JPH08245378A - Tranquilizer - Google Patents

Tranquilizer

Info

Publication number
JPH08245378A
JPH08245378A JP4952195A JP4952195A JPH08245378A JP H08245378 A JPH08245378 A JP H08245378A JP 4952195 A JP4952195 A JP 4952195A JP 4952195 A JP4952195 A JP 4952195A JP H08245378 A JPH08245378 A JP H08245378A
Authority
JP
Japan
Prior art keywords
oils
acid
fish
docosahexaenoic acid
tranquilizer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP4952195A
Other languages
Japanese (ja)
Inventor
Kazuyoshi Yazawa
一良 矢澤
Tomohito Hamazaki
智仁 浜崎
Shigeki Sawazaki
茂樹 澤▲崎▼
Yoko Nagao
陽子 長尾
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sagami Chemical Research Institute
Fuji Yakuhin Co Ltd
Original Assignee
Sagami Chemical Research Institute
Fuji Yakuhin Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sagami Chemical Research Institute, Fuji Yakuhin Co Ltd filed Critical Sagami Chemical Research Institute
Priority to JP4952195A priority Critical patent/JPH08245378A/en
Publication of JPH08245378A publication Critical patent/JPH08245378A/en
Pending legal-status Critical Current

Links

Abstract

PURPOSE: To obtain a tranquilizer, containing docosahexaenoic acid as an active ingredient, having no or extremely slight side effects and capable of manifesting remarkable tranquilizing effects especially in applying a stress. CONSTITUTION: This tranquilizer contains docosahexaenoic acid (salt) having preferably >=90% (especially >=95%) purity and its ester, glyceride, phospholipid, choline compound, ascorbic acid compound and amino acid compound as an active ingredient in an amount of 5-100wt.% (preferably 20-100wt.%) expressed in terms of a free acid. The daily dose thereof is about 100-500mg expressed in terms of the amount of the docosahexaenoic acid and orally or parenterally administered in one to several divided portions. Furthermore, fish oils extracted from a blueback fish such as a sardine, a mackerel, a horse mackerel, a salmon or a saury, fish oils derived from orbital fats of a large-sized marine fish such as a tuna or bonito, oils and fats derived from a microorganism or a seaweed, krill oils and oils and fats, etc., derived from a marine product extracted from a cod or a cuttlefish liver.

Description

【発明の詳細な説明】Detailed Description of the Invention

【0001】[0001]

【産業上の利用分野】本発明はドコサヘキサエン酸を有
効成分とする精神安定剤及び医薬組成物に関するもので
ある。
FIELD OF THE INVENTION The present invention relates to a tranquilizer and a pharmaceutical composition containing docosahexaenoic acid as an active ingredient.

【0002】[0002]

【従来の技術】ドコサヘキサエン酸(DHA)は脳や網
膜等の興奮性膜に多く含まれているn−3系の不飽和脂
肪酸であり、アラキドン酸カスケードを阻害する作用を
有していることが知られている。ドコサヘキサエン酸に
は記憶、学習能の改善、視力低下抑制、抗腫瘍作用、免
疫抑制作用等の薬理作用があるとされている。また、D
HA含有カプセルが健康食品として市販されている。
2. Description of the Related Art Docosahexaenoic acid (DHA) is an n-3 unsaturated fatty acid contained in excitable membranes such as the brain and retina, and has an action of inhibiting the arachidonic acid cascade. Are known. Docosahexaenoic acid is said to have pharmacological actions such as memory, improvement of learning ability, suppression of visual deterioration, antitumor action, and immunosuppressive action. Also, D
HA-containing capsules are commercially available as health foods.

