利脑心胶囊质量标准的方法学研究

目的建立利脑心胶囊质量标准。方法用薄层色谱法鉴别丹参、甘草;用高效液相色谱法测定葛根素含量,采用C18柱,以甲醇-水(12∶88)为流动相,流速1.0ml/min,检测波长250nm,柱温40.0℃。结果葛根素含量在0.0654～0.327μg呈良好的线性关系,平均回收率99.40%,RSD为1.03%。结论建立的方法简便、重复性好,可作为该制剂的质量控制。

Quality Standard of Linaoxin Capsules: Methodology study

Objective To establish the quality standard for Linaoxin Capsule. Method Radix Salviae Miltiorrhizae,Radix Glycyrrhizae in Linaoxin Capsule were identified by TLC, and puerarin was determined by HPLC. The analysis was carried out on C18 column by HPLC. The mobile phase was Methanol-Water (12∶88). The flow rate was 1.0 ml/min-1 and the detection wavelength was at 250 nm. The column temperature was at 40 ℃. Result The average recovery rate was 99.40% and RSD was 1.03% and the linear range of puerarin was in 0.065 4-0.327 μg. Conclusion This method is simple,rapid with a good reproducibility. This method can be used for the quality control of Linaoxin Capsule.