JP2015097594A - Medicine storage container and its manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine storage container that is superior in adequacy and stabilization of a medicine concentration, and a manufacturing method of the medicine storage container having high accuracy of weighing medicines and high safety in the compounding of the medicines.SOLUTION: A medicine storage container includes a mouth member sealed up by a stopper at the side of a medicine storage chamber of a container body where the medicine storage chamber is continuously arranged with a solution storage chamber. A distal surface of the stopper is configured to become substantially flush with the distal surface of the mouth member in all loaded state to the mouth member of the stopper, and thereby the total amount of medicines dissolves to a solution and the adequacy of the medicinal solution concentration is secured. Also, in the manufacture of the medicine storage container, the medicine storage container is stored in a vacuum freeze dryer while the stopper is half-loaded in the mouth member and is subjected to the vacuum freeze-drying, and thereby the medicines are not exposed to the outside air and the radiation exposure in the compounding of the medicines is prevented.

Description

  The present invention relates to a powder container or a solid-state vacuum freeze-dried drug and a solution, and to a drug container for use by dissolving the drug in a solution and a method for producing the same.

  For example, as one of the treatment methods for cancer patients, there is a drug therapy in which an anticancer drug is administered to a patient by injection, and this drug therapy tends to increase gradually in conjunction with the development of new drugs.

  By the way, most of this anticancer drug is housed in a vial as a very small amount of vacuum freeze-dried agent, and when administered to a patient, the solution in the ampule bottle is sucked with a syringe, and this is anticancer. Injection into the vial containing the drug to obtain the drug solution of the anticancer drug, calculate the dose according to the patient's body weight, suck the required amount of drug solution from the vial with a syringe, and instill it It is injected into a bag and administered to a patient together with an infusion solution.

  In this case, if a combination mistake of medicines or a measurement error of a dose occurs, it will affect the life of the patient, and therefore careful attention is required. In addition, anticancer drugs are often highly toxic drugs. For this reason, pharmacists who dispense anticancer drugs inhale and inhalate gas generated from the drugs, or chemicals adhere to the hands and become burned. Accidents related to dispensing have occurred.

  Based on such a background, techniques for preventing mistakes in combination of medicines, measurement errors in dosage, or accidents associated with dispensing have been proposed (see, for example, Patent Document 1 and Patent Document 2). ).

  Patent Document 1 discloses a flexible structure in which one chamber containing a liquid agent and the other chamber containing a powder agent are partitioned by a weak seal portion, and a mouth portion sealed by a rubber stopper is provided on the other chamber side. A multi-chamber container is shown. And the liquid agent is accommodated in the one chamber of the multi-chamber container, and the powder agent is accommodated in the other chamber, respectively, and at the time of administration to a patient, pressure is applied to the one chamber of the multi-chamber container with a palm. The weak seal portion is peeled off so that the one chamber communicates with the other chamber, and the liquid agent and the powder agent are mixed in an aseptic condition to obtain a required chemical solution. Thereafter, the injection needle is pierced through the rubber stopper of the mouth, and the chemical solution in the multi-chamber container is taken out.

  On the other hand, Patent Document 2 discloses an infusion container in which a vacuum freeze-dried drug is dissolved in a solution. The infusion container includes a drug storage chamber having an upper end sealed with a rubber stopper and a communication hole provided at the lower end, and a flexible solution storage chamber having an open upper end. Contains a small container filled with a predetermined amount of a vacuum freeze-dried drug, while the solution storage chamber stores a required amount of solution. When the drug solution is administered, the drug storage chamber and the solution storage chamber are communicated to dissolve the vacuum freeze-dried drug in the small container in the solution.

JP 2004-329433 A Japanese Patent No. 4617552

  However, in the multi-chamber container shown in Patent Document 1, the mouth portion provided on the chamber side containing the powder agent is a relatively long cylindrical body that communicates the chamber and the outside across the seal portion. On the other hand, since the rubber plug is attached only to the outer end portion of the mouth portion, the inner space of the mouth portion opens toward the chamber in which the powder agent is accommodated.

  For this reason, for example, when the powder agent penetrates into the mouth part due to vibration during transportation of the multi-chamber container and solidifies, and the powder agent and the liquid medicine are mixed to make a solution during drug administration, the mouth is There is concern that the powder agent that has entered the inside and solidified remains in the solution without being dissolved, and as a result, the drug concentration of the solution is lower than the initially set concentration, and the planned dosing effect cannot be obtained. Is done.

