JP2014074019A - Antirotavirus agent - Google Patents
Antirotavirus agent Download PDFInfo
- Publication number
- JP2014074019A JP2014074019A JP2013186882A JP2013186882A JP2014074019A JP 2014074019 A JP2014074019 A JP 2014074019A JP 2013186882 A JP2013186882 A JP 2013186882A JP 2013186882 A JP2013186882 A JP 2013186882A JP 2014074019 A JP2014074019 A JP 2014074019A
- Authority
- JP
- Japan
- Prior art keywords
- rotavirus
- agent
- preventive
- rotavirus infection
- therapeutic agent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明は、抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に関する。より詳細には、ロタウイルス感染に基づく感冒性胃腸症（胃腸かぜ）の予防及び／又は治療剤に関する。 The present invention relates to an anti-rotavirus agent, and a preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent. More specifically, the present invention relates to a preventive and / or therapeutic agent for cold gastroenteropathy (gastrointestinal cold) based on rotavirus infection.
かぜは、インフルエンザを引き起こすインフルエンザウイルス以外の、所謂かぜ症候群ウイルス感染を原因とし、鼻水、鼻づまり、くしゃみ、のどの痛み、せき、たん、悪寒、発熱、頭痛、関節の痛み、筋肉の痛み等の不快症状を呈する急性上気道炎の各種症状を示す状態を意味するが、例えば、ウイルス感染により、発熱、上気道炎症とともに、胃腸炎の症状を呈することが知られている。すなわち、「かぜをひくとおなかをこわす」ことがよくあるが、これは消化管のウイルス感染に伴ったものであり、小児、特に乳児では嘔吐、下痢症状を示すことが知られている（以上、例えば非特許文献１参照）。このような症状（お腹のかぜ）は、本邦では「胃腸かぜ」や「感冒性胃腸炎」と言われ、欧米では「Stomach Flu」と呼ばれている。
感冒性胃腸炎を引き起こす代表的なウイルスとしては、ロタウイルス、ノロウイルス、腸管アデノウイルスが知られており、ロタウイルス感染症では、感冒性胃腸炎とともに呼吸器症状が１／３程度に発現する（以上、例えば、非特許文献２参照）。冬場の、生後６ヶ月から２歳の乳幼児の嘔吐下痢症の原因の８０％は、ロタウイルス感染といわれており、５歳までにほとんどの小児が感染し、保育所、幼稚園、小学校等の小児や、病院、老人ホーム、福祉施設等の成人でも集団発生がみられることがある。しかしながら、ロタウイルス感染症に対する治療法としては、有効な治療薬が未だに存在しないため、ワクチンの接種や、感染を防ぐための予防策がとられているのが現状である。
Colds are caused by the so-called cold syndrome virus infection other than the influenza virus that causes influenza. It means a state showing various symptoms of acute upper respiratory tract inflammation that presents unpleasant symptoms. For example, it is known that viral infection causes symptoms of gastroenteritis along with fever and upper respiratory tract inflammation. In other words, “breaking colds often breaks the stomach” is accompanied by a viral infection of the gastrointestinal tract, and it is known that children, especially infants, exhibit vomiting and diarrhea (see above). For example, refer nonpatent literature 1). Such symptoms (gastric cold) are called “gastrointestinal cold” or “cold gastroenteritis” in Japan, and “Stomach Flu” in Europe and America.
As typical viruses that cause cold gastroenteritis, rotavirus, norovirus, and intestinal adenovirus are known, and in rotavirus infection, respiratory symptoms are manifested in about 1/3 together with cold gastroenteritis ( For example, see Non-Patent Document 2). 80% of the causes of vomiting diarrhea in infants aged 6 months to 2 years in the winter are said to be rotavirus infections, and most children are infected by the age of 5 and children in nurseries, kindergartens, elementary schools, etc. Or outbreaks may occur in adults such as hospitals, nursing homes, and welfare facilities. However, as a treatment for rotavirus infection, since there is no effective therapeutic agent yet, the current situation is that vaccination and preventive measures are taken to prevent infection.
