JP7526770B2 - Oral anthelmintic composition for pufferfish, oral composition for preventing emaciation disease for pufferfish, and myxosporean anthelmintic method and method for preventing emaciation disease in pufferfish using the same - Google Patents
Oral anthelmintic composition for pufferfish, oral composition for preventing emaciation disease for pufferfish, and myxosporean anthelmintic method and method for preventing emaciation disease in pufferfish using the same Download PDFInfo
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Description
本発明は、フグ科魚類用駆虫剤経口組成物、フグ科魚類用やせ病予防剤経口組成物、並びにこれらを用いたフグ科魚類用粘液胞子虫駆虫方法及びフグ科魚類のやせ病の予防方法の改良に関する。 The present invention relates to an oral anthelmintic composition for pufferfish, an oral composition for preventing emaciation disease for pufferfish, and an improved method for anthelminticating myxosporean parasites in pufferfish and a method for preventing emaciation disease in pufferfish using the same.
粘液胞子虫は、刺胞動物門粘液胞子虫鋼に属し、水棲無脊椎動物と脊椎動物の2つの宿主間を交替する複雑な生活環を有する顕微鏡サイズの寄生虫である。特に養殖魚等の魚類に対し産業上深刻な影響を与える種が多く知られており、具体例としては、双殻目に属するCeratomyxa属(ミカヅキムシ)、Chloromyxum属(シノウネンエキムシ)、Enteromyxum属(ハチノジホウシムシ)、Henneguya属(ウチワムシ)、Hoferellus属(ズキンネンエキムシ)、Myxidium属(ツムガタムシ)、Myxobolus属(シズクムシ)、Sphaerospora属(タマホウシムシ)、Thelohanellus属(イッキョクホウシムシ)、多殻目に属するKudoa属が挙げられる。 Myxosporea are microscopic parasites that belong to the class Myxosporea in the phylum Cnidaria and have a complex life cycle that alternates between two hosts, aquatic invertebrates and vertebrates. Many species are known to have serious industrial impacts on fish, particularly farmed fish, and specific examples include the bivalve genera Ceratomyxa (earthworms), Chloromyxum (single-striped beetles), Enteromyxum (striped beetles), Henneguya (rotary fans), Hoferellus (striped beetles), Myxidium (weave beetles), Myxobolus (striped beetles), Sphaerospora (striped beetles), Thelohanellus (striped beetles), and the multivalve genus Kudoa.
わが国における粘液胞子虫を原因寄生虫とする養殖魚の感染症として広く知られているものとしては、1990年代頃から九州地方の養殖トラフグにおいて確認されるようになったやせ病(粘液胞子虫性やせ病)が挙げられる(非特許文献1参照)。やせ病を発症した病魚は、頭骨が浮き出て目が落ちくぼむほどのやせ症状を呈し、最終的に死亡する。原因となる粘液胞子虫は、腸管に寄生し、腸管上皮組織の増生及び剥離を特徴とする病理変化を引き起こす。その結果、栄養吸収及び浸透圧調整に障害が生じ、やせ症状を引き起こすと考えられる。 In Japan, one well-known infectious disease in farmed fish caused by myxosporean parasites is emaciation disease (myxosporean emaciation disease), which has been identified in farmed tiger pufferfish in the Kyushu region since around the 1990s (see Non-Patent Document 1). Affected fish become so emaciated that their skulls protrude and their eyes become sunken, and eventually die. The causative agent, myxosporean parasites the intestines, causing pathological changes characterized by proliferation and exfoliation of intestinal epithelial tissue. This is thought to result in impaired nutrient absorption and osmotic pressure regulation, leading to emaciation.
トラフグのやせ病の病原体としては、病魚の腸管上皮組織より新種の粘液胞子虫Leptotheca fugu及び未同定種のMyxidium sp.が発見されたが、その後の18SリボソームRNA遺伝子を対象とする遺伝子解析等の結果に基づき、前者はSphaerospora属に転属され、後者は、Enteromyxum leeiに同定された。Enteromyxum leeiは、キプロスにおけるヨーロッパヘダイ、韓国におけるターボット等、種々の養殖魚及び水族館の飼育魚からも発見され、感染が報告された海産魚は50種を超える。上述のとおり、生活環には交替宿主の介在が推測されるが、胞子形成前の栄養体が魚から魚に直接伝播するために、養殖場内で急速に伝播し、被害が拡大しやすいことも問題となっている。 The pathogens of emaciation disease in tiger pufferfish were found in the intestinal epithelium of diseased fish, and a new species of myxosporean, Leptotheca fugu, and an unidentified species, Myxidium sp., were found. However, based on the results of subsequent genetic analysis of the 18S ribosomal RNA gene, the former was reclassified as Sphaerospora, and the latter was identified as Enteromyxum leei. Enteromyxum leei has also been found in various farmed fish and aquarium fish, such as gilthead seabream in Cyprus and turbot in Korea, and infection has been reported in over 50 species of marine fish. As mentioned above, it is believed that the life cycle involves alternate hosts, but because trophozoites before sporulation are transmitted directly from fish to fish, the disease can spread rapidly within farms, easily causing damage to spread.
トラフグをはじめとするフグ科に属する魚類のやせ病に対する治療法及び防除法は未だ確立されていないのが現状であり、種苗及び中間魚の導入時にPCR法等による検査を行い、飼育環境への感染魚の混入を避けることが、感染拡大を防止するための事実上唯一の方法となっている。 Currently, there is no established treatment or control method for emaciation disease in tiger pufferfish and other fish belonging to the pufferfish family, and the only effective way to prevent the spread of infection is to conduct PCR or other tests when introducing seedlings and intermediate fish and to avoid introducing infected fish into the breeding environment.
