With the improvement of people's living standards, the health care industry is gradually emerging in the domestic market. However, due to the lack of understanding of mass medical and health care products in society, many unscrupulous merchants and enterprises (including foreign countries) rely on their relatively rich marketing experience in the industry to confuse the concept of medical and health care products by hanging signs of high-tech and high-end biological products, maliciously exaggerating or deceiving the disadvantaged groups, thus prompting such consumers to buy products, achieving the curative effect of treating the symptoms rather than the root cause, and profiteering.
The domestic medical system is not perfect, the phenomenon that hospital doctors prescribe prescription drugs indiscriminately and repeatedly occurs from time to time, the drug price is too high, and the management of health care products production and sales industry is too loose. These are the important reasons why people are unwilling to face up to the theme and confuse the concept of biological products.
Medical biological preparation
As we all know, the main components of Radix Isatidis granules are extracted and processed from the stems of Radix Isatidis. Its main functions are relieving cough, clearing throat and relieving fever.
Healthy biological preparation
Harbin medicine calcium gluconate oral liquid, calcium lactate, calcium gluconate, zinc lactate, vitamin D.
Ruikafu bacteriostatic spray, the main components are lactic acid, lactic acid bacteria, lactic acid bacteria and so on. Its main function is to inhibit bacteria, relieve itching and care for reproductive infection diseases.
Overview of biological agents in science fiction movies and TV series
Umbrella Company in the game Resident Evil series is an enterprise engaged in the research of legal biological products on the surface and secretly conducting biochemical experiments for military purposes to make huge profits. The story tells the story of a deadly virus preparation leaked by Umbrella Company during the research of biochemical virus, which led to the near extinction of human beings. Viruses also belong to the research raw materials of biological products, but usually more stringent monitoring and experimental sites must be required.
The medical and scientific research institutions described in the film I am a Legend, through the reverse study of viruses, cultivated drugs for fighting and curing cancer for clinical use, which led to the destruction of new york.
Research object of Qiqi preparation
Berkeley Pit is located in beaufort, Montana, USA. It is 1 mile long, half a mile wide and 1780 feet deep. This used to be an open-pit copper mine. This pit is one of the few toxic scenic spots in the world, and it is full of toxic gas.
On the surface, the poisonous water in the mine is blood red and rich in copper, so miners can extract copper directly from the water. 400,000 pounds of copper can be extracted from 65,438+03 gallons of water. There are other chemicals in the water, such as arsenic, cadmium, zinc and sulfuric acid. Just one sip will erode the digestive system in the body.
1995, after a group of migrating geese stayed here, people found 342 dead geese. Since then, people have implemented a plan to watch birds here. Fortunately, scientists found a bacterium that can adapt to this condition in this poison pit, which may be helpful to cure cancer. Experts are doing further investigation and study.
Question 2: What drugs are biological agents? There are many kinds of biological agents. Generally, it is a macromolecular preparation made by biotechnology and bioreactor, such as protein antibody, vaccine made by inactivated virus, insulin extracted by cell fermentation, cytokines such as interferon and interleukin. , all belong to biological agents.
Question 3: What's the difference between biological agents and biopharmaceuticals? Bio-pharmacy refers to a kind of products that make use of the research results of microbiology, biology, medicine and biochemistry, and comprehensively utilize the scientific principles and methods of microbiology, chemistry, biochemistry, biotechnology and pharmacy from organisms, biological tissues, cells and body fluids for prevention, treatment and diagnosis.
Such as preparation of antibiotic, purification and extraction of biological vaccine and protein antibody.
Pharmaceutical engineering is an interdisciplinary engineering specialty of chemistry, pharmacy (traditional Chinese medicine) and engineering, aiming at cultivating talents engaged in drug manufacturing, development, amplification and design of new processes, new equipment and new varieties.
