左乙拉西坦可溶片的制备工艺及质量研究

Study on Preparation Technology and Quality of Levetiracetam Soluble Tablets

目的:制备左乙拉西坦可溶片并评价其质量。方法:通过考察原料药的流动性指标(堆密度、紧密度等)和制剂的中间体混合颗粒的粒径分布、流动性指标和水分等建立片剂制备工艺;采用高效液相色谱法测定左乙拉西坦含量,并评价可溶片的外观、崩解时限、主成分含量等质量指标。结果:确立了左乙拉西坦可溶片的制备工艺为湿法制粒压片法。所制可溶片规格为100mg/220 mg,外观片面光洁,崩解时限均在1 min内,左乙拉西坦平均含量为100.1%,硬度为7.5 kg,脆碎度合格。结论:左乙拉西坦可溶片处方及制备工艺合理、可控,成品各项质量指标均符合要求。

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 rain; 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 un to the reauirements.