薬剤による粘液胞子虫の駆除に関しては、ヨーロッパヘダイに対するEnteromyxum leeiの駆虫薬として、サリノマイシンナトリウム及びアンプロリウムからなる合剤の使用(それぞれ、魚体重1kgあたり70mg、及び100mg)が報告されている(非特許文献2参照)。この報告によれば、病魚を衛生環境下(21℃)で飼育し、上記用量で投薬を実施したところ、約6週間で正常のシストが消失した。 Regarding the use of drugs to eradicate myxosporean parasites, the use of a combination of sodium salinomycin and amprolium (70 mg and 100 mg per kg of fish body weight, respectively) as an anthelmintic for Enteromyxum leei in European sea bream has been reported (see Non-Patent Document 2). According to this report, when diseased fish were reared in a hygienic environment (21°C) and the above-mentioned doses were administered, normal cysts disappeared in about six weeks.
また、米国の水族館で飼育される複数魚種について、サリノマイシンナトリウム及びアンプロリウム(それぞれ、魚体重1kgあたり70mg、及び100mg)からなる合剤の経口投与による治療を行ったところ、死亡率の低下および臨床症状の改善をもたらしたことが報告されている(非特許文献3参照)。 It has also been reported that treatment of several fish species kept in aquariums in the United States with a combination of salinomycin sodium and amprolium (70 mg/kg of fish body weight and 100 mg/kg of fish body weight, respectively) by oral administration reduced mortality and improved clinical symptoms (see Non-Patent Document 3).
粘液胞子虫の寄生によりやせ病を発症した魚類は、腸管上皮組織の剥離により栄養の吸収効率が低下するため、発症後の駆虫が成功したとしても、その後の発育が悪化するため、養殖魚の場合、歩留まりの低下や商品価値の低下の問題が生じる。しかしながら、やせ病の原因となる粘液胞子虫の寄生を予防する方法は確立されていないのが現状である。更に、トラフグをはじめとするフグ科に属する魚類のやせ病の原因寄生虫を駆虫する方法、フグ科に属する魚類のやせ病の原因寄生虫の寄生を予防する方法のいずれについても、確立した方法は存在しないのが現状である。非特許文献2及び3に記載のサリノマイシンナトリウム及びアンプロジウムの合剤は、フグ科に属する魚類への適応が未確認であること、単位魚体重あたりの投与量(それぞれ、魚体重1kgあたり70mg、及び100mg)が多いため、養殖槽等の開放水系において餌料に混入して投与した場合、摂餌率の低下及びそれに伴う投与効率の悪化を招くおそれがある。 In fish that have developed emaciation disease due to infestation with myxosporean parasites, the efficiency of nutrient absorption is reduced due to the detachment of intestinal epithelial tissue, and even if deworming after the onset is successful, the growth of the fish is subsequently impaired, resulting in problems of reduced yield and reduced commercial value in the case of farmed fish. However, there is currently no established method for preventing infestation with myxosporean parasites that cause emaciation disease. Furthermore, there is currently no established method for either deworming the parasites that cause emaciation disease in fish belonging to the Tetraodontiidae family, including tiger pufferfish, or for preventing infestation with the parasites that cause emaciation disease in fish belonging to the Tetraodontiidae family. The combination of salinomycin sodium and amprodium described in Non-Patent Documents 2 and 3 has not been confirmed to be suitable for fish belonging to the Tetraodontiidae family, and the dosage per unit fish weight (70 mg and 100 mg per kg of fish weight, respectively) is high, so if it is mixed with feed and administered in an open water system such as an aquaculture tank, it may cause a decrease in feeding rate and a corresponding decrease in administration efficiency.
本発明はかかる事情に鑑みてなされたもので、フグ科魚類用駆虫剤経口組成物、フグ科魚類用やせ病予防剤経口組成物、並びにこれらを用いたフグ科魚類用粘液胞子虫駆虫方法及びフグ科魚類のやせ病の予防方法を提供することを目的とする。 The present invention has been made in consideration of such circumstances, and has as its object to provide an oral anthelmintic composition for pufferfish, an oral composition for preventing emaciation disease for pufferfish, and a method for anthelminticing myxosporean parasites in pufferfish and a method for preventing emaciation disease in pufferfish using these.
前記目的に沿う本発明の第1の態様は、サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを有効成分として含み、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除するためのフグ科魚類用駆虫剤経口組成物を提供することにより上記課題を解決するものである。 In accordance with the above-mentioned objective, the first aspect of the present invention solves the above-mentioned problems by providing an oral anthelmintic composition for pufferfish that contains only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient and is used to eliminate one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in fish belonging to the Tetraodontiformes and Tetraodontidae families.
本発明の第1の態様に係るフグ科魚類用駆虫剤経口組成物は、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~10mgとなるように前記フグ目フグ科に属する魚類に経口投与するためのものであることが好ましい。 The oral anthelmintic composition for pufferfish according to the first aspect of the present invention is preferably intended for oral administration to the fish belonging to the Tetraodontiformes and Tetraodontidae family so that the daily dose of the active ingredient is 0.5 to 10 mg per kg of fish body weight.
本発明の第1の態様に係るフグ科魚類用駆虫剤経口組成物は、前記有効成分の1回あたり投与量が、魚体重1kgあたり1~10mgとなるように前記フグ目フグ科に属する魚類に経口投与するためのものであってもよい。 The oral anthelmintic composition for pufferfish according to the first aspect of the present invention may be one for orally administering to fish belonging to the order Tetraodontiformes and family Tetraodontidae such that the single dose of the active ingredient is 1 to 10 mg per kg of fish body weight.
