盐酸乙胺丁醇片在4种溶出介质中溶出曲线的比较研究  

Comparative Study on Dissolution Profiles of Ethambutol Hydrochloride Tablets in 4 Kinds of Dissolution Mediums

作　　者：张耀文 刘慧颖 王铁军 孙苓苓 ZHANG Yao-wen;LIU Hui-ying;WANG Tie-jun;SUN Ling-ling(Liaoning Inspection,Examination&Certification Centre,Liaoning Shenyang 110036,China;Liaoning Institute for Drug Control,Liaoning Shenyang 110036,China;Dandong Center for Drug Control,Liaoning Dadong 118000,China)

机构地区：[1]辽宁省检验检测认证中心,辽宁沈阳110036 [2]辽宁省药品检验检测院,辽宁沈阳110036 [3]丹东市药品检验检测中心,辽宁丹东118000

出　　处：《中国药物评价》2021年第1期44-47,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:比较自研盐酸乙胺丁醇片与国外原研药在4种不同pH的溶出介质中的体外溶出行为,为完善盐酸乙胺丁醇片的质量评价提供参考。方法:采用《中国药典》2015年版(四部)通则0931第二法(桨法),转速为50 r·min-1(45~60 min转速为250 r·min-1),分别以水、pH 1.2盐酸溶液、pH 4.0和pH 6.8磷酸盐缓冲液为溶出介质,溶出介质体积为900 mL;以高效液相色谱法测定盐酸乙胺丁醇含量,并计算累积溶出度,绘制溶出曲线;采用相似因子(f 2)法评价溶出曲线的相似度。结果:在4种不同pH的溶出介质中,自研和原研盐酸乙胺丁醇片溶出行为基本一致,f 2均大于50。结论:自研盐酸乙胺丁醇片在4种溶介质中均可以完全释放,与原研制剂体外溶出行为均相似,能确保二者药品质量的一致性。Objective:To compare the dissolution profiles of self-prepared and original Ethambutol Hydrochloride Tablets in 4 kinds of mediums,and that as a reference for improving the quality evaluation Ethambutol Hydrochloride Tablets.Methods:According to the second dissolution method(paddle method)stated in general rule 0931 of Chinese Pharmacopeia(2015 edition Part 4),the rotation speed was 50 r·min-1(250 r·min-1 in 45 min to 60 min)with dissolution medium volume of 900 mL.HPLC was adopted to determine the content of Ethambutol Hydrochloride in water,pH 1.2 hydrochloride acid,pH 4.0 phosphoric acid and pH 6.8 phosphate buffer solution,calculate the cumulative dissolution and draw dissolution profiles,then similarity factor(f 2)was used to evaluate the similarity of dissolution profiles.Results:In four different pH solvents,self-prepared Ethambutol Hydrochloride Tablets dissolve behavior was similar to original drug and the f 2 was higher than 50 for both self-prepared and original.Conclusion:Self-prepared Ethambutol Hydrochloride Tablets could release completely in four solvents and the dissolve behavior was similar to original.That could guarantee the consistency for both qualities.

关 键 词：盐酸乙胺丁醇 高效液相色谱法 溶出曲线 f_(2) 

分 类 号：R927.2[医药卫生—药学]