WO2016117528A1 - Chlorure de sodium emballé et procédé de stockage pour chlorure de sodium - Google Patents

Chlorure de sodium emballé et procédé de stockage pour chlorure de sodium Download PDF

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Publication number
WO2016117528A1
WO2016117528A1 PCT/JP2016/051364 JP2016051364W WO2016117528A1 WO 2016117528 A1 WO2016117528 A1 WO 2016117528A1 JP 2016051364 W JP2016051364 W JP 2016051364W WO 2016117528 A1 WO2016117528 A1 WO 2016117528A1
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Prior art keywords
sodium chloride
container
moisture
less
proof
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PCT/JP2016/051364
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English (en)
Japanese (ja)
Inventor
秀幸 青山
高橋　修治
由泰 板東
敏之 青木
利広 亀和
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富田製薬株式会社
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Publication of WO2016117528A1 publication Critical patent/WO2016117528A1/fr

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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
    • A61K9/08—Solutions
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/18—Layered products comprising a layer of synthetic resin characterised by the use of special additives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants

Definitions

  • Patent Document 1 since the dry air must be pulverized, filled and sealed while strictly controlling the dry air to be about 0.5 g per kilogram, the production cost of sodium chloride is increased, and the sodium chloride is slightly reduced. Since the pulverization process is essential, the production process tends to be complicated. Further, even when salt with a water content of 0.1% is cooled in a low humidity atmosphere of about 1 to 2 g in 1 kg of dry air as described in Patent Document 1, the salt is substantially dried with dry air. Unless done, solidification cannot be prevented. In addition, Patent Document 1 does not clarify the relationship between the amount of water retained by sodium chloride after drying, the humidity in the package during storage, and the solidification of sodium chloride. Is disclosed that it does not solidify if it is pulverized and filled in as dry a state as possible.
  • Patent Document 2 discloses a method for suppressing solidification during storage by providing a heating means for stored sodium chloride.
  • moisture absorption of salt particles is caused by dew condensation when the temperature of the salt drops below the dew point temperature of the outside air and deliquescence when the salt particles are placed under conditions where the relative humidity exceeds 75%.
  • the purpose is to suppress the phenomenon, and it has been found that the two moisture absorption phenomena can be prevented by increasing the temperature of sodium chloride.
  • the method of Patent Document 2 does not strictly control the amount of water held by sodium chloride, and the amount of solidification is substantially suppressed to some extent. Further, the relationship between the humidity in the package that is also affected by the moisture contained in sodium chloride and the solidification of sodium chloride has not been clarified.
  • Patent Document 3 discloses that solidification can be suppressed by absorbing moisture in salt using dry kraft paper.
  • the method of Patent Document 3 there is a cost for drying the kraft paper bag, and it is necessary to directly fill the kraft paper with salt, so there is no problem for food use, but it is not preferable for pharmaceutical use.
  • bags made of hygroscopic materials such as kraft paper, like silica gel, may be released in reverse to moisture adsorption depending on the temperature and humidity of the storage environment, so sodium chloride is re-solidified due to environmental changes.
  • Patent Document 4 a method of adding water-soluble cellulose esters
  • Patent Document 5 a method of adding disodium hydrogen phosphate or magnesium carbonate
  • Patent Document 6 A method of adding 5 to 500 ppm of sodium alginate
  • the method of blending these additives cannot be applied in the pharmaceutical field where high-purity sodium chloride is required, and has a drawback that the field of application of sodium chloride is limited.
  • sodium chloride for pharmaceutical use has high purity and is easy to solidify.
  • sodium chloride as a pharmaceutical raw material that does not solidify for a long period of time without mixing of additives and the like. If possible, formulation operations such as weighing, blending, and mixing can be facilitated.
  • sodium chloride may be used as a simple preparation, and the sodium chloride single preparation is dissolved in a dialysis facility or the like that prepares the dialysis agent, and is solidified. If the above occurs, the dissolution operation becomes complicated and difficult to handle, and it becomes a defective product as a pharmaceutical preparation. Therefore, the development of sodium chloride that does not solidify even after long-term storage is strongly demanded in pharmaceutical applications including powder dialysis agents. At the same time, in the above-mentioned applications, the addition of a dispersant or an antioxidant that contaminates the contents does not simply prevent the solidification of sodium chloride. Is required to maintain.
  • an object of the present invention is to provide sodium chloride storage technology that can suppress solidification of sodium chloride and is excellent in property stability even if stored for a long period of time without blending additives.
  • the present inventor conducted intensive studies to solve the above-mentioned problems.
  • the purity of sodium chloride was set to 99.5% by weight or more, the average particle diameter was set to 150 ⁇ m or more, and the sodium chloride was subjected to moisture permeability of 3 g / m.
  • the present invention has been completed by further studies based on such knowledge.
  • this invention provides the preservation
  • Item 1 Sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more is contained in a moisture-proof container having a moisture permeability of less than 3 g / m 2 ⁇ 24 h, and the relative humidity in the moisture-proof container is 55% or less.
  • Sodium chloride in a container which is maintained and free from solidification of sodium chloride.
