喉咽灵口服液微生物限度检查法的建立

Provide methods of microbial limit tests for compound Houyanling oral solution

目的建立喉咽灵口服液的微生物限度检验方法。方法根据《中国药典》2010年版二部附录"微生物限度检查法"分别采用常规法、培养基稀释法进行喉咽灵口服液的微生物限度检查验证。结果实验表明采用培养基稀释法对喉咽灵口服液进行微生物限度检查,能充分消除药品中的抑菌作用,有效检出该药品中污染存活的细菌;回收率达70%以上。结论培养基稀释法可有效的控制喉咽灵口服液的质量,建立的方法准确可靠。

Objective To provide methods of microbial limit tests for compound Houyanling oral solution.Methods The microbial limit test of compound Houyanling oral solution was validated by routine method and medium dilution method in accordance with the appendix Ⅱof Chinese Pharmacopoeia（2010 edition）.Results Experiments show that the medium dilution method can fully eliminate the inhibitory effect of the drugs,effectively detect viable bacteria in the drugs.The recovery rates of tests were more than 70%.Conclusion Medium dilution method can control compound Houyanling oral solution quality effectively and the established method is accurate and reliable.