基于蛇床子配方颗粒的标准汤剂质量标准

Study on Quality Standard of Standard Decoction of Based on Shechuangzi Formula Granules

目的:对蛇床子饮片进行标准汤剂制备,并研究其质量标准。方法:按照中药配方颗粒质量控制与标准制定技术要求中的相关规定,对15批产自不同地区的蛇床子饮片进行标准汤剂制备,对其主含成分蛇床子素进行含量测定,计算15批标汤的出膏率及蛇床子素的含量转移率,并对高效液相色谱法(HPLC)特征图谱进行方法建立。结果:蛇床子素转移率为3.35%~6.09%,出膏率为14.10%~19.93%。对特征谱图中的8个特征峰中的5个色谱峰进行了指认。结论:蛇床子饮片标准汤剂符合中药配方颗粒质量控制与标准制定技术要求中的相关规定,测定方法精密度、稳定性和重复性良好,可以为蛇床子配方颗粒的质量控制提供参考。

Objective:To prepare the standard Shechuangzi Decoction Pieces and study its quality standard.Methods:According to the relevant provisions of the technical requirements for the quality control and standard formulation of Chinese medicine formula granules,a total of 15 batches of Shechuangzi Decoction Pieces from different origins were prepared for standard decoction.The content of osthole in its main component was determined,the cream extraction rate and the content transfer rate of osthole in 15 batches of standard decoction were calculated,and the HPLC characteristic map method was developed.Results:By analyzing the determination results of 15 batches of standard decoction of Shechuangzi Decoction Pieces,the transfer rate of osthole ranged from 3.35%to 6.09%.The extraction rate was 14.10%-19.93%.A HPLC characteristic atlas analysis was established,and 5 chromatographic peaks were identified from 8 characteristic peaks in characteristic atlas.Conclusion:The standard decoction of Shechuang zi Decoction Pieces meets the relevant regulations in the technical requirements for quality control and standard formulation of Chinese medicine formula granules.The determination method has good precision,stability and repeatability,and can provide reference for the quality control of the Shechuangzi Formula Granules.