复方黄芪胶囊的制备及质量控制

目的:制备复方黄芪胶囊并建立其质量控制方法。方法:采用薄层色谱法定性鉴别方中主药西洋参和山茱萸;采用高效液相色谱-蒸发光散射法测定主药黄芪中黄芪甲苷的含量。结果:薄层定性条件适合,斑点清晰;黄芪甲苷检测线性范围为2.8μg～8.4μg(r=0.9999),平均回收率为99.93%,RSD=1.17%。结论:该制剂制备工艺简单,质量稳定,定量控制方法简便、准确,精密度高。

Preparation and Quality Control of Compound Astragali Capsule

OBJECTIVE:To prepare compound astragali capsules and to establish its quality control standards.METHˉODS:The qualitation identification of the principal agents like American ginseng and asiatic cornelian cherry fruit were deˉtermined by TLC;the principal agent-astragalosideⅠin the astragali were identified by HPLC-ELSD.RESULTS:The condition for TLC qualitation was feasible and the spots were clear;good linear relationship was achieved when the detection concentration of astragalosideⅠwas within the range of2.8μg～8.4μg(r=0.9999);the average recovery was99.93%,RSD=1.17%.CONCLUSION:The preparing technique of this preparation was simple and the quality was stable,the quanˉtitation control method is simple,accurate and with high precision.