氨溴索注射亚微乳稳定性研究

Study on Stability of Injectable Ambroxol Submicromulsion

目的优化氨溴索亚微乳储存条件,保证药品理化性质稳定。方法以粒径和含量为检测指标,对氨溴索亚微乳进行影响因素试验、加速试验和长期试验,考察制剂的稳定性。结果影响因素试验结果显示,制备的乳剂在各条件下粒径变化不明显,但温度增高时,其含量和pH下降较明显;冻融试验结果显示,乳剂含量变化不明显,但40℃时粒径变化大于60℃时;6个月加速试验和长期试验结果显示,乳剂含量pH下降不明显,粒径略微增加。结论为确保氨溴索亚微乳注射剂的理化性质稳定,需冷藏储存。

Objective To optimize the storage conditions of ambroxol submicroemulsion,in order to ensure the stability of the physicochemical properties of the drugs.Methods The influencing factors test,accelerated test and long-term test of ambroxol submicroemulsion were carried out with particle size and content as indexes.Results The results of influencing factors test showed that the particle size of the emulsion prepared under all conditions did not change significantly,but the content and pH decreased significantly with the temperature increased.The results of freeze-thaw test showed that the content of emulsion did not change significantly,but the particle size at 40℃ changed greater than that at 60℃.The results of 6 months of accelerated test and long-term test showed that the content and pH of emulsion did not change significantly,but the particle size increased slightly.Conclusion The injectable ambroxol submicroemulsion should be refrigerated storage to ensure its stability of the physicochemical properties.