JPH0791190B2 - 器質性精神障害の治療に活性な制御放出形態の製薬組成物の調製に於ける、５―メチルテトラヒドロ葉酸、５―ホルミルテトラヒドロ葉酸及びそれらの製薬的に許容し得る塩の使用並びに関連する製薬組成物 - Google Patents

器質性精神障害の治療に活性な制御放出形態の製薬組成物の調製に於ける、５―メチルテトラヒドロ葉酸、５―ホルミルテトラヒドロ葉酸及びそれらの製薬的に許容し得る塩の使用並びに関連する製薬組成物

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JPH0791190B2
JPH0791190B2 JP2073156A JP7315690A JPH0791190B2 JP H0791190 B2 JPH0791190 B2 JP H0791190B2 JP 2073156 A JP2073156 A JP 2073156A JP 7315690 A JP7315690 A JP 7315690A JP H0791190 B2 JPH0791190 B2 JP H0791190B2
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レ グラジエ クリスティーナ
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バイオリサーチ エスピーエイ
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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Description

【発明の詳細な説明】 （発明の産業上の利用分野） 本発明は、器質性精神障害の治療に活性な制御放出形態
の製薬組成物の調製に於ける５−メチルテトラヒドロ葉
酸（MTHF）、５−ホルミルテトラヒドロ葉酸（FTHF）及
びそれらの製薬的に許容し得る塩の使用並びに関連する
製薬組成物に関する。
特に、本発明の製薬組成物は、老人期及び初老期のアル
ツハイマー型の一次変性痴呆の治療及び多梗塞形成性痴
呆（multiinfarctual dementia）の治療に活性である。
本発明書に於いて、一層明瞭かつ簡素化するため、５−
メチルテトラヒドロ葉酸という表現及び頭文字MTHFは、
下記の完全な化学名称、即ち（±）−Ｌ−５−メチル−
5,6,7,8−テトラヒドロ葉酸及び（−）−Ｌ−５−メチ
ル−5,6,7,8−テトラヒドロ葉酸を有する化合物並びに
それらの塩を表わし、一方、５−ホルミルテトラヒドロ
葉酸及び頭文字FTHFは、下記の完全な化学名称、即ち
（±）−Ｌ−５−ホルミル−5,6,7,8−テトラヒドロ葉
酸及び（−）−Ｌ−５−ホルミル−5,6,7,8−テトラヒ
ドロ葉酸を有する化合物並びにそれらの塩を表わす。
（従来の技術） 現在、器質性精神障害の治療に有効な処置がなく、アル
ツハイマー型の痴呆の特別な場合に於いて、現在検討中
の薬剤は明らかに活性と考えられるには未だほど遠いも
のである（デービス（Davis）K.L.、モース（Mohs）R.
C.著“Cholinergicdrugs in Alzheimer′s disease"、N
ew Engl.J.Med.315巻、1286〜1287頁、1986年を参照の
こと）。
云わゆる“老人性脳”を治療するのに使用される多数の
薬剤に関して、それらの有効性は、臨床的応答に関する
よりむしろ、大脳流及び脳波計に於ける薬剤により誘導
される改善に関して、現在まで評価されていた。それ
故、これらの生理学的変化が老人の患者に於ける実際の
改善に合致するか否かは確立されていなかった。
５−メチルテトラヒドロ葉酸、５−ホルミルテトラヒド
ロ葉酸及びそれらの塩は、プテロイルグルタミン酸（葉
酸）に構造的に関連する、ビタミンＢ複合体に関係があ
る一群の物質である。この酸（これは哺乳類の細胞によ
り合成されない）は、それが、モノ炭素基の転位を伴う
一連の化学反応、特にプリン環及びチミジレートの合成
並びにメチル基のネオゲネシスに干渉するので、特に生
