JP2022098251A - Premenstrual constipation improver - Google Patents
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Abstract
Description
本発明は、月経前便秘改善剤に関する。 The present invention relates to a premenstrual constipation improving agent.
便秘とは排泄物が長時間腸内にとどまり、水分が吸収されて排便に困難を伴う状態、又は排便がまれ(数日間に1回程度)である状態をいう。通常、1日に1~2回の排便が正常といわれているが、2~3日に1回の排便であっても便通状態が普通で、本人が苦痛を感じない場合には便秘とはいわない。一方、毎日排便があっても便が硬くて量が少なく残便感がある場合や、排便に苦痛を感じる場合には便秘とみなされる(非特許文献1~3)。 Constipation is a condition in which excrement stays in the intestine for a long time and water is absorbed, making it difficult to defecate, or defecation is rare (about once every few days). Normally, it is said that defecation once or twice a day is normal, but even if defecation is performed once every two to three days, the bowel movement is normal, and if the person does not feel pain, constipation is Not say. On the other hand, even if there is defecation every day, if the stool is hard and the amount is small and there is a feeling of residual stool, or if the stool feels painful, it is considered to be constipation (Non-Patent Documents 1 to 3).
便秘の中でも、女性の慢性便秘に多くみられるのが弛緩性便秘である。弛緩性便秘では、大腸の蠕動運動が障害され、糞便が大腸内に長時間とどまることで水分が過剰に吸収され、その結果便が硬くなり排便困難が生じる症状である。月経のある女性では、月経前に便秘を訴える人も多い。月経前の便秘はプロゲステロンの作用が関連しているとされており、このプロゲステロンの作用により、大腸の蠕動運動が起こりにくくなり、体に水分をためこんで便の水分量が減ることにより排便困難が生じる。 Among constipation, laxative constipation is the most common chronic constipation in women. Laxative constipation is a symptom in which the peristaltic movement of the large intestine is impaired, and the feces stay in the large intestine for a long time, resulting in excessive absorption of water, resulting in stiff stools and difficulty in defecation. Many women with menstruation complain of constipation before menstruation. Pre-menstrual constipation is said to be related to the action of progesterone, and this action makes it difficult for the peristaltic movement of the large intestine to occur, and it causes difficulty in defecation due to the accumulation of water in the body and the decrease in the amount of water in the stool. Occurs.
便秘の治療に用いられる西洋薬としては刺激性下剤及び塩類下剤が挙げられるが、効果が強いため、腹痛を起こしたり下痢を起こしたりすることがある。このため、西洋薬が体質に合わない人に対しては漢方薬が適用されることがある。 Western medicines used for the treatment of constipation include stimulant laxatives and salt laxatives, but because of their strong effects, they may cause abdominal pain or diarrhea. For this reason, Chinese medicine may be applied to people who are not fit for Western medicine.
便秘に用いられる漢方薬としてはいくつか知られているが、例えば防風通聖散及び調胃承気湯等は、センノシドを主成分とする大黄による腸管蠕動運動促進作用と、芒硝による塩類下剤としての作用とによって瀉下効果を奏すると理解されている(非特許文献4)。 There are several known Chinese herbal medicines used for constipation, but for example, Bofutsushosan and Chofutsushosan have sennoside-based rhubarb as a main component for promoting intestinal peristalsis and Glauber's salt as a salt laxative. It is understood that a laxative effect is exerted by the action (Non-Patent Document 4).
上述のとおり、慢性便秘であっても月経前の便秘であっても、大腸の蠕動運動が障害されて便の水分量が減ることで生じるという点でメカニズムは共通している。そこで、本発明者らは、月経前の便秘を訴える女性に対して、腸管蠕動運動促進作用と塩類下剤としての作用とによって瀉下効果を奏するとされている漢方の1つである防風通聖散の効果を検討した。しかしながら、防風通聖散では、月経前の便秘の改善成績が悪くなり、月経前便秘改善剤としての有効性に問題があることが分かった。 As mentioned above, both chronic constipation and premenstrual constipation have a common mechanism in that they are caused by impaired peristaltic movements of the large intestine and reduced stool water content. Therefore, the present inventors are one of the Chinese medicines, Bofutsushosan, which is said to exert a coagulation effect on women who complain of premenstrual constipation by promoting intestinal peristalsis and acting as a salt laxative. The effect of was examined. However, it was found that Bofutsushosan had poor results in improving premenstrual constipation and had a problem in its effectiveness as a premenstrual constipation improving agent.
