滋阴补肾丸质量标准研究  

Quality Standard of Ziyin Bushen Pills

作　　者：汪爱霞 孙芸 郭文宾 WANG Aixia;SUN Yun;GUO Wenbin(Gansu Hexi Pharmaceutical Co.Ltd.,Zhangye,Gansu,China 734000;Gansu Zhangye Foodand Drug Inspectionand Testing Center,Zhangye,Gansu,China 734000)

机构地区：[1]甘肃河西制药有限责任公司,甘肃张掖734000 [2]甘肃省张掖市食品药品检验检测中心,甘肃张掖734000

出　　处：《中国药业》2020年第15期51-54,共4页China Pharmaceuticals

摘　　要：目的完善滋阴补肾丸的质量标准。方法采用薄层色谱法对滋阴补肾丸处方中的人参、黄芪、五味子、山药、山茱萸进行定性鉴别,采用高效液相色谱法测定黄芪中黄芪甲苷的含量,用蒸发光散射检测器检测,雾化器温度为99.3℃,气体为氮气,流速为2.7 L/min,采用外标二点法对数方程计算含量。结果薄层色谱图斑点清晰,阴性对照无干扰;黄芪甲苷进样量在11.31~67.86μg,r=0.9990(n=6)范围内与峰面积线性关系良好;平均加样回收率为97.64%,RSD为1.70%(n=9)。结论该方法专属性强、重复性好,可为建立滋阴补肾丸的质量标准提供参考。Objective To improve the quality standard of Ziyin Bushen Pills.Methods Qualitative identification of ginseng,schisandra,yam,and cornus in the prescription of Ziyin Bushen Pills was conducted by thin layer chromatography(TLC);determination of astragalosideⅣin astragalus was conducted by high performance liquid chromatography(HPLC).Detection was done by evaporative light scattering detector;the atomizer temperature was 99.3℃,the gas was nitrogen and the flow rate was 2.7 L/min;the external standard two-point method was used to calculate the content by the logarithmic equation.Results TLC showed clear spots,with no interference with the negative contrast;the injection volume of astragalosideⅣin the range of 11.31-67.86μg had a good linear relationship with the peak area(r=0.9990),and the average sample recovery was 97.64%,the RSD was 1.70%(n=9).Conclusion This method is highly specific and reproducible,which can provide a reference for establishing the quality standard of Ziyin Bushen Pills.

关 键 词：滋阴补肾丸 薄层色谱法 高效液相色谱-蒸发光散射检测器法 黄芪甲苷 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]