JP2008501681A - Composition for prevention and treatment of urinary incontinence - Google Patents

Composition for prevention and treatment of urinary incontinence Download PDF

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JP2008501681A
JP2008501681A JP2007514883A JP2007514883A JP2008501681A JP 2008501681 A JP2008501681 A JP 2008501681A JP 2007514883 A JP2007514883 A JP 2007514883A JP 2007514883 A JP2007514883 A JP 2007514883A JP 2008501681 A JP2008501681 A JP 2008501681A
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urinary incontinence
composition
pumpkin seed
extract
isoflavone
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JP4621250B2 (en
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ジン オー
ミュン−ファン パク
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Ahn Gook Pharmaceutical Co Ltd
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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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • 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
    • A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus

Abstract

本発明は、カボチャ種油、又はカボチャ種抽出物、覆盆子抽出物及び大豆イソフラボンを含むことを特徴とする組成物に関するもので、本発明の組成物は、尿失禁患者の尿失禁頻度と昼間尿回数を著しく減少させる効果及び尿道をしめる圧力の増加、すなわち、尿道括約筋の調節能力の向上効果があって、尿失禁の治療効果及び予防効果がある。また、上記組成物は、安全な物質として広く使用されており、急性毒性がないので安全に服用することができる尿失禁の治療及び予防のための医薬品、及び機能性食品を提供することができる。
【選択図】なしThe present invention relates to a composition comprising pumpkin seed oil or pumpkin seed extract, bon bonsai extract and soy isoflavone, and the composition of the present invention relates to urinary incontinence frequency and daytime of urinary incontinence patients. It has the effect of significantly reducing the frequency of urine and the increase in pressure to tighten the urethra, that is, the effect of improving the ability to adjust the urethral sphincter, and has the effect of treating and preventing urinary incontinence. In addition, the composition is widely used as a safe substance, and can provide a pharmaceutical and functional food for treatment and prevention of urinary incontinence that can be safely taken because it has no acute toxicity. .
[Selection figure] None

Description

本発明は、尿失禁の予防及び治療に効果を発揮する、副作用のごくわずかな医薬用及び機能性食品として使用され得る新しい組成物に関する。より詳細には、カボチャ種油、又はカボチャ種抽出物、覆盆子抽出物及び大豆イソフラボンを最適の割合で混合した組成物を特徴とする。   The present invention relates to a new composition that can be used as a medicinal and functional food with few side effects, which is effective in preventing and treating urinary incontinence. More particularly, it is characterized by a composition in which pumpkin seed oil or pumpkin seed extract, bonsai extract and soy isoflavone are mixed in an optimum ratio.

尿失禁は、自分の意志とは無関係に尿が尿道の外に流れる症状であって、膀胱内部の圧力が尿道の抵抗より高ければ、その圧力の差により発生する。   Urinary incontinence is a symptom in which urine flows out of the urethra regardless of one's will, and is caused by the pressure difference if the pressure inside the bladder is higher than the resistance of the urethra.

尿失禁は、一般的に閉経期以後の女性において、骨盤筋が弛んで膀胱が下垂したり、尿道括約筋が衰えたりして、膀胱調節能力が低下することにより発生すると知られている。老年期の女性にはより多く発生して３２％以上が患者であり、出産経験のある女性は出産により尿失禁の病因が増加して２人のうち一人が尿失禁の症状を見せている。   Urinary incontinence is generally known to occur in post-menopausal women when the pelvic muscles loosen and the bladder droops, or the urethral sphincter muscles weaken and the ability to adjust the bladder decreases. More than 32% of older women are patients, and women who have given birth have increased the etiology of urinary incontinence due to childbirth, and one of the two has symptoms of urinary incontinence.

尿失禁の症状がひどいと悪臭、皮膚疾患を伴い、精神的に不安定な状態を誘発して活動が制限されるので社会的に問題となり、経済的にも大きい損失をもたらす憂慮がある。問題は、自分の症状が尿失禁であると認識しないことや、又は恥で治療を避けることである。実質的に治療を受ける人の割合は１０％未満であると知られている。   The symptoms of urinary incontinence are severe, accompanied by foul odors and skin diseases. It induces mental instability and restricts its activities, so there is a concern that it causes social problems and causes great economic losses. The problem is not recognizing that your symptoms are urinary incontinence or avoiding treatment with shame. It is known that the percentage of people who receive substantial treatment is less than 10%.

