[翻译文章]对两种新的无防腐剂甲基普雷迪尼索隆眼滴进行物理化学和微生物稳定性研究
Vicente Merino-Bohórquez1, Silvia Berisa-Prado2, Mercedes Delgado-Valverde3
1Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain; Departamento de Farmacología, Facultad de Farmacia, Universidad de Sevilla, Sevilla, Spain.
概括
没有防腐剂的甲基普雷迪尼索隆糖酸盐 (MTPSS) 眼滴在冷藏下显示出良好的稳定性. 1毫克/毫升的配方稳定21天,10毫克/毫升的配方稳定42天,推开封后使用7天.
科学领域:
- 眼科医生 眼科 眼科
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
背景情况:
- 没有防护剂的眼滴对于管理诸如Sjögren综合征和干眼综合征等眼部疾病至关重要.
- 甲基prednisolone糖酸盐 (MTPSS) 是一种皮质类固醇,因其抗炎性而用于眼科应用.
研究的目的:
- 在90天内评估两种无防腐剂的MTPSS眼滴配方 (1 mg/mL和10 mg/mL) 的物理化学和微生物稳定性.
- 为了确定这些眼科溶液的最佳储存条件和保质期.
主要方法:
- 使用注射式MTPSS制备配方,并在冷藏 (5°C),室温 (25°C) 和升高 (40°C) 条件下储存.
- 使用HPLC-UV对药物含量,pH,度和视觉检查进行了物理化学稳定性的评估.
- 在冷藏条件下,在开放和关闭的容器中测试了微生物无菌性.
主要成果:
- 冰箱储存 (5°C) 为两种MTPSS度提供了最佳的稳定性.
- 在冷藏下,药物的降解率在21天 (1 mg/mL) 和42天 (10 mg/mL) 保持在10%以下.
- 在5°C时,没有观察到pH或度的显著变化,与其他条件形成沉物或颗粒不同.
结论:
- 1毫克/毫升的MTPSS眼滴在冷藏下稳定21天,10毫克/毫升的配方稳定42天.
- 由于没有防腐剂,无论储存条件如何,两种配方都应在打开后7天内使用.
- 这些发现支持在适当处理时使用无防腐剂的MTPSS眼液治疗特定的眼部疾病.
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