そこで本発明は、月経前便秘改善剤として有効な医薬品を提供することを目的とする。 Therefore, an object of the present invention is to provide a drug effective as a premenstrual constipation improving agent.
本発明者は、桃核承気湯及び通導散が、月経前の便秘に対して特に効果が高い改善効果を奏することを見出した。本発明は、かかる知見に基づいて、更に検討を重ねることにより完成したものである。 The present inventor has found that Tokakujokito and Tsudosan have a particularly effective ameliorating effect on premenstrual constipation. The present invention has been completed by further studies based on such findings.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項1. 桃核承気湯エキス及び/又は通導散エキスを含む、月経前便秘改善剤。
項2. 月経周期が規則的な対象に用いられる、項1に記載の月経前便秘改善剤。
That is, the present invention provides the inventions of the following aspects.
Item 1. Premenstrual constipation improver, including Tokakujokito extract and / or Tsudosan extract.
Item 2. Item 2. The premenstrual constipation improving agent according to Item 1, which is used for a subject having a regular menstrual cycle.
本発明によれば、月経前便秘改善剤として有効な医薬品が提供される。 According to the present invention, a drug effective as a premenstrual constipation improving agent is provided.
1.月経前便秘改善剤
本発明の月経前便秘改善剤は、桃核承気湯エキス及び/又は通導散エキスを含むことを特徴とする。以下、本発明の月経便秘改善剤について詳述する。
1. 1. Premenstrual Constipation Improving Agent The premenstrual constipation improving agent of the present invention is characterized by containing Tokakujokito extract and / or Tsudosan extract. Hereinafter, the menstrual constipation improving agent of the present invention will be described in detail.
桃核承気湯エキス及び/又は通導散エキス
本発明の月経前便秘改善剤は、有効成分として、桃核承気湯エキス及び/又は通導散エキスを含む。
Tokakujokito extract and / or Tsudosan extract The premenstrual constipation improving agent of the present invention contains Tokakujokito extract and / or Tsudosan extract as active ingredients.
桃核承気湯は、「傷寒論」を原典とする処方であり、その構成生薬としては、トウニン、ケイヒ、ダイオウ、カンゾウ、及びボウショウからなる混合生薬が挙げられる。 Tokakujokito is a prescription based on "Kankanron", and its constituent crude drugs include mixed crude drugs consisting of tounin, cinnamon, rhubarb, licorice, and liquorice.
桃核承気湯を構成する各生薬の分量としては、トウニン2.0~7.0重量部、ケイヒ1.0~5.0重量部、ダイオウ1.0~5.0重量部、カンゾウ0.5~2.5重量部、及びボウショウ0.3~2.0重量部(無水ボウショウ換算量)が挙げられる。 The amount of each crude drug constituting Tokakujokito is 2.0 to 7.0 parts by weight of Tounin, 1.0 to 5.0 parts by weight of Keihi, 1.0 to 5.0 parts by weight of Daiou, and 0 parts of Kanzo. .5 to 2.5 parts by weight and 0.3 to 2.0 parts by weight of bow show (anhydrous bow show equivalent amount) can be mentioned.
通導散は、「万病回春」を原典とする処方であり、その構成生薬としては、トウキ、ダイオウ、ボウショウ、キジツ、コウボク、チンピ、モクツウ、コウカ、ソボク、及びカンゾウからなる混合生薬が挙げられる。 Tsudosan is a prescription based on "Man's disease rejuvenation", and its constituent crude drugs include mixed crude drugs consisting of Angelica acutiloba, rhubarb, bow show, angelica acutiloba, koboku, chimpi, mokutsu, kouka, soboku, and licorice. ..
通導散を構成する各生薬の分量としては、トウキ0.5~3.0重量部、ダイオウ0.5~3.0重量部、ボウショウ0.5~2.5重量部(無水ボウショウ換算量)、キジツ1.5~3.0重量部、コウボク0.3~2.5重量部、チンピ0.3~2.5重量部、モクツウ0.3~2.5重量部、コウカ0.3~2.5重量部、ソボク0.3~2.5重量部、及びカンゾウ0.3~2.5重量部が挙げられる。 The amount of each crude drug constituting Tsudosan is 0.5 to 3.0 parts by weight of Touki, 0.5 to 3.0 parts by weight of Daiou, and 0.5 to 2.5 parts by weight of Bowsho (amount converted to anhydrous Bowsho). ), Kijitsu 1.5-3.0 parts by weight, Koboku 0.3-2.5 parts by weight, Chinpi 0.3-2.5 parts by weight, Mokutsu 0.3-2.5 parts by weight, Kouka 0.3 Examples thereof include up to 2.5 parts by weight, 0.3 to 2.5 parts by weight of herbal medicine, and 0.3 to 2.5 parts by weight of herbal medicine.
