Mullins Nicholas D, Deadman Benjamin J, Moynihan Humphrey A, McCarthy Florence O, Lawrence Simon E, Thompson Jonathan, Maguire Anita R
Department of Chemistry, Analytical and Biological Chemistry Research Facility, Synthesis and Solid State Pharmaceutical Centre, University College, Cork, Ireland.
DePuy Synthes (Ireland), Loughbeg, Ringaskiddy, Co., Cork, Ireland.
J Pharm Anal. 2016 Dec;6(6):374-381. doi: 10.1016/j.jpha.2016.05.002. Epub 2016 May 26.
A systematic approach was developed to investigate the stability of gentamicin sulfate (GS) and GS/poly (lactic-co-glycolic acid) (PLGA) coatings on hydroxyapatite surfaces. The influence of environmental factors (light, humidity, oxidation and heat) upon degradation of the drug in the coatings was investigated using liquid chromatography with evaporative light scattering detection and mass spectrometry. GS coated rods were found to be stable across the range of environments assessed, with only an oxidizing atmosphere resulting in significant changes to the gentamicin composition. In contrast, rods coated with GS/PLGA were more sensitive to storage conditions with compositional changes being detected after storage at 60 °C, 75% relative humidity or exposure to light. The effect of γ-irradiation on the coated rods was also investigated and found to have no significant effect. Finally, liquid chromatography-mass spectrometry analysis revealed that known gentamines C, C and C were the major degradants formed. Forced degradation of gentamicin coatings did not produce any unexpected degradants or impurities.
开发了一种系统方法来研究硫酸庆大霉素（GS）以及GS/聚乳酸-乙醇酸共聚物（PLGA）在羟基磷灰石表面涂层的稳定性。使用配有蒸发光散射检测器的液相色谱法和质谱法，研究了环境因素（光照、湿度、氧化和热）对涂层中药物降解的影响。发现在评估的各种环境条件下，涂有GS的棒材是稳定的，只有在氧化气氛中庆大霉素的成分才会发生显著变化。相比之下，涂有GS/PLGA的棒材对储存条件更为敏感，在60°C、相对湿度75%下储存或光照后，其成分会发生变化。还研究了γ射线辐照对涂覆棒材的影响，发现没有显著影响。最后，液相色谱-质谱分析表明，已知的庆大胺C、C和C是形成的主要降解产物。庆大霉素涂层的强制降解未产生任何意外的降解产物或杂质。
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