JPH04197357A - Container filled with medical liquid - Google Patents

Abstract

PURPOSE:To permit the high pressure steam bacteriostasis and prevent the deterioration of the storage in a bacteria-free state and the quality of the medical liquid by enclosing a plastic container which is sealed for accommodating the medical liquid and constituting the inner wall of a film or sheet for sealing from a polymer composition containing polysiloxane. CONSTITUTION:A container filled with medical liquid consists of a plastic container which is sealed for accommodating the medical liquid and a film or sheet which is sealed for enclosing the container, and the plastic container is made of the soft polyvinyl chloride or polyolefine polymer. As the polymer which forms a polymeric composition with polysiloxane, is preferable the thermoplastic polymer having a melting point of 120-230 deg.C, particularly 130-210 deg.C. As polysiloxane, is preferable one or two kinds selected from the polydimethylsiloxane, polymethylphenylsiloxane, and polydiphenylsiloxane. The content of the polysiloxane in the polymer composition is preferably 0.05-5wt.%, and more preferably 0.1-3wt.%.

Description

[Detailed description of the invention] (Field of industrial use) TECHNICAL FIELD The present invention relates to a container containing a medical liquid.

Specifically, the present invention relates to a container containing a medicinal solution that is capable of high-pressure sterilization, maintains the sterile state of the outer surface of the plastic containing the medicinal solution, and is suitable for preventing deterioration of the stored medicinal solution due to air. be.

(Prior Art) Conventionally, in order to maintain the sterility of the outer surface of a plastic container (inner packaging material) containing an infusion solution or other medical solution, or to prevent the medical solution from deteriorating due to oxygen, the container has been further It is common practice to wrap and seal with packaging materials, especially plastic films or sheets (outer packaging material).

However, in conventional methods, polymers with low softening points (low melting points) and low glass transition points, such as soft polyvinyl chloride, polyethylene, and ethylene-vinyl acetate copolymers, are often used for the inner shell; When wrapped in plastic and subjected to high-pressure steam sterilization, the encapsulation softens and the tackiness of the surface increases.Furthermore, fusion occurs at the contact surface between the inner and outer packaging materials, resulting in them remaining stuck or blocked even after cooling. and
There is a problem in that it is difficult or impossible to open the outer envelope when using a medicinal solution. Furthermore, conventionally, a low softening point polymer is often used for the inner wall surface of the outer packaging material in order to have heat sealability, which further promotes the sticking or blocking phenomenon, which is undesirable.

Possible methods for solving the problems mentioned above include using polymers with a high softening point as the inner and outer packaging materials, and sterilization under relatively mild conditions. However, in the former method, for example, the glass transition point is 70~
If a polymer such as polyethylene terephthalate, which has a high melting point of 80°C, is used, the melting point will be as high as 250 to 260°C, making heat sealing difficult. This eliminates the disadvantage of losing flexibility, which is an advantage of plastic containers. (Even when polyethylene terephthalate is used, the effect of suppressing the blocking phenomenon is not sufficient.) Furthermore, even when both methods are combined, the glass transition point of polymers that can be used as packaging materials is usually Although the temperature is at most 50°C, it has the disadvantage that it is difficult to solve the problem of surface tack during high-pressure steam sterilization.

Therefore, at present, it is often necessary to wrap the inner packaging material containing the medicinal solution in an outer envelope after sterilization, but this method cannot guarantee the sterility of the outer surface of the inner packaging material, the inner wall surface of the outer envelope, and the atmosphere between the two. Have difficulty.

(Problems to be Solved by the Invention) Therefore, an object of the present invention is to provide a novel container containing a medical liquid. That is, an object of the present invention is to provide a container containing a medical solution that is sealed by an inner container and an outer packaging material, is capable of high-pressure steam sterilization, and is effective in preserving aseptic conditions and preventing deterioration of the drug solution. .

(Means for Solving the Problems) The above-mentioned device consists of a sealed plastic container (A) containing a medical solution and a sealed film or sheet (B) containing (A); ) is achieved by a container containing a pharmaceutical liquid, the inner wall of which is composed of a polymer composition containing polysiloxane.

The present invention also provides a container containing a pharmaceutical liquid, in which the plastic container (A) is made of flexible polyvinyl chloride or polyolefin polymer.

The present invention also provides a container containing a medicinal liquid in which the polymer composition is composed of polysiloxane and a thermoplastic polymer having a melting point of 120 to 230°C. The present invention further provides a container containing a pharmaceutical liquid, in which the polysiloxane is one or more selected from the group of polydimethylsiloxane, polymethylphenylsiloxane, and polydiphenylsiloxane. The invention further provides a container containing a pharmaceutical liquid, in which the content of polysiloxane in the polymer composition is from 0.05 to 5% by weight.

(Function) The container containing a medical liquid according to the present invention is composed of a sealed plastic container (A) containing a medical liquid and a sealed film or sheet (B) enclosing (A),
The inner wall of (B) is characterized by being composed of a polymer composition containing polysiloxane, and the polysiloxane contained in the polymer composition constituting the inner wall of (B), which is the outer packaging material, is low. Because it has interfacial tension, sticking or blocking phenomena are unlikely to occur even under severe conditions such as high-pressure steam sterilization.