  On the other hand, in the container for infusion shown in Patent Document 2, a liquid medicine is put into a small container, and after this is freeze-dried in a separately installed vacuum freeze-dryer, it is taken out from the vacuum freeze-dryer. Since the medicine is stored in the medicine storage chamber, there is a concern about the suction exposure of the medicine or the occurrence of burns as in the case of using the conventional vial. In addition, since the medicine storage chamber and the solution storage chamber formed separately are integrated by heat welding afterwards, there is a problem that the manufacturing work is complicated and the cost is increased.

  Accordingly, the present invention has been made for the purpose of proposing a drug storage container having an appropriate and stable drug concentration, and a method for manufacturing a drug storage container with high drug measurement accuracy and safety at the time of dispensing. .

  In the present invention, the following configuration is adopted as a specific means for solving such a problem.

  In the first invention of the present application, a flexible container main body in which a drug storage chamber for storing a drug and a solution storage chamber for storing a solution are connected via a weak seal portion, and the container main body A cylindrical mouth member attached to be communicable with the medicine housing chamber, and a medicine container comprising a stopper for sealing the mouth member by being loaded from the outer end side of the mouth member. In the half-loading state of the plug member, a small gap is formed between the plug member and the inner peripheral surface of the port member, while the port member is sealed and the front end surface in the full-loading state. Is configured to be substantially flush with the distal end surface of the mouth member.

  In the method for producing a medicine storage container according to the second invention of the present application, the medicine is stored in the medicine storage chamber of the medicine storage container according to the first invention, and the solution is stored in the solution storage chamber. When manufacturing a medicine storage container containing a solution, a container sterilization process for sterilizing the medicine storage container in an empty state, a medicine injection process for introducing a predetermined amount of liquid medicine into the medicine storage chamber through the mouth member, A vacuum freeze-drying process in which the medicine container is housed in a vacuum freeze-dryer with the plug half-loaded in the mouth member, and the liquid medicine is freeze-dried to obtain a powdery or solid medicine, and sublimation of moisture Replacing the water vapor generated in the drug storage chamber with nitrogen gas or air, and fully filling the plug member into the mouth member to seal the drug storage chamber, and the drug storage container Above A part of the solution storage chamber side is opened, a solution charging step for supplying a predetermined amount of the solution into the solution storage chamber from the opening, and the air in the solution storage chamber is aseptic air or aseptic nitrogen gas After the replacement, the second opening and closing step of closing the opening and sealing the solution storage chamber is performed.

  In the present invention, the following effects can be obtained.

(A) 1st invention of this application According to the chemical | medical agent storage container which concerns on 1st invention of this application, in the half-loading state to the said mouth member, the said plug body is between the internal peripheral surfaces of the said mouth member. It is configured so as to form a minute gap, and this minute gap can function as a discharge path for water vapor generated by sublimation of the moisture of the freeze-dried product during vacuum freeze-drying. It is possible to obtain a powdery or solid medicine by putting the liquid medicine into the container and placing the medicine container in a vacuum freeze-dryer as it is and freeze-drying it in a vacuum, thus facilitating simplification of the dispensing operation. The

  In addition, since the plug body is configured so as to seal the mouth member in the fully loaded state of the mouth member and its distal end surface is substantially flush with the distal end surface of the mouth member. The medicine stored in the storage chamber enters the inside of the mouth member due to vibration during transportation of the medicine storage container and solidifies, and further, the solidified medicine remains in the solution without dissolving. As a result, it is possible to prevent the concentration of the chemical solution from being lowered and reliably prevented, and as a result, the entire amount of the drug stored in the drug storage chamber is dissolved in the solution, thereby ensuring the optimization of the chemical concentration. .

(B) 2nd invention of this application According to the manufacturing method of the chemical | medical agent storage container which concerns on 2nd invention of this application, in the vacuum freeze-drying process, the said chemical | medical agent accommodation is carried out in the state which the said plug member was half-loaded in the said mouth member. Since the container is housed in a vacuum freeze dryer and the liquid drug is freeze-dried to obtain a powdery or solid drug, for example, the liquid drug is placed in a separate vacuum freeze dryer as in the prior art. Compared with the case where a powdery or solid drug obtained by vacuum freeze-drying is taken out from the vacuum freeze-dryer and stored in the drug container, the dispensing operation can be simplified and the cost can be reduced. .

