特异性鲎试剂检测人参多糖注射液中的细菌内毒素

尹银嘉;商小曼;

中国药学杂志 ›› 2002, Vol. 22 ›› Issue (11) : 677-679.

中国药学杂志 ›› 2002, Vol. 22 ›› Issue (11) : 677-679.
研究论文

特异性鲎试剂检测人参多糖注射液中的细菌内毒素

  • 尹银嘉;商小曼;
作者信息 +

Bacterial endotoxin test for Renshen Duotang injection

  • YIN Yin-Jia;SHANG Xiao-Man;
Author information +
文章历史 +

摘要

目的:建立快速的人参多糖注射液细菌内毒素检查法。方法:用特异性鲎试剂对不同批号的人参多糖注射液分别进行干扰试验,考察确立人参多糖注射液内毒素检查法。结果:将人参多糖注射液稀释25倍利用特异性鲎试剂检测可消除干扰作用,结果准确可靠。结论:选用特异性鲎试剂,细菌内毒素检查法代替人参多糖注射液热原检查是可行的。

Abstract

OBJECTIVE To study the bacterial endotoxins test of Renshen Duotang Injection using limulus lysate agent. METHODS To find the maximum valid dilution(MVD) according to inhibition test.RESULTS Using the especral limulus lysate agent, the bacterial endotoxins test is viable to replace the house rabit test.CONCLUSIONS When the limulus lysate's sensitivity(λ) is 0.5 EU·mL-1,the maximum valid dilution is 1∶25, the interference between the sample and the relative TAL is eliminable. And the result of bact erialendotoxins test is the same as that of pyrogen test with healthy mature rabbits.

关键词

人参多糖注射液 / 细菌内毒素 / 鲎试剂

Key words

Renshen Duotang injection / bacterial endotoxin / limulus lysate agent

引用本文

导出引用
尹银嘉;商小曼;. 特异性鲎试剂检测人参多糖注射液中的细菌内毒素[J]. 中国药学杂志, 2002, 22(11): 677-679
YIN Yin-Ji;SHNG Xio-Mn;. Bacterial endotoxin test for Renshen Duotang injection[J]. Chinese Pharmaceutical Journal, 2002, 22(11): 677-679

参考文献

[1] 中国药典.二部[S].2000.附录86. [2] 于庆华.右旋糖酐20葡萄糖注射液细菌内毒素检测[J].药物分析杂志,2001,21(4). [3] 黄清泉,夏振民.药品细菌内毒素检查的实验设计[J].中国药学杂志,1997,32(2)∶72.

21

Accesses

0

Citation

Detail

段落导航
相关文章

/