目的 预测泮托拉唑钠肠溶片、兰索拉唑肠溶胶囊仿制制剂的生物等效性。方法 利用平行人工膜渗透性模型，以泮托拉唑钠肠溶片、兰索拉唑肠溶胶囊为试验对象，先在0.1 mol/L盐酸溶液中溶出2 h，再转移至pH 6.8或pH 6.0磷酸盐缓冲液中，监测其溶出、渗透过程，通过比较渗透速率和总渗透量预测仿制制剂的生物等效性。结果 在pH 6.8磷酸盐缓冲液中，泮托拉唑钠肠溶片、兰索拉唑肠溶胶囊的两家仿制制剂的渗透速率和总渗透量几何均值比90%置信区间均在80.00%～125.00%。但在pH 6.0磷酸盐缓冲液中，泮托拉唑钠肠溶片、兰索拉唑肠溶胶囊的两家仿制制剂的渗透速率和总渗透量几何均值比90%置信区间均未在80.00%～125.00%。结论 平行人工膜渗透性模型可用于预测质子泵抑制剂类肠溶制剂仿制制剂与参比制剂的生物等效性，为仿制药一致性评价提供参考。

Objective To predict bioequivalence of Pantoprazole Sodium Enteric-coated Tablets and Lansoprazole Enteric-coated Capsules generic drugs. Methods Using the parallel artificial membrane permeability model, Pantoprazole Sodium Enteric-coated Tablets and Lansoprazole Enteric-coated Capsules were used, and dissolved in 0.1 mol/Lhydrochloric acid solution for 2 h and then transferred to pH 6.8 or pH 6.0 phosphate buffer to monitor the dissolution and permeation processes. The bioequivalence of the generic drugs was predicted by comparing permeation rate and total permeate volume. Results The geometric mean ratios of permeation rate and total permeation volume of two generic formulations of Pantoprazole Sodium Enteric-coated Tablets and Lansoprazole Enteric-coated Capsules in phosphate buffer at pH 6.8 were within the 90% confidence intervals of 80.00% to 125.00%. However, in pH 6.0 phosphate buffer, the geometric mean ratios of permeation rate and total permeation volume for two generic drugs of Pantoprazole Sodium Enteric-coated Tablets and Lansoprazole Enteric-coated Capsules were not within the 90% confidence interval of 80.00% to 125.00%. Conclusion The parallel artificial membrane permeability model can be used to predict bioequivalence of generic proton pump inhibitor enteric-coated preparations with reference preparations, providing a reference for the consistency evaluation of generic drugs.

R927.2

国家重点研发计划（2020YFE0201700）；国家药品监督管理局重点实验室学科建设课题（2023HYZX13，2024HYZX04）