复方乳酸钠注射液3号细菌内毒素检查方法的研究  

Research on bacterial endotoxin test for compound sodium lactate injection No.3

作　　者：付聪[1] 高锦[2] 嵇杨[2] 聂渝琼[2] 程洋[2] 付晓菲[2] 

机构地区：[1]解放军第307医院药学部,北京100071 [2]总后勤部卫生部药品仪器检验所,北京100071

出　　处：《药学实践杂志》2011年第2期120-121,148,共3页Journal of Pharmaceutical Practice

摘　　要：目的建立军队医院制剂复方乳酸钠注射液3号细菌内毒素检查方法。方法采用2005年版中国药典附录细菌内毒素检查法,以不同厂家的鲎试剂对2批复方乳酸钠注射液3号分别进行下扰试验。结果将复方乳酸钠注射液3号稀释为2倍稀释液后,用灵敏度为0.25EU/ml的鲎试剂进行干扰试验,结果对鲎试剂与细菌内毒素的凝胶反应无增强、抑制干扰。结论内毒素限值确定为0.5EU/ml时,可应用鲎试剂进行细菌内毒素法检查。该方法准确、可靠,可代替家免法检查该注射剂的热原。建议《中国人民解放军医疗机构制剂规范》再版时将家免法改为细菌内毒素法。Objective To establish the method of bacterial endotoxin test for compound sodium lactate injection No.3.Methods The method based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition was used.Results Neither inhibition nor enhancement was found in the bacterial eddotoxin interfere factors test after the drug was diluted and the sensitivity of TAL was 0.25 EU/ml.Conclusion The results suggested that bacterial endotoxin test was suitable for the detection of endotoxin in compound sodium lactate injection No.3 and the bacterial endotoxin limit is 0.5 EU/ml

关 键 词：复方乳酸钠注射液3号 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]