Training objectives
Students in this major mainly study the basic theories and knowledge of organic chemistry, physical chemistry, chemical engineering principles, medicinal chemistry, biochemistry, toxicology, pharmacology, pharmaceutical technology and pharmaceutical professional equipment, receive training in chemical and chemical experimental skills, engineering practice, computer application, scientific research and engineering design methods, and have the basic ability to produce pharmaceutical products, engineering design and research and development of new drugs.
Question 4: What are the biological products for human use: serum, vaccine, blood products, etc.
Biological products: immune preparations or bioactive preparations made by applying biotechnology such as genetic engineering, cell engineering and fermentation engineering. Can be used for the prevention, diagnosis and treatment of diseases.
According to the classification of biological products, it can be divided into three categories: preventive biological products, therapeutic biological products and diagnostic biological products.
1. Preventive biological products are all used to prevent infectious diseases. Include vaccines, toxoid and gamma globulin.
2. Therapeutic biological products include various blood preparations and immune preparations, such as interferon. According to the therapeutic mechanism, it can be divided into specificity (such as antitoxin and gamma globulin) and nonspecific (such as interferon and human albumin).
3. Diagnostic biological products are mostly used to detect the corresponding antigens, antibodies or immune status of the body, which belongs to immunological diagnosis. With the development of immunology technology, there are more and more kinds of biological products for diagnosis, which are not only used for infectious diseases, but also for other diseases. It mainly includes two kinds: ① diagnostic serum, including bacteria, virus rickettsia, antitoxin, tumor, hormone, blood type and HLA, immunoglobulin diagnostic serum, transferrin, erythrocyte hemolysin, biochemical preparation, etc. ② Diagnostic antigens, including bacteria, virus rickettsia, toxin, syphilis diagnostic antigen, plague phage, etc. In addition, there are red blood cells, fluorescent antibodies, enzyme-labeled preparations for enzyme-linked immunity, radioimmunoassay with radioactive nuclei, pregnancy diagnostic preparations (hormones) and monoclonal antibodies for diagnosis.
Registration classification
1. Unlisted vaccines at home and abroad.
2.DNA vaccine.
3. The vaccine that has been marketed is replaced by a new adjuvant, and the coupled vaccine is replaced by a new carrier.
4. From unpurified or whole cells (bacteria, viruses, etc.). ) vaccine to purified or component vaccine.
5 vaccines produced by strains without domestic approval (except influenza vaccine and leptospira vaccine).
Six vaccines have been listed abroad, but not in China.
7. Combined vaccine or combined vaccine prepared from vaccines that have been listed in China.
8. Its protective antigen spectrum is different from that of recombination vaccines, where vaccines have been marketed.
9. Replace other vaccines with approved expression systems or approved cell matrix production; The vaccine prepared by new technology and proved by laboratory research data has obviously improved the safety and effectiveness of the product.
10. change the vaccine with inactivator (method) or antidote (method).
1 1.
12. A vaccine that changes the dosage form of the vaccine that has been marketed in China, but does not change the route of administration.
13. Vaccines that change the immune dose or immune procedure.
14. Expand the use of vaccines in the population (increase the age group).
15. Vaccines with national drug standards.
Question 5: What are the traditional puzzles about biological products?
With the improvement of people's living standards, the health care industry is gradually emerging in the domestic market. However, due to the lack of understanding of mass medical and health care products in society, many unscrupulous merchants and enterprises (including foreign countries) rely on their relatively rich marketing experience in the industry to confuse the concept of medical and health care products by hanging signs of high-tech and high-end biological products, maliciously exaggerating or deceiving the disadvantaged groups, thus prompting such consumers to buy products, achieving the curative effect of treating the symptoms rather than the root cause, and profiteering.
The domestic medical system is not perfect, the phenomenon that hospital doctors prescribe prescription drugs indiscriminately and repeatedly occurs from time to time, the drug price is too high, and the management of health care products production and sales industry is too loose. These are the important reasons why people are unwilling to face up to the theme and confuse the concept of biological products.
