WO2020221184A1 - Pharmaceutical composition with effect of reducing uric acid - Google Patents

Pharmaceutical composition with effect of reducing uric acid Download PDF

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Publication number
WO2020221184A1
WO2020221184A1 PCT/CN2020/087128 CN2020087128W WO2020221184A1 WO 2020221184 A1 WO2020221184 A1 WO 2020221184A1 CN 2020087128 W CN2020087128 W CN 2020087128W WO 2020221184 A1 WO2020221184 A1 WO 2020221184A1
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parts
weight
pharmaceutical composition
inulin
citric acid
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PCT/CN2020/087128
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French (fr)
Chinese (zh)
Inventor
狄志鸿
张昌娟
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杭州泽健医药科技有限公司
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Publication of WO2020221184A1 publication Critical patent/WO2020221184A1/en

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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
    • 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
    • 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
    • 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
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • 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
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the invention belongs to the technical field of biomedicine, and specifically contains a pharmaceutical composition with uric acid lowering and anti-fatigue effects.
  • the essential cause of gout is the increase in the level of uric acid in the body, which causes the deposition of urate in the joints and kidneys.
  • the main causes of gout include but are not limited to: (1) dietary reasons. After eating too much meat and seafood, and drinking too much beer, the body's uric acid level increases, which may cause urate deposition; (2) Obesity. The consequence of obesity is the increase of uric acid in the body, and the kidneys cannot completely remove the excess uric acid; (3) Taking certain drugs. These drugs can increase the level of uric acid in the body; (4) Family history. If your family member suffers from gout, the probability of your illness will also increase greatly.
  • Gout is a common and complex type of arthritis, which can be affected by all ages.
  • the incidence rate of men is higher than that of women.
  • Gout patients often experience sudden joint pain at night, the onset is acute, severe pain, edema, redness, and inflammation appear in the joints. The pain is slowly reduced until it disappears, lasting several days or weeks. When the pain occurs, the patient wakes up in the middle of the night while sleeping.
  • Some patients describe the pain as similar to the burning of the big toe.
  • the most common joint is the big toe (medical term: first metatarsal), but the joints that are affected are not limited to this, and are also common in hand joints, knees, elbows, etc.
  • the affected joints will eventually become red, swollen and inflamed. After the edema, the tissues will become soft and movement will be restricted, which will eventually affect daily life. Therefore, research on new products that can reduce uric acid has important clinical significance.
  • the applicant obtained a new pharmaceutical composition after many creative researches, which is prepared from inulin, sodium citrate, potassium citrate and citric acid.
  • the research shows that the present invention
  • the composition has the pharmacological effect of lowering uric acid, which further illustrates that the composition of the present invention can be used for gout patients.
  • the special medical food mentioned in the present invention means that it must be consumed alone or in combination with other foods under the guidance of a doctor or clinical nutritionist. It refers to a formula food specially processed and formulated to meet the special needs of people with eating restrictions, digestion and absorption disorders, metabolic disorders or specific disease states for nutrients or diet. Special medical foods are not medicines, but they are not ordinary foods eaten by normal people. They are formula foods specially developed and produced after extensive medical research by clinicians and nutritionists and based on scientific objective facts. When the target population cannot eat ordinary meals or cannot meet their nutritional needs with daily meals, formula foods for special medical purposes can be used as a way of nutritional supplementation to play a nutritional support role. The food cannot replace the therapeutic effect of drugs, and the product cannot claim the preventive and therapeutic functions of diseases.
  • the inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
  • the present invention is achieved through the following technical solutions.
  • Said pharmaceutical composition comprises 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate and 1-5 parts by weight of citric acid.
  • Said pharmaceutical composition comprises 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
  • the pharmaceutical composition is applied in the preparation of special medical food for lowering uric acid.
  • a pharmaceutical composition for treating gout which is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate, and citric acid 1-5 parts by weight; the preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
  • a pharmaceutical composition with the effect of lowering uric acid which is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate and lemon The acid is 1-5 parts by weight; the preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
  • the inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
  • the inulin of the present invention has the following pharmacological effects: 1. Control blood lipids; 2. Lower blood sugar; 3. Promote the absorption of minerals; 4. Adjust the intestinal microflora, improve intestinal health, and prevent constipation; 5. . Inhibit the production of toxic fermentation products, protect the liver, and prevent colon cancer; 6. Prevent constipation and treat obesity. Dietary fiber reduces the residence time of food in the gastrointestinal tract and increases the amount of feces to effectively treat constipation. Its weight loss effect is to increase the viscosity of the contents and reduce the speed of food from the stomach to the small intestine, thereby reducing hunger and reducing food intake. 7. Inulin contains a small amount of 2-9 oligofructose.
