氯氮平口腔崩解片的制备及质量控制

目的制备氯氮平口腔崩解片并探讨其质量控制。方法考察填充剂微晶纤维素、甘露醇及崩解剂交联羧甲基纤维素钠的用量，以外观、口感及体外崩解时间为指标，通过正交试验优化处方，采用直接压片法制备口腔崩解片，并对其崩解时间、溶出度、含量进行检测。结果氯氮平口腔崩解片在30s内可完全崩解，2min溶出达90％以上，含量符合规定。结论处方设计合理，制备工艺可行，产品质量可控。

Preparation and Quality Control of Clozapine Oral Disintegrating Tablets

Objective To prepare Clozapine Oral Disintegrating Tablets and to control its quality. Methods Microcrystalline cellulose and mannitol as fillers, eroscarmellose sodium as disintegrant were used, their quantities were studied by the indexes of appearance, taste and disintegration time in vitro, The formulation was optimized through the orthogonal test, the oral disintegrating tablets were prepared by direct compression, and their disintegration time, dissolution and content were examined. Results Clozapine Oral Disintegrating Tablets disintegrated com- pletely in 30 s, dissolved more than 90% in 2 min, and the content accorded with regulation. Conclusion The formulation design is reasonable, the process of preparation is feasible, the quality can be controlled.