Medical biological preparation
As we all know, the main components of Radix Isatidis granules are extracted and processed from the stems of Radix Isatidis. Its main functions are relieving cough, clearing throat and relieving fever.
Healthy biological preparation
Harbin medicine calcium gluconate oral liquid, calcium lactate, calcium gluconate, zinc lactate, vitamin D.
Ruikafu bacteriostatic spray, the main components are lactic acid, lactic acid bacteria, lactic acid bacteria and so on. Its main function is to inhibit bacteria, relieve itching and care for reproductive infection diseases.
Overview of biological agents in science fiction movies and TV series
Umbrella Company in the game Resident Evil series is an enterprise engaged in the research of legal biological products on the surface and secretly conducting biochemical experiments for military purposes to make huge profits. The story tells the story of a deadly virus preparation leaked by Umbrella Company during the research of biochemical virus, which led to the near extinction of human beings. Viruses also belong to the research raw materials of biological products, but usually more stringent monitoring and experimental sites must be required.
The medical and scientific research institutions described in the film I am a Legend, through the reverse study of viruses, cultivated drugs for fighting and curing cancer for clinical use, which led to the destruction of new york.
Research object of Qiqi preparation
Berkeley Pit is located in beaufort, Montana, USA. It is 1 mile long, half a mile wide and 1780 feet deep. This used to be an open-pit copper mine. This pit is one of the few toxic scenic spots in the world, and it is full of toxic gas.
On the surface, the poisonous water in the mine is blood red and rich in copper, so miners can extract copper directly from the water. 400,000 pounds of copper can be extracted from 65,438+03 gallons of water. There are other chemicals in the water, such as arsenic, cadmium, zinc and sulfuric acid. Just one sip will erode the digestive system in the body.
1995, after a group of migrating geese stayed here, people found 342 dead geese. Since then, people have implemented a plan to watch birds here. Fortunately, scientists found a bacterium that can adapt to this condition in this poison pit, which may be helpful to cure cancer. Experts are doing further investigation and study.
Question 6: What is a biological agent? What are the advantages? This is a whole chapter in the pharmaceutical book. Let me tell you some important basic information.
Biological agents are not only different from ordinary drugs in raw materials, but also in production technology. To put it simply, it is the use of modern biotechnology, with the help of some microorganisms, plants or animals to produce the required drugs, and protein or nucleic acid drugs developed through DNA recombination technology or other new biotechnology have also become biological agents.
Pure biological preparation, that is to say, it does not contain traditional chemical drugs except auxiliary materials.
The earliest biological drug came from 1982, which was insulin. At present, there are only about 50 kinds of biological agents approved for marketing at home and abroad, but there are hundreds of very hot topics under study.
The differences and benefits from other drugs are. In the process of studying pathology and pathophysiology, it is found that protein or polypeptide in the body is unbalanced, so protein and polypeptide have been paid attention to in maintaining the balance of the body and treating diseases. Traditional chemical drugs treat diseases by mediating protein synthesis or secretion of some hormones and cytokines on the basis of small molecules. Biological agents directly supplement protein, hormones, cytokines, etc. However, these drugs are very unstable, and how to maintain their stability in production, transportation, storage and human body is the focus of research.
It is well known that protein and peptides have very large molecular weights and are digested by enzymes. Therefore, at present, most biological agents can not be made into oral preparations. They are usually inactivated by enzyme metabolism in oral cavity and gastrointestinal tract, and even if they survive, they cannot be absorbed by gastrointestinal tract because of their large molecular weight. Therefore, injection is still the most commonly used, and dosage forms absorbed through nasal mucosa and rectum have also been developed. Octreotide, commonly used biological drugs, oral.
So in general, the advantage of biological agents is direct treatment, which can make up for any imbalance and make up for any deficiency. They are more direct than chemical drugs and more individual than chemical drugs. The disadvantage is that it is unstable, not easy to absorb, and not as easy to take as chemical drugs. As for the adverse reactions, there is no comparability. Adverse reactions such as interferon can be written in thousands of words. It is absolutely unscientific to say that the adverse reactions of biological agents are small.
