复方妥布霉素滴眼液的质量控制及刺激性研究  

Study on the Quality Control and Irritation of Compound Tobramycin Eye Drops

作　　者：杨詹詹[1] 郑涛[1] 赵寅[1] 莫莎莎[1] 梅之南[1] 

机构地区：[1]中南民族大学药学院,武汉430074

出　　处：《中国药师》2011年第12期1764-1766,共3页China Pharmacist

摘　　要：目的:建立复方妥布霉素滴眼液的质量控制方法并对其进行刺激性研究。方法:采用高效液相色谱法测定复方妥布霉素滴眼液中主药的含量。给家兔右眼滴用复方妥布霉素滴眼液,每天5次,连续21 d后观察兔眼结膜、角膜、虹膜的刺激反应并评分。结果:妥布霉素和地塞米松分别在10.00～100.00 mg·L^(-1)(r=0.999 7)和6.25～200.00 mg·L^(-1)(r=0.999 8)范围内呈良好的线性关系,家兔眼刺激的综合平均分值在0～2范围内。结论:该方法简便快速,结果准确可靠,可用于复方妥布霉素滴眼液的定量分析。该滴眼液对家兔眼无明显刺激。Objective： To study the irritation and quality control of compound tobramycin eye drops. Method： HPLC was used to detect the main components of compound tobramycin eye drops. The right eye of each rabbit was treated with compound tobramycin eye drops five times a day for twenty-one days and the irritation reaction of conjunctiva,cornea and iris of rabbit eyes was observed for sco- ring. Result： The linear range of tobramycin and dexamethasone was 10. 00-100. 00 mg-L-1 （r =0. 999 7） and 6.25-200. 00 mg.L-1 （ r = 0. 999 7） ,respectively. The comprehensive score range of the irritation in rabbit eyes was 0-2. Conclusion： The method as a recommendable option for the quality control of the main components in compound tobramycin eye drops is accurate and simple. The eye drops show no obvvious irritation on rabbit eyes.

关 键 词：复方妥布霉素滴眼液 妥布霉素 地塞米松 质量控制 刺激性 

分 类 号：TQ460.72[医药卫生—药物分析学]