JPH07100185A - Container for medical liquid - Google Patents

Abstract

PURPOSE:To provide a container for medical liquid, which is transparent, with less troubles at disposal, having a character of barrier to oxygen and carbonic dioxide gas, and having a moderate permeability to vapor, so that the alternation of the medical liquid stored therein, and the wetting and clouding of the container can be prevented. CONSTITUTION:This container is made of sealing film containing sealed soft plastic container storing a medical liquid. The film comprises a multilayered film part having ceramic-coat film layer of gas barrier type and a multilayered film part having ethylene-vinylalcohol copolymer film layer.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a container containing a medical liquid in which the contained medical liquid is prevented from being deteriorated by oxygen, carbon dioxide gas and the like and the water vapor permeability is appropriately adjusted.

[0002]

2. Description of the Related Art Some infusions, blood preservatives and other medicinal liquids are altered by air, such as amino acid preparations, but the material for the container for storing and storing the medicinal liquid is light weight and shock resistance. In terms of properties, ease of handling, etc., soft polyvinyl chloride, polyethylene and ethylene vinyl acetate copolymer and other flexible plastics with excellent flexibility and transparency are often desired. Some measures are necessary because the barrier property against oxygen is not sufficient.

The most common countermeasure that has been or has been attempted in the past is to wrap the liquid medicine container with an outer wrapping material having a gas barrier property. As the outer wrapping material, (a) aluminum foil, (b) ) Polyvinylidene chloride, (C)
A multilayer film (or sheet) containing a barrier material such as an ethylene vinyl alcohol copolymer and (d) a ceramic coat film as a layer is used. As is well known, the advantages and disadvantages of these barrier materials are as follows: (a) Aluminum foil: A large barrier property against most of oxygen, carbon dioxide, water vapor and the like. There are problems that it is opaque and the contents cannot be seen, and it cannot be incinerated.

(B) Polyvinylidene chloride: It has a barrier property against most gases at room temperature and has good transparency, but since it contains chlorine, it has a problem in disposal. (C) Ethylene vinyl alcohol copolymer:
It has a good barrier property against oxygen and carbon dioxide in the room temperature range. Since it is hygroscopic, it is sensitive to moisture and is inferior to a barrier product in a high humidity atmosphere. It has good transparency and there are few disposal problems.

(D) Ceramic coat film: Shows barrier properties second only to aluminum foil, has a smaller temperature dependency than (b) and (c), and has good transparency. Also, since the coat layer can be made thin, the amount of ash is small, and there are few problems in disposal.

Therefore, although (d) can be said to be the most excellent packaging material, it remains unsatisfactory as an outer packaging material for a drug solution container. That is, since the water vapor barrier property is large, the water evaporated from the liquid medicine container often stays between the surface of the container and the outer packaging material to cause water wetting and clouding as water droplets, which is a value as a product. This is because it is significantly reduced.

[0007]

SUMMARY OF THE INVENTION In view of the above situation, the present invention has been made to solve the above-mentioned problems in the packaging material for preventing the deterioration of the contained medical liquid.

[0008]

DISCLOSURE OF THE INVENTION The inventors of the present invention have studied the application of the above-mentioned ceramic coat film, and as a result, the above-mentioned problem of "water droplets" has been solved by the combined use with an ethylene vinyl alcohol copolymer layer-containing packaging material. A container comprising a sealed film or sheet containing a sealed soft plastic container (A) and (B) for containing a medicinal solution, wherein (B) is a gas barrier ceramic coated film. The present invention is intended for a container containing a medicinal solution, which is characterized in that it is composed of a multi-layer film (C) part containing as a layer and a multi-layer film (D) part containing an ethylene vinyl alcohol copolymer film as a layer. . The container containing the liquid medicine of the present invention has excellent oxygen / carbon dioxide gas barrier property and appropriate water vapor permeability, so that the deterioration of the liquid medicine and the prevention of water wetting / fogging can be achieved, and it is transparent and has few problems at the time of disposal. That is also an advantage.

