JP2721949B2 - Holder for freeze-drying of the syringe body in a medicine container and syringe - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medicine container / injection syringe in which an injection is previously sealed in a syringe body of a syringe. A drug container / syringe in which a drug that has been freeze-dried and a dissolving solution for dissolving the drug are separated and the drug is dissolved with the dissolving solution inside the syringe barrel to make an injection solution during injection treatment. In the above, when freeze-drying the injection drug enclosed in the syringe barrel body, the syringe barrel body is charged into the vacuum drying chamber of the freeze-dryer in a state where the injection drug to be dried is injected. The present invention relates to an improvement in a freeze-drying holder in a medicine container and a syringe used to be supported in an upright posture in a vacuum drying chamber.

[0002] Injectable drugs are filled and sealed in small drug containers such as ampoules or vials at the time of manufacture, and are shipped and distributed. During use, a drug solution is sucked from the drug container into a syringe, and then aspirated from the syringe to the patient. The traditional method of injecting into the body such as
It is common today. However, in recent years, a medicine container / syringe in which an injection is pre-loaded inside the syringe body of the syringe has begun to be used under a name such as a pre-filled syringe. Prevents misuse, misoperation, contamination of foreign matter and damage to the needle tip associated with transfer of a drug solution from the drug container to the syringe barrel body of the syringe. This is to save time and labor for suctioning.

[0003] Injectable freeze-dried injections, which are unstable in a liquid state and are freeze-dried in a medicine container at the time of manufacture and are distributed with a dissolution solution attached to a container separate from the dried medicine container, are a rapid technology of biotechnology. With great progress, it is becoming more and more important as a therapeutic drug for cancer and the like, but the procedure at the time of use is more complicated than a liquid injection. That is, after the solution is sucked from the solution container into the syringe body of the syringe, the solution is injected into the dry medicine container from the syringe body to dissolve the dry medicine, and the dissolved drug solution is injected into the syringe body. It must be re-aspirated and injected into the body. Only in the case of such a dissolving injection at the time of use, the spread of a medicine container and a syringe is expected. The present invention improves a drug container / syringe for a lyophilized injection and promotes its use.

[0004]

2. Description of the Related Art As shown in FIG. 1, a conventional medicine container / syringe A for a freeze-dried injection is provided with a nipple-shaped nozzle 10 for mounting an injection needle 2 at the bottom of the lower end of a cylindrical portion 1a. A syringe body 1, a double-ended needle 2 attached to a nozzle 10 thereof, a plunger 3 inserted through an opening 11 at an upper end of the syringe body 1, and a cylindrical portion 1 of the syringe body 1.
The intermediate plug 50 inserted into the cylindrical portion 1a so as to seal the dry chemical 4 to be charged into the cylindrical portion 1a, and the upper end side inside the cylindrical portion 1a so as to seal the solution 6 to be injected into the cylindrical portion 1a. It comprises a liquid chamber plug 51 to be inserted and a hole plug 52 to be inserted into the nozzle portion 10.

As shown in FIG. 2, the syringe barrel body 1 used for the medicine container / syringe A has an opening 11 at the upper end, and an edge of the opening 11 has an edge flange projecting toward four sides. 12 having an outer diameter of 12 mm (inner diameter of 10 mm) having a nipple-shaped nozzle portion 10 for mounting the injection needle 2 at the bottom of the lower end.
A cylindrical plug made of a glass material of a degree, a hole plug 52 made of a rubber material such as synthetic rubber is fitted inside the nozzle portion 10,
A protective cover 53 made of a rubber material is attached to the tip of the nozzle portion 10.

The syringe body 1 is placed in the cylindrical portion 1a above the nozzle portion 10 sealed by the hole plug 52, in order from the lower end to the upper side, in the dry chemical chamber 13, the liquid passage bypass (liquid flow). 2), an intermediate stopper 15, a solution chamber 16, a liquid chamber stopper 17, and the like (FIG. 2).

FIG. 3 is a cross-sectional view of the syringe barrel main body 1 of FIG. FIG.
Is a front view of an intermediate plug 50 inserted into the intermediate plug 15 inside the syringe barrel main body 1, and FIG. 5 is a front view of a liquid chamber plug 51 inserted into the liquid chamber plug 17 of the syringe barrel main body 1. The intermediate plug 50 and the liquid chamber plug 51 shown here are both formed into a disc shape or a cylindrical shape with a rubber material such as synthetic rubber. And
The liquid chamber stopper 51 has a female screw 510 formed on the upper surface side.

