JP2006117586A - 総合輸液製剤 - Google Patents
総合輸液製剤 Download PDFInfo
- Publication number
- JP2006117586A JP2006117586A JP2004307382A JP2004307382A JP2006117586A JP 2006117586 A JP2006117586 A JP 2006117586A JP 2004307382 A JP2004307382 A JP 2004307382A JP 2004307382 A JP2004307382 A JP 2004307382A JP 2006117586 A JP2006117586 A JP 2006117586A
- Authority
- JP
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- Prior art keywords
- vitamin
- solution
- liquid
- amino acid
- container
- 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.)
- Granted
Links
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- 239000007788 liquid Substances 0.000 claims abstract description 70
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- JZRWCGZRTZMZEH-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 claims description 17
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 claims description 16
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- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 16
- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 claims description 15
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- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims description 15
- FDJOLVPMNUYSCM-UVKKECPRSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7, Chemical compound [Co+3].N#[C-].C1([C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)[N-]\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O FDJOLVPMNUYSCM-UVKKECPRSA-L 0.000 claims description 15
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- RBCOYOYDYNXAFA-UHFFFAOYSA-L (5-hydroxy-4,6-dimethylpyridin-3-yl)methyl phosphate Chemical compound CC1=NC=C(COP([O-])([O-])=O)C(C)=C1O RBCOYOYDYNXAFA-UHFFFAOYSA-L 0.000 claims description 12
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- IFGCUJZIWBUILZ-UHFFFAOYSA-N sodium 2-[[2-[[hydroxy-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyphosphoryl]amino]-4-methylpentanoyl]amino]-3-(1H-indol-3-yl)propanoic acid Chemical compound [Na+].C=1NC2=CC=CC=C2C=1CC(C(O)=O)NC(=O)C(CC(C)C)NP(O)(=O)OC1OC(C)C(O)C(O)C1O IFGCUJZIWBUILZ-UHFFFAOYSA-N 0.000 claims description 8
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- WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 claims description 5
