(Pharmaceutical Equipment and Engineering Design)
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Pharmaceutical 080 1 HU Xianmin 20080 10573 Gu
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20 1 1 June15th.
Wanxi University Institute of Biology and Pharmaceutical Engineering
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Design task book of pharmaceutical equipment and engineering design course
Design theme: the design of an annual output 1 100 million antiviral oral liquid factory. Pharmaceutical 080 1 Student Tutor Hu Xianmin Gu.
1. capacity: annual output 1 100 million pieces/year. 2. Process requirements: the sum of requirements for selecting the best process flow. 3. Quality requirements: conforming to GMP.
1. Design and description of process flow. Draw the main equipment diagram/process flow diagram/workshop plan/automobile task room elevation/factory plan with control points respectively.
Design work plan and schedule
1, Monday: collect and consult relevant documents; Tuesday: Preliminary determination of process plan; Wednesday: Material balance and main equipment selection; Thursday: Complete the process plan; Friday: Draw the main equipment diagram/process flow diagram/workshop plan/workshop elevation/factory plan with control points respectively.
Main references
Zhu Hongji, Zhang Mingxian. Pharmaceutical equipment and engineering design. Zhang Heng, Chemical Industry Press. Process design of pharmaceutical engineering. Chemical Industry Press Wanfang Database China National Intellectual Property Administration Website China Chemical machinery network China Machinery Equipment Network China Pharmaceutical Equipment Association China Pharmaceutical machinery network
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Wanxi University Institute of Biology and Pharmaceutical Engineering
Course design and explanation
Theme class
Goal: Cheng:
Factory design with an annual output of 1 100 million antiviral oral liquid.
Department of Pharmaceutical Equipment and Engineering Design Biology and Pharmaceutical Engineering Pharmaceutical Engineering 080 1 Hu Xianmin 20080 10573 Gu 20 1 1.06.30
Department (Department): Professional Industry: Grade:
Student Name: Student ID:
Lecturer: Date of Completion:
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Introduction to curriculum design
The antiviral oral liquid made of traditional Chinese medicine has the functions of clearing away heat and toxic materials, cooling blood, protecting organelles, antagonizing and alleviating endotoxin, adjuvant treating infectious diseases, inducing immune function and disease resistance, and has obvious antiviral and antibacterial effects and rapid action. Clinical trials have proved that the curative effect of the oral liquid is credible, because it is economical and simple to administer, and the route of administration is oral, non-invasive and has no obvious side effects. Early use of oral liquid is beneficial to shorten the treatment time and reduce the change of illness. Therefore, the oral liquid is a good medicine for treating respiratory tract infection, and it is also a compound oral liquid of traditional Chinese medicine with great development prospect. According to the survey, there is still a broad market space. The raw materials belong to common medicinal materials, which are convenient to obtain and cheap. According to the above situation, it is decided. Established an antiviral oral liquid factory with an annual output of 1 100 million in the west of Yueliangdao, Yu 'an District, Lu 'an City.
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Course design, explanation and catalogue
I. Design data
1. Design product introduction
Second, the process design and description
1. Process flow chart ... Scheme analysis
Third, material balance.
1. Total material balance of main materials 12.
Fourth, the choice of equipment.
1. Selection of equipment ........................................... 13
Five, energy cross calculation
1. Energy balance of leaching equipment ...................................... 13.
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2. Energy balance of other major equipment .................................. 14
Intransitive Verb Factory Overall Design and Drawing Selection
1. Site selection
Seven. Treatment and prevention of waste liquid
1. Treatment method of waste liquid .......................................... 17
Eight. Refer to ......................... 18.
