JP2005081124A - Drug container, its manufacturing method, and drug mixing apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a drug container capable of aseptically mixing drug with dissolved/diluted solution at minimized cost when the drug in the container is not heat-resistant, which does not require a part of a connecting member such as a packing or the like to be fixed to itself when a vial as the drug container and a solution container such as a flexible one or the like are connected and enables to maintain cleanliness and asepsis in a connecting part without a cap made of other member. <P>SOLUTION: The drug container 1 includes a connecting means 10 to mix the drug in a main body 2 with solution when it is used. Immediately after the main body 2 is formed of a thermoplastic resin, drug is filled therein. Soon after that, the connecting means 10 is mounted on an opening 5 of the main body 2 and a part of the thermoplastic resin is welded on the connecting means 10 so as to seal the opening 5 of the main body 2 and the connecting means 10 with a resin cap 7 made of the thermoplastic resin. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a drug mixing device for mixing a drug solution and a solution such as a dissolution solution or a diluting solution immediately before use, a drug container suitable as a drug container constituting the drug mixing device, and a method for manufacturing the same.

The drug mixing device used for the drip injection has a drug container for storing the drug and a liquid drug container for storing a solution or a diluent, and a communicating needle provided in the liquid drug container immediately before the drip use However, a drug mixing device has been developed in which a liquid and a drug are mixed through a communicating needle by breaking the plug of the drug container.
As an example of this medicine mixing device, a vial as a medicine container and a flexible container as a liquid medicine container are connected in advance by a connecting member, and a communication needle provided in the flexible container is moved to the vial side. Thus, there is known a drug mixing device that breaks the stopper of a vial immediately before use of an infusion (see, for example, Patent Document 1).

JP-A-6-254136 (page 2-4, FIGS. 1 and 2)

  However, in the conventional drug mixing apparatus described above, when connecting a vial as a drug container and a flexible container as a liquid drug container, the connection port provided in the flexible container fits in a liquid-tight manner. There is a drawback that a part of the connection member such as the connection packing needs to be separately assembled to the medicine container.

  In addition, if the drug to be filled in the drug container is a non-heat-resistant chemical solution that cannot be autoclaved, the drug container must be sterilized before filling the drug container aseptically, and if the drug container is a glass vial, It is only necessary to perform dry heat sterilization on a conventional aseptic filling line. However, if the drug container is a resin vial, it cannot be dry heat sterilized because it has no heat resistance, and a vial previously sterilized by another method is prepared. Had to do.

  In this way, when the drug to be filled in the drug container is a non-heat-resistant drug solution, if a glass vial is used, a conventional aseptic filling device can be used, so that it can be commercialized at a relatively low cost. However, glass vials and other plastic parts must be separated and disposed of separately. On the other hand, if resin vials are used to avoid the complexity of separation and disposal, for the reasons described above. Since the conventional aseptic filling apparatus cannot be used and aseptic filling becomes very difficult, there is a disadvantage that the cost is increased.

  Therefore, the inventors of the present application, as shown in Japanese Patent Application No. 2003-203344, in order to solve the above problems, when connecting a vial as a drug container and a liquid drug container such as a flexible container, It is not necessary to assemble part of the connection member such as connection packing into the drug container, and even if the drug to be filled in the drug container is a non-heat-resistant chemical solution, it is possible to dissolve and dilute while suppressing cost increase as much as possible. A drug mixing device that can be aseptically mixed with a liquid, a drug container suitable for the drug mixing device, and a method for manufacturing the same are proposed.

  The drug container disclosed in the above-mentioned Japanese Patent Application No. 2003-203344 is a sufficiently improved problem of the prior art. When this drug container and the liquid drug container are fitted and fixed in an aseptic condition, the drug container It was necessary to sterilize the connecting portion of the container immediately before fitting. Further, since the connecting portion of the medicine container is open, it is necessary to form a cap separately to cover the open portion in order to prevent contamination.

  Therefore, the present invention eliminates the need for separately assembling a part of a connection member such as a connection packing to the drug container when connecting a vial as a drug container and a liquid drug container such as a flexible container. It is possible to maintain the cleanliness and sterility of the connection part without the need for a cap, and even if the drug filled in the drug container is a non-heat-resistant drug solution, the solution and dilution can be reduced while minimizing the cost increase. It is an object of the present invention to provide a drug mixing apparatus that can be aseptically mixed with a liquid, a drug container suitable for the drug mixing apparatus, and a method for manufacturing the same.

