JP2021167309A - Fat reducer - Google Patents

Fat reducer Download PDF

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JP2021167309A
JP2021167309A JP2021074966A JP2021074966A JP2021167309A JP 2021167309 A JP2021167309 A JP 2021167309A JP 2021074966 A JP2021074966 A JP 2021074966A JP 2021074966 A JP2021074966 A JP 2021074966A JP 2021167309 A JP2021167309 A JP 2021167309A
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fat
blood
reducing agent
extract
weight
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貴大 田中
Takahiro Tanaka
美咲 中曽根
Misaki Nakasone
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Kobayashi Pharmaceutical Co Ltd
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Kobayashi Pharmaceutical Co Ltd
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Abstract

To provide a fat reducer useful for a subject having a high blood triglyceride level.SOLUTION: Bofu-tsusho-san extract has a significantly high fat reducing effect on a subject having a high blood triglyceride level, so that it is useful as a fat reducer.SELECTED DRAWING: None

Description

本発明は、脂肪低減剤に関する。より具体的には、本発明は、血中中性脂肪値が高い人に高い効果を示す脂肪低減剤に関する。 The present invention relates to a fat reducing agent. More specifically, the present invention relates to a fat-reducing agent that is highly effective in people with high triglyceride levels in blood.

血中中性脂肪は、血液中に存在するトリグリセライドであり、エネルギー源であるブドウ糖が不足した場合の代替エネルギー源として用いられる。血中中性脂肪の基準値は30〜149mg/dLとされている(非特許文献1)。 Neutral fat in blood is triglyceride present in blood and is used as an alternative energy source when glucose, which is an energy source, is deficient. The standard value of triglyceride in blood is 30 to 149 mg / dL (Non-Patent Document 1).

血中中性脂肪が基準値よりも高値になると、内臓脂肪の増加、血糖値の上昇、血圧の上昇等を引き起こす。血中中性脂肪が高くなる原因としては、糖尿病、腎疾患、内分泌疾患、肝疾患等の疾患、飲酒、食事内容、運動不足等の生活習慣、脂質が血中にたまりやすい体質、加齢等、多岐にわたる。 When the triglyceride level in the blood becomes higher than the standard value, it causes an increase in visceral fat, an increase in blood glucose level, an increase in blood pressure, and the like. Causes of high triglyceride in blood include diseases such as diabetes, renal disease, endocrine disease, liver disease, lifestyle-related diseases such as drinking, dietary content, lack of exercise, constitution in which lipids tend to accumulate in blood, aging, etc. , Wide variety.

“判定区分 2020年度版”、[online]、2020年4月1日改定、日本人間ドック学会、[令和3年4月18日検索]、インターネット<URL: https://www.ningen-dock.jp/wp/wp-content/uploads/2013/09/2020DockHantei.pdf>"Judgment classification 2020 version", [online], revised on April 1, 2020, Japan Society for Human Dock, [search on April 18, 3rd year of Reiwa], Internet <URL: https://www.ningen-dock. jp / wp / wp-content / uploads / 2013/09/2020DockHantei.pdf >

血中中性脂肪が高値となると生じる身体状態の中でも、内臓脂肪の増加は腹周りの増加につながるため忌避心理がより一層強く働き、特に、肥満でない人にとってその傾向が強い。 Among the physical conditions that occur when the blood triglyceride level is high, the increase in visceral fat leads to an increase in the abdominal circumference, so that the repellent psychology works even more strongly, especially for non-obese people.

そこで、本発明は、血中中性脂肪が高値である対象に有用な脂肪低減剤を提供することを目的とする。 Therefore, an object of the present invention is to provide a fat-reducing agent useful for a subject having a high triglyceride level in blood.

本発明者らが鋭意検討を行ったところ、防風通聖散エキスに、血中中性脂肪が高値である対象に対して顕著に脂肪を低減する効果があることを見出した。本発明は、この知見に基づいて、更に検討を重ねることにより完成したものである。 As a result of diligent studies by the present inventors, it was found that Bofutsushosan extract has a remarkable effect of reducing fat in a subject having a high triglyceride level in blood. The present invention has been completed by further studies based on this finding.