本発明の第1の態様に係るフグ科魚類用駆虫剤経口組成物は、12時間以上72日以下の投与間隔で前記フグ目フグ科に属する魚類に経口投与するためのものであるされることが好ましい。 The oral anthelmintic composition for pufferfish according to the first aspect of the present invention is preferably intended for oral administration to said fish belonging to the order Tetraodontiformes and family Tetraodontidae at administration intervals of 12 hours or more and 72 days or less.
本発明の第1の態様に係るフグ科魚類用駆虫剤経口組成物は、1日当たりの投与回数が1回を超えず、且つ1週間あたり4回以上7回以下の投与回数で前記フグ目フグ科に属する魚類に経口投与するためのものであるされることが好ましい。 The oral anthelmintic composition for pufferfish according to the first aspect of the present invention is preferably intended for oral administration to said fish belonging to the order Tetraodontiformes and family Tetraodontidae not more than once per day, and not less than four and not more than seven times per week.
本発明の第2の態様は、サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを有効成分として含み、フグ目フグ科に属する魚類の体内へのEnteromyxum leei及びSphaerospora fuguの一方又は双方の寄生を予防するためのフグ科魚類用やせ病予防剤経口組成物を提供することにより上記課題を解決するものである。 The second aspect of the present invention solves the above problems by providing an oral composition for preventing emaciation disease in pufferfish, which contains only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient, and which prevents parasitism of one or both of Enteromyxum leei and Sphaerospora fugu in fish belonging to the Tetraodontiformes and Tetraodontidae families.
本発明の第2の態様に係るフグ科魚類用やせ病予防剤経口組成物は、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~5mgとなるように前記フグ目フグ科に属する魚類に経口投与するためのものであることが好ましい。 The oral composition for preventing emaciation disease in pufferfish according to the second aspect of the present invention is preferably intended for oral administration to the fish belonging to the order Tetraodontiformes and family Tetraodontiidae so that the daily dose of the active ingredient is 0.5 to 5 mg per kg of fish body weight.
本発明の第2の態様に係るフグ科魚類用やせ病予防剤経口組成物は、前記有効成分の1回あたり投与量が、魚体重1kgあたり1~5mgとなるように前記フグ目フグ科に属する魚類に経口投与するためのものであってもよい。 The oral composition for preventing emaciation disease in pufferfish according to the second aspect of the present invention may be one for orally administering to fish belonging to the order Tetraodontiformes and family Tetraodontiidae such that the single dose of the active ingredient is 1 to 5 mg per kg of fish body weight.
本発明の第2の態様に係るフグ科魚類用やせ病予防剤経口組成物は、12時間以上72日以下の投与間隔で前記フグ目フグ科に属する魚類に経口投与するためのものであるされることが好ましい。 The oral composition for preventing emaciation disease in pufferfish according to the second aspect of the present invention is preferably intended for oral administration to the fish belonging to the order Tetraodontiformes and family Tetraodontiidae at administration intervals of 12 hours or more and 72 days or less.
本発明の第2の態様に係るフグ科魚類用やせ病予防剤経口組成物は、1日当たりの投与回数が1回を超えず、且つ1週間あたり4回以上7回以下の投与回数で前記フグ目フグ科に属する魚類に経口投与するためのものであるされることが好ましい。 The oral composition for preventing emaciation disease for Tetraodontiformes fish according to the second aspect of the present invention is preferably intended for oral administration to said fish belonging to the Tetraodontiformes and Tetraodontidae family not more than once per day and not less than four and not more than seven times per week.
本発明の第3の態様は、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除する方法であって、有効成分としてサリノマイシン又は医薬として許容されるその塩を単独で含む経口組成物を、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~10mgとなるように前記フグ目フグ科に属する魚類に経口投与する工程を有するフグ科魚類用粘液胞子虫駆虫方法を提供することにより上記課題を解決するものである。 A third aspect of the present invention solves the above-mentioned problems by providing a method for exterminating one or both of Enteromyxum leei and Sphaerospora fugu parasitizing fish belonging to the order Tetraodontiformes and family Tetraodontidae, which comprises a step of orally administering to said fish belonging to the order Tetraodontiformes and family Tetraodontidae an oral composition containing salinomycin or a medicamentously acceptable salt thereof alone as an active ingredient such that the daily dosage of the active ingredient is 0.5 to 10 mg per kg of fish body weight .
本発明の第3の態様に係るフグ科魚類用粘液胞子虫駆虫方法において、前記有効成分の1回あたり投与量が、魚体重1kgあたり1~10mgであることが好ましい。 In the method for anthelmintic fish of the pufferfish family according to the third aspect of the present invention, the amount of the active ingredient administered per time is preferably 1 to 10 mg per kg of fish body weight.
本発明の第3の態様に係るフグ科魚類用粘液胞子虫駆虫方法において、前記経口組成物の投与間隔が、12時間以上72日以下であることが好ましい。 In the method for anthelmintic myxosporean parasites for pufferfish according to the third aspect of the present invention, the oral composition is preferably administered at intervals of 12 hours or more and 72 days or less.
本発明の第3の態様に係るフグ科魚類用粘液胞子虫駆虫方法において、1日当たりの投与回数が1回を超えず、且つ1週間あたりの投与回数が4回以上7回以下であることが好ましい。 In the myxosporean anthelmintic method for pufferfish according to the third aspect of the present invention, it is preferred that the number of administrations per day does not exceed one, and the number of administrations per week is between four and seven.
