| 复方青花颗粒微生物限度检查方法的验证 |
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| 引用本文： | 杜凤霞,刘峰群,张诗龙,周燕萍,周旭,凌海慧.复方青花颗粒微生物限度检查方法的验证[J].华北国防医药,2012,24(8):50-52. |
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| 作者姓名： | 杜凤霞 刘峰群 张诗龙 周燕萍 周旭 凌海慧 |
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| 作者单位： | 解放军302医院药学部,北京,100039 |
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| 摘 要： | 目的 建立复方青花颗粒的微生物限度检查方法,并对其进行验证.方法 采用2010年版<中华人民共和国药典>(一部)附录"微生物限度检查法"项下相关内容进行方法学验证,采用培养基法.结果 试验组5株试验菌回收率均>70.00%,控制菌检查阳性菌生长良好,阴性对照组未检出大肠杆菌,符合验证要求.结论 复方青花颗粒微生物限度可以采用常规法检查.
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| 关 键 词： | 复方青花颗粒 集落计数 微生物 阈限值 |
Verfication of Microbial Limit in Testing Compound Recipe Qinghua Granule |
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| DU Feng-xia
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LIU Feng-qun
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ZHANG Shi-long
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ZHOU Yan-ping
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ZHOU Xu
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LING Hai-hui.Verfication of Microbial Limit in Testing Compound Recipe Qinghua Granule[J].Medical Journal of Beijing Military Region,2012,24(8):50-52. |
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| Authors: | DU Feng-xia LIU Feng-qun ZHANG Shi-long ZHOU Yan-ping ZHOU Xu LING Hai-hui |
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| Institution: | (Department of Pharmacy,the 302nd Hospital of PLA,Beijing 100039,China) |
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| Abstract: | Objective To establish a testing method of microbial limit for compound recipe Qinghua granule and validate it.Methods The testing method was jerqued by culture media under the guidance of the microbial limit test,which is described in the appendix of China Pharmacopoeia（2010 edition,Volume Ⅰ）.Results The coefficient of recovery of the test organism in 5 stubs was higher than 70.00%,positive bacteria growed well in control bacteria,and no escherichiacoli was found in the negative control group.Conclusion Routine testing method is useful in microbial limit test for compound recipe Qinghua granule. |
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| Keywords: | Compound recipe Qinghua granule Colony count microbial Threshold limit values |
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