3个厂家氯沙坦钾片的体外溶出度考察

Investigation on in Vitro Dissolution of Losartan Potassium Tablets Produced by Three Manufacturers

目的考察3个不同厂家生产的氯沙坦钾片的体外溶出度,为临床遴选药品提供参考。方法采用桨法进行体外溶出度试验,以高效液相色谱-紫外分光光度法进行含量测定,计算累积溶出百分率。以威布尔方程拟合溶出参数T50,Td,T80,m,再利用f2相似因子法对3种药物的溶出行为进行分析。结果 3个厂家氯沙坦钾片的溶出度体外均符合2010年版《中国药典(二部)》规定。虽然在30 min内不同厂家氯沙坦钾片溶出行为有差异,但在30 min以内溶出均达到85%以上。结论3种氯沙坦钾片均符合2010年版《中国药典(二部)》对于氯沙坦钾溶出度的规定。

Objective To investigate the in vitro dissolution of Osartan Potassium Tablets produced by three different pharmaceutical factories to provide reference for drug purchase in clinic.Methods The in vitro dissolution test was carried out by the paddle method.The content of Osartan Potassium Tablets was determined by HPLC-UV.The accumulative dissolution percentage was calculated and the Weibull′s equation was used to model the dissolution parameters T50,Td and T80 m.The f2 similarity factor method was used to analyze the in vitro dissolution behaviors of Osartan Potassium Tablets produced by 3 manufacturers.Results The in vitro dissolution of Osartan Potassium Tablets from three manufacturers conformed to the requirements of the Chinese Pharmacopoeia（edition 2010）.Although the dissolution behaviors of Osartan Potassium Tablets from different manufacturers had somewhat difference within 30 min,but their accumulative dissolution within 30 min all were over 85%.Conclusion Three kinds of Osartan Potassium Tablets all accord with the stipulations of the Chinese Pharmacopoeia（edition 2010）.