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依托泊苷注射液细菌内毒素检查法的建立 被引量:1

Establishment of bacterial endotoxins test for etoposide injection
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摘要 目的建立依托泊苷注射液的细菌内毒素检查法。方法按照《中国药典》2010年版二部附录ⅪE细菌内毒素检查法(凝胶法),用两个不同厂家的鲎试剂对3批依托泊苷注射液进行干扰试验和细菌内毒素检查。结果质量浓度为1.0mg/ml的依托泊苷注射液对鲎试剂与细菌内毒素之间的凝集反应有抑制现象,而质量浓度≤0.5 mg/ml的供试品溶液不干扰细菌内毒素检查。结论建立的依托泊苷注射液细菌内毒素检查法可行,样品的细菌内毒素限值为0.5 EU/mg。 Objective To establish a method for determining the bacterial endotoxins in etoposide injection.Methods The interference test and bacterial endotoxin test of 3 batches of etoposide injection were carried out according to the guideline and procedures specified in appendix Ⅺ E of Chinese Pharmacopoeia(2010 edition,volume 2) using tachypleus amebocyte lysates(TAL) produced by two manufactures.Results The agglutination reaction between tachypleus amebocyte lysate and bacterial endotoxins was inhibited by etoposide injection at the concentration of 1.0 mg/ml.However,this inhibition was eliminated at the concentration of no more than 0.5 mg/ml for the samples.Conclusion The established method of bacterial endotoxin test for etoposide injection is feasible and the limit of bacterial endotoxin for samples is 0.5 EU/mg.
出处 《山西医科大学学报》 CAS 2011年第12期972-974,共3页 Journal of Shanxi Medical University
基金 湖北省科技厅科技攻关项目(2002AA301C13)
关键词 细菌内毒素 鲎试剂 依托泊苷注射液 干扰试验 bacterial endotoxins tachypleus amebocyte lysate etoposide injection interference test
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  • 1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. 被引量:9
  • 2蔡彤,张国来,李波,肖华,周建平,周荔,曹春然,金鑫,姜素云,张晓莲,鲁京,张婷婷,李鸣,王江融,刘用国,李瑾翡,周智,陈邦树,游伯享,刘廷快,叶小青,李燕林,韩文华,张黎莉,周继春,徐晓月,李展,周效平,李庆忠,陈志英,牛慧玲,周素文,肖文华,杨雅婷,田洪,欧阳杰湖,梁春华,乔艳玲,卢海霞,汪岱延,陆益红,王秀英,刘彤,王丹,李昇刚,杨晓峰,刘国华,国明,祝清芬,朴晋华,董培智,高天红,阎凌霄,赵玉珍,肖珍,唐黎明,张振宇,马玉萍,张小萍,韩五成,芮菁,孙淑莲,韩晶,苑庆华,高秋芳,叶小敏,黄晓东,郑雨沛,杨林,迪丽努尔,叶青,高菊珍,张红宇,王莉,王璐,姚治,张劲松,匡荣,嵇扬,狄亚敏,姜春来.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. 被引量:34
  • 3马建丽,朴晋华,陈新文,周亮.注射用复方甘草酸苷细菌内毒素检查方法的研究[J].山西医科大学学报,2010,41(12):1047-1049. 被引量:4

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