  • Item 2. Item 2. The sodium chloride in a container according to Item 1, wherein the sodium chloride is not in direct contact with the hygroscopic material contained in the moisture-proof container.
  • Item 3. Item 3.
  • Item 4. Item 4. The sodium chloride in a container according to any one of Items 1 to 3, wherein the average particle size of the sodium chloride is 150 to 700 ⁇ m.
  • Item 5. The sodium chloride in a container according to any one of Items 1 to 4, wherein 0.1 kg to 1 t of sodium chloride is contained in a moisture-proof container.
  • Item 6. Item 6. The sodium chloride in a container according to any one of Items 1 to 5, wherein the water content of the sodium chloride is 0.002% by weight or less.
  • Item 7. Item 7.
  • Item 8. The sodium chloride in a container according to any one of Items 1 to 7, wherein the moisture-proof container is a polyolefin moisture-proof container having a moisture-absorbing layer made of polyolefin containing a hygroscopic inorganic material.
  • Item 10. Item 10.
  • the polyolefin moisture-proof container is formed of a laminate in which a resin layer having no additive is laminated on both surfaces of a moisture-absorbing layer made of polyolefin kneaded with a hygroscopic inorganic material.
  • Sodium chloride in a container Item 11.
  • Item 11. The sodium chloride in a container according to Item 10, wherein the laminate is a film or a sheet.
  • Item 14. The sodium chloride in a container according to any one of Items 1 to 13, wherein 0.1 to 50 kg of sodium chloride is contained in the container.
  • Item 15. Item 15. The sodium chloride in a container according to any one of Items 1 to 14, which is used as a raw material for a powder dialysis agent. Item 16.
  • Item 20. The method for preserving sodium chloride according to any one of Items 16 to 19, wherein 0.1 kg to 1 t of sodium chloride is contained in a container.
  • Item 21. The method for preserving sodium chloride according to any one of Items 16 to 20, wherein the product temperature during filling and storage is maintained at 4 ° C. or higher and 50 ° C. or lower.
  • the polyolefin moisture-proof container is formed of a laminate in which a resin layer having no additive is laminated on both surfaces of a moisture-absorbing layer made of polyolefin kneaded with a hygroscopic inorganic material. How to store sodium chloride.
  • Item 27. Item 27. The method for preserving sodium chloride according to Item 26, wherein the laminate is in the form of a film or a sheet.
  • Item 28. The method for preserving sodium chloride according to any one of Items 24 to 27, wherein the hygroscopic layer is substantially free of additives other than the hygroscopic material.
  • Item 30. The method for preserving sodium chloride in a container according to any one of Items 16 to 29, wherein 0.1 to 50 kg of sodium chloride is contained in a moisture-proof container.
  • Item 31. The method for storing sodium chloride according to any one of Items 16 to 30, which is a method for storing sodium chloride used as a raw material for a powder dialysis agent.
  • sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more is accommodated in a moisture-proof container having a moisture permeability of less than 3 g / m 2 ⁇ 24 h, and the relative humidity in the moisture-proof container is 55%.
  • the property stability of high-purity sodium chloride can be increased, and solidification of sodium chloride can be prevented even after long-term storage.
  • “property stability” means a property of maintaining a state in which sodium chloride is not solidified, and that sodium chloride is not solidified even when stored for a long period of time.
  • the sodium chloride does not directly contact the additive and the hygroscopic material (desiccant, dry material) contained as a constituent material of the moisture-proof container, and the property stability of high-purity sodium chloride is improved.
  • Sodium chloride utilizing the present invention is a simple preparation (single component preparation consisting of sodium chloride) used as a pharmaceutical raw material for which high-purity sodium chloride is required, especially for powder dialysis. Can be suitably used.
  • Test Example 1 sodium chloride is accommodated in an additive-free polyethylene inner bag, the exterior is accommodated in an aluminum foil laminated bag, and the relative humidity in the moisture-proof container is measured over time. is there.
  • sodium chloride is stored in a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material is kneaded, and the exterior is stored in an aluminum foil laminated bag.
  • the relative humidity in the moisture-proof container is set as follows. It is a figure which shows the result measured with time.
  • Test Example 2 sodium chloride is accommodated in an additive-free polyethylene inner bag, the exterior is accommodated in an aluminum foil laminate bag, and the relative humidity in the moisture-proof container is measured over time. is there.
  • Test Example 2 sodium chloride is contained in a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material is kneaded, and the exterior is contained in an aluminum foil laminated bag.
  • the relative humidity in the moisture-proof container is determined as follows. It is a figure which shows the result measured with time.
  • sodium chloride is accommodated in an additive-free polyethylene inner bag, the exterior is accommodated in an aluminum foil laminate bag, and the relative humidity in the moisture-proof container is measured over time. is there.
  • sodium chloride is contained in a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material is kneaded, and the exterior is contained in an aluminum foil laminated bag.
  • the relative humidity in the moisture-proof container is set as follows. It is a figure which shows the result measured with time.
  • Test Example 4 sodium chloride was accommodated in an additive-free polyethylene inner bag, the exterior was accommodated in a flexible container bag, and the relative humidity and temperature in this non-moisture-proof container were measured over time.
  • FIG. 4 sodium chloride was housed in a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material was kneaded, and the exterior was housed in a flexible container bag.