  The drug container according to claim 1 of the present invention is a drug container having connection means for mixing the drug contained in the drug container main body with the liquid at the time of use, wherein the drug container main body is formed by molding a thermoplastic resin. Immediately after the formation of the drug container body, the drug container body is filled with a drug, and immediately after the drug is filled, the connecting means is disposed in the opening of the drug container body, and a part of the thermoplastic resin Is welded to the connecting means to seal the opening of the drug container body, and the connecting means is sealed with a resin cap formed of a part of the thermoplastic resin.

  The drug container according to claim 2 of the present invention is the drug container according to claim 1, wherein the connecting means is a liquid-tight fit between a lid that seals the drug container main body during storage and a connection port of the liquid drug container And a connecting body.

  The medicine container according to claim 3 of the present invention is characterized in that, in the medicine container according to claim 2, the lid body and the connection body are made of the same member.

  The drug container according to a fourth aspect of the present invention is the drug container according to the second or third aspect, wherein the connecting means is configured such that the lid and the connection body are accommodated at one end side, and the connection port is disposed at the other end side. It has the connection cylinder inserted.

  The drug container according to claim 5 of the present invention is the drug container according to claim 4, wherein the lid, the connection body, and the connection tube are integrated in advance, and a part of the thermoplastic resin is the It is characterized by being welded to the connecting tube.

  The drug container according to claim 6 of the present invention is the drug container according to claim 4 or 5, wherein the distal end portion of the connection port and the connection body are fitted coaxially, and the proximal end portion of the connection port The connection tube is coaxially fitted, and the inner diameter of the connection body is smaller than the inner diameter of the connection tube.

  A drug container according to a seventh aspect of the present invention is the drug container according to any one of the fourth to sixth aspects, wherein the inner peripheral surface of the connection tube and the outer peripheral surface of the proximal end portion of the connection port are engaged with each other. It is characterized in that an engaging means is provided.

  The drug container according to claim 8 of the present invention is the drug container according to claim 7, characterized in that one of the engaging means is a claw portion and the other is a hole portion.

  A drug container according to a ninth aspect of the present invention is characterized in that, in the drug container according to any one of the first to eighth aspects, a suspension opening is provided in a non-opening portion of the drug container body.

The method for producing a drug container according to claim 10 of the present invention is a method for producing a drug container having connection means for mixing the drug contained in the drug container main body with a liquid agent at the time of use.
A first step of blow molding or vacuum forming a thermoplastic resin to form the drug container body;
A second step of filling the drug container body with a drug immediately after the blow molding or vacuum molding;
A third step of disposing the connecting means at the opening of the drug container body immediately after filling the drug solution;
A fourth step of welding a part of the thermoplastic resin to the connecting means and sealing the opening of the drug container body;
A fifth step of forming a resin cap so that a part of the thermoplastic resin covers the connecting means;
It is provided with.

  The method for manufacturing a drug container according to claim 11 of the present invention is the method for manufacturing a drug container according to claim 10, wherein the connection means includes a lid for sealing the drug container body and a connection port of the liquid drug container. A connection body that is closely fitted; and a connection cylinder into which the connection port is inserted. The lid body, the connection body, and the connection cylinder are integrated in advance, and one of the thermoplastic resins The portion is welded to the connecting tube.

A drug mixing device according to claim 12 of the present invention has a drug container body formed by molding a thermoplastic resin, and the drug container body is filled with a drug immediately after the drug container body is formed, Immediately after filling, the first connecting means is disposed in the opening of the drug container body, and a part of the thermoplastic resin is welded to the first connecting means to seal the opening of the drug container body. And a medicine container formed by sealing the first connecting means with a resin cap formed of a part of the thermoplastic resin,
Having a second connection means connected to the first connection means from which the resin cap has been removed immediately before connection, and a liquid agent container containing a liquid agent in a liquid agent container body,
In use, the medicine container main body and the liquid container main body can be communicated with each other via the first connecting means and the second connecting means.

