茵栀黄分散片处方优化与溶出度考察

Study on the Formulation Optimization and Dissolution of Yinzhihuang Dispersible Tablets

目的:优选茵栀黄分散片处方,并考察其溶出度。方法:以崩解时限为评价指标,以交联聚维酮(PVPP)、交联羧甲基纤维素钠(CMC-Na)、微晶纤维素(MCC)用量为考察因素,采用正交设计优选处方。结果:PVPP、CCNa、MCC的用量分别为10%、6%、40%,制得的分散片在3min内完全崩解且能通过2号筛,2min左右累积溶出百分率即可达到标示量的80%以上。结论:所选处方合理,制得的分散片崩解时限符合要求。

OBJECTIVE：To optimize the formulation of Yinzhihuang dispersible tablets and investigate its dissolution.METHODS：The formulation was optimized by orthogonal design with disintegration time as index using amounts of PVPP,CCNa and MCC as factors.RESULTS：The optimum formulation was composed of PVPP 10%,CMC-Na 6% and MCC 40%.The dispersible tablet could completely disintegrate within 3 min and pass No.2 sifter.The accumulative dissolution percentages could be above 80% of signal amount at 2 min.CONCLUSION：The formulation is reasonable,and the disintegration time is consistent with the requirements.