復(fù)方甘草酸苷片主要用于治療慢性肝病，改善肝功能異常，屬臨床常用保肝藥物，隨著國(guó)內(nèi)市場(chǎng)的逐年擴(kuò)增，近年來(lái)成為企業(yè)一致性評(píng)價(jià)以及仿制開(kāi)發(fā)的熱點(diǎn)品種之一。復(fù)方甘草酸苷片中主要活性成分甘草酸（GL）及其代謝產(chǎn)物甘草次酸（GA）均為低溶解度化合物，且復(fù)方甘草酸苷片屬高風(fēng)險(xiǎn)的復(fù)雜制劑，具有體內(nèi)高變異的藥動(dòng)學(xué)特征，其生物等效性試驗(yàn)研究對(duì)于該藥品的一致性評(píng)價(jià)具有重要影響。結(jié)合我國(guó)已發(fā)布的復(fù)方甘草酸苷片生物等效性試驗(yàn)技術(shù)指導(dǎo)原則要求，通過(guò)對(duì)近年來(lái)中國(guó)復(fù)方甘草酸苷片開(kāi)展生物等效性試驗(yàn)結(jié)果進(jìn)行總結(jié)、分析，結(jié)合復(fù)方甘草酸苷片中主要成分GL、GA的理化性質(zhì)及體內(nèi)代謝過(guò)程，提出本品生物等效性研究的一般考慮。以期為復(fù)方甘草酸苷片仿制藥研發(fā)提供一定參考，進(jìn)一步保障仿制藥與原研產(chǎn)品的臨床等效。

Compound Glycyrrhizin Tablet is mainly used to treat chronic liver disease and improve liver function abnormality, which is one of the commonly used liver protection drug in clinic. With the domestic market expanding year by year, it has become one of the hotspot varieties for enterprise consistency evaluation and generic development in recent years. The main active ingredients in Compound Glycyrrhizin Tablets, glycyrrhizic acid (GL) and its metabolite glycyrrhetinic acid (GA), are both low-solubility compounds. Furthermore, Compound Glycyrrhizin Tablets is high-risk complex preparations with highly variable pharmacokinetic characteristics in vivo. The bioequivalence study of this drug has a significant impact on the consistency evaluation of the drug. Combined with the published guidelines for bioequivalence test of Compound Glycyrrhizin Tablet in China, this paper summarized and analyzed the results of bioequivalence test of Compound Glycyrrhizin Tablet in recent years, combined with the physicochemical properties and metabolic processes of GL and GA, put forward general considerations for the study of bioequivalence of this tablet. To provide reference for the research and development of generic Compound Glycyrrhizin Tablet, and further ensure the clinical equivalence of generic drugs and original product.

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