[关键词]
[摘要]
目的 制备氯氮平口腔崩解片,优化处方工艺。方法 以崩解时限、硬度、片面情况和口感为考察指标,采用正交设计法对处方进行筛选,确定最优处方。结果 湿法制粒压片,每片含交联羧甲基纤维素钠20 mg、甘露醇50 mg、微晶纤维素50 mg和预胶化淀粉25 mg时,所得片剂崩解时限小于1 min,且片剂外观光洁,口感良好。结论 氯氮平口腔崩解片处方符合口腔崩解片的质量要求。
[Key word]
[Abstract]
Objective To optimize the formula technology of clozapine orally disintegrating tablets. Methods Prescription was optimized by orthogonal test with disintegration time limit, hardness, one-sided situation and taste as indexes. Results Wet granulation tabletting method was carried out. As each tablet contained CMC-Na 20 mg, mannitol 50 mg, MCC 50 mg, and pregelatinized starch 25 mg, and the disintegration time limit was less than 1 min, with smooth appearance, and good taste of tablet. Conclusion The prescription of clozapine orally disintegrating tablets accords with the quality requirements of oral disintegrating tablet.
[中图分类号]
[基金项目]