Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a tree having matured height of...
Reexamination Certificate
2001-12-28
2004-05-04
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a tree having matured height of...
C424S734000, C424S756000
Reexamination Certificate
active
06730332
ABSTRACT:
The present invention relates to an improved herbal composition having antiallergic properties, which is useful in the treatment of allergic conditions. The composition of the present invention is particularly useful for the treatment of allergic rhinitis, allergic bronchitis and bronchial asthma. This invention also relates to the process of preparing the antiallergic herbal composition.
INTRODUCTION TO ALLERGY
One of the common diseases that affects humankind is ‘allergy’ in its diverse manifestations. Allergy refers to any condition of the body mounting an attack on a specific foreign substance. People can experience allergic reactions to foods, chemicals, plants, animals and a variety of air borne substances. The substance to which the person is allergic is called the allergen. Allergy refers to a condition where in there is manifestation of conditions such as asthma, rhinitis, urticaria, and dermatitis alone or in combination. In majority of the cases there is a familial tendency. In most of the allergic individuals, there is an increase in levels of circulating IgE antibodies (special class of Immunoglobulins). Allergy is defined as a hypersensitivity or hyperimmunity caused by exposure to a particular antigen (allergen) resulting in marked increase in reactivity to that antigen/allergen upon subsequent exposure. This exposure sometimes results in harmful immunological consequences. Some common allergens responsible for allergy are dust, pollen, house-mites, grass weeds, pets, fungal spores, dust, etc. Sometimes corn, egg, soya, peanut, milk chocolate, caffeine, etc can be a source of food allergy.
An allergy is a state of altered immune response. The immune system's function is to identify and deal with the threats to the health. When a foreign body like dust or pollen enters the body, the exposure causes a reaction by the body. Usually the reaction itself is designed to rid the body of the allergens. This reaction can take many forms, one kind is an inflammatory reaction, the rushing of blood and/or mucus to the area of contact or site of invasion. This is healthy and normal. The increased blood supply to the affected area delivers healing nutrients, swelling, and heat may expel the invader and mucus may flush it out. Thus it acts as a protective phenomenon. But in the case of allergic individuals, this reaction persists for a longer time and causes inconvenience due to various clinical manifestations. An exaggerated defensive response by itself is the cause for this illness. A number of diseases like hay fever, bronchial asthma, urticaria and the like occur due to increased liberation of histamine or histamine like substances.
Air Borne/Inhalant Allergies
Headache, sneezing, watering of eyes, stuffy nose, wheezing and fatigue; these symptoms are the constant companions for an air borne allergy sufferer for several months (or more) every year. For those with perennial allergies, each day brings a cycle of misery, often broken only temporarily by powerful drugs like anti histaminics, steroids to suppress the immune system and decongestants, often with side effects like drowsiness etc. Air borne allergies usually affects the respiratory system. It involves sneezing, itching of throat and eyes, sinus headaches and sometimes coughing. Tree pollens, grass, weed pollens, pets, moulds, fungus, dust and cigarette smoke are common household allergens that can cause the allergic symptoms.
Pathogenesis of Allergy
On exposure to an antigen (allergen), special type of cells called antigen presenting cells carry the antigen, process it and present it to special type of white blood cells called T-lymphocytes [TH
2
subset of CD
4
+T helper lymphocytes]. These T-lymphocytes respond by releasing important chemical mediators called cytokines like interleukins IL4, IL5, IL6 and granulocyte-macrophage colony stimulating factor (GM-CSF). The cytokines interact with B-lymphocytes (white blood cells) present in lymph nodes. The B-lymphocytes transform themselves into plasma cells, which secrete IgE antibodies. These are specific to the antigen. Once formed, the IgE antibodies have a strong tendency to get attached to a special group of cells called mast cells and basophils. Mast cells are located on the skin, Lung mucosa, bronchial mucosa, intestinal mucosa, lymphnodes, breast parenchyma and liver. They play a vital role in allergic and inflammatory phenomenon. A mast cell is a storehouse of 15-20 chemical mediators, which is responsible for clinical manifestations of allergy. On reexposure to allergen (antigen), the preformed IgE antibody on mast cell reacts with the antigen. The combination evokes a series of changes at the molecular level, which ultimately release the following mediators:
1) Histamine
2) 5-Hydroxytryptamine (Serotonin)
3) Leucotrienes B
4
, C
4
, D
4
, E
4
4) Platelet activating factor
5) Prostaglandin D
2
6) Interleukins—IL-3, IL-4, IL-5, IL-6, Granulocyte macrophage colony stimulating factor (GMCSF), IL-1
7) Tumour necrosis factor-&agr;(TNF-&agr;)
8) Bradykinin etc.
Of all these mediators Leucotrienes C
4
& D
4
are the most potent vasoactive (capable of acting on blood vessels) and spasmogenic agents known. They increase the vascular permeability and cause vasodilatation and bronchial smooth muscle contraction. LTB
4
causes chemotaxis of neutrophils and eosinophils (white blood cells) which cause release of prostaglandin and bring about inflammatory changes. Prostaglandin PGD
2
causes broncospasm and increases mucus secretion. PAF (Platelet activating factor) causes platelet aggregation, release of histamine, broncospasm, increased vascular permeability and vasodilatation. It also acts as chemotactic for neutrophils and eosinophils. Therefore, it is important in late phase of inflammation. Cytokines like TNF, IL1, IL3, IL4, IL5, IL6 and GM-CSF are important cytokines that recruit inflammatory cells, which further cause degranulation. TNF-&agr; is extremely important for attracting the cells at the site of inflammation.
Phenomenon of Allergy
Allergy is characterised by two distinct phases, the immediate phase and the delayed phase. The immediate phase includes the initial response that lasts for first 1-2 hours characterised by
i) Vasodilatation, i.e. engorgement of the blood vessels that line the mucous membrane of the nose and
ii) Vascular leakage i.e. escape of plasma with proteins from the blood vessels. The mediators responsible are histamine and leucotrienes.
The delayed phase is the cellular phase or the inflammatory phase mediated by PAF, TNF, leucotrienes. On reexposure to allergen the preformed IgE antibody on mast cell reacts with the antigen. Unlike the protective inflammatory response in case of infections or any other trauma the phenomenon in case of allergy is different in that it is not self-limited. Antigen antibody reactions occur as long as the person gets exposed to allergen and as long as these reactions occur, the inflammation has to set in. As a result, the various effects of the cellular phase i.e. release of enzymes, free radicals, prostaglandins etc will continue to persist and cause persistent tissue damage, which eventually leads to chronic inflammation. Hence, a check is necessary. The main difference between allergy prone and non-allergy prone individuals is allergy prone individuals have been found to have an elevated IgE levels which means they over respond to antigenic stimulation unlike the other individuals. Further,
i) The tendency for susceptibility is inherited.
ii) There is a deficiency of intracellular control of mediator release or synthesis or both or possibly, extra cellular control signals that generally bring mediator inactivation are impaired.
For more details, reference may be made to Robbins: Pathologic Basis for Disease, 5
th
Edition 1994 W.B Saunder Company., Harrisons', “Principles of Internal Medicine”. 14
th
Edition, McGraw Hill Publications, 1998.
Allergic Rhinitis
Allergic rhinitis is a chronic inflammation of the mucus membrane lining the nasal passages that is caused by an allergic
Agarwal Anurag
Agarwal Ravindra Kumar
Jarvis William R. A.
Merchant & Gould P.C.
Natural Remedies Pvt. Ltd.
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