透明质酸滴眼剂制备及其临床初步应用

Preperation of hyaluronic acid eye drops and its preliminary application

选用新鲜正常人脐带为原料,经蛋白水解酶酶解消化,氯代十六烷基吡啶和乙醇分次沉淀,获透明质酸粗品,精制成钠盐成品。其核酸含量为2.67%,蛋白质含量为0.50%,锥板粘度为1.87mPa·?毛细管粘度为1.79mPa·s,pH为6.9。紫外和红外吸收图谱与文献报道基本一致。理化分析结果及质量已达眼科外用要求。将成品配制成滴眼剂,经动物实验证明,无致炎及毒副作用。作为辅助治疗用药经临床试用,对干眼症等疾病治疗,收到了较好效果。

Coarse hyaluronic acid was extracted from normal human fresh umbilical cord by tryps in digestion and fractional precipita-tion by cetylpyridine chloride and ethanol respectively. The refined sample was prepared as sodium salt, its preperty was as fol-low: nucleic acid 2.67 percent, protein 0.50 percent, rotary viscosity 1.87mPa. s, capillary viscosity 1.79mPa. s. pH value 6.9. The ultraviolet and infrared spectra were in concordance with those reported in the literature. The results showed that its quali-ty had reached the standard for ophthalmologic treatment. Both animal experiments and clinic trials indicated that it had no in-flammatory, toxic adverse reaction, and had a good effect on xerophthalmia.