Studies On Extraction Process And Quality Standards Of Bixiefenqing Capsule And Tablet

Bixiefenqing capsule and tablet, which are composed of Rhizoma Dioscoreae hypoglaucae, Fructus Alpiniae Oxyphyllae, Radix Linderae, Rhizoma Acori Tatarinowii and Radix Glycyrrhizae were investigated on the basis of Bixiefenqing pill. Bixiefenqing pill was reported originally in Danxixinfa as Bixiefenqing san. In the original quality standard of Bixiefenqing pill, no TLC identification and HPLC content determination were conducted. Moreover, due to the pill was directly prepared by the herb powder, large dosage was required. In the present study, the extraction process was optimized and the quality control methods of Bixiefenqing capsule and tablet were developed.(1) HPLC methods were established for the determination of diosgenin and glycyrrhizic acid in Bixiefenqing pill. In the determination of diosgenin, the column was Kromasil KR100-5C₁₈(250 mm×4.6 mm i.d, 5μm). The mobile phase consisted of methanol - acetonitrile (30:70, v/v). The determination wavelength was set at 206 nm and column temperature was room temperature. The calibration curve was linear in the range of 0.123～1.23 mg·mL^-1 of diosgenin with correlation coefficient 0.9998(n = 7). The average recovery of diosgenin was 98.9%, RSD was 0.4%(n = 9). In the determination of glycyrrhizic acid, the column was Kromasil KR100-5C₁₈ (250 mm×4.6 mm i.d, 5μm). The mobil phase consisted of acetonitrile-water-acetic acid (40:60:2, v/v). The determination wavelength was set at 254 nm and column temperature was room temperature. The calibration curve was linear in the range of 0.05～1.0 mg·mL^-1 of glycyrrhizic acid with correlation coefficient 0.9999(n = 7). The average recovery of glycyrrhizic acid was 98.4%, RSD was 1.1%(n = 9). The methods were simple, rapid , veracious and it can...