| 硫酸庆大霉素注射液无菌检查方法学验证 |
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| 引用本文： | 符春娜.硫酸庆大霉素注射液无菌检查方法学验证[J].企业科技与发展,2011(7):40-41,46. |
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| 作者姓名： | 符春娜 |
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| 作者单位： | 广西南宁百会药业集团有限公司,广西南宁530003 |
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| 摘 要： | 建立硫酸庆大霉素注射液的无菌检查方法。本试验取硫酸庆大霉素注射液,按《中国药典》2005年版二部附录所载的＂无菌检查法＂项下进行方法学验证试验。结果表明：采用本试验方法进行硫酸庆大霉素注射液的无菌检查,供试品无菌生长,而六株阳性菌生长良好,该方法可行。
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| 关 键 词： | 硫酸庆大霉素注射液 无菌检查法（薄膜过滤法） 方法学验证 |
Validation of Sterile Test Methodology of Gentamycin Sulfate Injection |
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| Authors: | FU Chun-na |
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| Institution: | FU Chun-na (Guangxi Nanning Baihui Pharmaceutical Group Co.,Ltd,Nanning Guangxi 530003) |
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| Abstract: | The purpose of the paper is to create sterile test methods for Gentamycin sulfate injection.According to the＂sterile test method＂which is recorded in the appendix in Chinese Pharmacopoeia（2005 Edition）,the methodology validation is experimented with Gentamycin sulfate injection.The results of the experiment show that the method is viable for the test article can grow aseptically and six positive bacteria grow well. |
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| Keywords: | Gentamycin sulfate injection sterile test method（Membrane filtration method） methodology validation |
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