【摘要】：根據(jù)藥品穩(wěn)定性試驗(yàn)的要求,采用高效液相色譜分析方法研究甲啶鉑在酸、堿、氧化和還原條件下的穩(wěn)定性,并研究了不同p H值對(duì)甲啶鉑穩(wěn)定性的影響,所有溶劑均用0.9%Na Cl溶液配制。研究結(jié)果表明,甲啶鉑在0.01 mol/L HCl溶液中放置24 h含量降解約7%;在0.01 mol/L Na OH溶液中放置24 h含量降解約78%;在0.3%H2O2溶液中放置24 h含量降解約49%;在0.01%Na HSO3溶液中放置24 h含量降解約9%;p H太高或者太低均不利于甲啶鉑的穩(wěn)定,最穩(wěn)定的p H在3~5之間。結(jié)果說(shuō)明,甲啶鉑在堿性和氧化性環(huán)境中極不穩(wěn)定,在還原性和酸性環(huán)境中相對(duì)穩(wěn)定,但還原劑和酸的加入量需嚴(yán)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.
【作者單位】： 昆明貴金屬研究所稀貴金屬綜合利用新技術(shù)國(guó)家重點(diǎn)實(shí)驗(yàn)室;昆明貴研藥業(yè)有限公司云南省鉑族金屬抗腫瘤藥物工程技術(shù)研究中心;
【基金】：云南省科技廳重點(diǎn)新產(chǎn)品開(kāi)發(fā)計(jì)劃(2013BC010):“抗腫瘤化學(xué)I類新藥甲啶鉑注射液的臨床前預(yù)研究”
【分類號(hào)】：R927.11;O657.72
，

本文編號(hào)：2375579