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药品微生物计数方法及方法适用性探讨

田冬梅,史春辉,娄志红,张肖宁   

  1. 黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所
  • 收稿日期:2016-12-07 修回日期:2017-04-06 出版日期:2017-04-25 发布日期:2017-04-25

Discussion of the Microbiological Counting Method and the Suitability Test in Pharmaceutical Products

田冬梅,史春辉,娄志红 and 张肖宁   

  1. Heilongjiang?Institute for Food and Drug Control Harbin 150088,,,
  • Received:2016-12-07 Revised:2017-04-06 Online:2017-04-25 Published:2017-04-25

摘要: 目的:探讨药品微生物计数方法及方法适用性试验,加强对方法适用性试验的理解。方法:分别从检验方法的选择、方法确认、中药制剂的特殊性以及实验过程等方面分析计数方法适用性试验。结果:药品微生物计数方法适用性试验必不可少,检验部门尚存在不足。结论:相关部门应重视微生物计数方法适用性,提高人员专业素质,加强质量控制。

Abstract: Objective: To discuss the microbiological counting method and the suitability test in pharmaceutical products and strengthen the understanding of suitability test.Methods:Through analyzing the selection and confirmation of test methods,the particularity of traditional Chinese medicine and the procedures of suitability test,to discuss the suitability test.Results:The suitability test in microbiological counting test is absolutely necessary.Inspection department is insufficient.Conclusion:Related departments should pay more attention to the suitability test of the microbiological counting method of pharmaceutical products, and improve the professional quality and quality control in the meantime.