JP2882839B2 - Container with contents for mixing - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a container containing contents in which contents are separated and sealed in a plurality of containers. More specifically, the present invention relates to a plurality of containers in advance. Before use, the contents containing components that are easily reacted with each other that are isolated and enclosed in
Moreover, the present invention relates to a bag-like container containing contents that can be mixed without exposing the contents to outside air.

[Related Art] Conventionally, there have been many demands for containers that are used immediately after use by mixing two kinds of chemicals or the like in a sealed state immediately before use. For example, when a reaction medium obtained by mixing two kinds of substances is used as a heat medium for keeping or cooling, or when two kinds of substances are mixed and the process is flown or stored for a long time. In particular, there are many demands for foods, pharmaceuticals, and the like that are often denatured.

Above all, pharmaceuticals are chemical substances, and when they are mixed and subjected to a heat treatment step or stored for a long time while being mixed, they often change over time.

For example, a high-calorie infusion used in high-calorie infusion therapy, which has recently become popular,
Basically, it must contain appropriate amounts of all nutrients necessary for the living body, that is, a multi-component infusion containing sugars, amino acids, lipids, major electrolytes, trace metals and vitamins, etc. At the present time, it is impossible to commercialize as a single composite liquid containing all of these in terms of stability over time. For example, when glucose and an amino acid are blended into a one-pack formulation and sealed in a container, a reaction occurs between the glucose and the amino acid during autoclave sterilization and storage, and the infusion solution is colored or deteriorated. Therefore, at present, several types of drug solutions that are marketed separately are used at the time of administration or mixed before administration, and such a method is complicated in operation and can cause dispensing errors. Not only is it not possible to mix with a completely closed system, but also the safety against nosocomial infections is not sufficient.Therefore, there is a demand for a container that can be mixed with a simple and completely closed system immediately before use. ing.

Recently, a plurality of containers are connected to each other, and an isolating means capable of communicating the plurality of containers is provided at the connecting portion. Immediately before use, the isolating means is opened to allow the plurality of drugs filled in the plurality of containers to be filled. Drug-containing containers that can be mixed in one of a plurality of containers have become commercially available. However, the conventional isolation means divides one container into a plurality of chambers and fixes a stopper to the isolation part, and folds the stopper from the outside of the container when in use, or divides the stopper into a plurality of chambers. The open part is partially opened, and this open part is clipped from the outside.In the former plug system, a separately manufactured plug must be placed in the container and bonded to the container. At this time, there was a high risk of contaminating the inside of the container. In addition, it is relatively difficult to bond the stopper and the container, and the material may be limited. For example, high-frequency welding is suitable for the bonding of the three-dimensional structure as described above, but materials that can be bonded by high-frequency welding include polyvinyl chloride resin, ethylene-vinyl acetate copolymer, and even a soft polyester resin. Although it is limited to materials having a large dielectric loss, it is highly safe for living organisms and low in raw material cost, but it is difficult to use a polyolefin resin having a small dielectric loss.

In addition, in the latter clip method, even if the connection has been opened during transportation or storage, it can be confirmed at a timing that can be confirmed, for example, if it is not opened at the time of use, that is, it is completely vulnerable to tampering However, building a medical system in this way has a very difficult problem.

[Problems to be Solved by the Invention] The present invention maintains a plurality of contents containing components that are susceptible to each other in a plurality of containers so that the contents do not deteriorate for a long time until immediately before use. The contents can be stored, and at the time of use, the contents can be mixed with the containers without opening the air by opening the isolating means and allowing the containers to communicate with each other without contacting the outside air. It is an object of the present invention to provide a container with good contents, which can be detected even when the isolation is broken, can be manufactured with a high degree of cleanliness in the container, has good productivity, and is inexpensive.

Means for Solving the Problems The present inventors have conducted intensive studies in order to achieve the above objects, and as a result, a predetermined portion of the inner surfaces of the container wall obtained by inflation molding or blow molding is sealed. Are formed as a plurality of bag-shaped containers, and there is a container with contents in which different contents are sealed in each of the bag-shaped containers,
In addition, a communication means having a flow path and provided with an openable isolation means formed in the middle of the flow path is heat-bonded at each end to the outer surface of each container wall of the plurality of bag-shaped containers. In use, the isolation means is broken and opened, and the plurality of bag-shaped containers are communicated through the communication means, whereby the contents can be mixed without exposing to the outside air, and the container wall of the bag-shaped container has an outer layer. Formed of a resin, the thermal bonding start temperature of the resin of the layer facing the inside of the container is provided higher than the thermal bonding start temperature of the resin of the layer facing the outside of the container, and the outer facing layer It has been found that the above object can be achieved by a container with contents, wherein the connecting means is joined to the container wall by heat bonding the connecting means, and the present invention has been accomplished.

