| 13种软膏剂微生物限度检查的方法验证探讨 |
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| 引用本文： | 方李,张心悦,吴晶晶,白玲玲,苏华,卜莹. 13种软膏剂微生物限度检查的方法验证探讨[J]. 中国药师, 2014, 0(9): 1580-1583 |
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| 作者姓名： | 方李 张心悦 吴晶晶 白玲玲 苏华 卜莹 |
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| 作者单位： | 南京军区总医院制剂科 南京210002;;南京军区联勤部药品仪器检验所;南京军区总医院制剂科;南京军区总医院制剂科;南京军区总医院制剂科;南京军区联勤部药品仪器检验所 |
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| 基金项目： | 全军医疗机构制剂标准提高科研专项课题重点项目（编号：13ZJZ21） |
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| 摘 要： | 摘 要 目的： 建立13种软膏剂微生物限度检查方法。方法: 采用常规法、培养基稀释法和薄膜过滤法，对13种软膏剂进行方法验证。结果:选择不同方法，各试验菌样品中的回收率均达到70%以上。结论: 确立了13种软膏剂微生物限度检查方法，可有效控制其质量。
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| 关 键 词： | 软膏剂；微生物限度检查；方法验证 |
| 收稿时间： | 2014-04-25 |
| 修稿时间： | 2014-05-27 |
Validation of Microbial Limit Test Methods for Thirteen Kinds of Ointments |
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| Fang Li,Zhang Xinyue,Wu Jingjing,Bai Lingling,Su Hua and Bu Yin. Validation of Microbial Limit Test Methods for Thirteen Kinds of Ointments[J]. China Pharmacist, 2014, 0(9): 1580-1583 |
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| Authors: | Fang Li Zhang Xinyue Wu Jingjing Bai Lingling Su Hua Bu Yin |
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| Affiliation: | Department of Preparation Division, Nanjing General Hospital of Nanjing Military Command, Nanjing 210002;;Institute of Quality Control of Medical Material and Equipment, Joint Logistic, Nanjing Military Command;Department of Preparation Division, Nanjing General Hospital of Nanjing Military Command;Department of Preparation Division, Nanjing General Hospital of Nanjing Military Command;Department of Preparation Division, Nanjing General Hospital of Nanjing Military Command;Institute of Quality Control of Medical Material and Equipment, Joint Logistic, Nanjing Military Command |
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| Abstract: | ABSTRACT Objective: To establish the microbial limit test methods for thirteen kinds of ointments.Methods:The microbial limit of 13 kinds of ointments was respectively determined by the routine method, culture medium dilution method and membrane filtration method. Results:The recovery of the tested bacteria in the samples was above 70% by the different methods. Conclusion:The microbial limit test methods for thirteen kinds of ointments are stablished, which may be used in the quality control. |
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| Keywords: | Ointments Microbial limit test Method validation |
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