JP7083116B2 - 四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法 - Google Patents
四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法 Download PDFInfo
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Description
前記凍結乾燥時、凍結条件は-30~-40℃の温度で凍結時間は8時間とするものの、乾燥条件は30~40℃の温度で、最小60時間以上とし、前記凍結乾燥麻黄散剤のエフェドリン含有量を測定してラベリングし、前記凍結乾燥麻黄散剤と体質別副作用防止散剤を一定量ずつ気密包装する段階を含むことができる。
本発明の実施例による四象医学により処方可能な韓方薬肥満治療タブレット製剤を構成するため、市中に出ている円形、長方形、三角形、四角形のタブレット製剤の形、タブレット製剤の一般サイズ、1/2一般サイズ程度、1/2一般サイズ以下、崩壊度時間20分、30分、40分、一時間以上、手ににじみ出る程度および硬度の選好度を非常に良い、良い、普通、悪いで質問して表1に示した。
太陰人用四象医学により処方可能な韓方薬肥満治療タブレット製剤のリパーゼ活性測定は、4-ジニトロフェニルブチルレート(4-dinitrophenyl butyrate)を基質として測定した。
油圧式煎湯過程でのブリックスの測定および各ブリックスでのエフェドリンの含有量測定は次の通り実施した。
総アルカロイド[エフェドリン(C10H15NO:165.23)およびプソイドエフェドリン(C10H15NO:165.23)]として測定するが、標準液:エフェドリン塩酸塩標準品(予め105℃で3時間乾燥する)約50mgを精密に測定して希釈させたメタノール(1→2)を入れて正確に20mLにする。この液2mLを正確に取って希釈させたメタノール(1→2)を入れて正確に100mLにする。
カラム:内径4~6mm、長さ15~20cmであるステンレス鋼管に5~10μmの液体クロマトグラフ用オクタデシルシリルシリカゲルを充填する。
45℃付近の一定温度
移動床:ラウリル硫酸ナトリウム溶液(1→128)*アセトニトリル*リン酸混合液(640:360:1)
本発明の実施例による四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法により製造された韓方薬肥満治療タブレット製剤が肥満減少に効果があるのか確認するために、93人の被験者にそれぞれ10日分ずつまたは5日分ずつ服用するようにした後、食欲抑制効果、服用時の利便性、吸収速度、選好度を確認した。
(1)3ヶ月服用後食欲抑制効果に対して、全くない、普通、ある、非常に良いの4種で確認した。
(2)服用時に利便性を確認するために既存の湯薬またはカプセルを摂取した者を対象にして利便性程度を、全くない、普通、ある、非常に良いの4種で確認した。
(3)吸収速度を確認するために既存の湯薬またはカプセルを摂取した者を対象にして利便性程度を、全くない、普通、ある、非常に良いの4種で確認した。
(4)全体的な選好度を確認するために、既存の湯薬またはカプセルを摂取した者を対象にして選好度を、全くない、普通、ある、非常に良いの4種で確認した。
Claims (5)
- 産地と採集時期によりエフェドリン含有量が0.5~2.5%(w/w)で差を示す麻黄のエフェドリン含有量を3.0~4.0%(w/w)含有量を有するように濃縮および定量化した麻黄散剤を製造する段階と、
前記エフェドリン含有量が3.0~4.0%(w/w)含有量に濃縮および定量化された麻黄散剤の四象医学体質による重量を決定し、前記麻黄散剤の重量に対して前記四象医学体質による副作用を防止および抑制するための体質別副作用防止散剤を製造する段階と、
前記麻黄散剤と前記防止散剤を混合するものの、体重、肥満度、四象医学体質、副作用を考慮して前記麻黄散剤と前記防止散剤の重量比率を変えて調剤する段階と、
前記調剤された前記麻黄散剤と前記防止散剤の混合散剤を打錠する段階と、
打錠後にコーティングする段階と、
前記コーティングする段階後に不良を選別して包装するものの、前記体重、肥満度、四象医学体質、副作用による調剤内容を含むラベリングを表示する段階を含み、
前記エフェドリン含有量を3.0~4.0%(w/w)に一定にした場合、前記麻黄散剤の3ヶ月間の総用量は、太陰人の場合、360g、少陰人の場合、297g、少陽人の場合、360gにし、前記麻黄散剤の重量に対する前記体質別副作用防止散剤の重量比率は、太陰人8~10:1、少陰人9~11:1、少陽人8~10:1にし、
前記エフェドリン含有量を1日基準として正常体重、過体重、初期肥満に対して60乃至90mg、過体重、肥満に対して80-120mg、中等度肥満、高度肥満に対して90-120mg、エフェドリンの耐性、中等度肥満、高度肥満に対して130-140mgで標準化し、
前記体質別副作用防止散剤は、太陰人の場合、前記麻黄散剤1に対して沢瀉1、桔梗1、葛根1、石菖蒲1、乾栗2、▲よく▼苡仁2、蘿▲ふく▼子1、杏仁1、山薬2、蓮子肉2の重量比率で含み、少陽人の場合、前記麻黄散剤1に対して滑石2、石膏1、薄荷1、梔子1、荊芥1、大黄1、姫昔蓬1、熟地黄2、牧丹皮1の重量比率で含み、少陰人の場合、前記麻黄散剤1に対して高麗人参1、黄耆2、白朮1、肉桂1、生姜1、白茯苓1、大棗1、山査1、陳皮1、厚朴1の重量比率で含み、
前記打錠する段階は、崩壊剤または硬度剤として、クロスカルメロースナトリウム、未結晶セルロース、ステアリン酸マグネシウムのうちの少なくとも1つを混合して打錠する、四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法。 - 前記エフェドリン含有量を3.0~4.0%(w/w)含有量を有するように濃縮および定量化した麻黄散剤を製造する段階は、油圧式煎湯過程で2時間ごとにブリックス測定を通じて7乃至8ブリックスになるように1次定量化する段階と、
低温真空濃縮過程で2時間ごとにブリックス測定を通じて30乃至35ブリックスになるように2次定量化する段階を含む、請求項1に記載の四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法。 - 前記2次定量化する段階後に、45メッシュ目盛りの篩で異物を濾過する段階をさらに含む、請求項2に記載の四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法。
- 前記エフェドリン含有量を3.0~4.0%(w/w)含有量を有するように濃縮および定量化した麻黄散剤を製造する段階は、前記2次定量化された30乃至35ブリックスの麻黄散剤を凍結乾燥する段階をさらに含み、
前記凍結乾燥時、凍結条件は-30~-40℃の温度で凍結時間は8時間とするものの、乾燥条件は30~40℃の温度で、最小60時間以上とする、請求項2に記載の四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法。 - 前記凍結乾燥麻黄散剤のエフェドリン含有量を測定してラベリングし、前記凍結乾燥麻黄散剤と体質別副作用防止散剤を一定量ずつ気密包装する段階を含む、請求項4に記載の四象医学により処方可能な韓方薬肥満治療タブレット製剤の製造方法。
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