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目的优化射干配方颗粒制备工艺,建立射干配方颗粒的质量标准。方法采用L9(34)正交设计安排试验,用TLC对射干配方颗粒进行定性鉴别,用HPLC法进行测定。结果射干配方颗粒制备工艺为加10倍量70%乙醇、加热煎煮2次,每次2h,射干苷转移率可达93%;薄层色谱中可检出特征斑点;射干苷在0.1712～1.712μg线性关系良好,平均回收率为96.99%。结论提取工艺合理,HPLC法易于操作,重复性好,能够控制射干配方颗粒的质量。
Objective To optimize the preparation process of Shegan formula and establish the quality standard of Shegan formula. Methods The orthogonal design of L9 (34) was used to arrange the experiment. The qualitative and quantitative identification of Shegan formula particles by TLC was determined by HPLC. Results Shegan formula granule preparation process plus 10 times the amount of 70% ethanol, heated boiling 2 times, each 2h, transdermal glycoside transfer rate of up to 93%; thin-layer chromatography can be detected in the characteristic spots; dry glycosides in 0.1712 ~ 1.712 μg linear relationship was good, the average recovery was 96.99%. Conclusion The extraction process is reasonable, HPLC method is easy to operate, reproducible, and can control the quality of Shegan formula particles.