  • inulin can increase the expression of neurotrophic factors in brain nerve cells, and has a good protective effect on corticosterone-induced neuronal damage. Antidepressant effect. After the composition of inulin and citric acid, sodium citrate and potassium citrate three substances, by regulating intestinal function, etc., thereby promoting the excretion of intestinal uric acid, it has a good effect of lowering uric acid.
  • the pharmaceutical composition of the present invention can be prepared into oral solid preparations, or can be prepared into granules by adding other raw and auxiliary materials.
  • the pharmaceutical composition of the present invention can also be prepared by adding one or more of sorbitol, isomaltulose (palatinose, sucrose), nutritional fortifier premix, and sucralose Into composite powder.
  • the nutritional supplement premix includes the following components by weight: 130-140 parts of taurine, 220-230 parts of vitamin C, 10-20 parts of vitamin E, 0.5-1 parts of ⁇ -carotene, vitamin B 2 2- 3 parts vitamin B 6 1-2 parts, 5-10 parts of pantothenic acid, folic acid, 0.05 to 2 parts.
  • Preferred dietary supplement premix parts by weight of component comprising: 140 parts of taurine, 225 parts of vitamin C, vitamin E 18 parts, 0.6 parts of [beta] -carotene, vitamin B 2 2.2 parts of Vitamin B 6 1.81 parts , 8 parts of pantothenic acid, 0.06 parts of folic acid.
  • the sources of the raw and auxiliary materials of the present invention are shown in Table 1.
  • the present invention is based on inulin, supplemented by sodium citrate, potassium citrate and citric acid. It is used for gout patients and it is used under the guidance of clinicians or nutritionists, rather than ordinary food; On the basis of inulin, sodium citrate, potassium citrate and citric acid, you can also add sorbitol, isomaltulose (palatinose, sucrose), nutritional fortifier premix, three One or more of sucralose.
  • the following experiments of the present invention are conclusive experiments by research and development personnel based on the technical solutions to be protected by the present invention on the basis of multiple creative experiments.
  • the quantitative experiments in the following examples are all set to three repeated experiments, and the data is the average value of the three repeated experiments or the average ⁇ standard deviation.
  • test group
  • Test group 1 inulin
  • Test group 2 Inulin 1.8g, sodium citrate 2.6g;
  • Test group 3 Inulin 1.8g, potassium citrate 2.6g;
  • Test group 4 Inulin 1.8g, sodium malate 1.73g;
  • Test group 5 inulin 1.8g, sodium bicarbonate 0.74g;
  • Test 7 inulin 1.8g, potassium citrate 1.5g, and citric acid 1.5g.
  • Test 8 group inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.4g.
  • Test method Kunming mice, male, weighing 18-22g, randomly grouped, blank control group, model group, test group, 10 mice in each group, except for mice in the blank group, the other groups are given potassium oxazinate every morning (100mg/kg) model, the present group was given 4g/kg of raw material every afternoon, and the model group was given the same volume of distilled water in the afternoon. Each group was administered once a day for a total of 30 days, and relevant indicators were tested on 30 days during the administration period. Index detection: Fasting for 12 hours (cannot help water) before the start of the formal experiment, and taking 1 mL of blood from the orbit before administration.
  • centrifuge 4000r/min, 15min to separate the serum and store it at -20°C for standby. Used to detect the serum UA level before the experiment. On the 30th day after the administration, the blood was collected by the same method, except for the UA level after 30 days.
  • Test group 1 Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.4g.
  • Test group 2 Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.6g.
  • Test group 4 Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 1.0g.
  • Test method same as test 1.
  • Sorbitol 3000g inulin 1500g, isomaltulose 1000g, potassium citrate 1000g, sodium citrate 1000g, citric acid 100g, nutrition enhancer premix 50g, sucralose 10g.
  • the above-mentioned raw materials are mixed completely.
  • the above-mentioned raw materials are mixed completely.
  • the above raw materials are mixed together.
  • the ratio between fortifier premix as a raw material 140 parts of taurine, 225 parts of vitamin C, vitamin E 18 parts, 0.6 parts of [beta] -carotene, vitamin B 2 2.2 parts of Vitamin B 6 1.81 Parts, 8 parts of pantothenic acid, 0.06 parts of folic acid.
  • the inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
  • the pharmaceutical composition of the present invention can be prepared into oral solid preparations, or can be prepared into granules by adding other raw and auxiliary materials.
  • composition of the present invention can be used alone to treat or prevent the onset of gout, or it can be combined with drugs for the treatment of gout, such as febuxostat, colchicine, and allopurin. Alcohol, benzbromarone and other drugs.

Abstract

Provided is a pharmaceutical composition with the effect of reducing uric acid. The pharmaceutical composition is made of inulin, sodium citrate, potassium citrate and citric acid, and can be used for patients with gout.

