JP6501923B2 - 腸管洗浄用の下剤組成物 - Google Patents
腸管洗浄用の下剤組成物 Download PDFInfo
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- JP6501923B2 JP6501923B2 JP2017565935A JP2017565935A JP6501923B2 JP 6501923 B2 JP6501923 B2 JP 6501923B2 JP 2017565935 A JP2017565935 A JP 2017565935A JP 2017565935 A JP2017565935 A JP 2017565935A JP 6501923 B2 JP6501923 B2 JP 6501923B2
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- water
- cleansing
- polyethylene glycol
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- 235000019202 steviosides Nutrition 0.000 description 1
- 239000000021 stimulant Substances 0.000 description 1
- 239000008143 stimulant laxative Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
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- 238000001356 surgical procedure Methods 0.000 description 1
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- 229960002675 xylitol Drugs 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
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Description
下記の表1に示している成分で腸管洗浄用の下剤組成物を製造した。適切な容器にポリエチレングリコール(数平均分子量4800)150gを入れ、精製水を適量加えて60℃に加熱して溶かした後、ソルビトール液(ソルビトール50%)60mL、ピコ硫酸ナトリウム10mg及び甘味剤を添加し、総体積が300mLになるよう精製水を添加した後、80℃で完全に溶かした。
数平均分子量が3000であるポリエチレングリコールを用いたことを除いては、前記実施例1と同一の条件で腸管洗浄用の下剤組成物を製造した。
下記の表2に示されている成分で腸管洗浄用の下剤組成物を製造した。適切な容器にポリエチレングリコール(数平均分子量4800)130gを入れ、精製水を適量加えて60℃に加熱して溶かした後、ソルビトール液(ソルビトール50%)90mL、ピコ硫酸ナトリウム10mg及び甘味剤を添加し、総体積が300mLになるよう精製水を添加した後、80℃で完全に溶かした。
下記の表3に示されている成分で腸管洗浄用の下剤組成物を製造した。適切な容器にポリエチレングリコール(数平均分子量4800)130gを入れ、精製水を適量加えて60℃に加熱して溶かした後、ソルビトール液(ソルビトール50%)90mL、ビサコジル15mg及び甘味剤を添加し、総体積が300mLになるよう精製数を添加した後、80℃で完全に溶かした。
下記の表4に示している成分で腸管洗浄用の下剤組成物を製造した。適切な容器にポリエチレングリコール(数平均分子量3350)150gを入れ、精製水を適量を加えて60℃に加熱して溶かした後、ソルビトール粉末54.6g、ピコ硫酸ナトリウム10mg及び甘味剤を添加し、総体積が300mLになるよう精製水を添加した後、80℃で完全に溶かした。
下記の表5に示している成分で腸管洗浄用の下剤組成物を製造した。適切な容器にポリエチレングリコール(数平均分子量3350)236gと塩化カリウム2.97g、塩化ナトリウム5.86g、炭酸水素ナトリウム6.74g、無水硫酸ナトリウム22.74gを添加し、総体積が4Lになるように精製水を添加した後、完全に溶かした。
下記表6に示されている成分で腸管洗浄用の下剤組成物を製造した。適切な容器にピコ硫酸ナトリウム0.01g、酸化マグネシウム3.5g、クエン酸12g、炭酸水素ナトリウム0.3g及び甘味剤を添加し、総体積が2Lになるよう精製水を添加した後、完全に溶かした。
注射用生理食塩水
<実験例1> 浸透圧比較
浸透圧測定機を用いて実施例1〜5及び比較例1〜3の腸管洗浄用の下剤組成物の浸透圧を測定し、下記の表7に示した。実施例1〜5は、一緒に服用する水の量を勘案して希釈して測定しており、比較例3は、体内浸透圧に類似な等張液である。また、比較例1及び比較例2は、通常使用されるポリエチレングリコール/電解質から構成された腸管洗浄用の下剤組成物またはピコ硫酸ナトリウムから構成された腸管洗浄用の下剤組成物である。
実施例1の組成物100mLを水500mLに希釈して服用し、次の服用前、水500mLをさらに飲んだ後、同様の方法で1時間おきでさらに2回反復して服用した後、内視鏡によって腸管の内部を検査した結果を図1に示した。
Claims (10)
