WO2005097144A1 - 腸管洗浄用組成物 - Google Patents
腸管洗浄用組成物 Download PDFInfo
- Publication number
- WO2005097144A1 WO2005097144A1 PCT/JP2005/002766 JP2005002766W WO2005097144A1 WO 2005097144 A1 WO2005097144 A1 WO 2005097144A1 JP 2005002766 W JP2005002766 W JP 2005002766W WO 2005097144 A1 WO2005097144 A1 WO 2005097144A1
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- WO
- WIPO (PCT)
- Prior art keywords
- composition
- cleaning
- package
- intestinal
- layer
- Prior art date
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Classifications
-
- 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
- A61K31/28—Compounds containing heavy metals
- A61K31/315—Zinc compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- 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
- A61K9/08—Solutions
-
- 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
Definitions
- the present invention relates to an intestinal lavage composition and a packaged intestinal lavage composition used for colonoscopy, enema X-ray examination, pretreatment for colorectal surgery, and the like.
- the Brown method which consists of dietary restriction with a low-residue, low-fat menu and administration of laxatives, has been the mainstream. Met.
- the dietary restriction of the Brown method puts a considerable burden on patients, and the laxative is difficult to drink and rapidly causes diarrhea.
- the intestinal cleaning method using a non-secretory, non-absorbable oral intestinal washing liquid has been replaced with the Brown method. Widely used.
- the oral intestinal lavage fluid contains electrolyte components and osmotic pressure regulators, and due to their peculiar odor and salty taste, patients endure unpleasant odor and taste. You have to keep taking it for a long time.
- Patent Document 1 Japanese Patent Application Laid-Open No. 11-228423
- Patent Document 2 Japanese Patent No. 3255641
- Patent Document 3 Japanese Patent Publication No. Hei 8-505609
- the present invention relates to an oral intestinal lavage composition, which is packaged in a package capable of flavoring and smelling in a manner that does not generate flammable gas in the intestine, and further maintaining the flavoring / smelling effect for a long period of time.
- the purpose is to provide.
- the present inventors have conducted intensive studies to solve the problems of taking the intestinal lavage solution in the aforementioned intestinal lavage method, and as a result, completed the present invention.
- the present invention provides:
- An intestinal cleansing composition comprising a crystalline osmotic pressure adjusting agent and a flavoring agent, which comprises a liquid flavor and is substantially free of saccharides. Composition.
- composition for cleaning an intestinal tract according to [4], further comprising a liquid fragrance, camonene.
- composition for cleaning an intestinal tract according to [4]
- a liquid fragrance for cleaning an intestinal tract
- camonene for cleaning an intestinal tract
- the intestinal lavage composition of [4] or [5] which further comprises a sweetener containing no saccharides as an additional component.
- the limonene is stored in a package formed so that the amount of adsorption or permeation and dissipation of limonene is less than 100 mg per package by the time of use.
- contact with the contents of the package layer is formed of a thermoplastic resin of polyolefin-based, characterized in that it is a gas permeability of the packaging Sokarada is 0- 20ccZm 2.
- Day ⁇ atm ( 25 ° C) [7] The composition for cleaning an intestinal tract according to [7].
- the intestinal cleansing composition of [7] or [8], wherein the layer in contact with the contents is formed of a polyolefin-based thermoplastic resin having a thickness of 100 ⁇ m or less.
- composition for intestinal tract cleaning according to [9], wherein the composition is filled in a package formed of two or more types of polyolefin-based thermoplastic resins having different amounts of limonene adsorbed and Z-permeated.
- the innermost layer (layer in contact with the contents) is made of low-density polyolefin-based thermoplastic resin
- the outer layer is made of high-density polyolefin-based thermoplastic resin
- the outer layer is low-density polyolefin-based thermoplastic.
- Composition [17] The composition for intestinal cleaning according to [16], wherein the package has a bottom surface that can be set up with the injection port facing upward when the composition for intestinal cleaning is dissolved in water.
- composition for cleaning an intestinal tract according to [18], wherein the inner layer is made of polyethylene.
- the oral intestinal lavage composition of the present invention can be stored for a long period of time without impairing the flavor and smelling effect by filling it into a package that is easy to take and has low gas permeability.
- the intestinal cleansing composition contains a crystalline osmotic pressure adjusting agent in order to exhibit an excellent intestinal cleansing effect that does not significantly disturb the electrolyte balance of blood during intestinal cleansing.
