JP2013216621A - Dysuria improvement medicine - Google Patents
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- JP2013216621A JP2013216621A JP2012089017A JP2012089017A JP2013216621A JP 2013216621 A JP2013216621 A JP 2013216621A JP 2012089017 A JP2012089017 A JP 2012089017A JP 2012089017 A JP2012089017 A JP 2012089017A JP 2013216621 A JP2013216621 A JP 2013216621A
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- dysuria
- astaxanthin
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Abstract
Description
本発明は、アスタキサンチンを有効成分として含有する、排尿障害の改善剤に関する。 The present invention relates to an agent for improving urination disorder, which contains astaxanthin as an active ingredient.
排尿障害は、排尿に関する機能の不全であり、昼間頻尿、尿意切迫、尿失禁、夜間頻尿等の蓄尿障害に関する症状、尿線途絶、尿勢低下、腹圧排尿等の排出障害に関する症状と残尿感に代表される排尿後症状等がみられる。
排尿障害は、患者の日常生活の質（ＱＯＬ）に影響を及ぼす疾患であり、その有効な治療剤が望まれている。また、その治療剤としては、安全性の高い製剤が望まれている。
Urination disorder is a dysfunction related to urination, symptoms related to urinary retention such as daytime frequent urination, urgency, urinary incontinence, nocturia, symptoms related to dysuria such as urinary line disruption, urinary decline, and abdominal pressure urination Symptoms such as post urination typified by feeling of residual urine are observed.
Urination disorder is a disease that affects the quality of life of patients (QOL), and an effective therapeutic agent is desired. Moreover, a highly safe preparation is desired as the therapeutic agent.
アスタキサンチンは、サケ科の魚類、甲殻類、藻類等の水生生物、植物等が含有する赤色カロテノイドである。近年、アスタキサンチンが抗酸化作用、腎臓機能改善等の生理活性を有することが報告されている（特許文献１）。
特許文献１では、アスタキサンチンにより、糸球体濾過率又は腎クリアランス値が改善することが示されている。しかし、昼間頻尿、尿意切迫、尿失禁、夜間頻尿等の蓄尿症状、尿線途絶、尿勢低下、腹圧排尿等の排出症状と残尿感に代表される排尿後症状等の排尿障害に有効であるかどうかについては示されていない。
Astaxanthin is a red carotenoid contained in aquatic organisms such as salmonid fish, crustaceans and algae, plants, and the like. In recent years, it has been reported that astaxanthin has physiological activities such as antioxidant action and improvement of kidney function (Patent Document 1).
Patent Document 1 shows that astaxanthin improves glomerular filtration rate or renal clearance value. However, urination disorders such as daytime frequent urination, urgency, urinary incontinence, nocturia such as nocturia, urinary line disruption, decreased urinary dysfunction, discharge symptoms such as abdominal pressure urination and post-urination symptoms such as residual urine It is not shown whether it is valid for
本発明は、安全性の高い、排尿障害の治療に有効な製剤を提供することを課題とする。 An object of the present invention is to provide a highly safe preparation effective for treating urination disorders.
本発明者らは、上記の課題を解決するために鋭意検討を行った。その結果、アスタキサンチンが排尿障害の治療に有効であることを知見した。すなわち、上記の課題に合致した排尿障害の治療に有効な製剤が達成されることを知見し、本発明を完成した。 The present inventors have intensively studied to solve the above problems. As a result, it has been found that astaxanthin is effective in treating dysuria. That is, the present invention has been completed by discovering that a preparation effective for the treatment of dysuria that meets the above-mentioned problems can be achieved.
すなわち、本発明は以下の通りである。 That is, the present invention is as follows.
＜１＞アスタキサンチンを有効成分として含有する、排尿障害の治療剤。
＜２＞排尿障害が蓄尿障害及び／又は排出障害である、＜１＞に記載の治療剤。
＜３＞蓄尿障害が頻尿、尿意切迫及び尿失禁から選ばれる疾患である、＜２＞に記載の治療剤。
<1> A therapeutic agent for dysuria containing astaxanthin as an active ingredient.
<2> The therapeutic agent according to <1>, wherein the urination disorder is a urine storage disorder and / or a discharge disorder.