[Specific Description of Configuration] Hereinafter, a medical drug solution bag of the present invention will be specifically described with reference to the drawings as an example.

By applying the present invention, the medical solution bag for medical use can not only prevent deterioration of the contents due to autoclave sterilization and aging, but also prevent contamination by bacteria when mixing the solution in a hospital. An effect can be expected, and further, by selecting a manufacturing method, it is easy to improve the cleanliness in the bag, that is, in the container. Therefore, it can be said that this is an application example in which the effect of the present invention can be most expected. It is.

FIG. 1 is a schematic plan view of a container containing the contents of the present invention, which is filled with two kinds of chemicals containing components that are liable to be degraded when mixed and autoclaved. FIG. 2 is a sectional view taken along the line XX '.

That is, the container 1 containing the contents of the present invention is composed of one container 2 in which the peripheral edges of a pair of sheets facing each other and sealed are sealed, and the other container 3 obtained in the same manner as the container wall 4. For connecting each other independently of the connecting means 6 with each other by means of connecting means 6 adhered to the outer surface 5 of the container. It is also connected by the connecting part 7. The connecting means 6 capable of communication uses the flow path 8 configured to move the contents filled in each container to the other container and the contents filled in each container, that is, And isolating means 9 for the purpose of isolating and storing until mixing, and breaking the isolating means 9 to open the flow path 8 at the time of mixing to communicate the respective containers. It has a mechanism that can do.

The structure of the connecting means 6 may be any structure as long as the separating means 9 can be broken during mixing to open the flow path 8.

FIG. 3 is a sectional view showing an example of the structure of the connecting means 6. The connecting means 6 is provided with a flange-shaped portion 11 for bonding to the container wall 4 and a flow path 8 for communicating the respective containers.
In the middle of the flow path 8 and the tube 12 having a soft raw material, the flow path 8 is closed until the time of use, the front and rear of the flow path 8 are isolated, and the opening point 13 is folded at the time of use, This is a communicable isolation means comprising an isolation means 9 capable of opening the flow path 8 by separating the front and rear of the opening point 13 of the isolation means 9.

In addition, the container has a structure for use when administering the mixed drug solution to the human body, and one end of the container has an outlet 20, that is, a port for discharging the drug solution from the bag. However, at the other end, there is a suspension hole 30, that is, a hole for hanging the container on a gertle table. Generally, the opening of the outlet is provided with a rubber stopper 21, a cap 22, and a diaphragm for preventing the chemical solution from directly contacting the rubber stopper.
Sealed by a cap assembly constituted by 23.

The container 1 is filled in one container 2 with one of two types of chemicals containing components that are liable to be degraded when mixed and sterilized in an autoclave, and the other container 3 is filled with the other chemical. Then, the container containing the contents is sterilized by autoclaving.

In use, the container 1 with its contents is folded by bending the flexible tube from the outside so that the isolation means 9 can be used.
By breaking the opening point 13 of the isolation means 9 and separating the front and rear of the opening point 13 of the isolation means 9, the flow path 8 can be easily opened, and the one container 2 and the other container 3 can be opened.
The two types of liquid medicines sealed in the respective containers can be easily mixed without exposing them to the outside air.

In the container 1, the connecting means 6 of the one container 2 and the other container 3 is constituted independently of the connecting part 7, and the bonding form of the connecting means 6 is 6
Is adhered to the outer surface 5 of the container wall while being kept in close contact therewith, so that a very simple method can be selected for bonding the connecting means 6 to the container wall 4. As a result, the manufacturing process and the manufacturing equipment become very simple, and the stability of the production is improved. Therefore, not only can the manufacturing process be performed at low cost, but also the inner surface of the container is hardly exposed to the atmosphere of the manufacturing process. Since it can be manufactured under the following conditions, the frequency of foreign matter entering the produced container can be significantly reduced.

