The greatest role of fingerprinting technology in the introduction of modern Chinese medicine research and quality control is to find a set of overall models that can best reflect the complexity of the chemical components of traditional Chinese medicines so far, and it can also be initially accepted by the international community. However, the shortcomings are also very obvious - mainly due to the unsatisfactory progress in the research on spectral and structural effects. “If we can find a drug efficacy test method that integrates the overall characterization and local characteristics of TCM treatment, strengthen research on bioinformatics (including chemometrics), and establish a completely different quality standard for TCM medicines than a Western medicine quality standard system. The system is just around the corner.â€
Wonderful news recommendation "" experts: conservative estimates that prices can drop for another two years
Outstanding results
The country began to propose the modernization of traditional Chinese medicine in 1993. In 1998, it formulated the Strategy for the Modernization of Traditional Chinese Medicine. In 1999, it began to implement the “Modernization of Traditional Chinese Medicine and Industrialization Development†special project. In 2002, it formulated the “Outline for the Development of Traditional Chinese Medicine Modernization (2002-2010)â€. Research institutes and enterprises carry out research on modernization of traditional Chinese medicine, introduce various high technologies, and vigorously promote innovation and development in the field of Chinese medicine. It should be said that modernization of Chinese medicine has achieved certain achievements to date.
In the research and development of traditional Chinese medicine, with the promulgation of the “Outline for the Development of Traditional Chinese Medicine Modernization†(2002-2010), during the “10th Five-Year Plan†period, the country established a major science and technology project of “innovative medicine and modernization of traditional Chinese medicine†to implement modern Chinese medicine, biomedical engineering, and biology. Special projects such as new drugs and high-tech industrialization have promoted the industrialization of new varieties of Chinese patent medicines, advanced technology and equipment, new types of decoction pieces and extracts, common bulk medicinal materials, and breeding of endangered and rare medicinal materials.
Under the active guidance of policies, China's pharmaceutical companies have substantially increased their investment in science and technology. The cost of R&D for enterprises has increased from 1.62 billion yuan in 2001 to 4.34 billion yuan in 2005. Innovative drug research has also achieved a series of major landmark results: 45 patents have been awarded for new drug certificates for major projects of “innovative drugs and modernization of traditional Chinese medicineâ€; 41 varieties have completed all research work and are applying for new drug certificates; 109 varieties have entered the clinical Test phase. At the same time, there are 206 innovative and promising prospects in the clinical research stage. The Chinese medicines include safflor yellow for injection, Danshen polyphenolate powder injection, and saff yellow yellow freeze-dried powder for injection. / Drip liquid and so on.
Looking at the development history of modernization of traditional Chinese medicine, from the perspective of R&D of traditional Chinese medicines, the modernization of traditional Chinese medicine has gone through three stages of development so far. The first stage is the innovation of the dosage form. The use of modern pharmaceutical preparation technology, the traditional Chinese medicine type pills, powder, cream, Dan into tablets, capsules, oral liquid, injection and other modern dosage forms. The purpose is to form a modern Chinese medicine preparation that is safe, convenient and effective. It can be said that Western medicine can now be made into dosage forms, and Chinese medicine can also be done.
The second stage is the extraction and separation technology applied to the development and production of traditional Chinese medicine. With the in-depth study on the basic material of medicinal materials, it was found that there are a lot of sugars, starches and other components and impurities that are confirmed to be ineffective in the medicinal materials. Various extraction and separation technologies are used to remove these ineffective components and impurities from traditional Chinese medicines, and effective parts of traditional Chinese medicines are obtained. Or the active ingredient extracts, and then made of these extracts into drugs, this is the second phase of development.
