静脈内投与された不溶性微粒子の体内分布

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For particulates forming as a result of precipitation in intravenous injections and those arising from injection devices, we examined their distribution in tissue distribution following intravenous administration. Barium sulfate was used as the particulate and 100% (w/v) suspensions of varying particle size (1.5, 5.0, 10.0μm) were prepared. Each test suspension was injected into the caudal vein of ICR mice in a single dose of 0.1 mL/10 g and whole-body radiography was performed. Each suspension was also injected into the internal jugular vein of Hartley guinea pigs in a single dose of 5 mL/kg and major organs were collected for radiographic examination. The experiments were model-like and barium sulfate was injected in large quantities. The whole-body radiography of the mice revealed the presence of barium sulfate in the lungs, heart, kidneys, liver and external carotid arteries and the radiography of the guinea pig organs showed that barium sulfate was present in the lungs, heart, coronary artery, kidneys and liver. There were no obvious differences in tissue distribution for the three different particle sizes. Our findings indicate that particulates of less than 10.0/^m could possibly be distributed throughout the body by passing through the lungs after intravenous dosing. The Japanese Pharmacopoeia places no restriction on particle fineness of 10μm or less to prevent pulmonary embolism and the results of the present study indicate that it is essential to eliminate particles of such size through the incorporation of a final filter (0.22μm).
日本医療薬学会の論文
2007-06-10

静脈内投与された不溶性微粒子の体内分布

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