JPS59181164A - Infusion liquid preserving method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for stably and well preserving infusion fluids used in medical treatment.

In recent years, with the development of medical technology, the use of transfusions has increased, and there is therefore a strong demand for stable storage of transfusions. Infusion fluids are usually stored in a suitable container, but as a container for storing infusion fluids, it is important to be able to see through the infusion fluid clearly and accurately, and to make mistakes in determining whether or not the fluid is denatured.
! It must be highly transparent so that it can be confirmed without any blemishes. In addition, it is required that water vapor permeability and oxygen gas permeability are as low as possible so as not to alter the quality of the infusion solution, and also characteristics such as high breaking strength and resistance to damage even if dropped are required. Furthermore, formation of the container,
Since it is necessary to perform heat sealing to seal after containing the infusion solution, the heat sealability must also be good.

Glass bottles, polypropylene blow containers, and PVC bags are known as containers for liquids that have been used in the past, but glass bottle containers are prone to damage due to dropping, alkali elution from the glass, and air intake. There are problems such as hospital-acquired infections due to needle punctures, polypropylene blow container containers lack transparency, and there are problems such as hospital-acquired infections due to needle punctures. There are problems such as plasticizer elution in PVC, and there are currently almost no infusion containers that have all of the above characteristics, so it is necessary to sacrifice one of the characteristics. This may cause problems in storing the infusion.

The present invention has been made to improve the above-mentioned situation, and an object of the present invention is to provide a method for preserving an infusion solution that stably and satisfactorily preserves an infusion solution.

That is, as a result of intensive research to achieve the above object, the present inventors have found that when storing an infusion solution, the outermost layer is formed of polyethylene terephthalate or biaxially oriented polyzoropyrene as a container, and the middle layer is formed as a container. It is formed from a polyamide resin or a highly transparent resin laminated thereon, and the innermost layer is formed from a transparent thermoadhesive resin, and the outermost layer preferably has a thickness of 12 to 30 μm.
, the thickness of the middle layer is 15 to 50 μm1, the thickness of the innermost layer is 5
0 to 120 μm, and the total thickness of all layers is 75 to 200 μm.
The present invention was made based on the discovery that if the infusion solution is stored in a container with micrometer diameter, and the infusion solution is stored in this container and sealed with a heat seal, the infusion solution will be stored stably and well for a long period of time. This is what led to this.

According to the infusion storage method of the present invention, since the above-mentioned container has extremely high transparency, the infusion can be clearly seen through, making it possible to reliably confirm whether or not the infusion has deteriorated, thereby preventing erroneous use of the deteriorated infusion. It is possible to eliminate such accidents.

In addition, it can reliably prevent the permeation of oxygen gas, water vapor, etc., has high breaking strength, is resistant to damage even if dropped, and has good heat sealing properties, allowing infusions to be stored in a completely sealed manner. Therefore, the infusion solution can be safely stored without foreign matter entering through the sealed portion during storage.

The present invention will be explained in more detail below.

As shown in the drawings, the infusion solution storage method according to the present invention is as follows:
The outermost layer 1 is made of polyethylene terephthalate or biaxially oriented polypropylene, the intermediate layer 2 is made of polyamide resin or a highly transparent resin laminated thereon, and the innermost layer 3 is made of a transparent thermoadhesive resin. This method uses an infusion solution container having at least three layers.

Here, the polyethylene terephthalate forming the outermost layer 1 may be stretched or unstretched, but biaxially stretched polyethylene terephthalate is particularly preferred. In addition, polyamide resins include 6-nylon, 6-6 nylon, and 11-nylon.
Nylon, 12-nylon, etc. can be used, but especially 6-nylon
Preferably, nylon or 6-6 nylon is used. These can be effectively used either stretched or unstretched. Further, in order to improve oxygen gas permeability and water vapor permeability, polyamide resin coated with polyvinylidene chloride resin can be effectively used as a laminated layer of highly transparent resins. Further, as the thermoadhesive resin, low density polyethylene, medium density diethylene, ethylene-vinyl acetate copolymer, etc. are preferably used.

