一套五种眼科活性药物成分的二氧化灭菌:对杂质概况和含量的影响
Elias Vanneste1, Quinten Speleers1, Anke Meyers1
1KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium.
二氧化 (NO2) 灭菌对一些眼科药物有希望,但会降解四环素化物和阿西克洛维尔. 这种新的绝育方法适用于甲基prednisolone,德克萨米他和三氨.
科学领域:
- 制药科学 制药科学
- 消毒技术 消毒技术
- 眼科药物开发 眼科药物开发
背景情况:
- 关于制药物质灭菌的文献有限.
- 新兴的灭菌技术需要对药物兼容性进行彻底评估.
- 眼科活性药物成分 (API) 需要严格的灭菌协议.
研究的目的:
- 评估二氧化 (NO2) 灭菌对五种眼科API的影响.
- 为了确定特定的眼科药物物质的安全NO2度.
- 评估NO2灭菌作为一种潜在的无菌加工方法.
主要方法:
- 在5,10和20毫克/升的四环素化物,阿西克洛维尔,德克萨米他,甲基prednisolone和triamcinolone上测试了NO2杀菌.
- 使用具有UV/Vis检测的高性能液态染色学 (HPLC) 来量化降解产品和API含量.
- 根据欧洲药典 (Ph. Ph. Ph. 欧元) 在欧元. 限制. 限制. 限制.
主要成果:
- 四环素化物和阿西克洛维尔显示出杂质增加,NO2度更高,估计分别为10 mg/L和2.5 mg/L的最大允许水平.
- 环素化物和阿西克洛维尔的显著降解发生在20 mg/L NO2的水平上.
- 甲基prednisolone,德克萨米他,和triamcinolone仍然在PH的范围内. 欧元. 欧元. 在欧元. 杂质限值,对它们的相对含量没有重大影响.
结论:
- 由于严重降解,不建议对四环素化物和阿西克洛维尔进行NO2灭菌.
- 在无菌加工中,NO2杀菌是甲基prednisolone,dexamethasone和triamcinolone的一个可行的选择.
- 进一步的研究可能会优化对敏感眼科API的NO2杀菌参数.
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