WO2020256017A1 - Agent d'amélioration du plasma laiteux - Google Patents

Agent d'amélioration du plasma laiteux Download PDF

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Publication number
WO2020256017A1
WO2020256017A1 PCT/JP2020/023776 JP2020023776W WO2020256017A1 WO 2020256017 A1 WO2020256017 A1 WO 2020256017A1 JP 2020023776 W JP2020023776 W JP 2020023776W WO 2020256017 A1 WO2020256017 A1 WO 2020256017A1
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WO
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Prior art keywords
plasma
red yeast
yeast rice
cholesterol
chylothorax
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PCT/JP2020/023776
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English (en)
Japanese (ja)
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浅野　幸一
悠貴 比嘉
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小林製薬株式会社
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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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Definitions

  • the present invention relates to a chylothorax plasma improving agent.
  • the present invention also relates to an agent for suppressing or ameliorating chylomicronemia.
  • lipids such as triglyceride, cholesterol, phospholipids, and free fatty acids are usually present.
  • the phenomenon that serum and plasma become cloudy white occurs as if milk was mixed. Such a state is called “chylothorax”.
  • the causes of "milk” are an increase in triglycerides and cholesterol (exogenous lipids) in the blood due to ingestion of a high-fat diet and a high-cholesterol diet, and a deficiency and function of lipoprotein lipase that decomposes lipids in the blood.
  • Various causes such as a decrease can be considered.
  • red yeast rice and its processed products have been conventionally used as functional foods having a cholesterol lowering action (for example).
  • Patent Document 1 Monascus is a bright red yeast rice in which red yeast rice is propagated on grains such as rice. In China and Taiwan, it is used as a brewing ingredient for red sake, old sake, red roasted milk, etc., and also helps digestion and improves blood circulation. It has long been known as a Chinese herbal medicine.
  • red yeast rice contains a plurality of functional substances such as GABA and coenzyme Q10.
  • GABA GABA
  • coenzyme Q10 In addition to the cholesterol-lowering action, blood pressure lowering action, blood sugar level lowering action, carcinogenesis-preventing action, etc. Has also been reported.
  • An object of the present invention is to provide a new functional composition based on the action newly found for red yeast rice. Specifically, it is an object of the present invention to provide a use as a chylothorax plasma improving agent and a use as a chylomicronemia suppressing or improving agent based on the chylothorax improving action of plasma and serum of red yeast rice. ..
  • the present inventors have been diligently studying to find a new effect on red koji, and found that plasma collected from rabbits fed with red koji together with a high-fat, high-cholesterol-loaded diet is a high-fat, high-cholesterol-loaded diet. It was found that the white turbidity phenomenon (milkiness) was significantly reduced compared to the plasma collected from rabbits fed only with red koji, and the red koji was eaten with a high-fat diet and a high-cholesterol diet. It was found that it has an effect of improving "milkiness" caused by the lipid (exogenous lipid) contained in.
  • red koji is not lactated due to a temporary diet, but is continuously high. It was confirmed that it has the effect of reducing and improving the milk loss caused by ingesting a fat diet or a high cholesterol diet, that is, the milk loss caused by eating habits and eating habits.
  • plasma turbidity phenomenon chylothorax
  • red yeast rice has an effect of suppressing or ameliorating chylomicronsemia.
  • the present invention has been completed based on these findings, and includes the following embodiments.
  • Chylothorax plasma improving agent and its production method (I-1) Chylothorax plasma improving agent containing red yeast rice or a processed product thereof.
  • the chylothorax plasma improving agent of the present invention can also be referred to as a chylothorax improving agent.
  • Oral Monascus-containing oral composition having a function of improving milky plasma which comprises a step of preparing an oral composition using Monascus purpureus or blending Monascus or a processed product thereof into the oral composition. Method for producing the composition.
  • (I-5) By preparing an oral composition using Monascus purpureus, or by blending Monascus or a processed product thereof in the oral composition, the oral composition is imparted with a function of improving milk plasma. How to use Monascus purpureus or Monascus, characterized by
  • An agent for suppressing or ameliorating chylomicronemia (II-1) An agent for suppressing or ameliorating chylomicronemia containing red yeast rice or a processed product thereof. (II-2) The agent for suppressing or ameliorating chylomicronemia according to (II-1), wherein the chylomicronemia is caused by a deficiency or functional deterioration of a lipolytic enzyme. (II-3) The agent for suppressing or ameliorating chylomicronemia according to (II-1) or (II-2), wherein the producing bacterium of Monascus pilosus is Monascus pilosus.
