| 胃蛋白酶口服溶液微生物限度检查方法验证 |
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| 引用本文： | 乐正永,李敏. 胃蛋白酶口服溶液微生物限度检查方法验证[J]. 北方药学, 2009, 6(1): 51-52 |
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| 作者姓名： | 乐正永 李敏 |
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| 作者单位： | 遵义市药品检验所,遵义,563002;遵义市药品检验所,遵义,563002 |
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| 摘 要： | 目的：建立胃蛋白酶口服溶液微生物限度检查法；方法：本试验按照《中国药典》2005版二部（附录XⅢC）所载的微生物限度检查法进行；结果：试验组各种菌的回收率达70％以上；控制菌（大肠埃希菌）试验组检出，阴性菌对照组未检出。结论：该制剂可采用常规法进行微生物限度检查。
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| 关 键 词： | 胃蛋白酶口服溶液 微生物限度检查 方法验证 |
Validation of Method for Microbial Limit Test of Pepsin Oral Solution |
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| Le Zheng yong,Li Min. Validation of Method for Microbial Limit Test of Pepsin Oral Solution[J]. BEIFANG YAOXUE, 2009, 6(1): 51-52 |
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| Authors: | Le Zheng yong Li Min |
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| Affiliation: | (Zunyi Institute for Drug Control, Zunyi 563002, China) |
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| Abstract: | Objective：To establish a method for microbial limit test of pepsin oral solution. Methods： According to the testing method stated in China Pharmacopoeia of 2005 edition, the microbial limit test of pepsin oral solution was accomplished. Results： The recoveries of all the bacteria in the testing group were over 70%. Control bacteria was detected in the testing group, but not detected in the negative control group. Conclusion： This method can be used for the routine microbial limit test of pepsin oral solution. |
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| Keywords: | Pepsin oral solution Microbial limit test Method validation |
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