JPH03236847A - Drug-contained receptacle having plural chambers - Google Patents

Abstract

PURPOSE:To surely keep plural drugs in isolation until they are used and to mix the same easily in air-tight condition at the time of use by screening a communicating chamber formed by communicating means, by means of a member for forming one chamber, and breaking the member for forming the chamber so as to mix drugs sealed in the chambers through the communicating chamber. CONSTITUTION:A receptacle 1 comprises an entrance portion 2, a receptacle portion 3 and a suspension opening portion 4, wherein the receptacle portion 3 is separated into the first chamber 5 and the second chamber 6 by an isolation means 7. A communi cating means 8 is liquid-tightly welded on the outer surface of the receptacle portion 3 in such a manner as to stride over the isolation means 7, and the first chamber 5 and the second chamber 6 are connected to each other by the communicating means 8. Different drugs are poured into the first chamber 5 and the second chamber 6, and the entrance portion 2 is sealed up by a cap 10. The suspension opening portion 4 has a suspension opening 9 to be caught by a suspension base. The communicating means 8 comprises a communication element 21, breaking members 22, 23 and a bearer 24, wherein the communication element 21 is pressed, a plastic sheet 27 of a member forming the first chamber 5 and the second chamber 6 are pierced by the breaking members 22, 23 to mix the drugs sealed in the chambers 5, 6 in the receptacle portion 3.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to a container containing a drug having a plurality of chambers. In particular, the present invention relates to a deformable drug-containing container that can contain a plurality of components that react with each other, such as high-calorie infusion solutions and elemental diets (hereinafter abbreviated as ED) used in closed medical systems.

[Prior Art] In recent years, high-calorie infusion methods for ingesting all the nutrients necessary for living organisms through veins have become popular.

High calorie infusion method is applied for cases of gastrointestinal sutural incompetence,
In cases where oral intake is insufficient or impossible due to gastrointestinal transit disorders, cases where oral intake is not desirable due to inflammatory bowel disease, severe diarrhea, etc., high-calorie supplementation that exceeds enteral supplementation is required in cases such as extensive burns or multiple severe injuries. If desired, metabolic specificities due to diseases such as liver failure, kidney failure, or diabetes may be applied.

The high-calorie infusion preparation used in the high-calorie infusion method basically contains all the nutrients necessary for the living body in appropriate amounts. That is, it is a multicomponent infusion containing carbohydrates, amino acids, lipids, major electrolytes, trace metals, and vitamins. However, it is currently impossible to commercialize a composite liquid containing all of these in terms of blendability and stability. Therefore, three methods are currently used.

■Use a commercially available high-calorie infusion base solution. This is a high concentration glucose solution mixed with major electrolytes, and when used, amino acids are mixed, and vitamins and insufficient electrolytes are added.

■Administer commercially available hypertonic glucose solution and amino acid solution by mixing them or by combining both.

■High-calorie infusion basic solution or glucose solution is prepared independently in the pharmacy formulation room.

In any case, the amino acid solution is mixed with the basic solution for high-calorie infusion or the hypertonic glucose solution at the time of use and administered to the patient.

[Problems to be solved by the invention] Conventionally, when glucose and amino acids were blended into a one-component formulation and sealed in a container, a reaction occurred between the glucose and the amino acid during high-pressure steam sterilization and storage, resulting in coloring of the infusion solution. . For this reason, as mentioned above, it is currently not possible to mix drugs that contain components that easily react with each other, such as glucose and amino acids, into a one-component preparation, and these drug solutions must be mixed at the time of use and administered to patients. are doing. In addition, for drugs such as ED that cannot be stored for long periods of time due to loss of stability if stored in a solution state, separate the drug into a powdered drug and a solution and mix them together immediately before use. administered to patients. As described above, the operation of mixing at the time of use may lead to dispensing errors, and there are also problems such as contamination during mixing.

Furthermore, in recent years, home health care has been attracting attention, and in the future there is a desire for a system that can reliably mix multiple drugs without making mistakes so that infusions can be easily performed at home.

An object of the present invention is to provide a drug-containing container having a plurality of chambers that can stably sterilize and store drugs containing components that are likely to react with each other for a long period of time.