For example, a hole is formed in at least one of the overlapping container walls of the container without opening the overlapping container wall, and a flange-like portion of the connecting means is provided on a front surface of the container wall on a perforated side. The heating means is pressed against the non-contact surface of the flange-like portion without opening the overlapping container wall,
Before the overlapping container walls are bonded to each other, by bonding the contact surface of the flange-shaped portion and ending the heating, the inner surface of the container is hardly exposed to the atmosphere of the manufacturing process. You can do it. In addition, when it is difficult to select conditions that can bond the contact surface without bonding the overlapping container walls to each other,
By using a multi-layer sheet in which the thermal bonding start temperature of the resin forming the layer facing the inside of the container is higher than the thermal bonding start temperature of the resin forming the layer facing the outside, more secure and stable bonding can be achieved. Is obtained.

In order to bond the connecting means 6 while keeping the connecting means 6 in close contact with the outer surface 5 of the container wall, the bonding surface of the connecting means with the outer surface 5 of the container wall is substantially flat, It must be a plane that can be developed on a plane.

Further, in the container 1, the connecting means 6 of the one container 2 and the other container 3 is formed independently of the connecting portion 7, that is, the total length of the container 1 is increased. By increasing the length of the connecting means 6 without using it, the surrounding area of the isolating means 9 can be made longer, so that the operation of breaking the isolating means is facilitated. That is, the one container 2 and the other container 3 communicate with each other, and the operation of mixing the contents can be easily performed.

Examples of the resin used for the container wall 4 of the container 1 include thermoplastic resins having general flexibility, for example, soft polyester, chlorinated polyethylene resin, vinyl chloride resin, ethylene-vinyl acetate-vinyl chloride graft polymer, It can be selected from ethylene-vinyl acetate copolymer, low-density polyethylene resin, linear low-density polyethylene resin, polybutadiene resin, polybutene resin, polypropylene resin, and copolymers or mixtures of these resins. Also,
It is preferable to stabilize the manufacturing conditions by forming the container wall into a multilayer. In this case, it is preferable to select a resin having a high thermal bonding initiation temperature for the inner layer and a lower resin for the outer layer. I just need. However, when the container is used as a container for filling a medical liquid, a polyolefin resin is preferable, that is, an ethylene-vinyl acetate copolymer, a low-density polyethylene resin, a linear low-density polyethylene resin, Polybutadiene resin, polybutene resin,
What is necessary is just to select from a polypropylene resin and a copolymer or a mixture of these resins. For example, the resin forming the outer facing layer is a polyolefin-based resin, preferably a linear low-density polyethylene-based resin,
The resin forming the inner-facing layer is a resin mixture of another polyolefin-based resin having a higher thermal bonding initiation temperature than the resin forming the outer surface, preferably,
A sheet having a structure that is a resin mixture of a linear low-density polyethylene-based resin and a polypropylene-based resin is used as a raw material for the bag-like container containing the contents of the present invention.

The appropriate mixing ratio of the resin mixture depends on the type of the resin to be used, the degree of copolymerization, etc., and the compatibility between the resins to be mixed and the sealing temperature. The mixing ratio of the resin having a higher melting start temperature is 10 to 90% Production conditions,
That is, in order to make the bonding conditions more stable, it is preferable that the resin having a higher thermal bonding start temperature has a thermal bonding start temperature higher by 8 ° C. or more than the resin having a lower thermal bonding start temperature. More preferably, the resin having the higher melting start temperature is a polypropylene resin or a copolymer thereof, and the mixing ratio thereof is preferably in the range of 20 to 80%.

Further, the container wall can be obtained by any of the inflation molding method, the blow molding method, the extrusion molding method, and the calendar molding method. One of the effects of the container containing the contents of the present invention, that is, it is not expected that the amount of foreign matter mixed is small. Therefore, among the above-mentioned molding methods, an inflation molding method and a blow molding method which can mold the inner surface of the container without exposing the inner surface of the container to the outside air in which foreign matters float are preferable. However, other molding methods cannot be adopted because it can be manufactured with less foreign matter adhered to the inside surface of the container by a management method at the time of molding and after molding.

Further, as the resin forming the connecting means, a resin having sufficient compatibility with the resin used for the outer layer may be selected from the above resins. Preferably, the same resin as the resin used for the outer layer or its injection molding grade is selected.

It is necessary to select a resin suitable for the structure as the resin forming the isolating means 9. However, if the resin has the form shown in FIG. 3, a polypropylene resin, a high-density polyethylene resin, polycarbonate It can be selected from relatively hard resins such as resin, vinyl chloride resin and polyester resin. As a method for sealing the separating means 9 and the connecting means 6, a heat seal is preferable, but an adhesive method using an adhesive,
Alternatively, sealing or the like by fitting can be selected.

