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重压法干法制粒工艺及设备应用研究

     

摘要

After prepare some products by Heavy-press granulation,such as Domperidone Dispersible Tablet,Acetylspiramycin Tablets,Flunarizine Hydrochloride Capsules,lbuprofen Tablets and Nvjin Capsules;and the weight variation,content,dissolution, and the process economic analysis were given.Results:The weight variation,content and dissolution of the products meet the requirements;and production costs reduced by 60% over Wet-granulation.Conclusion:Under the premise of prescription adjustments,Heavy-press granulation technology has the quality and economic alternative in comparison with Wet-granulation process.%应用重压法干法制粒工艺和设备对多潘立酮分散片、乙酰螺旋霉素片、盐酸氟桂利嗪胶囊、右旋布洛芬片和女金胶囊进行了制粒,比较了制剂重量差异、含量及溶出度,并对现行制粒工艺进行生产经济性分析。结果:各品种重压法干法制粒成品重量差异、含量及溶出度符合要求,生产成本较湿法制粒降低60%以上。结论:重压法干法制粒工艺在固体制剂成型处方进行适当调整的前提下对湿法制粒工艺具有质量和经济上的替代性。

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