摘要
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.
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.
出处
《药学研究》
CAS
2015年第12期719-721,730,共4页
Journal of Pharmaceutical Research
关键词
正交试验
氟康唑
卡波姆
硼砂
滴眼凝胶
质量控制
Orthogonal test
Fluconazole
Carbomer
Borax
Ophthalmic gel
Quality control