- Electrolyte is a substance that dissociates into ions in a solution, Na + , K + , Ca ++ , Mg ++ , Cl HCO-, SO--, HPO, organic
- Sodium sources include sodium chloride, sodium acetate, sodium citrate, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium sulfate, sodium lactate, and the like.
- Potassium sources include sodium chloride potassium, potassium acetate, and the like. Pum, potassium citrate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium sulfate, potassium lactate etc.
- Calcium sources include calcium chloride, calcium dalconate, calcium pantothenate, calcium lactate, calcium acetate, glycemic acid.
- Magnesium sources such as calcium phosphate and the like, magnesium sulfate, magnesium chloride, magnesium acetate, magnesium citrate, and the like
- Phosphorus sources include sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium glycerate, etc.
- salt Sodium bicarbonate, sodium chloride, calcium chloride, magnesium chloride, etc.
- bicarbonate ion sources include sodium bicarbonate and the like, and these compounds may be in the form of hydrates.
- a mixture of an electrolyte and a saccharide may be used for osmotic pressure adjustment, but the saccharide may be fermented by intestinal bacteria and increase the concentration of hydrogen gas and methane gas in the intestine. Therefore, it is important that the intestinal cleansing composition of the present invention does not contain saccharides.
- a colloid electrolyte in addition to the crystalline electrolyte.
- a colloid osmotic pressure adjusting agent it is preferable to blend a polymer which is not fermented by intestinal bacteria. More specifically, it is polyethylene glycol, and its molecular weight is preferably from 2000 to 8000, more preferably from 3,000 to 7,000.
- the intestinal lavage composition of the present invention is used by incorporating an osmotic pressure adjusting agent so as to minimize fluctuations in serum electrolyte balance and osmotic pressure in a living body.
- the amount is adjusted depending on the condition of the patient, the amount of intestinal residue, and the like, but it is preferably dissolved in water and used as an aqueous solution having an osmotic pressure of 200 to 440 mOsm / L. More preferably, the type and amount of each component should be selected so that they can be adjusted to an isotonic range of 280 to 320 mOsm / L or an osmotic pressure range close to isotonicity.
- the amount of the oncotic pressure adjusting agent used is 5 120 g, preferably 30 90 g, in a preparation dissolved in 1 liter of water.
- Na + 30-150 mEq / L
- K + 2- 20mEq /
- C1- 20- 70mEq / L
- HCO 10- 50mEq / L
- sO 2 0- adding an electrolyte so that 120 mEq / L
- hardly absorbable ions such as magnesium ions and sulfate ions are added.
- magnesium ions when the composition for cleaning the intestinal tract is dissolved in water, the concentration is adjusted to be 40 to 120 mEq / L.
- sulfate ion adjust the composition to 40 to 120 mEq / L when the intestinal cleaning composition is dissolved in water.
- a predetermined amount is dissolved in water to prepare a solution.
- the dose is preferably at a rate of about 1 liter per hour.
- the intestinal contents are excreted. If you have constipation with an average of less than 4 defecations per week, improve the bowel movement by taking 200 to 300 mL of a solution of the intestinal lavage composition continuously for 3 to 5 days to improve bowel movement.
- the intestinal contents can be excreted by taking 1L orally.
- the intestinal lavage is sufficiently performed by taking the intestinal lavage fluid, the intestinal bacterial count is 1Z. It is reduced from 100 to 1/1000, and the production of hydrogen gas and methane gas due to the breakdown of trace residues in the intestine by enterobacteria is suppressed.
- conventional intestinal lavage fluids have a taste and odor that are difficult to take, and in some cases, nausea, vomiting, and the like may prevent taking a sufficient amount for cleaning.
- a flavoring agent was incorporated into the intestinal cleansing composition to make it easier to take.
- the intestinal lavage composition of the present invention contains a flavoring agent which contains a liquid flavor and is substantially free of saccharides.
- the odor corrector used in the present invention is not particularly limited as long as it masks the odor caused by the crystalline electrolyte and the colloid electrolyte when the composition solution for intestinal lavage is taken orally.
- food flavors are suitable, especially fruit flavors.
- fruit flavors include flavors such as lemon, orange, grape fenolate, lemon lime, mandarin orange, grape, strawberry, cherry, apple, apricot, and raspberry.
- citrus aromas such as lemon, orange, grapefruit, and lemon lime are optimal because they provide a refreshing drink.
