说明书年产16亿粒长效盐酸苯海拉明胶囊.doc

华厦学院课程设计说明书
(参考资料)
年产16亿粒长效盐酸苯海拉明胶囊
车间工艺设计
摘要
班级:药物制剂(2)班
当前,口服药物制剂仍是主要给药剂型之一。深入研究口服新剂型对提高药物疗效、减少不良反应,不仅是开展临床药学研究迫切需要,而且在医药科研和制药工业的经济效益上均具有重要意义。缓释制剂可按需要在预定期间内人体提供适宜的血药浓度,减少服用次数并可获得良好的治疗效果。其重要特点是可使人体维持此种血液浓度达较长的时间,而不象普通制剂那样较快地下降,从而避免普通制剂频繁给药所出现的"蜂谷"现象,使药物的安全性、有效性和适应性有所提高。因减少了用药次数,大大方便了,特别是长期用药的病人。
本盐酸苯海拉明车间工艺设计是根据在某药业有限责任公司进行实习期间,通过充分实践、观察与收集大量资料和数据,按照《医药设计技术规定》、《药品生产质量管理规范》等多种规范和标准,在老师的指导下进行的,搜索与查询相关资料。本设计任务为年产16亿粒盐酸苯海拉明的车间工艺设计,根据年生产总量计算每天每小时的工作量,以此为基础结合工艺流程进行设备选型。根据设备尺寸和台数设计厂房的平面布置,并布置净化系统。本设计说明书综述了盐酸苯海拉明的药理作用,胶囊剂的生产工艺设计和车间设计,并较为详细的介绍了胶囊剂车间的组成、布置、生产设备、工艺管道、净化系统及生产管理等。本设计为初步工艺设计。最后设计结果为:车间总面积为4000m2,共选用粉碎机1台,筛分机1台,湿法混合制粒机2台,整粒机1台,干燥机1台,填充机4台,抛光机2台,印字机3台,铝塑包装机4台等。绘制了相关图纸,,并翻译了约3500字的专业文献。
关键词:盐酸苯海拉明;胶囊剂;缓释、控释制剂;车间工艺设计

Abstract
At present, the oral drug formulations is still one of the main administration formulations. In-depth study of new formulations of oral drugs to improve the efficacy and reduce adverse reactions, not only in clinical medicine research is urgently needed, but in Chinese medicine research and the pharmaceutical industry on the economic benefits are of great significance. Sustained-release formulations may need to provide the human body within the scheduled period for the blood concentration, and reduce the frequency of use will be a good therapeutic effect. Its will is an important feature of the human body to maintain the blood concentration of such longer period of time, not as fast as the general agent to decline, thus could be avoided by the General Administration agents frequent the "Bee Valley" and to the safety of drugs , Effectiveness and adaptability has improved. Due to a decrease of the number of medication, greatly facilitated, in particular the long-term treatment of patients.
The workshop diphenhydramine hydrochloride process design is based on good medicine in Yichang were limited panies graduate internship period, through the full practice, observation and collected a great deal of information and