JPH04319360A - Vessel containing liquid medicine - Google Patents

Abstract

PURPOSE:To provide a vessel containing liquid medicine capable of being sterilized under high pressure steam and maintaining the sterilized condition of the external plastic surface thereof, the suitable for resisting against the quality deterioration of contained liquid medicine or the like due to contact with the air therein. CONSTITUTION:A vessel containing liquid medicine comprises a sealed plastic vessel A to contain liquid medicine and a sealed film or sheet B for covering the vessel A. In addition, the inner side of the sheet B is constituted of a polycarbonate having 2,2-bis (4'-hydroxyphenyl)propane as dihydroxy-ingredient.

Description

[Detailed description of the invention]

0001

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to containers containing medicinal liquids. Specifically, the present invention relates to a container containing a medical solution that is capable of high-pressure steam sterilization, maintains the sterile state of the outer surface of the plastic container containing the medical solution, and is suitable for preventing deterioration of the stored medical solution due to air. be.

0002

[Prior Art] Conventionally, in order to maintain the sterile condition of the outer surface of a plastic container (inner packaging material) containing an infusion solution or other medicinal solution, or to prevent the deterioration of the medicinal solution due to oxygen,
It is common practice to further wrap the container with another packaging material, particularly a plastic film or sheet (outer packaging material), and seal it. 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 packaging material; If high-pressure steam sterilization is performed while the product is wrapped in water, the inner packaging material will soften, the surface will become more tacky, and fusion will occur at the contact surface between the inner and outer packaging materials, resulting in the product remaining stuck or blocked even after cooling. This causes a problem in that it becomes difficult or impossible to open the outer packaging material when using the medical solution. Furthermore, in the past, polymers with a low softening point were often used for the inner wall surface of the outer packaging material to improve heat sealability, which further promoted the sticking or blocking phenomenon.
Undesirable.

[0003] As a method for solving the above-mentioned problems,
Possible methods include using polymers with high softening points as the inner and outer packaging materials, and sterilization under relatively mild conditions. However, the former method makes heat sealing difficult, and since a high softening point polymer is a highly rigid polymer, it has the disadvantage that the flexibility, which is an advantage of plastic containers (inner packaging materials), is lost. have Furthermore, even when the latter method is combined using a polymer film with a relatively high melting point (melting point 250 to 260°C) such as polyethylene terephthalate as the outer packaging material, the polyethylene terephthalate film has low sealing strength and When the inner packaging material is made of a polymer with a low softening point as described above, a problem arises in that it is difficult to sufficiently suppress blocking.

[0004] Therefore, at present, it is often necessary to sterilize the inner packaging material containing the medicinal solution and then wrap it in an outer packaging material. It is difficult to guarantee the

[0005]

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a novel container containing a medicinal liquid. That is, an object of the present invention is to provide a container containing a medical liquid that is sealed by an inner packaging material and an outer packaging material and is capable of high-pressure steam sterilization. A further object of the present invention is to provide an outer packaging material that has both anti-blocking properties and sealing properties.

[0006]

[Means for Solving the Problems] The above objects are achieved by providing a sealed plastic container (A) and (A) containing a medicinal solution.
), and the inner wall of (B) is composed of polycarbonate containing 2,2-bis(4'-hydroxyphenyl)propane as a dihydroxy component. This is achieved by a container containing a medicinal liquid.

[0007]

[Operation] The container containing a medical solution according to the present invention is a sealed plastic container (A) and (A) containing a medical solution.
The inner wall of (B) is made of polycarbonate (hereinafter referred to as PC) containing 2,2-bis(4'-hydroxyphenyl)propane as a dihydroxy component. It is characterized by being

In the present invention, the PC constituting the inner wall of (B) not only has a practically satisfactory sealing property, but also has a high glass transition point and is chemically stable. It is possible to keep the surface inert even under sterilization. Therefore, by forming the inner wall of (B) from PC, it is possible to suppress the blocking phenomenon at the contact surface between the inner packaging material and the outer packaging material during high-pressure steam sterilization while maintaining sufficient sealing performance.

[0009] The plastic container (A) used as the inner packaging material in the present invention may be made of a polymer commonly used for accommodating medicinal liquids, and specifically, di(2-ethylhexyl) ) Phthalate, G-n
- α- such as (soft) polyvinyl chloride containing plasticizers such as decyl phthalate, high-pressure low density polyethylene, propylene, butene-1, hexene-1, octene-1, etc.
Linear low-density polyethylene containing a small amount (preferably 10 mol% or less) of olefins as a copolymer component, high-density polyethylene, ethylene-vinyl acetate copolymer having a vinyl acetate content of 2 to 35% by weight, etc., and mainly containing these. Component copolymers, these polymer compositions, and multilayer molded products (
A typical example is a film or sheet.