【0003】DHAを多く含む魚油にもマクロファージ
の活性を抑制したり(Dustin L. B., et al., J. IMMUN
OL, 144,488-4897 (1990))、LTB4、LTC4の産生
を抑制する(Lokesh B. R., et al., Biochem Biophys
Acta, 958,99-107, (1988))との報告があり、臓器移植
においてCyAと併用すると免疫抑制効果が増強される
との報告(Kelley V. E.,et al., Transplantation,48,
98-102,(1989) )がある。また、自己免疫疾患である、
慢性間節リウマチや乾癬の患者にこの魚油を投与して効
果が上がったという報告(特開平1−66118号公
報、特開平3−90022号公報)、ベーチェット病患
者への投与では皮膚症状が改善したという報告(橋本喬
司他,厚生省特定疾患ベーチェット病調査研究班,平成
3年度研究業績,185-187)がある。しかしながら、こ
れまでに、DHAが精神安定作用を示すことは知られて
いない。
Macrophage activity can also be suppressed in fish oil containing a large amount of DHA (Dustin LB, et al., J. IMMUN
OL, 144, 488-4897 (1990)), suppresses production of LTB 4 and LTC 4 (Lokesh BR, et al., Biochem Biophys
Acta, 958, 99-107, (1988)), and reports that the immunosuppressive effect is enhanced when combined with CyA in organ transplantation (Kelley VE, et al., Transplantation, 48,
98-102, (1989)). It is also an autoimmune disease,
It was reported that administration of this fish oil to patients with rheumatoid arthritis and psoriasis improved the effect (JP-A-1-66118, JP-A-3-90022), and skin symptoms were improved by administration to patients with Behcet's disease. Reported by Takashi Hashimoto et al., Ministry of Health and Welfare Specified Disease Behcet's Disease Survey Research Group, 1991 Research Results, 185-187. However, it has not been known so far that DHA exhibits a tranquilizing effect.

【0004】[0004]

【発明が解決しようとする課題】本発明は、副作用の極
めて少ない新しいタイプの精神安定剤を提供することを
目的とする。
SUMMARY OF THE INVENTION The present invention aims to provide a new type of tranquilizer with very few side effects.

【0005】[0005]

【課題を解決するための手段】本発明者らは、上記の課
題を解決するために、鋭意検討を行った結果、ドコサヘ
キサエン酸が精神安定作用を示すことを見いだし、本発
明を完成するに至った。
Means for Solving the Problems As a result of intensive studies to solve the above problems, the present inventors have found that docosahexaenoic acid has a tranquilizing effect, and have completed the present invention. It was

【0006】すなわち本発明は、ドコサヘキサエン酸を
有効成分とする精神安定剤を提供する。
That is, the present invention provides a tranquilizer containing docosahexaenoic acid as an active ingredient.

【0007】さらに本発明は、有効量のドコサヘキサエ
ン酸及び薬学上許容しうる担体を含有するカケクシア改
善用医薬組成物を提供する。
Further, the present invention provides a pharmaceutical composition for improving mosquitoes, which comprises an effective amount of docosahexaenoic acid and a pharmaceutically acceptable carrier.

【0008】本発明に用いるドコサヘキサエン酸とは、
遊離酸をはじめ、その塩、エステル、グリセリド、リン
脂質、コリン化合物、アスコルビン酸化合物、アミノ酸
化合物等を意味する。本発明に用いるドコサヘキサエン
酸としては、医薬目的では、純度90%以上のものが好
ましく、純度95%以上のものが特に好ましい。
Docosahexaenoic acid used in the present invention is
In addition to free acids, it means salts, esters, glycerides, phospholipids, choline compounds, ascorbic acid compounds, amino acid compounds and the like. For pharmaceutical purposes, the docosahexaenoic acid used in the present invention preferably has a purity of 90% or more, and particularly preferably a purity of 95% or more.

【0009】このようなドコサヘキサエン酸はドコサヘ
キサエン酸を含む油脂や混合物から、例えば、特開平4
−95048号公報、特開平4−159398号公報、
及び特開平4−243849号公報に記載の方法によ
り、ドコサヘキサエン酸を分離、精製することによって
得られる。また、イカの皮からDHA含有脂質が得られ
る。
Such docosahexaenoic acid can be obtained, for example, from Japanese Patent Application Laid-Open No. Hei 4 (1999) -58, from oils and fats and mixtures containing docosahexaenoic acid.
-95048, JP-A-4-159398,
And docosahexaenoic acid by the method described in JP-A-4-243849. Further, a DHA-containing lipid can be obtained from squid skin.

