灯盏花素口腔速崩片的研制

Preparation of Breviscapine Oral Disintegrating Tablets

目的以灯盏花素为模型药物制备口腔速崩片。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。结果灯盏花素口腔速崩片以甘露醇、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4s,体外溶出度4min达98.72%。结论灯盏花素口腔速崩片可迅速崩解于口腔内,制备工艺可行。

OBJECTIVE Breviscapine was used as the model drug to develop oral disintegrating tablets. METHODS The formulation and preparation process of breviscapine orally disintegrating tablets optimized by single factor experiment using sedimentation volume and disintegration time as the main evaluation parameter. RESULTS Breviscapine 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 4 s. The in vitro dissolution test indicated that 98.72% of breviscapine dissolved in 4 minutes from the oral disintegrating tablets. CONCLUSION The prepared breviscapine oral disintegrating tablets disintegrates rapidly in oral cavity. The process of preparation is feasible.