在醒脑静注射液质量标准中建立“生物活性测定”项的研究

Research on establishing bioactivity assay in the quality specification of Xingnaojing injection

目的:对不同厂家生产的醒脑静注射液的生物活性进行了比较,以探索醒脑静注射液质量标准中建立"生物活性测定"项目的必要性和可行性。方法:选择与该样品功能主治相关的主要药效学试验方法,即对戊巴比妥钠诱导小鼠睡眠的拮抗作用及对盐酸二甲福林致小鼠惊厥的影响。结果:在相同的检测限值下,不同厂家生产的不同规格的样品"生物活性测定"存在明显差异。结论:醒脑静注射液质量标准中建立生物活性测定项是可行的。

Objective： To compare bioactivity of Xingnaojing injections produced by different manufacturers, and study the necessity and feasibility in quality specification of Xingnaojing injection through establishing bioactivity assay. Methods： To select two experiments which are effect on sleep period of mice by Pentobarbital Sodium and effect on convulsions of mice by dimefine hydrochloride injection. Results：According the same measuring limited dose, Xingnaojing injection which were produced by different manufacturers, there bioactivity show a difference significantly. Conclusions： Establishing bioactivity determination is feasibility in quality standards of Xingnaojing injection.