不同厂家硫酸沙丁胺醇片体外溶出度比较

Dissolution in Vitro of Salbutamol Sulfate Tablets from Different Manufacturers

目的：比较不同厂家（A、B、C）硫酸沙丁胺醇片的溶出度。方法：参考2005年版《中国药典》相关标准对3厂家3批次硫酸沙丁胺醇片的含量和累积溶出百分率进行检测，再按威布尔分布模型提取溶出参数。结果：硫酸沙丁胺醇检测浓度的线性范围为2．7～27．0μg·mL^-1（r=0．9994）；平均回收率为99．95％（RSD=0．96％）。5、10、15min时片剂的累积溶出百分率为A〉B〉C（P〈0．01）；25min时A与B的累积溶出百分率无显著差异，二者均显著大于C（P〈0．01）；45rain时3种片剂的累积溶出百分率无显著差异。A与B、c的溶出参数m比较，具有非常显著差异（P〈0．01），B与c间比较无显著性差异；A、B、C的T50和Td两两比较具有非常显著性差异。结论：3厂家硫酸沙丁胺醇片的溶出度存在差异。

OBJECTIVE： To evaluate the in vitro dissolution of salbutamol sulfate tablets（SST） from three manufacturers （A, B, C） . METHODS： The contents and the dissolution percentages of 3 batches of SST from 3 manufacturers were determined in accordance with the related standard stated in Chinese Pharmacopeia （2005 Edition）, and the dissolution parameters of the salbutamol sulfate tablets were computed using Weibull formula. RESULTS： The linear range of salbutamol sulfate was 2.7--27.0μg ·mL^-1 （r =0.999 4） with an average recovery of 99.95% （RSD =0.96%）. At 5, 10, 15 rnin, the cumulative dissolution percentages of SST in descending order were as follows： A〉 B〉 C （P 〈 0.01）. At 25 min, there was no difference between A and B in the cumulative dissolution percentage, but which was significantly greater in both A and B as compared with C （P 〈 0.01）. At 45 min, there was no obvious difference among A, B and C tablets. Regarding the dissolution parameter m, tablet A was significantly different from tablet B and C （P〈0.01）, but there was no significant difference between B and C. There were significant differences in T50 and Td across the 3 groups （P 〈 0.01）. CONCLUSION： There were differences in the dissolution rate of SST from 3 manufacturers.