【0010】ドコサヘキサエン酸を含む油脂としては、
好ましくは総脂肪酸中のドコサヘキサエン酸の占める割
合が5%以上のものが良く、このようなものの例を上げ
るとイワシ、サバ、アジ、サケ、サンマなどの青背魚よ
り抽出した魚油、マグロやカツオなどの大型海産魚の眼
窩脂肪由来の魚油、微生物や海草由来の油脂、オキアミ
油、タラやイカ肝臓より抽出した海産物由来の油脂など
が好ましい例として挙げられる。
Examples of fats and oils containing docosahexaenoic acid include
Preferably, the proportion of docosahexaenoic acid in the total fatty acids is 5% or more, and examples of such ones include fish oil, tuna and bonito extracted from blue-backed fish such as sardines, mackerel, horse mackerel, salmon and saury. Preferred examples include fish oils derived from orbital fat of large marine fish such as, oils and fats derived from microorganisms and seaweeds, krill oil, and oils and fats derived from marine products extracted from cod and squid liver.

【0011】ドコサヘキサエン酸の投与量は、対象疾患
の種類、患者の年齢、性別、体重、症状、あるいは投与
形態により異なるが、一般には、DHAの量としては、
1日あたり約100〜5000mgであり、1回あるい
は数回に分けて服用される。
The dose of docosahexaenoic acid varies depending on the type of target disease, age, sex, body weight, symptom of patient, or administration form, but generally, the dose of DHA is
The daily dose is about 100-5000 mg, and it is taken once or in several divided doses.

【0012】本発明の精神安定剤及び医薬組成物は治療
のために経口的あるいは非経口的に投与することができ
る。経口投与剤とては散剤、顆粒剤、カプセル剤、錠剤
などの固形製剤あるいはシロップ剤、エリキシル剤など
の液状製剤とすることができる。また、非経口投与剤と
して注射剤とすることができる。
The tranquilizers and pharmaceutical compositions of the present invention can be administered orally or parenterally for therapeutic purposes. The orally-administered agent may be a solid preparation such as powder, granules, capsules and tablets, or a liquid preparation such as syrup and elixir. Moreover, an injection can be prepared as a parenteral preparation.

【0013】これらの製剤は活性成分に、必要に応じて
薬理学的、製剤学的に認容される製造助剤を加えること
により常法に従って製造される。更に公知の技術により
持続性製剤とすることも可能である。当該製造助剤を用
いる場合は、本発明の精神安定剤へのドコサヘキサエン
酸(遊離酸として)の配合量は通常は5〜100重量
%、好ましくは20〜100重量%である。
These preparations are manufactured according to a conventional method by adding a pharmacologically or pharmaceutically acceptable manufacturing auxiliary agent to the active ingredient, if necessary. Further, it is also possible to prepare a sustained-release preparation by a known technique. When the manufacturing aid is used, the content of docosahexaenoic acid (as a free acid) in the tranquilizer of the present invention is usually 5 to 100% by weight, preferably 20 to 100% by weight.

【0014】上記製造助剤としては、内服用製剤(経口
剤)、注射用製剤(注射剤)、粘膜投与剤(バッカル、
トロ−チ、坐剤等)、外用剤(軟膏、貼付剤等)などの
投与経路に応じた適当な製剤用成分から使用される。
The above-mentioned production aids include oral preparations (oral preparations), injectable preparations (injection preparations), mucosal administration preparations (buccal,
Troches, suppositories, etc.), external preparations (ointments, patches, etc.), and other suitable ingredients for formulation depending on the route of administration.

【0015】例えば、経口剤および粘膜投与剤にあって
は、賦形剤(例:澱粉、乳糖、結晶セルロース、乳酸カ
ルシウム、メタケイ酸アルミン酸マグネシウム、無水ケ
イ酸)、崩壊剤(例:カルボキシメチルセルロ−ス、カ
ルボキシメチルセルロースカルシウム)、滑沢剤(例:
ステアリン酸マグネシム、タルク)、コ−テング剤
(例:ヒドロキシエチルセルロ−ス、白糖、ヒドロキシ
プロピルセルロース、ポリビニルピロリドン)、矯味剤
などの製剤用成分を使用しうる。
For example, in the case of oral preparations and mucous membrane preparations, excipients (eg starch, lactose, crystalline cellulose, calcium lactate, magnesium aluminometasilicate, silicic acid anhydride), disintegrants (eg carboxymethyl) Cellulose, carboxymethylcellulose calcium), lubricant (eg:
Pharmaceutical ingredients such as magnesium stearate, talc), co-tenting agents (eg hydroxyethyl cellulose, sucrose, hydroxypropyl cellulose, polyvinylpyrrolidone), flavoring agents and the like may be used.

