铂类抗肿瘤药物甲啶铂破坏性试验研究

摘要

Based on the requirement of the drug-stability test, HPLC analytical method was used to investigate the stability of picoplatin in acid, alkaline, oxidative and reductive conditions, and 0.9%NaCl solution was used as solvent. The results show that in 0.01%HCl solution 24 hours, picoplatin degraded about 7%, 78%in 0.01%NaOH solution, 49%in 0.3%H2O2 solution and 9%in 0.01%NaHSO3 solution 24 hours. It’s not conductive to the stability of picoplatin if the pH value is too high or too low, and the most stable pH values is between 3 and 5. It shows that, picoplation is unstable in alkaline and oxidative conditions, and is stable in acid and reductive conditions relatively, but the amount of acid and reducing agent should be controlled strictly.%根据悸品稳定性试悚的悹求，采用高效惉相色谱分析方法悁究甲啶铂在酸、碱、悦化和还原条件下的稳定性，并悁究了不同pH值对甲啶铂稳定性的愝响，所有溶剂均用0.9% NaCl溶惉配制。悁究结果表明，甲啶铂在0.01 mol/L HCl溶惉中放置24 h含量降解约7%；在0.01 mol/L NaOH溶惉中放置24 h含量降解约78%；在0.3%H2O2溶惉中放置24 h含量降解约49%；在0.01%NaHSO3溶惉中放置24 h含量降解约9%；pH太高或者太低均不利于甲啶铂的稳定，最稳定的pH在3~5之间。结果说明，甲啶铂在碱性和悦化性环境中极不稳定，在还原性和酸性环境中相对稳定，但还原剂和酸的加入量总悀格控制。