碘[^131I]爱克妥昔单抗注射液细菌内毒素检查方法建立

为建立碘[^131I]爱克妥昔单抗注射液的细菌内毒素检查方法,采用《中国药典》二部细菌内毒素检查法进行实验。结果表明,将供试品稀释10倍、20倍、40倍进行细菌内毒素检查均存在干扰;对供试品稀释80倍进行检查或采用抗增液复溶鲎试剂,再将供试品稀释20倍进行检查,均无干扰。供试品的细菌内毒素检查可采用将供试品至少稀释80倍进行检验的方法;也可采用抗增液复溶鲎试剂,将供试品稀释至少20倍进行检查。结果表明,直接稀释法为产品检验的首选方法。...

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Bibliographic Details
Published in同位素 Vol. 28; no. 3; pp. 135 - 139
Main Author 孙祥敏 张云 张先 杨薇薇 蔡海燕
Format Journal Article
LanguageChinese
Published 原子高科股份有限公司,北京,102413%上海海抗中医药科技发展有限公司,上海,201318 2015
Subjects
干扰实验
碘[^131I]爱克妥昔单抗注射液
细菌内毒素检查
bacterial endotoxin test
interference test
细菌内毒素检查
iodine [131I]actuximab injection
碘131I爱克妥昔单抗注射液
干扰实验
Online AccessGet full text
ISSN1000-7512
DOI10.7538/tws.2015.28.03.0135

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Summary:为建立碘[^131I]爱克妥昔单抗注射液的细菌内毒素检查方法,采用《中国药典》二部细菌内毒素检查法进行实验。结果表明,将供试品稀释10倍、20倍、40倍进行细菌内毒素检查均存在干扰;对供试品稀释80倍进行检查或采用抗增液复溶鲎试剂,再将供试品稀释20倍进行检查,均无干扰。供试品的细菌内毒素检查可采用将供试品至少稀释80倍进行检验的方法;也可采用抗增液复溶鲎试剂,将供试品稀释至少20倍进行检查。结果表明,直接稀释法为产品检验的首选方法。
Bibliography:11-2566/TL
iodine [^131I] actuximab injection; bacterial endotoxin test ; interference test
To establish a method for the bacterial endotoxin test of Iodine [^131I] Actuximab Injection,The experiment was carried out according to the appendix XIE in Vol. II of the 2010 version of Chinese Pharmacopoeia. The results demonstrated that the preparation interfered with the test at 10 times, 20 times and 40 times dilution,and the interference can be eliminated after the sample was diluted to 80 times or the sample was diluted to 20 times with the endotoxin-specific buffer dissolving the Tachypleus Amebocyte Lysate. Two methods can be used to test the bacterial endotoxin of Iodine [^131I] Actuximab Injection. One is the sample should be diluted to atleast 80 times,the other is the sample was diluted to 20 times with the endotoxin-specific buffer dissolving the Tachypleus Amebocyte Lysate. The dilution method is the preferred method for the quality control.
SUN Xiang-min, ZHANG Yun , ZHANG Xian , YANG Wei-wei , CAI Hai-ya
ISSN:1000-7512
DOI:10.7538/tws.2015.28.03.0135