本発明の第4の態様は、フグ目フグ科に属する魚類の体内へのEnteromyxum leei及びSphaerospora fuguの一方又は双方の寄生を予防する方法であって、有効成分としてサリノマイシン又は医薬として許容されるその塩を単独で含む経口組成物を、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~5mgとなるように前記フグ目フグ科に属する魚類に経口投与する工程を有するフグ科魚類のやせ病の予防方法を提供することにより上記課題を解決するものである。 The fourth aspect of the present invention solves the above problems by providing a method for preventing emaciation disease in fish belonging to the Tetraodontiformes/Tetraodontidae family by preventing parasitism of one or both of Enteromyxum leei and Sphaerospora fugu in the body of fish belonging to the Tetraodontiformes/Tetraodontidae family, which comprises orally administering to said fish belonging to the Tetraodontiformes/Tetraodontidae family an oral composition containing salinomycin or a medicamentously acceptable salt thereof alone as an active ingredient such that the daily dose of the active ingredient is 0.5 to 5 mg per kg of fish body weight.
本発明の第4の態様に係るフグ科魚類のやせ病の予防方法において、前記有効成分の1回あたり投与量が、魚体重1kgあたり1~5mgであることが好ましい。 In the method for preventing emaciation disease in pufferfish according to the fourth aspect of the present invention, the amount of the active ingredient administered per dose is preferably 1 to 5 mg per kg of fish body weight.
本発明の第4の態様に係るフグ科魚類のやせ病の予防方法において、前記経口組成物の投与間隔が、12時間以上72日以下であることが好ましい。 In the method for preventing emaciation disease in pufferfish according to the fourth aspect of the present invention, the administration interval of the oral composition is preferably 12 hours or more and 72 days or less.
本発明の第4の態様に係るフグ科魚類のやせ病の予防方法において、1日当たりの投与回数が1回を超えず、且つ1週間あたりの投与回数が4回以上7回以下であることが好ましい。 In the method for preventing emaciation disease in pufferfish according to the fourth aspect of the present invention, it is preferable that the number of administrations per day does not exceed one, and that the number of administrations per week is between four and seven.
発明によると、フグ属フグ科に属する魚類におけるEnteromyxum leei及びSphaerospora fuguの寄生を原因とするやせ病の治療及び予防に関し、原因病原体の駆虫及び寄生の予防を可能にするフグ科魚類用駆虫剤経口組成物、フグ科魚類用やせ病予防剤経口組成物、並びにこれらを用いたフグ科魚類用粘液胞子虫駆虫方法及びフグ科魚類のやせ病の予防方法が提供される。 According to the invention, there is provided an oral anthelmintic composition for pufferfish that enables the anthelmintic treatment and prevention of parasitism by Enteromyxum leei and Sphaerospora fugu in fish belonging to the Tetraodontidae family, an oral composition for preventing emaciation in pufferfish that enables the anthelmintic treatment and prevention of parasitism by the causative pathogen, and a method for anthelmintic treatment of myxosporean parasites in pufferfish and a method for preventing emaciation in pufferfish using these compositions.
<フグ科魚類用駆虫剤経口組成物及びそれを用いた駆虫方法>
本発明のある実施形態は、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除するためのフグ科魚類用駆虫剤経口組成物(以下、「駆虫剤経口組成物」と略称する場合がある。)に関するものであり、同実施形態に関連する他の実施形態は、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除(駆虫)する方法(以下、「駆虫方法」と略称する場合がある。)に関するものである。駆虫剤経口組成物及び駆虫方法における有効成分、投与量及び投与間隔は両者に共通するため、以下、駆虫剤経口組成物及び駆虫方法について特に区別せずまとめて説明する。
<Anthelmintic oral composition for pufferfish and anthelmintic method using same>
One embodiment of the present invention relates to an oral anthelmintic composition for puffer fishes (hereinafter, sometimes abbreviated as "anthelmintic oral composition") for eliminating one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in the body of fishes belonging to the Tetraodontiformes and Tetraodontidae family, and another embodiment related to the embodiment relates to a method for eliminating (deworming) one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in the body of fishes belonging to the Tetraodontiformes and Tetraodontidae family (hereinafter, sometimes abbreviated as "anthelmintic method"). Since the active ingredient, dosage and administration interval in the oral anthelmintic composition and the anthelmintic method are common to both, hereinafter, the oral anthelmintic composition and the anthelmintic method will be described together without any particular distinction.
駆虫剤経口組成物は、サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを有効成分として含み、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除するための経口組成物である。なお、「経口組成物」とは、経口投与のための組成物をいい、「サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを有効成分として含み」とは、フグ目フグ科に属する魚類の体内に寄生したEnteromyxum leei及びSphaerospora fuguの一方又は双方を駆除するための有効成分として、サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを含むことを意味し、他の効能を有する医薬組成物又は他の有効成分との併用又は同時投与を排除するものではない。 The anthelmintic oral composition is an oral composition that contains only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient, and is used to eliminate one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in the body of fish belonging to the Tetraodontiformes and Tetraodontidae families. Note that "oral composition" refers to a composition for oral administration, and "containing only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient" means that it contains only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient for eliminating one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in the body of fish belonging to the Tetraodontiformes and Tetraodontidae families, and does not exclude the use in combination or simultaneous administration with a pharmaceutical composition having other efficacy or with other active ingredients.
