基于高效液相色谱特征图谱分析牡丹皮配方颗粒过程控制的质量

目的建立牡丹皮配方颗粒中间产品及成品的高效液相色谱特征图谱,分析生产过程控制的质量。方法采用高效液相色谱法,色谱柱为AgilentHC-C18柱(250mm×4.6mm,5μm);以乙腈-0.1%甲酸溶液为流动相梯度洗脱,检测波长254nm,体积流量为1.0mL/min,柱温30℃。以特征图谱为对照,对药材-饮片-浸膏粉及颗粒进行相关性评价。结果牡丹皮10批药材、饮片、浸膏粉和颗粒特征图谱均呈现12个共有特征峰,有良好的相关性。结论建立的牡丹皮药材-饮片-浸膏粉及颗粒的高效液相色谱特征图谱,为牡丹皮配方颗粒的工艺研究和过程控制提供参考。

Quality of Process Control of Cortex Moutan Formulated Granule Based on Specific Chromatogram of High-performance Liquid Chromatography

Objective To establish the high-performance liquid chromatography(HPLC)specific chromatogram of semifinished and finished products of Cortex Moutan formulated Granule,and to investigate the quality of production process control.Methods HPLC was performed on an Agilent HC-C 18 column(250 mm×4.6 mm,5μm)with a mobile phase of acetonitrile-0.1%phosphoric acid solution for gradient elution,at a detection wavelength of 254 nm,a flow rate of 1.0 mL/min,and a column temperature of 30℃.With the specific chromatogram as a control,the correlation between medicinal material,decoction pieces,extract powder,and granules was evaluated.Results A total of 12 common characteristic peaks were identified for all the 10 batches of medicinal material,decoction pieces,extract powder,and granules of Cortex Moutan,suggesting a good correlation between them.Conclusion The HPLC specific chromatogram is established for medicinal material,decoction pieces,extract powder,and granules of Cortex Moutan,which provides a reference for the technical study and process control of Cortex Moutan formulated Granule.