软性隐形眼镜包装溶液中的渗透压和缓冲剂。

Osmolality and buffering agents in soft contact lens packaging solutions.

作者信息

Lum Edward, Perera Indrani, Ho Arthur

机构信息

The Vision Cooperative Research Centre, The University of New South Wales, Sydney, NSW, Australia.

出版信息

Cont Lens Anterior Eye. 2004 Mar;27(1):21-6. doi: 10.1016/j.clae.2003.11.002.

DOI:10.1016/j.clae.2003.11.002

PMID:16303523

Abstract

AIM

The study determined the effects of packaging solution osmolality and buffering agent on soft contact lens parameters.

METHODS

One lens type from each FDA contact lens material category was equilibrated to phosphate buffered saline (PBS) or borate buffered saline (BBS), at three osmolality concentrations: 270, 310 and 414 mOsmol/kg. Lens diameter (LD), base curve (BOZR) and back vertex power (BVP) were measured and compared to nominal packaging label values.

RESULTS

Statistically significant differences were found in all three parameters across all osmolality levels for both buffering agents. Etafilcon A showed the largest amount of parameter change, followed by alphafilcon A and balafilcon A. Lotrafilcon A was the least affected. LD of alphafilcon A lenses (greater than +/- 0.2 mm) and BVP of lotrafilcon A and etafilcon A lenses (greater than +/- 0.25 D) measured outside the International Standards Organization (ISO) tolerance from their packaging labels when measured in solutions that mimicked their packaging solutions.

CONCLUSION

Osmolality and buffering agents influence lens parameters. Packaging solutions can vary the parameters of some lens types from their nominal value to outside the tolerance range set by ISO.

摘要

目的

本研究确定了包装溶液渗透压和缓冲剂对软性隐形眼镜参数的影响。

方法

从美国食品药品监督管理局（FDA）的每种隐形眼镜材料类别中选取一种镜片类型，在三种渗透压浓度下（270、310和414毫摩尔/千克），使其在磷酸盐缓冲盐水（PBS）或硼酸盐缓冲盐水（BBS）中达到平衡。测量镜片直径（LD）、基弧（BOZR）和后顶点屈光力（BVP），并与包装标签上的标称值进行比较。

结果

对于两种缓冲剂，在所有渗透压水平下，所有三个参数均存在统计学上的显著差异。依他氟康A显示出最大的参数变化量，其次是阿尔法氟康A和百保氟康A。洛替氟康A受影响最小。当在模拟其包装溶液的溶液中测量时，阿尔法氟康A镜片的LD（大于±0.2毫米）以及洛替氟康A和依他氟康A镜片的BVP（大于±0.25 D）超出了其包装标签的国际标准化组织（ISO）公差范围。