Description

一种具有降尿酸作用的药物组合物Pharmaceutical composition with uric acid lowering effect
本申请要求了2019年4月28日提交的、申请号为201910349869.X、发明名称为“一种具有降尿酸作用的药物组合物”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。This application claims the priority of the Chinese patent application filed on April 28, 2019, with the application number 201910349869.X and the invention title "A pharmaceutical composition with uric acid lowering effect", the entire content of which is incorporated by reference In this application.
技术领域Technical field
本发明属于生物医药技术领域，具体含有一种具有降尿酸和抗疲劳作用的药物组合物。The invention belongs to the technical field of biomedicine, and specifically contains a pharmaceutical composition with uric acid lowering and anti-fatigue effects.
背景技术Background technique
造成痛风的本质原因是体内尿酸水平的升高，造成了尿酸盐在关节和肾脏部位的沉积。通常来说，造成痛风的主要原因包括但不限于：(1)饮食原因。吃了太多的肉类和海鲜，畅饮了过多的啤酒之后，人体的尿酸水平升高，就可能造成尿酸盐沉积；(2)肥胖。肥胖导致的后果是体内尿酸的增加，肾脏无法彻底清除多余的尿酸；(3)服用了某些药物。这些药物会导致体内尿酸水平升高；(4)家族史。如果家人患有痛风，那么你患病的概率也会大大增加。The essential cause of gout is the increase in the level of uric acid in the body, which causes the deposition of urate in the joints and kidneys. Generally speaking, the main causes of gout include but are not limited to: (1) dietary reasons. After eating too much meat and seafood, and drinking too much beer, the body's uric acid level increases, which may cause urate deposition; (2) Obesity. The consequence of obesity is the increase of uric acid in the body, and the kidneys cannot completely remove the excess uric acid; (3) Taking certain drugs. These drugs can increase the level of uric acid in the body; (4) Family history. If your family member suffers from gout, the probability of your illness will also increase greatly.
痛风是一种常见且复杂的关节炎类型，各个年龄段均可能罹患本病，男性发病率高于女性。痛风患者经常会在夜晚出现突然性的关节疼，发病急，关节部位出现严重的疼痛、水肿、红肿和炎症，疼痛感慢慢减轻直至消失，持续几天或几周不等。当疼痛发作时，患者会在半夜熟睡中疼醒，有患者描述疼痛感类似于大脚趾被火烧一样。最常发病的关节是大脚趾(医学术语：第一跖骨)，但发病的关节不限于此，还常见于手部的关节、膝盖、肘部等。发病的关节最终会红肿、发炎，水肿后组织变软，活动受限，最后影响日常生活。因此，研究新的能够降低尿酸的新产品，具有重要临床意义。Gout is a common and complex type of arthritis, which can be affected by all ages. The incidence rate of men is higher than that of women. Gout patients often experience sudden joint pain at night, the onset is acute, severe pain, edema, redness, and inflammation appear in the joints. The pain is slowly reduced until it disappears, lasting several days or weeks. When the pain occurs, the patient wakes up in the middle of the night while sleeping. Some patients describe the pain as similar to the burning of the big toe. The most common joint is the big toe (medical term: first metatarsal), but the joints that are affected are not limited to this, and are also common in hand joints, knees, elbows, etc. The affected joints will eventually become red, swollen and inflamed. After the edema, the tissues will become soft and movement will be restricted, which will eventually affect daily life. Therefore, research on new products that can reduce uric acid has important clinical significance.
发明内容Summary of the invention
基于上述原因，申请人经过多次创造性研究，得到一种新的药物组合物，该组合物是由菊糖、柠檬酸钠、柠檬酸钾和柠檬酸制备而成的，研究表明，本发明所述的组合物具有降尿酸的药理作用，进一步说明，本发明组合物可以用于痛风患者。Based on the above reasons, the applicant obtained a new pharmaceutical composition after many creative researches, which is prepared from inulin, sodium citrate, potassium citrate and citric acid. The research shows that the present invention The composition has the pharmacological effect of lowering uric acid, which further illustrates that the composition of the present invention can be used for gout patients.
本发明所述的特医食品，是指必须在医生或临床营养师指导下，单独食用或与其他食品配合食用。是指为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。特医食品不是药品，但不是正常人吃的普通食品，而是经过临床医生和营养学家们大量的医学研究，以科学的客观事实为依据专门研制、生 产的配方食品。当目标人群无法进食普通膳食或无法用日常膳食满足其营养需求时，特殊医学用途配方食品可以作为一种营养补充途径，起到营养支持作用。该食品不能替代药物的治疗作用，产品也不得声称对疾病的预防和治疗功能。The special medical food mentioned in the present invention means that it must be consumed alone or in combination with other foods under the guidance of a doctor or clinical nutritionist. It refers to a formula food specially processed and formulated to meet the special needs of people with eating restrictions, digestion and absorption disorders, metabolic disorders or specific disease states for nutrients or diet. Special medical foods are not medicines, but they are not ordinary foods eaten by normal people. They are formula foods specially developed and produced after extensive medical research by clinicians and nutritionists and based on scientific objective facts. When the target population cannot eat ordinary meals or cannot meet their nutritional needs with daily meals, formula foods for special medical purposes can be used as a way of nutritional supplementation to play a nutritional support role. The food cannot replace the therapeutic effect of drugs, and the product cannot claim the preventive and therapeutic functions of diseases.
