中国药房2016，Vol.27Issue(30)：4307-4310,4.DOI:10.6039/j.issn.1001-0408.2016.30.43
相似因子法评价雷美替胺片自研制剂与原研制剂溶出曲线的相似性
Similarity Evaluation of the Dissolution Profiles of Self-made and Original Preparation of Ramelteon Tablet by f2
张琳 1刘葵葵 1李欣 1邢雪敏 1王伶2
作者信息
- 1. 山东省药学科学院/山东省化学药物重点实验室，济南250101
- 2. 山东福瑞达医药集团公司/山东省黏膜与皮肤给药技术重点实验室，济南 250101
- 折叠
摘要
Abstract
OBJECTIVE:To evaluate the similarity of in vitro dissolution of self-made and original preparation of Ramelteon tablet. METHODS:The paddle method was adopted with rotational speed of 50 r/min,using water,pH1.2 hydrochloric acid solu-tion,pH4.0 acetate buffer solution and pH6.8 phosphate buffer solution as dissolution media,HPLC was used to determine the cu-mulative dissolution of main components of self-made and original preparation of Ramelteon tablet at different time points,dissolu-tion profile was drew,then f2 was used to evaluate its similarity. RESULTS:In the 4 dissolution media,the f2 of self-made and original preparation of Ramelteon tablet was 62.8,80.0,77.7,76.2,respectively,which indicated that the dissolution profiles showed similarity. CONCLUSIONS:The established HPLC is suitable for the dissolution determination of Ramelteon tablet;the dissolution profiles of the self-made and original preparations are similar,it preliminary indicates the prescription and technological rationality of self-made preparation.关键词
雷美替胺片/自研制剂/原研制剂/高效液相色谱法/相似因子/溶出曲线/评价Key words
Ramelteon tablet/Self-made preparation/original preparation/HPLC/f2/Dissolution curve/Evaluation分类
医药卫生引用本文复制引用
张琳,刘葵葵,李欣,邢雪敏,王伶..相似因子法评价雷美替胺片自研制剂与原研制剂溶出曲线的相似性[J].中国药房,2016,27(30):4307-4310,4.