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Abstract
【解決手段】 連通可能な隔壁により隔てられた2室を有する容器の各室に分別収容された還元糖液(A)とアミノ酸液(B)、並びに前記2室のいずれか一方と連通可能な小容器に収容された脂溶性ビタミン液(C)を備え、ビタミンB2が脂溶性ビタミン液(C)に、ビタミンCが還元糖液(A)またはアミノ酸液(B)に配合されたことを特徴とする総合輸液製剤。
【選択図】なし
Description
[1] 連通可能な隔壁により隔てられた2室を有する容器の各室に分別収容された還元糖液(A)とアミノ酸液(B)、並びに前記2室のいずれか一方と連通可能な小容器に収容された脂溶性ビタミン液(C)を備え、ビタミンB2が脂溶性ビタミン液(C)に、ビタミンCが還元糖液(A)またはアミノ酸液(B)に配合されたことを特徴とする総合輸液製剤、
[2] ビタミンCがアミノ酸液(B)に配合されたことを特徴とする前記[1]に記載の総合輸液製剤、
[3] 容器が可撓性熱可塑性プラスチックフィルムより形成され、前記連通可能な隔壁が、容器本体の対向する内壁面同士を剥離可能にシールすることで構成され、前記小容器が可撓性熱可塑性プラスチックフィルムより形成され、前記容器の連通可能な隔壁の近傍で前記容器本体の対向する内壁面それぞれに固着されており、前記隔壁の開封に伴う内壁面の離間に伴って小容器が開封するようにされたことを特徴とする前記[1]または[2]に記載の総合輸液製剤、
[4] 前記小容器が2室に区切られ、一方の室に脂溶性ビタミン液(C)が、他方の室に微量金属元素製剤が収容され、容器の還元糖液(A)を収容する室中に配置されてなる前記[3]に記載の総合輸液製剤、
[5] ヨウ素が還元糖液(A)またはアミノ酸液(B)に配合されてなる前記[4]に記載の総合輸液製剤、
[6] 還元糖液(A)中の還元糖がブドウ糖である前記[1]〜[5]のいずれかに記載の総合輸液製剤、
[7] アミノ酸液(B)中のアミノ酸がL−イソロイシン、L−ロイシン、L−リジン、L−メチオニン、L−フェニルアラニン、L−スレオニン、L−トリプトファン、L−バリン、L−アラニン、L−アルギニン、L−アスパラギン酸、L−システイン、L−グルタミン酸、L−ヒスチジン、L−プロリン、L−セリン、L−チロシンおよびグリシンである前記[1]〜[6]のいずれかに記載の総合輸液製剤、
[8] 脂溶性ビタミン液(C)中の脂溶性ビタミンがビタミンA、ビタミンD、ビタミンEおよびビタミンKである前期[1]〜[7]のいずれかに記載の総合輸液製剤、
[9] 微量金属元素液(D)中の微量金属元素が鉄、マンガン、亜鉛および銅である前記[4]のいずれかに記載の総合輸液製剤、
[10] 還元糖液(A)がさらにビタミンB1、ビタミンB6,ビタミンB12、パンテノールおよびヨウ素を含み、アミノ酸液(B)がさらにアスコルビン酸、葉酸およびニコチン酸アミドを含む前記[9]記載の総合輸液製剤、および
[11] 前記(A)〜(D)の全ての溶液を混合した時の成分組成が、次の範囲である前記[10]記載の総合輸液製剤、
(1)還元糖液(A)の調製
注射用蒸留水にブドウ糖および電解質(塩化ナトリウム、塩化カリウム、リン酸二水素カリウム、ヨウ化カリウム)を溶解し、更にビタミンB1(塩酸チアミン)、ビタミンB6(塩酸ピリドキシン)、ビタミンB12
(シアノコバラミン)およびパンテノールを溶解し、酢酸でpH4とした後、無菌濾過して、表4に示した組成の還元糖液(A)を調製した。
また、各結晶アミノ酸および電解質(塩化カリウム、硫酸マグネシウム、酢酸カリウム)を注射用蒸留水に溶解し、ビタミンC(アスコルビン酸)、葉酸、ニコチン酸アミドを加えて溶解した後、コハク酸でpH6.5に調整し、無菌濾過して表5に示した組成のアミノ酸液(B)を調製した。なお、溶液(B)には、安定化剤として亜硫酸水素ナトリウムを濃度50mg/Lとなるように添加した。
上記液(A)および液(B)とは別に、ビタミンA(パルミチン酸レチノール)、ビタミンD3(コレカルシフェロール)、ビタミンE(酢酸トコフェロール)およびビタミンK(フィトナジオン)をポリソルベート80(液(C)中の濃度=5mg/mL)、ポリソルベート20(液(C)中の濃度=1mg/mL)およびポリエチレングリコール400(マクロゴール400)を加えて混和し、少量の注射用蒸留水を加えて可溶化した。更に、注射用蒸留水にビタミンB2
(リン酸リボフラビンナトリウム)およびD−ソルビトールを溶かし、クエン酸と水酸化ナトリウムでpH6とした後、前記可溶化液と混和した。この液を無菌濾過して、表6に示した組成の脂溶性ビタミン液(C)を調製した。
コンドロイチン硫酸ナトリウムの注射用蒸留水溶液に、塩化第二鉄の注射用蒸留水溶液と水酸化ナトリウムの注射用蒸留水溶液を、はじめに水酸化ナトリウム溶液から順に1/10量づつ交互に添加しながら、所定量の塩化第二鉄を添加した。この溶液に所定量の硫酸銅、塩化マンガン、硫酸亜鉛およびビオチンをそれぞれ注射用水の溶液として添加した後、pHを水酸化ナトリウムで5.3に調整し、常法により濾過して表7に示した組成の溶液を調製した。なお、コンドロイチン硫酸ナトリウムは濃度2.5g/Lとなるように添加した。
