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硝酸甘油片中有关物质检查探讨
引用本文:万莉,李万平,阎睿,崔小平. 硝酸甘油片中有关物质检查探讨[J]. 中国药师, 2014, 0(8): 1430-1432
作者姓名:万莉  李万平  阎睿  崔小平
作者单位:重庆市万州食品药品检验所 重庆 404000;;重庆市万州食品药品检验所 重庆 404000;;重庆市万州食品药品检验所 重庆 404000;;重庆三峡中心医院
摘    要:目的:对《中国药典》2010版二部中硝酸甘油片有关物质检查的质量标准提出修改建议.方法:对硝酸甘油片中有关物质检查方法的系统适用性试验、辅料及试验温度对检查结果的影响进行分析比较.结果:硝酸甘油片有关物质检查质量标准中系统适用性试验、试验条件规定不完善.结论:应完善并及时修订硝酸甘油片中有关物质检查的质量标准.

关 键 词:硝酸甘油片  有关物质  系统适用性试验  辅料  试验温度
收稿时间:2014-02-13
修稿时间:2014-04-21

Discussion on Determination Method for Related Substances in Nitroglycerin Tablets
Wan Li,Li Wanping,Yan Rui and Cui Xiaoping. Discussion on Determination Method for Related Substances in Nitroglycerin Tablets[J]. China Pharmacist, 2014, 0(8): 1430-1432
Authors:Wan Li  Li Wanping  Yan Rui  Cui Xiaoping
Affiliation:Wan Li , Li Wanping ,Yan Rui , Cui Xiaoping( 1. Chongqing Wanzhou Food and Drug Control Institute, Chongqing 404000, China; 2. Sanxia Central Hospital of Chongqing)
Abstract:Objective: To improve the quality standard for the related substances in nitroglycerin tablets described in the second part of Chinese pharmacopoeia(2010 edition). Methods: The effects of system suitability test, accessories and experimental tempera- ture on the determination results of the related substances in nitroglycerin tablets were studied and compared. Results : The system suit- ability test and experimental conditions for the determination of related substances in nitroglycerin tablets were imperfect. Conclusion: The quality standard for the related substances in nitroglycerin tablets should be improved and modified in time.
Keywords:Nitroglycerin tablets   Related substances   System suitability test   Accessories   Experimental temperature
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