一测多评法同时测定蒲元和胃胶囊中7种成分含量  

Simultaneous Determination of Seven Components in Puyuan Hewei Capsules by QAMS

作　　者：李怀伟 王劲 任仲丽 朱伟堃 张朋 LI Huaiwei;WANG Jin;REN Zhongli;ZHU Weikun;ZHANG Peng(Heze Institute for Food and Drug Control,Heze,Shandong,China 274000)

机构地区：[1]山东省菏泽市食品药品检验检测研究院,山东菏泽274000

出　　处：《中国药业》2024年第9期110-114,共5页China Pharmaceuticals

摘　　要：目的建立同时测定蒲元和胃胶囊中延胡索乙素、盐酸巴马汀、α-香附酮、咖啡酸、木犀草素、甘草苷、甘草酸铵的含量的一测多评法。方法采用高效液相色谱法测定,色谱柱为Diamonsil C_(18)柱(250 mm×4.6 mm,5µm),流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,柱温为30℃,检测波长为237 nm,进样量为10µL。以木犀草素为内参物,建立与延胡索乙素、盐酸巴马汀、α-香附酮、咖啡酸、甘草苷、甘草酸铵的相对校正因子;采用一测多评法和外标法检测7种成分的含量,比较计算值与实测值的差异。结果延胡索乙素、盐酸巴马汀、α-香附酮、咖啡酸、木犀草素、甘草苷、甘草酸铵的质量浓度分别在2.67~133.41µg/mL、0.89~44.60µg/mL、1.36~67.85µg/mL、1.53~76.65µg/mL、2.00~100.12µg/mL、3.00~150.20µg/mL、8.51~425.61µg/mL范围内与峰面积线性关系良好(r≥0.9995,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率分别为99.09%,97.34%,97.42%,96.85%,98.60%,99.20%,99.09%,RSD分别为0.72%,1.68%,1.75%,1.29%,0.69%,0.79%,0.97%(n=9)。延胡索乙素、盐酸巴马汀、α-香附酮、咖啡酸、木犀草素、甘草苷、甘草酸铵的相对校正因子分别为1.3159,0.7059,1.1805,1.2241,1.2385,6.7178;在不同色谱柱、色谱仪、流速、柱温下的重复性均良好,结果的RSD均低于1.50%。一测多评法与外标法的含量计算结果相对误差的绝对值均小于2.0%。结论该方法重复性好、结果准确可靠,可用于蒲元和胃胶囊的质量控制。Objective To establish a quantitative analysis of multi-components by single marker(QAMS)method for the simultaneous determination of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,luteolin,liquiritin and ammonium glycyrrhizinate in Puyuan Hewei Capsules.Methods High-performance liquid chromatography(HPLC)method was adopted,the chromatographic column was Diamonsil 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 1.0 mL/min,the column temperature was 30℃,the detection wavelength was 237 nm,and the injection volume was 10µL.With luteolin as the internal reference standard,the relative correction factors of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,liquiritin and ammonium glycyrrhizinate were established.The contents of seven components were determined by the methods of QAMS and external standard method(ESM),and the differences between the calculated values and the determined values were compared.Results The linear ranges of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,luteolin,liquiritin and ammonium glycyrrhizinate were 2.67-133.41µg/mL,0.89-44.60µg/mL,1.36-67.85µg/mL,1.53-76.65µg/mL,2.00-100.12µg/mL,3.00-150.20µg/mL,8.51-425.61µg/mL(r≥0.9995,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n=6).The average recoveries of the above seven components were 99.09%,97.34%,97.42%,96.85%,98.60%,99.20%,and 99.09%,with RSDs of 0.72%,1.68%,1.75%,1.29%,0.69%,0.79%,and 0.97%(n=9),respectively.The relative correction factors of the above seven components were 1.3159,0.7059,1.1805,1.2241,1.2385,and 6.7178,respectively.Good repeatability was observed in different chromatography columns,chromatographs,flow rates,and column temperatures,and the RSDs of the results were lower than 1.50%.The absolute value of the relative errors between the content determined by the QAMS method and the content calculated by the ESM was lowe

关 键 词：蒲元和胃胶囊 一测多评法 延胡索乙素 盐酸巴马汀 α香附酮 咖啡酸 木犀草素 甘草苷 甘草酸铵 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0