JP2009196990A - 抗肥満用医薬組成物 - Google Patents
抗肥満用医薬組成物 Download PDFInfo
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- JP2009196990A JP2009196990A JP2009014815A JP2009014815A JP2009196990A JP 2009196990 A JP2009196990 A JP 2009196990A JP 2009014815 A JP2009014815 A JP 2009014815A JP 2009014815 A JP2009014815 A JP 2009014815A JP 2009196990 A JP2009196990 A JP 2009196990A
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- Prior art keywords
- pantethine
- group
- weight
- obesity
- fat
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Abstract
【解決手段】下記(A)成分及び(B)成分を含有する医薬組成物:
(A)防風通聖散および大柴胡湯からなる群から選択される少なくとも1種の漢方薬、
(B)パンテチン、パンテチンの塩、パントテン酸、パントテン酸の塩、パンテテイン及びパンテノールから選択される少なくとも1種のパンテチン類。
【選択図】なし
Description
項1.下記(A)成分及び(B)成分を含有する抗肥満用医薬組成物:
(A)防風通聖散および大柴胡湯からなる群から選択される少なくとも1種の漢方薬、
(B)パンテチン、パンテチンの塩、パントテン酸、パントテン酸の塩、パンテテイン及びパンテノールからなる群から選択される少なくとも1種のパンテチン類。
項2.(A)成分が防風通聖散である項1に記載の抗肥満用医薬組成物。
項3.(B)成分がパンテチンである項1または2に記載の抗肥満用医薬組成物。
項4.(A)成分の乾燥重量100重量部に対する(B)成分の配合比率が総量で0.01〜30重量部である項1〜3のいずれかに記載の抗肥満用医薬組成物。
項5.(A)成分の乾燥重量100重量部に対する(B)成分の配合比率が総量で0.2〜20重量部である項1〜4のいずれかに記載の抗肥満用医薬組成物。
項6.肥満が内臓脂肪型肥満である項1〜5のいずれかに記載の抗肥満用医薬組成物
項7.錠剤または散剤の形態である項1〜6のいずれかに記載の抗肥満用医薬組成物。
項8.(A)成分の配合割合が30〜80重量%である項1〜7のいずれかに記載の抗肥満用医薬組成物。
項9.(B)成分の配合割合が0.1〜40重量%である項1〜8のいずれかに記載の抗肥満用医薬組成物。
項10.(B)成分の配合割合が0.1〜15重量%である項1〜8のいずれかに記載の抗肥満用医薬組成物。
本発明の(A)成分としては、防風通聖散および大柴胡湯からなる群から選択される1種以上の漢方薬が挙げられ、好ましくは防風通聖散である。これらの漢方薬は、いずれも腹痛などの副作用が知られている。
タイソウ(Zizypus jujube Miller var. inermis Rehder)、キジツ(Citrus aurantium Linne var. daidai Makino, Citrus aurantium Linne ,Citrus natsudaidai Hayata)、ボウショウ(芒硝:硫酸ナトリウム)、カッセキ(滑石:天然含水ケイ酸アルミニウム及び二酸化ケイ素含有物)およびセッコウ(石膏:含水硫酸カルシウム)である。
本発明の抗肥満用医薬組成物の(B)成分としては、パンテチン、パンテチンの塩、パントテン酸、パントテン酸の塩、パンテテイン及びパンテノールからなる群から選択される少なくとも1種のパンテチン類が挙げられ、1種単独でまたは2種以上を組み合わせて用いることができる。本発明においては、(B)成分としてパンテチンを用いることが好ましい。
