留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码
x 关闭 永久关闭

应中央军委要求，2022年9月起，《药学实践杂志》将更名为《药学实践与服务》，双月刊，正文96页；2023年1月起，拟出版月刊，正文64页，数据库收录情况与原《药学实践杂志》相同。欢迎作者踊跃投稿！

药物杂质研究现状概述

李娜,  娄子洋

downloadPDF
文章导航 > 药学实践与服务  > 2014 >  32(3): 179-185
李娜, 娄子洋. 药物杂质研究现状概述[J]. 药学实践与服务, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
引用本文: 李娜, 娄子洋. 药物杂质研究现状概述[J]. 药学实践与服务, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
shu
LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
Citation: LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
shu

药物杂质研究现状概述

doi: 10.3969/j.issn.1006-0111.2014.03.005

  • 第二军医大学药学院, 上海 200433

Overview of the research on drug impurity

  • School of Pharmacy, Second Military Medical University, Shanghai 200433, China

  • 摘要: 药品是一种特殊商品,与人们的健康和生命安全息息相关,药物杂质是影响药物稳定性和疗效的物质,与药品质量、安全性及效能密切相关。随着杂质控制在药物开发研究中越来越受到重视,研究者开始将注意力转移到痕量杂质的分析上。笔者总结近10年来国内外杂质研究的相关进展,内容涉及药物杂质研究的相关指导原则、杂质定性研究的相关技术以及杂质定量研究等的一般方法。
    Abstract: As special commodities, drugs had closely relationships with human beings' health and life safety. Impurity, which would influence the stability and efficacy of drugs, was closely related to the quality, safety and efficacy of drugs. With more and more attendance had been attached to the impurity's control in the development of drugs, researchers turned their attentions to the analysis of trace impurity. In this paper, related progresses in recent 10 years were summarized, including guiding principles in impurity research, technologies in qualitative research and general approaches in quantitative research.
  • [1] 国家食品药品监督管理局. 化学药物杂质研究的技术指导原则[S]. 2005.
    [2] Available from: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.
    [3] McMahon AW, Pratt RG, Hammad TA. Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008[J]. Pharm Epidemiol Drug Saf,2010,19(9): 921-933.
    [4] Müller L, Mauthe RJ, Riley CM. A rationale for determining,testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity[J]. Regul Toxicol Pharmacol. 2006,44(3): 198-211.
    [5] http://www.cde.org.cn/dzkw.do?method=largePage&id=311390.
    [6] 国家药典委员会.中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录205.
    [7] Görög S. Identification and determination of impurities in drugs[M]. Amsterdam (Netherlands): Elsevier Science,2000:506-547.
    [8] Pavón JLP, M.del NS, Laespada MEF. Analysis of class 1 residual solvents in pharmaceuticals using headspace-programmed temperature vaporization-fast gas chromatography-mass spectrometry[J]. J Chromatogr A,2007,1141(1): 123-130.
    [9] Saavedra L, Huidobro AL, García A. CE as orthogonal technique to HPLC for alprazolam degradation product identification[J]. Electrophoresis, 2006,27(12):2360-2366.
    [10] Wang X, Li W, Rasmussen HT. Orthogonal method development using hydrophilic interaction chromatography and reversed-phase high-performance liquid chromatography for the determination of pharmaceuticals and impurities[J]. J Chromatogr A, 2005,1083(1-2):58-62.
    [11] Slonecker PJ, Li X, Ridgway TH. Informational orthogonality of two-dimensional chromatographic separations[J]. Anal Chem, 1996,68(4): 682-689.
    [12] Cheng JYK, Chan MF, Chan TW. Impurity profiling of ecstasy tablets seized in Hong Kong by gas chromatography-mass spectrometry[J]. Forensic Sci Int, 2006,162(1-3): 87-94.
    [13] Bonadio F, Margot P, Delémont O. Optimization of HS-SPME/GC-MS analysis and its use in the profiling of illicit ecstasy tablets (Part 1)[J]. Forens Sci Int,2009,187(1-3): 73-80.
