Exploration of the application of extraction method in the preparation of drug sterility test solution
10.19778/j.chp.2025.02.016
- VernacularTitle:萃取法在药品无菌检查供试液制备中的应用探讨
- Author:
Fan SHE
1
;
Yamin LIU
;
Hong MIN
;
Rui ZHOU
;
Zhange XU
Author Information
1. 杨凌示范区药品检验监测评价中心,陕西 杨凌 712100
- Publication Type:Journal Article
- Keywords:
extraction method;
fatty matrix;
preparation of test solution;
oil phase and water phase;
sterility in-spection
- From:
Drug Standards of China
2025;26(2):227-231
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Investigating the migration pattern of microorganisms in the oil-water phase during the prep-aration of sterile test solutions for drugs by extraction method,providing reference for the pre-treatment of oil-based matrix test samples.Methods:Inoculate 6 strains of test bacteria separately into sterile isopropyl tetradecanoate,simulate the sample preparation process of extraction method,and detect the growth status of microorganisms in oil-water phase;Detect the recovery ratio of each test bacterium in the aqueous phase using the extraction method.Select semi-solid oily matrix samples and prepare the test solution using extraction method.Establish a sterility test method according to Part 1101 of the 2020 edition of the Chinese Pharmacopoeia.Results:After extraction,the recovery ratio of each test bacteria in the water phase is in the range of 0.64-0.89.After the oily matrix sample is extracted,the water phase is taken for microbial test,which effectively solves the problems of filter membrane blockage and difficult antibacterial removal,and is beneficial to the subsequent microbial inspection.Conclusion:The extraction method can improve the accuracy and sensitivity of microbial detection in the prepara-tion of test solutions for oily matrix samples.The applicability test of the established sterile inspection method meets the requirements of the Chinese Pharmacopoeia.