The third stage is the use of more advanced technology, detection and analysis technologies and high-throughput screening and other technical means, the development of a clear mechanism, a clear composition of modern Chinese medicine. The main effective ingredients, effective parts or effective parts (groups) are used for medicine or compatibility to form effective ingredients or components of traditional Chinese medicines with a basic basis for the efficacy of substances. The third stage of research and development of traditional Chinese medicine is considered by many experts as a research that can truly be in line with international standards and allow the world to identify. It is also a problem that modernization of traditional Chinese medicine must solve.
In fact, in the process of the modernization of traditional Chinese medicine, the controversy has been accompanied by the controversy. In the shadow of the safety issue of traditional Chinese medicine injections in the past two years, people's doubts about the modernization of traditional Chinese medicine have been magnified. Some experts even pointed out that “the modernization of Chinese medicine has come. crossroads".
Quality control is still a problem
In recent years, the government has continuously improved the national standards system for Chinese medicines. According to the State Council's White Paper on "China's Drug Safety Regulatory Status," there are 7,014 current national standards for Chinese medicine. Among them, the 2005 edition of the “Pharmacopoeia of the People's Republic of China†contained 582 varieties of Chinese herbal medicines, Chinese herbal medicines, oils and extracts, and 564 varieties of proprietary Chinese medicines; 438 Chinese herbal medicines and traditional Chinese medicines were included in the standards issued by ministries and bureaus. There are 4,690 varieties, 308 varieties of ethnic medicines and 432 varieties of ethnic medicines. In order to ensure the safety and effectiveness of TCM injections, the state has strengthened the standardization of TCM injections and established a scientific and systematic quality control standard system. In 2000, the quality standards of TCM injections that have been approved for production were improved, and fingerprints and other aspects were improved. The work published "Technical Requirements for the Study of Chinese Herbal Injection Fingerprints". At present, the state is improving the safety and quality control methods and indicators of 123 listed Chinese medicine injections in an all-round way, urging that traditional Chinese medicine injections must be fixed in production, strictly controlling the quality of raw materials, intermediates and finished products, and achieving full quality control over production and processing. .
Luo Guo'an, director of the Center for Modernization of Traditional Chinese Medicine at Tsinghua University, told reporters that there are three main difficulties in the construction of quality standards for Chinese medicine at the present stage: First, the concept of how to propose a quality standard system that meets the characteristics of Chinese medicine is accepted both at home and abroad; the second is the quality standard of Chinese medicine. Whether not only reflects the material basis of the traditional Chinese medicine - chemical composition group, but also can reflect these groups of ingredients and efficacy and safety are related; Third, the construction of Chinese medicine quality standards should be both scientific and can be used for actual production control.
In Luo Guo'an's view, the core of the construction of quality standards for Chinese medicine is to establish traditional methods that can reflect the overall characterization (fingerprints) and local characteristics (multi-indicator components) of traditional Chinese medicines, assist with traditional methods such as microscopic identification, heavy metal pesticides, and mold inspections. Different models for quantifying the individual components of western medicine. For instance, Qingkailing Injection's national sales amounted to less than 250 million in 2000 and reached 500 million in 2004, but adverse reaction reports have dropped by about 90% in the same period. This is a result of quantitative control of production using fingerprints combined with multiple indicators. .
The greatest effect of fingerprinting technology introduced into modern Chinese medicine research and quality control is to find a set of overall models that can best reflect the complexity of chemical components of Chinese herbs so far, and can also be initially accepted by the international (including US FDA). However, the shortcomings are also very obvious - mainly due to the unsatisfactory progress in the research on spectral and structural effects. “If we can find a drug efficacy test method that combines the overall characterization and local characteristics of TCM treatment, strengthen research on bioinformatics (including chemometrics), and establish a completely different quality standard for TCM medicines than a Western medicine quality standard system. The system is just around the corner," said Luo Guoan.
