| 不同厂家生产的西洛他唑片微生物限度检查方法验证 |
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| 引用本文： | 钱文静,张玫. 不同厂家生产的西洛他唑片微生物限度检查方法验证[J]. 中国药品标准, 2011, 12(1): 50-53 |
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| 作者姓名： | 钱文静 张玫 |
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| 作者单位： | 江苏省药品检验所,南京,210008 |
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| 摘 要： | 目的:建立不同厂家的西洛他唑片微生物限度检查方法的验证.方法:菌落计数方法的验证:一厂家采用常规平皿法,另一厂家采用霉菌及酵母菌数测定,为培养基稀释法,每皿0.2 mL,细菌数侧定为低速离心加薄膜过滤法,即取1:10的低速离心供试液10ML稀释后进行薄膜过滤,用300mL冲洗液分6次冲洗,泵速为150r.min-1.结...
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| 关 键 词： | 西洛他哇片 微生物限度 平皿法 薄膜过滤法 |
The Validation Method of Microbial Limit Tests for Different Companies of Cilostazol Tablets |
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| Qian Wen-jing and Zhang Mei. The Validation Method of Microbial Limit Tests for Different Companies of Cilostazol Tablets[J]. , 2011, 12(1): 50-53 |
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| Authors: | Qian Wen-jing and Zhang Mei |
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| Affiliation: | Qian Wen-jing,Zhang Mei(Jiangsu Institute for Drug Control,Nanjing 210008) |
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| Abstract: | Objective: To establish a method for determination of microbial limit test in different companies of Cilostazol Tablets.Methods: The validation of the colony-count methods: One is the normal plate count method,the other is that the mold and yeast colony count of other companies was used by the medium dilution method,0.2 mL for each plate.The bacteria colony count was used by the low-speed centrifugation and membrane filtration.Got 10 mL of 10% of the sample that had been low-speed centrifuged,then rinsed th... |
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| Keywords: | Different companies Cilostazaol Tablets Microbial limit tests Validation Plate count method low-speed centrifugation membrane filtration |
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