正交试验优化氯氮平口腔崩解片的处方  

Formula optimization of clozapine orally disintegrating tablets by orthogonal test

作　　者：阎卉[1,2] 刘欢[1] 王成港[1] 

机构地区：[1]天津药物研究院释药技术及药代动力学国家重点实验室,天津300193 [2]天津医科大学,天津300070

出　　处：《现代药物与临床》2012年第2期111-113,共3页Drugs & Clinic

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。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.

关 键 词：氯氮平口腔崩解片 处方优化 正交设计 

分 类 号：R944.4[医药卫生—药剂学]