理学的に重要である。循環血液中で、フォレート（fola
te）プールは、MTHFにより殆ど代表され、またFTHFによ
り代表される。MTHFは、血液中のフォレート輸送の主な
形態を代表する。脈絡集網レベルで、それは血液から体
液中に通り、ここから、受動的拡散により、組織細胞及
び神経細胞中に入る。中枢神経系に於いて、フォレー
ト、特にMTHFは、Ｓ−アデノシル−Ｌ−メチオニン（SA
Me）の合成、或種のアミノ酸（グリシン、セリン、グル
タミン酸）の代謝、モノアミン作動性の伝達系（ノルア
ドレノリン、セロトニン、ドーパミン）の小結節形成作
用、核酸合成並びにATP及びGTPの生産に干渉することに
より、基本的な生化学プロセスに関与する。
現在まで、葉酸及びそのコファクターの治療用途は、こ
のビタミンの生体欠乏の予防及び治療、即ちハイポフォ
ラテミック（hypofolatemic）患者の治療に制限されて
いた。
（発明が解決しようとする課題） 本発明の目的は、器質性精神障害の治療に実証された臨
床効果を有し、かつ副作用のない製薬組成物を提供する
ことにより、このような障害の有効な治療を可能にする
ことである。
（課題を解決するための手段） 今般、本発明者らは、15分〜８時間の範囲、好ましくは
20分〜60分の範囲の活性成分の放出時間を有し、且つ５
〜200mg、好ましくは10〜50mgのMTHFもしくはFTHFまた
はそれらの製薬的に許容し得る塩を含む、制御放出型の
製薬組成物が、器質性精神障害に冒された患者を治療す
るのに使用される場合に、予期しない薬理学的性質を示
すことを、驚くことに見い出した。
器質性精神障害は、1987年に米国精神医学会（the Amer
ican Psychiatric Association）により発行された“th
e Diagnostic and Statistical Manual of Mental Diso
rders"改訂第３編（DSM−111−Ｒ）に含まれる診断基準
に基いて診断される。このマニュアルは、下記の符号に
従って器質性精神障害を記載している。
290.21 うつ病を伴うアルツハイマー型の老人性一次変
性痴呆 290.13 うつ病を伴うアルツハイマー型の初老期一次変
性痴呆 290.43 うつ病を伴う多梗塞形成性痴呆 米国精神医学用語辞典（Am.Psych.Press,ワシントン、
６編、1988年、46頁）に於いて、ストーン（Stone）に
示された定義によれば、“痴呆は、既に取得された知能
の低下がある器質性精神障害であり、この低下は労働活
動または社会活動を妨げるのに充分な重度である。最も
重大な徴候は記憶障害である。その他、抽象的思考、判
断能力及び衝動の制御が損なわれ、且つ／または人格の
変化がある。痴呆は病的徴候及び有効な治療の使用可能
性に応じて、進行性、静止性または可逆性であり得
る。”痴呆に関する診断基準は、DMS−III−Ｒから引用
して、表１に示される。
表１ 痴呆の診断基準 A.社会活動または職業活動を妨げるような程度まで知的
能力の低下 B.記憶欠乏 C.下記の要素の少なくとも一つ： １） ことわざの文字解読、関連Ｂ語の類似性及び相違
を認識し得ないこと、言語及び相違を認識し得ないこ
と、言語及び概念を定義することの困難、及びその他の
同様の試験に於いて、見られる抽象的思考の欠乏； ２） 重大な判断の欠乏； ３） 失語症（大脳機能不全に関連する言語障害）、行
動不能症（理解の妥当性及びモトリシティ（motricit
y）にもかかわらず行動を実行できないこと）、認知不
能症（感覚機能の妥当性にもかかわらず物体を認識また
は識別し得ないこと）、“構成の行動の不能”（例え
ば、三次元図形を写しブロックを一緒に置くことができ
ないこと、またはスティックを所定の設計に配置できな
いこと）の如き、高等な皮質性機能のその他の障害； ４） 発病前の状態の変化または抑揚の如き、人格の変
化 D.意識のオブヌビレーション（obnubilation）の欠如、
即ち、これらの徴候が相互に重なることがあるが、せん
妄または中毒に関する診断基準に対する応答の欠如。
E.下記の要素の一つ： １） 病歴、臨床試験または研究所の試験に基いて、障
