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Study On The Preparing Technique And Quality Standard Of Sangju Oral Liquid

Posted on:2013-07-29Degree:MasterType:Thesis
Country:ChinaCandidate:K L PengFull Text:PDF
GTID:2251330428961007Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
objective:We studied and prepared Sangju oral liquid, optimized itspreparation technology, and established the quality standard of Sangju Oral Liquid,researched its stability.Methods:(1) Useing the orthogonal matrix experiment method to drawup thepreparation process route of the compound prescription,which included Mulberry leaf,Wild Chrysanthemum, Forsythia, Liquorice, Bitter almond, Platycodon Grandiflorum,Liquorice and Phragmites Communis7kinds of medicinal, the best process conditionswere screened by using the index such as extracts rate and content of Chlorogenicacid and Phillyrin;(2) In the extraction process of peppermint oil in volatile with mintextracts rate as index, optimized the extraction process;(3) TLC was used for thequalitative identification of Mulberry leaf, Forsythia, Glycyrrhiza uralensis in SangjuOral Liquid. The contents of Chlorogenic acid and Phillyrin were determined byHPLC, established the quality control method of Sangju Oral Liquid.(4) we studiedon its stability through the long-term experiments of product.Results:(1) Confirm the optimal extraction is acceding to eight times waterto distill2h, extracted time is1.5h, and extracting for2time; according to moldingtechnics to confirm preparation. The orthogonal experiment elected volatileconditions for the extraction process mint water added for600mL, extracting time is4h, ultrasonic processing time is90min, soaking time is1.0h;(2)Study on the qualitystandard of Sangju Oral Liquid: TLC indicated that three identified herbs could showthat the Spot separation effect is good.The linear range of Chlorogenic acid and Phillyrin was10~250ng and20~500ng, Y=38.935X+92.628(r=0.9994, n=7,Y=36.064X+159.02(r=0.9998,n=7), the average recovery of Chlorogenic acid andPhillyrin was97.82%and96.63%, RSD was1.33%and1.0%(n=6). Based on themeasured results of batch of samples, a preliminary content criterion was set up, forevery1mL Sangju oral liquid contains chlorogenic acid and forsythia respectively isnot less than0.06mg and0.1mg.(3) study on the stability of Sangju Oral Liquid:Based on the long-term accelerated test results, the oral liquid showed stable qualityin18months, meetting the quality standard of the draft.Conclusions:(1) The results of the optimizated preparation process showed that thepreparation process of Sangju oral liquid is stable, simple, low cost and suitable forindustrial mass production.(2) HPLC method established in the present experiment is simple, accurate,high-sensitivity control to provide some scientific basis for oral solution compoundSangju’s quality standards.
Keywords/Search Tags:Sangju oral liquid, Preparation technology, Quality standard, Phillyrin, Stability
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