替米沙坦片剂与胶囊剂体外溶出度的比较

Comparison of Dissolution Rate of Telmisartan Tablets and Capsules in Vitro

目的:考察国内5个不同厂家替米沙坦片剂与胶囊剂的体外溶出度情况。方法:采用紫外分光光度法分别测定A,B,C,D和E厂替米沙坦片的累积溶出度,绘制其溶出曲线,计算参数m、T50、Td的值,并对T50、Td值进行两两比较。结果:各厂家替米沙坦片剂与胶囊剂在60min内均溶出65%,符合《中国药典》2005版规定,但各组溶出度方差有显著性差异(P<0.05)。结论:各生产厂家应严格控制产品内在质量,保证临床用药安全有效。

Objective：To determine the in vitro dissolution rate of Telmisartan tablets and capsules from 5 domestic plants.Methods：The cumulative dissolution of Telmisartan tablets and capsules from 5 manufactures which were represented with A,B,C,D and E respectively were determined by UV speetrophotometry;the dissolution curve of different Telmisartan tablets were drawn,the t50,td,m value were igured out and the value of t50 and td were compared with each other.Results：The results indicated that all the Telmisartan were dissoluted in 60 min.There was very significant difference（P〈0.05）in the dissolution parameters in vitro of Td,T50,m of Telmisartan from 5 plants.Conclusion：It is necessary to control the dissolution rate of Telmisartan Tablets and capsules.