[0008] The intermediate stopper 50 and the liquid chamber stopper 51 are used for manufacturing the syringe body 1 of the medicine container / syringe A in a state where the dry medicine 4 and the dissolving solution 6 are sealed therein. It is attached to the intermediate stopper 15 and the liquid chamber stopper 17 in the main body 1 so as to hermetically shut off the interior of the syringe barrel main body 1 as shown in FIG. At the time of use, the inside of the syringe barrel main body 1 is slid in an airtight manner by the operation of the operator.

The plunger 3 is attached so as to be connected to the liquid chamber stopper 51 at the time of use. In addition, a double-ended needle 2 having a cutting edge at both ends is also attached to the nozzle portion 10 at the bottom of the lower end of the syringe barrel main body 1 during use.

In this example, the hole plug 52 fitted in the inner cavity of the nozzle portion 10 is a nipple-shaped cap body 10a formed separately from the cylindrical portion 1a. When fitted to the outer periphery of the base 10b, its base end 10b
The inner cavity of the nozzle portion 10 is sealed by being sandwiched between the lower end surface of the cap member 10a and the inner end surface of the cap body 10a.

The step of loading the freeze-dried dry medicine 4 and the solution 6 into the syringe barrel main body 1 of the medicine container and syringe A is performed in the following order.

The syringe barrel body 1 is fitted with a hole plug 52 in the inner cavity of the nipple-shaped nozzle portion 10 at the bottom thereof and sealed, and a protective cover 53 is attached to the outer periphery of the tip of the nozzle portion 10. To the state shown in FIG.

Next, a prescribed amount of a chemical solution is injected into the dry chemical chamber 13 at the bottom of the syringe barrel body 1, and a predetermined number of the syringe barrel bodies 1 in this state are placed in a test tube stand-shaped metal holder 7.
(Described later), placed on the shelf surface of a shelf in the freeze-drying chamber of the freeze-dryer, and the freeze-dryer operates to freeze the drug solution injected into the syringe barrel main body 1. The dried chemical 4 is obtained.

Next, in the airtight chamber where the air pressure inside the syringe barrel main body 1 is adjusted inside the freeze-drying chamber of the freeze-drying machine or provided separately outside the freeze-drying chamber, the intermediate stopper 50 is connected to the intermediate stopper 50 inside the syringe barrel main body 1. When it is pushed to the position of the part 15, the pressure inside the dry medicine chamber 13 is adjusted to the level of the atmospheric pressure, and in this state, the intermediate stopper formed into a cylindrical shape from the opening 11 on the upper end side of the syringe body 1. 50 is pushed to the position of the intermediate stopper 15 to seal the dry chemical chamber 13.

Next, a predetermined amount of the dissolving solution 6 is injected into the dissolving solution chamber 16 while the gas in the dissolving solution chamber 16 having the upper surface of the intermediate stopper 50 as the bottom surface is eliminated, the solution chamber stopper 51 is closed, and the dissolving solution chamber 16 is sealed. I do.

As a result, as shown in FIG. 1, the dried medicine 4 is sealed in the dry medicine chamber 13, and the lysis solution 6 thereof is sealed in the lysis solution chamber 16. Is completed.

The operation of the thus-manufactured syringe body 1 during use is performed according to the following operation procedure.

First, the plunger 3 is placed on the upper surface of the liquid chamber stopper 51.
Connect the lower ends of the. The head of the liquid chamber stopper 51 is usually provided with a female screw. The distal end of a plunger 3 having a male screw at the distal end is connected to the female screw as shown in FIG. 1, and the plunger 3 is pushed down.

As a result, the intermediate stopper 50 is also lowered by being pushed by the descending liquid chamber stopper 51 and the dissolving solution 6. And
When the descending intermediate plug 50 reaches the position of the liquid passing bypass 14, the vertical length L1 of the liquid passing bypass 14 is longer than the vertical thickness D1 of the intermediate plug 50. As described above, the solution 6 stops at the intermediate position above and below the liquid passage bypass 14, and the solution 6 in the solution solution chamber 16 leaks into the dry chemical chamber 13 through the solution passage 14 circumscribing the cylindrical surface of the intermediate stopper 50. Then, the dry medicine 4 in the dry medicine chamber 13 is dissolved.

Next, when the dissolving solution 6 is completely sent to the dry chemical chamber 13 by further depressing the plunger 3, the upper surface of the intermediate stopper 50 comes into close contact with the lower surface of the liquid chamber stopper 51. The stopper 50 starts to descend again together with the descending liquid chamber stopper 51, and the lower surface of the intermediate stopper 50 passes through the lower end of the liquid passage bypass 14, and as shown in FIG. The chemical solution M is sealed in the dry chemical chamber 13. Since these operations are performed with the syringe main body 1 in an upright posture in which the nozzle portion 10 is located at the lower end, only a part of the gas in the dry chemical chamber 13 is contained in the liquid passage bypass 14 and is dissolved. The entire amount of the chemical liquid M is sealed between the lower surface of the intermediate stopper 50 and the hole stopper 52.

