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.%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.
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