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优选金丹附延颗粒挥发油的饱和水溶液法环糊精包合制备工艺。在单因素考察的基础上，以包合率、得率、载药量的综合评分为评价指标，采用响应面法，对温度、时间、转速、β-环糊精与挥发油质量体积比进行考察。通过Design-Expert13软件分析各因素的交互作用优选最佳工艺参数。利用4种表征实验(电子显微镜、薄层色谱图、红外光谱、紫外光谱)检验包合物是否已成功形成。最佳的包合工艺参数为：实验温度30℃、搅拌时间2.15 h，转速1400 r/min,β-环糊精与挥发油质量体积比6∶1；响应面结果P值<0.05,R2>0.9，表明该方案可行性高。转速和β-环糊精与挥发油质量体积比之间存在交互影响。4种表征实验从多维度验证了包合物与其他材料的区别，证实包合物已形成，表明该工艺稳定可靠。优化了金丹附延颗粒挥发油β-环糊精包合物的包合制备工艺，该方法稳定可行，可为后续相关生产的研究和开发提供参考。
Abstract：This study aimed to optimize the preparation process of aβ-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 ofβ-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 aβ-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.
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基本信息:
DOI：10.13822/j.cnki.hxsj.2026.0036
中图分类号:TQ461
引用信息:
[1]朱良辉,吴倩颖,陈伟康,等.金丹附延颗粒挥发油包合工艺研究[J].化学试剂,2026,48(05):39-47.DOI:10.13822/j.cnki.hxsj.2026.0036.
基金信息:
2023年江西省药品监督管理局重点项目（2023JS11）
2026-02-12
2026
2026-03-16
2026-03-16
2026
1
2026-03-26
2026-03-26
2026-03-26