WO2013077553A1 - Composition for alleviating hypoglycemia - Google Patents
Composition for alleviating hypoglycemia 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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- 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
The present invention relates to a biopharmaceutical composition or a food composition in a solution formulation, wherein the composition includes 40-90 wt% of glucose and 10-60 wt% of water but excludes preservatives. The composition for alleviating hypoglycemia shows extraordinary long-term shelf-life even without preservatives. Since the composition is in a solution formulation, the composition can be easily ingested and rapidly absorbed by the human body. Also, the composition can rapidly increase blood glucose levels, and is thus highly effective at alleviating hypoglycemia.
Description
【명세서】 【Specification】
【발명의 명칭】 [Name of invention]
저혈당 개선용 조성물 Composition for improving hypoglycemia
【기술 분야】 [Technical field]
본 발명은 저혈당 예방, 치료 또는 개선용 조성물에 관한 것이다. 【배경 기술】 The present invention relates to a composition for preventing, treating or improving hypoglycemia. [Background technology]
정상인의 혈당은 공복 시 70-115 mg/dL 정도로 인체의 각 부분에 보내지는 에너지의 주요 공급원이 되며, 식사 후 2시간 혈당은 140 mg/dL 를 넘지 않는다. 저혈당은 여러 가지 다양한 원인에 의해 발생하지만， 가장 흔한 원인은 당뇨병 치료에 사용되는 경구 혈당강하제 또는 인슬린에 따른 부작용에 의해 발생된다. 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.
당뇨병의 치료는 경구 혈당강하제 또는 인슐린의 적절한 용량 및 투여시기， 규칙적인 식사량과 운동량 등의 균형이 증요하며, 경구 혈당강하제 또는 인슐린의 용량이 지나치게 많거나 투여시기가 부적절 했을 때 저혈당이 발생할 수 있다. 또한， 같은 용량과 같은 투여시기에 경구 혈당강하제 또는 인술린 치료를 했을경우에도 식사량이 불규칙하게 줄어들거나 운동량이 부적절하게 많아질 때， 그리고 음주에 의해서도 저혈당이 발생할 수 있다. 개인에 따라 저혈당 증상이 나타나는 혈당은 일정하지 않으나, 대체로 혈당이 50 mg/dL 이하로 떨어졌을 때 저혈당 증상이 나타난다. 즉， 저혈당증이란 여러 가지 원인에 의해서 혈당이 정상수치 이하로 감소함으로써 다양한 증상을 나타내는 상태를 의미한다. 이러한 저혈당증을 치료하기 위한 다양한 기술들이 개발되었다. 예를 들어， W02007/101179는 엔테로스타틴 (enterostat in)을 이용하여 저혈당증을 치료하는 방법을 제시하고 있다. 또한， W02009/114718은 글루카곤 방출을 자극하는 글루타메이트 수용체를 활성화시키는 화합물을 이용한 저혈당증 치료 기술을 개시하고 있다. 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. . In addition, 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. Various techniques have been developed to treat such hypoglycemia. For example, 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.
한편， 당류를 섭취하도록 하는 개발된 종래의 저혈당증 개선용 식품은 설탕 (sucrose)를 주성분으로 한다.
본 명세서 전체에 걸쳐 다수의 인용문헌 및 특허 문헌이 참조되고 그 인용이 표시되어 있다. 인용된 문헌 및 특허의 개시 내용은 그 전체로서 본 명세서에 참조로 삽입되어 본 발명이 속하는 기술 분야의 수준 및 본 발명의 내용이 보다 명확하게 설명된다. On the other hand, the conventional hypoglycemic improvement foods developed to intake sugars are mainly composed of sugar (sucrose). Throughout this specification, numerous citations and patent documents are referenced and their citations are indicated. The disclosures of cited documents and patents are incorporated herein by reference in their entirety, so that the level of the technical field to which the present invention belongs and the contents of the present invention are more clearly explained.
【발명의 내용】 [Content of invention]
【해결하려는 과제】 [Problem to solve]
본 발명자들은 저혈당증을 개선할 수 있는 조성물을 섭취가 편한 의약 또는 식품으로 개발하기 위하여 연구 노력하였다. 그 결과， 용액 제형으로 제조하였고， 이 용액 제형에 가장 적합하고， 장기 보존성이 우수한 제형으로 제조할 수 있으며， 저혈당증 개선에 현저한 효과를 나타내는 물질로서 포도당 (특히, 무수결정 포도당)을 사용하여 조성물을 제조하였으며， 제조된 조성물이 저혈당증에 우수한 효능을 나타냄을 확인함으로써, 본 발명을 완성하게 되었다. 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 (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.
따라서， 본 발명의 목적은 저혈당 예방 또는 치료용 약제학적 조성물올 제공하는 데 있다. Accordingly, it is an object of the present invention to provide a pharmaceutical composition for preventing or treating hypoglycemia.
본 발명의 다른 목적은 저혈당 개선용 식품 조성물을 제공하는 데 있다. Another object of the present invention to provide a food composition for improving hypoglycemia.
본 발명의 또 다른 목적은 저혈당의 예방 또는 치료방법, 및 저혈당증의 개선 방법을 제공하는 데 있다. 본 발명의 다른 목적 및 이점은 하기의 발명의 상세한 설명, 청구범위 및 도면에 의해 보다 명확하게 된다. 【과제의 해결 수단] Another object of the present invention is to provide a method for preventing or treating hypoglycemia, and a method for improving hypoglycemia. Other objects and advantages of the present invention will become apparent from the following detailed description, claims and drawings. [Measures of problem]
본 발명의 일 양태에 따르면， 본 발명은 포도당 4으90 중량 % 및 물 10-60 중량 ¾를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 저혈당 예방 또는 치료용 약제학적 조성물올 제공한다. According to an aspect of the present invention, 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.
본 발명의 다른 양태에 따르면， 본 발명은 포도당 40-90 중량 % 및 물 10-60 중량 %를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 조성물을 포유동물에게 투여하는 단계를 포함하는 저혈당의 예방 또는 치료
방법, 및 저혈당 증상의 개선 방법을 제공한다. 본 발명자들은 저혈당증을 개선할 수 있는 조성물을 섭취가 편한 의약 또는 식품으로 개발하기 위하여 연구 노력하였다. 그 결과， 용액 제형으로 제조하였고， 이 용액 제형에 가장 적합하고， 장기 보존성이 우수한 제형으로 제조할 수 있으며， 저혈당증 개선에 현저한 효과를 나타내는 물질로서 포도당 (특히， 무수결정 포도당)을 사용하여 조성물을 제조하였으며, 제조된 조성물이 저혈당증에 우수한 효능을 나타냄을 확인함으로써， 본 발명을 완성하게 되었다. According to another aspect of the present invention, 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.
