药品霉菌和酵母菌计数替代培养基验证

目的：探讨在非无菌产品微生物限度检查的微生物计数法中，若因沙氏葡萄糖琼脂培养基上生长的需氧菌使霉菌和酵母菌计数结果不符合微生物限度要求时，是否可以采用孟加拉红培养基来替代。方法：根据药品微生物检验替代方法验证指导原则验证此方法的准确度、精密度、专属性、定量下限、线性和耐用性。采用参数统计技术来分析以上实验结果。结果：孟加拉红琼脂对霉菌和酵母菌具有专属性；准确度的回收率均大于70%；精密度达到《中华人民共和国药典》2015年版要求；定量下限与药典方法无显著差异（P>0.05）；线性相关系数均高于0.95。以上参数均达到药典要求。结论：当需氧菌生长过多影响霉菌和酵母菌计数时，可以采用孟加拉红琼脂来代替沙氏葡萄糖琼脂进行霉菌和酵母总数测定。

Objective:To discuss whether rose Bengal medium could be used if the aerobic bacteria grown on the Sabouraud dextrose agar medium does not meet the microbial limit requirements for mold and yeast counts in the microbial counting method for microbiological limit inspection of non-sterile products.Method:The accuracy, precision, specificity, limit of quantitation, linearity and durability of the method were verified according to verification guideline for alternative methods of microbiological testing of drugs.The experimental results were analyzed by parametric statistical methods.Results:Rose Bengal agar was specific to fungi and yeasts.The recovery rate of accuracy was greater than 70%.The precision met the requirements of Chinese Pharmacopoeia.The limit of quantitation was not significantly different from that of the method of Chinese Pharmacopoeia (P>0.05).The linear correlation coefficient was higher than 0.95.The above parameters all met the requirements of the Pharmacopoeia.Conclusion:when the excessive growth of aerobic bacteria affects mold and yeast count, the rose Bengal medium can be a substitute of the sabouraud dextrose agar to determine the mold and yeast count.

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