在不同温度条件下储存的无防腐剂和冷PRGF眼滴的长期稳定性:体外比较研究
Eduardo Anitua1, María de la Fuente1, Mohammad Hamdan Alkhraisat2
1University Institute for Regenerative Medicine and Oral Implantology - UIRMI (UPV/EHU-Fundación Eduardo Anitua), Vitoria, Spain; BTI Biotechnology Institute, Vitoria, Spain.
Cryobiology
|February 16, 2025
概括
富含生长因子 (PRGF) 的冷干燥血眼滴在室温或5°C保存时,可保持其生物含量和活性长达24个月. 这种稳定性支持长期的临床使用和更绿色的制药实践.
科学领域:
- 眼科医生 眼科 眼科
- 再生医学是一种再生医学.
- 生物技术是生物技术.
背景情况:
- 血源眼滴的长期稳定性对于扩展的临床应用和可持续的制药实践至关重要.
- 富含生长因子 (PRGF) 的等离子眼滴具有治疗潜力,但需要稳定的配方才能广泛使用.
研究的目的:
- 为了评估冷干燥的PRGF眼液的长期储存稳定性.
- 评估PRGF眼滴在各种储存条件下维持生物含量和活性.
主要方法:
- 来自五名健康捐献者的血液被加工,以获得PRGF.
- PRGF眼滴被冷或冷,并在室温 (RT) 或+5°C下存储18个月和24个月.
- 评估了人类角质细胞 (HK) 的生长因子水平和增殖潜力.
主要成果:
- 在这两种条件下,所有评估的生长因子在整个24个月的储存期内都保持了它们的水平.
- 与新鲜样品相比,冷干燥的PRGF眼滴在角质细胞增殖活动中没有显著差异.
- 在任何存储的PRGF眼滴样本中都没有检测到微生物污染.
结论:
- 冷干燥的PRGF眼滴表现出卓越的长期稳定性,保留了关键的生长因子和生物活性.
- 对于冷干燥的PRGF眼滴,可在室温或+5°C保存长达24个月.
- 这些发现支持稳定的PRGF眼滴在长期治疗中的临床适用性.
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