3厂家氯沙坦钾片体外溶出度比较

目的:比较3厂家氯沙坦钾片的溶出度。方法:参考2010年版《中国药典》相关标准考察3厂家(A、B、C)3批次氯沙坦钾片的体外溶出行为,再按威布尔方程拟合溶出参数T50、Td、m,同时对其进行方差分析。结果:3、5、7、10min时片剂的累积溶出百分率为A>C>B(P>0.05),15、20、30、45min时片剂的累积溶出百分率为B>A>C(P>0.05),45min内的累积溶出百分率3厂家片剂均在92%以上。A与C的m、T50、Td比较无显著性差异(P>0.05),B与C的Td比较无显著性差异(P>0.05),A与B、B与C的m、T50比较具有显著性差异(P<0.05),A与B的Td比较具有显著性差异(P<0.01)。结论:3厂家氯沙坦钾片的溶出行为存在差异。

Comparison of the Dissolution Rate of Losartan Potassium Tablets from 3 Manufacturers in Vitro

OBJECTIVE： To compare the dissolution rate of Losartan potassium tablets produced by 3 manufacturers. METHODS： The dissolution percentages of 3 batches of Losartan potassium tablets from 3 manufacturers were determined in accordance with the related standard stated in Chinese Pharmacopeia （2010 edition）, and the dissolution parameters （T50, Td and m） of Losartan potassium tablets were computed using Weibull＇s equation. RESULTS： At 3, 5, 7, 10 min, the accumulative dissolution percentages of Losartan potassium tablets in descending order were as follows： A〉C〉B （P〉0.05）. At 15, 20, 30, 45 min, the accumulative dissolution percentages of Losartan potassium tablets in descending order were as follows： B 〉 A 〉 C （P〉 0.05）. The accumulative dissolution of Losartan potassium tablets from 3 manufacturers was more than 92 % at 45 min. There was no significant difference in dissolution parameters （m, T50, Td） between tablet A and tablet C （P〉0.05）. There was no significant difference in dissolution parameter T0 between tablet B and tablet C （P〉0.05）. There were significant differences in dissolution parameter m and T50 between tablet A and tablet C, and between tablet B and tablet C （P〈0.05）. There was significant difference in dissolution parameter Td between tablet A and tablet B （P〈0.01）. CONCLUSION： There are differences in the dissolution rate of Losartan potassium tablets from 3 manufacturers.