尿塞通糖衣片、薄膜衣片的体外溶出度考察

Study on in Vitro Dissolution Rate of Niaosaitong Sugar-coated Tablets and Film-coated Tablets

目的 :通过对不同批号的尿塞通片溶出速率的测定 ,考察其质量。方法 :转篮法 ,用紫外分光光度法测定累积溶出百分率 ,提取溶出参数 ,并对参数进行相关性研究。结果 :经过统计学处理 ,薄膜衣片和糖衣片溶出参数 (T50 )有极显著性差异 ,45分钟薄膜衣片累积溶出百分率在 90 %以上 ,糖衣片仅有 49- 78%。结论 :尿塞通薄膜衣片比糖衣片具有较好的溶出速率 ,有必要提高尿塞通糖衣片的制剂水平。

Objective:To investigate the quality of Naosaitong Tablets by determing of the dissolution rates of different batches of tablets. Methods: The rotatory-basket method was used. The cumulative dissolution percentage was determined by UV. The dissolution parameters were got and their correlation was studied. Results: Statistics indicated there was a significant difference in dissolution parameter (T 50) between film-coated tablets and sugar-coated tablets. The dissolution percentage of film-coated tablets in 45 minutes was over 90%, whereas sugar-coated tablets was only 49-78%. Conclusion: Niaosaitong Film-coated Tablets in superior to its sugar-coated tablets in dissolution rate. It is necessary to improve the quality of Niaosationg Sugar-coated Tablets.