参木肠溶胶囊的质量标准研究

目的：建立参木肠溶胶囊的质量控制方法。方法：采用薄层色谱法（TLC）对制剂中木香、白芍、茯苓进行定性鉴别;采用高效液相色谱法（HPLC）测定制剂中盐酸小檗碱的含量。结果：TLC法可专属性地鉴别木香、白芍、茯苓,且特征斑点清晰,阴性对照无干扰。含量测定结果显示,盐酸小檗碱在0.028-0.28μg范围内线性关系良好,r=0.9995;平均加样回收率为100.81%,RSD为1.65%。结论：所建立的方法简便可行、重复性好,可有效控制参木肠溶胶囊的质量。

Study on quality standard for Shenmu entericcoated capsules

Objective： To establish the quality control method for Shenmu entericcoated capsules. Methods： Thin -layer chromatography（TLC）was used to identify Saussurea costus ,Radix Paeoniae Alba ,and Poria cocos in the capsules. High -performance liquid chromatography was used to determine the content of berberine hydrochloride in capsules. Results： Saussurea costus, Radix Paeoniae Alba, and Poria cocos could be specifically identified by TLC, with clear characteristic spots, and the negative control had no interference. The content of berberine hydrochloride had a good linear relationship with the peak area within 0. 028 - 0. 28 Ixg （ r = 0. 9995 ）. The average recovery rate was 100. 81% ,with a relative standard deviation of 1.65%. Conclusion： The established method is simple,feasible, and repeatable, and can be used for effectively controlling the quality of Shenmu enteric -coated capsules.