明丹颗粒的质量标准研究

Study on Quality Standard of Mingdan Granule

目的:建立明丹颗粒的质量标准。方法:采用薄层色谱(TLC)法对制剂中的柴胡、苍术、地黄、丹参、甘草进行定性鉴别;用高效液相色谱法测定丹酚酸B和丹参酮ⅡA的含量。结果:柴胡、苍术、地黄、丹参、甘草的TLC鉴别特征专属性强,阴性对照无干扰。丹酚酸B、丹参酮ⅡA的进样量分别在0.2880～2.8800、0.0352～0.3520μg范围内与各自峰面积积分值呈良好的线性关系(r均为0.9999);二者精密度、稳定性、重复性试验的RSD均<2%;平均加样回收率分别为94.44%、94.85%,RSD分别为1.87%、1.37%(n均为6)。结论:所建标准可用于明丹颗粒的质量控制。

OBJECTIVE： To establish the quality standards of Mingdan granule. METHODS： The identification of Bupleuri Radix,Atractylodis Rhizoma,Rehmannia glutinosa,Salvia miltiorrhiza and Glycyrrhizae Radix et Rhizoma were carried out by TLC. The content of salvianolic acid B and tanshinone ⅡA were determined by HPLC. RESULTS： TLC spots of Bupleuri Radix, Atractylodis Rhizoma,R. glutinosa,S. miltiorrhiza and Glycyrrhizae Radix et Rhizoma were specific without interference from negative control. The linear range of salvianolic acid B and tanshinone ⅡA were 0.288 0-2.880 0 μg and 0.035 2-0.352 0 μg（both r=0.999 9）. RSDs of precision, stability and reproducibility were all lower than 2%; average recovery rates were 94.44%（RSD=1.87%, n=6） and 94.85%（RSD=1.37%,n=6）. CONCLUSIONS： Established standard can be used for the quality control of Mingdan granule.