Measures to Solve Problem E] As mentioned above, if drugs containing components that react with each other are made into one-part preparations, the drug solution will change color or deteriorate during sterilization or long-term storage, so be careful when using it. Need to mix. Problems such as dispensing errors and contamination have occurred during this mixing. In order to solve this problem, a container with multiple chambers is formed, and each chamber is filled with a predetermined amount of drugs containing components that are likely to react with each other. The above-mentioned problems can be solved by communicating the drugs with each other and mixing the drugs in the container.

The present invention has been made by the inventors in order to provide a container that can reliably isolate multiple drugs until they are used, and that can easily mix multiple drugs in a sealed state during use. As a result, the container is made up of a plurality of chambers and communication means for connecting the respective chambers, and the communication chamber constituted by the communication means is shielded by a member constituting at least one of the chambers, It has been found that by destroying the member, it is possible to provide a drug-containing container having a plurality of chambers in which the drugs sealed in the respective chambers can be mixed through the communication chambers constituted by the communication means. .

[Effect] Next, the present invention will be specifically explained based on the drawings.

FIG. 1 shows a drug-containing container 1 having a plurality of chambers manufactured according to the present invention.
It is composed of a hanging opening part 4.

The container section 3 is separated into a first chamber 5 and a second chamber 6 by an isolation means 7. A communication means 8 is liquid-tightly welded to the outer surface of the container portion 3 so as to straddle the isolation means 7, and connects the first chamber 5 and the second chamber 6. Different drugs are injected into the first chamber 5 and the second chamber 6, and the mouth part 2 is sealed with a stopper 10. Further, the suspension opening portion 4 has a suspension opening 9 for hanging on a suspension table.

The communication means 8 can take various forms. A specific form of the first embodiment of the communication means is shown in FIG.

The communication means includes the communication body 21, the destruction member 22, 23, and the pedestal 2.
It consists of 4. The communication body 21 has a bellows-like shape that can be expanded and contracted. The communication body 21 is liquid-tightly welded to one outer surface of the container portion 3 to form a communication chamber 25. Destructive members 22 , 23 are fixed inside the communication body 21 . The pedestal 24 is liquid-tightly welded to the other outer surface of the container portion on the opposite side to which the communication body 21 is welded, and forms a communication chamber 26 . This communication chamber 26 is not necessarily required. That is, this is because the communication chamber 25 exists as a communication path between the first chamber 5 and the second chamber 6. In addition, a stopper 53 as shown in FIG. 12 is provided to prevent the bellows portion of the communication body 21 from expanding and contracting so that the destructive members 22 and 23 do not penetrate the plastic sheet 27 during storage or transportation of the container.
may be provided.

The communication body 21 is pressed down from the outside, and the destruction members 22 and 23 are
The plastic sheet 27, which is the member forming the first chamber 5 and the second chamber 6, is penetrated. The state at that time is shown in FIG. At this time, two plastic sheets 27
, but it is also possible to penetrate only one plastic sheet.

In this case, since the pedestal 24 is not required, an embodiment of the communication means without a pedestal is also conceivable. Furthermore, the communication chamber 25 is in a sealed state, the air inside is compressed, and the destruction member 22
．． If a large force is required to penetrate the plastic sheet 27 through the passage 23, it is preferable to attach a hydrophobic filter to a part of the communication body 21. Since the hydrophobic filter does not allow aqueous solution to pass through it, but allows air to pass through it, it is easy to remove the destruction member 22. without increasing the pressure inside the communication chamber 25.
23 can be passed through the plastic sheet 27.

Next, the communicating body 21 is returned to its original state, and the state at that time is shown in FIG. Through holes 28 are provided in the first chamber 5 and the second chamber 6, respectively.
．． 29 is created, and the first chamber 5 and second chamber 6 are communication chambers 25.26
The medicines sealed in the first chamber 5 and the second chamber 6 are mixed in the container part 3.

Although the structure of the communication body 21 of the communication means 8 of the first embodiment shown in FIG. 2 is shown in the form of an expandable bellows, it may have any shape as long as it is expandable.
Further, the material forming the communication body may be made of a stretchable rubber-like material, and is not limited to a bellows-like shape.

