影响1,4-二氢吡啶类药物溶液稳定性的关键因素  

Key Influencing Factors of Stability of 1,4-Dihydropyridine Drug Solutions

作　　者：张玲玉[1] 王静[2] 周立新[2] 陆步实[2] 

机构地区：[1]南京工业大学药学院,南京211816 [2]南京工业大学江苏省药物研究所,南京210009

出　　处：《中国药学杂志》2017年第11期978-980,共3页Chinese Pharmaceutical Journal

摘　　要：目的考察1,4-二氢吡啶类药物的溶液稳定性及关键影响因素。方法采用HPLC,以盐酸贝尼地平、苯磺酸氨氯地平、硝苯地平为代表药物,分别比较在不同p H值溶液中的稳定性;考察不同金属离子、Fe^(3+)浓度及"相同Fe^(3+)浓度下"不同p H条件对药物溶液稳定性的影响。结果 Fe^(3+)会导致药物快速的降解,随着Fe^(3+)浓度的增大,药物降解速率增快;随着p H值的增大,药物的降解率逐渐减小。结论 Fe^(3+)对1,4-二氢吡啶类药物的氧化芳构化作用是造成此类药物降解的主要原因。OBJECTIVE To study the stability of 1,4-dihydropyridines solutions and the key influencing factors. METHODS The stabilities of the solutions of several representative drugs, ie, benidipine hydrochloride, amlodipine besylate and nifedipine, were tested in six kinds of solvents of different pHs （ pH 1.0, pH 1.2, pH 2. 0 hydrochloric acid solutions, pH 4. 0 acetic acid solution, pH 6. 8 phosphoric acid solution, water） by HPLC method. The effects of several metal ions, Fe3＋ concentration and different pH values on the stability of the drug solutions were also investigated. RESULTS Fe3＋ could lead to rapid degradation of 1,4-dihydropyridine drugs, the degradation rate was accelerated with the increase of Fe3＋ concentration, and the degradation rate was decreased with the increase of pH value. CONCLUSION The aromatization of 1,4-dihydropyridines by Fe3＋ is the main reason for the degradation of 1,4- dihydropyridines.

关 键 词：1 4-二氢吡啶类药物 稳定性 金属离子 酸性溶液 氧化芳构化 

分 类 号：R917[医药卫生—药物分析学]