WO2013077553A1 - Composition pour réduire l'hypoglycémie - Google Patents
Composition pour réduire l'hypoglycémie Download PDFInfo
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- WO2013077553A1 WO2013077553A1 PCT/KR2012/008491 KR2012008491W WO2013077553A1 WO 2013077553 A1 WO2013077553 A1 WO 2013077553A1 KR 2012008491 W KR2012008491 W KR 2012008491W WO 2013077553 A1 WO2013077553 A1 WO 2013077553A1
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- Prior art keywords
- composition
- glucose
- hypoglycemia
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Classifications
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- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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Definitions
- composition for improving hypoglycemia Composition for improving hypoglycemia
- the present invention relates to a composition for preventing, treating or improving hypoglycemia. [Background technology]
- Blood glucose in normal people is the main source of energy sent to each part of the body on an empty stomach at 70-115 mg / dL, and the blood sugar does not exceed 140 mg / dL for two hours after a meal.
- Hypoglycemia is caused by a variety of causes, but the most common cause is side effects due to oral hypoglycemic agents or insulin used to treat diabetes.
- Diabetes treatment requires a balance of proper dose and timing of oral hypoglycemic or insulin, regular meals and exercise, and hypoglycemia may occur when the dose of oral hypoglycemic or insulin is too high or inappropriate. .
- hypoglycemia may occur when oral hypoglycemic agents or insulin are treated at the same dose and when the amount of meals is irregularly reduced or the exercise is inadequately increased, and by drinking.
- Blood sugar which is associated with hypoglycemia, is not constant in some individuals. However, hypoglycemia occurs when blood sugar drops below 50 mg / dL. That is, hypoglycemia refers to a condition in which various symptoms are caused by a decrease in blood sugar below a normal level due to various causes.
- W02007 / 101179 suggests a method for treating hypoglycemia using entererostat in.
- W02009 / 114718 also discloses a technique for treating hypoglycemia with compounds that activate glutamate receptors that stimulate glucagon release.
- the present inventors have tried to develop a composition that can improve hypoglycemia into a medicine or food that is easy to consume.
- the composition was prepared using a solution (prepared glucose, especially anhydrous glucose) as a substance which is prepared in a solution formulation, which is most suitable for this solution formulation, can be prepared as a formulation with excellent long-term shelf life, and which has a remarkable effect on improving hypoglycemia.
- the present invention was completed by confirming that the prepared composition exhibited excellent efficacy on hypoglycemia.
- Another object of the present invention to provide a food composition for improving hypoglycemia.
- Another object of the present invention is to provide a method for preventing or treating hypoglycemia, and a method for improving hypoglycemia.
- the present invention provides a pharmaceutical composition for preventing or treating hypoglycemia of a solution formulation containing 90% by weight of glucose and 10-60% by weight of water and containing no preservatives.
- the present invention provides a method for treating hypoglycemia comprising administering to a mammal a composition of a solution formulation comprising 40-90% by weight glucose and 10-60% by weight water, wherein the composition contains a preservative free solution.
- Prevention or treatment Methods, and methods for ameliorating hypoglycemic symptoms The present inventors have tried to develop a composition that can improve hypoglycemia into a medicine or food that is easy to consume. As a result, the composition was prepared using a solution formulation, the most suitable for this solution formulation, the formulation with excellent long-term shelf life, and has a significant effect on improving hypoglycemia, using glucose (particularly anhydrous glucose).
- the present invention was completed by confirming that the prepared composition exhibited excellent efficacy on hypoglycemia.
- hypoglycemia or hypoglycemia refers to a condition in which various amounts of symptoms are reduced by decreasing the amount of pulp sugar supplied to body organs by reducing blood sugar below a normal level due to various causes.
- hypoglycemia occurs, glucose supplied to the brain and nervous organs is insufficient, and the brain nervous system feels lack of energy to operate the body's autonomic nervous system.
- the symptom is mainly divided into sympathetic nervous system symptoms and central nervous system symptoms.
- dizziness and fatigue may develop, and epileptic seizures and loss of consciousness may develop, and death may occur, and blood pressure may rise, pulse rate increases, palpitations, tremors, and blood flow as adrenaline is secreted to overcome hypoglycemia. Lining occurs, and the action of parasympathetic nerves may cause cold sweats, fasting, abnormal feelings, and the like.
- prevention means any action that inhibits or delays progression of hypoglycemia by administration of a composition of the present invention
- treatment refers to raising blood glucose levels, normalizing blood glucose. Recovery to the numerical range, and improvement of symptoms and suppression of progression by hypoglycemia.
- improvement is used herein interchangeably with the term “treatment”.