The present invention uses the above-mentioned infusion container, and the object of the present invention can only be achieved by the combination of the above-mentioned outermost layer, intermediate layer, and innermost layer.

1. In the above infusion container, the outermost layer 1 has a thickness of 12
~30μm, middle layer 2 has a thickness of 15~50μm1 innermost layer 3
The thickness of each layer is preferably 50 to 120 μm, and the total thickness of all layers is preferably 75 to 200 μm.
．． By setting the thickness of No. 3 and the total thickness within the above range, the object of the present invention can be more effectively achieved. If the total thickness is thinner than 75 μm, it has excellent transparency as a container, but has low drop impact strength and may not be suitable as an infusion container, and if it is thicker than 200 μm,
As an infusion solution container, it has poor flexibility, tends to leave behind the filled infusion solution during use, and may have reduced transparency and poor heat-sealing suitability when filling the infusion solution.

In addition, the preferred range of the thickness of each layer is that the outermost layer 1 is 12
~2°5 μm 1 Intermediate layer 2 is 15 to 30 μm 1 Innermost layer 3 is 60 to 120 μm, and the total thickness is 110 to 175 μm
It is more preferable that it is a fairy tale.

In the method of the present invention, an infusion solution is stored in the above-mentioned infusion solution container, the container is sealed by heat sealing, and the container is stored. In this case, the infusion solution can be stored in the container after the container and the infusion are each sterilized, and the sterilization process can be performed after the container is sealed. In addition, when carrying out the sterilization treatment after sealing, it is carried out at a low temperature so that the heat-adhesive resin constituting the innermost layer does not change in quality. Therefore, the method of the present invention is suitably used when sterilizing containers and infusions in advance, when pasteurizing containers after sealing, or in applications where sterilization is not particularly required. Further, it can be stored usually at room temperature, and can be stored in a state where the infusion solution can be effectively used for at least one year.

Since the infusion preservation method of the present invention has the above-described general structure, it is possible to effectively preserve medicinal infusion solutions such as glucose solutions, Lindahl's solutions, and amino acid preparations.

EXAMPLES Hereinafter, the present invention will be specifically explained with reference to examples, but the present invention is not limited to the following examples.

〔Example〕

An infusion container having the configuration shown in Table 1 was prepared, and its transparency,
The degree of haze, moisture permeability, and breaking strength were investigated. The results are shown in Table 2〇 [Note] ASTM-D 1003 (integrating sphere type/photoelectric photometer) Oxygen gas permeability evaluation method according to JIS-Z-0208 Breaking strength evaluation method and evaluation according to JIS-Z-1707 After filling the standard container with a specified amount of water and heat-sealing it, drop the container from a height of 1.8 m so that the flat surface touches the ground, and check the container with no leaks. Those that occurred were rated as ×.

According to the above results, the infusion container of the present invention has high transparency;
In addition, the container must have a low degree of haze, allow the object to be contained (infusion) to be clearly seen through, have low water vapor permeability and oxygen gas permeability, and have high breaking strength, and store the infusion in these containers.
It has been found that by sealing with heat sealing, the infusion solution can be stored stably and well.

[Brief explanation of the drawing]

The drawing is a schematic sectional view showing an example of a transportation container. 1... Outermost layer, 2... Middle layer, 3... Innermost layer. Applicant: Fujimori Industries Co., Ltd. Agent: Patent Attorney Takashi Kojima

Claims (1)

[Claims] 1. When storing infusions, the outermost layer is made of polyethylene terephthalate or biaxially oriented polypropylene as an infusion container, and the middle layer is made of polyamide resin or a highly transparent resin laminated thereon. The infusion storage method is characterized in that the innermost layer is made of transparent thermoadhesive resin, the infusion is stored in this infusion container, and the infusion is sealed with a heat seal to preserve the infusion. 15-50μm, innermost layer thickness 50-120μm
2. The method according to claim 1, wherein the total thickness of all layers is 75 to 200 μm.