As for health care products, to be honest, most of them are deceptive. Because the marketing of health care products does not need rigorous experiments to confirm how it is decomposed and absorbed in the human body, what is the absorbed concentration, and whether this concentration has therapeutic significance.
PS: The drugs mentioned upstairs are not biological drugs at all, and the examples cited are not drugs approved by the state.
Question 7: Exept is a biological agent. What is a biological agent? are there any side - effects? The earliest biological preparation was 1982 insulin. At present, there are only about 50 kinds of biological agents approved for marketing at home and abroad, but there are hundreds of very hot topics under study.
biological agent
All kinds of preparations with carbon-based organisms with medical research value as raw materials, which are made by traditional technology or modern biotechnology and act on the prevention (health care), treatment and diagnosis of various physiological symptoms of human body, are collectively called biological preparations.
"Biological agents" refers to "immune biological agents" in the pharmaceutical industry, and refers to biological products processed by microorganisms (bacteria, rickettsia, viruses, etc.). ) and its metabolites, animal toxins, human or animal blood or tissues, etc. It is used to prevent, treat and diagnose corresponding infectious diseases or other related diseases.
Medical biological agents:
The production of medical biological agents, such as vaccines and broad-spectrum biological agents, has a series of characteristics besides all the requirements of drug production. For example, there must be a first stage in production-the cultivation of microorganisms, viruses and living cells, followed by subsequent treatment to obtain biological substances. At the same time, they also have the characteristics of cleaning, passivation, extraction, freezing and freeze-drying. For example, Essep needs aseptic conditions when completing many production processes, which meets the requirements of micro-pollution control.
Treatment of rheumatoid arthritis and ankylosing spondylitis with biological agents
Modern medicine believes that both rheumatoid arthritis and ankylosing spondylitis are chronic systemic autoimmune diseases. Medical scholars have found through research that the "culprit" of this kind of arthritis is an inflammatory factor called "tumor necrosis factor", which can cause joint synovitis and activate osteoclasts to cause bone destruction and joint deformity. Therefore, medical scholars have developed biological agents to treat such diseases by inhibiting tumor necrosis factor.
At present, tumor necrosis factor antagonist is the most widely used, and its side effects are relatively small. Compared with traditional anti-rheumatic drugs to improve the condition, its main characteristics are rapid onset, obvious inhibition of bone destruction and good overall tolerance of patients. The preparation is mainly composed of exept, and it is also the most widely used biological preparation for treating rheumatoid arthritis and ankylosing spondylitis in China at present.
Biological rheumatoid arthritis and ankylosing spondylitis are autoimmune chronic diseases with the characteristics of high concealment, difficult diagnosis, irreversible joint damage and high disability rate, which are often ignored by patients and the public.
Rheumatoid arthritis has the characteristics of high concealment, difficult diagnosis, irreversible damage and high disability rate. It can occur in any joint of the body, often in the small joints of fingers, palms and wrists.
If you want to know more, it is recommended to refer to Baidu Encyclopedia Biological Agents.
Question 8: Biological products: What biological products are prepared from common microorganisms, cells, tissues and liquids of various animals and human beings or obtained through biotechnology such as genetic engineering, cell engineering, protein engineering and fermentation engineering, and used for the prevention, treatment and diagnosis of human diseases? Biological products are different from general medical drugs. They produce immune substances (such as antibodies) through the body's immune system, and humoral immunity, cellular immunity or cell-mediated immunity appear in the human body.
