JP3016347B2 - Manufacturing method of multi-chamber container - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a flexible multi-chamber container in which a liquid preparation and a dry preparation such as a powder preparation and a solid preparation are separately stored, and the liquid preparation and the dry preparation can be mixed at the time of use. It relates to a manufacturing method.

[0002]

2. Description of the Related Art A flexible multi-chamber container having a partitioning means which can be used in a medical field and which has a communication means is usually made of a synthetic resin, so that a very small amount of moisture and gas can be permeated. Therefore, for example, in the case of a multi-chamber container containing a hygroscopically unstable drug over time, such as an antibiotic, and a liquid solution such as a dissolving solution or a diluting solution, or a drug that easily oxidizes, such as tryptophan, Contains amino acid solution and sugar
In the case of a multi-chamber container containing an electrolyte solution, it is necessary to devise a method for preventing a temporal change due to moisture, oxygen, and the like (Japanese Patent Publication No. Sho 63-20550). Then, in order to prevent such a change over time due to moisture or oxygen, it is necessary to store it in an outer bag having a barrier property against moisture and gas together with a desiccant and an oxygen scavenger. Since the moisture of the liquid is absorbed, the hygroscopic drug cannot be dried sufficiently, and the liquid is concentrated. In order to solve such a problem, among the chambers of the multi-chamber container, an outer wall which is impermeable to moisture and gas is formed around a chamber for accommodating a drug or the like having hygroscopicity or oxidizability. Coated with a desiccant or a deoxidizer inside the outer wall (JP-A-4-364850, JP-A-4-364851, JP-A-6-149).
No. 75 gazette) has been proposed.

In these conventional multi-chamber containers, a medicine accommodating chamber and a medicinal liquid accommodating chamber are integrally formed, a medicinal liquid accommodating chamber is filled with a medicinal liquid, a stopper is attached to the medicinal liquid accommodating chamber and sealed, and after sterilization,
A medicine is housed and sealed in the medicine accommodating chamber, and the medicine accommodating chamber is covered with a packaging material having a barrier property against moisture and gas. Therefore, the medicine storage chamber and the medicine storage chamber cannot be sterilized separately. The medicine storage section is filled with the drug solution, sterilized once and dried, and then the seal portion of the medicine storage section is cut to aseptically store the medicine. You need to
There are drawbacks such as that the production is troublesome, and that steam does not enter the medicine container during steam sterilization, so that sterilization of this part may be incomplete.

[0004]

DISCLOSURE OF THE INVENTION The present invention has been made in view of the above circumstances, and a multi-chamber container which can sterilize a medicine chamber and a medicine chamber separately and does not require any trouble in manufacturing. It is an object of the present invention to provide a method for producing the same.

[0005]

SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, the present invention provides first and second seals each having a weak seal on one side.
Forming the first bag and the second bag, and welding the first bag and the second bag with each other at the weak seal portions to fluid-tightly connect the first bag and the second bag. When the weakly sealed portions of the bags 2 were peeled off,
A method of manufacturing a multi-chamber container in which the bag and the second bag are in liquid communication is adopted. Here, the weak seal portion can be formed by sandwiching the weak seal portion forming sheet between the plastic sheets constituting the bag and welding. In this case, the first bag and the second bag are welded by inserting the weak seal portion of the first bag so that the weak seal portion forming sheet is buried for a predetermined length in the two plastic sheets. Plastic sheet
And by welding the overlapped portion with the sheet for forming the roll portion , the weakly sealed portion of the second bag is
Insert the weak seal part forming sheet outside the cylindrical plastic sheet so as to protrude by a predetermined length, and
The weak seal portion is formed by welding an overlapped portion with the weak seal portion forming sheet, and the weak seal portion of the second bag is inserted between the two non-welded plastic sheet portions of the first bag, The sheet for forming the weak seal portion of the first bag and the sheet for forming the weak seal portion of the second bag are adjacent to each other, and the second bag of the second bag is located between the two non-welded plastic sheets of the first bag. Preferably, at least a part of the weakly bonded portion overlaps, and an overlapping portion between the two unsealed plastic sheet portions of the first bag and the weakly sealed portion of the second bag is welded. Further, the weak seal portion forming sheet is preferably formed of a material obtained by blending a plastic forming an inner layer of a plastic sheet constituting the bag and a plastic having no compatibility with the plastic.

[0006]

According to the above construction, since the first bag and the second bag are manufactured separately, sterilization can be performed separately. In addition, for example, when a medicine is stored in the first bag, the first bag can be sterilized by a method other than steam sterilization. Therefore, it is necessary to seal four sides of the bag so that water vapor does not enter the bag. Therefore, the inside of the first bag can be completely sterilized. Furthermore, for example, when the second bag is filled with a drug solution, the second bag is filled with the drug solution, steam-sterilized, dried, and then immediately sealed without cutting the first portion. Since it can be connected to a bag, there is no need for labor for accommodating the medicine.

