Let's talk about it with traditional Chinese Medicine

Editor's note: Traditional Chinese medicine, as a kind of medicine with Chinese characteristics, has been a hot topic in recent years, which cannot be discussed completely Today, we talk about traditional Chinese medicine The development of traditional Chinese medicine has reached the worst and the best times.. Look at the support of the central society at present At the beginning of Dickens' tale of two cities, there is a famous saying: "this is the best era, this is the worst era..." Xiaobian thought that everyone would have different understanding and interpretation of this phrase From the perspective of the pharmaceutical industry, the development of traditional Chinese medicine is in line with this phrase In the past long period of new China, there have always been some obstacles in the development of traditional Chinese medicine In the process of integration with the new society, new technology and new civilization, there have been some bottlenecks to be solved It can be said that its development has gone through the worst period, but now it has also ushered in the best period, because in the process of breakthrough, it will usher in a more different development situation In recent years, for the development and inheritance of traditional Chinese medicine, the state has always been emphasizing and seeking ways and methods On July 1 this year, the law of traditional Chinese medicine (TCM) was officially implemented, giving TCM laws to follow and really putting on a new development agenda At the opening ceremony of the 19th National Congress of the CPC, the central government made a directional statement on the development of TCM and the inheritance of TCM: "we should attach equal importance to both TCM and Western medicine and inherit and develop TCM We will support social efforts to run hospitals and develop health industries " With the overall support of the state, the development of Chinese medicine enterprises will usher in the spring In the past, there have been many obstacles According to the statistics of drug intelligence data, since 2000 (as of November 20, 2017), CDE has accepted 37692 traditional Chinese medicines (according to the acceptance number, the same below), including 16403 new drugs and 99 class 1 drugs Compared with 119661 chemical drugs with the most types in the pharmaceutical industry, we can see that the number of accepted traditional Chinese medicine is only about 31% of chemical drugs It can be seen that in the development of the pharmaceutical industry, there is still a lot of space for traditional Chinese medicine, and there are many prescriptions for traditional Chinese medicine to be explored and utilized In the past 17 years, in 2005 and 2006, the number of applications of traditional Chinese medicine was the largest From 2006 to 2007, the number dropped a lot In 2009, it fell again After 2010, it fluctuated a little As of November 20, 2017, 282 cases have been accepted, which has exceeded the number of last year, showing an upward trend (as shown in Figure 1 below) Figure 1: CDE's application for registration of traditional Chinese medicine is shown in Figure 2 below 22605 certificates have been prepared and approved, accounting for 60% of the total Only a few of them have been put on record It can be seen that in the past, more than half of the traditional Chinese medicine entering CDE has passed the review and approval Figure 2 CDE Chinese medicine processing status now, in the past two years, under the favorable situation of Chinese medicine policy, only see from January 1, 2017 to November 20, 2017, among the 282 Chinese medicine accepted by CDE, 151 are in the review and approval (as shown in Figure 3 below), and 103 have been certified and approved Among them, there are 32 new drugs, of which two are xiaoerqingzha oral liquid and peituqingxin granules, which have stepped on the fast track of priority evaluation (as shown in Figure 4) Peituqingxin granules have been accepted since March 24, 2017, and have been approved for clinical application since September 27, 2017, lasting for 6 months It is believed that with the support of more and more national leaders and social pharmacists, CDE will accept more review and approval of traditional Chinese medicine in the future, and more traditional Chinese medicine will be used to treat people's daily diseases, bringing people good news Fig 3 CDE Chinese medicine processing status in 2017 (as of November 20) Fig 4 there is still a difficult problem in the development and inheritance of traditional Chinese medicine in 2017 (as of November 20), that is, clinical trials of traditional Chinese medicine In order to keep up with the international standards, traditional Chinese medicine is imitating the western medicine in the evaluation and verification system In the eighties and nineties of last century, we began to promote clinical trials of traditional Chinese medicine The process of applying new traditional Chinese medicine is almost the same as that of Western medicine, and a large number of clinical research materials are needed According to the statistics of pharmaceutical intelligence data, there are 613 TCM clinical trials registered from January 1, 2014 to November 20, 2017 in the Chinese clinical trial database, of which 242 have been completed, 193 have been recruited, 108 have not been recruited, and 56 have been recruited In these test items, the test stages are shown in Figure 5 There are 126 in phase III and 22 in phase IV Figure 5 clinical trial stages of traditional Chinese medicine from 2017 to now, there are 9 clinical trials (as shown in Table 1), of which 6 have not been recruited and 3 are in recruitment Table 1 from the results of the registration of the current clinical trial database, it can be said that the development of traditional Chinese medicine is very slow We still have many classic traditional Chinese medicine prescriptions that have not been promoted In addition to the clinical trial mode, the progress of modern toxicology makes the clinical trial of traditional Chinese medicine face new challenges For example, aristolochic acid, which has been paid more attention at home and abroad recently, has been shown to have certain toxic and side effects, and excessive use may lead to renal failure This leads to more and more attention to the toxic and side effects of traditional Chinese medicine in Chinese and foreign academic circles, and promotes the new climax of supervision and evaluation of clinical trials of traditional Chinese medicine Facing the future, the country and the medical people are still exploring, trying to find a more reasonable development model of traditional Chinese medicine Many pharmaceutical companies have begun a new round of layout, and will put the research and development of traditional Chinese medicine and natural medicine on the company's strategy in the future We should have confidence in the future prospect of traditional Chinese medicine and traditional Chinese medicine industry The past has passed We should look forward to the future and believe that traditional Chinese medicine will eventually reappear its brilliance The fragrance of traditional Chinese medicine will spread at home and abroad and benefit the public Data source: drug intelligence drug registration and acceptance database drug intelligence China clinical trial database