舒冠胶囊质量标准研究

Quality Standards of Shuguan Capsules

目的:建立舒冠胶囊的质量标准。方法:采用薄层色谱(TLC)法鉴别处方中何首乌、川芎、丹参;用高效液相色谱(HPLC)法测定丹参中丹参素钠的含量。结果:TLC中能检出何首乌、川芎、丹参,色谱斑点清晰,阴性无干扰;丹参素钠的检测浓度在0.51～8.16μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9994),平均回收率为100%,RSD=1.23%(n=6)。结论:所建标准可用于舒冠胶囊的质量控制。

OBJECTIVE：To establish the quality standards of Shuguan capsules. METHODS：Polygonum multiflorum, Ligusticum chuanxiong, Salvia miltiorrhiza were identified by TLC. The content of salvianic acid was determined by HPLC. RESULTS：P. multiflorum, L. chuanxiong, S. miltiorrhiza could be detected by TLC. TLC spots were clear and the negative sample was no interference. The linear range of salvianic acid was 0.51～8.16 μg·mL-1（r=0.999 4）with an average recovery of 100%（RSD=1.23%, n=6）. CONCLUSION： Established standard is suitable for the quality control of Shuguan capsules.