JP2021161041A - Heart frequency increment inhibitor for inhibiting increment of heart frequency in drinking - Google Patents
Heart frequency increment inhibitor for inhibiting increment of heart frequency in drinking Download PDFInfo
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Abstract
Description
本発明は、飲酒による心拍数増加の抑制剤に関する。 The present invention relates to an agent that suppresses an increase in heart rate due to drinking.
アルコールは様々な疾病に関連しており、過度の飲酒がこれらの疾病に悪影響を及ぼすことが知られて久しい。一方で、適度の飲酒であれば、体への好ましい影響もあることも明らかになっており、飲酒と良い関係を保っていくことが推奨されている。 Alcohol is associated with a variety of illnesses, and it has long been known that excessive drinking has an adverse effect on these illnesses. On the other hand, it has been clarified that moderate drinking has a positive effect on the body, and it is recommended to maintain a good relationship with drinking.
過度な飲酒に伴う、アルコールの代謝過程で生じるアセトアルデヒドは、身体の生理機能に様々な影響を及ぼす。短期的には、アセトアルデヒドは毛細血管の拡張作用による顔面紅潮や顔の膨張や心拍数の増加（非特許文献１）等をもたらす。心拍数の増加変動が顕著になると、動悸等の不快な症状（非特許文献２）も引き起こす。 Acetaldehyde produced in the metabolic process of alcohol associated with excessive drinking has various effects on the physiological function of the body. In the short term, acetaldehyde causes hot flushes, facial swelling, and an increase in heart rate due to the dilation of capillaries (Non-Patent Document 1). When the increase and fluctuation of the heart rate becomes remarkable, it also causes unpleasant symptoms such as palpitation (Non-Patent Document 2).
飲食によって増加した心拍数は、長時間にわたって高いレベルを維持する。また、アセトアルデヒド代謝酵素の処理能力が比較的低い体質では、心拍数の増加変動が大きく動悸を伴いやすくなるとともに、長引く傾向にある。心拍数の増加変動が大きく長くなるほど循環器系等の身体に対して負担になることに鑑みると、より快適な飲酒のためには、心拍数の増加を抑制することが望まれる。しかしながら、これまで、飲酒による心拍数増加を抑制できる処方は知られていなかった。 The heart rate increased by eating and drinking remains at a high level for a long period of time. In addition, in a constitution in which the processing capacity of acetaldehyde-metabolizing enzyme is relatively low, the increase and fluctuation of the heart rate is large and palpitations are likely to occur, and the heart rate tends to be prolonged. Considering that the larger and longer the fluctuation of the increase in heart rate, the more burden is placed on the body such as the circulatory system, it is desired to suppress the increase in heart rate for more comfortable drinking. However, until now, no prescription has been known that can suppress the increase in heart rate due to drinking.
そこで、本発明は、飲酒による心拍数増加を抑制する処方を提供することを目的とする。 Therefore, an object of the present invention is to provide a prescription that suppresses an increase in heart rate due to drinking.
本発明者は、五苓散が、飲酒による心拍数の増加に対して抑制作用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 Goreisan has an inhibitory effect on the increase in heart rate due to drinking. 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． 五苓散エキスを含む、飲酒による心拍数増加の抑制剤。
項２． 前記心拍数増加が動悸を伴う、項１に記載の飲酒による心拍数増加の抑制剤。
項３． 純アルコール摂取量が１４〜３６．４ｇとなる量の飲酒に対して用いられる、項１又は２に記載の飲酒による心拍数増加の抑制剤。
That is, the present invention provides the inventions of the following aspects.
Item 1. An agent that suppresses the increase in heart rate due to drinking, including Goreisan extract.
Item 2. Item 2. The agent for suppressing an increase in heart rate due to drinking according to Item 1, wherein the increase in heart rate is accompanied by palpitation.
Item 3. Item 2. The agent for suppressing an increase in heart rate due to drinking according to Item 1 or 2, which is used for drinking alcohol in an amount of 14 to 36.4 g.
本発明によれば、飲酒による心拍数の増加を抑制する処方が提供される。 According to the present invention, a formulation that suppresses an increase in heart rate due to drinking is provided.
本発明の飲酒による心拍数増加の抑制剤は、五苓散エキスを含むことを特徴とする。以下、本発明の飲酒による心拍数増加の抑制剤について詳細に説明する。 The agent for suppressing an increase in heart rate due to drinking of the present invention is characterized by containing Goreisan extract. Hereinafter, the agent for suppressing an increase in heart rate due to drinking of the present invention will be described in detail.
