窄治疗指数药物多西他赛注射液无乙醇制剂的胶束性质对比研究  

Comparative Study on Micellar Properties of Ethanol-Free Formulations of Docetaxel Injection with Narrow Therapeutic Index

作　　者：孙鹏 曾佳 吴正红[1] SUN Peng;ZENG Jia;WU Zheng-hong(School of Pharmacy,China Pharmaceutical University,Jiangsu Nanjing 211198,China)

机构地区：[1]中国药科大学药学院,江苏南京211198

出　　处：《中国药物评价》2023年第1期36-41,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:研究比对不同配方的窄治疗指数药物多西他赛注射液配制的临床给药溶液胶束的性质。方法:选取不含乙醇的多西他赛注射液国产产品与含乙醇的原研参比制剂,对稀配后药液中所形成的胶束性质进行对比研究。结果:两种产品利用不同介质(0.9%NaCl注射液、5%葡萄糖注射液)稀配后得到的药液中,增溶剂的临界胶束浓度值无显著差异;胶束的平均粒径、分散系数基本一致;且2种产品稀配所形成胶束的稳定性均良好。结论:不同辅料的产品中增溶剂在稀配过程中均形成了稳定胶束,起到增加主药溶解度的作用。Objective:To investigate the micelle properties of clinical administration solutions prepared by different formulations of narrow therapeutic index drug docetaxel injection.Methods:The properties of docetaxel-loadedmicelles formed in dilute solution without ethanol and the original product containing ethanol were compared and studied.Results: There was no significant difference in the critical micelles concentration(CMC) value of the solubilizer in the solution obtained by diluting the three products with different media(0.9% sodium chloride solution and 5% glucose injection). The average particle size and dispersion coefficient of micelles were almost the same. The micelles formed by dilute mixing of these two products had good stability.Conclusion: The solubilizers in the products with different excipients form stable micelles during the dilution process, which plays a role in increasing the solubility of the main drug.

关 键 词：胶束 临界胶束浓度 稳定性 

分 类 号：R94[医药卫生—药剂学]