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消栓口服液质量标准的研究
引用本文:王志君,张润祥. 消栓口服液质量标准的研究[J]. 内蒙古医学杂志, 2010, 42(8): 900-903
作者姓名:王志君  张润祥
作者单位:内蒙古自治区食品药品检验所,内蒙古,呼和浩特,010020
摘    要:目的:制订消栓口服液的质量控制方法。方法:采用TLC法对处方中的赤芍、当归、川芎进行了定性鉴别,采用HPLC法对处方中黄芪进行了含量测定,以CAPCELL PAK C18柱(250 mm×4.6 mm,5μm)为分析柱,以乙腈-水(35∶65)为流动相,流速为1.0 ml/min,蒸发光散射检测器。结果:赤芍、当归、川芎可用薄层色谱鉴别;黄芪甲苷进样量在1.2795~12.795μg范围内进样量的自然对数与峰面积的自然对数呈良好的线性关系(r=0.9998);平均回收率(n=9)为101.25%,RSD为1.91%。结论:该方法准确灵敏、简便,重复性好,提高后的质量标准更有效的控制该制剂的质量。

关 键 词:消栓口服液  质量标准  薄层色谱  黄芪甲苷  高效液相色谱

Study on Quality of Xiaoshuan oral Liquid
WANG Zhi-jun,ZHANG Run-xiang. Study on Quality of Xiaoshuan oral Liquid[J]. Inner Mongolia Medical Journal, 2010, 42(8): 900-903
Authors:WANG Zhi-jun  ZHANG Run-xiang
Affiliation:WANG Zhi-jun ZHANG Run-xiang(Inner Mongolia for Food and Drug Control,Huhhot 010020 China)
Abstract:Objective:To establish the method for quality control of Xiaoshuan oral liquid.Methods:Radix paeoniae rubra ,Radix angelicae sinensis and Rhizoma chuanxiong in Xiaoshuan oral liquid were identified by TLC,Astragaloside Ⅳ was determined by HPLC.A CAPCELL PAK C18 column(250 mm×4.6 mm,5 μm)was adoped.The mobile phase was acetonitrile-water(35∶65),at the flow rate of 1.0 ml/min and ELSD.Results:The linearity was obtained within the range of(1.2795~12.795) μg(r=0.9998);The average recovery(n=9) was 101.25%,and RSD was 1.91%.Radix paeoniae rubra,Radix angelicae sinensis and rhizoma chuanxiong can be identified by TLC.Conclusion:The method is convenient,accurate,reproducible,and can be used for quality control of the preparation.
Keywords:Xiaoshuan oral liquid  Quality control  TLC  Astragaloside Ⅳ  HPLC
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