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WO2021200313A1 - Composition aqueuse conditionnée - Google Patents

Composition aqueuse conditionnée Download PDF

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Publication number
WO2021200313A1
WO2021200313A1 PCT/JP2021/011593 JP2021011593W WO2021200313A1 WO 2021200313 A1 WO2021200313 A1 WO 2021200313A1 JP 2021011593 W JP2021011593 W JP 2021011593W WO 2021200313 A1 WO2021200313 A1 WO 2021200313A1
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WO
WIPO (PCT)
Prior art keywords
water
containing composition
mass
package
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.)
Ceased
Application number
PCT/JP2021/011593
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English (en)
Japanese (ja)
Inventor
金子　靖
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kowa Co Ltd
Original Assignee
Kowa Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Kowa Co Ltd filed Critical Kowa Co Ltd
Priority to PH1/2022/552555A priority Critical patent/PH12022552555A1/en
Priority to JP2022511945A priority patent/JP7772690B2/ja
Priority to KR1020227032223A priority patent/KR20220161296A/ko
Priority to CN202180021436.7A priority patent/CN115279413A/zh
Publication of WO2021200313A1 publication Critical patent/WO2021200313A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis

Definitions

  • the present invention relates to a water-containing composition containing a package and the like.
  • a composition containing at least water as a solvent is widely used as a pharmaceutical product or a quasi-drug because of its advantages such as less irritation to the living body and the ability to blend various components. Has been done. However, since it contains water, there is a problem that it is easily contaminated by microorganisms. Therefore, the water-containing composition is often blended with an antiseptic (bactericidal agent) to have an antiseptic effect.
  • an antiseptic bacteriaicidal agent
  • the preservative for example, parabens, a quaternary ammonium type surfactant such as benzalkonium chloride, and the like are used.
  • Non-Patent Document 1 cytotoxicity
  • sodium zirconiumcyclosilicate hydrate which is a kind of zirconium cyclosilicate, is known as a compound whose effectiveness in the treatment of hyperpotassium is actually confirmed (Patent Documents 1 and 2).
  • Sodium zirconium silicate hydrate suspension powder package (powder preparation) will be sold in the United States, Japan, etc. as LOKELMA or Rokerma (both registered trademarks) for the indication of hyperpotassium. It has been reached (Non-Patent Documents 2 and 3).
  • LOKELMA or Rokerma both registered trademarks
  • New Ophthalmology 8 (10): 1599-1603, 1991 "LOKELMA®” package insert, 2018 "5g of Locerma Suspension Dispersion Package / 10g of Locerma Suspension Dispersion Package” Package insert, March 2020 "Medicine Bookmark 5g for Lokerma Suspension", May 2020
  • An object of the present invention is to provide a new means for reducing microbial contamination of a hydrous composition.
  • zirconium cyclosilicates such as sodium zirconium cyclosilicate hydrate, which are known to be useful for the treatment of hyperkalemia, have a water-containing composition. It has been found that it has a surprisingly excellent antiseptic effect when it is contained in a substance. Then, they have found that microbial contamination of the hydrous composition can be reduced for a long period of time by incorporating zirconium cyclosilicate in the hydrous composition and then containing the zirconium cyclosilicate in a package (container), and completed the present invention. ..
  • the present invention provides a water-containing composition containing a zirconium cyclosilicate in which the water-containing composition is contained in the package.
  • zirconium cyclosilicate means a component containing at least zirconium cyclosilicic acid and one or more cations, and may be a solvate such as a hydrate, for example.
  • the cation include cations of Group 1 elements such as potassium ion, sodium ion, rubidium ion and cesium ion; cations of Group 2 elements such as calcium ion and magnesium ion; hydrogen ion and the like.
  • One type or two or more types can be selected.
  • a cation selected from the group consisting of sodium ions and hydrogen ions is preferable from the viewpoint of reducing microbial contamination.
  • zirconium cyclosilicate at least one selected from the group consisting of sodium zirconium cyclosilicate and its solvent is preferable from the viewpoint of reducing microbial contamination, and sodium zirconium cyclosilicate hydrate (Japanese General Name). (JAN).
  • the US generic name (USAN) is Sodium zirconium cyclosilicate), which is particularly preferable.
  • Zirconium cyclosilicate is a component that is sparingly soluble in water, and its properties are not particularly limited, and examples thereof include powder.