  Further, since the transfer work of the medicine between the conventional vacuum freeze dryer and the medicine storage container can be omitted, the risks (for example, contamination of foreign substances during the transfer, exposure of the worker, etc.) associated with the transfer of the medicine are eliminated. be able to.

  Furthermore, in the case of medication, the liquid medicine previously measured and stored in the medicine storage chamber is vacuum freeze-dried while being stored in the medicine storage chamber, and the required amount is stored in advance in the solution storage chamber. The stored solution is mixed and dissolved in the drug storage container 1 to obtain a required amount of drug solution, and there is no human measurement operation in these series of dispensing operations, and this series of dispensings Since the operation is performed without touching the outside air in the medicine container, for example, the pharmacist takes out the solution from the ampoule bottle with a syringe and injects it into the vial to dissolve the medicine. It is possible to reliably prevent the occurrence of drug measurement mistakes, suction exposure during dispensing, and the like, as in the case of requiring a manual measurement operation using a syringe, such as making a required chemical solution.

It is a front view of the chemical | medical agent storage container which concerns on embodiment of this invention. It is an AA arrow line view of FIG. It is a side view of the stopper attached to the mouth member part of the medicine storage container. It is a BB arrow line view of FIG. It is a longitudinal cross-sectional view in the state where the plug body was half-loaded to the mouth member of the medicine container. It is a longitudinal cross-sectional view in the state which pushed the said plug into the opening member. It is a longitudinal cross-sectional view in the state which welded and sealed the said plug body to the opening member. It is a front view of the empty chemical | medical agent storage container before storage of a chemical | medical agent. It is explanatory drawing of injection | pouring operation | movement of the liquid chemical | medical agent to the chemical | medical agent storage chamber of a chemical | medical agent storage container. It is explanatory drawing in the case of performing vacuum freeze-drying with a stopper body as a half loading position. It is explanatory drawing of the state by which the chemical | medical agent was produced | generated in the chemical | medical agent storage chamber by vacuum freeze-drying. It is explanatory drawing of injection | pouring operation | movement of the solution to the solution storage chamber of a chemical | medical agent storage container. It is explanatory drawing of air replacement operation of a solution storage chamber. It is explanatory drawing of the state which melt | dissolved the chemical | medical agent with the solution at the time of dosing, and produced | generated the chemical solution. It is explanatory drawing at the time of the extraction start of the chemical | medical solution from a chemical | medical agent storage container. It is explanatory drawing of extraction operation of the chemical | medical solution from a chemical | medical agent storage container. It is explanatory drawing of the injection | pouring state of the extracted chemical | medical solution to an infusion bag.

  1 and 2 show a medicine container 1 according to an embodiment of the present invention. The drug storage container 1 includes a container main body 2 that individually stores a powdered or solid drug Ma (for example, an anticancer drug) and a solution L (for example, distilled water), and an end of the container main body 2. The mouth member 3 provided in the mouth member 4 and the plug body 4 loaded in the mouth member 3 are configured by vacuum lyophilization of the liquid medicine Mb (see FIG. 9), as will be described later. The vacuum freeze-drying operation for obtaining the medicine Ma and the medicine dissolving operation for obtaining the medicine Mc (see FIG. 14) by dissolving the medicine Ma in the dissolution liquid L can be performed in a closed state in the medicine container 1. It is what I did. Hereinafter, the container main body 2, the mouth member 3, and the stopper 4 will be described in detail.

"Container body 2"
The container body 2 is made of, for example, two long rectangular multilayer films made of flexible polypropylene-based resin or polyethylene-based resin, and the periphery thereof is heat-sealed at a high temperature to form a strong seal portion 23. An intermediate position in the longitudinal direction is welded at a low temperature to form a weak seal portion 24, and a medicine storage chamber 21 is formed on one side of the weak seal portion 24, and a solution storage chamber 22 is formed on the other side. The mouth member 3 described below is welded and fixed to the outer end portion of the medicine storage chamber 21 when the strong seal portion 23 is formed.

