氯氮平口腔崩解片的研制

目的以氯氮平为模型药物制备口腔崩解片。方法以沉降容积比及崩解时间为指标,单因素法筛选片剂的处方组成及工艺,并优化制备工艺。结果氯氮平口腔崩解片以甘露醇、明胶、阿司帕坦与薄荷香精为辅料,经冷冻干燥法制备,口感良好,崩解时间为5 s,体外溶出度3 m in达94%。结论氯氮平口腔崩解片可迅速崩解于口腔内,制备工艺可行。

Preparation of Clozapine Oral Disintegrating Tablets

OBJECTIVE Clozapine was used as the model drug to develop oral disintegrating tablets.METHODS The formulation and preparation process of clozapine orally disintegrating tablets optimized by single factor experiment using sedimentation volume and disintegration time as the main evaluation parameter. RESULTS Clozapine orally disintegrating tablets were prepared by lyopyilization,containing the inactive ingredient: mannitol,gelatin,xanthan gum,aspartame and field-mint.The prepared tablets tasted fine and could disintegrate in 5s.The in vitro dissolution test indicated that 94% of clozapine dissolved in 3 minutes from the oral disintegrating tablets.CONCLUSION The prepared clozapine oral disintegrating tablets disintegrated rapidly in oral cavity.The process of preparation is feasible.