25t年拉西地平无菌原料药车间设计
依据物料衡算数据和标准设备的生产能力选择生产所需的设备型号以及台套数,确保设备符合本次设计。在设计车间过程中,根据工艺需求,设置“L”型厂房,设置生产各主要工序位置,比如季膦化、缩合、环合等工序,以及相应的人员更衣、洁净处理、物料缓冲、器具消毒等其他区域。此外,还单独设计了必要的三废处理间等。最后进行人员分配,并绘制车间布局图。
目 录
This design is mainly about the workshop design of Raxidipine API. The raw materials are triphenylphosphine and tertbutyl chloroacetate. Raxidipine crude products are reacted by four steps: substitution, neutralization, condensation and cyclization, and then the finished products are refined. In the design, firstly, the design basis of API production is explained, and then the product is introduced. Combining with the process flow, the process flow chart is drawn. Secondly, according to the material balance data and the production capacity of standard equipment, select the type of equipment needed for production and the number of sets to ensure that the equipment meets the design.
In the process of designing workshop, according to the technological requirement, Ltype workshop is set up, and the main process positions of production are set up, such as the processes of quaternization, condensation and cyclization, as well as other areas such as changing clothes,cleaning treatment, material buffering, sterilization of appliances and so on. In addition, individually designed the necessary three wastes treatment room. Finally, the personnel are assigned and the layout of the workshop is drawn.
Key words: Lacidipine; Workshop layout; Process design
1 绪论
拉西地平,化学名(E)4{2【3(羧叔丁基)3—氧代1丙烯基】苯基}1,4二氢2,6二甲基3,5吡啶二甲酸二乙酯。又名乐息平等,是血管选择性钙拮抗剂,具有高长效的降压活性,用于治疗各种类型高血压。
产品结构式如下:
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质量标准:拉西地平为白色或类白色结晶性粉末,含量99% 。
分子式:C26H33NO6
分子量:455.5433
密度:1.127g/cm3
2 工艺流程设计
2.1设计题目
25t/年拉西地平无菌原料药车间设计
2.2 设计基础
根据设计任务,设计规模详见下表11
表11 设计规模
产品名称
设计规模
(t /a)
含量
包装规格
其他
拉西地平
25
99 %
铝听 5Kg /听
无菌原料药
2.3工艺路线
以三苯基膦、氯乙酸叔丁酯等为原料,经季膦化、中和、缩合、环合四步反应得到拉西地平粗品,再经精制得拉西地平成品。产品合成路线如下图所示。
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(1)1季膦化工序
【工艺配比】
原辅料名称
规格
质量比
三苯基膦
≥99%
1.00
氯乙酸叔丁酯
≥99%
1.25
二氯甲烷
≥99%
1.50
乙醚
≥99%
2.86
【工艺过程】
在反应釜中加入三苯基膦、氯乙酸叔丁酯和二氯甲烷,升温回流2小时。冷却静置后过滤,滤饼用10℃的乙醚洗涤,在分别收集母液、淋洗液,得中间体(2)的滤饼(含量71%)。分别回收母液中的二氯甲烷(回收率为90%)和淋洗液中的乙醚(回收率为85%),残留物送到处理站。
(2)中和工序
【工艺配比】拉西地平中和工序的各原辅料的规格及质量比如下表所示:
原辅料名称
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