知母标准汤剂的质量评价方法及指标成分的量值传递规律探索

Quality Evaluation Method and Quantity Transfer of Index Components of Anemarrhenae Rhizoma Standard Decoction

目的:建立知母标准汤剂的质量评价方法,明确10批知母标准汤剂中指标成分的含量及转移率范围,探索从饮片到标准汤剂,指标成分的量值传递规律。方法:制备10批知母标准汤剂,采用超高效液相色谱-二极管阵列检测器法(UPLC-PDA)对指标成分芒果苷进行含量测定,以0.1%甲酸水(A)-乙腈(B)为流动相进行梯度洗脱(0~3 min,10%~13%B;3~6 min,13%~14%B;6~7 min,14%~90%B),检测波长为258 nm;采用高效液相色谱-蒸发光散射检测器法(HPLC-ELSD)对知母皂苷BⅡ进行含量测定,以乙腈-水(25∶75)为流动相进行等度洗脱,载气流速为2.8 L·min^(–1),漂移管温度为104℃。结果:建立的指标成分含量测定方法的方法学验证均良好,能用于知母标准汤剂中2个指标性成分的定量检测。10批知母标准汤剂中芒果苷、知母皂苷BⅡ的质量分数分别为0.88%~1.12%和0.88%~2.53%,芒果苷含量位于其均值的±30%范围内;转移率分别为45.83%~57.27%和26.94%~43.49%,均在其均值的±30%范围内。结论:建立了知母标准汤剂的质量评价方法,指标成分芒果苷和知母皂苷BⅡ在不同批次的知母饮片与标准汤剂间的转移率一致性较好,表明这2个指标成分在标准汤剂的制备过程中转移情况稳定,为源于知母水煎液的制剂的质量控制方法的制定提供参考。

Objective:To establish the quality evaluation method for Anemarrhenae Rhizoma standard decoction,clarity the content and transfer rate ranges of index components in 10 batches of Anemarrhenae Rhizoma standard decoction,and explore the quantity transfer rule of index components from decoction pieces to standard decoction.Methods:Ten batches of Anemarrhenae Rhizoma standard decoction were prepared,and the content of mangiferin was determined by ultrahigh performance liquid chromatography(UPLC)-photodiode array(PDA)with the mobile phase of 0.1%formic acid aqueous solution(A)-acetonitrile(B)for gradient elution(0-3 min,10%-13%B;3-6 min,13%-14%B;6-7 min,14%-90%B)and the detection wavelength of 258 nm.The content of timosaponin BⅡwas determined by high performance liquid chromatography-evaporative light scattering detector(HPLC-ELSD)with the mobile phase of acetonitrile-water(25:75)for isometric elution.ELSD was performed with the carrier gas flow rate of 2.8 L·min^(–1)and the tube temperature of 104℃Results:After validation,the established method for the content determination of index components was good,which could be used for the content determination of two index components of Anemarrhenae Rhizoma standard decoction.The mass fractions of mangiferin and timosaponin BⅡin 10 batches of Anemarrhenae Rhizoma standard decoction were 0.88%-1.12%and 0.88%-2.53%,respectively,and the content of mangiferin was within the range of±30%of the mean value.The transfer rate ranges of mangiferin and timosaponin BⅡwere 45.83%-57.27%and 26.94%-43.49%,respectively,which were within the range of±30%of the mean value.Conclusion:This study established a quality evaluation method for Anemarrhenae Rhizoma standard decoction.The transfer rates of mangiferin and timosaponin BⅡbetween batches were good,indicating that the transfer of the two index components were stable during the preparation process of Anemarrhenae Rhizoma standard decoction.This study provides references for the quality control of all preparations derived from Anemarrhenae Rhizoma decoction.