我院制剂的微生物限度检查方法学验证.pdf

中国医药导刊 2197 2011年 第 13 卷 第 12 期（总第98期） 我院制剂的微生物限度检查方法学验证 费嘉1,张儒1,刘辉2 (1北京军区总医院药剂科,北京 100700;2北京军区总医院第二干部病房,北京 100700) 【摘要】目的:应用微生物验证试验建立我院制剂的微生物限度检查方法。方法:按照药典方法对我院自制制剂进行微生物验证试 验,并对其结果进行探讨。结果:大多数我院制剂可以用常规方法进行微生物检查,但对于有部分抑菌作用的制剂,我们采取了不同 的方法进行验证,确立了微生物试验的方法。结论:由于制剂中所含有的成分不同,其抑菌作用也不相同,为了真实反映制剂的微生 物情况,保证微生物检验方法的可靠性,必须对制剂进行微生物试验方法学验证。 【关键词】微生物限度检查;方法学验证;医院制剂;抑菌作用 【中图分类号】R286.0　【文献标识码】 A　【文章编号】1009-0959(2011)12-2197-03 Valitation Method for Microbial Limit Test of Drugs Fei Jia1, Zhang Ru1, Liu Hui2 (1Pharmacy Department of Beijing Command General Hospital, Beijing 100700; 2The Second Cadres Ward of Beijing Command General Hospital, Beijing 100700,China) 【ABSTRACT】Objective: To establish the method of microbial limit test of the drugs, by the valitation method for microbial limit test. Method: According to the method described in the Pharmacapeia of China 2005, the valitation test was held on the hospital’s preparations, and the results were discussed. Results: Most of the preparations could do the microbial limit test in a normal way, but some preparations with bacteriostasis sould take other methods to establish the microbial limit test. Conclusion: It is necessary to establish a valitation method for microbial limit test of the preparations to reflact the real microbial situation, because the bacreriostasis of the preparation is different with the compositions. 【KEY WORDS】 Microbial Limit Test; Valitation; Hospital Preparations; Bacteriostasis 微生物限度检查就是考察非规定灭菌制剂及其原料、 化学药,口服制剂和外用制剂。 辅料受微生物污染的程度,检查项目包括细菌数、霉菌数、