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
Quality of Process Control of Cortex Moutan Formulated Granule Based on Specific Chromatogram of High-performance Liquid Chromatography
  
DOI:
中文关键词:  牡丹皮  配方颗粒  特征图谱  过程控制  量值传递
英文关键词:Cortex Moutan  Formulated Granule  Specific chromatogram  Process control  Quantity value dissemination
基金项目:安徽省科技重大专项(17030801009)
作者单位
陈培胜,张 侠,孙婷婷,孟繁民,李 振,童佳兵,李泽庚 1.安徽济人药业有限公司安徽 亳州 2368002.安徽中医药大学第一附属医院安徽 合肥 2300313.安徽中医药大学安徽 合肥 230012 
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中文摘要:
      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Agilent HC-C18柱(250 mm×4.6 mm,5 μm);以乙腈-0.1%甲酸溶液为流动相梯度洗脱,检测波长254 nm,体积流量为1.0 mL/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。
英文摘要:
      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-C18 column (250 mm × 4.6 mm, 5 μm) 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.
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