【0016】顆粒剤を製造するには湿式又は乾式造粒
し、錠剤を製造するにはこれらの散剤及び顆粒剤をその
ままあるいはステアリン酸マグネシウム、タルクなどの
滑沢剤を加えて打錠すればよい。これらの顆粒又は錠剤
はヒドロキシプロピルメチルセルロースフタレート、メ
タアクリル酸、メタアクリル酸メチルコポリマーなどの
腸溶性基剤で被覆して腸溶性製剤、あるいはエチルセル
ロース、カルナウバロウ、硬化油などで被覆して持続性
製剤とすることもできる。
To manufacture granules, wet or dry granulation may be carried out, and to manufacture tablets, these powders and granules may be tableted as they are or by adding a lubricant such as magnesium stearate or talc. . These granules or tablets are coated with an enteric base such as hydroxypropylmethyl cellulose phthalate, methacrylic acid, and methyl methacrylate copolymer to form an enteric preparation, or coated with ethyl cellulose, carnauba wax, hardened oil, etc. to form a sustained-release preparation. You can also do it.

【0017】また、カプセル剤を製造するには活性成分
をそのままあるいは適当な助剤とともに硬カプセルに充
填するか、活性成分をそのままあるいはグリセリン、ポ
リエチレングリコール、ゴマ油、オリーブ油などに溶解
したのちゼラチン膜で被覆し軟カプセル剤とすることが
できる。
In order to produce capsules, the active ingredient is filled in a hard capsule as it is or together with a suitable auxiliary agent, or the active ingredient is dissolved as it is or in glycerin, polyethylene glycol, sesame oil, olive oil, etc. and then a gelatin film is used. It can be coated to give a soft capsule.

【0018】経口投与用の液状製剤を製造するには活性
成分と白糖、ソルビトール、グリセリンなどの甘味剤と
を適当な希釈剤に溶解して透明なシロップ剤、更に精
油、エタノールなどを加えてエリキシル剤とするか、ア
ラビアゴム、トラガント、ポリソルベート80、カルボ
キシメチルセルロースナトリウムなどを加えて乳剤又は
懸濁剤としてもよい。これらの液状製剤には所望により
矯味剤、着色剤、保存剤などを加えてもよい。
To prepare a liquid preparation for oral administration, an active ingredient and a sweetener such as sucrose, sorbitol or glycerin are dissolved in a suitable diluent and a transparent syrup is added, and further essential oil, ethanol or the like is added to elixir. Alternatively, gum arabic, tragacanth, polysorbate 80, sodium carboxymethyl cellulose or the like may be added to prepare an emulsion or suspension. If desired, flavoring agents, coloring agents, preservatives and the like may be added to these liquid preparations.

【0019】また注射剤にあっては、水性注射剤を構成
し得る溶解剤ないし溶解補助剤(例:注射用蒸留水、生
理食塩水、プロピレングリコ−ル)、懸濁化剤(例:ポ
リソルベ−ト80などの界面活性剤)、pH調整剤
(例:有機酸またはその金属塩)、安定剤などの製剤用
成分が使用される。
In the case of injectable preparations, solubilizers or solubilizers (eg, distilled water for injection, physiological saline, propylene glycol) and suspending agents (eg, polysorbate) that can form an aqueous injection preparation are used. -Pharmaceutical ingredients such as surfactants such as 80), pH adjusters (eg, organic acids or metal salts thereof), stabilizers, etc. are used.

