Preparation method of compound dexamethasone acetate cream

Abstract

The invention discloses a preparation method of compound dexamethasone acetate emulsifiable paste, which comprises the following steps: mixing and stirring menthol, camphor and a crystallization inhibitor to obtain a eutectic solution; the crystallization inhibitor is a mixture of cyclic olefin and unsaturated fatty acid; adding dexamethasone acetate into the eutectic solution, and then mixing with the matrix oil phase and the water phase to obtain the compound dexamethasone acetate cream. The crystallization inhibitor is added when the menthol and camphor eutectic solution is prepared, and the obtained eutectic solution is good in uniformity and not prone to crystallization, so that the prepared compound dexamethasone acetate cream is stable in component content and not prone to granular sensation at low temperature, and the production efficiency, the product quality stability and the user experience are greatly improved.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical preparations, and in particular to a method for preparing a compound dexamethasone acetate cream. Background Art

[0002] Compound dexamethasone acetate cream is an external skin medicine that has significant therapeutic effects on localized pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis and chronic eczema. The 2020 edition of the Chinese Pharmacopoeia, Part II, discloses the prescription composition of compound dexamethasone acetate cream as follows: 0.75g dexamethasone acetate; 10g camphor; 10g menthol; 1g paraben; appropriate amount of matrix; appropriate amount of purified water; made into 1000g; the camphor and menthol components provide a cool feeling and effectively relieve skin itching. However, since camphor and menthol are both highly volatile components, crystalline at room temperature, and extremely difficult to dissolve in water, this physical property increases the difficulty of the pharmaceutical process on the one hand, and on the other hand, it causes the preparation to crystallize and precipitate under low temperature conditions, resulting in crystalline particles in the ointment, affecting its use and efficacy. Specifically, in the prior art, a liquid phase solution containing camphor and menthol is prepared by an organic solvent dissolution method or a eutectic method. Liquid mixing is beneficial to improving the compatibility of the components, but the former will cause the problem of residual organic solvent, and the camphor and menthol eutectic solution obtained by the latter has poor stability and is easy to re-precipitate crystals, thereby affecting the accuracy of the feed ratio and the stability of the product quality.

[0003] In view of this, it is necessary to improve the formula and preparation process of the cream, improve the stability of camphor and menthol in the cream, and improve production efficiency and product quality. Summary of the invention

[0004] The invention provides a preparation method of a compound dexamethasone acetate cream, aiming to improve the stability of a camphor and menthol eutectic solution, thereby improving the phenomenon of camphor and menthol crystallization occurring in the cream at low temperature.

[0005] The present invention is achieved in that:

[0006] In a first aspect, the present invention provides a method for preparing a compound dexamethasone acetate cream, comprising the following steps:

[0007] (1) mixing menthol, camphor and a crystallization inhibitor to obtain a eutectic solution; the crystallization inhibitor is a mixture of cyclic olefins and unsaturated fatty acids;

[0008] (2) heating and stirring the oil phase matrix to obtain an oil phase; dissolving a moisturizer, an antibacterial agent, a carbomer, and an emulsifier in pure water to obtain an aqueous phase;

[0009] (3) adding dexamethasone acetate to the eutectic solution to obtain a drug phase mixture; mixing the oil phase and the water phase to obtain a first mixed solution;

[0010] (4) Add the drug phase mixture to the first mixed solution, add a pH adjuster, and stir evenly to obtain a compound dexamethasone acetate cream.

[0011] In some embodiments of the present invention, the cyclic olefin comprises at least one of pinene, limonene, and camphene.

[0012] In some embodiments of the present invention, the unsaturated fatty acid includes at least one of oleic acid, linoleic acid, and linolenic acid.

[0013] In some embodiments of the present invention, the temperature of the mixing and stirring is 30-40° C. and the pressure is 0.2-0.4 MPa.

[0014] In some embodiments of the present invention, the molar ratio of the cyclic olefin to the fatty acid in the crystallization inhibitor is (1:2) to (3:1).

[0015] In some embodiments of the present invention, the mass of the crystallization inhibitor is 10% to 20% of the total mass of menthol and camphor.