五苓散エキス
五苓散を構成する生薬の組成は、原典に基づいていれば特に限定されないが、具体的には、タクシャ、チョレイ、ブクリョウ、ジュツ、及びケイヒが挙げられる。五苓散を構成する生薬のより具体的な例としては、タクシャ、チョレイ、ブクリョウ、ビャクジュツ、及びケイヒ；又は、タクシャ、チョレイ、ブクリョウ、ソウジュツ、及びケイヒが挙げられる。
Goreisan Extract The composition of the crude drugs that make up Goreisan is not particularly limited as long as it is based on the original text, but specific examples thereof include Takusha, Chorei, Bukuryo, Jutsu, and Keihi. More specific examples of the herbal medicines constituting Goreisan include Takusha, Chorei, Bukuryo, Byakujutsu, and Keihi; or Takusha, Chorei, Bukuryo, Sojutsu, and Keihi.
これらの五苓散の構成生薬のうち、飲酒による心拍数増加の抑制効果をより一層高める観点から、タクシャ、チョレイ、ブクリョウ、ビャクジュツ、及びケイヒであることが好ましい。 Among these herbal medicines constituting Goreisan, Takusha, Chorei, Bukuryo, Byakujutsu, and Keihi are preferable from the viewpoint of further enhancing the effect of suppressing the increase in heart rate due to drinking.
五苓散の構成生薬それぞれの重量混合比（タクシャ：チョレイ：ブクリョウ：ジュツ：ケイヒ）としては、例えば、（１７〜３３）：（１７〜２２）：（１７〜２９）：（１７〜２９）：（８〜１７）が挙げられる。 The weight mixing ratio of each of the constituent crude drugs of Goreisan (Takusha: Chorei: Bukuryo: Jutsu: Keihi) is, for example, (17 to 33) :( 17 to 22) :( 17 to 29) :( 17 to 29). : (8 to 17).
これらの五苓散の構成生薬それぞれの重量混合比（タクシャ：チョレイ：ブクリョウ：ジュツ：ケイヒ）は、飲酒による心拍数増加の抑制効果をより一層高める観点から、（１８〜３２）：（１８〜２０）：（１８〜２８）：（１８〜２８）：（９〜１６）であることが好ましく、（２８〜３２）：（１７〜１９）：（１７〜１９）：（１７〜１９）：（１２〜１３）であることが更に好ましく、５：３：３：３：２であることが特に好ましい。 The weight mixing ratio of each of these five herbal medicines (Takusha: Chorei: Bukuryo: Jutsu: Keihi) is (18-32) :( 18-32) from the viewpoint of further enhancing the effect of suppressing the increase in heart rate due to drinking. 20) :( 18-28) :( 18-28): (9-16) is preferable, and (28-32) :( 17-19) :( 17-19) :( 17-19) :. It is more preferably (12 to 13), and particularly preferably 5: 3: 3: 3: 2.
五苓散エキスは、上述の５種類の構成生薬の混合物を、抽出溶媒を用いた抽出工程に供することにより得ることができる。抽出工程において抽出処理に使用される抽出溶媒としては、水；エタノール、イソプロパノール等の低級アルコール；１，３−ブチレングリコール、プロピレングリコール等の多価アルコール；これらの混合液等の極性溶媒が挙げられ、飲酒による心拍数増加の抑制効果をより一層高める観点から、水が挙げられる。抽出に供される混合物中の各生薬の大きさは日本薬局方に定める細切程度とし、混合物に対して、約５〜２０倍量の抽出溶媒を加え、８０〜１００℃程度で０．５〜３時間程度撹拌して抽出することができる。五苓散エキスは、抽出工程後に、遠心分離、濾過等の固液分離工程に供して固形分を除去することによって得られた抽出液を、更に濃縮工程に供して得たエキス液であってもよいし、更に乾燥工程に供して得たエキス末であってもよい。また、乾燥工程における乾燥処理としても特に限定されず、公知の方法を用いることができ、具体的には、スプレードライ法、減圧濃縮乾燥法、凍結乾燥法等が挙げられる。五苓散エキスを乾燥処理に供する場合、五苓散エキス液に賦形剤を添加して乾燥させてもよい。 Goreisan extract can be obtained by subjecting a mixture of the above-mentioned five kinds of constituent crude drugs to an extraction step using an extraction solvent. Examples of the extraction solvent used in the extraction treatment in the extraction step include water; lower alcohols such as ethanol and isopropanol; polyhydric alcohols such as 1,3-butylene glycol and propylene glycol; and polar solvents such as a mixture of these. , Water is mentioned from the viewpoint of further enhancing the effect of suppressing the increase in heart rate due to drinking. The size of each crude drug in the mixture to be extracted shall be about the size specified in the Japanese Pharmacopoeia, and about 5 to 20 times the amount of extraction solvent shall be added to the mixture, and 0.5 at about 80 to 100 ° C. It can be extracted by stirring for about 3 hours. Goreisan extract is an extract obtained by subjecting an extract obtained by subjecting it to a solid-liquid separation step such as centrifugation or filtration after the extraction step to remove solids, and further subjecting it to a concentration step. It may be an extract powder obtained by subjecting it to a drying step. Further, the drying treatment in the drying step is not particularly limited, and a known method can be used, and specific examples thereof include a spray drying method, a vacuum concentration drying method, and a freeze drying method. When the Goreisan extract is subjected to a drying treatment, an excipient may be added to the Goreisan extract solution to dry it.
