复方氯解磷定注射液细菌内毒素的检查方法
投稿时间:2007-09-01    点此下载全文
引用本文:高锦,付聪,嵇扬,聂渝琼,胡丹.复方氯解磷定注射液细菌内毒素的检查方法[J].药学实践杂志,2008,(2):133~135
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作者单位
高锦 总后勤部卫生部药品仪器检验所,北京100039 
付聪 中国人民解放军第307医院药学部,北京100071 
嵇扬 总后勤部卫生部药品仪器检验所,北京100039 
聂渝琼 总后勤部卫生部药品仪器检验所,北京100039 
胡丹 总后勤部卫生部药品仪器检验所,北京100039 
中文摘要:目的:建立复方氯解磷定注射液细菌内毒素检查法。方法:采用《中国药典》2005年版附录细菌内毒素检查法。结果:复方氯解磷定注射液稀释至含氯解磷定10 mg/mL及以下浓度时,用灵敏度为0.25 EU/mL的鲎试剂检测细菌内毒素,无干扰因素影响。结论:复方氯解磷定注射液细菌内毒素限值确定为0.2 EU/mg,可应用鲎试剂进行细菌内毒素法检查。
中文关键词:复方氯解磷定注射液  细菌内毒素  干扰试验
 
Application of bacterial endotoxin test to compound pralidoxime chloride injection
Abstract:Objective:To establish an application of bacterial endotoxin test to compound pralidoxime chloride injection.Methods:The expriment was carried out based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition.Results:It was proved that the maximum noninterference concentration of compound pralidoxime chloride injection was pralidoxime chloride 10 mg/mL and the sensitivity of TAL was 0.25 EU/mL.Conclusion:The results suggested that the bacterial endotoxin test was suitable for the detection of endotoxin in compound pralidoxime chloride injection and the bacterial endotoxin limit was 0.2 EU/mg.
keywords:compound pralidoxime chloride injection  bacterial endotoxin test  interfere factors test
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