通脉制剂质量一致性评价  

Quality consistency evaluation of Tongmai preparations

作　　者：许佳慧 刘玉红[2] 黄志芳[2] 刘云华[2] 陈燕[2] 胥亭亭 易进海 XU Jia-hui;LIU Yu-hong;HUANG Zhi-fang;LIU Yun-hua;CHEN Yan;XU Ting-ting;YI Jin-hai(College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611130,China;Sichuan-Chongqing Joint Key Laboratory of Innovation of New Drugs of Traditonal Chinese Medicine,The Quality and Innovation Research of Chinese Materia Key Laboratory of Sichuan Province,Sichuan Provincial Academy of Chinese Medicine Sciences,Chengdu 610041,China)

机构地区：[1]成都中医药大学药学院,四川成都611130 [2]四川省中医药科学院,中药新药创制川渝共建重点实验室,中药材品质及创新中药研究四川省重点实验室,四川成都610041

出　　处：《中成药》2025年第3期709-716,共8页Chinese Traditional Patent Medicine

基　　金：四川省省级科研院所科技成果转化项目(2024ZHYS0015);四川省中医药管理局科研专项“区域创新研究”(2024ZD012);四川省科技厅重点实验室中药材品质及创新中药(A-2022N-47)。

摘　　要：目的评价通脉颗粒、通脉片、通脉胶囊、通脉口服液的质量一致性。方法建立HPLC指纹图谱,测定丹参素、原儿茶醛、3′-羟基葛根素、葛根素、葛根素芹菜糖苷、大豆苷、阿魏酸、丹酚酸B、丹酚酸A含量,聚类分析和主成分分析从日摄入量角度进行质量分析。结果39批样品指纹图谱中有21个共有峰,相似度0.765~0.997。各批样品聚为5类,2个主成分累积方差贡献率为83.53%。不同剂型中各成分日摄入量差异明显,尤其是丹酚酸B;片剂、胶囊中其日摄入量较低,并且同一剂型之间存在不均一性。结论该方法简便准确,可为评价不同厂家通脉制剂质量提供参考。AIM To evaluate the quality consistency of Tongmai Granules,Tongmai Tablets,Tongmai Capsules and Tongmai Oral Liquid.METHODS The HPLC fingerprints were established,after which the contents of danshensu,protocatechuic aldehyde,3′-hydroxy puerarin,puerarin,puerarin apioside,daidzin,ferulic acid,salvianolic acid B and salvianolic acid A were determined,and cluster analysis and principal component analysis were adopted in the quality analysis from the perspective of daily intake.RESULTS There were 21 common peaks in the fingerprints for 39 batches of samples with the similarities of 0.765-0.997.Various batches of samples were clustered into 5 categories,2 principal components demonstrated the accumulative variance contribution rate of 83.53%.The daily intakes of various constituents in different dosage forms exhibited obvious differences,especially for that of salvianolic acid B,which were low in tablets and capsules,and their heterogeneities existed among the same dosage forms.CONCLUSION This simple and accurate method can provide a reference for the quality evaluation of Tongmai preparations from different manufacturers.

关 键 词：通脉颗粒 通脉片 通脉胶囊 通脉口服液 HPLC指纹图谱 含量测定 聚类分析 主成分分析 

分 类 号：R927.2[医药卫生—药学]