Research On WHO Monographs On Selected Medicinal Plants

Research Background: With the rapid development of herbal medicines in the world,many countries and regions have established herbal medicines standards or monographs to ensure the quality,safety and effectiveness of herbal medicines.WHO monographs on selected medicinal plants has a significant impact in the world,but domestic scholars pay little attention to this,few related research reports are found,and there is still a lack of "Chinese monographs on traditional Chinese medicine" compiled by standardized procedures in line with international standards at present in our country.Research Objective: Through the systematic study on the principle of WHO evaluation of herbal medicines and the monographs on selected medicinal plants,this paper provides a reference for the compilation of the "Chinese monographs on traditional Chinese medicine",and preliminarily constructs the basic framework of the "Chinese monographs on traditional Chinese medicine".Research Methods:(1)Literature research method A series of guidelines for WHO herbal medicines and WHO monographs on selected medicinal plants were systematically analyzed.(2)Inductive deduction method On the premise of systematic analysis of WHO series guidelines for herbal medicines,the principles and methods of WHO evaluation of herbal medicines were summarized.(3)Comparative research method Taking the varieties of traditional Chinese medicine jointly collected by WHO monographs on selected medicinal plants and Chinese Pharmacopoeia(2015 Edition)as the research object,By comparing WHO monographs on selected medicinal plants with Chinese Pharmacopoeia(2015 edition)and Clinical Drug use Notes,the similarities and differences in the quality,safety and efficacy of traditional Chinese medicine recorded by the two monographs were analyzed.It lays a foundation for the preliminary construction of the basic framework of "Chinese monographs on traditional Chinese medicine".Research Content and Results :(1)Analysis of WHO guidelines for herbal medicines evaluation WHO has issued a number of guidelines for herbal medicines including the Research guidelines for evaluating the safety and efficacy of herbal medicines,Guidelines for the Assessment of Herbal Medicines,and General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine.It provides guidance for the principles and methods of evaluating the quality,safety and effectiveness of herbal medicines based on literature,and provides a reference for WHO to formulate monographs on selected medicinal plants.It is found that WHO mainly refers to the contents under the quality of herbal medicines stipulated in pharmacopoeia or authoritative documents of various countries.The evaluation of the safety and effectiveness of herbal medicines mainly includes two parts: the evaluation of literature retrieval strategy and results and the evaluation of literature content.Firstly,the effect of literature retrieval is evaluated by evaluating the strategy of literature retrieval,the quantity and category of literature and the credibility of literature.On the premise of meeting the requirements,the content of the literature is evaluated.The evaluation of literature content is mainly divided into safety and effectiveness evaluation.For the evaluation of the safety of herbal medicines,WHO first evaluates whether herbal medicines have pharmacopoeia or toxicological research data,and if there is pharmacopoeia or toxicological research data,the safety of herbal medicines is evaluated according to their content.For herbal medicines lacking pharmacopoeia or toxicological data,WHO first evaluates whether there are reports of side effects on herbal medicines in clinical experience or review literature;if there are reports of side effects of herbal medicines,The safety of herbal medicines should be evaluated by toxicological basic research.If no side effects of herbal medicines were reported,the safety of herbal medicines was evaluated by detecting immunotoxicity,genotoxicity,reproductive toxicity and so on.For the evaluation of the effectiveness of herbal medicines,WHO is mainly based on the severity of herbal medicines in the treatment of diseases.For the treatment of minor diseases or as a preventive treatment of herbal medicines,WHO believes that observational researchand other less credible literature can determine the effectiveness of herbal medicines.For herbal medicines for the treatment of serious diseases,it is necessary to evaluate randomized controlled trials,systematic review of literature and other ways to determine the effectiveness of herbal medicines.From the above research content,it can be seen that the process scientific standard of WHO evaluation of herbal medicines provides an effective reference for evaluating the quality,safety and effectiveness of traditional Chinese medicine.(2)Systematic Analysis of WHO monographs on selected medicinal plants Based on the principles and methods of WHO evaluation of herbal medicines,WHO developed and published five volumes of monographs on medicinal plants,including130 varieties of medicinal plants,involving 176 species of basic plants.The evaluation and formulation process is scientific and rigorous,recording the quality,safety and efficacy of medicinal plants in a comprehensive and careful manner.In particular,the records of the effectiveness of herbal medicines vary according to the types of herbal medicines literature,The clinical use records of herbal medicines are divided into "Uses supported by clinical data","Uses described in pharmacopoeias and well established documents" and "Uses described in traditional medicine",which has high clinical reference value.(3)Comparison of traditional Chinese Medicine jointly contained in WHO monographs on selected medicinal plants and Chinese Pharmacopoeia(2015Edition)Compared with 28 kinds of common-contained traditional Chinese medicines,we found that compared with Chinese Pharmacopoeia and the instructions for Clinical Drug use,the quality,safety and efficacy of herbal medicines recorded in the WHO monographs on selected medicinal plants were more comprehensive and complete.It provides a good reference value for the preliminary construction of the basic framework of "Chinese monographs on traditional Chinese medicine".(4)Construction of the basic Framework of "Chinese monographs on traditional Chinese medicine" Based on the results of this paper,the evaluation principles and methods of the quality,safety and effectiveness of traditional Chinese medicine inChina were constructed,and the basic framework of the monograph on traditional Chinese Medicine is preliminarily constructed,which involves three aspects: quality,safety and effectiveness and includes basic information of traditional Chinese medicine,general identification test,main chemical components,clinical use supported by scientific data,clinical use recorded in Chinese Pharmacopoeia,clinical use recorded in traditional medicine,adverse reactions,etc.Research Conclusion: The evaluation and formulation process of WHO monographs on selected medicinal plants is scientific and rigorous,and the contents covered by the writing style are all-round and detailed.In this study,the evaluation system of the quality,safety and effectiveness of traditional Chinese medicine based on the literature was constructed.On this basis,the basic framework of "Chinese monographs on traditional Chinese medicine" is preliminarily constructed to provide reference for the subsequent compilation of "Chinese monographs on traditional Chinese medicine",to promote the rational use of traditional Chinese medicine,and to lay a solid foundation for the internationalization of traditional Chinese medicine development.