  • (II-4) The chylomicron according to any one of (II-1) to (II-3), wherein the chylomicronemia is caused by ingesting a high-fat diet and / or a high-cholesterol diet.
  • (II-5) A red yeast rice having a function of suppressing or ameliorating chylomicronemia, which comprises a step of preparing an oral composition using Monascus purpureus or blending red yeast rice or a processed product thereof into the oral composition.
  • a method for producing an oral composition containing koji A method for producing an oral composition containing koji.
  • lipids (exogenous lipids) contained in a diet such as ingestion of a high-fat diet or a high-cholesterol diet (hereinafter, these are also collectively referred to as "high-fat diet") )
  • high-fat diet lipids contained in a diet
  • a milky lotion plasma improving agent of the present invention a milky lotion produced by continuously ingesting a high-fat diet or the like, that is, a high-fat diet or the like is preferred rather than a milky lotion caused by a temporary diet. It is possible to reduce and improve lactation caused by eating habits and eating habits such as ingestion.
  • Chylothorax found in serum and plasma affects the values of biochemical tests performed using blood as a sample, especially those measured by the colorimetric method and the turbidimetric method. Is also useful for obtaining accurate test values.
  • red yeast rice is also useful for suppressing or ameliorating chylomicronsemia.
  • chylomicrons due to lipids (exogenous lipids) contained in the diet such as ingestion of a high-fat diet or a high-cholesterol diet, especially a high-fat diet. It is possible to suppress and improve chylomicronemia caused by eating habits and eating habits such as preferential intake of high-cholesterol diet.
  • the cause of chylomicrons increasing or accumulating in blood is a deficiency of neutral lipolytic enzyme or a decrease in its function, particularly a decrease in lipoprotein lipase activity. Therefore, the agent for suppressing or ameliorating chylomicrons of the present invention may be able to suppress or ameliorate chylomicronsemia caused by a deficiency of such a neutral lipolytic enzyme or a decrease in its function.
  • the time course of the blood cholesterol concentration of the rabbits (control group, red yeast rice group) ingesting the high-fat, high-cholesterol-loaded diet performed in the experimental example is shown.
  • T-Cho Total cholesterol
  • LDL-cholesterol (LDL-C) concentration in plasma are shown.
  • the blood cholesterol concentration of the high-fat, high-cholesterol-loaded diet-ingested rabbits (control group, red yeast rice group) performed in the experimental example and the time course of triglyceride are shown.
  • B) neutral fat (triglyceride) (TG) concentration in plasma are shown.
  • the light transmission rate (%) of plasma after ingesting a high-fat, high-cholesterol-loaded diet and red koji for 2 weeks after ingesting a cholesterol-loaded diet is shown.
  • the light transmission rate (%) of plasma after ingesting red koji for 3 weeks is shown. In each case, the value is the average value of each group.
  • the chylothorax plasma improving agent of the present invention is characterized by containing red yeast rice as an active ingredient.
  • Monascus is a koji obtained by breeding Monascus purpureus belonging to the genus Monascus using cereals as a raw material.
  • Monascus purpureus may belong to the genus Monascus, for example, Monascus pilosus, Monascus purpureus, Monascus pubigerus, Monascus anka, these. Variants or mutants can be mentioned.
  • Monascus purpureus having the ability to produce Monascus K Preference is given to Monascus purpureus having the ability to produce Monascus K, and examples thereof include Monascus pilosus, Monascus purpureus, and Monascus pubigerus. More preferably, it is Monascus pilosus.
  • the cereals used as a raw material for jiuqu are not limited, and examples thereof include rice such as white rice and brown rice, wheat, and beans such as soybean.
  • rice various kinds such as white soybean, black soybean, and green soybean can be used without limitation.
  • any of defatted soybean, soybean hypocotyl, and whole soybean may be used.
  • the cereals used as a raw material for jiuqu are preferably rice, and more preferably white rice.
  • the shape of these cereals is not particularly limited, and may be granular, or may be in a crushed or crushed state. Further, these cereals may be heat-treated in advance, and may be cooked rice or barley rice cooked with water, steamed cooked rice or barley rice, boiled beans or the like.