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Design description of pharmaceutical equipment and engineering I. Design data
1. Design product introduction
Brief introduction of antiviral oral liquid
Based on Treatise on Febrile Diseases written by Zhang Zhongjing, a famous doctor in the Western Han Dynasty, it is selected from Treatise on Febrile Diseases written by Zhang Zhongjing, a famous doctor in the Eastern Han Dynasty. The prescription is carefully selected and authentic, and the purity is 654.38+ 10,000. The low-temperature extraction process doubles the effective components and has good taste. Clearing heat and promoting diuresis, cooling blood and detoxifying. It is mainly used to treat influenza and cold, contains a variety of antiviral components, effectively inhibits viruses, and has quick absorption and quick effect. It is a first-line drug for treating and preventing influenza, influenza, hand, foot and mouth disease, upper respiratory tract infection, mumps and other viral infections! Research shows that more than 90% of colds are caused by viruses. Furen antiviral oral liquid contains a variety of antiviral ingredients, which can effectively inhibit the virus, absorb it quickly and take effect quickly! The curative effect is better than other similar products. This product is prepared from Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, Radix Rehmanniae, Radix Curcumae, Rhizoma Anemarrhenae, Rhizoma Acori Graminei, Herba Agastaches and Fructus Forsythiae. The auxiliary materials are honey, sucrose, hydroxymethyl ester and ethyl paraben. Bozhou has a large amount of medicinal materials and simple materials.
Advantages of antiviral oral liquid The disadvantages and harms of western medicine in treating influenza and western medicine in treating influenza and cold.
A treating the symptoms rather than the root cause-western medicine can only relieve the symptoms of influenza and cold, but can't fundamentally treat the cold. B Antibiotic abuse-Western medicine has serious antibiotic abuse in the treatment of influenza and cold, leading to the emergence of drug-resistant bacteria such as "super virus", which is easy to cause bacterial imbalance in human body. C toxic and side effects-western medicine has different degrees of damage to human liver and kidney function, with great toxic and side effects. D easy to rebound-western medicine is used to treat influenza and cold, and the symptoms are easy to repeat.
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Advantages of traditional Chinese medicine in preventing and treating influenza.
Classic prescription with remarkable curative effect-the prescription of Furen antiviral oral liquid is selected from Treatise on Febrile Diseases by Zhang Zhongjing, a famous doctor in the Eastern Han Dynasty. With more than 65,438+0,000 years of successful experience, it is the perfect combination of classic prescriptions and modern medical innovation technology, and has remarkable curative effect on colds. B strengthening the body resistance and treating both the symptoms and root causes-the principle of TCM treatment follows the principle of strengthening the body resistance and treating both the symptoms and root causes, which can not only enhance the body's resistance, but also restore the body to health. C improving immunity-antiviral oral liquid is doped with traditional Chinese medicine with special immune components, which fills the gap of cold components in western medicine. D Safety and no toxic side effects-all Chinese medicine materials come from nature, and plant medicine does not contain irritating and harmful ingredients. E does not rebound-the effect of traditional Chinese medicine in treating cold and high fever is stable and lasting, and it does not rebound.
Treat influenza
Influenza virus is a kind of acellular microorganism. After entering the human body, the virus parasitizes in human target cells, replicates and spreads by cell metabolism, and destroys human functions. At this time, only human immune cells and immunoglobulin can identify healthy cells and cells infected by the virus, thus eliminating the virus. If people's immune ability is low and their antibodies are insufficient, it is self-evident that influenza is difficult to treat. The antiviral mechanism of Furen antiviral oral liquid is that it can enhance human immune function after taking medicine, and kill the virus by activating antibodies, immune cells and immunoglobulin, thus eliminating the virus and restoring human health. This is why antiviral oral liquid is particularly effective in treating and preventing colds, especially influenza.
Clinical evidence
1, early prevention of colds: sneezing gives an alarm to remind you that the virus has invaded your body. Take antiviral oral liquid as soon as possible to prevent the spread of the virus. 2, the middle stage of cold treatment: the virus has a high incidence period and is highly contagious. Taking antiviral oral liquid on time is the basis of cold treatment. 3, the first recovery of the cold-Qing: At this time, the virus is still in the body. Insist on taking antiviral oral liquid, thoroughly clean up the virus and prevent the recurrence of the disease.
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Efficacy guarantee
At present, internationally, atlas, as a quality control method of Chinese patent medicine, Chinese medicine extract and other mixed substances, has become a knowledge in the medical field. FDA (American Food and Drug Administration) requires that the quality inspection standards of botanical drugs must be formulated, and the quality control of herbal medicines in Europe also adopts fingerprint technology.
