阿法替尼和塞瑞替尼微生物限度检查方法验证  

Methodology Validation of Microbial Limit Test for Afatinib and Ceritinib

作　　者：张光华[1] 李玉立[1] 刘文杰[1] 牛振东[1] 江志杰[1] ZHANG Guanghua;LI Yuli;LIU Wenjie;NIU Zhendong;JIANG Zhijie(Beijing Institute for Drug Control,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

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,北京102206

出　　处：《中国药业》2020年第17期55-59,共5页China Pharmaceuticals

摘　　要：目的建立并验证阿法替尼片和塞瑞替尼胶囊的微生物限度检查方法。方法按2015年版《中国药典(四部)》通则1105,1106,1107项下方法进行微生物限度检查方法适用性试验,采用常规法和稀释法筛查药品的抑菌性,利用稀释和中和的原理改进供试液的制备,在稀释剂和培养基里添加3%吐温80和0.3%卵磷脂,消除药品的抑菌性。结果稀释法和中和法联用消除了阿法替尼片和塞瑞替尼胶囊对金黄色葡萄球菌、枯草芽孢杆菌和白色念珠菌的抑菌作用,各试验菌的计数回收比值均在0.5~2.0范围内,控制菌阳性对照生长良好。结论建立的微生物限度检查方法准确可行,可用于阿法替尼片和塞瑞替尼胶囊的质量控制,为口服替尼类抗癌药物的微生物限度检查提供了参考。Objective To establish and validate a method for microbial limit test of afatinib tablets and ceritinib capsules.Methods According to the General Chapters 1105,1106 and 1107 of volumeⅣof Chinese Pharmacopoeia(Edition 2015),the methodology validation of microbial limit test method was conducted.The antibiotic effect of the drug was screened by conventional method and medium dilution method.Based on the principle of dilution and neutralization,3%Tween-80 and 0.3%lecithin were added into the diluent and medium to eliminate the bacteriostasis of the drug.Results It showed that the combination of dilution method and neutralization method eliminated the bacteriostatic effect of afatinib tablets and ceritinib capsules against Staphylococcus aureus,Bacillus subtilis and Candida albicans,and the counting recovery ratio of each test bacterium was in the range of 0.5-2.0.The validation test for specified microorganisms was positive.Conclusion An accurate and feasible microbial limit test method is established for afatinib tablets and ceritinib capsules by adding neutralizer,which can be used for the quality control of these products,and provide reference for the study of microbial limit test method for oral teicide anticancer drugs.

关 键 词：阿法替尼 塞瑞替尼 微生物限度 方法适用性试验 吐温80 卵磷脂 

分 类 号：R917[医药卫生—药物分析学] R927.1[医药卫生—药学]