본 명세서에서 사용되는 용어， "저혈당 또는 저혈당증" 은 여러 가지 원인에 의하여 혈당이 정상 수치 이하로 감소함으로써， 신체기관에 공급되는 포동당의 양이 감소하여 다양한 증상을 나타내는 상태를 의미한다. 저혈당이 발생하면 뇌와 신경기관에 공급되는 포도당이 부족해지고, 뇌신경계는 에너지 부족을 느끼게 되어 신체의 자율신경계를 작동시키게 되며 크게 교감신경계 증상과 중추신경계 증상 2가지로 구분되어 나타난다. 그 결과, 현기증， 피로감이 발생할 수 있고, 심해지면 간질발작과 의식소실이 발생할 수 있으며 사망할 수도 있고， 저혈당을 극복하기 위해 아드레날린이 분비됨에 따라 혈압상승， 맥박수증가， 가슴두근거림， 떨림， 블안감이 발생하고， 부교감신경의 작용으로 식은땀， 공복감, 이상감각 등이 발생할 수 있다. As used herein, the term "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. When 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. As a result, 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.
본 명세서에서 사용되는 용어， "예방" 은 본 발명의 조성물의 투여로 저혈당증을 억제시키거나 진행을 지연시키는 모든 행위를 의미하며， 용어ᅳ "치료" 는 혈중 당 농도를 상승시키는 것, 혈당을 정상 수치 범위로 회복시키는 것 및 저혈당증에 의한 제증상의 개선과 진행의 억제를 의미한다. 본 명세서에서 용어 "개선" 은 용어 "치료" 와 상호 교환적으로 사용된다. 본 발명에서， 포도당은 섭취 후 신속하게 인체에 흡수되어 혈당을 증가시켜 저혈당증을 효과적으로 개선시킬 수 있다. As used herein, the term "prevention" means any action that inhibits or delays progression of hypoglycemia by administration of a composition of the present invention, and the term "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. The term "improvement" is used herein interchangeably with the term "treatment". In the present invention, glucose can be rapidly absorbed by the human body after ingestion to increase blood sugar, thereby effectively improving hypoglycemia.
본 명세서에서 사용되는 용어， "포유동물" 은 인간, 돼지, 말, 소 양， 개 및 고양이를 포함하며, 바람직하게는 인간이다. As used herein, the term "mammal" includes humans, pigs, horses, cattle sheep, dogs and cats, preferably humans.
본 발명.의 바람직한 구현예에 따르면， 본 발명의 포도당은 무수결정 포도당이다. 무수결정 포도당은 본 발명의 조성물이 우수한 저장능 및
저혈당증 개선능을 나타내도록 한다. According to a preferred embodiment of the invention, the glucose of the invention is anhydrous glucose. Anhydrous crystalline glucose has excellent storage capacity and Show hypoglycemia improvement.
본 발명의 조성물은 포도당 4으90 중량 % 및 물 10-60 중량 %를 포함한다. 본 발명의 바람직한 구현예에 따르면， 본 발명의 조성물은 포도당 45-90 중량 % 및 물 10-55 증량 %， 바람직하게는 50-90 증량 % 및 물 10-50 중량 %， 보다 바람직하게는 55-90 중량 % 및 물 10-45 중량 %， 보다 더 바람직하게는 6으 90 중량 % 및 물 10-40 증량 %， 보다 더 바람직하게는 65-90 중량 % 및 물 10-35 중량 %, 보다 더 바람직하게는 7으90 중량 % 및 물 10-30 중량 %， 보다 더 바람직하게는 75-90 중량 % 및 물 1으 25 중량 %을 포함한다. 본 발명의 보다 바람직한 구현예에 따르면， 본 발명의 조성물은 포도당 45- 85 증량 % 및 물 15—55 중량 %， 바람직하게는 50-85 증량 % 및 물 15-50 중량 %, 보다 바람직하게는 55-85 중량 % 및 물 15-45 중량 %， 보다 더 바람직하게는 60-85 중량 % 및 물 15-40 중량 %， 보다 더 바람직하게는 65ᅳ 85 중량 ¾ 및 물 15-35 중량？ fc, 보다 더 바람직하게는 70-85 증량 % 및 물 15-30 중량 %， 보다 더 바람직하게는 75-85 중량 % 및 물 15ᅳ 25 증량 %, 보다 더 바람직하게는 78-83 중량 % 및 물 17-22 중량 ¾>을 포함한다. The composition of the present invention comprises 4% by weight of glucose and 10-60% by weight of water. According to a preferred embodiment of the present invention, 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. According to a more preferred embodiment of the present invention, 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 ᅳ 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 ¾>.
본 발명의 바람직한 구현예에 따르면, 본 발명의 조성물은 비타민 (：， 비타민 B1, 비타민 B3, 비타민 B5, 비타민 B6, 구연산 및 이의 조합으로 구성된 군으로부터 선택되는 보조 성분을 추가적으로 포함한다. 보조 성분 증, 비타민 B1은 탄수화물의 에너지 대사에 필요한 조효소로 피로 회복 및 스트레스 저하에 도움을 주며, 비타민 B6는 저혈당에 의한 말초 신경병증의 개선에 도움올 주고, 비타민 C는 탄수화물의 대사에 도움을 주며 피로감을 개선시키는 작용을 한다. 비타민 B3는 에너지 생성에 필요하고， 비타민 B5는 체내 보조 효소의 하나로 간 기능 및 부신 기능에 도움을 준다. According to a preferred embodiment of the present invention, 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.
본 발명의 바람직한 구현예에 따르면， 본 발명의 조성물은 색소 및 설탕을 포함하지 않는다. According to a preferred embodiment of the present invention, the composition of the present invention does not include pigments and sugars.
본 발명의 조성물은 10 ml 기준으로 하예 바람직하게는 20-60 kcal , 보다 바람직하게는 30-50 kcal, 보다 더 바람직하게는 4으50 kcal의 열량을 갖는다. The 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.
