中国药业2024，Vol.33Issue(1)：78-82,5.DOI:10.3969/j.issn.1006-4931.2024.01.017
醋酸阿比特龙仿制制剂与参比制剂溶出曲线相似度研究
Similarity of Dissolution Profiles Between Generic and Reference Preparations of Abiraterone Acetate
摘要
Abstract
Objective To establish a method for the determination of the dissolution of Abiraterone Acetate Tablets,and to evaluate the similarity of the dissolution profiles between generic and reference preparations of abiraterone acetate.Methods The paddle method(with a rotating speed of 50 r/min)was used to determine the dissolution profiles of generic preparation of Abiraterone Acetate Tablets(from manufacturers B,C,and D,nine batches)and reference preparation of Abiraterone Acetate Tablets(from manufacturer A,one batch)in four different dissolution media[water with 0.25%sodium dodecyl sulfate(SDS)and pH 2.0 hydrochloric acid solution with 0.25%SDS,pH 4.5 phosphate buffer with 0.25%SDS and pH 6.8 phosphate buffer with 0.25%SDS].High-performance liquid chromatography(HPLC)method was used to determine the dissolution of nine batches of generic preparations,the chromatographic column was Agilent Eclipse Plus C18 column(100 mm×4.6 mm,3.5 μm),the mobile phase was acetonitrile-water(80∶20,V/V),the flow rate was 1.0 mL/min,the column temperature was 50℃,the detection wavelength was 254 nm,and the injection volume was 10 μL.The cumulative dissolution rate was calculated,the dissolution profiles were drawn,and the similarity of the dissolution profiles was evaluated by the similarity factor(f2).Results The in vitro dissolution profiles of the nine batches of generic preparation all showed similarity with the reference preparation,with f2＞50.Conclusion The established method is suitable for the determination of the dissolution of Acetate Abiraterone Tablets,which can provide a reference for the improvement of the quality standard and quality consistency evaluation of Acetate Abiraterone Tablets.关键词
醋酸阿比特龙片/溶出曲线/相似因子法/仿制制剂/参比制剂/一致性评价Key words
Abiraterone Acetate Tablets/dissolution profile/similarity factor method/reference preparation/generic preparation/consistency evaluation分类
医药卫生引用本文复制引用
郝丽娟,韩佳芮,苗会娟,牛劲,刘瑞娜,徐艳梅..醋酸阿比特龙仿制制剂与参比制剂溶出曲线相似度研究[J].中国药业,2024,33(1):78-82,5.基金项目
河北省卫生健康委员会科研项目[20230228]. （）