尿失禁の種類は、急にお腹に力が入って腹圧の上昇により尿が排出される腹圧性尿失禁、膀胱のひどい刺激に耐えられずに尿が排出される感覚性の切迫性尿失禁及び、膀胱筋肉の鋭敏化で尿が少したまるだけでも尿を漏らすことになる運動性の切迫性尿失禁、下半身麻痺のうち強直性麻痺患者に現われる反射性尿失禁、下半身麻痺のうち弛緩性麻痺患者に現われる溢流性尿失禁、認知症患者によくある心因性尿失禁がある。そのうち、腹圧性尿失禁が５１％から７７％に増加し、切迫性尿失禁が１０％から１２％で安定的であり、その他、複合性尿失禁が３９％から１１％に減少する傾向がある（Ｊ．Ｃｌｉｎ．Ｅｐｉｄｅｍｉｏｌ．，４８，３３９（１９９５））。   Types of urinary incontinence include stress urinary incontinence in which urine is discharged suddenly due to abdominal pressure and urine is discharged, sensory urge incontinence in which urine is discharged without being able to withstand severe irritation And, urinary incontinence of motility that leaks urine even if a little urine accumulates due to sensitization of bladder muscles, reflex urinary incontinence that appears in patients with ankylosing paralysis among lower body paralysis, flaccid paralysis among lower body paralysis There are overflow urinary incontinence that appears in patients and psychogenic urinary incontinence that is common in patients with dementia. Among them, stress urinary incontinence increases from 51% to 77%, urge urinary incontinence is stable from 10% to 12%, and complex urinary incontinence tends to decrease from 39% to 11% (J. Clin. Epideiol., 48, 339 (1995)).

治療法としては、薬物療法、骨盤筋肉増強法、手術があるが、手術は費用が多くかかるし、骨盤筋肉増強法は長期間、持続的な運動が必要である。薬物療法により腹圧性尿失禁を治療するために、尿道括約筋を収縮させるためのアルファアドレナリン性の薬物であるフェニルプロパノールアミンが使用されたが、心臓に対する副作用で使用が禁止されており、切迫性尿失禁の治療のために膀胱筋の緊張を弛緩させる目的で抗コリン性の薬物を用いる。これらの薬物のうち、テロディリン（Ｔｅｒｏｄｉｌｉｎ）は心臓に対する深刻な副作用により使用が中止され（Ｅｕｒ．Ｊ．Ｃｌｉｎ．Ｐｈａｒｍａｃｏｌ．，４２，５７７（１９９２））、エメプロニウムブロマイド（Ｅｍｅｐｒｏｎｉｕｍ ｂｒｏｍｉｄｅ）が残っているが無作為二重盲検法による臨床結果においてよい結果を見せなかった。その他、トルテロジン（Ｔｏｌｔｅｒｏｄｉｎ）、プロピぺリン（Ｐｒｏｐｉｐｅｒｉｎｅ）、フラボキサート（Ｆｌａｖｏｘａｔｅ）などがある。しかし、薬物治療時、大部分は副作用が深刻であったり、又は效能が微弱であるので、副作用が無く症状が好転され得る新しい薬物の開発が切実に要請されている。   Treatment includes drug therapy, pelvic muscle augmentation, and surgery, but surgery is expensive and pelvic muscle augmentation requires long-term, continuous exercise. Phenylpropanolamine, an alpha-adrenergic drug for constricting the urethral sphincter, was used to treat stress urinary incontinence by medication, but it was banned because of side effects on the heart, and urge urine Anticholinergic drugs are used to relax bladder muscle tone to treat incontinence. Among these drugs, Terodilin has been discontinued due to serious side effects on the heart (Eur. J. Clin. Pharmacol., 42, 577 (1992)), and emepromonium bromide (Emepronium bromide) remains. However, the results of random double-blind clinical results were not good. In addition, there are tolterodine, propiperine, flavoxate and the like. However, since most of the side effects are serious or the efficacy is weak at the time of drug treatment, there is an urgent need for the development of new drugs that can improve symptoms without side effects.

上記のように、副作用がごくわずかで、十分な治療効果を示す尿失禁治療剤の開発研究において、広く用いられている安全性の既に確保されたカボチャ種油やカボチャ種抽出物、覆盆子抽出物、及び大豆イソフラボンを複合処方した新規な組成物が尿失禁の治療効果において確実に優れた効果を奏することを見出し、本発明を完成するに至った。   As described above, pumpkin seed oil, pumpkin seed extract, and bonsai extract that have been widely used in the development of urinary incontinence treatments with minimal side effects and sufficient therapeutic effects. And a novel composition in which soy isoflavones are combined and compounded have been found to surely have excellent effects in treating urinary incontinence, and the present invention has been completed.

