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Study On Quality Standard Of Puerariae Dispensing Granules

Posted on:2019-03-28Degree:MasterType:Thesis
Country:ChinaCandidate:T T JiFull Text:PDF
GTID:2404330545467169Subject:Pharmacy
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Purpose:1.Decoction pieces source can be preliminarily drafted by researching based on these experiments for the preparation of puerariae dispensing granules.2.What can also be drafted include the paste-forming rate,the metastasis rate and the fingerprints range of puerariae dispensing granules and puerariae standard decoction.3.Furthermore,the intermediate paste-forming rate,the content limit and the fingerprint of puerariae dispensing granules can be drafted as well.4.The production preparation and quality standard for puerariae dispensing can be made correspondingly.Method:1.Applying Moisture content,ash content and extract determination to puerariae decoction pieces measurement according to CP puerariae entry,2015 version.Checking the moisture and the size range of puerariae dispensing granules according to CP granules entry,2015 version.2.Freeze drying and vacuum drying should be respectively used for puerariae standard decoction and dry extract of puerariae intermediate to investigate paste-forming rate.Optimal method for puerariae extraction should be established by orthogonal experiment.3.TLC may be used in identifying puerariae decoction pieces and puerariae dispensing granules from different batches and resources.4.Another method,HPLC can be used in content determination of mainly effective components for puerariae decoction pieces,puerariae standard decoction,dry extract of puerariae intermediate and puerariae dispensing granule.Meanwhile,HPLC is also adopted in fingerprint determination of puerariae standard decoction,dry extract of puerariae intermediate and puerariae dispensing granule.Results:1.For 15 different batches of puerariae decoction pieces from different producing area,all test results meet the requirement of CP,2015 version,including TLC identification,moisture,ashes,extract and puerarin content.Overall quality is quite good for puerarin content is all higher than 2.4%,but puerarin content difference is significant among different batches from various producing area.2.For 15 batches of puerariae standard decoction:Puerarin content varies from 1.264% to 2.595%;Paste-forming rate varies from 11.92% to 28.90%(or 14.29%-26.53%);Metastasis rate range varies from 34.13% to 63.41%(or 34.14%-63.40%);Fingerprint has puerariae(peak 4)as its S-peak,and the specified value of relative retention time at 10 characteristic peaks are listed as following: 0.3349(peak 1)、0.4635(peak 2)、0.5514(peak 3)、1(peak 4)、1.1744(peak 5)、1.3750(peak 6)、1.6859(peak 7)、1.9544(peak 8)、2.2169(peak 9)、2.6670(peak 10).3.The extract optimization scheme for puerariae decoction pieces is: immerse for0.5h,then extract 3 times,add 11 times amount water every time,then decoct for 1h.According to this scheme,paste-forming rate of 15 batches of puerariae decoction pieces varies from 24.79% to 38.47%,the average value is 32.77%.Puerariae metastasis rate varies from 55.087% to 85.450%,its average value is 1.361%.Both of them are higher than standard value.Puerariae content has a various region of7.502%-10.135 and its average value is 8.967%.4.The appearance,identification,particle size and moisture inspection of 15 batches of puerariae dispensing granules are all accord with CP 2015 version.Puerariae content varies between 4.717% and 6.628% with an average value of5.796%.Fingerprint has puerariae(peak 4)as its S-peak,and the relative retention time at 10 characteristic peaks has met the RSDS requirement of CP,which is ±5% less than specified valueConclusion:The research preliminarily establishes a quality investigation system for puerariae standard decoction,dry extract of puerariae intermediate and puerariae dispensing granules.Further more,the research provides all of them a quality standard range.It also gives a certain guidance for the perfection of puerariae dispensing granules quality standard.
Keywords/Search Tags:puerariae, dispensing granule, puerarin, content determination, high performance liquid chromatography, fingerprint, quality standard
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