即ち、本発明は、下記に掲げる態様の発明を提供する。
項1. 防風通聖散エキスを含有し、血中中性脂肪が高値の対象に適用される、脂肪低減剤。
項2. 前記対象の血中中性脂肪値が150mg/dL以上である、項1に記載の脂肪低減剤。
項3. 前記対象が、乳びが認められる対象である、項1又は2に記載の脂肪低減剤。
項4. 前記対象が非肥満者である、項1〜3のいずれかに記載の脂肪低減剤。
項5. 前記対象が男性である、項1〜4のいずれかに記載の脂肪低減剤。
項6. 内臓脂肪を低減するために用いられる、項1〜5のいずれかに記載の脂肪低減剤。
That is, the present invention provides the inventions of the following aspects.
Item 1. A fat-reducing agent containing Bofutsushosan extract and applied to subjects with high triglyceride levels in blood.
Item 2. Item 2. The fat reducing agent according to Item 1, wherein the triglyceride level in the blood of the subject is 150 mg / dL or more.
Item 3. Item 2. The fat reducing agent according to Item 1 or 2, wherein the subject is a subject in which chyle is observed.
Item 4. Item 2. The fat reducing agent according to any one of Items 1 to 3, wherein the subject is a non-obese person.
Item 5. Item 2. The fat reducing agent according to any one of Items 1 to 4, wherein the subject is a male.
Item 6. Item 2. The fat reducing agent according to any one of Items 1 to 5, which is used for reducing visceral fat.

本発明によれば、血中中性脂肪が高値である対象に有用な脂肪低減剤が新たに提供される。 According to the present invention, a new fat reducing agent useful for a subject having a high triglyceride level in blood is provided.

本発明の脂肪低減剤は防風通聖散エキスを含有し、血中中性脂肪が高値である対象に適用されることを特徴とする。以下、本発明の脂肪低減剤について詳述する。 The fat-reducing agent of the present invention contains a bofutsushosan extract and is characterized by being applied to a subject having a high level of triglyceride in blood. Hereinafter, the fat reducing agent of the present invention will be described in detail.

有効成分
本発明の脂肪低減剤は、防風通聖散エキスを有効成分として含有する。防風通聖散を構成する生薬は、「一般用漢方処方の手引き」(厚生省薬務局監修、日薬連漢方専門委員会編集、薬業時報社発行)によれば、トウキ、シャクヤク、センキュウ、サンシシ、レンギョウ、ハッカ、ショウキョウ、ケイガイ、ボウフウ、マオウ、ダイオウ、ボウショウ、ビャクジュツ、キキョウ、オウゴン、カンゾウ、セッコウ、及びカッセキである。書簡によっては、前記生薬の内、ビャクジュツを含まないもの(例えば「経験漢方処方分量集」、大塚敬節・矢数道明監集、医道の日本社発行)や、オウゴンを含まないもの(例えば「続漢方あれこれ」大阪読売新聞社編、浪速社発行)がある。また、防風通聖散の処方によっては、ボウフウの代わりにハマボウフウを含むものや、ビャクジュツの代わりにソウジュツを含むものもある。本発明で用いることができる防風通聖散エキスは、これらのいずれの防風通聖散から得られるものであってもよいが、より一層高い脂肪低減剤を得る観点から、防風通聖散がビャクジュツ及びオウゴンを含む処方であることが好ましい。
Active ingredient The fat-reducing agent of the present invention contains bofutsushosan extract as an active ingredient. According to the "Guide for General Chinese Medicine Prescription" (supervised by the Ministry of Health and Welfare, edited by the Japan Yakuren Chinese Medicine Expert Committee, published by Yakuhin Jihosha), the crude drugs that make up Bofutsushosan are: Angelica acutiloba, peony, and licorice. Sanshishi, Forsythia, Hakka, Shokyo, Schizonepeta, Siler, Maou, Daiou, Bowsho, Byakujutsu, Kikyo, Ogon, Kanzo, Sekou, and Kaseki. Depending on the letter, some of the above-mentioned crude drugs do not contain Byakujutsu (for example, "Experienced Kampo Prescription Amount Collection", Keisetsu Otsuka / Domei Yakazu, published by Japan Co., Ltd.), and those that do not contain Scutellaria baicalensis (for example, "" There is a series of Chinese medicines, edited by Osaka Yomiuri Shimbun, published by Naniwasha). In addition, depending on the prescription of Bofutsushosan, some contain Hamaboufu instead of Bowfu, and some contain Sojutsu instead of Byakujutsu. The bofutsushosan extract that can be used in the present invention may be obtained from any of these bofutsushosan, but from the viewpoint of obtaining a higher fat reducing agent, bofutsushosan is used. And a formulation containing Scutellaria baicalensis is preferable.

