JP2005041540A - Manufacturing method for food in container or medical supplies - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To manufacture a food in a container having a low gas permeability or medical supplies with a favorable workability at a low cost. <P>SOLUTION: The food or medical supplies is packed in a container made of a thermoplastic resin, sealed, sterilized or germ-eliminated. Then, on a part or the total area of the container surface, a gas barrier layer is formed by using a liquid or molten gas barrier resin. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a method for producing a sterilized or sterilized food or medicine sealed in a resin container. More specifically, the present invention relates to a method for preventing the intrusion of a gas, for example, oxygen, into a resin container during storage of food or pharmaceuticals, or preventing the gas from being released from the resin container into the atmosphere to prevent the contents from being denatured.

  It has been widely practiced that pharmaceuticals and foods are prepared in a liquid, powder or solid form and then filled and sealed in a container made of a thermoplastic resin. Usually, a container made of a thermoplastic resin tends to transmit oxygen in the atmosphere. For this reason, it is necessary to prevent the invasion of oxygen in pharmaceuticals such as amino acid-containing infusion solutions that become unstable with oxygen over time. Further, in pharmaceuticals such as dialysate containing bicarbonate, carbon dioxide gas permeates through the container wall and dissipates, and the pH of the liquid agent changes, so it is necessary to prevent the gas from escaping. In order to cope with this, it is widely practiced to store the content components in another outer bag having gas barrier properties (gas-impermeable) after filling, sealing, sterilizing or sterilizing the containers (for example, patent documents) 1).

  Infusion preparations taken out of the outer bag are usually administered after injecting other drugs such as vitamin preparations and trace element preparations. Recently, infusion treatment has been frequently administered to patients who are treated at home, and other drugs are injected into the infusion product taken out of the outer bag at the hospital, and the patient is put together for 1 to 2 weeks (usually 14 to 28). When delivering, special considerations, such as storing in a refrigerator, are necessary to maintain the quality until it is taken out from the outer bag and administered.

  It has also been proposed to use a laminated film in which the entire container is laminated with a gas barrier resin without using such an exterior bag. However, when the laminated film is expensive, the container made of the laminated film lacks flexibility, making it difficult to fill, sterilize and sterilize the components. This is not widespread due to problems such as a decrease in gas barrier ability and changes in transparency of laminated films.

  In infusion preparations, multi-chamber containers are transfused in which separate ingredients are placed in a multi-chamber container separated by a weakly sealed part (easy peel seal), and the weakly sealed part is ruptured during use to mix and administer all ingredients. Is often used. In the case of an infusion containing a multi-chamber container, a component requiring gas barrier protection may be contained in only one of the multi-chambers. For such a case, it is also known that only a chamber that needs protection is protected by a gas barrier bag or film.

For example, Patent Document 2 describes a two-chamber container in which a liquid agent and a powder agent are housed in separate chambers, in which an outer bag is covered only on the powder agent portion. However, after storing the components in the two chambers, it is technically difficult to seal the outer bag to one of the chambers while maintaining the weak seal portion in the middle of the two chambers. Patent Document 3 proposes that the outer bag is bonded with an adhesive at the peripheral edge or the entire surface with an adhesive. However, if the exterior bag is bonded before the content components are added, flexibility is lost, and subsequent operations are difficult. In addition, if the outer bag is to be bonded after filling the contents, the contents of the container become uneven due to the contents, making the bonding extremely difficult.
Utility Model Registration No. 2509993 Japanese Patent No. 3060132 Registered Utility Model No. 3070506

  An object of the present invention is to produce a sterilized or sterilized food or pharmaceutical product capable of stably maintaining the contents of components without a conventionally used outer bag. More specifically, a gas barrier resin coating is formed on the surface of a container at a low cost by an easy process without impairing the workability of the process such as filling, sealing, sterilization, and sterilization of the contents of food or medicine.

  The present invention has been made in view of the above-mentioned problems. After filling and sealing a content component into a container made of a thermoplastic resin having good workability, the sealed content component is sterilized or sterilized together with the container, and then the container A method for producing a food or pharmaceutical product in a container, comprising forming a gas barrier layer using a liquid or molten gas barrier resin on part or all of the surface of the container.