【0020】注射剤を製造するには活性成分を必要に応
じ塩酸、水酸化ナトリウム、乳糖、乳酸ナトリウム、リ
ン酸一水素ナトリウム、リン酸二水素ナトリウムなどの
pH調整剤、塩化ナトリウム、ブドウ糖などの等張化剤
とともに注射用蒸留水に溶解し、無菌濾過してアンプル
に充填するか、更にマンニトール、デキストリン、シク
ロデキストリン、ゼラチンなどを加えて真空下凍結乾燥
し、用時溶解型の注射剤としてもよいし、活性成分にレ
シチン、ポリソルベート80、ポリオキシエチレン硬化
ヒマシ油などを加えて水中で乳化せしめ注射用乳剤とす
ることもできる。
In order to produce an injectable preparation, an active ingredient may be added, if necessary, to a pH adjusting agent such as hydrochloric acid, sodium hydroxide, lactose, sodium lactate, sodium monohydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, glucose or the like. It is dissolved in distilled water for injection with an isotonicity agent, aseptically filtered and filled into an ampoule, or mannitol, dextrin, cyclodextrin, gelatin, etc. are added and freeze-dried under vacuum to prepare a solution-type injection before use. Alternatively, lecithin, polysorbate 80, polyoxyethylene hydrogenated castor oil, etc. may be added to the active ingredient and emulsified in water to give an emulsion for injection.

【0021】その他、上記構成を有する本発明の精神安
定剤及び医薬組成物は、公知の製造法、例えば日本薬局
方第10版製剤総則記載の方法ないし適当な改良を加え
た方法によっても製造することができる。
In addition, the tranquilizer and the pharmaceutical composition of the present invention having the above-mentioned constitution are also produced by a known production method, for example, the method described in the Japanese Pharmacopoeia 10th Edition General Rules for Preparation or a method with appropriate modification. be able to.

【0022】[0022]

【実施例】以下、本発明を製剤例、試験例により詳細に
説明する。なお、精神安定作用の指標として、心理テス
トの一種であるPFスタディーを行った。
EXAMPLES The present invention will be described in detail below with reference to formulation examples and test examples. A PF study, which is a type of psychological test, was conducted as an index of mental stabilizing effects.

【0023】PFスタディーは、50年近く前にソール
・ローゼンツァィクにより作成されたもので、筆記によ
る心理テストとして広く活用され、また研究されてい
る。下記試験例では、一谷彊らによる日本版ローゼンツ
ァィク、PF−スタディー解説(1987年版)の成人
用を用いた。
The PF study was created almost 50 years ago by Saul Rosenzick, and is widely used and studied as a psychological test by writing. In the following test examples, the adult version of the Japanese version of Rosenzwick, PF-Study Commentary (1987 version) by Satoshi Ichiya et al. Was used.

【0024】E−アンダーバーE%は素朴な攻撃傾向の
指標であり、ヒトや物に対する直接的敵意(Eに当た
る。高すぎることは、他責や自己主張性が強すぎること
を示す)から、社会に適応するために必要な好ましい程
度の攻撃性や自己主張性(アンダーバーEに当たる)を
引いた数値である。E−アンダーバーE%が高すぎる場
合は精神発達の未熟性を示す。
E-underbar E% is an index of naive attack tendency, and is a direct hostility toward humans and objects (corresponding to E. Too high, indicates that other responsibility or self-assertion is too strong). It is a value obtained by subtracting the desirable degree of aggression and self-assertiveness (corresponding to the underbar E) necessary for adapting to. If the E-underbar E% is too high, it indicates immature mental development.

【0025】(MA)+アンダーバーI%は、欲求不満
の原因を他者に求めず、妥協や許容の要素(MAに当た
る)と、社会通念上必要と思われる程度の言い訳による
保身(アンダーバーI)との和であり、自己と他者の弁
護も意味し、社会性、精神発達の指標と見なせる。
(MA) + Underbar I% does not seek the cause of frustration from others, compromising and accepting elements (corresponding to MA), and self-protection (underbar I) by an excuse that seems to be necessary according to social norms. It is the sum of, and also means the defense of self and others, and can be regarded as an index of sociality and mental development.

【0026】製剤例1 DHAエチルエステル(純度95%以上)にα−トコフ
ェロール0.5重量%を加えた油状物質をゼラチン製軟
カプセルに充填し、軟カプセル剤を調製した。
Formulation Example 1 A soft capsule made of gelatin was filled with an oily substance obtained by adding 0.5% by weight of α-tocopherol to DHA ethyl ester (purity: 95% or more) to prepare a soft capsule.

