不同厂家盐酸伐昔洛韦片的体外溶出曲线比较

目的比较3个厂家盐酸伐昔洛韦片在4种溶出介质中溶出曲线的相似性。方法采用《中国药典》2010年版溶出度测定方法第一法装置,转速为50r/min,分别以pH1.2盐酸溶液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液和水为溶出介质,在252nm波长处测定吸光度,绘制3个厂家盐酸伐昔洛韦片的体外溶出曲线,并采用f2相似因子法考察其相似性。结果在4种不同溶出介质中,3个厂家的盐酸伐昔洛韦片溶出曲线的f2值差异较大,有1厂家产品只在一种介质中的溶出曲线与参比制剂相似,而另1厂家产品只在一种介质中的溶出曲线与参比制剂不相似。结论不同厂家的辅料、生产工艺和生产规模导致了盐酸伐昔洛韦片溶出度的差异。

The comparison of release rate of valaciclovir hydrochloride tablets from different pharmaceutical factories in vitro

Objective To compare the release profiles of valaciclovir hydrochloride tablets from three pharmaceutical factories in four kinds of medium.Methods According to the first dissolution method described in the appendix XC of Chinese Pharmacopoeia(edition 2010),the release profiles of valaciclovir hydrochloride tablets from three pharmaceutical factories in four kinds of medium(pH1.2 hydrochloric acid solution,pH4.5 acetate buffer,pH6.8 phosphate buffer and water solution)was determined.The rotate speed was 50r/min.The contents was measured by UV at the wavelength of 252nm,and their similarities were investigated according to the f2 factor method.Results The f2 factors among valaciclovir hydrochloride tablets from three pharmaceutical factories in four kinds of medium were significantly different.No significant difference was found between the one manufacture and reference preparation in one medium,however,there was a significant difference between the other manufacture and reference preparation in one medium.Conclusion The quality of excipients,the production process and the scale lead to the difference of the dissolution of valaciclovir hydrochloride tablets from different manufacturers.