中間層がポリ環状オレフィン、内外層がポリエチレンからなる厚さ50μmのフィルムより成形した2室小容器に、上記脂溶性ビタミン液(C)および微量金属元素液(D)それぞれ4mLを分別充填し、溶閉した。次に、ポリエチレン製2室輸液バッグの第1室に上記小容器を挿入し、バッグの両壁面に溶着した。続いて、小容器を挿入した第1室に上記還元糖液(A)692mL、第2室に上記アミノ酸液(B)300mLを充填し、それぞれヘッドスペース部が0mLとなるように密封し、図2のような容器入り総合輸液製剤を得た。
(1)還元糖液(A)の調製
実施例1と同様にして、表8に示した組成の還元糖液(A)を調製した。
(2)アミノ酸液(B)の調製
実施例1と同様にして、表9に示した組成のアミノ酸液(B)を調製した。なお、アミノ酸液(B)には、安定化剤として亜硫酸水素ナトリウムを濃度50mg/Lとなるように添加した。
(3)脂溶性ビタミン液(C)の調製
実施例1と同様にして、表10に示した組成の脂溶性ビタミン液(C)を調製した。
中間層がポリ環状オレフィン、内外層がポリエチレンからなる厚さ50μmのフィルムより成形した小容器に、上記液(C)4mLを充填し、溶閉した。次に、ポリエチレン製2室輸液バッグの1室に上記小容器を挿入し、バッグの両壁面に溶着した。続いて、小容器を挿入した室に上記液(B)300mLを、他方の室に上記液(A)696mLを充填し、それぞれヘッドスペース部が0mLとなるように密封し、図2のような容器入り総合輸液製剤を得た。
アスコルビン酸を、アミノ酸液(B)に配合する代わりに脂溶性ビタミン液(C)に12.5mg/mLの濃度となるように配合する他は実施例1と同様にして、容器入り総合輸液製剤を得た。
アスコルビン酸を、アミノ酸液(B)に配合する代わりに脂溶性ビタミン液(C)に12.5mg/mLの濃度となるように配合する他は実施例2と同様にして、容器入り総合輸液製剤を得た。
実施例1および2、並びに比較例1および2で得られた総合輸液製剤について、酸素濃度1%、3%および5%の気体40mLを、小容器を挿入した液に注入し、常法により加熱滅菌を行った後、脱酸素剤と共にガスバリア性遮光袋(アルミラミネート袋)により包装した。包装後1週間室温に放置した後、日本薬局方の一般試験法:高速液体クロマトグラフ法により、ビタミンB2含量を測定した。表11に未滅菌時のビタミンB2含量に対する滅菌包装後のビタミンB2含量を残存率として示した。
ビタミンB2はビタミンCと同時配合することにより、酸素に対し不安定となる(比較例1および2)。従って、ビタミンB2とビタミンCを同時配合する場合は、ヘッドスペースの酸素濃度を厳密に管理しなくてはならない。一方、本発明の実施例1および2のようにビタミンB2とビタミンCを別室に配合することにより、ヘッドスペース酸素濃度を厳密に管理しなくてもよいという利点がある。
2 容器本体
3 第1室
4 第2室
5 連通可能な隔壁(弱シール部)
6 小容器
7 固着部
8 薬液流出部
9 薬液流入部
10 吊掛孔
2a、2b 容器本体のフィルム
6a、6b 小容器の多層フィルム
Claims (11)
- 連通可能な隔壁により隔てられた2室を有する容器の各室に分別収容された還元糖液(A)とアミノ酸液(B)、並びに前記2室のいずれか一方と連通可能な小容器に収容された脂溶性ビタミン液(C)を備え、ビタミンB2が脂溶性ビタミン液(C)に、ビタミンCが還元糖液(A)またはアミノ酸液(B)に配合されたことを特徴とする総合輸液製剤。
- ビタミンCがアミノ酸液(B)に配合されたことを特徴とする請求項1に記載の総合輸液製剤。
- 容器が可撓性熱可塑性プラスチックフィルムより形成され、前記連通可能な隔壁が、容器本体の対向する内壁面同士を剥離可能にシールすることで構成され、前記小容器が可撓性熱可塑性プラスチックフィルムより形成され、前記容器の連通可能な隔壁の近傍で前記容器本体の対向する内壁面それぞれに固着されており、前記隔壁の開封に伴う内壁面の離間に伴って小容器が開封するようにされたことを特徴とする請求項1または2に記載の総合輸液製剤。
- 前記小容器が2室に区切られ、一方の室に脂溶性ビタミン液(C)が、他方の室に微量金属元素液(D)が収容され、かつ該小容器が容器の還元糖液(A)を収容する室中に配置されてなる請求項3に記載の総合輸液製剤。
- ヨウ素が還元糖液(A)またはアミノ酸液(B)に配合されてなる請求項4に記載の総合輸液製剤。
- 還元糖液(A)中の還元糖がブドウ糖である請求項1〜5のいずれかに記載の総合輸液製剤。
- アミノ酸液(B)中のアミノ酸がL−イソロイシン、L−ロイシン、L−リジン、L−メチオニン、L−フェニルアラニン、L−スレオニン、L−トリプトファン、L−バリン、L−アラニン、L−アルギニン、L−アスパラギン酸、L−システイン、L−グルタミン酸、L−ヒスチジン、L−プロリン、L−セリン、L−チロシンおよびグリシンである請求項1〜6のいずれかに記載の総合輸液製剤。
- 脂溶性ビタミン液(C)中の脂溶性ビタミンがビタミンA、ビタミンD、ビタミンEおよびビタミンKである請求項1〜7のいずれかに記載の総合輸液製剤。
- 微量金属元素液(D)中の微量金属元素が鉄、マンガン、亜鉛および銅である請求項4に記載の総合輸液製剤。