- 液状剤形であって、組成物100ml当たりポリエチレングリコール40〜60g、ソルビトール10〜28g及びピコ硫酸ナトリウム1〜10mgを含むことを特徴とする腸管洗浄用の下剤組成物。
- 液状剤形であって、組成物100ml当たりポリエチレングリコール40〜60g、ソルビトール10〜28g及びビサコジル1〜15mgを含むことを特徴とする腸管洗浄用の下剤組成物。
- 前記ポリエチレングリコールは、数平均分子量が1,000〜10,000であることを特徴とする請求項1又は2に記載の腸管洗浄用の下剤組成物。
- 前記ポリエチレングリコールは、数平均分子量が3,000〜4,800であることを特徴とする請求項3に記載の腸管洗浄用の下剤組成物。
- 前記組成物が、溶液剤、懸濁液剤及び乳剤のいずれかの形態で製造されることを特徴とする請求項1又は2に記載の腸管洗浄用の下剤組成物。
- 前記組成物100〜200mLを、水300〜400mLに希釈して20〜40分内に服用し、さらに20〜40分内に水400〜600mLを飲んだ後、50〜70分経過してから同様の方法でさらに1回反復して服用することを特徴とする請求項1又は2に記載の腸管洗浄用の下剤組成物。
- 前記組成物は、組成物1体積当り、水5〜10体積比で一緒に服用されることを特徴とする請求項1又は2に記載の腸管洗浄用の下剤組成物。
- 前記服用される組成物と水との総体積が、3.5L以下であることを特徴とする請求項7に記載の腸管洗浄用の下剤組成物。
- 組成物100ml当たりポリエチレングリコール40〜60g、ソルビトール10〜28g及びピコ硫酸ナトリウム1〜10mgを含むか、または組成物100ml当たりポリエチレングリコール40〜60g、ソルビトール10〜28g及びビサコジル1〜15mgを含む腸管洗浄用の液状剤形の下剤組成物と、
前記組成物1体積当り5〜10体積比の水と一緒に服用するように記載された服用説明書と、を含む腸管洗浄用の下剤製品。 - 前記服用説明書は、前記組成物100〜200mLを水300〜400mLに希釈して20〜40分内に服用し、さらに20〜40分内に水400〜600mLを飲んだ後、50〜70分経過してから同様の方法でさらに1回反復して服用するように記載されていることを特徴とする請求項9に記載の腸管洗浄用の下剤製品。
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US5843479A (en) * | 1993-02-26 | 1998-12-01 | The Procter & Gamble Company | Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery |
US7291324B2 (en) * | 2002-10-22 | 2007-11-06 | Braintree Laboratories Inc. | Method of bowel cleansing |
AU2004290580A1 (en) * | 2003-11-17 | 2005-06-02 | Braintree Laboratories, Inc. | Therapeutic PEG solution concentrate |
US7687075B2 (en) * | 2003-11-19 | 2010-03-30 | Salix Pharmaceuticals, Ltd. | Colonic purgative composition with soluble binding agent |
KR101438814B1 (ko) * | 2007-03-16 | 2014-09-17 | 엘지이노텍 주식회사 | 헤드램프 제어 장치 및 방법 |
DE112008002398A5 (de) * | 2007-09-22 | 2010-07-29 | Bayer Consumer Care Ag | Zusammensetzung mit Wirkstoffkombination aus einem Laxans und einem Entschäumer zur Behandlung von Obstipation |
AU2008312465A1 (en) * | 2007-10-17 | 2009-04-23 | Thomas Jefferson University | Bowel purgative and uses thereof |
CN101450049A (zh) * | 2007-12-07 | 2009-06-10 | 辉凌国际制药(瑞士)有限公司 | 药物组合物 |
ES2647813T3 (es) * | 2008-07-09 | 2017-12-26 | The General Hospital Corporation | Purgantes dietéticos |
WO2012046847A1 (ja) * | 2010-10-08 | 2012-04-12 | 味の素株式会社 | Ctコロノグラフィに用いられる経口投与用液剤及び消化管造影用組成物 |
JP5870119B2 (ja) * | 2011-01-28 | 2016-02-24 | ブレインツリー ラボラトリーズ、インク. | 腸洗浄のための、方法、組成物、およびパッケージ |
CN107260661A (zh) * | 2011-01-31 | 2017-10-20 | 诺金股份有限公司 | 对组合物的改进和与组合物有关的改进 |
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