安神宁口服液微生物限度检查方法的研究

 目的 建立安神宁口服液微生物限度检查方法。方法 按2010年版《中国药典》附录微生物限度检查法中细菌、霉菌及酵母菌数计数方法和控制菌检查方法进行验证。采用培养基稀释法对细菌、霉菌及酵母菌计数，采用常规法对控制菌检查方法进行方法学验证。结果 在对细菌、霉菌及酵母菌数计数方法验证的3次独立平行实验中，稀释剂5株对照组的菌回收率均大于70%，试验组的菌回收率均大于70%；在对控制菌检查方法验证的3次独立平行实验中，阴性对照组未检出阴性对照菌，实验组检出阳性试验菌，故可照相应的供试液制备方法和计数法，测定安神宁口服液的细菌、霉菌及酵母菌数和控制菌检查。结论 建立的微生物限度检查方法，可靠、准确、全面，该方法用于安神宁口服液的常规微生物限度检查方法。

Study on Microbial Limit Test Method of Anshenning Oral Liquid

OBJECTIVE To provide a method for the microbial limit test of Anshenning oral liquid and carry out validation of the mothed.METHODS The validation on the microbial limit test method was conducted in accordance with the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia(2010 edition).Culture dilution method was used in bacterium count and total combined molds and yeasts count;while routine method was used in the control bacteria test.RESULTS The recoveries of test organisms in the control group 3 preparations by routine method were more than 70%.The recoveries of the test group were more than 70%.In the 3 control bacteria tests the negative control bacterias,was not found in the negative control group,while the control bacteria was found in the test group.CONCLUSION The established method substances can eliminate the antimicrobial in Anshenning oral liquid is accurate,and comprehensive,and can be used for the microbial limit test of Anshenning oral liquid.