  In order to make it easy to form both the strong seal portion 23 and the weak seal portion 24, the resin forming the innermost layer of the multilayer film constituting the container body 2 is a so-called multiple resins having different melting points. A resin having a sea-island structure may be used.

"Mouth member 3"
As shown in FIG. 5, the mouth member 3 includes a tapered cylindrical portion 31 that has a predetermined length and slightly increases in diameter toward the outer end side, and is connected to the outer end portion of the cylindrical portion 31. And a flanged cylinder comprising a flange portion 32 provided with an annular groove 33 on its upper surface (outer end surface), the tip surface 31b of which is substantially the same position as the inner edge 23a of the strong seal portion 23. The medicine storage chamber 21 is in communication with the outside through the mouth member 3. The mouth member 3 is made of, for example, a relatively hard polyethylene resin or polypropylene resin.

"Plug 4"
The plug body 4 shown in FIG. 3 to FIG. 5 can be formed by a general resin two-color molding method. The end member 41 is formed first, and is formed later on the inner side of the end member 41. The elastic member 42 is provided.
However, the plug body 4 is not necessarily formed by the resin two-color molding method, and the end member 41 and the elastic member 42 formed separately are bonded using an adhesive, or an ultrasonic sealing machine. It may be formed by welding using, for example.

  The end member 41 is formed of a relatively hard polyethylene-based resin or polypropylene-based resin, and is connected to the cylindrical portion 41a that is elastically fitted into the outer end portion of the mouth member 3 and the upper end of the cylindrical portion 41a. The flange portion 41b is provided with a double annular ridge, that is, an inner ridge 43 and an outer ridge 44 on the back side of the flange portion 41b. The formation position and dimensions of the inner protrusion 43 are set so that the inner protrusion 43 can be fitted into the groove 33 of the mouth member 3. Further, the outer protrusion 44 becomes a welded portion to the flange portion 32 of the mouth member 3.

  The elastic member 42 is a rod-like body made of elastic thermoplastic synthetic resin, vulcanized rubber, or the like, and the outer end surface 42b side is encapsulated and fixed to the end member 41, while the end surface 42a A press-contact portion 46 bulging annularly from the outer peripheral surface 42c is provided in the vicinity. The length dimension of the elastic member 42 is set relative to the length of the mouth member 3 as will be described later.

  As shown in FIG. 5, the plug body 4 is configured such that the pressure contact portion 46 of the elastic member 42 is substantially in contact with the inner peripheral surface 31 a of the cylindrical portion 31 of the mouth member 3 and the flange portion 41 b of the end member 41 is the mouth member. 3 and a “half-loading position” appropriately separated in the axial direction from the flange portion 32, and the plug body 4 is further pushed in from the half-loading position as shown in FIG. In a state in which the flange portion 32 of the member 3 is brought into contact with the flange portion 32 (see FIG. 6), the flange portion 41b of the end member 41 and the flange portion 32 of the mouth member 3 are welded and fixed to each other. Position is set to “Position”.

  The flange portion 41b of the end member 41 and the flange portion 32 of the mouth member 3 are welded by, for example, an ultrasonic welding method. At the time of this welding, the groove 33 on the mouth member 3 side has the above-mentioned groove 33. When the inner protrusion 43 on the end member 41 side is fitted, the mouth member 3 and the plug body 4 are positioned in the planar direction.

  In the half-loading position shown in FIG. 5, the pressure contact portion 46 of the elastic member 42 is substantially in contact with the inner peripheral surface 31a of the cylindrical portion 31 of the mouth member 3, as described above. However, there are fine gaps as small as pinholes, and these fine gaps function as a water vapor discharge path by sublimation of frozen moisture during vacuum freeze-drying.

  In addition, in the half-loading position, a portion of the inner peripheral surface 31a of the cylindrical portion 31 of the mouth member 3 where the pressure contact portion 46 of the elastic member 42 is substantially in contact may be roughened or provided with a groove. The fine gap can be formed more reliably, which is preferable.

  In addition, at the full loading position shown in FIG. 7, the pressure contact portion 46 of the elastic member 42 is pressed against the inner peripheral surface 31 a of the mouth member 3, thereby sealing between the two. In this case, the length of the elastic member 42 in the axial direction is set so that the distal end surface 42 a thereof is substantially flush with the distal end surface 31 b of the mouth member 3. For this reason, at the full loading position of the plug 4, the mouth member 3 is closed by the elastic member 42 on the distal end surface 31 b side. For example, the medicine storage chamber is placed in the mouth member 3. Intrusion of the medicine Ma accommodated in 21 is reliably prevented.

