The Study On Quality Standard Of Biyan Tablets

Biyan tablet is recorded in Chinese Pharmacopoeia,it is helpful to cure chronic non-specific inflammation and allergic inflammation.The existing quality standards Biyan tablet is too simple to meet the requirements of modern traditional Chinese medicine quality control.The paper made systematic study on the quality standard for the Biyan tablet and established reasonal methods of analysis.The whole technological process were simple and rapid which can be used for quality control of the medicine.Method:Uses the thin-layer chromatography to carry on the qualitative distinction of three medicinal materials in the preparation.Radix Glycyrrhizae:a silica gel G plate was adopted with developing solvent consisted of Chloroform,Acetone and Ammonia(2:7:1),an alcoholic solution of sulfuric acid(10%) was used as colouring agent,inspected at sunlight. Saposhnikovia divaricata:a silica gel G plate was adopted with developing solvent consisted of Chloroform and methanol(4:1),an alcoholic solution of sulfuric acid(10%) was used as colouring agent,inspected at 365nm.Fructus Xanthii:a silica gel GF254 plate was adopted with developing solvent consisted of Cyclohexane,ethyl acetate and formic acid(1:3:0.2),inspected at 254 nm.Taking prim-O-glucosylcimifugin as the target,A reversed-phase high performance liquid chromatography method was developed to determine Saposhnikovia divaricata in the preparation.A Diamonsil C₁₈column(4.6*250mm, 5μm) was used.The mobile phase was consisted of methanol,acetonitrile and water(18:12:70),detected at 254nm,the velocity of flow was 1.Oml.min^-1, temperature of the column was Room' s temperature.Taking 4' -O-β-D-glucosyl -5-O-methylvisamminol as the target,A reversed-phase high performance liquid chromatography method was developed to determine Saposhnikovia divaricata in the preparation.A Diamonsil C₁₈ column(4.6*250mm,5μm) was used.The mobile phase was consisted of methanol,acetonitrile and 5%acetic acid(13:12:75) ,detected at 254nm,the velocity of flow was 1.Oml.min^-1,temperature of the column was Room' s temperature.Result:In the identification,the sample displayed the same spotes or fluorescence spots as the reference substance did in the Chromatography,while the negative sample did not.In the essay,the liner ranges of prim-O-glucosylcimifugin was 0.118-2.360μg,liner regression equation was Y=24.736X+0.7825,r=0.9998.The RSD of precision was less than 3%,of repeatability was less than 3%,of recovery was less than 3%.The sample solution was stable within 12 hours(RSD=1.58%).The content of prim-O-glucosylcimifugin was can be determined by this method in the concentration of 3.9-28.4μg/ml;The liner ranges of 4' -O-β-D-Glucosyl -5-0-methylvisamminol was 0.102 - 2.040μg,liner regression equation was Y=29.379X+0.6648,r=0.9997.The RSD of precision was less than 3%,of repeata bility was less than 3%,of recovery was less than 3%.The sample solution was stable within 12 hours(RSD=1.52%).The content of 4' -O-β-D-glucosyl-5-O -methylvisamminol was can be determined by this method in the concentration of 5.7-42.2μg/ml.Conclusion:The TLC methods for identification and HPLC method for assay have been developed and validated.The methods are simple,rapid,specific,sensitive and accurate.