防風通聖散を構成する各生薬の分量は、「一般用漢方処方の手引き」(厚生省薬務局監修、日薬連漢方専門委員会編集、薬業時報社発行)、「第十七改正日本薬局方」等によれば、トウキ1.2重量部、シャクヤク1.2重量部、センキュウ1.2重量部、サンシシ1.2重量部、レンギョウ1.2重量部、ハッカ1.2重量部、ショウキョウ0.3〜1.2重量部、ケイガイ1.2重量部、ボウフウ1.2重量部又はハマボウフウ1.2重量部、マオウ1.2重量部、ダイオウ1.5重量部、ボウショウ(硫酸ナトリウム無水物換算量)0.6〜1.5重量部、ビャクジュツ2重量部、キキョウ2重量部、オウゴン2重量部、カンゾウ2重量部、セッコウ2〜3重量部、及びカッセキ3〜5重量部である。また、書簡によっては、前記分量中、1.2重量部を全て1.5重量部としているものもある(例えば「明解漢方処方」、西岡一夫、高橋真太郎共著、浪速社発行)。さらに、上記書簡に示されている各生薬の分量のうち、ショウキョウの分量を0.6〜1.5重量部としてもよい。 The amount of each crude drug that makes up Bofutsushosan is "Guide for General Chinese Medicine Prescription" (supervised by the Ministry of Health and Welfare, edited by the Japanese Pharmacopoeia Special Committee, published by Yakuhin Jihosha), "17th Amendment Japan According to the Japanese Pharmacopoeia, 1.2 parts by weight of Angelica acutiloba, 1.2 parts by weight of Shakuyaku, 1.2 parts by weight of Senkyu, 1.2 parts by weight of Sanshishi, 1.2 parts by weight of Schizonepeta, 1.2 parts by weight of schizonepeta, 0.3 to 1.2 parts by weight of Shokyo, 1.2 parts by weight of Schizonepeta, 1.2 parts by weight of Siler or 1.2 parts by weight of Glehnia, 1.2 parts by weight of Maou, 1.5 parts by weight of Daiou, Bowsho (sulfate) (Sodium anhydride equivalent) 0.6 to 1.5 parts by weight, 2 parts by weight of Byakujutsu, 2 parts by weight of Kikyo, 2 parts by weight of Angelica acutiloba, 2 parts by weight of Kanzo, 2 to 3 parts by weight of Sekko, and 3 to 5 parts by weight of Casseki Is. In addition, depending on the letter, 1.2 parts by weight are all 1.5 parts by weight in the above amount (for example, "Meikaku Chinese Medicine Prescription", co-authored by Kazuo Nishioka and Shintaro Takahashi, published by Naniwasha). Further, among the amounts of each crude drug shown in the above letter, the amount of ginger may be 0.6 to 1.5 parts by weight.

