中药注射剂非临床安全性评价方法概述

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (3): 161-164.

中药注射剂非临床安全性评价方法概述

严光焰，卜迁, 岑小波

四川大学华西医院,国家成都中药安全性评价中心,四川成都 610041

收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-03-10 发布日期:2015-08-27
通讯作者: 岑小波,男,教授,博士生导师,药理毒理学。E-mail：xbcenalan@sina.com。
作者简介:严光焰,男,在读博士研究生,药理学。
基金资助:
重大新药创制（2008ZX09305-008）;国家自然科学基金（30870888,30970938）

Non-clinical Safety Evaluation Approaches Applied to Traditional Chinese Medicine Injection

YAN Guang-yan, BU Qian, CEN Xiao-bo

West China Hospital of Sichuan University, National Chengdu Center for Safety Evaluation of Drugs,Sichuan Chengdu 610041, China

Received:2015-08-27 Revised:2015-08-27 Online:2011-03-10 Published:2015-08-27

摘要/Abstract

摘要： 通过对当前中药注射剂不良反应的特点及安全性评价方法,尤其是针对过敏反应的评价方法的阐述,为中药注射剂的安全性研究提供思路。

关键词: 中药注射剂, 不良反应, 过敏反应, 代谢组学, 蛋白组学

Abstract: The adverse reaction feature of Traditional Chinese Medicine(TCM) injection as well as the safety evaluation approaches applied to TCM injection are described in this paper and the Methods used for allergic response evaluation are discussed intensively.,so as to provid suggestions for the safety study of TCM.

Key words: Traditional Chinese Medicine injection, adverse drug reaction, allergic response, metabonomics, proteomics

中图分类号:

R954

严光焰，卜迁, 岑小波. 中药注射剂非临床安全性评价方法概述[J]. 中国药物警戒, 2011, 8(3): 161-164.

YAN Guang-yan, BU Qian, CEN Xiao-bo. Non-clinical Safety Evaluation Approaches Applied to Traditional Chinese Medicine Injection[J]. Chinese Journal of Pharmacovigilance, 2011, 8(3): 161-164.

参考文献

[1] 袁强,王莉,成岚.国家基本药物目录(2004年版)33种中药注射剂不良反应/不良事件文献分析[J].中国循证医学杂志,2010,10(2):132–139.
[2] 刘屏.中药注射剂的过敏反应亟待进行科学系统研究[J].中国药物应用与监测,2010,7(2)：67-69.
[3] 曹学东.9种中药注射剂不溶性微粒观察[J].中医药研究,2004,11(5):55.
[4] 文洁,朱建梅,俞励平.磷酸川芎嗪注射液血管刺激性、溶血性及过敏性试验研究[J].国际医药卫生导报,2009,15(21)：28-31.
[5] 李瑾翡,黎吻,陈琪.注射用双黄连的免疫毒性研究[J].中药新药与临床药理,2008,5(19):172-174.
[6] 吴友苹,徐潘生,卢觅佳,等.鱼腥草注射液I型过敏反应试验[J].时珍国医国药,2009,20(6)：1522-1523.
[7] Lvik M, Alberg T, Nygaard U, et al.Popliteal lymph node (PLN) assay to study adjuvant effects on respiratory allergy[J].Methods,2007,41：72-79.
[8] Ravel G and Descotes J.Popliteal lymph node assay: facts and perspectives [J].J Appl Toxicol ,2005,25(6):451-458.
[9] 刘兆华,程芳,周庚寅.C57/6J小鼠腘窝淋巴结试验评价注射用双黄连致敏性的研究[J].中国中西医结合杂志,2010,30(1)：64-67.
[10] 郭姗姗,王意忠,张毅.BN大鼠和豚鼠评价双黄连注射液的过敏反应[J].中国药理学与毒理学杂志,2009,23(2):128-133.
[11] Li Z, Gao Y, Wang H, et al.A rat model of Shuang Huang Lian injection-induced anaphylaxis[J].Asian Pac J Allergy Immunol,2010,28(2-3):185-191.
[12] FDA: Guidance for Industry Immunotoxicology Evaluation of Investigational New Drugs[EB/OL].2002.http://www.fda.gov/downlo- ads/Drugs/GuidanceComplianceRegulatoryInformation/Guidan-ces/ucm079239.pdf.
[13] Choi YH, Yan GH. Silibinin attenuates mast cell-mediated anaphylaxis like reactions[J]. Biol Pharm Bull, 2009, 32(5): 868-875.
[14] 刘宝峰,李中港,刘兆平.大鼠嗜碱性粒细胞在过敏反应研究中的应用[J].齐鲁药事,2010,29（14）：230-232.
[15] 屈会化,赵琰,王庆国.利用免疫芯片技术筛查中药注射剂致敏成分[J].北京中医药大学学报,2008,31（1）：23-25.
[16] 闫位娟.中药注射剂致敏性研究[D].广西医科大学, 2009.
[17] Szebeni J.Complement activation-related pseudoallergy:a new class of drug-induced acute immune toxicity[J].Toxicology, 2005, 216(2-3): 106-121.
[18] Descotes J, Payen C, Vial T. Pseudo-allergic drug reactions with special reference to direct histamine release[J].Perspect Exp Clin Immunotoxicol, 2007, 141-150.
[19] 程芳,刘兆平.中药注射剂安全性评价与关键技术的研究[J].中国中药杂志,2009,34(8)：1052-1054.
[20] Szebeni J, Alving C R, Rosivall L, et al. Animal models of complement-mediated hypersensitivity reactions to liposomes and other lipid-based nanoparticles[J].Liposome Res, 2007, 17(2):107-117.
[21] 闫位娟,李连达,张美玉.7种中药注射剂对Beagle犬类过敏反应研究[J].中国新药杂志,2010,19(20):1895-1910.
[22] 梁爱华,李春英,郝然.用清醒Beagle犬进行中药注射液的类过敏试验方法研究[J].中国中药杂志,2010,35(17):2328-2333.
[23] 朱社敏,匡荣,王丹.参麦注射液渗透压和溶血率现状的调查[J].药物评价研究,2010,3(1)：5-8.
[24] Chai X, Li S and Li P . Quality evaluation of Flos Lonicerae through a simultaneous determination of seven saponins by HPLC with ELSD[J].J of Chromatogr A,2005,1070(1-2)：43-48.
[25] Gauthier C, Legault J, Girard-Lalancette K, et al.Haemolytic activity, cytotoxicity and membrane cell permeabilization of semi-synthetic and natural lupane-and oleanane-type saponins[J]. Bioorg med chem,2009,17(5)：2002-2008.
[26] Ren M, Chen J, Song Y, Sheng L,et al.Identification and quantification of 32 bioactive compounds in Lonicera species by high performance liquid chromatography coupled with time-of-flight mass spectrometry[J]. J pharm biomed anal,2008,48(5)：1351-1360. [27] 许桂艳,陈玉忠,张雅杰.双黄连注射液体外溶血试验方法改进[J]. 黑龙江医药科技,2001,24(5)：29.
（因版面有限,部分参考文献省略,如有需要,请联系编辑部）