头孢拉定及其胶囊剂中有关物质检查方法的探讨 |
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引用本文: | 翁鹭娜,赖东美,邱元素,李玲玲.头孢拉定及其胶囊剂中有关物质检查方法的探讨[J].中国药品标准,2004,5(4):25-26. |
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作者姓名: | 翁鹭娜 赖东美 邱元素 李玲玲 |
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作者单位: | 厦门市药品检验所,厦门,361012 |
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摘 要: | 目的:对头孢拉定原料及制剂的有关物质检查方法进行探讨.方法:对现行版药典中的头孢拉定及其制剂的有关物质检查方法进行比较和实验观察.结论:可用<中国药典>中检查拉定原料有关物质的方法对胶囊剂进行检查,并认为有必要增加此项目.同时建议对原料有关物质检查项中杂质对照的点样方法进行修改.
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关 键 词: | 头孢拉定 头孢拉定胶囊 有关物质 <中国药典> |
Discussion about The Methods For the Examination of Related Substances in Cefradine and its Capsules |
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Authors: | Weng Lun Lai Dongmei Qui Yuansu and Li Lingling |
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Institution: | Xiamen Institute for Drug Control, Xiamen, 361012;Xiamen Institute for Drug Control, Xiamen, 361012;Xiamen Institute for Drug Control, Xiamen, 361012;Xiamen Institute for Drug Control, Xiamen, 361012 |
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Abstract: | Objective:To discuss the methods for the examination of related substances(rs) in cefradine and its preparation. Methods: according to the comparison and test observation on the different methods for examination of rs in cefradine and its preparation collected in the pharmacopoeias in use. Conclusion: The related method in ChP2000 is suitable for cefradine capsules and necessary to add this examination of cefradine capsules to ChP. We suggest the amendment of dot method in examination of rs in cefradine. |
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Keywords: | cefradine cefradine capsules related substances Chinese Pharmacopoeia |
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