本発明で用いることができる防風通聖散エキスは、上記の生薬を混合した生薬調合物を公知の手法で抽出することによって得ることができる。例えば、生薬調合物に対して、約10〜20倍量の水を加え、80〜100℃程度で1〜3時間程度撹拌して抽出する方法が挙げられる。 The bofutsushosan extract that can be used in the present invention can be obtained by extracting a crude drug formulation containing the above crude drugs by a known method. For example, a method of adding about 10 to 20 times the amount of water to the crude drug preparation and stirring at about 80 to 100 ° C. for about 1 to 3 hours for extraction can be mentioned.

上記の生薬又は生薬調合物から抽出されたエキスの形態及び形状は特に制限されず、溶媒を含む液状又は粘稠形態(エキス液形態又は軟エキス形態)、及び乾燥形態(エキス末形態)のいずれであってもよい。これらの形態のエキスは、上記の抽出方法により得られた抽出液を、必要に応じて濃縮処理や乾燥処理に供することによって得ることができる。乾燥処理の具体的な方法としては、スプレードライ、減圧濃縮乾燥、凍結乾燥等が挙げられる。また、乾燥処理(特に、スプレードライによる乾燥処理)に供する際には、必要に応じて、抽出液にデキストリン等の賦形剤を添加してもよい。 The form and shape of the extract extracted from the above crude drug or crude drug formulation are not particularly limited, and may be either a liquid or viscous form containing a solvent (extract form or soft extract form) or a dry form (extract powder form). It may be. The extracts in these forms can be obtained by subjecting the extract obtained by the above extraction method to a concentration treatment or a drying treatment, if necessary. Specific methods of the drying treatment include spray drying, vacuum concentration drying, freeze drying and the like. Further, when subjected to a drying treatment (particularly, a drying treatment by spray drying), an excipient such as dextrin may be added to the extract, if necessary.

その他の成分
本発明の脂肪低減剤は、有効成分である上記の生薬エキスのみからなるものであってもよいし、製剤形態に応じた添加剤や基剤を含んでいてもよい。このような添加剤及び基剤としては、薬学的に許容されることを限度として特に制限されないが、例えば、賦形剤、結合剤、崩壊剤、滑沢剤、等張化剤、可塑剤、分散剤、乳化剤、溶解補助剤、湿潤化剤、安定化剤、懸濁化剤、粘着剤、コーティング剤、光沢化剤、水、油脂類、ロウ類、炭化水素類、脂肪酸類、高級アルコール類、エステル類、水溶性高分子、界面活性剤、金属石鹸、低級アルコール類、多価アルコール、pH調整剤、緩衝剤、酸化防止剤、紫外線防止剤、防腐剤、矯味剤、香料、粉体、増粘剤、色素、キレート剤等が挙げられる。これらの添加剤は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、これらの添加剤及び基剤の含有量については、使用する添加剤及び基剤の種類、脂肪低減剤の製剤形態等に応じて適宜設定される。
Other Ingredients The fat-reducing agent of the present invention may consist only of the above-mentioned crude drug extract as an active ingredient, or may contain additives and bases depending on the formulation form. Such additives and bases are not particularly limited as long as they are pharmaceutically acceptable, but for example, excipients, binders, disintegrants, lubricants, tonicity agents, plasticizers, etc. Dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, pressure-sensitive agents, coating agents, brighteners, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols , Esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, flavoring agents, fragrances, powders, Examples include thickeners, pigments, chelating agents and the like. These additives may be used alone or in combination of two or more. The contents of these additives and bases are appropriately set according to the types of additives and bases to be used, the form of the fat-reducing agent, and the like.