本発明の飲酒時による心拍数増加の抑制剤中の五苓散エキスの含有量としては、発揮させる心拍数増加の抑制効果に応じて適宜調整することができ、例えば、乾燥エキス換算量で４０〜１００重量％、好ましくは４５〜８０重量％が挙げられ、より好ましくは５０〜６０重量％が挙げられる。なお、本発明において、乾燥エキス換算量とは、乾燥エキス末を使用する場合にはそれ自体の量であり、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り、乾燥エキス末が製造時に添加される賦形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。 The content of Goreisan extract in the agent for suppressing the increase in heart rate due to drinking of the present invention can be appropriately adjusted according to the effect of suppressing the increase in heart rate to be exerted. -100% by weight, preferably 45-80% by weight, more preferably 50-60% by weight. In the present invention, the dry extract equivalent amount is the amount itself when the dry extract powder is used, and is the amount converted to the remaining amount after removing the solvent when the liquid extract is used. If the dried extract powder contains additives such as excipients added at the time of production, the amount is the amount excluding the additives.
その他の成分
本発明の飲酒による心拍数増加の抑制剤においては、有効成分である五苓散エキスの他に、更に製剤形態に応じた添加剤や基剤を含んでもよい。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、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、結合剤、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、好ましくは賦形剤及び乳糖が挙げられる。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、本発明の飲酒による心拍数増加抑制剤の製剤形態等に応じて適宜設定される。
Other Ingredients The agent for suppressing the increase in heart rate due to drinking of the present invention may further contain additives and bases depending on the form of the preparation in addition to the active ingredient, Goreisan extract. The additives and bases are not particularly limited as long as they are pharmaceutically acceptable, but are excipients, disintegrants, lubricants, tonicity agents, plasticizers, dispersants, emulsifiers, and solubilizers. , Wetting agents, binders, stabilizers, suspending agents, pressure-sensitive agents, 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 agents and the like, preferably excipients and lactose. These additives may be used alone or in combination of two or more. The contents of these additives and bases are appropriately set according to the types of additives and bases to be used, the formulation form of the heart rate increase inhibitor due to drinking of the present invention, and the like.
上記の添加剤及び基剤の具体例としては、賦形剤として、乳糖（好ましくは乳糖水和物）、マンニトール、エリスリトール、トレハロース、キシリトール、ソルビトール、結晶セルロース、タルク、二酸化ケイ素等が挙げられ、好ましくは乳糖（好ましくは乳糖水和物）が挙げられ；結合剤として、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、ポリビニルピロリドン、マクロゴール等が挙げられ、好ましくはヒドロキシプロピルセルロースが挙げられる。 Specific examples of the above additives and bases include, as excipients, lactose (preferably lactose hydrate), mannitol, erythritol, trehalose, xylitol, sorbitol, crystalline cellulose, talc, silicon dioxide and the like. Lactose (preferably lactose hydrate) can be mentioned; examples of the binder include hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, macrogol and the like, and hydroxypropyl cellulose is preferable.
