WO2010104023A1 - Solution de perfusion destinée à une administration dans une veine périphérique constituée d'une solution glucidique renfermant de la vitamine b1 de manière stable - Google Patents

Solution de perfusion destinée à une administration dans une veine périphérique constituée d'une solution glucidique renfermant de la vitamine b1 de manière stable Download PDF

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Publication number
WO2010104023A1
WO2010104023A1 PCT/JP2010/053758 JP2010053758W WO2010104023A1 WO 2010104023 A1 WO2010104023 A1 WO 2010104023A1 JP 2010053758 W JP2010053758 W JP 2010053758W WO 2010104023 A1 WO2010104023 A1 WO 2010104023A1
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Prior art keywords
solution
infusion
vitamin
sugar solution
amino acid
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PCT/JP2010/053758
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English (en)
Japanese (ja)
Inventor
睦夫 繁田
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味の素株式会社
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Priority to JP2011503800A priority Critical patent/JPWO2010104023A1/ja
Publication of WO2010104023A1 publication Critical patent/WO2010104023A1/fr

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Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals

Definitions

  • the present invention relates to a peripheral intravenous administration infusion solution in which a sugar solution and an amino acid solution are separately stored in a multi-chamber container, and relates to a technique for stably blending vitamin B1 into the sugar solution.
  • the stability of vitamin B1 can be improved by setting the titrated acidity of the electrolyte contained in the sugar solution containing vitamin B1 to 1 or less. There is a report that it is increased (Patent Document 1). There is also a report that antioxidants such as ascorbic acid and L-cysteine enhance the stability of vitamin B1 (Patent Document 2).
  • Patent Document 1 since the method of Patent Document 1 needs to reduce the buffering capacity of the sugar solution to the utmost limit, the electrolyte that can be blended is limited, pH adjustment is difficult, and the pH fluctuates with a slight decomposition of the blend. There is a problem in stability.
  • An object of the present invention is to stably add vitamin B1 to a sugar solution in an infusion for peripheral intravenous administration in which a sugar solution and an amino acid solution are separately stored in a multi-chamber container.
  • preferred embodiments of the present invention are as follows. (1) An infusion for peripheral vein administration, wherein the sugar solution contains vitamin B1 and N-acetylcysteine in an infusion for peripheral vein administration in which a sugar solution and an amino acid solution are separately stored in a multi-chamber container. (2) The infusion for peripheral vein administration according to (1), wherein the sugar solution contains 0.3 to 3.0 g / L of N-acetylcysteine.
  • Vitamin B1 can be stabilized by adding N-acetylcysteine to the sugar solution, and N-acetylcysteine added as a stabilizer can be used as an L-cysteine source.
  • N-acetylcysteine added as a stabilizer can be used as an L-cysteine source.
  • L-cysteine added as an antioxidant decreases during storage of the infusion solution. It became clear that the content could not be guaranteed.
  • N-acetylcysteine is used as a stabilizer for vitamin B1
  • the decrease in the content of N-acetylcysteine is small, so that a stabilizing effect is achieved and at the same time the content of N-acetylcysteine can be guaranteed.
  • N-acetylcysteine works in the same way as carboxylic acid and makes the pH acidic, so that the amount of pH regulator added to the sugar solution can be reduced.
  • the main point of the present invention is to stabilize vitamin B1 regardless of the titrated acidity of the sugar solution by containing N-acetylcysteine together with vitamin B1 in the sugar solution containing vitamin B1 and not containing sulfite ion.
  • conventionally known matters relating to peripheral infusion for peripheral intravenous administration can be applied.
  • the sugar solution contains sugar, an electrolyte and vitamin B1 as basic components and does not contain sulfite which inhibits the stabilization of vitamin B1.
  • the sugar that can be used is not particularly limited as long as it is a sugar that is usually used for infusion.
  • the reducing sugar include glucose, fructose, and maltose.
  • the non-reducing sugar include trehalose, xylitol, sorbitol, and glycerin.
  • glucose is preferably added from the viewpoint of nutritional effect.
  • glucose When glucose is used, glucose is used at a concentration of 35 to 150 g / L, preferably 70 to 130 g / L, in the infusion solution after mixing with the amino acid solution.
  • the pH of the sugar solution is preferably 4.0 to 4.5 in order to stably mix vitamin B1.
  • the pH adjuster is not limited as long as it can be used as a pharmaceutical additive.
  • sulfuric acid not containing chloro or organic acids such as acetic acid, lactic acid, citric acid, succinic acid and malic acid, and one or more of these pH regulators are added. be able to.
  • any known vitamin B1 can be used as the vitamin B1 contained in the sugar solution, and examples thereof include thiamine hydrochloride, thiamine nitrate, and fursultiamine.
  • the amount of vitamin B1 is preferably blended at 0.7 to 3.5 mg / L in an infusion solution in which a sugar solution and an amino acid solution are mixed.
  • N-acetylcysteine for stabilizing vitamin B1 is preferably added at a rate of 0.3 to 3.0 g / L. In this range, the blended N-acetylcysteine can be easily quantified by absorptiometry.
  • the same compounds as those used for general electrolyte infusion can be used, and examples thereof include sodium, potassium, magnesium, calcium, chloro, phosphorus, and the like, which are electrolytes essential for living bodies.
  • potassium glycerophosphate serves as a phosphate source and does not cause a precipitation reaction with calcium salt and magnesium salt, it can be blended in the same solution as calcium salt and magnesium salt.
  • a preferable potassium concentration in the infusion solution obtained by mixing the sugar solution and the amino acid solution is 10 to 30 mEq / L.
  • a preferable concentration of phosphoric acid in the infusion solution obtained by mixing the sugar solution and the amino acid solution is 5 to 20 mmol / L.
  • Calcium chloride is suitable for calcium
  • magnesium sulfate is suitable for magnesium.
  • the preferable calcium and magnesium concentrations in the infusion solution in which the sugar solution and the amino acid solution are mixed are each 2 to 8 mEq / L.