サリノマイシンは、抗菌性及びコクシジウム抑制性を有するイオノフォア治療薬として知られており、IUPAC名は、(2R)-2-[(5S,6R)-6-[(1S,2S,3S,5R)-5-[(2S,5R,7S,9S,10S,12R,15R)-2-[(2R,5R,6S)-5-エチル-5-ヒドロキシ-6-メチル-2-テトラヒドロピラニル]-15-ヒドロキシ-2,10,12-トリメチル-1,6,8-トリオキサジスピロ[4.1.57.35]ペンタデカ-13-エン-9-イル]-2-ヒドロキシ-1,3-ジメチル-4-オキソヘプチル]-5-メチル-2-テトラヒドロピラニル]ブタン酸、CAS番号は、53003-10-4で表される化合物である。 Salinomycin is known as an ionophore therapeutic agent having antibacterial and coccidiostatic properties, and has the IUPAC name (2R)-2-[(5S,6R)-6-[(1S,2S,3S,5R)-5-[(2S,5R,7S,9S,10S,12R,15R)-2-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyl-2-tetrahydropyranyl]-15-hydroxy-2,10,12-trimethyl-1,6,8-trioxadispiro[ 4.1.57.35 ] pentadec-13-en-9-yl]-2-hydroxy-1,3-dimethyl-4-oxoheptyl]-5-methyl-2-tetrahydropyranyl]butanoic acid and CAS number 53003-10-4.
サリノマイシンはカルボキシル基を有するが、カルボキシル基の全部又は一部が、医薬として許容される塩を形成していてもよい。サリノマイシンのカルボキシル基と、医薬として許容される塩を形成する対イオン(陽イオン)としては、少なくとも投与量のフグ科フグ属に属する魚類に対し、毒性等の有害な作用を示さず、水不溶性等の医薬用途に適しない性質を示さず、所望の薬理作用を有する限りにおいて任意のものであってよいが、具体例としては、ナトリウムイオン、カリウムイオン等のアルカリ金属イオン、マグネシウム塩、カルシウム塩等のアルカリ土類金属塩、アンモニウム塩等が挙げられる。 Salinomycin has a carboxyl group, and all or part of the carboxyl group may form a medicamentously acceptable salt. The counter ion (cation) that forms a medicamentously acceptable salt with the carboxyl group of salinomycin may be any ion as long as it does not have harmful effects such as toxicity on at least the administered amount of fish belonging to the Tetraodontidae family and the Tetraodon genus, does not exhibit properties unsuitable for medicinal use such as water insolubility, and has the desired pharmacological action. Specific examples include alkali metal ions such as sodium ions and potassium ions, alkaline earth metal salts such as magnesium salts and calcium salts, and ammonium salts.
先述のとおり、薬剤による粘液胞子虫の駆除に関しては、ヨーロッパヘダイ及び水族館で飼育されている複数魚種に対し、粘液胞子虫の一種であるEnteromyxum leeiの駆虫薬として、サリノマイシンナトリウム及びアンプロリウムからなる合剤の使用(それぞれ、魚体重1kgあたり70mg、及び100mg)が報告されているが、サリノマイシン単独で少量投与された例は報告されておらず、フグ目フグ科に属する魚類への投与例についても同様である。 As mentioned above, regarding the use of drugs to eradicate myxosporean parasites, the use of a combination of salinomycin sodium and amprolium (70 mg and 100 mg per kg of fish body weight, respectively) as an anthelmintic for the myxosporean Enteromyxum leei in European gilthead seabream and several fish species kept in aquariums has been reported, but there have been no reported cases of salinomycin being administered alone in small amounts, nor has it been administered to fish belonging to the Tetraodontiformes/Tetraodontiidae family.
駆虫剤経口組成物の投与の対象となる魚類は、フグ目(Tetraodontiformes)フグ科(Tetraodontidae)に属する任意の魚類(以下、「フグ科魚類」と略称する場合がある。)である。好ましくは、駆虫剤経口組成物の投与の対象となるフグ目フグ科に属する魚類は、養殖の対象となっており、Enteromyxum leei又はSphaerospora fuguの感染によりやせ病を発症する魚類である。具体例としては、サバフグ属(Lagocephalus)に属する魚類(シロサバフグ、クロサバフグ、カナフグ等)、トラフグ属(Takifugu)に属する魚類(トラフグ、カラス、アカメフグ、サンサイフグ、クサフグ、メフグ、ヒガンフグ、コモンフグ、マフグ、ショウサイフグ、ゴマフグ等)、ヨリトフグ属(Spheoeroides)に属する魚類(ヨリトフグ等)が挙げられる。 The fish to which the anthelmintic oral composition is administered are any fish belonging to the family Tetraodontiformes (hereinafter sometimes abbreviated as "Tetraodontidae fish"). Preferably, the fish belonging to the family Tetraodontiformes (Tetraodontiformes) to which the anthelmintic oral composition is administered are farmed fish that develop emaciation disease due to infection with Enteromyxum leei or Sphaerospora fugu. Specific examples include fish belonging to the Lagocephalus genus (such as the white mackerel puffer, black mackerel puffer, and Japanese puffer), fish belonging to the Takifugu genus (such as the tiger puffer, crow puffer, red-eyed puffer, Sansai puffer, Kusafugu, Messing puffer, red-eyed puffer, common puffer, spotted puffer, Japanese puffer, and spotted puffer), and fish belonging to the Spheoeroides genus (such as the Japanese puffer).
駆虫剤経口組成物による駆除の対象となる粘液胞子虫は、フグ科魚類のやせ病の原因病原体であるEnteromyxum leei及びSphaerospora fuguである。 The myxosporean parasites targeted for eradication by the oral anthelmintic composition are Enteromyxum leei and Sphaerospora fugu, which are causative pathogens of emaciation disease in pufferfish.
