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《中国药典》2010年版盐酸阿米替林片有关物质测定方法的改进
引用本文:堵伟锋,孙凌云,谢子立. 《中国药典》2010年版盐酸阿米替林片有关物质测定方法的改进[J]. 中国药品标准, 2012, 13(6): 443-445
作者姓名:堵伟锋  孙凌云  谢子立
作者单位:堵伟锋 (安徽省食品药品检验所,合肥,230051);孙凌云 (安徽省食品药品检验所,合肥,230051);谢子立 (安徽省食品药品检验所,合肥,230051);
摘    要:目的: 改进盐酸阿米替林片有关物质测定方法。方法: 提高有关物质检查的供试品溶液浓度,适当放宽杂质限度。结果: 改进后的有关物质检查能灵敏、有效的检测出更多杂质。结论: 改进后的盐酸阿米替林片有关物质测定方法更合理。

关 键 词:盐酸阿米替林片  评价性抽验  有关物质  改进

The Improvement of Testing Method about Related Substances in Amitriptyline Hydrochloride Tablets in Chinese Pharmacopoeia 2010 Edition
Du Weifeng,Sun Lingyun and Xie Zili. The Improvement of Testing Method about Related Substances in Amitriptyline Hydrochloride Tablets in Chinese Pharmacopoeia 2010 Edition[J]. , 2012, 13(6): 443-445
Authors:Du Weifeng  Sun Lingyun  Xie Zili
Affiliation:Anhui Institute for Food and Drug Control, Hefei 230051;Anhui Institute for Food and Drug Control, Hefei 230051;Anhui Institute for Food and Drug Control, Hefei 230051
Abstract:Objective: To improve the testing method about related substances in Amitriptyline Hydrochloride Tablets.Method: Increasing the concentration of test solution of related substances and relaxing appropriately the limit of related substances.Results: The improved method of related substances is more sensitive and effective,and should detect more impurities.Conclusion: The improved testing method about related substances in Amitriptyline Hydrochloride Tablets is more reasonable.
Keywords:Amitriptyline Hydrochloride Tablets  evaluative testing  related substances  improvement
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