摘要
目的建立甲硝唑片的体外溶出度检测方法,以所建立方法对自制甲硝唑片与参比制剂体外溶出行为的一致性进行评价。方法通过绘制甲硝唑片在双蒸水、pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液4种不同溶出介质中的溶出曲线,采用f 2相似因子对溶出曲线的相似度进行评价。结果自制甲硝唑片与参比制剂在pH 1.2盐酸溶液中15 min溶出度均超过85%,在双蒸水、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液中的相似因子分别为77.59,65.30和60.42。结论自制甲硝唑片与参比制剂在4种溶出介质中的体外溶出行为一致。
Objective To establish a method for determining the dissolution of metronidazole tablet in vitro,and evaluate the consistency of the dissolution behavior in vitro between self-prepared metronidazole tablet and reference listed drug using the constructed method.Methods Through determining the dissolution curve of self-prepared metronidazole tablet and reference listed drug in distilled water,pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer and pH 6.8 phosphate buffer,the similarity factor(f 2)was used to evaluate the similarity of dissolution curves.Results Both the dissolution of self-prepared metronidazole tablet and reference listed drug in pH 1.2 hydrochloric acid solution for 15 min exceeded 85%.The similarity factor was 77.59 for double distilled water,65.30 for pH 4.5 acetate buffer,and 60.42 for pH 6.8 phosphate buffer.Conclusion The dissolution behaviors of self-prepared metronidazole tablet and reference listed drug are equivalent in four kinds of dissolution media in vitro.
作者
叶松华
张文琴
王进东
王晓燕
阮文辉
YE Songhua;ZHANG Wenqin;WANG Jindong;WANG Xiaoyan;RUAN Wenhui(Shanxi Center for Drug Evaluation,Shanxi Institute of Medicine and Life Science,Taiyuan 030006,China)
出处
《山西医科大学学报》
CAS
2023年第3期382-387,共6页
Journal of Shanxi Medical University
基金
山西省省属科研院所技术开发实验室建设项目——仿制药质量一致性研究实验室建设项目。
关键词
甲硝唑
溶出曲线
一致性评价
相似因子
metronidazole
release curve
consistency evaluation
similarity factor
