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目的考察复方益肝灵系列品种体外生物利用度一致性。方法建立复方益肝灵系列品种体外溶出度的评价方法,通过考察复方益肝灵不同剂型、不同生产企业的体外溶出曲线,对其生物利用度进行评价。结果多数生产企业的批内溶出量RSD>10%,批间及不同企业样品的溶出曲线差异较大,水飞蓟素累积溶出度普遍低于75%,与进口同类制剂的生物利用度比较有一定的差异。结论应加强中药制剂的生物利用度合理研究,以保证临床合理用药。
Objective To investigate the in vitro bioavailability of compound Yiganling variety. Methods The evaluation method of compound Yiganling series in vitro dissolution was established. The in vitro dissolution curve of different Yifengling formulations and different production enterprises was investigated, and its bioavailability was evaluated. Results The results showed that the dissolution rate of the majority of manufacturing enterprises was more than 10%. The dissolution curves of samples from batch to batch and from different enterprises were quite different. The cumulative dissolution rate of silymarin was generally lower than 75%, which was different from the bioavailability of the imported preparations . Conclusion The reasonable study of the bioavailability of TCM preparations should be strengthened in order to ensure rational clinical use.