JP5412708B2 - 内服用液剤組成物 - Google Patents
内服用液剤組成物 Download PDFInfo
- Publication number
- JP5412708B2 JP5412708B2 JP2006351074A JP2006351074A JP5412708B2 JP 5412708 B2 JP5412708 B2 JP 5412708B2 JP 2006351074 A JP2006351074 A JP 2006351074A JP 2006351074 A JP2006351074 A JP 2006351074A JP 5412708 B2 JP5412708 B2 JP 5412708B2
- Authority
- JP
- Japan
- Prior art keywords
- acid
- internal use
- extracted
- glucuronolactone
- liquid composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 241000411851 herbal medicine Species 0.000 claims description 31
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- UYUXSRADSPPKRZ-SKNVOMKLSA-N D-glucurono-6,3-lactone Chemical compound O=C[C@H](O)[C@H]1OC(=O)[C@@H](O)[C@H]1O UYUXSRADSPPKRZ-SKNVOMKLSA-N 0.000 claims description 26
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- CCXAYLQLOLXXKE-DWJAGBRCSA-K trisodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxylato-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-t Chemical compound [Na+].[Na+].[Na+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C([O-])=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O CCXAYLQLOLXXKE-DWJAGBRCSA-K 0.000 description 1
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- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
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- 229940046008 vitamin d Drugs 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
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- 229940082509 xanthan gum Drugs 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
- GZIFEOYASATJEH-VHFRWLAGSA-N δ-tocopherol Chemical compound OC1=CC(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1 GZIFEOYASATJEH-VHFRWLAGSA-N 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Description
[1].(A)グルクロノラクトン、グルクロン酸、及びグルクロン酸塩から選ばれる1種又は2種以上100mg/100mL〜3000mg/100mLと、
(B)ショウキョウから抽出される生薬100mg/100mL〜1000mg/100mL、
ケイヒから抽出される生薬15mg/100mL〜1000mg/100mL、
タイソウから抽出される生薬50mg/100mL〜1000mg/100mL、又は
サイコから抽出される生薬100mg/100mL〜1000mg/100mL
とを含有し、pH2.0〜2.8であることを特徴とする内服用液剤組成物。
[2].(A)グルクロノラクトン、グルクロン酸、及びグルクロン酸塩から選ばれる1種又は2種以上100mg/100mL〜3000mg/100mLと、
(B)ショウキョウから抽出される生薬100mg/100mL〜1000mg/100mL、
ケイヒから抽出される生薬15mg/100mL〜1000mg/100mL、
タイソウから抽出される生薬50mg/100mL〜1000mg/100mL、又は
サイコから抽出される生薬100mg/100mL〜1000mg/100mL
とを含有し、(A)/(B)で表される質量比が1/0.01〜1/100であり、pH2.0〜2.8である、疲労回復用内服用液剤組成物。
下記表1〜12に示す成分を混合し、表中のpHになるように調整して100mLの組成物を調製した。調製法は日本薬局法製剤総則「液剤」の項に準じた。得られた組成物をNo5C(JIS規格)のろ紙でろ過し、滅菌して内服用液剤組成物を得た。得られた表1〜12の内服用液剤組成物について、外観安定性、グルクロノラクトン安定性を評価した。結果を表中に併記する。なお、グルクロノラクトンの単体化合物を配合したが、組成物中には、グルクロノラクトン、グルクロン酸(塩)が共存する。
褐色のガラス瓶に内服用液剤組成物(100mL)を充填し、保存条件:50℃・1週間における生薬のオリ発生状況を、目視にて下記評価基準に基づいて評価した。なお、「○」もしくは「△」の評価で、本発明の効果を確認できたと判断する。
<評価基準>
○:澄明である。
△:オリが微量に発生。飲用しても違和感が無いレベル。
×:オリが発生し、沈降もしくは浮揚している。飲用して違和感があるレベル。
褐色のガラス瓶に内服用液剤組成物(100mL)を充填し、保存条件:50℃・1週間における保存前後のグルクロノラクトンの含有量を、高速液体クロマトグラフィーを用いてそれぞれ測定した。保存前(調製直後)における含有量の値(初期値)に対する、保存後の含有量の割合%(質量基準)を求め、下記評価基準に基づいて安定性を評価した。なお、「○」の評価で、本発明の効果を確認できたと判断する。なお、組成物中のグルクロン酸(塩)については、グルクロノラクトンに換算した。
<評価基準>
○:安定(初期値に対して、残存率:90%以上100%以下)。
×:不安定(初期値に対して、残存率:90%未満)。
下記表13〜20に示す成分を混合し、表中のpHになるように調整して100mLの組成物を調製した。調製法は日本薬局法製剤総則「液剤」の項に準じた。得られた組成物をNo5C(JIS規格)のろ紙でろ過し、滅菌して内服用液剤組成物を得た。得られた表1〜12の内服用液剤組成物について、滋養強壮効果を評価した。結果を表中に併記する。なお、グルクロノラクトンの単体化合物を配合したが、組成物中には、グルクロノラクトン、グルクロン酸(塩)が共存する。
滋養強壮作用を評価するにあたり、疲労回復をひとつの指標として評価した。
褐色のガラス瓶に内服用液剤組成物100mLを充填した。パネラー10名がこの内服用液剤組成物を飲用し、翌日の疲労回復度合いを下記評価基準に基づいて官能評価した。結果をパネラー10名の平均値で示す。平均値5.0点以上で、本発明の効果を確認できたと判断する。
<評価基準>
7:疲労回復の効果を非常に感じた。
6:疲労回復の効果をかなり感じた。
5:疲労回復の効果をやや感じた。
4:どちらともいえない。
3:疲労回復の効果をあまり感じなかった。
2:疲労回復の効果をほとんど感じなかった。
1:疲労回復の効果をまったく感じなかった。
Claims (2)
- (A)グルクロノラクトン、グルクロン酸、及びグルクロン酸塩から選ばれる1種又は2種以上100mg/100mL〜3000mg/100mLと、
(B)ショウキョウから抽出される生薬100mg/100mL〜1000mg/100mL、
ケイヒから抽出される生薬15mg/100mL〜1000mg/100mL、
タイソウから抽出される生薬50mg/100mL〜1000mg/100mL、又は
サイコから抽出される生薬100mg/100mL〜1000mg/100mL
とを含有し、pH2.0〜2.8であることを特徴とする内服用液剤組成物。 - (A)グルクロノラクトン、グルクロン酸、及びグルクロン酸塩から選ばれる1種又は2種以上100mg/100mL〜3000mg/100mLと、
(B)ショウキョウから抽出される生薬100mg/100mL〜1000mg/100mL、
ケイヒから抽出される生薬15mg/100mL〜1000mg/100mL、
タイソウから抽出される生薬50mg/100mL〜1000mg/100mL、又は
サイコから抽出される生薬100mg/100mL〜1000mg/100mL
とを含有し、(A)/(B)で表される質量比が1/0.01〜1/100であり、pH2.0〜2.8である、疲労回復用内服用液剤組成物。
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