扎那米韦粉雾剂的研制  

Development of Zanamivir Powder Aerosol

作　　者：薛涛 黄乐冉 杨建龙 张成龙 吴恒坤 岳勇铭 王志城 常芷健 李剑男 Xue Tao;Huang Leran;Yang Jianlong;Zhang Chenglong;Wu Hengkun;Yue Yongming;Wang Zhicheng;Chang Zhijian;Li Jiannan(Quality department,Shenwei pharmaceutical Sichuan Co.,Ltd,Qionglai,Sichuan 611530,China;College of Pharmacy,Changchun University of Chinese Medicine,Changchun,Jilin 130117,China;Changchun Municipal Food and Drug Inspection Center,Changchun,Jilin 130000,China)

机构地区：[1]神威药业(四川)有限公司品质部,四川邛崃611530 [2]长春中医药大学药学院,吉林长春130117 [3]长春市食品药品检验中心,吉林长春130000

出　　处：《伊犁师范大学学报（自然科学版）》2023年第2期45-54,76,共11页Journal of Yili Normal University：Natural Science Edition

基　　金：国家大学生创新创业训练计划项目(201510199060);吉林省科技厅资助项目(02070021)。

摘　　要：通过对扎那米韦吸入粉雾剂原研品的研究,以显微镜观察原研品内容物;对自研制剂吸入装置、载体辅料及胶囊进行选择,并对原料药的微粉化方法进行确认;以吸湿增重为评价指标对原料药和粉雾剂内容物的吸湿性进行评价,以休止角为评价指标对物料流动性进行评价,并进行中试生产,考察自研制剂稳定性.选择Aerolizer作为吸入装置,以进口乳糖作为粉雾剂载体,将内容物装入羟丙甲纤维素胶囊中,制备出自研制剂.研究证明,自研制剂原料药粒径5μm以下至少占95%,微粉化的原料药和粉雾剂内容物均无吸湿性,物料休止角符合生产要求,微粉化工艺、制剂工艺对本品的晶型无影响,中试样品的质量和稳定性符合标准要求.The research on the original product of Zanamivir inhalation powder aerosol was conducted by means of observing the contents of the original product under a microscope,selecting the self-made inhalation device,carrier excipients and capsules,and confirming the micronization method of theAPI,evaluating the hygroscopicity of theAPI and powder aerosol contents by hygroscopic weight gain,evaluating the fluidity of materials by the angle of repose,conducting pilot production and investigating the stability of self-made products.Aerolizer was selected as the inhalation device,imported lactose was used as the powder carrier,and the self-made content was put into the hypromellose capsule to prepwere the self-made product.The results showed that the particle size of the self-developed API was at least 95% below 5 μm,the micro-powdered API and powder aerosol content had no hygroscopicity,the angle of repose of the material met the production requirements,the micro-powdered process and preparation process had no effect on the crystal shape of the product,and the quality and stability of the pilot test sample met the standard requirements.

关 键 词：扎那米韦 原料药 原研品 吸入粉雾剂 

分 类 号：R944.9[医药卫生—药剂学]