摘要
目的建立含绿原酸成分的中药及其制剂中所含的6种绿原酸“一测多评”(QAMS)的分析方法。方法以乙腈-0.4%磷酸为流动相梯度洗脱、柱温为25℃、流速为1.0 mL/min、检测波长为327 nm的高效液相色谱-二极管阵列检测器(HPLC-DAD)法,测定并计算以绿原酸为内参物的其他5种绿原酸类成分的相对校正因子;并考察相对校正因子的耐用性,确立以绿原酸为内参的QAMS法;分别采用已建立的QAMS分析方法和外标法计算含绿原酸中药(金银花、野菊花)及其滴眼剂中绿原酸类成分的含量,利用t检验和相对误差分析不同算法的含量差异,评价QAMS法的准确性;并采用相对保留时间方法对6种成分色谱峰进行准确定位。结果建立的以绿原酸为内参物的相对校正因子耐用性良好,采用2种方法计算10批次滴眼剂和3批次金银花及野菊花中绿原酸类成分的含量,两者相对误差范围为-3.32%~4.99%,差异无统计学意义(P>0.05)。结论建立的QAMS法可同时用于金银花、野菊花中药材及其滴眼剂中6种绿原酸类成分的质量评价,具有快速、准确、方便等特点。
Objective To establish the quantitative analysis of multi-components by single marker(QAMS)method for the analysis of six chlorogenic acids in traditional Chinese medicine and their preparations.Methods A high performance liquid chromatography-photodiode array detector(HPLC-DAD)method was developed with acetonitrile-0.4%phosphoric acid as mobile phase ingradient elution.The column temperature was 25℃.The flow rare was 1.0 mL/min and the detection wavelength was 327 nm.Then the relative correction factors among the other five chlorogenic acids were calculated,when the chlorogenic acid was used as internal referring substances.The ruggedness of relative correction factors was evaluated to establish the QAMS method,when the chlorogenic acid was used as internal referring substances.The content of chlorogenic acid in traditional Chinese medicine(Lonicerae Japonicae Flos and Chrysanthemi Indici Flos)and their eye drops were calculated by the established QAMS method and external standard method respectively,and the content difference of different algorithms was analyzed by t-test and relative error analysis to evaluate the accuracy of the QAMS method.The relative retention time method was used to accurately locate the chromatographic peaks of the six constituents.Results The established relative correction factor with chlorogenic acid as internal referring substances had good ruggedness.Two methods were used to calculate the content of chlorogenic acid in 10 batches of eye drops and three batches of Lonicerae Japonicae Flos and Chrysanthemi Indici Flos.The relative error range was-3.32%to 4.99%,and there was no statistically significant difference(P>0.05).Conclusion A rapid,accurate and convenient QAMS method for simultaneous measurement of six chlorogenic acids has been established,and this method can be used for quality analysis of six chlorogenic acids in Lonicerae Japonicae Flos,Chrysanthemi Indici Flos and their eye drops.
作者
张秋燕
张妮
张春礼
郭文全
崔翰明
ZHANG Qiuyan;ZHANG Ni;ZHANG Chunli;GUO Wenquan;CUI Hanming(Chinese Medicine Research and Development Center,Guang′anmen Hospital,China Academy of Chinese Medical Sciences,Beijing100053,China;Shaanxi Made All the Pharmaceutical Co.,Ltd,Shaanxi Province,Xianyang712000,China)
出处
《中国医药导报》
CAS
2020年第25期10-14,共5页
China Medical Herald
基金
国家自然科学基金资助项目(81803829)
中国中医科学院广安门医院国家中医临床研究示范基地科研专项暨所级科研基金课题(2017S392)。
关键词
一测多评法
相对校正因子
滴眼剂
金银花
野菊花
Quantitative analysis of multi-components by single marker
Relative correction factor
Eye drop
Lonicerae Japonicae Flos
Chrysanthemi Indici Flos