桃核承気湯エキス及び通導散エキスをそれぞれの製造において、抽出処理に使用される抽出溶媒としては、特に限定されないものの、一例として水又は含水エタノールが挙げられる。また、乾燥処理としても、特に限定されず、公知の方法、例えば、スプレードライ法や、エキス液の濃度を高めた軟エキスに対して適当な吸着剤(例えば無水ケイ酸、デンプン等)を加えて吸着末とする方法等が挙げられる。 The extraction solvent used in the extraction treatment of Tokakujokito extract and Tsudosan extract is not particularly limited, but examples thereof include water and hydrous ethanol. Further, the drying treatment is not particularly limited, and a known method such as a spray drying method or an appropriate adsorbent (for example, anhydrous silicic acid, starch, etc.) is added to the soft extract having an increased concentration of the extract solution. And the method of making it an adsorption powder.
本発明において用いられる桃核承気湯エキス及び通導散エキスとしては、前述の方法で調製したエキスを使用してもよいし、市販されるものを使用してもよい。例えば、桃核承気湯のエキス末としては、「桃核承気湯乾燥エキス-AM」(日本粉末薬品株式会社製)、「桃核承気湯乾燥エキス-F」(アルプス薬品工業株式会社製)等が商品として知られており、商業的に入手することもできる。また、通導散のエキス末については、「通導散エキス細粒Gコタロー」(小太郎漢方製薬)等から商業的に入手することもできる。 As the Tokakujokito extract and Tsudosan extract used in the present invention, the extract prepared by the above-mentioned method may be used, or a commercially available one may be used. For example, as the extract powder of Tokakujokito, "Tokokujokito Dry Extract-AM" (manufactured by Nippon Powder Chemicals Co., Ltd.) and "Tokokujokito Dry Extract-F" (Alps Pharmaceutical Industry Co., Ltd.) (Made) etc. are known as products and can be obtained commercially. The extract powder of Tsudosan can also be obtained commercially from "Tsudosan Extract Fine Granules G Kotaro" (Kotaro Pharmaceutical Co., Ltd.).
本発明の月経前便秘改善剤において、有効成分の漢方エキスの含有量としては、本発明の効果を奏する限り、特に限定されないが、有効成分の漢方エキスの乾燥エキス末量換算で、通常5~100重量%、好ましくは10~90重量%、より好ましくは20~80重量%、更に好ましくは30~60重量%が挙げられる。なお、本発明において、有効成分の漢方エキスの乾燥エキス末量換算とは、漢方エキスの乾燥エキス末を使用する場合にはそれ自体の量であり、漢方エキスの液状のエキスを使用する場合には、溶媒を除去した残量に換算した量である。また、漢方エキスの乾燥エキス末が、製造時に添加される吸着剤等の添加剤を含む場合は、当該添加剤を除いた量である。 In the pre-menstrual constipation improving agent of the present invention, the content of the Chinese herbal extract of the active ingredient is not particularly limited as long as the effect of the present invention is exhibited, but it is usually 5 to 5 in terms of the dry extract powder amount of the Chinese herbal extract of the active ingredient. 100% by weight, preferably 10 to 90% by weight, more preferably 20 to 80% by weight, still more preferably 30 to 60% by weight. In addition, in this invention, the dry extract powder amount conversion of the active ingredient Chinese medicine extract is the amount itself when the dry extract powder of Chinese medicine extract is used, and when the liquid extract of Chinese medicine extract is used, it is the amount of itself. Is the amount converted into the remaining amount after removing the solvent. When the dried extract powder of the Chinese herbal extract contains an additive such as an adsorbent added at the time of production, the amount is the amount excluding the additive.