A drug mixing device according to a thirteenth aspect of the present invention is the drug mixing device according to the twelfth aspect, wherein the first connection means includes a lid for sealing the drug container body and the second connection means. A connection body in which the connection port is liquid-tightly fitted, and the connection body in which the lid body and the connection body are accommodated on one end side and the connection port is inserted on the other end side,
The second connection means is provided in the connection port, a diaphragm provided in the connection port and shields the inside of the liquid container body from the outside, and disposed in the connection port, and an axial liquid flow path therein. And a communication needle formed,
The communicating needle is held at a position where the tip is separated from the diaphragm during storage, and the tip is movable to a position where it penetrates the diaphragm and the lid during use, and the communicating needle passes through the liquid flow path of the communicating needle. Thus, the medicine can flow into the liquid container body.

  As described above, according to the drug container and the manufacturing method thereof according to the present invention, the drug container body is filled with the drug immediately after the drug container body is formed. However, it is not necessary to sterilize the drug container in advance, and the connecting means is disposed at the opening of the drug container body immediately after the filling of the drug, and a part of the thermoplastic resin forming the drug container body is connected to the connecting means. Since the opening of the drug container main body is sealed by welding, it becomes possible to easily perform aseptic filling of the drug, and since the resin cap is formed so as to cover the connecting means, until the resin cap is removed Since the connection means is maintained in a sterile state, the sterile connection can be reliably and easily performed.

In addition, since the connection port as the connection means and the connection body are liquid-tightly fitted, it is possible to prevent the drug from leaking when the drug is allowed to flow from the drug container main body into the liquid drug container main body.
Moreover, the assembly of the connection means is facilitated by configuring the lid for sealing the drug container body and the connection body into which the connection port of the liquid drug container is fitted from the same member.
In addition, by connecting the connection port to the other end of the connection cylinder in which the lid body and the connection body are accommodated, the drug container and the liquid container can be easily connected.

  Further, the lid, the connecting body, and the connecting cylinder constituting the connecting means are assembled and integrated in advance, and a part of the thermoplastic resin forming the drug container body is welded to the connecting cylinder to connect the connecting means. Since it is attached, the attachment of the connecting means to the medicine container body can be performed very easily and instantaneously.

In addition, the distal end of the connection port and the connection body are fitted coaxially, and the proximal end of the connection port and the connection tube are fitted coaxially, so that the connection between the drug container and the liquid container is ensured. In addition, the connection port and the connection cylinder can be integrated in a substantially straight line.
Further, since the engaging means that engages the inner peripheral surface of the connection tube and the outer peripheral surface of the base end portion of the connection port is provided, the connection between the connection tube and the connection port can be ensured.
In addition, since the suspension opening is provided on the non-opening side of the drug container main body, the drug mixing device can be easily suspended when administering a drug such as an infusion.

  And since the drug container aseptically filled with the drug according to the present invention and a liquid drug container maintained in a sterilized state by autoclave sterilization, for example, can be aseptically connected. In addition, an inexpensive drug mixing device can be obtained.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. 1 is a plan view showing the entirety of a medicine container according to an embodiment of the present invention, FIG. 2 is a partial sectional view of the medicine container shown in FIG. 1, and FIGS. 3 (a) to 3 (e) are medicines shown in FIG. It is a fragmentary sectional view which shows the manufacturing process of a container.
As shown in FIGS. 1 and 2, the drug container 1 includes a drug container body 2 and first connection means (hereinafter referred to as “connection port assembly”) that is liquid-tightly connected to second connection means described later. 10) and the suspension port portion 3.

  The drug container body 2 is rich in flexibility such as low density polyethylene resin, linear low density polyethylene resin, high density polyethylene resin, polypropylene resin, soft polyester resin, chlorinated polyethylene resin, ethylene-vinyl acetate copolymer, etc. It is made of a thermoplastic resin and contains liquid medicine such as antibiotics, antibacterial agents, therapeutic drugs, and infusions from which easily reactable components are separated.

A connection port assembly 10 is liquid-tightly attached to the open end of the drug container body 2, thereby sealing the drug solution contained in the drug container body 2. 2 is integrated with the medicine container body 2 by heat welding of a fixing portion 4 made of a thermoplastic resin extending from one end.
Further, a resin cap 7 is integrally formed so as to completely cover the connection port assembly 10 with the thermoplastic resin extending from the fixing portion 4.

  As shown in FIG. 2, the connection port assembly 10 is liquid-tight and coaxial with the inner cap 11 that seals the drug container body 2 during storage, and the distal end of the connection port that constitutes the second connection means described later. And a connection cylinder 13 having a small-diameter portion 13a that is coaxially fitted to the base end portion of the connection port, and the inner cap 11 and the connection packing 12 are connected to the connection cylinder. The inner cap 11, the connection packing 12, and the connection cylinder 13 are assembled and integrated in advance before being attached to the open end of the drug container body 2. .

