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目的制备苦参碱眼用原位凝胶,建立其质量控制方法并进行相关评价。方法以脱乙酰结冷胶和海藻酸钠为基制备凝胶,采用高效液相色谱法测定含量,并进行稳定性试验,离体角膜渗透实验以及对家兔实验性眼炎的治疗作用等验。结果该制剂的pH值为7.5~8.0,苦参碱在10~60μg·mL-1内线性关系良好(r=0.9993),平均回收率为98.7%,RSD1.3%。本制剂能延长苦参碱的角膜接触时间,并对辣椒酊刺激引起的兔眼部炎症反应有抑制作用。结论该制剂制备工简便,性质稳定,质量可控。凝胶安全无刺激,对家兔实验性眼炎有较好的治疗效果。
OBJECTIVE To prepare in situ gels of matrine for ophthalmic use and to establish its quality control method and to evaluate the results. Methods The gels were prepared with deacetylated gellan gum and sodium alginate. The content of the gel was determined by high performance liquid chromatography (HPLC), and the stability test, in vitro corneal permeability test and the therapeutic effect on experimental ophthalmia in rabbits . Results The pH value of the formulation was 7.5 ~ 8.0. The linear range of matrine was 10 ~ 60μg · mL-1 (r = 0.9993). The average recovery was 98.7% and the RSD was 1.3%. The preparation can prolong the corneal contact time of matrine and inhibit the ocular inflammatory reaction of the rabbit caused by the chilli tincture stimulation. Conclusion The preparation of the preparation of simple, stable, quality controllable. Gel safe and stimulating, the experimental rabbit ophthalmia have a better therapeutic effect.