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目的:建立黄杨宁分散片溶出度的测定方法,为质量控制提供方法和参数。方法:以磷酸盐缓冲液为溶出介质,转速为100r·min-1,照分光光度法在410nm处测定吸光度,计算每片的溶出量。结果:3批黄杨宁分散片的溶出度基本一致,45min累积百分溶出总量均能达到中国药典2005年版中规定的释放标示量的70%,重复性良好。结论:所用方法具有灵敏、准确的优点,可较好地控制黄杨宁分散片的质量。
Objective: To establish a method for the determination of dissolution of Huangyangning dispersible tablets, and provide methods and parameters for quality control. Methods: Phosphate buffer solution was used as the dissolution medium and the rotation speed was 100 r·min-1. The absorbance at 410 nm was measured by spectrophotometry to calculate the dissolution amount of each tablet. Results: The dissolution of three batches of Huangyangning dispersible tablets was basically the same, and the total dissolution amount of 45 minutes could reach 70% of the release label amount specified in the 2005 edition of the Chinese Pharmacopoeia, and the repeatability was good. Conclusion: The method used has the advantages of sensitivity and accuracy, and can better control the quality of Huangyangning dispersible tablets.