Then, after the liquid passage bypass 14 is cut off from the dry chemical chamber 13 by the intermediate stopper 50, the protective cover 53 attached to the nozzle 10 is removed, and the injection needle 2 is attached to the nozzle 10. . When the injection needle 2 is attached, the disc-shaped rubber stopper 52 is broken at the cutting edge on the proximal end side of the injection needle 2, and the dry chemical chamber 13 communicates with the outside through the inner cavity of the injection needle 2. When the plunger 3 is pushed, the liquid medicine M is discharged from the tip of the injection needle 2 into the state of the medicine container / syringe A.

Next, the medicine container / syringe A is changed and the gas in the dry medicine chamber 13 is removed from the tip of the injection needle 2 (FIG. 9). After the gas is completely removed, the injection needle 2 is pierced into a predetermined part of the patient, and the plunger 3 is pushed down to push down the liquid chamber stopper 51 and the intermediate stopper 50, thereby functioning as a piston head surface. The drug solution M is injected into the body until the front surface of the intermediate stopper 50 is pressed against the lower end surface of the syringe barrel main body 1.

In the prior art manufacturing process of sealing the dry chemical 4 and the dissolving solution 6 in the syringe body 1, after freeze-drying the drug solution, the intermediate stopper 5 is opened through the opening 11 at the upper end of the syringe body 1.
0 to the position of the intermediate stopper 15, and the dry chemical chamber 1
The step of sealing 3 is a step of sealing the freeze-dried drug 4 from the outside, that is, from contamination, moisture absorption, oxidation and the like. This is one of the most important steps of an injection, but conventionally, it is performed by one of the following methods 1 and 2.

(1) As shown in FIG. 10, a predetermined number of syringe barrel bodies 1 into which a drug solution has been injected are supported upright on a test tube stand-shaped metal holder 7, and shelves in the freeze-drying chamber of the freeze-dryer are provided. When placed on the shelf of the step, the holder 7 is provided with the upper end of each syringe body 1 at the exact position just above the arrangement position of each syringe body 1 determined by the structure of the holder 7. Each of the intermediate plugs 50 is located at a position away from the opening 11 on the
And pressers 7a for pushing the intermediate stoppers 50 are supported, and freeze-drying is performed by operating a freeze-dryer (small arrows in the figure are flow paths of water vapor).

When the freeze-drying step is completed,
Aseptic dry nitrogen gas is introduced into the freeze-drying chamber in a vacuum state of the freeze-dryer up to a predetermined pressure.

Next, the shelf interval vertical drive device provided in the freeze dryer is operated to reduce the interval between each shelf,
The intermediate stopper 50 is inserted and sealed into the opening 11 at the upper end of the syringe barrel main body 1 via the pusher 7a supported on the holder 7 on the back (lower) surface of each shelf.

After that, the intervals between the respective shelves of the freeze dryer are opened, and the syringe main body 1 in which the dry medicine 4 has been sealed is opened from the freeze dryer.
Is carried out together with the holder 7.

The intermediate stopper 50 is connected to the intermediate stopper 50 in the syringe barrel body 1.
The step of pushing to the position of 5 may be performed together with the step of injecting the lysis solution 6 described above with another device outside the freeze dryer, or may be pushed to the position of the intermediate stopper 15 in the freeze dryer. is there.

(Part 2) The syringe barrel bodies 1 are supported by the holder 7 and inserted into the freeze-drying chamber of the freeze-dryer, and the freeze-drying step of the injected drug solution is completed.
These syringe barrel bodies 1 are connected to the opening 11 on the upper end side thereof.
With the open, the product is taken out of the freeze-drying room, brought into another room equipped with aseptic dry air (nitrogen) pressure regulating equipment, and the stopper is installed in that room. Are sequentially fed to the position immediately below, and the pressure inside the syringe barrels 1 is adjusted to a predetermined pressure with aseptic dry air (nitrogen) while the intermediate stopper 5 is being adjusted.
, And then push the intermediate stopper 50 to a predetermined position. Further, the syringe body 1 after this step is placed in the aforementioned chamber continuously or aseptically dried air of another device. (Nitrogen) is sent to a chamber below the pressure adjusting equipment, and is connected to the above-described step of injecting the solution 6 and stoppering the liquid chamber stopper 51.

