Otsuka Makoto, Tomita Hisako, Otsuka Kuniko, Kamae Isao, Jorgenson James A
Research Institute of Pharmaceutical Sciences, Musashino University, Shinmachi 1-1-20, Nishi-Tokyo 202-8585, Japan.
Biomed Mater Eng. 2006;16(2):129-35.
Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0+/-0.5 degrees C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.
按照美国药典第24版标准，通过手动和自动溶出度试验对日本和美国市场上的布洛芬片剂进行了比较。溶出度试验在900毫升pH值为7.2的磷酸盐缓冲液中于37.0±0.5℃、50转/分钟的条件下进行60分钟，评估达到70%溶出所需时间（T70%）以及60分钟后5%溶出量（A60）。自动法测定的日本和美国片剂的溶出曲线与手动法测定的几乎相同。手动法测定的美国和日本片剂的T70%在不同取样位置与自动法相比无显著差异（p>0.05）。手动法测定的美国和日本片剂的A60除一个位置外无显著差异（p>0.05）。结果表明，自动法比手动法更具重现性，且系统误差可忽略不计。美国片剂的T70%和A60与日本片剂有显著差异（p<0.05）。美国片剂是薄膜包衣非处方药，日本片剂是糖衣处方药。两国剂型的溶出行为存在差异。