  • the relative humidity and temperature in this moisture-proof container It is a figure which shows the result of having measured this over time.
  • Test Example 5 sodium chloride is contained in an additive-free polyethylene inner bag or a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material is kneaded, and the exterior is accommodated in an aluminum foil laminated bag. It is a figure which shows the result of having measured the relative humidity in this moisture-proof container with time.
  • Test Example 6 sodium chloride was accommodated in an additive-free polyethylene inner bag or a moisture-proof polyethylene inner bag in which a hygroscopic inorganic material was kneaded, and the exterior was accommodated in an aluminum foil laminated bag. It is a figure which shows the result of having measured the relative humidity in a moisture-proof container with time.
  • the sodium chloride in a container of the present invention is a sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more contained in a moisture-proof container having a moisture permeability of less than 3 g / m 2 ⁇ 24 h.
  • the relative humidity in the moisture-proof container is maintained at 55% or less, and there is no solidification of sodium chloride.
  • the sodium chloride contained in the container of the present invention will be described in detail.
  • the sodium chloride used in the present invention has a purity of 99.5% by weight or more and an average particle size of 150 ⁇ m or more. In this way, high-purity sodium chloride with a predetermined average particle diameter is adopted and stored in a moisture-proof container with a moisture permeability of less than 3 g / m 2 ⁇ 24 h, and the relative humidity is maintained at 55% or less. It is possible to suppress the solidification of sodium chloride.
  • the purity of sodium chloride is the ratio of sodium chloride contained in solid sodium chloride, and is the ratio of sodium chloride to the sum of sodium chloride and components other than sodium chloride (inorganic, organic, etc.). is there.
  • the purity of sodium chloride is not particularly limited as long as it is 99.5% by weight or more, but from the viewpoint of using sodium chloride mainly for pharmaceutical applications, it is preferably 99.8% by weight. As mentioned above, More preferably, 99.9 weight% or more is mentioned.
  • the sodium chloride used in the present invention is not particularly limited as long as the average particle diameter is 150 ⁇ m or more, and examples thereof include about 150 ⁇ m to 2000 ⁇ m.
  • the average particle diameter of sodium chloride is preferably more than 150 ⁇ m, more preferably 160 ⁇ m or more, still more preferably 200 to 700 ⁇ m, and most preferably 200 to 500 ⁇ m from the viewpoint of further improving the solidification preventing effect of sodium chloride.
  • the average particle diameter of sodium chloride refers to a value determined by an automatic dry sonic sieving measuring instrument.
  • the sodium chloride satisfies the above purity and the average particle diameter, and within a range in which the relative humidity in the container to be stored is maintained at 55% or less.
  • it is usually 0.002% by weight or less, particularly preferably 0.001% by weight or less.
  • the water content of sodium chloride is measured as a loss on drying. According to the measurement conditions (1 g, 105 ° C., 2 hours) of the loss on drying of “sodium chloride” described in the 16th revision Japanese Pharmacopoeia. It is the value obtained according to this.
  • no solidification of sodium chloride means that the high hygroscopic ability of sodium chloride itself and its equilibrium humidity are maintained by adjusting the purity and average particle diameter of sodium chloride to the specific conditions described above. This can be achieved by utilizing the capacity and storing it in a moisture-proof container described later and maintaining the relative humidity at 55% or less. In order to reduce the relative humidity in the moisture-proof container to 55% or less, it can be achieved by a relatively simple means of adjusting the temperature and humidity atmosphere when filling sodium chloride that has been dried to a normal degree. As long as the moisture resistance of the container is maintained, the relative humidity in the container is maintained at 55% or less.
  • the relative humidity in a container can be maintained by the hygroscopic action of sodium chloride itself, and even if sodium chloride is not in direct contact with the hygroscopic material, an environment in which sodium chloride does not solidify is stably created.
  • the sodium chloride of the present invention can be prevented from solidifying by maintaining the relative humidity at 55% or less for a long period of time from sealing to opening.
  • a moisture-proof container having a moisture permeability of less than 3.0 g / m 2 ⁇ 24 h is used.
  • the moisture permeability of the moisture-proof container is preferably 0.5 g / m 2 ⁇ 24 h or less, more preferably 0.3 g / m 2 ⁇ 24 h or less, more preferably 0.3 g / m 2 ⁇ 24 h or less from the viewpoint of more effectively preventing the solidification of sodium chloride.
  • 0.1 g / m 2 ⁇ 24 h or less is used.
  • the moisture permeability is a value measured according to a method defined in JIS 0208-1976 “Moisture permeability test method for moisture-proof packaging material (cup method)”.
  • the water vapor trapping container include a resin container including a hygroscopic layer made of a resin containing a hygroscopic inorganic material.
  • the hygroscopic layer can be formed of, for example, a resin kneaded with a hygroscopic inorganic material.
  • resin used for formation of a moisture absorption layer For example, polyolefin, such as polyethylene and a polypropylene, is mentioned.
  • the resin used in the moisture absorption layer may be one kind alone, or a combination of two or more kinds.
  • the hygroscopic inorganic material used for forming the hygroscopic layer is not particularly limited, and examples thereof include magnesium sulfate anhydride and zeolite.