Efficacy of antiviral oral liquid
Anti-virus oral liquid contains a variety of anti-virus ingredients, with authentic and strong efficacy, which can effectively inhibit viruses, absorb quickly and take effect quickly! Suppress the spread and spread of the virus.
2. Construction scale and governance objectives
Production task: The annual output of 654.38 billion antiviral oral liquid is calculated as 300 days per year, and it is continuously produced for 24 hours. The equipment is overhauled every two months, which ensures the smooth production. Adopt a shift system. Daily output: 65,438+000,000,000 pieces/300 ≈ 333,334 pieces; Hourly output: 100000 pieces /(300 * 24)≈65438 pieces +03889 pieces.
Two. Process design and description Process design and description
1. Schematic diagram of process flow
Clearing, drying, pulverizing, extracting and concentrating.
outsourcing
capsula interna
Filling and sterilization
Distribution filtering
Be stored
Preparation of inclusion compound
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2. Raw material production
The main ingredients are Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, Radix Rehmanniae, Radix Curcumae, Rhizoma Anemarrhenae, Rhizoma Acori Graminei, Herba Agastaches and Fructus Forsythiae. The auxiliary materials are honey, sucrose and hydroxypropyl-beta-cyclodextrin.
3. Process flow design principle 3. Principles of process flow design
(1) adopt advanced equipment, advanced production methods and mature scientific and technological achievements as far as possible to ensure product quality. (2) Use local materials and make full use of local materials to achieve the best economic results; (3) The adopted equipment has high efficiency and reduces the consumption of raw materials and water and electricity. Thereby reducing the product cost. (4) Design the technological process of pharmaceutical dosage forms according to GMP requirements. (5) For the production operations such as pretreatment, extraction and concentration of medicinal materials, the pretreatment process flow is designed according to a separate pretreatment workshop. (6) Follow the principle of three coordination, that is, the coordination of people flow and logistics, process flow and cleanliness level, correctly divide the cleanliness level of production areas in the production process, and make reasonable arrangements according to the process flow to avoid the circuitous, round-trip and cross-flow of people flow and logistics in the production process. (7) Fully predict the production failure, so as to handle it in time and ensure the stability of production.
4. Introduction of production technology
The design task is to produce antiviral oral liquid. Firstly, various main materials and auxiliary materials are washed, dried and crushed; Step two, extracting and concentrating the raw materials according to the production process to obtain a crude product; Thirdly, adding auxiliary materials, and filtering to prepare oral liquid; Fourthly, product filling and sterilization; Finally, the product is inspected and packaged.
5. Process scheme analysis
After a lot of experiments and searching for relevant data, the production technology of antiviral oral liquid containing water-soluble cyclodextrin was finally determined. The advantages of this process are: 1) The effective components of volatile oil in antiviral oral liquid are included by water-soluble cyclodextrin, and the inclusion rate is acceptable.
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Reaching 40%-85%, ensuring the product quality and increasing the stability of the volatile oil; 2) the taste of the antiviral oral liquid is improved, and the curative effect of the product is improved; 3) The production process of the product is simple, and it is suitable for industrial mass production.
6. Determination of production process The specific production process of water-soluble cyclodextrin antiviral oral liquid is as follows: The specific production process of water-soluble cyclodextrin antiviral oral liquid is as follows: 1. Raw material pretreatment 1. Pretreatment of raw materials.
Take 900g of Radix Isatidis, 400g of gypsum, 425g of Rhizoma Phragmitis, 225g of Radix Rehmanniae, 0/75g of Radix Curcumae, 0/75g of Rhizoma Anemarrhenae, 0/75g of Rhizoma Acori Graminei, 200g of Herba Agastaches and 325g of Fructus Forsythiae. Cleaning, drying, grading and crushing.
