| 喉咽灵口服液微生物限度检查法的建立 |
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| 引用本文： | 张祝花,温小霞,徐乐加.喉咽灵口服液微生物限度检查法的建立[J].中国实用医药,2012,7(31):24-25. |
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| 作者姓名： | 张祝花 温小霞 徐乐加 |
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| 作者单位： | 张祝花 (中山大学附属第三医院,广州,510630) ； 温小霞 (汕尾市食品药品检验所) ； 徐乐加 (中山大学附属第三医院,广州,510630) ； |
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| 摘 要： | 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。
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| 关 键 词： | 喉咽灵口服液 微生物限度检查法 培养基稀释法 验证 |
Provide methods of microbial limit tests for compound Houyanling oral solution |
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| ZHANG Zhu-hua,WEN Xiao-xia,XU Le-jia.Provide methods of microbial limit tests for compound Houyanling oral solution[J].China Practical Medical,2012,7(31):24-25. |
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| Authors: | ZHANG Zhu-hua WEN Xiao-xia XU Le-jia |
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| Institution: | .Department of Pharmacy,The Third Hospital Affiliated to Sun Yat-sen University,Guangzhou 510630,China |
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| Abstract: | 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. |
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| Keywords: | Compound Houyanling oral solution Microbial limit tests Medium dilution method Validation |
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