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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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青蒿素哌喹片杂质的初步研究

Primary analysis and evaluation of impurities in artemisinin and piperaquine tablets

分类号:
出版年·卷·期(页码):2014,34 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:对青蒿素哌喹片中主要杂质进行初步研究。方法:采用HPLC法,以Shim-pack VP-ODS C18(4.6 mm×150 mm,5 μm)为分析柱;乙腈-水(50:50)为流动相,流速为1.0 mL·min-1;检测波长为210 nm。采用LC-MS/MS高分辨质谱对其主要杂质进行结构研究并进行溯源。结果:主峰与各杂质分离良好,检测出4个主要杂质,对其中3个主要杂质进行了定性研究,为其工艺和质量控制提供了参考依据。结论:青蒿素哌喹片对酸、碱、热、光照不稳定,因而在本品生产及贮藏时应尽量避免光照及高温,防止药品发生降解。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To study the major impurities of artemisinin and piperaquine tablets. Methods: HPLC method was employed.Shim-pack VP-ODS C18 (4.6 mm×150 mm,5 μm) column was used,the mobile phase was composed of acetonitrile-water(50:50).The flow rate was 1.0 mL·min-1.The detection wavelength was 210 nm.High resolution LC-MS/MS was employed to identify the main impurities. Results: Main peak and impurities were separated well under the established HPLC condition.Four impurities were detected,and three of them were characterized by TOF/MS. Conclusion: The artemisinin and piperaquine tablets were unstable in the acid,alkali,illumination and thermal environment,so thermal and illumination conditions should be avoided during manufacturing and storage process in case of degradation.

-----参考文献:---------------------------------------------------------------------------------------
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[2] PENG Chuan-min(彭传敏), Ousseini Halarou.Efficacy of dihydroartemisinin-piperaquine tablets made in China in treatment of falciparum malaria in Africa(国产双氢青蒿素哌喹片治疗非洲恶性疟疾疗效观察)[J].China Trop Med(中国热带医学), 2009, 9(8):1462
[3] YBH08022006(国家食品药品监督管理局标准)[S].2006
[4] ChP 2010.VolⅡ(中国药典2010年版.二部)[S].2010:420
[5] World Health Organization.Int P (Draft for comment, July 2012), Artemisinin[DB/OL] .2012[2013-07-08].http://www.who.int/medicines/areas/quality_safety/quality_assurance/ArtemisininProposedRevision-QAS12-493_27072012.pdf
[6] Stringham R W, Lynam K G, Peter li, et al.High performance liquid chromatographic evaluation of artemisinin, and raw material in the synthesis of artesunate and artemether[J].J Chromatogr A, 2009, 1216(51):8918
[7] Stringham R W, Pennell M, Cabri W, et al.Identification of impurities in artemisinin, and their behavior in high performance liquid chromatography and implications for the quality of derived anti-malarial drugs[J].J Chromatogr A, 2011, 1218(38):6838
[8] YU Zheng-wen(余正文), WANG Bo-chu(王伯初), YANG Zhan-nan(杨占南), et al.Simultaneous extraction and analysis of artemisinic acid, artemisinin and dexoy-artemisinin of Artemisia annua L.(青蒿中青蒿酸、青蒿素及去氧青蒿素同时提取及检测)[J].Chin J Pharm Anal(药物分析杂志), 2011, 31(6):1020

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