本发明所述菊糖，是指菊粉或天然果聚糖，是以菊芋(洋姜)根状茎或菊苣为原料，去除蛋白，胶质，粗纤维和矿物质，经水提取，离子交换，膜过滤，喷雾干燥等生产工艺得到菊糖。The inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
本发明是通过下述技术方案实现的。The present invention is achieved through the following technical solutions.
一种药物组合物，该药物组合物由下述原料制备而成：菊糖、柠檬酸钠、柠檬酸钾和柠檬酸。A pharmaceutical composition prepared from the following raw materials: inulin, sodium citrate, potassium citrate and citric acid.
所述的一种药物组合物，其中菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份。Said pharmaceutical composition comprises 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate and 1-5 parts by weight of citric acid.
所述的一种药物组合物，其中菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。Said pharmaceutical composition comprises 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
该药物组合物在制备治疗痛风药物中的应用。Application of the pharmaceutical composition in preparing a medicine for treating gout.
该药物组合物在制备降尿酸药物中的应用。Application of the pharmaceutical composition in the preparation of uric acid lowering drugs.
该药物组合物在制备降尿酸特医食品中应用。The pharmaceutical composition is applied in the preparation of special medical food for lowering uric acid.
一种治疗痛风作用的药物组合物，该药物组合物由下述原料制备而成：菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份；优选的药物组合物由下述原料制备而成：菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。A pharmaceutical composition for treating gout, which is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate, and citric acid 1-5 parts by weight; the preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
一种具有降尿酸作用的药物组合物，该药物组合物由下述原料制备而成：菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份；优选的药物组合物由下述原料制备而成：菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。A pharmaceutical composition with the effect of lowering uric acid, which is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate and lemon The acid is 1-5 parts by weight; the preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
本发明所述菊糖，是指菊粉或天然果聚糖，是以菊芋(洋姜)根状茎或菊苣为原料，去除蛋白，胶质，粗纤维和矿物质，经水提取，离子交换，膜过滤，喷雾干燥等生产工艺得到菊糖。The inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
本发明的所述的菊糖具有下述药理作用：1、控制血脂；2、降低血糖；3、促进矿物质的吸收；4.调节肠道微生物菌群，改善肠道健康，防止便秘；5.抑制有毒发酵产物的生成，保护肝脏，预防结肠癌；6.防便秘及治疗肥胖症膳食纤维减少食物在胃肠的停留时间，以及增加粪便量，有效地治疗便秘。其减肥作用是提高内容物的黏度，降低食物从胃进入小肠的速度，从而降低饥饿感，减少食物的摄食量。7.菊糖中有少量的2-9低聚果糖，研究表明，菊糖可使大脑神经细胞营养因子表达升高，对皮质酮诱导的神经元损作有很好的保护作用，具有良好的抗抑郁作用。菊糖与枸橼酸、枸橼酸钠和枸橼酸钾三种物质的组合物之后，通过调节肠道功能等， 从而促进肠道尿酸排泄，从而具有很好的降尿酸的作用。The inulin of the present invention has the following pharmacological effects: 1. Control blood lipids; 2. Lower blood sugar; 3. Promote the absorption of minerals; 4. Adjust the intestinal microflora, improve intestinal health, and prevent constipation; 5. . Inhibit the production of toxic fermentation products, protect the liver, and prevent colon cancer; 6. Prevent constipation and treat obesity. Dietary fiber reduces the residence time of food in the gastrointestinal tract and increases the amount of feces to effectively treat constipation. Its weight loss effect is to increase the viscosity of the contents and reduce the speed of food from the stomach to the small intestine, thereby reducing hunger and reducing food intake. 7. Inulin contains a small amount of 2-9 oligofructose. Studies have shown that inulin can increase the expression of neurotrophic factors in brain nerve cells, and has a good protective effect on corticosterone-induced neuronal damage. Antidepressant effect. After the composition of inulin and citric acid, sodium citrate and potassium citrate three substances, by regulating intestinal function, etc., thereby promoting the excretion of intestinal uric acid, it has a good effect of lowering uric acid.