In the present invention, the non-plastic container (A) used as the inner packaging material may be any material as long as it is made of a polymer commonly used to contain medical solutions.
(soft) polyvinyl chloride containing plasticizers such as 2-ethylhexyl) phthalate and di-n-decyl phthalate, high-pressure low-density polyethylene, propylene, butene-1,
Linear low-density polyethylene containing a small amount (preferably 10 mol% or less) of α-olefin such as hexene-1 and octene-1 as a copolymer component, and ethylene-vinyl acetate copolymer containing 2 to 35% by weight of vinyl acetate. Typical examples include polymer compositions, polymer compositions, and multilayer molded products (in the form of films or sheets).

The film or sheet (B) of the outer packaging material in the present invention has a composition of polysiloxane and another polymer on its inner wall surface, and at least the inner wall surface is formed of a polysiloxane-containing polymer composition. This means that it is good, even if it is a multilayer sheet or film that has the inner wall of the polymer composition and a layer that does not contain polysiloxane, or a single layer made of the polymer composition. It may also be a layered sheet or film.

Polysiloxanes used in the present invention include polymers commonly known as silicone polymers, specifically polydimethylsiloxane, polymethylphenylsiloxane, polydiphenylsiloxane, and the like. Particularly preferred is one or more selected from the group of polydimethylsiloxane, polymethylphenylsiloxane, and polydiphenylsiloxane.

Further, the viscosity of the polysiloxane used in the present invention is 10,000 centistokes or more, preferably 20. C100 to 1000.000 centistokes.

The polymer forming the polymer composition with polysiloxane should have a melting point of 120 to 23, taking into consideration the conditions of high-pressure steam sterilization, the shape of the sheet or film, heat sealability, etc.
Thermoplastic polymers having a temperature of 0°C, especially 130-2100°C are preferred. Specifically, polypropylene or a copolymer thereof, a copolymer mainly composed of poly-4-methylpentene-1, polyvinylidene chloride polymer, nylon 6 copolyamide, nylon 8, nylon 12, etc. Copolyamides mainly composed of, copolyesters mainly composed of polyethylene terephthalate, polybutylene terephthalate or its copolyesters,
Typical examples include polyhexamethylene terephthalate polyester.

Further, in the present invention, the content of polysiloxane in the polymer composition is preferably 0.05 to 5% by weight, more preferably 0.1 to 3% by weight.

The higher the content of polysiloxane, the better the stick resistance and anti-blocking properties will be. However, polysiloxane is incompatible with the thermoplastic polymer mentioned in section 1, and the polymer composition will become cloudy, so transparency may be reduced. Care must be taken when emphasis is needed.

Furthermore, the film or sheet (B) constituting the outer shell of the container of the present invention has a layer made of the polysiloxane-containing polymer composition on the inner wall side and a layer not containing polysiloxane on the outside. In the case of a form in which these layers are bonded together, the polymer used in the layer may be selected depending on the purpose of improving the strength of the film or sheet (B) or improving the barrier property against gases such as oxygen and water vapor. You can choose. Specifically, polyethylene, polypropylene, poly-4-methylpentene-1, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polyvinylidene chloride, nylon 6, nylon 66,
Nylon 610, nylon 8, nylon 12, poly-m
-Xylylene adipamide, polyethylene terephthalate, polybutylene terephthalate, etc., and copolymers containing these as main components.

The plastic container (A) in the present invention can be produced by a commonly known method, such as an injection molding method, an extrusion molding method, a sheet molding method,
It can be manufactured by a blow molding method, an inflation molding method, or a combination thereof. Moreover, the thickness of the plastic container (A) of the present invention is 0.1 to 1 mm, preferably 200 to 500 μm. Further, the shape of the plastic container (A) of the present invention includes an unstretched product, a stretched product, and the like.

Note that the plastic container (A) of the present invention subjected to a crosslinking treatment by a physical method such as electron beam irradiation can withstand high-pressure steam sterilization, and thus can be particularly preferably used.

The film or sheet (B) as the outer packaging material in the present invention is also manufactured by the same method as the plastic container (A) or by the laminate molding method. In addition, the thickness of the polysiloxane-containing polymer composition at this time is 20 to 30 mm in the case of a single layer.
0 μm, more preferably 30 to 250 μm In the case of one multilayer, the thickness of each layer is 1 μm or more, more preferably 3 to 10
0 μm and a total thickness of about 0.02 to 0.5 mm, preferably about 0.05 to 0.3 mm. Furthermore, the shape of the film or sheet (B) of the outer shell of the present invention includes an unstretched product, a stretched product, and the like.

The atmosphere between the plastic container (A) and the outer wrapping material film or sheet (B) in the present invention can be arbitrarily selected depending on the use and requirements, such as vacuum (reduced pressure), nitrogen, carbon dioxide gas, etc.

