环孢素眼用乳剂的制备及质量控制  

Preparation and quality control of ciclosporin ophthalmic emulsion

作　　者：王延东[1] 陈茂玲[1] 叶成添[1] 唐细兰[1] 

机构地区：[1]中山大学中山眼科中心,广州510075

出　　处：《中国实用医药》2010年第12期7-9,共3页China Practical Medicine

基　　金：广东省医院药学研究基金项目(项目编号:2009B008)

摘　　要：目的研制低浓度的环孢素眼用乳剂,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,按处方制备低浓度的环孢素眼用乳剂,用高效液相色谱法测定环孢素的含量,观察家兔眼部刺激性,并对制剂的稳定性进行考察。结果环孢素在5～60 mg/L浓度范围内线性关系良好(r=0.9999),平均回收率为100.39%,相对标准偏差(RSD)为1.15%。滴眼后无刺激性,而且稳定性较好。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,是一种较理想的眼用制剂,可用于干眼症及其他眼部免疫性疾病的治疗。Objective To prepare low concentration ciclosporin ophthalmic emulsion and establish its quality control methods.MethodsLow concentration ciclosporin ophthalmic emulsion was prepared by means of the formula.Hypromellose was used as thickening agent and the content of ciclosporin was determined by HPLC.Stimulus of ciclosporin on rabbits＇ eye and the stability of low concentration ciclosporin ophthalmic emulsion were observed.ResultsThe calibration curve of ciclosporin was linear within the concentration range of 5~60 mg/L,r=0.9999.The average recovery of ciclosporin was 100.39%,（RSD=1.15%）.Ciclosporin had no stimulus on rabbits＇ eye and its stability was very good.ConclusionThe preparation is simple,its content determination is convenient and accurate,quality is stable,and it has stimulus on eyes.It is an ideal ophthalmic preparation and can be used to cure dry eyes and other ophthalmic immune diseases.

关 键 词：环孢素 眼用乳剂 制备 质量控制 

分 类 号：R944[医药卫生—药剂学]