Total Glucosides Of Paeony Study On Preparation And Quality Control Of Sichuan

Chishao,which is recorded in the 2005 edition of Chinese Pharmacopoeia,is the dry root of Paeonia laetiflora Pall.or Paeonia veitchii Lynch.It has many efficacy,such as:removing pathogenic heat from the blood,dissipating blood stasis and relieving pain.TPG,total paeony glycoside of Chishao,provides extensive pharmacologic activities,such as anticoagulation and antithrombosis,protecting heart and brain,anti-tumor.So TPG can be used as the treatment of cardiovascular disease drug material.With cardiovascular disease rates increase,TPG as raw material has broad market prospects.Now many companies have production.TPG currently have no national standards and industry standards.As extracts quality influenced by the source of medicine,the preparation process,quality analysis and other factors,TPG quality is not uniform.TPG is more from the dry root of Paeonia laetiflora Pall.,but few from Paeonia veitchii Lynch.Chuan Chishao,the dry root of Paeonia veitchii Lynch.,is the famous medicine of sichuan.In this paper,studied on the Chuan Chishao TPG extraction and purification technology and quality control,which lays the foundation to establish the medicine,TPG quality standards and Chuan Chishao TPG production processes,at the same time to evaluate the efficacy of TPG from different species.The research in the development of Sichuan medicineis significant.The study and the experimental results are as follows:1.Study on the Chuan Chishao quality controlAs Chishao in Sichuan province is from many species of plant,used content of paeoniflorin and chromatographic footprint to investigate Chuan Chishao.Choosing 15 batches of crude medicine with stable content of paeoniflorin,Studied the Chuan Chishao HPLC fingerprint.The condition is as follow:Acetonitrile-phosphate solution (pH=2.7) as a mobile phase gradient elution,the detection wavelength 230 nm,50 minutes to analyze.After validation,the method of fingerprinting is with the request of fingerprinting technology.Used the chromatographic fingerprint evaluation system (2004 A version) issued by national Pharmacopoeia Commission to analyze and compare the standard Chuan Chishao and Chishao HPLC fingerprints,and those similarity was below 0.6,which shows that HPLC fingerprint can be used to distinguish between the two species of Chishao.Used the standard Chuan Chishao as reference to analyze and compare 15 batches of crude medicine HPLC fingerprint.Apart from two batches,the remaining 13 batches of crude medicine similarity is greater than 0.9,which shows 13 batches of crude medicine from Paeonia veitchii Lynch..Used the above of 13 batches to establish the Chuan Chishao standard HPLC fingerprint with paeoniflorin as reference, which Calibrated 17 common peaks,the ratio of common peaks area and reservation time are all coincident with the request of fingerprinting technology.2.Study on extraction and purification of Chuan Chishao TPG.In extraction process,the optimum extraction technology was selected with the experiment.The optimum extraction process is as follows:adding 8 times of 70% ethanol,extract 3 times,1.5hour for each time.In purification process:firstly,selected the patterns of macroporous resin; secondly,studied the adsorption capability of macroporous resin.Thirdly,studied the elution process of macroporous resin.The result indicates that the optimum purification process is as follows:D101 macroporous adsorption resin,Diameter to alttitude 1.5/16,medicine liquid concentration 0.1g/ml,flow rate 3ml/min.Using elution ratio as the marker,the optimum elution method is as follows:eluted with 6BVdistilled water,5BV 30%ethanol in turn,flow rate 3BV/min.The purified PTG was collected in 30%ethanol eluting solvent.Using paeoniflorin content as a marker, the optimum concentrating and spray drying process is as follows:medicine liquid relative density 1.15 and temperature 50℃,entrance temperature 140℃,exit temperature 90℃.The preparation process is simple and easy to control,with the content of average paeoniflorin up to 317.45%and the ratio of yield of solids more than 5%。3.Study on method for quality control of Chuan Chishao TPG.Chromatographic footprint,TLC analysis,content of paeoniflorin,the content of water,the content of heavy metal,the content of arsenic salt were investigated to establish a method for Chuan Chishao TPG quality control.Established the TPG standard HPLC fingerprint by using 10 batches of samples,with calibration of the 13 common peaks.The similarity of 10 batches of samples HPLC fingerprints is greater than 0.9.The ratio of common peaks area and reservation time are all coincident with the request of fingerprinting technology.C and TPG is good correlation.By the determination of 10 batches of samples,the average of content of paeoniflorin is greater than 25%,with different batches of stable cotent of paeoniflorin,RSD is 2.48%;With the same the preparation process,contrasted Chishao TPG with Chuan Chishao TPG by HPLC fingerprinting.Those components are different and similarity is less than 0.7,which indicates there is a certain difference in quality.