Immunological preparations or biologically active preparations made using biological techniques such as genetic engineering, cell engineering, fermentation engineering, etc. It can be used for disease prevention, diagnosis and treatment.
Biological products are different from general medical drugs. It stimulates the body's immune system and produces immune substances (such as antibodies) to exert its effects. In the human body, humoral immunity, cellular immunity, or cell-mediated immunity appear. Escherichia coli modified by genetic engineering technology can produce a certain virus antigen, yeast can be genetically recombined to produce hepatitis B surface antigen, and recombinant vaccinia virus can also produce hepatitis B surface antigen. Cell engineering hybridoma technology came out, hybridoma cells can secrete antibodies, so antibodies do not necessarily have to immunize the animal's serum. This breaks the traditional concept of biological products, but vaccines do not necessarily use bacteria, vaccines do not necessarily use viruses, and serum products do not necessarily use blood.
China's biological products business can basically meet the needs of controlling the epidemic of infectious diseases, but it still lags behind some developed countries. Biological products are divided into human biological products and veterinary biological products. This entry only introduces human biological products.
Overview In the 10th century, China invented the vaccination technique and used human pox inoculation to prevent smallpox. This is the origin of artificial automatic immunity to prevent infectious diseases. Inoculation not only reduces illness, but also reduces death. In the 17th century, the Russians came to China to study acne, and then spread to Turkey, Britain, Japan, North Korea, Southeast Asian countries, and later spread to the Americas and Africa. In 1796, British E. Jenner invented the method of inoculating vaccinia vaccine to prevent smallpox. He inoculated people with attenuated virus (vaccinia) to prevent the infection of virulence virus (smallpox), preventing people from smallpox.
This method is safe and effective, and soon spread to all parts of the world. Vaccinia vaccine can be regarded as the first safe and effective biological product. The development of microbiology and chemistry has promoted the research and production of biological products. In the mid-19th century, the concept of "immunity" had basically taken shape. In 1885, the Frenchman L. Pasteur invented the rabies vaccine, artificially weakened the virus's virulence, and made it into a vaccine. People who are bitten by rabies can avoid the occurrence of rabies after timely injection of the vaccine. Pasteur made the live chicken cholera vaccine and the live anthrax vaccine in the same way, and changed the method of attacking the virus from the past to weakening the strong. DE Salmon, HO Smith and others studied heat-inactivated vaccines, and successively developed inactivated vaccines such as typhoid and cholera. At the end of the 19th century, Japanese Satoshi Kitari and German Bellin, E. (A.) used chemical methods to treat diphtheria and tetanus toxins, causing them to lose pathogenicity after treatment, and the serum after inoculation of animals neutralized the corresponding toxins. This serum is called antitoxin, and this detoxified toxin is called toxoid. R. Koch made tuberculin, used to check whether the body has tuberculosis infection. The emergence of the concept of antigen-antibody reaction is helpful for clinical diagnosis. These have laid the foundation for the development of microbiology and immunology, and continue to develop various biological products.
The prevention of diseases is becoming more and more important, and it is one of the indispensable means to control and eliminate infectious diseases.
China's biological products business began in the early 20th century. The Central Epidemic Prevention Office was established in 1919. This is the first biological product research institute in China. It is very small, with only vaccinia vaccines and rabies vaccines. Several dead bacteria vaccines, toxoids and serums are crude products. After the founding of the People ’s Republic of China, the Institute of Biological Products was established in Beijing, Shanghai, Wuhan, Chengdu, Changchun and Lanzhou, and the Central (now China) Biological Products Inspection Institute was established. Distribute bacterial toxins and standard products. Later, the Institute of Medical Biology of the Chinese Academy of Medical Sciences was established in Kunming to produce polio vaccine. Biological products now have a large production research team, which has become an immunology applied research and planned immune science and technology guidance center. Tang Feifan discovered trachoma trachomatis in 1957, he made a great contribution to China's biological products business.
In terms of controlling and eradicating infectious diseases, vaccination against biological products has a significant effect and the best benefits in public health measures. This is not only a country or region, but also a worldwide measure. The World Health Organization (WHO) issued a declaration in 1966, proposing the global elimination of smallpox within 10 years. In 1980, it was officially announced that smallpox was eliminated on earth. In 1978, WHO made the Expanded Immunization Program (EPI), which aims to immunize children worldwide. EPI is to prevent six diseases with four vaccines, namely BCG to prevent tuberculosis; live measles vaccine to prevent measles; polio vaccine to prevent poliomyelitis; Baibai Po triple to prevent whooping cough, diphtheria and tetanus. Immunize all children in the world. In 1981, China responded to the WHO ’s call to implement planned immunization, using domestically produced four vaccines to prevent six diseases as required. In 1988, the province reached 85% of the vaccination coverage rate. In 1990, with the county as the unit, children reached 85% of vaccination coverage. The increase in the variety of diagnostic preparations and the improvement of methods have promoted the improvement of the level of test diagnosis; now it has been applied to serum epidemiology and disease monitoring. China has been producing blood preparations for more than 30 years, and the variety is increasing year by year.
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