害に精神病学的に関連する特異的な器質因子の呈示、 ２） このような呈示の不在下に於いて、器質性精神障
害以外の状況を除外するのに適当な理由がある場合、及
び挙動変化が異なる領域に於ける知能欠如により表わさ
れる場合、徴候の発生に必要な器質性因子の推定 本発明の特徴及び利点は、本発明の組成物を用いて行な
った臨床試験から選ばれた重要な臨床試験の要約から一
層明らかである。臨 床 試 験 この試験の目的は、DSM−111−Ｒに示された定義に従っ
て、気分の抑うつ状態を伴う器質性精神障害に冒された
初老の患者に対し、制御放出形態でないMTHFの投与また
は偽薬の投与に比較して、制御放出MTHFの持続投与の治
療効果を確めることであった。これは、二重盲検制御型
のマルチセンターパースペクティブランダム化試験（mu
lticentre perspective randomized trial）であった。
試験は７つのセンターで行なったものであり、その夫々
は30人の患者を含み、合計210人の患者を含んだ。患者
を無作為に三つのサブグループに分け、これらは夫々制
御放出形態のMTHF、制御放出形態でないMTHF及び偽薬を
受けた。
包含基準に基いて、少なくとも３ケ月間施設に収容され
た65才以上の年令の男女の患者が参加した。患者は、少
なくとも１年間大脳衰退の明らかな臨床的徴候を示した
ものである必要があった。特に、下記の徴候のうち、少
なくとも三つの存在が必要とされた。妥協認識をもつ精
神錯乱、食欲の欠如または減退、消耗し易いこと、恐
怖、過敏性、衝動、協調性の欠如、情緒不安定、不充分
な社交性、不安及び抑うつ状態。許容に関する基準は、
MMSE（Mini Mental State Examination）スケールで10
〜24ポイントのスコアー及びハミルトン（Hamilton）う
つ病スケール（HAM−Ｄ）で18以上ポイントスコアーで
あった。
排除に関する基準は、65才未満の年令、10未満または24
より大きいMMSEポイントスコアー、18未満のHAM−Ｄポ
イントスコアー、重度の心血管、腎臓、呼吸器、肝臓、
代謝不全（dismetabolic）、血液病、または腫瘍性の病
気のあることにより代表された。また、下記の患者が排
除された。てんかんまたは痙攣性の症状発現の病歴を有
する患者、段階III,IVまたはＶのパーキンソン病を有す
る患者、自己創傷の傾向（selfwounding tendencies）
のある患者、外傷性もしくは感染性の源の脳損傷を有す
る患者、及び機能的精神病を有する患者。また、本研究
の結果に干渉し得る薬剤による治療を受けている患者が
排除された。試験下の病気に対する全ての薬理学的治療
が停止された後、参加する患者は、連続した無作為の方
法で治療に指定され、この治療は90日間のスケジュール
期間にわたって行なわれた。制御放出形態（平均放出時
間１時間）のMTHFが、１回の投与で毎日50mgの投薬量で
経口投与され、制御放出形態でないMTHFが１回の投与で
毎日50mgの投薬量で経口投与され、偽薬が同様に投与さ
れた。
治療の効果を評価するため、挙動、自律性及び抑うつさ
れた気分を調べるのに特に適した或種の精神病スケール
が使用された。使用した評価スケールは、以下のとおり
であった。
１） プルトチク（plutchik）のゲリアトリック・レー
ティング・スケール（Geriatric Rating Scale）（GR
S）（プルトチクら著、J.Amer.Geriatric Soc,1970年,1
8:491）。
これは患者の日常生活、即ち自己充足性（self−suffic
iency）及び挙動に影響を及ぼす身体的状態、精神状態
及び社交的状態の変化を評価する。このスケールは、０
（正常）から２（重症）まで段階付けされた31の項目を
含む。主として、これらの項目は、調査すべき特徴に関
して徴候群に合わせられる。こうして、自己充足性は６
項目を合わせ、睡眠障害は３項目を合わせ、総体欠乏
（global deficit）は５項目を合わせ、イニシアチブは
４項目を合わせ、そして積極性及び社交性は６項目を合
わせる。
