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金丹附延颗粒挥发油包合工艺研究

朱良辉 吴倩颖 陈伟康 刘德鸿 陈希 缪贵忠

化学试剂2026,Vol.48Issue(5):39-47,9.
化学试剂2026,Vol.48Issue(5):39-47,9.DOI:10.13822/j.cnki.hxsj.2026.0036

金丹附延颗粒挥发油包合工艺研究

Research on the Volatile Oil Embedding Process of Jindan Fuyan Granules

朱良辉 1吴倩颖 2陈伟康 1刘德鸿 1陈希 1缪贵忠3

作者信息

  • 1. 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029
  • 2. 江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029||江西中医药大学药学院,江西南昌 330004
  • 3. 江西华太药业有限公司,江西宜丰 336300
  • 折叠

摘要

Abstract

This study aimed to optimize the preparation process of a β-cyclodextrin(β-CD)inclusion complex containing the volatile oil from Jindan FuYan Granules via the saturated aqueous solution method.On the basis of single-factor experiments,response surface methodology(RSM)was employed to investigate the effects of the temperature,stirring time,stirring speed,and mass-volume ratio of β-CD to volatile oil,with the comprehensive score of the inclusion rate,yield,and drug loading capacity set as the evaluation index.Design-Expert 13 software was applied to analyze the interactions of various factors and optimize the process parameters.Four characterization experiments,including scanning electron microscopy,thin-layer chromatography,Fourier transform infrared spectroscopy,and ultraviolet-visible spectroscopy,were performed to verify the successful formation of the inclusion complex.The optimal inclusion process parameters were determined as follows:experimental temperature of 30 ℃,stirring time of 2.15 h,stirring speed of 1400 r/min,and mass-volume ratio of β-CD to volatile oil of 6∶1.The P-value of the RSM model was less than 0.05,and the coefficient of determination(R2)was greater than 0.9,indicating favorable fitting performance and high feasibility of the established model.A significant interaction was detected between the stirring speed and the mass-volume ratio of β-CD to volatile oil.The four characterization experiments verified the differences between the inclusion complex and raw materials from multiple dimensions,confirmed the successful formation of the inclusion complex,and proved the stability and reliability of the optimized process.This study optimizes the preparation process of a β-CD inclusion complex containing volatile oil from Jindan FuYan Granules.The established method is stable and feasible,and can provide insights for subsequent research and development of related industrial production.

关键词

金丹附延颗粒/挥发油/包合物/响应面/饱和水溶液法

Key words

Jindan Fuyan Granules/volatile oil/inclusion complex/response surface methodology/saturated aqueous solution method

分类

化学化工

引用本文复制引用

朱良辉,吴倩颖,陈伟康,刘德鸿,陈希,缪贵忠..金丹附延颗粒挥发油包合工艺研究[J].化学试剂,2026,48(5):39-47,9.

基金项目

2023年江西省药品监督管理局重点项目(2023JS11). (2023JS11)

化学试剂

0258-3283

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