その他の成分
本発明の月経前便秘改善剤は、有効成分の漢方エキス単独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、月経前便秘改善剤の製剤形態等に応じて適宜設定される。
Other Ingredients The premenstrual constipation improving agent of the present invention may consist of the active ingredient Chinese herbal extract alone, or may contain additives and bases according to the pharmaceutical 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, emulsifiers, 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 content of these additives and bases is appropriately set according to the types of additives and bases to be used, the pharmaceutical form of the premenstrual constipation improving agent, and the like.
また、本発明の月経前便秘改善剤は、上記有効成分の他に、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。 Further, the premenstrual constipation improving agent of the present invention may contain other nutritional components and pharmacological components in addition to the above active ingredients, if necessary. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable, and are, for example, antioxidants, 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, vasoconstrictors, 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
本発明の月経前便秘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。これらの製剤形態の中でも、含有成分の安定性や携帯性等の観点から、好ましくは固形状製剤、より好ましくは錠剤が挙げられる。
Formulation form The formulation form of the premenstrual constipation improving agent 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 granule, a tablet, a troche, a chewable agent, and the like. Examples thereof include solid preparations such as capsules (soft capsules and hard capsules) and rounds; semi-solid preparations such as jelly; liquid preparations such as liquids, suspensions and syrups. Among these preparation forms, a solid preparation is preferable, and a tablet is more preferable, from the viewpoint of stability and portability of the contained components.
製造方法
本発明の月経前便秘改善剤の製造方法は、有効成分の漢方エキスと、必要に応じて配合されるその他の成分とを用いて、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。
Manufacturing method The manufacturing method of the pre-menstrual constipation improving agent of the present invention uses a Chinese herbal extract as an active ingredient and other ingredients to be blended as needed, in accordance with a usual formulation method adopted in the pharmaceutical field. It may be formulated.
用途
本発明の月経前便秘改善剤は、月経前に生じる便秘を改善する目的で用いられ、より具体的には月経前に生じる便秘を予防又は治療する目的で用いられる。月経前に生じる便秘は、具体的には、月経前に悪化し月経開始とともに軽快する点で、月経前の期間に特徴的に生じる。月経前としては、具体的には、黄体期が挙げられ、より好ましくは黄体後期が挙げられる。
Use The premenstrual constipation improving agent of the present invention is used for the purpose of improving constipation that occurs before menstruation, and more specifically, for the purpose of preventing or treating constipation that occurs before menstruation. Constipation that occurs before menstruation is characteristically occurring during the premenstrual period in that it worsens before menstruation and improves with the onset of menstruation. Specific examples of premenstrual syndrome include the luteal phase, and more preferably the late luteal phase.
なお、本発明の月経前便秘改善剤の適用対象は、月経前の期間に特徴的な便秘を起こす人であればよく、月経前の期間に特徴的な便秘を起こし且つ月経前以外の期間には便秘を起こさない人だけでなく、月経前の期間に特徴的な便秘を起こし且つ月経前以外の期間には(月経前の期間に特徴的な便秘は一旦軽快するが)、時期に関わらず、女性ホルモン変動以外の不特定の要因(例えば、繊維摂取量不足、水分不足、朝食の欠食等)で不定期に便秘を起こす人も含まれる。 The target of the pre-menstrual constipation improving agent of the present invention may be a person who causes characteristic constipation during the pre-menstrual period, and causes characteristic constipation during the pre-menstrual period and during a period other than pre-menstrual period. Not only for those who do not have constipation, but also for those who have characteristic constipation during the pre-menstrual period and during non-menstrual periods (although the characteristic constipation during the pre-menstrual period is once relieved), regardless of the time of year. Also includes people who have irregular constipation due to unspecified factors other than female hormone fluctuations (eg, lack of fiber intake, lack of water, lack of breakfast, etc.).
本発明の月経前肌荒れ改善剤の適用対象は、月経前の期間に特徴的な便秘を起こす対象であれば特に限定されないが、好ましくは月経周期が規則的な対象が挙げられる。月経周期が規則的とは、月経周期日数が25日~38日、出血持続日数が3~7日でかつ変動が6日以内であることをいう。 The target of application of the premenstrual rough skin improving agent of the present invention is not particularly limited as long as it causes characteristic constipation during the premenstrual period, but preferably a target having a regular menstrual cycle. Regular menstrual cycle means that the number of days of the menstrual cycle is 25 to 38 days, the duration of bleeding is 3 to 7 days, and the fluctuation is within 6 days.
