基于全程质量控制理念建立忍冬藤配方颗粒特征图谱  

Establishing the characteristic spectrums of Honeysuckle stem formula granules based on the concept of whole-proce quality control

作　　者：韦敏灵 李海西 黄雄梅 梁冰丽 韦红言 WEI Minling;LI Haixi;HUANG Xiongmei;LIANG Bingli;WEI Hongyan(PuraPharm(Nanning)Pharmaceutica Company Limited,Nanning 530007,Guangxi)

机构地区：[1]培力(南宁)药业有限公司药物研究院,广西南宁530007

出　　处：《中药与临床》2024年第6期16-19,共4页Pharmacy and Clinics of Chinese Materia Medica

基　　金：2020年南宁市本级科学研究与技术开发计划重大项目(第一批)(20201048)。

摘　　要：目的:建立忍冬藤配方颗粒HPLC特征图谱检测方法,并以标准汤剂为基准,进行一致性分析与评价。方法:采用Agilent ZORBAX SB-C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-体积分数0.4%磷酸溶液(0.2∶99.8,V/V)为流动相、1.0 mL·min^(-1)的流速梯度洗脱;柱温为25℃;检测波长为236 nm;运用《中药色谱指纹图谱相似度评价系统》,对忍冬藤药材、标准汤剂、配方颗粒的特征图谱进行相似度评价。结果:忍冬藤药材、标准汤剂、配方颗粒特征图谱呈现很高的相似度(大于0.94),均呈现10个共有特征峰,并在10个共有峰中指认绿原酸、马钱苷、马钱苷酸、当药苷、新绿原酸、隐绿原酸6个成分。结论:本实验建立的方法,能较全面地体现忍冬藤中化学物质整体面貌及其传递规律,可为忍冬藤配方颗粒质量一致性提供实验依据。Objective:To establish HPLC characteristic spectrums of Honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.Methods:The chromatographic column ofAgilent ZORBAX SB-C_(18)(250 mm×4.6 mm,5μm)was used for gradient elution with two mixed solvents of acetonitrile-0.4%phosphoric acid solution(0.2:99.8,V/V)at the flow rate of 1.0 mL·min^(-1).The column temperature was 25°C.The detection wavelength was 236 nm.The similarity of characteristic spectrum of Honeysuckle herb,standard decoction and formula granule was evaluated by“Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System”.Results:There were 10 common characteristic peaks in all characteristic spectrums of raw herbs,standard decoction and formula granules,presenting high similarity(greater than 0.94),and 6 chemical compounds were identified including chlorogenic acid,loganin,loganic acid,Sweroside,neochlorogenic acid,cryptochlorogenic acid.Conclusion:The established method can more comprehensively reflect the overall appearance of the chemical substances in the honeysuckle stem and the transmission law,and can provide an experimental basis for the consistency of the quality of the honeysuckle stem formula granules.

关 键 词：忍冬藤配方颗粒 标准汤剂 特征图谱 HPLC 相关性 质量控制 

分 类 号：R283.1[医药卫生—中药学]