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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。
OBJECTIVE: To compare the distribution of each of the six salbutamol aerosol sprays and particle sizes in the domestic market. Methods: According to the British Pharmacopoeia, manual injection and two-chamber collision sampler were used to determine by HPLC. The average spray amount, zero, first and second deposition percentage of 10 spray before, during and after spraying were calculated respectively. Results: The spray volume of 6 kinds of products can be controlled within the scope of Pharmacopoeia, but the particle size distribution is quite different: the respirable fraction of the two kinds of solution products is less than 10% The second deposition was lower (21.72%), A products and D, E products are close (both higher than 35%), where A slightly better. Conclusion: The particle size distribution of domestic albuterol aerosols still has a big gap compared with the joint-venture pharmaceutical companies, and the preparation technology needs to be improved. Due to the possible differences in the quality of different brands, clinicians need to consider the bioequivalence issues of different brands of medicines when performing drug replacement.