基于标准汤剂的葛花(甘葛藤)配方颗粒质量标准

Study on quality standard of Pueraria(Kudzu)formula granules based on standard decoction

目的基于标准汤剂的研究建立葛花(甘葛藤)配方颗粒的质量标准。方法采用HPLC法测定葛花饮片、标准汤剂和配方颗粒中射干苷的质量分数,并计算转移率。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19批葛花(甘葛藤)饮片中射干苷质量分数为0.46%~2.19%,标准汤剂中射干苷的质量分数为7.4~26.3 mg/g,转移率为31.2%~55.7%,3批配方颗粒中射干苷的质量分数分别为14.3、12.6、10.5 mg/g,转移率分别为36.3%、37.6%、32.2%;19批标准汤剂HPLC特征图谱中有5个共有峰,指认了6″-O-木糖黄豆黄苷、黄豆黄苷、鸢尾黄素-7-O-木糖葡萄糖苷、染料木苷、射干苷5种成分,特征图谱相似度大于0.90,聚为4类,2种主成分统计的累积方差贡献率为81.963%,3批配方颗粒HPLC特征图谱中同样有5个共有特征峰,相似度分别为0.979、0.981、0.985;TLC法测定信息丰富、斑点清晰、分离度良好。结论所建立的方法稳定、合理,可全面评判葛花(甘葛藤)配方颗粒的质量,为其质量控制提供依据。

Objective To establish the quality standard of Pueraria(Kudzu)formula granules based on the study of standard decoction.Methods HPLC was used to determine the content of radioglycoside in decoction pieces,standard decoction and formula granules,and the transfer rate was calculated.HPLC chromatographic analysis and TLC identification of standard decoction and formula granules were established.Results The mass fraction of radioglycoside in 19 batches of Kudzu decoction pieces was 0.46%-2.19%.The mass fraction of radioglycoside in standard decoction was 7.4-26.3 mg/g,and the transfer rate was 31.2%-55.7%.The mass fraction of 3 batches of formula granules was 14.3,12.6,10.5 mg/g,respectively,and the transfer rates were 36.3%,37.6%and 32.2%,respectively.There were 5 common peaks in the HPLC characteristic maps of 19 batches of standard decoction,and 5 components of 6″-O-xylososide,dzein,iristin-7-O-xyloglucoside,genistein and radioglycoside were identified.The similarity of the characteristic maps was greater than 0.90,and the clustering was 4 classes.The cumulative variance contribution rate of the two principal components was 81.963%.There were also 5 common characteristic peaks in the HPLC chromatograms of the three batches of formula granules,and the similarity was 0.979,0.981,0.985,respectively.It could provide rich information,clear spots and good separation with TLC.Conclusion The established method is stable and reasonable,which can be used to evaluate the quality of the formula granules,and provide a basis for its quality control.