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在醒脑静注射液质量标准中建立“生物活性测定”项的研究
引用本文:王璐,张红宇,刘勤,赵祎. 在醒脑静注射液质量标准中建立“生物活性测定”项的研究[J]. 药物分析杂志, 2012, 0(2): 341-343
作者姓名:王璐  张红宇  刘勤  赵祎
作者单位:云南省食品药品检验所
摘    要:
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。

关 键 词:中药注射液  醒脑静  质量标准  生物活性测定  标准改进

Research on establishing bioactivity assay in the quality specification of Xingnaojing injection
WANG Lu,ZHANG Hong-yu,LIU Qin,ZHAO Yi. Research on establishing bioactivity assay in the quality specification of Xingnaojing injection[J]. Chinese Journal of Pharmaceutical Analysis, 2012, 0(2): 341-343
Authors:WANG Lu  ZHANG Hong-yu  LIU Qin  ZHAO Yi
Affiliation:(Yunnan Institute for Food and Drug Control,Kunming 650031,China)
Abstract:
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.
Keywords:traditional Chinese medicine injection  Xingnaojing  quality standards  bioactivity determination  standard improvement
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