用量・用法
本発明の月経前便秘改善剤は、経口投与によって使用される。本発明の月経前便秘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、桃核承気湯エキス及び通導散エキスの総量(乾燥エキス換算量)として、例えば500~7000mg、好ましくは1000~6000mg;桃核承気湯エキス量(乾燥エキス換算量)として、例えば500~5000mg、好ましくは1000~4000mg、より好ましくは1200~2000mg;通導散エキス量(乾燥エキス換算量)として、例えば3000~7000mg、好ましくは4000~6000mgとなる量で、1日1~4回、好ましくは2~3回の頻度で服用すればよい。
Dosage and Usage The premenstrual constipation improving agent of the present invention is used by oral administration. The dose of the pre-menstrual constipation improving agent of the present invention is appropriately set according to the age, constitution, degree of symptom, etc. of the administration subject. The total amount of the extract and tsudosan extract (equivalent to dry extract) is, for example, 500 to 7000 mg, preferably 1000 to 6000 mg; the amount of Tokakujokito extract (equivalent to dry extract) is, for example, 500 to 5000 mg, preferably 1000. ~ 4000 mg, more preferably 1200 ~ 2000 mg; the amount of tsudosan extract (dry extract equivalent amount) is, for example, 3000 to 7000 mg, preferably 4000 to 6000 mg, 1 to 4 times a day, preferably 2 to 3 times. It should be taken as often as once.
一日の中での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、好ましくは食前又は食間が挙げられる。 The timing of administration during the day is not particularly limited and may be pre-meal, post-meal, or inter-meal, but pre-meal or inter-meal is preferable.
また、月経周期の中での服用タイミングについても特に限定されない。例えば、本発明の月経前便秘改善剤が即効性に優れているため、改善したい月経前の便秘を感じたタイミングで服用を開始することができる。より具体的には、本発明の月経前便秘改善剤は、黄体後期開始時から服用しても、その黄体後期のうちに、便秘改善効果を得ることができる。なお、月経前便秘改善効果をより一層高める観点から、1回の月経周期あたり、例えば2日以上、好ましくは3日以上、より好ましくは4日以上、さらに好ましくは5日以上継続して服用することが好ましい。また、1回の月経周期当たりの服用継続日数としては特に限定されず、月経開始と同時に服用をやめればよい。具体的な服用継続日数としては、月経周期の長さによって異なるが、月経前から月経開始にかけて特徴的に現れる肌荒れに適用される場合においては、例えば9日以下、8日以下、又は7日以下が挙げられる。 In addition, the timing of administration during the menstrual cycle is not particularly limited. For example, since the premenstrual constipation improving agent of the present invention has an excellent immediate effect, it is possible to start taking the drug at the timing when the premenstrual constipation to be improved is felt. More specifically, even if the premenstrual constipation improving agent of the present invention is taken from the beginning of the late luteal phase, the constipation improving effect can be obtained during the late luteal phase. From the viewpoint of further enhancing the effect of improving premenstrual constipation, it should be taken continuously for, for example, 2 days or more, preferably 3 days or more, more preferably 4 days or more, and further preferably 5 days or more per menstrual cycle. Is preferable. In addition, the number of consecutive days of administration per menstrual cycle is not particularly limited, and the administration may be stopped at the same time as the start of menstruation. The specific number of days of continuous administration varies depending on the length of the menstrual cycle, but when applied to rough skin that appears characteristically from premenstrual period to the start of menstruation, for example, 9 days or less, 8 days or less, or 7 days or less. Can be mentioned.
また、本発明の月経前便秘改善剤は、便秘が起こる時期に先立って予防目的で服用してもよい。例えば、黄体後期から便秘が起こる人の場合、排卵期又は黄体期開始時から服用を始めることができる。この場合も、また、1回の月経周期当たりの服用継続日数としては特に限定されず、月経開始と同時に服用をやめればよい。 In addition, the premenstrual constipation improving agent of the present invention may be taken for preventive purposes prior to the time when constipation occurs. For example, in the case of a person who develops constipation from the late luteal phase, the administration can be started from the ovulation period or the beginning of the luteal phase. In this case as well, the number of consecutive days of administration per menstrual cycle is not particularly limited, and the administration may be stopped at the same time as the start of menstruation.