2. Extraction of raw materials. Extraction of raw materials
Put the mixed raw materials prepared in proportion into an extraction tank, add 8 times of water, heat and boil the interlayer for 3 hours, collect the emulsion containing volatile oil at the same time, and collect the volatile oil through an oil-water separator to obtain volatile oil 18ml and aromatic water 1953ml for later use. The extractive solution is discharged by a horizontal spiral discharge filtering centrifuge for later use. The residue was extracted with 6 times of water for 65438 0.5 hours, and the extract was discharged by a horizontal spiral discharge filter centrifuge and combined with the first extraction night for later use. Discard the residue.
3. Concentrate the extract 3. Concentrated extract
Combine the extractive solutions, concentrate in vacuum below 65℃ to the relative density of1.12 (measured at 60℃), cool to room temperature, slowly add 85% ethanol while stirring, let stand for 24 hours, filter, collect supernatant, recover ethanol and concentrate to the relative density of/kloc-0.
4. Preparation of Inclusion Compound 4. Preparation of inclusion compound
75g of hydroxypropyl-β cyclodextrin was made into saturated aqueous solution, and 15ml of volatile oil dehydrated by anhydrous sodium sulfate was added, and the mixture was stirred for 5h at 40~60℃ at a stirring speed of 300r/min to obtain 125g of hydroxypropyl-β ring paste inclusion solution. The inclusion rate is 75%.
5. match filtering 5. Matched filtering
Take antiviral concentrated solution 2 100ml, filter, add honey 840g, sucrose 1260g, hydroxypropyl-β cyclodextrin inclusion solution 125g, aromatic water 1935ml, adjust the PH to 5. 10, and mix well.
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To 7000ml, constant volume filtration.
6. fill, 6. Filling, sterilizing and filling.
Sterilize the product by filling 10ml/ piece of fixed liquid with oral liquid filling and sterilization machine.
7. Quality inspection and packaging. Quality inspection and packaging
Manually carry out quality inspection, then label, pack, and put into the box to make the finished product.
Third, material balance.
1. Total material balance of main materials 1. Total material balance of main materials.
Production task: annual output of antiviral oral liquid 10 billion pieces, each piece 10ml. 24 hours a day, 300 days a year. Daily output: 65,438+000,000,000 pieces/300 ≈ 333,334 pieces; Hourly output: 100000 tablets /(300 * 24)≈ 13889 tablets * * The total quality of medicinal materials required is as follows (calculated according to the total effective rate of 95%): Radix Isatidis: 10ml/95% ≈ 135t Shilu. 700095%≈64 tons of yellow:100000 pieces * (225g/7000ml) *10ml/95% ≈ 34 tons of gold:100000 pieces * (175g/7000ml)
Acorus gramineus:100,000,000 branches * (175g/7000ml) *10ml/95% ≈ 27 tons of patchouli:100,000,000 branches * (200g/7000ml).
Total auxiliary materials 2. Total balance of auxiliary materials
Bee cane honey: 65,438+000,000,000 sticks * (840g/7000ml) * 65,438+000ml = 65,438+020 tons of sugar: 65,438+000,000 sticks * (65,438
Hydroxypropyl-β cyclodextrin: 100 000 000 * (75g/7000ml) *10ml ≈1t.
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Fourth, the choice of equipment.
1, cleaning tank: production capacity: 100kg/h cleaning tank.
Overall dimensions: 100* 150CM (diameter * height)
2. Dryer: Model: CT-C-I Dryer:
Production capacity: 100kg/h overall dimensions: 140*80* 180 CM (length * width * height).
3. Crusher: model: HK- 180
Production capacity: 30- 120kg/h overall dimensions: 48* 100* 100 CM (length * width * height).
4. Extractor: model: BDHF-5B
Production capacity: 12~30Kg/h overall dimensions: 200* 120* 135 CM (length * width * height).
5. Thickener: Model: YZ-450 Thickener:
Production capacity: 20,000-50,000 ml Overall dimensions: 100*60* 180 cm (length * width * height)
6. Filter tank: model: WCG-20 filter tank
Production capacity: 20,000-50,000 ml Overall dimensions: 150* 100 cm (diameter * height)
7. Filling machine: model: GR-ZGF-40 filling machine;
Production capacity: 4,800 (cans/hour) Overall dimensions: 250*90* 140 cm (length * width * height)
V. Energy balance Energy balance
1. Energy balance of leaching equipment
Energy balance in leaching process: check the specific heat capacity of alcohol 2.4* 103J/(Kg. ℃).
