Study On The Quality Standards And Commercial Specification Grade Of Farfarae Flos

BACKGROUND: Farfarae Flos is the dry flower buds of Tussilago farfara L.of the family Compositae.It has the effect in moistening lung to lower qi and in curing cough and reducing phlegm.It is used principally in clinical for the treatment of cough,asthma,acute or chronic bronchitis and other diseases.According the survey,Flos Farfaraes is the main cultivars varieties produced from Gansu province in the marketplace.In addition,Hebei and Inner Mongolia are also cultivated.There are no unified Pieces quality standards in Flos Farfaraes according to the consumable market’s price analysis.Now,the price for Flos Farfaraes was set down based on the proportion of non-medicinal parts,such as pedicels or rhizomes,etc.This creates problems about the quality of Flos Farfaraes circulated in the market,but current Chinese pharmacopoeia has a certain limitations in evaluation the quality of Flos Farfaraes by the content of its exclusive component.It is impossible to reflect the quality of the medicinal materials,and even to divide the quality category classification.It cannot meet the demands of the present market in Chinese medicinal materials grade division according to the 76 kinds of commercial specifications standard for medicinal materials promulgated by the Ministry of Public Health and the State Administration for Medicine in 1984.Thus,the corresponding methods of determining content were built and the limits of content were determined about the active ingredients of Flos farfarae from the market research specific actual circumstances.At the same times,the fingerprints and specific chromatogram of Flos farfarae were established for completely effective quality control and supplemented the check items about the Chinese pharmacopoeia.Moreover,the market standard of Flos farfarae was preliminary studied.The completely effective quality control and grade dividing were used to guide the development of market.OBJECTIVE:(1)On the basis of the Chinese pharmacopoeia stand ard,the quality standard of Flos farfarae was improved and established a f oundation for industry standards of Flos farfarae.(2)The market conditions were analysized and established a foundation f or the grade dividing standards of Flos farfarae.METHOD:(1)The bioactive parts of Flos farfarae were screened by using "knock-out/in" of targeting ingredients based on the Relieving Cough and Expectorant Effects in mice,which was combined with the chemical composition analysis to identify the represent components.(2)Through analysis of a large number of samples,the method for the determination of Flos farfarae was established to create a rational content limit.(3)The HPLC-UV,similarity evaluation,clustering analysis and the multivariate statistical analysis were used to establish the fingerprints of FarfaraeFlos.(4)The check items of Flos farfarae in Chinese pharmacopoeia of the 2015 Edition were analyzed to make reasonable limit.(5)The current grade dividing standards of Flos farfarae were revised and based on market research.RESULTS:(1)The results of the knock-in the active parts and its pharmacology showed that the component of chlorogenic acid belong to Caffeoyl quinic acid from n-butanol phase is the major bioactive components.(2)The determination results of Flos farfarae showed that the limit of chlorogenic acid content is 0.800% based on the method of National Handbook for drug work.Through analysis of the different producing areas and different preservation time showed that the content of chlorogenic acid and tussilagone was higher in Shanxi province than others.In general,there are few differences between the Hebei province and the Gansu province.Furthermore,the contents of chlorogenic acid and tussilagone in the latest collection of medicinal materials were higher than the storaged for four years.But at the same time,the content of tussilagone was decreased obviously with the growth of storage time.(3)The results of fingerprints showed that there are good consistency in the similarity analysis,cluster analysis and multivariate statistical analysis in different habitats.Furthermore,the result of cluster analysis and multivariate statistical analysis showed that storage time has more serious influence than different habitats in chemical composition of Flos farfarae,but it need to be further studied and analyzed.(4)There was not check items of water content and ash content of Flos farfarae in Chinese pharmacopoeia of the 2015.The result in the inspecting limit of water content and total ashes showed that there should be not exceed 13% and 11.0%.(5)The grade dividing standards of Flos farfarae were formulated by characteristics,the ratio of pedicel to bud,water content,milden and rot,and so on.It was divided into the gradeless and uniformly-priced goods while the pedicel accounted for 40%~70% for all goods and buds.If the proportion of pedicel is more than 70%,which was divided into selected goods.CONCLUSION: In this study,the fingerprints of Flos farfarae was established and used extensively for quality control.We also supplemented the check items of water content and ash content and established the completely effective quality standards and the grade dividing standards,which was used to guide the development of market.