本发明所述的药物组合物，可以制备成口服固体制剂，也可以加入其它原辅料制备成颗粒剂。The pharmaceutical composition of the present invention can be prepared into oral solid preparations, or can be prepared into granules by adding other raw and auxiliary materials.
本发明所述的药物组合物，还可以加入山梨糖醇、异麦芽酮糖(帕拉金糖、异构蔗糖)、营养强化剂预混料、三氯蔗糖中的一种或几种，制备成复合粉。The pharmaceutical composition of the present invention can also be prepared by adding one or more of sorbitol, isomaltulose (palatinose, sucrose), nutritional fortifier premix, and sucralose Into composite powder.
所述营养强化剂预混料包括如下重量份的组分：牛磺酸130-140份、维生素C220-230份、维生素E10-20份、β-胡萝卜素0.5-1份、维生素B 2 2-3份、维生素B 6 1-2份、泛酸5-10份、叶酸0.05-2份。 The nutritional supplement premix includes the following components by weight: 130-140 parts of taurine, 220-230 parts of vitamin C, 10-20 parts of vitamin E, 0.5-1 parts of β-carotene, vitamin B 2 2- 3 parts vitamin B 6 1-2 parts, 5-10 parts of pantothenic acid, folic acid, 0.05 to 2 parts.
优选的营养强化剂预混料包括如下重量份的组分：牛磺酸140份、维生素C 225份、维生素E 18份、β-胡萝卜素0.6份、维生素B 2 2.2份、维生素B 6 1.81份、泛酸8份、叶酸0.06份。 Preferred dietary supplement premix parts by weight of component comprising: 140 parts of taurine, 225 parts of vitamin C, vitamin E 18 parts, 0.6 parts of [beta] -carotene, vitamin B 2 2.2 parts of Vitamin B 6 1.81 parts , 8 parts of pantothenic acid, 0.06 parts of folic acid.
本发明所述的原辅料来源见表1。The sources of the raw and auxiliary materials of the present invention are shown in Table 1.
表1本发明原辅料来源Table 1 Sources of raw materials of the present invention
Figure PCTCN2020087128-appb-000001
Figure PCTCN2020087128-appb-000001
本发明是以菊糖为主，辅以枸橼酸钠、枸橼酸钾和枸橼酸，用于痛风患者服用，是在临床医生或营养师的指导下进行使用，而不是普通食品；在菊糖、枸橼酸钠、枸橼酸钾和枸橼酸的基础上，还可以加入山梨糖醇、异麦芽酮糖(帕拉金糖、异构蔗糖)、营养强化剂预混料、三氯蔗糖中的一种或几种。The present invention is based on inulin, supplemented by sodium citrate, potassium citrate and citric acid. It is used for gout patients and it is used under the guidance of clinicians or nutritionists, rather than ordinary food; On the basis of inulin, sodium citrate, potassium citrate and citric acid, you can also add sorbitol, isomaltulose (palatinose, sucrose), nutritional fortifier premix, three One or more of sucralose.
具体实施方式Detailed ways
以下以具体实施例来说明本发明的技术方案，但本发明的保护范围不限于此。The following specific examples are used to illustrate the technical solutions of the present invention, but the protection scope of the present invention is not limited thereto.
本说明书实施例所述的内容仅仅是对发明构思的实现形式的列举，本发明的保护范围不应当被视为仅限于实施例所陈述的具体形式，本发明的保护范围也及于本领域技术人员根据本发明构思所能够想到的等同技术手段。尽管以下本发明的实施方案进行了描述，但本发明并不局 限于上述的具体实施方案和应用领域，下述的具体实施方案仅仅是示意性的、指导性的，而不是限制性的。本领域的普通技术人员在本说明书的启示下和在不脱离本发明权利要求所保护的范围的情况下，还可以做出很多种的形式，这些均属于本发明保护之列。The content described in the embodiments of this specification is only a list of the realization forms of the inventive concept. The protection scope of the present invention should not be regarded as limited to the specific forms stated in the embodiments. The protection scope of the present invention also extends to the technology in the field. People can think of equivalent technical means based on the inventive concept. Although the embodiments of the present invention are described below, the present invention is not limited to the above-mentioned specific embodiments and application fields, and the following specific embodiments are only illustrative, instructive, and not restrictive. Under the enlightenment of this specification and without departing from the scope of protection of the claims of the present invention, those of ordinary skill in the art can also make many forms, which all belong to the protection of the present invention.
本发明下述试验，是在多次创造性试验的基础上，以本发明所要保护的技术方案为基础，总结的研发人员的结论性试验。以下实施例中的定量试验，均设置三次重复实验，数据为三次重复实验的平均值或平均值±标准差。The following experiments of the present invention are conclusive experiments by research and development personnel based on the technical solutions to be protected by the present invention on the basis of multiple creative experiments. The quantitative experiments in the following examples are all set to three repeated experiments, and the data is the average value of the three repeated experiments or the average ± standard deviation.
