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目的:建立复方肿节风合剂的微生物限度检查方法。方法:采用平皿计数法对复方肿节风合剂的细菌、霉菌和酵母菌计数进行加样回收率试验;采用控制菌中大肠埃希菌、金黄色葡萄球菌和铜绿假单胞菌的相应检查法进行控制菌检查。结果:通过5种阳性菌的回收实验,复方肿节风合剂大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉菌回收率均高于70%;控制菌测定中,大肠埃希菌、金黄色葡萄球菌和铜绿假单胞菌均可检出试验菌,阴性菌对照组均无生长。结论:本文介绍方法可作为复方肿节风合剂的微生物限度检查方法学验证的依据。
OBJECTIVE: To establish a microbial limit test method for Compound Zengjiaofeng Mixture. Methods: Bacteria, molds and yeasts counts of Compound Zengjie Fenghe Mixture were tested by plate counting method. The recovery rate was tested by using the method of plate counting. The control method was used to detect Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa. Control bacteria check. Results: The recoveries of five positive bacteria, compound swollenge joint Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans, Aspergillus niger recovery were higher than 70%; control bacteria determination, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa can detect test bacteria, negative control group no growth. Conclusion: The method described in this paper can be used as the basis for validation of the methodological validation of microbial limit test for compound swollen joint.