摘要
目的:通过比较药品包装用膜/片材微生物计数回收率,选择合适的微生物限度检查供试液制备方法。方法:参照国家药品包装容器(材料)标准、ISO11737-1标准将药品包装用膜/片材制成含有已知标准菌株的人工负载样品,分别采用棉签擦拭及振荡洗涤二种方法制备供试液,再参照中国药典2015年版四部通则1105进行微生物限度检查,分别计算2种方法微生物计数回收率,并对结果进行双因素方差分析。结果:与棉签擦拭法相比,振荡洗涤法不同菌株回收率均显著提高,2种方法回收率具有统计学差异。结论:振荡洗涤法用于药品包装用膜/片材供试液制备操作简便,微生物计数回收率高,试验过程符合中国药典微生物限度检查法的相关规定,可用于相应项目的检测。
Objective： To compare the recovery rate of membrane/sheet microbiological counts for drug packaging, select the appropriate method to prepare the test solution for microbiological limits test. Methods： Cotton swab and oscillation washing methods were used to prepare pharmaceutical packaging film/sheet containing known standard strains of artificial load sample saccording to the national drug packaging container （ material ） standard, and ISO11737-1 standard 1105 microbiological limits were tested according to the Chinese Pharmacopoeia 2015 edition. Microbial counting recovery was calculated by both methods and the results were analyzed by two-factor analysis of variance. Results： Compared with cotton swab wiping method, the recovery rate of different strains were significantly increased by shaking washing method, and the recovery rate of the two methods were statistically significant. Conclusion： Shaking and washing method is simple and has high recovery rate, the test process meets the regulation of Chinese Pharmacopoeia microbial limit test and can be used for the corresponding test.
作者
朱莲花
吕杨格格
蔡荣
ZHU Lian-hua, LU Yang-ge-ge, CAI Rong(Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2018年第3期500-504,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
药品包装用膜/片材
棉签擦拭法
振荡洗涤法
双因素方差分析
微生物计数回收率
drug packaging film/sheet materials
cotton swab method
oscillating method
two-factor analysis of variance
microbial enumeration recovery rate
