JP2006212386A - Method for filling contents in prefilled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method for filling contents in a prefilled syringe, by which movement to a prescribed position is facilitated when mounting a gasket for a partition without damaging the sealability of the gasket for the partition. <P>SOLUTION: When partitioning the inside of an outer cylinder 12 by the gasket 15 for a plunger and the gasket 16 for the partition and housing contents in respective housing chambers 18 and 19, the gasket 16 for the partition is provided with a through-hole 21, a molded body 22 for the partition is arranged, a communicating path 25 for communicating or closing both side faces by the relative movement of the molded body 22 for the partition is provided, the side of the discharge part 11 of the outer cylinder 12 is closed, and the contents are housed from an opening 12b. The gasket 16 having the opened communicating path 25 is arranged inside the outer cylinder 12 on the side of the opening 12b, a gas inside the outer cylinder 12 is discharged from the communicating path 25, the gasket 16 for the partition is moved to the prescribed position inside the outer cylinder 12, also the communicating path 25 is closed, and the housing chamber 18 is tightly sealed. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  According to the present invention, a plunger gasket and a partitioning gasket are arranged in an outer cylinder to form a plurality of storage chambers, and the storage items are separately stored in these storage chambers, and the plunger gasket is used during use. The present invention relates to a prefilled syringe filling method capable of discharging the contents in each storage chamber by the pressing operation.

  Conventionally, a partition gasket and a plunger gasket are arranged in an outer cylinder having a discharge portion on one end side and an opening on the other end side to form a plurality of storage chambers. A number of prefilled syringes are known that can be accommodated and discharged from the accommodation chamber by pressing the plunger gasket during use.

  For example, in order to improve the storage stability of a drug, it is generally performed to store it as a dry preparation by a freeze-drying method or the like and dissolve and administer it with a solution such as distilled water at the time of use. Such drugs require time and labor for dissolution during use, and there is a risk of contamination by bacteria during dissolution, so a single prefilled syringe contains a dry preparation and a solution such as distilled water. It is preferable to keep it.

  By the way, in order to manufacture this prefilled syringe, one container is accommodated in the outer cylinder and sealed with a partition gasket, and another container is accommodated on the opening side from the partition gasket and sealed. is required. In this operation, the partition gasket must be airtightly disposed at an intermediate position inside the outer cylinder, and the gas in the outer cylinder must be removed before the partition gasket is disposed at a predetermined position.

  For example, in the following Patent Document 1, a gasket holder is attached to an opening of an outer cylinder, a liquid preparation prepared by dissolving a dry preparation with a dissolving liquid is filled in the outer cylinder, and the gasket is placed in a half-plugged state in the gasket holder. A gap is formed around the gasket, and at the time of freeze-drying, the solution is lyophilized by sublimating the solution, and the gasket is moved to a predetermined position by driving the gasket in a reduced pressure state and returning to normal pressure. It was arranged.

  Further, in Patent Document 2 below, a preparation liquid containing components of a dry preparation is used by using a gasket provided with a groove that allows the inside of the outer cylinder to communicate with the outside air in a half-plugged state and can be sealed in a sealed state. After filling in the cylinder, the gasket was freeze-dried in a half-plugged state, and then sealed in a reduced pressure state and moved to a predetermined position.

  Furthermore, in Patent Document 3 below, when manufacturing a prefilled syringe containing a chemical solution, the gasket is pushed down in a state where a tube-like air vent pin having both ends opened is sandwiched between the gasket and the inner surface of the outer cylinder. As a result, the internal air was moved to a predetermined position while being discharged from the bottle, and then the air vent pin was removed.

JP-A-8-164204 JP-A-8-112333 JP-A-6-285166

Problems to be solved by the invention

  However, in Patent Document 1, in order to mount the partitioning gasket, a gasket holder that is a separate member from the outer cylinder has to be assembled, and labor for mounting the partitioning gasket is required. In addition, in order to form a gap in the half-plugged state, the partition gasket must be partially compressed and deformed to exhaust the inside of the outer cylinder, and the seal of the outer peripheral seal portion of the partition gasket There was a possibility that the property might be impaired. In particular, in the partition gasket whose surface is covered with the laminate film, the laminate film is easily wrinkled, and the sealing performance is easily impaired.

  Further, in Patent Document 2, since the groove is formed on the outer peripheral surface of the partition gasket, the outer periphery seal portion of the partition gasket is reduced unless the partition gasket is excessively thickened. The sealability of the outer peripheral seal part of the gasket was apt to be insufficient.

  Furthermore, in Patent Document 3, the partition gasket is moved in the outer cylinder with the air vent pin sandwiched between them. Therefore, the outer peripheral seal portion of the partition gasket must be partially compressed and slid. In addition, scratches or the like were generated in the outer peripheral seal portion, and the sealing performance of the partition gasket could be impaired.

  As described above, in all of the conventional techniques, the sealing performance of the partitioning gasket is easily impaired, and the partitioning gasket is formed excessively thick or using a special member. There was room for improvement, such as having to wear.

  Therefore, the present invention does not impair the sealing performance of the partition gasket, and can easily move to a predetermined position when the partition gasket is mounted, and thus can be accommodated in the prefilled syringe. It is an object of the present invention to provide a prefilled syringe filling method capable of easily filling an object.

Means for solving the problem

The invention according to claim 1, which solves the above-mentioned problem, includes a discharge portion on one end side and an outer cylinder having an opening on the other end, and the discharge portion and a partitioning gasket disposed in the outer tube. The partition gasket includes a through-hole penetrating in the longitudinal direction, a partition molded body slidably disposed in the through-hole in the longitudinal direction, and the partition gasket. In a prefilled syringe containing filling method comprising an opening / closing means in which a gap between both end faces of the partitioning gasket is communicated or closed via the through hole depending on a relative position between the partitioning molded body and the partitioning molded body.
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
After the partitioning gasket is disposed in the opening, the partitioning gasket is moved to a predetermined position in the outer cylinder while discharging the gas on the discharge part side of the partitioning gasket through the opening / closing means. A process of
Closing the opening / closing means of the partition gasket;
It is provided with.

