Anti-edema agent

Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,...

Reexamination Certificate

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C514S002600, C514S021800

Reexamination Certificate

active

06238665

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to suppression of edema formation and suppression against an increase of vascular permeability of the blood-brain barrier using an anti-edema agent containing histamine-added immunoglobulin as an effective component.
BACKGROUND OF THE INVENTION
A complex of immunoglobulin and histamine has been known as a drug preparation, histamine-added immunoglobulin. It restores histamine fixing ability which is lowered in patients suffering from allergy and asthma. Accordingly, histamine-added immunoglobulin is used as an agent for nonspecific hyposensitizing therapy for bronchial asthma, allergic rhinitis, vasomotor rhinitis and allergic skin diseases such as urticaria, chronic eczema, atopic dermatitis, etc. Histamine-added immunoglobulin also exhibits suppressive action to liberation of histamine. It does not exhibit side effects exhibited by antihistamines and adrenocortical hormones used as symptomatic remedies. It has therefore been widely used as a pharmaceutical agent with high safety. See pages 463 and 464 of “Drugs in Japan, Ethical Drugs,” edited by Japan Pharmaceutical Information Center; published by Yakugyo Jiho Co., Ltd., Japan in October 1996.
In addition to said medical indications, it has been reported that histamine-added immunoglobulin has a suppressive action against hypereosinophilicity, immunomodulating action and the like, and the oral administration of histamine-added immunoglobulin expresses the same pharmacological activity as shown by usual hypodermic injection. See, for example, Japanese Laid-Open Patent Publications Hei-7/53406, and Hei-9/31311. However, there has been no report regarding a suppressive action against edema formation and a suppressive action against an increase of vascular permeability of the blood-brain barrier which is exhibited by histamine-added immunoglobulin.
The present inventor has conducted an extensive investigation on histamine-added immunoglobulin and found that it also has a suppressive action against edema and a suppressive action against an increase of vascular permeability of the blood-brain barrier. The present invention provides an anti-edema agent, a suppressive agent against edema formation, and a suppressive agent against an increase of vascular permeability of the blood-brain barrier containing histamine-added immunoglobulin as an effective component. The anti-edema and suppressive agents have a high degree of safety with little side effects.
SUMMARY OF THE INVENTION
Edema, edema formation, and an increase of vascular permeability of the blood-brain barrier are substantially suppressed by administering to a patient in need of such treatment a pharmaceutical composition comprising a pharmaceutically effective amount of a histamine-added immunoglobulin and a pharmaceutically acceptable carrier. The histamine-added immunoglobulin may be prepared by dissolving about 1 mg to about 200 mg, preferably about 5 mg to about 50 mg, of immunoglobulin and about 0.01 &mgr;g to about 2 &mgr;g, preferably about 0.05 &mgr;g to about 0.5 &mgr;g, of a histamine component in a pharmaceutically acceptable solution.


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