Koch H P, Klissenbauer C, Ritzinger A, Wallentin A
Pharmazie. 1987 Mar;42(3):169-72.
The official dissolution apparatuses of the U.S.P. XXI or those recommended by the DAC 1979, respectively, are not suitable for the pertinent examination of rectal drug dosage forms. In the literature, on the other hand, numerous experimental setups have been proposed for the study of drug release from suppositories. However, these devices are all rather complicated as concerned with their construction as well as their handling, and, thus, cannot be considered as universally applicable test models. The rotating flask model, that has already been presented to the public earlier, in its two appearances, i.e. the dissolution tester (simple rotating flask) and the absorption model (compartmented rotating flask), can be employed for the testing of drug liberation from suppositories. The release parameters which have been determined in either of the two types of the rotating flask correlate well with each other and are also relevant characteristics of the bioavailability.
美国药典 XXI 的官方溶出装置或 1979 年药物制剂协会推荐的装置均不适用于直肠给药剂型的相关检查。另一方面,文献中已提出许多用于研究栓剂药物释放的实验装置。然而,这些装置在构造和操作方面都相当复杂,因此不能被视为普遍适用的测试模型。之前已向公众展示过的旋转烧瓶模型有两种形式,即溶出度测试仪(简单旋转烧瓶)和吸收模型(分隔旋转烧瓶),可用于测试栓剂的药物释放。在这两种旋转烧瓶中任何一种中测定的释放参数相互之间相关性良好,并且也是生物利用度的相关特征。