JP2021104956A - Agent for preventing or improving onset of premenstrual syndrome - Google Patents
Agent for preventing or improving onset of premenstrual syndrome Download PDFInfo
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- JP2021104956A JP2021104956A JP2019236224A JP2019236224A JP2021104956A JP 2021104956 A JP2021104956 A JP 2021104956A JP 2019236224 A JP2019236224 A JP 2019236224A JP 2019236224 A JP2019236224 A JP 2019236224A JP 2021104956 A JP2021104956 A JP 2021104956A
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Abstract
Description
本発明は、月経前症候群発症の予防又は改善剤に関する。 The present invention relates to a preventive or ameliorating agent for the onset of premenstrual syndrome.
月経前症候群(Premenstrual syndrome;PMS)は、日本産科婦人科学会によって、「月経前3〜10日の黄体期のあいだ続く精神的あるいは身体的症状で、月経発来とともに減退ないし消退するもの」と定義されている。 Premenstrual syndrome (PMS) is a mental or physical symptom that continues during the luteal phase of 3 to 10 days before menstruation and declines or disappears with the onset of menstruation, according to the Japan Society of Obstetrics and Gynecology. It is defined.
月経周期のある女性では、排卵から月経までの期間(黄体期)にエストロゲン(卵胞ホルモン)とプロゲステロン(黄体ホルモン)が多く分泌されるが、この黄体期の後半に卵胞ホルモンと黄体ホルモンが急激に低下する。PMSは、このようなホルモンの急激な変動が引き金となり、脳内のホルモンや神経伝達物質の異常を引き起こすことで発症すると考えられている。PMSによる精神的又は身体的症状は、程度によっては日常生活に支障をきたすこともあり、適切な処置が必要となる。 In women with a menstrual cycle, a large amount of estrogen (follicle hormone) and progesterone (luteal phase) are secreted during the period from ovulation to menstruation (luteal phase), but follicular hormone and progesterone rapidly increase in the latter half of this luteal phase. descend. PMS is thought to develop by causing abnormalities in hormones and neurotransmitters in the brain, triggered by such rapid fluctuations in hormones. Mental or physical symptoms caused by PMS may interfere with daily life to some extent, and appropriate treatment is required.
PMSに対する処置としては、食事や運動によって症状の緩和をはかる対処療法があるが、医薬品を選択する場合も多い。医薬品としては、鎮痛剤、吐き気止め、整腸剤、むくみ改善薬、ビタミン剤、アミノ酸製剤、滋養強壮剤、睡眠導入剤、精神安定剤等の、PMSによる具体的な症状に直接対処する医薬品が挙げられる一方で、PMSの原因である女性ホルモンの変動に着眼したホルモン補充療法もある。 As a treatment for PMS, there is a symptomatic treatment that alleviates the symptoms by diet and exercise, but in many cases, a drug is selected. Drugs include analgesics, anti-nausea, intestinal regulators, swelling-improving drugs, vitamins, amino acid preparations, nourishing tonics, sleep-inducing agents, tranquilizers, and other drugs that directly address specific symptoms caused by PMS. On the other hand, there is also hormone replacement therapy that focuses on changes in female hormones that cause PMS.
PMSに対して用いられる医薬品としては、上述したものの他に漢方薬が選択されることもあり、そのような漢方薬としては、具体的には、五苓散エキス、桃核承気湯エキス、当帰芍薬散エキス等が挙げられる。このうち、五苓散エキスはむくみに対して用いられ、桃核承気湯エキスはしつこい便秘や腹部の張った感じに対して用いられる。一方、当帰芍薬散エキスはエストロゲン様作用を持った漢方製剤として知られている(非特許文献1)ことから、ホルモン補充療法の代替として、ホルモン変動による影響を緩和するために用いられる。 In addition to the above-mentioned drugs, Chinese herbs may be selected as the drugs used for PMS. Specifically, such Chinese herbs include Goreisan extract, Tokakujokito extract, and Tokishakuyaku. Examples include Shakuyakusan extract. Of these, Goreisan extract is used for swelling, and Tokakujokito extract is used for persistent constipation and abdominal tension. On the other hand, Tokishakuyakusan extract is known as a Chinese herbal preparation having an estrogen-like action (Non-Patent Document 1), and is therefore used as an alternative to hormone replacement therapy to alleviate the effects of hormone fluctuations.
PMSに対してホルモン補充を目的として用いられる医薬品は、月経周期において急激なホルモン低下を起こしている状態に対して特有の作用効果を示すものであるため、現にPMSが発症している時期に服用することを当然の前提としている。女性の月経周期においては特有のホルモン状態があって、卵胞期、排卵期及び黄体期それぞれにおいてそのホルモン状態は異なるため、PMSへ対処する目的で、特有のホルモン状態を起こしているPMS発症期とは異なる時期に上記の医薬品を服用させることは、本来、全く意味をなさないものである。このため、PMSへ対処することを目的とする医薬品に関しては、現にPMSが発症している時期に服用することのみが前提となっており、PMSの発症を無く(発症予防)したり、発症の程度を緩やかに(発症改善)したりするという発想はこれまで全くなかった。 Drugs used for the purpose of hormone replacement for PMS show a peculiar effect on the state of rapid hormone decrease in the menstrual cycle, so they are taken at the time when PMS is actually occurring. It is a natural premise to do. There is a peculiar hormonal state in a woman's menstrual cycle, and the hormonal state is different in each of the follicular phase, ovulation phase and luteal phase. It makes no sense to have the above medications taken at different times. For this reason, with regard to drugs intended to deal with PMS, it is premised that they are taken only at the time when PMS is actually occurring, and the onset of PMS is eliminated (prevention of onset) or the onset of PMS occurs. Until now, there was no idea of gradual (improvement of onset).
