中国药典2010年版硝酸甘油系列质量标准修订建议
Some suggestions on revision of the quality standards of nitroglycerin in Chinese Pharmacopoeia Volume Ⅱ(2010 Edition)
分类号：
出版年·卷·期（页码）：2013,33 (5):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 针对2010年版中国药典二部硝酸甘油系列质量标准中色谱条件不完善,杂质计算不合理等问题,对该系列质量标准提出修订建议。 方法: 采用高效液相色谱法,通过改进系统适用性溶液制备方法,重新制定系统适用性要求。 结果: 按改进方法进行有关物质检查,4批硝酸甘油片和3批硝酸甘油注射液的最大单个杂质均不过1.0%,杂质总量均不过3.0%。 结论: 本改进方法操作简单,实验结果准确可靠,为2010年版中国药典二部中硝酸甘油系列质量标准修订提供了参考。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To put forward some practical revising suggestions on the nitroglycerin quality in Chinese pharmacopoeia focusing on the problems of imperfect chromatographic conditions and unreasonable calculation of impurities. Methods: An HPLC method was adopted.The requirements on system suitability were reformulated by advancing the preparation method for system suitability solvent. Results: Using the improved method to test the related substances of nitroglycerin tablets and nitroglycerin injection,the content of the maximum individual impurity were not more than 1.0%,and the total content were not more than 3.0%. Conclusion: The improved method is accurate and feasible.It provided a reference for revising the quality standards of nitroglycerin in the 2010 edition of Chinese Pharmacopoeia.
-----参考文献：---------------------------------------------------------------------------------------
1 GAO Feng-tong(高凤彤),SUN Zhan-bo(孙湛博),ZHANG Xiao-wen(张晓雯).Research progress in effects and drug-resistant mechanism of nitroglycerin(硝酸甘油作用机制及耐药机制的研究进展).Nat Med Front China(中国医疗前沿),2010,5(8):7
2 ChP(中国药典).2010.Vol Ⅱ(二部):947
3 BP 2012.2875
4 USP 35-NF30.2012.4066
5 JP ⅩⅥ.2011.1169
6 GAO Juan(高娟),TANG Su- fang(唐素芳),GAO Li-qin(高立勤),et al.Development of a near IR method for rapid determination of nitroglycerin tablets(近红外光谱法快速分析硝酸甘油片的含量).Chin J Pharm Anal(药物分析杂志),2010,30(7):1173
7 ZHANG Qian(张倩),LIN Yin-hua(林银花),WANG Juan(王娟),et al.Preparation and quality control of nitroglycerin ointment(硝酸甘油软膏的制备与质量控制).Her Med(医药导报),2010,29(6):768
8 HAO Gui-ming(郝桂明),HUA Lian(华莲),WANG Wei(王卫),et al.Determination of related substances in nitroglycerin tablets and nitroglycerin injections by HPLC(市售硝酸甘油片及注射液的有关物质考察).Tianjin Pharm(天津药学),2009,21(2):1
9 LUO Jian-Ming(罗建明),SITU Shao-Jin(司徒少金),LI Chun(黎春),et al.HPLC determination of the related substances of nitroglycerin solution(HPLC法测定硝酸甘油溶液中的有关物质).Jiangsu Pharm Clin Res(江苏药学与临床研究),2005,13(4):17
10 WU Liang-yong(伍良涌),PAN Xi-qiang(潘锡强),WU Jun-cheng(吴均成).RP-HPLC determination of nitroglycerin aerosol and its related substances(反相高效液相色谱法测定硝酸甘油气雾剂有关物质和硝酸甘油含量).Chin J Pharm Anal(药物分析杂志),2012,32(5):895
欢迎阅读《药物分析杂志》！您是该文第 2281位读者！
