Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from scutallaria
Reexamination Certificate
2002-03-20
2003-02-25
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from scutallaria
C424S725000, C424S747000, C424S769000, C424S773000, C424S775000, C424S776000, C424S777000
Reexamination Certificate
active
06524627
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a pharmaceutical composition for preventing and treating allergic diseases and to a method for preparation thereof. Specifically, the present invention relates to a pharmaceutical composition comprising Platycodi Radix, Scutellariae Radix, Ponciri Fructus, Schizonepetae Herba, Bupleuri Radix, Angelicae dahuricae Radix, Paeoniae Radix alba, Cnidii Rhizoma, Angelicae gigantis Radix, Ledebouriellae Radix, Forsythiae Fructus, Glycyrrhizae Radix, Lonicerae Flos, Taraxaci Herba, Trichosanthis Radix, Ulmi Cortex Radicis, Astragali Radix, Atractylodis Rhizoma alba, Rehmanniae Rhizoma, Zanthoxyli Fructus, Magnoliae Flos, Xanthii Fructus, Mori Cortex Radicis, Pinelliae Tuber, Cimicifugae Rhizoma, Puerariae Radix and Menthae Herba as the active ingredients for preventing and/or treating acute and/or chronic allergic nasal diseases (including chronic paranasal sinusitis), allergic dermatitis, allergic otitis media (including recurrent otitis media with effusions), allergic conjunctivitis, allergic asthma, etc., and to a method for preparation thereof.
2. Description of the Prior Art
A normal immune reaction may cause local inflammations or eliminate foreign substance without damaging tissues of their hosts by stimulating effective molecules to remove attacks from allergen through various mechanisms. However, the term of hypersensitivity or allergy is used when an immune reaction is excessively activated or progressed in an undesirable direction to harm the human body. Today, allergic diseases cost a lot of money, because they tend to be more severe in civilized societies. According to a literature [Scientific American, September, 1993], more than 20% of American people are suffering from various allergic symptoms, and allergic rhinitis is the most common form of allergy. The attack of allergen can sometimes be fatal. According to the statistical data of 1990, it was reported that 3.6 billion dollars had been spent to the direct medical cost for asthma. As to the number of patients who are suffering from these allergic diseases, Korea is also on the similar level to the developed countries. The number is increasing every year. In particular, young child patients are on rapid increase. Thus, many researchers are devoting themselves in developing a drastic cure to reduce economic, biological and physical burden of the patient from such allergic diseases.
It might be said that diversity and complexity of allergic diseases are from the exposure to many kinds of allergen in the modern life. Synthetic fibers such as nylon and Teflon, and synthetic resins such as polyethylene, polyester and epoxy resin, which brought innovation to the textile industry, cause anaphylactic contact dermatitis at skin or mucous membrane by various chemical substances like monomer and polymer that are produced in the manufacturing process. On the other hand, allergic inflammations on the skin are caused by contact with glass frames, artificial teeth, wrist watch chains, plastic raincoats, umbrella handles, etc. The substances such as polyurethane, which are widely used as paints for cars, furniture and musical instruments, are the main cause of bronchial asthma. Rubber, leather, cement, and metals such as platinum, gold, mercury and nickel may cause allergic contact dermatitis. Accessories, such as earrings, necklace and finger rings, or rubber products, may also cause allergy. It is well known that fast food, antiseptic, synthetic sweetening, and additives including food colors may also cause food allergy.
Moving into the age of synthetic medicine from that of natural medicine in which raw materials were the roots of herbs and the barks of trees, antibiotic shocks and drug allergies by chemical substances (e.g. sulfas, salicylic acids, pyrazolon and local anesthetic) and enzymatic substances have been frequently occurred. It has been revealed that the pathogenesis of food and drug allergy could occur in all types of hypersensitivity immune reactions I, II, III, and IV. Allergy to cosmetic materials has become common. Bronchial asthma has been rapidly increased since the environmental pollution has caused or worsened respiratory allergic diseases. Today, occupational allergies also draw our attention. We can take numerous examples of such occupational allergies as bakery asthma, dandruff asthma, librarian asthma of librarians, wood asthma of carpenters, poultry farming asthma, and contact dermatitis of welders.
The initial stage of allergic reaction is development of IgE antibody that makes a strong combination with the mast cell or receptors on the surface of basophilic leukocyte. After the antigen (allergen) eaten by antigen-presenting cells such as macrophages was processed, the peptide presented by MHC class II molecule on the surface of membrane is recognized by receptors on the surface of T-cell(TCR). Cell-activating substance (cytokines), such as IL-2, IFN-v and TNF (tumor necrosis factor)-&bgr;(derived from Th1-cells), and IL-4, IL-5, IL-6, IL-9 and IL-10 (derived from Th2-cells), are produced in the activated T-cells. The produced cell-activating substance acts on T and B cells to participate in proliferation and differentiation. Then, B-cells are activated by the combination of CD40 ligand (CD40L) on T-cells and CD 40 on B-cells. Furthermore, as IL-4 derived from T-cells is added, B-cells are differentiated into IgE-producing cells by a class switch. In the mast cells, two molecules of IgE are combined with polyvalent antigen to form a bridge on the receptors of membrane, leading to a series of biochemical processes causing degranulation. Various chemical media such as histamine are secreted from the mast cell by degranulation, and may increase the permeability of capillary, contract the smooth muscle, and enhance the mucus secretions, together with prostaglandins and leukotrienes produced newly by arachidonic acid metabolism within the membrane, which results in the followings: pruritis, flare, urticaria and angioedema on the skin; coughing, suffocating, chest tightness, respiratory difficulties. and cyanosis in the respiratory tract; paling, hypotension and arrhythmia in, cardiovascular system; nausea, vomiting and diarrhea in GI tract; and paresthesia, vertigo, headache, convulsion and loss of consciousness in the nerve system.
Chronic paranasal sinusitis as an example of allergic disease, which frequently occurs in an allergic constitution, may cause a nasal polyp when nasal hypertrophy gets more severe by irreversible changes such as desquamation, regression and coagulation of the blood vessel to the epidermis of mucous membrane on occurring the repetitive acute paranasal sinusitis. The chronic paranasal sinusitis poorly responds to internal medicines including antibiotic, and surgical operations for young children are not recommended because the paranasal sinuses of young children are in the development. Although adult patients can get surgical operations for the chronic paranasal sinusitis, the disease may easily recur if a drastic treatment for cold is not accompanied by immune reinforcement.
Also, otitis media is another common disease that occurs more than once in 70% of the infants, and about 10% of acute otitis media are progressed to the chronic stage in spite of antibiotic treatment. The recurrent otitis media with effusions (ROMEs) occurs when young children with weak immunity are exposed to upper respiratory infection before chronic otitis media are completely cured. The ROMEs tend to be increased if prolonged and may cause severe posteffects such as hearing disturbance, adhesion of tympanic membrane, and destruction of bone structure. In the young children with allergic constitution and weak immunity, the repeated colds by virus and secondary bacterial infection serve as complicated factors for ROME together with chronic paranasal sinusitis, adenoid hypertrophy, and middle ear ventilation problem by eustachian obstruction.
The medicines used currently in alleviating various allergic symptoms have the p
Hwang Woo-Jun
Jang Chul-Ho
Kim Hyung-Min
Park Eun-Jeung
Birch & Stewart Kolasch & Birch, LLP
Daehan Biolink Co., Ltd.
Lilling Herbert J.
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