西罗莫司口服溶液微生物限度检查方法的探讨

Exploration of Microbial Limit Test Method for Sirolimus Oral Solutions

建立了不同来源的西罗莫司口服溶液的微生物限度检查方法,本法操作统一、简便,且符合中国药典2015年版要求。微生物限度检查方法学适用性试验时采用常规法筛查了抑菌性,然后利用稀释和中和原理改进供试液的制备,即将中和剂3%Tween-80、0.3%卵磷脂和0.1%组氨酸添加至pH 7.0氯化钠-蛋白胨缓冲液作为稀释液,并稀释制成1∶20的供试液,消除抑菌性。结果表明,供试品均对微生物计数中白色念珠菌存在抑制作用;而采用中和法和稀释法联用的方法可使各试验菌的计数回收比值在0.5~2.0范围内,消除抑菌作用,适用于西罗莫司口服溶液的微生物限度检查。

The microbial limit test method for sirolimus oral solutions from different manufacturers was established, and it was untied, simple and in accordance with ChP 2015. Several methods were tried in the suitability of microbial limit test. When general method was used in the suitability of the test method, testing samples showed antibiotic effects on Candida albicans in microbial enumeration tests. When the samples were diluted in pH 7.0 sodium chloride buffer-peptone solution （containing 3 % Tween-80, 0.3 % lecithin and 0.1% histidine） and were made a 1 in 20 dilution, the ratio between the test group and the microorganism solution group were between 0.5 and 2.0. The results indicated that the antimicrobial activity had been eliminated by the combination of diluting method and neutralizing method. It was suitable for the microbial limit test of sirolimus oral solutions.