[0016] In some embodiments of the present invention, the oil phase base includes at least one of liquid paraffin, petrolatum, lanolin, cetyl alcohol, stearic acid, palmitic acid, lauric acid, stearyl alcohol and glyceryl stearate.

[0017] In some embodiments of the present invention, the humectant includes at least one of glycerin, propylene glycol, and butylene glycol.

[0018] In some embodiments of the present invention, the antimicrobial agent includes at least one of methylparaben, propylparaben, and ethylparaben.

[0019] In some embodiments of the present invention, the emulsifier includes at least one of polyoxyethylene 25 oxypropylene stearate, sodium lauryl sulfate, polyoxyl 40 stearate, polyethylene glycol 400 monostearate, polyethylene glycol 600 monostearate, polyoxyethylene 20 stearate and polyoxypropylene distearate.

[0020] In some embodiments of the present invention, the pH adjuster includes at least one of sodium bicarbonate and triethanolamine.

[0021] In a second aspect, the present invention provides a compound dexamethasone acetate cream prepared by the preparation method of any embodiment.

[0022] A compound dexamethasone acetate cream is composed of the following raw materials by weight based on a total weight of 1000 g: 0.75 g of dexamethasone acetate, 10-18 g of menthol, 10-18 g of camphor, 1-9 g of a crystallization inhibitor, 100-160 g of an oil phase matrix, 20-50 g of a moisturizer, 1-4 g of an antibacterial agent, 2-5 g of carbomer, 20-40 g of an emulsifier, 1-2 g of a pH regulator, and the balance is water.

[0023] The present invention has the following beneficial effects:

[0024] The invention provides a preparation method of a compound dexamethasone acetate cream. When preparing a menthol and camphor eutectic solution, a crystallization inhibitor is added, and the obtained eutectic solution has good uniformity and is not prone to crystallization. Therefore, the prepared compound dexamethasone acetate cream has stable contents of various components and is not prone to granularity at low temperatures, thereby greatly improving production efficiency, product quality stability and use experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 These are optical microscope images of Example 1 before and after the cold resistance test (standing at -20°C for 24 hours), with a scale of 25 μm.

[0026] Figure 2 These are optical microscope images of Example 10 before and after the cold resistance test (standing at -20°C for 24 hours), with a scale of 25 μm. DETAILED DESCRIPTION

[0027] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0028] In the description of the embodiments of the present application, technical terms such as "first" and "second" are only used to distinguish different objects and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features.

[0029] Reference to "embodiment" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiment may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments.

[0030] In the embodiment of the present application, the term "or / and" is only a description of the association relationship of associated objects, indicating that three relationships may exist. For example, A or / and B can represent three situations: A exists alone, A and B exist at the same time, and B exists alone.

[0031] In addition, the character “ / ” in this article generally indicates that the previous and next associated objects are in an “or” relationship.

[0032] In the embodiments of the present application, "multiple" means more than two (including two). Similarly, "multiple groups" means more than two groups (including two groups), and "multi-layer" means more than two layers (including two layers), unless otherwise clearly specified and limited.

[0033] In the embodiments of the present application, "at least one" means one or more than one.

[0034] In the embodiments of the present application, the orientations or positional relationships indicated by the technical terms "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed in a specific orientation, etc., and cannot be understood as limiting the embodiments of the present application. Those skilled in the art can understand the specific meanings of the above terms in the embodiments of the present application according to specific circumstances.

[0035] The present invention adds a crystallization inhibitor when preparing a menthol and camphor eutectic solution, so that the obtained eutectic solution has good uniformity and is not prone to crystallization. Therefore, the content of each component in the prepared compound dexamethasone acetate cream is stable, and it is not easy to have a granular feeling at low temperature, thereby greatly improving production efficiency, product quality stability and use experience.