<3> The therapeutic agent according to <2>, wherein the urinary storage disorder is a disease selected from frequent urination, urgency and incontinence.
本発明により、安全性の高い、排尿障害の治療に有効な製剤が提供される。
本発明の製剤は、昼間頻尿、尿意切迫、尿失禁、夜間頻尿等の蓄尿症状、尿線途絶、尿勢低下、腹圧排尿等の排出症状と残尿感に代表される排尿後症状等の排尿障害の各種の症状に適用可能である。また、本発明の製剤は、排尿障害患者のＱＯＬの改善に有効である。
The present invention provides a highly safe preparation effective for the treatment of urination disorders.
The preparation of the present invention is a urinary symptom represented by urinary retention, urinary urgency, urinary incontinence, nocturia, nocturia, urinary decline, abdominal pressure urination, etc. It is applicable to various symptoms of dysuria such as In addition, the preparation of the present invention is effective in improving QOL of patients with dysuria.
本明細書において用いた略号を説明する。
ＩＰＳＳ：国際前立腺症状スコア（International Prostate Symptom Score）
ＱＯＬ：生活の質（Quality of Life）
Abbreviations used in this specification will be described.
IPSS: International Prostate Symptom Score
QOL: Quality of Life
本発明は、アスタキサンチンを有効成分として含有する、排尿障害の治療剤に関する。 The present invention relates to a therapeutic agent for dysuria, which contains astaxanthin as an active ingredient.
本発明の排尿障害の治療剤が有効成分として含有するアスタキサンチンは、以下の式で示されるものを含む。 Astaxanthin contained as an active ingredient in the therapeutic agent for dysuria of the present invention includes those represented by the following formula.
また、アスタキサンチンは、上記の式で示される遊離型（フリー体）以外に、水酸基がエステル化された、モノエステル型、ジエステル型等の形態が存在する。本発明においては、遊離型、モノエステル型、ジエステル型のいずれの形態も使用可能である。モノエステル型、ジエステル型としては、生体内に存在し得るものであれば、特に限定されずに使用することができるが、例えばパルミチン酸、ステアリン酸等の飽和脂肪酸、あるいはオレイン酸、リノール酸、α−リノレン酸、γ−リノレン酸、ビスホモ−γ−リノレン酸、アラキドン酸、エイコサペンタエン酸、ドコサヘキサエン酸等の不飽和脂肪酸等のエステルが挙げられる。本発明においては、アスタキサンチンの遊離型、モノエステル型、ジエステル型の１種又は２種以上を組み合わせて使用することができる。
本明細書においては、特に断らない限り、用語「アスタキサンチン」は、アスタキサンチンの遊離型、モノエステル型、ジエステル型の総称を意味する。
Moreover, astaxanthin has forms, such as a monoester type and a diester type, in which a hydroxyl group is esterified, in addition to the free type (free form) represented by the above formula. In the present invention, any of a free type, a monoester type, and a diester type can be used. The monoester type and the diester type can be used without any particular limitation as long as they can exist in the living body. For example, saturated fatty acids such as palmitic acid and stearic acid, oleic acid, linoleic acid, Examples include esters of unsaturated fatty acids such as α-linolenic acid, γ-linolenic acid, bishomo-γ-linolenic acid, arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid. In the present invention, one or more of astaxanthin free type, monoester type and diester type can be used.
In the present specification, unless otherwise specified, the term “astaxanthin” means a generic name of free form, monoester form, and diester form of astaxanthin.
