基于不同茎叶比的仙鹤草配方颗粒研究

Study on the Formulation Granules of Agrimony Based on the Comparison of Different Medicinal Parts

目的:建立一个仙鹤草配方颗粒指标性含量数据筛选的方法。方法:基于仙鹤草茎、叶在黄酮类与鞣花酸的含量差异,以仙鹤草标准汤剂中茎叶比例为横坐标、黄酮/鞣花酸含量比为纵坐标建立仙鹤草标准汤剂所用饮片茎叶比例预测模型,并结合仙鹤草药材自然环境生长状况下茎/叶比例对数据进行筛选,确定入选用于仙鹤草配方颗粒指标性含量制定的仙鹤草标准汤剂参照数据。结果:通过对数据的筛选,确定了仙鹤草标准汤剂槲皮苷的含量范围为1.33~2.47 mg/g,鞣花酸的含量范围为1.35~2.50 mg/g。结论:建立的黄酮/鞣花酸含量比的方法可预测仙鹤草配方颗粒所用饮片的茎叶比例,利用茎/叶比例对仙鹤草标准汤剂指标性含量数据进行筛选,所得范围较筛选前明显缩窄,以此制定的指标性含量限度范围可有效地保证生产的中药配方颗粒与临床所用饮片的一致性。

Objective:To establish a method for screening the samples of Agrimony standard decoction for determining the content limit of agrimony formula granules.Methods:Based on the difference between the contents of flavonoids and ellagic acid in the stem and leaves of Agrimony,a prediction model was established with the content of leaves as the abscissa and the ratio of flavonoids to ellagic acid as the ordinate to determine the leaves content of the decoction pieces used in standard agrimony decoction,and the samples of the standard agrimony decoction used in the preparation of the limit of the content of Agrimony formula particles was determined with the content of Agrimony leaves under the growth state of the natural environment as the screening standard.Results:By filtering the data,the content range of quercitroside in the standard decoction of Agrimony was determined to be 1.33~2.47 mg/g,and the content range of ellagic acid was 1.35~2.50 mg/g.Conclusion:The established method can predict the amount of leaves in the decoction pieces used in Agrimony formula granules,and be screend by the natural conditions.The range obtained is significantly narrower than that before screening.The index content limit range of the Agrimony formula granules formulated after screening can effectively ensure the consistency between the produced traditional Chinese medicine granules and the decoction used in clinic.