[0036] Specifically, the crystallization inhibitor is a mixture of cyclic olefins and unsaturated fatty acids. Since the cyclic olefins have a structure similar to that of menthol and camphor, they hinder the orderly arrangement of menthol and camphor molecules, thereby inhibiting the formation of crystal nuclei and inhibiting crystallization. Furthermore, unsaturated fatty acids with a melting point lower than room temperature are added. On the one hand, they have a solubilizing effect on menthol and camphor, inhibiting the crystallization of the two. On the other hand, unsaturated fatty acids contain both carboxyl and alkenyl groups. The carboxyl group can combine with the hydroxyl group of menthol and the ketone group of camphor through hydrophilic action, while the alkenyl group can combine with the cyclic olefin through hydrophobic action, thereby improving the compatibility of the components and preventing phase separation, thereby improving the compatibility of menthol and camphor in the liquid phase and inhibiting their crystallization. Since the eutectic solution of menthol and camphor provided by the present invention has good stability and is difficult to crystallize, the phenomenon of crystals adhering to the wall will not occur during the preparation process, thereby greatly improving the production efficiency, and at the same time ensuring the stability of the component content, thereby improving the stability of product quality; furthermore, the compound dexamethasone acetate cream prepared by the present invention will not crystallize or have a granular feel at low temperatures, and therefore has a good feel in use.

[0037] The following is a specific implementation method to further illustrate the solution of the present invention.

[0038] Example 1

[0039] A method for preparing a compound dexamethasone acetate cream comprises the following steps:

[0040] (1) Menthol, camphor and crystallization inhibitor were added into a reaction kettle according to the formula, the temperature was set to 30° C., the pressure was controlled to 0.3 MPa, and the mixture was stirred until completely melted to obtain a eutectic solution, which was kept warm for later use.

[0041] The crystallization inhibitor is a mixture of α-pinene and oleic acid in a molar ratio of 1:1.

[0042] (2) mixing the oil phase matrix and heating it to 70° C. and stirring to obtain the oil phase, which is kept warm for later use; adding the carbomer into pure water, heating it to 60° C. and stirring to swell, then adding the moisturizer, antibacterial agent and emulsifier, and stirring and keeping warm to make them dispersed evenly to obtain the water phase, which is kept warm for later use;

[0043] Among them, the oil phase matrix is ​​a mixture of liquid paraffin, cetyl alcohol and glyceryl stearate in a mass ratio of 2:1:1; the moisturizer is glycerin, the antibacterial agent is ethyl hydroxybenzoate, and the emulsifier is polyethylene glycol 400 monostearate.

[0044] (3) adding dexamethasone acetate to the eutectic solution, heating to 60° C., controlling the pressure to 0.2 MPa, and stirring to obtain a drug phase mixture; mixing the oil phase and the water phase, keeping the mixture warm and homogenizing for 8 min under vacuum conditions (vacuum degree of −0.09 MPa) at a speed of 6000 rpm to obtain a first mixed solution, and cooling the mixture to 50° C. for standby use;

[0045] (4) adding the drug phase mixture to the first mixed solution, homogenizing at 6000 rpm for 2 min, adding a pH adjuster to adjust the pH to 6.7, and obtaining a compound dexamethasone acetate cream;

[0046] Wherein, the pH adjuster is sodium bicarbonate.

[0047] A compound dexamethasone acetate cream is composed of the following raw materials by weight based on a total weight of 1000 g: 0.75 g of dexamethasone acetate, 10 g of menthol, 10 g of camphor, 3 g of a crystallization inhibitor, 130 g of an oil phase matrix, 30 g of a moisturizer, 1.5 g of an antibacterial agent, 3 g of carbomer, 30 g of an emulsifier, 1.4 g of a pH regulator, and the balance is water.

[0048] Example 2

[0049] A method for preparing a compound dexamethasone acetate cream comprises the following steps:

[0050] (1) Menthol, camphor and crystallization inhibitor were added into a reaction kettle according to the formula, the temperature was set to 40° C., the pressure was controlled to 0.2 MPa, and the mixture was stirred until completely melted to obtain a eutectic solution, which was kept warm for later use.

[0051] The crystallization inhibitor is a mixture of limonene and linoleic acid in a molar ratio of 1:1.

