摘要
Abstract
OBJECTIVE:To prepare Levetiracetam soluble tablets and evaluate its quality. METHODS:The liquidity indexes of raw material(bulk density,tap density,etc.)and the particle size distribution,liquidity indexes,moisture of the intermediate,that was mixed granules,were investigated to establish preparation method of tablet. The content of levetiracetam was determined by HPLC,and quality indexes of soluble tablets were evaluated,such as appearance,disintegration time,the content of main com-ponent. RESULTS:The wet granulation method was established to prepare Levetiracetam soluble tablets. The specification was 100 mg/220 mg of prepared tablets,it was bright in appearance,and disintegration time was less than 1 min;average content of leveti-racetam was 100.1%,and rigidity was 7.5 kg;the friability of prepared tablets was up to the standard. CONCLUSIONS:The for-mulation and preparation technology of Levetiracetam soluble tablets are rational and controllable. The quality indexes of prepared tablets are all up to the requirements.关键词
左乙拉西坦/可溶片/流动性指标/处方/制备工艺/质量评价Key words
Levetiracet/Soluble tablet/Liquidity index/Formulation/Preparation technology/Quality evaluation分类
医药卫生