本発明に用いられるアスタキサンチンは、化学的に合成されたもの又は天然物より得られるもののいずれをも用いることができる。天然物より得られるものとしては、アスタキサンチンを含有する赤色酵母；ティグリオパス（赤ミジンコ）、オキアミ等の甲殻類の殻；ヘマトコッカス等の緑藻類等の微細藻類；植物等が挙げられる。本発明においては、アスタキサンチンの製造方法は、特に限定されない。製造方法の一例としては、アスタキサンチンを含有する生物を常法で破砕した破砕紛体を得る方法、アスタキサンチンを含有する生物から常法でアスタキサンチンを含有する抽出物を得る方法等が挙げられる。本発明においては、アスタキサンチンは抽出物、破砕物の状態であっても、適宜精製したものであってもよい。本発明においては、このようなアスタキサンチンを含有する抽出物、破砕粉体物、精製物、化学合成物の１種又は２種以上を組み合わせて使用することができる。 Astaxanthin used in the present invention may be either chemically synthesized or obtained from natural products. Examples of substances obtained from natural products include red yeast containing astaxanthin; shellfish shells such as tigliopath (red daphnia) and krill; microalgae such as green algae such as hematococcus; plants and the like. In the present invention, the method for producing astaxanthin is not particularly limited. Examples of the production method include a method of obtaining a crushed powder obtained by crushing an organism containing astaxanthin by a conventional method, a method of obtaining an extract containing astaxanthin from an organism containing astaxanthin by a conventional method, and the like. In the present invention, astaxanthin may be in the form of an extract or crushed material, or may be appropriately purified. In the present invention, one or more of these astaxanthin-containing extracts, crushed powders, purified products, and chemical compounds can be used in combination.
本発明の排尿障害の治療剤は、排尿障害を改善する。排尿障害の改善は、特に限定されないが、例えば、国際前立腺症状スコア（ＩＰＳＳ）及び／又はＱＯＬスコアにより確認することができる。すなわち、被験者に、排尿障害の治療剤の投与前及び投与後に、問診票によるアンケート形式でＩＰＳＳスコア及びＱＯＬスコアの変化を検査し、投与前と投与後でこれらスコアが有意差をもって改善する若しくは改善の傾向がある場合に、排尿障
害の治療剤が有効であると判定する。統計手法として、ウィルコクソンの符号順位検定（Wilcoxon signed-rank test）等を用いることができる。
The therapeutic agent for dysuria of the present invention improves dysuria. The improvement of dysuria is not particularly limited, but can be confirmed by, for example, the International Prostate Symptom Score (IPSS) and / or the QOL score. That is, subjects are examined for changes in the IPSS score and QOL score in a questionnaire based on questionnaires before and after administration of the therapeutic agent for dysuria, and these scores improve or improve significantly before and after administration. If it is determined that the therapeutic agent for dysuria is effective. As a statistical method, Wilcoxon signed-rank test or the like can be used.
本発明の排尿障害の治療剤は、排尿障害の治療及び改善に有効である。例えば、昼間頻尿、尿意切迫、尿失禁、夜間頻尿等の蓄尿症状、尿線途絶、尿勢低下、腹圧排尿等の排出症状と残尿感に代表される排尿後症状等の排尿障害の各種症状の予防、治療及び症状の緩和に有効である。 The therapeutic agent for dysuria of the present invention is effective for the treatment and improvement of dysuria. For example, urination disorders such as daytime frequent urination, urgency, urinary incontinence, urinary retention such as nocturia, urinary lineage loss, urinary dysfunction, discharge symptoms such as abdominal pressure urination and post-urination symptoms such as residual urine It is effective in the prevention, treatment and alleviation of various symptoms.
本発明の排尿障害の治療剤の投与経路は、経口投与又は非経口投与のいずれであってもよい。その剤形は、投与経路に応じて適宜選択される。例えば、注射液、輸液、散剤、顆粒剤、錠剤、カプセル剤、丸剤、腸溶剤、トローチ、内用液剤、懸濁剤、乳剤、シロップ剤、外用液剤、湿布剤、軟膏剤、ローション剤、坐剤、経腸栄養剤等が挙げられる。
本発明の排尿障害の治療剤の製造方法は、有効成分としてアスタキサンチンを含有すれば、特に限定されない。すなわち、通常の医薬の製剤技術を用いて、製造することができる。本発明の排尿障害の治療剤には、有効成分としてのアスタキサンチン以外に、必要に応じて、賦形剤、結合剤、防腐剤、酸化安定剤、崩壊剤、滑沢剤、矯味剤等の医薬の製剤技術分野において通常用いられる補助剤等を含有させることも可能である。なお、アスタキサンチンを含有する製剤は、市販されているものもあり、それを本発明の排尿障害の治療剤に使用することもできる。
The administration route of the therapeutic agent for dysuria of the present invention may be either oral administration or parenteral administration. The dosage form is appropriately selected depending on the administration route. For example, injections, infusions, powders, granules, tablets, capsules, pills, enteric solvents, troches, liquids for internal use, suspensions, emulsions, syrups, liquids for external use, poultices, ointments, lotions, Examples include suppositories and enteral nutrients.