下述试验由申请人委托隆誉翼尧(北京)科技有限公司完成。The following tests were commissioned by the applicant, Longyu Yiyao (Beijing) Technology Co., Ltd. to complete.
试验1对小鼠高尿酸血症的影响Test 1 Effect on mouse hyperuricemia
试验组：test group:
试验1组：菊糖；Test group 1: inulin;
试验2组：菊糖1.8g、柠檬酸钠2.6g；Test group 2: Inulin 1.8g, sodium citrate 2.6g;
试验3组：菊糖1.8g、柠檬酸钾2.6g；Test group 3: Inulin 1.8g, potassium citrate 2.6g;
试验4组：菊糖1.8g、苹果酸钠1.73g；Test group 4: Inulin 1.8g, sodium malate 1.73g;
试验5组：菊糖1.8g、碳酸氢钠0.74g；Test group 5: inulin 1.8g, sodium bicarbonate 0.74g;
试验6组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g。Test 6 groups: inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g.
试验7组：菊糖1.8g、柠檬酸钾1.5g、柠檬酸1.5g。Test 7 groups: inulin 1.8g, potassium citrate 1.5g, and citric acid 1.5g.
试验8组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸0.4g。Test 8 group: inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.4g.
试验方法：昆明小鼠，雄性，体重18～22g，随机分组，空白对照组、模型组、试验组，每组10只，除空白组小鼠外，其他组每天上午均灌胃氧嗪酸钾(100mg/kg)造模，本发明组每天下午给予原料4g/kg，模型组下午灌胃给予相同体积的蒸馏水。各组每天给药1次，共给药30d，在给药期间的30d进行相关指标检测。指标检测：在正式实验开始前禁食12h(不禁水)，并在给药前先从眼眶取血1mL，室温放置2h后，离心(4000r/min，15min)分离血清，放-20℃备用，用于检测实验前的血清UA水平。在给药第30d天用同样方法取血检测，30d后除了检测UA水平。Test method: Kunming mice, male, weighing 18-22g, randomly grouped, blank control group, model group, test group, 10 mice in each group, except for mice in the blank group, the other groups are given potassium oxazinate every morning (100mg/kg) model, the present group was given 4g/kg of raw material every afternoon, and the model group was given the same volume of distilled water in the afternoon. Each group was administered once a day for a total of 30 days, and relevant indicators were tested on 30 days during the administration period. Index detection: Fasting for 12 hours (cannot help water) before the start of the formal experiment, and taking 1 mL of blood from the orbit before administration. After placing it at room temperature for 2 hours, centrifuge (4000r/min, 15min) to separate the serum and store it at -20°C for standby. Used to detect the serum UA level before the experiment. On the 30th day after the administration, the blood was collected by the same method, except for the UA level after 30 days.
试验结果见表1：The test results are shown in Table 1:
表1对高尿酸血症小鼠尿酸的影响Table 1 Effect on uric acid in hyperuricemia mice
Figure PCTCN2020087128-appb-000002
Figure PCTCN2020087128-appb-000002
Figure PCTCN2020087128-appb-000003
Figure PCTCN2020087128-appb-000003
注：与模型组比较**P<0.01，*P<0.05；与0d比较##P<0.01，#P<0.05。Note: Compared with the model group **P<0.01, *P<0.05; compared with 0d ##P<0.01, #P<0.05.
试验结论：(1)饲养30d后，与空白组比较，模型组UA水平明显升高(p＜0.01)，说明造模成功；(2)与模型组比较，试验2组-试验7组均不能降低高尿酸血症小鼠的UA水平，不具有统计学意义，而试验8组能够降低大鼠的UA，充分说明，当菊糖与一定比例的枸橼酸钠、枸橼酸钾和枸橼酸组合后，具有降尿酸的作用。(3)从试验7组与试验8组来分析，柠檬酸盐与柠檬酸的比例关系，与菊糖的组合之后，降尿酸的效果具有一定的影响，在该组合物之中需要一定量的枸橼酸，但枸橼酸量不能超过一定量，申请人进行深入的试验。Test conclusion: (1) Compared with the blank group after 30 days of feeding, the UA level of the model group was significantly increased (p<0.01), indicating that the model was successful; (2) Compared with the model group, the test group 2-the test group 7 were not It is not statistically significant to reduce the UA level of hyperuricemia mice, while the test group 8 can reduce the UA of rats, which fully shows that when inulin is added to a certain proportion of sodium citrate, potassium citrate and citrate After the acid is combined, it has the effect of reducing uric acid. (3) Analyzed from the test 7 group and the test 8 group, the ratio of citrate to citric acid, after the combination with inulin, the effect of lowering uric acid has a certain influence, a certain amount of Citric acid, but the amount of citric acid cannot exceed a certain amount, the applicant conducts in-depth tests.
