盐杜仲配方颗粒的质量标准

Quality Standards of Salt Eucommia Dispensing Granules

目的建立杜仲炮制品盐杜仲配方颗粒的质量标准。方法采用醇溶热浸法测定盐杜仲配方颗粒的浸出物,采用高效液相色谱法对盐杜仲配方颗粒中松脂醇二葡萄糖苷进行含量测定,分别对Agilent 1260系列高效液相色谱仪与Waters高效液相色谱仪和不同品牌色谱柱进行考查,建立盐杜仲配方颗粒指纹图谱。结果松脂醇二葡萄糖苷进样量在102.8~2 056.0 mg·L^(-1)与峰面积呈良好线性关系(R^2=0.999 9),标准曲线为:Y=2.959 4X+3.282 5,平均加样回收率为99.85%(RSD=0.31%,n=9)。结论所采用方法可行,重复性好,可有效控制盐杜仲中药配方颗粒的质量。

Objective To establish the quality standards for salt eucommia dispensing granules.Methods The extractives were obtained by alcohol extraction method.HPLC was applied for the determination of pinoresinol diglucoside in dispensing granules.HPLC fingerprints were established by the contrast of Agilent 1260 HPLC,Waters HPLC and various chromatogram column.Results Pinoresinol diglucoside showed a good linear relationship(Y = 2.959 4 X + 3.282 5,R^2=0.999 9) at 102.8-2 056.0 mg·L^(-1) with average recovery of 99.85%(RSD = 0.31%,n = 9).Conclusion The method is easy-operated and accurate,which has a good specificity for the quality control of common salt eucommia dispensing granules.