[0030]

Means (Part 1) of the conventional means is that when freeze-drying is completed, aseptically filtered highly clean dry nitrogen gas is supplied to a vacuum freeze-drying chamber to a predetermined pressure. It is introduced and sealed, highly clean,
Low humidity and oxygen-tight sealing are possible. But,
Significantly lower efficiency and higher cost than lyophilization in current vials.

The reason is that in the case of a vial stopper, FIG.
As shown in FIG. 1, the rubber stopper 91 for sealing the upper opening 90 of the vial 9 is partially inserted into the opening 90 of each vial 9 while leaving a part of the cutout portion 911 of the lower stopper 910 as the ventilation hole 9a ( (Referred to as a half-stopper), which is placed on the shelf of the freeze-drying chamber of the freeze-dryer, so that accurate positioning of the opening 90 of the vial 9 and the rubber stopper 91 is not required. Are densely arranged on the shelf, and after the drying is completed, the rubber stopper 91 is completely plugged from the half-plugged state and the complete plugging is performed simply by compressing the gap between the shelves by the shelf stage vertical drive device. it can. However, in the case of the syringe barrel main body 1 of the medicine container / syringe A, the intermediate stopper 50 having a function of sealing the dried medicine 4 has a role of a piston head when the syringe barrel body 1 functions as a syringe barrel. Therefore, it is necessary that the lower surface thereof be flat so that the medicinal solution can be pushed out without any residue, and a cutout for a ventilation hole cannot be provided at a lower portion of the intermediate plug 50. Upper opening 11
However, there is a restriction that it cannot be set to the half-plugged state. Thousands to tens of thousands of injection stoppers per opening are separated upward from the openings 11 of the syringe barrel body 1, and the same number of intermediate stoppers 50 are provided immediately above the openings 11.
In order to properly arrange and support the pushers 7a and the like, a complicated holder 7 is required. Moreover, when setting the syringe barrel body 1, the intermediate stopper 50, and the pusher 7a in the holder 7, not only must a complicated aseptic process be performed, but also for this purpose, the syringe barrel body 1 ... Cannot be placed on the shelves in a dense state, and the number of pieces accommodated in the freeze-drying chamber is reduced to about 60% of the dense state.

Further, this means is provided for the holder 7 to be used.
However, since the intermediate stopper 50 and the pusher 7a for stoppering the intermediate stopper 50 are held on the intermediate stopper 50, the intermediate stopper 50 is raised up and down. In addition, there is a problem that a constraint that the shelf interval must be widened is generated.

The holder 7 has a structure in which the intermediate stopper 50 can be plugged into the syringe barrels 1 supported by the holder by lifting and lowering the shelf, and the holder 7 can be easily cleaned and sterilized. There is a problem that it is difficult to make the holder 7 simple.

The former (No. 2) means is that the mounting of the intermediate stopper 50 on the syringe barrel body 1 after the freeze-drying of the injected drug solution is performed by the step of freeze-drying the drug solution in the freeze-drying chamber of the freeze-dryer. The finished syringe barrel 1 is carried out of the freeze-drying chamber and fixed by a conveyor line.
Are sent to a predetermined position of the intermediate stopper plugging device, and are sequentially set at that position, and the intermediate stoppers 50 are plugged. Then, the injection device for the dissolving solution 6 in the next operation step is performed. The syringe body 1 after the freeze-drying of the injected drug solution is carried out to the outside of the freeze-dryer in an open state. However, there is a problem that it is difficult to perform the same high level of sealing, contamination prevention, moisture absorption prevention, and oxidation prevention as in the case of performing the above.

Further, during a long-term product distribution as a product in which the dry medicine 4 and the dissolving solution 6 are sealed in the syringe barrel main body 1, an intermediate stopper is provided by the pressure difference between the pressure in the dry medicine chamber 13 and the outside air pressure. In order to prevent an accident in which the solution 50 moves up or down and the solution 6 leaks out of the syringe barrel main body 1 or into the dry chemical chamber 13, the stopper device of the intermediate stopper 50 includes the syringe barrel main body 1. A function must be provided to control the internal air (nitrogen) pressure to an accurate level in consideration of the air temperature during the distribution period and to plug the intermediate stopper 50 into the syringe barrel body 1 continuously supplied from the conveyor line. . Equipped with these functions also in the intermediate stopper 50 tapping device without using the inside of the freeze dryer which originally possesses the highest functions of oxygen exclusion, nitrogen replacement, dehumidification, aseptic dust, and precise control of atmospheric pressure. However, it is also a disadvantage in manufacturing cost.

However, since the above-mentioned means (1) is difficult to implement particularly due to the restriction due to the configuration of the holder 7, this means (2) is often employed with the above-mentioned problem. I have.