[0010] The plastic container (A) used in the present invention is manufactured by a commonly known method, such as an injection molding method, an extrusion molding method, a blow molding method, an inflation molding method, a T-die method, or a combination thereof. Ru. Also,
The thickness of the plastic container (A) of the present invention is 0.1 to 1
mm, preferably 200 to 500 μm. Further, specific examples of the shape of the plastic container (A) of the present invention include unstretched products, stretched products, etc. Among these, unstretched products are preferable from the viewpoint of flexibility.

[0011] Note that the plastic container (A) used in the present invention that has been crosslinked by a method such as electron beam irradiation can withstand high-pressure steam sterilization and can therefore be suitably used.

PC used in the present invention is a representative polycarbonate formed from a dihydroxy component and a carbonic acid component, and is prepared by a commonly known method, ie, 2,2
It is obtained by polymerization of -bis(4'-hydroxyphenyl)propane (bisphenol A) and phosgene in a solution, or by melt polycondensation reaction of bisphenol A and diphenyl carbonate. When PC is a copolymer, the copolymer components used include dihydroxy components such as hydroquinone, 4,4'-dihydroxybiphenyl, and 1,1-bis(4'-hydroxy)-1-phenylethane. Can be mentioned. At this time, it is preferable to suppress the amount of the copolymer component introduced to about 10 mol % or less. Furthermore, considering the formability of the film or sheet (B) (film or sheet formability), the number average molecular weight of the PC used in the present invention is 10,000 to 10,000.
100,000, more preferably 15,000 to 60
,000 is preferable. Furthermore, in consideration of blocking prevention and heat sealability between the film or sheet (B) and the inner packaging material (A), the glass transition point of the PC used in the present invention is 120 to 150°C, more preferably 125 to 145°C. It is preferable that the degree of

The film or sheet (B) used as the outer packaging material in the present invention has an inner wall surface made of the above-mentioned PC, but this means that at least the inner wall surface should be made of PC. . That is, in the present invention, even if the film or sheet (B) is a single-layer film or sheet made of PC, the inner layer made of PC and the outer layer made of another polymer are bonded together directly or via an adhesive. It may be a multilayer film or a multilayer sheet having a different form. However, since PC has a relatively high stiffness, it is preferred to be in the form of a multilayer film or sheet with a flexible polymer to improve flexibility, rather than as a single layer film or sheet. preferable. Furthermore, an embodiment in which the film or sheet (B) is a multilayer film or a multilayer sheet is preferable in order to improve barrier properties against gases (oxygen, carbon dioxide, water vapor, etc.) and to improve mechanical properties.

Further, in the present invention, the film or sheet (B) has the layer made of the above-mentioned PC on the inner wall surface side, and
When the multilayer film or multilayer sheet has a layer made of other polymers on the outside, the above-mentioned "other polymers" include improving the mechanical properties of the film or sheet (B) and barrier properties against the above-mentioned gases. It can be arbitrarily selected depending on the purpose such as improving the performance. Specifically, polyamides such as polypropylene, poly-4-methylpentene-1, ethylene-vinyl alcohol copolymer, polyvinylidene chloride, nylon 6, nylon 8, nylon 12, nylon 66, or nylon 610, poly-m -Xylylene adipamide, polyethylene terephthalate, polybutylene terephthalate, etc., and copolymers containing these as main components.

[0015] The film or sheet (B) used as an outer packaging material in the present invention is a plastic container (A).
Manufactured using the same method or lamination molding method. In addition, when the outer wrapping material film or sheet (B) is a multilayer molded product in which an inner layer and an outer layer are bonded together with an adhesive, the adhesive used may be an isocyanate adhesive, a copolyester adhesive, or a copolyester adhesive. Examples include adhesives, polyolefin adhesives, and the like. In addition to the melt extrusion method, a solution casting method using methylene chloride or the like as a solvent can also be used as a method for forming the film or sheet (B) of the outer packaging material of the present invention. In the present invention, the thickness of the portion of the film or sheet (B) constituted by PC is 10 to 200 μm, more preferably 15 to 10 μm in the case of a single layer.
0 μm, in the case of multilayer, 1 to 100 μm, more preferably 5 to 50 μm, and the total thickness is 0.01 to 0.5 mm
, preferably about 0.02 to 0.3 mm. Furthermore, specific examples of the form of the film or sheet (B) of the outer packaging material of the present invention include unstretched products, uniaxially stretched products, biaxially stretched products, etc. It is preferable that it is a thing.