Further, a hole portion 14 that engages with a claw portion to be described later is formed on the inner peripheral surface of the small diameter portion 13 a of the connection cylinder 13, and the inner diameter of the connection packing 12 is that of the small diameter portion 13 a of the connection cylinder 13. It is formed smaller than the inner diameter.
The fixing portion 4 is thermally welded to the outer peripheral surface of the connection tube 13, and the tip portion 4 a of the fixing portion 4 extends to a position covering the step portion 13 c of the connection tube 13 and is connected to the connection port assembly 10. The installation of the is ensured.

Next, the manufacturing method of the chemical | medical agent container 1 which concerns on this Embodiment is demonstrated based on FIG. The drug container 1 is manufactured by a chemical solution simultaneous filling hollow molding method.
This will be described in detail below.
First, a thermoplastic resin is heated and melted to form a cylindrical parison. The parison is sandwiched between hollow molding dies 100 having a predetermined shape, air is fed from the upper opening portion 5 of the parison into the outer pipe of the supply nozzle 101 having a double tube structure, and the parison is inside the hollow molding dies 100. As shown in FIG. 3A, the medicine container main body 2 and the suspension opening 3 are formed. Immediately thereafter, a predetermined amount of the chemical solution filtered by the sterilization filter is filled in the drug container body 2 aseptically from the inner tube of the supply nozzle 101. Note that aseptic filling means filling using aseptic operation defined by the Japanese Pharmacopoeia.

  Immediately after filling with the chemical solution, as shown in FIGS. 3B and 3C, the connection port assembly 10 is disposed at a predetermined position of the upper opening 5 using a conveying means (not shown). At this time, the thermoplastic resin in the upper opening 5 is in a molten state.

  Next, as shown in FIG. 3D, the thermoplastic resin in the upper opening 5 is further sandwiched by the mold 102 while the thermoplastic resin is melted, and the upper opening 5 is thermally welded to the connection port assembly 10. Then, the resin cap 7 is formed by covering and sealing the upper portion so as to have a space. Thereafter, the molds 100 and 102 are opened, the drug container 1 is taken out of the molds 100 and 102, and the excess resin 6 in the upper opening 5 is cut away, whereby the drug container 1 is completed as shown in FIG. . The hollow mold 100 and the mold 102 are disposed in a sterile space.

When the medicine to be filled is weak against heat and cannot be sterilized by autoclave, it is preferable to aseptically fill the chemical liquid filling passage including the supply nozzle 101 aseptically. If the chemical solution to be filled is stable against heat and can be sterilized by autoclave, normal filling is performed, and after filling, the drug container 1 is sterilized by an autoclave, that is, a high-pressure steam sterilization apparatus.
In addition, although the thing by blow molding was illustrated in the manufacturing method of the chemical | medical agent container 1 mentioned above, the chemical | medical agent container 1 is not limited to blow molding, It can also manufacture by vacuum forming.

  As described above, according to the drug container 1 and the manufacturing method thereof according to the present embodiment, the drug container body 2 is filled with the drug immediately after the drug container body 2 is formed, and therefore the drug container 1 is aseptically filled with the drug. Even in this case, it is not necessary to sterilize the drug container 1 in advance, and the connection port assembly 10 is disposed in the upper opening 5 of the drug container main body 2 immediately after filling the drug, and the heat of the upper opening 5 is The plastic cap is further sandwiched between the molds 102 while the plastic resin is melted, the upper opening 5 is thermally welded to the connection port assembly 10, and the upper portion is covered and sealed so as to have a space. Therefore, aseptic filling of the medicine can be easily performed, the attachment of the connection port assembly 10 to the medicine container body 2 can be easily performed, and the connection port assembly 10 can be maintained in a sterile state. it can.

  Next, a drug mixing device according to an embodiment of the present invention will be described in detail with reference to the drawings. 4 is a plan view showing the resin cap of the medicine container shown in FIG. 1 being twisted, FIG. 5 is a plan view showing the whole medicine mixing apparatus using the medicine container shown in FIG. 4, and FIG. The top view which shows the whole flexible liquid agent container which comprises the chemical | medical agent mixing apparatus shown, FIG. 7 is an expanded partial sectional view of the flexible liquid agent container shown in FIG.

