JP4206428B1 - Composition for treating dementia and use thereof - Google Patents
Composition for treating dementia and use thereof Download PDFInfo
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- JP4206428B1 JP4206428B1 JP2008150941A JP2008150941A JP4206428B1 JP 4206428 B1 JP4206428 B1 JP 4206428B1 JP 2008150941 A JP2008150941 A JP 2008150941A JP 2008150941 A JP2008150941 A JP 2008150941A JP 4206428 B1 JP4206428 B1 JP 4206428B1
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- dementia
- alzheimer
- disease
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Abstract
【課題】新たな認知症を治療するための組成物を提供する。
【解決手段】本発明の認知症を処置するための組成物は、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含むので、新たな認知症を治療するための組成物を提供できる。
【選択図】なしA composition for treating new dementia is provided.
The composition for treating dementia of the present invention contains an iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 , so that a composition for treating new dementia can be provided. .
[Selection figure] None
Description
本発明は、例えば、アルツハイマー病等の認知症を処置するための組成物及びその利用に関するものである。 The present invention relates to a composition for treating dementia such as Alzheimer's disease and the use thereof.
認知症は、主に認知機能低下又は人格の変化等を呈する精神疾患であり、その中でも認知症の一種であるアルツハイマー病は、認知症の半分以上を占めるとされている。 Dementia is a mental illness that mainly exhibits cognitive decline or personality change. Among them, Alzheimer's disease, which is a type of dementia, is said to account for more than half of dementia.
また、アルツハイマー病には、家族性アルツハイマー病(Familial AD;FAD)、及びアルツハイマー型老年性認知症(senile dementia of Alzheimer type;SDAT)の2つのタイプがある。家族性アルツハイマー病は、30〜60歳代という比較的若年層が発症するものであり、アルツハイマー病の中でも極少数を占める。また、アルツハイマー型老年性認知症はアルツハイマー病患者の多くを占めており、通常60歳以上で発症するとされている。 In addition, there are two types of Alzheimer's disease: Familial Alzheimer's disease (Familial AD; FAD) and Alzheimer's type senile dementia of Alzheimer type (SDAT). Familial Alzheimer's disease develops in a younger age group of 30-60 years old, and accounts for a very small number of Alzheimer's disease. Alzheimer-type senile dementia occupies most of Alzheimer's disease patients and is usually considered to develop at the age of 60 years or older.
アルツハイマー病が発症する危険因子には、例えば、年齢、家族歴、高血圧、糖尿病、高脂血症、喫煙、及び生活習慣等が関連すると言われているが、或る特定の原因遺伝子を有することによって発症の危険性が高くなることが知られている(非特許文献1)。これまで、この原因遺伝子として21番染色体のアミロイド前躯体タンパク質(APP)717点突然変異が発見されており、その後、1番及び12番染色体上のプレセリン1,2遺伝子、また19番染色体上のアポE遺伝子が同定されている。これらの遺伝子には、近年、アルツハイマー病が発症する原因の一つとして考えられているβアミロイドというタンパク質の分解を阻害する作用が見られる。
The risk factors for developing Alzheimer's disease are said to be related to, for example, age, family history, hypertension, diabetes, hyperlipidemia, smoking, and lifestyle habits, but have certain causative genes. It is known that the risk of onset increases due to (Non-patent Document 1). So far, the amyloid precursor protein (APP) 717 point mutation of
通常、脳内で生産されたβアミロイドは直ちに分解されるが、上記遺伝子の保有者はβアミロイドの分解が阻害され、脳内に蓄積することになる。そのため、脳内に蓄積されたβアミロイドが神経細胞を死滅させ、各種神経伝達物質の分泌量を低下させる。これにより、脳内の神経伝達を円滑に行なうことが困難になるために、認知機能に支障を来たすとされている。これまで、βアミロイドが神経細胞を死滅させる機構について様々な検討がなされており、その中でもβアミロイドがミトコンドリアでの代謝活性に関与しているのではないかと注目されている。 Normally, β-amyloid produced in the brain is immediately degraded, but the above-mentioned gene holders inhibit the degradation of β-amyloid and accumulate in the brain. Therefore, β amyloid accumulated in the brain kills nerve cells and decreases the secretion amount of various neurotransmitters. As a result, it is difficult to smoothly perform nerve transmission in the brain, and it is said that the cognitive function is hindered. So far, various studies have been made on the mechanism by which β-amyloid kills nerve cells, and among them, attention has been focused on whether β-amyloid is involved in metabolic activity in mitochondria.
これまで、アルツハイマー病を治療するための薬剤としては、塩酸ドネペジル(アリセプト)が一般的に用いられている。この薬剤は、脳内に存在する神経伝達物質であるアセチルコリンの分解を抑制することができるため、アルツハイマー病を改善する効果が見られる。 Until now, donepezil hydrochloride (Aricept) has been generally used as a drug for treating Alzheimer's disease. Since this drug can suppress the degradation of acetylcholine, which is a neurotransmitter present in the brain, it has an effect of improving Alzheimer's disease.
一方、ミトコンドリアでの代謝活性を改善することにより、アルツハイマー病を治療することを目的とした技術も検討されており、本発明者らは、鉄剤、ビタミンB6、及びコエンザイムQ10の3剤を併用することによって、アルツハイマー病に対して優れた治療効果が得られることを見出している(特許文献1)。また、この他にも副作用の少ないアルツハイマー病の治療薬として、カルノジン酸あるいはロズマリン酸を有効成分とし、さらにビタミン類を含む健忘症の予防・治療剤(特許文献2)も知られている。
上述したように、様々なアルツハイマー病の治療薬が開発されているが、アルツハイマー病を根絶するには至っていない。 As described above, various therapeutic agents for Alzheimer's disease have been developed, but Alzheimer's disease has not been eradicated.
このような事情に鑑みると、従来公知のアルツハイマー病の治療薬のみで十分ということはなく、新たなアルツハイマー病の治療薬の開発が強く求められている。 In view of such circumstances, a conventionally known Alzheimer's disease therapeutic agent alone is not sufficient, and development of a new Alzheimer's disease therapeutic agent is strongly demanded.
すなわち、本発明者は上述した鉄剤、ビタミンB6及びコエンザイムQ10の3剤を併用した治療剤に関する特許(特許番号第3064360号、特許文献1)取得後も、さらに臨床試験を重ねて検討を行なった。その結果、当該3剤を治療対象者へ投与することにより一旦は顕著な改善効果が認められるものの、投与後にある程度の期間が経過すると次第に効果が低減することが明らかとなった。 That is, the present inventor conducted further clinical trials after the patent (Patent No. 3064360, Patent Document 1) related to the therapeutic agent using the above-mentioned iron agent, vitamin B 6 and coenzyme Q 10 in combination. I did it. As a result, it was clarified that, although a remarkable improvement effect was once recognized by administering the three agents to the treatment subject, the effect gradually decreased after a certain period of time after the administration.