本発明は、尿失禁を治療する効果に優れ、毒性がごくわずかで安全な医薬品及び機能性食品のための組成物を提供する。   The present invention provides a composition for pharmaceuticals and functional foods that has an excellent effect of treating urinary incontinence, has minimal toxicity, and is safe.

すなわち、本発明の要旨は、カボチャ種油又はカボチャ種抽出物、覆盆子抽出物、及び大豆イソフラボンを含む組成物で構成されており、より詳細には、カボチャ種油、又はカボチャ種抽出物の１００質量部に対して覆盆子抽出物は２０ないし８０質量部、大豆イソフラボンは５ないし３０質量部を混合して用いることを特徴とする。   That is, the gist of the present invention is composed of a composition containing pumpkin seed oil or pumpkin seed extract, bon bonsai extract, and soybean isoflavone, and more specifically, pumpkin seed oil or pumpkin seed extract. The bonsai extract is used in an amount of 20 to 80 parts by mass and soy isoflavone is used in an amount of 5 to 30 parts by mass with respect to 100 parts by mass.

カボチャ種の乾燥エキスは、前立腺肥大症の治療効果があり（Ｆｏｒｓｃｈ Ｋｏｍｐｌｅｍｅｎｔａｒｍｅｄ Ｋｌａｓｓ Ｎａｔｕｒｈｅｉｋｄ ７，２００（２０００））、女性の排尿障害にも効果があると知られている（Ｋｍｍｉｓｓｉｏｎ Ｅ．ｍｏｎｏｇｒａｐｈＮｏ．１１／１９９１．０１．１７）。   A dried extract of pumpkin species has a therapeutic effect on benign prostatic hyperplasia (Forsch Komplementarmed Klass Natureheikd 7, 200 (2000)) and is also known to be effective in dysuria of women (Kmmission E. monograph No. 11 / 1991.01.17).

カボチャ種油には、ククルビタシン、リグナン、植物ステロール、トコフェロール、不飽和脂肪酸、亜鉛、セレニウムなどが含有されていて、植物ステロールはテストステロン（Ｔｅｓｔｏｓｔｅｒｏｎ）からジヒドロテストステロン（Ｄｉｈｙｄｒｏｔｅｓｔｏｓｔｅｒｏｎ）への転換を抑制して前立腺の大きさを減少させる効果があると報告されていた。   Pumpkin seed oil contains cucurbitacin, lignan, plant sterol, tocopherol, unsaturated fatty acid, zinc, selenium, etc. The plant sterol suppresses the conversion from testosterone to dihydrotestosterone, and the prostate It has been reported that it has the effect of reducing the size of.

大豆イソフラボンは、植物性女性ホルモンと呼ばれ、体内で女性ホルモンのような効果を示すが、女性ホルモンが有する副作用はなく、広範囲に用いられている。更年期症状を緩和させ、癌発生を減少させるし、抗酸化作用、骨多孔症の治療効果なども報告されている。   Soy isoflavone is called a plant female hormone, and shows an effect similar to female hormone in the body, but has no side effects and is widely used. It has also been reported to relieve menopausal symptoms, reduce cancer incidence, antioxidant effects, and osteoporosis treatment effects.

覆盆子は、漢方で頻尿、遺尿症、勃起不全に効果を示し、解熱作用、強心作用、利尿作用が報告されている。   Buddhist bonsai is effective in Chinese medicine for frequent urination, enuresis, and erectile dysfunction, and has reported antipyretic, cardiotonic and diuretic effects.

本発明に用いられるカボチャ種油は、カボチャ種を圧搾したり、加熱しながら圧搾して製造したものを用いる。カボチャ種抽出物は、カボチャ種を含水アルコールで抽出して濃縮したものや、粉末にしたものを用いる。覆盆子抽出物は水で加熱したり、含水エチルアルコールで加熱して抽出した抽出物や濃縮して粉末化したものを用いるが、濃縮割合は通常、３：１以上のものを用いる。   As the pumpkin seed oil used in the present invention, one produced by squeezing pumpkin seed or squeezing while heating is used. As the pumpkin seed extract, a pumpkin seed extracted with water-containing alcohol and concentrated, or powdered is used. The cover bonsai extract is heated with water or extracted with water-containing ethyl alcohol or concentrated and powdered, and the concentration ratio is usually 3: 1 or more.

