高三尖杉酯碱注射液细菌内毒素检查法的建立
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摘要
目的建立高三尖杉酯碱注射液中细菌内毒素的检测方法。方法参照2010年版《中国药典》二部细菌内毒素检查方法,采用鲎试剂法对3批高三尖杉酯碱注射液进行干扰实验研究。结果高三尖杉酯碱注射液经150倍稀释后,用灵敏度λ为0.5EU.mL-1的鲎试剂进行实验,供试品不干扰细菌内毒素检查。结论建立的高三尖杉酯碱注射液细菌内毒素检查法可行,具有简便、快捷、可靠等优点。
Objective To establish a method for the detection of bacterial endotoxins in Homoharringtonine Injections.Methods The interference experiments of 3 batches of Homoharringtonine Injections were carried out according to bacterial endotoxins test specified in appendix Ⅺ E,volume two,Chinese Pharmacopoeia 2010 edition using tachypleus amebocyte lysates(TAL).Results By using tachypleus amebocyte lysates whose sensitivity was 0.5 EU·mL-1,the sample did not interfere with the bacterial endotoxins test when it was diluted 150 times.Conclusion The established method of bacterial endotoxin test for Homoharringtonine Injections is feasible,simple,rapid and reliable.
Objective To establish a method for the detection of bacterial endotoxins in Homoharringtonine Injections.Methods The interference experiments of 3 batches of Homoharringtonine Injections were carried out according to bacterial endotoxins test specified in appendix Ⅺ E,volume two,Chinese Pharmacopoeia 2010 edition using tachypleus amebocyte lysates(TAL).Results By using tachypleus amebocyte lysates whose sensitivity was 0.5 EU·mL-1,the sample did not interfere with the bacterial endotoxins test when it was diluted 150 times.Conclusion The established method of bacterial endotoxin test for Homoharringtonine Injections is feasible,simple,rapid and reliable.
引文
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[2]国家药典委员会.中国药典2010年版[S].二部.北京:中国医药科技出版社,2010:附录99-102.
[3]中国药品生物制品检定所.中国药品检验标准操作规范[M].北京:中国医药科技出版社,2005:287-302.
[4]吴婷,李薇.单硝酸异山梨酯注射液细菌内毒素检查法研究[J].中国医药导报,2010,7(12):68-70.
[5]李薇,吴婷.注射用葛根素的细菌内毒素检查法可行性研究[J].中国医药导报,2010,7(5):57-59.
[6]陈丹丹,黄清泉,王春仁.医用聚乙二醇小檗碱液的细菌内毒素检测[J].药物分析杂志,2009,29(10):1762-1764.
[7]潘卫松,肖瑛,潘建明.荧光素钠注射液细菌内毒素检查法的研究[J].中国药房,2009,20(13):1010-1012.
[8]张德波,仲华.注射用水溶性维生素细菌内毒素检查法质量标准研究[J].中国药品标准,2008,9(3):198-201.
[9]蔡彤,张国来,李波,等.84种注射用药品细菌内毒素检查法的方法学研究[J].中国药学杂志,2010,45(2):150-155.
[10]陈芳,沈伟,赵宏伟,等.亮菌甲素注射液细菌内毒素检查研究[J].西北药学杂志,2009,24(4):283-284.