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扬生远红外护脐带无菌检查法方法的研究
引用本文:方玲芬. 扬生远红外护脐带无菌检查法方法的研究[J]. 中国药品标准, 2012, 13(4): 287-289
作者姓名:方玲芬
作者单位:贵州省食品药品检验所,贵阳,550004
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。

关 键 词:扬生远红外护脐带  无菌检查法  方法验证

Study on Test for Sterility of Yang-sheng Yuanhongwai Huqi Dai
Fang Lingfen. Study on Test for Sterility of Yang-sheng Yuanhongwai Huqi Dai[J]. , 2012, 13(4): 287-289
Authors:Fang Lingfen
Affiliation:Fang Lingfen ( Guizhou Institute for Food and Drug Control, Guiyang 550004 )
Abstract:
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.
Keywords:Yang-sheng Yuanhongwai Huqi Dai  test for sterility  verifying of the method
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