Wonderful news recommendation "" experts: conservative estimates that prices can drop for another two years
Outstanding results
The country began to propose the modernization of traditional Chinese medicine in 1993. In 1998, it formulated the Strategy for the Modernization of Traditional Chinese Medicine. In 1999, it began to implement the “Modernization of Traditional Chinese Medicine and Industrialization Development†special project. In 2002, it formulated the “Outline for the Development of Traditional Chinese Medicine Modernization (2002-2010)â€. Research institutes and enterprises carry out research on modernization of traditional Chinese medicine, introduce various high technologies, and vigorously promote innovation and development in the field of Chinese medicine. It should be said that modernization of Chinese medicine has achieved certain achievements to date.
In the research and development of traditional Chinese medicine, with the promulgation of the “Outline for the Development of Traditional Chinese Medicine Modernization†(2002-2010), during the “10th Five-Year Plan†period, the country established a major science and technology project of “innovative medicine and modernization of traditional Chinese medicine†to implement modern Chinese medicine, biomedical engineering, and biology. Special projects such as new drugs and high-tech industrialization have promoted the industrialization of new varieties of Chinese patent medicines, advanced technology and equipment, new types of decoction pieces and extracts, common bulk medicinal materials, and breeding of endangered and rare medicinal materials.
Under the active guidance of policies, China's pharmaceutical companies have substantially increased their investment in science and technology. The cost of R&D for enterprises has increased from 1.62 billion yuan in 2001 to 4.34 billion yuan in 2005. Innovative drug research has also achieved a series of major landmark results: 45 patents have been awarded for new drug certificates for major projects of “innovative drugs and modernization of traditional Chinese medicineâ€; 41 varieties have completed all research work and are applying for new drug certificates; 109 varieties have entered the clinical Test phase. At the same time, there are 206 innovative and promising prospects in the clinical research stage. The Chinese medicines include safflor yellow for injection, Danshen polyphenolate powder injection, and saff yellow yellow freeze-dried powder for injection. / Drip liquid and so on.
Looking at the development history of modernization of traditional Chinese medicine, from the perspective of R&D of traditional Chinese medicines, the modernization of traditional Chinese medicine has gone through three stages of development so far. The first stage is the innovation of the dosage form. The use of modern pharmaceutical preparation technology, the traditional Chinese medicine type pills, powder, cream, Dan into tablets, capsules, oral liquid, injection and other modern dosage forms. The purpose is to form a modern Chinese medicine preparation that is safe, convenient and effective. It can be said that Western medicine can now be made into dosage forms, and Chinese medicine can also be done.
The second stage is the extraction and separation technology applied to the development and production of traditional Chinese medicine. With the in-depth study on the basic material of medicinal materials, it was found that there are a lot of sugars, starches and other components and impurities that are confirmed to be ineffective in the medicinal materials. Various extraction and separation technologies are used to remove these ineffective components and impurities from traditional Chinese medicines, and effective parts of traditional Chinese medicines are obtained. Or the active ingredient extracts, and then made of these extracts into drugs, this is the second phase of development.
The third stage is the use of more advanced technology, detection and analysis technologies and high-throughput screening and other technical means, the development of a clear mechanism, a clear composition of modern Chinese medicine. The main effective ingredients, effective parts or effective parts (groups) are used for medicine or compatibility to form effective ingredients or components of traditional Chinese medicines with a basic basis for the efficacy of substances. The third stage of research and development of traditional Chinese medicine is considered by many experts as a research that can truly be in line with international standards and allow the world to identify. It is also a problem that modernization of traditional Chinese medicine must solve.
In fact, in the process of the modernization of traditional Chinese medicine, the controversy has been accompanied by the controversy. In the shadow of the safety issue of traditional Chinese medicine injections in the past two years, people's doubts about the modernization of traditional Chinese medicine have been magnified. Some experts even pointed out that “the modernization of Chinese medicine has come. crossroads".
