摘要
目的:建立新药的细菌内毒素检查方法。方法:采用鲎试验检查法对新药中的细菌内毒素进行检查。结果:介绍了如何建立新药的细菌内毒素检查方法,重点是细菌内毒素检查限值的确认以及如何进行干扰试验。结论:细菌内毒素检查法为新药的质量控制以及应急检验提供了有益的基础。
Objective： To establish the method of bacterial endotoxin test for new drugs. Methods： Tachepleus amebocyte lysate test was applied to detect bacterial endotoxins in new drugs. Results： How to establish the method of bacterial endotoxin test for new drugs was introduced, and especially focused on how to define the limit of bacterial endotoxins and carry out the interference test. Conclusion： Bacterial endotoxin test provides useful bases in quality control and emergency test for new drugs.
出处
《中国医药导报》
CAS
2011年第32期159-160,162,共3页
China Medical Herald
基金
广东省食品药品监管局药检系统课题(项目编号:YJ201036)
关键词
新药
细菌内毒素检查法
干扰试验
New drugs
Bacterial endotoxin test
Interference test