本発明者は、PMSに対処する医薬品について、PMSの症状の抑制効果を高めるために、予めPMSの発症そのものに対する予防や改善という斬新な用途を発想した。 The present inventor has conceived in advance a novel use of a drug for dealing with PMS, which is prevention or improvement of the onset of PMS itself, in order to enhance the effect of suppressing the symptoms of PMS.
そこで、本発明は、PMS発症の予防又は改善剤として有効な剤を提供することを目的とする。 Therefore, an object of the present invention is to provide an agent effective as a preventive or ameliorating agent for the onset of PMS.
本発明者らは、鋭意検討した結果、トウキ末、シャクヤク末、及びセンキュウ末を含む生薬末製剤が、PMSの予防又は改善剤として有効であることを見出した。これは、トウキ、シャクヤク及びセンキュウを含む混合生薬のエキスである当帰芍薬散が、PMS発症時に、ホルモン変動による影響を緩和する作用機序によって効果を奏することに鑑みると、全く予想外のものであった。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, the present inventors have found that a crude drug powder preparation containing Angelica acutiloba powder, Peony powder, and Senkyu powder is effective as a preventive or ameliorating agent for PMS. This is completely unexpected in view of the fact that Tokishakuyakusan, an extract of mixed crude drugs containing Angelica acutiloba, Peony and Senkyu, is effective at the onset of PMS by a mechanism of action that alleviates the effects of hormonal fluctuations. Met. 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. トウキ末、シャクヤク末、及びセンキュウ末を含有する、月経前症候群発症の予防又は改善剤。
項2. 卵胞期から排卵期におけるいずれかの日から投与を開始する、項1に記載の月経前症候群発症の予防又は改善剤。
項3. 月経前症候群の体質改善剤である、項1又は2に記載の月経前症候群発症の予防又は改善剤。
項4. 月経周期の3周期以上連続服用する、項3に記載の月経前症候群の月経前症候群発症の予防又は改善剤。
項5. ブクリョウ末、ソウジュツ末、ケイヒ末、ボタンピ末、ダイオウ末、トウニン末、ニンジン末、及びタクシャ末からなる群より選択される生薬末を更に含有する、項1〜4のいずれかに記載の月経前症候群発症の予防又は改善剤。
That is, the present invention provides the inventions of the following aspects.
Item 1. A preventive or ameliorating agent for the onset of premenstrual syndrome, which contains powdered Angelica acutiloba, powdered peony, and powdered peony.
Item 2. Item 2. The preventive or ameliorating agent for the onset of premenstrual syndrome according to Item 1, wherein administration is started from any day from the follicular phase to the ovulation phase.
Item 3. Item 3. The agent for preventing or improving the onset of premenstrual syndrome according to Item 1 or 2, which is an agent for improving the constitution of premenstrual syndrome.
Item 4. Item 3. The agent for preventing or ameliorating the onset of premenstrual syndrome of premenstrual syndrome, which is taken continuously for 3 or more cycles of the menstrual cycle.
Item 5. The premenstrual syndrome according to any one of Items 1 to 4, further containing a crude drug powder selected from the group consisting of rhubarb powder, sojutsu powder, cinnamon powder, buttonpi powder, rhubarb powder, tounin powder, carrot powder, and taksha powder. A preventive or ameliorating agent for the onset of syndrome.
本発明によれば、PMS発症の予防又は改善剤として有効な剤が提供されるため、PMSの発症の予防又は改善に対して優れた効果を奏する。 According to the present invention, since an agent effective as a preventive or ameliorating agent for the onset of PMS is provided, an excellent effect is exerted on the prevention or amelioration of the onset of PMS.
本発明の月経前症候群発症の予防又は改善剤は、トウキ末、シャクヤク末、及びセンキュウ末を含有し、更年期以降の女性に用いられることを特徴とする。以下、本発明の月経前症候群発症の予防又は改善剤について詳述する。 The preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention is characterized by containing Angelica acutiloba powder, Peony powder, and Senkyu powder, and is used for women after menopause. Hereinafter, the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention will be described in detail.
有効成分Active ingredient
トウキ(当帰)は、セリ科(Umbelliferae)のトウキAngelica acutiloba Kitagawa又はその他近縁植物の根で、通例、湯通ししたものであり、生薬(日本薬局方)として、婦人薬、冷え症用薬、保健強壮薬、精神神経用薬及び尿路疾患用薬などの処方に配合して用いられる。トウキ末については、丸善製薬株式会社、三國株式会社、一丸ファルコス株式会社等から商業的に入手可能である。 Angelica acutiloba (Angelica acutiloba) is the root of Angelica acutiloba Kitagawa or other related plants of the Umbelliferae family, and is usually boiled in hot water. It is used in combination with prescriptions for tonics, neuropsychiatric drugs and urinary tract diseases. Angelica acutiloba powder is commercially available from Maruzen Pharmaceuticals Co., Ltd., Sangoku Co., Ltd., Ichimaru Falcos Co., Ltd., etc.
シャクヤク(芍薬)は、ボタン科(Paeoniaceae)のシャクヤクPaeonia lactiflora Pallas又はその他近縁植物の根であり、生薬(日本薬局方)として主に鎮痛鎮痙薬(胃腸薬)、婦人薬、冷え症用薬、風邪薬などの用途に使用される。なお、シャクヤクは、生薬名(日本薬局方)でもあるとともに植物名でもある。シャクヤク末については、丸善製薬株式会社、三國株式会社、一丸ファルコス株式会社等から商業的に入手可能である。 Peony (peony) is the root of peony Paeonia lactiflora Pallas or other related plants of the Peony family (Peonyaceae), and is mainly used as a crude drug (Japanese Pharmacopoeia) for analgesic and antispasmodic (gastrointestinal), women's medicine, and cold medicine. Used for applications such as peony. Peony is both a crude drug name (Japanese Pharmacopoeia) and a plant name. Peony powder is commercially available from Maruzen Pharmaceuticals Co., Ltd., Sangoku Co., Ltd., Ichimaru Falcos Co., Ltd., etc.
