Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-11-19
2001-09-18
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S457000, C514S460000, C514S925000, C514S926000, C514S927000, C424S766000
Reexamination Certificate
active
06291517
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates generally to a method for preventing and/or treating stress-induced gastric injury in persons with a predisposition to such injury.
Gastric discomfort is a common complaint among people. In a healthy human stomach and duodenum, an effective balance exists between the potential for gastric acid and pepsin to damage gastric mucosal cells, and the ability of these cells to protect themselves from injury. Disruption of this balance has been attributed to several factors, including environmental and emotional stress, age, diet, genetics and individual behavior. This disruption is evidenced as a burning, aching or gnawing pain that may be perceived as abdominal pressure or fullness. Most of the symptoms experienced by patients under such conditions result from a breakdown of the normal mucosal defense mechanisms. Various studies have demonstrated that gastric acid and pepsin are important in the pathogenesis of dyspepsia, stomach upset, gastroesophageal reflux disease, and duodenal and gastric ulcer. Several mechanisms are believed to be important in protecting gastric and duodenal mucosa from damage by gastric acid, pepsin, bile pancreatic enzymes, as well as these external stressors/factors. These defense mechanisms include mucus, mucosal blood flow, cell renewal and bicarbonate. These factors acting in balance help maintain mucosal integrity.
Physical stress has been shown to induce significant gastrointestinal mucosal injury in animals. Water-immersion restraint stress of rats results in an increase in cell loss accompanied by an accelerated cell migration and macroscopic mucosal injury. Cell migration was found to be accelerated in fundic mucosa after 90 minutes of exposure to stress. A combination of increased cell loss and depressed epithelial proliferation may play a role in stress-related gastric lesions and injury in the rats. It has been suggested that oxygen free radicals are greatly involved in the pathogenesis of gastric injury. Free radicals may play a major role in stress-induced gastrointestinal injury.
Current treatments for gastric discomfort include administration of antacids and H
2
-receptor antagonists. However, these treatments are not effective in preventing stress-induced gastric injury over the long term. There remains a need for an effective method to prevent and/or treat gastric injury caused by stress in persons who have or are at risk for such injury. The present invention fulfills this need and other needs, and provides further related advantages.
SUMMARY OF THE INVENTION
The present invention resides in a method to prevent and/or reduce gastric injury caused by stress. The method involves administering grape seed proanthocyanidin extract (GSPE) to a person identified to be at risk for such injury in an amount effective to prevent or reduce the injury.
Proanthocyanidins and polyphenolic bioflavonoids have demonstrated potential antioxidant and free radical scavenging ability, and have exhibited a broad spectrum of biological, pharmacological and medicinal properties. Previous studies have demonstrated that a novel IH636 GSPE is highly bioavailable to vital organs and provides significantly greater protection against biochemically generated free radicals and free radical-induced lipid peroxidation and DNA fragmentation than vitamin C, vitamin E, a combination of vitamins C plus E, and &bgr;-carotene.
The study provided as Example investigated the effects of acute and chronic stress on the enhanced production of superoxide anion, as well as lipid peroxidation, DNA fragmentation and membrane microviscosity (indices of oxidative tissue damage) in the gastric and intestinal mucosa of female Sprague-Dawley rats. Furthermore, the study determined the protective ability of GSPE against the gastrointestinal mucosal injury induced by acute and chronic stress.
Other features and advantages of the present invention should become apparent from the following detailed description of the invention, taken with the illustrative drawings, which illustrate the principles of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention involves administering grape seed proanthocyanidin extract (GSPE) to a person who has suffered, is at risk to suffer, or to prevent or reduce stress-induced gastric injury.
Proanthocyanidins comprise a group of polyphenolic bioflavonoids found in fruits and vegetables. They are the most common type of tannins found in fruits and vegetables, and are present in high amounts in the seeds and skins of grapes. Grape seed proanthocyanidins are natural antioxidants known to have a broad spectrum of biological, pharmacological, and chemoprotective properties against free radicals and oxidative stress. In particular, the novel GSPE, ActiVin™ IH636, is a highly bioavailable form of GSPE. High-pressure liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry studies indicate that the GSPE contains monomeric- dimeric-, trimeric-, tetrameric, oligomeric-, and polymeric proanthocyanidins, as well as tannin. Proanthocyanidins and polyphenolic bioflavonoids have demonstrated potential antioxidant and free radical scavenging ability, as well as exhibit a broad spectrum of biological, pharmacological and medicinal properties. Proanthocyanidins have been the subject of considerable interest because of their broad pharmacologic activity and therapeutic potential. The biological and medicinal properties of the proanthocyanidins have been extensively reviewed.
The present invention resides in a method to prevent and/or reduce the effect of stress-induced gastric injury by administering GSPE to a person identified to be at risk for such injury, in an amount effective to prevent or reduce the injury. To determine the effectiveness of GSPE in this method, the effects of acute and chronic stress on the enhanced production of superoxide anion, as well as lipid peroxidation, DNA fragmentation and membrane microviscosity (indices of oxidative tissue damage) in the gastric and intestinal mucosa of female Sprague-Dawley rats were investigated, and the protective ability of GSPE was determined against the gastrointestinal mucosal injury induced by acute and chronic stress.
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Bagchi, M., et al., “Acute and Chronic Stress-Induced Oxidative Gastrointestinal Injury in Rats, and The Protective Ability Of A Novel Grape Seed Proanthocyanidin Extract,”Nutrition Research, vol. 19, No. 8, 1189-1199 (Jun. 18, 1999).
Nguyen, P., et al., “Acute and Chronic Stress-Induced Gastrointestinal Injury in Rats, and Protection by a Novel IH636 Grape Seed Proanthocyanidin Extract (GSPE),”Midwest Student Biomedical Research Forum, (Feb. 19, 1999).
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Bagchi Debasis
Bagchi Manashi
Stohs Sidney J.
Dry Creek Nutrition, Inc
Krass Frederick
Marshall O'Toole Gerstein Murray & Borun
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