肠康颗粒制备工艺及其补骨脂素含量的测定

PREPARATION OF CHANGKANG GRANULES AND DETERMINATION OF PSORALEN

①目的探讨肠康颗粒中补骨脂素含量的测定方法,并优选肠康颗粒提取工艺.②方法选用薄层扫描法测定补骨脂素的含量;采用正交设计法,以补骨脂素为检测指标,优选肠康颗粒的提取工艺.③结果补骨脂素在1.00～9.45 μg范围内呈良好的线性关系,回归方程为Y=27 568.735X―15 312.625(r=0.999 6),平均回收率为99.15%(RSD=0.74%,n=3);肠康颗粒的最佳提取工艺为水煎煮提取两次,每次1 h,加水量10倍(质量浓度),并经体积分数0.60乙醇沉淀.④结论薄层扫描法可作为补骨脂素的含量测定方法,以控制肠康颗粒的质量;本文工艺制备的颗粒制剂性质稳定,为此产品的开发奠定了基础.

Objective To study the determination of the content of psoralen in ChangKang Granules and select an optimized extraction technique for the medicine. Methods Thin-layer chromatography （TLC） was used. Psoralen was taken as target constituents, and the optimized extraction technique for preparing ChangKang Granules was selected by orthogonal design. Results The calibration curve of psoralen was lined over the range of 1. 00 -9. 45μg, and regression equation was Y = 27 568.735X - 15 312. 625 （r=0.999 6）. The average recovery was 99. 15% （RSD=0. 74%, n=3）. The optimized technique was twice extraction by boiling method with 10 times water, one hour each time, precipitated with 60% alcohol. Conclusion TLC can be used for the quantitative determination of psoralen and control of the quality of ChangKang Granules.