摘要
目的探寻左氧氟沙星地塞米松眼用凝胶的优化处方及制备工艺,并建立其质量控制方法。方法以卡波姆934为凝胶基质,通过比较调整适宜浓度控制粘度,以氯化钠调节渗透压,氢氧化钠调节pH;采用紫外分光光度法测定主药含量,考察制剂稳定性。结果所得的制剂呈淡黄绿色透明状,盐酸左氧氟沙星和地塞米松磷酸钠的回收率分别为100.24%(RSD=0.83%)和100.35%(RSD=1.07%)。结论本法制备眼用凝胶的工艺简单易行,制剂质量稳定。
OBJECTIVE To explore the optimal prescription of levofloxacin dexamethasone ophthalmic gel and the proper preparation process of it, establish a quality control method of the formulation. METHODS Use carhomer 934 for gel matrix, control suitable viscosity by means of adjusting the concentration, add sodium chloride in order to regulate the osmotic pressure, use sodium hydroxide to adjust pH, adopt UV spectrophotometric to determine the content of main drugs and study the stability of the formulation. RESULTS The appearance of the formulation was light yellow-green and transparent, the recoveries of levofloxacin hydrochloride and dexamethasone sodium phosphate were 100.24% （RSD= 0.83% ）and 100.35% （RSD= 1.07% ） .CONCLUSION The process of preparation is simple and reliable, and the quality of the ophthalmic gel is stable.
出处
《海峡药学》
2010年第7期23-26,共4页
Strait Pharmaceutical Journal
