Symptomatic relief of allergic reactions

Details Symptomatic relief of allergic reactions Symptomatic relief of allergic reactions

1999-07-08

2001-01-30

Lilling, Herbert J. (Department: 1651)

Drug, bio-affecting and body treating compositions

Antigen, epitope, or other immunospecific immunoeffector

Conjugate or complex

Reexamination Certificate

active

06180106

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to pharmaceutical compositions and methods for the treatment of mammals suffering symptoms of allergic reactions.
2. Brief Description of Related Art
An allergy is defined as an immune response in a mammal induced by an environmental antigen that has deleterious effects resulting in significant tissue damage and inflammation. Allergies comprise one of the most common medical problems in the twentieth century with some estimates suggesting that as many at 10% of the population may be affected. The antigen (allergen) is a non-parasitic antigen and the immune response is generally a type I hypersensitivity reaction. This reaction, which comprises mast cell or basophil degranulation manifests itself clinically in disorders related to biological effects of mediators released by the degranulation. These mediators are pharmacologically active agents that act on local tissues to increase vascular permeability and inflammation. Primary mediators such as histamine, serotonin, protease, prostaglandins SRS-A and similar substances released during degranulation may actually be more detrimental than beneficial to the comfort and well-being of the affected individual. The biological effects are the symptoms of the hypersensitivity reactions.
The classical treatment of type I hypersensitivity reactions has heretofore comprised administration of, for example, antihistamines or a process termed desensitization. Desensitization involves multiple injections and requires frequent visits to a doctor over a long period of time. Antihistamines are, of course, effective to relieve the symptoms associated with the type I hypersensitivity reaction. Antihistamine treatment suffers from problems including drying of the mucous membranes and sedation as well as manifest side effects of depression and drowsiness. In addition, antihistamines can interact with other medicines. Warnings are given to refrain from operating machinery when antihistamines are administered. Both methods are expensive.
Ideally, the treatment of the symptoms associated with allergic hypersensitivity reactions avoids the administration of antihistamines or blocks the other mediators in the allergic cascade causing a reduction in the symptoms.
It has been observed that traditional Chinese pharmacopoeia includes medicinals which have been time-tested for safety and effectiveness. For example, ginseng has been used in China for over 5,000 years. In a traditional Chinese medical context, ginseng is a “tonic” or “adaptogen” considered by many to be a substance which is not harmful and causes minimal changes or symptoms in the physiological functions of an organism. This herbal root is used throughout Asia to promote an overall sense of well being, stamina and strength. In this regard, it is believed by many that ginseng preparations act to modulate stress, replenish vital energy, improve performances under a wide variety of stressful conditions, increase blood volume, promote appetite, quiet the spirit and provide wisdom. It is, in fact, listed in the Merck Index as therapeutically an “aromatic bitter”.
However, even in traditional Chinese medicine ginseng is not considered a panacea. The general practioner, after determining a diagnosis and before prescribing medication, will map a course of treatment strategy. When he prescribes medication, including ginseng, he will always prescribe the ginseng in combination with some other remedy which, depending on the diagnosis, will operate in the same direction or in the opposite direction to bring the yin and yang into balance, even though the condition under treatment may respond to administration of ginseng alone.
SUMMARY OF THE INVENTION
The invention comprises a composition for oral or local administration to a mammal suffering a type I hypersensitivity reaction to an allergen, for the relief of symptoms associated with the reaction, which comprises; in admixture, particlized
ginseng root;
Ginko biloba
leaf;
Ziziphus seed;
mume fruit; and
licorice root.
The invention also comprises a method for the symptomatic relief of a type I hypersensitivity reaction in a mammal, which comprises orally administering to said mammal an effective dose for said relief, of a mixture of ginseng root,
Ginko biloba
leaf, Ziziphus seed, mume fruit and licorice root.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
Those skilled in the art will gain an appreciation of the invention from the following discussion of the preferred embodiments of the invention.
Ginseng (called “renshen” in Chinese) is the root of a botanical, found naturally in China and Korea. The best known ginseng on a worldwide basis is Asian ginseng (
Panax ginseng
), which is also widely cultivated in the United States. There are other varieties, such as Siberian ginseng (
Eleutheroccus senticosus
). The root comprises resin, panaxatriol and other substances containing a steroid nucleus, sugar, starch, mucilage, a saponin, volatile oil or triterpenoid glycosides including, in particular,
P. quinquefolium
and
P. pseudoginseng
which are generally considered to be biologically active. Isolation and identification of ginseng saponins is described in Kaku et al., Arzneimittel-Forsch. 25, 343 (1975). Use in oriental medicine as tonic: K. Chimin Wong, Wu Lien-the, History of Chinese Medicine (Shanghai, 2nd ed., 1936) 906 pp. Comprehensive review of morphology, cultivation and uses appears in Baranov, Econ. Bot. 20, 403-406 (1966).
As a therapeutic composition, Ginseng is classified as an aromatic bitter; Merck Index, No. 4256. It has a sweet, aromatic taste which can be referred to as “exotic”.
Research suggests to some that ginseng has nonspecific immunostimulatory activity similar to that of the herb Echinacea.
The present invention does not make any claim for curative benefit from the use of ginseng, but suggests that its inclusion in the composition of the invention has accepted advantages, including but not limited to at least some of the advantages mentioned above.
Dried ginseng root is generally administered to adults in doses of 2 to 8 grams per day (when used singly).
The leaf of the
Ginkgo biloba
tree is rich in flavonoid glycosides content along with ginkogolides and bilbalides. Ginkgo biloba is a chemical mediator of allergic symptoms in the group of substances termed leukotrienes. Although these chemicals are partially inhibited by licorice, they are more completely inhibited by Ginkgo. As such, these herbs in combination serve to more effectively block the inflammatory component of allergies by inhibiting the effects of multiple inflammatory mediators. Extracts of the leaf (24% extract) are commercially available from a number of providers (for example, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Conn.) who manufacture a standardized 24 percent extract. The extract (Chinese name: bai goo) has been identified as a mild sedative which prevents smooth muscle spasms associated with type I hypersensitivity reactions. The herb is also a stimulant to the circulatory system. The dosage administered to adults is generally within the range of 40 to 120 mg/per day (when used singly).
The seed of
Ziziphus jujuba
(Rhamnaceae) known in China as suan zao ren provides an antihistamine effect without the usual sedative side effect. This herb acts as a general calmer to the immune system without compromising its ability to defend us from bacteria, viruses etc. Suan zao ren functions in allergic reactions to decrease the levels of symptoms by decreasing immune chemicals. In addition, it contains Vitamin C which also has been shown to be protective in allergic conditions. It may be administered to adults in a dosage of from 6 to 15 gms/day (used singly). The Chinese use this medication to calm the nerves and relax the body.
Commonly called licorice root, the root of
Glycyrrhiza uralensis
(leguminosae) known also as “gan cao” or Chinese licorice is used in Chinese medicine to slow and prolong the effect of strong tonics. In combination with t

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