不同厂家吲达帕胺片的体外溶出度考察

目的:比较5厂家吲达帕胺片的溶出度。方法:采用紫外分光光度法分别测定A、B、C、D、E厂吲达帕胺片的累积溶出度,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:A厂和E厂吲达帕胺片的t50、td值与其他3厂有显著性差异(P<0.05),其余3厂吲达帕胺片的t50、td值间无显著性差异(P>0.05);其中,E厂吲达帕胺片在60min时的累积溶出率小于65%,不符合中国药典规定,其他4厂吲达帕胺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 in vitro dissolution of indapamide tablets from different manufacturers

OBJECTIVE To compare the dissolution of Indapamide tablets from 5 manufacturers.METHODS The cumulative dissolution of Indapamide tablets from 5 manufactures which were represented with A,B,C,D and E respectively were determined by UV spectrophotometry;the dissolution curve of different Indapamide tablets were drawn,the t50,td,m value were figured out and the value of t50 and td were compared with each other.RESULTS There was a significant difference between the Indapamide tablets from manufacturer A and E and that from the other three ones with regard to t50 and td(P>0.05);however,no significant difference was found among the other 3 manufacturers in t50 and td(P>0.05).The cumulative dissolution rate of the Indapamide tablets from manufacturer E was below 65% at 60 min,which failed to be in line with the specification of China Pharmacopeia,whereas those from the other 4 manufacturers were up to the level specified in China Pharmacopeia.CONCLUSION It is advisable for the concerned manufacturer to improve the product quality by improving the quality of excipients that affects the dissolution of Indapamide tablets and the Production technics.