[0007]

Next, an embodiment of the present invention will be described with reference to the drawings. 1 is a diagram showing a manufacturing process of a first bag, FIG. 2 is a diagram showing a manufacturing process of a second bag, and FIGS. 3 and 4 show a process of connecting the first bag and the second bag. FIG. 5 is an enlarged sectional view taken along line XX of FIG. The method for producing a multi-chamber container according to the present invention comprises the first method in which one side is weakly sealed.
Forming the second bag 1 and the second bag 1, and bonding the first bag 1 and the second bag 2 to the respective weak seal portions 19,
29, and a step of fluid-tightly connecting the first bag 1 and the first bag 1 when the weak seal portion 19 of the first bag 1 and the weak seal portion 29 of the second bag 2 are peeled off. It is characterized in that the second bag 2 is in liquid communication.

The manufacture of the first bag 1 (here, described as a medicine-containing bag for convenience) is performed by the steps shown in FIG. That is, first, a sheet 11 on the back side (rear sheet), a sheet 13 on the front side (front sheet), and a sheet 12 for forming a weak seal portion are prepared, and as shown in FIG. Two sheets 1
1 and 13 so as to be buried for a predetermined length. Next, the side edges 15, 16 of the overlapping portion of the sheets 11, 13 and the band portion 14 passing through the overlapping portion of the sheets 11, 12, 13 are welded to form a bag-like one as shown in FIG. I do. At this time, the welded portion between the weak seal portion forming sheet 12 and the sheets 11 and 13 and the unwelded portion outside the band-like portion 14 of the sheets 11 and 12 become the weak seal portion 19. And this bag-like thing is
After sterilization with OG etc., the opening 17 of the bag
After filling with a drug (not shown) from above (see FIG. 1-C), the opening 17 may be welded (see FIG. 1-D).

Here, the rear sheet 11 is preferably an aluminum foil laminated film. For example, PET / aluminum foil / PE, in which the outermost layer is a polyethylene terephthalate (PET) layer and the innermost layer is a polyethylene (PE) layer.
Is preferably adopted, but another resin layer may be further interposed between the aluminum foil and the PE. Further, as the front sheet 13, a laminated film including a silica (SiO ₂ ) vapor-deposited layer is suitable. For example, the outermost layer is a copolymer of polyethylene and polypropylene (PP),
(PE + PP) / SiO, the innermost layer being polyethylene
_{A 2} / PET / SiO ₂ / PE configuration is employed.
The outermost layer may be polyethylene. The rear sheet 11 and the front sheet 1 are used as the weak seal portion forming sheet 12.
For example, a resin having a low welding strength (weak adhesion) with polyethylene as a resin constituting the innermost layer of No. 3 is adopted.
A polymer blend of polyethylene and a resin having no compatibility with the resin (for example, polypropylene) is preferably employed. Here, the mixing ratio of polyethylene and polypropylene is preferably 3: 7 to 7: 3.

On the other hand, the manufacture of the second bag 2 (which will be described here as a chemical solution storage bag for convenience) is performed by the steps shown in FIG. That is, first, as shown in FIG. 2A, a tubular sheet 21 (2) made of the same resin as the resin constituting the innermost layer of the first bag 1, for example, polyethylene.
2), and a weak seal portion forming sheet 22 is prepared, and the weak seal portion forming sheet 22 is fixed outside the cylindrical sheet 21 as shown in FIG. The sheets 21 and 22 are arranged so as to protrude long.
Is welded to one opening edge 23 of the cylindrical sheet 21 passing through the overlapping portion of the cylindrical sheet 21 to form a bag-like one. At this time, the weak seal portion forming sheet 22 protruding from the welded portion between the weak seal portion forming sheet 22 and the tubular sheet 21 and the opening edge 23 becomes the weak seal portion 29. Then, the port portion 25 is welded to the other opening portion 24 (see FIG. 2C), then the shoulder portion 26 of the opening portion 24 is welded and sealed as shown in FIG. Form a bag as shown in 2-E. Finally, a chemical solution (not shown) is filled from the port 25 and the plug 28 is inserted into the port 25.
(See FIG. 2-F). The second bag 2 is filled with a chemical solution, and a stopper 28 is attached to the port 25, and then subjected to high-pressure steam sterilization. In addition, as the tubular sheet 21, polyethylene or polypropylene is usually suitably used. As the weak seal portion forming sheet 22, the same material as the weak seal portion forming sheet 12 of the first bag 1 is employed. Further, the projecting length of the weak seal portion forming sheet 22 in the second bag 2 is determined by the first length.
When the first bag 1 is connected to the non-welded portion outside the band portion 14 of the first bag 1 and the second bag 2
In order to make the tubular sheets 21 overlap each other, that is, to prevent the leakage of the chemical solution when the weak seal portion is peeled off, the embedded length of the weak seal portion forming sheet 12 in the first bag 1 is reduced. It is decided smaller than.

