复方田七益智颗粒提取工艺及质量标准研究

Extraction Techniques and Quality Standards of Compound Tianqi Yizhi Granule

目的优选复方田七益智颗粒的最佳提取工艺,并建立其质量标准。方法以总皂苷的得率为指标,运用正交试验优选复方田七益智颗粒最佳提取工艺。用TLC法对制剂中三七、人参进行定性鉴别,用分光光度法测定制剂中总皂苷含量。结果最佳提取工艺为:微波提取3次,加水量为10倍,每次30min。TLC法供试品与对照品色谱相应位置上显相同颜色的斑点,阴性无干扰。人参皂苷Re在40～200μg范围内线性关系良好,Y=250.83X-0.017,r=0.9972,精密度和回收率符合要求。结论本试验确定的提取工艺及质量标准在实际生产中可行。

Objective To investigate the best conditions of extraction techniques for compound Tianqi Yizhi granule and to establish its quality standards. Methods The best conditions of extraction techniques for compound Tianqi Yizhi granule were optimized by orthogonal experiments, with the yield of total saponins as the index. The qualitative analysis of Panax Notoginseng and Ginseng with Thin-Layer Chromatography and determination of total saponins with UV-spectrophotometry was made. Results The optimal condition of total saponins was that the microwave extraction for 3 times and extracting for 30 minutes, the material-water rate of 1 ： 10. In TLC procedure, the control material and the test sample showed the same colored spots, while the negative control sample showed no interference. Ginsenoside Re showed a good linear relationship at the range of 40-200μg, Y=250.83X-0.017, r=0.997 2. The accuracy and precision were accord to the standards. Conclusion The extraction techniques and the quality standards are feasible.