(1)漢方エキスの調製
(1-1)桃核承気湯エキス
原料生薬を、トウニン3.0重量部、ケイヒ2.4重量部、ダイオウ1.8重量部、カンゾウ0.9重量部、及びボウショウ0.6重量部(無水ボウショウ換算量)の割合で用い、これらを刻んだ後、水20倍重量を用いて約100℃で1時間抽出し、遠心分離して抽出液を得、減圧下で濃縮してスプレードライヤーを用いて乾燥し、桃核承気湯エキス末を得た。得られた桃核承気湯エキス末は、原料生薬混合物8.7g当たり1584mg(1日用量)であった。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して行った。
(1) Preparation of Chinese herbal extract (1-1) Tokakujokito extract Raw herbal medicine was added to 3.0 parts by weight of Tounin, 2.4 parts by weight of Keihi, 1.8 parts by weight of Daiou, and 0.9 parts by weight of Kanzo. And 0.6 parts by weight of bow show (anhydrous bow show equivalent amount), after chopping these, extract at about 100 ° C. for 1 hour using 20 times the weight of water, centrifuge to obtain an extract, and reduce the pressure. It was concentrated underneath and dried using a spray dryer to obtain Tokakujokito extract powder. The obtained Tokakujokito extract powder was 1584 mg (daily dose) per 8.7 g of the raw material crude drug mixture. The drying with a spray dryer was carried out by dropping the extract onto an atomizer having a rotation speed of 10000 rpm and supplying hot air with air at 150 ° C.
(1-2)通導散エキス
原料生薬を、トウキ2.4重量部、ダイオウ2.4重量部、ボウショウ1.44量部(無水ボウショウ換算量)、キジツ2.4重量部、コウボク1.6重量部、チンピ1.6重量部、モクツウ1.6重量部、コウカ1.6重量部、ソボク1.6重量部、及びカンゾウ1.6重量部の割合で用い、これらを刻んだ後、水20倍重量を用いて約100℃で1時間抽出し、遠心分離して抽出液を得、減圧下で濃縮してスプレードライヤーを用いて乾燥し、通導散エキス末を得た。得られた通導散エキス末は、原料生薬混合物16.64g当たり5200mg(1日用量)であった。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して行った。
(1-2) Tsudosan extract The crude drug as the raw material was 2.4 parts by weight of Touki, 2.4 parts by weight of Daiou, 1.44 parts by weight of Bowsho (anhydrous Bowsho equivalent amount), 2.4 parts by weight of Kijitsu, and Koboku 1. 6 parts by weight, 1.6 parts by weight of chimpi, 1.6 parts by weight of mokutsu, 1.6 parts by weight of kouka, 1.6 parts by weight of soboku, and 1.6 parts by weight of kanzo. It was extracted at about 100 ° C. for 1 hour using 20 times the weight of water, centrifuged to obtain an extract, concentrated under reduced pressure and dried using a spray dryer to obtain a tsudosan extract powder. The obtained Tsudosan extract powder was 5200 mg (daily dose) per 16.64 g of the raw material crude drug mixture. The drying with a spray dryer was carried out by dropping the extract onto an atomizer having a rotation speed of 10000 rpm and supplying hot air with air at 150 ° C.
(1-3)防風通聖散エキス
原料生薬を、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1.2重量部、ケイガイ1.2重量部、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、無水ボウショウ1.5重量部、ビャクジュツ2.0重量部、キキョウ2.0重量部、オウゴン2.0重量部、カンゾウ2.0重量部、セッコウ2.0重量部、及びカッセキ3.0重量部、の割合で用い、これらを刻んだ後、水20倍重量を用いて約100℃で1時間抽出し、遠心分離して抽出液を得、減圧下で濃縮してスプレードライヤーを用いて乾燥し、防風通聖散エキス末を得た。得られた防風通聖散エキス末は、原料生薬混合物27.1g当たり5000mg(1日用量)であった。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して行った。
(1-3) Bofutsushosan extract Raw medicine, 1.2 parts by weight of Touki, 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 Renkyo, Hacka 1.2 parts by weight, 1.2 parts by weight of Shokyo, 1.2 parts by weight of Keigai, 1.2 parts by weight of Bofu, 1.2 parts by weight of Maou, 1.5 parts by weight of Daiou, 1.5 parts by weight of anhydrous bow show, 2.0 parts by weight of Byakujutsu, 2.0 parts by weight of Kikyo, 2.0 parts by weight of Ogon, 2.0 parts by weight of Kanzo, 2.0 parts by weight of Sekko, and 3.0 parts by weight of Kaseki. After chopping, extract at about 100 ° C. for 1 hour using 20 times the weight of water, centrifuge to obtain an extract, concentrate under reduced pressure and dry using a spray dryer to obtain bofutsushosan extract powder. Obtained. The obtained bofutsushosan extract powder was 5000 mg (daily dose) per 27.1 g of the raw material crude drug mixture. The drying with a spray dryer was carried out by dropping the extract onto an atomizer having a rotation speed of 10000 rpm and supplying hot air with air at 150 ° C.