    [14] 任丽萍, 田 芹, 潘灿平. 丁草胺原药中主要杂质的GC-MS定性分析[J]. 农药(Chinese Journal of Pesticides). 2005: 44(4): 74-78.
    [15] Chen W, Zhou P, Moon KCW. Identification of volatile degradants in formulations containing sesame oil using SPME/GC/MS[J]. J Pharm.Biomed.Anal.,2007,44(2): 450-455.
    [16] Łaniewsk K, Wannman T, Hagman G. Gas chromatography with mass spectrometric, atomic emission and fourier transform infrared spectroscopic detection as complementary analytical techniques for the identification of unknown impurities in pharmaceutical analysis[J]. J Chromatogr A, 2003,985(1-2): 275-282.
    [17] Łaniewsk K, VågeröM, Forsberg E. Complementary use of gas chromatography-mass spectrometry, gas chromatography-atomic emission detection and nuclear magnetic resonance for identification of pharmaceutically related impurities of unknown structures[J]. J Chromatogr A, 2004,1027(1-2):93-102.
    [18] Bedse G, Kumar V, Singh S. Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MSn[J]. J Pharm Biomed Anal,2009,49(1): 55-63.
    [19] Modhave D.T, Handa T, Shah RP. Successful characterization of degradation products of drugs using LC-MS tools: application to piroxicam and meloxicam[J]. Anal Methods,2011,3(12): 2864-2872.
    [20] Modhave DT, Handa T, Shah RP. Stress degradation studies on lornoxicam using LC, LC-MS/TOF and LC-MSn[J]. J Pharm Biomed Anal,2011,56(3): 538-545.
    [21] Shah RP, Singh S. Identification and characterization of a photolytic degradation product of telmisartan using LC-MS/TOF, LC-MSn, LC-NMR and on-line H/D exchange mass studies[J]. J Pharm.Biomed Anal,2010,53(3): 755-761.
    [22] Wang MJ, Pendela M, Hu CQ. Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry[J]. J Chromatogr A, 2010, 1217(42): 6531-6544.
    [23] Mehta S, Shah RP, Priyadarshi R. LC and LC-MS/TOF studies on stress degradation behaviour of candesartan cilexetil[J]. J Pharm Biomed Anal,2010,52(3): 345-354.
    [24] Liu DQ, Wu L, Sun M. On-line H/D exchange LC-MS strategy for structural elucidation of pharmaceutical impurities[J]. J Pharm Biomed.Anal,2007,44(2): 320-329.
    [25] Shah RP, Sahu A, Singh S. Identification and characterization of degradation products of irbesartan using LC-MS/TOF, MSn, on-line H/D exchange and LC-NMR[J]. J Pharm Biomed Anal,2010,51(5): 1037-1046.
    [26] Thurman EM, Ferrer I. The isotopic mass defect: a tool for limiting molecular formulas by accurate mass[J]. Anal Bioanal Chem, 2010,397(7): 2807-2816.
    [27] Bertinatto JA, Rodr'ıguez, Desimone MF. Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities[J]. J Pharm Biomed Anal,2007,44(1): 305-308.
    [28] Wijk AMv, Muijselaar PG, Stegman K. Capillary electrophoresis-mass spectrometry for impurity profiling of basic pharmaceuticals using non-volatile background electrolytes[J]. J Chromatogr A,2007,1159(1-2): 175-184.
    [29] Mol R, Kragt E, Jimidar I. Micellar electrokinetic chromate graphy-electrospray ionization mass spectrometry for the identification of drug impurities[J]. J Chromatogr B,2006,843(2): 283-288.
    [30] Hernández SL,Ruiz GC, Crego AL. Sensitive determination of D-carnitine as enantiomeric impurity of levo-carnitine in pharmaceutical formulations by capillary electrophoresis-tandem mass spectrometry[J]. J Pharm Biomed Anal,2010,53(5): 1217-1223.
    [31] Carvalho AZ, Attug EMN, Zayed SE. Micellar electrokinetic chromatography method development for determination of impurities in ritonavir[J]. J Pharm Biomed Anal,2010,53(5): 1210-1216.
    [32] Görög S. Identification and Determination of Impurities in Drugs[M].Amsterdam:Elsevier Science, 2000:67-82.
