JP2000070366A - Syringe serving as container and sealing of freeze-dried preparation in syringe serving as container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To attain production efficiency by making plugging of a rubber stopper further positive while maintaining a hygienic state. SOLUTION: A medicinal liquid 44 to be the pre-stage of a freeze-dried preparation is filled by placing the other end of a cartridge 7 with one end sealed by a first rubber stopper, on the top side, and a second rubber stopper 22 with a guide part 28 of almost truncated cone shape provided at one end is inserted in the upper end of the cartridge 7 in such a state that a groove formed in the guide part 28 is communicated with the outside. In this state, the cartridge 7 is carried into a freeze-drying device for freeze-drying, and after manufacturing the freeze-dried preparation in the cartridge 7, the second rubber stopper 22 is pushed down by a movable part 47 disposed in the freeze-drying device to completely plug, thus sealing the freeze-dried preparation in the cartridge 7.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a container / syringe in which a freeze-dried preparation is enclosed and a method for enclosing a freeze-dried preparation in a container / syringe.

[0002]

2. Description of the Related Art As a conventional method of enclosing a freeze-dried preparation in a container / syringe, a cartridge of a container / syringe having one end sealed by a rubber stopper in advance is placed on the unsealed end. In this state, the drug solution, which is the pre-stage of the freeze-dried preparation, is injected into the cartridge, and in this state, the whole cartridge is carried into the freeze-drying apparatus, and the drug solution is freeze-dried by setting the inside of the freeze-drying apparatus to a low-temperature, vacuum state. After adjusting the internal pressure of the freeze-drying device by filling the freeze-drying device with an inert gas such as nitrogen gas, and then disposing the freeze-dried device above the cartridge in the freeze-drying device, adjust the position of the cartridge in advance. From the top of the intermediate plate where the rubber stopper is attached to the hole provided, press the rubber stopper on the lower surface and align the rod-shaped projection with the cartridge. The movable portion provided downwardly lowered onto the cartridge, and stoppered with rubber stoppers at the top of the cartridge by contact, methods are known that sealing the lyophilized formulation into the cartridge.
Also, in the above-described sealing method, instead of attaching the rubber stopper to the movable part, a jig is attached to each upper end of the cartridge into which the chemical solution has been injected, and the rubber stopper is held by the jig so as to be spaced above the cartridge. After that, after the freeze-drying process, the movable part arranged on the upper part of the cartridge in the freeze-drying device is lowered onto the upper part of the jig attached to the cartridge, and the rubber stopper is pushed out of the jig by being brought into close contact therewith. It is also known to stopper the cartridge and seal the lyophilized formulation in the cartridge.

[0003]

SUMMARY OF THE INVENTION Among the above-mentioned conventional methods for encapsulating a lyophilized preparation in a container-cum-syringe, the above-mentioned method, that is, after freeze-drying treatment, the rubber stopper is stoppered by a movable part in the lyophilization apparatus. In the method of enclosing the freeze-dried preparation in the combined use syringe, since the rubber stopper was attached to the hole of the intermediate plate, the position of the cartridge and the rubber stopper did not match due to mounting errors and the like. In some cases, when the rubber stopper was plugged into the cartridge after the production of the freeze-dried preparation, the plugging could not be performed correctly.

[0004] In addition, when a large number of cartridges are simultaneously plugged by this method, if even one of the cartridges is not properly plugged, the rubber stopper that has not been properly plugged may cause the movable part and the cartridge to be closed. The movable part cannot be completely pushed down due to being caught in the middle, and the stoppers of other cartridges may be incompletely plugged. However, there is a fear that the cartridge may be damaged. To adjust the position of the rubber stopper in this state, the outside air enters the freeze-drying device when the freeze-drying device door is opened, and the freeze-dried preparation in the incompletely stoppered cartridge is exposed to the outside air. As a result, the cartridge is contaminated or deteriorated by touching the cartridge, so that all the cartridges have to be discarded, which has been a factor of greatly reducing the yield. On the other hand, the latter method of encapsulating the lyophilized preparation in the container / syringe described above, that is, after the lyophilization treatment, the rubber stopper held at the upper part of each cartridge by the jig is moved by the movable part in the lyophilization apparatus. In the method in which the freeze-dried preparation is sealed in the combined use of a container and a syringe, a step of holding the rubber stopper in a special jig is required, and sterilization after holding must be performed. Further, before putting the cartridge into the freeze-drying apparatus, a step of placing a jig holding the rubber stopper on the top of the cartridge, and after the freeze-drying, from the top of each cartridge outside the freeze-drying apparatus, It is difficult to remove the empty jig, perform cleaning, sterilization, etc., and always maintain a clean state for the next operation.