- 還元糖液(A)がさらにビタミンB1、ビタミンB6,ビタミンB12、パンテノールおよびヨウ素を含み、アミノ酸液(B)がさらにアスコルビン酸、葉酸およびニコチン酸アミドを含む請求項9に記載の総合輸液製剤。
- 前記(A)〜(D)の全ての溶液を混合した時の成分組成が、次の範囲である請求項10記載の総合輸液製剤。
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JP2008266288A (ja) * | 2006-11-08 | 2008-11-06 | Ajinomoto Co Inc | 中心静脈投与用輸液 |
EP2080501A1 (en) * | 2006-10-27 | 2009-07-22 | Otsuka Pharmaceutical Factory, Inc. | Drug solution having reduced dissolved oxygen content, method of producing the same and drug solution containing unit having reduced dissolved oxygen content |
WO2010047302A1 (ja) * | 2008-10-22 | 2010-04-29 | 味の素株式会社 | 総合栄養輸液剤 |
JP2011073995A (ja) * | 2009-09-29 | 2011-04-14 | Terumo Corp | ヨウ素配合脂溶性ビタミン含有液 |
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JP2013100251A (ja) * | 2011-11-09 | 2013-05-23 | Ajinomoto Co Inc | 栄養状態改善剤及び食欲改善剤 |
JP2018165255A (ja) * | 2017-03-28 | 2018-10-25 | テルモ株式会社 | 鉄含有輸液剤 |
JP2020050639A (ja) * | 2018-09-28 | 2020-04-02 | テルモ株式会社 | 鉄含有輸液剤 |
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EP2080501A1 (en) * | 2006-10-27 | 2009-07-22 | Otsuka Pharmaceutical Factory, Inc. | Drug solution having reduced dissolved oxygen content, method of producing the same and drug solution containing unit having reduced dissolved oxygen content |
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JP2008266288A (ja) * | 2006-11-08 | 2008-11-06 | Ajinomoto Co Inc | 中心静脈投与用輸液 |
JP5631737B2 (ja) * | 2008-10-22 | 2014-11-26 | エイワイファーマ株式会社 | 総合栄養輸液剤 |
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JP2014221787A (ja) * | 2008-10-22 | 2014-11-27 | エイワイファーマ株式会社 | 総合栄養輸液剤 |
JP2011073995A (ja) * | 2009-09-29 | 2011-04-14 | Terumo Corp | ヨウ素配合脂溶性ビタミン含有液 |
JP2013100251A (ja) * | 2011-11-09 | 2013-05-23 | Ajinomoto Co Inc | 栄養状態改善剤及び食欲改善剤 |
JP2018165255A (ja) * | 2017-03-28 | 2018-10-25 | テルモ株式会社 | 鉄含有輸液剤 |
JP2021178851A (ja) * | 2017-03-28 | 2021-11-18 | テルモ株式会社 | 鉄含有輸液剤 |
EP3684320B1 (de) | 2017-09-22 | 2023-06-07 | Fresenius Kabi Deutschland GmbH | Verfahren zum befüllen einer medizinischen verpackung, befüllvorrichtung, sowie als beutel ausgebildete medizinische verpackung |
JP2020050639A (ja) * | 2018-09-28 | 2020-04-02 | テルモ株式会社 | 鉄含有輸液剤 |
JP7188961B2 (ja) | 2018-09-28 | 2022-12-13 | テルモ株式会社 | 鉄含有輸液剤 |
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