According to a second aspect of the present invention, an outer cylinder having a discharge part on one end side and an opening on the other end side is formed between the discharge part and a partitioning gasket disposed in the outer cylinder. The partitioning gasket includes a through-hole penetrating in the longitudinal direction, a partition molding that is slidably disposed in the through-hole in the longitudinal direction, the partitioning gasket, and the partitioning In a prefilled syringe containing filling method comprising an opening / closing means in which a gap between both end faces of the partitioning gasket is communicated or closed via the through hole depending on a relative position to the molded article for use.
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
After disposing the partitioning gasket in the opening, and after discharging the gas on the discharge part side of the partitioning gasket through the opening / closing unit, closing the opening / closing unit of the partitioning gasket;
Moving the partition gasket to a predetermined position in the outer cylinder;
It is provided with.

According to a third aspect of the present invention, an outer cylinder having a discharge part on one end side and an opening on the other end side is formed between the discharge part and a partitioning gasket disposed in the outer cylinder. The partitioning gasket includes a through-hole penetrating in the longitudinal direction, a partition molding that is slidably disposed in the through-hole in the longitudinal direction, the partitioning gasket, and the partitioning In a prefilled syringe containing filling method comprising an opening / closing means in which a gap between both end faces of the partitioning gasket is communicated or closed via the through hole depending on a relative position to the molded article for use.
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
Placing the partitioning gasket in the opening;
By maintaining the opening and closing means in a communicating state and setting the atmosphere around the outer cylinder to a reduced pressure atmosphere, and then closing the opening and closing means and setting the atmosphere around the outer cylinder to an atmospheric pressure atmosphere, Moving the partition gasket to a predetermined position in the outer cylinder with a pressure difference of
It is provided with.

  Furthermore, in the invention of claim 4, in addition to the structure of claim 3, the container is made of a solution obtained by dissolving a powder preparation with a solution, and the solution component of the solution is sublimated from the opening / closing means. Thus, the dry preparation is accommodated in the accommodation chamber.

The invention's effect

  According to the first or second aspect of the invention, after accommodating the contents in the accommodating chamber in the outer cylinder, the partitioning gasket disposed in the opening is moved to a predetermined position, or the partitioning gasket is moved. Since the gas on the discharge portion side can be easily discharged through the opening / closing means provided in the partition gasket before the partition gasket is moved, the partition gasket can be easily moved to a predetermined position. Further, when the partitioning gasket is moved or before the partitioning gasket is moved, it is not necessary to provide a gas flow path for discharging the gas on the discharge part side on the outer periphery of the partitioning gasket. This eliminates the need for forming the flow path and forming the partition gasket into a thick and complicated shape.

  In addition, there is no need to provide a gas flow path on the outer periphery of the partition gasket, and the opening / closing means is easily closed by moving the partition molded body relative to the partition gasket. The opening / closing means can be closed while being inserted into the outer cylinder. Therefore, there is no need to partially compress and deform the outer peripheral seal portion of the partition gasket to discharge the gas in the outer cylinder, and the sealing performance of the outer peripheral seal portion of the partition gasket is not impaired.

  In addition, after the partitioning gasket is moved to a predetermined position in the outer cylinder or before the partitioning gasket is moved, the opening / closing means is closed by simply moving the partitioning molding relative to the partitioning gasket. Since it can be closed, it is easy to seal the storage chamber.

  According to the third aspect of the present invention, the opening / closing means is maintained in a communicating state so that the periphery of the outer cylinder is in a reduced pressure atmosphere, and then, after the opening / closing means is closed, the periphery of the outer cylinder is set to an atmospheric pressure atmosphere. Thus, the partition gasket is moved to a predetermined position in the outer cylinder by the pressure difference between the inside and the periphery of the outer cylinder, so that the partition gasket can be easily moved by the closing operation of the opening / closing means.

  Further, according to the invention described in claim 4, the container is made of a liquid for preparation containing the components of the dry preparation, and the outer cylinder is formed by discharging the gas in which the liquid component of the liquid for preparation is vaporized from the opening / closing means. Since the dry formulation is contained inside, a series of processes from forming the dry formulation from the formulation solution to sealing with the partition gasket is efficiently and easily performed by the decompression operation around the outer cylinder and the closing operation of the communication passage. be able to.

Embodiments of the present invention will be described below.
[Embodiment 1]

1 to 3 show this embodiment.
In the figure, reference numeral 10 denotes a two-chamber prefilled syringe. The prefilled syringe 10 is connected to the outer cylinder 12 having the discharge portion 11 on the front end side, the plunger 14 disposed on the rear end side of the outer cylinder 12, and the front end side of the plunger 14, and is liquid-tight in the outer cylinder 12. A plunger gasket 15 slidably disposed, and a partition gasket 16 disposed in a liquid-tight and slidable manner in an intermediate portion between the plunger gasket 15 and the discharge portion 11 in the outer cylinder 12. have. The partition gasket 16 is provided with an opening / closing means 20 capable of communicating between both sides of the partition gasket 16.

  Further, inside the outer cylinder 12, a front storage chamber 18 is formed between the partition gasket 16 and the discharge portion 11, and an internal storage chamber 19 is formed between the plunger gasket 15 and the partition gasket 16. Has been.

  The internal storage chamber 19 stores liquid, and the front storage chamber 18 stores liquid discharged continuously from the liquid in the internal storage chamber 19 during use, substances to be mixed during use, and the like. In this embodiment, the lyophilized preparation is stored in the front storage chamber 18 together with a predetermined amount of gas, and the internal storage chamber 19 stores a solution such as distilled water for dissolving the lyophilized preparation. .

