[exclusive] Drug Administration: some varieties in the top 100 of the classic famous recipe catalog cannot be developed

Guide: through the method of combining modern big data technology with ancient traditional books, nearly 10% of the 100 ancient classic prescriptions that have been published have been listed 1 "Helpless" way out for new product development of traditional Chinese medicine enterprises Compared with the registration and application of new Chinese medicine from 2005 to 2017, it is found that the "Waterloo" of new drug registration and application appeared in the drug registration verification in 2007, and the "July 22 Massacre" clinical trial verification in 2015 The number of new Chinese medicine applications decreased significantly from 2932 in 2005, 332 in 2007 and 36 in 2017 2 Development direction of traditional Chinese medicine R & D Enterprises Article 2 of the announcement on simplified registration and approval of ancient classic Chinese medicine compound preparations (No 27, 2018) issued by the State Drug Administration on June 1, 2018 stipulates that: the application for listing of traditional Chinese medicine compound preparations from ancient classic prescriptions in the catalogue of national publication without listed varieties (except for varieties that have simplified registration and approval for listing in accordance with the provisions) shall be in conformity with the requirements Simplified examination and approval shall be implemented as required by the regulations 3 Prescription tracing back to ancient Chinese prescriptions are included in Treatise on febrile diseases, synopsis of the golden chamber, prescriptions for preparing the urgent money, prescriptions for general economy and other books, but the prescription information is scattered, so it is difficult to accurately compare the prescription information Recommendation of data mining tools: intelligence data of medicine contains a complete set of ancient prescription information, including the following books, to provide users with prescription comparison solutions We use Xiaoyao Powder for big data mining and find that Xiaoyao Powder, Xiaoyao Pill (concentrated pill), Xiaoyao mixture and heixiaoyao powder are similar prescriptions, among which the first three prescriptions of traditional Chinese medicine are the same, and heixiaoyao powder adds a traditional Chinese Medicine - Rehmannia on the basis of Xiaoyao Powder 4 Some of the 100 classic prescriptions can't develop drug intelligence data with more than ten years of data accumulation As the only company in China that conducts big data research on traditional Chinese medicine prescriptions, we conduct big data association analysis on all known traditional Chinese medicine prescriptions The results show that nearly 10% of the 100 classic prescriptions that have been published have similar / similar traditional Chinese medicine varieties on the market We take the 98th sanpian Decoction in the list of ancient classic prescriptions (the first batch) as an example Sanpian Decoction comes from the second volume of dialectics (Chen Shiduo, Qing Dynasty) Its prescription is 15g white peony, 30g chuanxiong, 3G Yu Liren, 3G Chaihu, 9g white mustard seed, 6G Xiangfu, 3GG Glycyrrhiza and 1g Baizhi Through the big data association analysis of Medicine intelligence data, we can know that the prescription of ancient classic prescription of sanpiantang is the same as that of Zhipiantong granules At present, six enterprises have been listed for sale Therefore, sanpiantang can not simplify the registration and approval according to the ancient classic prescription of traditional Chinese medicine 5 Summary and discussion to sum up, has your new drug been compared with traditional Chinese medicine prescription system? If you have any questions, please ask Xiaobian (Tel: 1573036280).