セトラキサート塩酸塩は、各種胃粘膜病変に対する予防・治癒効果、胃粘膜微小循環の改善作用、胃粘膜内プロスタグランジンE2,I2生合成増加作用、胃粘膜粘液保持・合成促進作用、粘膜内ペプシノーゲンの活性化抑制作用、抗カリクレイン作用による胃液分泌抑制作用等を有し、医療用医薬としての適応は、次の疾患の胃粘膜病変(びらん、出血、発赤、浮腫)の改善：急性胃炎、慢性胃炎の急性増悪期、胃潰瘍である（例えば、非特許文献３参照）。また、セトラキサート塩酸塩は一般用医薬品において、胃腸薬に配合されている成分である（例えば、非特許文献４参照）。
さらに、セトラキサート塩酸塩には、抗インフルエンザウイルス作用（特許文献１参照）を有することも報告されている。しかしながら、セトラキサート塩酸塩の抗ロタウイルス作用についての報告はない。一般的に、抗インフルエンザウイルス作用を有するからといっても、ウイルスの構造や感染作用メカニズムはそれぞれウイルスによって異なることから、他の種類のウイルスに対しても有効であるとはいえない。
Setraxate hydrochloride prevents and cures various gastric mucosal lesions, improves gastric mucosal microcirculation, increases gastric mucosal prostaglandin E 2 and I 2 biosynthesis, maintains gastric mucosal mucus and promotes synthesis, intramucosal Inhibition of pepsinogen activation, anti-kallikrein action of gastric juice secretion, etc. Indication as a medical drug is improved gastric mucosal lesions (erosion, bleeding, redness, edema) of the following diseases: acute gastritis, It is a gastric ulcer during the acute exacerbation of chronic gastritis (for example, see Non-Patent Document 3). Moreover, cetraxate hydrochloride is a component blended in gastrointestinal drugs in over-the-counter medicines (see, for example, Non-Patent Document 4).
Furthermore, it has been reported that cetraxate hydrochloride has an anti-influenza virus action (see Patent Document 1). However, there is no report on the anti-rotavirus action of cetraxate hydrochloride. In general, even if it has an anti-influenza virus action, it cannot be said that it is effective against other types of viruses because the structure of the virus and the mechanism of infectious action differ from virus to virus.
本発明の課題は、乳幼児への投与も可能な高い安全性を有する、新規な抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤を提供することである。 An object of the present invention is to provide a novel anti-rotavirus agent having high safety that can be administered to infants, and a preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent. That is.
本発明者らは、かかる実情に鑑み鋭意研究を行った結果、意外にも、セトラキサート又はその塩が優れた抗ロタウイルス作用を有することを新たに見出し、本発明を完成するに至った。
すなわち本発明は、セトラキサート又はその塩を含有する、新規な抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防用及び／又は治療用の経口組成物であり、より詳しくは、セトラキサート又はその塩を有効成分とする感冒性胃腸炎の治療薬である。
As a result of intensive studies in view of such circumstances, the present inventors have unexpectedly newly found that cetraxate or a salt thereof has an excellent anti-rotavirus action, and have completed the present invention.
That is, the present invention is a novel anti-rotavirus agent containing cetraxate or a salt thereof, and an oral composition for preventing and / or treating rotavirus infection containing the anti-rotavirus agent, Specifically, it is a therapeutic agent for cold gastroenteritis comprising cetraxate or a salt thereof as an active ingredient.
すなわち、本発明は、以下の（１）〜（７）を提供する。
（１）セトラキサート又はその塩を含有する、抗ロタウイルス剤。
（２）セトラキサート又はその塩がセトラキサート塩酸塩である、（１）に記載の抗ロタウイルス剤。
（３）上記の（１）又は（２）に記載の抗ロタウイルス剤を含有する、ロタウイルス感染症の予防及び／又は治療剤。
（４）ロタウイルス感染症が、ロタウイルス感染による、発熱、上気道炎、及び、感冒性胃腸症である、（３）に記載のロタウイルス感染症の予防及び／又は治療剤。
（５）ロタウイルス感染症が、ロタウイルス感染による感冒性胃腸症である、（３）に記載のロタウイルス感染症の予防及び／又は治療剤。
（６）感冒性胃腸症が、胃腸症、嘔吐、及び、下痢である、（５）に記載のロタウイルス感染症の予防及び／又は治療剤。
（７）さらに、制酸薬、健胃薬、消化薬、整腸薬、止瀉薬、鎮痛鎮痙薬、解熱鎮痛薬、中枢神経興奮薬、鎮静剤、抗ヒスタミン薬、抗炎症薬、鎮咳薬、去痰薬、気管支拡張薬、抗アセチルコリン剤、殺菌消毒剤、局所麻酔剤、ビタミン剤、代謝性成分、生薬、及び、生薬抽出物、からなる群より選ばれる１種又は２種以上を含有する、（３）〜（６）のいずれか１に記載のロタウイルス感染症の予防及び／又は治療剤。
That is, the present invention provides the following (1) to (7).
(1) An anti-rotavirus agent containing cetraxate or a salt thereof.
(2) The anti-rotavirus agent according to (1), wherein the cetraxate or a salt thereof is cetraxate hydrochloride.
(3) A preventive and / or therapeutic agent for rotavirus infection, comprising the anti-rotavirus agent according to (1) or (2) above.
(4) The preventive and / or therapeutic agent for rotavirus infection according to (3), wherein the rotavirus infection is fever, upper respiratory tract inflammation and cold gastroenteropathy due to rotavirus infection.
(5) The preventive and / or therapeutic agent for rotavirus infection according to (3), wherein the rotavirus infection is cold gastroenteropathy due to rotavirus infection.
(6) The preventive and / or therapeutic agent for rotavirus infection according to (5), wherein the common gastroenteropathy is gastroenteropathy, vomiting, and diarrhea.