２） 症候群の増大する重度を示す、０から６まで段階
付けされた26項目を有する、ゴットフリィズ（Gottfrie
s）のデメンチア・レーティング・スケール（Dementia
Rating Scale）（DRS）（ゴットフリィズら著、Clin.Ne
uropharmacol.1984年、7/1:12）。それは、下記の４部
門に分けられ、これらはａ）〜ｂ）を評価する。
ａ）精神病的症候群（錯乱状態、過敏症、不安、窮迫、
気分の抑うつ状態、不穏）； ｂ）情緒； ｃ）身体運動、 ｄ）精神機能（記憶、注意力、覚醒） ３） 21項目を有するハミルトンうつ病評価（ハミルト
ン著、British J.Med.Psychol,1959年、32:50）。
上記のスケールの個々のパラメーターの評価は、治療の
開始前（基準値）、及び治療の21日、45日及び90日（T2
1,T45及びT90）後に行なった。
下記の精神測定試験を使用して、遂行行動の個個の状態
を評価した。
１） ウェチスラー・アダルト・インテリジェンス・ス
ケール・テスト（Wechsler Adult Intelligence Scale
Test）（W.A.I.S.）（ウェチスラー著、“Wechsler Adu
lt Intelligence Scale Manual"、プサイコロジカル・
コーポレーション（Psychological Corporation）、ニ
ューヨーク、1955年）。これは、５つのセグメントに分
けられた人の図形を再構成することからなる。
２） ５つの言語の習得及び反覆に制限された、ラント
・メモリー・テスト（Randt Memory Test）（ラントら
著、Clin.Neuropsychol,1980年,2:184）。それは種々の
記憶面の変更及びこの機能に関する薬理学的治療の有効
性の両方の評価を可能にする。
３） 目視診査に関するトウロウス−ピエロン・テスト
（Toulouse−Pieron Test）（アンドレオリ（Andreol
i）ら著、II Fracastoro、1975年、68/Suppl、１〜２
号:71）。
４） セマンティック・ベーバル・メモリー・テスト
（Semantic Verbal Memory Test）（Villardita,Inter
n.Neuropsychol.Soc.第７回ヨーロッパ会議、アアチエ
ン（Aachen）、13,06.1984年）。これは、三つの意味カ
テゴリィに関連する、15個の頻繁に使用される言語の直
ちの想起及び遅延（20分）された想起からなる。
５） ディジット・スパン（Digit Span）（ウェチスラ
ー著、“Wechsler Adult Intelligence Scale Manua
l"、プサイコロジカル・コーポレーション、ニューヨー
ク、1955年）。これは、試験者により患者に対して読ま
れる増大する長さの数の前、後の反覆からなる。
精神測定試験は、治療の開始前（基準値）並びに治療の
21日及び90日後（T21及びT90）に行なった。治療の経過
中（T21及びT45）並びに終了時（T90）に、医療開業医
は、患者の身内及び準医療従事者と協力して、治療の効
果に関して総体判断を表わした。
個々の変数の変化は、多重トウケイ（Tukey）比較でも
って、二つの評価基準（薬剤及び時間）を基準とした分
散分析を用いて、治療中及び治療後に評価された。
上記の選択操作を受けた184人の患者が、以下のように
分けられた評価に関して利用可能であった。
制御放出形態のMTHFを使用する群 60人 制御放出形態でないMTHFを使用する群 62人 偽薬を使用する群 62人 患者の人工統計学的特徴及び臨床的特徴が表２に示さ
れ、これからこれらの群の類似性が見られる。（ ）中
の数値は、標準偏差（S.D.）を表わす。
下記の数値に於いて、制御放出形態のMTHFはMTHF RCに
より示され、制御放出形態でないMTHFはMTHFノンRCによ
り示される。
第１図は、プルトチク・ゲリアティック・エバルーショ
ン・スケール（G.R.S.）を用いて得られた結果を示す。
第1a図〜第1e図に於いて、横軸は時間（日数）を表わ
し、縦軸は治療中の３つの群の患者に関してブルトチク