そこで、本発明の目的は、新たな認知症を処置するための組成物及びその利用を提供することにある。 Therefore, an object of the present invention is to provide a composition for treating new dementia and use thereof.
本発明者らは、上記課題を解決するために鋭意検討を行なった。その結果、鉄剤、ビタミンB6、及びコエンザイムQ10の3剤に加え、ビタミンB1をさらに併用することによって、新たな認知症の治療効果が見られることを見出し、本願発明を完成させるに至った。本発明は、かかる新規知見に基づいて完成されたものであり、以下の発明を包含する。 The present inventors have intensively studied to solve the above problems. As a result, it has been found that a new therapeutic effect for dementia can be seen by further using vitamin B 1 in addition to iron, vitamin B 6 , and coenzyme Q 10 , and the present invention has been completed. It was. The present invention has been completed based on such novel findings, and includes the following inventions.
上記課題を解決するために、本発明に係る認知症を処置するための組成物は、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含むことを特徴としている。 In order to solve the above problems, a composition for treating dementia according to the present invention is characterized by containing an iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 .
また、本発明に係る認知症を処置するための組成物において、上記認知症が、家族性アルツハイマー病又はアルツハイマー老年性認知症であることが好ましい。また、さらには脳血管性認知症も含めた認知症であることが好ましい。これは、本発明に係る組成物の治療効果が、特に言語性記憶及び動作性記憶の改善という点に関して著しいことによる。 In the composition for treating dementia according to the present invention, the dementia is preferably familial Alzheimer's disease or Alzheimer's senile dementia. Furthermore, it is preferable to have dementia including cerebrovascular dementia. This is due to the remarkable therapeutic effect of the composition according to the invention, in particular in terms of improving verbal memory and operative memory.
また、本発明に係る認知症を処置するための組成物は、鉄剤、ビタミンB6、及びコエンザイムQ10投与患者を対象とする、ビタミンB1を含むことを特徴としている。 Moreover, the composition for treating dementia according to the present invention is characterized by containing vitamin B 1 intended for patients administered with iron, vitamin B 6 , and coenzyme Q 10 .
また、本発明に係る飲食品は、上記本発明に係る認知症を処置するための組成物を含むことを特徴としている。 Moreover, the food-drinks which concern on this invention are characterized by including the composition for treating the dementia which concerns on the said invention.
本発明に係る認知症を処置するための組成物は、以上のように、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含むので、新たな認知症を処置するための組成物を提供できるという効果を奏する。 Since the composition for treating dementia according to the present invention contains iron, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 as described above, a composition for treating new dementia is provided. There is an effect that it can be provided.
本発明の一実施形態について説明すると以下の通りである。 An embodiment of the present invention will be described as follows.
〔1.本発明に係る組成物〕
本発明に係る認知症を処置するための組成物は、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含めばよい。本明細書中において使用される用語「組成物」は、各種成分が一物質中に含有されている形態を指す。
[1. Composition according to the present invention]
The composition for treating dementia according to the present invention may contain an iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 . As used herein, the term “composition” refers to a form in which various components are contained in one substance.
本発明に係る組成物は、認知症を処置するために使用され得る。認知症とは、一旦正常に発達した脳が、後天的な脳の器質的障害により、進行性の知能障害及び行動障害を呈する精神疾患である。この認知症は、主に脳血管性認知症又はアルツハイマー型認知症(以下、「アルツハイマー病」として記すこともある)に大別できる。なお、ここでいう「処置」とは、治療、予防、改善、及び症状悪化防止等の医学的及び/又は薬学的有効性のある諸効果を含むものとして扱う。 The composition according to the present invention can be used to treat dementia. Dementia is a psychiatric disorder in which a normally developed brain exhibits progressive intellectual and behavioral disorders due to acquired brain organic disorders. This dementia can be roughly classified into cerebrovascular dementia or Alzheimer type dementia (hereinafter sometimes referred to as “Alzheimer's disease”). The term “treatment” as used herein is treated as including various medically and / or pharmaceutically effective effects such as treatment, prevention, improvement, and prevention of worsening of symptoms.
また、本発明に係る組成物に含まれる、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1としては、一般的に知られている公知化合物を用いればよい。すなわち、使用可能な鉄剤は特に限定されず、例えばクエン酸第一鉄ナトリウム、硫酸第一鉄、塩化第二鉄、クエン酸第一鉄、EDTA鉄ナトリウム、グルコン酸第一鉄、乳酸鉄、ピロリン酸第一鉄、及びピロリン酸第二鉄等が挙げられる。また、使用可能なビタミンB6製剤は特に限定されず、例えば塩酸ピリドキシン及びリン酸ピリドキサールが挙げられる。使用可能なコエンザイムQ10製剤は特に限定されず、ユビデカレノンが挙げられる。また、使用可能なビタミンB1製剤は特に限定されず、例えば、ビタミンB1塩では硝酸チアミンが挙げられ、ビタミンB1誘導体では塩酸セトチアミン(塩酸ジセチアミン)、オクトチアミン、チアミンジスルフィド、ビスベンチアミン、フルスルチアミン、プロスルチアミン、及びベンフォチアミンが挙げられる。 Further, the present invention contained in the composition according to, iron, vitamin B 6, as the coenzyme Q 10 and vitamin B 1,, may be a known compound which is generally known. That is, the iron agent that can be used is not particularly limited. For example, sodium ferrous citrate, ferrous sulfate, ferric chloride, ferrous citrate, sodium EDTA, ferrous gluconate, iron lactate, pyrroline Examples thereof include ferrous acid and ferric pyrophosphate. Vitamin B 6 preparation usable are not particularly limited, for example, be mentioned pyridoxine hydrochloride and pyridoxal phosphate. Available Coenzyme Q 10 formulations is not particularly limited, include ubidecarenone. Vitamin B 1 formulation can be used is not particularly limited, for example, in the vitamin B 1 salt include thiamin nitrate, hydrochloride Setochiamin (hydrochloride dicethiamine) for vitamins B 1 derivatives, oct thiamine, thiamine disulfide, bisbentiamine, Examples include fursultiamine, prosultiamine, and benfotiamine.
本発明に係る組成物は、これら4種の化合物が含まれているので、新たな認知症の治療効果を得ることができる。 Since the composition according to the present invention contains these four compounds, a new therapeutic effect for dementia can be obtained.
