元胡止痛胶囊的制备及质量标准研究

目的制备元胡止痛胶囊并探讨其质量标准。方法用蒸馏法提取白芷中挥发油,用回流法提取延胡索与白芷药渣;用薄层色谱法对延胡索、白芷作定性鉴别;用高效液相色谱法测定制剂的延胡索乙素含量。结果在薄层色谱中可检出延胡索、白芷的特征斑点,阴性对照无干扰;延胡索乙素质量浓度在1.0～45.0μg/mL范围内与峰面积线性关系良好（r=0.999 9）,平均回收率为100.23%,RSD为0.83%（n=6）。结论所用制备方法合理,定性鉴别和定量方法专属性强,可用于元胡止痛胶囊的质量控制。

Study on Preparation and Quality Control of Yuanhu Anodyne Capsule

Objective To study the preparation and quality control method of Yuanhu Anodyne Capsule.Methods The volatile oil in Angelica dahurica was extracted by distillation method and the residues of Corydalis tuber and Angelica dahurica were extracted by reflux method.The thin layer chromatography（TLC） was used to qualitatively identify Corydalis tuber and Angelica dahurica.HPLC was used to determine the content of tetrahydropalmatine.Results The characteristic spots of Corydalis tuber and Angelica dahurica can been checked by TLC without the interference of negative control.The calibration curves of tetrahydropalmatine were linear within the range of 1.0-45.0 μg/mL（r = 0.999 9）;the average recovery rate was 100.23%（RSD = 0.83%）.Conclusion The preparation technology is reasonable with good specificity of qualitative and quantitative identification.The standard can provide a reference for the quality control of the capsule.