制备高空隙率口腔崩解片的新方法

New method of preparing high-porosity rapidly saliva soluble disaggregated tablets using mannitol and ammonium bicarbonate

目的:研究制备口腔崩解片的新方法。方法:将含有碳酸氢铵的片剂在干燥箱中加热至80℃,保温一段时间,碳酸氢铵全部分解成氨、水和二氧化碳从片剂中逸出,得高空隙片剂。考察碳酸氢铵用量、空隙率、硬度、含药量和硬脂酸镁与崩解时限的关系;考察加热温度和加热时间对碳酸氢铵残留量的影响。结果:碳酸氢铵用量、空隙率与崩解时限成反比;硬度、含药量和硬脂酸镁用量与崩解时限成正比;温度升高,加热时间延长,碳酸氢铵残留量减少。每片碳酸氢铵用量定为0.15g,硬脂酸镁用量为0.5%～1.5%,硬度为9kg,在80℃加热75min。结论:本方法简便易行,质量稳定可控,但碳酸氢铵残留量较高,有待进一步完善。

OBJECTIVE To research a new method of preparing high-porosity saliva soluble disaggregated tablets. METHODS The high-porosity saliva soluble disaggregated tablets of ammonium bicarbonate could be prepared by direct compression and heating at 80℃ ,ammonia water and carbon dioxide were liberated from the tablet. Furthermore, study the effects of different factors on disingtegrating time limit including the quantiry of ammonium bicarbonate, porosity, hardness, content of main ingredient and magnesium stearate,and study the relationship between ammonium bicarbonate remain quantity and heating tempreture and time. RESULIS The disintegrating time limit was proportional to porosity and content of ammonium bicarbonate, but was inversely proportional to hardness, contene of main ingredient and magnesium stearate. Forthermore, residual content of ammonium bicarbonate decreased along with temperature increasing and heating time extension. The tablets were prepared asfollowed： the content of ammonium bicarbonate was 0. 15 g, and the content range of magnesium stearate was 0. 5%-1.5% ; hardness was 9 kg,and heating 75 min at 80 ℃. CONCLUSION The method is feasible,further study is needed to eliminate residud ammonium bicarbonate.