Koch H P, Faltis I, Mladenow H
Pharmazie. 1987 Feb;42(2):90-4.
'Disintegration' and 'dissolution' of solid drug dosage forms are considered as partial processes of drug liberation. Besides the (apparent) disintegration time that is determined in the official disintegration tester, there is a second (intrinsic) disintegration time which can be deduced from the experimental dissolution data, but shows only limited correlation with the former. Various methods for the graphical resolution of dissolution data and the calculation of the intrinsic disintegration time therefrom are discussed. For the simultaneous determination of disintegration and dissolution, the approved rotating flask method is recommended.
固体药物剂型的“崩解”和“溶出”被视为药物释放的部分过程。除了在官方崩解试验仪中测定的(表观)崩解时间外,还有第二个(内在)崩解时间,它可以从实验溶出数据中推导出来,但与前者的相关性有限。本文讨论了用于溶出数据图形解析以及由此计算内在崩解时间的各种方法。对于同时测定崩解和溶出,推荐采用认可的转瓶法。