[0037]

SUMMARY OF THE INVENTION The present invention has been made to solve the above-mentioned problems occurring in the conventional means.
The intermediate stopper 50 for the syringe barrel body 1 that supports the holder 7 by supporting the holder 7 and supporting the holder 7 placed on the shelf in the freeze-drying chamber of the freeze-dryer by reducing the spacing between the shelves by raising and lowering the shelf.
Is constructed so that a large number of injection cylinder bodies 1 can be housed in a dense state, and can be carried in and out collectively, while having a simple structure that is easy to wash and sterilize. It is an object of the present invention to provide a new means that can improve the heat conduction from the shelf to the syringe barrel body 1.

[0038]

According to the present invention, as a means for achieving the above-mentioned object, a lyophilizer is provided in which a syringe body of a large number of drug containers and syringes into which a drug solution is injected is supported upright. After being freeze-dried of the medicinal solution in each syringe barrel main body, the intermediate stopper for the syringe barrel main body is moved up and down by the shelf tiers. In the holder for freeze-drying of the syringe body of the medicine container / syringe used to perform the entire stoppering, the height is higher than the axial length of the syringe body, and the front and rear thickness is the opening at the upper end of the syringe body. A plurality of upright plate-shaped ribs having a thickness greater than twice the projecting length of the shortest width portion of the brim portion formed on the brim of the first brim are formed outside the cylindrical portion of the syringe body. Fixedly connected in parallel parallel at a slightly wider interval than the diameter, At the middle part in the width direction before and after the upper end surface of these ribs, a ridge projecting slightly higher than the upper and lower thicknesses of the rim of the rim of the syringe body is provided in a guide rail shape continuous in the left-right direction. On both sides before and after the ridge, a locking step surface for locking the shortest width portion of the brim portion of the rim of the syringe body is provided, and gripping members are attached to both ends of the parallel ribs. A holder for freeze-drying a syringe body in a medicine container and syringe is proposed.

[0039]

Next, an embodiment will be described in detail with reference to the drawings. In the drawings, the same reference numerals are used for components having the same effects as those of the conventional means.

FIG. 14 is a vertical sectional side view of the holder 7 for freeze-drying the syringe barrel body in the medicine container / syringe embodying the present invention. In FIG. The formed ridge 1 indicates a syringe barrel main body.

The holder 7 in this embodiment is formed by extruding a large number of ribs 70... Which are parallel and fixedly connected in parallel with each other by using a metal material having good heat conductivity and extrudable, such as an aluminum alloy. This is an example of being formed integrally and continuously with the bottom plate 73 so as to be parallel and parallel at a predetermined effective interval Y.

As shown in FIG. 15, the syringe body 1 has a nipple-shaped nozzle 10 for mounting the injection needle 2 at the lower end of a cylindrical portion 1a formed of a glass material.
A plug 52 made of a rubber material is fitted in the nozzle portion 10, and a dry chemical chamber 13 for accommodating the dry chemical 4 in order from bottom to top in the cylindrical portion 1 a. A liquid bypass 14 having a part of the cylindrical wall enlarged, an intermediate plug portion 15 into which the intermediate plug 50 is fitted, and a solution chamber 16 containing the solution 6.
And a liquid chamber plug portion 17 into which the liquid chamber plug 51 is fitted, and an edge flange 12 protruding toward the four circumferences is formed at the edge of the opening 11 at the upper end. One or a plurality of ventilation bypasses or cutouts having the same shape as the liquid passage bypass 14 are provided at appropriate intervals in the circumferential direction in a range extending from the inner peripheral side of the edge flange portion 12 to the cylindrical wall of the cylindrical portion 1a. An individual plug is used, and the intermediate plug 50 can be set in a half-plugged state.

In the syringe body 1, an edge flange 12 formed at the edge of the opening 11 on the upper end side thereof has a longer diameter side and a shorter diameter in plan view as shown in FIG. The side has a substantially elliptical shape, and a pair of edges on the minor diameter side are formed in a plane that is linearly continuous.

The ventilation bypass 8 is formed at the upper end of the syringe body 1 in a range extending from the inner peripheral surface of the rim 12 to the upper end of the cylindrical wall of the cylindrical portion 1a. Length L
2 is formed to be shorter than the upper and lower thickness D1 of the intermediate plug 50, whereby when the intermediate plug 50 is inserted shallowly into the opening 11 of the syringe barrel main body 1 as shown in FIG. The inside of the syringe barrel main body 1 sealed by the intermediate plug 50 is in a half-plug state in which a part of the peripheral surface of the intermediate plug 50 communicates with the outside through a ventilation path formed by the ventilation bypass 8. . Further, when the intermediate plug 50 is inserted further deeply from this state, as shown in FIG. The entire stopper is fitted into the inner peripheral surface of the cylindrical wall of the portion 1a closely.