- glucose can be rapidly absorbed by the human body after ingestion to increase blood sugar, thereby effectively improving hypoglycemia.
- mammal includes humans, pigs, horses, cattle sheep, dogs and cats, preferably humans.
- the glucose of the invention is anhydrous glucose.
- Anhydrous crystalline glucose has excellent storage capacity and Show hypoglycemia improvement.
- the composition of the present invention comprises 4% by weight of glucose and 10-60% by weight of water.
- the composition of the present invention comprises 45-90% by weight of glucose and 10-55% by weight of water, preferably 50-90% by weight and 10-50% by weight of water, more preferably 55- 90 wt% and 10-45 wt% water, even more preferably 6 to 90 wt% and 10-40 wt% water, even more preferably 65-90 wt% and 10-35 wt% water, even more preferred Preferably 7% by weight and 10-30% by weight of water, even more preferably 75-90% by weight and 25% by weight of water.
- the composition of the present invention comprises 45-85% by weight of glucose and 15-55% by weight of water, preferably 50-85% by weight and 15-50% by weight of water, more preferably 55 -85% by weight and 15-45% by weight of water, more preferably 60-85% by weight and 15-40% by weight of water, even more preferably 65 ⁇ 85% by weight and 15-35% by weight of water? Fc, More preferably 70-85% by weight and 15-30% by weight of water, even more preferably 75-85% by weight and 15% by weight 25% by weight of water, even more preferably 78-83% by weight and water of 17-22 Weight 3 ⁇ 4>.
- the composition of the present invention further comprises an auxiliary ingredient selected from the group consisting of vitamin (:, vitamin B1, vitamin B3, vitamin B5, vitamin B6, citric acid and combinations thereof).
- Vitamin B1 is a coenzyme necessary for energy metabolism of carbohydrates. It helps to recover from fatigue and lower stress. Vitamin B6 helps improve peripheral neuropathy caused by hypoglycemia. Vitamin C helps metabolism of carbohydrates. Vitamin B3 is necessary for energy production, and vitamin B5 is one of the coenzymes in the body that helps liver and adrenal function.
- the composition of the present invention does not include pigments and sugars.
- composition of the present invention has a calorific value of 10-60 kcal, more preferably 30-50 kcal, even more preferably 4-50 kcal on a 10 ml basis.
- compositions of the present invention is its excellent long term storage capacity. According to a preferred embodiment of the present invention, the composition of the present invention is 6 months
- the composition of the present invention exhibits a bacterial content of less than 100 cfu / ml, no change in appearance, and tar detection of tar pigment in an accelerated test at 38-42 ° C temperature condition for 6 months, and 23- of 6 months.
- Long-term preservation tests at 27 ° C conditions show bacterial content below 100 cfu / ml, no change in appearance and no tar pigment detection.
- composition of the present invention does not contain a preservative because it has excellent long-term storage. This good long term storage is due to the use of anhydrous glucose.
- the composition of the present invention has a 18-180 nig / dL blood glucose increase, 50-180 mg / dL blood glucose increase, 60-180 mg / dL blood glucose increase, 70- within 30 minutes 180 mg / dL hyperglycemic activity, 8 180 mg / dL hyperglycemic activity, 90-180 mg / dL hyperglycemic activity, 100-180 mg / dL hyperglycemic activity, 110-180 mg / dL hyperglycemic activity, 110- 180 mg / dL hyperglycemic activity, 120-180 mg / dL hyperglycemic activity, 125-175 mg / dL hyperglycemic activity; 50—160 mg / dL hyperglycemic activity, 50-150 mg / dL hyperglycemic activity; 60-160 mg
- the term "pharmaceutically effective amount” means an amount sufficient to achieve the composition efficacy or activity of the present invention.
- Pharmaceutically acceptable carriers included in the pharmaceutical composition of the present invention are those commonly used in the preparation of lactose, dextrose, sucrose, sorbet, manny, starch, acacia rubber, calcium phosphate, alginate, Gelatin, calcium silicate, microcrystalline cellulose polyvinylpyridone, cellulose, water, syrup, methyl cellulose, methylhydroxy banjoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil Including, but not limited to.
- the pharmaceutical composition of the present invention may further include lubricants, wetting agents, sweeteners, flavoring agents, emulsifiers, suspending agents, preservatives, etc. in addition to the above components. have. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995).
- the pharmaceutical composition of the present invention may be administered orally or parenterally, preferably orally.
- Suitable dosages of the pharmaceutical compositions of the present invention may be prescribed in various ways depending on factors such as formulation method, mode of administration, age, weight, sex, morbidity, food, time of administration, route of administration, rate of excretion and reaction response to the patient. Can be.
- the oral dosage of the pharmaceutical composition of the present invention is preferably 0.0001-1000 mg / kg body weight per day.