[0052] (2) mixing the oil phase matrix and heating it to 70° C. and stirring to obtain the oil phase, which is kept warm for later use; adding the carbomer into pure water, heating it to 60° C. and stirring to swell, then adding the moisturizer, antibacterial agent and emulsifier, and stirring and keeping warm to make them dispersed evenly to obtain the water phase, which is kept warm for later use;

[0053] Among them, the oil phase matrix is ​​a mixture of white vaseline, cetyl alcohol, stearyl alcohol, and mono- and distearic glyceryl in a mass ratio of 3:9:1:4; the moisturizer is 1,3-propylene glycol, the antibacterial agent is ethyl hydroxybenzoate, and the emulsifier is polyoxyl 40 stearate.

[0054] (3) adding dexamethasone acetate to the eutectic solution, heating to 60° C., controlling the pressure to 0.2 MPa, and stirring to obtain a drug phase mixture; mixing the oil phase and the water phase, keeping the mixture warm and homogenizing for 8 min under vacuum conditions (vacuum degree of −0.09 MPa) at a speed of 6000 rpm to obtain a first mixed solution, and cooling the mixture to 50° C. for standby use;

[0055] (4) adding the drug phase mixture to the first mixed solution, homogenizing at 6000 rpm for 2 min, adding a pH adjuster to adjust the pH to 6.5, and obtaining a compound dexamethasone acetate cream;

[0056] Wherein, the pH adjuster is sodium bicarbonate.

[0057] A compound dexamethasone acetate cream is composed of the following raw materials by weight based on a total weight of 1000 g: 0.75 g of dexamethasone acetate, 18 g of menthol, 18 g of camphor, 3.6 g of a crystallization inhibitor, 100 g of an oil phase matrix, 20 g of a moisturizer, 2 g of an antibacterial agent, 5 g of carbomer, 20 g of an emulsifier, 1.2 g of a pH regulator, and the balance is water.

[0058] Example 3

[0059] A method for preparing a compound dexamethasone acetate cream comprises the following steps:

[0060] (1) Menthol, camphor and crystallization inhibitor were added into a reaction kettle according to the formula, the temperature was set to 35° C., the pressure was controlled to 0.4 MPa, and the mixture was stirred until completely melted to obtain a eutectic solution, which was kept warm for later use.

[0061] The crystallization inhibitor is a mixture of camphene and linolenic acid in a molar ratio of 3:1.

[0062] (2) mixing the oil phase matrix and heating it to 70° C. and stirring to obtain the oil phase, which is kept warm for later use; adding the carbomer into pure water, heating it to 60° C. and stirring to swell, then adding the moisturizer, antibacterial agent and emulsifier, and stirring and keeping warm to make them dispersed evenly to obtain the water phase, which is kept warm for later use;

[0063] Among them, the oil phase matrix is ​​a mixture of lanolin, white vaseline and stearic acid in a mass ratio of 1:3:8; the moisturizer is a mixture of 1,4-butylene glycol and glycerol in a mass ratio of 1:2, the antibacterial agent is ethylparaben, and the emulsifier is a mixture of polyoxyethylene 20 stearate and polyethylene glycol 600 monostearate in a mass ratio of 3:2.

[0064] (3) adding dexamethasone acetate to the eutectic solution, heating to 60° C., controlling the pressure to 0.2 MPa, and stirring to obtain a drug phase mixture; mixing the oil phase and the water phase, keeping the mixture warm and homogenizing for 8 min under vacuum conditions (vacuum degree of −0.09 MPa) at a speed of 6000 rpm to obtain a first mixed solution, and cooling the mixture to 50° C. for standby use;

[0065] (4) adding the drug phase mixture to the first mixed solution, homogenizing at 6000 rpm for 2 min, adding a pH adjuster to adjust the pH to 7.1, and obtaining a compound dexamethasone acetate cream;

[0066] Wherein, the pH adjuster is sodium bicarbonate.

[0067] A compound dexamethasone acetate cream is composed of the following raw materials by weight based on a total weight of 1000 g: 0.75 g of dexamethasone acetate, 18 g of menthol, 15 g of camphor, 8.6 g of a crystallization inhibitor, 160 g of an oil phase matrix, 50 g of a moisturizer, 3.2 g of an antibacterial agent, 2 g of carbomer, 40 g of an emulsifier, 1.8 g of a pH regulator, and the balance is water.

[0068] Example 4

[0069] The difference from Example 1 is that the pressure in step (1) is 0.2 MPa.

