WO2010005047A1 - 腸内環境改善剤 - Google Patents
腸内環境改善剤 Download PDFInfo
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- WO2010005047A1 WO2010005047A1 PCT/JP2009/062509 JP2009062509W WO2010005047A1 WO 2010005047 A1 WO2010005047 A1 WO 2010005047A1 JP 2009062509 W JP2009062509 W JP 2009062509W WO 2010005047 A1 WO2010005047 A1 WO 2010005047A1
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- WIPO (PCT)
- Prior art keywords
- intestinal environment
- improving agent
- lactobacillus brevis
- bacteria
- environment improving
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
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- 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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- 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
- A61K36/18—Magnoliophyta (angiosperms)
-
- 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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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- 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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates to an intestinal environment improving agent having an excellent intestinal environment improving effect.
- Symptoms such as inadequate intake of food and fiber, hormonal balance, worries, and mental stress due to the environment, etc. cause the intestinal environment to deteriorate and the number and amount of stools decrease. This deterioration of the intestinal environment may be one of the causes of colon cancer, bowel obstruction, and the like.
- the ingestion of Lactobacillus brevis has been confirmed to have an immunostimulatory effect and an intestinal age score improving effect.
- a safe and excellent intestinal environment improving effect has been desired.
- the present invention has been made in view of the above circumstances, and an object thereof is to provide an intestinal environment improving agent having an excellent intestinal environment improving effect.
- the present invention provides the following intestinal environment improving agent.
- the intestinal environment improving agent according to [1] which is an enteric preparation.
- the intestinal environment improving agent according to [1] or [2] which comprises 100 million or more live bacteria of Lactobacillus brevis.
- the intestinal environment improving agent according to [1] or [2] which contains 1 billion or more dead bacteria of Lactobacillus brevis.
- an intestinal environment improving agent having an excellent intestinal environment improving effect can be provided.
- lactoferrin are commercially available from lactoferrin, mammals (eg, humans, cows, sheep, goats, horses, etc.) colostrum, transitional milk, regular milk, end milk, etc. or processed products of these milks such as skim milk, whey, Examples include lactoferrin separated by a method (for example, ion exchange chromatography), lactoferrin produced from a plant (tomato, rice, tobacco), lactoferrin obtained by gene recombination, and the like. Lactoferrin may be a commercially available product or can be prepared and used by a known method. These can be used individually by 1 type or in combination of 2 or more types. In addition, as a lactoferrin, the thing derived from a cow is preferable and the enterofacted lactoferrin is preferable.
- the blending amount of lactoferrin with respect to the entire intestinal environment improving agent is appropriately selected depending on the dosage form, administration form, and administration target, but it is preferably 10 mg / day or more per adult, more preferably 50 to 5000 mg / day. preferable. Within this range, the effects of the present invention can be obtained. For example, when 300 mg is taken in 3 tablets, the amount per tablet is 1/3 of 100 mg.
- Lactobacillus brevis Lactobacillus brevis subsp. coagulans (Lactobacillus brevis subsp. coagulance), commonly known as "Labre bacterium”. It is a fungus discovered from pickles called “Ikuki-zuke”, and it is resistant to acids and salt, so it can withstand gastric and intestinal juices, reaches the intestines alive, and has a strong ability to survive in the intestines.
- the strain is not particularly limited and can be used alone or in combination of two or more. Among these, it is preferable to use strain number: FERM BP-4693.
- the amount of Lactobacillus brevis bacteria based on the entire intestinal environment-improving agent is appropriately selected depending on the dosage form, administration form, and administration target, but preferably 100 million or more live bacteria per adult per day is preferred. More than 100 million are more preferable, and 10 billion or more are more preferable. One billion or more dead bacteria are preferable, 10 billion or more are more preferable, and 18 billion or more are more preferable. Although both live bacteria and dead bacteria are discharged even if they are ingested in large amounts, they are not particularly limited, but they are 10 trillion or less. Within this range, the effect of the present invention can be obtained.
- API 50CHL Biomelieu manufactured by Biomelieu Japan
- an anaerobic culture is performed using an MRS agar medium, and the grown colonies are counted.
- the value measured using the MRS agar medium as with the live bacteria is defined as the number of dead bacteria.