(7) Furthermore, antacids, stomachic medicines, digestives, intestinals, antipruritics, analgesics and antispasmodics, antipyretic analgesics, central nervous stimulants, sedatives, antihistamines, anti-inflammatory drugs, antitussives, expectorants Containing one or more selected from the group consisting of drugs, bronchodilators, anti-acetylcholine agents, bactericides / disinfectants, local anesthetics, vitamins, metabolic components, herbal medicines and herbal extracts, ( The preventive and / or therapeutic agent for rotavirus infection according to any one of 3) to (6).
本発明のセトラキサート又はその塩を含有する経口組成物は、優れた抗ロタウイルス作用を有するため、ロタウイルス感染症の予防及び／又は治療に利用できる。特に、感冒性胃腸炎（胃腸かぜ）における嘔吐、下痢、又は感冒症状である発熱の予防及び／又は治療にも有用である。 Since the oral composition containing the cetraxate or a salt thereof of the present invention has an excellent anti-rotavirus action, it can be used for prevention and / or treatment of rotavirus infection. In particular, it is also useful for the prevention and / or treatment of vomiting, diarrhea or fever which is a common cold symptom in common cold gastroenteritis (gastrointestinal cold).
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に含有するセトラキサート又はその塩としては、セトラキサート塩酸塩［3-{4-[trans-4-(Aminomethyl)cyclohexylcarbonyloxy]phenyl}propanoic acid monohydrochloride］が知られ、第１６改正日本薬局方に収載されている。セトラキサートとしては、フリー体又は塩を用いてもよい。セトラキサートの塩としては、塩酸塩、フッ化水素酸塩、塩酸塩、臭化水素酸塩、ヨウ化水素酸塩等のハロゲン化水素酸塩；硝酸塩、過塩素酸塩、硫酸塩、リン酸塩等の無機酸塩；メタンスルホン酸塩、トリフルオロメタンスルホン酸塩、エタンスルホン酸塩等の低級アルカンスルホン酸塩；ベンゼンスルホン酸塩、ｐ−トルエンスルホン酸塩等のアリールスルホン酸塩；酢酸塩、リンゴ酸塩、フマル酸塩、コハク酸塩、クエン酸塩、アスコルビン酸塩、酒石酸塩、シュウ酸塩、マレイン酸塩等の有機酸塩；ナトリウム塩、カリウム塩等のアルカリ金属塩；カルシウム塩、マグネシウム塩等のアルカリ土類金属塩；Ｎ−メチルモルホリン塩、トリエチルアミン塩、トリブチルアミン塩、ジイソプロピルエチルアミン塩、ジシクロヘキシルアミン塩、Ｎ−メチルピペリジン塩、ピリジン塩、４−ピロリジノピリジン塩、ピコリン塩等の有機アミン塩類；グリシン塩、リジン塩、アルギニン塩、オルニチン塩、グルタミン酸塩、アスパラギン酸塩等のアミノ酸塩；等を挙げることができる。本発明におけるセトラキサート又はその塩としては、セトラキサート塩酸塩が好ましい。 Examples of cetraxate or a salt thereof contained in the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent include cetraxate hydrochloride [3- {4- [trans -4- (Aminomethyl) cyclohexylcarbonyloxy] phenyl} propanoic acid monohydrochloride] is known and listed in the 16th revision Japanese Pharmacopoeia. As a cetraxate, you may use a free body or a salt. As salts of cetraxate, hydrohalates such as hydrochloride, hydrofluoride, hydrochloride, hydrobromide, hydroiodide; nitrate, perchlorate, sulfate, phosphate Inorganic acid salts such as methanesulfonate, trifluoromethanesulfonate, ethanesulfonate, etc .; lower alkanesulfonates such as benzenesulfonate and p-toluenesulfonate; acetates; Malate, fumarate, succinate, citrate, ascorbate, tartrate, oxalate, maleate and other organic acid salts; sodium salts, potassium salts and other alkali metal salts; calcium salts, Alkaline earth metal salts such as magnesium salt; N-methylmorpholine salt, triethylamine salt, tributylamine salt, diisopropylethylamine salt, dicyclohexylamino Salts, organic amine salts such as N-methylpiperidine salt, pyridine salt, 4-pyrrolidinopyridine salt, picoline salt; amino acid salts such as glycine salt, lysine salt, arginine salt, ornithine salt, glutamate salt, aspartate salt, etc. Can be mentioned. In the present invention, cetraxate or a salt thereof is preferably cetraxate hydrochloride.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤は、上述のセトラキサート又はその塩の他に、適宜、（１）制酸薬、（２）健胃薬、（３）消化薬、（４）整腸薬、（５）止瀉薬、（６）鎮痛鎮痙薬、（７）解熱鎮痛薬、（８）中枢神経興奮薬、（９）鎮静剤、（１０）抗ヒスタミン薬、（１１）抗炎症薬、（１２）鎮咳薬、（１３）去痰薬、（１４）気管支拡張薬、（１５）抗アセチルコリン剤、（１６）ビタミン剤、（１７）代謝性成分、及び（１８）生薬及び生薬抽出物、からなる薬効成分群より選ばれる１種又は２種以上を含有するのが好ましく、特に、感冒性胃腸症状の緩和により効果的となる。 The anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent include, in addition to the above-mentioned cetraxate or a salt thereof, (1) an antacid, (2) stomachic medicine, (3) digestive, (4) intestinal, (5) antipruritic, (6) analgesic and antispasmodic, (7) antipyretic analgesic, (8) central nervous stimulant, (9) Sedative, (10) antihistamine, (11) anti-inflammatory, (12) antitussive, (13) expectorant, (14) bronchodilator, (15) antiacetylcholine, (16) vitamin, It is preferable to contain one or more selected from the group of medicinal components consisting of 17) metabolic components, and (18) crude drugs and herbal extracts, and is particularly effective in alleviating common cold gastrointestinal symptoms. .
