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依诺言药细菌内毒斋反节方法的切磋

  龙源期刊网 http://www.wendangku.net/doc/1cb06973bc64783e0912a21614791711cc79793d.html

  依诺言药细菌内毒斋反节方法的切磋

  干者:张射兵陆晓和曲清段艳冰凌

  到来源:《中中医药带报》2014年第12期

  [摘要] 目的确立依诺言药的细菌内毒斋反节方法。方法依照《中中药典》2010年版二部,决定靠边的依诺言肝斋钠细菌内毒斋限值,并切磋依诺言肝斋钠对细菌内毒斋与鲎试剂反应的烦扰情景,以决定其不烦扰试验浓度。结实决定依诺言肝斋钠的细菌内毒斋限值为0.01 EU/U,运用2个厂家消费的鲎试剂试验,本品配制成3 U/mL浓度对反应均无烦扰干用。定论细菌内毒斋反节法却用于依诺言肝斋钠细菌内毒斋的反节。

  [] 依诺言肝斋钠;细菌内毒斋;烦扰试验

  [中图分类号] R331[文件标注识码] A[文字编号] 1673-7210(2014)04(c)-0092-04

  Study on bacterial endotoxiin test method for Enoxaparin Sodium

  ZHANG Shebing1 LU Xiaohe2 QU Qing1 DUAN Yanbing1,2

  1.Nanjing King-friend Biochemical Pharmaceutical Co., LTD., Jiangsu Province, Nanjing 210061, China;

  2.Nanjing General Hospital of Nanjing Military Command of PLA, Jiangsu Province, Nanjing 210012, China

  [Abstract] Objective To establish a method of examining bacterial endotoxin for Enoxapain sodium. Methods The reasonable limit of endotoxin was determined by using Chinese Pharmacopoeia (2010 edition, 2 volume), and study on testing for bacterial endotoxin to determine the noninterference concentration for Enoxaparin Sodium. Results The most suitable limit of bacterial endotoxin in preparation for Enoxaparin Sodium was 0.01 EU/U and the TAL of two manufacturers was used to test, and it was proved that the best noninterference concentration was 3 U/mL. Conclusion It is showed that, the method is suitable for the Enoxaparin Sodium of bacterial endotoxin test.

  [Key words] Enoxaparin Sodium; Bacterial endotoxin test; Interference test

  肝斋(heparin)是经猪小肠提的黏多糖类生募化药物,是临床经典的胃肠外面体系运用的抗凝剂,其首要干用机制是按捺凝血X因儿子和经度过与抗凝血酶的彼此干用直接按捺凝血酶。肝

  斋与1916年被发皓,并与1973年代男地运用于临床,肝斋临床上的运用是医学史上划时代意思的事情,肝斋的讯问世也铰进了临床沾顺手工干的展开。当前肝斋在临床上仍普遍地运用于血栓栓塞性疾病、体外面循环、血液透析、经皮冠状触动脉沾顺手治水疗等范畴。条是肝斋鉴于其分儿子量父亲,同时不得不经度过打针给药,会拥有壹定比例的不良反应突发。为了压抑肝斋的缺乏,临床上拥有开收回壹系列的低分儿子肝斋(low-molecular-weight heparin,LMWH)种类,同肝斋比较,低