Betel Nut And Its Compound Safety Analysis And Detection Of Fatty Acid Impurities In Tween 80 From Different Manufacturers

In recent years,the adverse reaction of traditional Chinese medicine have occurred frequently.The compound of Chinese medicine determines the complexity of its toxicity effects and toxicity mechanism,the specificity of its safety evaluation,so the conclusion only inferred by composition,target,case neither objective nor scientific.The compatibility theory and medication principle of traditional Chinese medicine is an important reference of "efficiency attenuated" safe and effective to itself and its preparation.So,around the "mix of attenuated role",proceed from the clinical and production needs,the subject selecting four kinds of traditional Chinese medicine and related preparations as the representative,include Radix Sophorae Tonkinensis,Arecae semen,Polygonum cuspidatum,Eucommia ulmoides.Establishing a Chinese medicine risk signal mining system combine computer-aided and artificial,Improving the existing database to develop package,Constructing a network evaluation and research system based on bioinformatics technology.Traditional Chinese medicine Arecae semen is dried seed of Areca catechu L.,which have the effect of insecticide,consumer product,line gas,has been widely used in the treatment of.teniasis.The International Agency for Research on Cancer(IRAC)confirmed chewing betel nut can lead to oral cancer and identified Arecae semen as a carcinogen in 2003.Arecae semen was pushed to the cusp once again in 2013 after the "Hansen Si Mo Tang"event.The safe of Arecae semen has become a hot topic of concern.This article mainly research the Arecae semen and its preparation,the main work is as follows:1.Summarizing and analyzing the toxicity and medication risk factors of Arecae semen recorded in 67 ancient herb literatures,and proposed that more attention shall be given to the effect of the origins and the compatibility on the components and toxicity of Arecae semen in safety studies,which provides clues for the further studies.2.Collecting the adverse event report of Arecae semen and Arecae semen preparations by the China national knowledge infrastructure(CNKI),and explored the relationships between them.We find the aqueous extract of Arecae semen and arecoline can cause cancer and mutation,and had reproduction toxicity and neurotoxicity.There has possibility of side effects during processing and eating,which should be regulated.And the processing technology,usage,dosage,etc between Arecae semen for eating and Medicinal are different,which should be treated different.So there have no direct evidence for Arecae semen can cause cancer but does not rule out the possibility.Great care should be required in clinical application of Arecae semen.3.Collecting the adverse event report of 190 kinds of Arecae semen preparations by the National Adverse Reaction Monitoring Center,and their existing standards,composition,effect,taboo.Rough analyzing the varieties which has more adverse reactions reports,then combining the result with ancient herb literatures and modern literature,at last choosing a variety.Analyzing its adverse events/events reported,specification,Periodic Safety Update Reports for Marketed Drugs(PSUR),enterprise report information comprehensively.Compiling product safety assessment and risk management recommendations technical report in the end.Traditional chinese medicine injections is unique to our country,has been widely used in clinical disease treatment due to the high bioavailability and fast response.In recent years with the wide application of traditional Chinese medicine injection,Adverse event report(ADR)increased year by year,The safety of Chinese medicine injections has become an unprecedented concern.There are many factors that affect the safety of Chinese medicine injections such as raw materials,accessories,production technology,quality control,irrational drug use in clinical.As the "source" of the commonly used accessories,Tween-80(Polysorbate80)obviously relevant between the emergence of adverse reactions.And the sensitization of Tween 80 is not entirely related with the product itself,but with the product quality,especially with its impurity content.The purity of the raw material oleic acid directly determines the composition of the fatty acid impurities.Therefore,this article focuses on the fatty acid impurities in oleic acid,the main work is as follows:1.This paper summarizes the research status of traditional Chinese medicine injections and their adverse reactions,and the research status of Polysorbate80.2.GC determination contact of 7 Fatty Acids in Polysorbate80 from 8 different manufacturers.By measuring the fatty acid composition,in order to identify their quality.PEG20000(GsBP-INOWAX,30 m×0.53 mm×1.0?m)capillary column was used.Using temperature programmed,the initial temperature is 90? and keep for 25min,raising to 160?at 20?·min-1 and keep 1 min,then raising to 220?at 2? ·min-1 and keep 20 min;injection port temperature of GC was set at 190 ?,detector temperature was set at 250?.The detector was FID using nitrogen as carrier gas,which follow is lml·min-1.In this chapter the method of precision,reproducibility,sample stability were investigated,and the results were satisfactory,indicating that the precision of the method,reproducibility were well,and the samples remained stable within 16 hours.