西罗莫司口服溶液微生物限度检查方法的探讨

发布时间：2018-02-04 12:05

本文关键词： 西罗莫司口服溶液微生物限度方法适用性　出处：《中国医药工业杂志》2017年05期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:A method for microbial limit detection of sirolimus oral solution from different sources was established. The method is simple and simple. In accordance with the requirements of the 2015 edition of Chinese Pharmacopoeia, the bacteriostasis was screened by routine method in the applicability test of microbial limit test methodology, and then the preparation of test solution was improved by dilution and neutralization principle. The neutralizer Tween-80 + 0.3% lecithin and 0.1% histidine were added to the pH 7.0 sodium chloride peptone buffer as the diluent and the 1:20 test solution was prepared. The results showed that all the tested samples had inhibitory effect on Candida albicans in microbial count. The combination of neutralization method and dilution method can eliminate the bacteriostatic effect in the range of 0.5 ~ 2.0, which is suitable for the microbial limit test of sirolimus oral solution.
【作者单位】：上海市食品药品检验所;
【分类号】：R927
【正文快照】： 西罗莫司(sirolimus,1)是一种免疫抑制剂,临床上主要供器官移植和具有自身免疫性疾病的患者使用,不仅具有抗淋巴细胞增殖和抗肿瘤作用,还具有抗真菌活性[1—3]。产品存在抑菌性时,中国药典2015年版(Ch P 2015)强调的方法学适用性试验更显重要性,只有采用适宜方法去除抑菌活性,

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