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机构地区:[1]广州医药工业研究院,广东广州510240 [2]澳门大学中华医药研究院,中药质量研究国家重点实验室,澳门999078 [3]广东环球制药有限公司,广东佛山528305
出 处:《今日药学》2014年第7期477-480,共4页Pharmacy Today
基 金:科技部"重大新药创制"科技重大专项-口服调释微丸制剂国际化关键技术(编号:2009ZX09501-023);广州市科研条件建设项目(编号:穗科信字【2012】224-10号);海珠区科技计划项目(编号:2011-KG-05)
摘 要:目的采用流化床包敷/包衣法制备复方盐酸非索非那定/盐酸伪麻黄碱调释胶囊并进行流化床中试放大研究,为建立复方药物异步释放的24 h调释小丸研发和中试技术平台奠定基础。方法采用流化床批量递增设计以含量、收率、效率为主要考察因素,以溶出度和释放曲线作为评价指标,考察中试放大工艺。结果在包衣区温度和风速、雾化液滴大小相近的前提下,调整其他参数,可以将小试工艺顺利放大到中试。结论流化床包敷/包衣法制备复方非索伪麻调释胶囊的小试工艺可顺利放大到中试,为进一步扩大生产奠定了基础。Objective To prepare the compound fexofenadine hydrochlorjde and pseudoephedrine hydrochloride modified-release capsules by fluidized-bed layering/coating technology, and to study the fluidized-bed scale-up pilot in meanwhile. So as to provide foundation for the establishment of pellets technology platform of the compound preparations with multi-release in 24 h. Methods The fluidized-bed scale-up design was used to screen the optimal scale-up pilot process with the main factors: content, yield of the pellets, efficiency of coating, and with the evaluation indexes of dissolution and release curves. Results In the context of the similar temperature and wind speed in coating area and the size of atomized droplets, with adjusting the other parameters, it could scale up the process from small experiment to pilot successfully. Conclusion The small experiment of preparing compound fexofenadine hydrochloride and pseudoephedrine hydrochloride modified-release capsules via the fluidized-bed layering/coating technology can be successfully scaled up to the pilot test, which provides the foundation for further mass production.
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