【0027】製剤例2 DHAエチルエステル(純度95%以上)にα−トコフ
ェロール0.3重量%を加えた油状物質20g、乳糖3
00g、デンプン100g、及び美結晶セルロース20
gを均一に混合し、押し出し造粒機にかけて顆粒剤を調
製した。
Formulation Example 2 DHA ethyl ester (purity 95% or more) to which 0.3% by weight of α-tocopherol was added, 20 g of an oily substance, 3 lactose
00g, starch 100g, and beautiful crystalline cellulose 20
g was uniformly mixed and subjected to an extrusion granulator to prepare granules.

【0028】試験例1 〔被験者とプロトコル〕19歳〜30歳の非喫煙学生
(41名)を対象者とした。対象者はランダムに二群に
分け、一群(対照群、19名)には対照カプセルを、残
りの一群(DHA群、22名)にDHAカプセルを二重
盲検法にて3ヶ月間投与した。なお、試験期間として
は、9月上旬の夏休み明けでまだリラックスしている時
にカプセルの投与を開始し、12月上旬のテストが始ま
ってかなりストレスがかかると予想される時に終了する
ようにした。カプセル投与開始時と三カ月後の終了時
に、PFスタディー(24のストレス場面に対する回答
を、傷害優位、自我防御、要求固執型に分け、さらに攻
撃性の方向を他、自、無の三方向に分けて分析するも
の。)を行った。
Test Example 1 [Subject and Protocol] Non-smoking students (41 people) aged 19 to 30 were used as subjects. The subjects were randomly divided into two groups, one group (control group, 19 persons) was given a control capsule, and the other group (DHA group, 22 persons) was given a DHA capsule for 3 months by double-blind method. . As a test period, administration of the capsules was started when the summer vacation in early September was still relaxing, and the test was started in early December when the stress was expected to be considerably stressed. At the start of capsule administration and the end of 3 months later, PF studies (24 responses to stress scenes were divided into injury predominance, ego defense, and demand persistence type, and the aggression direction was divided into three directions: self and none. What is divided and analyzed.) Was performed.

【0029】データは、平均±標準偏差で表した。結果
はANOVAを用いて検討し、p<0.05を有意とし
た。なお、各群でのカプセル服用前後の差はpaire
d−tテストを用いた。副作用、あるいは盲検性につい
ての検討はX2テストを行った。
Data are expressed as mean ± standard deviation. The results were examined using ANOVA, and p <0.05 was considered significant. The difference between before and after taking capsules in each group is
The dt test was used. The X2 test was conducted to examine side effects or blindness.

【0030】〔使用した油のカプセル〕DHAカプセ
ル、対照カプセルともに、1個300mgの油が入ってお
り、DHAカプセルにはDHA濃縮魚油(DHA49.
3%、EPA6.7%、パルミチン酸9.0%、オレイ
ン酸7.3%、アラキドン酸3.3%、パルミトオレイ
ン酸3.2%、ステアリン酸2.3%)が含まれてい
る。対照カプセルには、大豆油97%に魚油が3%含ま
れた混合油(リノール酸54.1%、オレイン酸22.
3%、パルミチン酸10.8%、α−リノレン酸6.8
%、ステアリン酸3.7%、DHA0.5%)を利用し
た。対象カプセルに魚油を少量加えた理由は、対照カプ
セルに魚臭をつけ、DHAカプセルとの区別を不可能と
するためである。被験者にもそのように伝えた。
[Oil Capsules Used] Both DHA capsules and control capsules contained 300 mg of oil, and the DHA capsules contained DHA concentrated fish oil (DHA49.
3%, EPA 6.7%, palmitic acid 9.0%, oleic acid 7.3%, arachidonic acid 3.3%, palmitooleic acid 3.2%, stearic acid 2.3%). . The control capsule contained a mixed oil containing 97% soybean oil and 3% fish oil (54.1% linoleic acid, 22. oleic acid).
3%, palmitic acid 10.8%, α-linolenic acid 6.8
%, Stearic acid 3.7%, DHA 0.5%). The reason that a small amount of fish oil was added to the target capsules was that the control capsules had a fishy odor and could not be distinguished from the DHA capsules. I also told the subject that way.

【0031】カプセルは体重50Kgまでの人は1日10
個、55Kgまでは11個、55Kg以上の人は12個服用
とした。カプセルをきちんと服用したかどうかは、服用
し残したカプセルのカウントにより行った。また、カプ
セル投与開始時と終了時に採血し、血清総脂質中の脂肪
酸構成を測定した。
Capsules up to 50 kg for 10 people a day
11 pieces up to 55 kg, and 12 people over 55 kg. Whether or not the capsules were properly taken was determined by counting the remaining capsules. Blood was collected at the start and end of capsule administration, and the fatty acid composition in total serum lipids was measured.