试验2枸橼酸盐与枸橼酸比例关系研究Test 2 Study on the relationship between citrate and citric acid ratio
试验1组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸0.4g。Test group 1: Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.4g.
试验2组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸0.6g。Test group 2: Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.6g.
试验3组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸0.8g。Test 3 groups: inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 0.8g.
试验4组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸1.0g。Test group 4: Inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 1.0g.
试验5组：菊糖1.8g、柠檬酸钾1.4g、柠檬酸钠1.2g和柠檬酸1.2g。Test 5 groups: inulin 1.8g, potassium citrate 1.4g, sodium citrate 1.2g and citric acid 1.2g.
试验方法：同试验1。Test method: same as test 1.
试验结果见表2。The test results are shown in Table 2.
表2对高尿酸血症小鼠尿酸的影响Table 2 Effects on uric acid in hyperuricemia mice
Figure PCTCN2020087128-appb-000004
Figure PCTCN2020087128-appb-000004
Figure PCTCN2020087128-appb-000005
Figure PCTCN2020087128-appb-000005
注：与模型组比较**P<0.01，*P<0.05；与0d比较##P<0.01，#P<0.05。Note: Compared with the model group **P<0.01, *P<0.05; compared with 0d ##P<0.01, #P<0.05.
试验结论：(1)饲养30d后，与空白组比较，模型组UA水平明显升高(p＜0.01)，说明造模成功；(2)当枸橼酸在组合物中比例关系发生变化时，经过30天给药后，与模型组比较没有统计学意义，充分说明枸橼酸的重量在组合物中比例不能太多，这与体内调节尿酸有一定的关系。Test conclusions: (1) After 30 days of rearing, compared with the blank group, the UA level of the model group was significantly increased (p<0.01), indicating that the model was successful; (2) When the proportion of citric acid in the composition changed, After 30 days of administration, there is no statistical significance compared with the model group, which fully shows that the weight of citric acid can not be too much in the composition, which has a certain relationship with the regulation of uric acid in the body.
制备实施例Preparation examples
实施例1Example 1
山梨糖醇3000g、菊糖1500g、异麦芽酮糖1000g、柠檬酸钾1000g、柠檬酸钠1000g、柠檬酸100g，营养强化剂预混料50g、三氯蔗糖10g。上述原料混合完全即得。Sorbitol 3000g, inulin 1500g, isomaltulose 1000g, potassium citrate 1000g, sodium citrate 1000g, citric acid 100g, nutrition enhancer premix 50g, sucralose 10g. The above-mentioned raw materials are mixed completely.
实施例2Example 2
山梨糖醇4000g、菊糖2000g、异麦芽酮糖1500g、柠檬酸钾1500g、柠檬酸钠1500g、柠檬酸500g，营养强化剂预混料300g、三氯蔗糖50g。上述原料混合完全即得。Sorbitol 4000g, inulin 2000g, isomaltulose 1500g, potassium citrate 1500g, sodium citrate 1500g, citric acid 500g, nutrition enhancer premix 300g, sucralose 50g. The above-mentioned raw materials are mixed completely.
实施例3Example 3
山梨糖醇3630g、菊糖1800g、异麦芽酮糖1500g、柠檬酸钾1400g、柠檬酸钠1200g、柠檬酸400g，营养强化剂预混料50g、三氯蔗糖20g。上述原料混合即得。Sorbitol 3630g, inulin 1800g, isomaltulose 1500g, potassium citrate 1400g, sodium citrate 1200g, citric acid 400g, nutrition enhancer premix 50g, sucralose 20g. The above raw materials are mixed together.
实施例4Example 4
山梨糖醇3200g、菊糖1650g、异麦芽酮糖1200g、柠檬酸钾1200g、柠檬酸钠1150g、柠檬酸120g，营养强化剂预混料65g、三氯蔗糖12g。上述原料混合即得Sorbitol 3200g, inulin 1650g, isomaltulose 1200g, potassium citrate 1200g, sodium citrate 1150g, citric acid 120g, nutrition fortifier premix 65g, sucralose 12g. Mix the above raw materials
实施例5Example 5
山梨糖醇3850g、菊糖1850g、异麦芽酮糖1400g、柠檬酸钾1450g、柠檬酸钠1350g、柠檬酸450g，营养强化剂预混料250g、三氯蔗糖40g。Sorbitol 3850g, inulin 1850g, isomaltulose 1400g, potassium citrate 1450g, sodium citrate 1350g, citric acid 450g, nutrition fortifier premix 250g, sucralose 40g.
