| 摘要 |
Composition (C1) comprising albumin particles stained with a disazo dye, where at least 90% of the particles have a size of 5-1500 nm and the dye has an absorption peak at a wavelength of 550-680 nm, is new. Independent claims are also included for: (1) production of C1 by mixing the dye with the albumin particles, stirring the mixture, removing unbound dye by column chromatography or filtration and concentrating the product; (2) production of C1 by heating an aqueous albumin solution to 75-100degreesC, adding the dye, separating the stained albumin and suspending it in water, sonicating the suspension to produce particles of the desired size, removing any undersized particles or free dye by filtration, and monitoring the particle size distribution with a light microscope; (3) pharmaceutical composition (C2) comprising C1 in sterile pyrogen-free form in a solvent; (4) contrast agent (C3) for marking sentinel lymph nodes in human tissue, comprising albumin particles stained with Evans blue in sterile pyrogen-free form, where more than 95% of the particles have a size of 25-1000 nm; (5) surgical tumor treatment comprising injecting C2 or C3 into the tumor or its immediate vicinity before the operation, waiting until the composition flows through the lymph system and reaches the sentinel lymph nodes, and surgically removing the tumor and stained lymph node(s) and checking the latter for metastases.
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