G.R.S.で得られた平均ポイントスコアー（±標準誤差）
を表わす。夫々の図は、下記の項目を表わす。自己充足
性（第1a図）、睡眠障害（第1b図）、総体欠乏（第1c
図）、イニシアチブ（第1d図）及び不適合な挙動（第1e
図）を表わす。
制御放出形態でないMTHFまたは偽薬で治療された患者の
群はTO（ｂ）の基準値と治療の終了時（T90）に有意差
を示さないが、制御放出形態のMTHFで治療された患者の
群は総体欠乏（第1c図）及びイニシアチブ（第1d図）に
関してT21で、自己充足性に関してT45で統計学的有意差
を示すことがわかる。対照的に、睡眠障害（第1b図）及
び不適合挙動（第1e図）は、基準値と比較して治療期間
後に有意差を示さない。分散分析は、統計学的有意差で
もって、上記のパラメーターに関して治療と時間との間
に相互作用のあること（ｐ＜0.01）を示す。
第２図は、ゴットノリィズ・デメンチア・スケール・レ
ーティング（DRS）を使用して得られた結果を示し、図
中、横軸は時間（日数）を表わし、縦軸は平均ポイント
スコアー（±標準誤差）を表わし、結果は制御放出形態
のMTHFを受けた群で最も明らかである。T45まで、偽薬
及び制御放出形態でないMTHFによる治療と比較して、有
意差（ｐ＜0.05）があり、この差はT90まで更に増加す
る（ｐ＜0.01）。
第３図は、抑うつ状態に関して、ハミルトン・レーティ
ング・スケール（HAM−Ｄ）を使用して得られた結果を
示し、横軸は時間（日数）を表わし、縦軸は平均ポイン
トスコアー（±標準誤差）を表わす。制御放出形態のMT
HFによる治療は、気質に作用して、T21から抑うつ総体
的症状を明らかに改善する。治療の終了時（T90）に、H
AM−Ｄスケールに関する平均ポイントスコアー（基準評
価で20.3に等しい）は8.3になり、59.1％の改善に相当
し、これは制御放出形態でないMTHF（23.0％）または偽
薬で得られた改善よりも明らかに良好である（ｐ＜0.0
1）。
第４図〜第８図は、使用された精神測定試験、即ちW.A.
I.S試験（第４図）、言語習得に関するラント・メモリ
ー・テスト（第5a図）、言語反覆に関するラント・メモ
リー・テスト（第5b図）、トウロウス−ピエロンテスト
（第６図）、セマンティック・ベーバル・メモリー・テ
スト（第７図）、前進試験に関するディジット・スパン
（第8a図）及び後退試験に関するディジット・スパン
（第8b図）に関して得られた結果を示す。
トウロウス−ピエロンテスト（第６図）を除いた全ての
精神測定試験は、本発明の制御放出形態のMTHFによる治
療に関して統計上有意な改善を示した（ｐ＜0.05）。特
に、T21で、W.A.I.S.テスト（第４図）、ラントメモリ
ーテスト（第５図）、セマンティック・ベーバル・メモ
リー・テスト（第７図）及び前進試験に関するディジッ
ト・スパン（第8a図）に統計上の有意差があり、後退試
験に関するディジット・スパンの場合にはT90で統計上
の有意差がある。対称的に、制御放出形態でないMTHF及
び偽薬で治療された患者の群は、何らの改善を示さなか
った。
治療中の許容度は、MTHF制御放出群の２人の患者（彼ら
は、治療の初期の日数中にわずかな頭痛を訴えた）を除
く殆ど全ての患者に関して良好であった。この後、この
症状は、薬剤投与が続いていたが、直ちに消えた。
表３は、T21、T45及びT90で治療の有効性に関して、治
療を行なった医療開業医により示された総体的判断を示
す。また、この判断をするに際して、開業医は患者の身
内及び準医療従事者に相談した。制御放出形態のMTHFに
よる治療に関する、正の応答の一層大きな数は、T45ま
で統計的に有意であり、更にT90まで増加され、この時
患者の60％が改善されたと認められ、断言されるが、こ
れに対して制御放出形態でないMTHFを使用する群の患者
では24％であり、偽薬群では26％であった。
制御放出形態のMTHF及びFTHFの異なる投薬量、即ち5mg
（20人の患者）、15mg（20人の患者）、20mg（20人の患
者）、25mg（15人の患者）、40mg（20人の患者）、100m
