采用有区分力的溶出曲线筛选盐酸乙胺丁醇片制备工艺  

Distinguishable dissolution curves used to select the preparation technology of ethambutol hydrochloride tablets

作　　者：陈禧翎 王家祺 卢瑞芯 黄孟秋 周伟杰 覃宗玲 CHEN Xi-ling;WANG Jia-qi;LU Rui-xin(Guangzhou Baiyun shan Mingxing Pharmaceutical Co.,Ltd,Guangzhou 510000,China)

机构地区：[1]广州白云山明兴制药有限公司,广州510000 [2]广州帝奇医药技术有限公司,广州510000

出　　处：《中国处方药》2021年第7期45-47,共3页Journal of China Prescription Drug

摘　　要：目的通过比较盐酸乙胺丁醇片在四种介质中的溶出行为,获得具有区分力的溶出曲线,并以此为依据,筛选出溶出曲线与参比制剂最为相近的制备工艺。方法建立具有区分力的溶出曲线测定方法,以该溶出条件考察不同制备工艺自制制剂的溶出行为,采用相似因子(f_(2))法与参比制剂比较溶出曲线,得到最相近的制备工艺。结果溶出曲线方法采用桨法,溶出介质为水介质,体积为900 ml,转速为50 r/min,HPLC法检测;湿法制粒法和流化床制粒法的制备工艺对应的f_(2)因子分别为31.1、60.4,表明流化床制粒法与参比制剂制备工艺最为相似。结论具有区分力的溶出曲线可用于盐酸乙胺丁醇片制备工艺的筛选;两种制备工艺所得片剂溶出行为具有显著差异;流化床制粒法所得片剂与参比制剂体外溶出行为最相似。Objective To obtain the discriminating dissolution curve by comparing the dissolution behavior of ethambutol hydrochloride tablets in 4 dissolution media,and based on this,screen the preparation technology of self-made samples which is most similar to reference standard drugs.Methods To set up a method of the discriminating dissolution curve,use this dissolution conditions to investigate the dissolution behavior of self-made samples with different preparation technology.To obtain the most similar preparation technology by comparing the dissolution curve with f_(2) factors.Results HPLC method was used to detect dissolution curves.Apparatus:paddle apparatus,volume of the solution medium is 900 ml,rotation speed is 50 r/min.The f_(2) factors of the wet granulation and the fluid-bed granulation are 31.1 and 60.4.It shows that the fluid-bed granulation is most similar to the preparation technology of reference standard drugs.Conclusion The distinguishing dissolution curve can be used to screen ethambutol hydrochloride tablets the preparation technology.The dissolution behavior of the tablets obtained by the two preparation processes is significantly different.The in vitro dissolution behavior of the tablet obtained by the fluidized bed granulation method is most similar to that of the reference preparation.For ethambutol hydrochloride tablets,the fluid-bed granulation contributed to better in vitro dissolving similarity with the reference standard drugs.

关 键 词：盐酸乙胺丁醇片 溶出曲线 制备工艺 流化床制粒 

分 类 号：TQ460.6[化学工程—制药化工]