본 발명 조성물의 특징 증 하나는 우수한 장기 저장능을 갖는 것이다. 본 발명의 바람직한 구현예에 따르면， 본 발명의 조성물은 6개월의 One feature of the 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
38-42 °C 온도 조건에서의 가속시험 (저장 조건)에서 100 cfu/ml 이하의
박테리아 함량을 가지며， 6개월의 23-27°C 온도 조건에서의 장기보존 시험 (저장 조건)에서 100 cfu/ml 이하의 박테리아 함량을 갖는다. 바람직하게는， 본 발명의 조성물은 6개월의 38-42°C 온도 조건에서의 가속시험에서 100 cfu/ml 이하의 박테리아 함량， 성상의 무변화 및 타르색소의 블검출을 나타내며， 6개월의 23-27°C 온도 조건에서의 장기보존 시험에서 100 cfu/ml 이하의 박테리아 함량， 성상의 무변화 및 타르색소의 불검출을 나타낸다. 100 cfu / ml or less under accelerated testing (storage conditions) at 38-42 ° C It has a bacterial content and a bacterial content of less than 100 cfu / ml in the long-term preservation test (storage conditions) at 23-27 ° C temperature conditions of 6 months. Preferably, 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.
본 발명 조성물의 특징 중 하나는, 본 발명의 조성물은 우수한 장기 저장성을 갖기 때문에 방부제를 포함하지 않는다는 것이다. 이러한 우수한 장기 저장성은 무수결정 포도당의 이용 때문이다. One of the characteristics of the composition of the present invention is that the 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.
본 발명의 조성물의 특징 중 하나는, 하기의 실험예에서 입증된 바와 같이 신속한 혈당 증가능이다. 본 발명의 바람직한 구현예에 따르면, 본 발명의 조성물은 30분 이내의 18-180 nig/dL 혈당 증가능， 50-180 mg/dL 혈당 증가능， 60-180 mg/dL 혈당 증가능, 70-180 mg/dL 혈당 증가능, 8으 180 mg/dL 혈당 증가능， 90-180 mg/dL 혈당 증가능， 100-180 mg/dL 혈당 증가능， 110-180 mg/dL 혈당 증가능, 110-180 mg/dL 혈당 증가능, 120-180 mg/dL 혈당 증가능， 125-175 mg/dL 혈당 증가능 ; 50—160 mg/dL 혈당 증가능, 50-150 mg/dL 혈당 증가능; 60-160 mg/dL 혈당 증가능， 60-150 mg/dL 혈당 증가능; 70-160 mg/dL 혈당 증가능， 70-150 mg/dL 혈당 증가능; 75—160 mg/dL 혈당 증가능， 75-150 mg/dL 혈당 증가능; 80-150 mg/dL 혈당 증가능 또는 18-25 mg/dL 혈당 증가능을 갖는다. One of the features of the composition of the present invention is its rapid blood glucose increasing ability, as demonstrated in the following experimental example. According to a preferred embodiment of the present invention, 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 / dL hyperglycemic activity, 60-150 mg / dL hyperglycemic activity; 70-160 mg / dL hyperglycemic activity, 70-150 mg / dL hyperglycemic activity; 75—160 mg / dL hyperglycemic activity, 75-150 mg / dL hyperglycemic activity; 80-150 mg / dL blood glucose increase or 18-25 mg / dL blood glucose increase.
본 명세서에서 사용된 용어， "약제학적 유효량" 은 본 발명의 조성물 효능 또는 활성을 달성하는 데 충분한 양을 의미한다. As used herein, the term "pharmaceutically effective amount" means an amount sufficient to achieve the composition efficacy or activity of the present invention.
본 발명의 약제학적 조성물에 포함되는 약제학적으로 허용되는 담체는 제제시에 통상적으로 이용되는 것으로서， 락토스, 덱스트로스， 수크로스, 솔비틀， 만니를， 전분， 아카시아 고무， 인산 칼슘, 알기네이트， 젤라틴, 규산 칼슘, 미세결정성 셀롤로스ᅳ 폴리비닐피를리돈， 셀를로스, 물, 시럽 , 메틸 샐를로스， 메틸히드록시 밴조에이트， 프로필히드록시벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일 등을 포함하나， 이에 한정되는 것은 아니다. 본 발명의 약제학적 조성물은 상기 성분들 이외에 윤활제, 습윤제， 감미제， 향미제, 유화제, 현탁제， 보존제 등을 추가로 포함할 수
있다. 적합한 약제학적으로 허용되는 담체 및 제제는 Remington's Pharmaceutical Sciences (19th ed. , 1995)에 상세히 기재되어 있다. 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).
본 발명의 약제학적 조성물은 경구 또는 비경구로 투여할 수 있고， 바람직하게는 경구 투여이다. The pharmaceutical composition of the present invention may be administered orally or parenterally, preferably orally.
본 발명의 약제학적 조성물의 적합한 투여량은 제제화 방법， 투여 방식， 환자의 연령, 체중， 성, 병적 상태， 음식， 투여 시간， 투여 경로， 배설 속도 및 반웅 감응성과 같은 요인들에 의해 다양하게 처방될 수 있다. 본 발명의 약제학적 조성물의 경구 투여량은 바람직하게는 1일 당 0.0001- 1000 mg/kg (체중)이다. 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.
본 발명의 약제학적 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 약제학적으로 허용되는 담체 및 /또는 부형제를 이용하여 제제화함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기내에 내입시켜 제조될 수 있다. 이때 제형은 오일 또는 수성 매질증의 용액， 현탁액 또는 유화액 형태이거나 엑스제， 분말제, 과립제, 정제 또는 갑셀제 형태일 수도 있으며 분산제 또는 안정화제를 추가적으로 포함할 수 있다. 본 발명의 다른 양태에 따르면， 본 발명은 포도당 40-90 중량 % 및 물 10-60 중량 %를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 저혈당 개선용 식품 조성물을 제공한다. The pharmaceutical 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. In this case, 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. According to another aspect of the present invention, 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.
본 발명의 식품 조성물과 본 발병의 약제학적 조성물 사이에 공통된 내용은 본 명세서의 과도한 복잡성을 회피하기 위하여 그 기재를 생략한다. 본 발명의 식품 조성물은 특별히 이에 제한되지 않으나， 건강 기능성 식품, 영양 보조제, 영양제, 파머푸드 (pharmafood), 건강 식품, 뉴트라슈티칼 (nutraceutical), 디자이너 푸드, 식품 첨가제 등의 모든 형태의 식품으로 제조될 수 있다. 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.
