RÉSUMÉ
Objective:To study the dissolution behavior of panax notoginseng saponins R1 , ginseng saponin Rg1 and ginseng sapo-nin Rb1 in Xuesaitong soft capsules in two different dissolution media. Methods:The dissolution test conditions were confirmed accord-ing to“quality of medical drugs information set” of Japan and the dissolution media were chosen in accordance with the physicochemi-cal properties of Xuesaitong soft capsules, the in vitro dissolution of Xuesaitong soft capsules was inspected respectively in pH 6. 8 phosphate buffer and water. The dissolution rate was determined by HPLC-ELSD, and the similarity of the release curves for the three components was compared with similarity factors ( f2 ) method. Results: The assay displayed a good linearity over the concentration range of 0. 8-16. 0 mg·L-1(r=0. 999 6), 3. 0-60. 0 mg·L-1(r=0. 999 8) and 4. 0-80. 0 mg·L-1(r=0. 999 7) for panax notog-inseng saponins R1 , ginseng saponin Rg1 and ginseng saponin Rb1 , respectively. In pH 6. 8 phosphate buffer and water, f2 of ginseng saponin Rg1 and ginseng saponin Rb1 were both above 50 when compared with panax notoginseng saponins R1 . Conclusion:The meth-od is simple, accurate and reproducible in the dissolution determination of the soft capsules. The dissolution of ginseng saponin Rg1 and ginseng saponin Rb1 has similar characteristics with that of panax notoginseng saponins R1 in Xuesaitong soft capsules.
RÉSUMÉ
Objective: To establish a dissolution determing method for the two primary ingredients atenolol and nifedipine in YakepingⅡcapsules. Methods:A small glass method was adopted with the rotation rate of 50 r·min-1 . According to the dissolution conditions in Japan “quality of medical drugs information set” with appropriate adjustments in accordance with the actual situation of the samples, different YakepingⅡ capsules were determined by HPLC respectively in pH 1. 2 artificial gastric solution ( containing 0. 5% sodium dodecyl sulfate), pH 4. 0 acetate buffer(containing 0. 5% sodium dodecyl sulfate), pH 6. 8 phosphate buffer(contai-ning 0. 25% sodium dodecyl sulfate) and water(containing 0. 25% sodium dodecyl sulfate). Results:The assay displayed a good lin-earity over the concentration range of 10-30 μg·ml-1 for atenolol and nifedipine(r=0. 999 6 and r=0. 999 8), and the recovery of the two components in the different medium was 99. 64%(RSD=0. 73%), 99. 55%(RSD=0. 65%), 99. 53%(RSD=0. 47%)and 99.54% (RSD=0.51%), 99.52%(RSD=0.67%), 99.52%(RSD=0.72%), 99.51%(RSD=0.63%)and 99.61%(RSD=0. 59%)(n=9). The dissolution of different batches of YakepingⅡcapsules in the four media showed the similar behavior. Conclu-sion:The method is simple, accurate and reproducible in the dissolution determination of atenolol and nifedipine in YakepingⅡ cap-sules.