In the present invention, the soft plastic container (A) used as the encapsulating material (the material which comes into direct contact with the medicinal liquid) is made of a commonly known soft polymer,
Polyvinyl chloride having a plasticizer such as di (2-ethylhexyl) phthalate, di-n-decyl phthalate, butyryl tri-n-hexyl citrate (however, it is preferable to avoid this material as much as possible from the point of view of the present invention). , High pressure low density polyethylene, linear low density polyethylene, ethylene vinyl acetate copolymer, polypropylene and other polymers.

Next, the film or sheet (B) of the outer packaging material
Will be described.

The gas barrier ceramic coating film in the present invention is polyethylene terephthalate, polybutylene terephthalate, poly-1,4-cyclohexylene dimethylene terephthalate, polyethylene-2,6-.
Naphthalate, nylon-6, nylon-66, polymeta-xylylene adipamide, polycarbonate, polyvinyl alcohol, poly-4-methylpentene-1, etc., and relatively heat-resistant and dimensional-stable polymers composed of these A gas barrier formed by a known technique such as a vacuum vapor deposition method, an ion plating method, a sputtering method, a sol-gel method, or a chemical vapor deposition method, on one or both sides of a film, a ceramic layer such as silicon oxide or alumina (oxygen aluminum). It means a film, and a silica vapor-deposited polyethylene terephthalate film is a typical example in terms of balance of processability, transparency, gas barrier property and the like. The thickness of the ceramic layer varies depending on the required gas barrier property and the type of polymer film, but generally 0.001 to 1.0 μm per side, more preferably 0.005 per side.
~ 0.8 μm is suitable.

The multi-layer film (C) in the present invention is a multi-layer film containing such a gas barrier ceramic coating film as a layer component, and is made of polyethylene, polypropylene, nylon in view of mechanical properties, sealing properties, pinhole resistance and the like. It is appropriately laminated with a film such as polyester.

Needless to say, it does not prevent inclusion of an ethylene vinyl alcohol copolymer film as a layer component in addition to the ceramic coat film as a component of the multilayer film (C).

Next, the ethylene vinyl alcohol copolymer film in the present invention is obtained by forming an ethylene vinyl alcohol copolymer having an ethylene content of preferably 25 to 50 mol%, more preferably 27 to 45 mol% by a generally known method. Considering gas permeability, it is preferably 3 to 100 μm, more preferably 5 to 7 μm.
A diameter of about 0 μm is suitable.

The multi-layer film (D) in the present invention is a multi-layer film containing such an ethylene vinyl alcohol copolymer film as a layer component, and for the same reason as in the case of (C), a film such as polyethylene, polypropylene, nylon or polyester is used. It is pasted appropriately.

As described at the beginning, the film or sheet (B) of the outer wrapping material in the present invention is composed of the multilayer film of the above (C) and (D) and has a portion (C) as a barrier layer ( The feature is that the portions having D) as a barrier layer are separately present. This gives (C) and (D)
The gas barrier / gas permeability of is utilized. The ratios of (C) and (D) are the type of medicinal liquid, the surface area of the inner packaging material (A) and the outer packaging material with respect to the amount of the medicinal liquid, the atmosphere (temperature and humidity) during storage and transportation of the medicinal liquid, the storage time, and the number of layers. It is appropriately determined depending on the gas barrier property / gas permeability of the films (C) and (D), but generally the area is 95: 5.
To 20:80, more preferably 90:10 to 30:70.
The rank is good. When the ratio of (D) increases. Since it is easily affected by temperature and humidity and the amount of water in the encapsulated drug solution becomes a problem, the ratio of (D) should be as low as possible.

Needless to say, the packaging material (B) may contain a film (sheet) other than (C) and (D) within a range not impairing the gist of the present invention.

The container containing the pharmaceutical solution of the present invention can be manufactured by applying a generally known method. First, the soft plastic container (A) is formed into a sheet by a T-die method, an inflation method, a blow method, etc., and heat-sealed, a member (injection of a medicinal solution
It is manufactured by appropriately attaching (exhaust port, rubber stopper, tube, etc.). The thickness of the container sheet is 0.1-1 mm
Degree is general.

