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作 者:马旭颖 吴文娜 方瑜[1] MA Xuying;WU Wenna;FANG Yu(School of Pharmacy,Hebei Medical University,Hebei Shijiazhuang 050017,China)
出 处:《中国医院药学杂志》2024年第22期2661-2666,共6页Chinese Journal of Hospital Pharmacy
摘 要:肠上皮是口服药物吸收的主要限制步骤之一,药物在肠道的渗透性对其体内生物利用度非常重要。非仿生的体外渗透模型是一种用于口服药物肠道渗透性预测的工具,具有传质速率高,工艺简单等优点。该模型主要以无脂质的中空纤维膜为屏障,其与人体肠道面积与体积更相近且与体内流体动力学更相似,是一种在药物渗透性预测方面具有潜力的新材料。目前已有研究的非仿生体外渗透模型主要包括人工膜插入系统,人工肠道模拟器和溶解-中空纤维膜系统。近年来,非仿生的体外渗透模型逐渐成为国外研究者关注的热点,国内目前尚无相关研究报道。该文简述了肠道屏障及药物在肠道的转运机制,参考了关于中空纤维膜在口服药物吸收方面的相关文献,归纳总结了目前已经开发的非仿生体外渗透模型及其应用,以期对药物开发及仿制药一致性评价提供帮助。Intestinal epithelium is one of the major limiting steps in the absorption of orally dosed drugs.And permeability of a drug in intestine is vital for its in vivo bioavailability.Non-bionic in vitro permeation modeling is a practical tool for predicting intestinal permeability of orally dosed drugs with the advantages of high mass transfer rate and a simple process.With a lipid-free hollow fiber membrane as a barrier more closely resembling the area and volume of human gut and in vivo fluid dynamics,the model is a new material with potential for drug permeability prediction.The major non-bionic in vitro permeation models include artificial membrane insert system,artificial gut/absorption simulator and dissolution-hollow fiber membrane.In recent years,non-bionic in vitro permeation model has become a hot topic for foreign researchers.However,there is no relevant research report in China.This review focused upon intestinal barrier and transport mechanism of drugs in intestine,reviews the relevant literature on hollow fiber membranes during oral drug absorption.Non-bionic in vitro permeation models and applications were described for providing references for drug development and consistency evaluations of generic drugs.
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