目前仿制藥在我國(guó)醫(yī)藥市場(chǎng)占據(jù)很大規(guī)模，口服固體制劑一致性評(píng)價(jià)得到的關(guān)注最多。其中藥品的體內(nèi)外相關(guān)性一直是研究者關(guān)注的重點(diǎn)及難點(diǎn)，如何通過控制再評(píng)價(jià)品種與參比制劑體外某些特性（如溶出、制劑學(xué)因素等）的相似，達(dá)到兩者體內(nèi)生物等效，對(duì)于縮短藥品的一致性評(píng)價(jià)進(jìn)度，降低研究成本具有重大的意義。就目前口服固體制劑一致性評(píng)價(jià)體內(nèi)外相關(guān)性的相關(guān)研究進(jìn)展進(jìn)行綜述，以期為開展口服固體制劑一致性評(píng)價(jià)研究工作提供參考。

At present, generic drugs occupy a large scale in Chinese pharmaceutical market, and the consistency evaluation of oral solid preparations gained the most attention. The in vitro-in vivo correlation (IVIVC) study is the hot point and difficulty on researches about evaluation of oral preparations, it is benefit for decreasing the research progress and cost of drug consistency evaluation that how to control the similarity of some vitro characteristics (such as dissolution and formulation factors, etc.) of the reevaluate preparation and the reference preparation to achieve the vivo bioequivalence of them. This article will review the current research progress on the IVIVC of oral solid drug consistency evaluation, in order to provide reference for the study on the consistency evaluation of oral solid preparations.

R944.2

江西中醫(yī)藥大學(xué)“1050青年人才工程”項(xiàng)目（5142001012）