駆虫剤経口組成物は、上述の有効成分(サリノマイシン、医薬として許容されるその塩、又はそれらの混合物)を経口投与に用いられる任意の担体と混合することにより製造される。有効成分は、固体のまま担体と混合してもよく、所定の濃度の水溶液等の溶液の形態で担体と混合してもよい。担体は、フグ科魚類が経口摂取可能であり、毒性等の有害性を有しないものであれば、任意の担体を使用することができるが、担体として最も好ましいのは養魚用飼料である。飼料の形態は、フグ科魚類の養殖に通常用いられるものであれば特に制限はなく、具体例として、例えば、タンパク質源として魚粉、又はその一部を、脱皮大豆粕、コーングルテンミール、菜種油滓、綿実粕、ヒマワリ粕等の植物性タンパク質含有材料で置換したものに、馬鈴薯デンプン、フィードオイル、無機化合物、ビタミン混合物、α化馬鈴薯デンプン(例えば2~4重量%程度)、デキストリン等のその他の栄養源を配合した配合飼料が挙げられる。飼料の形態も、フグ科魚類の養殖に使用されるものであれば特に制限はなく、例えば、ペレット、クランブル等のフグ科フグ目に属する魚類が摂取しやすいものが好ましく用いられる。 The anthelmintic oral composition is produced by mixing the above-mentioned active ingredient (salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof) with any carrier used for oral administration. The active ingredient may be mixed with the carrier as a solid, or in the form of a solution such as an aqueous solution of a predetermined concentration. Any carrier may be used as the carrier as long as it is orally ingestible by pufferfish and does not have any harmful properties such as toxicity, but the most preferred carrier is fish feed. There are no particular restrictions on the form of the feed as long as it is one that is normally used in the culture of pufferfish. Specific examples include compound feeds in which fish meal or a portion of the fish meal is replaced with a vegetable protein-containing material such as dehulled soybean meal, corn gluten meal, rapeseed oil cake, cottonseed meal, sunflower meal, etc. as a protein source, and other nutritional sources such as potato starch, feed oil, inorganic compounds, vitamin mixtures, pregelatinized potato starch (for example, about 2 to 4% by weight), dextrin, etc. are mixed. There are no particular limitations on the form of the feed, so long as it is one that can be used in the aquaculture of pufferfish. For example, pellets, crumbles, and other forms that are easy for fish belonging to the pufferfish family to ingest are preferably used.
駆虫剤経口組成物に含まれる上述の有効成分の1日あたり投与量は、魚体重1kgあたり0.5~10mg、好ましくは1~10mgである。有効成分の1日あたり投与量が魚体重1kgあたり0.5mgを下回ると、十分な駆虫効果を達成することができず、有効成分の1日あたり投与量が魚体重1kgあたり10mgを超えると、摂餌率の低下を招くおそれがある。駆虫剤経口組成物の担体として養魚用飼料を用いる場合、例えば、1日当たりの飼料の消費量から、フグ科魚類1尾が1日に摂取する飼料の量(以下、「1尾・1日当たり摂取量」という。)を算出し、或いは養殖されているフグ科魚類の平均体重に基づいて1尾・1日当たり摂取量の推定値を求め、1尾・1日当たり摂取量の飼料に対し、上述の投与量の有効成分を添加する。なお、フグ科魚類の平均体重は、養殖されているフグ科魚類の全部又は一部の体重の測定値の平均値を用いてもよく、養殖日数又は魚齢に基づく推定値を用いてもよい。 The daily dose of the above-mentioned active ingredient contained in the anthelmintic oral composition is 0.5 to 10 mg, preferably 1 to 10 mg, per kg of fish body weight. If the daily dose of the active ingredient is less than 0.5 mg per kg of fish body weight, a sufficient anthelmintic effect cannot be achieved, and if the daily dose of the active ingredient is more than 10 mg per kg of fish body weight, there is a risk of a decrease in the feeding rate. When using fish feed as a carrier for the anthelmintic oral composition, for example, the amount of feed consumed per day by one pufferfish fish (hereinafter referred to as "intake per fish per day") is calculated from the daily feed consumption, or an estimate of the intake per fish per day is obtained based on the average body weight of farmed pufferfish fish, and the above-mentioned dose of the active ingredient is added to the feed intake per fish per day. The average weight of pufferfish may be calculated by averaging the measured weights of all or part of the farmed pufferfish, or it may be estimated based on the number of days farmed or the age of the fish.
駆虫剤経口組成物の投与間隔は、12時間以上72日以下である。投与間隔が12時間を下回ると、駆虫効果が飽和し費用対効果が低下し、投与間隔が72日を超えると、十分な駆虫効果が得られなくなる。駆虫剤経口組成物の担体として飼料を用いる場合、上述の範囲内で投与間隔を給餌間隔と一致させることが好ましい。具体的には、1日当たりの投与回数が1回を超えず、且つ1週間あたり4回以上7回以下の投与回数で、駆虫剤経口組成物をフグ科魚類に経口投与する。具体例としては、週に4~7回(週5回の場合、例えば、休日を除く月曜日から金曜日。)、1日1回の決まった時間の給餌の際に、上述の有効成分を添加した飼料(駆虫剤経口組成物)を経口投与することが挙げられる。 The administration interval of the anthelmintic oral composition is 12 hours or more and 72 days or less. If the administration interval is less than 12 hours, the anthelmintic effect saturates and the cost-effectiveness decreases, and if the administration interval is more than 72 days, sufficient anthelmintic effect cannot be obtained. When using feed as a carrier for the anthelmintic oral composition, it is preferable to match the administration interval with the feeding interval within the above-mentioned range. Specifically, the anthelmintic oral composition is orally administered to pufferfish fishes not more than once per day and not less than 4 times and not more than 7 times per week. As a specific example, the feed (anthelmintic oral composition) to which the above-mentioned active ingredient has been added is orally administered 4 to 7 times a week (5 times a week, for example, Monday to Friday excluding holidays) at a fixed feeding time once a day.