センキュウは、セリ科(Umbelliferae)のセンキュウCnidium officinale Makinoの根茎を、通例、湯通ししたものであり、生薬(日本薬局方)として主に血管補強薬、婦人薬などの用途に使用される。なお、センキュウは、生薬名(日本薬局方)でもあるとともに植物名でもある。センキュウ末については、日本粉末薬品株式会社、株式会社栃本天海堂等から商業的に入手可能である。 Senkyu is usually blanched rhizomes of Cnidium office Makino of the Umbelliferae family, and is mainly used as a crude drug (Japanese Pharmacopoeia) for vascular reinforcements, women's medicines, and the like. Senkyu is both a crude drug name (Japanese Pharmacopoeia) and a plant name. Senkyu powder is commercially available from Nippon Powder Chemicals Co., Ltd., Tochimoto Tenkaido Co., Ltd., etc.
本発明の月経前症候群発症の予防又は改善剤中のトウキ末、シャクヤク末、及びセンキュウ末の含有量としては特に限定されないが、例えば、総量で10〜98重量%、好ましくは13〜95重量%、より好ましくは16〜85重量%が挙げられる。また、本発明の月経前症候群発症の予防又は改善剤に含まれる全生薬末100重量部に対するトウキ末、シャクヤク末、及びセンキュウ末の含有量の比率としては、総量で例えば20〜98重量部、好ましくは28〜95重量部、より好ましくは34〜85重量部が挙げられる。 The content of Angelica acutiloba powder, Peony powder, and Senkyu powder in the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention is not particularly limited, but for example, the total amount is 10 to 98% by weight, preferably 13 to 95% by weight. , More preferably 16-85% by weight. In addition, the ratio of the contents of Angelica acutiloba powder, Peony powder, and Senkyu powder to 100 parts by weight of the total crude drug powder contained in the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention is, for example, 20 to 98 parts by weight in total. It is preferably 28 to 95 parts by weight, more preferably 34 to 85 parts by weight.
トウキ末、シャクヤク末、及びセンキュウ末それぞれの割合としては特に限定されないが、トウキ末:シャクヤク末:センキュウ末=1:0.5〜1.7:0.4〜1、好ましくは1:0.8〜1.2:0.6〜0.8が挙げられ、特に好ましくは、1:1:2/3が挙げられる。 The ratios of Angelica acutiloba powder, Peony powder, and Senkyu powder are not particularly limited, but Angelica acutiloba powder: Peony powder: Peony powder = 1: 0.5 to 1.7: 0.4 to 1, preferably 1: 0. 8 to 1.2: 0.6 to 0.8, and particularly preferably 1: 1: 2/3.
他の生薬成分
本発明の月経前症候群発症の予防又は改善剤は、月経前症候群発症の予防又は改善効果をより一層高める観点から、他の生薬として、ブクリョウ末、ソウジュツ末、ケイヒ末、ボタンピ末、ダイオウ末、トウニン末、ニンジン末、タクシャ末からなる群より選択される1種又は2種以上の生薬末を更に含有することが好ましい。
Other Crude Drug Ingredients The prophylactic or ameliorating agent for the onset of premenstrual syndrome of the present invention can be used as other herbal medicines as other herbal medicines, such as cinnamon powder, cinnamon powder, cinnamon powder, and buttonpi powder. It is preferable to further contain one or more kinds of crude drug powders selected from the group consisting of powders of daiou, powders of tounin, powders of carrots, and powders of taksha.
ブクリョウ(茯苓)は、サルノコシカケ科(Polyporaceae)のマツホド Wolfiporia cocos Ryvarden et Gilbertson (Poria cocos Wolf)の菌核で、通例、外層をほとんど除いたものであり、生薬(日本薬局方)として主に鎮静薬、利尿薬などの用途に使用される。ブクリョウ末については、高砂薬業株式会社、株式会社栃本天海堂等から商業的に入手可能である。 Bukuryo (Polyporaceae) is a sclerotium of the Chinese root Wolfiporia cocos Ryvarden et Gilbertson (Polia cocos Wolf) of the Polyporaceae family. , Used for diuretics, etc. Bukuryo powder is commercially available from Takasago Yakuhin Co., Ltd., Tochimoto Tenkaido Co., Ltd., etc.
ソウジュツ(蒼朮)は、キク科(Compositae)のホソバオケラAtractylodes lancea De Candolle又はAtractylodes chinensis Koidzumiの根茎であり、生薬(日本薬局方)として主に健胃薬の用途に使用される。ソウジュツ末については、株式会社栃本天海堂、吉見製薬株式会社等から商業的に入手可能である。 Atractylodes lanceolata is a rhizome of Atractylodes lancea De Candle or Atractylodes chinensis Koidzumi of the Asteraceae family, and is mainly used as a crude drug (Japanese Pharmacopoeia). Sojutsu powder is commercially available from Tochimoto Tenkaido Co., Ltd., Yoshimi Pharmaceutical Co., Ltd., etc.