  Furthermore, a concave needle puncture portion 45 is provided at the center position of the outer end surface 42 b of the elastic member 42. A cover film 5 (see FIG. 1) is attached to the upper surface side of the elastic member 42.

  The elastic member 42 is made of an elastic thermoplastic synthetic resin or vulcanized rubber. Examples of the thermoplastic synthetic resin include styrene, olefin, polyurethane, polyester, polychlorinated, and the like. Synthetic resins such as vinyl and polybutadiene are applicable, and it is desirable to use a styrenic thermoplastic elastomer, especially considering the ease of needle stick and the high resealability after needle removal. .

  The medicine storage chamber 21 of the medicine storage container 1 configured as described above is filled with the medicine Ma and the solution storage room 22 is filled with the solution L in the following procedure.

"Storage of drug Ma"
The medicine Ma is stored in the medicine storage chamber 21, but in this embodiment, the medicine Ma obtained by vacuum freeze-drying in advance in a separate vacuum freeze dryer as in the prior art is not stored. The liquid medicine Mb (the aqueous solution of the medicine Ma before vacuum freeze-drying) is stored in the medicine storage chamber 21 and is lyophilized while being stored in the medicine storage chamber 21 to be powdered or solid medicine Ma. Like to get. This will be specifically described as follows.

  As shown in FIG. 8, an empty medicine container 1 manufactured as described above is prepared. In the above description, the end edge on the side of the solution storage chamber 22 of the empty medicine container 1 before the medicine Ma or the like is stored has the other edge portion as the strong seal portion 23 in the same manner. Here, the case where the edge on the side of the solution storage chamber 22 is locally used as the weak seal portion 26 will be described as an example (note that the weak seal portion 26 is provided after the solution L is stored as described later. The strong seal portion 23 is obtained by re-welding). In the empty medicine container 1, the plug 4 is removed from the mouth member 3. Instead, the opening of the mouth member 3 is sealed with a film material (not shown). (That is, the empty medicine container 1 is in a sealed state).

  First, the empty medicine container 1 is sterilized. Here, as the sterilization method of the empty medicine storage container 1, pulsed light sterilization which is a non-heat sterilization method from the viewpoint of maintaining the quality of the medicine storage container 1 by avoiding thermal deformation of the medicine storage container 1 Is desirable.

  Next, as shown in FIG. 9, the film material sealing the opening of the mouth member 3 is removed, and a liquid injection nozzle 36 is inserted from the opening of the mouth member 3 into the medicine storage chamber 21 side. The medicine storage chamber 21 is filled with a predetermined amount of the liquid medicine Mb through the liquid injection nozzle 36. In FIG. 9, reference numeral 35 denotes a holding clamp on the liquid medicine filling machine (not shown) side that holds the medicine container 1.

  Next, after the liquid injection nozzle 36 is taken out from the mouth member 3 portion, the stopper 4 is lightly inserted into the mouth member 3 and positioned at the half-loading position. Thereafter, the medicine container 1 is stored in a drying chamber of a vacuum freeze dryer (not shown) while being held by the clamp 35, and vacuum freeze drying is performed.

  In the vacuum freeze dryer, first, the temperature of the drying chamber is set to about −40 ° C. to freeze the liquid medicine Mb. Thereafter, when the inside of the drying chamber is depressurized and evacuated, the water in the frozen liquid medicine Mb sublimates and becomes water vapor and is discharged from the medicine storage chamber 21 to the outside. Powdered or solid drug Ma is produced.

  Thereafter, when nitrogen gas or air is supplied into the drying chamber, the nitrogen gas or air is sucked into the medicine storage chamber 21, and the water vapor in the medicine storage chamber 21 is replaced with nitrogen gas or air. The storage chamber 21 is filled with the medicine Ma and nitrogen gas or air.

  It should be noted that both the discharge of water vapor from the medicine storage chamber 21 and the supply of nitrogen gas or air to the medicine storage chamber 21 are both the elastic member 42 and the mouth member 3 of the plug 4 in the half-loading position. This is carried out through a minute gap between the inner peripheral surface 31a of the two.

