盐酸苄丝肼化学稳定性影响因素的研究  

Study on the influencing factors of chemical stability of Benserazide Hydrochloride

作　　者：马桂芝[1] 李文英[2] 王娟[1] 贺鑫韬 马文娜[1] 滕亮[3] 

机构地区：[1]新疆医科大学药学院,新疆乌鲁木齐830011 [2]新疆医科大学第五附属医院药剂科,新疆乌鲁木齐830011 [3]新疆医科大学第一附属医院药学部,新疆乌鲁木齐830011

出　　处：《中国医药导报》2014年第35期4-7,11,共5页China Medical Herald

基　　金：新疆维吾尔自治区科技计划项目(编号201110106);新疆维吾尔自治区乌鲁木齐市科学技术计划项目(编号G121320003);新疆研究生科研创新项目(编号XJGRI2013084)

摘　　要：目的考察影响盐酸苄丝肼稳定性的因素。方法建立用于测定盐酸苄丝肼含量的高效液相色谱法。在此基础上,考察溶剂p H、光线、氧气、温度、湿度对盐酸苄丝肼稳定性的影响。结果所建立的含量测定方法符合方法学要求。考察结果表明,溶剂的p H越大,盐酸苄丝肼越不稳定;光线对盐酸苄丝肼稳定性有影响,需遮光保存;在氧气的作用下,盐酸苄丝肼会发生氧化现象,加入相对于药物的质量分数25%的维生素C后,12 h内稳定性良好;温度与湿度的变化对盐酸苄丝肼化学稳定性有影响。结论通过控制外部条件,有望改善盐酸苄丝肼的化学稳定性。Objective To investigate the influencing factors of chemical stability of Benserazide Hydrochloride. Meth-ods The HPLC method for determining the content of Benserazide Hydrochloride was established. And the influencing factors including solvent pH, light, oxygen, temperature and humidity were investigated. Results The HPLC method for the determination of Benserazide Hydrochloride was in conformity with methodological requirements. In the solution which had higher pH, the Benserazide Hydrochloride was less stable. Light influenced chemical stability of Benserazide Hydrochloride, so it should be kept away from light. Benserazide Hydrochloride was oxidized. But when added 25%Vitamin C （the mass ratio of antioxidants to drug, W/W ） to the Benserazide Hydrochloride solution, the drug was stable within 12 h. The temperature and humidity affected the chemical stability of Benserazide Hydrochloride, too. Conclu-sion If the external conditions are controlled, the chemical stability of Benserazide Hydrochloride will be improved.

关 键 词：盐酸苄丝肼 高效液相色谱法 化学稳定性 影响因素 

分 类 号：R971.5[医药卫生—药品]