- the intestinal environment improving agent of the present invention preferably contains an extract of a plant selected from the family Pepperaceae, Ginger and Eggplant.
- Pepperaceae Pepper (Pipe nigrum L.), Giant longhorn (Pipe longumum L.), Giant beetle (Pipe retrofractum Vahl), Ginger (Zingiber ophicinale), Can be used alone or in combination of two or more.
- the plant extract commercially available products or those obtained by known extraction methods can be used.
- the solvent used in the extraction method include water; alcohols such as methanol, ethanol, propanol, and butanol; polyhydric alcohols such as propylene glycol and butylene glycol, and the like. These may be used alone or in combination of two or more.
- the extraction temperature is preferably in the range of 5 to 80 ° C., and is preferably performed by immersing or stirring in the extraction solvent for 1 hour to 1 week.
- the extraction pH is not particularly limited as long as it is not extremely acidic or alkaline.
- the extraction solvent is a non-toxic solvent such as water, ethanol, water / ethanol (hydrous ethanol)
- the extract may be used as it is, or may be used as a diluent.
- the said extract may be used as a concentrated extract, and may be made into a dry powder by freeze-drying or the like, or may be prepared in a paste form.
- the amount of the plant extract selected from the pepper family, ginger family and solanaceae to the intestinal environment-improving agent is appropriately selected depending on the dosage form, dosage form and administration target. 0.1 to 5000 mg per day is preferable, and 1 to 500 mg is more preferable. Within this range, the effects of the present invention can be obtained.
- an appropriate amount of any one component can be used alone or in combination of two or more as long as the effects of the present invention are not impaired.
- the optional component include an oily component, a lubricant, an excipient, a disintegrant, a binder, a medicinal component other than the above components, a pigment, and a fragrance. Specifically, the following components can be mentioned.
- oil component examples include various fatty acid esters, hydrocarbons, higher fatty acids, higher alcohols and the like.
- Lubricants include gum arabic, cacao butter, carnauba wax, hydrous silicon dioxide, dry aluminum hydroxide gel, glycerin, magnesium silicate, liquid paraffin, crystalline cellulose, sucrose fatty acid ester, stearyl alcohol, stearic acid, gelatin, lactose Sucrose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, fumaric acid, beeswax sugar and the like.
- Excipients include gum arabic, ethylcellulose, kaolin, cacao butter, fructose, silicon dioxide, xylitol, citric acid or salts thereof, crystalline cellulose, stearic acid or salts thereof, dextran, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose , Polyvinyl pyrrolidone, macrogol, calcium hydrogen phosphate, sodium hydrogen phosphate, sucrose, glucose, sorbitol, lactitol, corn starch, potato starch and the like.
- the disintegrant include cellulose or a derivative thereof, starch or a derivative thereof.
- binder examples include hydroxypropyl cellulose, methyl cellulose, carboxymethyl cellulose, gelatin, vinyl pyrrolidone, and partially pregelatinized starch.
- medicinal ingredients include carotenoid substances ( ⁇ -carotene, ⁇ -carotene, ⁇ -carotene, lycopene, lutein, astaxanthin, zeaxanthin, etc.), coenzyme Q10, vitamin E, tocotrienol, DHA, EPA, and the like.
- the dosage form of the intestinal environment improving agent of the present invention is not particularly limited, and examples thereof include liquid, powder, granule, tablet, capsule and the like.
- the enteric environment improving agent of the present invention is preferably an enteric preparation.
- whether it is an enteric preparation depends on the 14th revised Japanese Pharmacopeia / Disintegration Test Method.
- the method for producing the intestinal environment improving agent of the present invention is not particularly limited and is appropriately selected according to the dosage form. After mixing lactoferrin, Lactobacillus brevis, and optional components, The method of preparing a tablet by the method of compression molding is mentioned. Further, a method of coating the tablet with an enteric component such as shellac to obtain an enteric preparation is preferable.
- the ingestion method of the intestinal environment-improving agent of the present invention varies depending on the dosage form and is not particularly limited. However, in the case of a tablet, it is preferably taken with water or the like. In the case of other dosage forms, there is no particular limitation, but since lactoferrin and live bacteria of Lactobacillus brevis are vulnerable to heat, it is not preferable to heat them before feeding.