g（20人の患者）及び20mg（20人の患者）を含む本発明
の製薬組成物を用いて、同様の実験を行ない、これらの
投薬量が分析されたパラメーターに関して陽性の効果を
示すことがわかった。
本発明に従って、ラセミ形態または光学活性形態のMTH
F、FTHF及びそれらの塩を使用して得られた製薬組成物
は、睡眠／起床サイクルを妨げず、鎮静を生じず、依存
性または慣れを生じず、しかも一般に副作用を生じな
い。
本発明の製薬組成物の幾つかの実施例が、非限定的な説
明の目的のため、以下に示される。
実施例１ MTHF10mgを含む耐胃液性制御放出錠剤、放出時間＝15分
または20分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 12.6mg （MTHF10mgに相当する） 前ゼラチン化澱粉 115.0mg ラクトース100メッシュ 72.7mg ヒドロキシプロピルメチルセルロース 5.0mg ステアリン酸マグネシウム 1.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例２ MTHF15mgを含む耐胃液性制御放出錠剤、放出時間＝20分
または30分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 18.8mg （MTHF15mgに相当する） 前ゼラチン化澱粉 115.0mg ラクトース100メッシュ 60.2mg ヒドロキシプロピルメチルセルロース 5.0mg ステアリン酸マグネシウム 1.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例３ MTHF20mgを含む耐胃液性制御放出錠剤、放出時間＝30分
または35分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 25.1mg （MTHF20mgに相当する） 微結晶性セルロース 80.0mg ラクトース100メッシュ 79.9mg ヒドロキシプロピルメチルセルロース 10.0mg ベヘン酸グリセリン 5.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例４ MTHF25mgを含む耐胃液性制御放出錠剤、放出時間＝35分
または40分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 31.6mg （MTHF25mgに相当する） 微結晶性セルロース 80.0mg ラクトース100メッシュ 73.4mg ヒドロキシプロピルメチルセルロース 10.0mg ベヘン酸グリセリン 5.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例５ MTHF40mgを含む耐胃液性制御放出錠剤、放出時間＝50分
または60分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 50.6mg （MTHF40mgに相当する） 微結晶性セルロース 80.0mg ラクトース100メッシュ 54.4mg ヒドロキシプロピルメチルセルロース 10.0mg ベヘン酸グリセリン 5.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例６ MTHF50mgを含む耐胃液性制御放出錠剤、放出時間＝60分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 63.2mg （MTHF50mgに相当する） 微結晶性セルロース 80.0mg ラクトース100メッシュ 41.7mg ヒドロキシプロピルメチルセルロース 10.0mg ベヘン酸グリセリン 5.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例７ FTHF50mgを含む耐胃液性制御放出錠剤、放出時間＝60分 １個の錠剤は、以下の成分を含む。
