| 复方槐米胶囊微生物限度检查法的方法验证 |
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| 引用本文： | 李妍,阚秀燕,杨静.复方槐米胶囊微生物限度检查法的方法验证[J].解放军药学学报,2007,23(5):372-373. |
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| 作者姓名： | 李妍 阚秀燕 杨静 |
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| 作者单位： | 北京军区联勤部药品仪器检验所,北京,100071 |
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| 摘 要： | 目的 建立复方槐米胶囊微生物限度检查方法.方法 按中国药典2005版有关规定,采用5种阳性对照菌回收率试验进行其方法学验证试验.结果 该药有一定程度的抑菌作用,但可通过培养基稀释法消除抑菌作用.结论 复方槐米胶囊细菌计数和大肠埃希菌检查采用培养基稀释法进行检测,霉菌、酵母菌计数和沙门菌检查采用常规法即可.
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| 关 键 词： | 复方槐米胶囊 微生物限度 培养基稀释法 复方 槐米 胶囊 微生物限度检查法 方法验证 Capsules Compound Used Method 常规法 沙门菌 细菌计数 酵母菌 霉菌 检测 大肠埃希菌 培养基稀释法 抑菌作用 程度 结果 |
| 文章编号： | 1008-9926（2007）05-0372-02 |
| 修稿时间： | 2006-12-12 |
Validation Method Used for Microbial Limit Tests of Compound Huaimi Capsules |
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| LI Yan,KAN Xiu-Yan,YANG Jing.Validation Method Used for Microbial Limit Tests of Compound Huaimi Capsules[J].Pharmaceutical Journal of Chinese People's Liberation Army,2007,23(5):372-373. |
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| Authors: | LI Yan KAN Xiu-Yan YANG Jing |
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| Institution: | Institute for Drug and Instrument Control, United Logistics Department of Beijing Command PLA, Beijing 100071 China |
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| Abstract: | Aim To establish a method for microbial limit tests of compound Huaimi capsules.Methods The 5 control strains recovery test validation method was used as described in the Chinese Pharmacopoeia 2005 edition.Results The medicine has some antimicrobial effect which can be eliminated by the culture medium dilution method.Conclusions The results suggested that culture medium dilution method could be used for counting bacteria and detecting Escherichia coli.while the conventional method could be used common method for counting fungi and for detecting salmonella. |
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| Keywords: | Compound Huaimi capsules Microbial limit Culture medium dilution method |
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