  • Zinc is blended in the sugar liquid as zinc sulfate and zinc chloride.
  • a preferable zinc concentration in the infusion solution obtained by mixing the sugar solution and the amino acid solution is 2.5 to 7.5 ⁇ mol / L.
  • the amino acid solution is a solution in which an amino acid containing at least essential amino acids is dissolved.
  • the amino acid is contained in a concentration of 10 to 70 g / L, preferably 15 to 45 g / L in terms of free amino acid.
  • the amino acid may be not only a free amino acid but also various salts, for example, metal salts such as sodium and potassium, salts with organic acids such as acetic acid, and salts with inorganic acids such as hydrochloric acid. Further, some of them may be acyl forms or peptides.
  • N-acetylcysteine is added to the sugar solution, L-cysteine can be omitted from the amino acid solution.
  • a phosphorus compound other than glycerophosphate is blended, it is preferably separated from the calcium salt and the magnesium salt and blended in different liquids. Specifically, when calcium salt and magnesium salt are blended in a sugar solution, the phosphorus compound is blended in an amino acid solution.
  • Other electrolytes are not particularly limited, and may be blended in either a sugar solution or an amino acid solution.
  • the sugar solution and the amino acid solution are mixed by breaking the partition that can be communicated by external pressure during use.
  • the infusion in the present invention is for peripheral intravenous administration, and it is preferable that the pH is in the range of 6 to 7.5 and the titratable acidity is in the range of 5 to 10 so as not to cause phlebitis or vascular pain at the time of administration.
  • the mixing ratio of the sugar solution and the amino acid solution is preferably 2 to 3: 1.
  • ⁇ About infusion containers Any known multi-chamber container configured to be able to communicate can be used. Of these, an infusion bag in which the partition wall is composed of an easily peelable seal is particularly preferable because the communication work is simple. Suitable materials for the infusion bag are, for example, polyolefins such as polyethylene, polypropylene and polybutene, ethylene / propylene copolymers, crosslinked ethylene / vinyl acetate copolymers, and laminates thereof.
  • polyolefins such as polyethylene, polypropylene and polybutene
  • ethylene / propylene copolymers ethylene / propylene copolymers
  • crosslinked ethylene / vinyl acetate copolymers and laminates thereof.
  • An infusion bag filled with a sugar solution and an amino acid solution under nitrogen substitution is packaged with a gas-impermeable outer packaging material having a light-shielding property together with an oxygen scavenger by a conventional method.
  • the gas non-permeable outer packaging material having light shielding properties include aluminum foil and aluminum vapor deposition film which are generally used.
  • transparent, gas-impermeable outer packaging materials such as polyethylene terephthalate, polyethylene naphthalate, ethylene / vinyl alcohol copolymer, polyvinylidene chloride, polyacrylonitrile, polyamide, alumina, silica, etc. It can be used by adding an ultraviolet cut layer.
  • oxygen scavenger those containing iron compounds such as iron hydroxide, iron oxide and iron carbide as main components are used.
  • Commercially available products include AGELESS (Mitsubishi Gas Chemical Co., Ltd.), Modulan (Nippon Kayaku Co., Ltd.), Secur (Nippon Soda Co., Ltd.) and the like.
  • the space between the infusion bag and the outer packaging container is preferably filled with an inert gas such as nitrogen.
  • Example 1 The sugar, electrolyte and vitamin B1 of the above formulation were dissolved in water for injection and adjusted to pH 4.3 using sulfuric acid as a pH regulator. After 350 mL of this liquid was filled in each chamber of a plastic container and sealed, high-pressure steam sterilization was performed in a nitrogen atmosphere. After sterilization, it was packaged under nitrogen gas in a gas-impermeable outer packaging material (Dai Nippon Printing Co., Ltd.) with an aluminum foil as a barrier layer together with an iron-based oxygen scavenger (trade name “AGELESS ZA-200”) .
  • a gas-impermeable outer packaging material Dai Nippon Printing Co., Ltd.
  • an aluminum foil as a barrier layer
  • an iron-based oxygen scavenger trade name “AGELESS ZA-200”.
  • Example 2 A chemical solution was obtained in the same manner as in Example 1 except that N-acetylcysteine was changed to 0.29 g / L in the formulation.
  • Examples 1 and 2 and Comparative Examples 1 and 2 were stored at 25 ° C./60% RH and 40 ° C./75% RH.
  • Vitamin B1 was measured by HPLC after 2 weeks, 4 weeks and 8 weeks.
  • N-acetylcysteine and L-cysteine were quantified by a colorimetric method.
  • the light absorbency was measured with the light absorption wavelength of 430 nm.
  • NAC represents N-acetylcysteine
  • the sugar solution was prepared by dissolving the above sugar, electrolyte, and vitamin B1 in water for injection and adjusting the pH to 4.5 using sulfuric acid as a pH regulator.
  • the amino acid solution was adjusted to pH 6.8 by dissolving the above-described amino acid in water for injection and using sulfuric acid as a pH adjuster. Both solutions were aseptically filtered, filled with 350 mL of a sugar solution and 150 mL of an amino acid solution into each chamber of a plastic container partitioned by an easy-release seal, and sealed and then autoclaved under a nitrogen atmosphere.
  • Example 4 A chemical solution was obtained in the same manner as in Example 3 except that N-acetylcysteine was changed to 1.17 g / L in the sugar solution formulation.
  • the titratable acidity of the sugar solution was 21.
  • Example 5 A chemical solution was obtained in the same manner as in Example 3 except that the sugar solution formulation was changed to 2.93 g / L of N-acetylcysteine. The titratable acidity of the sugar solution was 21.
  • Examples 3, 4, 5 and Comparative Example 3 were stored at room temperature. Two weeks later, two months later and four months later, vitamin B1 was quantified by HPLC. In addition, N-acetylcysteine was quantified by a colorimetric method after 2 months and 4 months after storage.
  • the measurement result regarding the residual amount of vitamin B1 is shown below.
  • the stability of vitamin B1 was improved in the infusion solution formulated with N-acetylcysteine compared to the non-added solution.
  • the N-acetylcysteine content was stable at 95% or more during the storage period compared to the prescribed amount.