また、飲酒による心拍数増加の抑制剤中における上記の添加剤及び基剤の含有量の具体例としては、賦形剤の含有量として、２０〜７０重量％、好ましくは３０〜６０重量％、より好ましくは４０〜５０重量％が挙げられ、結合剤の含有量として、１〜１０重量％、好ましくは２〜５重量％、より好ましくは２〜３．５重量％挙げられる。 Further, as a specific example of the content of the above-mentioned additive and base in the agent for suppressing the increase in heart rate due to drinking, the content of the excipient is 20 to 70% by weight, preferably 30 to 60% by weight. More preferably, it is 40 to 50% by weight, and the content of the binder is 1 to 10% by weight, preferably 2 to 5% by weight, and more preferably 2 to 3.5% by weight.
また、本発明の飲酒による心拍数増加の抑制剤は、必要に応じて、上記生薬成分以外の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、他の生薬末及び／又は他の生薬エキス、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 agent for suppressing the increase in heart rate due to drinking of the present invention may contain nutritional components and pharmacological components other than the above-mentioned crude drug 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 antitussives. Agents, antitussives, expectorants, anti-inflammatory enzymes, sedative hypnotics, antihistamines, caffeines, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, other herbal powders and / or other herbal medicines Examples include extracts and vitamins. 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
本発明の飲酒による心拍数増加の抑制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、易携帯性、易服用性等の観点から、好ましくは固形状製剤が挙げられ、より好ましくは顆粒剤が挙げられる。
Formulation form The formulation form of the agent for suppressing the increase in heart rate due to drinking of the present invention is not particularly limited as long as it can be orally administered. Examples include solid preparations such as chewables, capsules (soft capsules, hard capsules) and pills; semi-solid preparations such as jelly; liquid preparations such as liquids, suspending agents and syrups. Among these formulations, from the viewpoints of stability, portability, ease of ingestion and the like of the contained components, a solid formulation is preferable, and granules are more preferable.
製造方法
本発明の飲酒による心拍数増加の抑制剤の製造方法は、五苓散エキスと、必要に応じて配合される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 agent for suppressing the increase in heart rate due to drinking of the present invention is a usual formulation adopted in the pharmaceutical field using Goreisan extract and other ingredients to be blended as needed. It may be formulated according to the method.
用途
本発明の飲酒による心拍数増加の抑制剤は、飲酒によって生じる心拍数の増加の程度を低減する目的で用いられる。
Applications The agent for suppressing the increase in heart rate due to drinking of the present invention is used for the purpose of reducing the degree of increase in heart rate caused by drinking.
本発明において、増加を抑制すべき「心拍数」は、脈拍と一致する。従って、飲酒による心拍数増加の抑制は、飲酒による脈拍の増加の程度が低減されていることで確認することができる。また、飲酒によって心拍数が単純に１００回／分程度以上になると、動悸を自覚する人が多い。本発明は、飲酒による心拍数増加の抑制効果に優れているため、心拍数増加が動悸を伴う程度であっても、効果的に抑制効果を得ることができる。なお、本発明における動悸は、飲酒に起因する心拍数増加の一例であって、不整脈等の心疾患や甲状腺疾患に起因する動悸は含まない。本発明における動悸の具体例としては、心拍数（脈拍）が１００回／分以上、好ましくは１１０回／分以上、より好ましくは１２０回／分以上である状態をいう。 In the present invention, the "heart rate" for which the increase should be suppressed is consistent with the pulse. Therefore, the suppression of the increase in heart rate due to drinking can be confirmed by the fact that the degree of increase in pulse due to drinking is reduced. In addition, many people become aware of palpitation when their heart rate simply exceeds 100 beats / minute due to drinking alcohol. Since the present invention is excellent in the effect of suppressing the increase in heart rate due to drinking, the effect of suppressing the increase in heart rate can be effectively obtained even if the increase in heart rate is accompanied by palpitation. The palpitation in the present invention is an example of an increase in heart rate caused by drinking, and does not include palpitation caused by heart disease such as arrhythmia or thyroid disease. Specific examples of palpitation in the present invention refer to a state in which the heart rate (pulse) is 100 times / minute or more, preferably 110 times / minute or more, and more preferably 120 times / minute or more.
飲酒によって増加した心拍数は、通常、長時間にわたって高いレベルを維持するが、本発明の飲酒による心拍数増加の抑制剤は、増加した心拍数の程度を速やかに低減することができる。したがって、本発明の飲酒による心拍数増加の抑制剤は、飲酒開始後の心拍数の高い時間を短縮する目的でも使用することができる。 Although the heart rate increased by drinking usually maintains a high level for a long period of time, the inhibitor of the heart rate increase by drinking of the present invention can rapidly reduce the degree of the increased heart rate. Therefore, the agent for suppressing the increase in heart rate due to drinking of the present invention can also be used for the purpose of shortening the time when the heart rate is high after the start of drinking.