Further, another form of the communication means 8 is shown in FIG.

The communication means includes a communication body 31, a breaking member 32, and an O-ring 33.
and a pedestal 34. Communication body 31 and destruction member 3
2 is assembled using an O-ring 33 so that it can slide in a liquid-tight manner. The communication body 31 is liquid-tightly welded to one outer surface of the container portion 3 to form a communication chamber 35. pedestal 34
is liquid-tightly welded to the other outer surface of the container portion on the opposite side to which the communicating body 31 is welded, forming a communicating chamber 36.

The destructive member 32 is pressed down from the outside, and the plastic sheet 37 forming the first chamber 5 and the second chamber 6 is penetrated by the destructive member 32. The state at that time is shown in FIG.

Next, the destruction member 32 is returned to its original position. The state at that time is the seventh
As shown in the figure. The first chamber 5 and the second chamber 6 have through holes 38 and 39, respectively, and the second chamber 5 and the second chamber 6 have a communication chamber 35.
36, and the medicines sealed in the first chamber 5 and the second chamber 6 are mixed in the container part 3.

Furthermore, another form of the communication means 8 is shown in FIG.

The communication means is composed of a communication body 41, a breaking member 42, and a pedestal 44. The communication body 41 has a bellows-like shape that can be expanded and contracted. The communication body 41 is liquid-tightly welded to one outer surface of the container portion 3 to form a communication chamber 45.

The destruction member 42 is fixed inside the communication body 41.

The pedestal 44 is liquid-tightly welded to the other outer surface of the container portion on the opposite side to which the communication body 41 is welded, and forms a communication chamber 46 . A communication port 49 is provided in advance in a part of the plastic sheet constituting the second chamber 6. The communication port 49 may be formed by penetrating two plastic sheets, or may be formed by opening only one of the plastic sheets.

The communicating body 41 is pressed down from the outside and the destructive member 42 is used to
The plastic sheet 47 forming the chamber 5 is penetrated. The state at that time is shown in FIG.

Next, the communicating body 41 is returned to its original position. The state at that time is number 10.
As shown in the figure. A through hole 48 is formed in the first chamber 5, and the first chamber 5 and the second chamber 6 are communicated with each other through a communication chamber 45, 46, and the medicine sealed in the first chamber 5 and the second chamber 6 is transferred to the container part 5. mixed inside.

Next, a method for manufacturing the container of the present invention will be explained. The container part 3 is made of two stacked plastic sheets, and the mouth part 2 is welded to the container part 3 using a molded product formed by injection molding.

As for the material of the plastic sheet, there are almost no restrictions due to manufacturing methods, and it is important to select resins that are suitable for the purpose of the container, such as safe and inexpensive polyolefin resins, modified polyolefin resins, and polyester resins. I can do it.

The plastic sheet is formed by inflation molding, calendar molding, T-die extrusion molding, or the like. By these molding methods, single-layer or multi-layer sheets can be produced.

Here, a case will be described in which a sheet produced by calender molding or T-die extrusion molding is used. first,
Cut the sheet to size. Next, the outer seal 11 and the isolation means 7 are sealed by heat welding, and the container part 3 is sealed.
form. After welding, the unnecessary parts on the outside of the suspension opening 9 and the outer peripheral seal 11 are cut and removed.Next, the communicating body 21 and the pedestal 24 of the communicating means are sandwiched between the two plastic sheets constituting the container part 3. Heat weld. At this time, the plastic sheets are not welded together and the communication body 21
It is important to set the heating conditions for welding the plastic sheet and the pedestal 24 to the plastic sheet.

The heating conditions for welding the communication body 21 and the plastic sheet and the pedestal 24 and the plastic sheet are basically the settings of heating temperature, heating time, and press pressure, but the heating conditions can be more easily set by selecting the heating method. become.

That is, when heating is performed using the welding molds 51 and 52 shown in FIG. 11, one welding mold 51 is heated and the other welding mold 52 is not heated, and if a method is adopted in which the welding is performed alternately on each side, the plastic Welding between sheets is less likely to occur.

