摘要
目的建立复方毛冬青注射液细菌内毒素的检查方法(BET法)。方法按照《中国药典》2000年版二部的规定,对复方毛冬青注射液进行BET法(λ=0.25Eu/mL的TAL)的干扰试验。结果复方毛冬青注射液及其10,20,30,40倍稀释溶液对BET法有抑制作用,稀释50倍以上可消除干扰;BET法与家兔法的检查结果一致。结论复方毛冬青注射液稀释50倍可用BET法进行细菌内毒素检查,代替家兔法热源检查,用于该制剂的质量控制。
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 (λwas 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.
出处
《中药新药与临床药理》
CAS
CSCD
2004年第2期122-123,共2页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
复方毛冬青注射液
细菌内毒素检查
干扰试验
鲎试剂
Ilex pubescens compound injection
Bacterial endotoxin test
Interference test
Limulus lysate agents
