金丹附延颗粒挥发油包合工艺研究OA

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.