Furthermore, by using a multilayer plastic sheet having two or more layers, it is possible to easily set the heating conditions for welding the communicating body 21 and the plastic sheet, and the pedestal 24 and the plastic sheet. The resin constituting the innermost layer of the sheet corresponding to the inner surface of the container part 3 and the resin constituting the outermost layer of the sheet corresponding to the outer surface of the container part 3 may have different welding temperatures, and the resin constituting the outermost layer By selecting a resin that has a higher welding temperature than the resin that makes up the innermost layer, the inner surfaces of the plastic sheets are not welded together, and the connecting body 21 and the outer surface of the plastic sheet, and the pedestal 24 and the outer surface of the plastic sheet are bonded together. It is easier to set the heating conditions for welding6. For example, the innermost layer is high density polyethylene and the outermost layer is low density polyethylene or linear low density polyethylene, or the innermost layer is polypropylene and the outermost layer is low density polyethylene or linear low density polyethylene. Possible combinations include a combination of linear low-density polyethylene, a mixed resin of polypropylene and linear low-density polyethylene for the innermost layer, and linear low-density polyethylene for the outermost layer.

[Example] Hereinafter, the present invention will be explained in more detail using actual examples.

Example 1 Linear low density polyethylene (density 0.9228/ctl)
i) by inflation molding to create a fold diameter of 25
An inflation tube with a thickness of 0 mm and a wall thickness of 0.25+*m was produced. This inflation tube was heated at 160° C. for 5 seconds to heat weld the outer peripheral seal and isolation means as shown in FIG. 1. The outside of the outer seal and the unnecessary parts of the suspension port were cut and removed. Separately, a molded mouth part shown in FIG. 1 was produced by injection molding using linear low-density polyethylene (density 0.920 g/d'), and welded to an inflation tube whose outer periphery was sealed.

Next, linear low density polyethylene (density 0.935g/
The communicating body and pedestal shown in FIG. 2 were manufactured by injection molding using CIA). Furthermore, a breakable member shown in FIG. 2 was manufactured by injection molding using glass filler-containing polypropylene. The communicating body and the destructive member are fixed by heat welding, and the pedestal is sandwiched between welding molds as shown in Fig. 11.
The lower side is cooled to room temperature and the upper side is heated at 200° C. for 5 seconds to weld the communicating body and one side of the inflation tube. Next, the inflation tube and the communication body are turned over, and the other side of the pedestal and the inflation tube are similarly welded.

At this time, the inflation tubes were not welded together.

An infusion container was produced in the manner described above.

600 m of the basic high-calorie infusion was injected into the first chamber of this container, and 300 m of the amino acid infusion into the second chamber, and the opening was sealed with a linear low-density polyethylene film and fitted with a rubber stopper.

This infusion container was autoclaved at 115° C. for 40 minutes, but no significant deformation or communication between the first and second chambers was observed after sterilization. In addition, a leak test was conducted under pressurization, but there was no leakage of the liquid content from each welded portion.

Next, the communicating body of the communication means is pressed from the outside and the inflation tube is penetrated by a destructive member, and the amino acid infusion in the second chamber is introduced into the second chamber through the through hole, and the amino acid infusion and high-calorie infusion are injected into the first chamber. The base liquid was mixed.

Next, according to the usual infusion technique, the bottle needle of the infusion set is passed through the opening, and the height from the opening to the infusion needle is 70 mm.
When the relationship between the amount of drained liquid and time was measured, the amount of drained liquid was approximately proportional to time.

Example 2 Linear low density polyethylene (density 0.922g1
ont) as the inner layer and linear low density polyethylene (density 0.
90 gr7) and polypropylene (density 0.90 g/
A two-layer inflation tube with a fold diameter of 250 + * m and a wall thickness of 0.25 mm was produced by inflation molding using a mixed resin of 1/1 of crA>.