ケイヒ(桂皮)は、クスノキ科(Lauraceae)のケイCinnamomum cassia Blum又はその他同属植物の太い幹の樹皮を剥いだものであり、生薬(日本薬局方)として主に芳香性健胃薬などの用途に使用される。ケイヒ末については、日本粉末薬品株式会社、株式会社栃本天海堂等から商業的に入手可能である。 Cinnamon cinnamon cassia Blum of the Lauraceae family or other plants of the same genus is peeled from the bark of the thick trunk of cinnamon, and is mainly used as a crude drug (Japanese Pharmacy) for aromatic stomachic medicine. Will be done. Cinnamon powder is commercially available from Nippon Powder Chemicals Co., Ltd., Tochimoto Tenkaido Co., Ltd., etc.
ボタンピ(牡丹皮)は、ボタン科(Paeoniaceae)のボタンPaeonia suffruticosa Andrews(Paeonia moutan Sims)の根皮であり、生薬(日本薬局方)として主に婦人薬などの用途に使用される。ボタンピ末については、株式会社栃本天海堂、高砂薬業株式会社等から商業的に入手可能である。 Peony bark is the root bark of Peonya sufruticosa Andrews (Paeonia moustan Sims) of the Peony family, and is mainly used as a crude drug (Japanese Pharmacopoeia) for women's medicines and the like. Buttonpi powder is commercially available from Tochimoto Tenkaido Co., Ltd., Takasago Pharmaceutical Co., Ltd., etc.
ダイオウ(大黄)は、タデ科(Polygonaceae)のRheum palmatum L., Rheum tanguticum Maximowicz, Rheum officinale Baillon, Rheum coreanum Nakai又はそれらの種間雑種の通例、根茎であり、生薬(日本薬局方)として主に健胃薬や瀉下薬の用途に使用される。ダイオウ末については、三和生薬株式会社、株式会社栃本天海堂等から商業的に入手可能である。 Rhubarb (Rhubarb) is a member of the Polygonaceae family, Rheum palmatum L. et al. , Rheum tanguticum Maximowicz, Rheum office Ballon, Rheum coreanum Nakai or their interspecific hybrids, which are usually rhizomes and are mainly used as crude drugs (Japanese Pharmacopoeia) for stomachic and laxatives. Rhubarb powder is commercially available from Sanwa Crude Drug Co., Ltd., Tochimoto Tenkaido Co., Ltd., etc.
トウニン(桃仁)は、バラ科(Rosaceae)のモモPrunus persi−ca Batsch又はPrunus persica Batsch var. davidiana Maximowiczの種子であり、生薬(日本薬局方)として、婦人薬、瀉下薬とみなされる処方に使用される。トウニン末については、株式会社栃本天海堂、高砂薬業株式会社等から商業的に入手可能である。 Tounin (Peach Jin) is a peach of the Rosaceae family (Plumus persi-ca Basch) or Prunus persica Basch var. It is a seed of davidiana Maximowicz and is used as a crude drug (Japanese Pharmacopoeia) in prescriptions considered to be laxatives and laxatives. Tounin powder is commercially available from Tochimoto Tenkaido Co., Ltd., Takasago Pharmaceutical Co., Ltd., etc.
ニンジン(人参)は、ウコギ科(Araliaceae)のオタネニンジン Panax ginseng C.A. Meyer (Panax schinseng Nees)の細根を除いた根又はこれを軽く湯通ししたものであり、生薬(日本薬局方)として主に強壮強精薬、消化促進薬、下痢止め薬、精神安定薬、血糖降下薬、強心薬、保温薬、抗疲労薬などの用途に使用される。なお、ニンジンは、生薬名(日本薬局方)でもあるとともに植物名でもある。ニンジン末については、日本粉末薬品株式会社、株式会社栃本天海堂等から商業的に入手可能である。 Ginseng is a ginseng of the Araliaceae family, Panax ginseng C.I. A. Meyer (Panax schinseng Needs) roots excluding fine roots or lightly boiled ones, mainly as tonic tonics, digestive promoters, antidiarrhea, tranquilizers, hypoglycemic agents as crude drugs (Japanese Pharmacopoeia) It is used for medicines, cardiotonics, antidiarrheals, anti-fatigue drugs, etc. Carrot is both a crude drug name (Japanese Pharmacopoeia) and a plant name. Carrot powder is commercially available from Nippon Powder Chemicals Co., Ltd., Tochimoto Tenkaido Co., Ltd., etc.
タクシャ(沢瀉)は、オモダカ科(Alismataceae)のサジオモダカAlisma orientale Juzepczukの塊茎で、通例、周皮を除いたものであり、生薬(日本薬局方)として、利尿薬、尿路疾患用薬、鎮暈薬とみなされる処方に配合して用いられる。タクシャ末については、株式会社栃本天海堂、高砂薬業株式会社等から商業的に入手可能である。 Takusha is a lump of Sagittaria trifolia (Alisma orientale Juzepczuk) of the water-plantain family (Alisma orientale), which is usually excluding the peripheral skin. It is used in combination with the prescription considered to be. Takusha powder is commercially available from Tochimoto Tenkaido Co., Ltd., Takasago Pharmaceutical Co., Ltd., etc.
本発明の月経前症候群発症の予防又は改善剤の好適な例においては、上記の他の生薬の中でも、本発明による月経前症候群発症の予防又は改善効果をより一層向上させる観点から、少なくともソウジュツ末及びケイヒ末を含むこと、又は、ボタンピ末、ダイオウ末、トウニン末、及びタクシャ末を含むことが好ましく、ブクリョウ末、ソウジュツ末、ケイヒ末、ボタンピ末、ダイオウ末、トウニン末、ニンジン末、及びタクシャ末を含むことが特に好ましい。 In a preferred example of the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention, among the other crude drugs described above, at least the powder of Atractylodes lanceolata from the viewpoint of further improving the preventive or ameliorating effect of the onset of premenstrual syndrome by the present invention. And cinnamon powder, or preferably contains buttonpi powder, cinnamon powder, tounin powder, and takusha powder, and contains bukuryo powder, sojutsu powder, cinnamon powder, buttonpi powder, daiou powder, tounin powder, carrot powder, and takusha powder. It is particularly preferable to include powder.