例えば、本発明に係る組成物を重度のアルツハイマー病患者に投与することによって、従来、鉄剤、ビタミンB6、及びコエンザイムQ10の3成分を併用して投与する場合に比して、さらに長期に亘って症状の改善効果を維持することができる。 For example, by administering the composition according to the present invention to a severe Alzheimer's disease patient, compared with the case where the conventional three components of iron, vitamin B 6 , and coenzyme Q 10 are administered in combination, the treatment is further prolonged. The symptom improvement effect can be maintained throughout.
また、本発明に係る組成物では、認知症の中でも家族性アルツハイマー病又はアルツハイマー老年性認知症を処置することが好ましく、さらには脳血管性認知症も含めた認知症であることが好ましい。本発明に係る組成物によって家族性アルツハイマー病又はアルツハイマー老年性認知症を処置することは、その他の認知症を処置することに比べ、さらに顕著な改善効果が得られる。また、本発明に係る組成物の治療効果が、特に言語性記憶及び動作性記憶の改善という点に関して著しいために、脳血管性認知症も含めた認知症に対しても改善効果が得られる。 In the composition according to the present invention, it is preferable to treat familial Alzheimer's disease or Alzheimer's senile dementia among dementia, and it is more preferable to have dementia including cerebrovascular dementia. Treating familial Alzheimer's disease or Alzheimer's senile dementia with the composition according to the present invention provides a further remarkable improvement effect compared to treating other dementias. In addition, since the therapeutic effect of the composition according to the present invention is particularly remarkable in terms of improving verbal memory and operative memory, an improvement effect can be obtained for dementia including cerebrovascular dementia.
また、本発明に係る組成物は、哺乳動物(ヒト、マウス、ラット、ウサギ、イヌ、ネコ、ウシ、ウマ、ブタ、及びサルなど)に対して適用することができる。 Further, the composition according to the present invention can be applied to mammals (human, mouse, rat, rabbit, dog, cat, cow, horse, pig, monkey, etc.).
本発明に係る組成物において、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1の含有量としては限定されるものではないが、例えば、本発明に係る組成物を製剤の形態にて患者に投与する場合、後述にて例示する各有効成分の成人1日当りの投与量に従って含有量を設定すればよい。 In the composition according to the present invention, the contents of the iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 are not limited. For example, the composition according to the present invention is a patient in the form of a preparation. In the case of administration, the content may be set in accordance with the daily dose of each active ingredient exemplified below.
本発明に係る組成物は、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1をそのまま混合されたものであってもよいが、薬学的に受容可能なキャリアを含んでもよい。本発明に係る組成物の製造方法としては、例えば医薬組成物の製造法として公知の手段に従って製造することができる。 The composition according to the present invention may be a mixture of an iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 as it is, but may also contain a pharmaceutically acceptable carrier. As a manufacturing method of the composition which concerns on this invention, it can manufacture according to a well-known means as a manufacturing method of a pharmaceutical composition, for example.
一実施形態において、本発明に係る組成物は、医薬組成物であり得る。医薬組成物中に使用される薬学的に受容可能なキャリアは、医薬組成物の投与形態及び剤型に応じて選択することができる。 In one embodiment, the composition according to the invention may be a pharmaceutical composition. The pharmaceutically acceptable carrier used in the pharmaceutical composition can be selected depending on the dosage form and dosage form of the pharmaceutical composition.
本明細書中で使用される場合、薬理学的に受容可能なキャリアとしては、製剤素材として使用可能な各種有機又は無機のキャリア物質が用いられ、固形製剤における賦形剤、滑沢剤、結合剤、又は崩壊剤、あるいは液状製剤における溶剤、溶解補助剤、懸濁剤、等張化剤、緩衝剤、又は無痛化剤などとして配合される。 As used herein, pharmacologically acceptable carriers include various organic or inorganic carrier materials that can be used as pharmaceutical materials, and include excipients, lubricants, binding agents in solid formulations. Or a disintegrant, or a solvent, a solubilizing agent, a suspending agent, an isotonic agent, a buffering agent, or a soothing agent in a liquid preparation.
賦形剤としては、例えば、乳糖、白糖、D-マンニトール、キシリトール、ソルビトール、エリスリトール、デンプン、及び結晶セルロースなどが挙げられ、滑沢剤としては、例えば、ステアリン酸マグネシウム、ステアリン酸カルシウム、タルク、及びコロイドシリカなどが挙げられる。 Examples of excipients include lactose, sucrose, D-mannitol, xylitol, sorbitol, erythritol, starch, and crystalline cellulose. Lubricants include, for example, magnesium stearate, calcium stearate, talc, and Examples thereof include colloidal silica.
結合剤としては、例えば、α化デンプン、メチルセルロース、結晶セルロース、白糖、D-マンニトール、トレハロース、デキストリン、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、及びポリビニルピロリドンなどが挙げられる。 Examples of the binder include pregelatinized starch, methylcellulose, crystalline cellulose, sucrose, D-mannitol, trehalose, dextrin, hydroxypropylcellulose, hydroxypropylmethylcellulose, and polyvinylpyrrolidone.
崩壊剤としては、例えば、デンプン、カルボキシメチルセルロース、低置換度ヒドロキシプロピルセルロース、カルボキシメチルセルロースカルシウム、クロスカルメロースナトリウム、及びカルボキシメチルスターチナトリウムなどが挙げられる。 Examples of the disintegrant include starch, carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose calcium, croscarmellose sodium, and carboxymethyl starch sodium.
溶剤としては、例えば、注射用水、アルコール、プロピレングリコール、マクロゴール、ゴマ油、トウモロコシ油、及びトリカプリリンなどが挙げられる。 Examples of the solvent include water for injection, alcohol, propylene glycol, macrogol, sesame oil, corn oil, and tricaprylin.
溶解補助剤としては、例えば、ポリエチレングリコール、プロピレングリコール、D-マンニトール、トレハロース、安息香酸ベンジル、エタノール、トリスアミノメタン、コレステロール、トリエタノールアミン、炭酸ナトリウム、及びクエン酸ナトリウムなどが挙げられる。 Examples of the solubilizer include polyethylene glycol, propylene glycol, D-mannitol, trehalose, benzyl benzoate, ethanol, trisaminomethane, cholesterol, triethanolamine, sodium carbonate, and sodium citrate.
