JP5104884B2 - Method for producing medical drug enclosure and container therefor - Google Patents

Description

  The present invention relates to a method for producing a medical drug enclosure and a flexible container used therefor. Preferably, the present invention relates to a method for producing a medical medicinal liquid encapsulated material in which an infusion supplied to a human body is enclosed in a flexible container having a spout and a flexible container therefor.

  Conventionally, infusions for supplying nutrients to the human body typically have two infusions by means of separable separating means as disclosed in, for example, JP-A-7-178151 or JP-B-6-26563. A fat emulsion and an amino acid are contained in the first chamber of a container made of a flexible resin in which a single chamber is formed, a sugar and an electrolyte are contained in the second chamber, and the first chamber or the second chamber is pressed from the outside during administration. The separating means is separated to mix the liquids in both chambers. As disclosed in Japanese Patent Publication No. 5-10945, the first chamber or the second chamber is communicated with an infusion discharge port (spout port), and the outer end of the spout port is closed with a rubber stopper. The infusion solution in the container is sent from the inside of the container into the infusion tube by allowing the injection needle attached to the infusion tube to pierce the rubber stopper at the time of administration to allow the spout and the infusion tube to communicate with each other. The conventional general method of filling such a medical chemical solution into a flexible resin container is aseptically filling the chemical solution into the container from the spout with the stopper removed under an inert gas atmosphere. The outer end of the spout was closed with a rubber stopper.

  Thus, when the inside of the container is filled with the chemical solution through the spout with the stopper removed, and then the spout is closed with a rubber plug, the inside of the container is poured between the manufacturing of the container and the filling of the chemical solution. It was opened through the outlet, causing bacteria and other foreign objects to enter. In order to solve this problem, immediately after manufacturing the container, the outer end of the spout is sealed with a temporary stopper, an air hole seal, etc., and the outer end of the spout is opened immediately before the filling process, and the spout is inserted through the spout. A method of filling chemicals has been developed.

  According to the conventional method of filling the inside of the container with the chemical solution through the spout with the stopper removed, and then closing the outer end of the spout with the stopper, the step of sealing the spout with the plug is immediately after filling with the chemical solution. This has been a cause of complicating the mechanism of the filling machine. The stopper is generally composed of a plug body in which the outer peripheral surface of a cylindrical rubber stopper that can be pierced with an infusion needle is surrounded by a plastic resin. Fit and weld. The first object of the present invention is to eliminate the process of closing the spout with a stopper after filling the chemical solution, to eliminate the complexity of the mechanism of the filling machine, and to simplify the sealing process of the container after filling the chemical solution. .

  Another object of the present invention is that the spout is not sealed until the flexible container used for manufacturing the medical liquid filling material is filled with the chemical liquid after manufacturing, and foreign matter enters the container. It is an object of the present invention to provide a method for manufacturing a medical medicinal liquid enclosure and a container for the same. Another object of the present invention is to sterilize a flexible container for manufacturing a medical medicinal liquid enclosure so that the sterilized state can be maintained until the medicinal liquid filling step. Still another object of the present invention is to provide a sealed flexible container capable of forming a filling port by a simple process. Still another object of the present invention is to provide a medical medicinal liquid filling material and a container having a plurality of chambers in which the complexity of the mechanism of the filling machine is eliminated and the container sealing process after the chemical liquid filling is simplified. is there. Other objects and advantages of the present invention will become apparent in the following description.

According to the present invention, there is provided a method for producing a medical medicinal liquid encapsulated material in which a medical medicinal liquid is enclosed in a flexible container having a spout. A step of producing a flexible container having a spout sealed in a step, a step of cutting a part of a resin film surrounding the chemical solution storage chamber to form a filling port communicating the chemical solution storage chamber with the outside, the filling port And a step of filling the chemical solution storage chamber with a chemical solution, and a step of adhering a predetermined range of resin film around the filling port to seal the chemical solution storage chamber.

