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薄芝糖肽注射液细菌内毒素检查法可行性研究
引用本文:丁苏苏,李倚云,董登存. 薄芝糖肽注射液细菌内毒素检查法可行性研究[J]. 海峡药学, 2009, 21(11): 60-62
作者姓名:丁苏苏  李倚云  董登存
作者单位:江苏扬州药品检验所,扬州,225000;江苏扬州药品检验所,扬州,225000;江苏扬州药品检验所,扬州,225000
摘    要:目的研究薄芝糖肽注射液细菌内毒素检查法的可行性。方法用不同厂家生产的鲎试剂对薄芝糖肽注射液进行细菌内毒素检查法干扰试验。结果薄芝糖肽注射液在稀释120倍后对灵敏度为0.25EU.mL^-1的鲎试剂无干扰作用。结论薄芝糖肽注射液可以用内毒素检查法取代热原检查法。

关 键 词:薄芝糖肽注射液  鲎试剂  细菌内毒素检查  干扰试验

Study on the bacterial endotoxin test of Bozhi glycopeptide injection
DING Su-su,LI Yi-yun,DONG Deng-cun. Study on the bacterial endotoxin test of Bozhi glycopeptide injection[J]. Strait Pharmaceutical Journal, 2009, 21(11): 60-62
Authors:DING Su-su  LI Yi-yun  DONG Deng-cun
Affiliation:(Yangzhou Institute for Drug Control, Yangzhou 225000, China)
Abstract:OBJECTIVE To study the bacterial endotoxin test of Bozhi glycopeptide injection.METHODS The interference test of Bozhi glycopeptide injection were performed with TAL provided by different factories.RESULTS After diluted 120 times,Bozhi Glycopeptide injection has no interference to TAL (0.25 EU·mL^-1).CONCLUSION Bozhi glycopeptide injection can be examined by bacterial endotoxin test instead of the pyrogen test.
Keywords:Bozhi glycopeptide injection  Bacterial endotoxin  Tachypleus Amebocyte Lysate  Interference test
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