基于抗痴呆类药成分西伯利亚远志糖A5、西伯利亚远志糖A6和远志(咄)酮Ⅲ的开心散质量控制方法研究

目的建立基于抗痴呆类药成分西伯利亚远志糖A5、西伯利亚远志糖A6和远志酮Ⅲ的开心散质量控制方法,并运用此方法对开心散水提物和远志水提物的3个有效成分的提取量进行比较分析。方法采用HPLC-DAD分析方法,Waters XbridgeTMshield C18柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相梯度洗脱,流速1 mL/min。检测波长西伯利亚远志糖A5、西伯利亚远志糖A6为330 nm,远志酮Ⅲ为254 nm,柱温30℃。结果西伯利亚远志糖A5、西伯利亚远志糖A6和远志酮Ⅲ分别在0.043～1.085μg0、.090～2.250μg0、.008～0.234μg范围内线性关系良好;平均回收率分别为96.39%9、7.37%和99.66%。开心散水提物和远志水提物对3个有效成分的提取量有影响。结论 3批样品含量测定结果表明,该方法简便、准确,可用于开心散提取物中类药成分西伯利亚远志糖A5、西伯利亚远志糖A6和远志酮Ⅲ的含量测定,亦可作为开心散定量控制方法之一。

Quality control of Kaixin San based on its anti-dementia drug-like components-sibricose A5,sibricose A6 and xanthone Ⅲ

Objective To found a quality control method of Kaixin San based on anti-dementia drug-like components including sibricose A5,sibricose A6 and xanthone III,and compare and analyze the extractive quantity of 3 effective components extracted mixedly from whole formula of Kaixin San and Yuanzhi(Radix Polygalae).Methods The procedure of HPLC-DAD was performed on the chromatographic column of Waters XbridgeTM Shield C18(4.6 mm×250 mm,5 μm) at 30 ℃,and the mobile phase was acetonitrile-0.1% phosphoric acid solution in gradient elution.The flow velocity was 1.0 mL/min and the detection wavelength was 330 nm for sibricose A5 and sibricose A6 nm,and 254 nm for xanthone Ⅲ.Results Sibricose A5 showed a good linear relationship at a range from 0.043 μg to 1.085 μg,sibricose A,from 0.090 μg to 2.250 μg,and xanthone Ⅲ,from 0.008 μg to 0.234 μg.The average recovery was,respectively,96.39%,97.37% and 99.66%.The mixture extraction of whole formula of Kaixin San and extraction of Yuanzhi(Radix Polygalae) had influence on the extractive quantity of 3 effective components.Conclusion The method was simple and reliable,which can be used for the quantitative determination of sibricose A5,sibricose A6 and xanthone Ⅲ as well as quantity control of Kaixin San.