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Retapamulin ointment pharmaceutical composition and preparation method thereof

A technology of retapamulin and composition, which is applied in the field of retapamulin ointment pharmaceutical composition and its preparation, can solve the problems of poor stability of retapamulin, achieve non-irritation, ensure effectiveness and safety, The effect of not polluting clothes

Inactive Publication Date: 2015-02-04
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In order to overcome the stability problem that retapamulin is easily oxidized and degraded during the preparation and storage of the retapamulin ointment pharmaceutical composition in the prior art, the present invention provides a combination of tertiary butyl hydroquinone, Retapamulin ointment pharmaceutical composition with a mixture of malic acid as an antioxidant and a preparation method thereof, the composition prepared by the preparation method can significantly enhance the stability of retapamulin, and solve the problem of retapamulin ointment pharmaceutical composition The problem of poor stability of retapamulin, which is common in the prior art of the drug, is helpful to improve the effectiveness and safety of the clinical use of the preparation composition

Method used

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  • Retapamulin ointment pharmaceutical composition and preparation method thereof
  • Retapamulin ointment pharmaceutical composition and preparation method thereof
  • Retapamulin ointment pharmaceutical composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0036] The preparation of embodiment 1 retapamulin ointment pharmaceutical composition

[0037] prescription:

[0038]

[0039] The preparation method is prepared according to the following steps:

[0040] (1) Prepare the oil phase: weigh white vaseline, liquid paraffin and lanolin according to the prescription amount, heat and melt in a water bath at about 80°C, stir evenly, and slowly add the prepared one with an appropriate amount of ethanol when it is cooled to about 50°C Antioxidant ethanol solution (take tert-butyl hydroquinone and malic acid and dissolve in 75mL ethanol together by prescription), stir while adding until uniform;

[0041] (2) Prepare the water phase: take retapamulin according to the prescription amount, and dissolve it with 50mL distilled water;

[0042] (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 temperature;

...

Embodiment 2

[0044] The preparation of embodiment 2 retapamulin ointment pharmaceutical composition

[0045] prescription:

[0046]

[0047]

[0048] The preparation method is prepared according to the following steps:

[0049] (1) Preparation of oil phase: weigh white vaseline, beeswax and silicone oil according to the prescription amount, heat and melt in a water bath at about 80°C, stir evenly, and slowly add an antioxidant prepared with an appropriate amount of ethanol when it cools to about 50°C Ethanol solution (dissolve tert-butyl hydroquinone and malic acid in 30mL ethanol together according to prescription), stir while adding until uniform;

[0050] (2) Prepare the water phase: take retapamulin according to the prescription amount, and dissolve it with 50mL distilled water;

[0051] (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 temperatu...

Embodiment 3

[0053] The preparation of embodiment 3 retapamulin ointment pharmaceutical composition

[0054] prescription:

[0055]

[0056] The preparation method is prepared according to the following steps:

[0057] (1) Preparation of oil phase: Weigh stearic acid, liquid paraffin and lanolin according to the prescription amount, heat and melt in a water bath at about 80°C, stir evenly, and slowly add in an appropriate amount of ethanol when it is cooled to about 50°C Antioxidant ethanol solution (according to prescription measure tert-butyl hydroquinone and malic acid and be dissolved in 30mL ethanol together), stir while adding until uniform;

[0058] (2) Prepare the water phase: take retapamulin according to the prescription amount, and dissolve it with 200mL distilled water;

[0059] (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 temperature; ...

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Abstract

The invention belongs to the technical field of a medicine, and mainly relates to a retapamulin ointment pharmaceutical composition and a preparation method thereof. The composition comprises the following components in percentage by weight: 0.5-5% of retapamulin, 80-99% of an ointment matrix, 0.1-3% of an antioxidant and the balance being distilled water and ethanol. The preparation method comprises steps of oil phase preparation, aqueous phase preparation, ointment preparation, ointment filling and the like. The composition disclosed by the invention better solves a problem that the retapamulin is easy to be oxidized and degraded at high temperature in an ointment preparing process and effectively controls generation of impurities, so that retapamulin content in the product is kept stable, product quality is improved, local adverse reaction on the skin when clinical medication is relieved, and effectiveness and safety of the medicine in clinical application are better guaranteed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a retapamulin ointment pharmaceutical composition and a preparation method thereof. Background technique [0002] The discovery and use of antibiotics is of great significance in human history. Antibiotics not only prolong human life, but also improve people's quality of life. But in the past 30 years, the widespread use and even abuse of antibiotics has caused many bacteria to develop increasingly serious drug resistance. Due to the emergence of drug resistance, the curative effect of drugs with better curative effect is reduced or invalid. In particular, drug-resistant bacteria such as Staphylococcus aureus, Streptococcus pneumoniae and Mycobacterium tuberculosis that cause respiratory diseases cause more than two million deaths every year, seriously endangering the human health. Therefore, it is imminent to develop new antibiotics to control the increasingly se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/439A61K47/10A61K47/12A61P31/04
Inventor 杨平余悦东冯卫朱霞艳任东
Owner SICHUAN HAISCO PHARMA CO LTD
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