Sampling detection process for production of sodium fusidate for injection

By introducing a comprehensive sampling and testing process in the preparation process of sodium fusidate, including multi-faceted testing of mother liquor and waste, the product quality and safety problems caused by the limitations of traditional testing methods are solved, and the safety and effectiveness of production are improved.

CN119643524APending Publication Date: 2025-03-18CHENGDU TIANTAISHAN PHARMA
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Patent Information

Application Number
CN202411795665.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-09
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

In the traditional preparation of sodium fusidate, the sampling and testing method is limited to specific steps or parameters, and lacks a comprehensive grasp of the entire production chain, resulting in significant differences in the medical effect and quality of the product, and there are safety risks.

Method used

A sampling and testing process for the production of sodium fusidate for injection is proposed, including mother liquor sampling and waste sampling. The mother liquor random inspection passes sterile detection and cytotoxicity detection, and the waste material random inspection passes through various analytical methods to conduct detailed detection of waste materials in the fermentation, extraction and passivation, crystallization and drying processes.

Benefits of technology

Through more comprehensive testing methods, the safety and effectiveness of sodium fusidate production are improved, the stability and consistency of products are ensured, the quality differences between different batches of products are reduced, and potential safety hazards are reduced.

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Abstract

The invention provides a sampling detection process for production of sodium fusidate for injection, and relates to the field of sodium fusidate production, the sampling detection process comprises mother liquor sampling detection and waste sampling detection, the mother liquor sampling detection comprises the following steps: sterile detection; the method comprises the following steps: firstly, taking out produced sodium fusidate, diluting, centrifuging and filtering the sodium fusidate, selecting Hoechst33258 fluorescent dye, mixing the sodium fusidate and the Hoechst33258 fluorescent dye for dyeing, washing the sodium fusidate by the fluorescent dye through centrifuging and washing after dyeing, and then observing and recording the intensity, color and distribution of a fluorescence signal under a fluorescence microscope. The method is used for subsequent analysis and judgment. According to the method disclosed by the invention, more detailed and comprehensive mother liquor sampling inspection steps including sterility detection and cytotoxicity detection are adopted, so that the produced sodium fusidate has higher safety and effectiveness.
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