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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 the biological activity of Xingnaojing injection produced by different manufacturers in order to explore the necessity and feasibility of establishing the “bioactivity assay” project in the quality standard of Xingnaojing injection. Methods: The main pharmacodynamic test methods related to the main function of the sample were selected, that is, the antagonistic effect on pentobarbital sodium-induced mouse sleep and the effect on the convulsion of metformin hydrochloride-induced mice. Results: Under the same detection limit, there are obvious differences between samples of different specifications produced by different manufacturers. Conclusion: It is feasible to establish the bioassay in Xingnaojing injection quality standard.