- the intake time is not particularly limited, but is preferably from after dinner until before going to bed.
- intestinal environment improvement means improving the state of the intestines and intestines, making the stool hardness appropriate, returning the number of defecations and the amount of defecation to a normal state
- Intestinal environmental agents may be quasi-drugs, foods for specified health use, foods, etc., as intestinal preparations, constipation relieving agents, diarrhea relieving agents, laxatives, intestinal gas suppressors, abdominal bloating suppressants Is preferred.
- effects such as makeup paste and skin texture are obtained.
- Intestinal environment improving active ingredient consisting only of lactoferrin and Lactobacillus brevis bacteria
- intestine consisting only of lactoferrin and lactobacillus brevis bacteria and plant extracts selected from pepper family, ginger family and solanaceous family It can also be used as an internal environment improving active ingredient, and an intestinal environment improving method using these can be provided.
- Lactoferrin (MLF-EX manufactured by Morinaga Milk Industry) (2) Lactobacillus brevis viable bacteria Separated from a commercially available beverage (plant lactic acid bacteria Labre manufactured by Kagome), anaerobically cultured in MRS medium (Oxoid), collected and freeze-dried. 60 mg of this dry product corresponds to 100 million viable bacteria. (Including strain number: FERM BP-4693) (3) Lactobacillus brevis dead bacteria Separated from commercially available beverages (Kagome plant lactic acid bacteria Labre), cultured in MRS medium, collected, sterilized at 121 ° C for 20 minutes, and then freeze-dried It was.
- Example 1 to 4 Comparative Examples 1 and 2
- Ingredients other than shellac were mixed so that the proportions shown in the following table were obtained, and tablets with a diameter of 9 mm and a weight of 325 mg were compressed. Furthermore, except for Example 4, tablets were coated with shellac (enteric coating agent) to obtain enteric tablets.
- shellac enteric coating agent
- For identification of lactic acid bacteria API 50CHL Biomelieu (manufactured by Biomelieu Japan) was used.
- MRS agar medium an MRS agar medium, and the grown colonies were counted.
- the value measured using the MRS agar medium as in the case of live bacteria was used as the number of dead bacteria before sterilization.
- the following evaluation was performed about the obtained enteric tablet. The results are also shown in the table.
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Abstract
Description
[1].ラクトフェリンと、ラクトバチルス ブレビス菌とを有効成分として含有する腸内環境改善剤。
[2].腸溶製剤である[1]記載の腸内環境改善剤。
[3].ラクトバチルス ブレビス菌の生菌を1億個以上含む[1]又は[2]記載の腸内環境改善剤。
[4].ラクトバチルス ブレビス菌の死菌を10億個以上含む[1]又は[2]記載の腸内環境改善剤。
