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Enalapril maleate is currently used to treat high blood pressure drugs. Features: oral absorption, Jing mother small, half-length, in combination with a diuretic Jing, enhanced role. ACTION: renin angiotensin - aldosterone system and the incidence of hypertension is closely related to the role of antihypertensive effect may play in different aspects of the system in which the drug angiotensin-converting enzyme inhibitors are a class of valuable. antihypertensive drugs.
Source topics: one hundred Austrian Medical Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as: one hundred doctors Austrian company) is a Life Science Co., Ltd. of Japan (ba-o-Science Co., Ltd.) as the sole investment of chemical solid preparation drug manufacturers. Product solutions and construction scale: an annual output of 500 million enalapril maleate to 500 million / year to consider equipment.
Currently doctors hundred Austrian company introduced early enalapril maleate tablets and other cardiovascular drugs with good market prospects, the construction of this project, the company's pre-development will create a strong market share in providing support, and the company the future introduction of new products, accelerate sustainable development and lay a solid foundation.
2 Design principles:
(1)Strictly in accordance with the "Good Manufacturing Practices" (GMP) and "clean plant design specifications" requirement, while adhering to the relevant norms of the existing state and local fire, safety, health, environmental protection, energy conservation and labor protection, regulations and standards .
(2) Plant Layout in meeting the GMP security, fire protection and other aspects of the relevant standards and specifications as far as possible the conditions so that people, logistics separate, not regurgitation. And pay attention to the reasonable layout and convenient transportation, the path is short, Czech Republic.
(3)Use of advanced production technology and equipment, improve product quality and production efficiency.
(4) Clean air conditioning and comfort air conditioning systems can effectively control the temperature and humidity; advanced water technology, water quality meets the requirements.
(5) Under the control of an investment, reduce investment risk and to accelerate the process input and output of the premise, as far as possible to meet the production requirements of the advanced selection of energy-saving equipment.
(6) Strictly comply with existing safety regulations, take a variety of practical and reliable, effective accident prevention and treatment measures [4].
Design content and requirements:
（1） Determine the zoning process and purification;
（2） Material balance, selection of equipment (two classes per day considered by weighing 0.1g meter; requires tabletting process, granulation methods, packaging forms custom);
（3） Designed by GMP workshop process plan requirements;
（4） Written design specification.
Design results:
（1） The design manual. Including process overview, process and purify zoning instructions, material balance, process equipment selection shows workshop process layout instructions;
（2） Process and instrumentation layout; process equipment layout.
KeyWords：tablets; process; workshop; design
目录
设计总说明 I
Design Specification III
目录 V
附录: VII
1 绪论 1
1.1项目概述 1
1.2设计的目的及意义 1
1.3设计依据 2
1.4 设计内容 2
1.5 设计指导思想和设计原则 2
1.6 马来酸依那普利的介绍 3
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