<フグ科魚類用やせ病予防剤経口組成物及びそれを用いたやせ病の予防方法>
本発明の他の実施形態は、サリノマイシン、医薬として許容されるその塩及びそれらの混合物のいずれかのみを有効成分として含み、フグ目フグ科に属する魚類の体内へのEnteromyxum leei及びSphaerospora fuguの一方又は双方の寄生を予防するためのフグ科魚類用やせ病予防剤組成物(以下、「やせ病予防剤経口組成物」と略称する場合がある。)に関するものであり、同実施形態に関連する更に他の実施形態は、フグ目フグ科に属する魚類の体内へのEnteromyxum leei及びSphaerospora fuguの一方又は双方の寄生を予防する方法(以下、「やせ病予防方法」と略称する場合がある。)に関するものである。やせ病予防剤経口組成物及びやせ病予防方法における有効成分、投与量及び投与間隔は両者に共通するため、以下、やせ病予防剤経口組成物及びやせ病予防方法について特に区別せずまとめて説明する。
<Oral composition for preventing emaciation disease in pufferfish and method for preventing emaciation disease using the same>
Another embodiment of the present invention relates to an emaciation disease prevention agent composition for puffer fish (hereinafter, sometimes abbreviated as "emaciation disease prevention agent oral composition") that contains only salinomycin, a medicamentously acceptable salt thereof, or a mixture thereof as an active ingredient and is used to prevent the parasitism of one or both of Enteromyxum leei and Sphaerospora fugu in the body of fish belonging to the order Tetraodontiformes and the family Tetraodontiidae. Another embodiment related to the above embodiment relates to a method for preventing the parasitism of one or both of Enteromyxum leei and Sphaerospora fugu in the body of fish belonging to the order Tetraodontiformes and the family Tetraodontiidae (hereinafter, sometimes abbreviated as "emaciation disease prevention method"). Since the active ingredient, dosage, and administration interval in the emaciation disease prevention agent oral composition and the emaciation disease prevention method are common to both, hereinafter, the emaciation disease prevention agent oral composition and the emaciation disease prevention method will be described together without any particular distinction.
やせ病予防剤経口組成物の有効成分、投与対象となる魚種、感染予防対象となる粘液胞子虫、経口組成物の形態については、駆虫剤経口組成物の場合と同様であるため、詳細な説明を省略する。また、やせ病予防剤経口組成物の投与量及び投与間隔についても、有効成分の1日あたり投与量の上限値が、魚体重1kgあたり5mgである点を除くと、駆虫剤経口組成物と同様であるため、詳細な説明を省略する。 The active ingredient of the oral composition for preventing emaciation disease, the fish species to which it is administered, the myxosporean parasite to be prevented from infection, and the form of the oral composition are the same as those of the oral composition for preventing emaciation disease, and therefore detailed explanations are omitted. In addition, the dosage and administration interval of the oral composition for preventing emaciation disease are the same as those of the oral composition for preventing emaciation disease, except that the upper limit of the daily dosage of the active ingredient is 5 mg per kg of fish body weight, and therefore detailed explanations are omitted.
実施例1:サリノマイシンナトリウムによる駆虫試験
やせ病を発症したトラフグの当歳魚を約5000尾ずつの2群(投与群及び対照群)に分け、対照群にはサリノマイシンナトリウムを含まない飼料を、投与群にはサリノマイシンナトリウム(米ぬか油かす、炭酸カルシウム、流動パラフィンとの混合粉末。サリノマイシンナトリウムの含有量:10重量%)を、1日の摂食量に相当する重量に対し3~5mg/BW(魚体重1kgあたり3~5mg)の割合で添加した飼料(駆虫剤経口組成物)を、5回/週の間隔で(月曜日から金曜日まで、1日1回決まった時間に)給餌(経口投与)した。試験開始から3週間後及び12週間後に、投与群及び対照群より10尾ずつをサンプリングし、各群の平均魚体重及び採取した腸管内溶液の顕微鏡下での目視検査により決定される寄生スコア(下記の表1参照)の平均値を決定し、両群の結果の比較を行った。結果を、下記の表2に示す。なお、表2において「*」はp<0.01、「**」はp<0.001、「***」はp<0.0001であることを示す。
Example 1: Anthelmintic test using sodium salinomycin One-year-old tiger pufferfish that had developed emaciation disease were divided into two groups (administration group and control group) of about 5,000 fish each. The control group was fed a feed that did not contain sodium salinomycin, and the administration group was fed a feed (anthelmintic oral composition) containing sodium salinomycin (a mixed powder of rice bran oil cake, calcium carbonate, and liquid paraffin. The content of sodium salinomycin: 10% by weight) at a rate of 3 to 5 mg/BW (3 to 5 mg per kg of fish body weight) per weight equivalent to the daily food intake (administration by mouth) 5 times/week (Monday to Friday, once a day at a fixed time). Three and 12 weeks after the start of the test, 10 fish each were sampled from the administration group and the control group, and the average fish weight of each group and the average parasitism score (see Table 1 below) determined by visual inspection of the collected intestinal fluid under a microscope were determined, and the results of both groups were compared. The results are shown in Table 2 below. In Table 2, "*" indicates p<0.01, "**" indicates p<0.001, and "***" indicates p<0.0001.