[5].さらに、コショウ科、ショウガ科及びナス科から選ばれる植物の抽出物を含む[1]~[4]のいずれかに記載の腸内環境改善剤。
は、市販のラクトフェリン、哺乳類(例えば人、牛、羊、山羊、馬等)の初乳、移行乳、常乳、末期乳等又はこれらの乳の処理物である脱脂乳、ホエー等から、常法(例えば、イオン交換クロマトグラフィー)により分離したラクトフェリン、植物(トマト、イネ、タバコ)から生産されたラクトフェリン、遺伝子組み換えによって得られたラクトフェリン等が挙げられる。ラクトフェリンは、市販品を使用してもよいし、公知の方法により調製して使用することができる。これらは1種単独で又は2種以上を適宜組み合わせて用いることができる。なお、ラクトフェリンとしては、牛由来のものが好ましく、腸溶加工されたラクトフェリンが好ましい。
Lactobacillus brevis subsp. coagulans (ラクトバチルス ブレビス サブスピーシス コアギュランス)であり、通称を「ラブレ菌」という。「すぐき漬」という漬け物から発見された菌で、酸や塩分に強いので、胃液や腸液に耐え、生きたまま腸に届き、腸の中でも生きぬく力が強い。株は特に限定されず、1種単独で又は2種以上を適宜組み合わせて用いることができる。中でも、菌株番号:FERM BP-4693を用いるのが好ましい。
本発明の腸内環境改善剤には、さらに腸内環境改善効果を向上させるため、コショウ科、ショウガ科及びナス科から選ばれる植物の抽出物を配合することが好ましい。
具体的には、コショウ科として、コショウ(Piper nigrum L.)、ヒハツ(Piper longum L.)、ヒハツモドキ(Piper retrofractum Vahl)、ショウガ科としてショウガ(Zingiber officinale)、ナス科としてトウガラシ(Capsicum annuum)等が挙げられ、1種単独で又は2種以上を適宜組み合わせて用いることができる。
(1)ラクトフェリン(森永乳業製 MLF-EX)
(2)ラクトバチルス ブレビス生菌
市販飲料(カゴメ社製植物性乳酸菌ラブレ)より分離し、MRS培地(Oxoid社)にて嫌気培養後、集菌し凍結乾燥したものを用いた。本乾燥品60mgが生菌数1億個に相当する。(菌株番号:FERM BP-4693を含む)
(3)ラクトバチルス ブレビス死菌
市販飲料(カゴメ社製植物性乳酸菌ラブレ)より分離し、MRS培地にて培養後、集菌し、121℃・20分で殺菌した後、凍結乾燥したものを用いた。本乾燥品36mgが死菌数10億個に相当する。(菌株番号:FERM BP-4693を含む)
(4)ヒハツ抽出物(丸善製薬製 ヒハツエキスMF)
(5)賦形剤(乳糖と結晶セルロースを同重量混合)
下記表の割合となるように、シェラック以外の成分を混合し、直径9mm、重量325mgの錠剤を打錠した。さらに、実施例4以外は、シェラック(腸溶コート剤)を用いて錠剤をコーティングし腸溶錠とした。なお、乳酸菌の同定にはアピ50CHLビオメリュー(日本ビオメリュー社製)を用いた。生菌数の測定には、MRS寒天培地を用いて嫌気培養し、生育したコロニーを計測した。死菌の場合には殺菌処理をする前に、生菌と同様MRS寒天培地を用いて計測した値を死菌数とした。得られた腸溶錠について、下記評価を行った。結果を表中に併記する。
Claims (5)
- ラクトフェリンと、ラクトバチルス ブレビス菌とを有効成分として含有する腸内環境改善剤。
- 腸溶製剤である請求項1記載の腸内環境改善剤。
- ラクトバチルス ブレビス菌の生菌を1億個以上含む請求項1又は2記載の腸内環境改善剤。
- ラクトバチルス ブレビス菌の死菌を10億個以上含む請求項1又は2記載の腸内環境改善剤。
- さらに、コショウ科、ショウガ科及びナス科から選ばれる植物の抽出物を含む請求項1~4のいずれか1項記載の腸内環境改善剤。
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JP2010519812A JPWO2010005047A1 (ja) | 2008-07-10 | 2009-07-09 | 腸内環境改善剤 |
US13/003,254 US20110123576A1 (en) | 2008-07-10 | 2009-07-09 | Intestinal environment-improving agent |
CN2009801278204A CN102088985B (zh) | 2008-07-10 | 2009-07-09 | 肠内环境改善剂 |
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JP (2) | JPWO2010005047A1 (ja) |
KR (1) | KR101636096B1 (ja) |
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JP2021059508A (ja) * | 2019-10-04 | 2021-04-15 | 株式会社アカシアの樹 | 腸内環境改善剤 |
JP7370224B2 (ja) * | 2019-11-08 | 2023-10-27 | ライオン株式会社 | ラクトフェリン含有腸溶製剤 |
WO2021235486A1 (ja) | 2020-05-22 | 2021-11-25 | 森永乳業株式会社 | 腸管発達促進用組成物、肺機能改善用組成物および免疫機能向上用組成物 |
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KR20110031958A (ko) | 2011-03-29 |
CN102836421A (zh) | 2012-12-26 |
JPWO2010005047A1 (ja) | 2012-01-05 |
KR101636096B1 (ko) | 2016-07-04 |
CN102088985A (zh) | 2011-06-08 |
CN102088985B (zh) | 2012-09-26 |
JP2014111668A (ja) | 2014-06-19 |
US20110123576A1 (en) | 2011-05-26 |
JP5828349B2 (ja) | 2015-12-02 |
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