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に添加してもよい薬効成分としては、具体的には、（１）合成ヒドロタルサイト、メタケイ酸アルミン酸マグネシウム、ケイ酸アルミン酸マグネシウム、乾燥水酸化アルミニウムゲル、合成ケイ酸アルミニウム、天然ケイ酸アルミニウムなどのアルミニウム系制酸剤、酸化マグネシウム、炭酸マグネシウム、ケイ酸マグネシウム、水酸化マグネシウムなどのマグネシウム系制酸剤、炭酸水素ナトリウムのナトリウム系制酸剤、沈降炭酸カルシウム、リン酸水素カルシウム、無水リン酸水素カルシウム、ボレイ（末）等の制酸剤、（２）塩酸ベタイン、塩化カルニチン、乾燥酵母等の健胃薬、（３）ウルソデオキシコール酸、動物胆（熊胆、牛胆）、でんぷん消化酵素（ジアスターゼ）、脂肪消化酵素（リパーゼ）等の消化薬、（４）整腸生菌成分、赤芽柏、アセニンヤク、ウバイ等の整腸薬、（５）アクリノール、塩化ベルベリン、グアヤコール、クレオソート、カオリン、ペクチン、薬用炭、ジメチルポリシロキサン、次サリチル酸ビスマス、次炭酸ビスマス、次硝酸ビスマス、次没食子酸ビスマス、タンニン酸、タンニン酸アルブミン、並びにタンニン酸を含む種々の生薬（アセンヤク、ゲンノウショウコ）等の止瀉薬、（６）塩酸パパベリン、アミノ安息香酸エチル、臭化水素酸スコポラミン、臭化メチルスコポラミン、延胡索、甘草、厚朴、芍薬、臭化チメピジウム、塩酸オキシフェンサイクリミン、塩酸ジサイクロミン、塩酸メチキセン、臭化メチルアトロピン、臭化メチル−ｌ−ヒヨスチアミン、臭化メチルベナクチジウム、ベラドンナエキス、ロートエキス、ヨウ化ジフェニルピペリジノメチルジオキソラン、ロート根総アルカノイドクエン酸塩等を例示することができる。 Specific examples of the medicinal component that may be added to the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent include (1) synthetic hydro Talsite, magnesium aluminate metasilicate, magnesium silicate aluminate, dry aluminum hydroxide gel, synthetic aluminum silicate, natural aluminum silicate and other antacids, magnesium oxide, magnesium carbonate, magnesium silicate, hydroxylated Magnesium-based antacids such as magnesium, sodium bicarbonate-based antacids, precipitated calcium carbonate, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, borei (powder) and other antacids, (2) betaine hydrochloride, Stomachic drugs such as carnitine chloride, dry yeast, (3) ursodeoxycholic acid, animals (Bear gall, cow gall), digestive drugs such as starch digestive enzyme (diastase), fat digestive enzyme (lipase), (4) live colonic components, red bowel, adenine yak, uban, etc., (5) acrinol , Including berberine chloride, guaiacol, creosote, kaolin, pectin, medicinal charcoal, dimethylpolysiloxane, bismuth subsalicylate, bismuth subcarbonate, bismuth subnitrate, bismuth subgallate, tannic acid, albumin tannate, and tannic acid Herbal medicines (Asenyaku, Gennoshouko), etc., (6) papaverine hydrochloride, ethyl aminobenzoate, scopolamine hydrobromide, methyl scopolamine bromide, Yankogong, licorice, Kobaku, glaze, thimepidium bromide, oxyhydrochloride Phencyclimine, dicyclomine hydrochloride, methixene hydrochloride, methyl atrobromide Emissions, methyl bromide -l- hyoscyamine, methyl bromide Bena Chi indium, Belladonna, scopolia extract, can be exemplified iodide diphenyl piperidinocarbonyl methyl dioxolane, a funnel root total alkaloids citrate salt.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に添加してもよい好ましい薬効成分としては、（６）臭化メチルスコポラミン、臭化チメピジウム、臭化メチルアトロピン等の鎮痛鎮痙薬、（７）アスピリン、アスピリンアルミニウム、サザピリン、エテンザミド、サリチルアミド、イブプロフェン、アセトアミノフェン、イソプロピルアンチピリン、ロキソプロフェン等の解熱鎮痛薬、（８）カフェイン、無水カフェイン、安息香酸ナトリウムカフェイン、テオフィリン、アミノフィリン、ジプロフィリン等の中枢神経興奮薬、（９）ブロムワレリル尿素、アリルイソプロピルアセチル尿素等の鎮静剤、（１０）クロルフェニラミン、ジフェンヒドラミン、クレマスチン、カルビノキサミン、メキタジン、アリメマジン、ジフェニルピラリン、トリプロリジン、アゼラスチン、エピナスチン、フェキソフェナジン等の抗ヒスタミン薬、（１１）グリチルリチン酸、グリチルリチン酸ジカリウム、グリチルリチン酸アンモニウム、グリチルレチン酸、アズレンスルホン酸ナトリウム等の抗炎症薬、（１２）ジヒドロコデイン、コデイン、ノスカピン、デキストロメトルファン、ジメモルファン、チペピジン、エプラジノン等の鎮咳薬、（１３）Ｌ−エチルシステイン、グアヤコールスルホン酸カリウム、クレゾール酸カリウム、グアイフェネシン、ブロムヘキシン、カルボシステイン、フドステイン、アンブロキソール等の去痰薬、（１４）メチルエフェドリン、プソイドエフェドリン、メトキシフェナミン、トリメトキノール、フェニルプロパノールアミン、マオウ等の気管支拡張薬、（１５）ベラドンナ（総）アルカロイド、ベラドンナエキス、ヨウ化イソプロパミド、スコポラミン、ロートエキス、ブチルスコポラミン、メチルベナクチジウム、チメピジウム、ピレンゼピン等の抗アセチルコリン剤、（１６）ビタミンＡ 