摘要
目的建立同时测定补中益气丸中橙皮苷、毛蕊异黄酮葡萄糖苷、异阿魏酸、甘草苷、阿魏酸、甘草酸铵6种成分含量的一测多评(QAMS)法。方法色谱柱为Diamosil C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为0.8 m L/min,柱温为30℃,检测波长为270 nm,进样量为10μL。以橙皮苷为内参物,确立其与另外5种成分的相对校正因子(RCF),并计算含量;同时采用外标(ESM)法测定上述6种成分的含量,比较QAMS法计算值与ESM法实测值的差异,验证其结果的准确性和方法的可行性。结果毛蕊异黄酮葡萄糖苷、甘草苷、阿魏酸、异阿魏酸、橙皮苷、甘草酸铵质量浓度分别在0.0109~0.0729μg/m L(R^(2)=0.9993,n=7),0.0468~0.3120μg/m L(R^(2)=0.9996,n=7),0.0045~0.0300μg/m L(R^(2)=0.9976,n=7),0.0468~0.3120μg/m L(R^(2)=0.9999,n=7),0.3600~2.4000μg/m L(R^(2)=0.9999,n=7),0.1710~1.1400μg/m L(R^(2)=0.9999,n=7)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于3%(n=6);平均加样回收率分别为99.57%,98.29%,100.46%,101.07%,99.07%,100.12%,RSD分别为1.52%,1.46%,1.51%,1.37%,1.70%,1.33%(n=9)。QAMS法计算值与ESM法实测值无显著差异(P>0.05)。结论QAMS法操作简便,结果准确,重复性和稳定性均好,可用于同时测定补中益气丸中6种成分的含量。
Objective To establish a quantitative analysis of multi-components by single marker(QAMS)method for the simultaneous determination of hesperidin,calycosin-7-O-β-D-glucoside,isoferulic acid,liquiritin,ferulic acid,and ammonium glycyrrhizinate in Buzhong Yiqi Pills.Methods The chromatographic column was Diamosil C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(gradient elution),the flow rate was 0.8 m L/min,the column temperature was 30℃,the detection wavelength was 270 nm,and the injection volume was 10μL.The relative correction factors(RCFs)of hesperidin with the other components were established and the contents were calculated with hesperidin the internal reference.Meanwhile,The contents of the above six components were determined by external standard method(ESM),and the difference between the value calculated by QAMS and the value determined by ESM were compared to verify the accuracy of the results and the feasibility of the method.Results The linear ranges of calycosin-7-O-β-D-glucoside,liquiritin,ferulic acid,isoferulic acid,hesperidin and ammonium glycyrrhizinate were 0.0109-0.0729μg/m L(R^(2)=0.9993,n=7),0.0468-0.3120μg/m L(R^(2)=0.9996,n=7),0.0045-0.0300μg/m L(R^(2)=0.9976,n=7),0.0468-0.3120μg/mL(R^(2)=0.9999,n=7),0.3600-2.4000μg/mL(R^(2)=0.9999,n=7),0.1710-1.1400μg/mL(R^(2)=0.9999,n=7),respectively.The RSDs of the precision,stability and repeatability tests were all less than 3.0%(n=6).The average recoveries of calycosin-7-O-β-D-glucoside,liquiritin,ferulic acid,isoferulic acid,hesperidin and ammonium glycyrrhizinate were 99.57%,98.29%,100.46%,101.07%,99.07%and 100.12%with RSDs of 1.52%,1.46%,1.51%,1.37%,1.70%and 1.33%(n=9),respectively.There is no significant difference between the value calculated by QAMS and the value determined by ESM(P>0.05).Conclusion QAMS method is simple,accurate,reproducible and stable,which can be used for the simultaneous determina-tion of six components in Buzhong Yiqi Pills.
作者
张永昕
李莎恩
蔡琴琴
张莹
段付军
ZHANG Yongxin;LI Sha'en;CAI Qinqin;ZHANG Ying;DUAN Fujun(Air Force Hospital of Southern Theater Command of PLA,Guangzhou,Guangdong,China 510602)
出处
《中国药业》
CAS
2021年第23期71-75,共5页
China Pharmaceuticals