  • the hygroscopic inorganic material used in the hygroscopic layer may be one kind alone or a combination of two or more kinds.
  • the hygroscopic layer is preferably a polyolefin kneaded with a hygroscopic inorganic material, and more preferably a polyethylene kneaded with a hygroscopic inorganic material.
  • the hygroscopic layer is prepared by kneading a hygroscopic inorganic material into a heat-melted resin. Normally, when kneading the hygroscopic inorganic material into the resin, a dispersant or an antioxidant is added. The agent is being used. However, as described below, when a hygroscopic inorganic material is kneaded with a heat-melted resin, additives such as a dispersant and an antioxidant are essential. The hygroscopic layer contained has a problem of sodium chloride contamination due to bleedout of the additive.
  • the hygroscopic inorganic material cannot be uniformly dispersed in the resin, resulting in a decrease in moldability, film form, sheet form, etc.
  • additives such as dispersants and antioxidants
  • the hygroscopic inorganic material cannot be uniformly dispersed in the resin, resulting in a decrease in moldability, film form, sheet form, etc.
  • fish eyes and the like resulting from aggregated grains are generated as a typical example of poor dispersion, and the appearance of the molded body is impaired, and at the same time, the moisture absorption function itself is affected.
  • a hygroscopic inorganic material is kneaded into a thermoplastic resin with a twin-screw extruder without blending these additives, a lump called an eye attaches to the die and the continuity of strand molding is poor.
  • additives such as dispersants and antioxidants are likely to bleed out from the molded product and migrate (penetrate) into the sodium chloride content, discoloration on the appearance of sodium chloride, generation and dispersion of water insolubles. It has been a problem to cause contamination of chemicals and antioxidants. In particular, the problem due to the bleedout of such additives becomes more noticeable as the storage period becomes longer. Even a simple inorganic substance such as sodium chloride is contaminated by the additive when stored in a polyethylene film package to which additives such as a dispersant and an antioxidant are added.
  • the moisture-absorbing layer contained in the water vapor trapping container does not substantially contain additives such as dispersants, antioxidants, foaming agents, lubricants, and colorants (additives other than hygroscopic inorganic materials). It is desirable.
  • the moisture absorption layer which does not substantially contain an additive other than the hygroscopic inorganic material can prevent the additive from bleeding out.
  • substantially containing no additive other than the hygroscopic inorganic material means that the additive is not contained or the content is such that the original function of the additive cannot be exhibited.
  • the total content of additives other than the hygroscopic inorganic material is 0.04% by weight or less, preferably 0.01% by weight or less, more preferably 0% by weight. Means.
  • the moisture absorption layer substantially free of additives other than the hygroscopic inorganic material is a kneaded product of polyolefin and magnesium sulfate anhydride, and does not substantially contain additives other than magnesium sulfate anhydride, In addition, it can be molded using a polyolefin composition having a moisture content of 0.1% by weight or less (hereinafter sometimes referred to as “non-added polyolefin composition”). Details of the additive-free polyolefin composition will be described later.
  • the water vapor trapping container may be formed of the hygroscopic layer alone, but is preferably formed of a laminated body in which the hygroscopic layer and other layers are laminated.
  • the moisture absorbing layer is laminated with another resin layer in the water vapor trapping container. It is preferable that the container is disposed at a position other than the innermost surface of the container.
  • a moisture-proof resin container can be formed into a bag-like container, for example, when the laminate is molded into a film, and when the laminate is molded by blow molding It can be a bottle-shaped container.
  • the resin used in the resin layer is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene; polyesters such as polyethylene terephthalate; polyamides such as nylon.
  • polyolefin, particularly polyethylene is suitable as a resin used for the resin layer because it has heat sealability and can be easily sealed in addition to being easily molded.
  • the water vapor barrier container include glass containers; metal containers such as stainless steel and aluminum; and resin containers including a barrier layer having a water vapor barrier function.
  • the barrier layer is not particularly limited as long as it has a barrier function against water vapor, and examples thereof include metal foils such as aluminum foil; vapor deposition films such as aluminum oxide and silica.
  • the resin container including the barrier layer
  • examples include a container formed of a laminate in which resin layers are laminated.
  • the resin used in the resin layer is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene; polyesters such as polyethylene terephthalate; polyamides such as nylon.
  • the resin container including the barrier layer a resin layer is laminated on both surfaces of the barrier layer, and the resin layer on the surface located inside the container is made of polyolefin and located outside the container.
  • examples thereof include a container formed of a laminate in which the resin layer on the surface is made of polyester or polyamide.
  • a moisture-proof resin container can be formed into a bag-like container when the laminate is molded into a film, and is bottle-shaped when the laminate is molded by blow molding.
  • a resin container including such a barrier layer is provided with heat sealability by the resin layer disposed on the inside, water vapor barrier property by the barrier layer, strength and durability by the resin layer disposed on the outside, and sealed. Properties, water vapor barrier properties, strength, durability and the like can be provided in a well-balanced manner.
  • the moisture-proof container used in the present invention may be formed of a laminate in which the moisture absorption layer and the barrier layer are laminated.
