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A kind of sodium fusidate ointment pharmaceutical composition and preparation method thereof

A technology of sodium fusidate and its composition, which is applied in the field of sodium fusidate ointment pharmaceutical composition and its preparation, can solve the problems of poor stability of sodium fusidate, and solve the problem of being easily oxidized and degraded, reducing skin Local Adverse Reactions, Guaranteed Effectiveness and Safety Effects

Active Publication Date: 2019-10-29
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In order to overcome the stability problem that sodium fusidate is easily oxidized and degraded during the preparation and storage of sodium fusidate ointment in the prior art, the present invention provides a combination of dibutylhydroxytoluene, tert-butyl Sodium fusidate ointment using a mixture of p-hydroxyanisole and citric acid as an antioxidant and a preparation method thereof, the composition prepared by the preparation method can significantly enhance the stability of sodium fusidate and solve the problem of fusidate Sodium fusidate ointment The problem of poor stability of sodium fusidate, which is common in the prior art, helps to improve the effectiveness and safety of the clinical use of the preparation composition

Method used

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  • A kind of sodium fusidate ointment pharmaceutical composition and preparation method thereof
  • A kind of sodium fusidate ointment pharmaceutical composition and preparation method thereof
  • A kind of sodium fusidate ointment pharmaceutical composition and preparation method thereof

Examples

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Effect test

Embodiment 1

[0041] The preparation of embodiment 1 sodium fusidate ointment pharmaceutical composition

[0042] prescription:

[0043]

[0044] The preparation method is prepared according to the following steps:

[0045] (1) Preparation of oil phase: weigh white petrolatum, liquid paraffin, lanolin and cetyl alcohol according to the prescription, heat and melt in a water bath at about 80°C, stir evenly, and slowly add the used amount when it is cooled to about 50°C Antioxidant ethanol solution prepared by ethanol (dissolve dibutyl hydroxytoluene, tert-butyl p-hydroxyanisole and citric acid in 75mL ethanol together according to the prescription), and stir until uniform;

[0046] (2) Prepare the water phase: weigh sodium fusidate according to the prescription amount, and dissolve it with 50mL distilled water;

[0047] (3) Prepare ointment: slowly add the above water phase to the oil phase prepared in step (1), stir while adding in the same direction, continue to stir until uniform, an...

Embodiment 2

[0049] Example 2 Preparation of Sodium Fusidate Ointment Pharmaceutical Composition

[0050] prescription:

[0051]

[0052]

[0053] The preparation method is prepared according to the following steps:

[0054] (1) Preparation of oil phase: weigh white petrolatum, beeswax, silicone oil and cetyl alcohol according to the prescription, heat and melt in a water bath at about 80°C, stir evenly, and slowly add appropriate amount of ethanol when it is cooled to about 50°C Good antioxidant ethanol solution (dibutyl hydroxytoluene, tert-butyl p-hydroxyanisole and citric acid are dissolved in 30mL ethanol according to the prescription), and stir until uniform;

[0055] (2) Prepare the water phase: weigh sodium fusidate according to the prescription amount, and dissolve it with 50mL distilled water;

[0056] (3) Prepare ointment: slowly add the above water phase to the oil phase prepared in step (1), stir while adding in the same direction, continue to stir until uniform, and c...

Embodiment 3

[0058] Example 3 Preparation of Sodium Fusidate Ointment Pharmaceutical Composition

[0059] prescription:

[0060]

[0061]

[0062] The preparation method is prepared according to the following steps:

[0063] (1) Preparation of oil phase: Weigh stearic acid, liquid paraffin, lanolin and Tween-80 according to the prescription, heat and melt in a water bath at about 80°C, stir evenly, and slowly add the Antioxidant ethanol solution prepared with an appropriate amount of ethanol (dissolve dibutyl hydroxytoluene, tert-butyl p-hydroxyanisole and citric acid in 30mL ethanol together according to the prescription), and stir until uniform;

[0064] (2) Prepare the water phase: weigh sodium fusidate according to the prescription amount, and dissolve it with 200mL distilled water;

[0065] (3) Prepare ointment: slowly add the above water phase to the oil phase prepared in step (1), stir while adding in the same direction, continue to stir until uniform, and cool to room tempe...

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Abstract

The invention belongs to the technical field of medicines, and mainly relates to a sodium fusidate ointment medicine composition and a preparing method thereof. The composition comprises, by weight, 1%-10% of sodium fusidate, 80%-90% of ointment matrix, 0.2%-15% of emulgator, 0.1%-5% of antioxygen and the balanced distilled water and ethyl alcohol. The preparing method includes the steps of oil phase preparation, aqueous phase preparation, ointment mixing, ointment filling and the like. By means of the sodium fusidate ointment medicine composition and the preparing method, the problem that sodium fusidate is easily oxidized and degraded under the influences of the high temperature in the ointment preparation process is solved, generation of impurities is effectively controlled, the content of the sodium fusidate in the product can be stably kept, the product quality is improved, the local untoward effect of the skin during clinical medication is reduced, and the effectiveness and the safety of the medicine in clinic application are better guaranteed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sodium fusidate ointment pharmaceutical composition and a preparation method thereof. Background technique [0002] Since the discovery of penicillin in the 1940s, the development and research of antibiotics has made rapid progress. Researchers initially searched for new microorganisms from soil samples and extracted antibiotics from the culture fluid of microorganisms, and then began to apply chemical methods to fully synthesize or semi-synthesize new antibiotics. There are many types of antibacterial antibiotics, mainly β-lactam antibiotics, aminoglycoside antibiotics, macrolide antibiotics, glycopeptide antibiotics and other types of antibiotics, such as: Ansar antibiotics, rifamycin antibiotics Wait. [0003] Antibacterial drugs have made great contributions to the healthy survival and development of human beings. But the problem of bacterial resistance has ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/56A61K47/10A61K47/12A61P31/04
Inventor 任东冯卫范俊迈
Owner SICHUAN HAISCO PHARMA CO LTD
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