目的 制備氯氮平口腔崩解片，優(yōu)化處方工藝。方法 以崩解時(shí)限、硬度、片面情況和口感為考察指標(biāo)，采用正交設(shè)計(jì)法對(duì)處方進(jìn)行篩選，確定最優(yōu)處方。結(jié)果 濕法制粒壓片，每片含交聯(lián)羧甲基纖維素鈉20 mg、甘露醇50 mg、微晶纖維素50 mg和預(yù)膠化淀粉25 mg時(shí)，所得片劑崩解時(shí)限小于1 min，且片劑外觀光潔，口感良好。結(jié)論 氯氮平口腔崩解片處方符合口腔崩解片的質(zhì)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.