大豆イソフラボンは、市販のものを用いて、イソフラボンの含量が１０ないし５０％であるものを用いる。   As the soybean isoflavone, a commercially available product having an isoflavone content of 10 to 50% is used.

本発明の組成物は、医薬品、又は機能性健康食品として使用され得るが、医薬品、又は機能性食品に適用するための通常の剤形化方法を多様に適用することができる。例えば、経口的に服用可能な製剤に通常用いられる添加剤、乳化剤、滑沢剤、粘着剤、甘味剤、芳香剤、ビタミンなどを添加して軟質カプセル剤、丸剤、懸濁剤、顆粒剤、錠剤、液剤などを製造することができる。   The composition of the present invention can be used as a pharmaceutical product or a functional health food, but various conventional dosage forms for application to a pharmaceutical product or functional food can be applied. For example, soft capsules, pills, suspensions, granules by adding additives, emulsifiers, lubricants, adhesives, sweeteners, fragrances, vitamins, etc., which are commonly used for orally ingestible preparations Tablets, liquids and the like can be manufactured.

本発明の組成物は、大人基準で、２５００ｍｇから７５００ｍｇを２又は３回に分けて服用することが好ましい。   The composition of the present invention is preferably taken in an amount of 2500 to 7500 mg divided into 2 or 3 times on an adult basis.

以下、本発明を次の実施例に基づいてより詳しく説明するが、本発明がここに限定されるものではない。   EXAMPLES Hereinafter, although this invention is demonstrated in detail based on the following Example, this invention is not limited here.

＜実施例１：軟質カプセル剤（１）＞
カボチャ種油６８２０ｇ、覆盆子抽出物の粉末（３：１）２９２０ｇ、大豆イソフラボン（３０％）６８２ｇ、レシチン２８８ｇ、黄蝋２９０ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして５５０ｍｇずつカプセルを製造した。 <Example 1: Soft capsule (1)>
6820 g of pumpkin seed oil, 2920 g of bonsai extract powder (3: 1), 682 g of soy isoflavone (30%), 288 g of lecithin and 290 g of yellow wax were mixed well, and the gelatin soft capsule was based on the conventional soft capsule manufacturing method. Capsules were manufactured at 550 mg each.

＜実施例２：軟質カプセル剤（２）＞
カボチャ種抽出物３４１０ｇ、覆盆子抽出物の粉末（３：１）１４６０ｇ、大豆イソフラボン（イソフラボン３０％）３４１ｇ、ビタミンＢ６塩酸塩１２ｇ、ビタミンＢ１２ ０．２ｇ、葉酸０．４ｇ、レシチン１０４．４ｇ、黄蝋１１４ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして５５０ｍｇずつカプセルを製造した。 <Example 2: Soft capsule (2)>
3410 g of pumpkin seed extract, 1460 g of powdered bonsai extract (3: 1), 341 g of soy isoflavone (isoflavone 30%), 12 g of vitamin B6 hydrochloride, 0.2 g of vitamin B12, 0.4 g of folic acid, 104.4 g of lecithin, 114 g of yellow wax was mixed well, and 550 mg of capsules were manufactured using gelatin soft capsules as a base material by a conventional soft capsule manufacturing method.

＜実施例３：軟質カプセル剤（３）＞
大豆油５５００ｇ、カボチャ種抽出物３４１０ｇ、覆盆子抽出物の粉末（３：１）１４６０ｇ、大豆イソフラボン（イソフラボン３０％）３４１ｇ、レシチン２８８ｇ、黄蝋２９０ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして１１００ｍｇずつカプセルを製造した。 <Example 3: Soft capsule (3)>
5500 g of soybean oil, 3410 g of pumpkin seed extract, 1460 g of powdered bonsai extract (3: 1), 341 g of soy isoflavone (isoflavone 30%), 288 g of lecithin and 290 g of yellow wax are mixed well, and a normal soft capsule manufacturing method Thus, 1100 mg of capsules were produced using gelatin soft capsule as a base material.