、ビタミンＢ１、ビタミンＢ２、ビタミンＢ６、ビタミンＢ１２、ビタミンＣ、アスコルビン酸カルシウム、ビタミンＤ、ビタミンＥ、パントテン酸、パンテノール、パンテチン、ニコチン酸、ニコチン酸アミド等のビタミン剤、（１７）グルクロン酸、グルクロノラクトン、アミノエチルスルホン酸、ビオチン、γ −オリザノール等の代謝性成分、及び（１８）、アセンヤク、アニス実、アロエ、ウイキョウ、ウコン、ウバイ、ウヤク、エンゴサク、延命草、オウゴン、オウバク、オウレン、加工大蒜、ガジュツ、カッコウ、カラムス根、カンキョウ、カンゾウ、キジツ、クジン、ケイヒ、ケツメイシ、ゲンチアナ、ゲンノショウコ、コウジン、コウボク、ゴシュユ、胡椒、五倍子、コロンボ、コンズランゴ、サンザシ、サンショウ、山奈、シソシ、シャクヤク、シュクシャ、ショウキョウ、ショウズク、青皮、赤芽柏、石菖根、センタウリウム草、センブリ、ソウジュツ、ソヨウ、大茴香、ダイオウ、チクセツニンジン、チョウジ、チンピ、トウガラシ、トウヒ、ニガキ、ニクズク、ニンジン、ハッカ、セイヨウハッカ、ヒハツ、ビャクジュツ、ホップ、ホミカ、睡菜葉、モッコウ、ヤクチ、ヨウバイヒ、リュウタンおよびリョウキョウ、ジオウ、ケイヒ、ゴオウ、ショウキョウ、キキョウ、マオウ、カンゾウ、キョウニン、ハンゲ、シャゼンソウ、セネガ、サイコ、ブクリョウ、シンイ等の生薬およびこれら生薬の抽出物（エキス、チンキ等）、等からなる薬効成分群より選ばれる１種又は２種以上を挙げることができるが、添加してよい薬効成分としては上記のもののみに限定されない。なお、本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に添加する薬効成分として、より好適には、イブプロフェン、ブロムヘキシン、クレマスチン、及び無水カフェインを挙げることができる。セトラキサート又はその塩と併用する上記の制酸薬、健胃薬、消化薬、整腸薬、止瀉薬、鎮痛鎮痙薬、解熱鎮痛薬、中枢神経興奮薬、鎮静剤、抗ヒスタミン薬、抗炎症薬、鎮咳薬、去痰薬、気管支拡張薬、抗アセチルコリン剤、ビタミン剤、代謝性成分、生薬及び生薬抽出物は、公知の方法で製造され容易に入手できる。例えば、併用する薬効成分としてより好適な、ロキソプロフェンナトリウム、ブロムヘキシン塩酸塩、クレマスチンフマル酸塩、及び無水カフェインは、第１６改正日本薬局方に収載されている。 As preferred medicinal ingredients that may be added to the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent, (6) methylscopolamine bromide, odor Analgesic and antispasmodic drugs such as thimepidium bromide, methylatropine bromide, (7) antipyretic analgesics such as aspirin, aspirin aluminum, sazapyrine, etenzamide, salicylamide, ibuprofen, acetaminophen, isopropylantipyrine, loxoprofen, (8) caffeine, Caffeine anhydride, sodium benzoate caffeine, theophylline, aminophylline, diprofilin and other central nervous stimulants, (9) sedatives such as bromvalerylurea, allylisopropylacetylurea, (10) chlorpheniramine, diphenhydramine, clemastine, calf Antihistamines such as vinoxamine, mequitazine, alimemazine, diphenylpyralin, triprolidine, azelastine, epinastine, fexofenadine, etc. (11) anti-inflammatory such as glycyrrhizic acid, dipotassium glycyrrhizinate, ammonium glycyrrhizinate, glycyrrhetinic acid, sodium azulenesulfonate Drugs (12) Antitussives such as dihydrocodeine, codeine, noscapine, dextromethorphan, dimemorphan, tipepidine, and eprazinone, (13) L-ethylcysteine, potassium guaiacol sulfonate, potassium cresolate, guaifenesin, bromhexine, carbocysteine, hudstein Expectorants such as ambroxol, (14) methylephedrine, pseudoephedrine, methoxyphenamine, trime Bronchodilators such as quinol, phenylpropanolamine, mao, (15) belladonna (total) alkaloids, belladonna extract, isopropamide iodide, scopolamine, funnel extract, butyl scopolamine, methylbenactidium, thimepidium, pirenzepine and other antiacetylcholine agents (16) Vitamin preparations such as vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, calcium ascorbate, vitamin D, vitamin E, pantothenic acid, panthenol, panthetin, nicotinic acid, nicotinamide (17) metabolic components such as glucuronic acid, glucuronolactone, aminoethylsulfonic acid, biotin, γ-oryzanol, and (18), asenyaku, aniseed fruit, aloe, fennel, turmeric, ubai, Yak, Engosaku, Life-grass, Ogon, Obakaku, Ouren, Processed eagle, Gadget, Cuckoo, Calamus