본 발명의 식품 조성물은 유효성분으로서 포도당뿐만 아니라， 식품 제조 시에 통상적으로 첨가되는 성분을 포함하며, 예를 들어, 단백질, 탄수화물， 지방, 영양소, 조미제 및 향미제를 포함한다. 상술한 탄수화물의 예는 모노사카라이드， 예를 들어 , 포도당， 과당 등; 디사카라이드， 예를 들어 말토 스， 슈크로스, 올리고당 등; 및 폴리사카라이드, 예를 들어
덱스트린， 사이클로덱스트린 등과 같은 통상적인 당 및 자일리를, 소르비를， 에리트리를 등의 당알콜이다. 향미제로서 천연 향미제 [타우마틴， 스테비아 추출물 (예를 들어 레바우디오시드 A, 글리시르히진 등]) 및 합성 향미제 (사카린， 아스파르탐 등)를 사용할 수 있다. 상기 외에 본 발명의 식품 조성물은 여러 가지 영양제， 비타민류， 광물 (전해질)， 식이성분, 합성 풍미제 및 천연 풍미제 등의 풍미제， 착색제 및 중진제 (치즈， 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염， 유기산， 보호성 콜로이드 증점제， H 조절제， 안정화제， 방부제， 글리세린， 알콜, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 예컨대， 본 발명의 식품 조성물이 드링크제로 제조되는 경우에는 본 발명의 유효성분인 포당당 이외에 구연산, 액상과당， 설탕， 포도당, 초산， 사과산， 과즙， 각 종 식물 추출액 등을 추가로 포함시킬 수 있다. 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. As 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. In addition to the above, 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. For example, when 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. .
식품에 대한 용이한 접근성을 고려한다면, 본 발명의 식품 조성물은 저혈당증의 예방， 치료 및 개선에 매우 유용하다. Considering easy access to food, the food composition of the present invention is very useful for the prevention, treatment and improvement of hypoglycemia.
【발명의 효과】 【Effects of the Invention】
본 발명의 특징 및 이점을 요약하면 다음과 같다: The features and advantages of the present invention are summarized as follows:
(a) 본 발명은 포도당 (바람직하게는， 무수결정 포도당)을 주성분으로 한 용액 제형의 저혈당 예방, 치료 또는 개선용 조성물을 제공한다. (a) 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.
(b) 본 발명의 조성물은 방부제 없이도 매우 우수한 장기 저장능올 나타낸다. (b) The compositions of the present invention exhibit very good long term storage capacity without preservatives.
(c) 본 발명의 조성물은 용액의 제형을 가지기 때문에 섭취가 용이하고 인체 내 흡수가 신속하게 이루어질 수 있다. (c) Since the 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.
(d) 본 발명의 조성물은 신속하게 혈당을 증가시킬 수 있어 저혈당증의 예방, 치료 및 개선에 매우 유효하다. (d) The composition of the present invention can rapidly increase blood sugar and is very effective for the prevention, treatment and improvement of hypoglycemia.
【도면의 간단한 설명】 [Brief Description of Drawings]
도 1은 본 발명에 의해 제조된 아리메드글루코 및 대조군들을 경구 투여한 절식 랫트의 혈당 수치의 변화를 나타내는 그래프이다. 1 is a graph showing the change in blood glucose levels of fasted rats orally administered Arimedglucose and controls prepared by the present invention.
도 2는 본 발명에 의해 제조된 아리메드글루코 및 대조군들을 경구 투여한 인슐린 -유도 저혈당 랫트의 혈당 수치의 변화를 나타내는
그래프이다. 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.
【발명을 실시하기 위한 구체적인 내용】 [Specific contents to carry out invention]
이하, 실시예를 통하여 본ᅵ 발명을 더욱 상세히 설명하 ^자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로서， 본 발명의 요지에 따라 본 발명의 범위가 이들 실시예에 의해 제한되지 않는다는 것은 당업계에서 통상의 지식올 가진 자에 있어서 자명할 것이다. 실시예 More detailed description of the present i invention to the following examples and ^ and characters. These examples are only for illustrating the present invention in more detail, and it will be apparent to those skilled in the art that the scope of the present invention is not limited by these examples according to the gist of the present invention. . Example
실시예 1: 저혈당 개선용 조성물의 제조 Example 1: Preparation of a composition for improving hypoglycemia
정제수 0.5g에 무수결정 포도당 ((주 )에이아이코리아) 500g을 첨가하여 용해시킨 다음 무수결정 포도당 500g을 추가적으로 첨가하여 용해시켰다. 상기 용해는 8(rc의 온도 조건에서 교반하지 않고 방치시키는 방식 (allowed to stand)으로 실시하였다. 이어， 비타민 성분을 본 발명의 조성물에 추가하기 위하여 구연산 O.OOlg, 비타민 C O.OOlg, 판토텐산 (Vit B5) 칼슴 0.00037g, 니코틴산아미드 (나이아신， Vit B3) 0.00007g, 비타민 B1 염산염 0.000014g, 비타민 B6 염산염 0.000014g 및 레몬향을 상기 무수결정 포도당 용해액에 첨가하여 80°C에서 20분 동안 교반하여 용해시켰다. 이하, 실시예 1에서 제조된 조성물을 아리메드글루코라 한다. 실시예 2: 저장능력 분석 To 0.5 g of purified water, 500 g of anhydrous glucose was added and dissolved, and then 500 g of anhydrous glucose was added to dissolve. The dissolution was carried out in an allowed to stand without stirring at a temperature condition of 8 (rc. Then, citric acid O.OOlg, vitamin C O.OOlg, pantothenic acid were added to add the vitamin component to the composition of the present invention. (Vit B5) 0.00037 g of chestnut, 0.00007 g of nicotinamide (niacin, Vit B3), 0.000014 g of vitamin B1 hydrochloride, 0.000014 g of vitamin B6 hydrochloride, and lemon flavor were added to the anhydrous glucose solution for 20 minutes at 80 ° C. It was dissolved by stirring.Hereinafter, the composition prepared in Example 1 was called Arimedgluco.
실시예 1에서 제조된 조성물의 저장능력을 평가하였다. 저장능은 가속시험 및 장기보존 시험으로 평가하였으며， 평가 조건은 표 1과 같다. 【표 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
가속시험 결과는 표 2， 장기보존 시험 결과는 표 3에 요약되어 있다.
【표 2] The accelerated test results are summarized in Table 2 and the long-term storage test results are summarized in Table 3. [Table 2]
가속시험 결과 Acceleration test result
상기 표 2 및 표 3에 기재된 바와 같이， 본 발명의 저혈당 개선용 조성물은 저장능이 매우 우수하다. 실시예 3. As described in Table 2 and Table 3, the hypoglycemic composition of the present invention is very excellent in storage capacity. Example 3.