  • a resin container including a moisture-absorbing layer made of a resin containing a hygroscopic inorganic material, and a barrier layer having a water vapor barrier function are preferable.
  • a resin container including a hygroscopic layer is more preferable.
  • the shape of the moisture-proof container used in the present invention may be any of a bag shape, a bottle shape, a container shape, and the like, and may be appropriately set according to the amount of sodium chloride to be filled.
  • two or more containers may be used in multiple layers.
  • a resin container including the moisture absorption layer may be used as the inner bag
  • a resin container including the barrier layer may be used as the outer bag.
  • the entire container to be used has a moistureproof property capable of maintaining the internal relative humidity at 55% or less when sealed, for example, two or more containers.
  • a combination of containers having moisture resistance may be used, or a combination of a container having moisture resistance and a container having no moisture resistance may be used.
  • the container as a whole may be a combination of two or more layers in which moisture resistance cannot be obtained alone, provided that the moisture permeability described above is provided.
  • a so-called flexible container bag when filling sodium chloride of about 150 kg to 1 t, a so-called flexible container bag can be used.
  • a film-like moisture-proof container preferably a film-like water vapor trapping container, may be used as the inner bag and / or the outer bag of the flexible container bag.
  • the additive-free polyolefin composition contains magnesium sulfate anhydride as a hygroscopic inorganic material.
  • the average particle diameter of magnesium sulfate anhydride is not particularly limited, but from the viewpoint of dispersibility with respect to polyolefin, it is preferably 1 to 30 ⁇ m, more preferably 1 to 20 ⁇ m, and particularly preferably 1 to 10 ⁇ m.
  • the average particle diameter of magnesium sulfate anhydride is a cumulative 50% diameter obtained from a weight cumulative particle size distribution measured by a laser diffraction / scattering particle diameter distribution measuring apparatus.
  • the moisture content of the magnesium sulfate anhydride itself kneaded as a raw material is preferably small, particularly 2 wt% or less, more preferably 1 wt% or less. It is preferable.
  • the magnesium sulfate anhydride kneaded as a raw material in the additive-free polyolefin composition is usually such that the magnesium sulfate crystals (7 hydrate) are dried and calcined, and then the above-mentioned average particle size is obtained using a pulverizer. It can be obtained by grinding. By calcination of magnesium sulfate crystals (7 hydrate) at 200 ° C.
  • a magnesium sulfate anhydride having a water content of about 1% by weight or less can usually be obtained.
  • the magnesium sulfate anhydride obtained after firing is easy to absorb moisture, it is desirable that the grinding after firing is performed in the presence of dry air having an absolute humidity of about 10 g / kg DA or less.
  • the content of magnesium sulfate anhydride may be appropriately set according to the use of the polyolefin composition, the moisture absorption characteristics to be provided, etc., for example, 5 to 60% by weight, preferably 20%. -50% by weight, more preferably 20-40% by weight.
  • the additive-free polyolefin composition is a kneaded product of polyolefin and magnesium sulfate anhydride, and is produced by kneading magnesium sulfate anhydride into molten polyolefin so as to satisfy the above-described moisture content.
  • polyolefin and magnesium sulfate anhydride each have moisture, and simply kneading polyolefin and magnesium sulfate anhydride cannot satisfy the moisture content described above, and the dispersibility of magnesium sulfate anhydride is low. Only a polyolefin composition having poor moldability can be obtained.
  • polyolefin and magnesium sulfate anhydride under reduced pressure conditions, it is possible to remove moisture during kneading and obtain an additive-free polyolefin composition that satisfies the moisture content described above.
  • Specific examples of the pressure atmosphere when kneading the polyolefin and magnesium sulfate anhydride include ⁇ 65 Kpa or less, preferably ⁇ 75 Kpa or less, and more preferably ⁇ 85 Kpa or less.
  • the container is filled with sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more, and the relative humidity in the container is kept from when the container is sealed until it is opened. Set to maintain below 55%.
  • maintaining the relative humidity in the container at 55% or less means that the relative humidity to which sodium chloride is exposed is 55% or less from the time the container containing sodium chloride is sealed until the container is opened at the time of use. Means holding.
  • sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more has a relative humidity of more than 55%, even if it is designed to remove the water in the container using any method.
  • the sodium chloride having a purity of 99.5% by weight or more and an average particle size of 150 ⁇ m or more is sealed from when sealed to the container until the container is opened at the time of use. It is necessary to maintain the relative humidity to which sodium chloride is exposed at 55% or less.
  • the relative humidity in the container containing sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more is maintained at 50% or less from the viewpoint of more effectively preventing the solidification of sodium chloride. It is preferable. Moreover, the lower limit value of the relative humidity in the container is not limited. By maintaining such a range of relative humidity, the present invention can utilize the moisture absorption characteristics of sodium chloride adjusted to the above-mentioned predetermined conditions, even in an extremely low humidity environment that requires equipment costs. Solidification can be prevented.
  • the purity is 99% in an atmosphere having a relative humidity of 55% or less, preferably 50% or less.
  • the container may be filled with sodium chloride having an average particle diameter of 150 ⁇ m or more by 5 wt% or more.
