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目前,体外溶出试验是已确立的考察口服控释制剂的试验方法,通常采用一种试验方法和设备去测定不同批次药物制剂生物利用度间的差别。常用的方法有转签法、悬浆法和直流法。转签法USP采用的设备和方法,它包括六个装有1000ml溶出介质的烧杯,一个具有一定几何形状和固定位置的搅拌器。这种装置适用于含有易溶药物的各种口服固体制剂。因此,可应用于各生产部门的质量控制。当转谷法和悬浆法不能符合试验需要的时候,就可以考虑采用直流法,此外,这种试验技术也提供了研究另一种流体力学影响的可能性。即通过外部的泵,使在放有样品小池中形成自下而上的连续水流。
At present, the in vitro dissolution test is an established test method for oral controlled release formulations. A test method and equipment are usually used to determine the differences in bioavailability of different batches of pharmaceutical preparations. Commonly used methods are rotary sign method, suspension method and DC method. The method and method used by the USP for the re-labelling method consists of six beakers containing 1000 ml of dissolution medium, a stirrer with a certain geometry and fixed position. This device is suitable for a variety of oral solid preparations containing soluble drugs. Therefore, it can be applied to the quality control of each production department. When the valleys and the suspension method do not meet the test requirements, the DC method can be considered. In addition, this experimental technique also offers the possibility of studying the influence of another hydrodynamics. That is, through an external pump, a continuous bottom-up stream of water is formed in the sample cuvette.