A Comparative Study On The Application Guidance Of Japanese Kampo Medicines And Chinese Patent Medicines

Traditional Chinese Medicine(TCM),a discipline with original advantages in China,has developed thousands of years with a subdivision called TCM Classical Formulas of great treasure.The formulation of the relevant standards is of great significance not only to the promotion of the application and development of TCM Classical Formulas but to the internationalization and the enhancement of competitiveness of Chinese medicine as well.At the policy level,with the issue of the“Regulations of the Simplified Registration and Approval Management for Compound Preparations of TCM Classical Formulas"and the"First Batch of TCM Classical Formulas Catalogue"and other national policies and regulations,the application of the TCM Classical Formulas and related research has become key tasks of the current efforts.The study over how to effectively implement the national policies of the TCM Classical Formulas;how to integrate the development of the TCM Classical Formulas effectively with the market sufficiently;how to sort out and study the relevant links remains critical.At the market level,the TCM Classical Formulas are highly valued in Japan,South Korea and Taiwan,and their applications are very common.The industrialization of Japanese Kampo medicine will have a certain impact on the protection and development of TCM Classical Formulas of our nation.In recent years,Japanese Kampo medicine companies and scientific research institutions are still striving to rush to the international patents and intellectual property rights of Kampo medicine,and to promote the international application of Japanese Kampo medicine.As the original country of these formulas,China has recognized the seriousness and urgency of the problem.In 2017,Ping An Insurance of China launched its acquisition plan for Tsumura,Japan,and became the largest shareholder of Tsumura with a 10%share holding which indicated that the market of the TCM Classical Formulas was expected to reach a new level of maturity.At the research level,the study of TCM Classical Formulas has been concentrated in industries,patents,quality,and clinical applications in China,and there is a lack of holistic research on popularization of application.Therefore,in view of the above conditions,it is of great practical significance to carry out research on the application of TCM Classical Formulas.First of all,it will provide reference for the implementation of the state’s policy on the development of TCM Classical Formulas,especially in the promulgation of the TCM Classical Formulas Catalogue and the improvement of the specification standards.Secondly,it will provide the basis and specific content information for the research and development and marketization of related enterprises;Thirdly,new ideas for the research on TCM Classical Formulas will be put forward to perfect its research system.In this study,128 items from the Japanese Kampo preparations were selected as the research object.Contrasts were made between 100 items released in the TCM Classical Formulas Catalogue together with major formulas from Formula textbooks.Through specific content listing,basic content classification,statistical comparison and other methods,the following aspects are discussed:(1)The selection strategy of the TCM Classical Formulas Catalogue;(2)The presentation and docking methods of the main contents in the drug instructions;(3)The dosage form strategy;(4)The formulation of the national guidebook on TCM Classical Formulas;(5)Further segmentation market research on four important categories of cold medicine,gastrointestinal medicine,gynecological medicine and pediatric medicine.The conclusions are as follows:(1)The selection of the TCM ClassicalFormulas Catalogue should be focused and subdivided into categories.The value of the Formulas should be taken into consideration,and priority should be given not only to key ones such as cold medicines and gastrointestinal medicines but also the medicines with typical population characteristics of gynecology and pediatrics;(2)The naming standards for the TCM Classical Formulas should be improved and the drugs that have been on the market long time and the ones newly launched should be reviewed to keep accordance with the classical ones;(3)The instructions of existing Chinese patent drugs lack of specific doses and proportions in the"Ingredients"item which involves the formulation and implementation of professional standards.It is a key point that restricts the dissemination of the TCM Classical Formulas,and it is also an important link for enterprises to create the advantages of the TCM Classical Formulas;(4)The TCM Classical Formulas is the treasure of TCM,and it is the typical brand under the meaning of"Made in China".The establishment of national standard database and the formulation for instruction manual have important scientific significance and practical value over relevant government,enterprises,medical institutions and practitioners,public and even international standards;(5)The application and popularization of the TCM Classical Formulas are related to the brand of Chinese traditional medicine.It is related to the development of the entire TCM industry and to the cause of human health.A national brand strategy should be established for a benchmark to be referred by the content of professional textbooks,the TCM Classical Formulas Catalogue published by the state and the company’s TCM Classical Formulas products.Efforts should be made to allow every common disease with a TCM Classical Formula to be applied,every health institution with Classic Formula books available,every research group with national standards to check.