Thus, the holder 7 has its rib 70
... is extruded from a metal material such as an aluminum alloy, the thickness W of the rib 70 is larger than twice the projection length L3 of the shortest width portion of the rim 12 of the syringe barrel body 1 described above. It is set and the height H is set to be longer than the length of the syringe barrel body 1 in the axial direction, and is pushed out continuously in the left-right direction.

At this time, the metal mold for the extrusion is such that the ribs 70 to be extruded correspond to the cylindrical portion 1a of the syringe barrel main body 1.
Are formed in such a manner that they are extruded in parallel back and forth at a distance Y slightly larger than the outer diameter R of the outside, and a bottom plate 73 is formed integrally and continuously at the lower end side of the parallel ribs 70. To be done.

In the mold, the shortest width portion of the above-mentioned edge flange portion 12 is provided on the upper end surface of each rib 70... The protrusion ridge 71 continuous in the left-right direction with a width corresponding to the remaining thickness when a length substantially twice the protrusion length L3 of the injection tube body L3 is subtracted, It protrudes higher than the thickness, and before and after the ridge 71, the rim 1
2 is set to a shape in which locking step surfaces 72 for locking the shortest width side are formed. In this case, the mold is a rib 7
0 may be formed so that the upper end surface is flat, and after extrusion molding, the ridge 71 and the locking step surface 72 may be formed on the upper surface by cutting. In this case, by leaving one end in the longitudinal direction of the protruding ridge 71 and the locking step surfaces 72, 72, the remaining portion serves as a stopper for preventing the syringe barrel body 1 from coming out.

The ribs 70 located at the front and rear ends of the ribs 70 arranged in parallel are arranged so that the ridge 71 formed on the upper end surface thereof is not located at the center of the front and rear, but is moved outward. Of the locking step surfaces 72 provided on both sides of the ridge 71, the outer locking step surface 72 is omitted, and only the width corresponding to the omitted locking step surface 72 is omitted. The front and rear plate thicknesses may be reduced.

As a result, the ribs 70, which are extruded in a fixed shape and at predetermined intervals as shown in FIG. Cut to size. Then, the gripping members 74 are respectively attached to the left and right ends, which are the cutting openings, in which the interval Y formed between the parallel ribs 70 is opened. The holding members 74 may be formed in an appropriate shape. In addition, as shown in FIG. 14 and FIG.
Of stoppers that prevent the syringe barrel bodies 1 from coming out of the ends of the intervals Y when they are inserted in a line while being locked to the locking step surfaces 72 formed on the upper end surface of the cylinder 0. It may be a combination of roles.

In this example, the holding members 74
As shown in FIG. 19, on one end side, the cross section is formed to have an angle shape, and is integrally assembled by means such as welding or fitting, and on the other end side, The main body 74 having a U-shaped cross-section
0 is formed on one side of a horizontal sleeve wall 741 in a continuous shape so as to form an angle.
The U-shaped main part 74 of the gripping member 74 is inserted into a notch groove 75 previously formed in a region extending from the lower end to the bottom plate 73.
By fitting 0, it is designed to be removably assembled.

When the syringe body 1 is inserted into the space Y between the ribs 70 arranged side by side, the detachable gripping member 74 is removed, and the end of the space Y opened by this is removed. When the loading is completed, the gripping member 74 is fitted to prevent the escape and to carry the whole.

Next, FIG. 20 shows another embodiment.
In this example, the ribs 70 are made of a metal material such as stainless steel which is difficult to be adapted to extrusion molding. The ribs 70 are formed in the same shape and dimensions as those of the above-described embodiment, and are assembled by welding the holding members 74 to both left and right ends thereof, and omitting the bottom plate 73. In this example, the gripping members 74 are provided as close to the lower side as possible so that the loading of the syringe body 1 from the side can be performed easily.

Next, FIG. 22 shows still another embodiment. This example is a modification in the case of forming a metal material that is not suitable for extrusion molding such as stainless steel, and as described above, when forming the ribs 70.
At the lower end thereof, divided bottom plates 730 are formed integrally and continuously, and the ribs 70 are arranged in parallel at a predetermined interval Y, and are angled at both left and right ends thereof. This is an example in which the formed gripping member 74 is assembled by welding.

In this embodiment, a bottom plate 73 for transmitting heat from the shelf of the freeze-drying chamber to the ribs 70 supporting the syringe barrel bodies 1 is formed integrally and continuously with the ribs 70. By doing so, the efficiency of heat conduction is improved in comparison with the embodiment without the bottom plate 73 shown in FIG.

