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出 处:《中华中医药学刊》2010年第9期1932-1934,共3页Chinese Archives of Traditional Chinese Medicine
基 金:杭州市科技局资助项目(20051333838)
摘 要:目的:确定合适的甘草酸二铵磷脂复合物注射剂处方。方法:分别考察了溶媒、溶液pH值对注射剂稳定性的影响,并通过筛选不同种类和浓度的稳定剂确定最适处方。结果:采用pH8.5的注射用水为溶媒,0.2%去氧胆酸钠为稳定剂,所制备的甘草酸二铵磷脂复合物注射液的平均粒径为50.9nm,Zeta电位为-54.2mV,过氧化值合格。注射剂在40℃高温和强度4500LUX光照下放置10天理化性质没有发生明显变化。结论:按优化处方得到的注射剂粒径和电位符合肝脏靶向要求,且质量稳定。Objective:To optimize the formulation of diammonium glycyrrhizinate phospholipid complex injection.Methods: Factors to influence stability, including solvent, pH value, as well as the stabilizers, were investigated.Results:The optimal formulation was made of water solution with pH8.5, 0.2% sodium deoxycholate as the stabilizer. The average particle size was 50.9nm, the Zeta potential was -54.2mV and the POV was under limit. The injection was stable under 40℃ temperature or 4500Lux illumination for ten days.Conclusion: The appropriate formulation can be used to prepare diammonium glycyrrhizinate phospholipid complex injection successfully.
关 键 词:甘草酸二铵磷脂复合物 水针剂 处方优化
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