflammation induction was used as the swelling degree. The differences in the swelling degrees of each group were compared and statistically analyzed. The results are shown in Table 4.

[0064] (2) Rats (weighing 140 - 160 g) were randomly grouped by body weight, with 8 rats in each group, half male and half female. The abdominal hair was removed with depilatory cream, and the area was 2 cm × 2 cm. The loxoprofen sodium cataplasm (administration groups TS1 - TS3 and TD1 - TD3) or blank cataplasm (without the anti-inflammatory and analgesic topical composition, blank group) was applied to the abdomen, and the time was recorded. Then the rats were fixed on a wooden board to prevent them from scratching off the drug. 1 hour after administration, a pain inducer (0.6% acetic acid solution, 0.2 mL / 10 g) was injected intraperitoneally, and the time when the first writhing of the mice occurred within 10 minutes was observed and recorded. If it exceeded 10 minutes, it was recorded as 10 minutes. The test results were statistically analyzed, and the results are shown in Table 4 below.

[0065] Table 4

[0066] Note: Compared with the blank group, *P < 0.05.

[0067] Results showed that compared with the blank group, the swelling degree of rats in the drug administration group TS1 - TS3 was significantly reduced (P < 0.05), and the writhing reaction time was significantly prolonged (P < 0.05), indicating that the anti - inflammatory and analgesic external composition prepared in Examples 1 - 3 had anti - inflammatory and analgesic effects.

[0068] Compared with the blank group, there were no significant changes in the swelling degree and writhing reaction time of rats in the drug administration group TD1 - TD3 (P > 0.05), indicating that the anti - inflammatory and analgesic effects of the anti - inflammatory and analgesic external composition prepared in Comparative Examples 1 - 3 were poor.

[0069] By comparing the drug administration groups TD1 - TD2 and TS3, it can be seen that the anti - inflammatory and analgesic effects of the anti - inflammatory and analgesic external composition prepared by combining loxoprofen sodium, stir - fried semen sinapis albae and licorice or loxoprofen sodium, arctium lappa and licorice were poor, but the anti - inflammatory and analgesic effects were significantly improved after the combination of loxoprofen sodium, stir - fried semen sinapis albae, arctium lappa and licorice. It shows that the combination of loxoprofen sodium with stir - fried semen sinapis albae, arctium lappa and licorice plays a synergistic effect in anti - inflammatory and analgesic aspects.

[0070] The above is a further description of the present invention in combination with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that without departing from the spirit and scope of the present invention, modifications or substitutions can be made to the details and forms of the technical solutions of the present invention, but these modifications and substitutions all fall within the protection scope of the present invention.

Claims

1. An external composition for reducing inflammation and relieving pain, characterized in that, Comprising the following active ingredients in parts by weight: 3 - 8 parts of loxoprofen sodium, 500 - 1000 parts of stir-fried semen sinapis, 300 - 500 parts of arctium fruit, and 10 - 30 parts of liquorice.

2. The anti-inflammatory and pain-relieving external composition according to claim 1, wherein, Comprising the following active ingredients in parts by weight: 6 parts of loxoprofen sodium, 750 parts of stir-fried semen sinapis, 400 parts of arctium fruit, and 20 parts of liquorice.

3. The preparation method of the anti-inflammatory and analgesic external composition according to any one of claims 1-2, characterized in that, Comprising the following steps: (1) Subjecting the formula amount of stir-fried semen sinapis, arctium fruit, and liquorice to water extraction, separating solid from liquid, concentrating the filtrate, and performing alcohol precipitation to obtain a supernatant, and drying the supernatant to obtain a Chinese medicine extract; (2) Mixing the Chinese medicine extract with the formula amount of loxoprofen sodium.

4. The preparation method according to claim 3, characterized in that, The water extraction in step (1) is decocting with water, the amount of water used is 8 - 12 times the total weight of stir-fried semen sinapis, arctium fruit, and liquorice, the number of decocting times is 1 - 3 times, and the time for each time is 0.5 - 2 h; and / or the concentration in step (1) is reduced pressure concentration at 50 - 60 °C to a relative density of 1.04 - 1.08; and / or the alcohol precipitation in step (1) is adding ethanol to make the ethanol concentration 60 - 70 v / v %.

5. Use of the anti-inflammatory and analgesic external composition according to any one of claims 1 - 2 or the anti-inflammatory and analgesic external composition prepared by the preparation method according to any one of claims 3 - 4 in the preparation of an anti-inflammatory and analgesic drug.

6. An anti-inflammatory and analgesic gel preparation, characterized in that, Comprising the anti-inflammatory and analgesic external composition according to any one of claims 1 - 2 or the anti-inflammatory and analgesic external composition prepared by the preparation method according to any one of claims 3 - 4 and a pharmaceutically acceptable excipient.

7. The anti-inflammatory and pain-relieving gel preparation according to claim 6, characterized in that, The excipient includes at least one of a gel matrix, a surfactant, a humectant, and a preservative.

8. The anti-inflammatory and pain-relieving gel preparation according to claim 7, wherein The gel matrix includes at least one of carbomer 940, sodium carboxymethyl cellulose, and hydroxypropyl methylcellulose; The surfactant includes at least one of polyethylene glycol 400 and tween 80; The humectant includes at least one of glycerol, sorbitol, and hyaluronic acid; The preservative includes at least one of sodium benzoate, glycerol monostearate, glycerol monolaurate, glycerol monooleate, methyl paraben, propyl paraben, sorbic acid, and benzoic acid.

9. The anti-inflammatory and analgesic gel preparation according to claim 6, wherein The anti-inflammatory and analgesic gel preparation is a gel plaster or a gel patch.

10. The preparation method of the anti-inflammatory and pain-relieving gel preparation according to any one of claims 6-9, characterized in that, Comprising the following steps: S1. Mixing and stirring the humectant and the gel matrix to obtain material 1, S2. Stirring the anti-inflammatory and analgesic external composition, the surfactant, and the preservative evenly to obtain material 2; S3. Mixing material 1 and material 2, adding water and stirring to obtain a gel plaster.

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