また、本発明の脂肪低減剤は、有効成分である上記の漢方エキスの他に、必要に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、薬学的に許容されることを限度として特に制限されないが、例えば、制酸剤、健胃剤、消化剤、整腸剤、鎮痙剤、粘膜修復剤、抗炎症剤、収れん剤、鎮吐剤、鎮咳剤、去痰剤、消炎酵素剤、鎮静催眠剤、抗ヒスタミン剤、カフェイン類、強心利尿剤、抗菌剤、血管収縮剤、血管拡張剤、局所麻酔剤、生薬エキス、ビタミン類、メントール類等が挙げられる。これらの栄養成分や薬理成分は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、これらの成分の含有量については、使用する成分の種類等に応じて適宜設定される。 In addition to the above-mentioned Chinese herbal extract, which is an active ingredient, the fat-reducing agent of the present invention may contain other nutritional components and pharmacological components, if necessary. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable, but for example, antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, and astringents. Agents, antiemetics, antitussives, sputum, anti-inflammatory enzyme agents, sedative hypnotics, antihistamines, caffeines, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, crude drug extracts, vitamins, menthol Kind and the like. These nutritional components and pharmacological components may be used alone or in combination of two or more. Further, the content of these components is appropriately set according to the type of the component to be used and the like.

製剤形態
本発明の脂肪低減剤の製剤形態については、経口投与が可能であることを限度として特に制限されないが、例えば、散剤、細粒剤、顆粒剤(ドライシロップを含む)、錠剤、丸剤、カプセル剤(軟カプセル剤、硬カプセル剤)等の固形状製剤;ゼリー剤等の半固形状製剤;液剤、懸濁剤、シロップ剤等の液状製剤が挙げられる。本発明の脂肪低減剤をこれらの製剤形態に調製するには、有効成分である上記の漢方エキス、並びに必要に応じて添加される添加剤、基剤、及び/又は薬理成分を用いて、通常の製剤化手法に従って製剤化すればよい。
Formulation form The formulation form of the fat-reducing agent of the present invention is not particularly limited as long as it can be orally administered, and for example, powders, fine granules, granules (including dry syrup), tablets, pills, and the like. Solid preparations such as capsules (soft capsules, hard capsules); semi-solid preparations such as jelly; liquid preparations such as liquids, suspensions and syrups. In order to prepare the fat-reducing agent of the present invention in these pharmaceutical forms, it is usual to use the above-mentioned Chinese herbal extract as an active ingredient and additives, bases and / or pharmacological components added as needed. It may be formulated according to the formulation method of.

用途
本発明の脂肪低減剤は、血中中性脂肪が高値の対象に対して、脂肪を低減する目的で使用される。好ましくは、本発明の脂肪低減剤は、中性脂肪を低減する目的で使用することができる。
Uses The fat-reducing agent of the present invention is used for the purpose of reducing fat in a subject having a high triglyceride level in blood. Preferably, the fat-reducing agent of the present invention can be used for the purpose of reducing triglycerides.

本発明の脂肪低減剤の対象の血中中性脂肪値としては、通常150mg/dL以上であり、好ましい形態においては、160mg/dL以上、170mg/dL以上、175mg/dL以上、200mg/dL以上、250mg/dL以上、又は300mg/dL以上であってもよい。なお、血中中性脂肪値は、空腹時の血液における中性脂肪値をいう。 The blood triglyceride level of the target of the fat reducing agent of the present invention is usually 150 mg / dL or more, and in a preferable form, 160 mg / dL or more, 170 mg / dL or more, 175 mg / dL or more, 200 mg / dL or more. , 250 mg / dL or more, or 300 mg / dL or more. The triglyceride level in blood refers to the triglyceride level in fasting blood.

また、本発明の脂肪低減剤は、乳びが認められるほど血中中性脂肪が高い対象に対しても好ましく適用される。なお、乳びは、空腹時の血液において認められるものをいう。 In addition, the fat-reducing agent of the present invention is preferably applied to a subject whose blood triglyceride is so high that chyle is observed. Chyle refers to what is found in fasting blood.