  As shown in FIG. 5, the drug mixing apparatus 50 includes a flexible liquid container 51 in which a solution such as a solution, a diluent, or an infusion is contained in a sterile state, and a drug solution in the drug container body 2 described above. It is comprised by the chemical | medical agent container 1 accommodated in the aseptic state, and the resin cap 7 shown in FIG. 4 connected to said flexible liquid agent container 51 was twisted off.

Details of the flexible liquid container 51 will be described with reference to FIG.
The flexible liquid container 51 is made of a flexible material such as a low density polyethylene resin, a linear low density polyethylene resin, a high density polyethylene resin, a polypropylene resin, a soft polyester resin, a chlorinated polyethylene resin, or an ethylene-vinyl acetate copolymer. A liquid container body 52 formed of a resin film made of a rich material, and the lower end of the liquid container body 52 in FIG. An outlet member 53 is provided. After filling the liquid agent container body 52 with the liquid agent, the chemical liquid discharge passage is closed by inserting the rubber plug 58 into the discharge port member 53.

A resin connection port member 21 constituting the second connection means 20 is provided at the upper end portion of the liquid agent container body 52 in FIG. 6, and the connection port member 21 has an inside of the liquid agent container body 52. A communicating path that communicates is formed, and a diaphragm 22 is provided at the tip for shielding the communicating path with the outside of the flexible liquid container 51.
As shown in FIGS. 6 and 7, the connection port 23 of the connection port member 21 has a cylindrical shape, and has a small-diameter distal end portion 23a and a large-diameter proximal end portion 23b, and the proximal end portion 23b. A claw portion 23c that engages with the above-described hole portion 14 is formed on the outer peripheral surface.

  A synthetic resin communication needle 24 is provided in the communication path of the connection port member 21 so as to be movable in the axial direction. The synthetic resin communication needle 24 has a pointed tip and a large-diameter rear end. . A communication hole 24 a is formed in the central portion of the synthetic resin communication needle 24, and the communication hole 24 a is formed to penetrate from the side surface of the front end portion of the synthetic resin communication needle 24 to the rear end portion.

  A support sleeve 25 for supporting the synthetic resin communication needle 24 is fixed to the rear end side of the connection port member 21. The support sleeve 25 is formed in an annular shape on the outer peripheral surface of the synthetic resin communication needle 24. A convex portion 27 that engages with the temporary fixing portion 26 is provided. In the state where the temporary fixing portion 26 is engaged with the convex portion 27, the distal end portion of the synthetic resin communication needle 24 is set to be held at a position away from the diaphragm 22.

Next, a procedure for manufacturing the medicine mixing device 50 including the flexible liquid medicine container 51 shown in FIG. 6 and the medicine container 1 shown in FIG. 2 will be described. The flexible liquid container 51 contains a liquid and is autoclaved.
The flexible liquid container 51 and the medicine container 1 are sterilized by ultraviolet irradiation or the like on the surface of each container, and are conveyed into the aseptic assembly apparatus. The connection port 23 of the connection port member 21 of the flexible liquid container 51 is autoclaved with a sterilization cap (not shown) attached in a liquid-tight manner, and therefore is fitted to the connection tube 13 of the drug container 1. Until the sterilization cap is removed immediately before the connection, the connection port 23 remains in a sterile state.

  2 is sealed by the resin cap 7 as described above, and is shown in FIG. 4 just before fitting with the connection port 23 of the flexible liquid agent container 51. Thus, the sterility is maintained until the resin cap 7 is removed. In this manner, the connection port member 21 of the flexible liquid container 51 and the connection tube 13 of the drug container 1 are fitted and fixed in a sterile state. A hole 14 is formed in the small-diameter portion 13a of the connection tube 13, and the connection tube 13 and the connection port member 21 are fixed by hooking the claw portion 23c of the connection port member 21 into the hole 14. For this reason, the inside of the connecting tube 13 can be reliably maintained in a sterilized state, and even when the drug mixing device 50 is suspended by the suspension port 3 of the drug container 1, the flexible liquid drug container 51 is provided. It can be held securely.

