Research and development of new drug of TCM to be broken 
 
 
2015/2/10 
 
 
Source: the observer Author: the reactions 

    As is known to all, new drug research and development cycle is long, to 15 years on average, it takes more than 10 years in China is generally to developed a new drug. New drug r&d investment is high, in the United States a new drug research and development need for an average of more than $1 billion. New drug risk big, the statistics show that success rate is only one over ten thousand of new drug research and development in the United States. Look at the new drug research and development funding allocation, new drug innovation phase accounts for 82% of research and development, product improvement stage is about 18%. China's new product research and development on the traditional Chinese medicine (TCM) in the invention stage investment is less, the investment in research and development between not balance, so want to invest in research.
 
    Few of new drug of TCM products
 
    Since 1985, our country has approved the new drugs more than 10000. The FDA has approved per year on average more than 20 new drug, that is to say, we need approval of new drugs in the United States in 500 to all approved.
 
    Although the national approval of more than 10000 new varieties contains almost all varieties of traditional Chinese medicines can cure, take a hard look at what you will find, however, although many new variety, but the lack of high-quality goods.
 
    The so-called boutique is its curative effect is superior to similar products, toxicity is lower than similar products, and it was characterized by his treatment of traditional Chinese medicine. For example, in the heart of artemisinin is a kind of high-quality goods. Artemisinin is a kind of antimalarial drugs, in the past two hundred and thirty years at least save the lives of millions of African children. Tu because the contribution of research and development of artemisinin was awarded the lasker award, this is our country won the highest award of biological medicine field.
 
    In 2007, the state food and drug administration, raise the standard for new drug research and development. In clinical trials, must have a placebo-controlled, thus avoiding the drug before with any positive drug control, as long as the new drug curative effect as good as positive medicine can be approved, can eliminate false positive results. According to the international general principle, now need to use a placebo control. So in 2007 completes two phase 3 clinical trials of new drugs, need to fill do a placebo in clinical research, can to get the approval of human medicinal center.
 
    To a certain extent, new drug research and development standards, led to the examination and approval by the number of new drugs from one extreme to another extreme. In recent two or three years, human medicinal center each year only more than 10 kinds of the number of new drug approval, less than the United States. For example, in 2010, approved by the five kinds of medicine is only two, six drugs only 10.
 
    The listed again evaluation is of great significance
 
    Today is very difficult to develop a new drug, it has to do with drug firms operating mode. A general manager of the state-owned companies is a five-year term, and new drug research and development tend to need more than a decade. During his tenure, general manager can't see the new drug r&d performance, only to see for new drug research and development spending, its results demonstrate.
 
    In such cases, large variety consolidation promote arises at the historic moment. The drug companies are thinking, how to revitalize the existing inventory. In recent years, many pharmaceutical companies are revitalize their great variety, including listed again after evaluation and large variety to upgrade. Such as Dan red injection of step length pharmaceutical co., LTD., jinan, turned out to be a little variety, drug companies through mergers before is close to collapse and regenerate the Dan red injection, make it grow into a big varieties, annual sales of 4 billion yuan now.
 
    Public evaluation contents related to the specific what again? In medicine, including an increase in the standard, the improvement of technology, and in terms of pharmacology, involves the function mechanism of traditional Chinese medicine, promote role characteristics and adverse reaction signal and the safety evaluation of the system. The most important is to evaluate clinical again, from the clinical characteristic of drug discovery.
 
    For example, a drug firms doing adhd medication, how to design clinical evaluation it is critical that again. How to find children, how to design clinical trials will display the curative effect of the drug, determines the stand or fall of clinical evaluation again. Once the successful completion of clinical evaluation again, will certainly be helpful to the promotion of enterprise sales.
 
    The five kinds of new drug research and development model
 
    New drug research and development has a certain pattern. Is one of the most common natural medicine research and development mode, namely the traditional Chinese medicine as a natural medicine, animal model and evaluation method is used in the medicine. Such as artemisinin-based antimalarial drugs, huperzine a (AD), curculigo glycosides (antidepressants) is the research and development mode.
 
    The second is combination of Chinese and western research and development mode, this mode has the shadow of the traditional Chinese medicine. Drugs to treat AIDS, for example. How HIV adhesion and invasion of human lymphocytes, how to copy with reverse enzymes in human body, these processes are clear. Build a chinese-american, puts forward the concept of using traditional Chinese medicine compound treatment of HIV/AIDS, he used "cocktail therapy" to describe the treatment. Traditional Chinese medicine and western medicine like general against the cocktail together, good curative effect on treatment of AIDS, can prevent the virus at the same time.
 
    The third is secondary development research and development mode, such as open spirit is from qing palace bezoar bolus secondary development.
 
    The fourth is components of traditional Chinese medicine research and development mode. It is under the guidance of medicinal components in Chinese medicine theory, based on the traditional by the party, prescription of TCM new drug research and development components model. This pattern has both the advanced nature of modern medicine, Chinese medicine polypharmacy advantages and characteristic. Are added yinpian prescription of traditional Chinese medicines such as the original, now don't slices, but with the effective components instead of medicine.
 
    The last one is from the clinical pattern of new drug research and development. The biggest difference is that traditional Chinese medicine and chemical medicine research and development of traditional Chinese medicine has a long application history, especially in the clinical applications of history. Now some old Chinese medicine prescription still enduring. Sue particles, such as the Yangtze river pharmaceutical stomach he comes from a "traditional Chinese medicine holds," said the old tung chee-hwa's prescriptions of traditional Chinese medicine.
 
(the author is national engineering research center, deputy director of new Chinese herbal compound)
 
    A link to the
 
    Research and development of traditional Chinese medicine (TCM) from the innovation breakthrough the bottleneck
 
    Traditional Chinese medicine, in the traditional sense of the concept called "materia medica", until after the opium war, is the concept of traditional Chinese medicine (TCM). Traditional Chinese medicine has the property of geographical, cultural and scientific, and fully reflects China's natural resources and historical and cultural characteristics.
 
    Traditional Chinese medicine (TCM) is a very complex system, with many sources, many varieties, many specifications, composition, dosage form, way, performance, multifunctional and multipurpose. Chinese medicine major varieties include new resources, new varieties, medicinal herbs, slices, intermediate extracts, formulation in granular, proprietary Chinese medicine, Chinese medicine health care products, veterinary medicine, Chinese medicine, Chinese medicine pesticide such as cosmetics, is a complete system.
 
    Research and development of traditional Chinese medicine (TCM) is a system engineering, is the study of the traditional Chinese medicine quality utility theory technology such as knowledge of the system. In the process of research, there are many bottlenecks. For example, lack of basic research, comprehensive exploitation and utilization is insufficient, system running mechanism is not sound, etc.
 
    Chengdu university of traditional Chinese medicine in the study of innovative drugs, insist on the policy, production, study and research, combined with, adhere to the resource advantage, science and education, industry advantages, talent advantage, collaborative innovation subject chain docking industry chain, product development docking project research. Such as the study of lateral root development, is a good practice.
 
    Monkshood is Mao Yin branch plant, for example, aconitum, Chinese drugs, the curative effect is good. In traditional theory, it is a life-saving drugs, collapse disorder drug treatment, but its toxicity is very large. Toxicity of effective control, therefore, its effectiveness, with the quality of the varieties, aconite, medicinal properties, efficacy and application of research, is of great significance. This project not only in the process of research has obtained the national patent, also won the state science and technology progress prize.