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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2006年第9期705-708,共4页
Chinese Journal of New Drugs
关键词
盐酸氨溴索
三层泡腾片
稳定性
ambroxol hydrochloride
three-layer tablets
stability
