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目的:建立龙甘胃舒分散片溶出度的测定方法。方法:采用高效液相色谱法,以龙胆苦苷为指标,测定龙甘胃舒分散片在不同介质及不同溶出时间点的溶出度。结果:采用桨法测定,以水100mL为溶出介质,转速为100 r/m in。以龙胆苦苷为对照品计算累积溶出率,龙胆苦苷在16.2~324μg/mL的范围内,浓度与其峰面积呈良好线性关系,平均回收率99.92%,RSD=1.92%,溶出度测定结果显示45m in时均大于80%。结论:该溶出度测定法稳定,结果可靠。
Objective: To establish a method for the determination of dissolution of Longgan Weishu Dispersible Tablets. Methods: The dissolution rate of Longgan Weishu dispersible tablets in different media and at different dissolution time points was determined by high performance liquid chromatography and gentiopicrin as indicators. Results: Using a paddle method, 100 mL of water was used as the dissolution medium. The speed was 100 r/min. The cumulative dissolution rate was calculated with gentiopicrin as the reference substance. Within the range of 16.2 to 324 μg/mL, the gentiopicroside was in a good linear relationship with the peak area. The average recovery rate was 99.92%, RSD was 1.92%, and the dissolution was measured. The results showed that all were greater than 80% at 45m in. Conclusion: The dissolution assay is stable and reliable.