＜実施例４：軟質カプセル剤（４）＞
カボチャ種油１０００ｇ、覆盆子抽出物の粉末（３：１）２００ｇ、大豆イソフラボン（イソフラボン１０％）５０ｇ、黄蝋２５ｇ、レシチン２５ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして３５０ｍｇずつカプセルを製造した。 <Example 4: Soft capsule (4)>
Mix well with 1000g of pumpkin seed oil, 200g of powdered bonsai extract (3: 1), 50g of soy isoflavone (isoflavone 10%), 25g of yellow wax and 25g of lecithin. Capsules were manufactured at 350 mg each as a base material.

＜実施例５：軟質カプセル剤（５）＞
カボチャ種油１０００ｇ、覆盆子抽出物の粉末（３：１）８００ｇ、大豆イソフラボン（イソフラボン１０％）５０ｇ、黄蝋２５ｇ、レシチン２５ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして３５０ｍｇずつカプセルを製造した。 <Example 5: Soft capsule (5)>
Mix well with 1000g of pumpkin seed oil, 800g of powdered bonsai extract (3: 1), 50g of soy isoflavone (isoflavone 10%), 25g of yellow wax and 25g of lecithin. Capsules were manufactured at 350 mg each as a base material.

＜実施例６：軟質カプセル剤（６）＞
カボチャ種油１０００ｇ、覆盆子抽出物の粉末（３：１）２００ｇ、大豆イソフラボン（イソフラボン１０％）３００ｇ、黄蝋２５ｇ、レシチン２５ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして３５０ｍｇずつカプセルを製造した。 <Example 6: Soft capsule (6)>
Gelatin soft capsules were prepared by mixing well with 1000 g of pumpkin seed oil, 200 g of powdered bonsai extract (3: 1), 300 g of soy isoflavone (isoflavone 10%), 25 g of yellow wax and 25 g of lecithin. Capsules were manufactured at 350 mg each as a base material.

＜実施例６：軟質カプセル剤（７）＞
カボチャ種油１０００ｇ、覆盆子抽出物の粉末（３：１）７８０ｇ、大豆イソフラボン（イソフラボン１０％）２８０ｇ、黄蝋２５ｇ、レシチン２５ｇをよく混合して通常の軟質カプセルの製造工法によりゼラチン軟質カプセルを基材にして３５０ｍｇずつカプセルを製造した。 <Example 6: Soft capsule (7)>
Mix well with 1000g of pumpkin seed oil, 780g of powdered bonsai extract (3: 1), 280g of soy isoflavone (isoflavone 10%), 25g of yellow wax and 25g of lecithin. Capsules were manufactured at 350 mg each as a base material.

＜実施例７：丸剤＞
カボチャ種油２００ｇ、覆盆子抽出物の粉末（３：１）１００ｇ、大豆イソフラボン（イソフラボン３０％）４５ｇ、結晶性セルロース６００ｇ、トウモロコシ澱粉２００ｇをよく混合して通常の丸剤の製造工程により３５０ｍｇの丸剤を製造した。 <Example 7: Pills>
200 g of pumpkin seed oil, 100 g of bonsai extract powder (3: 1), 45 g of soy isoflavone (isoflavone 30%), 600 g of crystalline cellulose and 200 g of corn starch were mixed well and 350 mg was obtained by a normal pill manufacturing process. Pills were produced.

＜実施例８：懸濁剤＞
カボチャ種油１００ｇ、覆盆子抽出物の粉末（３：１）６０ｇ、大豆イソフラボン（イソフラボン３０％）６ｇを、カルボキシメチルセルロースソジウム１０ｇ、Ｔｗｅｅｎ−６０ ５ｇを水７００ｍｌに溶かした溶液に加えて超音波発生器にて分散させ水をさらに加えて１０００ｍｌにした懸濁液を製造した。 <Example 8: Suspending agent>
100 g of pumpkin seed oil, 60 g of powdered bonsai extract (3: 1), 6 g of soy isoflavone (isoflavone 30%) are added to a solution of 10 g of carboxymethylcellulose sodium and 5 g of Tween-60 in 700 ml of water and subjected to ultrasound. A suspension was prepared by dispersing in a generator and adding water to 1000 ml.

＜実施例９：錠剤＞
カボチャ種油１００ｇ、覆盆子抽出物の粉末（３：１）７５ｇ、大豆イソフラボン（イソフラボン４５％）１５ｇ、結晶性セルロース１０００ｇ、ステアリン酸マグネシウム１０ｇをよく混合して通常の錠剤の製造工程により５００ｍｇの錠剤を製造した。 <Example 9: Tablet>
100 g of pumpkin seed oil, 75 g of bonsai extract powder (3: 1), 15 g of soy isoflavone (isoflavone 45%), 1000 g of crystalline cellulose, and 10 g of magnesium stearate are mixed well, and 500 mg of the usual tablet manufacturing process is performed. Tablets were manufactured.

