多潘立酮口腔崩解片的处方优化及体外评价

目的:优化多潘立酮口腔崩解片的处方并评价其质量。方法:以直接粉末压片法制备多潘立酮口腔崩解片,采用HPLC法测定其含量,以崩解时限和体外溶出度为指标优化处方。结果:以6%的交联聚维酮作为崩解剂,制备的多潘立酮口腔崩解片外观圆整光洁,硬度为(3.3±0.8)kg/cm2,脆碎度<1%,体外崩解时限和口腔内崩解时限分别为(9.00±0.56),(17.00±2.00)s,15min的累积溶出度为(99.22±0.38)%。结论:按最优处方制备的多潘立酮口腔崩解片符合《中华人民共和国药典》2010年版的要求,质控方法准确可靠。

Formulation optimization and in vitro evaluation of orally disintegrating domperidone tablets

Objective：To optimize the formulation of orally disintegrating domperidone tablets and to evaluate its quality. Methods： （）rally disintegrating domperidone tablets were prepared by direct compression process. The content of domperidone was determined by HPLC method. The formulation was optimized with disintegration time and dissolution in vitro as evalua tion indices. Results： Orally disintegrating domperidone tablets prepared by using polyvinylpolypyrrolidone （PVPP） as disinte- grant were spherical and smooth in outward appearance. The hardness of the drug was （3.3±0.8） kg/em2 and the friability was less than 1%. The disintegration time was （9.00±0.56） s in vitro and （17.00±2.00） s in oral cavity. Cumulative disso- lution in 15 min was （99.22±0.38） %. Conclusion： Orally disintegrating domperidone tablets prepared according to the optimal formulation could meet the requirements of Pharmacopoeia of the People＇s Republic of China 2010 ed. The quality control method is accurate and reliable.