懸濁剤としては、例えば、ステアリルトリエタノールアミン、ラウリル硫酸ナトリウム、ラウリルアミノプロピオン酸、レシチン、塩化ベンザルコニウム、塩化ベンゼトニウム、モノステアリン酸グリセリンなどの界面活性剤、あるいはポリビニルアルコール、ポリビニルピロリドン、カルボキシメチルセルロースナトリウム、メチルセルロース、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロースなどの親水性高分子が挙げられる。 Examples of the suspension include surfactants such as stearyltriethanolamine, sodium lauryl sulfate, laurylaminopropionic acid, lecithin, benzalkonium chloride, benzethonium chloride, and glyceryl monostearate, or polyvinyl alcohol, polyvinylpyrrolidone, carboxy Examples include hydrophilic polymers such as sodium methylcellulose, methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, and hydroxypropylcellulose.
等張化剤としては、例えば、塩化ナトリウム、グリセリン、及びD-マンニトールなどが挙げられる。 Examples of isotonic agents include sodium chloride, glycerin, and D-mannitol.
緩衝剤としては、例えば、リン酸塩、酢酸塩、炭酸塩、及びクエン酸塩などの緩衝液などが挙げられる。 Examples of the buffer include buffer solutions such as phosphate, acetate, carbonate, and citrate.
無痛化剤としては、例えば、ベンジルアルコールなどが挙げられる。 Examples of soothing agents include benzyl alcohol.
防腐剤としては、例えば、パラオキシ安息香酸エステル類、クロロブタノール、ベンジルアルコール、フェネチルアルコール、デヒドロ酢酸、及びソルビン酸などが挙げられる。 Examples of the preservative include p-hydroxybenzoates, chlorobutanol, benzyl alcohol, phenethyl alcohol, dehydroacetic acid, and sorbic acid.
抗酸化剤としては、例えば、亜硫酸塩及びアスコルビン酸などが挙げられる。 Examples of the antioxidant include sulfite and ascorbic acid.
本実施形態に係る医薬組成物は、製剤技術分野において慣用的な方法に従って製造することができる。本実施形態に係る医薬組成物における鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1の含有量は、投与形態、投与方法などを考慮し、当該医薬組成物を用いて後述の投与量範囲で鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を投与できるような量であれば特に限定されない。 The pharmaceutical composition which concerns on this embodiment can be manufactured in accordance with a method conventionally used in the formulation technical field. The content of iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 in the pharmaceutical composition according to the present embodiment is based on the dosage form, administration method, etc., and the dosage range described below using the pharmaceutical composition. However, there is no particular limitation as long as it can administer iron, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 .
本実施形態に係る医薬組成物の剤形としては、例えば、錠剤、カプセル剤(ソフトカプセル、マイクロカプセルを含む)、散剤、顆粒剤、シロップ剤などの経口剤、あるいは、注射剤、坐剤、ペレット、点滴剤などの非経口剤が挙げられる。用語「非経口」は、本明細書中で使用される場合、静脈内、筋肉内、腹腔内、胸骨内、皮下、及び関節内の注射及び注入を含む投与の様式をいう。 Examples of the dosage form of the pharmaceutical composition according to this embodiment include tablets, capsules (including soft capsules and microcapsules), powders, granules, syrups and other oral preparations, or injections, suppositories, and pellets. And parenteral agents such as drops. The term “parenteral” as used herein refers to modes of administration including intravenous, intramuscular, intraperitoneal, intrasternal, subcutaneous, and intraarticular injections and infusions.
本実施形態に係る医薬組成物の投与量は、投与対象、投与経路、症状などによっても異なるが、当業者は、これら投与対象、投与経路、又は症状などに応じて最適な条件を適宜設定することができる。 The dosage of the pharmaceutical composition according to the present embodiment varies depending on the administration subject, administration route, symptom, and the like, but those skilled in the art appropriately set optimal conditions according to the administration subject, administration route, symptom, etc. be able to.
本実施形態に係る医薬組成物は、製剤形態に応じた適当な投与経路で投与できる。投与方法も特に限定はなく、内用、外用及び注射によって適用することができる。注射剤は、例えば静脈内、筋肉内、皮下、及び皮内などに投与することができる。 The pharmaceutical composition according to the present embodiment can be administered by an appropriate administration route according to the preparation form. The administration method is not particularly limited, and can be applied by internal use, external use or injection. The injection can be administered, for example, intravenously, intramuscularly, subcutaneously, and intradermally.
本実施形態に係る医薬組成物の投与量は、その製剤形態、投与方法、使用目的及び当該医薬の投与対象である患者の年齢、体重、及び症状によって適宜設定され一定ではない。例えば、製剤中に含有される各有効成分の成人1日当りの投与量は、鉄剤では50〜250mg、好ましくは100〜250mgであり、さらに好ましくは100〜150mgであり、ビタミンB6では40〜210mg、好ましくは180〜210mgであり、コエンザイムQ10では60〜180mg、好ましくは60〜120mgであり、ビタミンB1では140〜280mg、好ましくは210〜235mgである。また、症状に応じて各成分の投与量を調整してもよい。例えば、症状の軽い患者に対しては、各成分の投与量をここに例示した範囲の各下限値としてもよく、症状の重い患者に対しては、各成分の投与量をここに例示した範囲の各上限値としてもよい。もちろん投与量は、種々の条件によって変動するので、上記投与量より少ない量で十分な場合もあるし、あるいは範囲を超えて必要な場合もある。投与は、所望の投与量範囲内において、1日内において単回で、又は数回に分けて行なってもよい。また、本実施形態に係る医薬組成物はそのまま経口投与するほか、任意の飲食品に添加して日常的に摂取させることもできる。 The dosage of the pharmaceutical composition according to the present embodiment is appropriately set according to the formulation form, administration method, purpose of use, and age, weight, and symptom of the patient to whom the pharmaceutical is administered, and is not constant. For example, the dosage for adults per day of each active ingredient contained in the formulation, the iron is 50 to 250 mg, preferably 100 to 250 mg, more preferably from 100 to 150 mg, 40~210Mg the vitamin B 6 , Preferably 180 to 210 mg, coenzyme Q 10 is 60 to 180 mg, preferably 60 to 120 mg, and vitamin B 1 is 140 to 280 mg, preferably 210 to 235 mg. Moreover, you may adjust the dosage of each component according to a symptom. For example, for patients with mild symptoms, the dose of each component may be the lower limit of the range exemplified here, and for patients with severe symptoms, the dose of each component is the range exemplified here. It is good also as each upper limit of. Of course, since the dosage varies depending on various conditions, an amount smaller than the above dosage may be sufficient or may be necessary beyond the range. Administration may be performed once or divided into several times within one day within a desired dose range. Moreover, the pharmaceutical composition according to the present embodiment can be orally administered as it is, or can be added to any food or drink and taken daily.
