扎那米韦吸入粉雾剂理化性质及其初步稳定性考察  

Physicochemical Property and Stability of Zanamivir Dry Powder Inhalation

作　　者：郭娜[1,2] 杨阳[2] 杨资伟[3] 王思玲[1] 梅兴国[2] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]军事医学科学院毒物药物研究所,北京100850 [3]武汉工程大学,武汉430073

出　　处：《中国药学杂志》2012年第23期1911-1914,共4页Chinese Pharmaceutical Journal

基　　金：国家科技重大专项资金项目(2009ZX09301-002)

摘　　要：目的研究扎那米韦吸入粉雾剂的理化性质并考察其稳定性。方法采用喷雾干燥法制备扎那米韦吸入粉雾剂,考察其吸湿性及临界相对湿度;观察其粒径分布、粉末形态;热重(TGA)法测定其水分;检测其排空率和沉积率;对制剂进行加速实验和长期实验以考察其稳定性。结果所得扎那米韦制剂的临界相对湿度为67%,平均空气动力学径小于5μm,样品所含水分小于5%,排空率均大于90%,肺部沉积率均大于30%;稳定性实验中各指标在观察期内无明显变化。结论所制扎那米韦吸入粉雾剂适合肺部吸入给药,且具有较好的稳定性。OBJECTIVE To study the physicochemical property and stability of zanamivir dry powder inhalation （ZDI）. METHODS ZDI was prepared by spray-drying method. The hygroscopicity, relative humidity, particle size, powder morphology, emptying rate and deposition rate of the inhalation were determined. Water contents were analyzed by TGA. The stability of ZDI was determined by accelerated test and long-term test. RESULTS The resultant powder inhalation exhibited the following properties ： crit- ical relative humidity was 67%, and average aerodynamic diameter do was 〈 5 μm;DTA showed that the water content of the samples was less than 5% ;emptying rate was 〉 90%, and deposition rate was 〉 30% for thress batches of samples; the accelerated test and the long-term test indicated that zanamivir dry powder inhalation was stable. CONCLUSION Zanamivir dry powder inhalation is stable and suitable for drug delivery.

关 键 词：扎那米韦 吸入粉雾剂 肺部沉积率 理化性质 稳定性 

分 类 号：R944[医药卫生—药剂学]