四联抗结核药物配伍稳定性的研究  

Compatibility and stability of anti-tubercular fixed-dose combinations

作　　者：王曦培[1] 王思玲[1] 姜同英[1] 张晓伟[1] 王朝辉[1] 郑威威[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2009年第3期154-160,共7页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的为四联抗结核药物制剂的设计和贮存提供参考。方法采用差示扫描量热(DSC)法初步判定四联药物间配伍性,考察单药和不同配伍混合物在光照、高温、高湿及不同pH条件下的配伍稳定性;采用RP-HPLC法对样品中有关物质含量进行检测。结果DSC图谱显示,不同配伍混合物中特征峰有变化并有新的吸热峰产生;在光照、高温、高湿条件下,物理混合物中有关物质的量明显增加;混合物有关物质的量随pH值降低而增加。结论四联药物彼此之间存在配伍禁忌,且高湿或低pH条件对四联药物稳定性影响显著,制剂设计应避开体内酸性环境并防潮避光贮存。Objective To study the compatibility and stability of four anti-tuberculosis drugs.Methods DSC was employed to study the compatibility of the four drugs.After being exposed to light and relative humidity of 75 % for 10 d, the amount of impurities was determined by RP-HPLC and compared with those of 0d samples.Under various pH conditions, the amount of impurities was determined at fixed time points.Results New peaks in the DSC profiles of various physical mixtures were observed.The amount of impurities in physical mixtures increased significantly when exposed under light, at 60 ℃ and relative humidity of 75 %.The stability of the mixtures decreased greatly with the reduction of pH values.Conclusions Four anti-tuberculosis drugs are incompatible with each other, especially under high moisture and low pH conditions.

关 键 词：药剂学 配伍性 反相高效液相色谱法 利福平 异烟肼 吡嗪酰胺 盐酸乙胺丁醇 抗结核四联药物 

分 类 号：R942[医药卫生—药剂学]