실험재료 및 실험방법 Experimental Materials and Methods
실험동물 및사육 Laboratory Animals and Breeding
총 30 마리의 건강한 수컷 SD(Spr ague-Daw ley) 랫트 (6 주령， SIX, 일본; 체중 170-190g)을 7-8 일 동안 순웅시킨 후 실험에 이용하였다. 동물들은 5 마리씩 폴리카보네이트 케이지에 분배하였으며， 온도 2()ᅳ 25°C, 습도 5으55¾로 유지된 방에서 사육하였다. 명암 주기는 12 시간씩이며, 설치류 일반 사료 (삼양, 한국)와 물은 제한 없이 제공하였다. 모든 동물들은 미국 실험동물 자원 협회 (미국 국립 연구 회의, 생명 과학 위원회, 1996 년， 워싱턴 DC)에서 발행된 실험동물 관리 및 이용에 관한 지침을 기초로 한 대구한의대학교의 실험동물 관리 및 이용에 관한 지침에 따라
처리하였다. 3 그룹은 각각 5 마리씩 절식과 인슬린 -유도 저혈당군으로 나누어 총 30 마리가 이용되었으며, 실험 방법은 다음과 같다. 실험군 (군당 5 마리) A total of 30 healthy male SD (Spr ague-Daw ley) rats (6 weeks old, SIX, Japan; body weight 170-190 g) were roamed for 7-8 days before being used for the experiment. Animals were distributed in polycarbonate cages of five animals and bred in a room maintained at a temperature of 2 () ° 25 ° C and a humidity of 55¾. The light and dark cycle was 12 hours, and rodent general feed (Samyang, Korea) and water were provided without limitation. All animals were used for the management and use of laboratory animals at Daegu Haany University based on guidelines for the management and use of laboratory animals issued by the American Institute for Laboratory Animal Resources (National Research Council, Life Sciences Committee, Washington, DC, 1996). According to the instructions Treated. Three groups were divided into 5 groups, fasting and insulin-induced hypoglycemia. A total of 30 animals were used. Experimental group (5 per group)
1. 매체 대조군: 매체로서 증류수 투여 1.Medium control: Distilled water administration as medium
2. 무수 포도당군: 80%무수결정 포도당 수화물 투여 2. Anhydrous Glucose Group: Administration of 80% Anhydrous Glucose Hydrate
3. 아리메드글루코군: 아리메드글루코액 투여 3. Arimedgluco group: Administration of Arimed Glucoside
시험물질 재료 준비 및 투여 Test Material Preparation and Administration
아리메드글루코 ™ 은 실시예 1 에서 제조된 복합. 비타민 기능성 포도당 음료로서 80% 무수결정 포도당을 함유하고 있으며， 무색의 투명한 용액이다ᅳ 무수결정 포도당은 백색 결정의 분말상태로 제공되었다. 아리메드글루코는 상온에서 보관하였고， 무수결정 포도당은 빛과 습기로부터 보호하기 위하여 사용 전까지 4°C 냉장보관 하였다. 용액형인 아리메드글루코는 투여 용량 5 ml /kg 의 시험물질을 3 ml 주사기에 넣고 존데를 이용하여 1 회 구강내로 직접 경구 투여하였다. 투여 최소 24 시간 전에 80% 무수결정 포도당 수용액을 준비해두었다. 간단히 설명하면, 제공된 무수결정 포도당 4g 을 예열된 80°C 증류수에서 잘 섞고, 4°C에서 밤새 넁장보관 해두었다. 이후, 상기 무수결정 포도당 수용액은 무색 투명한 수용액으로 변한다. 미리 준비된 80% 무수결정 포도당 수용액을 한번에 5 ml /kg 용량을 경구 투여하였다. 매체 대조군은 시험물질 대신 동량인 5 ml/kg의 증류수를 경구투여하였다 (표 4).
Arimedgluco ™ 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. distilled water and stored at 4 ° C. overnight. Thereafter, the anhydrous crystalline glucose aqueous solution turns into a colorless transparent aqueous solution. 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).
【표 4】
Table 4
혈당 수치는 투여 30 분 전부터 시작하여 0.5， 1， 2, 3, 4， 5， 6, 7 및 24 시간까지 총 10 회 연속적으로 관찰하였다. 세 그룹은 각 그룹마다 각각 5 마리씩 절식군과 인슬린 -유도 저혈당군으로 나워 이용하였다ᅳ 아리메드글루코는 용액형이기에 80% 무수결정 포도당 수용액을 참조군으로 준비하였으며， 각각 5 ml /kg 용량 (용해시키지 않은 무수결정 포도당 기준으로 4 g/kg)으로 경구 투여하였다. 매체 대조군에는 시험물질 대신 동량의 5 ml /kg 증류수만을 경구 투여하였다. 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. 리 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.
시험 물질 Test substance
물질명： 아리메드글루코¾1 Substance name: Arimedgluco ¾1
도착일： 2011년 9월 20일 Arrival date: September 20, 2011
제공: 아리메드 테라퓨틱스 (Arimed Therapeutics, 한국) Provided by Arimed Therapeutics (Korea)
승인된 시험물질 투여량: 제공자의 요청에 따라 5 ml /kg 투여 제형: 80%무수결정 포도당을 함유하고 있는 무색 투명 용액 매체 용해성: 용액형이기에 시험하지 않았음. 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.
보관: 4°C 넁장 상온 보관 참조 물질 Storage: Store at room temperature at 4 ° C
물질명: 무수결정 포도당 Material Name: Anhydrous Glucose
도착일 : 2011년 9월 26일 Arrival date: September 26, 2011
제공: 아리메드 테라퓨틱스 (Arimed Therapeutics, 한국) Provided by Arimed Therapeutics (Korea)
승인된 시험물질 투여량: 아리메드글루코와 같은 농도의 4 g/kg 제형: 백색 결정
매체 용해성: 용해되면 투명해짐. 증류수를 매체로 하여 800 mg/ml 농도. 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.
보관: 4°C 넁장 보관 저혈당 유발 Storage: Store at 4 ° C. Store hypoglycemia.