  The outer cylinder 12 includes a cylindrical portion 12 a having a constant cross-sectional shape in the longitudinal direction, and the distal end side is closed by the end surface 11 a of the discharge portion 11. A discharge port 11c and a luer lock structure 11b are provided on the end surface 11a of the discharge unit 11, and the tip of the discharge port 11c is sealed with a tip cap 11d. Further, a bypass groove 12c is provided at a predetermined position in the middle of the outer cylinder 12 in the longitudinal direction so as to communicate the front storage chamber 18 and the internal storage chamber 19 by positioning the partition gasket 16 during use. The outer cylinder 12 is integrally formed of a material such as glass or synthetic resin.

  The plunger gasket 15 has an outer peripheral shape corresponding to the inner wall surface of the outer cylinder 12, and a plurality of rib-shaped outer peripheral seal portions 15 a formed in an annular shape are formed around the plunger gasket 15. The plunger gasket 15 is made of, for example, various rubber materials such as natural rubber and synthetic rubber, and elastically deformable materials such as various elastomers, and the outer peripheral seal portion 15 a is elastically connected to the inner wall surface of the outer cylinder 12. Liquid-tight and slidable contact.

  As shown in FIGS. 1 and 2, the partition gasket 16 has an outer peripheral shape corresponding to the inner wall surface of the outer cylinder 12, and is formed with a plurality of rib-shaped outer peripheral seal portions 16 a formed in an annular shape around the periphery. The opening / closing means 20 is provided inside. Examples of the material for the partition gasket 16 include the same materials as those for the plunger gasket.

  The opening / closing means 20 provided inside the partition gasket 16 includes a through-hole 21 formed in the partition gasket 16 so as to be in the longitudinal direction of the outer cylinder 12, and a partition slidably disposed in the through-hole 21. And a molded body 22 for use.

  The through-hole 21 has an inner peripheral shape corresponding to the shape of the partition molded body 22, and an inner peripheral seal portion 21 a is formed on the inner periphery thereof. The inner peripheral seal portion 21a is formed at a position corresponding to the outer peripheral seal portion.

  The partition molding 22 is formed using a material that can be used for the outer cylinder 12, and has a constant cross-sectional shape in the longitudinal direction as shown in FIGS. 1 and 3. It has a columnar sealing portion 23 that is in liquid-tight and slidable contact with the portion 21a over the entire circumference. Here, the sealing portion 23 is disposed in a state of penetrating the inner peripheral seal portion 21 a of the through hole 21, and a flange portion 26 larger than the through hole 21 is formed on the inner housing chamber 19 side of the sealing portion 23.

  On the discharge portion 11 side of the sealing portion 23, the protruding portion 24 protrudes from the end portion on the discharge portion 11 side of the partition gasket 16 to the discharge portion 11 side in a state where the sealing portion 23 is disposed in the through hole 21. Is provided. In this embodiment, the projecting portion 24 is formed continuously from the sealing portion 23, and includes a plurality of rib pieces 24 a formed to have an outer periphery smaller than the outer peripheral shape of the sealing portion 23.

  A groove-shaped communication path 25 formed between the rib pieces 24a and 24a is formed on the surface of the molded body 22 for partitioning on the discharge unit 11 side from the sealing portion 23, here, the surface of the protruding portion 24. It is formed so as to be distributed substantially evenly around the body 22. The communication passage 25 is closed between the inner housing chamber 19 by the inner peripheral seal portion 21a on the one end 25a side in a state where the sealing portion 23 is disposed in the inner peripheral seal portion 21a of the through hole 21. The molded body 22 is opened by moving relative to the partition gasket 16, and communicates between both end faces of the partition gasket 16. Further, a notch-like recess 24b is formed at the end of the rib piece 24a on the discharge portion 11 side at a position facing the discharge port 11c, and the protruding portion 24 contacts the end surface 11a of the discharge portion 11. In this state, a flow path from the communication path 25 to the discharge port 11c can be secured.

  As shown in FIG. 4, the prefilled syringe 10 having the above-described configuration can be filled with the contents.

  First, as a first step, a through hole 21 is provided in advance when the partition gasket 16 is formed, and a partition molding 22 that is slidably disposed in the through hole 21 is disposed. As described above, the partition molded body 22 is provided with a communication path 25 that is communicated or closed by relative movement of the partition molded body 22 with respect to the partition gasket 16.

  Next, as a second step, as shown in FIG. 4 (a), the discharge part 11 of the outer cylinder 12 is closed in advance with a tip cap 11d, and the freeze-dried preparation is supplied from the opening 12b of the outer cylinder 12. A liquid for formulation 28 containing the obtained component is filled by a predetermined amount with a filling nozzle 27 and stored.

  Then, as a third step, as shown in FIG. 4 (b), a partitioning gasket 16 is inserted at least on the opening 12b side, more preferably on the opening 12b side from the preparation liquid. To do. At this time, the partitioning molded body 22 is disposed at a predetermined position on the opening 12b side with respect to the partitioning gasket 16 so that the communication passage 25 is in a state where the both surfaces of the partitioning gasket 16 communicate with each other.

  Next, as a fourth step, such an outer cylinder 12 is placed in a decompression chamber of a sterilization drying apparatus (not shown), and the preparation liquid 28 is dried. At the time of this drying, the periphery of the outer cylinder 12 is made a highly decompressed atmosphere with the communication passage 25 of the opening / closing means 20 opened. Thereby, while the gas in the outer cylinder 12 on the discharge part 11 side is discharged from the partition gasket 16 through the communication passage 25, the inside of the outer cylinder 12 is decompressed, and the liquid component of the preparation liquid 28 is vaporized, The generated gas is also discharged through the communication path 25. And by continuing this vaporization and discharge | emission, as shown in FIG.4 (c), the dry formulation 29 will be produced | generated and accommodated in the outer cylinder 12. FIG.

  Subsequently, in the decompression chamber of such a sterilization drying apparatus, a predetermined amount of a gas such as nitrogen inert to the dry preparation 29 is filled into the outer cylinder 12 on the discharge part 11 side from the partition gasket 16 as necessary. After that, the partition molding 22 is pressed by the plugging device 31, the partition gasket 22 is moved relative to the through hole 21 of the partition gasket 16, and the one end 25 a of the communication path 25 is closed.