Here, the thermal bonding start temperature means that when the object to be welded is heated for a certain period of time (for example, this time is set to 20 seconds) in a state where the object to be welded is adhered, the object to be welded is melted. It represents the lowest temperature at which substantial adhesion occurs.

The heating medium may be a normal heater, an impulse heater, or a heating medium utilizing heat generation such as ultrasonic waves, high-frequency induction, or high-frequency induction.

Example 1 By a multilayer inflation molding machine. Linear low-density polyethylene (trade name: Nipolon-L, manufactured by Tosoh Corporation, density: 0.925 g / cm ³ , MI: 0.8) and polypropylene (trade name: Chisso Polypro, manufactured by Chisso Corporation, density: 0.90 g)
/ cm ³ , MI: 0.7) in a ratio of 1: 1 having a 30 μm layer (a thermal bonding initiation temperature of 156 ° C.) made of a resin mixture in the inner layer,
Folded diameter having a layer of linear low-density polyethylene (trade name: Nipoloso-L, manufactured by Tosoh Corporation, density: 0.925 g / cm ³ , MI: 0.8) 220 μm (thermal bonding initiation temperature: 117 ° C.) in the outer layer
A 250 mm multilayer inflation sheet was formed. The inner diameter is 6.6 m with linear polyethylene (trade name: Nipolon-L, manufactured by Tosoh Corporation, density: 0.920 g / cm ³ , MI: 20).
m, connecting means having a flange having a thickness of 0.7 mm and an outer diameter of 14 mm at both ends of a cylindrical molded product having an outer diameter of 8 mm, and an inner diameter of 17 mm,
One end of a cylindrical molded product with an outer diameter of 21 mm, width 1 mm, outer diameter 37 m
Ports with m flanges were molded. Isolation means shown in Fig. 3 using a polycarbonate resin (trade name: NOVAREX, Mitsubishi Kasei Kogyo Co., Ltd.), that is, an inner diameter of 4 mm and an outer diameter of 7 m
An isolation means consisting of a cylindrical portion having a length of 15 mm and a length of 15 mm and a rod-shaped portion having an outer diameter of 5 mm and a length of 12 mm connected to each other by a thin film while sealing one open end thereof was formed. Then, the separating means was pushed into the inside diameter of the connecting means, thereby closing the flow path of the connecting means.

Next, the inflation sheet was cut into a width of 200 mm, a port was bonded to one fold side, a bottom part having a hanging hole was formed on the other fold side, both sides were sealed, and one container was sealed. Had made. Further, a center seal for separating the vicinity of the center of the container into two containers on the suspension portion side and the port side of the container was performed.

Next, a hole is punched with a punch through the overlapping upper and lower sheets at a position where the connecting means is adhered to the container wall of the container on the suspension part side and the container on the port side, and one of the container walls having the hole is opened. A flange-like portion of the connecting means whose flow path is closed by an isolation means on the front surface is brought into close contact with the hole so that the flow path coincides with the flow path. 145 ° C on the other side of the part
The hot plate was pressed through a 0.18 mm Teflon glass cloth with little pressure for 15 seconds to bond the connecting means to the respective container walls. A hole formed in the opposite surface of the container was sealed with a sheet made of the same material as the connecting means in the same manner as the connecting means. Then, the connecting means and the container wall were sufficiently welded, but the container walls were not welded to each other, whereby the container was obtained in which the connecting means was adhered.

The seals on both sides were sealed with an impulse sealing machine (model FA-300-5w) manufactured by Fuji Impulse Co., Ltd. under the sealing conditions of 1.5 seconds of heating and 5 seconds of cooling. Also,
The seal of the suspension portion was sealed by a heat seal machine manufactured by the company under a sealing condition of 170 ° C. and 12 seconds through 0.1 mm of Teflon glass cloth.

Next, each container was filled with distilled water filtered by a membrane filter having a pore size of 0.45 μm, that is, purified water for fine particle test according to the Japanese Pharmacopoeia, from a port or a filling port opened in the container wall, and each opening was filled. After sealing the part, the autoclave was sterilized. After confirming that there is no leakage, the water filled in the container on the side of the hanging hole is easily transferred to the container on the side of the discharge port by folding and separating the separating means incorporated in the connecting means and connecting them. Could be transferred to In addition, the degree of contamination of the filling liquid with foreign substances was examined according to the insoluble particle test method for injections prescribed in the Japanese Pharmacopoeia, and it was confirmed that the test method was compatible with the test method.

