›› 2010, Vol. 30 ›› Issue (2): 244-.

• 技术与方法 • 上一篇    下一篇

分光光度法测定角膜接触镜护理液中泊洛沙姆含量

李家忠, 张 莉, 何 涛, 齐伟明   

  1. 国家食品药品监督管理局 杭州医疗器械质量监督检验中心, 杭州 310009
  • 出版日期:2010-02-25 发布日期:2010-02-25
  • 作者简介:李家忠(1956—), 男, 高级工程师;电子信箱: hzljz12@163.com。

Spectrophotometric study of Poloxamer in contact lens care solution

LI Jia-zhong, ZHANG Li, HE Tao, QI Wei-ming   

  1. Medical Device Supervising and Testing Center of Hangzhou, State Food and Drug Administration, Hangzhou 310009, China
  • Online:2010-02-25 Published:2010-02-25

摘要:

目的 用分光光度法测定角膜接触镜护理液中泊洛沙姆的含量,探讨护理液中其他润滑成分对测定的影响。方法 选择市场上5种含有羟丙甲纤维素(HPMC)的多功能护理液,采用加热、迅速过滤的方法除去HPMC干扰后,采用以碘-碘化钾溶液为显色剂的分光光度法测定泊洛沙姆的含量。结果 经过处理后的护理液分光光度法测定波长为500 nm,显色时间为120 min。泊洛沙姆的浓度范围在0.001~0.020 mg/mL内线性良好,标准曲线方程为Y=0.050 91X+0.017 15, r2=0.998 2。精密度实验(n=6)显示,精密度(RSD)为1.331 4%,日间重复性RSD为2.971 3%;回收率实验显示,80%、100%和120%的样品回收率为90%~105%。结论 以碘-碘化钾溶液为显色剂的分光光度法操作简单、方法稳定且准确,可作为角膜接触镜护理液中有效成分泊洛沙姆质量控制的方法之一。

关键词: 非离子表面活性剂, 分光光度法, 角膜接触镜护理液

Abstract:

Objective To determine the contents of Poloxamer in contact lens care solution by spectrophotometric method, and investigate the effect of the other lubrication composition on the measurement. Methods Five brands of contact lens care solution with hydroxypropyl methyl cellulose (HPMC) were obtained. The interference of HPMC in contact lens care solution was removed by heating and rapid filtering, and the contents of Poloxamer was determined by KI-I2 spectrophotometry. Results For the pre-treated contact lens care solution, the tested wavelength was 500 nm and the development time was 120 min. Favourable linearity was observed when Poloxamer ranged between 0.001 mg/mL and 0.020 mg/mL, with standard curve of Y=0.050 91X+0.017 15 and r2=0.998 2. Precision (n=6) test revealed that RSD was 1.331 4%, and RSD of daytime repeatability experiment was 2.971 3%. The recovery rates of 80%, 100% and 120% samples ranged between 90% to 105%. Conclusion KI-I2 spectrophotometry is a convenient, stable and reliable method, and may serve as a mass control method for nonionic surfactant Poloxamer content in contact lens care solution.

Key words: nonionic surfactant, spectrophotometry, contact lens care solution