  • sodium chloride having a purity of 99.5% by weight or more and an average particle diameter of 150 ⁇ m or more is contained in a moisture-proof container having a moisture permeability of less than 3 g / m 2 ⁇ 24 h, and is moisture-proof.
  • the relative humidity in the conductive container is maintained at 55% or less.
  • Test example 1 (1) Preparation of sodium chloride Pharmaceutical sodium chloride (average particle size 316 ⁇ m) was transferred onto a vat, dried at 85 ° C. for 5 hours, dried at 130 ° C. for 10 hours, and then cooled to 85 ° C.
  • the sodium chloride contained in the container had a purity of 99.9% by weight and a water content of 0% by weight.
  • the sodium chloride whose moisture content is 0.001 weight%, 0.002 weight%, and 0.005 weight% it created by the method similar to the below-mentioned reference example 8 as a polyethylene bag used as an inner bag.
  • Moisture-proof polyethylene container (three-layer film) in which hygroscopic inorganic material is kneaded (layer structure: PE layer 20 ⁇ m / PE layer 60 ⁇ m containing hygroscopic inorganic material / PE layer 20 ⁇ m three-layer structure; moisture permeability
  • Two containers of about 2.5 g / m 2 ⁇ 24 h) and an additive-free polyethylene container (layer structure: polyethylene 1 layer 80 ⁇ m; moisture permeability of about 6 g / m 2 ⁇ 24 h) were used.
  • an additive-free polyethylene container containing no hygroscopic inorganic material (layer structure: polyethylene one layer 80 ⁇ m; moisture permeability about 20 g / m 2 ⁇ 24 h).
  • Table 1 shows the conditions employed in this test example (water content of sodium chloride and types of inner bags used).
  • sodium chloride in a container was prepared and stored in a refrigerator set at 4 ° C. for 24 days.
  • the relative humidity in the container was measured over time, the container was opened after storage, and the degree of solidification of sodium chloride was measured.
  • the degree of solidification of sodium chloride is such that the stored sodium chloride is placed on an 8 mm grid (mesh: wire diameter 2 mm), passed through the grid, and the weight of sodium chloride remaining on the grid is measured.
  • the weight of sodium chloride remaining on the lattice with respect to was calculated as the degree of solidification (%).
  • an aluminum foil laminated bag (outer bag) (layer structure: PET / Al / PE three-layer structure; moisture permeability of 0 g / m 2 ⁇ 24 h) prevents the solidification of sodium chloride.
  • an aluminum foil laminated bag (layer structure: PET / Al / PE three-layer structure; moisture permeability of 0 g / m 2 ⁇ 24 h) prevents the solidification of sodium chloride.
  • a moisture-proof polyethylene container in which a hygroscopic inorganic material has been kneaded, it is predicted that the hygroscopic inorganic material will function as a desiccant when an exterior formed of aluminum foil is used. Both 001% and 0.002% showed an effect of lowering the humidity.
  • Test example 2 (1) Preparation of Sodium Chloride Sodium chloride (purity 99.9% by weight, water content 0) contained in a container using sodium chloride for medical use (average particle size 316 ⁇ m) in the same manner as in Test Example 1 above. % By weight) was prepared.
  • Test example 3 (1) Preparation of Sodium Chloride Sodium chloride (purity 99.9% by weight, water content 0) contained in a container using sodium chloride for medical use (average particle size 316 ⁇ m) in the same manner as in Test Example 1 above. % By weight) was prepared.
  • Test example 4 1000 kg of medical sodium chloride (average particle size: 313 ⁇ m, purity 99.9% by weight, water content: 0.02% by weight) was prepared by a method similar to that of an additive-free polyethylene inner bag or Reference Example 8 described later.
  • Hygroscopic polyethylene container in which hygroscopic inorganic material is kneaded (layer structure: PE layer 20 ⁇ m / PE layer 60 ⁇ m containing hygroscopic inorganic material / PE layer 20 ⁇ m); 5 g / m 2 ⁇ 24 h) and sealed, put in a flexible container bag, and stored for one month in a warehouse where temperature control is not performed. During the storage period, the temperature and relative humidity in the inner bag were measured over time. Further, after one month of storage, sodium chloride was discharged from the bottom of the flexible container bag, and the presence or absence of solidification of sodium chloride was confirmed.
  • FIG. 7 and 8 show the results of measuring the temperature and relative humidity in the inner bag over time.
  • FIG. 7 shows the result when an additive-free polyethylene inner bag is used
  • FIG. 8 shows the result when a moisture-proof polyethylene inner bag into which a hygroscopic inorganic material is kneaded is used.
  • the temperature in the inner bag was about 45 ° C., but the temperature gradually decreased during the storage period and finally stabilized at about 30 ° C.
  • the relative humidity inside the container gradually increased due to the influence of the humidity of the external environment, and eventually moved around 70%.
  • the humidity effect from the external environment was prevented by the excellent moisture resistance, and the relative humidity was maintained at 55% or less.
  • Test Example 5 (1) Preparation of sodium chloride Sodium chloride contained in a container (purity 99.9 wt%, water content 0 under the same conditions as in Test Example 1 except that sodium chloride (average particle size 167 ⁇ m) was used. % By weight) was prepared.