  • the particle size of the zirconium cyclosilicate is not particularly limited, but from the viewpoint of improving the suspension property (dispersion stability) in the water-containing composition and imparting an antiseptic effect over the entire water-containing composition, 1 to 1 to 200 ⁇ m is preferable, 3 to 150 ⁇ m is more preferable, 5 to 100 ⁇ m is further preferable, and 10 to 50 ⁇ m is particularly preferable.
  • the particle size means a median diameter, and can be measured by, for example, a particle size distribution measuring device (specifically, for example, a particle size distribution measuring device LS 13 320 (Beckman Coulter)).
  • Zirconium cyclosilicate is a known compound and may be produced by a known method, or a commercially available product may be used. Examples of commercially available products include sodium zirconium cyclosilicate hydrate (trade name: LOKELMA (registered trademark) (AstraZeneca)).
  • the content of zirconium cyclosilicate is not particularly limited, but from the viewpoint of reducing microbial contamination, it is preferably 1% by mass or more, more preferably 2% by mass or more, still more preferably 3 with respect to the total mass of the hydrous composition. It is preferably 65% by mass or less, particularly preferably 4% by mass or more, and more preferably 65% by mass or less, more preferably 60% by mass or less, still more preferably, with respect to the total mass of the hydrous composition from the viewpoint of ingestion feeling and the like.
  • 1 to 60% by mass is preferable, 2 to 50% by mass is more preferable, 3 to 40% by mass is further preferable, and 4 to 35% by mass is particularly preferable with respect to the total mass of the water-containing composition. ..
  • the mass ratio of (A) water to (B) zirconium cyclosilicate in the hydrous composition [(A) / (B)] is preferably 0.01 or more from the viewpoint of reducing microbial contamination. More preferably 0.1 or more, still more preferably 0.3 or more, still more preferably 0.5 or more, still more preferably 0.7 or more, still more preferably 1 or more, still more preferably 1.5 or more, particularly preferably 2 From the viewpoint of the feeling of administration and the like, it is preferably 50 or less, more preferably 45 or less, still more preferably 30 or less, still more preferably 25 or less, still more preferably 20 or less, still more preferably 10 or less, still more preferable.
  • 0.1 or more and 45 or less are preferable, 0.5 or more and 30 or less are more preferable, 1 or more and 25 or less are further preferable, 1.5 or more and 20 or less are further preferable, and 2 or more and 10 or less are particularly preferable. preferable.
  • the term "hydrous composition” means a composition containing at least water.
  • the "moisture-containing composition containing a package” means a composition comprising the water-containing composition and the package, and the water-containing composition is contained in the package, and is preferably a pharmaceutical preparation.
  • the properties of the water-containing composition are not particularly limited, and examples thereof include a liquid (suspension, etc.) and a semi-solid (gel (jelly), ointment, etc.).
  • a viscous liquid or semi-solid state is preferable from the viewpoint of improving the suspension property (dispersion stability) in the water-containing composition and imparting an antiseptic effect over the entire water-containing composition. ..
  • a water-containing composition having a shear viscosity of 1 Pa ⁇ s or more (more preferably 3 to 50 Pa ⁇ s, particularly preferably 5 to 20 Pa ⁇ s) when measured at 25 ° C. with a conical flat plate type rotational viscometer.
  • a semi-solid water-containing composition is preferable.
  • the conical flat plate type rotational viscometer include a modular rheometer MCR301 (Anton Pearl Co., Ltd.).
  • Examples of the water in the water-containing composition include purified water, water for injection, sterilized purified water, and the like.
  • the water content is not particularly limited, but from the viewpoint of reducing microbial contamination, it is preferably 10% by mass or more, more preferably 25% by mass or more, still more preferably 40% by mass, based on the total mass of the water-containing composition.
  • the above is more preferably 55% by mass or more, further preferably 60% by mass or more, particularly preferably 70% by mass or more, and preferably 99% by mass or less, more preferably 95% by mass, based on the total mass of the hydrous composition. It is mass% or less, more preferably 90% by mass or less, further preferably 85% by mass or less, and particularly preferably 80% by mass or less.
  • 60 to 95% by mass is more preferable, and 70 to 90% by mass is particularly preferable, based on the total mass of the water-containing composition.
