摘要
目的研究盐酸氯丙嗪注射液对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准。方法参照《中国药典》2005年版二部附录XIE细菌内毒素检查法进行实验,应用两个生产厂家的鲎试剂对两个厂家的盐酸氯丙嗪注射液进行干扰试验研究。结果盐酸氯丙嗪注射液对细菌内毒素检查有干扰作用,但通过盐酸三羟甲基氨基甲烷(Tris)缓冲液(pH7.2)稀释可消除干扰。结论该制剂可以用细菌内毒素检查法(凝胶法)代替兔热原检查法控制其产品质量。
Objective To study the interferential effect of Chlorpromazine Hydrochloride Injection on bacterial endotoxin test and to establish bacterial endotoxin test method for the sample. Methods According to China Pharmacopoeia 2005, inhibition and enhancement test was performed with amebocyte lysate manufactured by two different companies in Chlorpromazine Hydrochloride Injection manufactured by two different companies. Results The injection can interfere to the bacterial endotoxins test,but the inhibition effect can be eliminated by appropriate dilution with Tris Buffer Solution （pH7.2）. Conclusions The results suggest that Bacterial Endotoxins test （gel-clot method） can be used as an alternative method for the rabbit pyrogen test for Chlorpromazine Hydrochloride Injection.
出处
《药品评价》
CAS
2006年第3期191-194,共4页
Drug Evaluation
关键词
盐酸氯丙嗪注射液
细菌内毒素
干扰试验
Chlorpromazine Hydrochloride Injection
bacterial endotoxin
interference test
