JP4827175B2 - Two-chamber container and syringe - Google Patents

Description

  The present invention relates to a two-chamber container / syringe in which two types of drugs are accommodated in one syringe container. More particularly, the present invention relates to a two-chamber container / injector in which mixing or solubility during use of two kinds of contained drugs is improved.

  In Patent Document 1, as shown in FIG. 6, a rear end piston 7 is provided on the flange 2 side of the syringe barrel 3, an intermediate piston 5 is provided between the rear end piston 7 and the nozzle 1, and the intermediate piston 5 The inside of the syringe barrel 3 is divided into an anterior chamber 9 and a posterior chamber 6, and a powder or liquid medicine 11 is enclosed in the anterior chamber 9, and a liquid agent 12 such as a solution is enclosed in the posterior chamber 6. In the inner wall of the syringe barrel 3 between the nozzle 1 and the intermediate piston 5, a bypass 10 that connects the front chamber 9 and the rear chamber 6 is provided in the container wall of the syringe barrel 3. Those of different structures are known.

  Prior to use, the syringe shown in FIG. 6 is configured such that the rear end piston is fitted by a plunger rod (not shown) in which an injection needle is fitted into the nozzle portion 1 and then screwed into a thread portion of the rear end piston 7. 7, the internal pressure of the liquid agent 12 in the rear chamber 6 is increased, the intermediate piston 5 moves forward, the intermediate piston 5 enters the bypass 10, and the rear chamber 6 and the front chamber 9 are communicated with each other. The liquid 12 flows into the front chamber 9 at an instant. When the entire amount of the liquid 12 in the rear chamber 6 moves to the front chamber 9, the rear end piston 7 contacts the intermediate piston 5, applies pressure to the injection solution, and discharges the injection solution from the needle.

As shown in FIG. 7 which is a partially enlarged arrow view of FIG. 6, the shape of the conventional bypass shown in FIG. 6 is the same as that of the liquid agent inlet (14) and the injection port (13). ing. With such a structure, with the injection needle inserted into the syringe, an operation for transferring the liquid agent 12 on the rear chamber 6 side to the front chamber 9 in which the dry medicine 11 is stored is performed. In order to speed up, it is only necessary to increase the speed of pushing the plunger rod, but if it is pushed too fast, the internal pressure on the liquid agent 12 side increases, the piston moves before the liquid agent moves to the front chamber 9, and the bypass is blocked. End up. Therefore, there is a limit to the speed at which the plunger rod can be pushed, and the inflow rate of the liquid depends on the user's ability to push the plunger. For example, when the solubility of the dry medicine in the liquid is low, In the case of fine powder, mixing and dissolution of the dry drug and the liquid may be insufficient.
Japanese Patent Laid-Open No. 10-212280

  Therefore, an object of the present invention is to provide a two-chamber container / syringe in which the dry drug always mixes and dissolves well with the liquid even if the plunger is pushed quickly even if the piston does not block the bypass and the usage state of the user is different. It is to be.

The above object is achieved by the present invention described below. That is, the present invention comprises a syringe barrel (3) having a nozzle portion (1) for attaching an injection needle to one end portion, a flange (2) for placing a finger on the other end portion, and a nozzle portion (1 ), A middle piston (5) that divides the inside of the syringe barrel (3) into two chambers, and a rear end piston (6) that seals the rear chamber (6) on the flange (2) side. 7) and a plunger rod engaged with the rear end piston (7), and the intermediate piston (5) is disposed on the side wall in the front chamber (9) on the nozzle (1) side of the syringe barrel (3). In the two-chamber container / syringe in which a bypass (10) connecting the two chambers is formed,
The shape of the bypass (10) is, when the intermediate piston (5) has entered the upper Symbol bypass (10), the flow velocity in the the posterior chamber of the liquid in the (6) nozzle (1) side end portion, flange (2) side Ri Do to larger than the flow rate at the end, and liquid in the rear chamber (6) to flow at an angle to the horizontal wall of the barrel (3), a spiral a front chamber Provided is a two-chamber container / syringe which is formed so as to be ejected in a shape .