本発明の月経前症候群発症の予防又は改善剤中のブクリョウ末、ソウジュツ末、ケイヒ末、ボタンピ末、ダイオウ末、トウニン末、ニンジン末、及びタクシャ末からなる群より選択される生薬末(他の生薬末)の含有量としては、特に限定されないが、例えば、総量で2〜70重量%が挙げられる。 Crude drug powder selected from the group consisting of rhubarb powder, sojutsu powder, cinnamon powder, buttonpi powder, rhubarb powder, tounin powder, carrot powder, and takusha powder in the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention (others). The content of crude drug powder) is not particularly limited, and examples thereof include 2 to 70% by weight in total.
また、トウキ末、シャクヤク末及びセンキュウ末の総量に対する他の生薬末の総量の比率としては特に限定されないが、月経前症候群発症の予防又は改善効果をより一層高める観点から、トウキ末、シャクヤク末及びセンキュウ末の総量100重量部に対して、100〜350重量部、好ましくは230〜300重量部が挙げられる。 The ratio of the total amount of other crude drug powders to the total amount of Angelica acutiloba powder, Peony powder and Senkyu powder is not particularly limited, but from the viewpoint of further enhancing the preventive or ameliorating effect of the onset of PMS, Angelica acutiloba powder, Peony powder and With respect to 100 parts by weight of the total amount of peony powder, 100 to 350 parts by weight, preferably 230 to 300 parts by weight can be mentioned.
具体的には、トウキ末、シャクヤク末及びセンキュウ末の総量に対する他の生薬末それぞれの含有量としても特に限定されないが、月経前症候群発症の予防又は改善効果をより一層高める観点から、トウキ末、シャクヤク末及びセンキュウ末の総量100重量部に対して、ブクリョウ末の場合は1〜40重量部、好ましくは23〜30重量部が挙げられ;ソウジュツ末の場合は8〜30重量部、好ましくは23〜28重量部が挙げられ;ケイヒ末の場合は15〜40重量部、好ましくは20〜26重量部が挙げられ;ボタンピ末の場合は15〜40重量部、好ましくは23〜28重量部が挙げられ;ダイオウ末の場合は10〜30重量部が挙げられ;トウニン末の場合は8〜40重量部、好ましくは10〜20重量部が挙げられ;ニンジン末の場合は1〜50重量部、好ましくは3〜6.5重量部が挙げられ;タクシャ末の場合は10〜40重量部、好ましく10〜20重量部が挙げられる。 Specifically, the content of each of the powders of other crude drugs with respect to the total amount of powders of Touki, Shakuyaku and Senkyu is not particularly limited, but from the viewpoint of further enhancing the effect of preventing or improving the onset of premenstrual syndrome, the powder of Touki, For 100 parts by weight of the total amount of the powder of Shakuyaku and the powder of Senkyu, 1 to 40 parts by weight, preferably 23 to 30 parts by weight of the powder of Bukuryo; 8 to 30 parts by weight, preferably 23 of the powder of Sojutsu. ~ 28 parts by weight; 15-40 parts by weight, preferably 20-26 parts by weight; 15-40 parts by weight, preferably 23-28 parts by weight of buttonpi powder. In the case of powdered daiou, 10 to 30 parts by weight is mentioned; in the case of powdered tounin, 8 to 40 parts by weight, preferably 10 to 20 parts by weight; in the case of powdered carrot, 1 to 50 parts by weight, preferably. 3 to 6.5 parts by weight; in the case of takusha powder, 10 to 40 parts by weight, preferably 10 to 20 parts by weight.
その他の成分
本発明の月経前症候群発症の予防又は改善剤には、上述の生薬成分の他に、製剤形態に応じた添加剤や基剤をさらに含んでいてもよい。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、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、本発明の月経前症候群発症の予防又は改善剤の製剤形態等に応じて適宜設定される。
Other Ingredients The prophylactic or ameliorating agent for the onset of premenstrual syndrome of the present invention may further contain additives and bases according to the form of the preparation in addition to the above-mentioned crude drug ingredients. Additives and bases are not particularly limited as long as they are pharmaceutically acceptable, but excipients, binders, disintegrants, lubricants, tonicity agents, plasticizers, dispersants, emulsifiers, etc. Dissolving aids, wetting agents, stabilizers, suspending agents, pressure-sensitive adhesives, coating agents, brighteners, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble High polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, flavoring agents, fragrances, powders, thickeners, pigments , Chelating agent and the like. These additives may be used alone or in combination of two or more. The content of these additives and bases is appropriately set according to the types of additives and bases to be used, the form of the prophylaxis or ameliorating agent for preventing or improving the onset of premenstrual syndrome of the present invention, and the like.
添加剤及び基剤としては、具体的には、デンプン、乳糖、カルメロースカルシウム、軽質無水ケイ酸、ステアリン酸マグネシウム、合成ケイ酸アルミニウム、メタケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、ケイ酸マグネシウム、合成ハイドロタルサイト、無水リン酸水素カルシウム、カルメロース、クロスカルメロースナトリウム、デンプングリコール酸ナトリウム、クロスポピドンが挙げられ、好ましくは、カルメロースカルシウム、軽質無水ケイ酸、ステアリン酸マグネシウム、及び合成ケイ酸アルミニウムが挙げられる。デンプンとしては、バレイショデンプン、トウモロコシデンプン等が挙げられ、好ましくはトウモロコシデンプンが挙げられる。これらの添加剤及び基剤の含有量は、使用する添加剤及び基剤の種類に応じて適宜設定される。 Specific examples of the additives and bases include starch, lactose, carmellose calcium, light anhydrous silicic acid, magnesium stearate, synthetic aluminum silicate, magnesium aluminometasilicate, calcium silicate, magnesium silicate, and synthetic. Hydrotalcite, anhydrous calcium hydrogen phosphate, carmellose, croscarmellose sodium, sodium starch glycolate, crospopidone are mentioned, preferably carmellose calcium, light anhydrous silicic acid, magnesium stearate, and synthetic aluminum silicate. Can be mentioned. Examples of starch include potato starch, corn starch and the like, and corn starch is preferable. The contents of these additives and bases are appropriately set according to the types of additives and bases used.
