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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 stability of clarithromycin emulsion and its influencing factors. Methods The effects of different temperature on the stability of clarithromycin emulsion were investigated with the particle size, pH value and drug content as indexes. Results The stability of the emulsion was good when stored at low temperature. The higher the temperature, the more the stability of the emulsion was affected, resulting in the increase of particle size and the decrease of pH. According to Arrhenius formula, the storage temperature is 5 ℃, T0.9 = 9.66 years, the long-term stability test results show that the physical and chemical properties of the loaded emulsion at 12 months are stable. Conclusion Low temperature preservation is beneficial to improve the stability of the emulsion.