Academicians and experts are at the helm to lead the phase IV clinical research direction of zedoary turmeric oil injection

In response to and in cooperation with the re evaluation of the safety and effectiveness of injection drugs by the State Food and drug administration, the pharmaceutical industry (Group) in the future specially invited more than ten experts, including Chen Keji, academician of the Chinese Academy of Sciences, Fang Shuting, President of the Chinese Traditional Medicine Association and former deputy director of the State Administration of traditional Chinese medicine, Professor Gao Xuemin, Beijing University of traditional Chinese medicine, on November 21, 2017 The fourth phase clinical research plan of zedoary turmeric oil injection was discussed in Feitian building, Beijing At the beginning of the meeting, Mr Li Xiaoxiang, the chief scientist of future pharmaceutical (Group), reported to the experts the development process and market status of future pharmaceutical (Group) in the past 6 years During the meeting, experts listened to the report of "introduction of zedoary turmeric oil injection products", discussed the development history, research status and treatment status of zedoary oil injection, agreed that zedoary oil injection should carry out four phase clinical research, and gave guidance to the four phase clinical research program of zedoary oil injection Academician Chen Keji highly recognized the therapeutic effect of zedoary turmeric oil injection on respiratory tract infections, especially pneumonia Chen Lao pointed out that in the four phase clinical research, we should expand the sample, expand the indications, summarize the cases with significant efficacy, and closely observe and analyze the adverse reactions President Fang Shuting fully affirmed the quality control and production process of zedoary turmeric oil injection In the fourth phase of clinical research, we should focus on the content of active ingredients, pharmacological action, clinical drug compatibility and other issues After analyzing the development history and market environment of traditional Chinese medicine injection, Professor Gao Xuemin thinks that zedoary turmeric oil injection has high clinical treatment value We should organize experts to discuss and formulate four phase clinical research plan after repeated discussion, and strive to answer the three questions of "safety, effectiveness and controllability" Professor Zhang Hongchun thinks that in the four phase clinical research plan of zedoary turmeric oil injection, the indications should focus on the lower respiratory tract infection, digestive tract infection, perioperative anti infection and severe upper respiratory tract infection Professor Fu Changgeng pointed out that since zedoary turmeric oil injection has anti-virus, anti-bacterial and anti-inflammatory pharmacological effects at the same time, it can be included in the study of infection cases with antibiotic resistance Professor Du Shouying believes that we should pay attention to the adverse reactions of zedoary turmeric oil injection while clarifying its clinical location The quality difference between imported Tween-80 and domestic Tween-80 and its influence on the incidence of adverse reactions were compared Secretary General Wang Guihua suggested combing and analyzing the existing materials of zedoary turmeric oil injection, deepening the research on unknown and unclear data, and giving guidance on the research direction and methods Dr Wang Hongfei deeply analyzed the policies and regulations, and proposed from the perspective of enterprise development: first, the R & D department should take the lead to re sort out the policies and regulations, Pharmacopoeia, specifications, etc.; second, the experts should take the lead to sort out the safety, effectiveness and economy from the perspective of market and medicine According to Liu Zhanglin, the fourth phase clinical study of zedoary turmeric oil injection should be designed according to different purposes At the same time, according to the requirements of Pharmacopoeia, the research sample size should be expanded, and the design of research scheme should be completed in combination with the brand construction in the future Director Wang Qingwei suggested to strengthen the research on how to remove impurities with molecular weight greater than 3000 in the production process of zedoary turmeric oil injection, so as to reduce or avoid adverse reactions After expert discussion, the following opinions were formed on the value of zedoary turmeric oil injection products, future development and the research work to be carried out: 1 The experts at the meeting agreed that the effective ingredients of zedoary oil injection were basically clear, the pharmacological effect was clear, the clinical application in the treatment of various respiratory tract and xiaohuadao infectious diseases, and the efficacy was recognized by medical workers and patients 2 Experts at the meeting suggested a deeper study on its basic theory, effective ingredients and quality control According to the requirements of the state on the effectiveness, safety, uniformity and stability of the injection, further re evaluation work shall be done, focusing on the four phase clinical research work 3 In order to make zedoary turmeric oil injection better serve the clinical practice, we should organize clinical experts to formulate technical specifications for clinical rational use of zedoary oil injection, so as to guide clinicians to use it correctly and avoid adverse reactions caused by improper use 4 At the meeting, it was suggested to establish the expert Steering Committee for the phase IV clinical research of zedoary turmeric oil injection Academician Chen Keji is specially appointed as the general consultant and Professor Gao Xuemin as the chairman Specific matters will be discussed separately Finally, on behalf of the group, Mr Zhao Lijun, chairman of the future pharmaceutical industry (Group), thanked the experts for their participation and guidance, and made it clear that a large amount of human and material resources would be invested Under the guidance of the association, the academician and the support of experts, a more in-depth study on zedoary turmeric oil injection will be carried out to provide patients with more effective and safer non antibiotic anti infective drugs.