摘要
目的探讨静脉注射用门冬氨酸洛美沙星脂肪乳剂的制备方法,并对终乳稳定性进行分析。方法将甘油、泊洛沙姆溶于水后加入卵磷脂,超声加热后于相同温度下与油相缓慢混合,用组织粉碎机进行分散,经高压乳匀机乳化至符合制剂的粒径;进行成品的常规稳定性实验。结果脂肪乳剂的药剂学性质:平均粒径为(162.50±9.32)nm,Zeta平均电位为(-30.67±1.93)mV,pH值为7.32±0.02,均符合2010版药典中注射剂的相关标准;常规稳定性试验结果显示终乳有良好的贮存稳定性。结论本乳剂制备方法简单,试剂用量少且基本无毒,成品质量稳定,为进一步动物实验及临床应用提供基础。
Objective To investigate the intravenous lipid emulsion of lomefloxacin aspartate and evaluate its stability. Methods After lecithin in glycerin and poloxamer were dissolved in purified water, heated by ultrasound machine then gently mixed with the oil phase at the same temperature, dispersed in tissue grinder before homogenized to the required standard. Its stability of the normal experiments was tested. Results Pharmacy properties of the lipid emulsion were studied, the average particle size was （162.50 ~ 9.32 ）nm; Zeta potential was （-30.67 ~ 1.93 ）mV and pH value was 7.32 ~ 0.02, all consistent with the intravenous standards of Pharmacopoeia 2010.hs stability was tested and verified by normal stability test and there was no significant change occurred. Conclusion The production process is simple and agent consumption is moderate and basically atoxic. The quality of the final product is stable. It could provide foundations for further animal experiments and clinic researches.
出处
《中国医药科学》
2013年第2期50-51,共2页
China Medicine And Pharmacy
关键词
门冬氨酸洛美沙星
脂肪乳剂
制备
高压乳匀
Lomefloxacin aspartate
Lipid emulsion
Production
High pressure homogenize
