多西他赛注射液与不同溶媒配伍的稳定性考察

目的:考察多西他赛注射液分别与0.9%氯化钠注射液、5%葡萄糖注射液及长链脂肪乳注射液配伍后的稳定性。方法:考察室温下0,1,2,4,6,8,10,12,16,20,24 h时配伍液的外观、不溶微粒分布及粒径大小、pH值,采用高效液相色谱法测定多西他赛的含量。结果:24 h内,药物与0.9%氯化钠注射液、5%葡萄糖注射液的配伍液外观与pH值均无明显改变,但多西他赛的含量在配置后8 h均有明显下降(RSD>2%);24 h内,药物与长链脂肪乳注射液的配伍液外观与pH值均无明显改变,但多西他赛的含量在配置后20 h有明显下降(RSD>2%)。结论:室温条件下,多西他赛注射液与长链脂肪乳注射液配伍的稳定性明显优于0.9%氯化钠注射液及5%葡萄糖注射液。

Evaluation on stability of docetaxel injection in different solvent

OBJECTIVE To investigate the stability of docetaxel injection mixed with 0.9% sodium chloride injection, 5% glucose injection and long chain fat emulsion-injection, respectively.METHODS The appearances, undissolved particle distribution, particle size and pH values of docetaxel injection mixed with different solvents were observed at 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 h under room temperature. HPLC method was used to determine the content of docetaxel. RESULTS Within 24 hours, in mixture of docetaxel with 0.9% sodium chloride injection or 5% glucose injection, no significant change in the appearance or pH value was observed, but the content of docetaxel declined after 8 h (RSD>2%). In the mixture of docetaxel and long chain fat emulsion-injection, no significant change in appearance or pH value was observed within 24 h, but content of docetaxel significantly declined 20 hours later (RSD>2%). CONCLUSION At room temperature, the stability of docetaxel injection in long chain fat emulsion injection is significantly superior.