  Here, the steps from filling and sealing the content component into a container made of a thermoplastic resin with good workability and sterilizing or sterilizing the sealed content component together with the container can be performed by a conventionally known method. . A gas barrier layer is formed on a part or the whole surface of a sterilized or sterilized container by applying the gas barrier resin as a solution or suspension and drying, or by laminating the gas barrier resin in a molten state on the container surface. be able to. The method of applying and drying the gas barrier resin in the form of a solution or suspension and the method of laminating the gas barrier resin in the molten state may be any methods as long as they are applicable to containers containing foods or pharmaceuticals.

  According to the production method of the present invention, it is possible to solve the problem of quality deterioration of a chemical solution or the like after the outer bag is once opened without producing a container with an expensive laminated film including a gas barrier layer. By improving the components and thickness of the gas barrier layer, expensive exterior bags can be omitted. Moreover, since the coating of the gas barrier layer is performed after filling, sealing, sterilization or sterilization of the content components, the workability is good and it can be formed at a necessary site at a low cost. Further, by applying the gas barrier resin in a liquid state, a coating having a uniform thickness can be formed even though the surface is not flat because the container contains the contents.

  Examples of the liquid pharmaceutical produced by the method of the present invention include an infusion solution for intravenous administration, a liquid nutrient, and a peritoneal dialysis solution. Examples of powdered or solid pharmaceuticals include a wide range of pharmaceuticals such as antibiotics, anticancer agents, analgesics, immunizing agents, gastric acid inhibitors, vitamins and the like. Examples of foods include foods containing nutrients, powder seasonings, herbal extracts and the like processed into powder or granules.

  The container for foods and pharmaceuticals in the present invention is formed of a thermoplastic resin that is heat resistant and flexible and has good workability. Examples of the thermoplastic resin forming the container include various types of polyolefins such as polyethylene, ethylene-propylene copolymer, ethylene-butene copolymer, ethylene-hexene copolymer, polypropylene, olefin elastomer, and styrene elastomer. A thermoplastic elastomer or any combination thereof can be used. These thermoplastic resins are preferable in that they have heat resistance and water resistance that can withstand sterilization and the like.

  As the container made of the thermoplastic resin of the present invention, a container formed by blowing a bottle, a sheet or a film formed by a blow molding method can be used. It is preferable that the sheet is formed by a cylinder formed by an inflation molding method. The sheet or film forming the container may be a single layer made of the above-mentioned thermoplastic resin or a multilayer laminate in which different materials are laminated in a plurality of layers depending on the contents to be filled and usage.

  When it is necessary to separate a plurality of components into a container, it is desirable to use a multi-chamber container that is divided into multiple chambers by a communication part (easy peel seal) that can be pressed by hand from the outside and broken. .

  A container filled and sealed with the contents by a conventionally known method is sterilized or sterilized by sterilization such as high-pressure steam sterilization, shower sterilization, immersion sterilization sealing, or a heat sterilization process. In this sterilization or sterilization process, the container retains heat resistance and water resistance, but is not provided with high barrier properties, so if the components to be filled are likely to be altered by oxygen, an inert gas is put into the sterilization or sterilizer. Can be used to prevent quality degradation. The sterilization or sterilization process is not necessarily performed by heating, and can be performed, for example, by sterilizing light irradiation or radiation treatment.

  The container after the sterilization or sterilization process is dried with hot air as necessary, and then a gas barrier layer having a gas barrier property is formed on the surface of the container. In order to make it easy to form a gas barrier layer on the container surface, a urethane-based anchor coating agent may be applied in advance. Further, corona discharge on the surface of the container is preferable as a pretreatment for forming the gas barrier layer.

  As the resin for forming the gas barrier layer, any resin that does not transmit oxygen, carbon dioxide gas, or the like can be used. Preferred examples of the resin include polyvinyl alcohol (PVA), ethylene vinyl alcohol copolymer (EVOH), polyvinylidene chloride (PVDC), and modified products thereof.

  The gas barrier layer can be formed by applying a gas barrier resin solution or dispersion and drying, or laminating the gas barrier resin as a molten thin film on the surface of the container. As the solvent in the case where the gas barrier resin is used in a liquid state, it is preferable to use water or alcohol since the contents are foods and pharmaceuticals. Polyvinyl alcohol and modified products thereof, ethylene-vinyl alcohol copolymer and modified products thereof, and polyvinylidene chloride and modified products thereof can be used to prepare a coating solution with an aqueous solvent and form a homogeneous gas barrier layer. Preferred material. More preferable examples of the material for forming the gas barrier layer include a polyvinyl alcohol and an ethylene vinyl alcohol copolymer which can easily prepare a solution having a low viscosity from 20% w / w by using an alcohol-water mixed solvent. . The resin concentration of the solution or dispersion containing the gas barrier resin for coating is preferably 1 to 20 w / w%, more preferably 5 to 10 w / w%. The viscosity of the synthetic polymer gas barrier resin greatly varies depending on the molecular weight and the degree of polymerization. In order to improve the uniformity of the film thickness that affects the workability and gas barrier properties of the coating, the viscosity of the solution containing the gas barrier resin is preferably adjusted in the range of 100 to 3000 cps.

