复方甘草酸苷片主要用于治疗慢性肝病，改善肝功能异常，属临床常用保肝药物，随着国内市场的逐年扩增，近年来成为企业一致性评价以及仿制开发的热点品种之一。复方甘草酸苷片中主要活性成分甘草酸（GL）及其代谢产物甘草次酸（GA）均为低溶解度化合物，且复方甘草酸苷片属高风险的复杂制剂，具有体内高变异的药动学特征，其生物等效性试验研究对于该药品的一致性评价具有重要影响。结合我国已发布的复方甘草酸苷片生物等效性试验技术指导原则要求，通过对近年来中国复方甘草酸苷片开展生物等效性试验结果进行总结、分析，结合复方甘草酸苷片中主要成分GL、GA的理化性质及体内代谢过程，提出本品生物等效性研究的一般考虑。以期为复方甘草酸苷片仿制药研发提供一定参考，进一步保障仿制药与原研产品的临床等效。

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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