铂类抗肿瘤药物甲啶铂破坏性试验研究
发布时间：2018-12-13 01:08
【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。
[Abstract]:According to the requirements of drug stability test, the stability of methaliplatin under acid, alkali, oxidation and reduction conditions was studied by high performance liquid chromatography, and the effects of different pH values on the stability of triadidine platinum were studied. All solvents are prepared with 0.9%Na Cl solution. The results showed that the content of methylplatin was degraded in 0. 01 mol/L HCl solution for 24 h, about 7% in 0. 01 mol/L Na OH solution for 24 h, and 78% in 0. 01 mol/L Na OH solution. In 0.3%H2O2 solution, the degradation rate was about 49% for 24 h, and about 9% in 0.01%Na HSO3 solution for 24 h. Too high or too low pH was not conducive to the stability of triadidine platinum, and the most stable pH was between 3 and 5. The results show that methaliplatin is extremely unstable in alkaline and oxidizing environments, and relatively stable in reductive and acidic environments, but the amount of reductant and acid must be strictly controlled.
【作者单位】： 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;
【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”
【分类号】：R927.11;O657.72
，
本文编号：2375579
[Abstract]:According to the requirements of drug stability test, the stability of methaliplatin under acid, alkali, oxidation and reduction conditions was studied by high performance liquid chromatography, and the effects of different pH values on the stability of triadidine platinum were studied. All solvents are prepared with 0.9%Na Cl solution. The results showed that the content of methylplatin was degraded in 0. 01 mol/L HCl solution for 24 h, about 7% in 0. 01 mol/L Na OH solution for 24 h, and 78% in 0. 01 mol/L Na OH solution. In 0.3%H2O2 solution, the degradation rate was about 49% for 24 h, and about 9% in 0.01%Na HSO3 solution for 24 h. Too high or too low pH was not conducive to the stability of triadidine platinum, and the most stable pH was between 3 and 5. The results show that methaliplatin is extremely unstable in alkaline and oxidizing environments, and relatively stable in reductive and acidic environments, but the amount of reductant and acid must be strictly controlled.
【作者单位】： 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;
【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”
【分类号】：R927.11;O657.72
，
本文编号：2375579
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