本発明の月経前症候群発症の予防又は改善剤が、上述の生薬成分の他に、添加剤や基剤をさらに含む場合、医薬組成物全体中の添加剤及び基剤の配合量としては、総量で、2〜70重量%、好ましくは5〜60重量%が挙げられる。 When the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention further contains additives and bases in addition to the above-mentioned crude drug components, the total amount of the additives and bases to be blended in the entire pharmaceutical composition 2 to 70% by weight, preferably 5 to 60% by weight.
また、本発明の月経前症候群発症の予防又は改善剤は、必要に応じて、更に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、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、生薬及び/又は生薬抽出物、ビタミン類等が挙げられる。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, the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention may further 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 antiemetics. Agents, antitussives, sputum, anti-inflammatory enzyme agents, sedative hypnotics, antihistamines, caffeines, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, crude drugs and / or crude drug extracts, vitamins And so on. 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
本発明の月経前症候群発症の予防又は改善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、錠剤、トローチ剤、チュアブル剤、カプセル剤(軟カプセル剤、硬カプセル剤)、丸剤等の固形状製剤;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。
Formulation form The formulation form of the agent for preventing or ameliorating the onset of premenopausal syndrome of the present invention is not particularly limited as long as it can be orally administered, and is, for example, a powder, a fine granule, a capsule, a tablet, or a troche. , Chewables, capsules (soft capsules, hard capsules), rounds and other solid formulations; semi-solid formulations such as jelly; liquid formulations such as liquids, suspending agents and syrups.
製造方法
本発明の月経前症候群発症の予防又は改善剤の製造方法は、上記生薬成分を用いて、医薬分野で採用されている通常の製剤化手法に従って製剤化すればよい。
Production method The method for producing a preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention may be formulated by using the above-mentioned crude drug components according to a usual formulation method adopted in the pharmaceutical field.
用途
本発明の月経前症候群発症の予防又は改善剤は、月経前症候群(PMS)がある女性に対し、PMSの発症を予防又は改善する目的で使用される。
Uses The agent for preventing or ameliorating the onset of premenstrual syndrome of the present invention is used for the purpose of preventing or ameliorating the onset of PMS in women with premenstrual syndrome (PMS).
本発明におけるPMSとは、月経前3〜10日の黄体期の間続く精神的又は身体的症状で、月経発来とともに減退ないし消退するものである。精神的症状としては、イライラする、怒りやすい、攻撃的になる、落ち込みやすい、憂うつ、涙もろい、不安が高まる等が挙げられ、身体的症状としては、手足などが冷える、首や肩がこる、乳房が痛い、乳房が張る、下腹部が痛い、下腹部が張る、頭が痛い、腰が痛い、だるい、めまいがする、動悸がする、貧血になる、むくむ、肌が荒れる、ニキビができやすくなる、疲れやすい、食欲が増す、眠くなる、便秘になる、下痢になる等が挙げられる。 PMS in the present invention is a mental or physical symptom that lasts during the luteal phase 3 to 10 days before menstruation, and diminishes or disappears with the onset of menstruation. Mental symptoms include frustration, anger, aggressiveness, depression, depression, fragile tears, increased anxiety, and physical symptoms include cold hands and feet, stiff neck and shoulders, and so on. Breast pain, breast tension, lower abdomen pain, lower abdomen tension, head pain, lower back pain, dullness, dizziness, palpitation, anemia, swelling, rough skin, prone to acne It is easy to get tired, has increased appetite, becomes sleepy, has constipation, and has dizziness.
PMS発症の予防とは、PMSの発症を無くすことをいい、PMS発症の改善とは、発症するPMSの症状の程度を軽減することをいう。 Prevention of the onset of PMS means eliminating the onset of PMS, and improvement of the onset of PMS means reducing the degree of symptoms of the onset of PMS.
本発明の月経前症候群発症の予防又は改善剤は、用法によっては、PMSがある女性に対し、PMSの体質改善の目的でも使用される。PMSの体質改善とは、本発明の月経前症候群発症の予防又は改善剤の服用を中止した後、本発明の経前症候群発症の予防又は改善剤を服用していない間にも、PMSの発症が無くなった状態又は発症するPMSの症状の程度が軽減された状態が維持されることをいう。 The agent for preventing or improving the onset of PMS of the present invention is also used for the purpose of improving the constitution of PMS for women with PMS, depending on the usage. Improving the constitution of PMS means the onset of PMS even after the prevention or ameliorating agent for the onset of PMS of the present invention is stopped and the prevention or ameliorating agent for the onset of PMS of the present invention is not taken. It means that the state where the symptom disappears or the degree of the symptom of PMS that develops is reduced is maintained.