In addition, the pharmaceutical solution of the present invention is not particularly limited, but suitable examples include physiological saline, electrolyte solutions, dextran preparations, mannitol preparations, saccharide preparations, amino acid preparations, and the like.

In addition, high-pressure steam sterilization is usually performed at a gauge pressure of 1.2 to 2.0.
1 at a temperature of 100-1300C under a pressure of kg/am2
It is carried out for 0 to 60 minutes.

Furthermore, other sterilization methods such as radiation sterilization may be applied to the container sterilization method of the present invention.

(Examples) Hereinafter, the present invention will be explained in more detail with reference to Examples and Comparative Examples. Note that all the films used in the present invention are unstretched films.

Example 1 Polypropylene (melting point 1) containing 1% by weight polydimethylsiloxane (viscosity 200,000 centistokes)
70°C) to a thickness of 100° by the inflation method.
A film (B1) having a fold width of 1'80 mm per μm was produced. In addition, a width of 300 It m thick ethylene-vinyl acetate copolymer film (with a vinyl acetate content of 10% by weight and cross-linked by electric wire) containing 1°000 rrJ of physiological saline was used. Approximately 14cm, length approximately 30cm.

A container (A1) having a flat shape with a thickness of about 2.5 cm was produced, and this container (A1) was vacuum-packed with a film (B1) and sealed by heat sealing.

Next, the double-wrapped bag was placed in a retort type high-pressure steam sterilizer at a temperature of 115°C and a gauge pressure of 1.8.
Sterilization was carried out at kg/cm2 for 30 minutes. In addition, in order to ensure pressure, the saturated steam was pressurized with nitrogen gas.

As a result, in the bag after sterilization, there was no blocking phenomenon between the film of the container (A1) and the film of the outer packaging material (B1), and they could be easily peeled off.

Comparative Example 1 The same operation as in Example 1 was performed except that a polypropylene film (C1) containing no polydimethylsiloxane was used instead of the film (B1).

As a result, after sterilization, blocking was observed between the film of the container (A1) and the film (C1), and it was difficult to remove the film.

13 Example 2, Comparative Example 2 Nylon 6-based copolymer containing 1.5% by weight of polymethylphenylsiloxane (viscosity 300°000 centistokes) (comonomer is ω-aminododecanoic acid, melting point is 180°C ) The operation was carried out in the same manner as in Example 1, except that film (B2) was used instead of film (B1).

As a result, no blocking phenomenon was observed between the film of the container (A1) and the film (B2) after sterilization.

Furthermore, when a similar operation was performed using a nylon 6 copolymer film (C2) that did not contain polymethylphenylsiloxane, blocking was observed after sterilization.

Example 3, Comparative Examples 3 to 4 The inner layer (30 μm thick) was made of polypropylene (melting point 170°C) containing 0.5% by weight of polydimethylsiloxane (viscosity 500,000 centistokes), and did not contain polydimethylsiloxane. Two-layer blown film (B) with polypropylene as the outer layer (thickness 70 μm)
, ) as the outer wrapping material and a linear low-density polyethylene film (A2) containing octene-1 as a copolymer component (density 0
A container containing physiological saline (Example 3) containing 929 g/am3) was prepared in the same manner as in Example 1, and at a temperature of 1
15°C, gauge pressure 1, 8 kg/cm2
Sterilization was performed for 30 minutes.

As a result, no blocking was observed after sterilization.

On the other hand, a container using film (C1) instead of film (B3) (Comparative Example 3) or film (C2
) in place of the film (B3) (Comparative Example 4)
), blocking was observed after sterilization.

(Effects of the Invention) As described above, the present invention comprises a sealed plastic container (A) containing a medical solution and a sealed film or sheet (B) containing (A);
) The inner wall of the container is composed of a polymer composition containing polysiloxane, so it can be directly sterilized using high-pressure steam, which has the effect of preserving aseptic conditions and preventing deterioration of the drug solution. It is expected that it will greatly contribute to medical treatment.

Claims (5)

[Claims] (1) A sealed plastic container containing a medicinal solution (
A container containing a pharmaceutical liquid, comprising A) and a sealed film or sheet (B) containing (A), wherein the inner wall of (B) is composed of a polymer composition containing polysiloxane. . (2) The container containing a medical liquid according to claim 1, wherein the plastic container (A) is made of flexible polyvinyl chloride or a polyolefin polymer. (3) The polymer composition and polysiloxane have a melting point of 120~
2. The container containing a pharmaceutical liquid according to claim 1, wherein the container is made of a thermoplastic polymer having a temperature of 230°C. (4) The container containing a pharmaceutical liquid according to claim 1, wherein the polysiloxane is one or more selected from the group of polydimethylsiloxane, polymethylphenylsiloxane, and polydiphenylsiloxane. (5) The content of polysiloxane in the polymer composition is 0.0
The container containing the pharmaceutical liquid according to claim 1, wherein the amount is 5 to 5% by weight.