Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
2000-01-07
2001-03-20
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C435S101000
Reexamination Certificate
active
06203797
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a dietary supplement and method for use as a probiotic(immuno-stimulant) and for alleviating the symptoms associated with irritable bowel syndrome.
2. Description of Related Art
The use of dietary supplements for alleviating specific symptoms associated with particular human health problems is well known. Going back to ancient times, references are made to various dietary foods, herbs, and other naturally produced substances that are associated with improving the human health condition.
Many times, a person has poor health conditions based on dietary deficiencies, such as vitamins, minerals, and other natural elements that are essential for good human health. Many times, the dietary supplements available can supply missing dietary minerals and vitamins that are essential for proper metabolism and function of the human body. Therefore, it is well known that improvements to human health and well-being can be achieved using dietary supplements, especially if they provide for deficiencies in a person's diet. The use of daily or weekly supplements supplying missing natural dietary elements such as vitamins and minerals can alleviate symptoms for improvement related to specific maladies of human health.
The human condition known as irritable bowel syndrome can best be defined as a chronic disorder of the bowels, resulting in variable abdominal discomfort or pain, constipation, diarrhea, cramps, nausea, belching, excess flatus, spasm, abdominal distention, tired and weak feeling, and mechanical irritation of the bowel. Medical treatment has traditionally entailed bland diet, mild sedatives, hydrophilic colloid laxatives, anti-cholinergics, and anti-diarrhea agents and are often associated with numerous side effects such as drowsiness, dry mouth, visual disturbances, and food intolerances.
Aloe is a tropical or subtropical plant with thick lance-shaped leaves with jagged edges and has been known for centuries for its medicinal and therapeutic properties useful in treating many different human conditions.
The aloe plant and extracts from aloe, aloe vera, and various specific aloe extracts from the natural plant can alleviate symptoms related to irritable bowel syndrome as shown in the following literature.
Title or Subject
Authors
Date
Reference
“The Small Intestines
Chikalo, I. &
Sept.
Quoted in “The
Function Affected by
Bolovyeve, V.
1966
Aloes of
Aloe Extract”
Ukraine
Tropical Africa
and Madagascar”
by Reynolds,
G. W.
“Aloe Vera Gel in
Blitz, J.,
1963
J. Amer.
Peptic Ulcer Therapy;
Smith, J., &
Osteopathic
Preliminary Report”
Gerard, J.
Assoc.
62
731-
735
Aloenin and Aloe-Ulcin
Yamamoto, I.
1970
J. Med. Soc.
From
A arborescens
Toho Jpn. 17
Inhibit Gastric
361
Secretion
Aloe-Ulcin Equals Mg
Hirata, T. &
1977
Naturforsch
32c
Lactate
Suga, T.
731
Aloenin and Aloe-Ulcin
Hirata, T. &
1978
Bull. Chem.
From
A arborescens
Suga, T.
Soc. Jpan. 51
Inhibit Gastric
842
Secretion
“Effect of Orally
Bland, J.
1985
Preventive
Consumed Aloe Vera
Medicine,
Juice on
March/April
Gastrointestinal
Function in Normal
Humans”
“Effects of Aloe
Salto, H.,
1989
Jpn. Yakugaku
Extracts Aloctin A on
Imanishi, K.,
Zasshi 109 (5)
Gastric Secretion and
Okabe, S.
335-339
on Experimental Gastric
Lesions in Rats”
“A Double-Blind Trial
Odes, H. S. &
1991
Digestion -49
of a Celandin, Aloe
Madar, Z.
(2) 65-71
Vera and Psyllium
Laxative Preparation in
Adult Patients with
Constipation”
Freeze-dried aloe and extract from the natural aloe plant have been determined to have a positive influence as a dietary supplement and probiotic to improve the overall health and condition of a person. Specifically, freeze dried aloe and aloe extracts have been found to have antibacterial and antiviral properties.
The following information is from UK Patent No. GB 2245143B, describing a freeze-dried aloe process that could be used to prepare aloe for use in the present invention. Aloe has been extensively used as medicine. In U.S. Pat. No. 5,455,033 to Silverman, the soothing action of aloe vera extract was disclosed and utilized in an topical anti-inflammatory composition. In addition, the Silverman patent reported inulin, an ingredient in Applicant's present invention, as being an activator in the immune system and the root extract demonstrating anti-viral activity against influenza, herpes and vesicular stomatis viruses. Reference to aloe powders is also made in the Japanese Pharmacopeia. Certain low, medium, and high molecular weight compounds have been separated from aloe. For example, it is known that aloe arborescens var. natalensis (referred to hereinafter as “Kidacki aloe”) contains polysaccharides such as aloetin, alcenin, aloeursin or D-mannose, aloemannan or aloe albonacite; that aloe vera contains polysaccharides; and that Cape aloe contains anthraquinonic ingredients such as aloin or aloe-emodin. Bioactive factors were separated from freeze dried aloe in U.S. Pat. No. 5,902,796 to Shand. Mixtures of these active chemical substances identified, isolated, and stabilized from aloe vera leaves have been described in U.S. Pat. Nos. 4,735,935; 4,851,224; 4,917,890; 4,957,907; 4,959, 241; and 4,966,892. One group of these active chemical substances has been referred to as aloe vera mucilaginous polysaccharides, which are comprised of oligomers and polymers of carbohydrates. The pharmaceutical application of these mucilaginous polysaccharides and uses of aloe products have been described in U.S. Pat. Nos. 5,106,616; 5,118,673; 5,308,838; 5,441,943; and 5,443,830.
Intensive attempts have been made to process aloe into medicines. Presently, as an officially allowed health food, food products prepared from Kidachi aloe have been extensively commercialized in Japan. Most of these products, however, are prepared by drying aloe leaves under the sun or by hot air and, at the time of tableting, up to about 10% of an additive such as Avicel® microcrystalline cellulose or cornstarch, is added as a binder to facilitate tableting.
It is noted that most ingredients isolated and purified from the aloe and found to be medically efficacious to animals by animal experiments, are polysaccharides, glycoproteins, or enzymes, all of which may exhibit activity in a stable condition through purification at lower temperatures. For this reason, it is generally thought to be desirable to apply as little heat as possible for the preparation of a health food or medicine from aloe.
However, since the products now available on the market are prepared by drying aloe leaves under the sun or by circulation of hot air, the polysaccharides, glycoproteins, and enzymes in them will have been thermally degraded or oxidized in the course of drying.
Furthermore, the additives for facilitating tableting, such as Avicel® or cornstarch, are added in an amount of several to tens of percents in the conventional aloe tablet products. Since a small amount of water is added under heating to knead the additives with the dried aloe mass, the resulting product undergoes further thermal degradation by such heating.
Soluble fiber in the diet is well known for its salutary effects on gastrointestinal health and for being a very good fermentation substrate for intestinal flora. Such salutary effects include providing bulk to the stool, decreasing the pH of the gastrointestinal tract, producing volatile fatty acids, decreasing intestinal transit time, and beneficially influencing various blood parameters. Dietary fiber has also been shown to have a beneficial effect on cholesterol and lipid metabolism that results in decreased serum cholesterol, triglycerides, and phospholipids and an improved (increased) HDL to LKL ratio. A study on laboratory animals showed that adding fiber to the diet decreases the incidence of bacterial translocation, i.e. corrsing the intestinal barrier and entering systemic circulation. C. Palacio et al., Dietary Fiber: Physiologic Effects and Potential Applications to Enteral Nutrition,
Lilling Herbert J.
Malin Haley & DiMaggio, P.A.
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