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The material-liquid ratio adopted is 1:8.
The initial temperature was 25℃ and the alcohol concentration was 0.8g/ml.
The heating temperature is 50℃
The daily consumption of Radix Isatidis is 450kg, so the alcohol consumption is 450*8*0.8kg=720kg. The energy consumed by electricity is q = cm (T2-t1) = 2.4 *103 * 720 * (50-25) j = 4449600j = 4449. 3600= 1.236 kwh motor power: 6.5KW total electricity consumption in leaching process: 6.5 * 24+1.236 =157.236 kwh.
2. Energy balance of other major equipment
Power of cleaning, drying and crushing combined equipment: 7.38KW filling and sterilizing machine: 5.5KW mixer: 2.8 KW automatic filling and sealing machine: 3.4 KW Other total: 1 1.6 KW daily electricity consumption: (7.38+5.5+2.8+3.4+165433)
Intransitive Verb Factory Overall Design and Drawing Selection
1). Site selection.
Our factory is planned to be located on the west side of Moon Island in Yu 'an District of Lu 'an City for the following reasons: 1. Moon Island has a beautiful environment, low concentration of dust and bacteria in the air, good natural environment, no factors harmful to drug quality and good sanitary conditions. 2. Moon Island is in the downwind direction of the maximum frequency wind direction in residential areas, and the waste gas produced by pharmaceutical factories will not affect the health of residents. 3. Predict the municipal regional planning, and the planning of building a pharmaceutical factory in the municipal regional planning will not affect the drug quality. 4. Moon Island is located in Lu 'an, with developed traffic and close to the origin of raw materials, which is convenient for raw material procurement and product sales.
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Moon Island is rich in hydropower resources, and there will be no shortage of energy. Our factory plans to import a batch of sewage treatment systems. By then, our sewage will be properly treated.
2). Overall layout of the workshop
1. according to the code for fire protection design of buildings (GBJ 1s-87), the general layout of our factory meets the requirements of fire prevention, safety and hygiene. There is a certain distance between buildings, and the spacing is different for different types of workshops that produce drugs. The main roads in our factory should be straight and short, and the fire exits should be considered. The roads in the factory area are connected in a ring shape, and the main roads in the factory area are two lanes. Try to avoid crossing and circuitous between people flow and logistics, goods flow and goods flow. 3. The production workshop of our factory is arranged in the clean area of the factory to prevent the pollution of the ground, road surface and transportation of the factory to drug production. 4. According to the technological characteristics of products, the layout and spacing should be reasonable in order to prevent cross-contamination during weighing. The API production area of our factory should be located at the downwind side of the preparation scale area. Distribution of workshops, warehouses, etc. It is arranged according to the flow direction of drugs. 5. There should be a sanitary buffer zone with a certain distance between the factory building and the road, and the lawn should be planted in the buffer zone, and the greening design should be "soil can not see the sky". Minimize particles in the air to prevent drugs from being contaminated. 6. The vehicle parking lot of our factory is located in front of the office area, far away from the pharmaceutical production plant to prevent explosion. 7. Our factory is involved in the extraction of traditional Chinese medicine, and there are residues. In order to prevent pollution, production waste recycling is set up independently.
3). General layout design of the factory
According to the needs of production development, the factory area shall be divided first, and the mutual positions of buildings, structures, roads, yards, pipelines and landscaping facilities in the plane of the factory area shall be determined. The general graphic design of the factory not only needs the following basis: 1 approved design task book. 2. Site selection report. 3. Sketch of the general layout of the factory.
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4 production process flow chart. Graphic design also needs some requirements: 1 to meet the production process requirements. The main production workshop is located in the center of a large area. 3. Consider the influence of regional main wind direction. 4. Separate people flow and logistics channels to avoid crossing. 5. Follow the requirements of urban planning. 6 in line with relevant national norms and regulations.
