JP2004155779A - 更年期症の予防・治療用経口組成物 - Google Patents
更年期症の予防・治療用経口組成物 Download PDFInfo
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- JP2004155779A JP2004155779A JP2003356472A JP2003356472A JP2004155779A JP 2004155779 A JP2004155779 A JP 2004155779A JP 2003356472 A JP2003356472 A JP 2003356472A JP 2003356472 A JP2003356472 A JP 2003356472A JP 2004155779 A JP2004155779 A JP 2004155779A
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Abstract
【解決手段】エストロゲン及び熟地黄を含有することを特徴とするエストロゲン作用増強経口用組成物。または、エストロゲン及び熟地黄を含有し、更年期障害の予防又は治療に用いる経口用組成物。
【選択図】なし
Description
熟地黄 200 mg(500mg)
エストラジオール 0.3 mg
プロゲステロン 1 mg
γ−オリザノール 20 mg
乳糖 500 mg
トウモロコシデンプン 245 mg
メタケイ酸アルミン酸マグネシウム 32.5 mg
軽質無水ケイ酸 37.5 mg
低置換度ヒドロキシプロピルセルロース 50 mg
ヒドロキシプロピルセルロース 50 mg
上記組成の粉体1136.3gを湿式で攪拌造粒し、流動層乾燥機で乾燥した。24メッシュの篩で分級し、篩残は粗砕した。これにステアリン酸マグネシウム4gを添加して混合し、打錠用顆粒を得た。この打錠用顆粒を打錠機で打錠し、1錠重量200mgの錠剤を得た。
熟地黄 200 mg(500mg)
当帰 125 mg(500mg)
芍薬 70 mg(500mg)
川きゅう 120 mg(500mg)
ビタミンB6 5 mg
ビタミンB12 10 mg
γ−オリザノール 20 mg
乳糖 500 mg
トウモロコシデンプン 245 mg
メタケイ酸アルミン酸マグネシウム 32.5 mg
軽質無水ケイ酸 37.5 mg
低置換度ヒドロキシプロピルセルロース 50 mg
ヒドロキシプロピルセルロース 50 mg
上記組成の粉体976gを湿式で攪拌造粒し、流動層乾燥機で乾燥した。24メッシュの篩で分級し、篩残は粗砕した。これにステアリン酸マグネシウム10gを添加して混合し、打錠用顆粒を得た。この打錠用顆粒を打錠機で打錠し、1錠重量250mgの錠剤を得た。
熟地黄 200 mg(500mg)
イソフラボン 100 mg
タウリン 1500 mg
ビタミンB6 5 mg
ビタミンB12 10 mg
ビタミンC 90 mg
ビタミンE 10 mg
ニコチン酸アミド 20 mg
リンゴ酸ナトリウム 100 mg
クエン酸 適量(pH4.5)
ショ糖 7000 mg
キシリトール 2500 mg
ポリオキシエチレン硬化ひまし油60 20 mg
上記成分を精製水に溶解させ、加熱滅菌し、全量50mLの内服液剤を得た。
熟地黄 200 mg(500mg)
レッドクローバー 80 mg(400mg)
プエラリアミリフィカ 50 mg(500mg)
ビタミンC 90 mg
ビタミンE 10 mg
ニコチン酸アミド 20 mg
ローヤルゼリー 20 mg
乳糖 500 mg
トウモロコシデンプン 245 mg
メタケイ酸アルミン酸マグネシウム 32.5 mg
軽質無水ケイ酸 37.5 mg
低置換度ヒドロキシプロピルセルロース 50 mg
ヒドロキシプロピルセルロース 50 mg
上記組成の粉体923gを湿式で攪拌造粒し、流動層乾燥機で乾燥した。24メッシュの篩で分級し、篩残は粗砕した。これにステアリン酸マグネシウム20g及びタルク30gを添加して混合した。得られた顆粒を400mgずつ1号カプセルに充填し、カプセル剤を得た。
実験材料:エストラジオール、熟地黄エキス
実験動物:Wistar系雌性ラット(10週齢、チャールズリバー社から購入)
試験方法:子宮重量を指標としたエストロゲン効果測定試験
ラットをペントバルビタール麻酔下、背部を切開、卵巣を摘出した(以下、「OVX」と称する)。縫合後、放置し、その3時間後及び24時間後にセファゾリンナトリウム水和物20mg(力価)/kgを皮下投与した。OVX4日後から、エストラジオール(5%エタノール/オリーブ油に溶解、0.2mL/100g)及び熟地黄エキス(0.5%カルボキシルメチルセルロース・ナトリウムに懸濁、0.5mL/100g)を単独あるいは併用にて、1日1回28日間連続経口投与を行った。最終経口投与1日後、ペントバルビタール麻酔下、開腹し、子宮を摘出し、その内容液を除去後、子宮重量を測定した。なお、正常群は、上記と同様に背部を切開、擬似的に卵巣を処理し、体内に戻した後、縫合した。正常群及び対照群は5%エタノール/オリーブ油と0.5%カルボキシルメチルセルロース・ナトリウムの混液(1:1)を0.5mL/100gの投与割合で投与した。
疑似手術群に比較し、OVXを施したラットの子宮重量は有意に減少した。これに対してエストラジオール単独投与は0.03及び0.1mg/kgの投与量において子宮重量の低下を抑制した.熟地黄エキスはどの投与量においても、無効であった。そこで、子宮重量の低下を抑制しない投与量のエストラジオール0.01mg/kgと熟地黄エキス200mg/kgを併用投与したところ、有意に子宮の萎縮を抑制した。
Claims (7)
- エストロゲン及び熟地黄を含有することを特徴とするエストロゲン作用増強経口用組成物。
- エストロゲン及び熟地黄を含有し、更年期障害の予防又は治療に用いる経口用組成物。
- エストロゲン及び熟地黄を含有し、若年性更年期障害の予防又は治療に用いる経口用組成物。
- エストロゲン及び熟地黄を含有し、月経前症候群の予防又は治療に用いる経口用組成物。
- エストロゲン1質量部に対し、熟地黄を原生薬に換算して10質量部以上含有する請求項1〜4の何れか1項に記載の経口用組成物。
- エストロゲンが植物性エストロゲンである請求項1〜5の何れか1項に記載の経口用組成物。
- エストロゲンがエストラジオールである請求項1〜5の何れか1項に記載の経口用組成物。
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