Recently, the new version of the National Medical Insurance Drug List was released, adding 148 new varieties, including 47 Western medicines and 101 proprietary Chinese medicines. The new number of proprietary Chinese medicines is more than twice that of Western medicines. The number of proprietary Chinese medicines and Western medicines in the medical insurance catalog is the same for the first time. The country's affirmation of Chinese patent medicines and its development support. But at the same time, some drugs with inaccurate curative effects and obvious abuse have been kicked out of the list. Many of them are proprietary Chinese medicines. Therefore, in order to avoid being eliminated by the pharmaceutical market, the modernization of Chinese medicine has to be launched!

The development of Chinese medicine

1. The national policy is favorable to the situation

In recent years, my country's traditional Chinese medicine policies and regulations have been frequently published, and they have been continuously improved and improved, providing a good top-level design and guidance for the long-term development of my country's traditional Chinese medicine industry.

The efficient legalization process of Chinese medicine demonstrates my country's determination and strength to support and promote the development of Chinese medicine. The state uses actions to convince society and enterprises that traditional Chinese medicine, the precious wealth of the Chinese nation, will be better carried forward to benefit the broad masses of people.

2. Modernization research is imminent

Since 2017, various provinces have successively issued notices to stop or modify various auxiliary drugs, the core purpose of which is to reduce fees, and focus on monitoring drugs with inaccurate curative effects, large dosages, or expensive prices.

In March of this year, the world's first evidence-based medicine in traditional Chinese medicine was established. The center will provide evidence for the effectiveness and safety of traditional Chinese medicine. If the commonality of evidence-based medicine and traditional Chinese medicine can be organically combined into case practice, it will not only greatly improve the level of clinical diagnosis and treatment, but also prove the price of medicine for traditional Chinese medicine and rank among the world's scientific system supply arena and opportunities.

In July, the National Health Commission issued the “Notice on Printing and Distributing the First Batch of National Key Drug Lists (Chemical Drugs and Biological Products) for Key Monitoring of Rational Use”. The notice is the most lethal to the use of Chinese patent medicines. Western medicine cannot prescribe Chinese medicines. Patent medicine, this move is not to restrict the use of proprietary Chinese medicines, but to regulate the use of proprietary Chinese medicines.

Under such circumstances, if proprietary Chinese medicines can supplement evidence-based medicine, break the barriers between traditional Chinese medicine and western medicine, and enter medical guidelines and consensus, it may help Chinese medicine to break the situation smoothly!

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Under the new situation of "One Belt One Road", the internationalization of Chinese medicine has great potential

In 2015, Ms. Tu Youyou won the Nobel Prize in Physiology or Medicine for the invention of artemisinin, which increased the influence of Chinese medicine overseas. Although Chinese medicine has made outstanding contributions to the development of world medicine, the internationalization of Chinese medicine still faces many difficulties such as culture and technical standards.

The first is the dilemma of medical culture. TCM treatment emphasizes syndrome differentiation and treatment, which treats diseases through the analysis and adjustment of the human body; while Western medicine focuses on simple disease types and localized treatments, and eliminates them by finding the cause of the disease. The second is the difficulty of technical standards. Western medicine pays attention to unity, accuracy and data. The admission of medicines is based on the requirements of drug safety and effectiveness. Western medicine management agencies also propose corresponding admission standards for Chinese medicines. However, most Chinese medicines are currently in my country. The research and development only stayed at the rough observation stage, the corresponding GLP and GCP were not established, and the clinical efficacy evaluation supported by the scientific data obtained from clinical trials was lacking. In addition, the increasingly fierce international market competition has also brought severe challenges to the Chinese medicine industry, and the superposition of various difficulties has led to the slowing of the internationalization of Chinese medicine.

In 2015, my country issued the "Vision and Actions for Promoting the Joint Construction of the Silk Road Economic Belt and the 21st Century Maritime Silk Road". The national "One Belt One Road" policy was formally proposed. This is a "new Silk Road" for the internationalization of my country's industry and promotes my country's economic development has entered a new high. my country’s traditional Chinese medicine actively participates in the “Belt and Road” construction. Through the policy plan of “Going Global” of Chinese medicine culture, it promotes the inheritance and innovation of Chinese medicine, and accelerates the integration and development of original Chinese medicine thinking and modern technology. This strategy provides internal impetus and new opportunities for the internationalization of Chinese medicine.

According to China Customs statistics, in 2016, my country's traditional Chinese medicine products have been exported to 185 countries and regions, and relevant agencies of countries along the route have signed 86 traditional Chinese medicine cooperation agreements with my country. The growth rate of traditional Chinese medicine products exports is steadily increasing. It can be seen that under the new situation of “One Belt One Road”, the internationalization of Chinese medicine is promising!