【0032】副作用としては、対照群で約半数に消化器
症状、ニキビの増加、口渇、頭痛、イライラ感、痒み、
太りやすくなる状態(重複あり)が出現したが、ニキビ
(2名)と痒み(1名)以外は一過性であった。また、
DHA群では、約4割に消化器症状、ニキビの増加、生
理不順、頭痛、イライラ感、太りやすくなる状態(重複
あり)が出現したが、太りやすくなった1名以外は一過
性であった。したがって、両群の間に副作用に関して有
意差はなく、またいずれも軽度のものであった。
As side effects, about half of the control group had digestive symptoms, increased acne, dry mouth, headache, irritability, itching,
Although a condition of becoming fat easily (with overlap) appeared, it was transient except for acne (2 persons) and itching (1 person). Also,
In the DHA group, about 40% developed digestive symptoms, increased acne, menstrual irregularities, headache, irritability, and a tendency to gain weight (duplicate), but it was transient except for one person who tended to gain weight. It was Therefore, there was no significant difference in the side effects between the two groups, and all were mild.

【0033】二重盲検性の確認はアンケートにより行
い、いずれの群においても、正解率は50%前後であ
り、盲検性は充分に保たれたと判断された。
The double-blindness was confirmed by a questionnaire. In all groups, the correct answer rate was around 50%, and it was judged that the blindness was sufficiently maintained.

【0034】〔結果〕PFスタディーにおける超自我因
子の中で、E−アンダーバーE%(未熟な攻撃性を表す
指標)と(MA)+アンダーバーI%(社会性、精神発
達性を見る指標)についての両群での変化を図1及び図
2に示す。
[Results] Among the super-ego factors in the PF study, regarding E-underbar E% (index indicating immature aggression) and (MA) + underbar I% (index indicating sociality and mental development) The changes in both groups are shown in FIGS. 1 and 2.

【0035】カプセル服用前後でE−アンダーバーE%
に関しては対照群では10.6±6.9%から18.8
±9.3%へと上昇(P=0.0041)したが、DH
A群では9.0±6.9%から10.0±8.8%と有
意な変化は見られなかった。両群での前後の差(対照群
8.2±7.8%とDHA群1.0±7.7%)には有
意差(p=0.0049)があった。
E-underbar E% before and after taking capsules
For the control group, 10.6 ± 6.9% to 18.8
It rose to ± 9.3% (P = 0.0041), but DH
In group A, no significant change was observed from 9.0 ± 6.9% to 10.0 ± 8.8%. There was a significant difference (p = 0.0049) between the front and back differences between the two groups (control group 8.2 ± 7.8% and DHA group 1.0 ± 7.7%).

【0036】(MA)+アンダーバーI%に関しては、
対照群37.9±11.5%から31.5±8.5%へ
低下傾向(p=0.058)を示したが、DHA群では
37.8±7.0%から39.8±8.8%へと少し上
昇した(有意差なし)。両群での前後の差(対照群−
6.4±10.3%とDHA群2.0±7.2%)には
有意差(p=0.0037)があった。
Regarding (MA) + underbar I%,
The control group showed a decreasing tendency from 37.9 ± 11.5% to 31.5 ± 8.5% (p = 0.058), but the DHA group showed 37.8 ± 7.0% to 39.8 ±. It slightly increased to 8.8% (no significant difference). Difference between before and after both groups (control group-
There was a significant difference (p = 0.0037) between 6.4 ± 10.3% and DHA group 2.0 ± 7.2%).

【0037】かなりのストレスがかかる状況下で、対照
群ではE−アンダーバーE%と(MA)+アンダーバー
I%が上記のように悪化した一方で、DHA群では全体
として変化が小さかった。したがって、DHAカプセル
の投与により、精神安定効果が発現したことは明らかで
ある。
Under considerable stress, E-underbar E% and (MA) + underbar I% deteriorated as described above in the control group, whereas the DHA group showed a small change as a whole. Therefore, it is clear that the administration of DHA capsule exerted a tranquilizing effect.

