| 甲硝唑注射液无菌检查方法学验证 |
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| 引用本文： | 应国红,邓颖. 甲硝唑注射液无菌检查方法学验证[J]. 中国药师, 2008, 11(8) |
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| 作者姓名： | 应国红 邓颖 |
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| 作者单位： | 深圳市药品检验所,广东深圳,518029 |
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| 摘 要： | 目的：建立甲硝唑注射液的无菌检查方法。方法：采用薄膜过滤法，以不同冲洗量，联合加入表面活性剂等方法以消除甲硝唑的抑菌活性。结果：样品、阴性对照无菌生长，所有阳性对照及试验组菌在2d内生长良好。结论：薄膜过滤法可以用于无菌检查，检查时甲硝唑注射液以伽．2％聚山梨酯80的冲洗液500ml 5次冲洗后依法培养，生孢梭菌为阳性对照菌。
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| 关 键 词： | 甲硝唑注射液 薄膜过滤法 方法验证 |
Studies on Test for Sterility of Metronidazole Injection |
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| Ying Guohong Deng Ying. Studies on Test for Sterility of Metronidazole Injection[J]. China Pharmacist, 2008, 11(8) |
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| Authors: | Ying Guohong Deng Ying |
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| Affiliation: | Ying Guohong Deng Ying(Shenzhen Institute for Drug Control,Guangdong Shenzhen 518029,China) |
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| Abstract: | Objective:To establish a method to detect the microbial contamination of metronidazole injection.Method:Membrane filtration method was used by modifying the amount of rinsing fruid or adds something to inactivate the antibiotic.Result:All of positive strains and test strains revealed growth of microorganism and the substance control and negative control give no evidence of growth. Conclusion:Through testing and verifying,membrane filtration method can be used for sterility tests of metronidazole injection.0... |
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| Keywords: | Metronidazole injection Sterility test (Membrane filtration method) Testing and verifying of the method |
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