含玻璃酸钠海藻糖滴眼液的研究

Preparation of Trehalose Eye Drops Containing Sodium Hyaluronate

目的研制用于治疗眼干燥症的含玻璃酸钠(SH)海藻糖滴眼液。方法筛选合理处方;通过优化样品预处理条件,建立HPLC含量测定法;以泪液蒸发过强型小鼠眼干燥症模型评估其药效。结果用于含量测定样品预处理条件为氯化钠用量2·0%,无水乙醇与样品量的比值为2·5-4·0,静置30min,20μm滤膜过滤;平均回收率为100·6%,RSD为0·61%;与0·1%SH滴眼液相比,研制的滴眼液可使眼干燥症模型小鼠的泪液分泌量明显增加,荧光素染色评分显著改善,角膜和结膜上皮形态恢复正常,杯状细胞密度显著提高。结论研制的含玻璃酸钠海藻糖滴眼液处方合理,质量可控,治疗眼干燥症有效。

OBJECTIVE To study and develop trehalose eye drops containing SH for the treatment of ophthalmoxerosis. METHODS The formulation of the eye drops was selected. By optimization of samples pretreatment conditions, the method for determining the content of trehalose in the eye drops was established. The effects on the ophthalmoxerosis in the model of mice were evaluated. RESULTS The conditions of samples pretreatment for assay were as follows：2.0% sodium chloride, 2. 5 - 4. 0 ratio of the volume of anhydrous alcohol to the sample, standing for 30min, filtrated by 20 μm film. The mean recovery was 100.6% with RSD of 0. 61%. Fluorescein staining scores, tear secretion, and goblet cells density were improved significantly as well as corneal and conjunctiva epithelial morphology were recovered with trehalose eye drops compared with 0.1% SH. CONCLUSION Trehalose eye drops containing SH with reasonable formulation is effective for the treatment of ophthalmoxerosis.