| 黄体酮注射液无菌检查方法的改进及验证 |
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| 引用本文： | 韦永朴.黄体酮注射液无菌检查方法的改进及验证[J].中国医药指南,2014(30):33-34. |
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| 作者姓名： | 韦永朴 |
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| 作者单位： | 广西柳州食品药品检验所 |
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| 摘 要： | 目的对黄体酮注射液无菌检查方法进行改进并验证。方法按《中国药典》2010年版二部无菌检查法的有关要求,采用封闭式薄膜过滤器过滤,最后用大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉对所采用的方法进行验证。结果黄体酮注射液采用封闭式薄膜过滤器进行无菌检查,所用的各验证菌均生长良好。结论改进后的方法重现性好,稳定、可靠,可作为黄体酮注射液的无菌检查方法。
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| 关 键 词： | 黄体酮注射液 无菌检查 方法改进及验证 |
Method Study to Improve The Method for Sterility Test of Progesterone Injection |
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| WEI Yong-pu.Method Study to Improve The Method for Sterility Test of Progesterone Injection[J].Guide of China Medicine,2014(30):33-34. |
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| Authors: | WEI Yong-pu |
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| Institution: | WEI Yong-pu (Liuzhou Food and Drug Control in Guangxi Zhuang Autonomous Region, Liuzhou 545006, China) |
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| Abstract: | Objective A method study to improve the method for sterility test of progesterone injection. Methods According to the sterility test in Chinese Pharmacopoeia（2010 edition, VolumeⅡ）, filter with the enclosed membrane filter, and using the Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Clostridium Sporogenes, Candida albicans, Aspergillus niger to verifying the method that is uesed. Result Adopt the enclosed membrane filter to do the sterility test of progesterone injection, and all the verification bacteria grow well. Conclusion This improved method is stabilization, credibility, reproducible and suitable for the sterility text of progesterone injection. |
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| Keywords: | Progesterone injection Sterility test Method improvement |
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