维药一枝蒿散热颗粒质量标准及指纹图谱研究  

Study on Quality Standard and Fingerprint of Uyghur Medicine Artemisia rupestris L.Heat-dissipating Granules

作　　者：王云飞 帕依曼·亥米提 于睿 于宁 苏文玲 WANG Yun-fei;PAYIMAN·Haimiti;YU Rui;YU Ning;SU Wen-ling(Xinjiang Institute of Meteria Medica/Xinjiang Uyghur Pharmaceutical Laboratory,Urumqi 830054,China;Institute for Drug Control of Xinjiang Uygur Autonomous Region,NMPA key Laboratory of Quality Control of Traditional Chinese Medicine(Uyghur medicine),Urumqi 830054,China)

机构地区：[1]新疆维吾尔自治区药物研究所/新疆维吾尔药重点实验室,新疆乌鲁木齐830004 [2]新疆维吾尔自治区药品检验研究院/国家药品监督管理局中药(维药)质量控制重点实验室,新疆乌鲁木齐830054

出　　处：《海峡药学》2024年第12期38-43,共6页Strait Pharmaceutical Journal

基　　金：新疆维吾尔自治区卫生健康青年医学科技人才专项(WJWY-202424)。

摘　　要：目的对一枝蒿散热颗粒进行定性定量实验研究,建立质量标准及HPLC指纹图谱。方法采用薄层色谱法对制剂中的一枝蒿进行定性鉴别;采用高效液相色谱法测定制剂中一枝蒿酮酸和没食子酸的含量;建立10批一枝蒿散热颗粒的HPLC指纹图谱,并采用中药色谱指纹图谱的相似度评价软件A版(2004版)展开相似度分析,同时根据聚类分析对颗粒进行质量评价。结果一枝蒿药材的薄层色谱斑点清晰,特征明显,专属性强。一枝蒿酮酸线性方程为:y=37.906x+32.428,r^(2)=0.9998;一枝蒿酮酸在2.45~78.48μg·mL^(-1)范围内,与峰面积呈良好的线性关系;没食子酸线性方程为y=33.38x+34.727,r^(2)=0.9998;没食子酸的线性范围为8.02~256.69μg·mL^(-1),与峰面积呈良好的线性关系。10批一枝蒿散热颗粒的HPLC特征图谱,标定峰共有14个,相似度均>0.9,聚类分析将样品分为2类。结论该文建立的质量控制方法简便、准确,专属性强,重复性好,能够全面系统的反映制剂的质量,可用于一枝蒿散热颗粒的质量控制。OBJECTIVE The Artemisia rupestris L.heat-dissipating granules were established for qualitative and quantitative experiments,and the quality standard and HPLC fingerprint were established.METHODS TLC was used to qualitatively identify Artemisia Argus in the preparation.The contents of artemisia acid and gallic acid in the preparation were determined by high performance liquid chromatography.HPLC fingerprints of 10 batches of Artemisia rupestris L.heat-dissipating granules were established,and the fingerprints were analyzed by TCM chromatographic.Fingerprint similarity evaluation software(2004 edition),and the quality of Artemisia rupestris L.heat-dissipating granules was evaluated by cluster analysis.RESULTS The thin layer chromatographic spots of Artemisia were clear,distinctive and specific.The linear equation of artemisia acid is y=37.906x+32.428,r^(2)=0.9998;In the range of 2.45-78.48μg·mL^(-1),the linear relationship with peak area was good.The linear equation of gallic acid is y=33.38x+34.727,r^(2)=0.9998;Gallic acid was in the range of 8.02-256.69μg·mL^(-1) and had a good linear relationship with the peak area.HPLC characteristics of 10 batches of granules showed 14 calibration peaks with similarity>0.9.The samples were divided into 2 categories by cluster analysis.CONCLUSION The established quality control method is simple,accurate,specific and reproducible.This methord could be applied to quality control of heat dissipating Aimini particles.

关 键 词：维药一枝蒿散热颗粒 质量标准 薄层色谱鉴别 含量测定 指纹图谱 

分 类 号：R927[医药卫生—药学]