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    Home > Biochemistry News > Plant Extracts News > Approval of Chinese medicine formula granules is tight to go out of the national standard to raise the barriers to entry

    Approval of Chinese medicine formula granules is tight to go out of the national standard to raise the barriers to entry

    • Last Update: 2013-07-18
    • Source: Internet
    • Author: User
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    Just as the rapid development of traditional Chinese medicine formula granules, many traditional Chinese medicine enterprises take this scientific research project as a key problem, the State Food and Drug Administration recently stipulated that only six enterprises are allowed to carry out pilot production, and each provincial food and drug administration department shall not approve the pilot of traditional Chinese Medicine formula granules in any name Some media questioned whether it was determined to rectify deviation or deliberately monopolize? Wu Bin, executive vice president of China Pharmaceutical Business Association, told reporters his real goal The traditional Chinese medicine formula granules were treated coldly ten years ago "Now all the traditional Chinese medicine enterprises have seen the market prospect of the traditional Chinese medicine formula granules, and all hope to pilot the expansion, and their own enterprises can participate in it At that time, even famous traditional Chinese medicine enterprises were afraid to avoid the research of traditional Chinese medicine formula granules Wu Bin laments that most Chinese medicine enterprises are lack of preparation Wu Bin said that from 2001 to 2004, six enterprises including Tianjiang Pharmaceutical Co., Ltd., Guangdong Yifang Pharmaceutical Co., Ltd., Guangdong Sanjiu Pharmaceutical Co., Ltd., Sichuan green Pharmaceutical Co., Ltd., Beijing kangrentang Pharmaceutical Co., Ltd and Nanning Peili Pharmaceutical Co., Ltd were approved by the state as the production enterprises of traditional Chinese medicine formula granules "It needs a lot of research to make traditional Chinese medicine formula granules At that time, when Beijing kangrentang pharmaceutical, a subsidiary of HongRi pharmaceutical, obtained the qualification to be a pilot production enterprise, there was a great pressure on scientific research At that time, the relevant institutions of the state did not have the support of scientific research funds, and the traditional Chinese Medicine Association did not make safety evaluation on the traditional Chinese medicine formula particles The main reason why the traditional Chinese medicine hospital did not accept the traditional Chinese medicine formula particles was that the sales volume was too small They are looking for funds and talents everywhere to carry out the research and development of this project under very difficult circumstances " Beijing kangrentang Pharmaceutical Co., Ltd has made a breakthrough in this project after more than ten years; in the past two years, kangrentang Pharmaceutical Co., Ltd has provided Dongzhimen traditional Chinese medicine hospital with 100 million yuan of traditional Chinese medicine formula granules every year "Now a lot of enterprises have seen profits and are scrambling to do pilot projects More than ten years ago, when the state invited some brand Chinese medicine enterprises to carry out pilot production, they were all rejected to varying degrees Some famous brand enterprises admit that scientific research takes a long time, costs a lot of money and does not see the market prospect, so they refuse to do this scientific research project " Traditional Chinese medicine formula granules is a new business model Jiang Liangduo, a national famous old Chinese Medicine professor and doctoral supervisor of Dongzhimen Hospital of Beijing University of traditional Chinese medicine, told Beijing Business Daily: "the clinical effect of traditional Chinese medicine formula granules is better than that of traditional Chinese medicine decoction, and my patient has a good effect after taking traditional Chinese medicine formula granules It has a good market prospect and is worth popularizing Now the relevant departments of the state call for a halt in order to improve standards and standardize the market The traditional Chinese medicine formula granule is not what enterprise wants to produce can produce Tu Zhitao, deputy director of Beijing Municipal Administration of traditional Chinese medicine, also expressed a similar view He believed that traditional Chinese medicine formula granules are convenient for patients and are the direction of development, but they have high technology content For the sake of safety, production enterprises need to have considerable qualifications Wubin is very optimistic about the traditional Chinese medicine formula particles, "it is a sign of the modernization of traditional Chinese medicine and a new business model Its use can reduce the space for traditional Chinese medicine hospitals to place pieces of traditional Chinese medicine, and use more space to build clinics The state is promoting this business model, which hospital will give subsidies to buy traditional Chinese medicine formula granules " Conceptually, traditional Chinese medicine formula granules are pure Chinese medicine product series, which are extracted, concentrated, separated, dried, pelleted and packaged by modern pharmaceutical technology, using traditional Chinese medicine pieces that meet the processing specifications as raw materials According to Wu Bin, traditional Chinese medicine formula granules embody the individualized characteristics of traditional Chinese medicine It is usually the doctor of traditional Chinese medicine who prescribes a prescription According to the prescription, each medicine is input into the computer compatibility machine The prescription can be input as many grams as it is written Finally, what comes out of the machine is the prescription granules of traditional Chinese medicine "Now the scientific research of traditional Chinese medicine formula granules is in the final stage, and the standard will come out soon." Wu Bin said that it is more personalized than traditional Chinese medicine and Chinese medicine For example, the price pill of six kinds of Rehmannia of traditional Chinese medicine needs 6 grams of Cornus officinalis, but according to the patient's condition, the doctor needs 3 grams, so the doctor directly prescribes 3 grams According to the prescription, through the computer compatibility machine, the Chinese medicine granules of the prescription come out of the hopper "One prescription in one bag, this bag of formula particles is the" six Dihuang price pill "suitable for this patient." Dr Wang Shubin, director of traditional Chinese Medicine Department of Yiling Pharmaceutical Research Institute, said to the reporter: "I used to work in Sichuan green pharmaceutical science and Technology Development Co., Ltd and I have a better understanding of the process of traditional Chinese medicine formula granules Now it is 6 enterprises that produce them For example, some of them use 10 times of water to extract 3 grams from 10 grams of traditional Chinese medicine pieces, and some of them use 8 times of water to extract 2 grams from 10 grams of traditional Chinese medicine pieces Art standards are not the same, which needs to be summarized according to the scientific research results of six companies, and relevant standards should be formulated Now, tightening the approval right is to improve the access threshold and standardize the industry " It is understood that the traditional Chinese medicine formula granule industry increased from 230 million yuan in 2006 to 3.2 billion yuan in 2012, with a compound annual growth rate of more than 50% "These six enterprises seized the opportunity of this market more than ten years ago, which warned other enterprises to prepare for independent innovation The market capacity of traditional Chinese medicine formula granules is very large, and each enterprise occupying a region will also be in short supply For Chinese pharmaceutical companies, we need to wait for the relevant standards to be issued before a large number of standardized production "
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