Research On The Project Approval Evaluation And Research Strategy Of Classical Compound Preparations

Objective: The classical prescription is an important means of traditional Chinese medicine to serve human health,and it is also an typical representative of TCM prescription.The research and development of the classical prescriptions is the inheritance and excavation of the classic Chinese medicine,and also the inevitable choice for the development of Chinese medicine industry.With the publication and implementation of “Regulations on the Simplified Registration and Approval of Ancient Classical Preparations” and the “Catalogue of Ancient Classical Preparation(First Batch)”,the ancient classical prescription became the focus of the traditional Chinese medicine enterprises and scholars.However,some key points such as herbal origin,processing,dosage and technics of prescriptions involved in the catalogue had not reached an agreement and standards.There was no successful R&D case of classic compound formulations that can be referenced in China.Based on the comparative analysis of development,registration,and regulatory processes of traditional compound preparation from domestic and overseas,the project approval evaluation model of classical compound preparations were constructed.Five compounds of L enterprise were taken as the object of empirical research.The obstacles to the project approval and R&D of ancient classical prescriptions were explored from the perspective of stakeholders,to provid an reference for the scientific project decision and R&D supervision of ancient classical prescriptions.Methods:(1)Comparative analysis was used to compare the R&D,registration and supervision of traditional compound preparations in Japan,Korea,Hong Kong,Taiwan and mainland China,which enlightened policy support,strict control of quality standards and application of advanced technoloty for the R&D and registration of ancient classical prescriptions.(2)Expert interview was used to construct the evaluation index system.Questionnaire survey and entropy weight method were used to determine the weights of evaluation indexes.(3)Grey correlation-TOPSIS method was used to prioritize projects,which were applied to evaluate the 5 projects of L enterprise.Results:(1)We are inspired to adhere to the policy support,strict control ofquality standards and advanced technology in the R&D and registration of classical compound preparations,by contrastive analysis the R&D,registration and supervision of traditional compound preparations in Japan,Korea and Hong Kong,Taiwan and mainland China.(2)The evaluation index system of project approval was constructed by expert interview method.The first-level indicators were market factor,clinical factos,technical factor and environmental factor.The second-level indicators were market characteristics,economic feasibility analysis,clinical value,clinical and experimental data,etc.There were 18 third-level indicators.The weights of indicators were calculated by means of questionnaire survey and entropy weight method.The indicators weights were ranked as follows: the company's strategic matching degree0.3260 > clinical safety evaluation data 0.0929 > dose situation 0.0912 > prescription quantity 0.0845 > clinical application advantage 0.0760 > market capacity Potential0.0591 >Process feasibility and industrialization degree 0.0456 > Mechanical processing conditions 0.0372 > medicine resources,herbal origin conditions 0.0321,etc.(3)The grey related-TOPSIS method was used to prioritize the classical compound preparations' projects of traditional Chinese medicine enterprises,which were used to evaluate the approval of 5 projects of L enterprise.The results were as follows: project F 0.7562 > project D 0.6735 >project G 0.6022 >project H0.4788 >project E 0.3304.Conclusion: The following suggestions are proposed from the perspectives of government and enterprises: enterprises should maintain the long-term effectiveness of the classical compound preparations' model,strictly control quality standards and make classical compound preparations into high-quality preparations.On the government side,first,the reform of the classical prescription compound preparations should be encouraged;second,the dosage range should be set;third,classical compound preparations expert committee should be set up and the method of different classical compound preparations should be simplified to promote the development of high-quality preparations.