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控释制剂的出现引起了医药界的很大关注,由于它具有减少给药次数,提供平稳血浓、降低毒副作用,改善疗效等优点,使这种新剂型的研制得到迅速发展。但人们往往把注意力集中于控释制剂的处方设计、体外释药及其药动学过程,而很少研究控释制剂成为合格产品所应具备的条件。本文针对这一问题介绍了控释制剂生物等效性的评价方法。该法涉及到二
The emergence of controlled release preparations has aroused great concern in the pharmaceutical industry. Due to its advantages of reducing administration times, providing stable blood concentration, reducing side effects and improving curative effect, the development of such new dosage forms has been rapidly developed. However, people tend to focus on the formulation design of controlled release preparations, drug release in vitro and their pharmacokinetic processes, and few studies have investigated the conditions that controlled release preparations should be eligible for. In this paper, the evaluation of the bioequivalence of controlled release formulations is introduced. The law involves two