    [33] Murakami T, Konno H, Fukutsu N. Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques[J]. J Pharm Biomed Anal, 2008,47(3):553-559.
    [34] Wolters AM, Jayawickrama DA, Larive CK. Capillary isotachophoresis/NMR: extension to trace impurity analysis and improved instrumental coupling[J]. Anal Chem, 2002,74(10): 2306-2313.
    [35] Prabha Srinivasu, Devarakonda V, SubbaRao A. validated stabilityúindicating LC method for acetazolamide in the presence of degradation products and its process-related impurities[J]. J Pharm Biomed Anal., 2011, 52(1):142-148.
    [36] Székely Gy, Henriques B, Gil M. Design of experiments as a tool for LC-MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethy laminopyridine impurity in glucocorticoids[J]. J Pharm Biomed Anal, 2012,70:251-258.
    [37] 徐宜宏,蒋 施,付海滨,等.气相色谱-三重四极杆质谱法同时测定五味子中117种农药残留量[J]. 福建分析测试,2012,21(5):1-10.
  • [1] 刘汝雄, 杨万镇, 涂杰, 盛春泉.  铁死亡调控蛋白GPX4的小分子抑制剂研究进展 . 药学实践与服务, 2024, 42(9): 375-378. doi: 10.12206/j.issn.2097-2024.202312075
    [2] 陈炳辰, 王思真, 郭贝贝, 杨峰.  紫杉醇棕榈酸酯的合成及其脂质体的制备与处方研究 . 药学实践与服务, 2024, 42(9): 379-384, 410. doi: 10.12206/j.issn.2097-2024.202404062
    [3] 何静, 安晔, 张朝绅.  复方黑参滴丸与复方黑参丸药效学实验比较研究 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202404009
    [4] 练鲁英, 刘盈, 殷佳, 诸国樑, 徐飞.  上海某三级公立医院药品管理内部控制评价实践研究 . 药学实践与服务, 2024, 42(): 1-7. doi: 10.12206/j.issn.2097-2024.202402003
    [5] 李清, 郭宜银, 陈颖, 瞿发林, 董文燊, 戈煜.  夜宁胶囊对小鼠镇静催眠作用及其机制的研究 . 药学实践与服务, 2024, 42(8): 346-349. doi: 10.12206/j.issn.2097-2024.202211047
    [6] 张成中, 朱雪艳, 卜其涛, 王宏瑞, 黄宝康.  基于网络药理学与分子对接预测鸡骨草特征图谱研究 . 药学实践与服务, 2024, 42(8): 350-358. doi: 10.12206/j.issn.2097-2024.202303048
    [7] 顾佳钰, 胡馨儿, 王晓飞, 张颖, 张海, 曹岩.  侧流免疫层析定量检测方法的研究进展 . 药学实践与服务, 2024, 42(7): 273-277, 284. doi: 10.12206/j.issn.2097-2024.202307037
    [8] 王耀振, 徐灿, 吕顺莉, 田泾, 张东炜.  钾离子竞争性酸阻滞剂的药学特征研究进展 . 药学实践与服务, 2024, 42(7): 278-284. doi: 10.12206/j.issn.2097-2024.202306040
    [9] 毛泽玲, 文波.  大黄的HPLC指纹图谱及禁用农药的残留研究 . 药学实践与服务, 2024, 42(7): 297-304, 314. doi: 10.12206/j.issn.2097-2024.202310057
    [10] 姚小静, 计佩影, 陆峰, 施国荣, 傅翔.  表面增强拉曼光谱法快速测定尿液中曲马多的研究 . 药学实践与服务, 2024, 42(): 1-5. doi: 10.12206/j.issn.2097-2024.202401072
    [11] 马兹芬, 许维恒, 金煜翔, 薛磊.  食管癌的靶向治疗与免疫治疗研究进展 . 药学实践与服务, 2024, 42(6): 231-237. doi: 10.12206/j.issn.2097-2024.202306008
    [12] 徐飞, 陈瑾, 鲁育含, 李志勇.  肠道菌群参与糖尿病肾病的机制研究进展 . 药学实践与服务, 2024, 42(5): 181-184, 197. doi: 10.12206/j.issn.2097-2024.202312023
    [13] 杨凤艳, 张月, 陈恩贤, 缪雪蓉, 魏凯.  瑞马唑仑临床应用研究进展 . 药学实践与服务, 2024, 42(9): 365-374. doi: 10.12206/j.issn.2097-2024.202405026
    [14] 陈莹, 许子华, 胡北, 崔亚玲, 高欢, 吴琼.  通便灵胶囊治疗便秘的药效与机制研究 . 药学实践与服务, 2024, 42(): 1-7. doi: 10.12206/j.issn.2097-2024.202404008
    [15] 张林晨, 张小琴, 张俊平.  山楂酸药理作用的研究进展 . 药学实践与服务, 2024, 42(5): 185-189. doi: 10.12206/j.issn.2097-2024.202307052
    [16] 赖立勇, 夏天爽, 徐圣焱, 蒋益萍, 岳小强, 辛海量.  中药青蒿抗氧化活性的谱效关系研究 . 药学实践与服务, 2024, 42(5): 203-210, 216. doi: 10.12206/j.issn.2097-2024.202211012
    [17] 宋泽成, 陈林林, 鲁仁义, 刘梦肖, 王彦.  脓毒症治疗的研究进展 . 药学实践与服务, 2024, 42(11): 1-5. doi: 10.12206/j.issn.2097-2024.202405059
    [18] 崔俐俊, 陈嫣婷, 费永和, 陈静.  中外药品应急审批制度对比研究 . 药学实践与服务, 2024, 42(8): 359-364. doi: 10.12206/j.issn.2097-2024.202310015
    [19] 陈静, 何瑞华, 翁月, 徐熠, 刘静, 黄瑾.  基于网络药理学和分子对接技术探究定清片活性成分治疗白血病的作用机制 . 药学实践与服务, 2024, 42(11): 1-8. doi: 10.12206/j.issn.2097-2024.202401073
    [20] 张元林, 宋凯, 孙蕊, 舒飞, 舒丽芯, 杨樟卫.  基于真实世界数据的药物利用研究综述 . 药学实践与服务, 2024, 42(6): 238-243. doi: 10.12206/j.issn.2097-2024.202312010
  • 加载中
WeChat 点击查看大图
计量
  • 文章访问数:  2933
  • HTML全文浏览量:  379
  • PDF下载量:  183
  • 被引次数: 0
出版历程
  • 收稿日期:  2013-11-06
  • 修回日期:  2014-01-16

