抑舒胶囊质量标准的研究

Studies on Quality Standard of Yishu Capsules

目的建立抑舒胶囊的质量标准。方法采用薄层色谱法对制剂中红花、枳壳、黄连、白芥子进行定性鉴别,采用高效液相色谱法对制剂中柚皮苷进行定量分析。结果薄层色谱法均能对红花、枳壳、黄连、白芥子进行专属性分析;柚皮苷进样量在0.4851～2.911μg范围内呈良好的线性关系,r=0.9998;平均回收率为103.1%,RSD=2.5%(n=5)。结论该方法可准确地进行定性、定量检测,且专属性强、灵敏度高,重复性好,可用于抑舒胶囊的质量控制。

Objective To establish quality standard of Yishu capsules. Methods TLC method was used to identify Carthamus Tinctorius, Pefiearpium Citri Reticulatae, Coptis chinensis Franch and Semen Sinapis Aibae in the preparation. HPLC method was used to determine the content of naringin in Yishu capsules. Results TLC method could provide distinguishing analysis of Carthamus tinctorius, Pefiearpium Cirri Retieulatae, Coptis chinensis Franch and Semen Sinapis Aibae. The sampling content of naringin showed the good linear relationship in the range of 0.485 1 -2.911μg（ r = 0. 999 8 ）and the average recovery was 103. 1% ,RSD was 2.5 % （ n = 5 ）. Conclusion This method can provide precise qualitative and quantitative determination and is strong in specificity, high in sensitivity and good in repeatability. This method can be used in quality control of Yishu Capsules.