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Ornithine- or aspartate-containing compositions and the uses thereof

A technology of aspartic acid and composition, applied to the composition containing ornithine and/or aspartic acid and its application field, capable of solving problems such as symptoms of weakness, increased blood sugar level, rhabdomyolysis, etc.

Active Publication Date: 2016-01-13
WUHAN QR PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Although statins are generally effective and safe for the treatment of hyperlipidemia, clinical evidence suggests that long-term administration of atorvastatin or other statins, especially at high doses, can lead to rhabdomyolysis and muscle lesions, and these side effects are clearly dose-related and can lead to severe muscle pain and debilitating symptoms in patients
[0004] In addition, it has been reported that compared with low-dose statins, high-dose statins can significantly increase blood glucose levels in patients, which further increases the risk of primary diabetes
Drug warning issued by the FDA advises that cholesterol-lowering drugs such as Lipitor may increase blood sugar levels in patients taking them and cause disturbance of consciousness
Such side effects of statins may lead to early discontinuation of this regimen, limiting its clinical use

Method used

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  • Ornithine- or aspartate-containing compositions and the uses thereof

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preparation example Construction

[0101] The preparation methods and compositions described herein can be used to reduce the level of one or more risk factors for hyperlipidemia in serum. In certain embodiments, the methods and compositions can be used to reduce total cholesterol, triglycerides, or low-density lipoprotein levels; in certain embodiments, the methods and compositions can be used to reduce CPK levels in an individual; In certain embodiments, the methods and compositions are useful for increasing high-density lipoprotein levels in an individual; in certain embodiments, the methods and compositions are useful for reducing serum glucose levels; abnormal hyperlipidemia risk factors A level means that the risk factors for hyperlipidemia in the individual's serum are beyond the range generally expected by those skilled in the art. General expected ranges for total cholesterol, LDL, HDL, and triglyceride levels are defined by the National Heart, Lung, and Blood Institute, National Institutes of Health (...

example 1

[0122] Example 1: Effect of Ornithine and / or Aspartate on Rat Plasma Triglycerides and CPK Activity

[0123] This trial conducted a study on the use of a composition comprising ornithine and / or aspartate, which also includes ornithine aspartate, for the treatment of hyperlipidemia in individuals Hyperemia, lowering triglyceride levels. In addition, the administration of lipid-lowering drugs such as atorvastatin may cause the increase of CPK in plasma, and the composition containing ornithine-aspartate may reduce the increase of CPK, and we have also conducted related research accordingly.

[0124] Male Wistar rats (purchased from Beijing Huafukang Co., Ltd., Beijing, China), each weighing about 180-250g, were divided into five groups and raised in animal rooms with good ambient temperature (about 21±1°C) and humidity control. Give lighting 12h every day and dark avoiding light (lighting starts at 7:00 a.m.), cycle feeding, diet and water intake are not limited, and the food c...

example 2

[0139] Example 2: The formula and preparation process of ornithine-aspartate tablet

[0140]Compositions containing ornithine and / or aspartic acid can be prepared in the form of tablets. This experiment describes the preparation process of ornithine-aspartate tablets. The formulation of the tablets is shown in Table 3.

[0141] First mix 302.7g of povidone, 0.5g of sweet orange essence, and 0.0025g of sunset yellow pigment with 135g of 80% ethanol, and simply ultrasonically mix to prepare a viscous mixture. This viscous mixture was then added to a mixture formed by thoroughly mixing 150 g ornithine aspartate, 7.5 g citric acid, 105 g mannitol, and 2.5 g aspartame, mixed thoroughly again to form a soft mass, and then Dry, form granules and pass the granules through a 18 mesh screen. The sieved granules were added with 5 g of talcum powder and thoroughly mixed to prepare tablets.

[0142] Table 3. Formulation of ornithine-aspartate tablets

[0143] Ornithine Aspartat...

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Abstract

Methods and compositions comprising ornithine and / or aspartate that are useful for lowering one or more hyperlipidemic risk factor levels are described. More specifically, compositions comprising ornithine and / or aspartate that are useful for lowering lipid and / or lipoprotein levels, such as triglyceride, cholesterol and LDL levels, in the bloodstream in a subject are described. Methods of using compositions comprising ornithine and / or aspartate for ameliorating the side-effect induced by a therapeutic agent (e.g., statin) or a condition that is associated with an elevation of CPK (e.g., rhabdomyolysis or myopathy) are also described.

Description

Background technique [0001] Hyperlipidemia is a heterogeneous disease characterized by excessive levels of lipids such as cholesterol, cholesteryl esters, phospholipids and triglycerides in the body's blood, which are transported in the blood in the form of large lipoproteins. Hyperlipidemia is mainly caused by diseases such as diabetes, thyroid disease, kidney disease, liver disease and Cushing's syndrome; in addition, obesity, alcohol consumption, use of estrogen and other drugs that can change lipid metabolism can also cause hyperlipidemia; Hyperlipidemia is also a major, modifiable risk factor for atherosclerosis, cardiovascular diseases such as coronary heart disease. Under normal conditions, lipids flow with the blood in the blood; if the level of lipids in the blood is too high, excess lipids can accumulate on the walls of arteries, where cholesterol and other substances further accumulate to form plaques, causing narrowing of the arterial lumen , leading to atheroscle...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K31/22A61P3/06
Inventor 葛建王朝东
Owner WUHAN QR PHARMA CO LTD
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