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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
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
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
ultrasound contrast agent
quanfuxian
perfluorocarbon
size distribution analysis
purge and trap con-centrator - GC - MS
