制药工艺学习问答题及答案 .doc

1、Delegates, staff: Hello! in the run-up to the Spring Festival, we held one session of four staff representatives Conference 2013-workshop, full back in 2012, careful analysis of the current situation, discuss 2013 development plans. Here, on behalf of my company 2013 work reports to the General Asse

2、mbly, for consideration. Pillar I, 2012 back in 2012, XX power companies adhere to the partys 17 great spirit for guidance, comprehensively implement the scientific concept of development, promoting cost-leadership strategy, standards, focus on implementation, lean management, continuously improve,

3、smooth present safety situation of enterprise management, business management and control scientific and standardized, and the dedication of staff, manage a harmonious and democratic atmosphere of the good situation. Main indicators are as follows:-the battery indicator: power generation totaled 7.8

4、15 billion kWh, beyond the annual budget implementation capacity of 315 million kWh, an increase of 757 million kWh. Sales totaled 7.425 billion kWh, exceeding sales of 330 million kWh the annual Executive budget, an increase of 729 million kWh. -Security measures: unplanned outages 2.5 times. No pe

5、rsonal injury accident occurred, no major accident and above, no major fire accidents without environmental pollution accidents, safety for three consecutive years to maintain stability to good posture. Business financial indicators: total profits of 255 million Yuan, beyond the annual budget of 207

6、 million Yuan, beyond the Datang company index 41.89 million Yuan, an increase of 1.76 million Yuan, FCM assessment at grade four. -Energy: power supply standard coal completing 312.25 g/kWh, down 0.1 g/kWh; integrated auxiliary power consumption ratio in 5.12%, down 0.26%; pollutant emissions perfo

7、rmance greatly reduced compared to last year, carbon 0.09 g/kWh, sulfur dioxide 0.104 g/kWh NOx 0.512 g/kWh; dust removal efficiency of more than 99.8%. -Reliability index: equivalent availability factor in 93.47%, increased 7.95% from a year earlier. Equivalent forced outage rate 0.08%, 0.16% reduc

8、tion over the same period a year earlier. Major achievements: first, we should adhere to the two “management system“ basis, strengthening technological research, strengthen hidden hazards control and intrinsic safety Enterprise construction took new steps. -The two “management system“ for improvemen

9、t. Focus on promoting the power of the company management system and the application and implementation of the safety loop five-star management system, improve the safety management system, realize the system of safety control. Further regulate security routines, safety supervision and management ne

10、twork role to play to achieve closed-loop. Strengthening the supervision and management of habitual violation of, strengthening the safety supervision of outsourcing contractors. Carried out in spring and autumn of security inspections, flood control and inspection, safety production month, day supe

11、rvision of production safety and the Olympic Games and otheractivities, comprehensive and tamping Safety Foundation . Troubleshooting, management mechanism, give full play to role of technical supervision and realization of troubleshooting, management, improved process management. This year complete

12、d the boiler lower header leakage, boiler pressure, a major risk management, completed 29 of great risks and 3 General problems of governance. Complete chemistry lab construction, thermal control, and complete the boiler scale integrated management, host shafting vibration of 10 scientific and techn

13、ological projects, such as. Complete supercritical 630MW on-line simulation system development and application of circulating water MCC standby power transformation, the transformation of desulfurization waste water, the unit water supply system of comprehensive treatment and discharge valve modific

14、ation of coal mill 5 key technological transformation projects, group health is improved. -Science and technology innovation is further increased. Strengthen the characteristics of supercritical unit major issues, gradually clearing the particularity of supercritical unit and regularity. Developed m

15、otor oil time management, switch action times, statistics, coal-aided measurement software, improves the production level of lean management. Increased investment in science and technology, reporting science and technology projects and 14 technical project total cost percentage of the total annual p

16、roduction output of 0.25%. “Large-scale coal-fired power plant flue gas desulfurization, denitrification complete development and application of key technologies“ project, won the national science and technology progress second prize. 630MW supercritical units optimized control strategies and the 63

17、0MW development and application of on-line simulation system for supercritical units, supercritical 600MW units of turbine driven boiler feed pump set of comprehensive treatment of defects Datang technology respectively one or two and third. Meanwhile, information technology achievements, the compan

18、y was named “China power information technology benchmarking enterprises.“ -Repair and maintenance has improved further. Modify the inspection standards and standards on a regular basis, standardizing work procedures, checking and inspection project. Deepening the BFS+ system, and implements mainten

19、ance information shared. Reorganizing RB logic again, and ensure the success of the RB. Innovating the mechanism of maintenance management, implemented a project manager system. Successful completion of two autonomous maintenance, reliability improved steadily. Implementing two c-level maintenance,

20、project themselves 48.7% and 42.3%, respectively. Accomplish two circulating pumps repair and overhaul of four Mills, maintenance teams to get exercise. Promote the work of energy saving and consumption reducing, complete the unit energy consumption diagnosis, plant water balance test, 10 energy-sav