用量・用法
本発明の月経前症候群発症の予防又は改善剤は、経口投与によって使用される。本発明の月経前症候群発症の予防又は改善剤の用量については、投与対象者の年齢、体質、症状の程度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、全生薬成分の総量として0.3〜7g、好ましくは1.8〜5.5g、より好ましくは2.2〜4gとなる量が挙げられ、トウキ末、シャクヤク末、及びセンキュウ末の総量としては0.1〜1.5g、好ましくは0.5〜1.2g、より好ましくは0.7〜0.9gが挙げられる。また、本発明の月経前症候群発症の予防又は改善剤は、1日1〜3回、好ましくは2又は3回、より好ましくは3回の頻度で服用することができる。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、好ましくは食後が挙げられる。
Dosage and Usage The preventive or ameliorating agent for the onset of PMS of the present invention is used by oral administration. The dose of the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention is appropriately set according to the age, constitution, degree of symptom, etc. of the administration subject. The total amount of crude drug components is 0.3 to 7 g, preferably 1.8 to 5.5 g, more preferably 2.2 to 4 g, and the total amount of touki powder, symptomatological powder, and senkyu powder is 0. .1 to 1.5 g, preferably 0.5 to 1.2 g, more preferably 0.7 to 0.9 g. In addition, the preventive or ameliorating agent for the onset of PMS of the present invention can be taken 1 to 3 times a day, preferably 2 or 3 times, more preferably 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 after meals.
本発明の月経前症候群発症の予防又は改善剤の服用スケジュールについては、月経前症候群が発症する前に服用する限りにおいて特に限定されないが、PMSが黄体期後半から発症することに鑑みると、卵胞期から排卵期におけるいずれかの日から投与を開始することが好ましい。本発明による月経前症候群発症の予防又は改善効果をより一層向上させる観点から、月経周期のより早い時期から投与を開始することが好ましい。このため、本発明の月経前症候群発症の予防又は改善剤の服用スケジュールの好適な例においては、卵胞期におけるいずれかの日から投与を開始することが好ましく、卵胞期開始から(月経終了直後に)投与を開始することがより好ましい。なお、卵胞期、排卵期及び黄体期は、個人の月経周期によって決定される。 The schedule for taking the preventive or ameliorating agent for the onset of PMS of the present invention is not particularly limited as long as it is taken before the onset of PMS, but in view of the onset of PMS from the latter half of the luteal phase, the follicular phase. It is preferable to start administration from any day during the ovulation phase. From the viewpoint of further improving the preventive or ameliorating effect of the onset of premenstrual syndrome according to the present invention, it is preferable to start the administration at an earlier stage of the menstrual cycle. Therefore, in a preferable example of the administration schedule of the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention, it is preferable to start the administration from any day in the follicular phase, and from the start of the follicular phase (immediately after the end of menstruation). ) It is more preferable to start administration. The follicular phase, ovulation phase and luteal phase are determined by the individual's menstrual cycle.
また、本発明の月経前症候群発症の予防又は改善剤の服用期間については、月経前症候群が発症する前から毎日服用し、少なくとも、服用を開始した月経周期における黄体期の終了時(月経開始前)までは連続服用することが好ましい。本発明による月経前症候群発症の予防又は改善効果をより一層向上させる観点から、月経周期の2周期以上毎日連続服用することが好ましい。更に、PMSの体質改善を図る観点からは、月経周期の3周期以上毎日連続服用することが好ましい。 Regarding the period of taking the preventive or ameliorating agent for the onset of premenstrual syndrome of the present invention, it should be taken every day before the onset of premenstrual syndrome, and at least at the end of the luteal phase in the menstrual cycle in which the administration was started (before the start of menstruation). ) Is preferably taken continuously. From the viewpoint of further improving the preventive or ameliorating effect of the onset of premenstrual syndrome according to the present invention, it is preferable to take it continuously for two or more cycles of the menstrual cycle every day. Furthermore, from the viewpoint of improving the constitution of PMS, it is preferable to take it continuously every day for 3 or more cycles of the menstrual cycle.
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.
試験例1
(1)月経前症候群発症の予防又は改善剤の調製
表1(ヒト1日量)に示す配合比率で被験薬を調製した。
Test Example 1
(1) Preparation of preventive or ameliorating agent for the onset of premenstrual syndrome The test drug was prepared at the compounding ratio shown in Table 1 (daily dose for humans).
(2)試験方法1
(2−1)実施例1:PMS発症の予防又は改善用途(卵胞期の開始から黄体期終了までの服用)
PMSの症状を持つ成人女性モニター23名の投与スケジュールを図1に示す。当該モニターは、前回の月経(月経0)開始日からその次の月経(月経1)が開始するまで(月経周期の0周期目)、被験薬を服用せず、基礎体温を記録して月経周期を把握し、PMSの具体的症状の記録を行った。当該モニターは、月経1の終了後(つまり卵胞期の開始)から次の月経(月経2)が開始するまで(つまり黄体期終了まで)(月経周期の1周期目)、被験薬を毎日、1日当たり3回の頻度で、毎食後に水又はお湯で服用した。
(2) Test method 1
(2-1) Example 1: Use for prevention or improvement of PMS onset (taken from the start of the follicular phase to the end of the luteal phase)
The administration schedule of 23 adult female monitors with PMS symptoms is shown in FIG. From the start date of the previous menstruation (0 menstruation) to the start of the next menstruation (1st menstruation) (the 0th cycle of the menstrual cycle), the monitor records the basal body temperature without taking the test drug and records the menstrual cycle. And recorded the specific symptoms of PMS. From the end of menstruation 1 (that is, the start of the follicular phase) to the start of the next menstruation (that is, the end of the luteal phase) (that is, the first cycle of the luteal phase), the monitor takes 1 test drug daily. It was taken with water or hot water after each meal at a frequency of 3 times a day.