  Preferably, the manufacturing method of the present invention has the following configuration. (A) The step of adhering the predetermined range of resin film around the filling port includes the step of adhering the predetermined range of resin film around the filling port by heat sealing. (B) In the flexible container, the peripheral portions of the overlapped flexible resin films are bonded to each other, and a chemical solution storage chamber is formed between the flexible films. (C) The step of forming the filling port includes a step of cutting off a part of the peripheral portion to which the flexible film is adhered. (D) A step of sterilizing the flexible container with radiation or the like is further included before the step of filling the chemical solution. (E) The peripheral portion of the flexible container is composed of an upper edge portion, a lower edge portion, and two side edge portions, the drug solution outlet is disposed in the lower edge portion, and a penetrating hole for suspension is provided in the upper edge portion. It is formed. (F) One side edge portion has a protruding adhesive portion, and the step of forming the filling port includes a step of cutting off the protruding adhesive portion. (G) The chemical solution enclosed in the flexible container includes a chemical component supplied to the human body by drip. (H) The stopper that seals the spout is a rubber stopper that can penetrate the injection needle attached to the drip tube. (I) The chemical solution storage chamber is divided into a first chamber and a second chamber by an isolation portion formed by welding a part of the inner wall thereof. (J) cutting a part of the resin film to form a filling port that communicates with the chemical solution storage chamber and the outside, filling the liquid storage chamber with the chemical solution through the filling port, and a predetermined range around the filling port The step of adhering the resin film and sealing the chemical solution storage chamber is performed for each of the first chamber and the second chamber, and the first chamber and the second chamber are filled with different chemical solutions. (K) The isolation portion is easily separated by manually pressing the first chamber or the second chamber filled with the chemical solution, and the chemical solutions in the first chamber and the second chamber are mixed.

  A flexible container used for manufacturing a medical chemical liquid filling material in which a medical chemical liquid is sealed in a flexible container having a spout according to the present invention contains a chemical liquid surrounded by a flexible resin film. The outlet has a spout connected to the chamber and the chemical storage chamber and sealed with a stopper. The spout comprises a resin conduit, one end of the conduit is connected to the chemical storage chamber, and a stopper is fitted to the other end of the conduit. The stopper is composed of a rubber stopper capable of penetrating an injection needle attached to an infusion tube, and the drug solution storage chamber is completely sealed from the outside of the flexible container. Preferably, (l) the resin film is obtained by laminating two resin films and bonding the peripheral portion. (M) The conduit forming the spout is disposed between two superposed resin films and bonded to the peripheral portion of the resin film. (N) The peripheral portion of the flexible container is composed of an upper edge portion, a lower edge portion, and two side edge portions, and the drug solution outlet is disposed at the lower edge portion, and a through hole is provided to hang on the upper edge portion. One of the side edge portions is provided with a protruding portion, and the protruding portion can be cut to form a filling port that communicates the chemical solution storage chamber with the outside. (O) The flexible container is sterilized or sterilized. (P) The chemical solution storage chamber is divided into a first chamber and a second chamber by an isolation portion formed by bonding a part of the inner wall of the storage chamber, and one of the first chamber and the second chamber A side edge part is provided with a protrusion part.

  In the present invention, the medicinal liquid encapsulant includes a medicinal solution storage chamber surrounded by a flexible resin film and a flexible container having a spout connected to the medicinal solution storage chamber and sealed with a stopper, Cutting a part of a resin film surrounding the chemical solution storage chamber to form a filling port communicating with the chemical solution storage chamber and the outside, filling the liquid storage chamber with the chemical solution through the filling port, and around the filling port Are manufactured by a process of adhering a predetermined range of resin film to seal the chemical solution storage chamber. The flexible container is hermetically sealed until it is filled with a chemical solution after manufacture, so that no foreign matter enters the container.

  Since the chemical solution storage chamber of the present invention is hermetically sealed off from the outside when the container is manufactured, it does not intrude foreign substances or bacteria before filling the container with the chemical solution, and stores the medical chemical solution. It is suitable for. In addition, since the filling port for the chemical solution of the present invention is formed separately from the spout that must be sealed by the stopper, it is not necessary to perform a complicated process of closing the plug by the stopper of the spout after filling the chemical, and the mechanism of the filling machine There is an advantage that does not complicate. Moreover, this invention can sterilize the flexible container for manufacture of medical chemical | medical solution enclosure, and can maintain a sterilization state until a chemical | medical solution filling process. Furthermore, the present invention can provide a sealed flexible container capable of forming a filling port by a simple process. The present invention further eliminates the complexity of the mechanism of the filling machine and provides an effect that can provide a medical medicinal liquid enclosure and a container including a plurality of chambers in which the sealing process of the container after the chemical liquid filling is simplified. .

