Bacterial Endotoxins Test for Ilex Pubescens Compound Injection
- VernacularTitle:复方毛冬青注射液的细菌内毒素检查
- Author:
Yi ZHUO
;
Yue HUANG
;
Yilu CHEN
- Publication Type:Journal Article
- Keywords:
Ilex pubescens compound injection;
Bacterial endotoxin test;
Interference test;
Limulus lysate agents
- From:
Traditional Chinese Drug Research & Clinical Pharmacology
1993;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for the determination of bacterial endotoxin in Ilex pubescens compound injection(LPCJ) .Methods According to China Pharmacopoeia (second part,2000),interference test was carried out to detect the endotoxins in LPCJ with limulus lysate agents (?was 0.25 EU/mL).Results Inhibition action was found in bacterial endotoxin test for LPCJ and in the 10-,20-,30-and 40-fold diluted liquid of LPCJ.It was proved that the maximum noninterference concentration was the 50-fold dilution.The inspection results are the same as that of rabbit pyrogen test.Conclusion The 50-fold diluted LPCJ is suitable for the determination of bacterial endotoxin and can be used as the quality control standard for its preparation.