  • the method for producing Monascus purpureus using the above-mentioned Monascus purpureus and the raw material for Jiuqu is not particularly limited and can be carried out according to a conventional method.
  • Monascus can be produced and obtained by inoculating a koji raw material such as steamed white rice, soybeans or wheat flour with Monascus purpureus and statically culturing it under aerobic conditions of 20 ° C to 40 ° C.
  • the red yeast rice used in the present invention is preferably rice red yeast rice produced by using Monascus pyrosus as a red yeast rice, and cooked or steamed polished rice as a raw material for the yeast rice.
  • the red yeast rice prepared in this way can be used as it is, but it can also be further processed.
  • the red yeast rice produced by the above method may be dried after inactivating bacteria and enzymes by heat treatment to obtain dried red yeast rice. It can also be prepared as a fine granule or powder by crushing or pulverizing after drying. It is also possible to grind red yeast rice to prepare a paste.
  • dried red yeast rice can be extracted with an arbitrary solvent to be used as an extract, and it can be further concentrated to make a concentrated extract, or dried and used as an extract powder. It is preferably dried red yeast rice, and more preferably a powdered product thereof.
  • Red yeast rice can also be obtained commercially.
  • dry powder of rice red yeast rice can be obtained from Kobayashi Pharmaceutical Co., Ltd. as "3P-D" or "3P-D20".
  • the milky plasma improving agent of the present invention is composed of, for example, the above-mentioned red yeast rice or a processed product thereof (hereinafter, these are also collectively referred to as "red yeast rice"), or other edible components are added to the red yeast rice.
  • red yeast rice a processed product thereof
  • It is an oral composition prepared by blending.
  • the oral composition includes foods and drinks, oral or oral medicines, and oral or oral quasi-drugs.
  • the foods and drinks, pharmaceuticals, and quasi-drugs targeted by the present invention are products having an effect of improving chylothorax.
  • Chylothorax is a state or finding in which blood samples such as serum and plasma collected from warm-blooded animals including humans are milky white.
  • the causative substance is mainly chylomicrons containing triglycerides, and when a large amount of it is suspended in the blood, serum and plasma, which are liquid components after removing blood cell components such as red blood cells and white blood cells from the blood, are released. Observed in a milky state. Chylothorax is often caused by triglycerides (exogenous lipids) ingested from the diet, so even healthy humans may develop chylothorax if a certain amount of time has not passed since the diet before collecting blood.
  • the chylothorax plasma improving agent of the present invention can be used to improve chylothorax observed in blood samples collected on an empty stomach 12 hours or more after a meal, rather than chylothorax that occurs transiently after a meal.
  • the causes include secondary dyslipidemia caused by continuous intake of a high-fat diet and / and a high-cholesterol diet, deficiency of lipid-degrading enzymes in blood, and functional deterioration.
  • the chylothorax improving agent of the present invention improves chylothorax in a blood sample by suppressing or improving the blood retention of chylomicrons caused by dietary triglyceride (exogenous lipid). Can be suitably used for.
  • Chylothorax plasma improvement means to reduce chylothorax (whitening / turbidity of plasma) observed in plasma.
  • the presence or absence of chylothorax in plasma can be evaluated by measuring the light transmittance to plasma.
  • the light transmittance can be measured by measuring the absorbance (OD660) of plasma at a wavelength of 660 nm using an absorptiometer (colorimeter).
  • the absorbance (OD660) of the collected plasma was compared between the case where the milk plasma improving agent was taken orally and the case where it was not taken (or before it was taken), and the milk plasma was compared.
  • the foods and drinks targeted by the present invention are foods and drinks having an effect of improving milky plasma, for example, functional foods (foods for specified health use [including conditional foods for specified health use], and functional claims. Includes foods), health foods, general foods and drinks, nutritional supplements (including nutritional drinks), and foods and drinks for the sick.
  • functional foods and health foods include supplements having orally administered preparation forms such as tablets, capsules (hard capsules, soft capsules), powders (powder), granules, pills, and liquids.
  • the food or drink can be prepared as a food or drink having a chylothorax plasma improving effect by combining the above-mentioned red yeast rice with ingredients, materials and the like conventionally known in the field of food and drink.