  Thereafter, when the atmosphere around the outer cylinder 12 in a state where the communication path 25 is closed is an atmospheric pressure atmosphere, the partition gasket 16 moves to a predetermined position in the outer cylinder 12 and is sealed by the partition gasket 16 and the opening / closing means 20. Thus, the front storage chamber 18 in which the freeze-dried preparation 29 is stored is formed.

Then, as a fifth step, the outer cylinder 12 on the opening 12b side of the partition gasket 16 is filled with the solution 33 by the filling nozzle 32, and the inside of the outer cylinder 12 on the opening 12b side from the solution 33. The gasket 15 for plunger is inserted and arranged. At this time, the plunger gasket 15 is not provided with the opening / closing means 20, but after the plunger gasket 15 is inserted into the opening 12b in the outer cylinder 12, the amount of movement to a predetermined position is small. It is possible to install it.
Thereby, the stored matter filling operation of the prefilled syringe 10 in which the freeze-dried preparation 29 and the solution 33 thereof are stored is completed.

  As described above, according to the prefilled syringe filling method according to the present embodiment, the partitioning gasket 16 has the through hole 21 and the partitioning molded body 22, and the communication path 25 communicates with the relative movement. An opening / closing means 20 for closing is provided. After the preparation liquid is accommodated in the second and third steps and the partition gasket 16 is disposed in the vicinity of the opening 12b of the outer cylinder 12, the fourth step is performed. Since the gas in the outer cylinder 12 is discharged from the communication passage 25 of the partition gasket 16 and the partition gasket 16 is moved to a predetermined position, the gas flow for discharging the gas in the outer cylinder 12 as in the prior art. There is no need to provide a path on the outer periphery of the partitioning gasket 16, and it is possible to save troubles such as forming a gas flow path using another member or forming the partitioning gasket 16 into a thick and complicated shape. It is possible To move to a predetermined position of the partition gasket 16 can be easily performed.

  Further, it is not necessary to provide a gas flow path on the outer periphery of the partitioning gasket 16, and furthermore, the communication passage 25 can be closed by moving the partitioning molded body 22 relative to the partitioning gasket 16, so that the partitioning gasket 16 can be closed. The communication path 25 can be closed with the entirety inserted into the outer cylinder 12. Therefore, it is not necessary to partially compress and deform the outer periphery of the partition gasket 16 to discharge the gas in the outer cylinder 12, and the sealing performance of the outer peripheral seal portion 15a of the partition gasket 16 is not impaired.

  Moreover, after the partition gasket 16 is moved to a predetermined position in the outer cylinder 12, the communication passage 25 is closed by simply pressing the partition molding 22 and moving it relative to the partition gasket 16. Since the part accommodating chamber 18 can be closed, the sealing operation of the front accommodating chamber 18 is also easy.

  Further, in the fourth step, after the gas in the outer cylinder 12 is exhausted from the communication path 25, the communication path 25 is closed and the partition gasket 16 is moved to a predetermined position in the outer cylinder 12. The communication path 25 can be closed when the gasket 16 is moved, and the freeze-dried preparation 29 accommodated in the outer cylinder 12 on the discharge part 11 side from the partitioning gasket 16 moves from the communication path 25 to the opening 12b side. There is no leakage.

  Further, in the fourth step, the periphery of the outer cylinder 12 is set to a reduced pressure atmosphere in a state where the communication path 25 is communicated, and then the atmosphere of the outer cylinder 12 is set to an atmospheric pressure atmosphere after the communication path 25 is closed. Since the partition gasket 16 is moved to a predetermined position in the outer cylinder by the pressure difference between the inside and the periphery of the outer cylinder 12, the partition gasket 16 can be easily moved by closing the communication passage 25.

  Further, since the liquid component is vaporized from the liquid for formulation containing the components of the dry formulation, and this gas is discharged from the communication path 25 to store the dry formulation 31 in the outer cylinder 12, the dry formulation 31 is removed from the formulation solution 29. A series of processes from forming to sealing with the partition gasket 16 can be easily performed by decompression operation around the outer cylinder 12 and closing operation of the communication passage 25.

  Next, how to use the prefilled syringe 10 filled with the contents in this way will be described.

  First, in the storage state, as shown in FIG. 1, the plunger 14 is disposed on the rear end side of the outer cylinder 12, and the lyophilized preparation 29 and the dissolution solution 33 are provided in the front storage chamber 18 and the internal storage chamber 19. Are contained in a liquid-tight manner in a state of being isolated from each other. In this state, the partition gasket 16 is disposed on the opening 12b side with respect to the bypass groove 12c in the outer cylinder 12.

  In order to mix the lyophilized preparation 29 stored in the front storage chamber 18 and the lysing solution 33 stored in the internal storage chamber 19 to dissolve the lyophilized preparation 29 and discharge it from the discharge port 11c, first, Then, the tip cap 11d of the discharge part 11 of the prefilled syringe 10 is removed, and an unillustrated injection needle or a liquid feeding tube is connected to the luer lock structure part 11b to press the plunger 14 toward the discharge part 11 side.

  When the plunger 14 is pressed toward the discharge portion 11, the partition gasket 16 is moved by the internal pressure in the internal storage chamber 19 through the solution 33 in the internal storage chamber 19 as shown in FIG. The volume of the part accommodating chamber 18 is reduced. During this pressing operation, the flange portion 26 is in contact with the end portion on the side of the internal storage chamber 19 of the partition gasket 16 in a state where the internal pressure in the internal storage chamber 19 is loaded. The initial relative position is maintained in the through-hole 21 and the communication path 25 is maintained in a closed state.

  Then, as shown in FIG. 5B, when the partition gasket 16 reaches the bypass groove 12c, the front storage chamber 18 and the internal storage chamber 19 are communicated with each other via the bypass groove 12c, and the solution 33 is It flows into the front housing chamber 18 via the bypass groove 12c. Then, the lyophilized preparation 29 is dissolved by the dissolving solution 33.