本発明の飲酒時の心拍数増加の抑制剤の具体的な適用対象としては、飲酒によって心拍数が増加する人であれば特に限定されない。また、飲酒時に毛細血管の拡張現象（具体的には、顔面紅潮等）を生じる人は、心拍数の増加の程度が大きい傾向にあるため、本発明の飲酒時の心拍数増加の抑制剤の好ましい適用対象としては、飲酒時に毛細血管の拡張現象を生じる人が挙げられる。本発明の飲酒時の心拍数増加の抑制剤の適用対象のさらなる例としては、純アルコール摂取量が１４〜３６．４ｇとなる量の飲酒を行う人、特に１５分で純アルコール摂取量が１４〜３６．４ｇとなる速度で飲酒を行う人等が挙げられる。 The specific application target of the inhibitor of the heart rate increase during drinking of the present invention is not particularly limited as long as it is a person whose heart rate increases due to drinking. In addition, since a person who develops a dilation phenomenon of capillaries (specifically, facial flushing, etc.) during drinking tends to have a large degree of increase in heart rate, the agent for suppressing the increase in heart rate during drinking of the present invention. Preferable application targets include those who develop the dilation phenomenon of capillaries when drinking. As a further example of the application target of the inhibitor of the increase in heart rate during drinking of the present invention, a person who drinks an amount of pure alcohol intake of 14 to 36.4 g, particularly a pure alcohol intake of 14 in 15 minutes. Examples include people who drink alcohol at a rate of up to 36.4 g.
用量・用法
本発明の飲酒による心拍数増加の抑制剤は、経口投与によって使用される。本発明の飲酒による心拍数増加の抑制剤の用量については、投与対象者の年齢、性別、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、五苓散エキスの原生薬換算量で５〜３０ｇ、好ましくは１０〜２５ｇとなる量、又は、五苓散エキスの乾燥エキス換算量で１０００〜３０００ｍｇ、好ましくは１５００〜２７００ｍｇ、より好ましくは２０００〜２４００ｍｇとなる量で、１日１〜３回、好ましくは１回の頻度で服用すればよい。服用タイミングについては特に制限されず、食前、食後、又は食間のいずれであってもよいが、飲酒による心拍数増加の抑制効果をより一層高める観点から、好ましくはアルコール摂取の前、より好ましくはアルコール摂取の２０〜４０分前、さらに好ましくはアルコール摂取の３０分前が挙げられる。
Dosage and Usage The drug for suppressing the increase in heart rate due to drinking of the present invention is used by oral administration. The dose of the agent for suppressing the increase in heart rate due to drinking of the present invention is appropriately set according to the age, sex, constitution, degree of symptoms, etc. of the subject to be administered. The crude drug equivalent of Goreisan extract is 5 to 30 g, preferably 10 to 25 g, or the dry extract equivalent of Goreisan extract is 1000 to 3000 mg, preferably 1500 to 2700 mg, more preferably 2000 to. It may be taken in an amount of 2400 mg 1 to 3 times a day, preferably once a day. The timing of administration is not particularly limited and may be before, after, or between meals, but from the viewpoint of further enhancing the effect of suppressing the increase in heart rate due to drinking, it is preferable before alcohol intake, and more preferably alcohol. 20-40 minutes before ingestion, more preferably 30 minutes before alcohol ingestion.
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
（飲酒による心拍数増加の抑制剤の調製）
表１に示す組成の生薬組成物に、重量比で１０倍量の水を抽出溶媒として加えて、約１００℃で１時間撹拌しながら抽出を行った。その後、遠心分離にて抽出液を回収し、減圧濃縮し、更にスプレードライヤーで乾燥させることによって、顆粒状の五苓散エキスを調製した。この五苓散エキスを乾燥エキス換算量で２３００ｍｇ（原生薬換算量では１６ｇ）用いて、表２に示す成分を混合し、練合及び造粒することによって、飲酒による心拍数増加の抑制剤の顆粒剤を製剤した。
Test example (preparation of an agent that suppresses the increase in heart rate due to drinking)
To the crude drug composition having the composition shown in Table 1, 10 times the amount of water by weight was added as an extraction solvent, and extraction was performed with stirring at about 100 ° C. for 1 hour. Then, the extract was collected by centrifugation, concentrated under reduced pressure, and further dried with a spray dryer to prepare a granular Goreisan extract. Using 2300 mg of this Goreisan extract in terms of dry extract (16 g in terms of crude drug), the ingredients shown in Table 2 are mixed, kneaded and granulated to suppress the increase in heart rate due to drinking. Granules were formulated.
