铂类抗肿瘤药物甲啶铂破坏性试验研究  

The Research of Devastating Test on Picoplatin, a Platinum-based Anti-tumor Drug

作　　者：陈宏[1,2] 栾春芳 丛艳伟 张琪 普绍平 

机构地区：[1]昆明贵金属研究所稀贵金属综合利用新技术国家重点实验室,昆明650106 [2]昆明贵研药业有限公司云南省铂族金属抗肿瘤药物工程技术研究中心,昆明650106

出　　处：《贵金属》2015年第1期41-45,共5页Precious Metals

基　　金：云南省科技厅重点新产品开发计划(2013BC010):"抗肿瘤化学I类新药甲啶铂注射液的临床前预研究"

摘　　要：根据药品稳定性试验的要求,采用高效液相色谱分析方法研究甲啶铂在酸、碱、氧化和还原条件下的稳定性,并研究了不同p H值对甲啶铂稳定性的影响,所有溶剂均用0.9%Na Cl溶液配制。研究结果表明,甲啶铂在0.01 mol/L HCl溶液中放置24 h含量降解约7%;在0.01 mol/L Na OH溶液中放置24 h含量降解约78%;在0.3%H2O2溶液中放置24 h含量降解约49%;在0.01%Na HSO3溶液中放置24 h含量降解约9%;p H太高或者太低均不利于甲啶铂的稳定,最稳定的p H在3~5之间。结果说明,甲啶铂在碱性和氧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需严格控制。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% NaC1 solution was used as solvent. The results show that in 0.01% HC1 solution 24 hours, picoplatin degraded about 7%, 78% in 0.01%NaOH solution, 49% in 0.3% H202 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.

关 键 词：药物化学 铂抗癌药 甲啶铂 破坏试验 稳定性 高效液相色谱 

分 类 号：R979.1[医药卫生—药品] O627.8[医药卫生—药学]