How to break the bottleneck of traditional Chinese medicine pharmaceutical industry?

[editor's point of view of chinapharma.com 】In recent years, the traditional Chinese medicine industry has developed vigorously According to the data, there are more than 1500 traditional Chinese medicine enterprises and nearly 10000 varieties of Chinese patent medicines in China However, more than 90% of Chinese patent medicines still have some common problems, such as unclear effective substances and their mechanism of action, lack of clinical evidence, rough pharmaceutical technology and poor quality control, which lead to the low scientific and technological content of Chinese patent medicine products and lack of international market competitiveness Therefore, the innovation of pharmaceutical technology and the improvement of quality control level and scientific and technological connotation of traditional Chinese medicine products have become the problems that must be solved to realize the leapfrog development of traditional Chinese medicine pharmaceutical industry (how to break through the bottleneck of traditional Chinese medicine pharmaceutical industry? Picture source: Baidu picture) quality is an important foundation to ensure the curative effect of traditional Chinese medicine Ren Dequan, honorary president of Modern International Association of traditional Chinese medicine and chairman of cooperative organization of production, learning and research of traditional Chinese medicine injection, once pointed out that "drugs have three attributes: safety, effectiveness and controllable quality First of all, we should control the quality If the quality can not be guaranteed, it is difficult to explain the research results of safety, effectiveness and even mechanism Therefore, quality is an important basis for ensuring curative effect " Ren Dequan introduced the specific content of quality risk management of Chinese patent medicine First, product safety risk management He pointed out that enterprises should strengthen the research of "real world" adverse drug reactions (ADRs) ADRs can only be found for a period of time after the drug is put on the market, and the reasons are complex Therefore, the research of ADRs is endless Attention should be paid to distinguish ADR and ade (adverse drug events) in the research The important thing is to actively add the adverse reactions found in the research into the drug specification, "this is for doctors and doctors Patient responsibility is also an exemption for the enterprise itself In addition, adverse drug reactions should also become one of the important contents of academic promotion The second is the embodiment and management of the clinical value of product effectiveness, including the effectiveness research of "real world" and the effect of combined medication The third is the management of product quality stability, including the setting and management of quality standards; process design based on quality requirements, such as dosing, process and unit technical equipment, control parameters, operation parameters, design parameters, etc.; the management of quality consistency, such as the risk management of raw and auxiliary material quality and traceability; the scientific and rigorous operation and management of production process, Quality consistency control from feeding, production process, finished products to commodities Intelligent manufacturing is the inevitable way to achieve the quality uniformity of traditional Chinese medicine Intelligent manufacturing is the general trend of the development of global manufacturing industry, which is no exception in the pharmaceutical industry of traditional Chinese medicine Xiao Wei, chairman of Jiangsu Kangyuan Group Co., Ltd., said that intelligent manufacturing is an inevitable way to achieve the quality uniformity of traditional Chinese medicine and the consistency of clinical efficacy, and many large and well-known enterprises in China have shown their achievements For example, Jiangzhong pharmaceutical Valley liquid workshop has a fully automatic and unmanned production line for Chinese traditional medicine manufacturing, which has been rated as the "intelligent manufacturing pilot demonstration" base by the state industry and Information Technology Commission In the liquid preparation workshop of traditional Chinese medicine, extraction, separation, purification, ingredients, bottle washing, filling, sealing, detection, boxing, stacking 107 industrial robots cooperate tacitly to complete a series of production line processes Zhong Zhijian, director of the workshop, said in an interview that the robot automatic production line can reduce human errors to a low level, thus greatly improving and guaranteeing product quality Experts believe that the significance of intelligent manufacturing lies in standardization, flexibility and automation Through advanced technology to improve the level of process control, improve the standards of engineering equipment, improve the quality and efficacy of traditional Chinese medicine, lay the International Foundation of traditional Chinese medicine In the future pharmaceutical industry of traditional Chinese medicine, intelligent manufacturing will play an important role in promoting the quality of traditional Chinese medicine more stable and scientific Summary: China's traditional Chinese medicine industry has a bright future, but there are many difficulties The current problem is the problem left by the traditional pharmaceutical industry for a long time, so the road to improvement is still very long How to grasp the trend of intelligent manufacturing and innovate the development of pharmaceutical technology and pharmaceutical equipment under the favorable prospect of current policies is a problem that needs to be considered by major pharmaceutical enterprises of traditional Chinese medicine.