| 硫酸链霉素注射液无菌检查法试验验证 |
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| 引用本文： | 陈万里,史蕙.硫酸链霉素注射液无菌检查法试验验证[J].抗感染药学,2008,5(3):152-154. |
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| 作者姓名： | 陈万里 史蕙 |
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| 作者单位： | 贵州省药品检验所,贵州,贵阳,550004 |
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| 摘 要： | 目的：探讨硫酸链霉素注射液的无菌检查方法，考察其抑菌作用及测定方法的可行性。方法：采用薄膜过滤法．通过无菌验证试验确定无菌检查方法的有效性。结果：含供试品各容器中的试验菌均生长良好。结论：通过验证试验的无菌检查方法可行，所得结果可靠，适合该药品的无菌检查。
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| 关 键 词： | 硫酸链霉素注射液 薄膜过滤法 验证试验 |
Validation of sterility test for streptomycin sulfate injection |
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| CHEN Wan-li,SHI Hui.Validation of sterility test for streptomycin sulfate injection[J].Anti-infection Pharmacy,2008,5(3):152-154. |
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| Authors: | CHEN Wan-li SHI Hui |
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| Institution: | (Guizhou Provincial Institute for Drug Control, Guiyang 550004, China) |
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| Abstract: | Objective:To study and to establish the method of sterility test for streptomycin sulfate injection. Methods:Membrane filtration method was selected and verified to be effective through validation.Results:The bacteria in vessels for drug experiment all grew well.Conclusion:The sterility test reassured by validation test is feasible and reliable. |
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| Keywords: | streptomycin sulfate Injection membrane filtration method validation test |
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