[0070] Example 5

[0071] The difference from Example 1 is that the pressure in step (1) is 0.4 MPa.

[0072] Example 6

[0073] The difference from Example 1 is that the mass of the crystallization inhibitor is 10% of the total mass of menthol and camphor, that is, a compound dexamethasone acetate cream, based on a total weight of 1000g, is composed of the following raw materials by weight: dexamethasone acetate 0.75g, menthol 10g, camphor 10g, crystallization inhibitor 2g, oil phase base 130g, moisturizer 30g, antibacterial agent 1.5g, carbomer 3g, emulsifier 30g, pH adjuster 1.4g, and the balance is water.

[0074] Example 7

[0075] The difference from Example 1 is that the mass of the crystallization inhibitor is 20% of the total mass of menthol and camphor, that is, a compound dexamethasone acetate cream, based on a total weight of 1000g, is composed of the following raw materials by weight: dexamethasone acetate 0.75g, menthol 10g, camphor 10g, crystallization inhibitor 4g, oil phase base 130g, moisturizer 30g, antibacterial agent 1.5g, carbomer 3g, emulsifier 30g, pH adjuster 1.4g, and the balance is water.

[0076] Example 8

[0077] The difference from Example 1 is that the crystallization inhibitor is a mixture of α-pinene and linoleic acid in a molar ratio of 2:1.

[0078] Example 9

[0079] The difference from Example 1 is that the crystallization inhibitor is a mixture of limonene and oleic acid in a molar ratio of 1:2.

[0080] Example 10

[0081] The difference from Example 1 is that the eutectic solution is prepared under normal pressure and sealed and stirred.

[0082] Comparative Example 1

[0083] The difference from Example 1 is that the crystallization inhibitor is α-pinene.

[0084] Comparative Example 2

[0085] The difference from Example 1 is that the crystallization inhibitor is oleic acid.

[0086] Comparative Example 3

[0087] The difference from Example 1 is that no crystallization inhibitor was added.

[0088] The physical properties of the products of the embodiments and comparative examples were tested using the following test methods:

[0089] (1) Eutectic stability test: The uniformity of the eutectic prepared in each specific embodiment after standing (25°C, 75% RH) for a certain period of time (1h, 10h, 24h) was measured by gas chromatograph, and samples were taken from the liquid surface and liquid bottom of the sealed tank containing the eutectic solution, and the camphor and menthol contents were measured. The uniformity was evaluated by the content difference between the liquid surface and the liquid bottom. The camphor and menthol content was tested according to the camphor and menthol content test method described in the "Compound Dexamethasone Acetate Cream" in the "Chinese Pharmacopoeia 2020 Edition·Part II". The content difference between the liquid surface and the liquid bottom was measured by the coefficient of variation (RSD value, = sample standard deviation ÷ mean) of the liquid surface content and the liquid bottom content. The results are shown in Table 1.

[0090] Table 1: Coefficient of variation of liquid surface content and liquid bottom content

[0091]

[0092] As can be seen from the data in Table 1, the difference in the content of menthol and camphor at the liquid surface and the liquid bottom of the eutectic solution prepared by the preparation method of the present invention after standing is less than that of the comparative example, indicating that the uniformity is higher, indicating that the addition of the crystallization inhibitor improves the compatibility and dispersibility of each phase, thereby inhibiting the crystallization and precipitation of menthol and camphor. From the comparison between Example 1 and Comparative Examples 1 to 3, it can be seen that the effect of only containing cyclic olefins or unsaturated fatty acids in the crystallization inhibitor is not as good as containing both at the same time, but compared with not adding, only adding liquid containing cyclic olefins or unsaturated fatty acids is also beneficial to improving the uniformity of the eutectic solution.

[0093] (2) Temperature stability test of ointment: The stability of the ointment at low and high temperatures was evaluated by observation. The specific steps are as follows: ① Place the cream in a sealed bottle and place it at 60°C for 24 hours and at -20°C for 24 hours; ② Observe whether the cream has stratification or obvious particles, and describe them; ③ Use an optical microscope to observe the size of the crystal particles in the cream, and randomly select 5 areas for observation and record. The results are shown in Table 2.