21、ing projects. Second, we should adhere to “three“ on the economic benefits of improving, outreach第一章 绪论 1. 制药工业的特殊性主要表现在哪几方面？答： （1）药品质量要求特别严格。药品质量必须符合中华人民共和国药典规定的标准和GMP 要求。（2）生产过程要求高。在药品生产中，经常遇到易燃、易爆及有毒、有害的溶剂、原料和中间体，因此，对于防火、防爆、安全生产、劳动保护、操作方法、工艺流程设备等均有特殊要求。（3）药品供应时间性强。社会需求往往有突发性(如灾情、疫情和战争) ，这就决定了医药生产

22、要具有超前性和必要的储备。（4）品种多、更新快。2. 制药工业的特点有哪几方面？答： （1）高度的科学性、技术性（2）生产分工细致、质量要求严格（3）生产技术复杂、品种多、剂型多（4）生产的比例性、连续性（5）高投入、高产出、高效益3新药研发的内容是什么？答： （1）新药研究与开发是一项较复杂的系统工程，涉及化学、药学、生物学、药理学、毒理学、药剂学、临床医学等各学科，经历新药设计、工艺制备、药理筛选、安全评价、临床研究、质量控制和中试放大等较多步骤。（2）新药研究与开发应包括新药从实验室研究到生产上市，扩大临床应用的整个过程，是制药工艺学研究的一个基本内容。（3）创新药物的研究开发是一项多学

23、科、跨行业、投资高、周期长、风险大、回报颇丰的技术密集型系统工程,必须以大的制药企业为背景才能持续下去。新药研发的特点（1）高投入（2）高风险（3）高利润（4）周期长（5）竞争激烈（6）专利保护严密（7）品种更新迅速（8）发展潜力巨大（3）制药工业是一个以新药研究与开发为基础的工业。4我国制药工业的发展方向有哪些？（1）化学制药工业应向创制新药和改进生产工艺方向发展（2） 开发新剂型，改造老剂型5 针对当前我国化学药品生产所面临的问题，如何提高我国医药企业的研发能力？答： （1）仿制创新是必经阶段。针对当前我国化学药品生产所面临的新形势，首先在战Delegates, staff: Hello!

24、 in the run-up to the Spring Festival, we held one session of four staff representatives Conference 2013-workshop, full back in 2012, careful analysis of the current situation, discuss 2013 development plans. Here, on behalf of my company 2013 work reports to the General Assembly, for consideration.

25、 Pillar I, 2012 back in 2012, XX power companies adhere to the partys 17 great spirit for guidance, comprehensively implement the scientific concept of development, promoting cost-leadership strategy, standards, focus on implementation, lean management, continuously improve, smooth present safety si

26、tuation of enterprise management, business management and control scientific and standardized, and the dedication of staff, manage a harmonious and democratic atmosphere of the good situation. Main indicators are as follows:-the battery indicator: power generation totaled 7.815 billion kWh, beyond t

27、he annual budget implementation capacity of 315 million kWh, an increase of 757 million kWh. Sales totaled 7.425 billion kWh, exceeding sales of 330 million kWh the annual Executive budget, an increase of 729 million kWh. -Security measures: unplanned outages 2.5 times. No personal injury accident o

28、ccurred, no major accident and above, no major fire accidents without environmental pollution accidents, safety for three consecutive years to maintain stability to good posture. Business financial indicators: total profits of 255 million Yuan, beyond the annual budget of 207 million Yuan, beyond th

29、e Datang company index 41.89 million Yuan, an increase of 1.76 million Yuan, FCM assessment at grade four. -Energy: power supply standard coal completing 312.25 g/kWh, down 0.1 g/kWh; integrated auxiliary power consumption ratio in 5.12%, down 0.26%; pollutant emissions performance greatly reduced c

30、ompared to last year, carbon 0.09 g/kWh, sulfur dioxide 0.104 g/kWh NOx 0.512 g/kWh; dust removal efficiency of more than 99.8%. -Reliability index: equivalent availability factor in 93.47%, increased 7.95% from a year earlier. Equivalent forced outage rate 0.08%, 0.16% reduction over the same perio

31、d a year earlier. Major achievements: first, we should adhere to the two “management system“ basis, strengthening technological research, strengthen hidden hazards control and intrinsic safety Enterprise construction took new steps. -The two “management system“ for improvement. Focus on promoting th

32、e power of the company management system and the application and implementation of the safety loop five-star management system, improve the safety management system, realize the system of safety control. Further regulate security routines, safety supervision and management network role to play to ac

33、hieve closed-loop. Strengthening the supervision and management of habitual violation of, strengthening the safety supervision of outsourcing contractors. Carried out in spring and autumn of security inspections, flood control and inspection, safety production month, day supervision of production sa

34、fety and the Olympic Games and otheractivities, comprehensive and tamping Safety Foundation . Troubleshooting, management mechanism, give full play to role of technical supervision and realization of troubleshooting, management, improved process management. This year completed the boiler lower heade

