JPH0624575B2 - Manufacturing method of synthetic resin container with infusion - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a method for producing a synthetic resin container containing an infusion solution suitable for containing an infusion solution which is easily deteriorated by oxygen.

(Prior Art) Conventionally, for example, as a method for producing a synthetic resin container containing an infusion solution that contains an infusion solution that is easily deteriorated by oxygen, such as an amino acid infusion solution, after replacing the inside of the sterilizer with an inert gas,
A method is known in which steam is blown into the sterilizer to create a state in which oxygen is substantially absent, and the infusion contained in the synthetic resin container is sterilized therein (JP-A-57-2).
No. 06447). Further, a manufacturing method is also known in which a synthetic resin container is enclosed with an oxygen scavenger in an outer bag having a high gas barrier, and then sterilized (Japanese Patent Laid-Open No. 62-
221352).

(Problems to be Solved by the Invention) In a synthetic resin container for storing an infusion solution as described above, as a material thereof, one in which a part of the container does not elute into the solution must be selected, and generally polyethylene. , Polypropylene, etc. are currently used as the most suitable ones. However, these materials have a high oxygen gas permeability particularly at high temperatures, and when the contents in the container are altered by oxygen such as amino acids, in order to sterilize them, as described above, Although a method of blowing steam after filling the sterilizer with an inert gas is used, a large amount of gas is required to substantially eliminate oxygen. Also, in order to completely replace the inside of the sterilizer with an inert gas,
Generally, since the inside of the sterilizer is temporarily vacuumed and then an inert gas is blown into it, the container is likely to be deformed or damaged. Furthermore, since high-purity nitrogen gas is generally used as the inert gas, heating, sterilizing, and cooling treatments are expensive.

On the other hand, even when pressurized superheated water was used for sterilization, even if the temperature was high, a large amount of dissolved oxygen existed in the water under pressure, so that the alteration of the content liquid could not be prevented.

In addition, the method of sealing the outer bag together with the oxygen absorber before sterilization is
In the manufacturing process, after the infusion solution is filled in the container, what is attached to the outside of the container of the filling liquid is washed, dried and then stored in an outer bag together with an oxygen scavenger, and a complicated process of sterilizing after sealing is required, Furthermore, the material of this outer bag must be selected so that it does not cause blocking with the inner container due to heat during sterilization, and that has low gas permeability even under high temperature and high humidity, and there was a restriction on the material. .

The present invention has been made to solve the above-mentioned conventional problems, and an object of the present invention is to provide a method for manufacturing a synthetic resin container containing an infusion solution which simplifies the manufacturing process.

(Means for Solving the Problems) In order to solve the above problems, the first invention is an amount capable of reacting with dissolved oxygen in an infusion solution contained in an inner bag made of a film material of a sealed heat-resistant synthetic resin. After sterilizing and cooling in sterilized water of 100 ° C. to 121 ° C. under pressure and overheat in which the above sulfite is dissolved, this inner bag is made from a synthetic resin film material having a high oxygen gas barrier together with an oxygen scavenger. The outer bag was sealed.

A second aspect of the present invention is a sterilized water under pressurized superheated state in which the amount of dissolved oxygen is reduced by degassing the infusion solution contained in an inner bag made of a film material of a sealed heat-resistant synthetic resin by degassing means. After being sterilized and cooled, the inner bag container was sealed with an oxygen scavenger in an outer bag made of a synthetic resin film material having a high oxygen gas barrier.

(Example) Next, an example of the present invention will be described with reference to the drawings.

FIG. 1 shows a synthetic resin container containing an infusion solution manufactured by the method according to the first invention or the second invention, in which a sealed inner bag 3 having a mouth portion 2 for injecting and removing the infusion solution 1 is provided. The inner bag 3 is housed together with the oxygen scavenger 4, and the outer bag 6 is sealed by the seal portion 5. Of these, the inner bag 3 is made of a material that has heat resistance and is permeable to oxygen gas under high temperature, for example, a polyethylene film material, and the outer bag 6 is made of a material having a high oxygen gas barrier, for example, inner layer-polyethylene, Intermediate-Eval (trade name, manufactured by Kuraray Co., Ltd.), outer layer-consisting of a three-layer film material with nylon arranged.

Next, a method for manufacturing the synthetic resin container with an infusion solution having the above-described configuration will be described.

First, in the first invention, the infusion solution 1 contained in the sealed inner bag 3 is sterilized by using a sterilizer. Specifically, 100 ° C. in which an amount of sulfite, such as sodium sulfite or sodium hydrogen sulfite, that is more than the amount capable of reacting with dissolved oxygen is dissolved.
Sterilization is performed for about 20 minutes in sterilized water in a pressurized and heated state of ˜121 ° C., preferably about 110 ° C. Here, if the concentration of sulfite is too high, the sulfite decomposes at high temperature,
Since hydrogen hydride may be generated in some cases, it is preferable to inject the sulfite aqueous solution with a metering pump or the like while monitoring the dissolved oxygen in water.