This inflation tube was heated at 230° C. for 5 seconds to heat weld the outer peripheral seal and isolation means as shown in FIG. 1. The outside of the outer seal and the unnecessary parts of the suspension port were cut and removed. Separately, linear low-density polyethylene (density 0.92
A molded article with a mouth portion shown in FIG. 1 was produced by injection molding using a material (0 g/crl) and welded to an inflation tube whose outer periphery was sealed.

Next, linear low density polyethylene (density 0.935g/
A communicating body and a pedestal shown in FIG. 2 were manufactured by injection molding using co(). Further, a breakable member shown in FIG. 2 was produced by injection molding using glass filler polypropylene. The communicating body and the destructible member are fixed by heat welding, and the pedestal is sandwiched between welding molds as shown in Fig. 11.
Heat at 190°C for 4 seconds from the top and bottom to heat weld the communicating body and the inflation tube, and the pedestal and the inflation tube. At this time, the inflation tubes were not welded together.

An infusion container was produced in the manner described above.

A basic high-calorie infusion solution 600- was injected into the first chamber of this container, and an amino acid infusion 300- was injected into the second chamber, and the opening was sealed with a linear low-density polyethylene film and a rubber stopper was attached.

This infusion container was autoclaved at 115° C. for 40 minutes, but no significant deformation or communication between the first and second chambers was observed after sterilization. In addition, a leak test was conducted under pressurization, but there was no leakage of the liquid content from each welded part.

Next, the communicating body of the communication means is pressed from the outside and the inflation tube is penetrated by a destructive member, and the amino acid infusion in the second chamber is introduced into the second chamber through the through hole, and the amino acid infusion and high-calorie infusion are injected into the first chamber. The base liquid was mixed.

Next, according to the usual infusion technique, the bottle needle of the infusion set is passed through the opening, and the height from the opening to the infusion needle is 70 mm.
When the relationship between the amount of drained liquid and time was measured, the amount of drained liquid was approximately proportional to time.

[Effects of the Invention] As described above, the drug-containing container having a plurality of chambers of the present invention has the following advantages.

■The multiple chambers are reliably isolated until use, and each chamber can be easily and reliably communicated with each other during use.

■Manufacturing is easy because the container manufacturing process only requires external processing.

[Brief explanation of drawings]

FIG. 1 is a front view showing an embodiment of a drug-containing container having a plurality of chambers according to the present invention, FIG. 2 is a cross-sectional view showing a first embodiment of a communication means, and FIG. 4 is a cross-sectional view showing how a through hole is formed using the same communication means and a plurality of chambers communicate with each other. FIG. A cross-sectional view showing the second embodiment, FIG. 6 is a cross-sectional view showing how a through hole is formed using the same communication means, and FIG. 8 is a sectional view showing a third embodiment of the communication means, and FIG. 9 is a sectional view showing a through hole being formed using the same communication means. , FIG. 10 is a cross-sectional view showing a plurality of chambers communicating with each other by forming a through hole using the same communication means.
FIG. 1 is a cross-sectional view showing the communicating means heat-welded to the container part, and FIG. 12 is a cross-sectional view showing the communicating means with a stopper installed. 1... Container, 2... Mouth part, 3... Container part, 4... Hanging mouth part, 5... Third chamber 6.
...Second room, 7.Isolation means, 8.Communication means,
9... Suspension port, 10... Plug, 11... Outer seal, 21.31.41... Communication body, 22.23, 32.42... Destruction member, 24.34.
44... pedestal,

Claims (3)

[Claims] (1) A container consisting of a plurality of chambers and communication means connecting the respective chambers, wherein the communication chamber constituted by the communication means is shielded by a member constituting at least one of the chambers, and the communication chamber constituted by the communication means is shielded by a member constituting at least one chamber, A drug-containing container having a plurality of chambers, characterized in that the drugs sealed in the respective chambers are mixed through the communication chambers constituted by the communication means by breaking the connecting member. (2) A drug-containing container having a plurality of chambers as set forth in claim 1, wherein the communication means has a destruction member that can easily destroy the members constituting the chambers. (3) Claim 1, wherein the communication means is comprised of a communication body constituting a communication chamber, a destructible member existing inside the communication chamber, and a pedestal for receiving the destructible member. Or a drug-containing container having a plurality of chambers according to item 2.