  • FIG. 9 shows the results of measuring the relative humidity in the container over time
  • Table 8 shows the results of measuring the degree of solidification (%). From this result, it was confirmed that solidification of sodium chloride could be prevented when the relative humidity in the container was constantly maintained at 55% or less during the storage period (conditions 5-1 and 5-2).
  • the action of the moisture-proof polyethylene into which the hygroscopic inorganic material was kneaded was the same as in Test Example 2.
  • Test Example 6 (1) Preparation of sodium chloride Sodium chloride contained in a container (purity 99.9 wt%, moisture content 0 under the same conditions as in Test Example 1 except that sodium chloride (average particle size 27 ⁇ m) was used. % By weight) was prepared.
  • the sodium chloride moisture content and inner bag type are set to the conditions shown in Table 9, and the storage conditions are 25 ° C. (constant temperature and high humidity tank, relative humidity 60%). The test was conducted under the same conditions as in Test Example 1 except that the period was changed to days, and the relative humidity in the container and the solidification degree of sodium chloride after storage were measured over time.
  • FIG. 10 shows the results of measuring the relative humidity in the container over time
  • Table 10 shows the results of measuring the degree of solidification (%). Regardless of which container was used, solidification of sodium chloride occurred even though the relative humidity was maintained at 55% or less during the storage period. This is because the average particle size of the sodium chloride used was very fine at 27 ⁇ m, so the surface area and the contact area of sodium chloride were so large that it was easy to form a soft block-like lump, and it was difficult to pass through the 8 mm lattice in the solidification test. . Also, the presence or absence of hygroscopic inorganic materials was irrelevant.
  • Reference test example 1 1-1. Production of films containing hygroscopic layers Reference example 1
  • Each of the raw materials shown below is a twin-screw kneading extruder (resin temperature during kneading is 160 to 210 ° C., vent pressure is ⁇ 88 kPa, extrusion amount is 25 kg to 50 kg / h, and the raw material charging hopper is replaced with nitrogen)
  • the mixture was kneaded and extruded by Twin Screw Extruder PCM-45 (manufactured by Ikekai Iron Works Co., Ltd.) to obtain a polyolefin composition containing additives in the form of pellets.
  • the obtained additive-containing polyolefin composition was subjected to extrusion molding with a T-die film molding machine (PLABOR GT-25-A, manufactured by Plastic Engineering Laboratory Co., Ltd.), thereby forming a single layer having a thickness of 60 ⁇ m. A film was obtained.
  • Additive-free polyethylene (LDPE), the polyolefin composition prepared in Reference Example 1, and additive-free polyethylene (LDPE) are co-extruded in three layers using a three-layer three-layer inflation molding machine (manufactured by Sumitomo Heavy Industries Modern Co., Ltd.).
  • a resin layer inner layer having a thickness of 20 ⁇ m
  • a moisture absorption layer an intermediate layer having a thickness of 60 ⁇ m
  • Table 11 shows the obtained results. As shown in Table 11, both the single-layer film of Reference Example 1 and the three-layer film of Reference Example 2 have a filtration rate as slow as 3 minutes or more, and the coloration (color difference) of the filtration filter is remarkably recognized as 1 or more. It was. That is, from this result, it was confirmed that the additives (dispersant, antioxidant) contained in the film bleed out and mixed into the sodium chloride in the sachet, resulting in a decrease in quality.
  • Reference test example 2 A sachet (inner bag) made of an additive-free polyethylene film (thickness 80 ⁇ m) is covered with a sachet (outer bag) made of the three-layer film of Reference Example 2 (Package of Reference Structure 3) It was created. 500 g of Japanese Pharmacopoeia sodium chloride was put into the inner bag of the double structure package, and the inner bag was heat sealed. Next, the outer bag covering the inner bag was also heat sealed. The bleed out of the additive was evaluated under the same conditions as in Reference Test Example 1.
  • Table 12 shows the obtained results. From this result, even if an additive-free polyethylene film having a thickness of 80 ⁇ m is used as an inner bag, it cannot prevent the additive contained in the outer bag from being mixed into sodium chloride due to bleed-out. confirmed. Accordingly, it has been clarified that it is desirable that the polyolefin composition used for forming the moisture absorption layer of the package is substantially free of additives other than magnesium sulfate anhydride.
  • additive-free polyolefin composition was extruded using a T-die film molding machine (PLABOR GT-25-A, manufactured by Plastic Engineering Laboratory Co., Ltd.), thereby forming a single layer film having a thickness of 60 ⁇ m.
  • LDPE Polyethylene
  • UBE polyethylene F120N MFR1.2
  • Magnesium sulfate anhydride 33% by weight
  • Table 13 shows the obtained results. From this result, when pressure reduction was not performed when kneading polyethylene and magnesium sulfate anhydride (Reference Example 4), the water content exceeded 0.15% by weight, and the dispersibility of magnesium sulfate anhydride was very poor. The single-layer film was found to have many aggregates, many perforations were observed, and the moldability was poor. On the other hand, when kneading polyethylene and magnesium sulfate anhydride under reduced pressure (Reference Examples 5 to 7), the water content was 0.1% by weight or less, and the dispersibility of magnesium sulfate anhydride was good.