1 is a schematic view of a flexible container according to a first embodiment of the present invention. II-II arrow line view of the flexible container of FIG. FIG. 3 is a cross-sectional view of the outlet of the flexible container of FIG. Sectional drawing similar to FIG. 3 of another example of the spout of a flexible container. 3 is a schematic view of a flexible container according to a second embodiment of the present invention. It is a flowchart which shows the main processes of the manufacturing method of this invention.

  Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is a schematic view of a flexible container 20 according to a first embodiment of the present invention, FIG. 2 is a view of the flexible container of FIG. 1 taken along the line II-II, and FIG. It is III-III arrow sectional drawing of the spout of a flexible container. The flexible container 20 shown in FIG. 1 includes a chemical solution storage chamber 21 surrounded by a flexible resin film 22 made of, for example, polyethylene or polypropylene, and a spout that communicates with the chemical solution storage chamber 20 and is sealed with a stopper 42. 40. As shown in FIG. 3, the spout 40 includes a resin conduit 43, one end of the conduit 43 communicates with the chemical solution storage chamber 21, and a plug 42 is fitted to the other end of the conduit 43. The stopper 42 is a rubber stopper capable of penetrating an injection needle (not shown) attached to an infusion tube. The plug 42 and the conduit 43 cooperate with the lid 41 to form a sealing engagement, as shown in the cross section of FIG.

  The resin film 22 surrounding the chemical solution storage chamber 21 is formed of a substantially transparent resin so that the amount of the medical chemical solution stored in the chemical solution storage chamber 21 can be seen from the outside of the container 20. A scale 26 for indicating the amount of the chemical solution is provided on the outer surface of the chemical solution storage chamber 21. The resin film 22 is hermetically welded to the outer periphery of one end of the conduit 43 adjacent to the liquid storage chamber 20 so as not to leak liquid. In the adjacent portion of the conduit 43, the resin film is laminated and welded to form the lower edge portion 25 for reinforcement. The container 20 in FIG. 1 includes an upper edge portion 24 in which a resin film is overlapped and welded on the opposite side of the lower edge portion 25. The upper edge portion 24 includes a through hole 29 so that the container can be suspended when the chemical solution is used. The inside of the container 20 of FIG. 1 is completely sealed off from the outside of the container 20 until the stage of containing the chemical solution after the container is manufactured. Preferably, the inside and outside of the container 20 are sterilized by irradiation or other methods, and the sterilized state is maintained until a step of forming a filling port for filling with a chemical solution.

  FIG. 4 is a modification of the spout 40, and the outer flange portion of the lid 41 is formed so that the outer shape of the lid 41 and the conduit 43 is deformed and the radial dimension of the spout 40 is reduced. It is made cylindrical and extends along the outer peripheral surface of the conduit 43. The spout 40 shown in FIG. 4 is shown in that the resin film 22 is welded to the outer peripheral surface of the conduit 43, and the stopper 42, the conduit 43 and the lid 41 are sealed and welded so as not to leak from their joints. This is the same as the third example.

  FIG. 5 is a schematic diagram of the flexible container 20 of the second embodiment of the present invention. In the flexible container 20 of the second embodiment, the chemical solution storage chamber is divided into a first chamber 18 and a second chamber 19 by an isolation portion 34 formed by adhering a part of the inner wall of the chemical solution storage chamber. The isolation part 34 can be easily separated by pressing manually with the first chamber and the second chamber filled with the chemical solution, and the chemical solution in the first chamber and the second chamber can be mixed. The container 20 of FIG. 5 is suitable for containing a two-component mixed infusion that supplies nutrients to the human body by infusion, for example, a fat emulsion and amino acids are contained in the first chamber, and sugar and sugar are contained in the second chamber. The electrolyte solution is accommodated, and the first chamber or the second chamber is pressed from the outside at the time of administration to separate the separating means and mix the liquids in both chambers.

