LeBelle M, Pike R K, Graham S J, Ormsby E D, Bogard H A
Health Canada, Health Protection Branch, Drugs Directorate, Tunney's Pasture, Ottawa, Ont., Canada.
J Pharm Biomed Anal. 1996 May;14(7):793-800. doi: 10.1016/0731-7085(96)01730-x.
Four commercially available beclomethasone metered dose inhalers were analyzed for both spray content uniformity and particle size. The drug contents of primed and unprimed sprays collected at the beginning of the lifetime of the canister were not significantly different from those collected throughout the experiment. Particle size analysis of the four products using the Andersen Cascade Impactor Mark II showed that the distribution profiles were not identical. An existing HPLC method was modified to quantitate single sprays for content uniformity and to measure the amount on an impactor stage for particle sizing.
对四种市售倍氯米松定量吸入器的喷雾含量均匀性和粒径进行了分析。在药罐使用寿命开始时收集的已启动和未启动喷雾的药物含量与整个实验过程中收集的药物含量无显著差异。使用安德逊二级串联冲击器对这四种产品进行粒径分析，结果表明分布曲线并不相同。对现有的高效液相色谱法进行了改进，以定量单次喷雾的含量均匀性，并测量冲击器级上的量以进行粒径测定。
