| 国产注射用阿奇霉素杂质谱及其与成盐工艺相关性的考察 |
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| 引用本文： | 张斗胜,王悦雯,李进,李娅萍,刘文,杨亚莉,胡昌勤.国产注射用阿奇霉素杂质谱及其与成盐工艺相关性的考察[J].药物分析杂志,2011(8). |
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| 作者姓名： | 张斗胜 王悦雯 李进 李娅萍 刘文 杨亚莉 胡昌勤 |
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| 作者单位： | 中国食品药品检定研究院;天津市药品检验所; |
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| 基金项目： | 国家科技支撑计划《药品注射剂检测技术体系研究》课题(No:2008BA155B04-2) |
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| 摘 要： | 目的:考察国产不同成盐注射用阿奇霉素所含杂质谱情况,并对其工艺进行相关性评价。方法:以217批注射用阿奇霉素有关物质HPLC检验数据为基础,采用数理统计与化学计量学方法,对其杂质谱及与成盐工艺相关性进行考察,并通过加速实验验证考察结果。结果:所检样品中均检出阿奇霉素B(EP-B)和3′-去克拉定糖阿奇霉素(EP-J)杂质,且在不同厂家、不同成盐工艺产品中变化幅度较大,统计标准偏差(SD)分别达2.5和2.0;其他杂质还检出阿奇霉素-N-氧化物(EP-L)、氮红霉素(EP-A)。结论:目前国产注射用阿奇霉素中主要杂质为阿奇霉素-N-氧化物、3′-去克拉定糖阿奇霉素、氮红霉素和阿奇霉素B;氮红霉素和阿奇霉素B为工艺杂质,分别源于合成反应残留和起始原料红霉素中红霉素B残留;阿奇霉素-N-氧化物和3′-去克拉定糖阿奇霉素分别为阿奇霉素氧化和酸降解物,其中酸降解物为主要降解形式;不同厂家注射用阿奇霉素中所含杂质的种类、数目及水平均存在较大差异,且与其成盐工艺密切相关。
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| 关 键 词： | 注射剂 阿奇霉素 杂质谱 成盐工艺 相关性 考察 |
The investigation between impurity profile of domestic azithromycin for injection and correlation of its salifiable craft |
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| ZHANG Dou-sheng,WANG Yue-wen,LI Jin,LI Ya-ping,LIU Wen,YANG Ya-li,HU Chang-qin.The investigation between impurity profile of domestic azithromycin for injection and correlation of its salifiable craft[J].Chinese Journal of Pharmaceutical Analysis,2011(8). |
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| Authors: | ZHANG Dou-sheng WANG Yue-wen LI Jin LI Ya-ping LIU Wen YANG Ya-li HU Chang-qin |
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| Institution: | ZHANG Dou-sheng1,WANG Yue-wen2,LI Jin1,LI Ya-ping1,LIU Wen1,YANG Ya-li1,HU Chang-qin1(1.National institutes for food and drug control,Beijing 100050,China,2.Tianjin institute for drug control,Tianjin 300070,China) |
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| Abstract: | Objective:To investigate the impurity profile status of domestic azithromycin for injection by using different salifiable technologies,and evaluate the correlation of its crafts.Methods:Based on 217 batches of impurity testing datas of azithromycin for injection by HPLC,investigate the impurity profile and correlation of its salifiable technologies according to mathematical statistics and chemometrics methods,and validate the investigate results by using acceleration experiment.Results:Azithromycin B(EP-B) ... |
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| Keywords: | azithromycin injection impurity profile salifiable craft correlation investigation |
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