Quality Research Of Shu Gan Li Dan Zhong Yao Tang Ji

ObjectiveShu Gan Li Dan Zhong Yao Tang Ji can be used for treating Gallstone.It has the function of treating Gallstone,Cholecystitis and Jaundice etc.Being shortage of data ofquality control methods,In the thesis,the quality control methods was studied to establish methods ofquality control of Shu Gan Li Dan Zhong Yao Tang Ji.MethodsRP-HPLC methods were developed and validated to determine Baicalin and chlorogenic acid in Shu Gan Li Dan Zhong Yao Tang Ji.TLC methods were developed to identify Radix Scutellariae,Herba Artemisiae Scopariae,Glycyrrhiza uraiensis Fisch in Shu Gan Li Dan Zhong Yao Tang Ji.ResultsDetermination of Baicalin in the chromatographic conditions:Column:Hypersil ODS₂ column(250rnm×4.6mm,5um);Mobile phase:methano1-water-phosphoric acid (47:53:0.2);Column Temperature:25℃;A flow rate of 1.0 ml·min^-1;Detection wavelength 280nm;Injection volume 20μl.The linear ranges was 0.21-21μg·m1^-1(r=0.9999) and the recovery was 100.3%(RSD=1.40%).Determination of chlorogenic acid in the chromatographic conditions:Column:Hypersil ODS2 (250mm×4.6mm,5μrn);Mobile phase was methanol-water-phosphoric acid(13:87:0.4); A flow rate of 1 ml-min^-1;Column temperature 25℃;Detection wavelength 327nm; Injection volume 20μl.The linear ranges were 0.19375-15.5μg·ml^-1(r=0.9999) and the recovery were 102.8%(RSD=1.76%).Baicalin identification using Polyamide thin-layer chromatography plate(10cm×10cm),the mobile phase was toluene-ethyl acetate-methanol-formic acid(10:3:1:2). Capillaris identification using silica gel G thin-layer chromatography plate(10cm×20cm),the mobile phase was petroleum ether(60-90℃)-ethyl acetate-acetone(12:6:2). Glycyrrhizic identification using silica gel G thin-layer chromatography plate(10cm×20cm),a mobile phase of chloroform-methanol-water(13:6:2),Reagent alcohol for 10%sulfuric acid solution.ConclusionsThe HPLC methods were established in line with the quantitative analysis of the requirements.The TLC methods were established in line with the quantitative analysis of the requirements.They can be used for quality control of Shu Gan Li Dan Zhong Yao Tang Ji.