一测多评法同时测定补肾清利颗粒中8种成分  

Simultaneous determination of eight ingredients in Bushen Qingli Granules by HPLC-QAMS

作　　者：董迎[1] 夏彦铭 狄留庆[1,2,3] 李俊松 赵晓莉[1,2,3] 

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]江苏省中药高效给药系统工程技术研究中心,江苏南京210046 [3]南京市中药微丸产业化工程技术研究中心,江苏南京210046

出　　处：《中草药》2017年第24期5158-5167,共10页Chinese Traditional and Herbal Drugs

基　　金：江苏省科技厅产学研前瞻性联合项目(BY2013008-01);江苏高校优势学科建设工程资助项目(2015)

摘　　要：目的建立一测多评(QAMS)法同时测定补肾清利颗粒(BQG)中8种成分京尼平苷酸(GA)、绿原酸、栀子苷、滨蒿内酯、丹酚酸B(SAB)、黄芩苷、槲皮素7-O-α-L-鼠李糖苷(QR)及黄芩素的方法,验证该法在BQG中应用的可行性和技术适应性。方法以8种成分为研究对象,利用QAMS 3种校正方法计算各待测成分与内参物滨蒿内酯的相对校正因子(fk/s),推算待测组分量;对回归方程和3种校正方法计算值与外标法实测值进行误差和相关性评价。结果 8种目标成分在一定范围内线性关系良好(r>0.999 9),滨蒿内酯与GA、绿原酸、栀子苷、SAB、黄芩苷、QR及黄芩素的fk/s分别是0.562、0.818、0.627、0.877、0.935、1.113、2.339,且在不同条件下重现性良好;6批样品中各成分量分别为GA 1.633~1.736 mg/g、绿原酸1.777~1.950 mg/g、栀子苷6.017~6.422 mg/g、滨蒿内酯1.765~1.851 mg/g、SAB 2.326~2.522 mg/g、黄芩苷19.476~21.329 mg/g、QR 3.077~3.265 mg/g及黄芩素0.161~0.186 mg/g,且计算所得量与实测量测得结果无显著差异。结论 QAMS法为BQG提供了一个快捷可行的多指标同步质量评价模式。Objective To establish a novel method for QAMS to realize simultaneous determination of eight ingredients in Bushen Qingli Granules（BQG）, including geniposidic acid（GA）, chlorogenic acid, geniposide, scoparone, salvianolic acid B（SAB）, baicalin, quercetin-7-O-α-L-rhamnoside（QR）, and baicalein, and to verify the feasibility and technical adaptability of this method for application in BQG. Methods Taking BQG as research objects and the above eight components as indexes, three correction methods of QAMS were used to calculate the relative correction factor（fk/s） of each tested component and 6,7-dimethoxycoumarin regarded as reference, in order to estimate the content of each component; The error and correlation evaluation was carried out by comparing the calculated values of the regression equation and three correction methods with the real data of the external reference. Results Within certain linear ranges, eight kinds of target components showed good linear relationships（r 0.999 9）. The values of relative correction factors（RCF） of scoparone to GA, chlorogenic acid, geniposide, SAB, baicalin, QR, and baicalein respectively were 0.562, 0.818, 0.627, 0.877, 0.935, 1.113, and 2.339, and the RCF had a good reproducibility. The contents of eight components of six batches of samples were GA 1.633—1.736 mg/g, chlorogenic acid 1.777—1.950 mg/g, geniposide 6.017—6.422 mg/g, scoparone 1.765—1.851 mg/g, SAB 2.326—2.522 mg/g, baicalin 19.476—21.329 mg/g, QR 3.077—3.265 mg/g, and baicalein 0.161—0.186 mg/g. No significant difference was found in these tested results by comparing the measured values and the real values. ConclusionThe QAMS method can provide a quick and feasible method with simultaneous determination to establish multitude index quality evaluation model for BQG.

关 键 词：HPLC 一测多评法 补肾清利颗粒 相对校正因子 京尼平苷酸 绿原酸 栀子苷 滨蒿内酯 丹酚酸B 黄芩苷 槲皮素7-O-α-L-鼠李糖苷 黄芩素 质量评价 

分 类 号：R286.02[医药卫生—中药学]