注射用单磷酸阿糖腺苷无菌检查方法适用性研究

目的 建立注射用单磷酸阿糖腺苷无菌检查方法标准.方法 按照2015年版《中国药典》规定,采用薄膜过滤法,对14家企业生产的注射用单磷酸阿糖腺苷进行无菌方法适用性研究.结果 确定了规格为0.1g注射用单磷酸阿糖腺苷的无菌检查方法.14家企业(共111批次)无菌检验方法均为:取样品60支,采用薄膜过滤法,用pH 7.0氯化钠-蛋白胨缓冲液冲洗,每次100 mL,共冲洗2次.结论 通过对14家企业生产的注射用单磷酸阿糖腺苷的方法验证资料进行整理、归纳、分析、试验,最终确定严谨统一的无菌检查方法.

Applicability of the sterility test method of adenine arabinoside monophosphate for injection

Objective To set up the standards for the sterility test of adenine arabinoside monophosphate for injection.Methods According to Chinese pharmacopoeia (2015),the sterility tests on adenine arabinoside monophosphate for injection from 14 producers were performed by membrane-filtration procedure.Results The sterility test on 0.1 g adenine arabinoside monophosphate for injection was confirmed.The sterility tests of all 14 producers (111 batches) were carried out as follows:60 samples were filtered by membranefiltration procedure,and washed twice by pH 7.0 sodium chloride peptone buffer,100 mL each time.Conclusions A strict and unified sterility test has been confirmedby reorganizing,concluding,analyzing and testing of the data on the adenine arabinoside monophosphate for injection from the 14 producers.