Using the holder 7 configured as described above,
When the injection cylinder main body 1 of the medicine container / syringe A is inserted into the freeze-drying chamber of the freeze-dryer to freeze-dry the drug solution,
After the injection of the predetermined amount of the drug solution is completed, the syringe body 1 with the intermediate stopper 50 fitted into the upper end opening 11 in a half-stopped state is inserted between the ribs 70 of the holder 7 arranged in parallel. Y ...
Charge inside.

This operation is performed by the rim 12 of the syringe body 1.
The shortest width portion of the edge flange 12 is locked to the locking step surfaces 72, 72 of the pair of ribs 70, right and left, so that the shortest width portion is in the width direction before and after the interval Y. Then, the flat outer surface of the shortest width portion of the brim portion 12 comes into sliding contact with the side surface of the ridge 71 of the rib 70, and the ridge 7
Since it is inserted into the space Y while being guided by 1, it can be performed extremely easily.

When the loading of the syringe barrels 1 has been completed, the lid member 74 is assembled, the holder 7 is placed in the vacuum drying chamber of the freeze dryer, and placed on the shelf surface of the shelf T. If a predetermined freeze-drying process is performed, the chemical solution in the syringe barrel main body 1 is dried by flowing steam through the ventilation bypass 8.

Next, when the freeze-drying process is completed, the multi-shelf shelf T
23 is operated so as to reduce the spacing between the shelves by the operation of the elevating operation device attached thereto, as shown in FIG. The intermediate plug 50 is in contact with the upper surface of the intermediate plug 50 inserted into the opening 11 at the upper end of the plug, and is pressed down to bring the plug into a fully plugged state.

At this time, since the protruding ridges 71 project higher than the thickness of the rim 12 of the syringe barrel main body 1, the lower surface of the descending upper shelf T1 comes into contact with the upper end surface of the protruding ridge 71. As a result, the syringe barrel main body 1 does not come into direct contact with the syringe barrel main body 1 and is prevented from being damaged.

[0060]

As described above, since the holder for freeze-drying the syringe barrel body in the medicine container and syringe according to the present invention is constituted as described above, the following effects can be obtained.

(1) The interval between the shelf stages T is reduced, and the intermediate stopper 50 inserted into the opening 11 at the upper end of the syringe barrel main body 1 supported on the holder 7 in a half stoppered state is brought into a fully stoppered state. When pushed in, there is no fear that the glass syringe body 1 is destroyed by the pressure of the upper and lower shelves TT.

(2) The work of loading the holder 7 with the syringe barrels 1... And the work of collecting the syringe barrels 1.
Formed on the upper end surface of the guide rail are smoothly used as guide rails.

This is because the interval Y between the adjacent ribs 70...
However, when the syringe main body 1 is set in a posture in which the shortest width portion of the edge flange portion 12 at the upper end thereof is in the width direction of the interval Y, the cylindrical portion 1a
Are set so as to be fitted, and the inserted state is in a state in which the linear portion of the outer surface of the shortest width portion of the rim flange portion 12 is in sliding contact with the side surface of the ridge 71, so that the rim 71 does not rotate. Due to the restriction, the protrusions on the outer surfaces of the liquid passage bypass 14 and the ventilation bypass 8 provided so as to expand in diameter on the cylindrical wall of the cylindrical portion 1a are not allowed to bite into the inner surface of the interval Y between the ribs 70. This is because a regular operation is prevented.

Further, the injection cylinder main bodies 1 to be inserted are
When the pitch of the parallel intervals Y ... is set to be equal to or less than the length of the longest width portion of the rim 12 of the syringe barrel main body 1, the syringe barrels 1 in the adjacent intervals Y ... Irregular movement due to contact / collision of the rim 12 of the rim is prevented.

(3) The width of the ridge 71 at the upper end of the rib 70 (approximately 1 to 2 mm depending on the strength of the material) only becomes a dead space, and almost the periphery of the rim 12 of the syringe body 1. As a state without gaps, a fine arrangement is obtained, and the storage efficiency in the freeze dryer is increased.

(4) The structure is simple, and in any of the embodiments, it is possible to eliminate the joints between the discontinuous materials, such as bolts and screws, which are difficult to clean and sterilize.

[Brief description of the drawings]

FIG. 1 is a partially cutaway front view of the entire medicine container / syringe.

FIG. 2 is a longitudinal sectional front view of a syringe barrel main body of the medicine container and syringe.

FIG. 3 is a cross-sectional plan view of the syringe barrel main body.

FIG. 4 is a front view of an intermediate stopper fitted into the syringe body according to the first embodiment.

