JP2008133234A - 消化管への刺激性を減少した経口固形組成物 - Google Patents
消化管への刺激性を減少した経口固形組成物 Download PDFInfo
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- JP2008133234A JP2008133234A JP2006321343A JP2006321343A JP2008133234A JP 2008133234 A JP2008133234 A JP 2008133234A JP 2006321343 A JP2006321343 A JP 2006321343A JP 2006321343 A JP2006321343 A JP 2006321343A JP 2008133234 A JP2008133234 A JP 2008133234A
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Abstract
【解決手段】消化管刺激性薬物および水膨潤性高分子を含有し、水又は含水アルコールで湿式造粒して得られる経口固形組成物。
【選択図】なし
Description
本発明において用いられる消化管刺激性薬物とは、経口で服用後に胃痛、胃部不快感、胃部膨満感、腹痛、腹部膨満感、悪心・嘔吐、食欲不振などの消化器官症状の副作用が出現するような薬物である。消化管刺激性薬物としては、例えば一般用医薬品では、かぜ薬(内用)、解熱鎮痛薬、催眠鎮静薬、眠気防止薬、および、ダイオウを含有する小児鎮静薬などの精神神経用薬に分類される薬物; 駆虫薬などの消化器官用薬に分類される薬物; 強心薬、動脈硬化用薬、および、貧血用薬などの循環器・血液用薬に分類される薬物; 鎮咳去痰薬などの呼吸器官用薬に分類される薬物; 内用痔疾用薬などの泌尿生殖器管および肛門用薬に分類される薬物; ビタミンA主薬製剤、ビタミンD主薬製剤、ビタミンE主薬製剤、ビタミンB1主薬製剤、ビタミンB2主薬製剤、ビタミンB6主薬製剤、ビタミンC主薬製剤、ビタミンAD主薬製剤、ビタミンB2B6主薬製剤、ビタミンEC主薬製剤、ビタミンB1B6B12主薬製剤、ビタミン含有保健薬、タンパク・アミノ酸主薬製剤、および、生薬主薬製剤などの滋養強壮保健薬に分類される薬物; 婦人薬などの女性用薬に分類される薬物; 抗ヒスタミン薬主薬製剤などのアレルギー用薬に分類される薬物、鼻炎用内服薬などの耳鼻科用薬に分類される薬物、禁煙補助剤などの禁煙補助剤に分類される薬物; 茵陳蒿湯、温清飲、温胆湯、応鐘散、乙字湯、葛根紅花湯、葛根湯、葛根湯加川弓辛夷、加味温胆湯、加味逍遙散、桔梗湯、弓帰膠艾湯、弓帰調血飲、弓帰調血飲第一加減、響声破笛丸、駆風解毒散、荊芥連翹湯、桂枝加芍薬大黄湯、桂枝茯苓丸、桂枝茯苓丸料加意苡仁、荊防敗毒散、甲字湯、五虎湯、牛車腎気丸、五物解毒散、五淋散、柴胡加竜骨牡蛎湯、柴胡桂枝乾姜湯、柴胡清肝湯、三黄瀉心湯、三棗仁湯、三物黄か湯、滋陰降火湯、滋陰至宝湯、七物降下湯、四物湯、炙甘草湯、鷓鴣菜湯、十全大補湯、潤腸湯、小承気湯、小青竜湯、小青竜湯加石膏、小青竜湯合麻杏甘石湯、消風散、辛夷清風湯、秦几防風湯、神秘湯、清上防風湯、折衝飲、川弓茶調散、千金鶏鳴散、疎経活血散、大黄甘草湯、大黄牡丹皮湯、大柴胡湯、治頭瘡一方、調胃承気湯、釣藤散、猪苓湯合四物湯、通導散、桃核承気湯、当帰飲子、当帰散、当帰芍薬散、独活葛根湯、独活湯、女神散、人参養栄湯、排膿散、排膿湯、麦門冬湯、八味地黄丸、白虎加桂枝湯、白虎加人参湯、白虎湯、防已黄耆湯、防風通聖散、麻杏甘石湯、麻杏意甘湯、麻子仁丸、意苡仁湯、竜胆瀉肝湯、六味丸などの漢方・生薬製剤に分類される薬物が挙げられる。これらは、服用後、消化器官症状の副作用が出現することが知られているため、消化管刺激性薬物であり、本発明を適用するのに好ましい薬物である。
本発明に用いる消化管刺激性薬物としては、イブプロフェン、アスピリン、アセトアミノフェン、エテンザミド、サリチルアミド、塩酸ジフェンヒドラミン、安息香酸ナトリウムカフェイン、無水カフェイン、カフェインが特に好ましい。
消化管刺激性薬物としてイブプロフェン(BASF ジャパン(株)製)900g、および、水膨潤性高分子として低置換度ヒドロキシプロピルセルロース(LHPC:LH−31(ヒドロキシプロポキシ基10.0〜12.9質量%):信越化学(株)製)1500gをバーチカルグラニュレーターVG−25(パウレック(株))で混合後、精製水4537gを添加し練合した後、ツインドームグランTDG−80(不二パウダル(株)製)0.6mmスクリーンで押し出し造粒し、マルメライザーQ400(不二パウダル(株)製)で球形化処理を施した後、流動層乾燥装置FLO−5A/2(フロイント産業(株)製)にて乾燥し、平均粒径約500mの顆粒剤として実施例1の製剤を得た。
イブプロフェン(BASFジャパン(株)製)45g、および、低置換度ヒドロキシプロピルセルロース(LHPC:LH−31:信越化学(株)製)75gを均一に混合し、比較例1の製剤を得た。
実施例1の本発明の製剤と比較例1の比較製剤の溶出を日本薬局方第15改正・溶出試験法に準じて行なった。試験液は第二液(pH6.8緩衝液)を用い、パドル法50r.p.mにて溶出試験を行ない、溶出液中のイブプロフェン濃度を高速液体クロマトグラフで測定し、溶出速度を算出し、その結果を図1に示した。