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Research on Modernization of Traditional Chinese Medicine

The purpose of modernization of Chinese medicine is to make full use of the methods and means of modern science and technology on the basis of carrying forward the advantages and characteristics of Chinese medicine, and to learn from international medical standards and norms, to research and develop Chinese medicine products that can legally enter the international medicine market, and to improve the international market of Chinese medicine. The competitiveness of the market.

The modernization of traditional Chinese medicine is a complex system engineering. According to the industrial chain, it can be divided into upstream (land/resources), midstream (factory/production) and downstream (research/clinical). At present, the modernization of traditional Chinese medicine is unbalanced, presenting a situation of "heavy in the middle and light at the two ends". The research on modernization of traditional Chinese medicine combined with clinical practice is the weakest link for a long time, but it is also the most important link in the process of modernization of traditional Chinese medicine. The main content of the current research on the downstream industry chain is compound prescriptions, including the research on the chemical components of traditional Chinese medicine, that is, the research on its chemical composition and the research on the law of composition changes during processing; the research on the traditional Chinese medicine preparation technology, such as the improvement, improvement and newness of traditional technology. The development of dosage forms, etc.; the pharmacological research of traditional Chinese medicine, that is, the study of traditional medicinal properties and modern experimental pharmacology; the objective evaluation of clinical efficacy.

1. Research on the ingredients of traditional Chinese medicine compound prescriptions

Because the chemical components contained in Chinese medicines and their compounds are extremely complex, the so-called "active ingredients" mentioned or measured in the current quality standards of most Chinese medicines and their compounds are mostly the main ingredients of the main medicine or called the index ingredients, which are not sufficient. The evidence proves that it is an effective ingredient. Using modern analysis and detection methods and computer-aided technology to carry out high-throughput screening (HTS) and characterization (including chemical and biological characterization) of the massive component information in traditional Chinese medicine and its compound prescriptions, and exploring the material basis of the efficacy of traditional Chinese medicine is the research of the modernization of traditional Chinese medicine. The key step. With the gradual improvement of HPLC, GC-MS, LC-MS, and nuclear magnetic technology, as well as the continuous introduction of various cutting-edge theories and methods such as chemometrics, pattern recognition theory, metabolomics, serum medicinal chemistry, etc., It is possible to realize the simultaneous online separation and analysis of multiple groups of compounds in the traditional Chinese medicine samples, obtain qualitative/quantitative data and information, and clarify the effective material basis of traditional Chinese medicines and compound prescriptions.

2. Research on the efficacy and mechanism of Chinese herbal compound prescriptions

In addition to the above-mentioned research on the components of the compound, the research on the efficacy and mechanism of the compound is also an indispensable research content. The efficacy of the compound is verified through cell models and animal models, through metabolomics, proteomics, transcriptomics, phenomics, and genomics. To clarify the scientific connotation of traditional Chinese medicine and lay a strong scientific foundation for the scientific connotation of traditional Chinese medicine and the internationalization of traditional Chinese medicine.

3. Research on Translational Medicine of Traditional Chinese Medicine

In the 21st century, translational medicine research is a new trend in the development of international life sciences. The proposal and advancement of translational medicine research provides a "green" channel for the combination of medicine, basic and clinical, and also provides a new opportunity for the modernization of Chinese medicine research. "Quality, quality, properties, effectiveness, and use" are the basic elements of Chinese medicine, which together constitute a unified and organic whole of Chinese medicine standards. Carrying out clinical needs-oriented research on the integration of "quality-quality-performance-effectiveness-use" of traditional Chinese medicine is an important way for the modernization of traditional Chinese medicine to approach the clinic as soon as possible. It is also an inevitable requirement for the transformation of traditional Chinese medicine research into clinical practice, and it is also the return of modern traditional Chinese medicine research. An important manifestation of the original thinking model of Chinese medicine, and therefore has important strategic and practical significance.

Research on the modernization of traditional Chinese medicine is not only a scientific issue, but also related to the overall development of my country’s pharmaceutical industry. Under the overall favorable situation of national policies, research on modernization of traditional Chinese medicine and its internationalization is imperative. Of course, it is inseparable from this process. The joint efforts of all front-line scientific researchers!

In view of the modernization research of traditional Chinese medicine compound prescriptions, Puluo Medicine has summarized a set of innovative and feasible research ideas:

First, use animal models for efficacy verification, and determine the effects and measurement through disease-related indicators; second, use compound-target-pathway prediction based on network pharmacology, use metabolomics, proteomics, transcriptomics, and phenotypes , Genomics research to predict the direction/mechanism of compound regulation; then use cell and animal models to detect and verify the direction of regulation through detection of inflammatory factors, oxidative stress, etc., and perform target detection through detection of signal molecules, regulatory factors, and target gene content And verification; Finally, use high-performance liquid phase, mass spectrometry, etc. to analyze the composition of the compound, and use the cell model to screen effective monomers.

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