参芪五味子浓缩丸的制备及质量研究

Preparation and Quality of Shenqi Wuweizi Concentrated Pill

目的制备参芪五味子浓缩丸,建立质量评价方法。方法将药材党参、五味子的细粉及黄芪、酸枣仁、五味子的渗漉液与适量辅料按照浓缩水蜜丸的制备工艺研制。采用薄层色谱法定性鉴别。采用HPLC法测定含量。色谱柱为Hypersil ODS柱（250 mm×4.6 mm,5μm）;流动相：乙腈—水—醋酸（64∶35∶1）;检测波长为249 nm。理论板数按五味子甲素峰计算不低于4 000。结果方法精密度和稳定性良好,五味子甲素在0.181 2~1.208 0μg范围内进样量和峰面积呈良好的线性关系（r=0.999 9）,平均回收率分别为98.3%,RSD=1.19%。结论本法简单、快速、准确,可用于测定参芪五味子浓缩丸的控制质量。

Objective To prepare and establish quality evaluation method of shenqi wuweizi concentrated pill. Methods To grind together the fine powder of lanceolata,schisandra,the percolating liquid of astragalus,spine date seed,schisandra,and auxiliary materials according to the requirement of preparing concentrated honeyed pill. TLC was used to determine the quality and HPLC was used to measure content. Hypersil ODS（250 mm × 4. 6 mm,5 μm） served as the chromatographic column and acetonitrile-water-acetic acid（64： 35： 1） served as the mobile phase. The detection wavelength was 249 nm. Theoretical Plate Number was no less than 4,000 according to the peak value of deoxyschizandrin. Results The method is with precision and stability. There was a good linear relationship between the injection volume and peak area when the deoxyschizandrin was in the range from 0. 1812 μg to 1. 208 0μg（r =0. 999 9）. The average recovery rate is 98. 3%,RSD =1. 19%. Conclusion The method can be used to determine the quality of shenqi wuweizi conterated pill due to its simplicity,rapidness and accuracy.