连钱草的质量标准提高研究  

Improvement in Quality Standards of Glechomae Herba

作　　者：周雷罡 马银松 喻何云 袁铭铭 吴西 ZHOU Leigang;MA Yinsong;YU Heyun;YUAN Mingming;WU Xi(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2023年第6期672-675,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2021KY19);江西省重点研发计划项目(2017BBG70104);2022年度国家药品标准制修订研究课题(2022Z03)。

摘　　要：目的对连钱草进行薄层鉴别和含量测定研究,提高其质量控制方法和标准。方法薄层色谱法(TLC),以熊果酸为对照品,连钱草为对照药材,以环己烷-乙酸乙酯-甲酸(3∶1∶0.1)为展开剂,以10%硫酸乙醇为显色剂;建立高效液相色谱法(HPLC)测定迷迭香酸的含量,色谱柱为waters SunFire C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(21∶79),检测波长为330 nm,柱温为30℃,流速为1.0 mL/min。结果建立的TLC鉴别方法,斑点清晰,分离效果较好;HPLC法测定迷迭香酸在4.62~231.03μg/mL范围内线性关系良好(r=0.9999),精密度、稳定性、重复性RSD均小于1.0%;平均加样回收率为99.6%,RSD=1.16%。26批样品中迷迭香酸的含量在0.827~12.484 mg/g。结论建立的方法简便、易操作,结果准确,能有效控制连钱草的药材质量。Objective To improve the quality standards for glechomae herba by TLC and quantitate determine.Methods Thin layer chromatography(TLC)was performed with ursolic acid as reference substances,glechomae herba as the control herb,cyclohexane-ethyl acetate-formic acid(3∶1∶0.1)as the developing solvent,and 10%ethanol sulfate as the colorimetric agent.The contents of rosmarinic acid determined by HPLC.The waters SunFire C18(250 mm×4.6 mm,5μm)was used with the mobile phase of acetonitrile-phosphoric acid solution(21∶79),at the detection wavelength was 330 nm,and the column temperature was at 30℃,the flow rate of 1.0 mL/min.Results The spots in the TLC were clear and well-separated;the linear ranges of rosmarinic acidwas 4.62-231.03μg/mL(r=0.9999),respectively.RSDs of precision,stability and repeatability tests were less than 1.0%;the average recoveries was 99.6%(RSD=1.16%).The contents of rosmarinic acidwas in 26 batches of samples were 0.827-12.484 mg/g.Conclusion The established method is simple,easy to operate with accurate results,whereby it can effectively control the quality of glechomae herba.

关 键 词：连钱草 质量标准 高效液相色谱法 薄层色谱法 迷迭香酸 

分 类 号：R284.1[医药卫生—中药学]