Next, the connection between the first bag 1 and the second bag 2 will be described. First, a first bag 1 and the second bag 2 is arranged as shown in FIG. 3, then, a weak seal in the weak seal part 29 first bag 1 second bag 2 as shown in FIG. 4 The two non-welded plastic sheet portions of the first bag 1 are inserted into the two non-welded plastic sheet portions of the portion 19, and the two non-welded plastic sheet portions of the second bag 2 are weakly sealed. The 29 overlapping portions 3 may be welded. In this case, the first bag 1
The two plastic sheet portions of the first bag 1 and the welded portion of the weak sealing portion forming sheet 22 of the second bag 2 are weakly sealed, but the two plastic sheet portions of the first bag 1 and the second bag 2 The welded portion of the tubular sheet 21 is firmly welded. In addition, the weak seal portion 29 of the second bag 2
Sheet seal portion 1 for forming weak seal portion of first bag 1
9 into the two non-welded plastic sheet portions, the sheet 1 for forming a weakly sealed portion of the first bag 1
2 and the weak seal portion forming sheet 22 of the second bag 2 are preferably adjacent to each other, and the weak seal portions (19, 2
(Parts 9 and 3) are peeled off, so that the leakage of the chemical solution does not occur, even if the weak seal portion forming sheets 12 and 21 are separated from each other, even if the weak seal portion 19 of the first bag 1 is separated. At least a part of the tubular sheet 21 of the second bag 2 must be overlapped between the two plastic sheets that are not welded (see FIGS. 4 and 5).

Example 1 Production of First Bag: Aluminum foil laminated film (PET / aluminum foil / PE) as rear sheet, and polymer blend of polyethylene and polypropylene (PE: PP = 7: 3), a laminated film PE containing a silica deposition layer as a front sheet /
Using _{SiO 2 / PET / SiO 2 /} PE. A weak seal portion forming sheet is point-welded to the PE side of the rear sheet, and a front sheet is overlapped with this to seal both side edges and a band-shaped portion of the weak seal portion forming sheet having a narrow width of about 5 mm. Manufacture of the second bag: a cylindrical sheet made of polyethylene and a sheet for forming a weakly sealed portion (PE + PP, mixing ratio 7: 3)
You are using The weak seal portion forming sheet is made to protrude by about 5 mm from the tubular sheet, and the seal width is made narrower by about 5 mm above and below the weak seal portion forming sheet. The weakly sealed portion of the multi-chamber container made according to the method of the present invention could be easily peeled off by pushing the second bag by hand. Also, no leakage of the chemical solution occurred.

[0013]

As is apparent from the above description, by employing the present invention, the medicine storage chamber (first bag) and the chemical storage chamber (second bag) can be sterilized separately. Therefore, it is possible to reliably sterilize the medicine storage chamber, and to omit extra work for storing the medicine, thereby saving the manufacturing labor and the cost. Can be

[Brief description of the drawings]

FIG. 1 is a diagram showing a manufacturing process of a first bag.

FIG. 2 is a diagram showing a manufacturing process of a second bag.

FIG. 3 is a view showing a step of connecting a first bag and a second bag.

FIG. 4 is a view showing a step of connecting a first bag and a second bag.

FIG. 5 is an enlarged sectional view taken along line XX of FIG. 4;

[Explanation of symbols]

 REFERENCE SIGNS LIST 1 first bag 11 rear sheet 12 sheet for forming weak seal portion 13 front sheet 14 band portion 2 second bag 21 tubular sheet 22 sheet for forming weak seal portion 23 opening edge 3 overlapping portion

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61J 1/05 A61J 1/20 B65D 25/08 B65D 77/04

Claims (4)

(57) [Claims] 1. A step of forming first and second bags having one side weakly sealed, and the first bag and the second bag are welded to each other at the respective weakly sealed portions and connected in a fluid-tight manner. A two-chamber container wherein the first bag and the second bag are in liquid communication when the weak seal portion of the first bag and the weak seal portion of the second bag are peeled off, respectively. Manufacturing method. 2. The method for manufacturing a multi-chamber container according to claim 1, wherein the weakly sealed portion is formed by sandwiching and welding a sheet for forming a weakly sealed portion between plastic sheets constituting a bag. 3. The weak seal portion of the first bag is inserted into the two plastic sheets so that the weak seal portion forming sheet is embedded in the two plastic sheets for a predetermined length.
And by welding the overlapped portion with the sheet for forming the roll portion , the weakly sealed portion of the second bag is
Insert the weak seal part forming sheet outside the cylindrical plastic sheet so as to protrude by a predetermined length, and
The overlapped portion with the weak seal portion forming sheet is formed by welding, and the weak seal portion of the second bag is inserted into the two non-welded plastic sheet portions of the first bag to form the first bag. Adhesion of the second bag between the two unsealed plastic sheets of the first bag, wherein the weak seal forming sheet of the second bag is adjacent to the weak seal forming sheet of the second bag The unfused 2 of the first bag with at least part of the parts overlapping
3. The method for manufacturing a multi-chamber container according to claim 2, wherein an overlapping portion of the two plastic sheet portions and the weakly sealed portion of the second bag is welded. 4. The sheet according to claim 3, wherein the weak seal portion forming sheet is formed of a material obtained by blending a plastic forming an inner layer of a plastic sheet constituting the bag and a plastic having no compatibility with the plastic. Manufacturing method of multi-chamber container.