超声造影剂全氟显质量标准的研究  

Studies on quality specification for ultrasound contrast agent of Quanfuxian

作　　者：杨莉[1] 王新亚[1] 刘世霆[1] 

机构地区：[1]南方医科大学南方医院药学部,广州510515

出　　处：《药物分析杂志》2006年第1期17-19,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重点科技攻关项目

摘　　要：目的:对全氟显进行质量标准研究。方法:采用库尔特仪对微囊浓度及粒径分布进行分析,应用吹扫捕集-GC-MS 联用仪测定微囊中全氟丙烷包裹量。结果:本品直径在7μm以下的微囊百分含量不低于95%,采用吹扫捕集-GC-MS 法测定全氟丙烷含量的线性范围为84.0～503.6ng,r=0.9998,平均回收率为95.7%,RSD 为3.4%。结论:建立的质控方法准确可靠,能有效地控制制剂质量,保证产品安全有效。Abstract Objective： To establish methods for quality control of Quanfuxian. Methods：Microcapsule concentration and size distribution was measured with a Coulter Mutisizer Ⅱ, and the content of perfluorocarbon was determined by a HP5972 GC/MS coupled with Tekmar 3000 purge and trap concentrator. Results：More than 95% of microcapsules 〈 7 μm in diameter. Perfluorocarbon showed a good linear relationship in the range of 84. 0 - 503.6 ng,r =0. 9998. The average recovery was 95.7% ,and RSD was 3.4%. Conclusion：The methods are accurate and reliable, and can control the quality of this preparation effectively.

关 键 词：超声造影剂 全氟显 全氟丙烷 粒度分析 吹扫捕集-GC—MS 

分 类 号：R917[医药卫生—药物分析学]