  • the types of foods and drinks are not particularly limited, and for example, beverages (dairy beverages, lactic acid bacteria beverages, soft drinks containing fruit juice, carbonated beverages, fruit juice beverages, vegetable beverages, vegetable / fruit beverages, alcoholic beverages, coffee beverages, sports beverage powders.
  • beverages airy beverages, lactic acid bacteria beverages, soft drinks containing fruit juice, carbonated beverages, fruit juice beverages, vegetable beverages, vegetable / fruit beverages, alcoholic beverages, coffee beverages, sports beverage powders.
  • Beverages, tea beverages confectionery (chewing gum, bubble gum and other gums [including plate gum and sugar-coated granular gum]
  • coated chocolate such as marble chocolate, chocolates with flavors such as strawberry chocolate and bullberry chocolate
  • hard Candy including bonbons, butterballs, marbles, etc.]
  • soft candies including caramel, nougat, gummy candies, marshmallows, etc.]
  • film-like candies film-like candies [edible film]
  • baked sweets such as hard biscuits, cookies, okaki, and rice cakes.
  • the daily intake of the food and drink of the present invention may be any amount as long as the effect of the present invention can be obtained, and is not limited.
  • the total amount of red yeast rice is per daily intake (for an adult weighing about 60 kg). It can be appropriately set from a range of about 100 to 60,000 mg / day, preferably about 200 to 30,000 mg / day.
  • the proportion of red yeast rice to be blended in the food and drink of the present invention can be appropriately set based on the above daily intake so as to achieve the effect of the present application, and the total amount of red yeast rice is, for example, 5 to 100% by mass. It can be selected and set as appropriate from the range of.
  • the drugs or quasi-drugs covered by the present invention are drugs or quasi-drugs that have the effect of improving milk plasma when administered orally or applied orally. is there.
  • the drug or quasi-drug is produced by blending the above-mentioned red yeast rice with a pharmaceutically acceptable carrier and / or additive and molding it into a desired shape.
  • the formulation form may be an oral administration form, for example, a liquid formulation such as a liquid preparation (including syrup), tablets (including troche tablets and chewable tablets), pills, powders, granules, etc.
  • Oral preparations in the form of solid preparations such as capsules (including soft capsules) can be mentioned. It is preferably in the form of a solid preparation.
  • the carriers and / or additives described above may be selected according to a conventional method according to the dosage form, as long as they do not impair the effects of the present invention.
  • the dose of the drug or quasi-drug of the present invention is not particularly limited as long as the effect of the present invention is exhibited, and can be appropriately set depending on the age, weight, degree of symptoms, etc. of the patient.
  • the total amount of red yeast rice is appropriately set as a daily dose (for an adult weighing about 60 kg) from about 100 to 60,000 mg / day, preferably about 200 to 30,000 mg / day. can do.
  • the dose can also be administered once or in multiple divided doses per day.
  • the proportion of red yeast rice to be blended in the pharmaceutical product or quasi-drug of the present invention can be appropriately set based on the above daily intake so as to achieve the effect of the present application, and the total amount of red yeast rice is, for example, 5. It can be appropriately selected and set from the range of about 100% by mass.
  • red yeast rice itself has the effect of improving chylothorax. Therefore, by blending red yeast rice or its processed product in an oral composition (including foods and drinks, pharmaceuticals, quasi-drugs), the oral composition is given a function of improving plasma chylothorax. Can be done. In other words, by blending red yeast rice or a processed product thereof into the oral composition, a red yeast rice-containing oral composition having a function of improving chylothorax can be produced and obtained. As described above, even when an oral composition containing Monascus purpureus is prepared using Monascus purpureus, the oral composition can be imparted with a function of improving plasma chylothorax. That is, even in that case, an oral composition containing red yeast rice having a function of improving chylothorax can be produced and obtained.
  • the suppressing or ameliorating agent for chylomicronemia of the present invention is characterized by containing red yeast rice or a processed product thereof as an active ingredient.
  • the red yeast rice used as an active ingredient, its processed product, and the method for obtaining the production thereof are as described in (I), and the above description can be incorporated herein by reference.
  • the agent for suppressing or ameliorating chylomicronemia of the present invention is prepared as an oral composition (food and drink, pharmaceuticals, quasi-drugs) in the same manner as the above-mentioned chylothorax improving agent, and is used for chylomicronemia.
