盐酸厄洛替尼片微生物限度检查方法研究  

Microbial Limit Test Method of Erlotinib Hydrochloride Tablets

作　　者：牛振东[1] 刘文杰[1] 江志杰[1] 井良义[1] 郝运伟 姚英[1] NIU Zhen-dong;Liu Wenjie;Jiang Zhijie;Jing Liangyi;Hao Yunwei;Yao Ting((Beijing Institute for Drug Control, Beijing Key laboratory o f Analysis and Evaluation on ChineseMedicine, Beijing 102206 China)

机构地区：[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室

出　　处：《生命科学仪器》2019年第4期86-90,共5页Life Science Instruments

摘　　要：目的盐酸厄洛替尼片属于口服制剂,根据中国药典2015年版四部制剂通则0101片剂要求,片剂在生产和贮存期间微生物限度应符合要求,建立了盐酸厄洛替尼片的微生物限度检查方法,并对方法进行验证和评价。方法根据2015年版《中国药典(四部)》通则1105非无菌产品微生物限度检查中的微生物计数法,通则1106非无菌产品微生物限度检查中的控制菌检查法和通则1107非无菌药品微生物限度标准进行方法适用性试验。将中和剂3%Tween-80、0.3%卵磷脂添加至pH7.0氯化钠-蛋白胨缓冲液作为稀释液,需氧菌总数计数(稀释成1:100)及霉菌和酵母菌总数计数(稀释成1:50)均采用平皿法,控制菌检查法采用培养基稀释法(500ml TSB)。结果 5种试验菌的回收试验结果均在0.5~2.0之间。结论中和法能有效去除盐酸厄洛替尼片的抑菌成分,不影响污染微生物的生长,该方法适用于盐酸厄洛替尼片微生物限度的检查。Objective: Erlotinib Hydrochloride Tablets belong to oral preparations. According to the requirements of General Principles 0101 of the fourth volume of Chinese Pharmacopoeia( The 2015 edition ), the microbial limit of Erlotinib Hydrochloride Tablets should meet the requirements during production and storage.To establish a microbial limit test method of :Erlotinib Hydrochloride Tablets carry out the verification of the method . Methods: According to the fourth volume of Chinese Pharmacopoeia( The 2015 edition ), general rule 1105: microbial counting method for microbial limit test of non - sterile products, general rule 1106: the control bacteria examination method for microbial limit test of non - sterile products, general rule 1107: the test method for suitability of microbiological limits for non sterile drugs. When the samples were diluted in pH7.0 sodium chloride buffer-peptone solution (containing 3% Tween-80, 0.3% lecithin) and were made a 1 in 100 dilution (the total aerobic microbial count), 1 in 50(the total yeast and mold count).A plate method was used in the total aerobic microbial count and the total yeast and mold count , The direct inoculation method was used for the detection of Escherichia coli (500ml TSB).Results: The recoveries of the five strains were from 0.5 to 2. 0. Conclusion: The neutralization method can effectively remove the bacteriostasis components of .Erlotinib Hydrochloride Tablets, and does not affect the growth of contaminated microorganisms.The method is suitable for the microbial limit examination of .Erlotinib Hydrochloride Tablets.

关 键 词：盐酸厄洛替尼片 微生物限度检查 方法验证 

分 类 号：Q93[生物学—微生物学]