저혈당은 이전 연구 (Hino et al. , 2002)에 따라 두 가지 방법으로 유도되었다. 경증 저혈당을 일으키기 위해 정상인 건강한 수컷 랫트를 단순하게 밤새 절식 하는 방법과 중.증 저혈당을 일으키도록 밤새 절식한 수컷 랫트에게 인슐린 (돼지 췌장; Sigma, MO, USA) 20 U/kg 을 복강 내에 주사하는 방법이다. 혈액 채취 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
모든 실험동물들은 매체나 글루코오스를 경구 투여한 후 연속적으로 30 분， 1, 2, 3， 4， 5， 6， 7 및 24 시간이 지났을 때 안와혈관총에서 채취하고， 2.5 mg/ml NAF 및 2 ml/ml 포타슘 옥살레이트 트리티드 튜브에 모은다. 살아있을 때 혈장을 분리하고, 수집된 모든 혈장은 분석 전까지 - 70°C에서 넁동 보관하였다. 혈당 수치 측정 All animals were harvested from the orbital vascular plexus 30 minutes, 1, 2, 3, 4, 5, 6, 7 and 24 hours continuously after oral administration of medium or glucose, 2.5 mg / ml NAF and 2 Collect in ml / ml potassium oxalate treated tube. Plasma was isolated when live and all collected plasma was kept at -70 ° C until analysis. Blood glucose level measurement
자동 혈액 분석기 (Toshiba 200 FR, Japan)를 이용하여 mg/dl 의 단위로 혈당 수치를 측정하였다. 통계적 분석 Blood glucose levels were measured in mg / dl using an automated blood analyzer (Toshiba 200 FR, Japan). Statistical analysis
모든 혈당 수치는 살아있을 때 채취한 혈액에 대한 평균 土 표준편차 (SD)로 나타내었다. 서로 다른 투여량 그룹을 위해 다중 비교 검정을 수행하였다. 변량 동질성은 레빈 검정 (Levene, 1981)를 이용하였다. 만약 레빈 검정 결과가 변화의 동질성으로부터 아무런 유효성이 없는 편차를 나타낸다면， 그 결과는 어떤 그룹 비교의 쌍이 의미있게 변하였는지를 결정하기 위해 일원배치 아노바 (AN0VA) 테스트를 진행하고 최소유의차 (LSD) 다중 -비교 테스트를 진행하여 분석하였다. 레빈 검정에서 변량 동질성으로부터 유효한 편차가 나온 경우에는 비 -모수 비교 검정,
크러스칼-왈리스 검정을 수행하였다. 크러스칼-왈리스 검정에서 유효한 차이가 관찰되면 그룹 비교의 특이적인 쌍을 결정하기 위해서 만-휘트니 U- 월콕슨 탱크 섬 w 검정을 수행하였다. 통계적 분석은 원도우용 SPSS(Re lease 14. OK, SPSS Inc. , USA)(Ludbrook, 1997)을 이용하여 수행하였다. 매체 대조군과 시험물질 투여군 간 백분율 변화 및 아리메드글루코와 80% 무수결정 포도당 수용액 투여군 간 백분율 변화는 검증의 효용성 이해를 돕기 위하여 다음과 같이 계산되었다. All blood glucose levels are expressed as mean 土 standard deviation (SD) for blood taken while alive. Multiple comparison assays were performed for different dose groups. Variable homogeneity was used for Levin's test (Levene, 1981). If the Levin test results show an ineffective deviation from the homogeneity of the change, the results are run through a one-way ANOVA (AN0VA) test to determine which pairs of comparisons have changed significantly and the least significant difference (LSD). The analysis was carried out with a multi-comparison test. If the Levin test yields a valid deviation from the variance homogeneity, then the non-parametric comparison test, Kruskal-Wallis assay was performed. If a valid difference was observed in the Kruskal-Wallis test, the Mann-Whitney U-Walcoxon tank island w test was performed to determine specific pairs of group comparisons. Statistical analysis was performed using SPSS for Windows (Re lease 14. OK, SPSS Inc., USA) (Ludbrook, 1997). The percentage change between the medium control group and the test substance administration group and the percentage change between the Arimedglucose and 80% anhydrous glucose aqueous solution administration groups were calculated as follows to help understand the utility of the validation.
<공식 1> <Formula 1>
매체 대조군에 비교한 백분율 변화 (%) = [ ( (시험 글루코오스 투여군의 데이터 - 매체 대조군의 데이터 )/ 매체 대조군의 데이터 )χ loo]Percent change compared to the medium control (%) = [((data from test glucose administration group-data from media control) / data from media control) χ loo]
<공식 2〉 <Formula 2>
아리메드글루코 투여군과 80% 무수결정 포도당 수용액 투여군 간의 백분율 변화 (%) = [ ((아리메드글루코 투여군의 데이터 - 80% 무수결정 포도당 수용액 투여군의 데이터 )/ 80% 무수결정 포도당 수용액 투여군의 데이터 )x 100] 실험 결과 및 고찰 Percent change (%) between Arimedglucose administered group and 80% anhydrous glucose aqueous solution group = ((Data of Arimedglucose administered group-Data of 80% anhydrous glucose aqueous solution group) / 80% anhydrous glucose aqueous solution group) x 100] Experimental Results and Discussion
절식 랫트의 혈당 수치 Blood Glucose Levels in Fasting Rats
멸균증류수를 투여한 매체 대조군에 비해 유의성 있는 (p<0.01 또는 p<0.05) 혈당의 상승이 80% 무수결정 포도당 수용액 및 아리메드글루코 투여군에서 각각 투여 후 30 분부터 나타나기 시작하여， 80¾ 무수결정 포도당 수용액 투여군에서는 투여 후 5 시간까지, 아리메드글루코 투여군에서는 투여 후 24 시간까지 각각 매체 대조군에 비해 유의성 있는 혈당의 증가를 나타내었다. 특히 아리메드글루코 투여군에서는 투여 후 30 분부터 측정한 모든 시간대에서 24 시간까지 80% 무수결정 포도당 수용액 투여군에서 비해서도 유의성 있는 혈당의 증가를 각각 나타내었다 (p<0.05; 표 5 및 도 1).
