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3. Design steps: Determine the design, the material balance and energy balance, equipment selection, workshop layout, etc. Material balance is go to calculate the actual feeding amount, the total mass balance process, the drying process material balance; In the equipment selection, the equipment is briefly explained and the equipment is introduced; In the workshop, the type of air conditioning system is chosen, and the cleanness of the clean zone is pided. To cleanliness clean area to be pided, pipeline specifications should be calculated, calculation of the requirements for pipe specifications. The design process is the center of quality, safety, efficiency, economy, etc., in strict accordance with GMP requirements. In the drawing, the AutoCAD2007 is used to carry out the drawing of the workshop layout, the process flow chart and the flow of people logistics. According to the design of raw materials as well as the requirements of the economy and the final production of the product of the profit, calculate the economic benefits. Design content based on "GMP", "Drug Administration Law" required to design, pharmaceutical plant design process for referring various books, written in strict accordance with specifications.
4. Design scheme: Main unit operation of the manufacture of tablets is crushing, screening, weighing, mixing (solid-solid or solid-liquid), granulation, drying and tabletting, coating, and packaging. If the material is too coarse granularity, or scaly crystalline polymorph monoclinic system, should crushed and sieved through a 100 mesh powder over screened to achieve the required fineness; Raw material mixing granulation in accordance with the regulations, according to the scale of production to determine the tablet size, choose the appropriate mesh sieve and granulation can improve liquidity, reduce dust, drying temperature should be based on drug and heat labile drug drying temperature is low, the drug heating drying temperature of heat resistant to high; In the process of the tablet press, the weight of the film is often checked, and the weight of the tablet is adjusted according to the weight of the tablet, and the problem of the particle diffusion and dust is paid, and the relative negative pressure is kept. The design of the method of the acetylating, production aspirin is salicylic acid as a starting material, by acieration, crude, refined, and other chemical and physical processes of production aspirin products Aspirin production is with salicylic acid as starting material, through acieration, crude, refined, and other chemical and physical processes production aspirin products.
Preparation plant design project is pided into three phases: pre-design work stage, stage design, the design of post-service work. At different stages do the different works, and these stages are closely linked. On the basis of solid preparation workshop designed the State Food and Drug Administration issued the "drug production quality management standards", "pharmaceutical industry clean plant design specifications" and national norms on construction, consumer, environmental, and energy aspects.
Keywords: aspirin; enteric-coated tablets; preparation workshop; GMP
目录
1 绪论…1
1.1 关于阿司匹林肠溶片1
1.2 关于制剂生产车间…1
1.3 阿司匹林肠溶片的国内外研究…2
2 工艺概况3
2.1 工艺流程设计…3
2.2 工艺流程图3
3 物料衡算5
3.1 生产安排…5
3.2 主药的计算5
3.3 实际投料量计算6
3.4 总过程的物料衡算…7
3.5 干燥过程的物料衡算8
3.5.1 干燥后的产品量…8