Further, when the plunger 14 is pressed, the entire amount of the solution 33 in the internal storage chamber 19 is transferred to the front storage chamber 18, whereby the lyophilized preparation 29 becomes a liquid preparation that can be administered to the patient.
And by continuing pressing of the plunger 14 as it is, as shown in FIG.5 (c), all the chemical | medical agents accommodated in the prefilled syringe 10 are discharged | emitted from the discharge part 11, and use can be completed.

  In addition, the said Embodiment 1 can be suitably changed within the scope of the present invention. For example, in the above-described method for filling the prefilled syringe 10, the lyophilized preparation 29 is stored in the front storage chamber 18 in the above description. In addition, the formulation liquid 27 is accommodated in the outer cylinder 12, and the partition gasket 16 is disposed inside the opening 12b side of the outer cylinder 12 with the communication passage 25 of the opening / closing means 20 opened, and the pressure is reduced. Although the liquid 27 for medicine was dried by this, solids, such as powder and a tablet formed previously, can also be accommodated in the front accommodating chamber 18.

Further, when the partition gasket 16 is moved from the opening 12 b side in the outer cylinder 12 to a predetermined position, the inside of the outer cylinder 12 is in a reduced pressure state, and the partition molding 22 is relatively moved to close the communication passage 25. Thereafter, the partition gasket 16 was moved to a predetermined position by the pressure difference between the pressure around the outer cylinder 12 and the pressure inside the outer cylinder 12 by setting the circumference of the outer cylinder 12 to atmospheric pressure. In the state where gas is present in the outer cylinder 12 as in the form 2, the communication path 25 of the opening / closing means 20 is opened, and the gas in the outer cylinder 12 is discharged from the communication path 25 while partitioning. It is also possible to move the gasket 12 to a predetermined position.
[Embodiment 2]

Next, another embodiment will be described. FIG. 6 shows the second embodiment.
The prefilled syringe 10 according to the second embodiment uses the outer cylinder 12 that does not have the bypass groove 12c at the intermediate position of the cylindrical portion 12a of the outer cylinder 12, and the cylindrical portion 12a has a substantially constant circular cross-sectional shape. . Both the front storage chamber 18 and the internal storage chamber 19 store liquid, the front storage chamber 18 stores a contrast medium, and the internal storage chamber 19 stores physiological saline.

  Since such a prefilled syringe 10 stores the liquid in the front storage chamber 18, it is not necessary to perform lyophilization as in the first embodiment, and can be filled with the storage as follows.

  Here, as in the first embodiment, first, as a first step, a through-hole 21 is provided in advance when the partition gasket 16 is formed, and the through-hole 21 is slidably disposed. The partitioning molded body 22 is disposed. The partition molding 22 is provided with a communication passage 25 that is communicated or closed by relative movement of the partition molding 22 with respect to the partition gasket 16.

  Then, as a second step, as shown in FIG. 7A, the discharge portion 11 of the outer cylinder 12 is previously closed with a tip cap 11d, and a predetermined amount of contrast medium 36 is filled with the filling nozzle 35. Accommodate.

  Next, as a third step, as shown in FIG. 7B, the partition gasket 16 is inserted into the outer cylinder 12 on the opening 12 b side from the contrast agent 36. At this time, the partitioning molded body 22 is disposed at a predetermined position on the opening 12b side with respect to the partitioning gasket 16 so that the communication path 25 communicates between both sides of the partitioning gasket 16.

  Then, as a fourth step, as shown in FIG. 7C, the partition gasket 16 is pressed by the pressing member 37 from the opening 12 b side of the outer cylinder 12 and moved to a predetermined position in the outer cylinder 12. At this time, the communication path 25 of the opening / closing means 20 is maintained in the opened state. Accordingly, the gas corresponding to the reduced volume in the outer cylinder 12 can be discharged through the communication passage 25 by the movement of the partition gasket 16.

  The partition gasket 16 is moved to a predetermined position in the outer cylinder 12 by continuing the movement of the partition gasket 16 while discharging the gas in the outer cylinder 12 from the communication passage 25.

  And as shown in FIG.7 (d), the communicating path 25 is obstruct | occluded in the state which has arrange | positioned the gasket 16 for a partition in the predetermined position in the outer cylinder 12. FIG. Here, the push-in member 37 is a double tube, and the central portion is the plugging device 31 of the partitioning molded body 22. The plugging device 31 presses the partition molding 22 to move the partition gasket 22 relative to the through hole 21 of the partition gasket 16, thereby closing one end 25 a of the communication path 25. Thereby, as shown in FIG. 7E, the filling operation of the contrast agent 36 is completed, and the sealed front housing chamber 18 is formed.

Then, as a fifth step, as shown in FIG. 7 (f), physiological saline 39 is filled into the outer cylinder 12 on the opening 12b side from the partitioning gasket 16 by the filling nozzle 38, and FIG. ), The plunger gasket 15 is inserted and arranged in the outer cylinder 12 on the opening 12b side from the physiological saline 39. At this time, the plunger gasket 15 is not provided with the opening / closing means 20, but after the plunger gasket 15 is inserted into the opening 12b in the outer cylinder 12, the amount of movement to a predetermined position is small. It is possible to install it.
Thereafter, by attaching the plunger 14 to the plunger gasket 15, the prefilled syringe 10 containing the contrast agent 36 and the physiological saline 39 can be obtained.

  According to such a prefilled syringe filling method, a gas flow path for discharging the gas in the outer cylinder 12 is provided on the outer periphery of the partition gasket 16 as in the prior art. There is no need, and it is possible to save the trouble of forming gas flow paths using other members or forming the partition gasket 16 in a thick and complex shape, and the partition gasket 16 can be easily mounted. It is. Further, since the communication passage 25 can be closed in a state where the entire partition gasket 16 is inserted into the outer cylinder 12, the outer periphery of the partition gasket 16 is not partially compressed and deformed, and the partition gasket 16. The sealing performance of the outer peripheral seal portion 15a is not impaired. In addition, the communication path 25 can be closed and the front housing chamber 18 can be sealed simply by pressing the partition molding 22 and moving it relative to the partition gasket 16, so that the sealing operation is easy. .