[0005] The present invention has been made in view of the above circumstances, and its object is to maintain hygiene while maintaining
It is an object of the present invention to provide a container / syringe and a method for encapsulating a lyophilized preparation in a container / syringe, in which the production efficiency is improved by easily and more reliably plugging the rubber stopper into the lyophilizer.

[0006]

The container / injection syringe according to claim 1, wherein the cartridge, a cylindrical portion fitted to one end of the cartridge, a finger grip fitted to the other end of the cartridge, First and second rubber stoppers which are arranged at predetermined intervals in the cartridge and hermetically seal the medicine therebetween, and the rubber on the finger grip side of the first and second rubber stoppers When the rubber stopper is inserted into the cartridge and the insertion is temporarily stopped in a half-plugged state, the stopper is provided with a communication portion for communicating the inside and the outside of the cartridge with each other.

[0007] Thus, since the inside and the outside of the cartridge of the container / syringe are communicated with each other by the communication part, the medicinal solution which is the pre-stage of the lyophilized preparation is injected into the cartridge, and the rubber stopper is inserted into one end of the cartridge of the container / syringe. Is inserted into the half-stopper state and carried into the freeze-drying apparatus.Then, in this state, the internal temperature of the freeze-drying apparatus is lowered to a predetermined temperature, and the chemical solution is evacuated by evacuating the freeze-drying apparatus. A freeze-dried preparation can be obtained by freeze-drying. After the lyophilized preparation is manufactured, since the rubber stopper is already in a half-stopped state, the rubber stopper is moved by a movable part arranged in the freeze dryer, for example, a flat movable part or a movable shelf board. By simply pressing down, the rubber stopper can be easily and reliably plugged into the cartridge.

[0008] The container / syringe according to claim 2,
A rubber stopper provided on the side of the cartridge to which the finger grip is attached has a guide portion having a substantially frustoconical shape provided at an end portion on the side to be inserted into the cartridge, and the guide portion is provided along the insertion direction. And a groove formed to serve as the communication part. As a result, rubber stopper
By inserting the guide portion into the cartridge, the cartridge can be easily half-plugged, and when the rubber stopper is completely stoppered by the movable portion, the rubber stopper is guided by the guide portion. It can be plugged reliably.

[0009] In the container and syringe according to claim 3,
A communication part is provided at an end of the cartridge on the side where the finger grip is mounted, instead of a communication part formed on a rubber stopper to be inserted on the side where the finger grip of the cartridge is mounted. And 5. The container-and-syringe according to claim 4, wherein the communicating portion provided in the cartridge has a notch formed in an end portion of the cartridge in a longitudinal direction of the cartridge, a groove formed in an inner surface of the cartridge, or It is characterized by comprising one of the vent holes formed near the end of the cartridge.
Thus, a lyophilized preparation can be produced in a cartridge using a normal rubber stopper and sealed.