- Essential oils obtained from these fruits by squeezing or steam distillation can be used as flavors.
- the liquid fragrance includes a water-soluble liquid fragrance obtained by extracting or dissolving a fragrance component with aqueous alcohol or the like, and an oil-soluble liquid fragrance obtained by dissolving a fragrance component in an oily solvent. It also includes flavoring components (essential oils) plus preservatives. As the liquid flavor, it is preferable to use oil-soluble or essential oil-derived flavors rather than water-soluble liquid flavors from the viewpoint of storage stability.
- the addition amount is 0.001 0.3% by mass of the composition for intestinal washing.
- the liquid fragrance is directly adsorbed on the electrolyte powder. It is necessary to avoid mixing liquid fragrances with saccharides in advance, because there is a risk of generating hydrogen gas and methane gas.
- the flavoring agent used in the present invention makes it easy to drink when taking a large amount of the intestinal lavage composition solution, and a sweetener is usually used. Hydrogen in the intestine as a sweetener There must be no or extremely low generation of gas or methane gas. In particular
- Saccharin, saccharin sodium, acesulfame_ ⁇ , ticramate (sodium cyclohexylsulfamate), aspartame and the like are preferably used alone or in combination.
- the preferable addition amount of these sweeteners is 0.0013% by mass of the intestinal tract cleaning composition. More preferably, it is 0.01-0.3% by mass.
- the intestinal lavage composition to which the flavoring agent has been added has a reduced swallowing ability, is sensitive to taste and odor, and is easily nausea and vomiting, and can be easily taken by patients.
- the intestinal tract cleaning composition of the present invention can be used as a metal bag such as aluminum lined with a thermoplastic resin, a can-like package, or a plastic package formed with a thermoplastic resin. Will be filled.
- the fragrance containing limonene is particularly adsorbed by the polyolefin-based thermoplastic resin or easily permeated and dissipated therethrough, so that it is necessary to prepare a package in which a sufficient amount of the fragrance remains when used.
- the thickness of the resin layer as well as the area of the inner surface of the package determines the amount of adsorption and the amount of permeation and dissipation, it does not cause a decrease in the sealing strength of the package, and the resin has a force within a range where a sufficient amount of fragrance remains when used. It is necessary to set the thickness of the layer. In particular, it is preferable to use a package in which the amount of limonene adsorbed or permeated and dissipated is less than 100 mg per package by the time of use.
- the intestinal tract cleaning composition of the present invention can be transferred to a package container, dissolved in water, and taken.
- the package itself is made of a plastic container that can hold the required dissolving water (for example, 2 liters), and if the dissolving water is directly put into the package at the time of use and dissolved and taken, a separate dissolving container will be required.
- the plastic container is preferably formed of a polyolefin-based thermoplastic resin. Examples of the polyolefin-based thermoplastic resin include polyethylene and polypropylene.
- Soft polyolefin has good adhesion between resins required for molding a container, but has high gas-adsorbing and Z-permeability of a fragrance containing limonene.
- hard polyolefin has low gas adsorbing property and low Z permeability, but poor adhesion between resins. Therefore, in order to satisfy both the requirements for molding and the requirements for gas adsorption and Z permeability, soft polyolefin is used for the inner layer (the surface in contact with the intestinal lavage composition), and hard polyolefin is further added. If the layers are overlaid, the overall gas adhesion / permeability is low and the adhesion (formability) is good.
- the innermost layer (the surface in contact with the composition for cleaning the intestinal tract) is made of a soft polyolefin, a hard polyolefin on the outside, and a soft polyolefin on the outside.
- the thickness of the innermost layer is preferably formed of a polyolefin-based thermoplastic resin of 100 xm or less, preferably 50 xm or less, in order to suppress a decrease due to adsorption or permeation and dissipation of the fragrance containing limonene.
- a plastic package is formed of two layers, an inner layer made of soft polyolefin and an outer layer made of hard polyolefin, the total thickness should be 70-200 ⁇ m, and the thickness of each of the inner and outer layers should be 35 100 ⁇ m. m is preferable.
- the total thickness is 70-200 ⁇ m.
- sodium bicarbonate generates carbon dioxide gas over time to prevent the content from decreasing, and to achieve both of the purpose of preventing the limonene from escaping from the package.
- the gas permeability of the body must be less than 20cc / m 2 'day' atm (25 ° C).