また、本発明に係る組成物は、鉄剤、ビタミンB6、及びコエンザイムQ10投与患者を対象とする、ビタミンB1を含むものであってもよい。すなわち、鉄剤、ビタミンB6、及びコエンザイムQ10投与患者に対して、ビタミンB1を含む組成物を投与すればよい。これにより、鉄剤、ビタミンB6、及びコエンザイムQ10の3成分が投与された患者の認知症の改善効果を、長期に亘って維持することができる。なお、鉄剤、ビタミンB6、及びコエンザイムQ10投与患者とは、鉄剤、ビタミンB6、及びコエンザイムQ10が投与された患者を意味し、鉄剤、ビタミンB6、及びコエンザイムQ10を投与する目的としては認知症の処置に限定されない。
The compositions according to the present invention, iron, vitamin B 6, and directed to a coenzyme Q 10 treated patients, may include vitamin B 1. That is, a composition containing vitamin B 1 may be administered to a patient who is administered iron, vitamin B 6 , and coenzyme Q 10 . Thus, iron, vitamin B 6, and the effect of improving
〔2.本発明に係る飲食品〕
本発明に係る飲食品は、上記本発明に係る認知症を処置するための組成物を含んでいればよい。本発明に係る飲食品は、上記本発明に係る組成物を含んでいるので、認知症を処置するための新たな効果が期待できる。
[2. Food and drink according to the present invention]
The food-drinks which concern on this invention should just contain the composition for treating the dementia which concerns on the said invention. Since the food-drinks which concern on this invention contain the composition which concerns on the said invention, the new effect for treating dementia can be anticipated.
本発明の組成物を飲食品に利用する場合、そのままの形態、オイルなどに希釈した形態、乳液状形態食、又は食品業界で一般的に使用される担体を添加した形態などのものを調製してもよい。 When the composition of the present invention is used for foods and drinks, it is prepared as it is, in a form diluted with oil, a milk form meal, or a form to which a carrier generally used in the food industry is added. May be.
乳液状形態としては、例えば、油相部に組成物を添加し、さらにグリセリン脂肪酸エステル、ソルビタン脂肪酸エステル、ショ糖脂肪酸エステル、グリセロール、デキストリン、ナタネ油、大豆油、コーン油などの液状の脂肪を加え、水相部にL−アスコルビン酸あるいはそのエステル又は塩、例えばローカストビーンガム、アラビアガム又はゼラチンなどのガム質、例えばヘスペリジン、ルチン、ケルセチン、カテキン、チアニジンなどのフラボノイド類又はポリフェノール類或いはその混合物などを添加し、乳化することによって調製できる。 As an emulsion form, for example, a composition is added to the oil phase part, and liquid fats such as glycerin fatty acid ester, sorbitan fatty acid ester, sucrose fatty acid ester, glycerol, dextrin, rapeseed oil, soybean oil, corn oil and the like are added. In addition, L-ascorbic acid or an ester or salt thereof, for example, gum such as locust bean gum, gum arabic or gelatin, for example, flavonoids such as hesperidin, rutin, quercetin, catechin, thianidine or polyphenols or a mixture thereof Etc. can be added and emulsified.
飲料の形態では、例えば、非アルコール飲料又はアルコール飲料であってもよい。非アルコール飲料としては、例えば、炭酸系飲料、果汁飲料、ネクター飲料などの非炭酸系飲料、清涼飲料、スポーツ飲料、茶、コーヒー、及びココアなどが挙げられる。また、アルコール飲料の形態としては、例えば、スピリッツ、リキュール、チューハイ、果実酒類、麦酒、発泡酒、及び薬用酒などの一般食品の形態を例示できる。 In the form of a beverage, for example, it may be a non-alcoholic beverage or an alcoholic beverage. Examples of non-alcoholic drinks include non-carbonated drinks such as carbonated drinks, fruit juice drinks, and nectar drinks, soft drinks, sports drinks, tea, coffee, and cocoa. Moreover, as a form of alcoholic drink, the form of general foods, such as spirits, liqueur, chuhai, fruit liquor, malt liquor, happoshu, and medicinal liquor, can be illustrated, for example.
飲食物としては、例えば、洋菓子類(プリン、ゼリー、グミキャンディー、キャンディー、ドロップ、キャラメル、チューインガム、チョコレート、ペストリー、バタークリーム、カスタードグリーム、シュークリーム、ホットケーキ、パン、ポテトチップス、フライドポテト、ポップコーン、ビスケット、クラッカー、パイ、スポンジケーキ、カステラ、ワッフル、ケーキ、ドーナツ、ビスケット、クッキー、せんべい、おかき、おこし、まんじゅう、あめなど)、乾燥麺製品(マカロニ、パスタ)、卵製品(マヨネーズ、生クリーム)、飲料(機能性飲料、乳酸飲料、乳酸菌飲料、濃厚乳性飲料、果汁飲料、無果汁飲料、果肉飲料、透明炭酸飲料、果汁入り炭酸飲料、果実着色炭酸飲料)、嗜好品(緑茶、紅茶、インスタントコーヒー、ココア、缶入りコーヒードリンク)、乳製品(アイスクリーム、ヨーグルト、コーヒー用ミルク、バター、バターソース、チーズ、発酵乳、加工乳)、ペースト類(マーマレード、ジャム、フラワーペースト、ピーナッツペースト、フルーツペースト、果実のシロップ漬け)、畜肉製品(ハム、ソーセージ、ベーコン、ドライソーセージ、ビーフジャーキー、ラード)、魚介類製品(魚肉ハム、魚肉ソーセージ、蒲鉾、ちくわ、ハンペン、魚の干物、鰹節、鯖節、煮干し、うに、いかの塩辛、スルメ、魚のみりん干し、貝の干物、鮭などの燻製品)、佃煮類(小魚、貝類、山菜、茸、昆布)、カレー類(即席カレー、レトルトカレー、缶詰カレー)、調味料剤(みそ、粉末みそ、醤油、粉末醤油、もろみ、魚醤、ソース、ケチャップ、オイスターソース、固形ブイヨン、焼き肉のたれ、カレールー、シチューの素、スープの素、だしの素、ペースト、インスタントスープ、ふりかけ、ドレッシング、サラダ油)、揚げ製品(油揚げ、油揚げ菓子、即席ラーメン)、豆乳、マーガリン、ショートニングなどを挙げることができる。なお、上記飲食物は、組成物を従来公知の製造方法に従って、一般食品の原料と配合することにより、加工製造することができる。 Examples of food and drink include confectionery (pudding, jelly, gummy candy, candy, drop, caramel, chewing gum, chocolate, pastry, butter cream, custard cream, cream puff, hot cake, bread, potato chips, french fries, popcorn, Biscuits, crackers, pies, sponge cakes, castella, waffles, cakes, donuts, biscuits, cookies, rice crackers, rice cakes, rice cakes, manju, candy etc., dried noodle products (macaroni, pasta), egg products (mayonnaise, fresh cream) , Beverages (functional beverages, lactic acid beverages, lactic acid bacteria beverages, concentrated milk beverages, fruit juice beverages, fruit juice beverages, fruit beverages, transparent carbonated beverages, carbonated beverages with fruit juice, fruit colored carbonated beverages), luxury products (green tea, tea, Instant coffee, Core, canned coffee drink), dairy products (ice cream, yogurt, coffee milk, butter, butter sauce, cheese, fermented milk, processed milk), pastes (marmalade, jam, flower paste, peanut paste, fruit paste, Fruit syrup), livestock products (ham, sausage, bacon, dry sausage, beef jerky, lard), seafood products (fish ham, fish sausage, salmon, chikuwa, hampen, fish dried fish, bonito, bonito, boiled and dried , Sea urchin, sea cucumber salted fish, dried squid, dried fish shellfish, dried fish shellfish, salmon products), boiled fish (small fish, shellfish, wild vegetables, sea bream, kelp), curry (instant curry, retort curry, canned curry) ), Seasonings (Miso, powdered miso, soy sauce, powdered soy sauce, moromi, fish sauce, sauce, ketchup, oyster -Sauce, solid bouillon, grilled meat sauce, curry roux, stew sauce, soup sauce, soup stock, paste, instant soup, sprinkle, dressing, salad oil), fried products (fried food, fried confectionery, instant ramen), soy milk, margarine And shortening. In addition, the said food-drinks can be processed and manufactured by mix | blending a composition with the raw material of a general food according to a conventionally well-known manufacturing method.