According to a fifth aspect of the present invention, in the method for enclosing a freeze-dried preparation in a container / syringe, the cartridge of the container / syringe, one end of which is hermetically and liquid-tightly sealed by a rubber stopper, is sealed by a stand. Fixed in an upright state such that the end on the side not facing up, and inject the drug solution which is a pre-stage of the lyophilized preparation into the cartridge,
At one end, insert a rubber stopper with a substantially frustoconical guide having a groove formed in the side surface into the cartridge in such a manner that the groove is in a half-plugged state in which the groove communicates with the outside, and then the cartridge Is transported into the freeze-drying apparatus together with the stand, the inside of the freeze-drying apparatus is kept at a low temperature and in a vacuum, and the drug solution is freeze-dried into a freeze-dried preparation, and then nitrogen gas or the like is introduced into the freeze-drying apparatus. After the inert gas is filled and the internal pressure of the freeze-drying apparatus is adjusted to the atmospheric pressure or a predetermined pressure, the rubber stopper in the half stoppered state by the movable portion disposed in the freeze-drying apparatus. The lyophilized preparation is enclosed in the cartridge by pushing down the cartridge and completely stoppering the cartridge.

According to this, when freeze-drying the chemical solution injected into the container / syringe, it is carried into the freeze-drying apparatus with the rubber stopper inserted into one end of the cartridge of the container / syringe in a half-stopped state. Then, in this state, the internal temperature of the freeze-drying device can be lowered to a predetermined temperature, and the drug solution can be freeze-dried by performing evacuation. Thus, the rubber stopper can be easily and reliably plugged without worrying about the position of the rubber stopper.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following is a description of an embodiment of a container / syringe according to the present invention. As shown in FIG. 1, the container / syringe 1 is used by connecting a container / syringe 4 to a cylinder tip portion 2 such that a cylinder tip portion 3 faces each other. These are removably connected by a connecting means 5, and the connecting portion can be protected by a sealing material 6 so as to maintain an aseptic state.
The container / syringe 1 and the container / syringe 4 have substantially the same configuration, each having cartridges 7 and 8, cylindrical tip portions 2 and 3 respectively fitted at one end thereof, and finger grips 9 respectively fitted at the other end. , And 10. In use, each plunger rod 1
1 and 12 are used in combination.

In the cartridges 7 and 8, the cylinder tip portion 2,
The first rubber stoppers 20, 2
1 is provided with second rubber stoppers 22 and 23 at ends on the fitting portion side with finger grips 9 and 10, respectively.
The first and second rubber stoppers form medicine enclosing portions 24 and 25 in the cartridges 7 and 8, respectively. Further, the second rubber stoppers 22 and 23 are provided with screw holes 26 and 27 for screwing the plunger rods 11 and 12 during the compounding operation, respectively. An end of the second rubber stopper 22 on the side to be inserted into the cartridge 7 has a guide portion 2 having a substantially truncated cone shape.
8 are formed, and a groove 29 is formed in the guide portion 28 along the insertion direction.

A lyophilized preparation 30 is contained in the medicine enclosure 24,
Liquid medicines 31 are sealed in the medicine enclosing portions 25, respectively. A female luer taper portion 32 formed in an inverted tapered shape is provided on the side opposite to the fitting portion with the cartridge 7 on the cylinder tip portion 2 of the container / syringe 1. The portion 3 is provided with a male luer taper portion 33 formed in a tapered shape on the side opposite to the fitting portion with the cartridge 8.
Further, at the tip of the female luer taper portion 32, a pair of projection portions 34, 34 are provided so as to form a pair at an angle of 180 degrees, and the female luer taper portion 32 forms an engaging portion 35. Also, male luer taper part 33
A cylindrical portion 36 is provided outside the periphery of the cylindrical portion 3.
6 is provided with an internal thread portion 37 on the inner peripheral surface. And by these, namely, the female luer taper portion 3
2. The connecting means 5 is constituted by the male luer taper portion 33, the projecting portions 34, 34, and the female thread portion 37.

The male luer taper portion 33 has the same luer taper shape as the injection needle mounting portion of a general syringe, and the female luer taper portion 32 has the same taper angle as the male luer taper portion 33. ,
Male luer taper portion 33 is female luer taper portion 32
When they are pushed in, they are fitted tightly by the elastic force of each other. In addition, the female luer taper portion 32 is provided with protrusions 34, 34 provided at the distal end.
Is screwed into the female screw portion 37. In this way,
The connecting portions 5, that is, the engaging portions 35, the male luer taper portions 33, and the female thread portions 37 connect the tube tip portions 2 and 3 to face each other.

