目的 探讨符合中医药特点的中药固体制剂质量控制与评价的化学-生物联合评价模式。方法 以复方鳖甲软肝片为模型药，考察在pH 7.4磷酸盐缓冲液溶出介质中，不同溶出时间的复方鳖甲软肝片溶出液对LX-2肝星状细胞的抑制作用，提出基于细胞抑制率所得复方鳖甲软肝片的累积溶出度，与HPLC法所测的芍药苷、连翘苷、人参皂苷Rg₁各指标成分的溶出度及自定义权重系数的多成分整合的溶出度运用f₂相似因子法分别进行相关性评价。结果 芍药苷、连翘苷、人参皂苷Rg₁各指标成分的溶出度及其整合的溶出度f₂相似因子依次为43、58、61、59，说明多成分整合的溶出度能较为全面地反映全方的生物效价。结论 以生物活性为导向的多成分整合的溶出度评价方法有望成为评价中药固体制剂体外溶出度的有效手段之一。

Objective To explore the chemical-biological assay pattern for quanlity control and evaluation of Chinese materia medica solid preparations (CMMSP). Methods MTT assay was used to obtain the characteristic cell inhibitory rate on LX-2 hepatic stellate cells by Compound Biejia Ruangan Tablet (CBRT) dissolving solutions in PBS dissolution medium with pH 7.4 for different time periods. From these results, the cumulative dissolution of CBRT was obtained based on the cell inhibitory rate. The dissolution rates of paeoniflorin, phillyrin, and ginsenosides Rg₁ were determined by HPLC method. A novel approach of self-defined weighting coefficient based on the quality had been created to establish the integrated dissolution rate model. Then f₂ similar factor method was used to evaluate the relevance of these two methods. Results The f₂ values for paeoniflorin, phillyrin, ginsenosides, and the integration dissolution were 43, 58, 61, and 59, respectively. It was indicated that the dissolution of multicomponent integration could fully reflect the biological potency of all parties. Conclusion The biological activity-multicomponents integrated evaluation method of dissolution is expected to be one of the effective means for in vitro dissolution test of CMMSP.

国家新药创制重大专项（2011ZX09201-201-14，2011ZX09201-201-35）；国家自然科学基金资助项目（81073069）