本発明の脂肪低減剤は、脂肪低減効果をより一層高める観点から、好ましくは非肥満者(具体的には、BMIが25未満である人)に適用される。また、本発明の脂肪低減剤は、脂肪低減効果をより一層高める観点から、好ましくは男性に適用される。本発明の脂肪低減剤は、脂肪低減効果を各段に高める観点から、最も好ましくは非肥満の男性に適用される。 The fat-reducing agent of the present invention is preferably applied to non-obese persons (specifically, persons having a BMI of less than 25) from the viewpoint of further enhancing the fat-reducing effect. In addition, the fat-reducing agent of the present invention is preferably applied to men from the viewpoint of further enhancing the fat-reducing effect. The fat-reducing agent of the present invention is most preferably applied to non-obese men from the viewpoint of further enhancing the fat-reducing effect.

用量・用法
本発明の脂肪低減剤は経口投与によって使用される。本発明の脂肪低減剤の用量については、有効成分の種類、投与対象者の年齢、性別、体質等に応じて適宜設定されるが、例えば、ヒト1人に対して1日当たり、脂肪低減剤の有効成分である防風通聖散エキスの量(但し、生薬由来成分の量を指す。例えば、スプレードライ等による乾燥処理で賦形剤を用いずに調製されたエキス末を用いる場合は、エキス末そのものの量を指し、スプレードライ等による乾燥処理で賦形剤等の添加物を添加した状態で調製されたエキス末を用いる場合は、エキス末から当該添加物を除いた量を指す。)で、例えば1〜10g程度、好ましくは3〜8g程度、より好ましくは4〜6g程度となる量で、1日1〜3回、好ましくは2又は3回の頻度で服用すればよい。服用タイミングについては、特に制限されず、食前、食後、又は食間のいずれであってもよいが、食前(食事の30分前)又は食間(食後2時間後)が好ましい。
Dosage and Usage The fat-reducing agent of the present invention is used by oral administration. The dose of the fat-reducing agent of the present invention is appropriately set according to the type of the active ingredient, the age, sex, constitution, etc. of the administration subject. The amount of bofutsushosan extract, which is the active ingredient (however, it refers to the amount of crude drug-derived ingredients. For example, when using an extract powder prepared by spray-drying or the like without using an excipient, the extract powder is used. Refers to the amount of the extract itself, and when using an extract powder prepared with additives such as excipients added by drying treatment such as spray drying, it refers to the amount obtained by removing the additive from the extract powder). For example, the dose may be about 1 to 10 g, preferably about 3 to 8 g, more preferably about 4 to 6 g, and may be taken 1 to 3 times a day, preferably 2 or 3 times a day. The timing of administration is not particularly limited and may be before meals, after meals, or between meals, but it is preferably before meals (30 minutes before meals) or between meals (2 hours after meals).

以下、本発明を実施例により具体的に説明するが、本発明はこれらの実施例に限定されるものではない。 Hereinafter, the present invention will be specifically described with reference to Examples, but the present invention is not limited to these Examples.

防風通聖散エキスの調製
原料生薬として、トウキ1.2(重量部、以下同じ)、シャクヤク1.2、センキュウ1.2、サンシシ1.2、レンギョウ1.2、ハッカ1.2、ショウキョウ1.2、ケイガイ1.2、ボウフウ1.2、マオウ1.2、ダイオウ1.5、硫酸ナトリウム無水物1.5、ビャクジュツ2.0、キキョウ2.0、オウゴン2.0、カンゾウ2.0、セッコウ2.0及びカッセキ3.0の割合で用い、これらを刻んだ後、水12倍重量を用いて約100℃で30分間抽出し、遠心分離して抽出液を得た。抽出液を減圧下で濃縮し、スプレードライヤーを用いて乾燥した。なお、スプレードライヤーによる乾燥は、抽出液を回転数10000rpmのアトマイザーに落下させ、150℃の空気の熱風を供給することによって行った。
As crude drugs for preparing bofutsushosan extract , Touki 1.2 (part by weight, same below), Shakuyaku 1.2, Senkyu 1.2, Sanshishi 1.2, Renkyo 1.2, Hacka 1.2, Shokyo 1.2, Keigai 1.2, Bofu 1.2, Maou 1.2, Daiou 1.5, Sodium Sulfate Anhydrous 1.5, Byakujutsu 2.0, Kikyo 2.0, Ogon 2.0, Kanzo 2. The mixture was used at a ratio of 0, Seckou 2.0 and Casseki 3.0, and after chopping these, extraction was performed at about 100 ° C. for 30 minutes using 12 times the weight of water, and the mixture was centrifuged to obtain an extract. The extract was concentrated under reduced pressure and dried using a spray dryer. The drying with a spray dryer was performed by dropping the extract onto an atomizer having a rotation speed of 10000 rpm and supplying hot air with air at 150 ° C.

