What is this invention?

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What is this invention?

A New Pharmaceutical composition, patented in Korea and Worldwide, comprising an extract or compounds isolated from Elfvingia applanata for the prevention and the treatment of diabetes and diabetic complications

extract of Elfvingia applanata The present invention relates to an extract of Elfvingia applanata, which shows a therapeutic activity for diabetes and diabetic complications and a pharmaceutical composition for the treatment of diabetes and diabetic complications comprising the extract

It was found that MeOH extract had promising activity, as it not only inhibited AR in vitro, but also suppressed the serum glucose concentration and sorbitol accumulation in the tissues of STZ-induced diabetic rats.- Phytotherapy Research, 2005.

Glucose and Inhibition of Aldose reductase in prevention and treatments of diabetes and diabetic complications

Glucose is the main energy source of cells in animal tissues including human, however, excess amount of glucose in tissues leads to hyperglycemia. Several metabolic pathways have been implicated in the toxic effects of hyperglycemia, and many experimental data have demonstrated a link between glucose metabolism via the polyol pathway and diabetic complications. Aldose reductase, the first enzyme of this pathway, catalyzes the NADPH-dependent reduction of glucose to sorbitol. The significance of this enzyme has been shown in the pathogenesis of diabetic complications, such as neuropathy, retinopathy and cataract. This enzyme catalyses the reduction of various aldehydes such as glucose and galactose to their corresponding sugar alcohols. Sorbitol can be produced more rapidly by aldose reductase than it is converted to fructose by sorbitol dehydrogenase, resulting in an accumulation of sorbitol. The intracellular accumulation of a polar sugar alcohol can produce a hyperosmotic effect, which has been observed to lead to changes in membrane permeability and the onset of cellular pathology. Therefore, the inhibition of aldose reductase may be effective in preventing diabetic complications.
(source: Planta Medica, 69, 853(2003)

BACKGROUND OF ART in the patent

Diabetes mellitus is a mammalian condition in which the amount of glucose in the blood plasma is abnormally high. Elevated glucose levels in some instances can lead to higher than normal amounts of particular hemoglobin, HbA1c. This condition can be life-threatening and high glucose levels in the blood plasma, hyperglycemia, can lead to a number of chronic diabetes syndromes, for example, atherosclerosis, microangiopathy, kidney disorders or failure, cardiac disease, diabetic retinopathy and other ocular disorders, including blindness.

Diabetes mellitus is known to be existed in two forms of the disease. One of those is known as Type II, non-insulin dependent diabetes (NIDDM) or adult-onset, and another is juvenile diabetes or Type I, of which pancreas often continues to secrete normal amounts of insulin. However, this insulin is ineffective in preventing the symptoms of diabetes which include cardiovascular risk factors such as hyperglycemia, impaired carbohydrate mechanism, particularly glucose metabolism, glycosuria, decreased insulin sensitivity, centralized obesity hypertriglyceridemia, low HDL levels, elevated blood pressure and various cardiovascular effects. Many of these cardiovascular risk factors are known to precede the onset of diabetes by as much as a decade. These symptoms, if left untreated, often lead to severe complications, including premature atherosclerosis, retinopathy, nephropathy, and neuropathy. Insulin resistance is believed to be a precursor to overt NIDDM and strategies directed toward ameliorating insulin resistance may provide unique benefits to patients with NIDDM.

Current drugs used for managing Type II diabetes and its precursor syndromes, such as insulin resistance, fall within five classes of compounds: the biguanides, thiazolidinediones, the sulfonylureas, benzoic acid derivatives and alpha-glucosidase inhibitors. The biguanides, such as metformin, are believed to prevent excessive hepatic gluconeogenesis. The thiazolidinediones are believed to act by increasing the rate of peripheral glucose disposal. The sulfonylureas, such as tolbutamide and glyburide, the benzoic acid derivatives, such as repaglinide, and the alpha-glucosidase inhibitors, such as acarbose, lower plasma glucose primarily by stimulating insulin secretion.

Above sulfonylureas have disadvantages that these drugs cannot be administered to IDDM patient, NIDDM patient having decreased insulin secretion, and fecund female being worried about anomalous child birth, abortion and stillbirth. Additionally, most of the sulfonylureas should be administered carefully to liver dysfunction patient and kidney dysfunction patient because of sulfonylurea metabolism.

The pathway of biguanides such as metformin has not been verified clearly but the biguanides cannot increase the insulin secretion of pancreas. The biguanides have lower glucose-decreasing effect than the sulfonylureas but have low occurrence of hypoglycemia. And the biguanides treatment may happen nausea, vomiting, diarrhea, eruption etc. in early stage and causes lactic acidosis of fatal side effect, so those are used only as experimental agents in U.S.A.

The sulfonylureas or the biguanides have above disadvantages and side effects; therefore it is required to develop a new hypoglycemic drug having fewer side effects and greater safeties for effective treatment than those of current drugs.

Elfvingia applanata KARST employed in the present invention belong to Polyporaceae and is distributed all over the world. Elfvingia applanata KARST, white rot mycelium, grows naturally on a latifoliate tree horizontally in summer and its fruit body is an annual plant in the form of semicircle and is known to have anti-cancer effect.

New and Innovative Pharmaceutical compositions

This invention is composed of 5 kinds of pharmaceutical compositions.
This invention demonstrated excellent results for treating of diabetes(type2) and diabetic complication in the tests.
  1. Pharmaceutical composition comprising the phenyl derivatives isolated from Ganoderma applanatum for treating or preventing diabetes.
  2. Pharmaceutical composition comprising cerebroside, 5-dihydroergosterol, 2-methoxyfatty or cerevisterol isolated from Ganoderma applanatum for treating or preventing diabetes.
  3. Pharmaceutical composition comprising the applanatic acid derivatives isolated from Ganoderma applanatum for treating or preventing diabetes.
  4. Pharmaceutical composition comprising the applanatic acid derivatives isolated from Ganoderma applanatum for treating or preventing diabetes.
  5. Pharmaceutical composition comprising the extractmor the polyphenol fraction isolated from Ganoderma applanatum for treating or preventing diabetes.

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