root, Citrus, Licorice, Pheasant, Kujin, Keihi, Ketsumeishi, Gentian, Gentianko, Kojin, Koboku, Goshuyu, Pepper, Pagoda, Colon , Conslango, Hawthorn, Salamander, Yamana, Shisoshi, Peonies, Shukusha, Shokyo, Shozuk, Blue skin, Red bud, Ishizone, Centaurium grass, Sembli, Soryu, Soyo, Daikon, Daiou, Chikutsujinjin, Choji, Chimpi, Pepper, spruce, oyster, nutmeg, carrot, mint, mint, cherries, peafowl, hops, honey, rape leaves, mokko, yakchi, bay hawk, ryutan and ryekyo, jiou, keihi, gooh, shii 1 or 2 selected from the group of medicinal ingredients consisting of herbal medicines such as kyokyo, kyoko, mao, licorice, kyonin, hange, shazensou, senega, psycho, bukkyou, shinnyi and extracts of these herbal medicines (extracts, tinctures, etc.) More than one species can be mentioned, but the medicinal components that may be added are not limited to the above. As the medicinal component added to the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent, more preferably, ibuprofen, bromhexine, clemastine, and Mention may be made of anhydrous caffeine. The above-mentioned antacids used in combination with cetraxate or its salts, stomachic drugs, digestive drugs, intestinal drugs, antipruritics, analgesics, antispasmodics, antipyretic analgesics, central nervous stimulants, sedatives, antihistamines, anti-inflammatory drugs, Antitussives, expectorants, bronchodilators, anti-acetylcholine agents, vitamins, metabolic components, herbal medicines and herbal extracts are easily produced by known methods. For example, loxoprofen sodium, bromhexine hydrochloride, clemastine fumarate, and anhydrous caffeine, which are more suitable as a medicinal ingredient to be used in combination, are listed in the 16th revised Japanese Pharmacopoeia.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤は、ロタウイルスに感染する怖れのある患者、又はロタウイルスに感染した患者に投与するものである。ロタウイルス感染症としては、例えば、ロタウイルス感染に起因した、嘔吐、下痢、又は感冒症状である発熱等を挙げることができる。従って、本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤は、これらの疾患の患者に投与されるのが好ましい。 The anti-rotavirus agent of the present invention, and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent are provided for patients who are likely to be infected with rotavirus or who are infected with rotavirus. To be administered. Examples of the rotavirus infection include vomiting, diarrhea, or fever which is a cold symptom caused by rotavirus infection. Therefore, the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent are preferably administered to patients with these diseases.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤は経口剤が好ましい。また、経口剤の具体的な剤形としては、例えば、錠剤、細粒剤（顆粒剤、散剤を含む）、カプセル等の固形製剤、及び液剤（シロップ剤を含む）、ゼリー剤等をあげることができ、各剤形に適した添加剤や基材を適宜使用し、日本薬局方等に記載された通常の方法に従い、製造することができる。 The anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent are preferably oral agents. Specific examples of oral dosage forms include solid preparations such as tablets, fine granules (including granules and powders), capsules, liquids (including syrups), and jelly preparations. It can be produced according to the usual methods described in the Japanese Pharmacopoeia, using appropriate additives and base materials suitable for each dosage form.