  • the pH value of the hydrous composition when measured at 25 ° C. is not particularly limited and is usually 2 to 13, but from the viewpoint of reducing microbial contamination, it is preferably 2.5 to 12, more preferably 3 to 11. Particularly preferably, it is 3 to 10.
  • the hydrous composition may contain one or more active ingredients of pharmaceuticals other than zirconium cyclosilicate.
  • active ingredients of pharmaceuticals include calcium polystyrene sulfonate, sodium polystyrene sulfonate, and the like.
  • the hydrous composition can be in various dosage forms according to a known method described in, for example, the 17th revised Japanese Pharmacopoeia General Regulations for Formulation.
  • the dosage form is not particularly limited, but the dosage form described in the 17th revised Japanese Pharmacopoeia can be mentioned, and specifically, an oral solution, an elixir, a suspension, an emulsion, a limonade, a syrup, and an oral jelly.
  • Orally administered preparations examples thereof include oral liquid preparations, oral semi-solid preparations and the like that are applied to the oral cavity.
  • the dosage form of the water-containing composition is selected from suspension agents and oral jelly agents from the viewpoint of improving the suspension property (dispersion stability) in the water-containing composition and imparting an antiseptic effect over the entire water-containing composition.
  • the dosage form is preferable.
  • the water-containing composition may contain one or more general-purpose pharmaceutical additives in the fields of pharmaceuticals, foods, etc., depending on the dosage form and the like.
  • pharmaceutical additives include suspending agents, polymer gel bases, pH regulators, sweeteners, flavors, preservatives and the like.
  • at least one selected from a suspending agent and a polymer gel base from the viewpoint of improving the suspendability (dispersion stability) in the hydrous composition and imparting an antiseptic effect over the entire hydrous composition. It is preferable to include the above-mentioned pharmaceutical additives in the hydrous composition.
  • the water-containing composition one containing no acetic acid is preferable.
  • suspending agent examples include cellulose derivatives such as carmellose sodium, hydroxypropylmethylcellulose (hypromerose), hydroxypropylcellulose, methylcellulose, and croscarmellose sodium; gum arabic, sodium alginate, pregelatinized starch, curdlan, carrageenan, and the like.
  • Natural polymers such as canten, xanthan gum, guar gum, glucomannan, psyllium seed gum, gellan gum, tamarind seed gum, tara gum, starch, locust bean gum, pectin, etc. may be mentioned, and these may be used alone or in combination of two or more.
  • the polymer gel base examples include pectin, carrageenan, sodium polyacrylate, canten, gelatin and the like, and these can be used alone or in combination of two or more.
  • Examples of the pH adjuster include ascorbic acid, magnesium L-aspartate, benzoic acid, sodium benzoate, sodium chloride, dilute hydrochloric acid, calcium citrate, citrate hydrate, sodium citrate hydrate, and dihydrogen citrate.
  • Sodium, disodium citrate, calcium gluconate hydrate, tartrate acid, sodium tartrate, sorbic acid, sodium hydrogen carbonate, lactic acid, calcium lactate hydrate, anhydrous citrate, anhydrous sodium citrate, anhydrous sodium monohydrogen phosphate examples thereof include malic acid, calcium hydrogen phosphate hydrate, sodium hydrogen phosphate hydrate, calcium dihydrogen phosphate hydrate, sodium dihydrogen phosphate, etc., which are used alone or in combination of two or more. can.
  • sweeteners include aspartame, liquid sugar, fructose, fructose-glucose liquid sugar, reduced maltose water candy, acesulfam potassium, high glucose water candy, saccharin, saccharin sodium hydrate, sucralose, purified sucrose, purified honey, sorbitol, and sorbitol.
  • Liquids, simple syrups, sucrose, honey, powdered reduced maltose water candy, martitol, martitol liquid, water candy sugar, isomalt, lactose hydrate, mannitol, etc. may be mentioned, and these may be used alone or in combination of two or more. Can be used.
  • Flavors include, for example, orange flavor, kiwi fruit flavor, grapefruit flavor, strawberry flavor, cherry flavor, fruit flavor, muscat flavor, raspberry flavor, apple flavor, lemon flavor, caramel flavor, green tea flavor, cocoa flavor, coffee flavor, Sugar flavor, honey flavor, vanilla flavor, peppermint flavor, bellmot flavor, mint flavor, maple flavor, yogurt flavor and the like can be mentioned, and these can be used alone or in combination of two or more.
