氟康唑滴眼凝胶的制备与质量控制

摘要

Objective To prepare Fluconazole Ophthalmic Gel and establish its quality control standards. Methods the matrix formulation was optimized by orthogonal design;HPLC was used to determine the content of fluconazole,and in-vestigate the stimulating and stability of the preparation. Results The best prescription of Fluconazole Ophthalmic Gel for quality(mass to volume ratio)were:carbomer - 940 0. 3% ,borax 0. 4% and glycerol 2% . The linear range of fluconazole was 1. 0 ~ 8. 0 μg(r = 0. 999 8),and the average recovery was 99. 43%(RSD = 0. 75% );The prescription was stable and nonirritating. Conclusion The prescription of Fluconazole Ophthalmic Gel was reasonable,and the quality was controlla-ble.%目的：制备氟康唑滴眼凝胶并建立质量控制方法。方法采用正交设计对基质处方进行优化；用高效液相色谱法测定氟康唑的含量，并进行制剂刺激性及稳定性考察。结果氟康唑眼凝胶最佳基质处方为（质量体积比）：卡波姆-9400.3%，硼砂0.4%，甘油2%；氟康唑进样量在1.0~8.0μg 的范围内线性关系良好（ r =0.9998），加样回收率为99.43%（RSD =0.75%）；制剂无刺激性，稳定性好。结论氟康唑滴眼凝胶处方合理，质量可控。