Preparation and Quality Evaluation of Flupirtine Maleate Dry Suspension
- VernacularTitle:马来酸氟吡汀干混悬剂的制备及质量评价
- Author:
Aihong LI
;
Yanfei SHI
;
Teng XU
- Publication Type:Journal Article
- Keywords:
Flupirtine maleate;
Drug suspension;
Preparation;
Quality control
- From:
China Pharmacist
2016;19(9):1675-1678
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To prepare flupirtine maleate dry suspension and establish its quality control method. Methods: The dry suspension was prepared by a powder direct mixing method. With the sedimentation and redispersibility as the indices,the suspending effect of the hydrophilic polymers HPMC and CMC-Na was investigated. The optimal formula was obtained. The viscosity was deter-mined by a rotary viscometer. An HPLC fluorescence method was used to determine the content of main component. Results:The sedi-mentation ratio of flupirtine maleate dry suspension was 1 in 3h with good redispersibility and liquidity. The cumulative dissolution in 30min was above 80%. Conclusion:The quality of the prepared flupirtine maleate dry suspension is stable and controllable, and the production process is feasible, which provides basis for the research and development of new preparation of flupirtine maleate.