（試験方法）
体重及び体格にあまり差が無い２０〜３０歳の健常な男女５人を被験者とし、調製した飲酒による心拍数増加の抑制剤の顆粒剤を１回１包分（表２に示す用量）、コップ１杯の水で服用させた。服用３０分後に、純アルコール量１４〜３６．４ｇに相当する酒の飲酒を開始し、１５分で飲酒を完了させた（実施例）。また、比較試験として、別の日に、同じ被験者に対して、飲酒による心拍数増加の抑制剤を服用せずコップ１杯の水のみを飲用したことを除いて、上述と同様に飲酒させた（比較例）。なお、すべての試験は、１日に１試験とし、いずれも通常体調の日に行った。
(Test method)
Five healthy men and women aged 20 to 30 years with little difference in body weight and physique were used as subjects, and one packet (dose shown in Table 2) of the prepared granules of a heart rate increase inhibitor due to drinking was used as a glass. It was taken with a glass of water. After 30 minutes of administration, drinking of alcohol corresponding to a pure alcohol amount of 14 to 36.4 g was started, and the drinking was completed in 15 minutes (Example). In addition, as a comparative test, the same subject was allowed to drink alcohol on another day in the same manner as described above, except that he drank only a glass of water without taking an inhibitor of heart rate increase due to drinking. (Comparative example). In addition, all the tests were performed once a day, and all of them were performed on the day of normal physical condition.
飲酒開始時を０分として、３０分、６０分、９０分、及び１２０分経過時における１分当たりの脈拍を測定し、測定時ごとに、飲酒前の１分当たりの脈拍を差し引いた値を平均化し、心拍数の増加量（拍数／分）とした。心拍数の増加量の経時変化を図１に示す。 With 0 minutes as the start of drinking, the pulse per minute at 30, 60, 90, and 120 minutes was measured, and the value obtained by subtracting the pulse per minute before drinking was calculated for each measurement. It was averaged and used as the amount of increase in heart rate (beat rate / minute). The time course of the increase in heart rate is shown in FIG.
図１に示される通り、五苓散エキスの服用によって、飲酒によって生じる心拍数の増加の程度が低減することが認められ、飲酒開始後の心拍数の高い時間が短縮された。また、被験者の中の一部には、飲酒時に顔面紅潮が認められ、そのような者も、飲酒によって生じる心拍数の増加の程度が低減することが認められ、飲酒開始後の心拍数の高い時間が短縮された。更に、飲酒時に顔面紅潮が認められた者の中には、飲酒により脈拍が１２０回／分を超える動悸が認められたが、そのような者も、飲酒によって生じる心拍数の増加の程度が低減することが認められ、飲酒開始後の心拍数の高い時間が短縮されるとともに、動悸も緩和されて楽になった。 As shown in FIG. 1, it was found that the degree of increase in heart rate caused by drinking alcohol was reduced by taking Goreisan extract, and the time when the heart rate was high after the start of drinking was shortened. In addition, some of the subjects had hot flushes during drinking, and such persons were also found to reduce the degree of increase in heart rate caused by drinking, and the heart rate after the start of drinking was high. Time has been reduced. Furthermore, among those who had hot flashes when drinking alcohol, palpitations with a pulse rate of more than 120 beats / minute were observed, but even in such persons, the degree of increase in heart rate caused by drinking alcohol was reduced. It was admitted that he was allowed to do so, and the time when the heart rate was high after the start of drinking was shortened, and the palpitations were alleviated and eased.
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Non-Patent Citations (4)
| Title |
|---|
| VOL.16:たかが脈拍されど脈拍？！, JPN6023044122, 1 September 2017 (2017-09-01), ISSN: 0005190390 * |
| 五苓散, 小林製薬の漢方・生薬, JPN6023044119, ISSN: 0005190388 * |
| 国立循環器病センター監修, 「健康で長生きするために 知っておきたい循環器病あれこれ シリーズ1 酒、たばこと循環器病」, JPN6023044121, 1998, pages 1 - 16, ISSN: 0005190389 * |
| 相談/医療/平成24年8月号, 定年時代, JPN6023044124, ISSN: 0005190391 * |
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