FIG. 5 is a vertical sectional front view of a liquid chamber stopper fitted into the syringe body according to the first embodiment.

FIG. 6 is a vertical sectional front view showing a state in which the medicinal solution injected into the syringe barrel body is freeze-dried and an intermediate stopper and a liquid chamber stopper are stoppered.

FIG. 7 is an explanatory view of a step of pouring a dissolving solution into a dry chemical, which is performed immediately before use for injection in the syringe barrel main body.

FIG. 8 is an explanatory view showing a state in which a step of dissolving dry chemicals with a dissolving solution of the syringe barrel body has been completed.

FIG. 9 is an explanatory view of a step of attaching an injection needle to the syringe barrel main body and expelling internal air.

FIG. 10 is an explanatory view of a step of lyophilizing a liquid medicine injected into the holder by supporting the syringe barrel main body on the holder.

FIG. 11 is a front view of a vial used to freeze-dry a drug solution.

FIG. 12 is a front view of a rubber stopper of the vial.

FIG. 13 is a bottom view of the rubber stopper.

FIG. 14 is a vertical sectional side view in which a part of a freeze-drying holder of a syringe barrel main body in a medicine container and syringe according to the present invention is omitted.

FIG. 15 is a vertical sectional front view of the syringe barrel main body of the medicine container / syringe used in the practice of the present invention, in a state in which the intermediate stopper is fitted in a half stoppered state.

FIG. 16 is a longitudinal sectional front view showing a state where the intermediate stopper of the syringe barrel main body is fitted in a fully stoppered state.

FIG. 17 is a plan view of the syringe barrel main body.

FIG. 18 is a plan view in which a part of a freeze-drying holder for a syringe barrel main body in a medicine container and syringe according to the present invention is omitted.

FIG. 19 is a partially broken perspective view of a main part of the holder.

FIG. 20 is a partially broken perspective view of another embodiment of the holder.

FIG. 21 is a front view of a main part of the holder.

FIG. 22 is a partially broken perspective view of a main part of still another embodiment of the holder.

FIG. 23 is an explanatory view of the operation of the holder according to the present invention.

[Explanation of symbols]

A: medicine container / syringe, D: thickness, H: height, L: length, T: shelf, W: thickness, R: outer diameter, M: drug solution, Y: interval, 1: syringe barrel body 1a: cylindrical portion, 10: nozzle portion,
10a: cap portion, 10b: base end portion, 11: opening, 1
Reference numeral 2: rim flange portion, 13: dried chemical chamber, 14: liquid passage bypass, 15: intermediate stopper portion, 16: dissolving solution chamber, 17: liquid chamber stopper portion, 2: injection needle, 3: plunger, 4 ... Dry chemicals, 5
0: intermediate stopper, 51: liquid chamber stopper, 510: female screw, 52: hole stopper, 53: protective cover, 6: dissolving liquid, 7: holder, 7
a ... push rod, 70 ... rib, 71 ... protrusion, 72 ... locking step surface, 73/730 ... bottom plate, 74 ... gripping member, 740 ... main body part, 741 ... sleeve wall, 75 ... cut groove, 8 ... Ventilation bypass, 9: vial, 9a ... vent, 90 ... opening, 91 ...
Rubber stopper, 910: lower part of the stopper, 911: notch.

Claims (1)

(57) [Claims] The present invention relates to a plurality of medicine containers and syringes A into which a liquid medicine has been injected. After being freeze-dried on each of the syringe barrels 1 and then freeze-dried in each syringe barrel body 1, the injection of the medicine container and syringe is used to perform the entire stoppering of the intermediate stoppers to the syringe barrel bodies 1 by raising and lowering the shelf T. In the holder 7 for freeze-drying the cylinder body, the height H
Is greater than the axial length of the syringe barrel main body 1, and the front and rear thicknesses of the protruding length L <b> 3 at the shortest width of the edge flange 12 formed on the edge of the opening 11 at the upper end of the syringe barrel main body 1. A plurality of upright plate-like ribs 7 having a thickness W greater than twice and continuing in the left-right direction
0... Are fixedly connected in parallel with each other at an interval Y slightly larger than the outer diameter R of the cylindrical portion 1a of the syringe barrel main body 1 at the intermediate portions in the width direction before and after the upper end surfaces of the ribs 70. A ridge 71 projecting slightly higher than the vertical thickness of the rim 12 of the syringe barrel body 1 is provided in a guide rail shape that is continuous in the left-right direction. Locking step surface 7 for locking the shortest width portion of the rim 12 of the cylindrical body 1
2 and the gripping members 7 are provided at both ends of the ribs 70.
4. A freeze-drying holder for a syringe barrel body in a medicine container / syringe to which 4 is attached.