[0016] In forming the container containing the pharmaceutical liquid of the present invention,
As a sealing method for the outer packaging film or sheet (B), PC has a relatively high melting temperature and low dielectric constant and dielectric loss tangent, so hot plate bonding and high frequency sealing are not very suitable, but impulse sealing is method, ultrasonic sealing method, etc. can be suitably used. Taking practicality into consideration, the seal strength is preferably 180° peel strength of 1.5 kg/15 mm or more, more preferably 1.8 k.
g/15mm or more.

[0017] 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. .

The pharmaceutical solution of the present invention is not particularly limited, but includes, for example, physiological saline, electrolyte solution,
Preferred examples include dextran preparations, mannitol preparations, saccharide preparations, and amino acid preparations.

[0019] Also, high-pressure steam sterilization is usually performed at a gauge pressure of 1
．． 100-130℃ under pressure of 2-2.0kg/cm2
It is carried out for 10 to 60 minutes at a temperature of .

[0020] Regarding the method of sterilizing the container of the present invention,
Other sterilization methods such as radiation sterilization may also be applied.

[0021]

[Examples] The present invention will be explained in more detail below with reference to Examples and Comparative Examples. Note that all the films used in this example were unstretched films.

Example 1 (1) Experimental method ■Plastic container (A1): Ethylene-vinyl acetate copolymer film (vinyl acetate content is 10% by weight,
(Thickness is 350 μm and has been subjected to electron beam cross-linking)
Consisting of When 1,000 ml of physiological saline was put into this container, it became a flat shape of approximately 2.5 cm x 14 cm x 30 cm.

■Outer packaging material (B1): number average molecular weight approximately 20,
An outer packaging material in the form of a 50 μm thick film made of 000 PC was obtained.

[0024] ■ Container containing medical liquid: ■ Container (A1)
The package was vacuum packed and impulse sealed using the outer packaging material (B1). At this time, the sealing conditions were 45V, 900W, pressure 10kg/300mm, and current application time 0.5 seconds.

■Sterilization: Place the container obtained in (■) into a retort type high-pressure steam sterilizer, temperature 115°C, gauge pressure 1.8kg.
/cm2 for 30 minutes. In addition, in order to ensure pressure, the saturated steam was pressurized with nitrogen gas.

[0026] Observation of blocking phenomenon: After sterilization, the inner wrapping material (container (A1)) and outer wrapping material (B1) were peeled off to determine whether blocking had occurred.

(2) Experimental results The seal strength (180° peel) of the outer packaging material (B1) was 2
．． 3kg/15mm, which is a practically sufficient value,
Furthermore, no blocking phenomenon was observed.

Comparative Example 1 An experiment was carried out in the same manner as in Example 1, except that a polypropylene film was used instead of (B1) as the outer packaging material. ) and polypropylene film were observed.

Example 2 (1) Experimental method (operations were carried out in the same manner as in Example 1 except for the conditions shown below) ■Plastic container (A2): Linear low-density container containing butene-1 as a copolymer component It consists of polyethylene (density 0.92 g/cm3) film.

■Outer packaging material (B2): number average molecular weight approximately 20,
By laminating and molding a film with 000 PC as an inner layer and polypropylene as an outer layer, we created a film in which the thickness of the portion made of PC is 15 μm and the thickness of the portion made of polypropylene is 50 μm. An outer packaging material (B2) having the following properties was obtained.

■ Container containing medical liquid: ■ Container (A2)
The package was vacuum packaged using the outer packaging material (B2) and sealed using an ultrasonic bonding method. At this time, the sealing condition is an output of 70W.
, frequency was 28kc, and horn pressure was 1.5kg.

(2) Experimental results: Sufficient sealing strength of 2.4 kg/15 mm (180
° peel), and blocking resistance was also confirmed.

Comparative Example 2 An experiment was conducted in the same manner as in Example 2, except that a single polypropylene film (thickness: 100 μm) was used instead of the outer packaging material (B2). The bag was causing blocking.

[0034]

Effects of the Invention As described above, the container containing a medical solution of the present invention comprises a sealed plastic container (A) containing a medical solution and a sealed film or sheet (B) enclosing the plastic container (A). The inner wall of (B) is made of polycarbonate containing 2,2-bis(4'-hydroxyphenyl)propane as a dihydroxy component, and is capable of high-pressure steam sterilization. , it is possible to maintain sterile conditions and prevent deterioration of the drug solution. Furthermore, the container containing the pharmaceutical liquid of the present invention has high industrial value in combination with the high transparency of the polycarbonate.

Claims (1)

[Claims] Claim 1: Comprised of a sealed plastic container (A) containing a medical solution and a sealed film or sheet (B) enclosing (A), the inner wall of (B) being 2.
, 2-bis(4'-hydroxyphenyl)propane as a dihydroxy component.