試験例1
30歳〜40歳代(男性10名、女性10名)を対象とし、防風通聖散エキス錠を、1日あたり、前記調製例で調整した防風通聖散エキスの生薬由来成分の量が5.0gとなるよう、12週間、1日3回食前又は食間に1回5錠を服用させた。防風通聖散エキスの服用前及び服用後において、BMI、血中中性脂肪量(空腹時)、及び腹部脂肪面積測定に基づく内臓脂肪量の測定を行い、服用前後における内臓脂肪量の減少量を算出した。結果を表1及び表2に示す。
Test Example 1
For people in their 30s to 40s (10 males and 10 females), the amount of bofutsushosan extract tablets adjusted in the above preparation example was 5 per day. For 12 weeks, 5 tablets were taken 3 times a day before or between meals so as to be 0.0 g. Before and after taking Bofutsushosan extract, measure the amount of visceral fat based on BMI, triglyceride volume in blood (on an empty stomach), and abdominal fat area measurement, and reduce the amount of visceral fat before and after taking. Was calculated. The results are shown in Tables 1 and 2.

Figure 2021167309
Figure 2021167309

Figure 2021167309
Figure 2021167309

表1及び表2から明らかな通り、内臓脂肪量減少量の平均が、血中中性脂肪値が低い人(比較例1〜10)で−4.36gであることに対し、血中中性脂肪値が高い人(実施例1〜10)で−26.51gであることから、血中中性脂肪値が高い人において顕著な内臓脂肪減少効果が認められた。 As is clear from Tables 1 and 2, the average amount of decrease in triglyceride mass in blood is -4.36 g in people with low triglyceride level in blood (Comparative Examples 1 to 10), whereas it is neutral in blood. Since the weight was -26.51 g in those with a high fat level (Examples 1 to 10), a remarkable visceral fat reducing effect was observed in those with a high blood triglyceride level.

また、内臓脂肪量減少量の平均が、血中中性脂肪値が高く非肥満である人(実施例1〜4)で−29.125gであることに対し、血中中性脂肪値が高く肥満である人(実施例5〜10)で−24.767gであることから、非肥満の人において一層優れた内臓脂肪減少効果が認められた。 In addition, the average amount of decrease in visceral fat mass is -29.125 g in persons who are non-obese with high triglyceride level in blood (Examples 1 to 4), whereas the triglyceride level in blood is high. Since the weight was -24.767 g in obese people (Examples 5 to 10), a more excellent visceral fat reducing effect was observed in non-obese people.

さらに、内臓脂肪量減少量の平均が、血中中性脂肪値が高い男性(実施例1,2,5,6,10)で−36.82g、血中中性脂肪値が高い女性(実施例3,4,7,8,9)で−16.2gであることから、男性において一層優れた内臓脂肪減少効果が認められた。 Furthermore, the average amount of decrease in visceral fat mass was -36.82 g for men with high triglyceride levels in blood (Examples 1, 2, 5, 6, 10), and women with high triglyceride levels in blood (implementation). In Examples 3, 4, 7, 8, 9), the weight was -16.2 g, indicating that a more excellent visceral fat reducing effect was observed in men.

