Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1998-02-17
2001-02-13
Tate, Christopher (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S451000, C424S456000, C424S464000, C424S489000, C424S405000
Reexamination Certificate
active
06187313
ABSTRACT:
I. BACKGROUND OF THE INVENTION
A. Field of the Invention
This invention relates to the field of compositions and methods for treating and preventing
Helicobactor pylori
-associated stomach gastritis, ulcers and cancer. More specifically, this invention relates to the field of compositions of herbs, herb parts or herb extracts which can be used to treat or prevent
Helicobactor pylori
-associated stomach gastritis, ulcers and cancer, and methods for making and using such compositions.
B. Description of Related Art
Twelve years ago it was first reported and subsequently verified by many scientific studies that a particular bacterium known as
Helicobacter pylori
(“H. pylori”) commonly infects the human stomach. Many people so infected subsequently acquire what is known as chronic superficial gastritis (“stomach inflammation”) which may continue on for many decades. It is now known that left untreated, this condition may lead to stomach ulcers and even stomach cancer disease. (Marshall, B. J. and Warren, J. B. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration.
Lancet
, No.8390: 1311-1315 (1984); Nomura, A., Stemmermann, G. N., Chyou, P.-H., et al.,
Helicobacter pylori
infection and gastric carcinoma among Japanese Americans in Hawaii.
New Engl. J. Med.,
325: 1132-1136 (1991); Blaser, M. J. and Parsonnet, J., Parasitism by the “slow” bacterium Helicobacter leads to altered gastric homeostasis and neoplasia.
J. Clin, Invest.,
94: 4-8 (1994).) Extensive laboratory as well as clinical studies have been reported which clearly show that people suffering from chronic gastritis and/or stomach ulcer disease caused by
H. pylori
infection can be cured when administered certain antibiotics which eradicate
H. pylori
[Rubinstein, G., Dunkin, K. and Howard, A. J., The susceptibility of
Helicobacter pylori
to 12 antimicrobial agents, omeprazole and bismuth salts.
J. Antimicrob. Chemother.,
34: 409-413 (1994); Rosioru, C. Glassman, M. S., Berezin, S. H., et al., Treatment of
Helicobacter pylori
—associated gastroduodenal disease in children.
Dig. Dis. Sci.,
38: 123-128 (1993); Blaser, M. J., The bacteria behind the ulcers.
Sci. Amer.
, February 1996, 104-107]. On the other hand, the use of antibiotics has some drawbacks, including the rapid resistance of
H. pylori
to antimicrobial agents (Rubinstein, G. et al., op. cit.) as well as the well known fact that many people are allergic to antibiotics and some develop severe diarrhea and/or secondary infections which complicate antibiotic therapy. Furthermore, the antibiotics used to treat (i.e., kill
H. pylori
) ulcers also kill a wide variety of non-pathogenic bacteria in the body, a most undesirable feature of antibiotic therapy (i.e., “non-selectivity”).
II. SUMMARY OF THE INVENTION
The present invention is based on the unexpected discovery that several herbs and an insect product are capable of being orally administered to humans, either singly or in combination, to destroy or inhibit the growth of
H. pylori
so that gastritis and ulcer disease can be prevented or cured. In this manner stomach cancer can also be prevented. The composition may also be combined with certain other beneficial and healing substances (i.e., licorice root (
Glycyrrhiza glabra
)).
The present invention provides the additional benefit that these herbs specifically affect
H. pylori
and not other bacteria normally found in humans. A second advantage of the invention is that these herbs may be used at the same time with standard antibiotics employed to treat ulcer disease without adversely affecting the beneficial and positive effects of such antibiotics.
These and other objects, features and advantages of the invention will be clear to a person of ordinary skill in the art upon reading this specification in light of the appended drawings.
IV. DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
The present invention is based on the unexpected discovery that several herbs are capable of being orally administered to humans, either singly or in combination, to destroy or inhibit the growth of
H. pylori
so that gastritis and ulcer disease can be prevented or cured and so that stomach cancer can be prevented. The herbs contain an anti-
Helicobacter pylori
activity which reduces the growth rate, survival rate or proliferative ability of
H. pylori
. The herbs may be administered to humans as an oral dosage form alone or in combination with food. The anti-
H. pylori
activity may be effective in treating or preventing disease in all parts of a mammalian digestive tract including, but not limited to, the esophagus, stomach and duodenum. In the most preferred embodiment of the invention, the anti-
H. pylori
activity will be effective at preventing or treating stomach gastritis or ulcers, and in the prevention of stomach cancer.
Composition of the Invention
The herbs of the present invention, which contain an anti-
H. pylori
activity, may be administered in the form of one or more herbs, including herb parts such as leaves, stems, barks, roots, flowers and seeds. In the preferred embodiment of the invention, the herb is one of the herbs identified in Table 1. The herb is preferably ground or powdered to form part of an oral dosage form.
In a more preferred embodiment of the invention, the anti-
H. pylori
activity is isolated from one or more herbs as a dried extract. The extract may be formed by mixing coarsely ground or powdered herb with an extraction solution. Suitable extraction solutions may include water, a buffered aqueous solution, an aqueous alcohol or pure alcohol. In a more preferred embodiment of the invention, the extraction solution is a aqueous alcohol solution comprising from 0 to 100% water and from 0% to 100% pure alcohol by volume. Suitable alcohols include ethanol and methanol. Glycerin may be added as a co-solvent and to stabilize the extract. In the most preferred embodiment of the invention, the extraction solution is 50% aqueous ethanol.
The anti-
H. pylori
activity may be extracted from the herb by any suitable extraction method including, but not limited to, by percolation and by using a mechanical mixer. In either method, the herb is preferably exhaustively extracted to form a concentrated extraction solution. Extraction may be performed from about 20° C. to about 50° C. and beyond. After extraction is complete, the solution is evaporated to form a dried extract. Alternatively, the alcohol may be evaporated from the extraction solution to form an aqueous extract. If dried extracts are formed, the ratio of extract to starting material is generally about 1:5, although greater and lesser yields are within the scope of the invention.
Orally-administrable dosage forms of the invention may include, but are not limited to, capsules, tablets, powders and liquids (hereinafter referred to as “oral dosage forms”). Oral dosage forms may contain one or more herbs or herb extracts. In a preferred embodiment of the invention, an oral dosage from contains from about 10 to about 400 mg total weight of herb or herb extract. In the most preferred embodiment, the oral dosage will contain about 100 mg each of one or more herbs or herb extracts. If a liquid extract is used, the liquid extract can be calibrated by determining the amount of dried extract contained in a given volume of liquid extract. The herb or herb extract may be mixed with inert carriers such that the total activity of the composition can be adjusted. Suitable inert carriers may include inter alia maltodextrin, beet root fiber and tomato fiber.
The composition may further include additional beneficial substances, such as a licorice extract. In a preferred embodiment of the invention, the licorice extract is a deglycyrrhizinated extract.
The extracts containing anti-
H. pylori
activity may beneficially also be admixed with various inactive excipients, carriers, diluents, lubricants and other so-called “pharmaceutical aids” (adjuvants) and then formed into capsules and tablets. Examples of inactive excipients, carriers, diluents, lub
Nature's Sunshine Products, Inc.
Parsons Behle & Latimer
Tate Christopher
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