苦参碱离子敏感型原位凝胶的制备与评价

Preparation and Evaluation of Ion-activated In Situ Gels for Matrine

关键词:  原位凝胶  苦参碱  高效液相色谱法  实验性眼炎

Key words:  in situ gels  matrine  HPLC  experimental ophthalmia

摘要:

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质制备凝胶，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试验。结果 该制剂的pH值为7.5~8.0，苦参碱在10~60 μg·mL^-1内线性关系良好(r=0.999 3)，平均回收率为98.7％，RSD为1.3％。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 该制剂制备工艺简便，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。

Abstract:

OBJECTIVE To prepare the in situ gelling of matrine for ocular use, methods of quality monitoring and evaluating the preparation were established. METHODS HPLC was adopted to measure the contents of Gelrite alginate-based in situ gellings. As a complement, the results of stability studies, in vitro studies and the ability to inhibit ocular inflammation were obtained. RESULTS The pH values of formulations were 7.5-8.0, linear relationships for matrine between 10-60 μg·mL^-1 were good(r=0.999 3). The average recovery rate was 98.7%, RSD was 1.3%. The gels could prolong the contact time upon the cornea and markedly inhibit ophthalmic inflammation caused by the tincture of chili. CONCLUSION The preparation was stable, safe, anti-irritation and effective for the experimental ophthalmia, while using HPLC to control its quality was feasible.