＜比較例１＞
カボチャ種油３４１０ｇ、大豆イソフラボン（イソフラボン３０％）３４１ｇ、デキストリン１４６０ｇ、レシチン１４４ｇ、黄蝋１４５ｇをよく混合して通常の軟質カプセルの製造工程により５５０ｍｇの軟質カプセルを製造した。 <Comparative Example 1>
550 mg of soft capsules were produced by well mixing 3410 g of pumpkin seed oil, 341 g of soy isoflavone (isoflavone 30%), 1460 g of dextrin, 144 g of lecithin, and 145 g of yellow wax by a normal soft capsule production process.

＜比較例２＞
大豆油３４１０ｇ、覆盆子抽出物の粉末（３：１）１４６０ｇ、デキストリン３４１ｇ、レシチン１４４ｇ、黄蝋１４５ｇをよく混合して通常の軟質カプセルの製造工程により５５０ｍｇの軟質カプセルを製造した。 <Comparative example 2>
550 mg of soft capsules were manufactured by a normal soft capsule manufacturing process by mixing 3410 g of soybean oil, 1460 g of powdered bonsai extract (3: 1), 341 g of dextrin, 144 g of lecithin and 145 g of yellow wax.

＜比較例３＞
大豆油３４１０ｇ、デキストリン１４６０ｇ、大豆イソフラボン（イソフラボン３０％）３４１ｇ、レシチン１４４ｇ、黄蝋１４５ｇをよく混合して通常の軟質カプセルの製造工程により５５０ｍｇの軟質カプセルを製造した。 <Comparative Example 3>
550 mg of soft capsules were manufactured through a normal soft capsule manufacturing process by thoroughly mixing 3410 g of soybean oil, 1460 g of dextrin, 341 g of soy isoflavone (isoflavone 30%), 144 g of lecithin, and 145 g of yellow wax.

＜参考例１：カボチャ種抽出物の製造＞
カボチャ種３ｋｇを粉碎して７０％のエチルアルコールを３０Ｌずつ２回、３時間ずつ加熱抽出した後冷却して濾過した濾液を減圧濃縮してカボチャ種抽出物２８０ｇを得た。 <Reference Example 1: Production of pumpkin seed extract>
3 kg of pumpkin seeds were pulverized, and 30% of 70% ethyl alcohol was heated and extracted twice for 3 hours, cooled, filtered, and concentrated under reduced pressure to obtain 280 g of pumpkin seed extract.

＜実験例１：尿失禁及び頻尿に対する治療効果＞
５２歳から７０歳までの女性のうち、尿失禁の回数が週７回−９回（Ｇｒａｄｅ ＩＩＩ）、昼間排尿回数が１０回−１２回である尿失禁患者５０人を無作為で五つの群に分けて、実施例１、３及び比較例１、２、３から製造した軟質カプセルを１日２回（朝、夕方）、１回３カプセルずつ６週間服用させた後に尿失禁の頻度、昼間排尿回数を測定して服用前と比較した。 <Experimental example 1: therapeutic effect on urinary incontinence and frequent urination>
Among women aged 52 to 70 years, 50 groups of urinary incontinence who are 7-9 times a week (Grade III) and 10-12 times of urinary urination are randomized into 5 groups. The frequency of urinary incontinence after the soft capsules produced from Examples 1 and 3 and Comparative Examples 1, 2 and 3 were taken twice a day (morning and evening), 3 capsules each time for 6 weeks, daytime The number of urinations was measured and compared with before taking.

