浅析2种供试液制备方法对药品包装用膜/片材微生物计数回收率的影响

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.

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