JP3550421B2 - Medical bag - Google Patents

Description

[0001]
[Industrial applications]
The present invention relates to a medical bag used for storing a liquid drug such as Ringer's solution or glucose solution, or for accommodating drainage during artificial dialysis.
[0002]
[Prior art]
As a medical bag used for storing a liquid drug such as Ringer's solution or glucose solution, or for accommodating drainage during artificial dialysis, a bag made of a soft vinyl chloride resin or a bag made of a polyolefin resin is used.
[0003]
[Problems to be solved by the invention]
The above-mentioned soft vinyl chloride resin bag contains a plasticizer or a stabilizer in the resin, and when storing a liquid drug such as Ringer's solution or glucose solution, these additives may elute into the liquid drug. There is a problem, and there is a drawback such as generation of harmful gas when the used bag is incinerated and disposed of.
[0004]
Although the polyolefin resin bag solves the above-mentioned drawbacks of the soft vinyl chloride resin bag, a thickness of 250 to 350 μm is required to obtain the handling strength as a medical bag. For this reason, the bag itself becomes hard and inferior in flexibility, so that there is a problem in handling properties, for example, because a liquid medicine is difficult to come out during infusion. Further, there are disadvantages such as low transparency and difficulty in seeing through the state of the liquid medicine in the bag.
[0005]
On the other hand, the present invention has good flexibility and transparency, and furthermore, there is no problem such as the plasticizer or the stabilizer being eluted into the contents of Ringer's solution or glucose solution, etc., and the use of a retort or autoclave Provided is a medical bag having a strength that can withstand high-temperature sterilization.
[0006]
[Means for Solving the Problems]
The present invention is an inner layer of a polyolefin resin, an ethylene-butene / 1 copolymer, a propylene-butene / 1 copolymer, or an intermediate layer of a mixed resin of any of these copolymers and polyethylene or polypropylene, This object is achieved by providing a medical bag formed in a bag shape by coextruding a laminated sheet with an outer layer of a polyester resin so that an inner layer of the laminated sheet becomes an inner peripheral layer.
[0007]
The inner layer of the medical bag of the present invention having the above-described structure is a portion which is in direct contact with the contents such as Ringer's solution and glucose solution, and there is no dissolution of additives such as a plasticizer and a stabilizer, and the contents are stable with respect to the contents. It is formed to a thickness of about 10 to 50 μm with a polyolefin-based resin such as polyethylene, acid-modified polyethylene, polypropylene, and ethylene-propylene copolymer so as to have heat sealing performance.
[0008]
The intermediate layer between the inner layer and the outer layer is a layer that imparts flexibility to the medical bag of the present invention, and includes ethylene-butene / 1 copolymer, propylene-butene / 1 copolymer, or a copolymer thereof. It is formed to a thickness of about 80 to 380 μ by a mixed resin of any of the coalesced materials and polyethylene or polypropylene.
[0009]
Polyethylene or polypropylene mixed with ethylene-butene / 1 copolymer or propylene-butene / 1 copolymer is effective for adjusting the flexibility and strength of the intermediate layer. If the added amount is too large, the flexibility is impaired. Therefore, the proportion of polyethylene or polypropylene is not more than 240 parts by weight based on 100 parts by weight of ethylene-butene / 1 copolymer or propylene-butene / 1 copolymer. It is preferred to add.
[0010]
The outer layer is a layer that imparts surface strength to the medical bag of the present invention, and is formed to a thickness of about 10 to 50 μ with a polyester resin.
[0011]
The laminated sheet including the inner layer, the intermediate layer, and the outer layer is made of a co-extruded laminated sheet, and has a thickness of about 100 to 400 μ as a whole.
[0012]
The medical bag of the present invention can be obtained by sealing the above-described coextruded laminated sheet of the inner layer, the intermediate layer, and the outer layer such that the inner layer of the laminated sheet becomes the inner peripheral surface layer, in four sides.
[0013]
The high-temperature sterilization is performed by a retort or an autoclave.
[0014]
[Action]