- compositions of the present invention may be prepared in unit dosage form by formulating with a pharmaceutically acceptable carrier and / or excipient according to methods which can be easily carried out by those skilled in the art. Or may be prepared by incorporating into a multi-dose container.
- the formulation may be in the form of a solution, suspension or emulsion of an oil or aqueous medium, or may be in the form of extract, powder, granule, tablet, or accelerator, and may further include a dispersing or stabilizing agent.
- the present invention provides a food composition for improving hypoglycemia of a solution formulation containing 40-90 wt% glucose and 10-60 wt% water, and containing no preservatives.
- the common content between the food composition of the present invention and the pharmaceutical composition of the present invention omits the description in order to avoid excessive complexity of the present specification.
- the food composition of the present invention is not particularly limited thereto, but is prepared from all types of foods such as health functional foods, nutritional supplements, nutrients, pharmafood, health food, nutraceutical, designer food, and food additives. Can be.
- the food composition of the present invention contains not only glucose as an active ingredient, but also components commonly added in food production, and include, for example, proteins, carbohydrates, fats, nutrients, seasonings, and flavoring agents.
- examples of the above carbohydrates include monosaccharides such as glucose, fructose and the like; Disaccharides such as maltose, sucrose, oligosaccharides and the like; And polysaccharides, for example Conventional sugars such as dextrin, cyclodextrin and the like, and sugar alcohols such as Xyl, sorby and erythritol.
- the flavoring agent natural flavoring agents [tautin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used.
- the food composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), dietary ingredients, flavoring agents such as synthetic and natural flavoring agents, coloring and neutralizing agents (cheese, chocolate, etc.), pectic acid and its Salts, alginic acid and salts thereof, organic acids, protective colloidal thickeners, H modifiers, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks and the like.
- the food composition of the present invention is prepared with a drink
- citric acid liquid fructose
- sugar glucose
- acetic acid malic acid
- fruit juice and various plant extracts may be further included in addition to the fructose which is the active ingredient of the present invention.
- the food composition of the present invention is very useful for the prevention, treatment and improvement of hypoglycemia.
- the present invention provides a composition for preventing, treating or improving hypoglycemia of a solution formulation containing glucose (preferably anhydrous glucose) as a main component.
- glucose preferably anhydrous glucose
- compositions of the present invention exhibit very good long term storage capacity without preservatives.
- composition of the present invention has a formulation of a solution, it is easy to ingest and can be quickly absorbed into the human body.
- composition of the present invention can rapidly increase blood sugar and is very effective for the prevention, treatment and improvement of hypoglycemia.
- 1 is a graph showing the change in blood glucose levels of fasted rats orally administered Arimedglucose and controls prepared by the present invention.
- Figure 2 shows the change in blood glucose levels of insulin-induced hypoglycemic rats orally administered Arimedglucose and controls prepared by the present invention. It is a graph.
- Example 1 Preparation of a composition for improving hypoglycemia
- Example 1 The storage capacity of the composition prepared in Example 1 was evaluated. Storage capacity was evaluated by accelerated test and long-term storage test, the evaluation conditions are shown in Table 1. Table 1
- hypoglycemic composition of the present invention is very excellent in storage capacity.
- Example 3 As described in Table 2 and Table 3, the hypoglycemic composition of the present invention is very excellent in storage capacity. Example 3.
- Anhydrous Glucose Group Administration of 80% Anhydrous Glucose Hydrate
- Arimedgluco group Administration of Arimed Glucoside
- Arimedgluco TM is a composite prepared in Example 1. It is a vitamin functional glucose drink containing 80% anhydrous crystalline glucose and is a colorless, clear solution. Crystalline anhydrous glucose was provided as a powder of white crystals. Arimedglucoin was stored at room temperature, and anhydrous glucose was refrigerated at 4 ° C until use to protect it from light and moisture. Arimedglucoin, a solution type, was administered orally by injection into 5 ml / kg of test substance in a 3 ml syringe and once using oral. Aqueous solution of 80% anhydrous glucose was prepared at least 24 hours before administration. Briefly, 4 g of anhydrous glucose provided was mixed well in preheated 80 ° C.
- the prepared 80% anhydrous glucose solution was orally administered at a dose of 5 ml / kg at a time.
- the medium control group was orally administered 5 ml / kg of distilled water in the same amount instead of the test substance (Table 4).
- Blood glucose levels were observed 10 consecutive times, starting 30 minutes prior to dosing up to 0.5, 1, 2, 3, 4, 5, 6, 7 and 24 hours. Each group was divided into five groups, fasting group and insulin-induced hypoglycemic group. ⁇ Arimedglucoin was a solution type, and 80% anhydrous glucose solution was prepared as a reference group. 4 g / kg) based on undissolved anhydrous glucose. The medium control group was orally administered with the same amount of 5 ml / kg distilled water instead of the test substance.
