<p><b>OBJECTIVE</b>To develop
animal models and methodologies for assay of pseudoallergy induced by
injectable drugs.</p><p><b>
METHOD</b>
Mouse anaphylactoid reaction model was developed by
intravenous injection of test substance
solutions containing
Evans blue (EB). Scores of
ear blue
staining and quantitation of
ear EB exudation were the
parameters for the pseudoallergy reaction.</p><p><b>RESULT</b>
Mouse anaphylactoid reaction was characterized as vascular hyperpermeability which was detectable in
ears by quantitation of blue
staining score and EB exudation. Compound 48/80 and
histamine caused severe
ear bluing and EB exudation by inducing obvious vascular hyperpermeability which indicated that they can induce
mouse pseudoallergy.
Intravenous injection of either
normal saline or 5%
glucose injection showed no
ear bluing. The
mouse pseudoallergy model was validated by
intravenous injections of western
drugs and
Chinese medicine.</p><p><b>CONCLUSION</b>
Mice could be developed into pseudoallergy model for preclinical
safety evaluation of
injectable drugs. The pseudoallergy reaction in this model is of high clinic consistency,
sensitivity, reproducibility, and maneuverability. The model is suitable for the evaluation for pseudoallergy induced by
injectable products prepared from
Chinese materia medica This model can also be used for
safety assay and
quality control in manufacturing process, spot checking of marketed products,
screening of
allergen as well as studying of pseudoallergy mechanism.</p>