中成药

目的 评价连花清瘟胶囊、银翘解毒颗粒质量。方法 建立HPLC指纹图谱，进行层次聚类分析、主成分分析、正交偏最小二乘法-判别分析，测定连翘酯苷A、连翘酯苷B、连翘苷、连翘脂素、绿原酸、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸的含量。结果 13批连花清瘟胶囊指纹图谱中有40个共有峰，指认出10个，相似度均大于0.98,各批样品聚为2类，7个主成分累积方差贡献率为92.610%;10批银翘解毒颗粒指纹图谱中有34个共有峰，指认出8个，相似度均大于0.94,各批样品聚为2类，2个主成分累积方差贡献率为93.714%。7种成分在各自范围内线性关系良好(r≥0.999 7),平均加样回收率99.14%～102.91%,RSD 1.32%～2.48%。结论 该方法稳定可靠，可用于连花清瘟胶囊、银翘解毒颗粒的质量控制，并可为含有相似组成的其他中成药质量评价提供参考。

AIM To evaluate the quality of Lianhua Qingwen Capsules and Yinqiao Jiedu Granules.METHODS The HPLC fingerprints were established, after which hierarchical cluster analysis, principal component analysis and orthogonal partial least squares-discriminant analysis were performed, the contents of forsythoside A, forsythoside B, forsythiaside, forsythol, chlorogenic acid, 3,5-di-O-caffeoylquinic acid and 4,5-di-O-caffeoylquinic acid were determined.RESULTS There were 40 common peaks in the fingerprints for 13 batches of Lianhua Qingwen Capsules with the similarities of more than 0.98, 10 of which were identified, and various batches of samples were clustered into 2 types, 7 principal components demonstrated the accumulative variance contribution rate of 92.610%; there were 34 common peaks in the fingerprints for 10 batches of Yinqiao Jiedu Granules with the similarities of more than 0.94, 8 of which were identified, and various batches of samples were clustered into 2 categories, 2 principal components demonstrated the accumulative variance contribution rate of 93.714%. Seven constituents showed good linear relationships within their own ranges(r≥0.999 7), whose average recoveries were 99.14%-102.91% with the RSDs of 1.32%-2.48%.CONCLUSION This stable and reliable method can be used for the quality control of Lianhua Qingwen Capsules and Yinqiao Jiedu Granules, whicn can provide a reference for the quality evaluation of other Chinese traditional patent medicines with similar prescriptions.