基于模型的银杏叶提取物冷冻干燥优化的研究

摘要

为了对银杏叶提取物冷冻干燥工艺进行优化,文章进行了传热传质模型的建立及简化,测量了银杏叶提取物的干层传质阻力系数等,进行了工艺模拟,给出了温度在-40--15℃,压力从2-40 Pa的范围,升华时间小于100 h的模拟结果,模拟结果显示:压力越低升华时间越短,温度越高升华时间越短.在温度较低时,压力的变化对升华时间影响较大,温度较高时,压力的变化对升华时间影响较小.据此模拟结果及冻干显微镜实验,确定了优化的工艺操作参数为Pc=8 Pa,制品的最高温度为32℃,并进行了冻干实验,实验获得冻干产品性能好.该方法可以为其他药品的冷冻干燥最优参数的确定及升华时间的预测提供借鉴.%In order to optimize the Ginkgo extracts lyophilization technology,the heat and mass transfer mathematical model were established and simplified,and the dry layer resistance coefficient and heat transfer coefficient was also obtained through experiment.The lyophilization simulation was carried out at the shelf temperature-40--15 ℃,chamber pressure 2-40 Pa and the sublimating dry time limits in 100 hours.The simulation results show that the lower the chamber pressure is,the shorter the sublimation drying time is,and the higher the shelf temperature is,the shorter the sublimation drying time is.Moreover,when the shelf temperature is low,the change of chamber pressure affects the sublimating dry time significantly,but when the shelf temperature is high,the change of chamber pressure affects the sublimating dry time less.Based on the results of simulation and the freeze-drying microscopy experiment,the optimum operation parameter were ensured as:chamber pressure is 8 Pa,the shelf temperature is-32 ℃.According to this parameter,the validity experiment is performed,and the product performance from experiment is good.The comparision results between experiments and simulation show that the simplified mathematical model is correct to simulate the lyophilization process to forecast the Ginkgo extracts sublimating drying time and give the optimum technology parameter.The simplified mathematical model can be applied in the other drug lyophilization process.