基于标准汤剂的地耳草配方颗粒质量标准研究

Study on the quality standard of Hypericum japonicum Thunb formula granules based on standard decoction

目的以地耳草标准汤剂为基础建立其配方颗粒的质量标准,为地耳草配方颗粒质量评价提供参考。方法采用高效液相色谱法测定饮片、标准汤剂及配方颗粒中槲皮苷、异槲皮苷的质量分数,计算2种成分转移率,并且采用高效液相色谱建立了标准汤剂及配方颗粒特征分析方法。结果15批标准汤剂样品中槲皮苷、异槲皮苷的质量分数为13.66~32.11 mg/g,4.00~16.81 mg/g,转移率为45.7%~63.5%,37.8%~56.9%,3批配方颗粒槲皮苷的质量分数为16.16、17.02、16.52 mg/g,转移率为55.2%、58.2%、55.3%,异槲皮苷的质量分数为7.61、7.93、7.56 mg/g,转移率为45.0%、48.8%、44.7%;各样品特征图谱与对照图谱的相似度均大于0.90,所建立的特征图谱标定共有峰7个,其中指认了4个,峰3为异槲皮苷、峰5为槲皮苷、峰6为白前苷B、峰7为槲皮素;聚为2类,2种主成分的累积方差贡献率达84.85%。结论所创建的质量分数测定及特征图谱HPLC方法的专属性强、重复性好、合理准确,得到的地耳草标准汤剂、配方颗粒一致性良好,可以对地耳草配方颗粒的质量进行控制和整体性评价提供参考。

Objective The quality standard of the formula granules was established based on the standard decoction of Hypericum japonicum Thunb to provide reference for the quality evaluation of the formula granules.Methods The contents of quercetin and isoquercetin in decoction pieces,standard decoction and formula granules were determined by high performance liquid chromatography(HPLC),and the transfer rates of the two components were calculated.The analysis method of standard decoction and formula granules was established by HPLC.Results The contents of quercetin and isoquercetin in 15 batches of standard decoction were 13.66-32.11 mg/g,4.00-16.81 mg/g,the transfer rates were 45.7%-63.5%,37.8%-56.9%.The contents of quercetin in 3 batches of formula granules were 16.16,17.02 and 16.52 mg/g,the transfer rate was 55.2%,58.2%,55.3%.The isoquercitrin content was 7.61,7.93,7.56 mg/g,and the transfer rate was 45.0%,48.8%and 44.7%.The similarity between the characteristic maps of each sample and the control maps was greater than 0.90.The established characteristic maps identified a total of 7 peaks,of which 4 were identified.Peak 3 was isoquercetin,peak 5 was quercetin,peak 6 was leucoside B and peak 7 was quercetin.It was divided into two categories,the cumulative variance contribution of the two principal components was 84.85%.Conclusion The established HPLC method of content determination and characteristic map is specific,reproducible,reasonable and accurate,and the obtained standard decoction and formula granules are in good consistency,which can provide a reference for the quality control and overall evaluation of the formula granules.