摘要
无菌检查法是针对无菌或灭菌药品、原敷料及医疗器具等的无菌可靠性而建立的检查法,而无菌检测的可信度与抽样量、检查用的培养基质量、材料、操作环境、无菌技术、方法学验证等有关。本文探讨与无菌检查法有密切直接关系的阳性对照菌种类的选择、菌量的多少、培养时间以及结果的判断,同时提出了具体改进意见,为2005版药典无菌检查法的修订提供参考。
Test for sterility is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. The selection of positive control microorganisms, the incubation number, the incubation temperature, conditions and time, and the interpretation are very important in sterility tests. Guidance on these factors and further requirements for demonstration the sterility tests were discussed.
出处
《中国药师》
CAS
2003年第11期730-732,共3页
China Pharmacist
关键词
无菌检查法
阳性对照菌
培养条件
结果判断
药物检查
Sterility test
Positive control microorganism
Incubation conditions
Interpretation