【0038】なお、DHAにE−アンダーバーE%を上
昇させず、(MA)+アンダーバーI%を低下させない
効果が認められたことは、ストレス時においても他者を
無意味に攻撃せず、他者および自己の弁護をすることが
維持されたことを意味する。したがって、傾向として二
つとも同じ方向の効果であり、二つの比較的独立した因
子が同方向を示すことは、この検査結果の信頼性を示し
ている。
The fact that DHA did not raise E-underbar E% and did not lower (MA) + underbar I% was found to be meaningless to attack others even during stress, and It means that the defense of the person and self was maintained. Therefore, the tendency is that the two effects are in the same direction, and two relatively independent factors exhibit the same direction, which indicates the reliability of the test result.

【0039】[0039]

【発明の効果】本発明の精神安定剤はとくに副作用を示
すことなく、顕著な精神安定効果、とくにストレス時に
おける精神安定効果をもたらす。
INDUSTRIAL APPLICABILITY The tranquilizer of the present invention brings about a remarkable tranquilizing effect, particularly a tranquilizing effect under stress without causing any side effect.

【図面の簡単な説明】[Brief description of drawings]

【図1】 超自我因子のうち、E−アンダーバーE%の
対照群とDHA群における変化を示すグラフである。
FIG. 1 is a graph showing changes in E-underbar E% of a control group and a DHA group among hyperego factors.

【図2】 超自我因子のうち、(MA)+アンダーバー
I%の対照群とDHA群における変化を示すグラフであ
る。
FIG. 2 is a graph showing changes in (MA) + underbar I% of the control group and the DHA group among the hyperego factors.

Claims (2)

【特許請求の範囲】[Claims] 【請求項1】 ドコサヘキサエン酸を有効成分とする精
神安定剤。
1. A tranquilizer containing docosahexaenoic acid as an active ingredient.
【請求項2】 有効量のドコサヘキサエン酸及び薬学上
許容しうる担体を含有する精神安定用医薬組成物。
2. A tranquilizer pharmaceutical composition comprising an effective amount of docosahexaenoic acid and a pharmaceutically acceptable carrier.
JP4952195A 1995-03-09 1995-03-09 Tranquilizer Pending JPH08245378A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP4952195A JPH08245378A (en) 1995-03-09 1995-03-09 Tranquilizer

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP4952195A JPH08245378A (en) 1995-03-09 1995-03-09 Tranquilizer

Publications (1)

Publication Number Publication Date
JPH08245378A true JPH08245378A (en) 1996-09-24

Family

ID=12833450

Family Applications (1)

Application Number Title Priority Date Filing Date
JP4952195A Pending JPH08245378A (en) 1995-03-09 1995-03-09 Tranquilizer

Country Status (1)

Country Link
JP (1) JPH08245378A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001031566A (en) * 1999-07-19 2001-02-06 Taiyo Kagaku Co Ltd Inhibitory composition for problematic behavior of pet
US6225444B1 (en) 1998-02-10 2001-05-01 Protarga, Inc. Neuroprotective peptides and uses thereof
US7816398B2 (en) 2001-03-23 2010-10-19 Luitpold Pharmaceuticals, Inc. Fatty alcohol drug conjugates
US8314077B2 (en) 1996-05-22 2012-11-20 Luitpold Pharmaceuticals, Inc. Fatty acid-pharmaceutical agent conjugates

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8314077B2 (en) 1996-05-22 2012-11-20 Luitpold Pharmaceuticals, Inc. Fatty acid-pharmaceutical agent conjugates
US6225444B1 (en) 1998-02-10 2001-05-01 Protarga, Inc. Neuroprotective peptides and uses thereof
US6627601B2 (en) 1998-02-10 2003-09-30 Protarga, Inc. Neuroprotective peptides and uses thereof
JP2001031566A (en) * 1999-07-19 2001-02-06 Taiyo Kagaku Co Ltd Inhibitory composition for problematic behavior of pet
JP4669095B2 (en) * 1999-07-19 2011-04-13 太陽化学株式会社 Composition for suppressing behavioral problems in pets
US7816398B2 (en) 2001-03-23 2010-10-19 Luitpold Pharmaceuticals, Inc. Fatty alcohol drug conjugates

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