上記の結果より、試験開始後3週間後には、投与群における寄生スコアについて、対照群のそれに対し有意な改善が認められた。試験開始後12週間経過後も、投与群における寄生スコアの有意な改善効果は維持されており、投与群における平均魚体重についても、対照群に対し有意な増加が認められた。これらの結果から、投与群において、低用量(1日当たり3~5mg/BW)のサリノマイシンナトリウムの単独での投与により、3週間経過後にはやせ病の原因病原体である粘液胞子虫の駆虫により寄生スコアが低下し、腸粘膜の状態が改善することにより栄養状態が改善され、対照群よりも魚体重が有意に増加することが確認された。 The above results show that three weeks after the start of the study, the parasitism score in the treatment group was significantly improved compared to the control group. Even 12 weeks after the start of the study, the significant improvement in parasitism score in the treatment group was maintained, and the average fish weight in the treatment group was also significantly increased compared to the control group. These results confirm that administration of a low dose (3-5 mg/BW per day) of salinomycin sodium alone reduced parasitism score in the treatment group after three weeks due to the anthelmintic effect of myxosporean parasites, which are the causative agent of emaciation disease, and improved the condition of the intestinal mucosa, thereby improving nutritional status, resulting in a significant increase in fish weight compared to the control group.
実施例2:サリノマイシンナトリウムによるやせ病の予防試験
健康なトラフグの当歳魚を約5000尾ずつの2群(投与群及び対照群)に分け、対照群にはサリノマイシンナトリウムを含まない飼料を、投与群にはサリノマイシンナトリウム(米ぬか油かす、炭酸カルシウム、流動パラフィンとの混合粉末。サリノマイシンナトリウムの含有量:10重量%)を、1日の摂食量に相当する重量に対し3mg/BW(魚体重1kgあたり3~5mg)の割合で添加した飼料(やせ病予防剤経口組成物)を、5回/週の間隔で(月曜日から金曜日まで、1日1回決まった時間に)給餌(経口投与)した。試験開始から1月後、2月後、3月後、4月後、5月後及び6月後に、投与群及び対照群より10尾ずつをサンプリングし、投与群の平均魚体重及び採取した腸管内溶液の顕微鏡下での目視検査により決定される寄生スコア(上記の表1参照)の平均値を決定した。結果を、下記の表3に示す。
Example 2: Test for preventing emaciation disease with salinomycin sodium Healthy tiger pufferfish of the year were divided into two groups (treatment group and control group) of about 5,000 fish each. The control group was fed a feed that did not contain salinomycin sodium, and the treatment group was fed a feed (emaceration disease preventive agent oral composition) containing salinomycin sodium (a mixed powder of rice bran oil cake, calcium carbonate, and liquid paraffin. The content of salinomycin sodium: 10% by weight) at a rate of 3 mg/BW (3-5 mg per kg of fish body weight) per weight equivalent to the daily food intake (oral administration) 5 times/week (Monday to Friday, once a day at a fixed time). One month, two months, three months, four months, five months, and six months after the start of the test, 10 fish each were sampled from the treatment group and the control group, and the average fish body weight of the treatment group and the average parasitism score (see Table 1 above) determined by visual inspection under a microscope of the collected intestinal fluid were determined. The results are shown in Table 3 below.
上記の結果より、低用量のサリノマイシンナトリウム(1日当たり3mg/BW)の投与により、やせ病を発症していない健康なトラフグと同程度の魚体重の増加及び低い寄生スコア(0~0.2)が、6月に亘り維持されることが確認された。なお、対照群における寄生スコアの平均値は、試験開始後6月経過時において2.8であった、これらの結果より、投与群において、対照群に対しやせ病の発生(寄生スコアの増加)が顕著に抑制されていることが確認された。 The above results confirmed that administration of a low dose of salinomycin sodium (3 mg/BW per day) maintained fish weight gain and low infestation scores (0-0.2) for six months, comparable to those of healthy tiger pufferfish that had not developed emaciation disease. The average infestation score in the control group was 2.8 six months after the start of the study. These results confirmed that the incidence of emaciation disease (increase in infestation score) was significantly suppressed in the treatment group compared to the control group.
Claims (14)
有効成分としてサリノマイシン又は医薬として許容されるその塩を単独で含む経口組成物を、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~10mgとなるように前記フグ目フグ科に属する魚類に経口投与する工程を有することを特徴とするフグ科魚類用粘液胞子虫駆虫方法。 A method for eliminating one or both of Enteromyxum leei and Sphaerospora fugu that are parasitic in fish belonging to the Tetraodontiformes, Tetraodontiidae family, comprising:
A method for exterminating myxosporean parasites in Tetraodontiformes, comprising the step of orally administering to said fish belonging to the Tetraodontiformes/Tetraodontiidae family an oral composition containing salinomycin or a medicamentously acceptable salt thereof alone as an active ingredient such that the daily dosage of said active ingredient is 0.5 to 10 mg per kg of fish body weight.
有効成分としてサリノマイシン又は医薬として許容されるその塩を単独で含む経口組成物を、前記有効成分の1日あたり投与量が、魚体重1kgあたり0.5~5mgとなるように前記フグ目フグ科に属する魚類に経口投与する工程を有することを特徴とするフグ科魚類のやせ病の予防方法。 A method for preventing parasitism of one or both of Enteromyxum leei and Sphaerospora fugu in fish belonging to the Tetraodontiformes, Tetraodontiidae family, comprising:
A method for preventing emaciation disease in pectinidae fish, comprising a step of orally administering to said fish belonging to the Tetraodontiformes/Tetraodontiidae family an oral composition containing salinomycin or a medicamentously acceptable salt thereof alone as an active ingredient such that the daily dosage of said active ingredient is 0.5 to 5 mg per kg of fish body weight.
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