& 1^^ᅳ Significant (p <0.01 or p <0.05) elevations in blood glucose, compared to media controls with sterile distilled water, began to appear 30 minutes after administration in 80% anhydrous aqueous solution of glucose and aqueous glucose, respectively, 80¾ anhydrous glucose Aqueous administration group showed a significant increase in blood glucose up to 5 hours after administration and up to 24 hours after administration in arimedglucose administration group compared to the medium control group. In particular, the group administered with Arimeglugluco showed a significant increase in blood glucose levels compared to the group administered with 80% anhydrous glucose solution for 24 hours at all time periods measured from 30 minutes after administration (p <0.05; Table 5 and FIG. 1). & 1 ^^ ᅳ
【표 5】Table 5
값은 5마리에 대한 실험의 평균士 SD이다 (mg/dl). Values are mean mean SD of the experiment for 5 animals (mg / dl).
ap의 통계학적 유의 수준은 p<0.()l이고 bp의 통계학적 유의 수준은 ρ<0·05이며， LDS 검정에 의하여 매체 대조군 값과 비교하였다.
cp의 통계학적 유의 수준은 ρθ.01이고, dp의 통계학적 유의 수준은The statistical significance level of ap was p <0. () l and the statistical significance level of b p was ρ <0 · 05 and compared with media control values by LDS test. The statistical significance level of c p is ρθ.01, and the statistical significance level of d p is
P<0.05 이며， LDS 검정에 의하여 80% 무수결정 포도당 수용액 투여군 값과 비교하였다. 실험결과， 80% 무수결정 포도당 수용액 투여군에서는 매체 대조군에 비해 투여 후 30분， 1， 2， 3, 4, 5， 6, 7 및 24 시간에 각각 116.56, 92.01, 48.59, 35.10, 29.89, 15.45, 10.53, 0.50 및 -3.13%의 변화를 나타내었고， 아리메드글루코 투여군에서는 매체 대조군에 비해 각각 152.80, 138.11, 88.31, 55.10, 47.89, 38.55, 37.93, 28.33 및 15.65%의 변화를 나타내었다. 아리메드글루코 투여군에서는 80% 무수결정 포도당 수용액 투여군에 비해 투여후 30 분, 1， 2, 3, 4, 5, 6， 7 및 24 시간에 각각 16.73， 24.01, 26.73, 14.80， 13.86， 20.00, 24.79, 27.69 및 19.39%의 변화를 나타내었다. 이와 같은 결과들은 절식 랫트군의 경증 저혈당 조건일 때 아리메드글루코가 동일량의 80% 무수결정포도당 수용액보다 더 빠른 흡수와 지속성을 나타냈다는 것올 의미한다. 인슐린 -유도 저혈당 랫트의 혈당 수치 P <0.05, and compared with 80% anhydrous glucose aqueous solution administration group by LDS assay. The experimental results showed that in the 80% anhydrous glucose aqueous solution group, 116.56, 92.01, 48.59, 35.10, 29.89, 15.45, 30 minutes, 1, 2, 3, 4, 5, 6, 7 and 24 hours, respectively, compared to the medium control group. Changes of 10.53, 0.50 and -3.13% were shown, and in the aridmegluco administration group, changes of 152.80, 138.11, 88.31, 55.10, 47.89, 38.55, 37.93, 28.33 and 15.65% were compared with the medium control group, respectively. In the Arimedglucoin group, 16.73, 24.01, 26.73, 14.80, 13.86, 20.00, 24.79 at 30 minutes, 1, 2, 3, 4, 5, 6, 7 and 24 hours after administration compared to the 80% anhydrous glucose aqueous solution group. , 27.69 and 19.39%. These results indicate that, under mild hypoglycemic conditions in fasted rat groups, arimedgluco showed faster absorption and persistence than the same amount of 80% anhydrous glucose solution. Blood Glucose Levels in Insulin-Induced Hypoglycemic Rats
인술린 20 U/kg 투여 후 증류수를 투여한 모든 매체 대조군에서는 인슐린 투여 후 4.5 시간 이내에 5 마리의 모든 랫트가 발작과 흔수 같은 저혈당성 쇼크를 나타낸 후 사망하였으며 (5/5; 100%) , 80% 무수결정 포도당 수용액 투여군에서 인슐린 투여 후 6.5 시간 이내에 2 마리가 사망하였다 (2/5; 40%). 그러나， 아리메드글루코 투여군에서는 실험 전기간인 인슐린 투여 후 26 시간 동안 사망례가 나타나지 않았다 (표 6). 또한， 매체 대조군에 비해 유의성 있는 (p<0.01 또는 ρθ.05) 혈당의 상승이 80% 무수결정 포도당 수용액 및 아리메드글루코 투여군에서 각각 투여후 30 분부터 나타나기 시작하예 80% 무수결정 포도당 수용액 투여군에서는 투여 후 1 시간까지, 아리메드글루코 투여군에서는 매체 대조군의 실험동물이 생존한 투여 후 2 시간까지 각각 매체 대조군에 비해 유의성 있는 혈당의 증가를 나타내었다. 특히， 아리메드글루코 투여군에서는 투여 후 30 ^부터 5 시간까지 80%무수결정 포도당 수용액 투여군에 비해 유의성 있는 혈당의 증가를 각각 나타내었다 (ρθ.01 또는 p<0.05; 표 7 및 도 2).
【표 6】 In all media controls treated with distilled water after 20 U / kg of insulin, all 5 rats died after seizure and common hypoglycemic shock (4.5 / 5; 100%) within 4.5 hours of insulin administration. Two mice died within 6.5 hours of insulin administration in the% anhydrous glucose aqueous solution group (2/5; 40%). However, in the Arimedgluco treated group, there was no death for 26 hours after insulin administration, which was the whole period of the experiment (Table 6). In addition, significant (p <0.01 or ρθ.05) increase in blood glucose level was observed in the 80% anhydrous glucose solution and the arimedglucose group from 30 minutes after the administration of the 80% anhydrous glucose solution group. Up to 1 hour after administration, 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. In particular, 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 (ρθ.01 or p <0.05; Table 7 and FIG. 2). Table 6
AGCAS: 무수결정 포도당 수용액 AGCAS: anhydrous glucose solution
관찰기간인 14 일 동안 총 사망수 - 사망 개체 /총 관찰 개체 수 (백분율; 그룹당 5 마리)
Total deaths-14 deaths / total observations (percent; 5 per group) during the 14-day observation period
【표 7】 Table 7
dp 의 통계학적 유의 수준은 p으 05 이며, MW 검정에 의하여 80% 무수결정 포도당 수용액 투여군 값과 비교하였다. 실험결과， 80% 무수결정 포도당 수용액 투여군에서 혈당 수치는 매체 대조군에 비해 투여 후 30 분, 1 및 2 시간에 각각 309.92， 56.59 및 42.29%의 변화를 나타내었고， 아리메드글루코 투여군에서는 매체 대조군에 비해 각각 467.94， 296.12 및 193.14%의 변화를 나타내었다. 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.
