目的:建立花红胶囊的质量控制方法。方法:采用TLC法对花红胶囊中红花、伸筋草进行定性鉴别;用HPLC法测定胶囊剂中羟基红花黄色素A的含量。结果:各供试品TLC在与对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;羟基红花黄色素A进样量在0.321~1.605μg范围内线性关系良好,r=0.9999,平均回收率为103.67%,RSD%值为1.45%(n=6)。结论:本法操作简单,重复性好,能够有效地控制花红胶囊的质量。 Objective: To establish the quality control method of Huaxin capsule. Methods: The TLC method was used to qualitatively identify safflower and sassafra in Huagong capsules. The content of safflower yellow A in capsules was determined by HPLC. Results: TLC for each test showed spots of the same color on the position corresponding to the reference drug, with no interference in the negative control. The linearity of hydroxysafflor yellow A injection in the range of 0.321 ~ 1.605 μg was good, r = 0.9999, The average recovery was 103.67% and the RSD% was 1.45% (n = 6). Conclusion: This method is simple, reproducible, and can effectively control the quality of the capsule.