また、上記飲食物は、例えば、機能性食品、栄養補助食品、又は健康食品類として用いることができる。その形態は、特に限定されるものではなく、例えば、食品の製造例としては、アミノ酸バランスのとれた栄養価の高い乳蛋白質、大豆蛋白質、卵アルブミンなどの蛋白質、これらの分解物、卵白のオリゴペプチド、大豆加水分解物などの他、アミノ酸単体の混合物などを、従来公知の方法に従って使用することができる。また、ソフトカプセル、タブレットなどの形態で利用することもできる。 Moreover, the said food-drinks can be used as a functional food, a dietary supplement, or health food, for example. The form is not particularly limited, and examples of food production include milk proteins with high amino acid balance, soy protein, and proteins such as egg albumin, degradation products thereof, and egg white oligos. In addition to peptides, soybean hydrolysates, and the like, mixtures of amino acids alone can be used according to conventionally known methods. It can also be used in the form of a soft capsule, a tablet or the like.
栄養補助食品又は機能性食品の一例としては、糖類、脂肪、微量元素、ビタミン類、乳化剤、香料などが配合された流動食、半消化態栄養食、成分栄養食、ドリンク剤、カプセル剤、経腸栄養剤などの加工形態を挙げることができる。上記各種食品には、例えば、スポーツドリンク、栄養ドリンクなどの飲食物は、栄養バランス、風味を良くするために、さらにアミノ酸、ビタミン類、ミネラル類などの栄養的添加物、甘味料、香辛料、香料、又は色素などを配合することもできる。 Examples of dietary supplements or functional foods include liquid foods, semi-digested nutritional foods, ingredient nutritional foods, drinks, capsules, and sucrose containing sugars, fats, trace elements, vitamins, emulsifiers, and fragrances. Processing forms such as enteral nutrients can be mentioned. In the above-mentioned various foods, for example, foods and drinks such as sports drinks and nutritional drinks are further supplemented with nutritional additives such as amino acids, vitamins and minerals, sweeteners, spices and fragrances to improve nutritional balance and flavor. Or a pigment | dye etc. can also be mix | blended.
また、本発明の組成物を安定化させるために抗酸化剤等を用いてもよく、例えば、トコフェロール、L−アスコルビン酸、BHA、及びローズマリー抽出物などを従来公知の方法に従って併用することができる。 In addition, an antioxidant or the like may be used to stabilize the composition of the present invention. For example, tocopherol, L-ascorbic acid, BHA, rosemary extract and the like may be used in combination according to a conventionally known method. it can.
また、本発明に係る飲食品において、本発明に係る組成物の含有量としては特に限定されない。 Moreover, in the food / beverage products which concern on this invention, it does not specifically limit as content of the composition concerning this invention.
このように、本発明に係る組成物は、少なくとも、鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含めばよいといえる。すなわち、複数の鉄剤、ビタミンB6、コエンザイムQ10、及びビタミンB1を含有する薬剤もまた、本発明の技術的範囲に含まれる点に留意すべきである。 Thus, it can be said that the composition according to the present invention should contain at least an iron preparation, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 . That is, it should be noted that a drug containing a plurality of iron preparations, vitamin B 6 , coenzyme Q 10 , and vitamin B 1 is also included in the technical scope of the present invention.
以下に実施例を示し、本発明の実施の形態についてさらに詳しく説明する。もちろん、本発明は以下の実施例に限定されるものではなく、細部については様々な態様が可能であることはいうまでもない。さらに、本発明は上述した実施形態に限定されるものではなく、請求項に示した範囲で種々の変更が可能であり、それぞれ開示された技術的手段を適宜組み合わせて得られる実施形態についても本発明の技術的範囲に含まれる。また、本明細書中に記載された特許文献及び非特許文献の全てが、本明細書中において参考として援用される。 Examples will be shown below, and the embodiments of the present invention will be described in more detail. Of course, the present invention is not limited to the following examples, and it goes without saying that various aspects are possible in detail. Further, the present invention is not limited to the above-described embodiments, and various modifications can be made within the scope shown in the claims, and the present invention is also applied to the embodiments obtained by appropriately combining the disclosed technical means. It is included in the technical scope of the invention. Moreover, all the patent documents and nonpatent literatures described in this specification are used as reference in this specification.
