【摘要】：近年來(lái),口服緩釋技術(shù)發(fā)展迅速,口服緩釋制劑在增加患者的順應(yīng)性,提高藥物療效,減少藥物不良反應(yīng)等方面發(fā)揮著重要作用,日益成為臨床關(guān)注的重點(diǎn)。因此,不斷提高緩釋制劑的質(zhì)量,滿足臨床需求是藥物制劑發(fā)展的動(dòng)力。本文綜述比較了緩釋制劑的評(píng)價(jià)手段,包括體外溶出試驗(yàn)、Beagle犬藥動(dòng)學(xué)實(shí)驗(yàn)、人體生物利用度和生物等效性試驗(yàn)、以適應(yīng)癥患者為對(duì)象的臨床試驗(yàn)等4個(gè)層次的手段,特別對(duì)Beagle犬藥動(dòng)學(xué)實(shí)驗(yàn)在緩釋制劑評(píng)價(jià)中的作用和定位進(jìn)行了系統(tǒng)分析,并從胃腸道生理方面分析了影響B(tài)eagle犬實(shí)驗(yàn)結(jié)果的各種因素。
[Abstract]:In recent years, oral sustained-release technology has developed rapidly. Oral sustained-release formulations play an important role in increasing compliance of patients, improving drug efficacy and reducing adverse drug reactions, and increasingly become the focus of clinical attention. Therefore, continuous improvement of the quality of sustained-release preparations to meet clinical needs is the driving force for the development of pharmaceutical preparations. This article reviewed and compared the evaluation methods of sustained-release preparations, including in vitro dissolution test, Beagle canine pharmacokinetic test, human bioavailability and bioequivalence test, and clinical trials for patients with indications. In particular, the role and localization of Beagle canine pharmacokinetics in the evaluation of sustained-release preparations were systematically analyzed, and various factors affecting the results of Beagle canine experiments were analyzed from the aspects of gastrointestinal physiology.
【作者單位】： 中國(guó)藥科大學(xué)藥物代謝與動(dòng)力學(xué)研究中心;
【分類號(hào)】：R965

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