(2−2)比較例1:PMSの改善用途(黄体期後半から黄体期終了までの服用)
PMSの症状を持つ成人女性モニター8名の投与スケジュールを図2に示す。当該モニターは、前回の月経(月経0)開始日からその次の月経(月経1)が開始するまで(月経周期の0周期目)、被験薬を服用せず、基礎体温を記録して月経周期を把握し、PMSの具体的症状の記録を行った。当該モニターは、月経1から始まる月経周期(月経周期の1周期目)において、次の月経(月経2)予測日の1週間前(つまり黄体期後半)から月経2が開始するまで(つまり黄体期終了まで)、被験薬を毎日、1日当たり3回の頻度で食間に服用した。
(2-2) Comparative Example 1: PMS improvement application (taken from the latter half of the luteal phase to the end of the luteal phase)
The administration schedule of eight adult female monitors with PMS symptoms is shown in FIG. From the start date of the previous menstruation (0 menstruation) to the start of the next menstruation (1st menstruation) (the 0th cycle of the menstrual cycle), the monitor records the basal body temperature without taking the test drug and records the menstrual cycle. And recorded the specific symptoms of PMS. In the menstrual cycle starting from menstruation 1 (the first cycle of the menstrual cycle), the monitor is used from one week before the predicted date of the next menstruation (menstruation 2) (that is, the latter half of the luteal phase) until the start of menstruation 2 (that is, the luteal phase). Until the end), the test drug was taken daily between meals three times a day.
(3)PMS症状の確認1
実施例1及び比較例1のモニターそれぞれに、月経周期の0周期目におけるPMS症状の有無と、月経周期の1週目におけるPMS症状の有無とをアンケートした。結果を表2に示す。表2では、各PMS症状が有ると回答した人数(有訴者数(人))、服用前の有訴者数に対する、服用により当該PMS症状について効果があった(つまり、PMS症状の程度が低減した又はPMS症状が無くなった)と回答した人数の割合(有効率1(%))、及び服用前の有訴者数に対する、服用により当該PMS症状が無くなったと回答した人数の割合(有効率2(%))を示す。
(3) Confirmation of PMS symptoms 1
The monitors of Example 1 and Comparative Example 1 were surveyed for the presence or absence of PMS symptoms in the 0th cycle of the menstrual cycle and the presence or absence of PMS symptoms in the 1st week of the menstrual cycle. The results are shown in Table 2. In Table 2, the number of people who answered that they had each PMS symptom (number of complainants (persons)) and the number of complainants before taking the drug were effective for the PMS symptom (that is, the degree of PMS symptom). The ratio of the number of people who answered that the PMS symptom was reduced or disappeared (effective rate 1 (%)), and the ratio of the number of people who answered that the PMS symptom disappeared by taking the drug (effective rate) to the number of complainants before taking the drug. 2 (%)) is shown.
表2の、比較例1の有効率1に対する実施例1の有効率1に示されるとおり、被験薬をPMS発症の予防又は改善用途に用いることで、PMSの症状が顕著に抑制されたことを確認した。さらに、実施例1の有効率2に示される通り、被験薬によって、PMS症状が軽減しただけでなく、PMS症状が無くなるという格別顕著な効果が認められたモニターもいた。 As shown in Table 2, the efficacy rate 1 of Example 1 with respect to the efficacy rate 1 of Comparative Example 1, the use of the test drug for the prevention or amelioration of the onset of PMS significantly suppressed the symptoms of PMS. confirmed. Furthermore, as shown in the efficacy rate 2 of Example 1, some monitors showed a particularly remarkable effect that the test drug not only reduced the PMS symptom but also eliminated the PMS symptom.
(3)試験方法2
上記試験方法1の実施例1を行ったモニター23名が、試験方法1に引き続き、毎日、月経周期の3周期目終了まで被験薬を服用し、月経周期の4週目は全く被験薬を服用しなかった(実施例2)。実施例2におけるモニターの服用スケジュールを図3に示す。
(3) Test method 2
Twenty-three monitors who performed Example 1 of the above test method 1 took the test drug every day until the end of the third cycle of the menstrual cycle, and took the test drug at all in the fourth week of the menstrual cycle, following the test method 1. Did not (Example 2). The dosing schedule of the monitor in Example 2 is shown in FIG.
(4)PMS症状の確認2
実施例2のモニターに、各月経周期におけるPMS症状の有無をアンケートした。表3に、服用前の有訴者数に対する、服用により当該PMS症状が無くなったと回答した人数の割合(有効率2(%))を示す。
(4) Confirmation of PMS symptoms 2
The monitor of Example 2 was surveyed for the presence or absence of PMS symptoms in each menstrual cycle. Table 3 shows the ratio of the number of people who answered that the PMS symptom disappeared by taking the drug (effective rate 2 (%)) to the number of complainants before taking the drug.
表3に示されるように、服用の継続によるPMS症状が消失した人の割合の変動は様々であるが、月経周期の4周期目には全く被験薬を服用していないにも関わらず、PMS症状の消失が継続している例さえ認められた。また、ほとんどのPMS症状において、被験薬を服用しなかった4周期目の有効率が、服用期間における有効率よりも高く(又は同等)、本発明の被験薬が高いPMS発症予防効果を示したことが確認できた。このように、本発明の被験薬の継続服用によって、PMS症状が起こらない体質への改善さえ可能であることが認められた。 As shown in Table 3, the proportion of people who have lost PMS symptoms due to continued administration varies, but PMS is not taken at all in the 4th cycle of the menstrual cycle. There were even cases in which the disappearance of symptoms continued. In addition, in most PMS symptoms, the efficacy rate in the 4th cycle in which the test drug was not taken was higher (or equivalent) than the efficacy rate during the period of administration, and the test drug of the present invention showed a high PMS onset preventive effect. I was able to confirm that. As described above, it was confirmed that continuous administration of the test drug of the present invention can even improve the constitution in which PMS symptoms do not occur.
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