  • preservatives include sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, methyl paraoxybenzoate, butyl paraoxybenzoate, propyl paraoxybenzoate, benzalconium chloride, benzododecinium bromide and the like. These can be used alone or in combination of two or more.
  • the packaged water-containing composition of the present invention is obtained by incorporating zirconium cyclosilicate into the packaged water-containing composition as a result of hindering the invasion of microorganisms from the outside by containing the water-containing composition in the package. Combined with the antiseptic effect, microbial contamination of the hydrous composition can be reduced.
  • the shape, material (material), and the like of the "packaging body” are not particularly limited as long as they can accommodate the water-containing composition, and may be appropriately selected depending on the dosage form and the like.
  • the package refers to a package that is used in a transported or stored state, and is a concept excluding a reactor.
  • the package should be a "sealed container" defined in the 17th revised Japanese Pharmacy Regulations (preventing solid foreign matter from entering during normal handling, transportation or storage, and preventing loss of the contents of the drug.
  • a "sealed container” (a container that does not allow gas to enter under normal handling, transportation, or storage) is preferable, and the above-mentioned “airtight container” or “sealed container” is preferable from the viewpoint of further preventing the invasion of microorganisms from the outside.
  • the form of the package is not particularly limited, and may be appropriately selected depending on the dosage form, application, etc. of the water-containing composition.
  • the packaging may be a standard container or an irregular container (flexible packaging container), and specific examples thereof include bottle packaging (bottle packaging), SP (Strip Package) packaging, pillow packaging, stick packaging, and tube packaging.
  • the material (material) of the package is not particularly limited, and the material used for packaging the water-containing composition can be appropriately used in the fields of pharmaceuticals, foods and the like.
  • Examples of the material of the bottle body used for bottle packaging include glass, plastic (polyester, polyethylene (low density (LDPE), high density (HDPE), etc.), polypropylene, polystyrene, polycarbonate, etc.), metal (aluminum, etc.), and the like. Can be mentioned.
  • Examples of the material of the stopper and the lid include plastic (polyester, polyethylene, polypropylene, polystyrene, polycarbonate, etc.), metal (aluminum, etc.) and the like.
  • Examples of packaging materials used for SP packaging, pillow packaging, stick packaging, tube packaging, etc. include biaxially stretched polypropylene (OPP), biaxially stretched polyester (PET), glucose-modified PET (PET-G), and two.
  • a multi-layer structure may be formed by appropriately combining two or more of these.
  • a multilayer structure include a laminated structure of PVC and PVCC (PVC / PVCC; hereinafter, abbreviated in the same manner), PVC / PVDC / PE / PVC, PVC / PVCC / PE / PVDC / PVC, and the like.
  • PVC / PVCC laminated structure of PVC and PVCC
  • Examples of the method for forming such a multilayer structure include known laminating methods such as extrusion laminating, dry laminating, co-extruded laminating, thermal laminating, wet laminating, non-solvent laminating, and heat laminating.
  • the "moisture-containing composition containing a package" itself is placed in distribution and transported or stored.
  • zirconium cyclosilicate to the water-containing composition to impart an antiseptic effect, and by housing the water-containing composition in a package to reduce the invasion of microorganisms from the outside, microbial contamination can be prevented for a long period of time. Since it can be reduced, it can be stably placed in distribution for a long period of time as it is.
  • the packaged hydrous composition of the present invention contains zirconium cyclosilicate which is useful for the treatment of hyperkalemia, and is used as a pharmaceutical product having hyperkalemia as an indication, for example. be able to.
  • the packaged water-containing composition of the present invention is an instruction sheet (a Noh book or an instruction explanation document) for use as a pharmaceutical, and specifically, for example, explanatory matters concerning usage / dose, efficacy / effect, and the like. Etc.) may be included.
  • the instruction sheet may be displayed on the surface of the package itself, or may be displayed on a separate paper or the like separate from the package and combined with the water-containing composition containing the package (for example).
  • the state in which the water-containing composition containing the package and the paper on which the instruction sheet is written are stored in the same container, etc.), and further, after further containing the water-containing composition containing the package in the container, the said It may be displayed on the surface of the container.
  • the packaged water-containing composition of the present invention can be produced, for example, by a known method described in the 17th revised Japanese Pharmacopoeia.