表１に示したように、「好転」以上を有効であると判断するとすれば、覆盆子抽出物（比較例２）と大豆イソフラボン（比較例３）の場合は尿失禁の治療効果は微々たるものであったが、カボチャ種油とイソフラボン（比較例１）は有効率４０％を示し、三つの成分を混合した本発明の組成物である実施例１及び実施例３の組成物においては著しく増加して有効率９０％を示した。

Figure 2008501681
Figure 2008501681
 As shown in Table 1, if it is judged that “improvement” or more is effective, the bonin extract (Comparative Example 2) and soybean isoflavone (Comparative Example 3) have a slight therapeutic effect on urinary incontinence. However, the pumpkin seed oil and isoflavone (Comparative Example 1) showed an effective rate of 40%, and the compositions of Example 1 and Example 3 which are the compositions of the present invention in which the three components were mixed were remarkably different. The effective rate increased to 90%.
Figure 2008501681
Figure 2008501681

表２に示したように「好転」以上を有効であると判断する場合、覆盆子抽出物（比較例２）と大豆イソフラボン（比較例３）では、昼間頻尿の治療効果が微々たるものであったが、カボチャ種油と大豆イソフラボン（比較例１）では有効率４０％を示し、本発明の組成物である実施例１及び実施例３では三つの成分を混合することで著しく増加された有効率８０％を示した。   As shown in Table 2, when it is judged that “improvement” or more is effective, the bonbon extract (Comparative Example 2) and the soybean isoflavone (Comparative Example 3) have a slight therapeutic effect on daytime frequent urination. However, the pumpkin seed oil and soybean isoflavone (Comparative Example 1) showed an effective rate of 40%, and the compositions of the present invention, Example 1 and Example 3, were significantly increased by mixing the three components. The effective rate was 80%.

＜実験例２：尿道をしめる圧力の増強効果＞
３．５ｋｇ前後の雌ウサギ３０匹を５匹ずつ６群に分けて、カボチャ種油１０２０ｇ、覆盆子抽出物の粉末（３：１）４３８ｇ、大豆イソフラボン（イソフラボン３０％）１０２ｇの混合物（本発明の組成物１）、カボチャ種抽出物１０２０ｇと大豆イソフラボン（イソフラボン３０％）１０２ｇの混合物、覆盆子抽出物の粉末（３：１）４３８ｇと大豆イソフラボン（イソフラボン３０％）の混合物（本発明の組成物２）、カボチャ種油１０２０ｇと大豆イソフラボン（イソフラボン３０％）１０２ｇの混合物、覆盆子抽出物の粉末（３：１）、大豆イソフラボン（イソフラボン３０％）をそれぞれ２％Ｔｗｅｅｎ−８０（ポリオキシエチレンソルビタンモノ−オレイト）水溶液に分散させたものを、ゾンデ（Ｓｏｎｄｅ）を用いて一日２回（朝、夕方）経口投与で３０日間投与して、マイクロカテーテル（Ｇａｅｌｔｅｃ Ｌｔｄ．製品）を用いて尿道をしめる圧力の最大値を測定して試料の投与前に測定した数値と比べて、変化した値の平均百分率を表３に示した。 <Experimental example 2: Effect of increasing pressure to tighten urethra>
30 female rabbits weighing about 3.5 kg were divided into 6 groups of 5 each, and a mixture of pumpkin seed oil 1020 g, bonbon extract powder (3: 1) 438 g, soybean isoflavone (isoflavone 30%) 102 g (invention) 1), a mixture of 1020 g of pumpkin seed extract and 102 g of soy isoflavone (isoflavone 30%), a mixture of 438 g of powdered bonsai extract (3: 1) and soy isoflavone (isoflavone 30%) (composition of the present invention) 2), a mixture of 1020 g of pumpkin seed oil and 102 g of soy isoflavone (isoflavone 30%), powder of dried bonsai extract (3: 1), soy isoflavone (isoflavone 30%), 2% Tween-80 (polyoxyethylene) Sorbitan mono-oleate) dispersed in an aqueous solution using a sonde 2 times a day (Morning, evening) Orally administered for 30 days, the maximum value of pressure squeezing the urethra was measured using a microcatheter (Gaeltec Ltd. product) and changed compared to the value measured before administration of the sample The average percentage of values is shown in Table 3.

表３のように、兎の尿道をしめる圧力に対する効果は、覆盆子と大豆イソフラボンを投与した群では効果が充分ではなかったが、カボチャ種油と大豆イソフラボンの混合物を投与した群では平均１６．６％増加した。本発明の組成物１では用量依存的に増加し、高用量投与群は３２．６％、低用量投与群は２４．８％、本発明の組成物２は３２．２％の著しい増強効果を示した。

Figure 2008501681
As shown in Table 3, the effect of pressure on the urethra of the vagina was not sufficient in the group administered with the bon bonsai and soy isoflavone, but averaged 16 in the group administered with the mixture of pumpkin seed oil and soy isoflavone. 6% increase. The composition 1 of the present invention increases in a dose-dependent manner, with a significant enhancement effect of 32.6% in the high dose group, 24.8% in the low dose group, and 32.2% in the composition 2 of the present invention. Indicated.
Figure 2008501681

