天津医院制剂抽检微生物限度检查结果及质量分析-中国药事.pdf

100 ·医院药事· 天津市医院制剂抽检微生物限度检查结果及质量 分析 张文燕，郭福庆 （天津市药品检验研究院，天津 300070） 摘要 目的：依据《中国药典》2015年版，对抽检的41批医院制剂进行微生物限度检查和质量分析。 方法：检验方法为制剂生产医院提供，并根据药典要求，对每批样品进行控制菌检查时均加入阳性对 照。结果：抽检的41批医院制剂样品微生物限度检查，37批次检验结果均符合规定，1批次检验结果不符 合规定，3批样品由于医院提供的微生物限度检查的方法依据为2010版《中国药典》，不符合现行药典要 求，故而未做检验。结论：医院制剂微生物限度检查方面存在诸多问题，应引起各方重视。 关键词： 医院制剂；微生物限度检查；质量分析 R927.11 A 1002-7777(2019)01-0100-08 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2019.01.018 Results of Microbial Limit Tests and Quality Analysis of Hospital Preparation Sampling Inspection of Tianjin Zhang Wenyan, Guo Fuqing (Tianjin Institute for Drug Control, Tianjin 300070, China) Abstract Objective: To carry out the microbial limit tests and quality analysis of 41 batches of hospital preparations according to the Chinese Pharmacopeia 2015 edition. Methods: The examining methods were provided by the hospitals which manufactured the preparations. According to the requirements of the Chinese Pharmacopeia 2015 edition, positive controls were added in each patch of the samples for specific microorganisms test. Results: Among all the 41 batches of hospital preparations in microbial limit test, 37 batches met the test requirements, 1 batch did not meet the requirements and 3 batches were not tested, because the 3 batches of samples did not meet the requirement of The Chinese Pharmacopeia 2015 edition but were based on The Chinese Pharmacopeia 2010 edition. Conclusion: There existed many problems in the microbial limit test of hospital preparations, which should be paid more attention to by all parties. Keywords hospital preparation; microbial limit test; quality analysis ： 医疗机构制剂（以下简称医院制剂），是指 标准是控制医院制剂质量的有效手段[2] 。制剂质量 医疗机构根据本单位临床需要经批准而配制、自用 直接关系到用药者的安全和疗效。而微生物限度检 的固定处方制剂[1] 。医院制剂作为药品的一种特殊 查在制剂质量控制方面起着重要的质量评估作用， 补充形式，长期以来，因其便捷、有效等特点在临 其准确与否直接关系到患者用药的安全性和有效