红花配方颗粒质量标准研究

Study on Quality Standards for Honghua Dispensing Granules

目的:建立红花配方颗粒的质量标准。方法:采用薄层色谱法对红花配方颗粒进行定性鉴别;采用高效液相色谱法对红花配方颗粒中的羟基红花黄色素A进行含量测定。结果:定性鉴别薄层色谱特征明显,专属性强;含量测定方法在0.091～3.64μg/mL内呈良好的线性关系(r=0.9995),平均回收率为100.8%(RSD%=1.79%,n=6)。结论:本方法可行,重复性好,能有效地控制该中药配方颗粒的质量。

Objective：To establish the quality standard for honghua dispensing granules, Methods. Honghua dispensing granules was identi- fied by TLC. Hydroxysafflor yellow A could be determined by HPLC. Results： The quality control study showed that the characteristic for i- dentification by TLC was distinct and highly specific; Hydroxysafflor yellow A in honghua dispensing granules was determined. The linear relationship of hydroxysaffior yellow A was at the range of 0. 091~3.64μg/mL（r=0. 9995） ,The average recovery was 100.8% （RSD%= 1.79%, n= 6）. Conclusion：The method is available with a good reproducibility and can control the quality effectively.