药学研究
藥學研究
약학연구
Journal of Pharmaceutical Research
2015年
12期
719-721,730
,共4页
满玉清%魏传梅%刘明华%左小信%胡丽敏
滿玉清%魏傳梅%劉明華%左小信%鬍麗敏
만옥청%위전매%류명화%좌소신%호려민
正交试验%氟康唑%卡波姆%硼砂%滴眼凝胶%质量控制
正交試驗%氟康唑%卡波姆%硼砂%滴眼凝膠%質量控製
정교시험%불강서%잡파모%붕사%적안응효%질량공제
Orthogonal test%Fluconazole%Carbomer%Borax%Ophthalmic gel%Quality control
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。
目的：製備氟康唑滴眼凝膠併建立質量控製方法。方法採用正交設計對基質處方進行優化；用高效液相色譜法測定氟康唑的含量，併進行製劑刺激性及穩定性攷察。結果氟康唑眼凝膠最佳基質處方為（質量體積比）：卡波姆-9400.3%，硼砂0.4%，甘油2%；氟康唑進樣量在1.0~8.0μg 的範圍內線性關繫良好（ r =0.9998），加樣迴收率為99.43%（RSD =0.75%）；製劑無刺激性，穩定性好。結論氟康唑滴眼凝膠處方閤理，質量可控。
목적：제비불강서적안응효병건립질량공제방법。방법채용정교설계대기질처방진행우화；용고효액상색보법측정불강서적함량，병진행제제자격성급은정성고찰。결과불강서안응효최가기질처방위（질량체적비）：잡파모-9400.3%，붕사0.4%，감유2%；불강서진양량재1.0~8.0μg 적범위내선성관계량호（ r =0.9998），가양회수솔위99.43%（RSD =0.75%）；제제무자격성，은정성호。결론불강서적안응효처방합리，질량가공。
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.
