摘要
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 study the in vitro dissolution of domperidone tablets from six different pharmaceutical factories, and provide a reference for clinical use. Method： The dissolubility of domperidone tablets from six different pharmaceutical factories was inspected in the following 5 mediums：water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution （ the above 4 mediums were used according to the project of drug quality＇ s re-evaluation in Japan） and the mediums that used in ministry standard. Result： Domperidone tablets dissolution in acid medium was well, in the water and in pH6.8 phosphate buffer solution were lower than 60% in 6 h. Conclusion ： The dissolution of the same batch of domperidone tablets in different mediums were obviously different. There are significant difference among the quality of the domperidone tablets from different pharmaceutical factories which should be given attention in clinical application.
出处
《中国药师》
CAS
2010年第1期74-76,共3页
China Pharmacist
关键词
多潘立酮片
溶出度
相似因子
Domperidone tablets
Dissolution
Similar factor
