复方二氯醋酸二异丙胺注射液的细菌内毒素检查法研究.pdfVIP

复方二氯醋酸二异丙胺注射液的细菌内毒素检查法研究 ＊ 刘 春 ，赵毓梅，郑 霞（海南省药品检验所，海口 570216） + 中图分类号 R927.12；R975.5 文献标志码 A 文章编号 1001-0408（2014）01-0080-02 DOI 10.6039/j.issn. 1001-0408.2014.01.29 摘 要 目的：建立复方二氯醋酸二异丙胺注射液的细菌内毒素检查方法。方法：按2010年版《中国药典》（二部）附录细菌内毒 素检查法，采用2个厂家不同规格的鲎试剂对4个厂家7批样品进行干扰试验和细菌内毒素检查。结果：本品原液稀释2倍以上时 对细菌内毒素检查法无干扰作用；按拟定标准，4个厂家7批样品均符合规定。结论：采用本文建立的细菌内毒素检查法检查复方 二氯醋酸二异丙胺注射液方法可行，其细菌内毒素的限值确定为0.5EU/ml 。 关键词 复方二氯醋酸二异丙胺注射液；细菌内毒素检查法；鲎试剂 Study on Bacterial Endotoxins Test of Compound Diisopropylamine Dichloroacetate Injection LIU Chun ，ZHAO Yu-mei ，ZHENG Xia （Hainan Provincial Institute for Drug Control ，Haikou 570216，China ） ABSTRACT OBJECTIVE ：To establish a method for bacterial endotoxin test of Compound diisopropylamine dichloroacetate in- jection. METHODS ：According to the bacterial endotoxin test stated in Chinese Pharmacopeia （2010 edition）Ⅱ，interference test and bacterial endotoxin test were carried out by using tachypleus amebocyte lysate （TAL ）with different specifications from 2manu- facturers for 7 bacthes of Compound diisopropylamine ascorbate injection from 4 manufacturers. RESULTS ：No interference was found in the bacterial endotoxin test after the sample was diluted over 2-fold. The results of bacterial endotoxin test of 7 bacthes from 4 manufacturers were all accorded with the standard of the quality control. CONCLUSIONS ：Established method is feasible for quality control of Compound diisopropylamine dichloroacetate injection. The endotoxin limit of it is 0.5EU/ml. KEYWORDS Compound diisopropylamine dichloroacetate injection ；Bacterial endotoxin test ；Tachypleus amebocyte lysate 复方二氯醋酸二异丙胺注射液临床主要用于急慢性肝 按规定的给药途径人用每千克体质量每小时最大可接受的内 炎、肝肿大、早期肝硬化的辅助治疗，亦可用于脂肪肝、肝内胆 毒素剂量，注射剂K ＝5EU/ （kg ·h ）；M 为人用每千克体质量每 [1]