  • Chylomicron is a lipoprotein in which neutral fat in the blood is bound to a protein, and when the amount of suspension in the blood is large, a phenomenon (chylothorax) in which plasma and serum become milky white is observed. That is, chylomicronemia means a state in which the blood has a large amount of chylomicrons, in other words, a state in which the amount of triglycerides is large.
  • the cause is not particularly limited, but secondary dyslipidemia caused by continuous intake (dietary habits / eating habits) of a high-fat diet and / or a high-cholesterol diet, and lipid-degrading enzymes in the blood Insufficient or functional deterioration is included.
  • the inhibitor or ameliorating agent for chylomicrons of the present invention increases or stores chylomicrons in blood caused by triglyceride (exogenous lipid) derived from diet, especially blood caused by eating habits and eating habits. It is possible to suppress or improve the increase and storage of chylomicrons in the blood.
  • the inhibitory or ameliorating effect of chylomicrons can be evaluated from the decrease in the amount of chylomicrons in plasma.
  • the amount of chylomicrons in plasma can be evaluated by measuring the light transmittance to plasma in the same manner as the above-mentioned chylothorax effect.
  • the evaluation method is as described in (I) as in the evaluation method of the chylothorax improving effect, and the above description can be incorporated herein by reference.
  • a loaded diet (0.25% cholesterol loaded) (Oriental Yeast Co., Ltd.) was ingested 100 g daily. Each rabbit was kept individually in a cage, water was freely ingested, and food was restricted.
  • T-Cho Total cholesterol
  • LDL-C LDL-cholesterol
  • HDL-C HDL-cholesterol
  • FIG. 3 (A) shows the plasma light transmittance (%) of the rabbits (control group) that did not ingest the red yeast rice and the plasma light transmittance (%) of the plasma of the rabbits (monascus group) that received the red yeast rice.
  • FIG. 3 (B) shows changes in plasma light transmittance due to administration of red koji (weeks 2 and 3) (light transmittance of plasma in the red koji group (mean value) -light transmittance of plasma in the control group.

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Abstract

Le problème décrit par la présente invention est de fournir un agent d'amélioration du plasma laiteux et un agent prophylactique ou améliorant la chylomicronémie. La solution selon l'invention porte sur une levure de riz rouge ou un produit transformé de celle-ci qui est contenu(e) en tant que principe actif.
PCT/JP2020/023776 2019-06-21 2020-06-17 Agent d'amélioration du plasma laiteux WO2020256017A1 (fr)

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JP2019-115854 2019-06-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022186042A1 (fr) * 2021-03-04 2022-09-09 小林製薬株式会社 Agent hypocholestérolémiant

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09288111A (ja) * 1996-04-23 1997-11-04 Iatron Lab Inc 生体試料の濁りを除去するための試薬
WO2001006243A1 (fr) * 1999-07-16 2001-01-25 Asahi Kasei Kabushiki Kaisha Procede de mesure d'une substance et reactif a cet usage
JP2012158553A (ja) * 2011-02-01 2012-08-23 Gunze Ltd 内臓脂肪蓄積抑制剤
JP2013063925A (ja) * 2011-09-16 2013-04-11 Sunway Biotech Co Ltd 血液脂質を引き下げ、ｈｄｌコレステロールを引き上げることができる混合物とその製造方法
JP2014531418A (ja) * 2011-09-06 2014-11-27 アイピー サイエンス リミテッド 生成物および方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09288111A (ja) * 1996-04-23 1997-11-04 Iatron Lab Inc 生体試料の濁りを除去するための試薬
WO2001006243A1 (fr) * 1999-07-16 2001-01-25 Asahi Kasei Kabushiki Kaisha Procede de mesure d'une substance et reactif a cet usage
JP2012158553A (ja) * 2011-02-01 2012-08-23 Gunze Ltd 内臓脂肪蓄積抑制剤
JP2014531418A (ja) * 2011-09-06 2014-11-27 アイピー サイエンス リミテッド 生成物および方法
JP2013063925A (ja) * 2011-09-16 2013-04-11 Sunway Biotech Co Ltd 血液脂質を引き下げ、ｈｄｌコレステロールを引き上げることができる混合物とその製造方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022186042A1 (fr) * 2021-03-04 2022-09-09 小林製薬株式会社 Agent hypocholestérolémiant

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