＜実験例３：急性毒性＞
体重２３ｇのＩＣＲ系ネズミ４０匹を２群に分け、実験例２より製造した本発明の組成物１及び本発明の組成物２をそれぞれ５０００ｍｇ／ｋｇずつ１日１回、７日間、経口投与した。投与後、２週間観察したが死亡したネズミはなかった。 <Experimental example 3: Acute toxicity>
Forty ICR rats weighing 23 g were divided into two groups, and the composition 1 of the present invention and the composition 2 of the present invention prepared from Experimental Example 2 were orally administered once a day for 7 days at 5000 mg / kg, respectively. . After administration, the mice were observed for 2 weeks, but no mice died.

本発明によれば、カボチャ種油、又はカボチャ種抽出物、覆盆子抽出物及び大豆イソフラボンで混合された組成物は、尿失禁患者の尿失禁頻度と昼間尿回数を著しく減少させる効果があるので、尿失禁治療剤として用いることができる。動物実験で尿道をしめる圧力の増加、すなわち、尿道括約筋の調節能力の増加が観察されるので、尿失禁治療効果の以外にも尿失禁の予防効果がある。また、上記成分は広く用いられている安全な素材であって副作用のごくわずかなものであると判明されたので、安全に服用することができる尿失禁治療及び予防のための医薬品及び機能性食品を提供することができて医薬分野及び機能性食品分野において非常に有用な発明である。   According to the present invention, the composition mixed with pumpkin seed oil or pumpkin seed extract, bonsai extract and soy isoflavone has the effect of significantly reducing the frequency of urinary incontinence and the number of daytime urine in urinary incontinence patients. It can be used as a therapeutic agent for urinary incontinence. In animal experiments, an increase in pressure to tighten the urethra, that is, an increase in the ability to regulate the urethral sphincter is observed, so that it has a preventive effect on urinary incontinence in addition to the therapeutic effect on urinary incontinence. In addition, since the above ingredients were found to be widely used and safe materials with few side effects, they can be safely taken as urinary incontinence medicines and functional foods It is a very useful invention in the pharmaceutical field and functional food field.

Claims (4)

カボチャ種油、又はカボチャ種抽出物、覆盆子抽出物、及び大豆イソフラボンを有効成分として含む尿失禁予防又は治療用組成物。   A composition for preventing or treating urinary incontinence comprising pumpkin seed oil, or a pumpkin seed extract, a bonsai extract, and soy isoflavone as active ingredients. カボチャ種油、又はカボチャ種抽出物１００質量部に対し覆盆子抽出物が２０ないし８０質量部、大豆イソフラボンが５ないし３０質量部の割合で混合されることを特徴とする請求項１に記載の尿失禁予防又は治療用組成物。   The bonsai extract is mixed in a ratio of 20 to 80 parts by weight and soy isoflavone in a ratio of 5 to 30 parts by weight with respect to 100 parts by weight of the pumpkin seed oil or the pumpkin seed extract. A composition for preventing or treating urinary incontinence. 前記組成物は、軟質カプセル剤、丸剤、懸濁液、顆粒剤、錠剤、又は液剤の形態に製造されることを特徴とする請求項１又は２に記載の尿失禁予防又は治療用組成物。   The composition for preventing or treating urinary incontinence according to claim 1 or 2, wherein the composition is produced in the form of a soft capsule, pill, suspension, granule, tablet, or liquid. . 前記組成物は、添加剤、乳化剤、滑沢剤、粘着剤、甘味剤、芳香剤及びビタミンの中の少なくとも一つを添加することを特徴とする請求項１又は２に記載の尿失禁予防又は治療用組成物。   The urinary incontinence prevention according to claim 1 or 2, wherein the composition contains at least one of an additive, an emulsifier, a lubricant, an adhesive, a sweetener, a fragrance, and a vitamin. Therapeutic composition.
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JP2010088367A (en) * 2008-10-09 2010-04-22 S Net:Kk Livestock feed
JP2017137290A (en) * 2016-02-01 2017-08-10 株式会社日本健康食品研究所 5α-REDUCTASE INHIBITOR AND COMPOSITION FOR TREATING/PREVENTING URINARY SYSTEM DISEASE, AND METHOD FOR PRODUCING THE SAME

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