The method for producing a therapeutic agent for dysuria of the present invention is not particularly limited as long as it contains astaxanthin as an active ingredient. That is, it can be produced using a conventional pharmaceutical formulation technique. In the therapeutic agent for dysuria of the present invention, in addition to astaxanthin as an active ingredient, if necessary, pharmaceuticals such as excipients, binders, preservatives, oxidative stabilizers, disintegrants, lubricants, and flavoring agents. It is also possible to contain adjuvants or the like normally used in the field of pharmaceutical technology. Some preparations containing astaxanthin are commercially available, and can be used as the therapeutic agent for dysuria according to the present invention.
本発明の排尿障害の治療剤の投与量は、投与の目的（症状、症状の程度等）や投与対象者の状況（性別、年齢、体重等）に応じて異なるが、通常、成人に対して、アスタキサンチンフリー体換算で、経口投与の場合、１日あたり０．１ｍｇ〜１０００ｍｇ、好ましくは１ｍｇ〜１００ｍｇで投与され得る。
投与期間は、投与の目的（症状、症状の程度等）や投与対象者の状況（性別、年齢、体重等）に応じて異なるが、１日〜２００日、好ましくは１０日〜１００日投与され得る。本発明の排尿障害の治療剤は、生体に対する安全性が高く、症状の改善の程度によって又は発症若しくは再発の予防の目的で、上記期間を超えて長期間投与され得る。
The dose of the therapeutic agent for dysuria of the present invention varies depending on the purpose of administration (symptoms, degree of symptoms, etc.) and the situation of the administration subject (gender, age, weight, etc.), but usually for adults In the case of oral administration in terms of astaxanthin-free form, 0.1 mg to 1000 mg, preferably 1 mg to 100 mg per day can be administered.
The administration period varies depending on the purpose of administration (symptom, degree of symptom, etc.) and the situation of the subject of administration (sex, age, weight, etc.), but is administered for 1 to 200 days, preferably 10 to 100 days. obtain. The therapeutic agent for dysuria of the present invention is highly safe for a living body and can be administered for a long period of time exceeding the above-mentioned period depending on the degree of symptom improvement or prevention of onset or relapse.
本発明の排尿障害の治療剤は、医薬品として以外にも、医薬部外品、機能性食品、栄養補助剤、飲食物等として使用することができる。医薬部外品として使用する場合、必要に応じて、医薬部外品または化粧品等の技術分野で通常用いられている種々の補助剤とともに使用され得る。あるいは、機能性食品、栄養補助剤、または飲食物として使用する場合、必要に応じて、例えば、甘味料、香辛料、調味料、防腐剤、保存料、殺菌剤、酸化防止剤等の食品に通常用いられる添加剤とともに使用してもよい。また、溶液状、懸濁液状、シロップ状、顆粒状、クリーム状、ペースト状、ゼリー状等の所望の形状で、あるいは必要に応じて成形して使用してもよい。これらに含まれるアスタキサンチンの割合は、特に限定されず、使用目的、使用形態、および使用量に応じて適宜選択することができる。 The therapeutic agent for dysuria according to the present invention can be used as a quasi-drug, a functional food, a nutritional supplement, a food and drink, etc., as well as a pharmaceutical. When used as a quasi-drug, it can be used together with various adjuvants usually used in the technical field such as a quasi-drug or cosmetic. Alternatively, when used as a functional food, nutritional supplement, or food or drink, it is usually used in foods such as sweeteners, spices, seasonings, preservatives, preservatives, bactericides, and antioxidants as necessary. You may use with the additive used. Further, it may be used in a desired shape such as solution, suspension, syrup, granule, cream, paste, jelly, etc., or as necessary. The ratio of the astaxanthin contained in these is not specifically limited, It can select suitably according to a use purpose, a usage form, and a usage-amount.
以下に実施例を挙げて本発明の詳細を説明するが、本発明は以下の実施例に限定されるものではない。 Hereinafter, the present invention will be described in detail with reference to examples. However, the present invention is not limited to the following examples.