By-pass chambers 38 and 39 for accommodating the first rubber stoppers 20 and 21 are provided on the inner periphery of the cylinder tip portions 2 and 3 on the sides fitted with the cartridges 7 and 8, respectively. Further, on the inner wall surfaces of the bypass chambers 38 and 39, a bypass groove 40 communicating from the fitting portion with the cartridge 7 to the female luer taper portion 32, and a bypass groove communicating from the fitting portion with the cartridge 8 to the male luer taper portion 33, respectively. 41 are provided. The container / syringe 1 and the container / syringe 4 are individually sealed in a state where they are separately separated from each other, and the container / syringe 4 filled with the liquid agent is sterilized and then connected in a sterile state. The connection 5 is connected to the container / syringe 1 and the connection portion is covered with the sealing material 6, so that the aseptic condition is maintained until immediately before use.

The method of using the container / syringe 1 configured as described above is as follows. First, the plunger rod 11 of the container / syringe 1 is pushed in to increase the pressure in the medicine enclosing portion 24 of the container / syringe 1. The first rubber stopper 20 of the container-and-syringe 1 is pushed into the bypass chamber 38 of the cylinder tip portion 2, and the medicine sealing portion 24 is communicated with the container-and-syringe 4 by a bypass groove 40 formed on the inner surface of the bypass chamber 38. next,
Similarly, plunger rod 12 of container / syringe 4
Is pushed halfway, and the medicine enclosure 2 of the container / syringe 4
5 is communicated with the container / syringe 1, and in this state, the plunger rod 12 is further pushed in to inject the liquid medicine 31 in the container / syringe 4 into the medicine sealing portion 24 of the container / syringe 1 and freeze A dry preparation 30 and a liquid drug 31 are prepared. Next, these container-combined syringes 1 and 4 are held vertically with the container-combined syringe 1 facing upward, and the medicine in the medicine-encapsulated portion 24 of the container-combined syringe 1 is collected on the cylinder tip portion 2 side of the medicine-encapsulated portion 24. By pulling the plunger rod 12 of the container / syringe 4 in this state,
These medicines prepared in the medicine enclosing section 24 of the container / syringe 1 are sucked into the medicine enclosing section 25 of the container / syringe 4 through the bypass grooves 40 and 41 in the bypass chambers 38 and 39. Then, the container / syringe 1 is detached from the cylinder / tip 3 of the container / syringe 4, and an injection needle is attached to the cylinder / tip 3 of the container / syringe 4 to perform injection.

In the above-described embodiment, the projections 34, 34 and the female thread 37 are employed as the connecting means 5.
The present invention is not limited to this. The female luer taper portion 32 and the male luer taper portion 33 may be fitted to each other and connected by their elastic force.
Instead of the pair of projections 34, 34 provided at the distal end of the cylinder 2, a flange is provided over the entire circumference, and a step or groove is provided instead of the female thread 37 provided at the tube tip 3, and these are provided. Such as connecting by engaging,
Generally, the same configuration as the means used for connecting the syringe and the injection needle is used. In addition, the number and position of rubber stoppers can be selected.

Next, a method for enclosing the freeze-dried preparation in the container / syringe according to the present invention will be described. First, FIG.
As shown in (a), a finger grip 9 is attached to one end in advance, and the other end is the first rubber stopper 2.
Cartridge 7 sealed air-tight and liquid-tight by 0
Is inserted into a cartridge receiver 43 formed into a hole on the upper surface of the stand 42 so that the end on the side to which the finger grip 9 is attached faces upward, and is held upright. In addition, instead of using the cartridge 7 in which the finger grip 9 is attached to one end in advance, FIG.
As shown in FIG. 1, a cartridge 7 having the cylinder tip 2 attached to the end on the side where the first rubber stopper 20 is inserted, and a cartridge 7 having both the finger grip 9 and the cylinder tip 2 attached thereto are used. The finger grip 9 and the tube tip portion 2 may be used.
The cartridge 7 into which only the first rubber stopper is inserted may be used without attaching the first rubber stopper.