上述实施例中营养强化剂预混料中原料的比例关系为：牛磺酸140份、维生素C 225份、维生素E 18份、β-胡萝卜素0.6份、维生素B 2 2.2份、维生素B 6 1.81份、泛酸8份、叶酸0.06份。 The above-described embodiment, the ratio between fortifier premix as a raw material: 140 parts of taurine, 225 parts of vitamin C, vitamin E 18 parts, 0.6 parts of [beta] -carotene, vitamin B 2 2.2 parts of Vitamin B 6 1.81 Parts, 8 parts of pantothenic acid, 0.06 parts of folic acid.
本发明所述菊糖，是指菊粉或天然果聚糖，是以菊芋(洋姜)根状茎或菊苣为原料，去除 蛋白，胶质，粗纤维和矿物质，经水提取，离子交换，膜过滤，喷雾干燥等生产工艺得到菊糖。The inulin in the present invention refers to inulin or natural fructan, which uses Jerusalem artichoke (Jerusalem artichoke) rhizome or chicory as raw material to remove protein, gum, crude fiber and minerals, and is extracted with water and ion exchanged. , Membrane filtration, spray drying and other production processes to obtain inulin.
本发明所述的药物组合物，可以制备成口服固体制剂，也可以加入其它原辅料制备成颗粒剂。The pharmaceutical composition of the present invention can be prepared into oral solid preparations, or can be prepared into granules by adding other raw and auxiliary materials.
本发明所述的药物组合物(包括实施例的组合物)，可以单独使用，用以治疗或预防痛风发作，也可以与治疗痛风的药物合用，比如非布司他、秋水仙碱、别嘌醇、苯溴马隆等药物。The pharmaceutical composition of the present invention (including the composition of the examples) can be used alone to treat or prevent the onset of gout, or it can be combined with drugs for the treatment of gout, such as febuxostat, colchicine, and allopurin. Alcohol, benzbromarone and other drugs.

Claims (8)

  1. 一种药物组合物，其特征在于该药物组合物由下述原料制备而成：菊糖、柠檬酸钠、柠檬酸钾和柠檬酸。A pharmaceutical composition characterized in that the pharmaceutical composition is prepared from the following raw materials: inulin, sodium citrate, potassium citrate and citric acid.
  2. 根据权利要求1所述的一种药物组合物，其中菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份。A pharmaceutical composition according to claim 1, wherein 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, 10-15 parts by weight of potassium citrate and 1-5 parts by weight of citric acid.
  3. 根据权利要求1所述的一种药物组合物，其中菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。A pharmaceutical composition according to claim 1, wherein 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
  4. 根据权利要求1-3任一项所述的一种药物组合物，其特征在于该药物组合物在制备治疗痛风药物中的应用。A pharmaceutical composition according to any one of claims 1-3, characterized in that the pharmaceutical composition is used in the preparation of drugs for treating gout.
  5. 根据权利要求1-3任一项所述的一种药物组合物，其特征在于该药物组合物在制备降尿酸药物中的应用。A pharmaceutical composition according to any one of claims 1-3, characterized in that the pharmaceutical composition is used in the preparation of uric acid lowering drugs.
  6. 根据权利要求1-3任一项所述的一种药物组合物，其特征在于该药物组合物在制备降尿酸特医食品中应用。A pharmaceutical composition according to any one of claims 1 to 3, characterized in that the pharmaceutical composition is used in the preparation of special medical food for lowering uric acid.
  7. 一种治疗痛风作用的药物组合物，其特征在于该药物组合物由下述原料制备而成：菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份；优选的药物组合物由下述原料制备而成：菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。A pharmaceutical composition for the treatment of gout, characterized in that the pharmaceutical composition is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, and 10-15 parts by weight of potassium citrate And 1-5 parts by weight of citric acid; the preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
  8. 一种具有降尿酸作用的药物组合物，其特征在于该药物组合物由下述原料制备而成：菊糖15-20重量份、柠檬酸钠10-15重量份、柠檬酸钾10-15重量份和柠檬酸1-5重量份；优选的药物组合物由下述原料制备而成：菊糖18重量份、柠檬酸钾14重量份、柠檬酸钠12重量份和柠檬酸4重量份。A pharmaceutical composition with the effect of lowering uric acid, characterized in that the pharmaceutical composition is prepared from the following raw materials: 15-20 parts by weight of inulin, 10-15 parts by weight of sodium citrate, and 10-15 parts by weight of potassium citrate The preferred pharmaceutical composition is prepared from the following raw materials: 18 parts by weight of inulin, 14 parts by weight of potassium citrate, 12 parts by weight of sodium citrate and 4 parts by weight of citric acid.
PCT/CN2020/087128 2019-04-28 2020-04-27 Pharmaceutical composition with effect of reducing uric acid WO2020221184A1 (en)

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CN110651862A (en) * 2019-11-21 2020-01-07 李海齐 Oral solid beverage capable of promoting uric acid reduction after tea drinking and preparation method thereof
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