  • the hydrous composition is a suspending agent
  • water and, if necessary, a suspending agent or other additives are added to the zirconium cyclosilicate, and a homomixer, a homogenizer, a colloid mill, or the like is used.
  • a homomixer, a homogenizer, a colloid mill, or the like is used. It can be produced by suspending it by an appropriate method, homogenizing the whole, and then packaging it in a stick or the like.
  • the hydrous composition is an oral jelly agent
  • water, a polymer gel base and other additives are added to the zirconium cyclosilicate and mixed, and a standard container (for example, a portion cup or the like) is mixed. ), Then gelled and molded into a certain shape.
  • the packaged hydrous composition of the present invention contains a zirconium cyclosilicate useful for the treatment of hyperkalemia. Therefore, zirconium cyclosilicate can be used as an active ingredient and can be used as a drug having hyperkalemia as an indication.
  • a hydrous composition having an amount such that the dose of zirconium cyclosilicate is about 10 g per dose is administered to an adult three times a day for several days (for example). After the administration (for 2 to 3 days), the hydrous composition in an amount such that the dose of zirconium cyclosilicate is 5 g per dose may be orally administered once a day.
  • the dose may be appropriately increased or decreased depending on the serum potassium level and the patient's condition, but the maximum dose is preferably up to an amount such that the dose of zirconium cyclosilicate is 15 g per day.
  • the serum potassium level before dialysis after the maximum dialysis interval and the condition of the patient may be appropriately increased or decreased, but the maximum dose is an amount at which the dose of zirconium cyclosilicate is 15 g once a day. It is preferable to use up to.
  • the packaged water-containing composition of the present invention has reduced microbial contamination of the water-containing composition and has good storage stability.
  • the microorganisms are roughly classified into bacteria and fungi.
  • the bacterium include Gram-positive bacteria such as Staphylococcus aureus; and Gram-negative bacteria such as Pseudomonas aeruginosa and Escherichia coli.
  • the fungus include Candida albicans and the like. Among these, the effect of reducing fungal contamination is particularly excellent.
  • a method for imparting an antiseptic effect to a hydrous composition which comprises step A of incorporating zirconium cyclosilicate into the hydrous composition and step B of accommodating the hydrous composition in a package.
  • the step B may be performed after the step A or the step A may be performed after the step B.
  • the antiseptic effect is determined to be effective if the antiseptic power to be evaluated is superior to that in the case where zirconium cyclosilicate is not blended, and the degree of the effect is determined. Does not matter.
  • the zirconium cyclosilicate is preferably one or more selected from the group consisting of sodium zirconium cyclosilicate and a solvate thereof, and more preferably sodium zirconium cyclosilicate hydrate.
  • the content of the zirconium cyclosilicate is preferably 1% by mass or more, more preferably 2% by mass or more, still more preferably 3% by mass or more, particularly preferably 3% by mass or more, based on the total mass of the hydrous composition.
  • [1-5] The description according to any one of [1-1] to [1-4], wherein the package is preferably a closed container, an airtight container or a sealed container, and more preferably an airtight container or a sealed container.
  • [1-6] The packaging according to any one of [1-1] to [1-5], wherein the dosage form of the water-containing composition is preferably a dosage form selected from a suspension agent and an oral jelly agent. Hydrous composition.
  • [1-7] The water-containing composition containing a package according to any one of [1-1] to [1-6], which is a pharmaceutical preparation.
  • [1-8] The packaged water-containing composition according to any one of [1-1] to [1-7], which is a drug having hyperkalemia as an indication.
  • [1-9] The water-containing composition in a package according to any one of [1-1] to [1-8], which comprises an instruction sheet for use as a medicine.
  • a method for imparting an antiseptic effect to a hydrous composition which comprises a step A of incorporating zirconium cyclosilicate into the hydrous composition and a step B of accommodating the hydrous composition in a package.
  • the zirconium cyclosilicate is preferably one or more selected from the group consisting of sodium zirconium cyclosilicate and a solvate thereof, and more preferably sodium zirconium cyclosilicate hydrate. , [2-1].
