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。
Objective: To discuss the microbiological counting method and the suitability test in pharmaceutical products and strength- en the understanding of suitability test. Methods:Through analyzing the selection and confirmation of test methods, the particularity of tra- ditional 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 con- trol in the meantime.
出处
《中国药物评价》
2017年第2期97-99,103,共4页
Chinese Journal of Drug Evaluation
关键词
计数方法
微生物检查
方法适用性
Counting method
Microbiological test
Method suitability