Next, a drug solution 44, which is a stage before the freeze-dried preparation and is freeze-dried to be a freeze-dried preparation, is injected into the cartridge 7. Subsequently, a guide portion 28 having a substantially frustoconical shape is provided at the end in the insertion direction into the cartridge 7, and the end of the guide portion 28 is divided into two by a groove 29 to form a communication portion 45. The rubber stopper 22 is inserted into the upper end of the cartridge 7 such that the groove 29 of the guide portion 28 is in a half-plugged state in which the groove 29 is communicated to the outside. In this state, as shown in FIG. 3, the cartridge 7 is transported together with the stand 42 into the freeze-drying device 46, and as shown in FIG. The drug solution 44 is freeze-dried to obtain a freeze-dried preparation 30.

Subsequently, an inert gas such as nitrogen gas is filled in the freeze-drying device 46, and the internal pressure of the freeze-drying device 46 is adjusted to the atmospheric pressure or a predetermined pressure so as not to adversely affect the sealing of the cartridge. . The internal pressure of the freeze-drying device 46 is set slightly lower than the atmospheric pressure in consideration of the fact that the nitrogen gas in the cartridge 7 is compressed by inserting the rubber stopper 22 into the cartridge 7 to increase the pressure. Often set. Thereafter, as shown in FIG.
The movable part 47 in the form of a lithographic plate, which is disposed above the slab and is movable up and down, is lowered, whereby the second rubber stopper 22 arranged in a half-plugged state in the cartridge 7 is pushed down, and the cartridge 7 is completely inserted into the cartridge 7. Then, the freeze-dried preparation 30 is sealed in the cartridge 7.

According to the method for enclosing the freeze-dried preparation in the container / syringe thus configured, after injecting the drug solution 44 into the container / syringe 1, the second end of the cartridge 7 of the container / syringe 1 is By inserting the guide portion 28 of the rubber stopper 22, it is possible to easily bring the stopper into a half-plugged state. In the half-plugged state, the inside and the outside of the cartridge 7 are communicated by the communication portion 45. Therefore, after the cartridge 7 is loaded into the freeze-drying apparatus 46, the internal temperature of the freeze-drying apparatus is kept at a predetermined level in this state. The drug solution 44 can be lyophilized by lowering the temperature to a lower temperature and evacuating to obtain the lyophilized preparation 30. After the production of the lyophilized preparation 30, the second rubber stopper 2
Since the cartridge 2 is previously half-plugged with respect to the cartridge 7, there is no need to worry about the mounting position of the second rubber stopper 22.

Further, since the second rubber stopper 22 is guided into the cartridge 7 by the guide part 28, the second rubber stopper 22 is simply pushed down by the movable part 47 disposed in the freeze-drying device 46, so that it can be easily obtained. And securely insert the second rubber stopper 2 into the cartridge 7.
2 can be stoppered.

In the above embodiments,
Communication portion 45 formed in second rubber stopper 22
Is formed by a groove 29 that divides the tip of the guide portion 28 into two. However, the present invention is not limited to this. One or more grooves are formed around the guide portion 28 along the insertion direction of the guide portion 28. The communication part 45 may be formed by the following. Further, the guide portion 28 is provided with a projection-like stopping means 4 as shown in FIG. 5 so that the second rubber stopper 22 is temporarily stopped in a half-plugged state when it is inserted into the cartridge 7.
8 may be provided.

