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目的:制备多潘立酮口腔崩解片并对其崩解时限、溶出度、有关物质和含量进行测定。方法:采用直接压片法制备,紫外分光光度法测定其溶出度和含量,HPLC法测定其有关物质。结果:制备的多潘立酮口腔崩解片崩解时间不超过30s,标示含量达到99.45%以上,有关物质在0.10%以下,5min内溶出93%以上。结论:多潘立酮口腔崩解片制备过程简单,质量可控,适用于工业大生产。
OBJECTIVE: To prepare domperidone orally disintegrating tablets and determine its disintegration time, dissolution, related substances and contents. Methods: The tablets were prepared by direct compression method. The dissolution and content were determined by ultraviolet spectrophotometry. The related substances were determined by HPLC. Results: The disintegration time of domperidone orally disintegrating tablets was not more than 30s, the content of labeled product was over 99.45%, the related substances were below 0.10%, and the overdispersion of over 93% was over 5 minutes. Conclusion: The preparation process of domperidone orally disintegrating tablets is simple and its quality is controllable. It is suitable for large-scale industrial production.