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Abstract

La présente invention concerne une solution de perfusion destinée à une administration dans une veine périphérique qui comprend une solution glucidique et une solution d'acides aminés, la solution glucidique et la solution d'acides aminés étant contenues séparément dans un récipient à chambre double. Dans la solution de reperfusion, de la N-acétylcystéine est ajoutée à la solution glucidique contenant de la vitamine B1 pour stabiliser cette dernière.
PCT/JP2010/053758 2009-03-11 2010-03-08 Solution de perfusion destinée à une administration dans une veine périphérique constituée d'une solution glucidique renfermant de la vitamine b1 de manière stable WO2010104023A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2011503800A JPWO2010104023A1 (ja) 2009-03-11 2010-03-08 ビタミンｂ１を安定に配合した糖液を含む末梢静脈投与用輸液

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JP2009-057227 2009-03-11
JP2009057227 2009-03-11

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WO2010104023A1 true WO2010104023A1 (fr) 2010-09-16

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110898005A (zh) * 2019-12-30 2020-03-24 滨州医学院附属医院 一种减毒增效的长春瑞滨注射液及其抗肺癌应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04210629A (ja) * 1990-11-30 1992-07-31 Tanabe Seiyaku Co Ltd 亜硫酸イオンフリーの二重包装型アミノ酸輸液製剤
JPH07502025A (ja) * 1991-10-21 1995-03-02 ファルマチア・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング ヒト非経口栄養補給に用いる、安定性に優れた熱量栄養剤溶液、および複数隔壁容器または複式受容器
WO2004103375A1 (fr) * 2003-05-22 2004-12-02 Otsuka Pharmaceutical Factory, Inc. Preparation de transfusions pour administration intraveineuse peripherique et procede de stabilisation de la vitamine b1
JP2005179200A (ja) * 2003-12-16 2005-07-07 Terumo Corp ビタミンｂ１類配合輸液剤

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04210629A (ja) * 1990-11-30 1992-07-31 Tanabe Seiyaku Co Ltd 亜硫酸イオンフリーの二重包装型アミノ酸輸液製剤
JPH07502025A (ja) * 1991-10-21 1995-03-02 ファルマチア・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング ヒト非経口栄養補給に用いる、安定性に優れた熱量栄養剤溶液、および複数隔壁容器または複式受容器
WO2004103375A1 (fr) * 2003-05-22 2004-12-02 Otsuka Pharmaceutical Factory, Inc. Preparation de transfusions pour administration intraveineuse peripherique et procede de stabilisation de la vitamine b1
JP2005179200A (ja) * 2003-12-16 2005-07-07 Terumo Corp ビタミンｂ１類配合輸液剤

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110898005A (zh) * 2019-12-30 2020-03-24 滨州医学院附属医院 一种减毒增效的长春瑞滨注射液及其抗肺癌应用

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