  Next, as shown in FIG. 11, the plug body 4 in the half-loading position is further pushed in, and the flange portion 32 of the mouth member 3 and the flange portion 41b of the end member 41 of the plug body 4 are welded, The stopper 4 is fixed at all loading positions. Thereby, the medicine storage chamber 21 is sealed by the stopper 4. Thus, the storing operation of the medicine Ma in the medicine storage chamber 21 is completed.

  In this way, the liquid medicine Mb is charged into the medicine storage chamber 21 of the medicine storage container 1, and then the medicine storage container 1 is placed in a vacuum freeze dryer and vacuum freeze-dried to obtain a powdery or solid medicine. By obtaining Ma, the drug is not exposed to the outside air during dispensing. For example, a powder or solid obtained by vacuum freeze-drying a liquid drug in a separate vacuum freeze dryer as in the past Thus, it is possible to reliably prevent the occurrence of suction exposure, burns, etc. during dispensing as in the case of taking out the medicine from the vacuum freeze dryer and storing it in the medicine storage container.

"Storage of solution L"
When storing the solution L (for example, distilled water) in the solution storage chamber 22, first, as shown in FIG. 12, the drug storage container in which the drug Ma is stored in the drug storage chamber 21. 1 is turned upside down, and the weak seal portion 26 on the solution storage chamber 22 side is positioned on the upper side. Thereafter, the weak seal portion 26 is broken and opened to open the solution storage chamber 22. A liquid injection nozzle 37 is inserted into the opening, and a predetermined amount of the solution L is filled into the solution storage chamber 22 through the liquid injection nozzle 37.

  In addition, instead of the above-described method in which one end of the solution storage chamber 22 is used as the weak seal portion 26 and the weak seal portion 26 is opened to open the solution storage chamber 22, as described above, for example, the weak seal portion 26, the entire periphery of the medicine container 1 may be used as the strong seal portion 23, and a portion of the strong seal portion 23 may be cut off when the solution storage chamber 22 is opened. .

  Next, as shown in FIG. 13, a double tube 38 is inserted into the solution storage chamber 22 from the opening thereof, and the air in the solution storage chamber 22 is passed through the inner tube of the double tube 38 to the outside. While discharging, a predetermined amount of sterile air or sterile nitrogen gas is sent into the solution storage chamber 22 through the outer tube, and the air in the solution storage chamber 22 is replaced with sterile air or sterile nitrogen gas.

  Here, the amount of sterile air or sterile nitrogen gas sealed in the solution storage chamber 22 is the amount of the sterile solution storage chamber 22, but in this embodiment, as shown in FIG. The amount is set so as to swell even larger than the enclosed medicine storage chamber 21. This is because the drug storage container 1 is usually “about 100 mm × 50 mm in length and width” and the solution storage chamber 22 is “about 35 mm × 40 mm in length and width”, both of which are small. If the sterilized air or the sterilized nitrogen gas is not sufficiently contained, it is difficult to press the lysate storage chamber 22 from the outside and open the weak seal portion 24 with the internal gas pressure. A large amount of sterile air or sterile nitrogen gas is put in the storage chamber 22.

  Simultaneously with degassing of the solution storage chamber 22 and filling with sterile air or sterile nitrogen gas, as shown in FIG. It is sandwiched by 39 and welded by high temperature heat welding. Thereafter, the double pipe 38 is taken out, and the left and right seal portions are pulled outward in this state, so that the drawing hole of the double pipe 38 is closed. Weld by high temperature heat welding. Thus, the opening of the solution storage chamber 22 is sealed as the strong seal portion 23, and the solution storage chamber 22 is sealed. If necessary, a suspension hole 25 (see FIG. 1) is provided in the strong seal portion 23 portion.

  Thus, the storage operation of the solution L in the solution storage chamber 22 is completed. That is, the manufacture of the medicine container 1 is completed.

"How to use the medicine container 1"
Then, the usage method of the said chemical | medical agent storage container 1 is demonstrated.

  In using the drug storage container 1, first, in the drug storage container 1 shown in FIG. 1, the dissolution liquid storage chamber 22 is pressed by hand or the like, and the weak pressure is generated by the gas pressure in the dissolution liquid storage chamber 22. As shown in FIG. 14, the seal portion 24 is opened, and the solution storage chamber 22 and the drug storage chamber 21 are communicated, and the drug Ma is dissolved by the solution L to obtain a drug solution Mc.

