氢地油乳剂的制备及质量控制  

Preparation and Quality Control of Qindiyou Emulsion

作　　者：张全梅[1] 葛继红[1] 张茂慧[1] 刘冰[1] 

机构地区：[1]新疆医科大学第一附属医院药剂科,乌鲁木齐市830054

出　　处：《中国药房》2008年第22期1730-1731,共2页China Pharmacy

摘　　要：目的:制备氢地油乳剂并建立其质量控制方法。方法:采用乳化法,以盐酸丁卡因为主药制备氢地油乳剂;采用紫外分光光度法测定其中盐酸丁卡因的含量;考察3批样品的稳定性。结果:所制制剂为白色乳状物;盐酸丁卡因检测浓度的线性范围为3.168～9.504μg.mL-1(r=0.9999),平均回收率为99.68%(RSD=0.49%)。3批样品经留样试验考察,质量稳定。结论:该制剂制备方法简便,含量测定准确,质量在保质期内稳定可控。OBJECTIVE： To prepare qingdiyou emulsion and to establish its quality control. METHODS： Qindiyou emulsion was prepared by emulsification by using tetracaine hydrochloride as principal agent. The content of tetracaine hydrochloride was determined by UV spectrophotometry. The stability of 3 batches of samples was investigated. RESULTS： The preparation was white emulsion. The linear range of tetracaine hydrochloride was 3.168-9.504 μg·mL^-1（r = 0.999 9）, with an average recovery rate of 99.68% （RSD=0.49% ） . The 3 batches of sample preparations were proved to be stable in quality. CONCLUSION： This method is simple in operation, accurate in content determination, and stable and controllable in quality within expiration date.

关 键 词：氢地油乳剂 盐酸丁卡因 制备 质量控制 

分 类 号：R927.2[医药卫生—药学] R944