The multilayer films (C) and (D) are also manufactured by using the same method as that of (A) or the laminating method. The thickness of the multilayer film is 0. because of its mechanical properties and ease of handling.
About 0.5 to 0.5 mm is suitable. The outer packaging material (B) is
(C) and (D) may be joined by a heat sealing method (hot plate bonding method, impulse method, ultrasonic method, high frequency method, etc.).

It should be noted that wrapping (A) with (B) is (A)
Before sterilization or after sterilization, it does not matter.

In the present invention, the atmosphere between (A) and (B) may be a vacuum (reduced pressure), nitrogen, etc., and an oxygen scavenger may be added between (A) and (B) depending on the application and requirements. .

The medicinal liquid targeted by the present invention includes not only the above-mentioned amino acid preparation but also physiological saline, electrolyte solution, dextran preparation, mannitol preparation, sugar preparation and the like.

[0023]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.

(Examples 1 to 3 and Comparative Examples 1 and 2) (1) Container and Film Container (A) directly containing the medicinal liquid and the same: Density with hexene-1 as a copolymerization component 0.92 g / cm ² linear low-density polyethylene bag (made of 300 μm-thick sheet, flat shape of 40 × 180 × 130 mm, with rubber plug attached to one end The cylindrical drain port of is fixed)
500 ml of an infusion solution consisting of an aqueous solution containing about 8 wt / V% of amino acid was incorporated into the solution and sterilized under high pressure steam at 115 ° C. for 20 minutes.

Multilayer film (C): A silicon oxide film was formed by a vapor deposition method (the vapor deposition surface was one side), and the thickness was 12 μm.
A nylon 6 film having a thickness of 15 μm was laminated on a low density polyethylene film having a thickness of 50 μm on the vapor-deposited surface side of the polyethylene terephthalate film (1) to obtain a transparent multilayer film (C). The oxygen gas permeability and moisture permeability of this film (C) are shown in Table 1 (using a MOCON device).

Multilayer film (D): 12 μm thick polyethylene terephthalate film, 15 μm thick ethylene vinyl alcohol copolymer film (ethylene content 32 mol%), 12 μm thick nylon film and 50 μm thick low density polyethylene film. By laminating in this order, a transparent multilayer film (D) was obtained.
Table 1 shows the oxygen gas permeability and moisture permeability of this film (D).

[0027]

[Table 1]

Preparation of Container Containing Pharmaceutical Solution: The container containing medical solution (A) was wrapped and sealed within 10 minutes after sterilization with an outer packaging material composed of the multilayer film (C) and / or the multilayer film (D). (The sealing surface is the low density polyethylene side). The total surface area of each of these outer packaging materials is 7
It is 50 cm ² .

Test of time-dependent change of containers containing medicinal liquid: Five kinds of containers containing medicinal liquid were left in an atmosphere of 40 ° C. × 90% RH (12 hours) and left in an atmosphere of 23 ° C. × 90% RH. (12 hours) was repeated 20 times. (20 days in total).

(2) Experimental results (see Table 2) As shown in Table 2, the observation results of the samples obtained in the above-described aging test are as follows: Film (C) alone (Comparative Example 1) and Film (D) alone. It was found that the water droplet generation and the yellowing of the content liquid, which are the respective problems of (Comparative Example 2), were eliminated by the combined use of (C) and (D).

[0031]

[0032]

[Table 2]

[0033]

[0034]

Industrial Applicability As described above, the container of the present invention containing a medicinal solution is produced by skillfully utilizing the characteristics of the ceramic coat film and the ethylene vinyl alcohol copolymer film, and exerts a great effect on the stable storage of the medicinal solution. However, there are few problems during disposal. In addition, the structure is versatile and has high industrial value.

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁶ Identification code Office reference number FI technical display location B65D 75/38

Claims (1)

[Claims] 1. A container comprising a sealed soft plastic container (A) containing a medicinal solution and a sealed film or sheet (B) containing (A), which comprises (B)
Is composed of a multi-layer film (C) part containing a gas barrier ceramic coat film as a layer and a multi-layer film (D) part containing an ethylene vinyl alcohol copolymer film as a layer. .