<実施例1>
本実施例の組成物は、次のように調製した。すなわち、クエン酸第一鉄ナトリウム100〜150mg、ビタミンB640〜180mg、コエンザイムQ10120mg(分3投与)、及びビタミンB1210〜235mgを秤量し、これらをカプセルに充填した。なお、上記組成物中の各成分の含有量は、例えば、症状が軽度認知障害である患者には各成分の含有量における下限値とし、症状が重症ADである患者には各成分の含有量における上限値とした。また、軽度AD、中等度ADの患者に対しては、クエン酸第一鉄ナトリウムをそれぞれ、100mg、100〜150mg、ビタミンB6を100mg、100〜180mg、ビタミンB1を210mg、210〜235mgとした。
<Example 1>
The composition of this example was prepared as follows. That is, 100-150 mg of ferrous sodium citrate, 40-180 mg of vitamin B 6 , 120 mg of coenzyme Q 10 (3 minutes administration), and 210-235 mg of vitamin B 1 were weighed and filled into capsules. The content of each component in the composition is, for example, the lower limit of the content of each component for patients with mild cognitive impairment, and the content of each component for patients with severe AD. It was set as the upper limit value. For patients with mild AD and moderate AD, sodium ferrous citrate 100 mg, 100-150 mg, vitamin B 6 100 mg, 100-180 mg, vitamin B 1 210 mg, 210-235 mg, respectively. did.
このように調製した組成物を被験者に投与した。本実施例の被験者はアルツハイマー病を発症している人、あるいは、その前段階に位置する人であり、各被験者の症状の進行度は以下に示すMMSE(mini-mental state examination)検査による指標を用いた。 The composition thus prepared was administered to the subject. The subject of this example is a person who has developed Alzheimer's disease or a person who is located in the previous stage, and the degree of symptom progression of each subject is an index based on the following MMSE (mini-mental state examination) test. Using.
ここで、「アルツハイマー病の前段階に位置する人」とは、最近問題となっている軽度認知障害(MCI:Mild Cognitive Impairment)の患者を指す。軽度認知障害とは、アルツハイマー病と健康な状態との間のグレーゾーンのことであり、アルツハイマー病の前段階に位置付けられている。例えば、以下に示すMMSE検査において24〜30点の「正常」であっても、忘れっぽくなった(物忘れ)等の軽い認知障害が伴う場合には、その約半数がアルツハイマー病を発症するといわれている。 Here, “a person in the pre-stage of Alzheimer's disease” refers to a patient with mild cognitive impairment (MCI), which has recently become a problem. Mild cognitive impairment is a gray zone between Alzheimer's disease and a healthy state and is positioned in the pre-stage of Alzheimer's disease. For example, in the MMSE test shown below, even if it is “normal” of 24-30 points, about half of them are said to develop Alzheimer's disease if they are accompanied by mild cognitive impairment such as forgetfulness (forgetfulness). .
MMSE検査とは、認知症のスクリーニングテストとして世界的に広く用いられており、図1に示す11項目の質問からなる。図1は、MMSE検査における設問事項を表わす。このMMSE検査の回答から総合得点を導き出し、症状の進行度を判定した。具体的には、全問正解すると30点であり、総合得点が21点以下の場合には、認知症などの認知障害がある可能性が高いと判断される。その中でも重症度を3段階に分類しており、軽度では23〜20点、中等度では19〜10点、及び重度では9〜0点である。また、24〜30点であっても、軽い認知障害が伴う場合には軽度認知障害として扱った。この指標に基づき、各段階の被験者を抽出して本実施例の組成物を12ヶ月間投与した。抽出した被験者は、男性4人(59〜71歳)、及び女性8人(57〜81歳)であった。 The MMSE test is widely used worldwide as a screening test for dementia, and consists of 11 questions shown in FIG. FIG. 1 shows the questions in the MMSE inspection. An overall score was derived from the MMSE test responses, and the degree of symptom progression was determined. Specifically, when all questions are answered correctly, the score is 30 points. When the total score is 21 points or less, it is determined that there is a high possibility that there is a cognitive disorder such as dementia. Among them, the severity is classified into three levels, with 23 to 20 points for mild, 19 to 10 for moderate, and 9 to 0 for severe. Moreover, even if it was 24-30 points | pieces, when mild cognitive impairment accompanied, it was handled as mild cognitive impairment. Based on this index, subjects at each stage were extracted and the composition of this example was administered for 12 months. The extracted subjects were 4 males (59-71 years old) and 8 females (57-81 years old).
また、アルツハイマー病、及びMCI患者に対する治療効果の判定も、上述したMMSE検査により行なった。なお、当該検査は、投与前、投与開始後1ヶ月、3ヶ月、6ヶ月、8ヶ月及び12ヶ月の時点で行なった。これにより得られた結果を以下の表1に示す。 Moreover, the determination of the therapeutic effect on Alzheimer's disease and MCI patients was also performed by the MMSE test described above. The test was performed before administration and at 1 month, 3 months, 6 months, 8 months and 12 months after the start of administration. The results thus obtained are shown in Table 1 below.
なお、表中、FA、MM、MT、HN、YI、MR、HT、TY、NS、TS、及びIKは被験者のイニシャルを表わす。ADはアルツハイマー病を表わす。 In the table, FA, MM, MT, HN, YI, MR, HT, TY, NS, TS, and IK represent the initials of the subject. AD represents Alzheimer's disease.
また、この結果を示したグラフを図2〜5に示す。図2は、実施例の組成物又は比較例の組成物を投与した軽度のAD患者に行なったMMSE検査の得点の推移を表わすグラフであり、図3は、実施例の組成物又は比較例の組成物を投与した中等度のAD患者に行なったMMSE検査の得点の推移を表わすグラフであり、図4は、実施例の組成物又は比較例の組成物を投与した重度のAD患者に行なったMMSE検査の得点の推移を表わすグラフである。また、図5は、実施例の組成物を投与したMCI患者に行なったMMSE検査の得点の推移を表わすグラフである。 Moreover, the graph which showed this result is shown in FIGS. FIG. 2 is a graph showing changes in scores of MMSE tests performed on mild AD patients administered with the composition of the example or the composition of the comparative example, and FIG. 3 shows the transition of the composition of the example or the comparative example. FIG. 4 is a graph showing changes in scores of MMSE tests performed on moderate AD patients administered with the composition, and FIG. 4 was performed on severe AD patients administered with the composition of the example or the comparative composition. It is a graph showing transition of the score of a MMSE test | inspection. FIG. 5 is a graph showing changes in scores of MMSE examinations performed on MCI patients administered with the compositions of the examples.
この表に示すように、実施例の組成物を投与したすべての被験者が開始前から投与後1ヶ月までの間で、MMSE検査の得点が1〜5点上昇した。その後、3ヶ月、6ヶ月、及び8ヶ月経過した時点では何れも投与後1ヶ月よりも高い又は同じ値であった。また、中等度AD患者であるYI及びTY、重症AD患者であるTS及びIK、ならびに軽度認知障害FAでは、12ヶ月経過した時点でも投与後1ヶ月よりも高い又は同じ値であった。 As shown in this table, the MMSE test scores increased by 1 to 5 points from all subjects who received the composition of the examples from before the start to 1 month after the administration. Thereafter, at the time when 3 months, 6 months, and 8 months passed, all were higher than or equal to 1 month after administration. In addition, YI and TY, which are moderate AD patients, TS and IK, which are severe AD patients, and mild cognitive impairment FA, were higher than or equal to those after one month even after 12 months.
