一测多评法同时测定复方玄驹胶囊中7种成分的含量

Simultaneous Determination of Seven Components in Fufang Xuanju Capsule by QAMS

目的 建立一测多评法同时测定复方玄驹胶囊中淫羊藿苷、宝藿苷I、佛手柑内酯、欧前胡素、蛇床子素、儿茶素、表儿茶素的含量,验证此方法的准确性和可行性.方法 以复方玄驹胶囊为研究对象,选定欧前胡素为内参物,建立淫羊藿苷、宝藿苷I、佛手柑内酯、蛇床子素、儿茶素、表儿茶素与其相对校正因子,计算含量,同时对外标法实测值与一测多评法的计算值进行比对,以验证一测多评法的准确性和可靠性.结果 淫羊藿苷、宝藿苷I、佛手柑内酯、欧前胡素、蛇床子素、儿茶素、表儿茶素的线性范围分别为7.07-141.40,3.49-69.80,1.06-21.20,6.43-128.60,9.02-180.40,1.86-37.20,5.69-113.80μg/ml,相关系数(r)为0.9993-0.9999;平均加样回收率分别为98.82%,97.90%,96.84%,99.93%,98.26%,97.64%和99.07%,RSD分别为0.94%,1.33%,1.16%,0.98%,1.41%,1.20%和1.03%(n=9);一测多评法计算结果与外标法测得结果差异无统计学意义.结论 该方法简便、准确,可用于复方玄驹胶囊的质量评价研究.

Objective To establish a quantitative analysis of multi-components by single marker(QAMS)method for the determination of seven components in Fufang Xuanju Capsules,which were icariin,baohuoside I,bergapten,imperatorin,osthole,(+)-catechin and epicatechin,and to validate the accuracy and feasibility of the method for quality control of Fufang Xuanju Capsules.Mothods Taking Fufang Xuanju Capsules as research object,imperatorin was selected as the internal reference substance.The relative correction factors of icariin,baohuoside I,bergapten,osthole,(+)-catechin and epicatechin were established and their contents were calculated.At the same time,the measured values of the external standard method were compared with the calculated values of QAMS to verify the accuracy and reliability of QAMS.Results The linear ranges of icariin,baohuoside I,bergapten,imperatorin,osthole,(+)-catechin and epicatechin were 7.07-141.40,3.49-69.80,1.06-21.20,6.43-128.60,9.02-180.40,1.86-37.20,5.69-113.80μg/ml(r=0.9993-0.9999).The average recoveries were 98.82%,97.90%,96.84%,99.93%,98.26%,97.64%and 99.07%,with RSDs of 0.94%,1.33%,1.16%,0.98%,1.41%,1.20%and 1.03%(n=9),respectively.There were no significant differences between the calculated and measured values of icariin,baohuoside I,bergapten,imperatorin,osthole,(+)-catechin and epicatechin.Conclusion The method is simple and accurate,and can be used for quality evaluation of Fufang Xuanju Capsules.