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Study On The Improvement Of Hospital Preparation Rutongan Oral Liquid Quality Control Based On Content Determination

Posted on:2018-04-03Degree:MasterType:Thesis
Country:ChinaCandidate:X P TaiFull Text:PDF
GTID:2321330542454136Subject:Pharmaceutical engineering
Abstract/Summary:PDF Full Text Request
In the development of traditional Chinese medicine,the quality control of it is one of the key problems.With the current situation of globalization,Chinese herbal medicine goes abroad to the world is the inevitable trend in the future.In order to gain a foothold in the global medicine industry,Chinese herbal medicine quality evaluation methods must be improved.Using modern analytical techniques and methods to identify the characters and content of traditional Chinese medicine has been widely used in quality control of traditional Chinese medicine and product.Hospital prescriptions derived from classic prescriptions of TCM are widely available,but their quality standards often differ greatly from the quality standards of modern Chinese medicine preparations and are in urgent need of improvement and improvement.In this study,aimed at the lack of content determination in the existing quality standards of the hospital preparations Rutongan oral liquid only for identification,high performance liquid chromatography was used to measure the content of hospital preparation of Routongan oral liquid so as to further improve the existing quality evaluation methods.At the same time,the feasibility of near-infrared spectroscopy(NIR)analysis for the rapid determination of the main components in the Ruotongan oral liquid was analyzed in order to expand the quality control range of Rutongan oral liquid and apply it to the real-time of the main components in the production process monitoring,in order to provide reference for ensure product quality controllable.This study mainly involves the following two major contents:(1)Determination of the content of three main components of caffeic acid,rosemarinic acid and forsythin in Rutongan oral liquid by HPLC.The chromatograPHic conditions of caffeic acid and rosmarinic acid were 0.2%formic acid and methanol gradient elution,and the chromatograPHic condition of forsythin was acetonitrile:water(25:75).The liner correlation coefficients of three kinds of components reached more than 0.9999.The RSD value of stability test,precision test and sample recovery rate is less than 2%,which indicate that the HPLC method is stable and reliable,it can be used for the determination of main components in the Rutongan oral liquid of milk pain,and to provide reference for improving the quality standard.(2)The partial least squares quantitative analysis models for determination three main components of caffeic acid,rosemarinic acid and forsythin glycoside in Rutongan oral liquid were established by Near-infrared spectroscopy.Using MicroNIR1700 with transmission module to collect the spectral of Rutongan oral liquid,and the HPLC method is the reference datas.The samples need to be divided into calibration and validation sets while the spectral needs to be pretreated and selected the interval for modeling.The values of RMSEC?RMSEP?Rc?Rp were used to evaluate the established model.Finally,the evaluation parameters of the model were as follows:caffeic acid RMESC=0.873 pg/ml,RMESP=0.686 ?g/ml,RC=0.9852,RP=0.9899;rosemarinic acid RMSEC= 2.40 ?g/ml,RMSEP=2.87 ?g/ml,Rc=0.9810,RP=0.9839;forsythin RMSEC=0.00528 mg/ml,RMSEP=0.00697 mg/ml,RC=0.9856,RP=0.9823.These models are good and can be used for rapid determination of three main components in Rutongan oral liquid.The above results show that the HPLC method can be used to determine the content of the main components in Rutongan oral liquid,which can be included in the quality standard to improve the quality of the existing quality standard of Rutongan and improve the products ' efficacy.
Keywords/Search Tags:Rutongan oral liquid, quality evaluation, High performance liquid chromatograPHy, Near-infrared spectroscopy technology
PDF Full Text Request
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