Koch H P, Alcorn G, Ritschel W A
Pharmazie. 1983 Apr;38(4):233-5.
The U.S.P./N.F. dissolution test (method I or rotating basket method) and the rotating flask technique (RESO-TEST dissolution method) were applied to four commercial prolonged release theophylline dosage forms. The dissolution data obtained were converted into dissolution efficiencies and submitted to a correlation analysis, the result of which demonstrates the equivalency of both methods with respect to the characterization of the dissolution behaviour of the dosage forms tested. It is suggested to consider replacement of the official dissolution technique, the shortcomings of which are well-known from the literature, by the rotating flask technique.
采用美国药典/国家处方集溶出度试验(方法I或转篮法)和转瓶技术(RESO-TEST溶出度法)对四种市售长效茶碱剂型进行了研究。将获得的溶出数据换算成溶出效率,并进行相关分析,结果表明两种方法在测试剂型溶出行为表征方面具有等效性。鉴于官方溶出技术的缺点在文献中已广为人知,建议考虑用转瓶技术取而代之。