Studies On Preparation Process And Quality Assessment Methods Of Dingkun Capsule And Tablet

Dingkun capsule and tablet are processed from Dingkun pill, which is composed of 27 kinds of Traditional Chinese Medicine.This paper is about the first assay of several contents(ginsenoside Re, ginsenoside Rb₁,paeoniflorin and baicalin)in Dingkun pill, and the preparation process and quality assessment of Dingkun capsule and tablet.(1) The ginsenoside Re and ginsenoside Rb₁ in the 9 batches of Dingkun pill from 3 different companies were simultaneously analyzed. The chromatographic condition included a Kromasil C₁₈ column (250 mm×4.6 mm i.d., 5 μm) and the gradient elution with acetonitrile and 0.025% phosphate acid solution and the detection wavelength was 203 nm.The calibration curve was linear over the range of 4.62～46.2 μg·mL^-1 (ginsenoside Re) with the correlation coefficient 0.9999 (n = 5) ,and 8.22～82.2 μg·mL^-1 (ginsenoside Rb₁) with the correlation coefficient 0.9998 (n = 5).The mean recoveries were 98.3%(RSD = 1.9%)and 100.1%(RSD = 1.9%)respectively. This method can be used in the quality control of Dingkun pill with satisfactory accuracy and reproducibility.(2) The paeoniflorin in the 9 batches of Dingkun pill from 3 different companies was analyzed. The chromatographic condition included a Kromasil C_<sub>18 column (250 mm×4.6mm i.d.,5 μm) and the gradient elution with acetonitrile and water and the detection wavelength was 230 nm.The calibration curve was linear over the range of 3.664～36.64 μg·mL^-1 with the correlation coefficient 0.9997 (n = 5) .The mean recoveries were 99.6% (RSD=1.0%) .This method was found to be simple and can be used in the quality control of Dingkun pill with satisfactory accuracy and reproducibility.(3) The baicalin in the 9 batches of Dingkun pill from 3 different companies was analyzed. The chromatographic condition included a Kromasil C₁₈ column (250 mm×4.6mm i.d.,5 μm) and acetonitrile-water-phosphate acid (29 : 71 : 0.05) and the absorbance was monitored at 280 nm. The calibration curve was linear over the range of 5.54～55.4 μg·mL^-1 with the correlation coefficient 0.9999 (n = 5 ) .The mean recoveries were 97.8% (RSD = 1.7%) . This method was...