4). Design and layout principles and requirements of production workshop 1
(1) The production equipment shall be configured according to the sequence of process flow. Under the premise of ensuring production requirements, safety and environmental sanitation, the workshop area and space shall be saved as much as possible, and the length of various pipelines shall be reduced. (2) Ensure that the workshop makes full use of natural lighting and ventilation conditions as much as possible, so that each workplace has good working conditions. (3) Ensure convenient transportation and management in the workshop. In the event of an accident, people can evacuate quickly and safely. (4) The plant structure should be compact and simple, creating favorable conditions for production development and technological innovation.
2. Principles
(1) The equipment arrangement of each working procedure should be consistent with the sequence of the main working procedure, that is, the production lines are arranged in a chain, and there is no cross or circuitous phenomenon, so as to convey by themselves as far as possible and minimize the assembly line. (2) Pay attention to improving working conditions. For sections with poor working conditions, fully consider the direction, wind direction, installation position of doors and windows, exhaust, dust removal and ventilation facilities. The operating surface of the equipment should face the light, so that the operator can operate under the backlight. (3) The auxiliary material preparation workshop should be close to the applicable equipment, but the parts with pollution and dust such as liquid chlorine vaporization and bleaching should be separated from the workshop with walls and necessary ventilation facilities. (4) Factories in areas where freezing is not serious in winter may consider arranging unsuitable facilities in outdoor workshops. Equipment with explosion danger such as high-pressure vessels should be arranged outdoors. And there are safety measures such as safety alarm and accident evacuation.
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(5) Interconnected equipment should be as close as possible under the conditions of ensuring normal operation, operation, maintenance, convenient transportation and safety. (6) When no one passes, the distance between the equipment and the wall column shall be at least 500mm, and when someone passes, it shall be at least 800mm. (7) The pump spacing is generally 1000mm, and the pump group spacing is about1500 mm.. (8) The installation position of the equipment should not ride on the expansion joint or settlement joint of the building. (9) The production part that emits harmful substances and produces huge noise and high temperature should be properly separated from the general production part to avoid mutual interference. (10) All operating platforms, various pipes, ditches, pits and huge or vibrating equipment foundations of the workshop shall be uniformly arranged to avoid conflicts with the workshop foundation. (1 1) The width of the operating platform should be greater than 500mm, and the distance from the platform to the beam bottom or floor should be greater than 2000mm. If someone leaves the platform or the equipment needs maintenance, the clear height at the bottom of the platform should not be less than 2000 mm. (12) Reasonable layout of workshop entrances and exits. Each workshop should have at least two entrances and exits. The width of the workshop door should be 200mm larger than the width of the equipment that needs to pass through, and 600~ 1000mm larger than the width of the fully loaded vehicle, and the total width should not be less than 2000mm ~ 2500mm. (13) The necessary cone material area should be considered. (14) Comply with the national labor hygiene and fire safety regulations and the Code for Fire Protection Design of Buildings. (15) The need for factory expansion should be considered. (16) While meeting the requirements of production technology, the equipment layout should meet the requirements of building structure standardization as far as possible. /kloc-buildings below 0/8m shall adopt multiples of 3m, and buildings above 18m shall adopt multiples of 6m. The span and column spacing of multi-storey factory buildings shall be 6m, and the height shall be a multiple of 300mm. (17) Professional requirements related to workshop layout.
Seven. Treatment and prevention of waste liquid
1. Disposal method of waste liquid 1. Treatment method of waste liquid
Our factory plans to import a complete set of sewage treatment circulation system from Germany, which greatly reduces the discharge of sewage. At the same time, the sewage discharged by our factory will also meet the relevant national standards.
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Eight. refer to
Zhu Hongji, Zhang Mingxian. Pharmaceutical equipment and engineering design. Zhang Heng, Chemical Industry Press. Process design of pharmaceutical engineering. Chemical Industry Press, Liu Hongxia, Liang Jun, Ma Wenhui. Pharmaceutical preparation engineering and workshop process design. Gao Junting, Bi Wanquan, Ma Quanming, Chemical Industry Press. Engineering drawing. Wang Zhikui Higher Education Press. Principles of chemistry. Chemical Industry Press China machinery network China National Intellectual Property Administration Net.
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