  Moreover, if the connection cylinder 13 and the connection port member 21 are shape | molded with the same thermoplastic resin, the nail | claw part 23c can be heat-melted and the nail | claw part 23c and the connection cylinder 13 can be welded. In this case, the connection cylinder 13 and the connection port member 21 are more firmly fixed.

  Moreover, in this Embodiment, the connection packing 12 is used so that the flexible liquid container 51 and the chemical | medical agent container 1 can be connected liquid-tightly reliably. The connection packing 12 is a donut-shaped flat plate, and the distal end portion 23a of the connection port 23 of the connection port member 21 is inserted into the inner space. Since the inner diameter of the space inside the connection packing 12 is smaller than the outer diameter of the tip 23a of the connection port 23, the connection packing 12 and the connection port 23 can be fitted in a liquid-tight manner.

  Further, in the present embodiment, since the base end portion 23b of the connection port 23 is configured to fit into the small diameter portion 13a of the connection cylinder 13, the connection between the flexible liquid agent container 51 and the drug container 1 is established. It is more certain. Thereby, since the connection port 23 and the connection cylinder 13 are integrated in a substantially straight line, the workability when the synthetic resin communication needle 24 is slid in the direction of the medicine container 1 is improved.

Next, based on FIG.8 and FIG.9, the state which the chemical | medical agent mixing apparatus 50 of this invention is connected by the synthetic resin communication needle 24 is demonstrated.
FIG. 8 is a partial cross-sectional view showing the entirety of the drug mixing apparatus shown in FIG. 5, and FIG. 9 is a partial cross-sectional view showing a communication state of the drug mixing apparatus shown in FIG.
First, the flange 24b of the synthetic resin communication needle 24 is slid to the connection port member 21 side by an operation through the flexible liquid container 51. Then, the tip of the synthetic resin communication needle 24 breaks through the diaphragm 22 of the connection port member. Further, when the flange 24b is slid toward the connecting port member 21, the tip of the synthetic resin communication needle 24 penetrates the inner cap 11 of the drug container 1 and is flexible with the inside of the drug container body 2 of the drug container 1. The inside of the liquid agent container body 52 of the liquid agent container 51 is brought into a communication state via the communication hole 24 a of the synthetic resin communication needle 24.

  Thus, when the inside of the medicine container body 2 of the medicine container 1 and the inside of the liquid medicine container body 52 of the flexible liquid medicine container 51 communicate with each other, the medicine liquid is pressed by pressing the medicine container body 2 of the medicine container 1 from the outside. It flows into the flexible liquid agent container 51 through the communication hole 24 a of the synthetic resin communication needle 24. After all the chemical liquid flows into the flexible liquid container 52, it is mixed with the diluent. Then, an infusion set or the like is connected to the rubber plug 58 and the mixed drug is administered to the patient.

  It goes without saying that the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the scope of the invention. For example, the outer shape of the drug container shown in FIG. 1 is not limited to a cylindrical shape, but may be a square shape such as a quadrangular prism shape or a hexagonal prism shape, or a flat elliptical shape. Also, the resin cap is not limited to the shape of the above embodiment, and the shape is arbitrary.

  It is a top view which shows the whole chemical | medical agent container which concerns on one embodiment of this invention.   It is a fragmentary sectional view of the medicine container shown in FIG.   It is a fragmentary sectional view which shows the manufacturing process of the chemical | medical agent container shown in FIG.   It is a fragmentary sectional view which shows the place which twisted off the resin cap of the chemical | medical agent container shown in FIG.   It is a top view which shows the whole chemical | medical agent mixing apparatus using the chemical | medical agent container shown in FIG.   It is a top view which shows the whole flexible liquid agent container which comprises the chemical | medical agent mixing apparatus shown in FIG.   It is an expanded partial sectional view of the flexible liquid agent container shown in FIG.   It is a fragmentary sectional view which shows the whole chemical | medical agent mixing apparatus shown in FIG.   It is a fragmentary sectional view which shows the communication state of the chemical | medical agent mixing apparatus shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Drug container 2 Drug container main body 3 Hanging part 4 Fixing part 5 Upper opening part 7 Resin cap 10 1st connection means (connection port assembly)
11 Inner cap (lid)
12 connection packing 13 insulating cylinder 13a small diameter part 13b large diameter part 14 hole (engagement means)
20 2nd connection means 21 Connecting port member 22 Diaphragm 23 Connection port 23a Tip part 23b Base end part 23c Claw part (engagement means)
24 Synthetic Resin Communication Needle 24a Communication Hole 24b Flange 50 Drug Mixing Device 51 Flexible Liquid Agent Container 52 Liquid Agent Container Body 100 Hollow Molding Mold 101 Supply Nozzle 102 Mold

