机构地区:[1]江西中医药大学,江西南昌330004 [2]中药固体制剂制造技术国家工程研究中心,江西南昌330006
出 处:《中药新药与临床药理》2023年第5期668-674,共7页Traditional Chinese Drug Research and Clinical Pharmacology
基 金:中药材大品种铁皮石斛产业链关键技术研究(20203ABC28W019);江西省中医药标委会2020年度第二批标准化项目(2020B07);江西中医药大学博士科研启动基金(2021BSZR021);南昌市博士科研创新中心科研项目(BSKYCXZX 2021-001)。
摘 要:目的基于“辨状论质”建立杜仲药材质量等级标准,并通过高效液相色谱(HPLC)指纹图谱对不同等级药材进行评价。方法以28批杜仲药材为研究对象,测定外在性状(厚度、杜仲胶、皮长、皮宽、内表皮颜色)和内在质量指标性成分(松脂醇二葡萄糖苷、京尼平苷酸、京尼平苷和京尼平含量),并进行Pearson相关性分析,结合主成分分析、正交偏最小二乘判别分析和K-均值聚类分析筛选指标,建立杜仲药材质量等级标准。建立28批杜仲药材的HPLC指纹图谱,运用系统聚类分析对不同等级的杜仲药材进行质量评价。结果相关性分析表明,杜仲胶含量及药材规格大小与杜仲内在质量无显著性相关,指标筛选确定厚度、松脂醇二葡萄糖苷、京尼平苷酸为等级划分的关键指标,结合市场实际情况,制定了杜仲一等、二等、统货的质量等级标准。建立的杜仲药材HPLC指纹图谱中有10个共有峰,以共有峰面积进行聚类分析可将不同等级杜仲药材明显分为3类,表明该标准可体现不同等级间的药材质量。结论所建立的质量等级标准不仅从外观性状上对杜仲进行了等级评价,同时在其内在质量差异上进行了表征,可为相关标准的建立提供参考。Objective The quality grade standard of Eucommiae Cortex was established based on the“quality evaluation through morphological identification”,and different grades of Eucommiae Cortex were evaluated by high performance liquid chromatography(HPLC)fingerprint.Methods Taking 28 batches of Eucommiae Cortex as the research objects,we determined the external properties(thickness,gutta-percha,length,width,innerepidermis color)and index components of internal quality(pinoresinol diglucoside,geniposidic acid,geniposide and genipin content).Pearson correlated analysis was carried out and the quality grade standards of Eucommiae Cortex were established after combining principal component analysis,partial least squares analysis and K-means clustering analysis.The HPLC fingerprints of 28 batches of Eucommiae Cortex were established,and the quality of different grades of Eucommiae Cortex was evaluated by systematic cluster analysis.Results The correlation analysis results showed that the content of gutta-percha and the size of medicinal materials were not significantly related to the intrinsic quality of Eucommiae Cortex.It has been concluded that thickness,pinoresinol diglucoside and geniposidic acid were the key indicators of grade division by the index screening.Considering the actual conditions of market,we set quality grade standards of Eucommiae Cortex for first-class,second-class,and third-class.There are 10 common peaks in the HPLC fingerprint of Eucommiae Cortex,and cluster analysis of the common peak area can clearly divide Eucommiae Cortex into 3 categories.It is indicated that this standard can reflect the quality of medicinal materials between different grades.Conclusion This established quality grade standard not only evaluates Eucommiae Cortex from the appearance and characteristics,but also characterizes its inherent quality differences,which provides reference for the establishment of relevant standards.
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