溶出度试验预测固体制剂餐后生物利用度的研究进展

Progress in Prediction of Postprandial Bioavailability of Solid Oral Preparations by Dissolution Test

关键词:  生物利用度  餐后  溶出度

Key words:  bioavailability  postprandial  dissolution

摘要:

目的 综述近年来国内外溶出度试验方法的研究进展，为餐后生物利用度的预测提供理论依据。方法 综述药物的食物效应、溶出介质、溶出方法等对溶出度试验体内外相关性的影响。结果 药物性质、食物效应、溶出介质、溶出装置均影响溶出度方法的体内外相关性，均影响口服药物的餐后生物利用度。结论 在一致性评价任务重，国内餐后生物利用度研究经验少的前提下，开发能够预测餐后体内药动学的体外溶出方法，可以一定程度上减少研发风险和成本。

Abstract:

OBJECTIVE To provide a theoretical basis for the prediction of postprandial bioavailability test by in vitro dissolution test in recent years. METHODS In this paper, the effects of food, the dissolution medium and dissolution methods on the in vitro and in vivo correlation of dissolution test were reviewed. RESULTS The food effects of drug, the dissolution medium, dissolution methods and data evaluation methods had effects on the in vitro and in vivo correlations of dissolution methods and the postprandial bioavailability of oral drugs. CONCLUSION In China, there is heavy workload in consistency evaluation and few studies on postprandial bioavailability, the development of an in vitro dissolution method for predicting in vivo pharmacokinetics can reduce the research risk and cost of development.