摘要
目的:建立扬生远红外护脐带的无菌检查方法。方法:本试验取扬生远红外护脐带,按《中国药典》2010年版二部"无菌检查法"项下进行。结果:样品瓶无菌生长,六株试验菌生长良好。结论:采用方法验证II进行扬生远红外护脐带的无菌检查,可行。
Objective: To establish a method to detect the microbial contamination of Yang-sheng Yuanhongwai Huqi Dai. Method: Test for sterility (Ch. P. 2010) was selected to determin the microbial contamination of it. Result: All of six strains positive control flasks reveal growth of micro-organism and the substance control gives no evidence of growth. Conclusion:This method ( H ) could be used to detect the microbial contamination of this preparation.
出处
《中国药品标准》
CAS
2012年第4期287-289,共3页
Drug Standards of China
关键词
扬生远红外护脐带
无菌检查法
方法验证
Yang-sheng Yuanhongwai Huqi Dai
test for sterility
verifying of the method