上記各剤形において、その剤形に応じ、通常使用される各種添加剤を使用することができる。例えば、賦形剤、安定化剤、コーティング剤、滑沢剤、吸着剤、結合剤、崩壊剤、界面活性剤、着色剤、ｐＨ調節剤及び香料等を添加することができる。 In each of the above dosage forms, various commonly used additives can be used depending on the dosage form. For example, an excipient, a stabilizer, a coating agent, a lubricant, an adsorbent, a binder, a disintegrant, a surfactant, a colorant, a pH adjuster, and a fragrance can be added.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に含まれるセトラキサート又はその塩の１回投与量は、適応症や症状、年齢、性別等により異なるが、通常、セトラキサート塩酸塩として１０ｍｇ〜３０００ｍｇ、好適には１００ｍｇ〜６００ｍｇであり、これを１日に１〜３回投与する。 The single dose of cetraxate or a salt thereof contained in the anti-rotavirus agent of the present invention and the preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent is indicated by indication, symptom, age, Although it varies depending on gender, etc., it is generally 10 mg to 3000 mg, preferably 100 mg to 600 mg as cetraxate hydrochloride, which is administered 1 to 3 times a day.
本発明の抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤に併用する薬効成分として、ロキソプロフェンナトリウムを用いる場合、ロキソプロフェンナトリウムの含有量は、無水物として、通常、５０ｍｇ〜１０００ｍｇであり、好適には１００ｍｇ〜５００ｍｇである。さらに、併用薬としてブロムヘキシン塩酸塩を用いる場合、ブロムヘキシン塩酸塩の含有量は、通常０．６ｍｇ〜２４ｍｇであり、好適には１．２ｍｇ〜１２ｍｇである。また、併用薬としてクレマスチンフマル酸塩を用いる場合、クレマスチンフマル酸塩の含有量は、通常０．１ｍｇ〜８ｍｇであり、好適には０．４ｍｇ〜４ｍｇである。 When loxoprofen sodium is used as a medicinal ingredient used in combination with the anti-rotavirus agent of the present invention and a preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent, the content of loxoprofen sodium is anhydrous. The product is usually 50 mg to 1000 mg, preferably 100 mg to 500 mg. Furthermore, when bromhexine hydrochloride is used as a concomitant drug, the content of bromhexine hydrochloride is usually 0.6 mg to 24 mg, preferably 1.2 mg to 12 mg. When clemastine fumarate is used as a concomitant drug, the content of clemastine fumarate is usually 0.1 mg to 8 mg, preferably 0.4 mg to 4 mg.
以下に、実施例等を示し、本発明をさらに詳細に説明するが、本発明の範囲はこれらに限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to examples and the like, but the scope of the present invention is not limited thereto.
（実施例１）錠剤
（１）成分（６錠中、ｍｇ）
(Example 1) Tablet (1) component (in 6 tablets, mg)
（２）製法
上記成分及び分量をとり、第１６改正日本薬局方製剤総則「錠剤」の項に準じて錠剤を製造した。
(2) Manufacturing method The said component and quantity were taken, and the tablet was manufactured according to the 16th revision Japanese Pharmacopoeia preparation general rule "Tablet".
（試験例）抗ロタウイルス試験
（１）被験物質
セトラキサート塩酸塩は第一ファインケミカル（株）製のものを使用した。
(Test example) Anti-rotavirus test (1) Test substance A cetraxate hydrochloride manufactured by Daiichi Fine Chemical Co., Ltd. was used.
（２）使用ウイルス
ウイルスは、Human rotavirus VR-2018（ATCC）を使用した。
(2) Virus used Human rotavirus VR-2018 (ATCC) was used as the virus.
（３）使用細胞
宿主細胞として、MA104細胞RCB0994（独立行政法人理化学研究所バイオリソースセンター）を使用した。
(3) Cells used MA104 cells RCB0994 (RIKEN BioResource Center) were used as host cells.
（４）使用培地
細胞増殖培地として、イーグルMEM培地に牛胎仔血清を10 %加えたものを使用した。また、細胞維持培地として、イーグルMEM培地を使用した。
(4) Medium used As a cell growth medium, an MEM medium supplemented with 10% fetal calf serum was used. In addition, Eagle MEM medium was used as a cell maintenance medium.
