摘要
目的制备稳定性良好的伊曲康唑(itraconazole,ITZ)静脉注射乳剂。方法采用乳化匀质法,制备O/W型的ITZ乳剂;测定乳剂的pH值、粒径大小和ζ电位,评价其物理化学稳定性。结果 ITZ静脉注射乳剂的稳定性良好,质量浓度为0.991 2 mg·mL-1,平均粒径为152 nm,ζ电位为-18.95 mV,pH值为7.64,6个月的稳定性考察结果表明:各项性质几乎没有发生变化。结论 ITZ静脉注射乳剂各项性质符合中国药典2005版对乳剂的要求。
Objective To design a stable emulsion formulation of itraconazole(ITZ) for intravenous administration. Methods The ITZ O/W emulsion was prepared by a high-pressure homogenization method. Emulsion was characterized regarding particle size, pH and Zeta potential measurements. Results ITZ intravenous emulsion was proved to have a good stability with drug content of 0.991 2 mg·mL-1.The mean droplet size, pH and Zeta potential of ITZ emulsion was 152 nm, 7.64 and -18.95 mV, respectively.No changes in the various physicochemical properties were observed after 6 months. Conclusion It is showed that the formulation meets specification in the Pharmacopoeia of China.
出处
《中国药剂学杂志（网络版）》
2006年第1期7-11,共5页
Chinese Journal of Pharmaceutics：Online Edition
关键词
药剂学
理化性质
药物稳定性
伊曲康唑
静脉注射乳剂
pharmaceutics
physicochemical properties
drug stability
itraconazole
intravenous emulsion
