Research On The Status Quo Of Local Standards For Chinese Medicinal Materials And Suggestions For Improvement

Purpose:The research of domestic Chinese medicinal materials standards is to understand the extant standard system and its development status.The systematic research of local Chinese medicinal materials standards is to clarify the defects and deficiencies of the local standards,and to give suggestions for improvement.It is helpful to improve the quality supervision of traditional Chinese medicine and the standard system of traditional Chinese medicine,to ensure the people’s drug safety,and to provide reference for the unified standard of traditional Chinese medicine in China.Material and method:1.Literature research method: Use libraries,archives and the Internet to search for original standard of Chinese medicinal materials and literature or materials related to Chinese medicinal materials standards.Through the integration of literature research,to understand the development status of Chinese medicinal materials standards in China,especially local standards.Through the research of local standards,obtain the corresponding data,find the number of repeated medicinal materials in local standards and the standard content of repeated medicinal materials,and obtain the repetition rate of recorded medicinal materials in different regions.At the same time,the relevant laws and regulations are studied to find out whether the current applicable laws and regulations of local standards are imperfect.2.Comparative research method: To compare the local standards for Chinese medicinal materials published in the current edition in all provinces,autonomous regions and municipalities directly under the central government with official Numbers,and to compare the situation of publication,receipt and storage among the local standards,the situation of duplicates and the standard differences among the regions.The medicinal materials are only collected according to local standards,but not according to pharmacopoeia and ministry standards.3.Field investigation method: Visit and investigate the professional market of Chinese medicinal materials in Bozhou,Anhui Province,to understand the circulation of Chinese medicinal materials with top 5 high repetition rate in local standards in the professional market,and to observe the combination conditions of existing standards and practical application,to observe the implementation of corresponding laws and regulations.4.Statistical analysis method: Relevant software is used to summarize,screen,count and analyze all the data related to drug standards,so as to further understand the publishing situation of local standards,drug collection and repetition rate.SPSS software is used for statistical analysis of repeated data in local standards and to study whether there is a certain correlation between the number of repeated medicinal materials and the number of local standards.Results:A total of 3,447 kinds of Chinese medicinal materials are included in the standards of 21 regions,and a total of 573 kinds of Chinese medicinal materials are repeated between regions.Among them,there are 334 Chinese medicinal materials from different sources.And the repetition rate exceeds 50% in 10 regions.There is a linear correlation between the number of Chinese medicinal materials in local standards and the number of duplicates in statistical analysis.The top five medicinal materials with high repetition rate are 21 in total,with zero from completely consistent sources,three from completely different sources,and the rest are partially inconsistent.The highest repetition rate of Chinese medicinal materials is Hedyotidis diffusa,recorded in 14 local standards,there are 7 kinds of medicinal Latin name,7 kinds of inspection standard,6 kinds of extract,identification and content determination standard are 3kinds separately,seven kinds of flavour and six classics,usage and dosage,function and the attending,attention and storage also have difference.Other kinds of medicinal materials also have the phenomenon that the standard is not unified.Conclusion:For the first time,this paper conducted a comprehensive,systematic and in-depth horizontal comparative study on the local standards of Chinese medicinal materials issued before December 1,2017.It is found that there are some problems in local standards in terms of publication,content,collection varieties and relevant laws and regulations.In view of the problems found,the following solutions are proposed:Local standards shall be issued regularly and updated in a timely manner,the old edition shall be invalidated when the new versions are implemented.Relevant state departments and experts and scholars should strengthen basic research,improve standard items,and improve the scientific quality testing and analysis.In addition,it is necessary to strengthen the protection of medicinal materials resources and the management of toxic medicinal materials,remove relevant varieties in time,separate the standards of traditional Chinese medicinal materials and ethnic medicinal materials,and include the loose standard into the books of local standards in time.The government should increase publicity and application,establish a multi-channel information platform for free access to the public,and improve relevant laws and regulations.According to the overall requirement of reform of national standardization,standardized local standards and screening and gradually transformed into a revised national standard [1],and set up a perfect quality standard system,makes the Chinese medicinal materials quality control one and the only standard can depend on,to promote healthy development of TCM industry,improve the international competitiveness and influence of traditional Chinese medicine.