不同厂家盐酸地芬尼多片溶出曲线相似性考察

Comparative Study on Dissolution Curves of Difenidol Hydrochloride Tablets from Different Manufacturers

目的:考察8个厂家盐酸地芬尼多片在不同溶出介质中的溶出曲线,比较不同厂家药品内在品质,为药品质量控制提供参考。方法:采用高效液相色谱法测定8个厂家盐酸地芬尼多片在水、pH 1.2、pH4.0和pH 6.8四种介质中的溶出曲线,结合AV值对溶出曲线得相似性进行比较分析。结果:在pH 1.2、pH 4.0和水三种溶出介质中各厂家盐酸地芬尼多片溶出量均符合药典规定,但溶出曲线差异性较大;在pH 6.8中溶出量偏低。结论:仅1家企业4条溶出曲线均与原研厂家标准溶出曲线相似,企业仍需进一步改进处方及生产工艺以提高产品质量。

Objective ： To investigate the dissolution curves of difenidol hydrochloride tablets from 8 pharmaceutical manufacturers in different dissolution medium and compare the internal quality so as to provide reference for the drug quality control. Methods： The dissolution process of difenidol hydrochloride tablets was monitored in the following respective medium： water solution with pH of 1.2, 4.0 and 6.8, and pure water. The dissolution curves were determined by HPLC, and comparatively analyzed by the AV value. Re- sults： The dissolution rate of difenidol hydrochloride tablets was accorded with the requirement in Chinese Pharmacopoeia in pH 1.2, pH 4.0 and pure water, while the dissolution curves of the tablets showed significant difference from each other, expecially the dissolu- tion in pH 6.8 was low. Conclusion ： The dissolution of the tablets from only one pharmaceutical manufacturer is similar to that of the original drug in the 4 dissolution media. The pharmaceutical manufacturers should improve the quality by changing the formula and pre- partion process.