淫羊藿苷喷雾干燥所得干粉吸入剂的制备与干粉吸入装置的评价  

Preparation of icariin dry powder inhalation by spray drying and evaluation of dry powder inhalation device

作　　者：周扬[1] 洪燕龙 刘逊[1] 孙锋[1] 王慧芳[1] 宋如珺 韩赟 ZHOU Yang;HONG Yan-long;LIU Xun;SUN Feng;WANG Hui-fang;SONG Ru-jun;HAN Yun(Suzhou Vocational Health College,Suzhou Key Laboratory of Medical Biotechnology,Suzhou 215009,China;Shanghai University of Traditional Chinese Medicine,Shanghai Collaborative Innovation Center of TCM Health Service,Shanghai 201203,China;Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine,Suzhou 215009,China)

机构地区：[1]苏州卫生职业技术学院,苏州检验医学生物技术重点实验室,苏州215009 [2]上海中医药大学,上海中医健康服务协同创新中心,上海201203 [3]南京中医药大学附属苏州市中医医院,苏州215009

出　　处：《中华中医药杂志》2021年第8期4917-4923,共7页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：江苏省卫生健康委医学科研项目(No.Z2019051)。

摘　　要：目的:制备载药量高、质量合格的淫羊藿苷吸入微粉和优选干粉吸入装置。方法:采用B-290喷雾干燥仪制备淫羊藿苷吸入微粉,确定辅料为甘露醇,以平均粒径、收率和吸湿率为评价指标,考察进风口温度、气体体积流量和进料体积流量对制备工艺的影响,得到淫羊藿苷微粉最佳制备工艺。采用计算流体动力学(CFD)进行微粉颗粒在2种吸入装置内部的运动情况模拟,并与体外沉积结果进行对比,优选干粉吸入装置。结果:淫羊藿苷微粉最佳工艺条件为进风口温度130℃,气体体积流量630L/h,进料体积流量2mL/min,药液质量分数2%,药物与辅料比3∶7。制得的淫羊藿苷吸入微粉收率高,吸湿性好,物理性质稳定。体外沉积实验表明圆筒型装置(Twister)优于长吸嘴刺破型装置(Osmohaler),CFD模拟结果表明Twister结构更有利于微粉颗粒吸出。结论:采用喷雾干燥技术制备淫羊藿苷微粉的工艺可靠稳定,Twister装置更适合作为淫羊藿苷吸入微粉的干粉吸入装置。Objective:To prepare icariin inhalation powder with high drug loading and quality,and to optimize dry powder inhalation device.Methods:B-290 spray dryer was used to prepare icariin inhalation powder and the excipient was mannitol.The average particle size,yield and moisture absorption rate were used as evaluation indexes,then the air inlet temperature,gas volume flow rate and feed volume flow rate on the preparation process were investigated,and the best preparation process of icariin micro powder was obtained.Computational fluid dynamics(CFD)was used to simulate the movement of drug particles in the two kinds of inhalation devices,and the results were compared with the in vitro deposition results to optimize the dry powder inhalation device.Results:The optimal process conditions of icariin powder were as follows:air inlet temperature at 130℃,gas volume flow rate at 630L/h,feed volume flow at 2mL/min,liquid mass fraction at 2%with drug and excipient ratio of 3∶7.The obtained icariin inhalation powder has high yield,good hygroscopicity and stable physical properties.In vitro deposition experiments demonstrated that Twister was better than Osmohaler.CFD simulation results showed that the structure of Twister was more conducive to the extraction of dry powder particles.Conclusion:The preparation technology of icariin micro powder by spray drying technology is reliable and stable.Twister is more suitable for dry powder inhalation device of icariin inhalation powder.

关 键 词：肺部疾病 喷雾干燥 淫羊藿苷 吸入微粉 计算流体动力学 干粉吸入剂 工艺 干粉吸入装置 

分 类 号：R283.6[医药卫生—中药学]