石斛爽目软胶囊的质量控制方法探讨

Discustion of quality control methods of Shihushuangmu soft capsule

目的探讨石斛爽目软胶囊的质量控制方法。方法采用薄层色谱(TLC)法对石斛爽目软胶囊中的石斛、白芍及柴胡进行定性鉴别,并采用高效液相色谱(HPLC)法测定芍药苷的含量。结果在TLC中能检出石斛碱、芍药苷及柴胡皂苷,芍药苷在0.597～5.629μg(r=0.9995)范围内呈良好的线性关系,平均回收率为98.25%,RSD为1.89%。结论 TLC法和HPLC法可快速、准确地对石斛爽目软胶囊中的成分进行定性、定量检测,可用于该制剂的质量控制。

Objective To study the quality control methods of Shihushuangmu soft capsule.Methods The thin-layer chromatography（TLC） method was used to identify dendrobium,white peony root and bupleurum in Shihushuangmu soft capsules.High performance liquid chromatography（HPLC） was used to determine the content of paeoniflorin.Results The TLC can be used for qualitative identification of dendrobium alkali,paeoniflorin and saikosaponin.A linear range of the detecting concentration of paeoniflorin was within 0.597～5.629μg（r=0.9995）,and it showed good relationship.The average recovery rate was 98.25%,and RSD was 1.89%.Conclusion TLC method and HPLC method can be fast and accurate in qualitative and quantitative detection of the prescription medicines,it can be used for the quality control of the preparation.