川芎挥发油鼻腔喷雾剂微生物限度检查法方法学验证

Methodology Validation on Microbial Limit Inspection Technique of Chuanxiong Rhizome Volatile Oil Nasal Spray

目的:建立川芎挥发油鼻腔喷雾剂微生物限度检查方法。方法:采用薄膜过滤法对样品进行微生物限度检查,通过比较加入已知阳性对照菌的回收率来确定适宜的检验方法。结果:根据回收率实验得出,细菌数测定以及霉菌数和酵母菌数测定采用薄膜过滤法;控制菌检查采用常规法检验。验证菌株的回收率均大于70%。结论:用该法进行川芎挥发油鼻腔喷雾剂微生物限度检查,可行性强,能达到检测目的。

Objective： To examine Microbial Limit Inspection Technique of Chuanxiong Rhizome Volatile Oil Nasal Spray.Method： To test microbial limit of samples using membrane-filter procedure,and determine suitable test methods by comparing with recovery rate of adding given positive control bacteria.Results： According to the recovery rate experiment,membrane-filter procedure is applied in measuring bacteria population,mucedine population and saccharomycetes; and conventional method is used for controlled bacteria inspection.The recovery rate of bacterial strain is generally more than 70%.Conclusion： Inspection of Chuanxiong Rhizome Volatile Oil Nasal Spray is of better feasibility in this way.