| 醒脑静注射液无菌检查方法的验证 |
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| 引用本文： | 王丽华,孙亚玲.醒脑静注射液无菌检查方法的验证[J].生物技术通讯,2010,21(6):861-863. |
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| 作者姓名： | 王丽华 孙亚玲 |
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| 作者单位： | 解放军总医院,药品保障中心外科药房,北京,100853 |
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| 摘 要： | 目的:验证醒脑静注射液无菌检查法。方法:采用《中华人民共和国药典》2005年版二部附录无菌检查项下的直接接种法。结果:供试品管无菌生长,6株阳性菌生长良好。结论:经方法学验证,醒脑静注射液无菌检查法准确可靠。
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| 关 键 词： | 醒脑静注射液 直接接种法 无菌检查 方法验证 |
Verification of Sterility Test for Xingnaojing Injection |
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| WANG Li-Hua,SUN Ya-Ling.Verification of Sterility Test for Xingnaojing Injection[J].Letters in Biotechnology,2010,21(6):861-863. |
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| Authors: | WANG Li-Hua SUN Ya-Ling |
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| Institution: | Surgery Pharmacy,General Hospital of PLA,Beijing 100853,China |
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| Abstract: | Objective： To verify the sterility test of Xingnaojing injection.Methods： The direct inoculation method was selected and verified to be effective through verification.Results： There were no bacteria in test tubes and the bacteria grouth well in positive tubes.Conclusion： The method is accurate and reliable.It can be used for sterility test of Xingnaojing injection. |
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| Keywords: | Xingnaojing injection sterility test direct inoculation method method validation |
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