【作者】 王杰；

【导师】 尚振华；

【作者基本信息】 河北科技大学 ， 药物化学， 2010， 硕士

【摘要】 本文以复方氨敏虎杖胶囊为研究对象,通过工艺筛选和工艺优化,获得本制剂主要原料虎杖、千里光的提取工艺及胶囊生产的最佳处方和生产工艺。首先,通过试验考察了中药虎杖和千里光的提取溶剂的浓度、溶剂量、提取时间、提取次数等对药物的影响,从而分析筛查出虎杖和千里光的最佳提取条件,制定出其提取工艺路线,生产出合格的复方氨敏虎杖胶囊的中药原料。其次根据现有生产设备利用玻璃化温度原理对虎杖和千里光的喷雾干燥工序的工艺进行了优化,使干膏粉的质量和收率大大提高,有效降低了能源消耗和喷雾干燥时间,大大提高了干膏粉的出粉率。再次,对复方氨敏虎杖硬胶囊的生产工艺进行了研究改进,通过改变辅料及辅料添加方法等手段,使本产品的生产工艺更具合理性和可操作性,使产品在保证质量的前提下既节约能耗又降低了生产成本,为今后大规模生产打下基础。最后,进行稳定性考察,通过加速稳定性试验和含量变化分析,进一步验证复方氨敏虎杖胶囊研究中处方筛选和工艺优化的可靠性。更多还原

【Abstract】 Compound Paracetamol and Chlorphenamine Maleate Capsules were studied in this paper. Through process screening and optimization, the extraction process of Polygonum cospidatum and climbing groundsel was obtained and the production technique and the formulation were founded.First of all, the density, quantity, extraction time, extraction number of times of extraction resolver of Polygonum cospidatum and the climbing groundsel were inspected through the experiments. The best extraction conditions were obtained and the extraction process route and produced the qualified traditional Chinese medicine raw material of Compound Paracetamol and Chlorphenamine Maleate Capsule was formulated.Secondly, under the existing equipment,utilizing glass temperature principle,the process of spray drying working procedure of Polygonum cospidatum and the climbing groundsel was optimized.The quality and yield of the dry powder have been improved greatly, the energy consumption and spray drying time have been reduced effectively,and producing powder rate of dry powder have been improved greatly.Moreover, we made the research to improve the production processes of the compound made of two or more ingredients ammonia Polygonum cospidatum capsule.By changing the means of adjuvants and add method of adjuvants,we enriched the production technology with more rationality and effectiveness, making the products save energy consumption and reduce producing cost on the premise of ensuring the quality of products. All of this laid a foundation for producing on a large scale in the future.Finally, we carried on the stable inspection.Through the acceleration stability test and the content change analysis,we further confirmed the reliability of prescription screening and the craft optimization which were applied in the research of the compound made of Compound Paracetamol and Chlorphenamine Maleate Capsule.更多还原