Quality control is still a problem
In recent years, the government has continuously improved the national standards system for Chinese medicines. According to the State Council's White Paper on "China's Drug Safety Regulatory Status," there are 7,014 current national standards for Chinese medicine. Among them, the 2005 edition of the “Pharmacopoeia of the People's Republic of China†contained 582 varieties of Chinese herbal medicines, Chinese herbal medicines, oils and extracts, and 564 varieties of proprietary Chinese medicines; 438 Chinese herbal medicines and traditional Chinese medicines were included in the standards issued by ministries and bureaus. There are 4,690 varieties, 308 varieties of ethnic medicines and 432 varieties of ethnic medicines. In order to ensure the safety and effectiveness of TCM injections, the state has strengthened the standardization of TCM injections and established a scientific and systematic quality control standard system. In 2000, the quality standards of TCM injections that have been approved for production were improved, and fingerprints and other aspects were improved. The work published "Technical Requirements for the Study of Chinese Herbal Injection Fingerprints". At present, the state is improving the safety and quality control methods and indicators of 123 listed Chinese medicine injections in an all-round way, urging that traditional Chinese medicine injections must be fixed in production, strictly controlling the quality of raw materials, intermediates and finished products, and achieving full quality control over production and processing. .
Luo Guo'an, director of the Center for Modernization of Traditional Chinese Medicine at Tsinghua University, told reporters that there are three main difficulties in the construction of quality standards for Chinese medicine at the present stage: First, the concept of how to propose a quality standard system that meets the characteristics of Chinese medicine is accepted both at home and abroad; the second is the quality standard of Chinese medicine. Whether not only reflects the material basis of the traditional Chinese medicine - chemical composition group, but also can reflect these groups of ingredients and efficacy and safety are related; Third, the construction of Chinese medicine quality standards should be both scientific and can be used for actual production control.
In Luo Guo'an's view, the core of the construction of quality standards for Chinese medicine is to establish traditional methods that can reflect the overall characterization (fingerprints) and local characteristics (multi-indicator components) of traditional Chinese medicines, assist with traditional methods such as microscopic identification, heavy metal pesticides, and mold inspections. Different models for quantifying the individual components of western medicine. For instance, Qingkailing Injection's national sales amounted to less than 250 million in 2000 and reached 500 million in 2004, but adverse reaction reports have dropped by about 90% in the same period. This is a result of quantitative control of production using fingerprints combined with multiple indicators. .
The greatest effect of fingerprinting technology introduced into modern Chinese medicine research and quality control is to find a set of overall models that can best reflect the complexity of chemical components of Chinese herbs so far, and can also be initially accepted by the international (including US FDA). However, the shortcomings are also very obvious - mainly due to the unsatisfactory progress in the research on spectral and structural effects. “If we can find a drug efficacy test method that combines the overall characterization and local characteristics of TCM treatment, strengthen research on bioinformatics (including chemometrics), and establish a completely different quality standard for TCM medicines than a Western medicine quality standard system. The system is just around the corner," said Luo Guoan.
Flatbed textile Printer is capable of printing on black, red, white and any color T-Shirts, and other materials , color-printing without silk screen and printing plate. It can accomplish printing white, gradient color picture at once. No color fading and comfortable handle. It accords with the international universal standard and uses green environmental protective inks which completely reach to the highest European quality inspection standard.
|
Name |
Textile printer |
|
Print head |
DX5 |
|
Printer size |
33*43cm(33*60cm) |
|
Printing speed |
A4 photo/111s |
|
Printng resolution |
5760*1440dpi |
|
Nozzles |
90*6=540 |
|
Interface |
USB2.0 |
|
Net weight/Gross weight |
55Kg/60Kg |
|
Printer size |
750*630*510mm |
|
Height adjustment |
Automatic |
|
Working power |
110V/220V 50/60Hz 30-75W |
|
Operation system |
Windows 7/XP/2000/Vista etc |
|
Temperature |
5-35o |
Textile Printer,Dtg Textile Printer,Digital Textile Printer,Textile Printer Machine
Shenzhen Refinecolor Technology Co., LTD. , https://www.szcakeprinter.com