  FIG. 6 is a flowchart showing the main steps of the manufacturing method of the present invention. FIG. 6A is a schematic plan view of a flexible container 20 including a chemical solution storage chamber 21 surrounded by a flexible resin film, and a chemical solution outlet port 40 communicated with the chemical solution storage chamber 21 and sealed with a stopper. FIG. The configuration of the spout 40 of the container 20 of FIG. 6A, the upper edge portion 24 opposite to the lower edge portion 25, and the container through-hole 29 formed in the upper edge portion 24 is the first embodiment of FIG. Same as example container. The flexible resin film that surrounds the chemical solution storage chamber 21 of the container 20 in FIG. 6A is obtained by stacking two resin films and thermally welding the peripheral portion, and is respectively attached to the upper edge portion 24 and the lower edge portion 25. Side edge portions 26 and 27 are provided by welding the resin films continuously. As shown in FIG. 6A, one side edge portion 27 includes a protruding portion 28. The container 20 is irradiated with radiation, for example, gamma rays, electron beams, etc. after being manufactured, sterilized, and supplied to the process of FIG. 6B.

  FIG. 6B shows a process of cutting the protruding portion 28 of the side edge portion 27 of the container 20 to form the filling port 30 for the chemical solution. As shown in FIG. 6B, the filling port 30 is formed so as to allow communication between the chemical solution storage chamber 21 and the outside by separating the protruding portion 28 and spreading two overlapping resin films. The cutting method of the protruding portion 28 is selected so that the amount of cutting waste generated is small and the cutting waste does not enter the chemical solution storage chamber 21. In the case of the container of FIG. 1 in which the protruding portion 28 is not formed, the filling port 30 can be formed by making an appropriate cut in the resin film 22 surrounding the storage chamber at the end without a cut-out portion.

  FIG. 6C is a schematic diagram showing a process of disposing the tip of the chemical solution supply nozzle 12 into the chemical solution storage chamber 21 of the container 20 through the filling port 30 and filling the chemical solution 10 through the nozzle 12 into the chemical solution storage chamber 21. . The container 20 is held by means not shown with the filling port 30 facing upward, and the chemical solution storage chamber 21 is filled with a predetermined amount of the chemical solution 10.

  FIG. 6D shows a sealed portion 32 formed by welding a predetermined range of resin film around the filling port 30 of the container 20 filled with a predetermined amount of the chemical solution 10, and again sealing the chemical solution storage chamber 21 from the outside. It is the schematic which shows the process made into. As in the case of the container in FIG. 1, even when the filling port is not adjacent to the overlapped peripheral portion, the seal portion 32 is formed by overlapping and welding a predetermined range of resin film around the filling port 30. be able to. Upon completion of the process of FIG. 6D, the medical medicinal solution enclosure 8 made of the medical medicinal solution 10 sealed in the container 20 and the container is manufactured. Thereafter, the medical solution enclosure 8 is sterilized by, for example, a high-pressure steam sterilization process.

  The filling of the chemical solution into the two-chamber container of FIG. 5 can be performed by performing the process in the container having the single chemical solution storage chamber 21 of FIGS. 6A to 6D twice, simultaneously or separately. The first chamber 18 and the second chamber 19 of the flexible container 40 of FIG. 5 are both substantially rectangular and include filling ports 30 and 30 at the side edges. Similarly to the case of FIG. 6A, the filling ports 30 and 30 can be formed by providing a protruding portion on the outer side of the portion that becomes the filling port 30 of the side edge portion 26 and manufacturing the container. As shown in FIG. 5, when the filling ports 30 and 30 are formed in the same side edge portion of the container 20, it is suitable for simultaneously filling the first chamber and the second chamber with the chemical solution and forming the seal portions respectively. is there.

10: Chemical solution, 12: Chemical solution supply nozzle, 18: First chamber, 19: Second chamber, 20: Container, 21: Storage chamber, 22: Film, 23: Conduit, 24: Upper edge portion, 25: Lower edge portion , 26, 27: side edge portion, 28: protruding portion, 29: through hole, 30: injection port, 32: seal portion, 34: isolation portion, 40: spout, 42: rubber stopper, 43: conduit.