- thermoplastic resin such as polyethylene terephthalate or polyamide is laminated on the outer side of the two or three polyethylene layers to form a package with increased strength against drop impact and piercing of the package. Is preferred.
- the shape of the package is not particularly limited. However, when the package also serves as a plastic container capable of storing dissolved water, it is provided with an inlet for the dissolved water and has a bottom surface which can be set up when dissolved. Is preferably provided. Considering the convenience of manufacturing, it has two vertically long, almost triangular side walls that are longer than the bottom, an inlet at the top of the side wall, and a shape like a camellia leaf at the bottom of the side wall Those having a bottom surface are preferred. The two side walls and the bottom are made of flexible plastic, the inlet is made of hard plastic, and the inlet is covered.
- the two side walls and the bottom are made of flexible plastic, and the bottom is Until the water is injected, the structure can be folded inside so that the entire package can be removed from the package until air is removed from the package (container), so it is convenient for storage and transportation. .
- the two side walls are preferably made of a transparent or translucent plastic so that the contents can be confirmed by eyes.
- a scale indicating the amount of dissolved water is provided on the side wall, so that a meter is not required for injecting the dissolved water, and the dose can be confirmed visually at the time of taking.
- the intestinal lavage composition of the present invention can be prepared by mixing predetermined components by a conventionally known method. When filling the package, it is convenient to remove air as much as possible, since it is not bulky and it is easy to store and transport. If long-term storage is required, the package can be sealed in a gas-impermeable outer bag made of aluminum laminated film or the like.
- Example 3 2.93 g of sodium chloride, 1.49 g of potassium chloride, 3.37 g of sodium hydrogen carbonate, 11.37 g of anhydrous sodium sulfate, 118 g of polyethylene glycolone, 0.137 g of lemon lime flavor 32-112 containing limonene as a main component (manufactured by Taiyo Koryo Co., Ltd.) It was mixed with 0.0686 g of sodium saccharin to prepare a composition for cleaning the intestinal tract.
- This is a plastic package with an inlet of 2300 mL in inner volume made of soft polyethylene of 33 xm, hard polyethylene of 33 ⁇ m in the middle layer, and soft polyethylene of 33 ⁇ m in the outermost layer. And sealed as much as possible after removing air. This package contains 2 liters of water and dissolves when used.
- a 40 ⁇ m-thick outer layer consisting of a polyethylene terephthalate layer and a nylon layer is combined with a 33 ⁇ m-thick linear low-density polyethylene, a 33 ⁇ m-thick high-density polyethylene, and a A plastic package with an inlet capacity of 2300 mL, made of a total of five layers of thermoplastic resin, in which three layers of 33 ⁇ m linear low-density polyethylene are sequentially laminated are made of thermoplastic resin.
- the surface area was filled to 600 cm 2 ), air was removed as much as possible, and the container was sealed. This was stored in an exterior bag made of aluminum laminated film and sealed. This package contains 2 liters of water when used Dissolve and take.
- Test Example 1 Sensory test for flavoring agent
- Lemon-lime flavor 32—112 (manufactured by Taiyo Perfume Co., Ltd.), (2) orange-22-222 (manufactured by Taiyo Perfume Co., Ltd.) and (3) grapefruit For 22-204B (manufactured by Taiyo Koryo Co., Ltd.)
- a sensory test was conducted using 89 adults as a panel.
- 46% of panelists named lemon lime flavors 32-112 of (1) No. 1 as the most preferred flavoring agent.
- Test Example 2 Adsorbability of perfume containing polyethylene limonene Z-permeability test
- Package 1 used for the test A total of three layers consisting of a 40 ⁇ m thick outer layer consisting of a polyethylene terephthalate layer and a nylon layer and a 140 ⁇ m thick linear low-density polyethylene inner layer
- Package used for the test 2 Film consisting of two layers, polyethylene terephthalate layer and nylon layer A total of 5 layers of thermoplastic resin laminated in three layers, in which im linear low-density polyethylene, 33 / im high-density polyethylene and 33 ⁇ m-thick linear low-density polyethylene are sequentially laminated.
- Intestinal lavage composition used in the test 2.93 g of sodium salt sodium chloride, 1.49 g of potassium salt sodium chloride, 3.37 g of sodium hydrogen carbonate, 11.37 g of anhydrous sodium sulfate, 118 g of polyethylene glycol, and a lemon-lime flavor mainly composed of limonene 32-112 (manufactured by Taiyo Koryo Co., Ltd.) 0.137 g, mixed with 0.0686 g of saccharin sodium.