この結果から、本実施例の組成物では、アルツハイマー病患者及びMCI患者に対する治療効果が何れの進行段階においても見られ、さらに8ヶ月又は12ヶ月まで効果を持続させることができると分かった。 From these results, it was found that in the composition of this example, the therapeutic effect on Alzheimer's disease patients and MCI patients was observed at any stage of progression, and the effect could be further maintained for up to 8 months or 12 months.
<比較例>
比較例では、クエン酸第一鉄ナトリウム100〜150mg、ビタミンB640〜180mg、及びコエンザイムQ10120mg(分3投与)を秤量し、カプセルに充填した。なお、比較例においても、上記組成物中の各成分の含有量は、例えば、症状が軽度認知障害である患者には各成分の含有量における下限値とし、症状が重症ADである患者には各成分の含有量における上限値とした。また、軽度AD、中等度ADの患者に対しては、クエン酸第一鉄ナトリウムをそれぞれ、100mg、100〜150mg、ビタミンB6を100mg、100〜180mg、ビタミンB1を210mg、210〜235mgとした。また、比較例における被験者は、軽度AD患者は30人、中等度AD患者は88人、また重度AD患者は46人であった。
<Comparative example>
In the comparative example, 100-150 mg of ferrous sodium citrate, 40-180 mg of vitamin B 6 and 120 mg of coenzyme Q 10 (3 minutes administration) were weighed and filled into capsules. In the comparative example, the content of each component in the composition is, for example, a lower limit for the content of each component for patients with mild cognitive impairment, and for patients with severe AD It was set as the upper limit in content of each component. For patients with mild AD and moderate AD, sodium ferrous citrate 100 mg, 100-150 mg, vitamin B 6 100 mg, 100-180 mg, vitamin B 1 210 mg, 210-235 mg, respectively. did. Moreover, the subject in the comparative example was 30 patients with mild AD, 88 patients with moderate AD, and 46 patients with severe AD.
この比較例の組成物をアルツハイマー病患者及びMCI患者に投与した結果を、上述した図2〜5に示している。 The results of administration of the composition of this comparative example to Alzheimer's disease patients and MCI patients are shown in FIGS.
図2に示すように、比較例の組成物を投与した軽度AD患者では開始後1ヶ月で1.5点程上昇し、さらに6ヶ月経過した時点で開始前よりも1.8点程上昇していることが分かった。しかしながら、その後は低下傾向にあり、12ヶ月後には3ヶ月目と同値にまで下がった。 As shown in FIG. 2, in mild AD patients to which the composition of the comparative example was administered, it increased by 1.5 points in one month after the start, and further increased by 1.8 points from the start after 6 months. I found out. However, it has been on a downward trend since then, and after 12 months it has fallen to the same value as in the third month.
比較例の組成物を投与した中等度AD患者では、図3に示すように開始後1ヶ月で3点程上昇するが、その後6ヶ月経過した時点から徐々に低下することが分かった。 In moderate AD patients to which the composition of the comparative example was administered, as shown in FIG. 3, it was found that it increased by about 3 points in 1 month after the start, but gradually decreased after 6 months.
また、図4に示す比較例の組成物を投与した重度AD患者では、開始後1ヶ月で3点程上昇するが、その直後に徐々に低下することが分かった。 In addition, in severe AD patients administered with the composition of the comparative example shown in FIG. 4, it was found that it increased by about 3 points in 1 month after the start, but gradually decreased immediately thereafter.
図5は、最近問題となってきたアルツハイマー病の前段階に位置し、その約半数がアルツハイマー病に移行すると言われている軽度認知障害患者2名のMMSEの推移を表わすグラフである。この比較例は一例ではあるが、やはり他の群と同様に一旦は改善するものの、その後、時間の経過とともに徐々に低下する傾向が見られる。一方、実施例は組成物投与後速やかに正常値に改善し、その後も低下が見られていないことは注目に値する。 FIG. 5 is a graph showing the transition of MMSE of two mild cognitive impairment patients who are located in the previous stage of Alzheimer's disease, which has recently become a problem, and about half of which are said to shift to Alzheimer's disease. Although this comparative example is an example, it is once improved as in the other groups, but after that, there is a tendency to gradually decrease with time. On the other hand, it is noteworthy that the Examples improve to normal values immediately after administration of the composition and no decrease is observed thereafter.
以上の結果より、実施例の組成物では、8ヶ月又は12ヶ月が経過した時点でも一旦回復した症状が再び悪化する兆候が見られないため、本発明の組成物によるアルツハイマー病疾患治療の開発を期待させるものである。 From the above results, in the compositions of the examples, there is no sign that the symptoms once recovered even after 8 months or 12 months have passed, so the development of treatment for Alzheimer's disease using the composition of the present invention is not possible. It is what you expect.
本発明に係る組成物によれば、例えば、家族性アルツハイマー病又はアルツハイマー老年性認知症等の認知症の処置に新たな効果が見られるので、医薬産業、又は食品産業等において好適に利用できる。 According to the composition according to the present invention, for example, a new effect is seen in the treatment of dementia such as familial Alzheimer's disease or Alzheimer's senile dementia, and therefore, it can be suitably used in the pharmaceutical industry or the food industry.
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EP2497380A1 (en) * | 2011-03-10 | 2012-09-12 | DSM IP Assets B.V. | Process for iron supplementation of beverages |
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JP2006160627A (en) * | 2004-12-03 | 2006-06-22 | Kyowa Hakko Kogyo Co Ltd | Method for performing limited-time release |
JP2006320311A (en) * | 2005-04-19 | 2006-11-30 | Nisshin Pharma Inc | Food containing coenzyme Q10 and minerals and method for producing the same |
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CN104784442A (en) * | 2015-04-28 | 2015-07-22 | 苏州大学 | Nutrient solution for alleviating cognitive function decline and preparation method of nutrient solution |
CN104784442B (en) * | 2015-04-28 | 2018-04-03 | 苏州大学 | It is a kind of to be used to slow down nutrient solution of cognitive function decline and preparation method thereof |
WO2023036105A1 (en) * | 2021-09-09 | 2023-03-16 | 上海日馨医药科技股份有限公司 | Method for treating neurodegenerative disease |
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