Research on Evaluating Method of Location of Dyeing Materials for Color Contact Lenses / 中国医疗器械杂志

Combining frozen section and scanning electron microscopy experiments to observe the cross section and surface state of the samples, this study finds an effective method to evaluate the location of dyeing materials of color contact lenses. Sixty samples were evaluated on their dyeing location statistically using this method. The results showed that there were only 7 lots of samples with their dyeing materials within their product. This method is effective in evaluating the location of dyeing materials for color contact lenses.

Determination of Residual Organic Solvents in Bromfenac Sodium by Headspace Gas Chromatography / 中国药师

Objective:To establish a headspace capillary GC method for the determination of residual solvents in bromfenac sodi-um. Methods:A headspace GC was used to separate the residual solvents on an HP-5 capillary column with an FID detector. The car-rier gas was nitrogen at the flow rate of 0. 8 ml·min-1 . The temperature of the injector was 200 ℃ and that of the FID was 250 ℃. The programmed column temperature was set as follows:maintained at 40℃ for 10 min, and then raised to 150℃ at the rate of 30℃·min-1 and maintained for 5 min. The containers of headspace injector were in equilibrium at 100 ℃ for 20 min. Dimethyl sulfoxide was used as the solvent. The amount of the residual solvents, such as methylbenzene, isopropanol, dichloromethane, methanol and iso-propyl ether was calculated by an external standard method. Results:All the solvents could be completely separated with good linear relationship. The average recovery of the five solvents was 98. 9%( RSD =2. 01%),99. 2% ( RSD =1. 95%),99. 6% ( RSD =1. 65%),100. 5%(RSD=1. 38%)and 100. 8%(RSD=1. 36%)(n=9),respectively. Conclusion:The method is simple and accu-rate in the determination of the five residual solvents in bromfenac sodium.