Similarity Evaluation of the Dissolution Profiles of Self-made and Original Preparation of Ramelteon Tablet by f2 / 中国药房
China Pharmacy
;
(12): 4307-4310, 2016.
Article
in Chinese
| WPRIM
| ID: wpr-503381
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2016
Type:
Article
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