本文關(guān)鍵詞： 生物藥劑學(xué)分類系統(tǒng) 生物豁免 生物等效性 速釋制劑 溶解度 滲透性　出處：《中國(guó)新藥雜志》2016年05期 　論文類型：期刊論文

【摘要】：生物藥劑學(xué)分類系統(tǒng)將藥物按溶解度和滲透性分為4類,在指導(dǎo)新藥研發(fā)和劑型設(shè)計(jì)、預(yù)測(cè)藥物體內(nèi)體外相關(guān)性、進(jìn)行生物豁免研究等方面發(fā)揮了非常重要的作用。本文綜述了基于生物藥劑學(xué)分類系統(tǒng)的口服固體速釋制劑生物豁免所需溶解度、滲透性和溶出度的接受標(biāo)準(zhǔn)和測(cè)定方法,并分類描述了進(jìn)行過生物豁免研究的藥物及其有關(guān)資料;建議我國(guó)盡快開展和接受生物豁免。
[Abstract]:The biopharmaceutical classification system divides the drugs into four categories according to their solubility and permeability, which are used to guide the development and formulation of new drugs, and to predict the correlation of drugs in vivo and in vitro. Biological immunity research has played a very important role in this paper. This review based on the biopharmaceutical classification system of oral solid rapid release formulations of biological immunity required solubility. Acceptance criteria and methods for determination of permeability and dissolution, and classification of drugs and their related information for studies of biological exemptions; It is suggested that our country should carry out and accept biological exemption as soon as possible.
【作者單位】： 航天中心醫(yī)院臨床藥理室;寧夏醫(yī)科大學(xué)總醫(yī)院藥劑科臨床藥理研究室;
【分類號(hào)】：R943
【正文快照】： 基于生物藥劑學(xué)分類系統(tǒng)(biopharmaceuticalclassification system,BCS)的口服固體速釋制劑生物豁免(biowaiver)已經(jīng)陸續(xù)得到美國(guó)食品藥品監(jiān)督管理局(Food and Drug Administration,FDA)、世界衛(wèi)生組織(World Health Organization,WHO)和歐洲藥品監(jiān)督管理局(European Medicine，

本文編號(hào)：1466364