Bielen Neda
Smrecnikova 24, 8000, Novo mesto, Slovenia.
Int J Pharm. 2002 Feb 21;233(1-2):123-9. doi: 10.1016/s0378-5173(01)00932-2.
USP dissolution calibrator tablets were analysed by the flow-through cell method with the intention of examining its applicability for the flow-through cell apparatus suitability test. Test was performed with Dissotest CE-6 apparatus, (Sotax, Switzerland) in flow-through cells for tablets and capsules: smaller cells of 12 mm diameter and larger ones of 22.6 mm diameter. Analyses were performed with laminar and turbulent flow of dissolution medium. The flow rates were 16 and 8 ml/min for laminar flow and only 16 ml/min for turbulent flow. From the results it can be concluded that both salicylic acid tablets and prednisone tablets could be used for apparatus suitability test also for the flow-through cell under the conditions of laminar flows of 16 and 8 ml/min in cells phi 12 and 22.6 mm. As regards the turbulent flow of 16 ml/min, without a holder, cells phi 12 mm could be used for salicylic acid tablets and both cells (phi 12 and 22.6 mm) for prednisone tablets.
采用流通池法对美国药典溶出度校准片进行分析，目的是检验其在流通池装置适用性试验中的适用性。使用Dissotest CE - 6装置（瑞士Sotax公司）在片剂和胶囊的流通池中进行试验：直径较小的为12 mm的流通池，直径较大的为22.6 mm的流通池。在溶出介质呈层流和湍流的情况下进行分析。层流时流速分别为16和8 ml/min，湍流时仅为16 ml/min。从结果可以得出结论，在直径为12和22.6 mm的流通池中，层流流速为16和8 ml/min的条件下，水杨酸片和泼尼松片均可用于流通池的装置适用性试验。至于16 ml/min的湍流，在没有固定架的情况下，直径12 mm的流通池可用于水杨酸片，两种流通池（直径12和22.6 mm）均可用于泼尼松片。