  A dipping method, a spin coating method, or a spray coating method can be used to apply the gas barrier resin solution or dispersion. Preferred examples of the coating apparatus include a spray coating apparatus including an air type or airless type spray gun and a supply device capable of quantitatively supplying a gas barrier resin solution or dispersion to the gun. Since this container contains the contents, the surface is not flat, but the thickness of the resin can be made uniform by such a coating method. After the gas barrier resin is applied to the surface of the container, an insoluble film is formed by removing the solvent at an appropriate rate so as not to impair the appearance and gas barrier property of the gas barrier layer by hot air drying or the like.

  The coating of the gas barrier layer is desirably 2 to 15 μm, usually 5 to 10 μm. If the film is thick, the gas barrier property is increased, but the cost is increased and the flexibility is lowered, which makes it difficult to handle. Therefore, an appropriate thickness is selected according to the contents.

  In the case where a container made of a thermoplastic resin is partitioned into a plurality of storage chambers, a gas barrier layer may be formed only at a necessary part of the container (such as a part in which a chemical solution that needs to be shielded from oxygen is enclosed). For example, in the case of a two-chamber container filled with a saccharide solution and an amino acid solution divided into two chambers, it is only necessary to form a gas barrier layer only on the amino acid solution side because the invasion of oxygen is an amino acid solution. .

  Filled with a high-calorie infusion sugar and electrolyte in one of the polyethylene containers divided into two chambers with a weak seal (easy peel seal) in the center, and filled and sealed the amino acid solution in the other chamber by a standard method. Sterilized by heating in water at 100 ° C. A two-fluid (liquid-air) spray gun (manufactured by Anest Iwata Co., Ltd.) containing an aqueous solution containing 10% w / w of polyvinylpyrrolidone (trade name: Gohsenol EG, manufactured by Nippon Synthetic Chemical Co., Ltd.) on the surface of the amino acid liquid side container that requires oxygen blocking. W-100-132P type) and a pressurized container (manufactured by Anest Iwata) were applied and dried.

After drying, in order to investigate the oxygen barrier effect due to the formation of the polyvinylpyrrolidone layer on the surface of the container, using an oxygen transmission rate measurement device (OX-TRAN TWIN type, manufactured by MOCON) under the conditions of 20 ° C. and 65% RH. As a result of measuring the oxygen transmission rate, it was 48 mL / m ² / day / atm. Since the oxygen permeation amount of the polyethylene container not forming the polyvinylpyrrolidone layer is about 3000 to 4000 mL / m ² / day / atm, it is clear that the intrusion of oxygen can be suppressed by the production method of the present invention.

  Further, after the product of this example was stored at 25 ° C. for 2 weeks, the content of L-cysteine in the amino acid solution was measured by a colorimetric method (4-PDS) using a 4 ′, 4-dithiodipyridine reagent. When the content before storage is 100, the L-cysteine content in this example is 98.67% (average value of three measured values of 98.68%, 98.61%, and 98.73%). ) And almost no decrease in content.

Claims (4)

Filling and sealing a liquid, powder or solid food or medicine in a container made of a thermoplastic resin, sealing the food or medicine in the sealed container, and sterilizing or sterilizing the container And a step of forming a gas barrier layer using a liquid or molten gas barrier resin on part or all of the surface of the container. The method for producing a food or pharmaceutical product in a container according to claim 1, wherein a gas barrier resin liquefied using water and / or alcohol is applied and dried to form a gas barrier layer. The container according to claim 1 or 2, wherein the gas barrier resin is selected from the group consisting of polyvinyl alcohol and a modified product thereof, an ethylene-vinyl alcohol copolymer and a modified product thereof, and polyvinylidene chloride and a modified product thereof. A method of manufacturing food or pharmaceutical products. The method for producing a food or medicine in a container according to any one of claims 1 to 3, wherein the gas barrier layer is formed only on the surface of a part of the chamber of the multi-chamber container.