不同厂家格列齐特片溶出度考察

目的 :比较6厂家格列齐特片的溶出度 ,为临床选用提供参考。方法 :采用分光光度法分别测定A、B、C、D、E、F厂格列齐特片的累积溶出度 ,绘制其溶出曲线 ,计算参数T50、Td、m的值 ,并对T50、Td 值进行两两比较。结果 :E厂格列齐特片的T50、Td 值与其它5厂有显著性差异 (P<0 01) ,其余5厂格列齐特片的T50、Td 值间无显著性差异 (P>0 05)。其中 ,E厂格列齐特片在180min时的累积溶出率<75 %,不符合《中国药典》规定 ,其它5厂格列齐特片的溶出度均符合规定。结论 :建议有关厂家对影响制剂溶出度的辅料及生产工艺进行改进 ,以提高产品质量。

Study on the Dissolution of Gliclazide Tabletes from Different Manufacturers

OBJECTIVE:To compare the dissolution of Gliclazide tablets from6manufacturers and provide for suggestions for clinical use.METHODS:The cumulative dissolution of Gliclazide tablets from6manufactures(which were represented with A,B,C,D,E and F respectively)were determined by spectrophotometry;the dissolution curve of different gliclazide tablets were drawn,the T 50 ,T d ,m value were figured out and the value of T 50 and T d were compared with each other.RESULTS:There was a significant difference between the gliclazide tablets from manufacturer E and that from the other five ones with regard to T 50 and T d (P<0.01);however,no significant difference was found among the other5manufacturers in T 50 and T d (P>0.05). The cumulative dissolution rate of the gliclazide tablets from manufacturer E was below75%at180min,which failed to be in line with the specification of China pharmacopeia,whereas those from the other5manufacturers were up to the level specified in China pharmacopeia.CONCLUSION:It is advisable for the concerned manufacturer to improve the product quality by imˉproving the quality of excipients that affects the dissolution of Gliclazide tablets and the production technics.