  • the content of the zirconium cyclosilicate is preferably 1% by mass or more, more preferably 2% by mass or more, still more preferably 3% by mass or more, particularly preferably 3% by mass or more, based on the total mass of the hydrous composition. Is 4% by mass or more, and is preferably 65% by mass or less, more preferably 60% by mass or less, still more preferably 55% by mass or less, still more preferably 50% by mass or less, and further, based on the total mass of the hydrous composition. [2-1] or [2-2], wherein the content is preferably 45% by mass or less, more preferably 40% by mass or less, further preferably 37% by mass or less, and particularly preferably 35% by mass or less. Method.
  • Aureus NBRC 13276 strain was inoculated on soybean casein digest canten medium (manufactured by Nissui Pharmaceutical Co., Ltd.) and cultured at 30 to 35 ° C. for 18 to 24 hours. After culturing, the cells were suspended in physiological saline and diluted with physiological saline to a concentration of 100 to 10000 CFU / mL to obtain a test bacterial solution.
  • a sample sample was prepared by mixing 5 mL of the sample suspension and 0.05 mL of the test bacterial solution (a mixture of 5 mL of sterilized purified water and 0.05 mL of the test bacterial solution was used as a control sample).
  • the obtained sample sample and control sample were each housed in a 14 mL volume polystyrene round tube and stored at 20 to 25 ° C. for 1 hour under light-shielded conditions.
  • the viable cell count immediately after sample preparation and after storage for 1 hour was measured by the canten plate pour method as follows. That is, 1 mL of each sample immediately after preparation and after storage for 1 hour is dispensed into a Petri dish, mixed with a soybean casein digest canten medium that has been preheated at about 45 ° C., and at 30 to 35 ° C. Incubated for 3 days. After culturing, the number of colonies formed was counted. The same culture was performed twice, and the average value of the number of colonies measured from two Petri dishes was defined as the "viable cell count".
  • the survival rate (%) after storage for 1 hour was calculated by the following formula.
  • Candida albicans NBRC 1594 strain was inoculated on Sabouraud-dextrose canten medium (manufactured by Nissui Pharmaceutical Co., Ltd.) and cultured at 20 to 25 ° C. for 44 to 52 hours. After culturing, the cells were suspended in physiological saline and diluted with physiological saline to a concentration of 100 to 10000 CFU / mL to obtain a test bacterial solution. Using the obtained test bacterial solution, the same operation as the above-mentioned test for Staphylococcus aureus was performed (however, in the canten plate pour method, Sabouraud glucose canten medium was used instead of soybean casein digest canten medium. , The culture conditions were 20 to 25 ° C. for 3 days), and the survival rate (%) was calculated in the same manner. The results are shown in Table 1.
  • a hydrous composition (oral jelly agent) containing the components and amounts shown in Table 2 is prepared by a conventional method.
  • the prepared water-containing composition is contained in a polypropylene portion cup container (heat seal is a polyethylene-laminated aluminum foil film) in an amount of 100 g per container, and is contained in the packaging of Production Examples 1 to 9.
  • a water-containing composition can be produced.
  • a water-containing composition (suspension agent) containing the components and amounts shown in Table 3 is prepared by a conventional method.
  • the prepared water-containing composition is contained in a stick packaging container made of aluminum foil subjected to polyethylene laminating processing in an amount of 100 mL per package, and the water-containing composition containing the package of Production Examples 10 to 18 can be produced.
  • a water-containing composition in a package in which microbial contamination is reduced, and it can be used, for example, in the pharmaceutical industry.

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Abstract

L'invention concerne un nouveau moyen de réduction de la contamination microbienne d'une composition aqueuse.　L'invention concerne spécifiquement une composition aqueuse conditionnée obtenue au moyen d'une composition aqueuse qui contient un cyclosilicate de zirconium dans un conditionnement.
PCT/JP2021/011593 2020-03-31 2021-03-22 Composition aqueuse conditionnée Ceased WO2021200313A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PH1/2022/552555A PH12022552555A1 (en) 2020-03-31 2021-03-22 Packaged aqueous composition
JP2022511945A JP7772690B2 (ja) 2020-03-31 2021-03-22 包装体入り含水組成物
KR1020227032223A KR20220161296A (ko) 2020-03-31 2021-03-22 포장체에 들어가는 함수 조성물
CN202180021436.7A CN115279413A (zh) 2020-03-31 2021-03-22 装在包装体中的含水组合物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JPPCT/JP2020/014743 2020-03-31
PCT/JP2020/014743 WO2021199239A1 (fr) 2020-03-31 2020-03-31 Composition aqueuse conditionnée

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