아리메드글루코 투여군에서 혈당 수치는 80% 무수결정 포도당 수용액 투여군에 비해 투여 후 30 분， 1， 2， 3， 4, 5, 6， 7 및 24 시간에 각각 38.55, 152.97, 106.02, 107.30, 106.44, 44.00, 25.10, 26.34 및 -7.38%의 변화를 나타내었다. 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%.
이와 같은 결과는， 인술린 -유도 저혈당 절식군의 증증 저혈당 조건에서도 마찬가지로 아리메드글루코가 동일량의 80% 무수결정 포도당 수용액보다 더 빠른 흡수와 지속성을 나타냈다는 것을 의미한다. 결론 These results indicate that even in the hypertensive hypoglycemic conditions of the insulin-induced hypoglycemic fasting group, arimedgluco showed faster absorption and persistence than the same amount of aqueous 80% anhydrous glucose solution. conclusion
본 실험에서 절식 및 인슐린 -유도 저혈당 랫트에 아리메드글루코를 경구 투여했을 시 각각 80% 무수결정 포도당 수용액보다 더 빠른 흡수와 혈당 지속성을 나타내는 것을 확인하였다. 그리고， 아리메드글루코는 동일한 용량의 80% 무수결정 포도당 수용액보다 더 효과적으로 저혈당성 쇼크사를 방지하였다. 따라서， 아리메드글루코는 빠르고 효과적인 포도당 공급원으로써 저혈당으로 인한 피로나 쇼크의 방지 및 치료에 매우 유용하다. 이상으로 본 발명의 특정한 부분을 상세히 기술하였는바， 당업계의 통상의 지식을 가진 자에게 있어서 이러한 구체적인 기술은 단지 바람직한 구현 예일 뿐이며， 이에 본 발명의 범위가 제한되는 것이 아닌 점은 명백하다. 따라서 본 발명의 실질적인 범위는 첨부된 청구항과 그의 등가물에 의하여 정의된다고 할 것이다.
In this experiment, oral administration of arimedglucose to fasting and insulin-induced hypoglycemic rats showed faster absorption and glucose persistence than 80% anhydrous aqueous glucose solution, respectively. Arimedgluco prevented hypoglycemic shock more effectively than the same dose of 80% anhydrous aqueous glucose solution. Arimegluco is thus a fast and effective source of glucose and is very useful for the prevention and treatment of fatigue or shock caused by hypoglycemia. The specific parts of the present invention have been described in detail above, and it is apparent to those skilled in the art that these specific technologies are merely preferred embodiments, and thus the scope of the present invention is not limited thereto. Therefore, the substantial scope of the present invention will be defined by the appended claims and equivalents thereof.
Claims
【청구항 1】 [Claim 1]
포도당 40-90 중량 % 및 물 10-60 중량 ¾를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 저혈당 예방 또는 치료용 약제학적 조성물. A pharmaceutical composition for the prevention or treatment of hypoglycemia in a solution formulation comprising 40-90 wt% glucose and 10-60 wt ¾ water, which does not contain preservatives.
【청구항 2】 [Claim 2]
포도당 40-90 증량 % 및 물 10-60 중량 %를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 저혈당 개선용 식품 조성물. A food composition for improving hypoglycemia of a solution formulation containing 40-90% by weight of glucose and 10-60% by weight of water, and containing no preservatives.
【청구항 3】 [Claim 3]
제 1 항 또는 제 2 항에 있어서， 상기 포도당은 무수결정 포도당인 것을 특징으로 하는 조성물. The composition of claim 1 or 2, wherein the glucose is anhydrous crystalline glucose.
【청구항 4】 [Claim 4]
제 1 항 또는 게 2 항에 있어서， 상기 조성물은 6 개월의 38-42 °C 온도 조건에서의 가속시험에서 100 cfu/ml 이하의 박테리아 함량을 가지며 6 개월의 23-27°C 온도 조건에서의 장기보존 시험에서 100 cfu/ml 이하의 박테리아 함량을 가지는 것을 특징으로 하는 조성물. The composition according to claim 1 or 2, wherein the composition has a bacterial content of 100 cfu / ml or less in an accelerated test at 38-42 ° C. for 6 months and 23-27 ° C. for 6 months. A composition comprising a bacterial content of less than 100 cfu / ml in a long term preservation test.
【청구항 51 [Claim 51]
게 1 항 또는 제 2 항에 있어서, 상기 조성물은 비타민 (：， 비타민 B1, 비타민 B3, 비타민 B5, 비타민 B6, 구연산 및 이의 조합으로 구성된 군으로부터 선택되는 보조성분을 추가적으로 포함하는 것을 특징으로 하는 조성물. The composition according to claim 1 or 2, wherein the composition further comprises an auxiliary component selected from the group consisting of vitamin (:, vitamin B1, vitamin B3, vitamin B5, vitamin B6, citric acid and combinations thereof). .
【청구항 6】 [Claim 6]
제 1 항 또는 제 2 항에 있어서， 상기 조성물은 색소 및 설탕을 포함하지 않는 것을 특징으로 하는 조성물.
【청구항 71 A composition according to claim 1 or 2, wherein the composition does not contain pigments and sugars. [Claim 71
제 1 항 또는 제 2 항에 있어서， 상기 조성물은 18-180 mg/dL/30 분 신속 혈당 증가능을 가지는 것을 특징으로 하는 조성물. 【청구항 8】 The composition of claim 1 or 2, wherein the composition has a fast blood glucose increase of 18-180 mg / dL / 30 minutes. [Claim 8]
포도당 40-90 중량 % 및 물 10-60 중량 ¾>를 포함하며, 방부제가 포함되어 있지 않는 용액 제형의 조성물을 포유동물에게 투여하는 단계를 포함하는 저혈당의 예방 또는 치료 방법 . 【청구항 9】 A method of preventing or treating hypoglycemia comprising administering to a mammal a composition of a solution formulation comprising 40-90 wt% glucose and 10-60 wt ¾ water, wherein the composition does not contain a preservative. [Claim 9]
포도당 40-90 중량 % 및 물 10-60 중량 %를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 조성물을 포유동물에게 투여하는 단계를 포함하는 저혈당 증상의 개선 방법. 【청구항 10】 A method for ameliorating hypoglycemic symptoms 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 comprises a preservative free solution. [Claim 10]
포도당 40-90 중량 % 및 물 10-60 중량 %를 포함하며， 방부제가 포함되어 있지 않는 용액 제형의 조성물의 저혈당의 예방 또는 치료를 위한 용도.
Use for the prevention or treatment of hypoglycemia of a composition of a solution formulation comprising 40-90% by weight of glucose and 10-60% by weight of water and which do not contain preservatives.
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