What are biological products?
biological product
biological product
Biological products are composed of microorganisms, cells, animal or human tissues and body fluids. Use traditional technology or modern biotechnology to prevent, treat and diagnose human diseases. Biological products for human use include: bacterial vaccines (including toxoid), virus vaccines, antitoxin and antiserum, blood products, cytokines, growth factors, enzymes, in-vivo and in-vitro diagnostic products and other bioactive substances, such as toxins, antigens, allergens, monoclonal antibodies, antigen-antibody complexes, immunomodulators and microecological agents.
Biological products can be divided into three categories according to their uses: preventive biological products, therapeutic biological products and diagnostic biological products.
Preventive biological products are all used to prevent infectious diseases. Include vaccines, toxoid and gamma globulin.
From UC browser
Question 9: What are biological products and what are they? Biological products refer to drugs for the prevention, treatment and diagnosis of human diseases, which are prepared from common microorganisms, cells, tissues and liquids of various animals and humans or obtained through biotechnology such as genetic engineering, cell engineering, protein engineering and fermentation engineering. Biological products are different from general medical drugs. They produce immune substances (such as antibodies) through the body's immune system, and humoral immunity, cellular immunity or cell-mediated immunity appear in the human body. Biological agents include preventive biological products, therapeutic biological products and diagnostic biological products. Commonly used in clinic are: human albumin, human immunoglobulin, influenza virus split vaccine, transfer factor and so on!
Question 10: What are the biological products for human use: serum, vaccine, blood products, etc.
Biological products: immune preparations or bioactive preparations made by applying biotechnology such as genetic engineering, cell engineering and fermentation engineering. Can be used for the prevention, diagnosis and treatment of diseases.
According to the classification of biological products, it can be divided into three categories: preventive biological products, therapeutic biological products and diagnostic biological products.
1. Preventive biological products are all used to prevent infectious diseases. Include vaccines, toxoid and gamma globulin.
2. Therapeutic biological products include various blood preparations and immune preparations, such as interferon. According to the therapeutic mechanism, it can be divided into specificity (such as antitoxin and gamma globulin) and nonspecific (such as interferon and human albumin).
3. Diagnostic biological products are mostly used to detect the corresponding antigens, antibodies or immune status of the body, which belongs to immunological diagnosis. With the development of immunology technology, there are more and more kinds of biological products for diagnosis, which are not only used for infectious diseases, but also for other diseases. It mainly includes two kinds: ① diagnostic serum, including bacteria, virus rickettsia, antitoxin, tumor, hormone, blood type and HLA, immunoglobulin diagnostic serum, transferrin, erythrocyte hemolysin, biochemical preparation, etc. ② Diagnostic antigens, including bacteria, virus rickettsia, toxin, syphilis diagnostic antigen, plague phage, etc. In addition, there are red blood cells, fluorescent antibodies, enzyme-labeled preparations for enzyme-linked immunity, radioimmunoassay with radioactive nuclei, pregnancy diagnostic preparations (hormones) and monoclonal antibodies for diagnosis.
Registration classification
1. Unlisted vaccines at home and abroad.
2.DNA vaccine.
3. The vaccine that has been marketed is replaced by a new adjuvant, and the coupled vaccine is replaced by a new carrier.
4. From unpurified or whole cells (bacteria, viruses, etc.). ) vaccine to purified or component vaccine.
5 vaccines produced by strains without domestic approval (except influenza vaccine and leptospira vaccine).
Six vaccines have been listed abroad, but not in China.
7. Combined vaccine or combined vaccine prepared from vaccines that have been listed in China.
8. Its protective antigen spectrum is different from that of recombination vaccines, where vaccines have been marketed.
9. Replace other vaccines with approved expression systems or approved cell matrix production; The vaccine prepared by new technology and proved by laboratory research data has obviously improved the safety and effectiveness of the product.
10. change the vaccine with inactivator (method) or antidote (method).
1 1.
12. A vaccine that changes the dosage form of the vaccine that has been marketed in China, but does not change the route of administration.
13. Vaccines that change the immune dose or immune procedure.
14. Expand the use of vaccines in the population (increase the age group).
15. Vaccines with national drug standards.