| 注射用七叶皂苷钠无菌检查方法学验证 |
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| 引用本文： | 陈晓宁.注射用七叶皂苷钠无菌检查方法学验证[J].中国医药导报,2011,8(1):48-49. |
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| 作者姓名： | 陈晓宁 |
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| 作者单位： | 山东绿叶制药有限公司,山东,烟台,264003 |
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| 摘 要： | 目的：验证注射用七叶皂苷钠的无菌检查方法。方法：采用《中国药典》2005年版二部附录无菌检查法项下薄膜过滤法。结果：样品、阴性对照无菌生长，所有阳性对照及试验组菌生长良好。结论：经方法学验证，该法准确可靠，可作为注射用七叶皂苷钠的无菌检查方法。
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| 关 键 词： | 注射用七叶皂苷钠 无菌检查 方法验证 |
Verification for sterility test of Sodium Aescinate for Injection |
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| CHEN Xiaoning.Verification for sterility test of Sodium Aescinate for Injection[J].China Medical Herald,2011,8(1):48-49. |
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| Authors: | CHEN Xiaoning |
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| Institution: | CHEN Xiaoning(Lüye Pharma Group Co.,Ltd.,Shandong Province,Yantai 264003,China) |
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| Abstract: | Objective： To verify the sterility test of Sodium Aescinate for Injection. Methods： CP 2005 Volume Ⅱ ,Appendix Ⅺ, Membrane filtration method was used. Results： All of positive strains and test strains revealed growth of microorganism and the substance control and negative control gave no evidence of growth. Conclusion： This method is accurate. It can be used for sterility test of Sodium Aescinate for Injection. |
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| Keywords: | Sodium Aescinate for Injection Sterility test Verification |
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