<p><b>OBJECTIVE</b>To investigate the
safety of different level of
tween 80 by comparing the degree of pseudoanaphylactoid reactions (PR) induced by medicinal
tween 80 and
injectable tween 80.</p><p><b>
METHOD</b>The
analysis of
vascular permeability of the
mice ears ICR mouse were divided into different test groups, the
mice were intravenously injected with
solutions of medicinal
tween 80 and
injectable tween 80 with 0.2%, 1% and 5% concentration, positive control Compound 48/80 and 5%
glucose injection. All test substances were mixed with 0.4%
Evans blue. The reaction and
vascular permeability of the
ears were observed and measured 30 min after
injection. The
analysis of
vascular permeability of the
rat's
skin the
rats were intravenous injected with 0. 6%
Evans blue normal saline solution first, 10 minutes later, the same substances were intradermal administrated into the
back of
rats. The
rats were sacrificed and the diameter of
locus ceruleus and the content of
Evans blue leak out were measured 20 min after
injection.</p><p><b>RESULT</b>Medicinal
tween 80 and
injectable tween 80 with 5% concentration caused obvious vascular hyper
permeability in
ICR mice, but the degree of vascular hyperpermeability caused by
injectable tween 80 was lighter than by medicinal
tween 80. Other
tween 80 didn't cause obvious vascular hyper
permeability in the
ears of
mouse. The
solution of different concentration of
tween 80 caused obvious
locus ceruleus reaction in
rat's
back. As for the content
Evans blue leak out, there was no statistical significance between each group except positive control Compound 48/80 group.</p><p><b>CONCLUSION</b>
Tween 80 can cause obvious vascular hyper
permeability and the effect is
dose dependent, which indicated that
tween 80 can cause PR. On the other
hand,
injectable tween 80 is more security than medicinal
tween 80, the
dosage of
tween 80 should be still controlled strictly so that to decrease the
incidence of PR.</p>