Claims (13)

In a drug container having a connecting means for mixing a drug contained in a drug container main body with a liquid at the time of use,
The medicine container body is formed by molding a thermoplastic resin, the medicine container body is filled immediately after the medicine container body is formed, and the connecting means is connected to the opening of the medicine container body immediately after the medicine is filled. A resin cap composed of a part of the thermoplastic resin, and a portion of the thermoplastic resin is welded to the connecting means to seal the opening of the drug container body. A drug container characterized by being sealed.   The drug container according to claim 1, wherein the connecting means includes a lid that seals the drug container main body, and a connection body in which a connection port of the liquid drug container fits in a liquid tight manner.   The medicine container according to claim 2, wherein the lid and the connection body are made of the same member.   The drug container according to claim 2 or 3, wherein the connection means includes a connection cylinder in which the lid and the connection body are accommodated on one end side, and the connection port is inserted on the other end side.   The drug container according to claim 4, wherein the lid, the connection body, and the connection cylinder are integrated in advance, and a part of the thermoplastic resin is welded to the connection cylinder.   The distal end portion of the connection port and the connection body are fitted coaxially, the proximal end portion of the connection port and the connection tube are fitted coaxially, and the inner diameter of the connection body is the inner diameter of the connection tube The medicine container according to claim 4 or 5, wherein the medicine container is smaller.   The medicine container according to any one of claims 4 to 6, further comprising engagement means for engaging the inner peripheral surface of the connection tube and the outer peripheral surface of the proximal end portion of the connection port.   8. The drug container according to claim 7, wherein one of the engaging means is a claw portion and the other is a hole portion.   The drug container according to any one of claims 1 to 8, wherein a suspension opening is provided in a non-opening portion of the drug container main body. In the method of manufacturing a drug container having a connection means for mixing the drug contained in the drug container body with the liquid at the time of use,
A first step of blow molding or vacuum forming a thermoplastic resin to form the drug container body;
A second step of filling the drug container body with a drug immediately after the blow molding or vacuum molding;
A third step of disposing the connecting means at the opening of the drug container body immediately after the filling of the drug;
A fourth step of welding a part of the thermoplastic resin to the connecting means and sealing the opening of the drug container body;
And a fifth step of forming a resin cap so that a part of the thermoplastic resin covers the connecting means.   The connection means includes a lid for sealing the drug container body, a connection body in which a connection port of a liquid medicine container is fitted in a liquid-tight manner, and a connection cylinder into which the connection port is inserted, the lid body, The method for producing a drug container according to claim 10, wherein the connection body and the connection cylinder are integrated in advance, and a part of the thermoplastic resin is welded to the connection cylinder. It has a medicine container body formed by molding a thermoplastic resin, the medicine container body is filled with the medicine immediately after the medicine container body is formed, and immediately after the medicine is filled, the opening is formed in the opening of the medicine container body. 1 connection means is disposed, and a part of the thermoplastic resin is welded to the first connection means to seal the opening of the drug container body, and the thermoplastic resin part is constituted by a part of the thermoplastic resin. A drug container in which the first connecting means is sealed with a resin cap;
And a second liquid connection container connected to the first connection means from which the resin cap has been removed immediately before connection, and a liquid agent container containing a liquid agent in a liquid agent container body. A drug mixing apparatus, wherein the drug container main body and the liquid drug container main body can communicate with each other via a connection means and the second connection means. The first connection means includes a lid for sealing the drug container body, a connection body in which a connection port constituting the second connection means is fitted in a liquid-tight manner, and the lid and the connection on one end side. And a connecting cylinder into which the connection port is inserted on the other end side,
The second connection means is provided in the connection port, a diaphragm provided in the connection port and shields the inside of the liquid container body from the outside, and disposed in the connection port, and an axial liquid flow path therein. And a communication needle formed,
The communicating needle is held at a position where the tip is separated from the diaphragm during storage, and the tip is movable to a position where it penetrates the diaphragm and the lid during use, and the communicating needle passes through the liquid flow path of the communicating needle. The drug mixing device according to claim 12, wherein the drug is allowed to flow into the liquid drug container body.

Images