| 脑立清胶囊微生物限度检查法的建立及方法学验证 |
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| 引用本文： | 孙蕾,;杨竞,;张克勤. 脑立清胶囊微生物限度检查法的建立及方法学验证[J]. 中国药房, 2009, 0(18): 1418-1420 |
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| 作者姓名： | 孙蕾, 杨竞, 张克勤 |
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| 作者单位： | [1]江苏省中医院,南京市210029; [2]南京市脑科医院,南京市210029 |
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| 摘 要： | 目的:建立脑立清胶囊微生物限度检查的方法并验证。方法:按2005年版《中国药典》,用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉和白色念珠菌对脑立清胶囊进行微生物限度检查方法学验证试验。结果:各试验菌的回收率均高于70%,稀释剂对5种试验菌回收率均高于70%。结论:常规法可以用于脑立清胶囊的微生物限度检查。
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| 关 键 词： | 脑立清胶囊 微生物限度检查法 验证 |
Establishment of Microbial Limit Test Method for Naoliqing Capsules and Verification of the Methodology |
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| Affiliation: | SUN Lei, ZHANG Ke-qin,YANG Jing(Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing 210029, China;Nanjing Brain Hospital, Nanjing 210029,China) |
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| Abstract: | OBJECTIVE： To establish a microbial limit test method for Naoliqing capsules and validate the methodology. METHODS：In accordance with Chinese Pharmacopoeia 2005th edition, a verification test on the microbial limit test mothod of Naoliqing capsules was carried out using escherichia coli, bacillu subtilis, staphylocoecus aureus, aspergillus niger and candida albicans. RESULTS： The recovery rates of the above different test bacteria were all above 70%, and the recovery rates of 5 test bacteria in diluting agent were all above 70%. CONCLUSION： The routine method is applicable for microbial limit test of Naoliqing capsules. |
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| Keywords: | Naoliqing capsule Microbial limit test Verification |
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