Preparation and Quality Control of Warfarin Sodium Granules
- VernacularTitle:华法林钠颗粒的制备及质量控制
- Author:
Maobai LIU
;
Bin ZHENG
;
Xiaofang ZENG
- Publication Type:Journal Article
- Keywords:
Warfarin sodium;
Granules;
Optimize of formulation;
Preparation;
Quality control
- From:
China Pharmacy
2005;0(17):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To prepare warfarin sodium granules(WSG)and to establish it’s quality control methods .METHO_DS:To prepare WSG with part.aeq.geometric method,to optimize the amounts of all sorts of agents in the formulation in terms of dissolution time and abilityof WSG by orthogonal experiment.To determin the content of WS by UV. RESULTS:The formulation was designed and optimized,the WSG’s size were evenly.The concentration of WS was linear within the range of 5.92～17.86?g/ml with r=0.9 998(n=7),the average recovery rate was 101.26%～101.84%(n=5)with the RSD lower than 1.0%.The solution dissolved by granules is stable within 10 days.CONCLUSIONS:The preparation method is simple and feasible,the content determination methods is accurate,realible and sensitive,suitable for the quality control of WSG.The dissolved solution can be divided in accurate doses.
