注射用克拉霉素乳剂稳定性及影响因素考察

Study on the Formulation Stability and Its Influence Factors of Clarithromycin Emulsion for Injection

目的考察克拉霉素乳剂稳定性及其影响因素。方法以乳剂粒径,pH值变化和药物含量作为指标,考察了不同温度对克拉霉素乳剂稳定性的影响。结果乳剂在低温保存时稳定性良好,温度升高会显著影响乳剂稳定性,导致粒径增大和pH降低。根据Arrhenius公式求得储存温度为5℃时,T0.9=9.06年,长期稳定性试验结果表明,载药乳剂在12个月理化性质稳定。结论低温保存有利于提高该乳剂的稳定性。

OBJECTIVE To investigate the formulation stability and influence factor of clarithromycin emulsing. METHODS The particle size, pH reduction and drug content were used as the indexes to investigate the clarithromycin emulsion stability in different storage temperature. RESULTS The drug loaded emulsion was stable when at low storage temperature. As the storage temperature increased, the particle size of clarithromycin emulsion increased significantly. And lead to pH reduction. Based on Arrhenius equation, T0.9 would increase to 9.06 years, when storage temperature was 5 ℃. Long term stability testing results indicate that the physical and chemical properties of clarithromycin emulsion was stable within 12 months. CONCLUSION Low storage temperature is hepful to improve the formulation stability.