基于标准汤剂的海金沙草配方颗粒质量标准研究

Study on quality standard of Lygodium japonicum(Thunb.)Sw.formula granules based on standard decoction

目的基于标准汤剂建立海金沙草配方颗粒的质量标准。方法采用HPLC法测定饮片、标准汤剂和配方颗粒中咖啡酸的质量分数,计算转移率。建立标准汤剂和配方颗粒HPLC特征图谱分析方法及TLC鉴别方法。结果通过对18批海金沙草质量分数进行测定,标准汤剂咖啡酸的质量分数为0.22~1.11 mg/g,转移率为48.7%~92.8%,3批配方颗粒咖啡酸的质量分数分别为0.65、0.64、0.61 mg/g,转移率分别为86.5%、85.1%、81.1%;18批标准汤剂HPLC特征图谱中有11个共有峰,指认了原儿茶酸、咖啡酸、4-香豆酸、异槲皮苷、山柰酚-3-O-芸香糖苷、蒙花苷6种成分,特征图谱相似度大于0.90,聚为3类,3种主成分统计的累积方差贡献率达93.86%,3批配方颗粒HPLC特征图谱中有11个共有峰,相似度分别为0.974、0.988、0.989;TLC信息丰富,斑点清晰,分离度良好。结论所建立的方法合理可靠,可全面评价海金沙草配方颗粒质量,为其质量控制提供参考。

Objective To establish the quality standard of formula granules based on standard decoction.Methods The content of caffeic acid in decoction pieces,standard decoction and formula granules was determined by HPLC,and the transfer rate was calculated.HPLC chromatographic analysis method and TLC identification method were established for standard decoction and formula granules.Results By measuring the mass fraction of 18 batches of Lygodium japonicum(Thunb.)Sw,the content of caffeic acid in standard decoction was 0.22-1.11 mg/g,and the transfer rate was 48.7%-92.8%,which in the three batches of formula granules was 0.65,0.64 and 0.61 mg/g,and the transfer rates were 86.5%,85.1%and 81.1%.There were 11 common peaks in the HPLC chromatograms of 18 batches of standard decoction,and 6 components were identified as protocatechuic acid,caffeic acid,4-coumaric acid,isoquercetin,kaempferol-3-O-rutin and montanin,and the similarity of chromatograms was greater than 0.90 which clustered into 3 categories.The cumulative variance contribution rate of the three principal components was 93.86%.There were 11 common peaks in the HPLC characteristics chromatgrams of the three batches of formula particles,and the similarity was 0.974,0.988,0.989,respectively.TLC had rich information,clear spots and good separation.Conclusion The established methods are reasonable and reliable,which can be used to evaluate the quality of Lygodium japonicum(Thunb.)Sw.formula granule,and provide reference for its quality control.