本発明の抗肥満用医薬組成物は、薬学的に許容される賦形剤、担体等と共に、従来公知の方法に従って、例えば、液剤(シロップ等を含む)等の液状製剤(懸濁剤含む)や、錠剤、丸剤、散剤、顆粒剤、カプセル剤(ソフトカプセルを含む)等の固形製剤形態の経口製剤;液剤等の液状製剤が挙げられる。本発明の組成物としては、素錠(裸錠)、フィルムコート錠、糖衣錠、甘味剤コート錠、カプセル剤、舌下錠等の形態が好ましい。
男性30名(平均年齢32.5歳)を、10名ずつ(1)防風通聖散群(防風通聖散のみを服用する群)、(2)パンテチン群(パンテチンのみを服用する群)、(3)防風通聖散・パンテチン群(防風通聖散とパンテチンを服用する群)の3群に分け、それぞれの群について、1日3回、食間または食前に、それぞれ被験薬を1週間服用させ、腹痛について毎日観察した。
SDラット(4週齢)雄を普通飼料「CE−2」(日本クレア株式会社製)で1週間馴化した(馴化時平均体重:180g)。
SDラット(4週齢)雄を普通飼料「CE−2」(日本クレア株式会社製)で1週間馴化した(馴化時平均体重:174g)。
各群の血清中の中性脂肪、遊離脂肪酸、ケトン体の測定結果を表6および図1、肝臓中脂質(中性脂肪・コレステロール)の測定結果を表7および図2にそれぞれ示す。
試験例4.ラットにおける肝機能上昇効果
SDラット(4週齢)雄を普通飼料「CE−2」(日本クレア株式会社製)で1週間馴化した(馴化時平均体重:180g)。
試験例5.ラットにおける抗肥満効果
SDラット(6ヶ月齢)雄を普通飼料「CE−2」(日本クレア株式会社製)で1週間馴化した(馴化時平均体重:563g)。
肥満傾向にある男性30名;女性 8名(BMI25以上35未満、ウェスト男性85cm以上、女性90cm以上、試験開始時平均体重:81kg)を、BMI(体重(kg)/(身長(m)の2乗))とウエスト径が均等に分散するよう2群((i)防風通聖散群17名、(ii)防風通聖散・パンテチン群21名)に分け、それぞれの群について、1日3回、食間または食前に、それぞれの被験薬を24週間服用させ、試験初日から4週間ごとに体重を測定し、試験初日と24週目に「全身用X線コンピューター断層装置 Pronto Xi・Si」(株式会社日立メディコ社製)にて臍部CT撮影を行い、内臓脂肪面積と、皮下脂肪面積を測定した。また、試験初日と16週目に採血を行い、酵素法に則って血清中中性脂肪を、JSCC標準化対応法に則ってASTとALTを測定した。
体重変化を実証と、虚証及び中間証に分けて図5に示す。これらの図に示されるように、防風通聖散群は、防風通聖散の適応証とされている実証においては体重減少効果を確認できたものの、中間証および虚証ではほとんど効果がないことが示された。一方、防風通聖散・パンテチン群では、実証で防風通聖散群を上回る体重減少効果を発揮した。さらに、実証のみならず中間証や虚証においても高い体重減少効果を発揮した。
以下に処方例を示すが、本発明はこれらに限定されない。
Claims (5)
- 下記(A)成分及び(B)成分を含有する抗肥満用医薬組成物:
(A)防風通聖散および大柴胡湯からなる群から選択される少なくとも1種の漢方薬、
(B)パンテチン、パンテチンの塩、パントテン酸、パントテン酸の塩、パンテテイン及びパンテノールからなる群から選択される少なくとも1種のパンテチン類。 - (A)成分が防風通聖散である請求項1に記載の抗肥満用医薬組成物。
- (B)成分がパンテチンである請求項1または2に記載の抗肥満用医薬組成物。
- (A)成分の乾燥重量100重量部に対する(B)成分の配合比率が総量で0.01〜30重量部である請求項1〜3のいずれかに記載の抗肥満用医薬組成物。
- 肥満が内臓脂肪型肥満である請求項1〜4のいずれかに記載の抗肥満用医薬組成物。
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JP2018058831A (ja) * | 2016-09-28 | 2018-04-12 | 小林製薬株式会社 | 医薬組成物 |
JP2018058830A (ja) * | 2016-09-28 | 2018-04-12 | 小林製薬株式会社 | 錠剤 |
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JP7133982B2 (ja) | 2017-08-10 | 2022-09-09 | 小林製薬株式会社 | 錠剤組成物 |
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