眼科溶液的pH稳定性
pH stability of ophthalmic solutions.
作者信息
Garcia-Valldecabres Monica, López-Alemany Antonio, Refojo Miguel F
机构信息
Ocular Surface, Cornea, and Contact Lenses Research Group, Department d'Optica, Universitat de València, València, Spain.
出版信息
Optometry. 2004 Mar;75(3):161-8. doi: 10.1016/s1529-1839(04)70035-4.
BACKGROUND
In this study, we evaluated the pH value of 17 ophthalmic solutions, and we investigated whether the pH of these solutions changed over time after the bottle was opened.
METHODS
Fifteen bottles of each type of solution were chosen at random from different production lots. A 0.05-ml increment was taken from each bottle and was measured daily using a micropH 2002 Crison pH-meter over a period of 30 days.
RESULTS
The results revealed differences between the pH values of the solutions; nine solutions presented pH values within ocular comfort range and eight solutions presented pH values between 3.5 and 6.4. Ten solutions presented nonstatistically significant variations over time (p > 0.01) and seven solutions presented isolated but statistically significant variations.
CONCLUSIONS
We may assume that the nine solutions with pH values within the ocular comfort range will not produce initial discomfort. The solutions with acid pH values will produce initial discomfort. The solutions with nonstatistically significant pH variations over 30 days in relation to their initial pH values presented great stability.
背景
在本研究中，我们评估了17种眼科溶液的pH值，并研究了这些溶液在打开瓶子后其pH值是否随时间变化。
方法
从不同生产批次中随机选取每种溶液的15瓶。从每瓶中取出0.05毫升增量，在30天的时间内每天使用Crison micropH 2002 pH计进行测量。
结果
结果显示溶液的pH值之间存在差异；9种溶液的pH值在眼部舒适范围内，8种溶液的pH值在3.5至6.4之间。10种溶液随时间呈现无统计学意义的变化（p>0.01），7种溶液呈现孤立但有统计学意义的变化。
结论
我们可以假设pH值在眼部舒适范围内的9种溶液不会产生初始不适。酸性pH值的溶液会产生初始不适。与初始pH值相比，在30天内pH值无统计学意义变化的溶液具有很高的稳定性。
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