[0094] Table 2

[0095]

[0096] It can be seen from the data in Table 2 that the creams prepared in Examples 1 to 10 of the present invention all have good cold resistance, no particles appear in the low temperature test, and the particle size of the crystalline particles obtained by observation under a microscope is small, indicating that the compatibility of the components in the compound dexamethasone acetate ointment provided by the present invention is increased, and the crystallization and precipitation of the oil-soluble components therein are inhibited.

[0097] Figure 1 and 2The optical microscope images are respectively before and after the cold resistance test (standing at -20°C for 24 hours) of Example 1 and Example 10. As can be seen from the figure, the particle size and number of the precipitated crystals after the cold resistance test of Example 10 are larger than those of Example 1, indicating that appropriate pressure when preparing the eutectic solution is conducive to obtaining a eutectic solution that is not easy to crystallize and has higher uniformity.

[0098] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for preparing a compound dexamethasone acetate cream, characterized in that: The steps include: (1) mixing menthol, camphor and a crystallization inhibitor to obtain a eutectic solution; the crystallization inhibitor is a mixture of cyclic olefins and unsaturated fatty acids; (2) heating and stirring the oil phase matrix to obtain an oil phase; dissolving a moisturizer, an antibacterial agent, a carbomer, and an emulsifier in pure water to obtain an aqueous phase; (3) adding dexamethasone acetate to the eutectic solution to obtain a drug phase mixture; mixing the oil phase and the water phase to obtain a first mixed solution; (4) adding the drug phase mixture to the first mixed solution, adding a pH adjuster, and stirring evenly to obtain a compound dexamethasone acetate cream.

2. The preparation method of compound dexamethasone acetate cream according to claim 1, characterized in that, The cyclic olefin includes at least one of pinene, limonene and camphene.

3. The preparation method of the compound dexamethasone acetate cream according to claim 1 or 2, characterized in that, The unsaturated fatty acid includes at least one of oleic acid, linoleic acid and linolenic acid.

4. The preparation method of compound dexamethasone acetate cream according to claim 1, characterized in that, The mixing and stirring in step (1) is carried out at a temperature of 30 to 40° C. and a pressure of 0.2 to 0.4 MPa.

5. The preparation method of compound dexamethasone acetate cream according to claim 1, characterized in that, The molar ratio of the cyclic olefin to the fatty acid in the crystallization inhibitor is (1:2) to (3:1).

6. The preparation method of compound dexamethasone acetate cream according to claim 1, characterized in that, The mass of the crystallization inhibitor is 10% to 20% of the total mass of the menthol and the camphor.

7. The preparation method of compound dexamethasone acetate cream according to claim 1, characterized in that, The oil phase matrix includes at least one of liquid paraffin, vaseline, lanolin, cetyl alcohol, stearic acid, palmitic acid, lauric acid, stearyl alcohol and stearyl glyceryl; and / or, the humectant comprises at least one of glycerin, propylene glycol and butylene glycol; and / or, the antibacterial agent comprises at least one of methylparaben, propylparaben and ethylparaben; And / or, the emulsifier includes at least one of polyoxyethylene 25 oxypropylene stearate, sodium lauryl sulfate, polyoxyl 40 stearate, polyethylene glycol 400 monostearate, polyethylene glycol 600 monostearate, polyoxyethylene 20 stearate and polyoxypropylene distearate; And / or, the pH adjuster includes at least one of sodium bicarbonate and triethanolamine.

8. A compound dexamethasone acetate cream, characterized in that: The compound dexamethasone acetate cream is prepared according to the preparation method according to any one of claims 1 to 7.

9. The compound dexamethasone acetate cream according to claim 8, characterized in that Based on a total weight of 1000 g, the compound dexamethasone acetate cream is composed of the following raw materials by weight: 0.75 g of dexamethasone acetate, 10 to 18 g of menthol, 10 to 18 g of camphor, 1 to 9 g of a crystallization inhibitor, 100 to 160 g of an oil phase matrix, 20 to 50 g of a moisturizer, 1 to 4 g of an antibacterial agent, 2 to 5 g of carbomer, 20 to 40 g of an emulsifier, 1 to 2 g of a pH regulator, and the balance is water.

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