【摘要】 目的 对抗菌药物复方磺胺甲噁唑片开展一致性评价研究。方法 采用Phoenix^?? WinNonlin^??软件分析体外溶出与体内药代动力学数据，确定关键溶出曲线，优化确定处方工艺，并对制得的自研制剂的溶出曲线进行生物等效性预测。结果 自研制剂的关键溶出曲线与参比制剂相似（相似因子f₂均大于50），预测得到药代动力学参数C_max与AUC_all并计算对应的T/R值，结果表明，自研制剂与参比制剂生物等效。结论 利用软件可以依照体外溶出及体内药代动力学数据确定关键溶出曲线，并依照自研制剂与参比制剂的溶出曲线预测生物等效性情况，提高研发效率。更多还原

【Abstract】 Objective To conduct a consistency evaluation study on the antibacterial drug compound sulfamethoxazole. Methods The Pheonix^?? Winnonlin^?? software was employed to analyze in vitro dissolution and in vivo pharmacokinetic data, identify critical dissolution profiles, optimize formulation processes, and predict bioequivalence of the self-developed product’s dissolution profile. Results The f₂ value of key dissolution curve of the self-developed product and the reference preparation was greater than 50, indicating the similar dissolution curves. The predicted pharmacokinetic parameters C_max and AUC_all were calculated, and the corresponding T/R values were obtained. The results showed that the self-developed product was bioequivalent to the reference preparation. Conclusion The software can be used to determine the key dissolution curves based on in vitro dissolution and in vivo pharmacokinetic data, and to predict the bioequivalence situation based on the dissolution curves of the self-developed product and the reference preparation, thereby improving research and development efficiency.更多还原