摘要
目的 建立罗红霉素片体内外相关性模型,并验证体内外相关性,用于仿制产品评价与开发。方法 测定罗红霉素片参比制剂及4批次国内自研样品溶出曲线,使用GstroPlus软件,建立罗红霉素片体内外相关性模型。采用参比制剂罗红霉素片(罗力得片)及国内自研样品的溶出曲线相关研究数据对模型进行验证和再验证。结果 参比制剂在pH 6.0介质条件更具有体内外相关性,Cmax值、AUC预测误差都更小;国内自研样品在pH 6.0介质条件下模型拟合结果与体外溶出曲线相似性测定结果一致。结论 建立的评价模型能通过体外溶出实验反映体内情况,该模型可用于仿制产品评价与开发。
Objective To establish and verify the correlation model of roxithromycin tablets in vivo and in vitro,for the evaluation and development of imitation products. Methods The dissolution curves of reference preparation and 4 batches of domestic self-developed samples of roxithromycin tablets were determined. Establish the correlation model of roxithromycin tablets in vitro and in vivo by GstroPlus software. The model was validated and revalidated with the dissolution curve data of reference preparation and domestic self-developed samples. Results The reference preparation is more relevant in vivo and in vitro under pH 6.0 medium conditions, C max value and AUC prediction deviation are smaller. The model fitting results of domestic self-developed samples in pH 6.0 medium are consistent with the determination results of the similarity of dissolution curves in vitro. Conclusion The established evaluation model can reflect the situation in vivo through in vitro dissolution test. The model can be used for evaluation and development of imitation products.
作者
傅蓉
刘亚威
姚兰
张亚杰
王棘
Fu Rong;Liu Ya-wei;Yao Lan;Zhang Ya-jie;Wang Ji(Liaoning Inspection,Examination&Certification Centre,Liaoning Institute for Drug Control,Shenyang 110036)
出处
《国外医药（抗生素分册）》
CAS
2023年第1期19-25,共7页
World Notes on Antibiotics
关键词
罗红霉素片
溶出度
溶出曲线
体外溶出模型
验证
仿制药一致性
roxithromycin tablets
dissolution
dissolution curve
in vitro dissolution model
validated
similarity assessment of generic grugs