Example 2 Another connecting means whose sectional view is shown in FIG. 4 was formed as follows. That is, linear polyethylene (trade name: Nipolon-L, manufactured by Tosoh Corporation, density: 0.920 g /
cm ³ , MI: 20) At both ends of the cylindrical molded product having an inner diameter of 6.6 mm and an outer diameter of 8 mm, a flange having a thickness of 0.7 mm and an outer diameter of 14 mm is provided. And a bamboo spear having an inner diameter of 3 mm, an outer diameter of 5 mm, and a length of 15 mm in polypropylene (trade name: Chisso Polypro, manufactured by Chisso Corporation, density: 0.90 g / cm ³ , MI: 0.7). A shaped product 15 was formed. And on one side of the isolation means of the coupling means,
The sharp end was placed toward the separator 14.

Next, the container was manufactured in the same manner as in Example 1, filled with purified water for fine particle test, each opening was sealed, and then autoclaved. After confirming that there is no leakage, the bamboo spear-shaped molded product 15 is pierced and communicated with the separating membrane 14 incorporated in the connecting means, whereby water filled in the container on the suspension hole side is discharged. When transferred to a container, it could be easily transferred. In addition, when the degree of contamination of the filling liquid with foreign substances was examined by the same method as in Example 1, it was confirmed that the liquid was suitable for the insoluble fine particle test method.

[Effects of the present invention] As described above, the container containing the contents of the present invention maintains a plurality of contents containing components that are susceptible to each other in a state of being isolated from each other in a plurality of containers, so that the container is ready for use. Can be stored for a long period of time without deterioration, and at the time of use, the contents can be easily mixed without contacting the outside air by opening the isolation means and communicating between the plurality of containers. The isolation means has a good hermeticity, can be found even if the isolation is broken, can be manufactured with a high degree of cleanliness in the container, is highly productive and is inexpensive. Can be provided.

If the container with the contents of the present invention is used for a medical container,
Further, the following advantages can be obtained.

Since the material of the container can be all polyolefin resin, a container with highly safe contents can be obtained. Also,
Since a flexible resin can be selected for the container, an ideal closed system infusion system can be assembled.

[Brief description of the drawings]

FIG. 1 is a schematic plan view of a container containing the contents of the present invention, which is filled with two kinds of chemicals containing components that are liable to be degraded when mixed and autoclaved. FIG. 2 shows the X
It is -X 'sectional drawing. FIG. 3 is a sectional view of an example of the structure of the connecting means, and FIG. 4 is a sectional view of another example of the structure of the connecting means. 1. Container with contents, 11. Flanged part 2. One container, 12. Tube 3. The other container, 13. Opening point 4. Container wall, 14. Isolation membrane 5. Outer surface, 15. Bamboo spear -Shaped molded product 6. Connecting means, 20. Outlet 7. Connecting part, 21. Rubber stopper 8. Flow path, 22. Cap 9. Isolating means, 23. Diaphragm, 30. Hanging hole

Claims (3)

(57) [Claims] 1. A predetermined portion between inner surfaces of a container wall obtained by inflation molding or blow molding is sealed to form a plurality of bag-shaped containers, and different contents are enclosed in each of the bag-shaped containers. Each of the ends of the communication means having a flow path and provided with an openable isolation means formed in the middle of the flow path is provided on each wall of the plurality of bag-shaped containers. The contents can be mixed without exposing the contents to the outside by being thermally bonded to the outer surface, breaking open the separating means at the time of use and opening the bag, and communicating the plurality of bag-shaped containers through the communicating means. The container wall of the container is formed of an outer layer resin, and the thermal bonding start temperature of the resin of the layer facing the inside of the container is provided higher than the thermal bonding start temperature of the resin of the layer facing the outside of the container, The outer facing layer and the connecting means are thermally bonded The container with contents, wherein the connection means is joined to the container wall. 2. The resin forming the multilayer is a polyolefin resin, and the resin forming the layer facing the inside is:
The container with contents according to claim 1, wherein the container is a mixture of two or more kinds of polyolefin resins. 3. The resin mixture having a low heat-bonding initiation temperature among the resin mixture forming a layer facing the inside of the container wall, the resin forming a layer facing the outside of the container wall. The content-containing container according to claim 2, wherein the resin having a higher thermal bonding start temperature has a mixing ratio of 10 to 90% by weight in the resin mixture.