【摘要】 目的 以市售来曲唑片为参比制剂进行仿制研究。方法 通过调研参比制剂的文献信息，掌握了参比制剂的辅料种类及用量，进行单因素考察；以相似因子（f₂）作为评价指标，确定处方和工艺，经批量放大，进行稳定性和生物等效实验。结果 自研制剂制备工艺稳定，能够持续稳定地生产符合质量要求的制剂。结论 自研制剂质量稳定，疗效与参比制剂一致，符合仿制药的要求。更多还原

【Abstract】 Objective Commercially available letrozole tablets were used as the reference preparation for imitation. Methods By investigating the literature information of the reference preparation, the types and dosages of excipients of the reference preparation were mastered. The single factor investigation was adopted, and the similarity factor（f₂） was used as the evaluation index to determine the prescription and process, which were scaled up in batches, and the stability and bioequivalence tests were carried out. Results The preparation process of the self-developed agent was stable, and the preparation that met the quality requirements could be continuously and stably produced. Conclusion The self-developed agent exhibits stable quality, and its efficacy is consistent with that of the reference preparation, which fully meets the relevant requirements for generic drugs.更多还原