  Moreover, in the second embodiment, in the fourth step, the partition gasket 16 is moved to a predetermined position in the outer cylinder 12 while discharging the gas in the outer cylinder 12 from the communication path 25, and then the communication path. 25 is closed, so that when the partition gasket 16 is moved to the discharge portion 11 side, even if gas is present in the outer cylinder 12, the gas corresponding to the reduced volume of this space is supplied to the communication path 25. The gas can be easily discharged.

Next, the usage method of such a prefilled syringe 10 is demonstrated.
First, in the storage state, as shown in FIG. 8, the plunger 14 is disposed on the rear end side of the outer cylinder 12, and a predetermined amount of stored liquid is stored in the front storage chamber 18 and the internal storage chamber 19, respectively. Has been. In this state, the partition gasket 16 is disposed in the first region.

  Here, the first region is a range from the position where the partition gasket 16 is initially arranged so as to partition the chambers 18 and 19 to the vicinity of the discharge portion 11, and the contents in the front storage chamber 18. It is the section which discharges only. Specifically, it is determined by the amount of protrusion of the protrusion 24 in the moving range of the partition gasket 16 until the partition molding 22 contacts the end surface 11 a of the discharge portion 11.

  In the first region, the sealing portion 23 is arranged in a state of penetrating the inner peripheral seal portion 21a and is in liquid-tight contact with the inner peripheral seal portion 21a of the through hole 21. Further, the protruding portion 24 protrudes toward the discharge portion 11 from the end portion on the discharge portion 11 side of the partition gasket 16. Furthermore, the end 25a of the communication passage 25 on the inner storage chamber 19 side is closed by an inner peripheral seal portion 21a. Further, since the partition molding 22 is disposed in the through hole 21, there is substantially no hollow portion inside the partition gasket 16, and the partition gasket 16 has sufficient strength, and the outer peripheral seal. The portion 16a is pressed against the inner wall surface of the outer cylinder 12 with sufficient pressure. Therefore, the sealing performance of the partition gasket 16 is sufficiently ensured, and the internal storage chamber 19 is reliably maintained in a sealed state.

  In order to discharge the storage liquid stored in the front storage chamber 18 and the storage liquid stored in the internal storage chamber 19 from the discharge port 11c, first, the tip cap 11d of the discharge section 11 of the prefilled syringe 10 is removed. Then, an injection needle (not shown) or a liquid feeding tube (not shown) is connected to the luer lock structure portion 11b to press the plunger 14 toward the discharge portion 11 side.

  As a result, as shown in FIG. 8A, the partition gasket 16 moves through the first region due to the internal pressure in the internal storage chamber 19 via the storage liquid in the internal storage chamber 19, and the partition gasket 16. , The liquid stored in the front storage chamber 18 is pressurized and discharged from the discharge port 11c. During this pressing operation, the flange portion 26 is in contact with the end portion on the side of the internal storage chamber 19 of the partition gasket 16 in a state where the internal pressure in the internal storage chamber 19 is loaded. It is maintained at the initial relative position in the through-hole 21, and the internal storage chamber 19 is maintained in a liquid-tightly closed state. Therefore, the storage liquid in the internal storage chamber 19 is held in the internal storage chamber 19 without flowing out to the front storage chamber 18 side on the discharge portion 11 side.

When the plunger gasket 15 is further pressed toward the discharge portion and the pressing operation proceeds, the partition gasket 16 reaches the second region.
Here, the second region is a range in the vicinity of the discharge unit 11 and is a section in which the stored liquid in the internal storage chamber 19 is discharged. Specifically, this is a range after the partitioning molded body 22 abuts against the end surface 11 a of the discharge portion 11.

  Then, as shown in FIG.8 (b), the protrusion part 24 of the molded object 22 for partition | abutment contact | abuts to the edge part 11a of the discharge part 11, and is further pressed as shown in FIG.8 (c). Thus, only the partition gasket 16 moves to the discharge unit 11 side while the partition molding 22 is in contact with the end surface 11a of the discharge unit 11. Thereby, substantially all the contrast agent in the front storage chamber 18 is discharged from the discharge port 11c. At the same time, only the partitioning gasket 16 moves, so that the partitioning molded body 22 moves relative to the through hole 21 of the partitioning gasket 16. Then, due to the movement of the partition molding 22 with respect to the through hole 21, the sealing portion 23 moves into the internal storage chamber 19, and the end 25 a on the internal storage chamber 19 side of the communication path 25 opens to the internal storage chamber 19 side. Thus, the opening / closing means 20 is opened. Thereby, the internal storage chamber 19 and the discharge port 11c are communicated. Thereafter, as shown in FIG. 8 (d), when the pressing operation further proceeds, the physiological saline in the internal storage chamber 19 flows out from the communication passage 25 and is discharged to the discharge port 11c side. The discharge of all contents can be completed.

  According to such a prefilled syringe 10, in order to arrange | position the gasket 16 for a partition in the predetermined position in the outer cylinder 12, the molded object 22 for partition used in order to discharge | emit the gas in the outer cylinder 12 is used at the time of use. The following effects can be obtained.

  That is, while the partition molding 22 is disposed in the first region, the internal storage chamber 19 can be maintained in a sealed state, and the partition gasket 16 is moved by the pressing operation of the plunger 14. Between the movement of the area and the arrival of the second area, the liquid stored in the front storage chamber 18 can be discharged from the discharge port 11c, and after the partition gasket 16 has moved to the second area, Since the communication path 25 of the molded body 22 opens into the internal storage chamber 19 and the liquid stored in the internal storage chamber 19 can be discharged from the discharge port 11 c, the liquid stored in the front storage chamber 18 and the storage of the internal storage chamber 19 are accommodated. It is possible to sequentially discharge the liquid.