- Test method The intestinal lavage composition was filled into package 1 and package 2, sealed tightly, stored in an outer bag made of anoremy laminate film, sealed, and kept at 20 ° C. and 60% RH. At this time, the change over time of the limonene content was measured by gas chromatography.
- a liquid flavor and optionally a saccharide-free sweetener to the oral intestinal lavage composition facilitates ingestion. Also, by using a package having a low gas permeability, it is possible to prevent the liquid fragrance from being dissipated.
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Abstract
Description
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Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2005800119749A CN1953757B (zh) | 2004-04-02 | 2005-02-22 | 肠道清洗用组合物 |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2004-109993 | 2004-04-02 | ||
JP2004109993A JP2005187448A (ja) | 2004-04-02 | 2004-04-02 | 腸管洗浄用組成物 |
Publications (1)
Publication Number | Publication Date |
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WO2005097144A1 true WO2005097144A1 (ja) | 2005-10-20 |
Family
ID=34792638
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2005/002766 WO2005097144A1 (ja) | 2004-04-02 | 2005-02-22 | 腸管洗浄用組成物 |
Country Status (4)
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JP (1) | JP2005187448A (ja) |
CN (1) | CN1953757B (ja) |
TW (1) | TWI372062B (ja) |
WO (1) | WO2005097144A1 (ja) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100389779C (zh) * | 2006-07-07 | 2008-05-28 | 北京昭衍博纳新药研究有限公司 | 一种用于肠道清洁的药物组合物 |
WO2011041300A1 (en) * | 2009-10-02 | 2011-04-07 | Basf Se | Reduced-odor polyol composition and method of producing same |
JP2015500702A (ja) * | 2011-12-07 | 2015-01-08 | エムエスエム イノベーションズ、インク. | 腸管前処置のための方法 |
US9585937B2 (en) | 2011-12-07 | 2017-03-07 | Msm Innovations, Inc. | Method and kit for bowel preparation |
Families Citing this family (4)
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AU2010256491B2 (en) * | 2009-06-03 | 2015-02-05 | Aptalis Pharma Us, Inc. | L-sugar colon cleansing agent and uses thereof |
EP2564875A4 (en) | 2010-04-30 | 2016-03-30 | Ajinomoto Kk | LIQUID PREPARATION FOR ORAL ADMINISTRATION THAT CAN BE USED IN CT COLONOGRAPHY, AND COMPOSITION FOR DIGESTIVE TRACT IMAGING |
CN102133225B (zh) * | 2011-03-18 | 2012-11-21 | 海南锦瑞制药股份有限公司 | 一种复方聚乙二醇电解质散剂及其制备方法 |
JP5708141B2 (ja) * | 2011-03-30 | 2015-04-30 | 味の素株式会社 | 経口投与用液剤を調製するための経口投与用製剤 |
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- 2005-02-22 TW TW094105366A patent/TWI372062B/zh not_active IP Right Cessation
- 2005-02-22 CN CN2005800119749A patent/CN1953757B/zh not_active Expired - Fee Related
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CN100389779C (zh) * | 2006-07-07 | 2008-05-28 | 北京昭衍博纳新药研究有限公司 | 一种用于肠道清洁的药物组合物 |
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JP2013506732A (ja) * | 2009-10-02 | 2013-02-28 | ビーエーエスエフ ソシエタス・ヨーロピア | 臭気低減ポリオール組成物およびその製造方法 |
JP2015500702A (ja) * | 2011-12-07 | 2015-01-08 | エムエスエム イノベーションズ、インク. | 腸管前処置のための方法 |
US9585937B2 (en) | 2011-12-07 | 2017-03-07 | Msm Innovations, Inc. | Method and kit for bowel preparation |
US9629917B2 (en) | 2011-12-07 | 2017-04-25 | Msm Innovations, Inc. | Method for bowel preparation |
JP2018100273A (ja) * | 2011-12-07 | 2018-06-28 | エムエスエム イノベーションズ、インク. | 腸管前処置のための方法 |
Also Published As
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TWI372062B (en) | 2012-09-11 |
JP2005187448A (ja) | 2005-07-14 |
TW200533373A (en) | 2005-10-16 |
CN1953757B (zh) | 2010-05-05 |
CN1953757A (zh) | 2007-04-25 |
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