  Next, as shown in FIG. 15, the needle 7 is inserted into the needle puncture portion 45 of the plug 4, and the amount of the drug solution Mc set for each patient is extracted by the syringe 6 as shown in FIG. 16.

  Thereafter, as shown in FIG. 17, the drug solution Mc extracted from the drug storage container 1 side by the syringe 6 is injected into the infusion bag 8 and mixed with the infusion solution Md, and this is instilled into the patient.

  In this case, since the mouth member 3 is provided on the drug storage chamber 21 side of the drug storage container 1, in order to extract the drug solution Mc with the syringe 6, the weak seal portion 24 is opened and the drug storage chamber 21 is opened. And the solution storage chamber 22 are communicated, and the drug Ma is dissolved in the solution L to generate the drug solution Mc. For example, the solution Ma is dissolved in the solution L without dissolving the drug Ma. Dispensing mistakes in which only L is extracted by the syringe 6 and used are reliably prevented.

  Further, as shown in FIG. 14, the weak seal portion 24 of the medicine container 1 is opened to allow the medicine storage chamber 21 and the solution storage chamber 22 to communicate with each other, thereby dissolving the medicine Ma in the solution L and supplying the medicine Mc. In the case of obtaining, the mouth member 3 is closed by the elastic member 42 on the distal end surface 31b side at the full loading position of the plug body 4 as described above, and entry of the medicine Ma into the mouth member 3 is prevented. Therefore, for example, it is certain that a part of the medicine Ma intrudes into the mouth member 3 and solidifies and remains undissolved by the dissolution liquid L, and the concentration of the medicine Mc decreases. Therefore, appropriateness and stability of the drug concentration are ensured.

  In the above embodiment, the drug Ma has been described as an anticancer agent, but the present invention is not limited to this and can be widely applied to vacuum freeze-dried preparations.

  The drug storage container and the manufacturing method thereof according to the present invention are used in the field of manufacturing a vacuum freeze-dried preparation such as an anticancer drug in a container.

1 .. Drug storage container 2 .. Container body 3 .. Mouth member 4 .. Plug body 5 .. Cover film 6 .. Syringe 7 .. Needle 8 .. Infusion bag 21 .. Drug storage chamber 22. Storage chamber 23 .. Strong seal part 24 .. Weak seal part 25 .. Hanging hole 31 .. Cylindrical part 32 .. Flange part 33 .. Groove 41 .. End member 42 .. Elastic member 43. Strip 44 ··· Outer projection 45 ·· Needlestick portion 46 ·· Pressure contact portion Ma ·· Drug L ·· Solution

Claims (2)

A flexible container body in which a drug storage chamber for storing a drug and a solution storage chamber for storing a solution are connected via a weak seal portion, and can communicate with the drug storage chamber of the container body A medicine container that includes a cylindrical mouth member attached to the mouth member and a stopper that seals the mouth member by being loaded from the outer end side of the mouth member,
While the plug body forms a minute gap with the inner peripheral surface of the mouth member in a half-loading state to the mouth member, the mouth member seals the mouth member and has a front end surface in the full-loading state. A medicine container which is configured to be substantially flush with the distal end surface of the mouth member. A method for producing a medicine storage container containing a medicine and a solution by storing the medicine in the medicine storage chamber of the medicine storage container according to claim 1, and storing the solution in the solution storage room.
A container sterilization step of sterilizing the medicine container in an empty state;
A drug charging step of charging a predetermined amount of liquid drug into the drug storage chamber through the mouth member;
A vacuum lyophilization step of obtaining a powdery or solid drug by lyophilizing the liquid drug by storing the drug container in a vacuum freeze dryer with the plug half-loaded to the mouth member;
A first replacement sealing step of replacing the water vapor generated in the drug storage chamber by sublimation of moisture with nitrogen gas or air, and fully charging the plug member into the mouth member to seal the drug storage chamber;
Opening a part of the drug storage container on the side of the solution storage chamber, and charging a predetermined amount of the solution into the solution storage chamber from the opening;
A second replacement sealing step of replacing the air in the solution storage chamber with sterile air or sterile nitrogen gas and then closing the opening to seal the solution storage chamber;
The manufacturing method of the chemical | medical agent storage container characterized by the above-mentioned.