摘 要：目的：建立2005年版药典微生物限度检查法中的细菌真菌计数的验证方法和判断标准。方法：按设立的验证试验方法，在样品中加入试验菌，测定试验菌的回收率。结果：各试验菌在试验样品中的回收率基本可达到70％以上。结论：药品中污染的细菌真菌计数方法的验证试验可按设立的验证试验方法进行，试验菌的回收率不得低于70％。 Objective： To establish the validation method and criteria for counting bacteria and fungi in microbial limit test which is described in the Pharmacopeia of China （ChP） 2005. Method： According to the method set up for validation, the tested microorganisms with known counts were added to samples followed by the determination of the recovery. Result： With different preparing method for testing sampies, the recoveries for the tested microorganisms in testing samples were found to be over 70%. Conclusion： Validation method for counting contaminated bacteria and fungi in drugs is recommended to follow the method established in this paper. The recovery for tested microorganisms should be not less than 70%.
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