The medical bag of the present invention comprises an inner layer made of a polyolefin resin and an ethylene-butene / 1 copolymer, a propylene-butene / 1 copolymer, or a mixed resin of any one of these copolymers and polyethylene or polypropylene. The laminated sheet is formed in a bag shape by a co-extruded laminated sheet of an intermediate layer and an outer layer made of a polyester resin such that the inner layer of the laminated sheet becomes the inner peripheral surface layer.
[0015]
The medical bag of the present invention having the above-described configuration has excellent flexibility due to the characteristics of the intermediate layer. In addition, due to the characteristics of the inner layer, additives such as plasticizers and stabilizers are not eluted from liquid contents such as Ringer's solution and glucose solution, which are contents in the bag, and have stability to contents. And has heat sealing performance. In addition, the properties of the outer layer provide the required surface strength for the medical bag.
[0016]
Furthermore, the medical bag of the present invention has heat resistance enough to withstand high-temperature sterilization treatment by a retort or an autoclave due to the properties of each resin forming the inner layer, the intermediate layer, and the outer layer.
[0017]
【Example】
The specific configuration of the medical bag of the present invention will be described with reference to production examples.
[0018]
Example 1
An inner layer (25 μ) of an ethylene-propylene copolymer, an intermediate layer (200 μ) of a mixed resin of 100 parts by weight of a propylene-butene / 1 copolymer and 100 parts by weight of a polypropylene, and an outer layer (200 μm) of an ethylene-propylene copolymer 25 μ) to obtain a three-layer co-extruded laminated sheet.
[0019]
With this co-extruded laminated sheet, the inner layer in the laminated sheet becomes the inner peripheral surface layer, and the four sides are heat-sealed except for the filling port of the contents, thereby obtaining a 200-ml flexible medical bag. Was.
[0020]
Next, the medical bag was filled with Ringer's solution, and the filling port was sealed by heat sealing, followed by retort sterilization at 120 ° C. for 30 minutes.
[0021]
This medical bag was subjected to transparency, appearance, water vapor transmission test, heavy metal dissolution test, and ignition residue dissolution test in accordance with the Japanese Pharmacopoeia Law "Transfusion plastic container test method". Further, when the medical bag was subjected to a drop test from a 1.8-m-high place, no breakage occurred, and the strength of the seal portion was sufficient.
[0022]
Example 2
Co-extrusion in a three-layer configuration comprising an inner layer (15μ) of polypropylene, an intermediate layer (130μ) of a mixed resin of 100 parts by weight of ethylene-butene / 1 copolymer and 54 parts by weight of polyethylene, and an outer layer (25μ) of polypropylene. A laminated sheet was obtained.
[0023]
With this co-extruded laminated sheet, the inner layer of the laminated sheet becomes the inner peripheral surface layer, and heat sealing is performed on all sides except for the filling port of the contents, and a flexible medical bag of 2.5 liter capacity is provided. Got.
[0024]
Next, the medical bag was subjected to an autoclave sterilization treatment at 120 ° C. for 70 minutes.
[0025]
Using this medical bag as a storage bag for drainage of artificial dialysis, and examining the transparency, appearance, and storage stability of the drainage after the storage of the drainage, all showed good results. Obtained. When the medical bag containing the drainage was subjected to a drop test from a 1.8-m-high place, no breakage occurred, and the strength of the seal portion was sufficient.
[0026]
【The invention's effect】
The medical bag of the present invention has good flexibility and transparency, and furthermore, there is no problem such as dissolution of plasticizers and stabilizers in contents such as Ringer's solution and glucose solution, and the use of a retort or autoclave It has the strength to withstand high-temperature sterilization.
[0027]
In particular, since the medical bag of the present invention has good flexibility, for example, a liquid drug as a content does not easily come out during infusion, and an excellent effect in practical use is obtained. Can be

Claims (1)

And the inner layer by a polyolefin resin, an ethylene - butene-1 copolymer, a propylene - an intermediate layer butene-1 copolymer, or with any of these copolymers by mixing a resin of polyethylene or polypropylene, by port Riesuteru resin A medical bag, wherein a co-extruded laminated sheet with an outer layer is formed into a bag shape such that an inner layer of the laminated sheet becomes an inner peripheral layer.