复方夫西地酸眼用乳剂的制备及质量控制  

Preparation and quality control of compound fusidic acid ophthalmic emulsion

作　　者：王延东[1] 马淑媚[1] 吴伟[1] 唐细兰[1] 

机构地区：[1]中山大学中山眼科中心,广州510060

出　　处：《中国临床药学杂志》2010年第1期29-32,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的制备复方夫西地酸眼用乳剂并建立该制剂的质量控制方法。方法采用羟丙甲纤维素为增稠剂,按处方制备复方夫西地酸眼用乳剂,根据《中国药典》2005年版眼用制剂项下规定建立其质量控制方法,并用HPLC法分别测定该制剂中夫西地酸和地塞米松磷酸钠的含量。结果夫西地酸、地塞米松磷酸钠的检测浓度线性范围分别为20～120 mg·L^(-1)和6.25～200 mg·L^(-1),平均回收率分别为99.57%(RSD为1.53%)和99.62%(RSD为0.60%),方法重现性的RSD分别为0.46%(n=6)和0.29%(n=6);滴眼后无刺激性,质量稳定有效期在1 a以上。结论该制剂制备工艺简单,含量测定方法简便、准确,质量稳定,对眼部无刺激性。AIM To prepare compound fusidic acid ophthalmic emulsion and establish its quality control methods. METHODS Compound fusidic acid ophthalmic emulsion was prepared in accordance with prescription. Hypromellose was used as thickening agent. Quality control methods of compound fusidic acid ophthalmic emulsion were established according to Chinese Pharmacopoeia（2005）, and the contents of fusidic acid and dexamethasone sodium phosphate were determined by HPLC. RESULTS The calibration curve of fusidic acid and dexamethasone sodium phosphate were linear within the concentration range of 20 - 120 mg·L^-1 and 6.25 - 200 mg·L^-1, respectively. The average recovery rates were 99.57 % （RSD = 1.53 % ） and 99.62 % （RSD = 0.60% ） respectively, and the RSD of the repeatability test were 0.46% （n = 6） and 0.29% （n = 6） respectively. Compound fusidic acid ophthalmic emulsion had no stimulus on rabbits＇ eyes and was stable in one year. CONCLUSION The preparation process is simple. The method of content determination is convenient and accurate. The quality is stable, and compound fusidic acid ophthalmic emulsion has no stimulus on eyes.

关 键 词：夫西地酸 地塞米松磷酸钠 眼用乳剂 制备 质量控制 

分 类 号：R944[医药卫生—药剂学]