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A fusidic acid-betamethasone valerate cream medicine composition and a preparing method thereof

A technology for fusidic acid valeric acid and betamethasone valerate, which is applied in the field of medicine, can solve the problems affecting the stability of creams, the stability of active ingredients and the like, and achieves the effects of low cost, stable quality and advanced preparation technology.

Inactive Publication Date: 2016-06-22
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, to prepare cream for this type of compound, generally the compound is first dissolved in an organic solvent, such as propylene glycol or dimethyl sulfoxide, such as triamcinolone acetonide urea cream with approval number H44024203, approval number No. H44024204 compound dexamethasone cream, but this will have a certain impact on the stability of active ingredients sensitive to organic solvents, especially compounds with ester groups such as fusidic acid and betamethasone valerate , in the case of soluble in organic solvents, transesterification is prone to occur, which will seriously affect the stability of the cream

Method used

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  • A fusidic acid-betamethasone valerate cream medicine composition and a preparing method thereof
  • A fusidic acid-betamethasone valerate cream medicine composition and a preparing method thereof
  • A fusidic acid-betamethasone valerate cream medicine composition and a preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The preparation of embodiment 1 fusidic acid betamethasone valerate cream

[0036]

[0037] Accurately weighed according to the above ratio, the water is divided into two parts: 500g and 257g, ready, the cream preparation process is as follows:

[0038] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, glyceryl monostearate, liquid paraffin, and Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 72±2°C;

[0039] (2) Preparation of water phase: Accurately weigh according to the above proportions, take glycerin, disodium edetate and 500g of water, put them in a container, heat, and keep the temperature at 70±2°C;

[0040] (3) Phase combination: Pour the oil phase prepared in step (1) into the water phase prepared in step (2), stir, keep the temperature at 75±2°C, and add benzyl alcohol;

[0041] (4) main drug suspension: put fusidic acid, betamethasone valerate, 257g water, and polyvinylpyrrolidone in a container, stir or sonic...

Embodiment 2

[0043] The preparation of embodiment 2 fusidic acid betamethasone valerate cream

[0044]

[0045] Accurately weighed according to the above ratio, the water is divided into two parts: 380g and 259g, ready, the cream preparation process is as follows:

[0046] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, cetyl alcohol, glyceryl monostearate, liquid paraffin, and put Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 72±2 ℃;

[0047] (2) Preparation of water phase: Accurately weigh according to the above proportions, take glycerin, disodium edetate and 380g of water, put them in a container, heat, and keep the temperature at 70±2°C;

[0048] (3) Phase combination: Pour the oil phase prepared in step (1) into the water phase prepared in step (2), stir, keep the temperature at 75±2°C, and add benzyl alcohol;

[0049] (4) main drug suspension: put fusidic acid, betamethasone valerate, 259 g of water, and polyvinylpyrrolidone in a ...

Embodiment 3

[0051] The preparation of embodiment 3 fusidic acid betamethasone valerate cream

[0052]

[0053] Accurately weighed according to the above ratio, the water is divided into two parts: 380g and 260g, ready, the cream preparation process is as follows:

[0054] (1) Oil phase preparation: take white petrolatum, stearyl alcohol, glyceryl monostearate, liquid paraffin, and Pingpingjia A-20 in a container, heat to melt, and keep the temperature at 77±2°C;

[0055] (2) Preparation of water phase: Accurately weigh according to the above ratio, take glycerin, disodium ethylenediamine tetraacetate and 380g of water, put them in a container, heat, and keep the temperature at 75±2°C;

[0056] (3) Phase combination: Pour the oil phase prepared in step (1) into the water phase prepared in step (2), stir, keep the temperature at 75±2°C, and add benzyl alcohol;

[0057] (4) main drug suspension: put fusidic acid, betamethasone valerate, 260g water, and hydroxypropyl methylcellulose in a ...

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Abstract

The invention relates to a pharmaceutical composition of fusidic acid betamethasone valerate cream for treating inflammatory skin diseases accompanied by bacterial infection and a preparation method thereof, belonging to the technical field of medicines. The composition is composed of active ingredients, an oil phase base, a consistency regulator, a moisturizer, an emulsifier, a stabilizer, a bacteriostat, and the rest of water. The cream has moderate viscosity, good drug stability, simple process, and suitable in industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition of fusidic acid betamethasone valerate cream and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Fusidic acid (Fusidic acid, FA) belongs to the class of fusidic acid antibiotics. It was discovered and extracted from the fermentation broth of Fusidium coccineum by Danish Leo Pharmaceutical Company in 1962. Fusidic acid has steroidal structural characteristics (Formula 1), and its mechanism of action is unique. It inhibits the translocation of ribosomes by interfering with the elongation factor G, thereby hindering the synthesis of bacterial proteins. Strains resistant to penicillin, methicillin and other antibiotics are highly sensitive to fusidic acid. [0003] Fusidic acid is a colorless crystal, containing half of crystal water, insoluble in water, soluble in benzene, methanol, ethyl acetate and other organic solvents, fusidic acid is a we...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K9/06A61P17/00A61P31/04A61P31/02A61K31/56
Inventor 蒋德军杨平余悦东冯卫杨必坤
Owner SICHUAN HAISCO PHARMA CO LTD
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