| 薄性康药膜微生物限度检查方法的建立和验证 |
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| 引用本文： | 王翠蓉. 薄性康药膜微生物限度检查方法的建立和验证[J]. 中国药事, 2008, 22(1): 74-76 |
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| 作者姓名： | 王翠蓉 |
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| 作者单位： | 贵州省六盘水市药品检验所,六盘水,553001 |
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| 摘 要： | 建立薄性康药膜的微生物限度检查方法。按照《中国药典》2005版微生物限度检查方法进行验证试验。该药膜的细菌计数方法为培养基稀释法;霉菌及酵母菌计数方法为平皿法;金黄色葡萄球菌和铜绿假单胞菌可采用常规法检验。
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| 关 键 词： | 验证试验 薄性康药膜 稀释法 平皿法 常规法 药膜 微生物限度 检查方法 验证试验 Method Validation 检验 常规法 铜绿假单胞菌 黄色葡萄球菌 平皿法 酵母菌 霉菌 培养基稀释法 计数方法 细菌 药典 中国 |
| 文章编号： | 1002-7777（2008）01-0074-03 |
Establishment and Validation of Microbial Limit Method for the Boxingkang Pellicles |
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| Wang Cuirong. Establishment and Validation of Microbial Limit Method for the Boxingkang Pellicles[J]. Chinese Pharmaceutical Affairs, 2008, 22(1): 74-76 |
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| Authors: | Wang Cuirong |
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| Abstract: | A method for microbial limit of Boxingkang Pellicles was established.Microbial limit tests were validated according to Chinese Pharmacopoeia Edition 2005.Culture medium diluting method was used with count of bacterium,Plate count methods was used with count of mold and yeasts of Boxingkang Pellicles.Staphylococcus aureus and Pseudomonas aeruginosa can be tested when general method were used. |
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| Keywords: | validation Boxingkang Pellicles diluting method plate count method general method |
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