6种沙丁胺醇气雾剂的质量比较

 目的:对国内市场上6种沙丁胺醇气雾剂的每喷药量和粒径分布特征进行比较?方法:按照英国药典,采用手动喷射和二室碰撞取样器,利用HPLC进行测定,并分别计算标示喷数前、中、后10喷的平均每喷药量和零、一、二级沉积百分数?结果:6种产品的每喷药量均能控制在药典规定范围内,但粒径分布差异较大:两种溶液型产品的可呼吸分数均低于10%;混悬型产品中,F的第二级沉积量较低(21.72%),A产品与D,E产品接近(均高于35%),其中A略优?结论:国产沙丁胺醇气雾剂的粒径分布与合资药厂相比仍存在较大的差距,需要对制剂工艺进行改进?由于不同品牌间质量的可能差异,临床医生在进行用药替换时,需要考虑不同厂牌药物的生物等效性问题?

In vitro comparison of salbutamol metered dose inhalers

OBJECTIVE:To compare the content of salbutamol per actuation and the particle size distribution of six brands of salbutamol metered dose inhalers on the civil market. METHOD:Twin impinger was used to determine the particle size distribution of salbutamol metered dose inhalers. HPLC was used to determine the salbutamol content. RESULTS:There was no difference in salbutamol content per actuation among the experiment samples, but the six products had significantly different particle size distribution. CONCLUSION:It indicated that there were statistic differences between the six brands investigated. It also suggested that the clinicians had better consider the bioequivalence of different products before switching from one brand to another.