The infusion solution 1 is, for example, a solution of various amino acids including tryptophan dissolved in distilled water at a concentration of 12%. After being injected from the mouth portion 2 into the inner bag 3, the mouth portion 2 is sealed and stored. ing.

After sterilization, this infusion solution 1 is cooled in cooling water in which an amount of sulfite, for example, sodium sulfite or sodium hydrogen sulfite, which is more than the amount capable of reacting with dissolved oxygen is dissolved, and then an inner bag 3 containing this infusion solution 3 With the mouth 2 exposed, the synthetic resin container containing the infusion solution is completed by accommodating and sealing it in the outer bag 6 together with the oxygen scavenger 4.

By forming in this way, as shown in the table below, the infusion solution 1 has less contact with oxygen permeating from the outside of the container, has no deterioration, and is stable for a long time.

This table shows the absorbance measured for infusion solution 1 at a wavelength of 350 nm when sodium bisulfite was used as the sulfite, showing that there was a large difference between the case of 0% concentration and the other cases.

This sodium bisulfite is a highly safe compound that is also used as a food additive.

Furthermore, when polyethylene was used for the container, the measurement result showed that permeation of sulfite ion and sulfate ion of the infusion solution 1 into the container was not detected.

When the concentration was 1%, turbidity was generated in sterilized water, and when one month had passed after sterilization, the inner bag 3 was sealed together with the oxygen scavenger 4 in an outer bag 6 having a high gas barrier. .

In addition, when 3% of sodium sulfite was added, precipitation of sulfur was observed in the sterilizer, and a strong hydrogen sulfide odor was produced when the lid of the sterilizer was opened.

Further, the tank for storing the sterilized water and the cooling water is preferably a closed tank so that the water is not exposed to the air as much as possible and the amount of sulfite added can be reduced.

Next, in the second invention, sterilized water is degassed using a vacuum degasser to reduce dissolved oxygen, and preferably 1 ppm
Reduce the amount to below and then sterilize in sterilized water under pressure and overheat to avoid exposing the sterilized water to air as much as possible and degas the cooling water after sterilization to reduce the amount of dissolved oxygen. Then, the inner bag 1 is reduced to 1 ppm or less and then used for cooling, as in the first invention.
Is sealed in the outer bag 6 together with the oxygen absorber 4. And, even in the case of degassing in this way, as a result of the experiment, alteration of the infusion solution could be suppressed as in the case of adding sulfite to the sterilized water and the cooling water.

(Effects of the Invention) As is apparent from the above description, according to the first invention,
In sterilized water of 100 ° C to 121 ° C under pressure and overheating, in which an infusion solution contained in an inner bag made of a film material of a heat-resistant synthetic resin that has been sealed has dissolved sulfite in an amount more than that capable of reacting with dissolved oxygen. After sterilization and cooling, this inner bag is sealed together with an oxygen scavenger in an outer bag made of a synthetic resin film material having a high oxygen gas barrier.

Therefore, it is possible to supply an infusion solution that is less decomposed by oxygen over a long period of time, including during sterilization and cooling, with a simple manufacturing process.

According to the second aspect of the present invention, the infusion solution contained in the inner bag made of the film material of the sealed heat-resistant synthetic resin is degassed by the degassing means to reduce the amount of dissolved oxygen. After sterilizing in sterilized water and cooling, the inner bag container is sealed with an oxygen scavenger in an outer bag made of a synthetic resin film material having a high oxygen gas barrier.

Therefore, similar to the first invention, there is an effect that it is possible to stably supply an infusion solution for a long period of time with little deterioration by a simple manufacturing process.

[Brief description of drawings]

FIG. 1 is a front view of a synthetic resin container containing an infusion solution to which the method according to the present invention is applied. 1 ... Infusion, 3 ... inner bag, 4 ... oxygen absorber, 6 ... outer bag.

Claims (2)

[Claims] 1. Pressurized heating at 100 ° C. to 121 ° C. in which an infusion solution contained in an inner bag made of a film material made of a heat-resistant synthetic resin that has been sealed has dissolved sulfite in an amount more than that capable of reacting with dissolved oxygen. After sterilizing and cooling in sterile water in the state,
A method for producing a synthetic resin container containing an infusion, wherein the inner bag is sealed together with an oxygen scavenger in an outer bag made of a synthetic resin film material having a high oxygen gas barrier. 2. Sterilized in pressurized superheated sterilized water in which the amount of dissolved oxygen is reduced by degassing the infusion solution contained in a sealed inner bag made of a heat-resistant synthetic resin film material by a degassing means. After the treatment and cooling, the inner bag container is sealed together with an oxygen scavenger in an outer bag made of a synthetic resin film material having a high oxygen gas barrier. .