  During this pressing operation, the communication passage 25 is formed in the partition molding 22 in the second region, so there is no need to elastically deform the partition gasket 16 and the communication passage 25 is greatly stabilized. Can be formed. In addition, since the partition molding 22 is disposed inside the through hole 21, even if the communication passage 25 is formed large, the flow path is hardly contracted by the elasticity of the partition gasket 16, and the strength of the partition gasket 16 is increased. Can be secured. Therefore, it is easy to ensure a sufficiently large flow path for discharging the stored liquid in the internal storage chamber 19 without reducing the liquid tightness of the internal storage chamber 19.

  As a result, the liquid stored in the front storage chamber 18 and the liquid stored in the internal storage chamber 19 can be easily discharged all at once, and the contrast medium in the front storage chamber 18 is injected to the inside of the syringe 10 and the tube thereafter. It is possible to perform a continuous extrusion operation such as extruding the contrast medium remaining in the path with the physiological saline in the internal storage chamber 19 in a short time, and switching between the contrast medium and the physiological saline as in the past. Compared with an extrusion operation such as extrusion, the effect of the total amount of contrast agent used can be sufficiently exerted.

In Embodiment 2, when the contrast gasket 16 is filled in the outer cylinder 12 and the partition gasket 16 is accommodated in the outer cylinder 12 and moved to a predetermined position, the communication passage 25 of the opening / closing means 20 is opened. In this state, the partition gasket 16 is moved while exhausting the gas in the outer cylinder 12 from the communication passage 25. However, as in the first embodiment, the partition gasket 16 is moved to the opening 12b of the outer cylinder 12. The pressure inside the outer cylinder 12 is reduced in a state of being disposed inside the side, the partition molding 22 is relatively moved, the communication passage 25 is closed, and the pressure of the atmosphere around the outer cylinder 12 and the outer cylinder 12 are It is also possible to move the partitioning gasket 16 to a predetermined position due to the difference in internal pressure.
[Embodiment 3]

FIG. 9 shows a prefilled syringe according to the third embodiment.
In the prefilled syringe 10, a plurality of partition gaskets 16 </ b> X and 16 </ b> Y are disposed between the discharge portion 11 in the outer cylinder 12 and the plunger gasket 15, and between the partition gasket 16 </ b> X and the discharge portion 11. A front storage chamber 18 is formed, a first internal liquid chamber 19a is formed between the partition gasket 16X and the partition gasket 16Y, and a second internal chamber is formed between the partition gasket 16Y and the plunger gasket 15. A liquid chamber 19b is formed. In addition, the partition gaskets 16X and 16Y are provided with opening / closing means 20 capable of communicating between both sides of the partition gaskets 16X and 16Y at the same position in the surface direction of the partition gaskets 16X and 16Y. It has been. The rest of the configuration is the same as that of the second embodiment.

  The prefilled syringe 10 has a front storage chamber 18 and first and second internal liquid chambers 19a and 19b, respectively, in which liquids such as chemical liquids sequentially discharged at the time of use are stored in an isolated state. Yes. The drug solution may be a drug that is discharged from the prefilled syringe 10 and directly administered to the human body, or may be a drug that is once discharged after discharging other containers or the like. Contains vitamin-containing fluids mixed with calorie infusions.

  The prefilled syringe 10 having such a configuration can be filled with the same contents as in the second embodiment. First, in the first step, when the partition gaskets 16X and 16Y are formed in advance, the through holes are respectively provided. 21, partitioning molded bodies 22 that are slidably disposed in the through holes 21 are respectively disposed, and communication passages 25 that are communicated or closed by relative movement of the partitioning molded body 22 with respect to the partitioning gasket 16 are provided. Keep it.

  Then, in the second step, the discharge portion 11 of the outer cylinder 12 is closed with the tip cap 11d, and a predetermined amount of the contents in the front storage chamber 18 is filled, and in the third step, the opening 12b side is filled. A partition gasket 16X is inserted into the outer cylinder 12. At this time, the communication passage 25 is in a state of communicating between both sides of the partitioning gasket 16X.

  Next, in a fourth step, the partition gasket 16X is pressed from the opening 12b side of the outer cylinder 12 and moved to a predetermined position in the outer cylinder 12. At this time, the gas in the outer cylinder 12 is discharged through the communication passage 25 of the opening / closing means 20. Then, the communication passage 25 is closed in a state where the partition gasket 16X is disposed at a predetermined position in the outer cylinder 12.

  Thereafter, the second to fourth steps are repeated. That is, in a state in which the discharge part 11 side of the outer cylinder 12 is sealed with the partition gasket 16X, a predetermined amount of the contents in the inner storage chamber 19a is filled, and the partition gasket is placed inside the outer cylinder 12 on the opening part 12b side. 16Y is inserted. Then, with the communication path 25 communicating between both sides of the partitioning gasket 16Y, the partitioning gasket 16Y is pressed from the opening 12b side of the outer cylinder 12, and the inside of the outer cylinder 12 is passed through the communication path 25 of the opening / closing means 20. While discharging the gas, the outer cylinder 12 is moved to a predetermined position to close the communication passage 25 of the partition gasket 16X.

  Thereafter, in a fifth step, the contents in the internal storage chamber 19b are filled into the outer cylinder 12 on the opening 12b side from the partitioning gasket 16Y, and the plunger gasket 15 is inserted and arranged. Thereafter, the plunger 14 is attached to the plunger gasket 15, whereby the contents filling operation of the prefilled syringe 10 is completed.

  According to such a prefilled syringe filling method, a gas flow path for discharging the gas in the outer cylinder 12 is provided on the outer periphery of the partitioning gasket 16 as in the conventional embodiment. There is no need, and it is possible to save the trouble of forming gas flow paths using other members or forming the partition gasket 16 in a thick and complex shape, and the partition gasket 16 can be easily mounted. It is. Further, since the communication passage 25 can be closed in a state where the entire partition gasket 16 is inserted into the outer cylinder 12, the outer periphery of the partition gasket 16 is not partially compressed and deformed, and the partition gasket 16. The sealing performance of the outer peripheral seal portion 15a is not impaired. Furthermore, the communication passage 25 can be closed and the front storage chamber 18 can be closed by simply pressing the partition molding 22 and moving it relative to the partition gasket 16. Sealing work is also easy.

