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目的:建立脑得生固体分散体胶囊中葛根异黄酮类成分(葛根素、大豆苷、大豆苷元、染料木素)的含量测定方法。方法:采用高效液相色谱法,Hyspersil ODS-2色谱柱(5μm,250 mm×4.6 mm),柱温25℃,流动相甲醇-水系统梯度洗脱,流速0.8 mL·min~(-1),检测波长250 nm。结果:葛根素在0.540 8~3.244 8μg(r=0.999 9)范围,大豆苷在0.130 0~0.780 0μg(r=0.999 9)范围,大豆苷元在0.073 2~0.439 2μg(r=0.999 9)范围,染料木素在0.044 8~0.268 8μg(r=0.999 9)范围均呈良好的线性关系;平均回收率分别为99.08%,98.10%,97.91%,99.26%;RSD分别为1.67%,1.57%,2.43%,2.92%。结论:所建立方法简便、准确、重复性好,可有效控制该制剂质量。
OBJECTIVE: To establish a method for the determination of isoflavones (puerarin, daidzin, daidzein, genistein) in Pueraria Procelaris Capsules. Methods: The mobile phase was eluted with Hyspersil ODS-2 column (5 μm, 250 mm × 4.6 mm) at a column temperature of 25 ℃ with a mobile phase of methanol-water at a flow rate of 0.8 mL · min -1 , Detection wavelength of 250 nm. Results: The range of puerarin was 0.540 8 ~ 3.244 8μg (r = 0.999 9), daidzein was in the range of 0.130 0 ~ 0.780 0μg (r = 0.999 9), daidzein was in the range of 0.073 2 ~ 0.439 2μg (r = 0.999 9) The average recoveries of genistein were 99.08%, 98.10%, 97.91% and 99.26%, respectively. The RSDs were 1.67% and 1.57%, respectively. 2.43%, 2.92%. Conclusion: The established method is simple, accurate and reproducible, which can effectively control the quality of the preparation.