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
分类号：
出版年·卷·期（页码）：2012,32 (2):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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。
-----英文摘要：---------------------------------------------------------------------------------------
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.
-----参考文献：---------------------------------------------------------------------------------------
[1] ZHANG Lu-han(张路晗),XIANG Jin-lian(向金莲),CHENG Rui(程睿),et al.Pharmacodynamics study of Xingnaojing injection(醒脑静注射液的药效学研究).West Chem J Pharm Sci(华西药学杂志),2001,16(6):429
[2] MIAO Ming-san(苗明三).The effect on central nervous system of Xingnaojing injection(醒脑静注射液对中枢神经系统的影响).Pharmacol Clin Chin Mater Med(中药药理与临床),2004,20(3):42
[3] TANG Yuan-tai(唐元泰),RUI Qing(芮箐).To suggest the biological activity determination adopted in the TCM standards(关于中药标准采用"生物活性测定"项目的建议).Drug Stand China(中国药品标准),2007,8(6):39
[4] XU Shu-yun(徐叔云),BIAN Ru-lian(卞如濂),CHEN Xiu(陈修).Experimental Methodology of Pharmacology(药理实验方法学).Beijing(北京):People’s Medical Publishing House(人民卫生出版社).2002.801,813
[5] ChP(中国药典).2010.Vol Ⅰ(一部):132
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