FTHFカルシウム塩五水和物 66.7mg （MTHF50mgに相当する） カルボキシビニルポリマー 20.0mg 微結晶性セルロース 112.3mg ステアリン酸マグネシウム 1.0mg セルロースアセトフタレート 7.5mg ジエチルフタレート 2.5mg 実施例８ MTHF100mgを含む耐胃液性制御放出錠剤、放出時間＝90
分または120分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 126.5mg （MTHF100mgに相当する） 二塩基性リン酸カルシウム 90.0mg ラクトース100メッシュ 163.0mg ヒドロキシプロピルメチルセルロース 15.0mg ステアリン酸マグネシウム 5.5mg セルロースアセトフタレート 15.0mg ジエチルフタレート 5.0mg 実施例９ MTHF200mgを含む耐胃液性制御放出錠剤、放出時間＝180
分または210分または240分 １個の錠剤は、以下の成分を含む。
MTHFカルシウム塩五水和物 251.0mg （MTHF200mgに相当する） ヒドロキシプロピルメチルセルロース 30.0mg ラクトース100メッシュ 149.0mg ベヘン酸グリセリン 5.5mg セルロースアセトフタレート 15.0mg ジエチルフタレート 5.0mg 実施例10 FTHF200mgを含む耐胃液性制御放出錠剤、放出時間＝４
時間 １個の錠剤は、以下の成分を含む。
FTHFカルシウム塩五水和物 266.7mg 微結晶性セルロース 63.3mg 水添ひまし油 100.0mg ベヘン酸グリセリン 20.0mg セルロースアセトフタレート 15.0mg ジエチルフタレート 5.0mg 実施例11 MTHF50mgを含む制御放出坐薬 １個の坐薬は、以下の成分を含む。
MTHFカルシウム塩五水和物 63.2mg （MTHF50mgに相当する） ヒドロキシプロピルメチルセルロース 50.0mg 半合成グリセリド 1886.8mg 実施例12 MTHF50mgを含む制御放出注射形態 １個のバイアルは、以下の成分を含む。
MTHFカルシウム塩五水和物 63.2mg （MTHF50mgに相当する） グルタチオン 10.0mg クエン酸 30.0mg ビドロキシエチルセルロース 10.0mg マンニトール 160.0mg メチルｐ−ヒドロキシベンゾエート 1.0mg 水酸化ナトリウム 17.7mg 3mlにするのに充分な、注射製剤用の水 実施例13 MTHF20mgを含む制御放出経皮系 一つの経皮系は、以下の成分を含む。
MTHFカルシウム塩五水和物 25.1mg （MTHF20mgに相当する） シリコーン液体 174.8mg 沈降シリカ 15.2mg 実施例14 MTHF50mgを含む制御放出経皮系 一つの経皮系は、以下の成分を含む。
MTHFカルシウム塩五水和物 63.3mg （MTHF50mgに相当する） グリセリン 135.0mg ポリビニルアルコール 7.5mg ポリビニルピロリドン 5.0mg クエン酸 2.5mg 精製水 100.0mg 本発明は、多くの改良を受け、これら全てが、本発明に
包含される。更に、詳細の全てが技術的に均等な他の物
により置換し得る。
【図面の簡単な説明】
第１図は、プルトチク・ゲリアティック・エバルーショ
ン・スケール（G.R.S.）を用いて得られた結果を示す。 第1a図〜第1e図に於いて、横軸は時間（日数）を表わ
し、縦軸は治療中の３つの群の患者に関してプルトチク
G.R.S.で得られた平均ポイントスコアー（±標準誤差）
を表わす。夫々の図は、下記の項目を表わす。自己充足
性（第1a図）、睡眠障害（第1b図）、総体欠乏（第1c
図）、イニシアチブ（第1d図）及び不適合な挙動（第1e
図）を表わす。 第２図は、ゴットフリィズ・デメンチア・スケール・レ
ーティング（DRS）を使用して得られた結果を示し、図
中、横軸は時間（日数）を表わし、縦軸は平均ポイント
スコアー（±標準誤差）を表わす。 第３図は、抑うつ状態に関して、ハミルトン・レーティ
ング・スケール（HAM−Ｄ）を使用して得られた結果を
示し、横軸は時間（日数）を表わし、縦軸は平均ポイン
トスコアー（±標準誤差）を表わす。 第４図〜第８図は、使用された精神測定試験、即ちW.A.
