Nijkerk A J, Vermeer J M, Imanse M, De Vos D
Pharm Weekbl Sci. 1983 Oct 21;5(5):210-2. doi: 10.1007/BF02332945.
Two new preparations of spironolactone tablets containing 25 and 100 mg of spironolactone have been characterized by their disintegration time, tablet spironolactone content, dissolution profile and bioavailability in comparison with two known spironolactone preparations as reference material. The preparations were found to possess almost identical characteristics, assuring a proper clinical use of the new tablet preparations. For spironolactone, a positive outcome of the in vitro dissolution test coincides with an excellent bioavailability.
与两种已知的螺内酯制剂作为参考材料相比,对两种含有25毫克和100毫克螺内酯的新螺内酯片剂制剂进行了崩解时间、片剂螺内酯含量、溶出曲线和生物利用度的表征。发现这些制剂具有几乎相同的特性,确保了新片剂制剂的合理临床应用。对于螺内酯,体外溶出试验的阳性结果与优异的生物利用度一致。