(2)被験者及び投薬スケジュール
(2-1)
月経前に特徴的な便秘を訴える、規則的な月経周期のある20~40歳の女性(N=30)を被験者とした。これらの被験者を、便秘の程度にばらつきが無いように3群(各群N=10)に分け、それぞれの群に、月経前に便秘の出現を感じた時から5日間、桃核承気湯エキス、通導散エキス、又は防風通聖散エキスを、1日3回、食前又は食間に服用させた。服用期間における便秘の症状が、前回の月経周期における月経前の便秘の症状と比較して比較してどの程度改善を感じたかについて、5段階(改善を感じた、どちらかといえば改善を感じた、どちらともいえない、どちらかといえば改善を感じなかった、改善を感じなかった)にて評価を行った。結果を表1に示す。
(2) Subject and dosing schedule (2-1)
The subjects were women aged 20-40 years (N = 30) with a regular menstrual cycle who complained of characteristic constipation before menstruation. These subjects were divided into 3 groups (N = 10 in each group) so that the degree of constipation did not vary, and each group had constipation for 5 days from the time when they felt the appearance of constipation before menstruation. The extract, tsudosan extract, or bofutsushosan extract was taken 3 times a day before or between meals. How much improvement was felt in the symptoms of constipation during the period of administration compared to the symptoms of premenstrual constipation in the previous menstrual cycle? , I can't say either, I didn't feel any improvement, I didn't feel any improvement). The results are shown in Table 1.
(2-2)
また、上記の被験者は、月経前に特徴的な便秘の他、月経前以外の期間において不定期に、女性ホルモン変動以外の要因で便秘を起こしていた。上記(2-1)の試験を行った後断薬期間を経て、月経前に特徴的な便秘の復活を確認した後、月経前以外の期間において不定期な便秘の出現を感じた時から5日間、桃核承気湯エキス、通導散エキス、又は防風通聖散エキスを、1日3回、食前又は食間に服用させ、上記(2-1)と同様にして当該不定期な便秘の改善の如何を評価した。結果を表2に示す。
(2-2)
In addition to the characteristic constipation before menstruation, the above-mentioned subjects had constipation due to factors other than female hormone fluctuations irregularly during periods other than premenstrual syndrome. After confirming the recovery of characteristic constipation before menstruation after the drug withdrawal period after conducting the above test (2-1), from the time when irregular constipation appears in the period other than before menstruation 5 For days, take Tokakujokito extract, Tsudosan extract, or Bofutsushosan extract three times a day before or between meals, and in the same way as in (2-1) above, for the irregular constipation. I evaluated how it improved. The results are shown in Table 2.
表1に示す通り、桃核承気湯エキス及び通導散エキスは、防風通聖散エキスと比べて、月経前の便秘に対して優れた改善効果を示した。表2に示す通り、桃核承気湯エキス及び通導散エキスが、月経前以外の不定期の便秘に対しては改善効果が乏しく、むしろ防風通聖散エキスの方で改善効果が高いことに鑑みると、月経前の便秘状態と月経前以外の不定期の便秘状態とは、桃核承気湯エキス及び通導散エキスと、防風通聖散エキスとに対する感受性が本質的に異なっており、桃核承気湯エキス及び通導散エキスによる便秘改善効果は、月経前の便秘に対する特有の効果であると認められる。 As shown in Table 1, the Tokakujokito extract and Tsudosan extract showed an excellent improvement effect on premenstrual constipation as compared with the bofutsushosan extract. As shown in Table 2, the improvement effect of Tokakujokito extract and Tsudosan extract is poor for irregular constipation other than before menstruation, but rather the improvement effect of Bofutsushosan extract is higher. In view of the above, the pre-menstrual constipation and the non-pre-menopausal constipation are essentially different in sensitivity to the Tokakujokito extract and Tsudosan extract and the Bofutsushosan extract. , The effect of improving constipation by Tokakujokito extract and Tsudosan extract is recognized to be a peculiar effect on constipation before menstruation.
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