晶珠肝泰舒胶囊的质量标准研究

Study on quality standard for Jingzhu Gantaishu capsules(Radix Astragali,Herba Hypeco,etc.)

目的 :对晶珠肝泰舒胶囊中的黄芪、节裂角茴香、唐古特乌头等成分进行了薄层鉴别 ,同时测定了该制剂中川西獐牙菜的有效成分芒果苷的含量。方法 :采用TLC和HPLC。在HPLC中色谱柱为C18柱 ,流动相为甲醇 水 (30∶70 ) ,以冰乙酸调 pH值为 4.5 ,检测波长为 2 6 2nm。TLC采用阴阳对照试验 ,对方中的 3种成份进行了确认 ,以达到鉴别的目的。结果 :用HPLC测定芒果苷的含量。芒果苷在 0 .0 5 2～ 0 .1 82 μg·ml-1范围内呈线性关系 ,胶囊中芒果苷的平均回收率为 97.3% ,RSD =1 .5 %。结论 :方法简便、稳定 ,能有效地控制该制剂的质量。

OBJECTIVE:To establish TLC method for the identification of Radix Astragli,Herba Hypecoi,Herba Swertiae and HPLC method for the determination of mangiferin as efficacious composition in the Jingzhu Gantaishu capsules.METHOD:TLC and HPLC were used.The HPLC method was carried on C 18 column using 30% methanol (pH=4.5 adjusted by HAc) as mobile phase.Detector was set at 262 nm.RESULTS:The three medicines contained in the capsules were identified by TLC with contrast experiment.In the HPLC method the calibration curve for mangiferin was linear over the range of 0.052～0.182 μg·ml -1 .The average recovery was 97.3% with RSD =1.5%.CONCLUSION:The method is simple,rapid and reliable for quality control of the capsules.