南方医科大学学报

南方医科大学学报 ›› 2006, Vol. 26 ›› Issue (06): 788-790.

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全氟丙烷人血白蛋白微球注射剂中全氟丙烷气体含量测定

杨凌； 陈志良；   

  1. 南方医科大学南方医院药材科； 南方医科大学南方医院药材科 广东广州510515； 广东广州510515；
  • 出版日期:2006-06-20 发布日期:2006-06-20
  • 基金资助:
    国家重点科技攻关项目(969010588)~~

Determination of octafluoropropane content in human albumin micropheres loaded with octafluoropropane

YANG Ling, CHEN Zhi-liang Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China   

  1. 南方医科大学南方医院药材科； 南方医科大学南方医院药材科 广东广州510515； 广东广州510515；
  • Online:2006-06-20 Published:2006-06-20

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摘要： 目的建立一种新型的测定全氟丙烷人血白蛋白微球注射剂中全氟丙烷气体含量的方法。方法采用气相色谱-质谱选择离子方式(GC-MS/SIM)。结果该方法在全氟丙烷浓度为40.92-16368nmol/L范围内,线性关系良好,标准曲线方程为Y=51.13X+40.38,R2=0.9999;其方法检测限为8.18nmol/L。在低(204nmol/L)、中(2046nmol/L)、高(8184nmol/L)3个浓度下回收率分别为(100.98±1.4)%、(102.63±2.29)%和(97.5±2.2)%;日内精密度RSD%分别为0.6%、1.67%和2.0%;日间精密度RSD%分别为0.86%、1.75%和2.3%。结论该方法简便、快速、灵敏、准确、精密度高,可作为质控的有效手段

Abstract: Objective To develop a method for determinating the octafluoropropane (OFP) content in human albumin micropheres loaded with OFP. Methods OFP content in the loaded human albumin micropheres was determined by means of gas chromatograpgy coupled with mass spetrum/selected ion monitoring (GC-MS/SIM). Results The calibration curve was linear within the concentration range of 40.92-16 368 nmol/L (R2=0.999 9). The limit of detection was 8.18 nmol/L, and the recovery?rate was (100.98±1.4)% (204 nmol/L), (102.63±2.29)% (2 046 nmol/L) and (97.5±2.2)% (8 184 nmol/L), respectively. The intra-day and inter-day RSDs were 0.6%-2.0% and 0.86%-2.3%, respectively. Conclusion The method of GC-MS/SIM is accurate, sensitive, precise and applicable for OFP determination in the microspheres. 

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