  Even in such a prefilled syringe 10, as in the second embodiment, the stored contents in the front storage chamber 18, the storage in the internal storage chamber 19a, and the storage in the internal storage chamber 19b are obtained by pressing the plunger 14. Can be sequentially discharged from the discharge portion 11 by the opening / closing action of the opening / closing means 20 of each partitioning gasket 16X, 16Y. Here, the partition molded body 22 of the opening / closing means 20 of the partition gasket 16Y is the same as that of the second embodiment except that the communication path 25 is opened by contacting the molded body 22 of the partition gasket 16X. .

  In the third embodiment, an example having a total of three storage chambers has been described. However, by increasing the number of partition gaskets, a prefilled syringe 10 having more than three storage chambers can be provided. It is. In that case, it is possible to manufacture by repeating the 2nd process to the 4th process according to the number of partition gaskets.

  Further, as a prefilled syringe having three or more storage chambers, for example, as shown in FIG. 10, in addition to the partition gasket 16X having the opening / closing means 20, the opening / closing means 20 is added to the prefilled syringe 10 of the first embodiment. You may arrange | position the gasket 16Z for partition which does not have. Even such a prefilled syringe 10 can be filled with the contents using the same steps as in the first embodiment. And in the prefilled syringe 10 obtained by this, while being able to mix and discharge the contents of the front storage chamber 18 and the storage of the internal storage chamber 19a via the bypass 12c at the time of use, The contents stored in the internal storage chamber 19b can be sequentially discharged via the opening / closing means 20 after the mixture is discharged.

  It is a partial cross section figure which shows the structure of the prefilled syringe which concerns on Embodiment 1 of this invention.   The gasket for a partition of the prefilled syringe of FIG. 1 is shown, (a) is a perspective view, (b) is sectional drawing.   The molded object for partitioning of the prefilled syringe of FIG. 1 is shown, (a) is a perspective view, (b) is a bottom view.   (A)-(f) is a schematic diagram which shows the accommodation filling process of the prefilled syringe of FIG.   (A)-(c) is a partial cross section figure which shows pressing operation of the prefilled syringe of FIG.   It is a partial cross section figure which shows the structure of the prefilled syringe which concerns on Embodiment 2 of this invention.   (A)-(h) is a schematic diagram which shows the accommodation filling process of the prefilled syringe of FIG.   (A)-(d) is a partial cross section figure which shows pressing operation of the prefilled syringe of FIG.   It is a partial cross section figure which shows the structure of the prefilled syringe which concerns on Embodiment 3 of this invention.   It is a partial cross section figure which shows the other example of the prefilled syringe which concerns on Embodiment 3 of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Prefilled syringe 11 Discharge part 12 Outer cylinder 15 Plunger gasket 16, 32, 55 Partition gasket 18 Front part storage chamber 19 Internal liquid chamber 20 Opening / closing means 21 Through-hole 21a Internal seal part 22 40, 50, 60 Partition molding 23 Sealing part 25 Liquid flow path 26 Flange part 36 Concave part

Claims (4)

The partition gasket is provided with a storage chamber formed between the discharge portion and a partition gasket disposed in the outer cylinder in an outer cylinder having a discharge portion on one end side and an opening on the other end side. Includes a through hole penetrating in the longitudinal direction, a partition molded body disposed in the through hole so as to be slidable in the longitudinal direction, and a relative position between the partition gasket and the partition molded body. In the prefilled syringe filling method comprising an opening / closing means in which the gap between both end faces of the gasket communicates or is closed through the through hole,
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
After the partitioning gasket is disposed in the opening, the partitioning gasket is moved to a predetermined position in the outer cylinder while discharging the gas on the discharge part side of the partitioning gasket through the opening / closing means. A process of
Closing the opening / closing means of the partition gasket;
A method for filling a prefilled syringe containing material, comprising: The partition gasket is provided with a storage chamber formed between the discharge portion and a partition gasket disposed in the outer cylinder in an outer cylinder having a discharge portion on one end side and an opening on the other end side. Includes a through hole penetrating in the longitudinal direction, a partition molded body disposed in the through hole so as to be slidable in the longitudinal direction, and a relative position between the partition gasket and the partition molded body. In the prefilled syringe filling method comprising an opening / closing means in which the gap between both end faces of the gasket communicates or is closed through the through hole,
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
After disposing the partitioning gasket in the opening, and after discharging the gas on the discharge part side of the partitioning gasket through the opening / closing unit, closing the opening / closing unit of the partitioning gasket;
Moving the partition gasket to a predetermined position in the outer cylinder;
A method for filling a prefilled syringe containing material, comprising: The partition gasket is provided with a storage chamber formed between the discharge portion and a partition gasket disposed in the outer cylinder in an outer cylinder having a discharge portion on one end side and an opening on the other end side. Includes a through hole penetrating in the longitudinal direction, a partition molded body disposed in the through hole so as to be slidable in the longitudinal direction, and a relative position between the partition gasket and the partition molded body. In the prefilled syringe filling method comprising an opening / closing means in which the gap between both end faces of the gasket communicates or is closed through the through hole,
A step of closing the discharge portion and storing an object in the storage chamber from the opening;
Placing the partitioning gasket in the opening;
By maintaining the opening and closing means in a communicating state and setting the atmosphere around the outer cylinder to a reduced pressure atmosphere, and then closing the opening and closing means and setting the atmosphere around the outer cylinder to an atmospheric pressure atmosphere, Moving the partition gasket to a predetermined position in the outer cylinder with a pressure difference of
A method for filling a prefilled syringe containing material, comprising:   The said stored item consists of a liquid agent which melt | dissolved the dry formulation with the solution, The said dry formulation is accommodated in the said storage chamber by sublimating the solution component of the said liquid agent from the said opening / closing means. The method for filling a prefilled syringe according to claim 1.

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