盐酸环丙沙星胃漂浮缓释片处方工艺及产业化研究

Formulation technology and industrialization for intragastric floating sustained-release tablet of ciprofloxacin hydrochloride

目的:通过考察各处方工艺影响因素,解决盐酸环丙沙星胃漂浮缓释片产业化问题。方法:以释放性能和漂浮性能为指标,通过考察片剂硬度、颗粒粒度、HPMC用量、HPMC黏度级别、PVP XL用量、NaHCO3用量等,获得成熟的产业化工艺参数。结果:大规模生产所得制剂可在漂浮状态下完全释放药物,释放度试验结果表明产品释放度指标符合标准。结论:盐酸环丙沙星胃漂浮缓释片可使用HPMC,PVP XL,NaHCO3作为骨架材料,并可获得合格工业产品。

Objective： To investigate the industrialization for intragatric floating sustained release tablet of ciprofloxacin hydrochloride,and the formulation and preparation procedures.Methods： The process parameters were established by investigation of tablet hardness,granule size,amount and viscosity grade of HPMC,and amount of PVP XL and NaHCO_3,with the release and floating properties as indexes.Results： The preparations processed by large-scale industrialization production released the drug in an entirely floating condition in the medium.The results of in vitro dissolution showed that the drug release profile met the requirements.Conclusion： The qualified products can be obtained using HPMC,PVP XL,NaHCO_3 as complex matrix materials for intragastric floating sustained-release tablets.