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目的:考察不同药厂生产的多潘立酮片的体外溶出情况,为临床用药提供参考。方法:参照日本在“药品品质再评价”拟定流程中对溶出度试验条件的规定,分别考察不同药厂多潘立酮片在水、pH 1.2人工胃液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,同时和部颁标准中规定的多潘立酮片溶出方法进行比较。结果:各药厂生产的多潘立酮片在酸性介质中均溶出良好,在水和pH 6.8磷酸盐缓冲液中6 h溶出均低于60%。结论:同一批多潘立酮片在不同溶出介质中溶出差异很大;不同药厂多潘立酮片的质量有显著性差异,临床用药时应加以注意。
Objective: To investigate the in vitro dissolution of domperidone tablets produced by different pharmaceutical factories, and to provide reference for clinical use. Methods: With reference to Japan’s prescription of dissolution test conditions in the process of drafting drug quality re-evaluation, the effects of different dosage forms of domperidone tablets in water, pH 1.2 artificial gastric juice, pH 4.0 acetate buffer and pH 6 were investigated. 8 phosphate buffer in four dissolution media dissolution behavior in vitro and at the same time, and ministerial standards domperidone tablets dissolution method were compared. RESULTS: Domperidone tablets produced in each pharmaceutical factory were well dissolved in acidic medium and were less than 60% dissolved in water and pH 6.8 phosphate buffer solution at 6 h. Conclusion: The dissolution rates of domperidone tablets in the same dissolution medium vary greatly. The quality of domperidone tablets in different pharmaceutical factories is significantly different, and should be paid attention to in clinical application.