环孢素眼用乳剂的制备和含量测定  

Preparation and Determination of Cyclosporine Ophthalmic Emulsion

作　　者：陈宇翔[1] 王娟[1] 魏宗有[1] 陈忠[1] 陈韡彬 江宁宇[1] CHEN Yuxiang WANG Juan WEI Zongyou CHEN Zhong CHEN Weibin JIANG Ningyu(Fujian Institute of Microbiology, Fuzhou, Fujian 350007, Chin)

机构地区：[1]福建省微生物研究所,福建福州350007

出　　处：《今日药学》2017年第1期24-25,29,共3页Pharmacy Today

基　　金：福建省自然科学基金(2014J01274);福州市科技计划项目(2016X0014);福建省化药技术重大研发平台(2014Y2001);福州市生物制药行业技术创新中心(2016-PT-36)

摘　　要：目的研究环孢素眼用乳剂的制备,建立含量测定方法。方法采用高压均质机制备环孢素眼用乳剂,以高效液相色谱法(HPLC)测定环孢素含量,Gemini C_(18)柱为色谱柱;流动相:乙腈∶水∶甲醇∶磷酸(550∶400∶50∶0.5,v/v),柱温:70℃,流速:1 m L·min^(-1),紫外检测波长:210 nm。结果在0.099 5~0.278 6 mg·m L^(-1)范围内,环孢素峰面积和质量浓度呈良好的线性关系,平均回收率为99.1%,RSD为0.84%。结论该处方和制备工艺可行,含量测定方法准确、可靠。OBJECTIVE To establish the procedures to produce cyclosporine ophthalmic emulsion and a method for the determination. METHODS Cyclosporine ophthalmic emulsion was prepared by a high-pressure homogenization. The separation was performed on Gemini C18 column,the mobile phase was acetonitrile-water-methanol-phosphoric acid（ 550 ∶ 400 ∶ 50 ∶ 0. 5,v / v）,with the flow rate of 1m L·min^-1,the detection wavelength was at 210 nm and column temperature was 70 ℃. RESULTS The calibration curve of cyclosporine ophthalmic emulsion was linear within the conventration range of 0.099 5-0.278 6 mg·mL^-1.The average recovery rate of cyclosporine ophthalmic emulsion was 99. 1%（ RSD = 0. 84%）. CONCLUSION The formulation and preparation technology is feasible,and the determination method is accurate and reliable.

关 键 词：环孢素眼用乳剂 环孢素 高效液相色谱法 制备工艺 

分 类 号：R927.2[医药卫生—药学]