Quality standard for Kudingcha Tablets / 中成药

ABSTRACT

AIM: To establish a quality standard for Kudingcha Tablets(Cratoxylum Prunifolium Dyer). METHODS: TLC was adopted for identification of Kudingcha Tablets.RP-HPLC was used to determine the contents of ursolic acid,quercetin and kaempferol in the preparation.The Nova-Pak C_(18) column(3.9 mm?150 mm,4.0 ?m) was used to determine the ursolic acid of content.The mobile phase was methanol-water-H_3PO_4(85∶15∶0.1).The detection wavelength was at 220 nm.The flow rate was 0.8 mL/min and the temperature was at 30 ℃.The Nova-Pak C_(18) column(3.9 mm?300 mm,4.0 ?m) was used to determine the contents of quercetin and kaempferol.The mobile phase was methanol-0.4%H_3PO_4(5050).The detection wavelength was at 360 nm.The flow rate was 0.7 mL/min.The temperature was at 40 ℃. RESULTS: A good linear relation was obtained when the sample size of ursolic acid was in the range of 0.334-6.672 ?g.The linear range of quercetin was(0.012 99-0.649 6) ?g and the linear range of kaempferol was 0.013 34-0.667 2 ?g.The average recoveries of ursolic acid,quercetin and kaempferol were 97.70%,96.89% and 97.41%,respectively.The RSD were 0.87%,(1.06%) and 1.40%(n=6),respectively. CONCLUSION: This standard is accurate and reliable,and can effectively control the quality of Kudingcha Tablets.