（５）ウイルス浮遊液の調製
細胞の培養として、細胞増殖培地を用い、使用細胞を組織培養用フラスコ内に単層培養した。単層培養後にフラスコ内から細胞増殖培地を除き、試験ウイルスを接種した。次に、細胞維持培地を加えて培養した。
ウイルス浮遊液の調製は、培養後、細胞に形態変化(細胞変性効果)が起こっていることを確認した。次に、培養液を遠心分離(3000 r/min，10分間)し、得られた上澄み液をウイルス浮遊液とした。
(5) Preparation of virus suspension As a cell culture, a cell growth medium was used, and the used cells were cultured in a single layer in a tissue culture flask. After monolayer culture, the cell growth medium was removed from the flask and inoculated with the test virus. Next, cell maintenance medium was added and cultured.
Preparation of the virus suspension confirmed that morphological changes (cytopathic effect) occurred in the cells after culturing. Next, the culture solution was centrifuged (3000 r / min, 10 minutes), and the resulting supernatant was used as a virus suspension.
（６）試験操作
20μg/mLトリプシン含有細胞維持培地で調製した試験液を室温で30分保存した後、試験液0.9 mLにウイルス浮遊液0.1 mLを添加、混合後、試験液を用いて10倍段階希釈し、ウイルス感染価を測定した。
(6) Test operation
After storing the test solution prepared in 20 μg / mL trypsin-containing cell maintenance medium at room temperature for 30 minutes, add 0.1 mL of the virus suspension to 0.9 mL of the test solution, mix, and 10-fold serial dilution with the test solution. Infectivity titer was measured.
（７）ウイルス感染価の測定
細胞増殖培地を用い、使用細胞を組織培養用マイクロプレート(96穴)内で単層培養した後、細胞増殖培地を除き、リン酸緩衝生理食塩水を加えた。リン酸緩衝生理食塩水を除いた後、細胞維持培地を0.1 mLずつ加えた。次に、ウイルス浮遊液を添加した試験液及びその希釈液0.1 mLを4穴ずつに接種し、14日間培養した。培養後細胞の形態変化(細胞変性効果)の有無を観察し、Reed-Muench法により50 %組織培養感染量(TCID50)を算出してウイルス浮遊液1 mL当たりのウイルス感染価に換算した。
(7) Measurement of virus infectivity titer Using the cell growth medium, the used cells were cultured in a single layer in a tissue culture microplate (96 wells), the cell growth medium was removed, and phosphate buffered saline was added. After removing phosphate buffered saline, 0.1 mL of cell maintenance medium was added. Next, the test solution to which the virus suspension was added and 0.1 mL of the diluted solution were inoculated into 4 wells and cultured for 14 days. After culturing, the cells were observed for morphological change (cytopathic effect), and the 50% tissue culture infectious dose (TCID 50 ) was calculated by the Reed-Muench method and converted to the virus infectivity per mL of virus suspension.
（８）試験結果
セトラキサート塩酸塩のウイルス感染価を測定した結果を表２に示す。表２より、セトラキサート塩酸塩の添加により、ウイルス感染価（log TCID50/mL）の低下が認められ、セトラキサート塩酸塩が抗ロタウイルス作用を有することが確認された。
(8) Test results Table 2 shows the results of measuring the virus infectivity of cetraxate hydrochloride. From Table 2, the addition of cetraxate hydrochloride decreased the viral infectivity (log TCID 50 / mL), confirming that cetraxate hydrochloride has anti-rotavirus activity.
TCID50：50% tissue culture infectious dose（50 %組織培養感染量）
*1：室温で30分保存したもの
*2：ウイルス浮遊液1 mL当たりのTCID50の対数値
*3：検体未添加（20 μg/mLトリプシン含有細胞維持培地のみ）
TCID 50 : 50% tissue culture infectious dose
* 1: Stored at room temperature for 30 minutes
* 2: Logarithmic value of TCID 50 per mL of virus suspension
* 3: No sample added (20 μg / mL trypsin-containing cell maintenance medium only)
本発明のセトラキサート又はその塩を含有する経口組成物は、抗ロタウイルス作用を有するため、抗ロタウイルス剤、並びに、該抗ロタウイルス剤を含有するロタウイルス感染症の予防及び／又は治療剤として利用できる。特に、感冒性胃腸炎（胃腸かぜ）の主症状である、嘔吐、下痢、発熱の予防及び／又は治療剤として有用である。 Since the oral composition containing cetraxate or a salt thereof of the present invention has an anti-rotavirus action, it is used as an anti-rotavirus agent and a preventive and / or therapeutic agent for rotavirus infection containing the anti-rotavirus agent. Available. In particular, it is useful as an agent for preventing and / or treating vomiting, diarrhea, and fever, which are the main symptoms of cold gastroenteritis (gastrointestinal cold).
Claims (7)
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| CN111518070A (en) * | 2020-06-08 | 2020-08-11 | 云南民族大学 | Rotavirus-resistant compound in cassia wingnut, preparation method and application thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111518070A (en) * | 2020-06-08 | 2020-08-11 | 云南民族大学 | Rotavirus-resistant compound in cassia wingnut, preparation method and application thereof |
| CN111518070B (en) * | 2020-06-08 | 2022-12-09 | 云南民族大学 | A kind of anti-rotavirus compound in Cassia pterygium, preparation method and application thereof |
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