- Approved Test Substance Dose: 5 ml / kg as requested by the supplier. Formulation: Colorless, clear solution containing 80% Anhydrous Glucose. Media Solubility: Not tested because it is in solution.
- Approved Test Substance Dose: 4 g / kg Formulation: Same as Arimedglucose Formulation: White crystals Medium Solubility: Clear when dissolved. 800 mg / ml concentration with distilled water as the medium.
- hypoglycemia was induced in two ways according to previous studies (Hino et al., 2002). Simple overnight fasting of healthy healthy male rats to cause mild hypoglycemia and 20 U / kg of insulin (porcine pancreas; Sigma, MO, USA) intraperitoneally injected into male rats fasting overnight to cause severe hypoglycemia Way. Blood collection
- Values are mean mean SD of the experiment for 5 animals (mg / dl).
- the statistical significance level of ap was p ⁇ 0. () l and the statistical significance level of b p was ⁇ ⁇ 0 ⁇ 05 and compared with media control values by LDS test.
- the statistical significance level of c p is ⁇ .01, and the statistical significance level of d p is
- the arimedglucose group showed significant increase in blood glucose compared to the media control until 2 hours after the surviving administration of the experimental animals of the media control.
- the arimedglucose group showed a significant increase in blood glucose from the 30% to 5 hours post administration compared to the 80% anhydrous glucose aqueous solution group ( ⁇ .01 or p ⁇ 0.05; Table 7 and FIG. 2).
- Table 6
- the value is expressed as the number of animals that died.
- the value is the mean SD of the experiment for the rat with variable (Table 5) (mg / dl), ND: The statistical significance level of ap is ⁇ ⁇ 0 if it cannot be represented because of high mortality (5 deaths).
- the statistical significance level of. () 1, b p was ⁇ ⁇ 0 ⁇ 05, and compared with media control values by LDS test.
- the statistical significance level of c p was ⁇ .01 and compared with 80% anhydrous glucose aqueous solution group by LDS assay.
- the statistically significant level of dp was p 05 and compared with that of the 80% anhydrous glucose aqueous solution group by MW test.
- the experimental results showed that the blood glucose level of the 80% anhydrous glucose solution was changed to 309.92, 56.59 and 42.29% at 30 minutes, 1 and 2 hours after the administration of the medium control group. 467.94, 296.12 and 193.14%, respectively.
- Blood glucose levels in the Arimedgluco treated group were 38.55, 152.97, 106.02, 107.30, 106.44, 30 minutes, 1, 2, 3, 4, 5, 6, 7 and 24 hours after administration compared to the 80% anhydrous glucose aqueous solution group. 44.00, 25.10, 26.34 and -7.38%.
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Abstract
La présente invention concerne une composition biopharmaceutique ou une composition alimentaire incorporée dans une formulation en solution, ladite composition contenant de 40 à 90% en poids de glucose et de 10 à 60% en poids d'eau mais ne contenant pas de conservateurs. La composition pour réduire l'hypoglycémie présente une durée de conservation extraordinairement longue même si elle ne contient pas de conservateurs. Etant donné que la composition se trouve dans une formulation en solution, la composition peut être facilement ingérée et rapidement absorbée par le corps humain. De plus, la composition peut rapidement augmenter les taux de glycémie et par conséquent se trouve hautement efficace pour réduire l'hypoglycémie.
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Non-Patent Citations (4)
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AGARDHT, C. D. ET AL.: "hypoglycemic Brain Injury I. Metabolic and Light Microscopic Findings in Rat Cerebral Cortex During Profound Insulin-induced Hypoglycemia and in the Recovery Period Following Glucose Administration.", ACTA NEUROPATHOL, vol. 50, 1980, BERL, pages 31 - 41 * |
COLLIER, A. ET AL.: "Comparison of Intravenous Glucagon and Dextrose in Treatment of Severe Hypoglycemia in an Accident and Emergency Department.", DIABETES CARE., vol. 10, no. 6, 1987, pages 712 - 715 * |
MOORE, C. ET AL.: "Dextrose 10% or 50% in the treatment of hypoglycaemia out of hospital? A randomised controlled trial.", EMERG MED J., vol. 22, 2005, pages 512 - 515 * |
SUNG KWON, KIM ET AL.: "The effect of continuous glucose injection on prevention hypoglycemia during hemodialysis", THE KOREAN JOURNAL OF MEDICINE., vol. 62, no. 6, 2002, pages 642 - 647 * |
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