35、r leakage, boiler pressure, a major risk management, completed 29 of great risks and 3 General problems of governance. Complete chemistry lab construction, thermal control, and complete the boiler scale integrated management, host shafting vibration of 10 scientific and technological projects, such

36、as. Complete supercritical 630MW on-line simulation system development and application of circulating water MCC standby power transformation, the transformation of desulfurization waste water, the unit water supply system of comprehensive treatment and discharge valve modification of coal mill 5 key

37、 technological transformation projects, group health is improved. -Science and technology innovation is further increased. Strengthen the characteristics of supercritical unit major issues, gradually clearing the particularity of supercritical unit and regularity. Developed motor oil time management

38、, switch action times, statistics, coal-aided measurement software, improves the production level of lean management. Increased investment in science and technology, reporting science and technology projects and 14 technical project total cost percentage of the total annual production output of 0.25

39、%. “Large-scale coal-fired power plant flue gas desulfurization, denitrification complete development and application of key technologies“ project, won the national science and technology progress second prize. 630MW supercritical units optimized control strategies and the 630MW development and appl

40、ication of on-line simulation system for supercritical units, supercritical 600MW units of turbine driven boiler feed pump set of comprehensive treatment of defects Datang technology respectively one or two and third. Meanwhile, information technology achievements, the company was named “China power

41、 information technology benchmarking enterprises.“ -Repair and maintenance has improved further. Modify the inspection standards and standards on a regular basis, standardizing work procedures, checking and inspection project. Deepening the BFS+ system, and implements maintenance information shared.

42、 Reorganizing RB logic again, and ensure the success of the RB. Innovating the mechanism of maintenance management, implemented a project manager system. Successful completion of two autonomous maintenance, reliability improved steadily. Implementing two c-level maintenance, project themselves 48.7%

43、 and 42.3%, respectively. Accomplish two circulating pumps repair and overhaul of four Mills, maintenance teams to get exercise. Promote the work of energy saving and consumption reducing, complete the unit energy consumption diagnosis, plant water balance test, 10 energy-saving projects. Second, we

44、 should adhere to “three“ on the economic benefits of improving, outreach略上要把化学药品研究从仿制为主转变到以创新为主的轨道上来。（2）改进创新是主要途径。目前非专利化学原料药国际市场竞争日趋剧烈，要在这一市场上取得一席之地，必须提高劳动生产率，拥有创新的先进技术路线、生产工艺和高效率的生产线，具备经济合理的生产规模，才能立于不败之地。（3）完全创新是发展方向。自主创新，发挥优势，有条件的领域实现原始创新，有的是在引进消化吸收基础上实现再创新，也包括用先进技术改造传统产业。第二章 药物路线的设计和选择1. 药物工艺路线的

45、设计要求有哪些？答： （1）合成途径简易；（2）原材料易得；（3）中间体易分离；（4）反应条件易控制；（5）设备条件不苛求；（6） “三废”易治理；（7）操作简便，经分离、纯化易达到药用标准，最好是多步反应连续操作，实现自动化；（8）收率最佳、成本最低。2. 药物的结构剖析原则有哪些？答： （1）药物的化学结构剖析包括分清主要部分（主环）和次要部分（侧链） ，基本骨架与官能团；（2）研究分子中各部分的结合情况，找出易拆键部位；（3）考虑基本骨架的组合方式，形成方法；（4）官能团的引入、转换和消除，官能团的保护与去保护等；（5）若系手性药物，还必须考虑手性中心的构建方法和整个工艺路线中的位置等问

46、题。3药物生产工艺路线的设计和选择的一般程序：答：（1）必须先对类似的化合物进行国内外文献资料的调查和研究工作。（2）优选一条或若干条技术先进，操作条件切实可行，设备条件容易解决，原辅材料有可靠来源的技术路线。（3）写出文献总结和生产研究方案（包括多条技术路线的对比试验）（4）确证其化学结构的数据和图谱（红外、紫外、核磁、质谱等） ；（5）生产过程中可能产生或残留的杂质、质量标准；（6）稳定性试验数据；Delegates, staff: Hello! in the run-up to the Spring Festival, we held one session of four staff

47、representatives Conference 2013-workshop, full back in 2012, careful analysis of the current situation, discuss 2013 development plans. Here, on behalf of my company 2013 work reports to the General Assembly, for consideration. Pillar I, 2012 back in 2012, XX power companies adhere to the partys 17

48、great spirit for guidance, comprehensively implement the scientific concept of development, promoting cost-leadership strategy, standards, focus on implementation, lean management, continuously improve, smooth present safety situation of enterprise management, business management and control scienti

49、fic and standardized, and the dedication of staff, manage a harmonious and democratic atmosphere of the good situation. Main indicators are as follows:-the battery indicator: power generation totaled 7.815 billion kWh, beyond the annual budget implementation capacity of 315 million kWh, an increase of 757 million kWh. Sales totaled 7.425 billion kWh, exceeding sales of 330 million kWh the annual Executive budget, an increase of 729 million kWh. -Security measures: unplanned outages 2.