特に、内臓脂肪量減少量の平均が、血中中性脂肪値が高く非肥満である男性(実施例1,2)で−41.6g、血中中性脂肪値が高く非肥満である女性(実施例3,4)で−16.65g、血中中性脂肪値が高く肥満である男性(実施例5,6,10)で−33.633g、血中中性脂肪値が高く肥満である女性(実施例7,8,9)で−15.9gであることから、非肥満である男性において格別顕著な内臓脂肪減少効果が認められた。 In particular, the average amount of decrease in visceral fat mass is -41.6 g for men who are non-obese with high triglyceride levels in blood (Examples 1 and 2), and women who are non-obese with high triglyceride levels in blood. (Examples 3 and 4) -16.65 g, males with high triglyceride level in blood and obesity (Examples 5, 6 and 10) -33.633 g, high triglyceride level in blood and obese Since the weight was -15.9 g in a certain woman (Examples 7, 8 and 9), a particularly remarkable effect of reducing visceral fat was observed in a non-obese man.

試験例2
マウス(C57BL/6Jマウス、5週齢、雄)に高脂肪食(HFD32、日本クレア株式会社)を4週間自由摂食させて飼育し、乳び(空腹時)が認められなかった試験群(乳びなし群)と、乳びが認められた試験群(乳びあり群)と、コントロール群(乳びが認められなかったマウスと乳びが認められたとの両方を同数含む)と、に分けた。試験群には、前記の高脂肪食に防風通聖散エキスを2重量%となるように配合した飼料を1ヶ月間自由給餌した。コントロール群には、防風通聖散エキスを配合していない高脂肪食を1ヶ月間自由給餌した。1ヶ月の飼育後、腹部脂肪面積測定を行い、内臓脂肪量を算出した。さらに、コントロール群における内臓脂肪量の平均を100%とし、各試験群の内臓脂肪量の平均の比率(%)を算出した。結果を表3に示す。
Test Example 2
A test group in which mice (C57BL / 6J mice, 5 weeks old, male) were fed a high-fat diet (HFD32, Japan Claire Co., Ltd.) for 4 weeks and chyle (fasting) was not observed. Chyle-free group), test group with chyle (chyle group), and control group (including the same number of mice without chyle and chyle). divided. The test group was free-fed for one month with a feed containing the above-mentioned high-fat diet containing Bofutsushosan extract in an amount of 2% by weight. The control group was free-fed for one month with a high-fat diet containing no bofutsushosan extract. After 1 month of breeding, the abdominal fat area was measured and the visceral fat mass was calculated. Further, the average of the visceral fat mass in the control group was set to 100%, and the ratio (%) of the average visceral fat mass in each test group was calculated. The results are shown in Table 3.

Figure 2021167309
Figure 2021167309

表3から明らかなとおり、乳びあり群では防風通聖散の服用による内臓脂肪量の減少効果が、乳びなし群に比べて顕著に優れていた。 As is clear from Table 3, in the group with chyle, the effect of reducing the amount of visceral fat by taking Bofutsushosan was significantly superior to that in the group without chyle.

Claims (6)

防風通聖散エキスを含有し、血中中性脂肪が高値の対象に適用される、脂肪低減剤。 A fat-reducing agent containing Bofutsushosan extract and applied to subjects with high triglyceride levels in blood. 前記対象の血中中性脂肪値が150mg/dL以上である、請求項1に記載の脂肪低減剤。 The fat reducing agent according to claim 1, wherein the triglyceride level in the blood of the subject is 150 mg / dL or more. 前記対象が、乳びが認められる対象である、請求項1又は2に記載の脂肪低減剤。 The fat-reducing agent according to claim 1 or 2, wherein the subject is a subject in which chyle is observed. 前記対象が非肥満者である、請求項1〜3のいずれかに記載の脂肪低減剤。 The fat-reducing agent according to any one of claims 1 to 3, wherein the subject is a non-obese person. 前記対象が男性である、請求項1〜4のいずれかに記載の脂肪低減剤。 The fat-reducing agent according to any one of claims 1 to 4, wherein the subject is a man. 内臓脂肪を低減するために用いられる、請求項1〜5のいずれかに記載の脂肪低減剤。 The fat reducing agent according to any one of claims 1 to 5, which is used for reducing visceral fat.
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