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引用本文:吴文娜,丁丽,冯仲亮,何晓明,何朝星,方瑜.非细胞渗透模型在BSCⅡ类药物渗透性研究中的应用进展[J].中国现代应用药学,2024,41(8):1135-1141.
WU Wenna,DING Li,FENG Zhongliang,HE Xiaoming,HE Chaoxing,FANG Yu.Progress in the Application of Non-cell-based Permeation Model in the Study of the Permeability of BSC Class Ⅱ Drugs[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(8):1135-1141.
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非细胞渗透模型在BSCⅡ类药物渗透性研究中的应用进展
吴文娜, 丁丽, 冯仲亮, 何晓明, 何朝星, 方瑜
河北医科大学药学院药剂教研室, 石家庄 050017
摘要:
渗透性是肠道吸收和口服生物利用度的决定因素之一。非细胞渗透模型是一种体外渗透性测定工具,具有高效率、低成本、性质稳定、使用方便、可定制化等优点。根据屏障类型,非细胞渗透模型可分为含有(磷酸)脂质的仿生屏障和无脂质的非仿生屏障。仿生非细胞渗透模型包括平行人工膜渗透性测定模型、基于囊泡的渗透测定模型和人工纤维素-磷脂仿生膜测定模型。非仿生无细胞渗透模型有基于聚醚砜材料的中空纤维膜模型等。在国外,应用这4种屏障进行不同目的的研究正逐渐成为药物吸收研究的热点,但在国内,仅对平行人工膜渗透性测定模型的应用研究较多,缺乏对其他3种屏障的应用研究。笔者总结了渗透性装置和渗透性计算方法,检索了近几年非细胞渗透模型在BSCⅡ类药物渗透性方面的应用,对3种仿生屏障,和无脂质的中空纤维膜的特点应用进行归纳总结,以期满足难溶性药物配方开发需求。
关键词:  渗透性  BSCⅡ类药物  非细胞渗透模型  仿生屏障  中空纤维膜
DOI:10.13748/j.cnki.issn1007-7693.20230310
分类号:R965.2
基金项目:河北省中医药管理局科研计划项目(2023134)
Progress in the Application of Non-cell-based Permeation Model in the Study of the Permeability of BSC Class Ⅱ Drugs
WU Wenna, DING Li, FENG Zhongliang, HE Xiaoming, HE Chaoxing, FANG Yu
Department of Pharmaceutics, School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China
Abstract:
Permeability is one of the determinants of intestinal absorption and oral bioavailability. The non-cell-based permeation model is a kind of in vitro permeability measurement tool, which has the advantages of high efficiency, low cost, stable property, easy to use and customizable. According to the barrier type, non-cell-based permeation model can be divided into biomimetic barriers containing (phosphate) lipids and non-biomimetic barriers without lipids. Biomimetic permeation models include parallel artificial membrane permeability assay, vesicle-based permeation assay and PermeaPad®. Non biomimetic permeation models include Hollow fiber membrane models based on polyether sulfone materials. In foreign countries, the application of these four barriers for different purposes is gradually becoming a hot spot in drug absorption research. However, in China, there are only more applied studies on PMAPM and few published applied studies on the other three barriers. In order to meet the development needs of insoluble drug formulations, the author summarized the permeability devices and permeability calculation methods, searched the application of non-cell-based permeation model in the permeability of BSCⅡ drugs in recent years, and summarized the characteristic applications of three Biomimetic permeation models and hollow fiber membranes.
Key words:  permeability  BSC class Ⅱ drugs  non-cell-based permeation model  biomimetic barrier  hollow fiber membrane
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