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Compound dexamethasone acetate cream composition and preparation method thereof

A technology of dexamethasone acetate and composition, which is applied in the field of medicine, can solve problems such as increased content of dexamethasone, and achieve the effects of improved stability, simple preparation method, and good stability

Pending Publication Date: 2019-07-26
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, according to the compound dexamethasone acetate cream prepared by the prior art, it is relatively stable under acid, oxidation, and light damage conditions, but, under high temperature and alkali damage conditions, the main component degradation impurity dexamethasone content is significantly increase

Method used

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  • Compound dexamethasone acetate cream composition and preparation method thereof
  • Compound dexamethasone acetate cream composition and preparation method thereof
  • Compound dexamethasone acetate cream composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment approach

[0038] According to one embodiment of the present application, a compound dexamethasone acetate cream composition comprises the following components:

[0039] Dexamethasone acetate 0.05% to 0.1%;

[0040] Camphor 0.5% ~ 1.5%;

[0041] Menthol 0.5% ~ 1.5%;

[0042] Cream base material 20% to 40%;

[0043] Dimethyl sulfoxide 0.5% to 2.5%;

[0044] pH regulator 0.02% ~ 0.08%;

[0045] The balance is water.

[0046] The oil phase substance in the cream base material is one or more mixtures of glyceryl monostearate, cetostearyl alcohol, vaseline, stearic acid, liquid paraffin, cetyl alcohol and stearyl alcohol .

[0047] The surfactant in the cream base material is one or a mixture of glyceryl monostearate and sodium lauryl sulfate.

[0048] The pH regulator is one or a mixture of carbomer and polycarbophil.

Embodiment 1

[0050] This embodiment relates to the formula of compound dexamethasone acetate cream composition, specifically as shown in table 1:

[0051] Table 1 Compound dexamethasone acetate cream composition formula table

[0052]

[0053]

Embodiment 2

[0055] This embodiment relates to a preparation method of compound dexamethasone acetate cream composition.

[0056] A preparation method of compound dexamethasone acetate cream composition, is characterized in that, described method comprises the steps:

[0057] (1) Add purified water and carbomer according to formula 1, heat to 85±5°C after the carbomer is completely swollen, add the prescribed amount of sodium lauryl sulfate and glycerin to dissolve to obtain a water phase.

[0058] (2) Add the prescribed amount of glyceryl monostearate, cetostearyl alcohol, petrolatum and ethylparaben to the oil phase pot. Heat to 75-80°C to completely melt to obtain the oil phase.

[0059] (3) Stir the camphor and menthol repeatedly to make them melt.

[0060] (4) Weigh the prescribed amount of dexamethasone acetate and dissolve it in dimethyl sulfoxide.

[0061] (5) Preheat the emulsification and homogenization pot, and start the vacuum to make the vacuum pressure ≤ -40KPA, inhale the...

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Abstract

The invention discloses a compound dexamethasone acetate cream composition comprising the following components by the weight percentage: 0.05%-0.1% of dexamethasone acetate, 0.5%-1.5% of camphor, 0.5%-1.5% of menthol, 20%-40% of a cream matrix material, 0.5%-2.5% of dimethyl sulfoxide, 0.02%-0.08% of a pH regulator, and the balance being water. The stability of the compound dexamethasone acetate cream composition provided by the invention is obviously improved compared with the prior art. The invention also discloses a preparation method of the compound dexamethasone acetate cream composition.

Description

technical field [0001] The application belongs to the technical field of medicine, and more specifically, the application relates to a compound dexamethasone acetate cream composition and a preparation method thereof. Background technique [0002] Dexamethasone acetate, chemical name: 16α-methyl-11β, 17α, 21-trihydroxy-9α-flupregna-1,4-diene-3,20-dione 21-acetate. Compound dexamethasone acetate cream is a compound preparation for external use, which is clinically used for localized pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis and chronic eczema and other dermatological diseases. [0003] At present, dexamethasone acetate is prepared into various external dosage forms at home and abroad, such as compound dexamethasone acetate nano cream, compound dexamethasone acetate gel, compound dexamethasone acetate cream, etc., especially compound dexamethasone acetate milk The ointment has been used in the market for a long time and has been recognized by consum...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/573A61K31/045A61K31/125A61K47/10A61K47/20A61P17/04A61P17/00A61P17/08A61P25/00
CPCA61K31/573A61K31/045A61K31/125A61K9/06A61K9/0014A61K47/10A61K47/20A61K2300/00
Inventor 马则秀王洪萍杨彩霞吴鸣
Owner 湖北舒邦药业有限公司
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