Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
1999-02-24
2003-04-29
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S046000, C514S398000, C514S399000
Reexamination Certificate
active
06555141
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions for the protection, treatment and repair of liver tissues in humans and animals.
BACKGROUND OF THE INVENTION
The liver is an extremely important organ. As the major metabolic organ of the body, the liver plays some role in almost every biochemical process, including the deamination of amino acids and the formation of urea, the regulation of blood sugar through the formation of glycogen, the production of plasma proteins, the production and secretion of bile, phagocytosis of particulate matter from the splanchnic (intestinal) circulation, and the detoxification and elimination of both endogenous and exogenous toxins.
The many functions of the liver depend on its intimate association with circulating blood. Each liver cell is exposed on at least one face to a blood sinusoid which contains oxygenated arterial blood mixed with venous blood from the splanchnic circulation. This profuse blood supply is necessary for the liver to function. The blood from the sinusoids supplies the hepatocytes with oxygen and nutrients. The hepatocytes use the nutrients both for their own metabolic needs and for the synthesis of the liver's many essential products. Abnormalities in the blood or vasculature can have immediate and severe effects on the liver. For example, liver cells are exposed to high concentrations of any toxic compounds that are ingested orally, such as ethyl alcohol. Even when the ingested compound is not itself toxic, intermediate derivatives produced during hepatic metabolism of the compound may damage the hepatocytes. This phenomenon occurs, for example, in carbon tetrachloride poisoning. Since the blood moves slowly through hepatic sinusoids, liver cells are also quite vulnerable to blood-borne infectious agents such as viruses and bacteria. Furthermore, derangements in hepatic blood pressure can damage liver tissue. Right-sided cardiac failure increases hepatic blood pressure and can lead to pressure necrosis (hepatocellular death) and fibrosis. Left-sided cardiac failure can reduce hepatic perfusion and lead to hepatocellular anoxia and death.
Liver damage from any source may result in liver regeneration, necrosis (cell death), degeneration, inflammation, fibrosis, or mixtures of these processes, depending on the type and extent of injury and its location within the liver. The liver has great functional reserves, but with progressive injury, disruption of liver function can have life-threatening consequences. Cirrhosis, which is a type of end-stage liver disease, is one of the top ten causes of death in the Western world.
Despite the significance and potential severity of liver disease, therapeutic approaches are limited. Treatment is generally symptomatic, e.g., the use of diuretics to combat tissue edema caused by low levels of plasma proteins. Many types of liver disease are the result of viruses (e.g., hepatitis A, B, C, D and E, to name a few), and effective antiviral therapies are rare and commonly cause potentially severe side effects. Other liver diseases are the result of previous toxic exposure (such as alcoholic cirrhosis and exposure to toxic plants, or environmental pollutants) which may be difficult to control. In still other cases, liver disease is the result of poorly understood interplay of various factors, including genetic factors, environmental conditions, and immune system activity (autoimmune hepatitis). These cases are, in a word, idiopathic, and as such are difficult to treat except symptomatically. In short, due in part to the complexity of liver disease, therapies do not currently exist that address its causes. Nor does there currently exist a therapy that supports normal liver function and helps heal damaged liver tissue. Currently available therapies either focus only on the secondary symptoms of liver disease or have significant side effects, as is the case with antiviral drugs. There is a need for a therapeutic composition that will support liver structure, function and healing, with few or no side effects.
SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide compositions for the protection, treatment and repair of liver tissue in humans and animals.
It is a further primary object of the present invention to provide such compositions that also produce a low level of side effects.
It is a further primary object of the present invention to provide a method of using the novel compositions of the present invention to protect, treat or repair liver tissue in humans or animals in need thereof.
The present invention provides novel compositions and methods for protecting, treating and repairing liver tissue. The compositions of the invention include two or more of the following compounds: S-adenosylmethionine, L-ergothioneine and a compound selected from the group consisting of milk thistle, silymarin and active components of silymarin, whether naturally, synthetically, or semi-synthetically derived.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1
is the molecular structure of S-adenosylmethionine.
FIG. 2
diagrams the major metabolic pathways of S-adenosylmethionine in the body.
FIG. 3
diagrams the effects of ethanol in the hepatocyte.
FIG. 4
is the molecular structure of L-ergothioneine.
FIG. 5
shows the effect of ergothioneine and other compounds on lipid peroxide formation in mouse liver homogenate.
FIG. 6
is a drawing of the herb Milk thistle (
Silybum marianun
).
FIG. 7
is the molecular structures of silybin and other compounds from Milk thistle.
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Corson Barbara E.
Henderson Todd R.
Nutramax Laboratories, Inc.
Prats Francisco
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