本発明の製剤は、原末を分散した比較例1の製剤とイブプロフェンの溶出ははぼ変わらず、イブプロフェンが速やかに溶出され、即放性製剤の溶出特性を示すことがわかる。
ラットによる胃粘膜刺激性試験:
試験方法:SD系雄性ラット(日本チャールス・リバー(株)より購入)を1週間の予備飼育を施した。一群10匹の試験薬剤投与前に24時間絶食した動物(210〜230g)に、イブプロフェンとして10mg/kgを経口投与した。4時間後、頭部殴打および頚動脈放血により動物を致死させ胃を摘出した。1%ホルマリン液10mLを胃内に注入し、同液中で軽度に固定した。胃を大弯に沿って切開し、実体顕微鏡下(10倍)で潰瘍の有無を観察し潰瘍発現率を求め、発生した潰瘍の長さ(mm)を測定加算し、1匹当たりの潰瘍係数とした。
結果:表1に示したように、本発明の実施例1の製剤は潰瘍の発現がなかったのに対し、比較例1の製剤では、40%の各薬剤の潰瘍発現率があり、潰瘍係数も0.9±0.4mm(平均±標準偏差)であった。このことから、本発明の製剤は、イブプロフェンによる消化管への刺激性を低減し、潰瘍の発生を抑制したことが示唆された。
消化管刺激性薬物として塩酸ジフェンヒドラミン(金剛化学(株)製)80g、および、水膨潤性高分子として低置換度ヒドロキシプロピルセルロース(LHPC:LH−31:信越化学(株)製)720gをバーチカルグラニュレーターVG−10(パウレック(株))で混合後、15%エタノール/精製水2026gを添加し練合した後、ツインドームグランTDG−80(不二パウダル(株)製)0.6mmスクリーンで押し出し造粒し、流動層乾燥装置FLO−5A/2(フロイント産業(株)製)にて乾燥し、平均粒径約500μmの顆粒剤を得た。
消化管刺激性薬物としてカフェイン(静岡カフェイン工業(株)製)400gと硝酸チアミン(BASFジャパン(株)製)20g、および、水膨潤性高分子として低置換度ヒドロキシプロピルセルロース(LHPC:LH−31:信越化学(株)製)380gをバーチカルグラニュレーターVG−10(パウレック(株))で混合後、精製水1053gを添加し練合した後、ツインドームグランTDG−80(不二パウダル(株)製)1.0mmスクリーンで押し出し造粒し、マルメライザーQ400(不二パウダル(株)製)で球形化処理を施した後、流動層乾燥装置FLO−5A/2(フロイント産業(株)製)にて乾燥し、平均粒径約800μmの球形顆粒を調製し、この顆粒を1カプセルあたり200mgとなるように硬カプセルに充填してカプセル剤を得た。
Claims (4)
- 消化管刺激性薬物および水膨潤性高分子を含有し、水又は含水アルコールで湿式造粒して得られる経口固形組成物。
- 消化管刺激性薬物1質量部に対し、水膨潤性高分子を0.2質量部以上含有する請求項1記載の経口固形組成物。
- 水膨潤性高分子が、低置換度ヒドロキシプロピルセルロース、クロスカルメロースナトリウム、クロスポピドン、カルボキシメチルセルロースカルシウム、カルボキシメチルセルロースナトリウム、カルボキシメチルセルロース及び結晶セルロースから選ばれる1種又は2種以上である請求項1記載の経口固形組成物。
- 湿式造粒して得られる顆粒の平均粒径が25μm以上である請求項1、2又は3記載の経口固形組成物。
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TW096139731A TW200824710A (en) | 2006-11-29 | 2007-10-23 | Oral solid composition reduced in stimulation to the castrointestinal tract |
KR1020070113515A KR20080048923A (ko) | 2006-11-29 | 2007-11-08 | 소화관에의 자극성을 감소한 경구 고형 조성물 |
CN2007101964216A CN101190206B (zh) | 2006-11-29 | 2007-11-28 | 减少了对消化管的刺激性的口服固形组合物 |
HK08109356.1A HK1118208A1 (en) | 2006-11-29 | 2008-08-21 | Oral solid composition reduced in stimulation to the gastrointestinal tract |
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JP5676834B2 (ja) | 2015-02-25 |
CN101190206A (zh) | 2008-06-04 |
HK1118208A1 (en) | 2009-02-06 |
TW200824710A (en) | 2008-06-16 |
KR20080048923A (ko) | 2008-06-03 |
CN101190206B (zh) | 2013-04-24 |
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