Christiansen C, Kryvi H, Sontum P C, Skotland T
Research and Development Section, Nycomed Imaging AS, Oslo, Norway.
Biotechnol Appl Biochem. 1994 Jun;19(3):307-20.
Albunex is a new ultrasound contrast agent for medical imaging. The product consists of air-filled albumin microspheres suspended in a solution of 5% (w/v) human albumin. The suspension is sterile, non-pyrogenic and isotonic, with a pH of 7.0 and a viscosity of 1.4 relative to water. The contrast effect is caused by the air-filled microspheres, which range in diameter from 1 to 15 microns, with less than 5% being larger than 10 microns. The product contains a total of about 7 x 10(8) microspheres/ml of suspension. The number concentration of microspheres with diameters between 4 and 10 microns is about 2 x 10(8)/ml. The latter microsphere fraction is assumed to give the main contribution to the ultrasound signal in the left ventricle of the heart after intravenous injection. The air-filled microspheres are prepared by sonication of a heated solution of 5% (w/v) human albumin. During the sonication process, microbubbles of air are formed which become encapsulated in a thin shell of aggregated albumin about 15 nm in thickness. Due to the stabilizing effect of the albumin shell, the air-filled microsphere suspension is stable for at least 2 years when stored refrigerated. The microsphere protein represents about 1.5% of the total protein in the suspension. The remaining protein is soluble albumin molecules which behave like the albumin molecules in the starting material when analysed by a number of biochemical techniques.
Albunex是一种用于医学成像的新型超声造影剂。该产品由悬浮于5%(重量/体积)人白蛋白溶液中的充气白蛋白微球组成。该悬浮液无菌、无热原且等渗,pH值为7.0,相对于水的粘度为1.4。造影效果由直径为1至15微米的充气微球引起,直径大于10微米的微球占比不到5%。该产品每毫升悬浮液中总共含有约7×10⁸个微球。直径在4至10微米之间的微球数量浓度约为2×10⁸/毫升。假定静脉注射后,后一种微球组分对心脏左心室的超声信号起主要作用。充气微球通过对5%(重量/体积)人白蛋白的加热溶液进行超声处理制备。在超声处理过程中,形成空气微泡,这些微泡被包裹在厚度约为15纳米的聚集白蛋白薄壳中。由于白蛋白壳的稳定作用,充气微球悬浮液冷藏保存时至少可稳定2年。微球蛋白约占悬浮液中总蛋白的1.5%。其余蛋白为可溶性白蛋白分子,通过多种生化技术分析时,其行为与起始材料中的白蛋白分子相似。