肿节风配方颗粒制备工艺和质量标准研究

目的优化肿节风配方颗粒制备工艺,并建立肿节风配方颗粒质量标准。方法采用L9(34)正交设计安排实验,用薄层法进行定性鉴别,用紫外分光光度法测量总黄酮的含量,HPLC法测定异秦皮啶的含量。结果肿节风的提取工艺为:加热2.0 h,加水量10倍,提取3次,异秦皮啶提取率可达92.04%;总黄酮提取率可达89.69%;在薄层色谱中可检出特征斑点,异秦皮啶进样量在0.101～0.606μg范围内线性关良好(r=0.999 9),平均回收率97.64%(RSD=1.40%,n=6);配方颗粒中异秦皮啶和总黄酮含量分别不低于0.95mg.g-1和6.00 mg·g-1。结论提取工艺科学合理;定性鉴别准确,HPLC法易于操作,重复性好,能够控制肿节风配方颗粒的质量。

Preparation and Quality Standard of Sarcandra glabra Dispensing Granules

Objective To optimize the preparation and to set up the quality standard of Sarcandra glabra Dispensing Granules.Methods Nine experiments were carried out by L9(34)orthogonal design.Sarcandra glabra Dispensing Granules was identified by TLC and the contents of isofraxidin and total flavonoids were determined by HPLC and ultraviolet spectrophotometry.Results The optimal extraction process was as follows: 10 times of water,extraction 3 times,and 2 hours each time.The linear relation of isofraxidin was within 0.101 ~0.606 μg(r=0.999 9)and the averge recovery was 97.64%(RSD=1.40%,n=6).The contents of isofraxidin and total flavonoids were more than 0.95 mg·g-1 and 6.00 mg·g-1,respectively.Conclusion The extraction technology is scientific and it can be used for the quality control of Sarcandra glabra Dispensing Granules.