【摘要】 根据中国药典要求,采用高速液相色谱法研究了口服铂类金属抗癌药物赛特铂在一定的环境中放置后其外观、色泽及含量的变化,以此表征赛特铂的稳定性。试验结果表明:赛特铂在80℃和在25℃、RH92.5%环境中放置10d,或在DMSO体系和纯水中放置8h含量是稳定的;在0.01mol/LHCl中放置8h或在40℃、RH75%环境中放置6个月,含量略有降低;在25℃、RH60%环境中放置3年,或在0.1mol/LHCl中放置5h,含量仍≥98%,可确定赛特铂的有效期为3年。赛特铂对光极不稳定,在45001x光照强度下放置10d,含量降低到<80%,应严格避光储存。试验结果为赛特铂原料药的研究、生产、包装、储运提供了科学依据。更多还原

【Abstract】 The changes in appearance, color and content of satraplatin after laying up in a certain circumstance and for certain time in according to Chinese Pharmacopoeia were tested by HPLC. Experiment results showed that satraplatin is stable at 80℃ and at 25℃ RH 92.5% for 10 days, or in DMSO system and in pure water for 8 hours; the content of satraplatin is slightly decreased in 0.01mol/L HCl for 8 hours, or at 40℃ RH 75% for 6 months; the content of satraplatin is still ≥98% at 25℃ RH 60% for 3 years, or in 0.1mol/L HCl for 5 hours. it can be confirmed that the term of validity of satraplatin is 3 years. But it is very unstable against light, the content of it decreases to < 80 at 45001x for 10 days, so it must be strictly kept away from light for storage. The results provide basis for preparation, package, storage and transportation of satraplatin.更多还原