肝炎灵注射液的生物活性测定方法研究  

Determination of Bioactivity in Ganyanling Injection

作　　者：潘善庆[1] 田洪[1] 陈子渊[1] 欧阳杰湖[1] 

机构地区：[1]湖南省药品检验所,长沙410001

出　　处：《中国药品标准》2009年第4期264-268,共5页Drug Standards of China

摘　　要：目的:建立肝炎灵注射液生物活性的测定方法,以探讨用生物活性测定控制其质量的可行性。方法:测定CCl4肝损伤小鼠ALT水平,并对模型的影响因素进行研究,比较了同一厂家多批样品和不同厂家样品的生物活性。结果:雄性小鼠ig0.1%CCl4造模,并于造模后于1、24、48h分别ip肝炎灵注射液5mg·kg-1。给药组与模型组比较,ALT均明显降低。同时两个厂家8个批号肝炎灵注射液均显示出生物活性。结论:生物活性测定能有效控制肝炎灵注射液的内在质量。Objective： To establish determination method of bioactivity in Ganyanling Injection, and investigate the application of controlling qualities through measuring bioactivity. Methods：To select the models of liver injury in mites by CCl4 and determinate ALT level in those mices, compare bioaetivity of batches of samples from the same and different manufactures. Results： After modeled by i.g. 0.1% CCl4 in male mice, in 1, 24, 48 hours treated with 5 mg · kg^ - 1 Ganyanling Injection through i. p. for three times, respectively. The experimental results showed that the serum ALT activity were markedly decreased in Ganyanling group compared with model group, and eight samples from two manufacturers had bioactivity. Conclusion：Measuring bioactivity can effectively control intrinsic quality in Ganyanling Injection.

关 键 词：肝炎灵注射液 生物活性测定 质量控制 

分 类 号：R392-33[医药卫生—免疫学] R512.62[医药卫生—基础医学]