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目的:评价2-甲氧基雌二醇静脉乳剂的性质及初步的安全性,为进一步临床研究奠定基础。方法:依据相关指导原则对2-甲氧基雌二醇静脉乳剂的理化性质、稳定性、体外释药、溶血性及过敏性进行研究。结果:理化性质及稳定性符合《中华人民共和国药典》对静脉乳剂的要求,2-甲氧基雌二醇静脉乳剂体外释放度在30 h达(92.6±4.2)%,溶血度小于5%,无过敏反应。结论:2-甲氧基雌二醇静脉乳剂性质稳定,无溶血性及过敏反应,体外释药显示有一定的缓释作用,具有临床应用前景。
Objective: To evaluate the properties and safety of 2-methoxyestradiol intravenous emulsion and lay the foundation for further clinical research. Methods: According to the relevant guidelines, the physicochemical properties, stability, in vitro release, hemolytic and allergic effects of 2-methoxyestradiol intravenous emulsion were studied. RESULTS: Physicochemical properties and stability were in accordance with the requirements of Pharmacopoeia of the People’s Republic of China for intravenous emulsion. The in vitro release of 2-methoxyestradiol intravenous emulsion reached 92.6 ± 4.2% at 30 h, the degree of hemolysis was less than 5% No allergic reaction. Conclusion: The 2-methoxyestradiol intravenous emulsion is stable in nature, has no hemolysis and allergic reaction, and has some sustained release effects in vitro. It has the clinical application prospect.