药物杂质研究现状概述

doi: 10.3969/j.issn.1006-0111.2014.03.005
  • 第二军医大学药学院, 上海 200433
  • 收稿日期: 2013-11-06
  • 修回日期: 2014-01-16

摘要: 药品是一种特殊商品,与人们的健康和生命安全息息相关,药物杂质是影响药物稳定性和疗效的物质,与药品质量、安全性及效能密切相关。随着杂质控制在药物开发研究中越来越受到重视,研究者开始将注意力转移到痕量杂质的分析上。笔者总结近10年来国内外杂质研究的相关进展,内容涉及药物杂质研究的相关指导原则、杂质定性研究的相关技术以及杂质定量研究等的一般方法。

English Abstract

李娜, 娄子洋. 药物杂质研究现状概述[J]. 药学实践与服务, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
引用本文: 李娜, 娄子洋. 药物杂质研究现状概述[J]. 药学实践与服务, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
shu
LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
Citation: LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005
shu

    全文HTML

参考文献 (37)

目录

    /

    返回文章
    返回

    版权所有：《药学实践与服务》编辑委员会

    主管、主办: 中国人民解放军海军军医大学地址: 上海市杨浦区国和路325号邮政编码: 200433

    电话: （021）81871324,81871397 E-mail: yxsjzzs@163.com

    网站备案号 沪ICP备05003363号-1

    本系统由 北京仁和汇智信息技术有限公司 开发    百度统计