盐酸氨溴索三层泡腾片的制备及稳定性的因素考察  

Preparation and stability of ambroxol hydrochloride zhree-layer effervescent tablets

作　　者：张玲玲[1] 邓意辉[1] 周欣羽[1] 吴红兵[1] 徐速[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2006年第9期705-708,共4页Chinese Journal of New Drugs

摘　　要：目的:以盐酸氨溴索为模型药物制备三层泡腾片,并考察其稳定性。方法:将泡腾片的酸碱对分别置于不同的片层,中间用不与泡腾系统反应的物质隔开后直接压制成硬度为5kg的片剂。分别对三层片的性状、崩解时限、pH值、含量测定以及稳定性进行考察。结果:盐酸氨溴索泡腾片能在3min内完全崩解。三层泡腾片在高湿、强光照射和高温下的初步稳定性和长期稳定性均优于普通泡腾片。结论:将盐酸氨溴索制备成三层片有助于提高普通泡腾片的稳定性。Objective： To investigate the preparation and stability of ambroxol hydrochloride three-layer effervescent tablets. Methods： Each effervescent tablet contained a three-layer structure： a layer of acidic substance and a layer of alkaline substance separated by a layer of the substance that does not react with either effervescent reactant separated the layers above. Three layers were compressed to tablets with the hardness of 5 kg. Appearance, disintegrating time, pH value, content, and the stability of three-layer effervescent tablets were investigated, results： The three-layer effervescent tablets were disintegrating within 3 minutes, and showed more stable than conventional effervescent tablets under the short-term experiments of high humidity, strong light exposure and high temperature and long-term stability tests. Conclusion： The stability of effervescent tablets was significantly improved by preparing them into three-layer tablets.

关 键 词：盐酸氨溴索 三层泡腾片 稳定性 

分 类 号：R943.41[医药卫生—药剂学] R944.4[医药卫生—药学]