Ophthalmology Service, Hospital Cruz Roja, Madrid, Spain.
Ophthalmology Service, Hospital Infanta Sofia, Madrid, Spain.
Am J Ophthalmol. 2020 May;213:260-266. doi: 10.1016/j.ajo.2020.01.027. Epub 2020 Mar 19.
To analyze the biological stability of autologous serum eyedrops after lyophilization.
Prospective, comparative experimental study.
This was a comparative study with serum obtained from 12 healthy volunteers. The concentrations of different epitheliotropic factors (eg, transforming growth factor-β [TGF-β1], epidermal growth factor [EGF], platelet-derived growth factor AB [PDGF-AB], and albumin) were measured in fresh and lyophilized serum. The samples were studied after serum preparation (fresh serum) and immediately after saline solution reconstitution of lyophilized serum (0), 15, and 30 days later. The biological effects of both serum samples were also compared on conjunctival and corneal cell cultures. The pH, osmolarity, and serum density were also determined.
No significant differences were found in the concentration of growth factors between fresh serum and re-dissolved serum samples after lyophilization. The concentration of growth factors remained stable during 1 month at 4°C in re-dissolved lyophilized form with saline solution. No differences were found related to osmolarity, pH, and density between fresh and lyophilized serum. In addition, no differences were found on the conjunctival and corneal cells proliferation and differentiation in cells cultures between either serum preparation.
The properties of autologous serum remain after lyophilization. The lyophilized serum can be easily stored without temperature restrictions and easily reconstituted for preparation of eyedrops for standard clinical use.
分析冻干后自体血清滴眼液的生物学稳定性。
前瞻性、对比实验研究。
这是一项对比研究,使用了 12 名健康志愿者的血清。测量了新鲜和冻干血清中不同上皮趋化因子(如转化生长因子-β[ TGF-β1]、表皮生长因子[ EGF]、血小板衍生生长因子 AB [ PDGF-AB]和白蛋白)的浓度。在血清制备后(新鲜血清)和立即用生理盐水重悬冻干血清后(0、15 和 30 天后)研究了这些样本。还比较了两种血清样本在结膜和角膜细胞培养物中的生物学效应。还测定了 pH 值、渗透压和血清密度。
在冻干后再溶解的血清样本中,生长因子的浓度在新鲜血清和再溶解血清样本之间没有显著差异。在 4°C 下,在重悬的冻干形式中,生长因子的浓度在 1 个月内保持稳定,用生理盐水溶解。在新鲜和冻干血清之间,渗透压、pH 值和密度均无差异。此外,在结膜和角膜细胞培养中,两种血清制备物对细胞增殖和分化的影响也无差异。
冻干后自体血清的特性仍然存在。冻干血清可以在没有温度限制的情况下方便地储存,并且可以轻松重构成用于标准临床用途的滴眼液制剂。