The communication portion 45 is not limited to the groove 29 formed in the guide portion 28 of the second rubber stopper 22, but as shown in FIGS.
However, the cutout 49 or the vent hole 50 formed on the side where the second rubber stopper 22 is disposed may be used. Further, a groove may be formed on the inner surface of the end of the cartridge 7 on the side where the second rubber stopper 22 is disposed, and the groove may be used as the communication portion 45. In these cases, the upper part of the second rubber stopper 22 or the movable part 4
For example, the second rubber stopper 22 may be more reliably plugged by providing the protrusion 51 on the bottom surface of the nozzle 7. In this case, since the rubber stopper 22 having a normal shape can be used as the rubber stopper 22, there is no need to provide a new facility for producing the rubber stopper 22 provided with the guide portion 28, thereby reducing the manufacturing cost. can do. In addition, since the dead space in the combined use syringe 1 is eliminated by using the ordinary rubber stopper, the cylinder tip 3 is attached instead of the cylinder tip 2, and the male taper 3 of the cylinder tip 3 is further attached.
By attaching an injection needle to the container 2, the container / injector 1 can be used as a normal, container / injector that can perform direct injection.
1 is pierced into the vial in which the container 1 is enclosed, and in this state, the liquid medicine 31 is sucked into the container / syringe 1 and mixed with the lyophilized preparation 30 in the container / syringe 1 to directly use the container / syringe 1 alone. Injections can be made. Further, in the above-described embodiment, the movable portion 47 of the freeze-drying device 46 is a lithographic plate arranged above the cartridge 7 and movable up and down. However, the present invention is not limited to this. A plurality of shelves on which the cartridges 7 are mounted can be moved up and down.
7 is acceptable.

[0026]

According to the method for encapsulating a lyophilized preparation in a container / syringe or container / projectile according to the present invention, the following effects can be expected.

According to the container / syringe of the first aspect,
Since the inside and outside of the cartridge of the container / syringe are communicated by the communication part, the drug solution, which is the pre-stage of the lyophilized preparation, is injected into the cartridge, and the rubber stopper is half-stopped at one end of the cartridge of the container / syringe. After being inserted and carried into the freeze-drying apparatus, the internal temperature of the freeze-drying apparatus can be lowered to a predetermined temperature in this state, and the drug solution can be freeze-dried by evacuation to obtain a freeze-dried preparation. In addition, after the lyophilized preparation is manufactured, the rubber stopper is already in a half-stopped state, so simply press down the rubber stopper with the movable part arranged in the freeze-drying device, and simply and reliably plug the rubber stopper into the cartridge. can do.

According to the container / syringe of the second aspect,
The rubber stopper can be easily half-plugged into the cartridge by inserting the rubber stopper into the cartridge.Also, when the rubber stopper is completely stoppered by the movable part, the rubber stopper is guided by the guide. Since it is guided, the stopper can be reliably inserted.

According to the third aspect of the present invention, instead of the communicating portion formed in the rubber stopper inserted into the side where the finger grip of the cartridge is mounted, the side of the cartridge where the finger grip is mounted. The communication part is formed by one of the notch formed at the end of the cartridge, the groove formed on the inner surface of the cartridge, and the vent formed near the end of the cartridge. A freeze-dried preparation can be manufactured and sealed by using the same, and it is not necessary to provide a new facility for producing a rubber stopper with a guide portion, and the manufacturing cost can be reduced. In addition, since a dead space in the container / syringe is eliminated by using a normal rubber stopper, the end of the cartridge opposite to the side where the finger grip is fitted is opposite to the side where the cartridge is fitted. By attaching a barrel portion provided with a male luer taper portion to the end on the side, and further attaching an injection needle to the male luer taper portion of the barrel portion, it is possible to perform normal, direct injection of this container / syringe. In this state, the syringe needle can be pierced into a vial in which a liquid medicine is sealed, and in this state, the liquid medicine is sucked into the container / syringe and frozen in the container / syringe. By mixing with the dry preparation, the container / syringe can be made into a container / syringe that can be injected alone.

According to the method for enclosing a freeze-dried preparation in a container / syringe according to claim 5, when a drug solution to be injected into the container / syringe is processed into a freeze-dried preparation, one end of a cartridge of the container / syringe is previously prepared. After the rubber stopper is inserted into the half-stopper state, it is carried into the freeze-drying apparatus, and the freeze-drying process can be performed in this state.After manufacturing the freeze-dried preparation, only the movable part is lowered. The rubber stopper can be easily and reliably plugged without worrying about the position of the rubber stopper.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing an embodiment of a container / syringe according to the present invention.

