Studies On Preparation And Quality Control For Arecae Pericarpium

pharmacopoeia standards improve project "quality standards of Arecae Pericarpium"(No.779).Arecae Pericarpium is the dry peels of Areca catechu L.The unripe fruit harvested from winter to next spring,boiled and dried,cut into two vertically,husking,is called "DAFUPI".Harvest the immature fruit from winter to next spring,boiled and dried it,cut it into two vertically,the husked peel is called "DAFUMAO".Both of them are taken as "Arecae Pericarpium”in Ch.p.The functions of "Arecae Pericarpium "are regulating the flow of qi and warming middle-jiao,resolving dampness by transporting the water in the body.Arecae Pericarpium has been used to cure retention of dampness,stagnation of qi,epigastric distension and depression in China more than 1000 years.Recently,it has been discussed with much interest by the designers who try to discovery new drugs to regulate gastrointestinal motility with fewer side effects and efficiently.It has been contained in various editions of Ch.p.However,there are only the properties,micrograph and TLC spectrum and the limit standards of moisture in 2010 Ch.p.,no exclusive identification or objective quality control index,the level of quality standard is very low.Our market survey informs that the nut shell is used as Arecae Pericarpium in clinic,which doesn't meet the requirement of cutting in Ch.p.The results are uneven quality of Arecae Pericarpium or its decoction pieces.All of these are disadvantageous for clinical application or preparation.So it's considerable realistic significance to study the method to improve the quality level of Arecae Pericarpium,perfect its preparation technology.This paper builds quality standard of Arecae Pericarpium by studying its herbs,prepared products of pilot products and commercial samples,increases identification of TLC spectrum,the limit standards of moisture,total ash and the extract content,establishes the method of quantitative analysis of multi-components by single-marker(QAMS)to determinate alkaloids in Arecae Pericarpium and HPLC fingerprints,A scientific,feasible draft for Quality standards of Arecae Pericarpium are made.Meanwhile,stability of alkaloids is studied,storage methods cutting process optimization.Research and findings are as follows:1 Quality standard research on Arecae PericarpiumAccording to the technical requirements of the State Pharmacopoeia Commission for the study of traditional Chinese medicine quality standards,12 batches DAFUPI and 8 batches for different sources of the country have been studied systematically.The properties,discrimination,examination and content determination of them were added.The moisture content of herbs must not be more than 13%;updating the TLC items,The total ash of the herbs must be less than 6.0%,the acid insoluble ash must be less than 2.2%,the extract content of DAFUPI must be more than 15.0%,and DAFUMAO,more than 8.0%;Arecae content of DAFUPI must be more than 0.15%,DAFUMAO may not be detect,updat the HPLC fingerprint of alkaloids in Arecae Pericarpium.Based on these studies,exploratory study of method to measure 4 alkaloids(arecoline,arecaidine,guvacoline and guvacine)in Arecae Pericarpium by quantitative analysis of multi-components by single-marker(QAMS).Arecoline is taken as an internal correction factor,for it is cheap and easy to get.The correction factor durability study met the technical requirements of QAMS.The relative retention time of different columns in the same HPLC is very different,but it meets the technology requirements of QAMS when chromatographic peak of analyte are positioned.These relate with the nature of strong cation exchange column packed with silica filler bonding.Thermo column is picked on study the method to position the peak of analyte,for the preferred resolution and peak shape are better.The brand must be same when alkaloids in Arecae Pericarpium are defined by QAMS method.These results provide reference for the research of QAMS method with larger peaks positioned difference.The study is to improve the level of quality control Arecae made reasonable parameters and indicators.2 Quality stability research of Arecae PericarpiumSince main alkaloid alkaloids in Arecae Pericarpium are small molecule and volatile,the stability is inspected.Three different packages Arecae Pericarpium(open packaging,not in addition to air sealing plastic packaging,in addition to air sealing plastic packaging)had been conserved in the condition of temperature of 40?± 2?,relative humidity of 75%± 5%for 3 months,and the quality was reviewed according to quality standard at the zero,the first,the second,the third month.And the same three batches of Arecae Pericarpium had been conserved in natural for 3 months too.Their quality was reviewed at the zero,the first,the second and the third month according to quality standard.The results of quality stability research indicated that Arecae Pericarpium could be conserved about 3 months.3 Processing technology research of Arecae PericarpiumOrthogonal design was used with three factors:cut width,drying temperature and time.Four alkaloids in Arecae Pericarpium were determined by HPLC.Technology was satisfied with the conditions as the following:cut width,1.0 cm;drying temperature,50?;drying time,2.5 h.