Based On CNKI China's Children's Drug Adverse Reaction Report Analysis Model And SooPAT Based On China's Children's Chinese Medicine Compound Patent Application Analysis

Part1 Pattern Research on the Analysis of Ped:iatric ADR Reports in China——Based on Bibliometrics and Bibliographic informations of CNKIObjective:To research the pattern of the analysis of pediatric ADR reports in China.Methods:Literatures from CNKI Database were retrieved,compliant literatures were screened according to inclusion requirements,and bibliometric indicators were used to analyze by bibliometric metrology from three aspects:the publishment(including the annual output,the literature quantity proportion and the distribution of major publications),the source situation(including the document authors and cooperation,the dispatch agencies and cooperation,the dispatch area and administrative level distribution),the content situation(including the high frequency keywords,the literature data sources and subject distributions of the literature)are included as well.Results:The number of the ducuments which about the analysis of pediatric ADR reports in China increased year by year,whom distributed in the pharmacy class publications,the post agencies focused on hospital especially with organizations teamed,the major subjects of documents are conventional analysis,antibiotic medicines analysis and Traditional Chinese medicine.Conclusion:There is still large room for improvement of the research on analysis of pediatric ADR reports in China,we should Speed up the construction of ADR basic level monitoring and standardization of children in our country,attach importance to the multi-center-cooperation,make an effective use of the pediatric ADR reports in China,in the hope of reducing the pediatric ADRs in the future.Part 2 Analysis of patenting application on the compound Tradtional Chinese Medicine for children in china based on SooPATObjective:To preliminarily explore the overall distribution and research topics about patent applications of compound traditional Chinese medicine for children in China.Methods:First,we needed to formulate the retrieval-type.Then we used the SooPAT patent search engine to screen the patent literatures which met the standard.About 4268 patent articles were selected to build the database.Finally,we analysized the patent information form two aspects with the method of descriptive statistics.These two aspects included the overall distribution of patent application(such as the application date,region,entity and inventors,main classification and the patent grant conditions)and the distribution of subject content about the authoried patent(classified statistics analysis---classifeid according to the therapeutic activity,the active ingredients;A16 patent title record---analysized based on the keywords of efficacy/symptoms,dosage form/directions for use and methods).Results:Depending on the patent data employed by our study,the patent applications of compound traditional Chinese medicine for children in China were started in 2004 and they were increased in volatility as the whole trend;The regions which applied for the patent of compound traditional Chinese medicine for children in China were aggregatively distributed in Shandong,Jiangsu and Anhui provinces(the proportion amounted to 52.68%),and the Northwest regions which were presented by the autonomous regions had a very small proportion;the application types were concentrated on individual(accounting for 72.56%)and enterprises(accounting for 21.46%).So there is still a large potential for hospitals,research institutes and universities to apply for the patent of compound traditional Chinese medicine for children.The rate of patent grant(75.01%)has been shown an increasing trend year by year from 2008;Among the authorized patents,compound traditional Chinese medcines for aiding digestion,antidiarrheal,respiratory diseases,skin diseases and antitussives accounted for a considerably large propotion,and the active ingredients of these drugs were primarily extracted from plants of the the Gramineae and ginger family;the efficacy of patented drugs were maimly focused on the pediatric digestive diseases,respiratory diseases and skin diseases and the dosage form were principally concentrated in decoctin,oral liquid and granules.The involved research contents mainly contained quality control,quality inspection or preparation method.Conclusion:The application of compound traditional Chinese medicine for children in China started relatively late and is still in the development period.According to the importance of patent protection of traditional Chinese medicine combined with the situation of its overall distribution and research subject,we forward some constructive suggestions about how to protect the intellectual property rights of compound traditional Chinese medicine for children with the means of patent in the future.Firstly,we should strengthen training and establish special protection system with the support of our government to ehance the awareness of the whole industry on Chinese Materia Medica intellectual property protection;secondly,the cooperations between enterprises and scientific research institutions,multi-center and international exchange and collaboration should be promoted to make full use of the rich traditional Chinese medicine and botanical resources of our country;Thirdly,we must raise the utiliztion rate of the existing patent information about compound traditional Chinese medicine for children,then analysize,process and optimize(such as group addition and subtraction and dosage form improvement)the patents which are already in existence.With the hope that these measures would accelerate the development of the children's Chinese patent medicine market in future.