FIG. 2 is a cross-sectional view showing a preparation stage of a freeze-drying operation in the method of enclosing a freeze-dried preparation in a container / syringe according to the embodiment.

FIG. 3 is a cross-sectional view showing the inside of a freeze-drying apparatus for freeze-drying in the method for enclosing a freeze-dried preparation in a container / syringe according to the embodiment.

FIG. 4 is a cross-sectional view showing each step of freeze-drying and capping of a cartridge in the method for enclosing a freeze-dried preparation in a container / syringe according to the embodiment.

FIG. 5 is a side view showing an example of the shape of a second rubber stopper of the container / syringe according to the present invention.

FIG. 6 is a side view showing an example of the shape of the end of the cartridge of the container / syringe according to the present invention and the shape of the movable part of the vacuum device.

FIG. 7 is a side view showing an example of the shape of the end of the cartridge of the container / syringe according to the present invention and the shape of the second rubber stopper.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Container combined syringe 2, 3 cylinder tip parts 4 Container combined syringe 5 Connecting means 7, 8 Cartridge 20, 21 First rubber stopper 22, 23 Second rubber stopper 24, 25 Drug enclosing part 28 Guide part 29 Groove 30 Freeze-drying Formulation 31 Liquid drug 44 Chemical solution 45 Communication part 46 Freeze-drying device 47 Movable part 48 Stop means 49 Notch 50 Vent hole 51 Projecting part

Claims (5)

[Claims] 1. A cartridge, a cylinder tip portion fitted to one end of the cartridge, a finger grip fitted to the other end of the cartridge, and a predetermined distance between the cartridges. First and second rubber stoppers for hermetically enclosing a drug therein, and among the first and second rubber stoppers, the rubber stopper is inserted into the cartridge in the rubber stopper on the finger grip side. When the insertion is temporarily stopped in a half-plugged state, a communication part for communicating between the inside and the outside of the cartridge is formed. 2. A rubber stopper provided on a side of the cartridge to which the finger grip is attached, a substantially frustoconical guide provided at an end of the cartridge inserted into the cartridge, The container / injection syringe according to claim 1, further comprising a groove formed along the insertion direction and serving as the communication portion. 3. A communication part is provided at an end of the cartridge to which the finger grip is attached, instead of a communication part formed in a rubber stopper to be inserted into a side of the cartridge to which a finger grip is attached. 2. The container / syringe device according to claim 1, wherein: 4. A communication portion provided in the cartridge, a notch formed in an end portion of the cartridge in a longitudinal direction of the cartridge, a groove formed in an inner surface of the cartridge, or an end portion of the cartridge. 4. The container / syringe according to claim 3, wherein the syringe is made of one of vent holes formed in the vicinity. 5. A cartridge of a container / syringe, one end of which is air-tightly and liquid-tightly sealed by a rubber stopper in advance, is erected so that the end not sealed by the stand stands upward. A drug solution which is a pre-stage of a freeze-dried preparation is injected into the cartridge, and a rubber stopper having a substantially frustoconical guide portion having a groove formed on a side surface at one end thereof, wherein the groove is communicated to the outside. Inserted into the cartridge in a half-stopped state, and then the cartridge is carried into the freeze-drying apparatus together with the stand, and then the inside of the freeze-drying apparatus is set to a low-temperature, vacuum state, and After freeze-drying to obtain a freeze-dried preparation, and then filling the freeze-drying apparatus with an inert gas such as nitrogen gas and adjusting the internal pressure of the freeze-drying apparatus to atmospheric pressure or a predetermined pressure, By pushing down the rubber stopper in the half-plugged state by the movable portion arranged in the freeze-drying device and completely plugging the cartridge, the lyophilized preparation is sealed in the cartridge. Characteristic method of encapsulating a lyophilized preparation in a combined use syringe.