注射用过氧化碳酰胺氯化钠的研制  

Study of Carbamide Peroxide and Sodium Chloride for Injection

作　　者：李健和[1] 彭六保[1] 曹俊华[1] 刘艳文[1] 黎银波[1] 谭重庆[1] 万小敏[1] 

机构地区：[1]中南大学湘雅二医院药剂科,长沙410011

出　　处：《中国药物应用与监测》2009年第2期101-104,123,共5页Chinese Journal of Drug Application and Monitoring

基　　金：湖南省卫生厅科研基金课题(B2006-037)

摘　　要：目的:研制一种使用方便、易于保存的高氧高渗药物,满足临床严重休克等急救病人的治疗需求。方法:优化处方组成与制备工艺,并进行性状、鉴别、检查等质量研究,采用容量法测定过氧化氢和氯化钠的含量,血管刺激性实验、溶血性实验以及过敏性实验评价其用药的安全性。结果:碘量法和银量法分别测定过氧化氢和氯化钠的线性关系良好,其平均回收率分别为34.78%,99.91%,RSD分别为1.08%,0.54%。结论:该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。Objective： To develop a hyperoxia and hyperosmotic preparation which is convenient to use and easy to preserve, to meet the needs of emergency patients such as severe shock, et al. Methods： The prescription and preparation technology was optimized. The characterization, identification and examination were tested. Volumetric method was applied to determine the contents of hydrogen peroxide and sodium chloride, and the safety was evaluated by testing the vessel stimulation, haemolyticus and hypersensitivity. Results： The linear regression data for both of the contents of hydrogen peroxide and sodium chloride showed a good linearity relationship and the average recovery was 34.78% （RSD was 1.08%） and 99.91% （RSD was 0.54%） by iodometry and argentometry, respectively. Conclusion： The preparation is reasonable in formulation, simple and convenient in preparation technique, accurate in quality control, good in stability, and safe in application.

关 键 词：过氧化碳酰胺 氯化钠 注射用无菌粉末 制备 质量控制 安全性 

分 类 号：R943[医药卫生—药剂学] R92[医药卫生—药学]