黄精舒眠颗粒质量标准研究

A Study on the Quality Standard of Huangjing Shumian Granules

目的:建立黄精舒眠颗粒的质量标准,为该制剂的质量控制提供参考。方法:薄层色谱法鉴别黄精舒眠颗粒处方中的天麻、灵芝、茯苓;以无水葡萄糖为对照品,采用苯酚-硫酸比色法,检测波长为486nm,测定黄精舒眠颗粒中总多糖的含量。结果:薄层色谱中展开效果较好,置紫外光灯(254nm)下或喷显色剂后,供试品色谱中,与各对照药材色谱相应的位置上,显相同颜色的斑点;总多糖测定结果,在0.04008~0.2405 mg/m L范围内吸光度值与葡萄糖溶液浓度的线性关系良好(r=0.9997),精密度、稳定性、重复性试验的RSD<2.0%,其平均回收率为98.28%,RSD为1.5%(N=6);三批黄精舒眠颗粒的总多糖含量分别为71.44mg/g、69.84 mg/g、69.94 mg/g,RSD=1.3%。结论:该方法简便快捷,准确可行,为黄精舒眠颗粒的质量控制提供了实验依据。

Objective： To establish the quality standard of Huangjing Shumian granule and provide reference for the quality control of the formulation. Methods： TLC was used to identify Gastrodia elata, Gano- derma lucidum, and Poria in prescription of Huang Jing Shu Mian granules. Anhydrous glucose was used as ref- erence substance. The phenol-sulfuric acid co]orimetric method was taken to determine the total polysaccharides in Huangjing Shumian granules with 486nm of detection wavelength. Results： The spreading effect in TLC was good. After the UV lamp （254 nm） and the coloring agent were sprayed, the spots of the same color were found in the chromatograms of the test materials corresponding to the respective reference materials. The results showed that the linear relationship between absorbance and glucose concentration was good in the range of 0.04008-0. 2405 mg/mL （r=0.9997）, RSD〈2.0% for precision, stability and repeatability test, and the average recovery was 98.28%. RSD was 1.5% （N = 6）. The total polysaccharide content of the three batches of Huangjing Shumi- an granules was 71.44 mg/g, 69.84 mg/g, and 69.94 mg/g respectively. RSD= 1.3%. Conclusion： The method is simple, rapid, accurate and feasible. It provides experimental basis for quality control of Huangjing Shumian granules.