Similarity Evaluation of the Dissolution Profiles of Self-made and Original Preparation of Ramelteon Tablet by f2
10.6039/j.issn.1001-0408.2016.30.43
- VernacularTitle: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
- Author:
Lin ZHANG
;
Kuikui LIU
;
Xin LI
;
Xuemin XING
;
Ling WANG
- Publication Type:Journal Article
- Keywords:
Ramelteon tablet;
Self-made preparation;
original preparation;
HPLC;
f2;
Dissolution curve;
Evaluation
- From:
China Pharmacy
2016;27(30):4307-4310
- CountryChina
- Language:Chinese
-
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.