＜実施例１＞
インフォームド・コンセントが得られた排尿障害を有する患者１０名（年齢：５２，６２，４７，４６，５４，４２，５１，５５，５３，５５歳）を対象に、アスタキサンチン含有ヘマトコッカス藻色素製剤［大塚製薬製：アスタキサンチン（フリー体換算）６ｍｇ／剤］を、１日１２ｍｇ、１ヶ月服用してもらい、経口投与試験を行った。
投与前と投与後に、ＩＰＳＳスコア及びＱＯＬスコアの問診票（図１参照）によるアンケート形式で、症状の程度に関する検査を行った。
<Example 1>
Astaxanthin-containing Haematococcus alga pigment for 10 patients (age: 52, 62, 47, 46, 54, 42, 51, 55, 53, 55 years old) who have informed consent and have dysuria The formulation [manufactured by Otsuka Pharmaceutical: astaxanthin (free body equivalent) 6 mg / drug] was taken at 12 mg per day for 1 month, and an oral administration test was conducted.
Before and after administration, an examination regarding the degree of symptoms was performed in a questionnaire format using an IPSS score and QOL score questionnaire (see FIG. 1).
ＩＰＳＳスコアの問診票の７項目のうち、ＩＰＳＳ−２，−４，−７が蓄尿に関する項目であり、ＩＰＳＳ−２，−４，−７の合計点数が蓄尿（症状）スコアである。
ＩＰＳＳスコアの問診票の７項目のうち、ＩＰＳＳ−３，−５，−６が排尿に関する項目であり、ＩＰＳＳ−３，−５，−６の合計点数が排尿（症状）スコアである。
１０名の患者の、製剤投与前と投与後の、蓄尿（症状）スコア、排尿（症状）スコア、ＩＰＳＳ合計スコア（ＩＰＳＳ−Ｔ）及びＱＯＬスコアを統計解析した。結果を以下の表に示す。
Of the seven items in the IPSS score questionnaire, IPSS-2, -4, and -7 are items related to urine storage, and the total score of IPSS-2, -4, and -7 is the urine storage (symptom) score.
Of the seven items on the IPSS score questionnaire, IPSS-3, -5, and -6 are items related to urination, and the total score of IPSS-3, -5, and -6 is the urination (symptom) score.
The urine accumulation (symptom) score, micturition (symptom) score, IPSS total score (IPSS-T) and QOL score of 10 patients before and after administration of the preparation were statistically analyzed. The results are shown in the table below.
統計解析の結果、蓄尿スコアは、アスタキサンチン服用前に比較して服用後は有意に改善した。(P=0.0051)
排尿スコアは、アスタキサンチン服用前に比較して服用後は有意に改善した。(P=0.0077)
ＩＰＳＳ合計スコアは、アスタキサンチン服用前に比較して服用後は有意に改善した。(P=0.0051)
QOLスコアは、アスタキサンチン服用前に比較して服用後は改善傾向を認めた。(P=0.0679)
以上の結果から、アスタキサンチン含有ヘマトコッカス藻色素製剤の投与により、蓄尿症状、排尿症状のいずれも改善することが分かる。さらに、患者のＱＯＬも改善することが分かる。
As a result of statistical analysis, the urine accumulation score improved significantly after taking as compared with before taking astaxanthin. (P = 0.0051)
The urination score improved significantly after taking compared to before taking astaxanthin. (P = 0.0077)
The IPSS total score improved significantly after taking as compared to before taking astaxanthin. (P = 0.0051)
The QOL score improved after taking astaxanthin compared to before taking astaxanthin. (P = 0.0679)
From the above results, it can be seen that administration of an astaxanthin-containing Haematococcus alga pigment preparation improves both urine storage symptoms and urination symptoms. It can also be seen that the patient's QOL also improves.
既存疾患に影響されず、長期間の服用が可能な安全性の高い製剤であり、排尿障害の各種症状の改善及び／又はＱＯＬの改善に利用できる。 It is a highly safe preparation that can be taken for a long period of time without being affected by existing diseases, and can be used to improve various symptoms of dysuria and / or QOL.
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