Preparation and Quality Evaluation of Flupirtine Maleate Dry Suspension / 中国药师

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.