摘要
研制阿奇霉素盐酸溴己新复方干混悬剂。将药物阿奇霉素和盐酸溴己新与羧甲基淀粉钠、蔗糖等辅料在高温、高湿条件下开展相容性考察,由此选择合适辅料,单因素优化阿奇霉素盐酸溴己新复方干混悬剂的处方工艺条件。将优化处方工艺制得干混悬剂样品进行影响因素和加速稳定性考察。结果表明,优选得到阿奇霉素盐酸溴己新复方干混悬剂处方工艺条件,样品经稳定性考察,稳定性良好(有关物质<2%;0 min药物溶出>85%)。研制的阿奇霉素盐酸溴己新复方干混悬剂工艺质量稳定,有望为临床提供一种新型的复方抗感染制剂。
TOprepare the compound azithromycin for suspension and the quality of the new designed suspension was investigated.The interaction between azithromycin/bromhexine hydrochloride and excipients was investigated.The suitable excipients were used tOdevelop the compound azithromycin for suspension.Compound azithromycin for suspension were screened using single factor design.The quality and stability of the new designed suspension was investigated by influence factor and accelerated tests.Results showed that the 30 min accumulative amount was beyond 85%in dissolution media.The related substances of the suspension were below 2%.The compound azithromycin for suspension with good technology quality was suited for clinical practice.
作者
陈刚
龚穗菁
刘哲鹏
CHME Gang;GONG Hui-jing;LIU Zhe-peng(Medical Department of 113 Hospital,NingbO315040,China;School of Medical Instrument and Food Engineering,University of Shanghai for Science and Technology,Shanghai 200093,China)
出处
《应用化工》
CAS
CSCD
北大核心
2018年第S02期257-259,263,共4页
Applied Chemical Industry
