有机金属抗癌原料药二氯二茂钛的稳定性试验  

Stability of Organometallic Antitumor Crude Drug Titanocene Dichloride

作　　者：李云兰[1] 宁美英[1] 李青山[1] 

机构地区：[1]山西医科大学药学院,太原030001

出　　处：《中国现代应用药学》2008年第1期22-25,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：国家教育部新世纪优秀人才支持计划项目(NCET-04-0258);山西省重点科技攻关项目(No051105-2);山西省首批青年学科带头人基金(晋教科No200413);山西省青年科技研究基金(2007021035);山西省研究生教育创新项目(20061038);太原市大学生创新基金(07010729)

摘　　要：目的考察二氯二茂钛原料药的稳定性,并预测其有效期。方法采用正相高效液相色谱法测定原料药含量和有关物质,以正己烷-二氯甲烷(50∶50)为流动相考察加速和长期稳定性试验,经典恒温法预测其有效期。结果含量和有关物质测定方法的平均回收率为99.9%(n=9),RSD为0.45%。拟市售包装,40℃加速试验6个月,长期室温试验24个月,有关物质稍有增加,其他各考察指标无明显变化。经典恒温法预测本原料药在25℃贮存时有效期大于10年。结论拟市售包装条件下二氯二茂钛稳定性较好,有效期暂定2年。OBJECTIVE To investigate the stability of titanocene dichloride crude drug, and predict its validity duration. METHODS A normal-phase high performance liquid chromatography system was adopted with Lichrosorb-CN column to determine the content of titanocene dichloride and its relative impurities. The mobile phase consist of hexane-dichloromethane （50： 50）. The appearance character, content of relative impurities and titanocene dichloride, clarity, melting point and pH were investigated through the periods of accelerating and long-term tests. Classical isothermal method was used to predict the validity duration of titanocene dichloride. RESULTS The average recovery of titanocene dichloride was 99.9% （ n = 9, RSD = 0.45% ）. No obvious changes were found after the samples were accelerated under 40℃ for 6 months and then tested for 2 years at room temperature （25℃ ） , excepting slightly increase of relative impurities. The validity duration of titanocene dichloride was more than 10 years at 25℃ , which was predicted using classical isothermal method. CONCLUSION The titanocene dichloride had good stability under marketed package conditions, and the useful life could be arranged for 2 years.

关 键 词：二氯二茂钛 高效液相色谱法 稳定性 

分 类 号：R979.1[医药卫生—药品]