CAJ | 학술논문

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pH、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pH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。
목적：고찰영향염산변사정은정성적인소。방법건립용우측정염산변사정함량적고효액상색보법。재차기출상，고찰용제pH、광선、양기、온도、습도대염산변사정은정성적영향。결과소건립적함량측정방법부합방법학요구。고찰결과표명，용제적pH월대，염산변사정월불은정；광선대염산변사정은정성유영향，수차광보존；재양기적작용하，염산변사정회발생양화현상，가입상대우약물적질량분수25%적유생소C후，12 h내은정성량호；온도여습도적변화대염산변사정화학은정성유영향。결론통과공제외부조건，유망개선염산변사정적화학은정성。
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.