Claims (7)

A flexible container having a spout, wherein the flexible containers are bonded to each other at the peripheral portions of the overlapped flexible resin films, and a chemical solution storage chamber is formed between the flexible films. Is,
The chemical solution storage chamber is divided into a first chamber and a second chamber by an isolation portion formed by welding a part of the inner wall thereof,
The peripheral portion includes an upper edge portion, a lower edge portion, and two side edge portions, and the chemical liquid extraction port is disposed in the upper edge portion and the lower edge portion, and one side edge portion includes the first chamber and the second edge portion. A method for producing a medical medicinal liquid encapsulated material in which a medical medicinal liquid is encapsulated in a flexible container having an adhesive part protruding in a chamber,
A step of producing a flexible container having the chemical solution storage chamber and a spout communicated with the chemical solution storage chamber and sealed with a stopper;
A step of simultaneously cutting off the protruding adhesion portions of the first chamber and the second chamber to form a filling port that communicates the chemical solution storage chamber with the outside;
A step of separately filling the chemical solution storage chamber through the respective filling ports of the first chamber and the second chamber, and a predetermined range of resin around the filling ports of the first chamber and the second chamber; A manufacturing method characterized in that a film is adhered at the same time or separately and the chemical solution storage chamber is sealed. A flexible container having a spout, wherein the flexible containers are bonded to each other at the peripheral portions of the overlapped flexible resin films, and a chemical solution storage chamber is formed between the flexible films. Is,
The chemical solution storage chamber is divided into a first chamber and a second chamber by an isolation portion formed by welding a part of the inner wall thereof,
The peripheral portion includes an upper edge portion, a lower edge portion, and two side edge portions, and the chemical liquid extraction port is disposed in the upper edge portion and the lower edge portion, and one side edge portion includes the first chamber and the second edge portion. A method for producing a medical medicinal liquid encapsulated material in which a medical medicinal liquid is encapsulated in a flexible container having an adhesive part protruding in a chamber,
A step of producing a flexible container having the chemical solution storage chamber and a spout communicated with the chemical solution storage chamber and sealed with a stopper;
A step of simultaneously cutting off the protruding adhesion portions of the first chamber and the second chamber to form a filling port that communicates the chemical solution storage chamber with the outside;
A step of simultaneously filling a chemical solution storage chamber through the respective filling ports of the first chamber and the second chamber, and a resin film having a predetermined range around the filling ports of the first chamber and the second chamber; The manufacturing method characterized by adhering separately and sealing the chemical solution storage chamber.   3. The method according to claim 1, wherein the step of bonding a predetermined range of resin film around the filling port includes the step of bonding the predetermined range of resin film around the filling port by heat sealing.   The medicinal solution sealed in the flexible container contains medicinal solution components supplied to the human body by drip, and the plug that seals the spout is a rubber plug that can penetrate the injection needle attached to the drip tube. The manufacturing method of any one of Claims 1 thru | or 3.   The first chamber and the second chamber are filled with different chemical solutions, and the isolation portion is easily separated by manually pressing the first chamber or the second chamber filled with the chemical solution. The manufacturing method of any one of Claims 1 thru | or 4 with which a chemical | medical solution is mixed.   A flexible container manufactured using the manufacturing method according to claim 1.   A flexible container having a spout, wherein the flexible containers are bonded to each other at the peripheral portions of the overlapped flexible resin films, and a chemical solution storage chamber is formed between the flexible films. Is to be
  The chemical solution storage chamber is divided into a first chamber and a second chamber by an isolation portion formed by welding a part of the inner wall thereof,
  The peripheral portion includes an upper edge portion, a lower edge portion, and two side edge portions, and the chemical liquid extraction port is disposed in the upper edge portion and the lower edge portion, and one side edge portion includes the first chamber and the second edge portion. A method of forming a filling port for enclosing a medical drug solution in a flexible container that has an adhesive part protruding in the chamber,
  A step of producing a flexible container having the chemical solution storage chamber and a spout communicated with the chemical solution storage chamber and sealed with a stopper;
  A step of simultaneously cutting off the protruding adhesion portions of the first chamber and the second chamber to form a filling port that communicates the chemical solution storage chamber with the outside;
The filling port formation method characterized by this.

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