I.S試験（第４図）、言語習得に関するラント・メモリ
ー・テスト（第5a図）、言語反覆に関するラント・メモ
リー・テスト（第5b図）、トウロウス−ピエロンテスト
（第６図）、セマンティック・ベーバル・メモリー・テ
スト（第７図）、前進試験に関するディジット・スパン
（第8a図）及び後退試験に関するディジット・スパン
（第8b図）に関して得られた結果を示す。
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 9/22 Ｂ Ｃ０７Ｃ 233/81 7106−4Ｈ Ｃ０７Ｄ 475/04 (54)【発明の名称】 器質性精神障害の治療に活性な制御放出形態の製薬組成物の調製に於ける、５―メチルテトラヒ ドロ葉酸、５―ホルミルテトラヒドロ葉酸及びそれらの製薬的に許容し得る塩の使用並びに関連 する製薬組成物

Claims (8)

    【特許請求の範囲】
  1. 【請求項１】活性成分が５−メチルテトラヒドロ葉酸、
    ５−ホルミルテトラヒドロ葉酸及びそれらの製薬的に許
    容し得る塩からなる群から選ばれることを特徴とするう
    つ病を伴うアルツハイマー型の老人性一次変性痴呆、う
    つ病を伴うアルツハイマー型の初老期一次変性痴呆及び
    うつ病を伴う多梗塞形成性痴呆の如き、器質性精神障害
    の治療に使用するのに適した、活性成分の放出時間が15
    分〜８時間の制御放出形態の製薬組成物。
  2. 【請求項２】制御放出形態の５−メチルテトラヒドロ葉
    酸もしくは５−ホルミルテトラヒドロ葉酸またはそれら
    の塩の含量が５〜200mgであることを特徴とする、請求
    項１記載の製薬組成物。
  3. 【請求項３】５−メチルテトラヒドロ葉酸もしくは５−
    ホルミルテトラヒドロ葉酸またはそれらの塩の含量が10
    〜50mgであることを特徴とする、請求項１記載の製薬組
    成物。
  4. 【請求項４】経口投与に適した胃液可溶性形態であるこ
    とを特徴とする、請求項１記載の製薬組成物。
  5. 【請求項５】経口投与に適した腸可溶性形態であること
    を特徴とする、請求項１記載の製薬組成物。
  6. 【請求項６】注射可能な形態であることを特徴とする、
    請求項１記載の製薬組成物。
  7. 【請求項７】直腸投与のための坐薬の形態であることを
    特徴とする、請求項１記載の製薬組成物。
  8. 【請求項８】経皮系の形態であることを特徴とする、請
    求項１記載の製薬組成物。
JP2073156A 1989-03-22 1990-03-22 器質性精神障害の治療に活性な制御放出形態の製薬組成物の調製に於ける、５―メチルテトラヒドロ葉酸、５―ホルミルテトラヒドロ葉酸及びそれらの製薬的に許容し得る塩の使用並びに関連する製薬組成物 Expired - Lifetime JPH0791190B2 (ja)

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IT8919867A IT1229203B (it) 1989-03-22 1989-03-22 Impiego di acido 5 metiltetraidrofolico, di acido 5 formiltetraidrofolico e dei loro sali farmaceuticamente accettabili per la preparazione di composizioni farmaceutiche in forma a rilascio controllato attive nella terapia dei disturbi mentali organici e composizioni farmaceutiche relative.
IT19867A/89 1989-03-22

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JPH0791190B2 true JPH0791190B2 (ja) 1995-10-04

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CA (1) CA2012876C (ja)
DE (1) DE69004837T2 (ja)
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IT8919867A0 (it) 1989-03-22
DK0388827T3 (da) 1994-03-21
EP0388827A1 (en) 1990-09-26
ES2062141T3 (es) 1994-12-16
DE69004837T2 (de) 1994-04-07
DE69004837D1 (de) 1994-01-13
ATE97809T1 (de) 1993-12-15
JPH02289517A (ja) 1990-11-29
CA2012876A1 (en) 1990-09-22
CA2012876C (en) 2001-02-13
AU637086B2 (en) 1993-05-20
EP0388827B1 (en) 1993-12-01
US5059595A (en) 1991-10-22
AU5209290A (en) 1990-09-27
ZA902153B (en) 1990-12-28
IT1229203B (it) 1991-07-25

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