  • Reference test example 4 4-1 Production of polyolefin compositions and films Reference Example 8 Using the raw materials shown below, they were kneaded with a twin-screw kneading extruder (Twin Screw Extruder PCM-45, manufactured by Ikekai Iron Works Co., Ltd.) under the same conditions as in Reference Test Example 3 (pressure atmosphere of -88 KPa). By extruding, 200 kg of pellet-shaped additive-free polyolefin composition was obtained.
  • a twin-screw kneading extruder Twin Screw Extruder PCM-45, manufactured by Ikekai Iron Works Co., Ltd.
  • the additive-free polyethylene (LDPE), the additive-free polyolefin composition obtained above, and the additive-free polyethylene (LDPE) are three-layered using a three-layer three-layer inflation molding machine (manufactured by Sumitomo Heavy Industries Modern Co., Ltd.).
  • a three-layer film in which the resin layers (outer layers having a thickness of 20 ⁇ m) formed in step 1 were sequentially laminated was prepared.
  • ⁇ Raw material composition of additive-free polyolefin composition > Polyethylene (LDPE; trade name “UBE polyethylene R300” (MFR0.35), manufactured by Ube Maruzen Polyethylene Co., Ltd.) 67% by weight Magnesium sulfate anhydride 33% by weight
  • Reference Example 10 By using the raw materials shown below and kneading and extruding under the same conditions as in Reference Test Example 3 (pressure atmosphere of -88 KPa) with a twin-screw kneading extruder (PCM-80 manufactured by Ikegai Iron Works Co., Ltd.) A pellet-shaped additive-free polyolefin composition was obtained. Subsequently, additive-free polyethylene (LDPE), the additive-free polyolefin composition obtained above, and additive-free polyethylene (LLDPE) are coextruded in three layers with an air-cooled inflation multilayer film forming apparatus (Placo Corporation).
  • LDPE additive-free polyethylene
  • LLDPE additive-free polyethylene
  • LLDPE additive-free polyethylene
  • a resin layer (inner layer with a thickness of 20 ⁇ m) formed of additive-free polyethylene (LDPE), a moisture absorption layer (an intermediate layer of thickness of 60 ⁇ m) formed with the polyolefin composition, and an additive-free polyethylene (LLDPE) were formed.
  • LDPE additive-free polyethylene
  • UBE polyethylene F120N (MFR1.2) manufactured by Ube Maruzen Polyethylene Co., Ltd.
  • Table 14 shows the results of measuring the water content of the additive-free polyolefin compositions obtained in Reference Example 8 (same as Reference Example 9) and 10 by the same method as in Reference Test Example 3.
  • all of the additive-free polyolefin compositions obtained in Reference Examples 8 and 10 had a water content of 0.1% by weight or less. That is, also from this test result, when obtaining a polyolefin composition without adding additives other than magnesium sulfate anhydride, by kneading so that the water content is 0.1% by weight or less, magnesium sulfate is obtained. It was confirmed that the anhydride was excellent in dispersibility and the moldability was good.

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Abstract

La présente invention vise à procurer une technologie de stockage pour du chlorure de sodium ayant une excellente propriété de stabilité, avec laquelle il est possible d'empêcher la solidification du chlorure de sodium, même pendant un stockage de longue durée, sans l'ajout d'additifs. A cet effet, selon l'invention, par l'établissement de la pureté du chlorure de sodium à au moins 99,5 % en poids et du diamètre moyen de particules à au moins 150 μm, le stockage du chlorure de sodium dans un récipient étanche vis-à-vis de l'humidité ayant une perméabilité à l'humidité inférieure à 3 g/m2∙24 h, et l'établissement de l'humidité relative à l'intérieur du récipient étanche vis-à-vis de l'humidité de telle sorte qu'elle est maintenue à 55 % ou moins, il est possible d'empêcher le chlorure de sodium de se solidifier, même pendant un stockage de longue durée, et d'accroître la la propriété de stabilité du chlorure de sodium.
PCT/JP2016/051364 2015-01-23 2016-01-19 Chlorure de sodium emballé et procédé de stockage pour chlorure de sodium WO2016117528A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5984765A (ja) * 1982-10-26 1984-05-16 日本食塩製造株式会社 粉体の固結防止方法
JP2002200108A (ja) * 2000-12-28 2002-07-16 Maikooru Kk 防湿性包装材、それを使用した発熱体用防湿性外袋、発熱体用防湿性まとめ包装袋等の防湿性包装用容器並びにそれらに収納された発熱体
JP2014000998A (ja) * 2012-06-20 2014-01-09 Kyodo Printing Co Ltd 包装袋及び包装体

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5984765A (ja) * 1982-10-26 1984-05-16 日本食塩製造株式会社 粉体の固結防止方法
JP2002200108A (ja) * 2000-12-28 2002-07-16 Maikooru Kk 防湿性包装材、それを使用した発熱体用防湿性外袋、発熱体用防湿性まとめ包装袋等の防湿性包装用容器並びにそれらに収納された発熱体
JP2014000998A (ja) * 2012-06-20 2014-01-09 Kyodo Printing Co Ltd 包装袋及び包装体

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