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目的:建立自身对照法测定复方黄连素片溶出度。方法:采用自身对照法(UV)测定复方黄连素片的溶出度。采用篮法,溶出介质为纯化水(900 mL),转速100 r.min-1,取样时间90 min。结果:复方黄连素片溶出度测定自身对照法在1.2～9.0μg.mL-1浓度范围内呈线性(r=0.9995,n=5),回收率98.9%,RSD=0.03%。结论:本法简便、准确、可行,可作为复方黄连素片的质量标准中控制项目之一。
Objective: To establish a self-control method for the determination of compound berberine tablets dissolution. Methods: The dissolution of compound berberine tablets was determined by self-contrast method (UV). The basket method was used. The dissolution medium was purified water (900 mL), the speed of rotation was 100 r.min-1 and the sampling time was 90 min. Results: The dissolution of compound berberine tablets was linear in the concentration range of 1.2-9.0μg.mL-1 (r = 0.9995, n = 5). The recoveries were 98.9% and the RSD was 0.03%. Conclusion: This method is simple, accurate and feasible and can be used as one of the control items in the quality standard of compound berberine tablets.