In the above-described present invention, the shape of the bypass, Roh nozzle (1) side end portion of the depth (h1), are formed smaller than the flange (2) side end portion of the depth (h2); The length (L) of the bypass (10) and the contact width (H) of the intermediate piston (5) with respect to the wall surface of the syringe barrel (3) have a relationship of H / L = 0.5 to 0.8. Is preferred.

  According to the present invention, when the intermediate piston 5 enters the bypass 10, the flow rate at the nozzle side end of the liquid agent in the rear chamber 6 is formed to be larger than the flow rate at the flange side end. Therefore, the flow rate of the liquid agent flowing into the front chamber 9 becomes larger than the peristaltic resistance of the piston, and the mixing property of the drug in the front chamber and the liquid agent in the rear chamber is increased by the stirring action of the liquid agent having a large flow rate. Or solubility improves.

  The present invention will now be described in more detail with reference to the accompanying drawings showing the best mode for carrying out the invention. FIG. 1 is a cross-sectional view for explaining the structure of a two-chamber container and syringe according to the present invention. As shown in FIG. 1, the two-chamber container / injector of the present invention has a syringe part 3 having a nozzle part 1 for attaching an injection needle to one end part and a flange 2 for placing a finger on the other end part. A nozzle cap 4 that seals the nozzle portion 1, an intermediate piston 5 that divides the inside of the syringe barrel 3 into two chambers, a rear end piston 7 that seals the rear chamber 6 on the flange 2 side, and a rear end piston 7 And a plunger rod (not shown) to be engaged. In such a configuration, a bypass 10 that connects the rear chamber 6 and the front chamber 9 across the intermediate piston 5 is formed on the side wall in the front chamber 9 on the nozzle 1 side of the syringe barrel 3. A feature of the present invention is that when the intermediate piston 5 enters the bypass 10, the flow rate at the nozzle 1 side end of the liquid agent 12 in the rear chamber 6 is higher than the flow rate at the flange 2 side end. It is characterized by being formed to be large.

  The operation of the two-chamber container and syringe of the present invention will be described. The front chamber 9 of the two-chamber container and syringe of the present invention is filled with, for example, a dry medicine 11, and the rear chamber 6 is filled with a liquid 12 such as water. In this two-chamber container / injector, an injection needle is fitted to the nozzle portion 1 prior to use. Next, as shown in FIG. 5A, the rear end piston 7 is advanced by a plunger rod (not shown) screwed to the thread portion of the rear end piston 7. By this advance, the internal pressure by the liquid agent 12 in the rear chamber 6 increases, and the intermediate piston 5 advances. When the intermediate piston 5 moves forward and enters the bypass 10, as shown in FIG. 5B, the rear chamber 6 and the front chamber 9 are communicated, and the liquid agent 12 flows into the front chamber 9 at that moment, The dry medicine 11 and the liquid agent 12 are vigorously stirred and mixed by the ejection of the liquid agent 12, and the dry medicine 11 quickly dissolves in the liquid agent 12 (FIG. 5C). Subsequently, the dissolved drug is released from the injection needle. The rear end piston 7 comes into contact with the intermediate piston 5 when the total amount of the liquid agent 12 in the rear chamber 6 moves to the front chamber 9.

  In the above operation, the bypass 10 in the two-chamber container and syringe of the present invention has the same shape and the same depth (h) as shown in FIG. 2 (a), which is a partially enlarged view of FIG. However, the width A of the nozzle side end portion (the width of the bypass where the front end of the intermediate piston is located) is narrower than the width B of the end portion on the flange 2 side (the width of the bypass where the rear end of the intermediate piston is located). Thus, the flow resistance of the liquid agent flowing through the bypass 10 is low. The liquid agent in the rear chamber 6 is formed in a shape that flows horizontally in the flow direction with respect to the wall surface of the syringe barrel 3. Therefore, the flow rate of the liquid agent 12 ejected into the front chamber 9 is increased, and the dry drug 11 is strongly stirred by the jet of the liquid agent 12, and the mixing and dissolution of both are promoted.

  As shown in FIG. 2B, which is a partially enlarged arrow view of FIG. 1, the shape of the bypass has the same depth (h), but the width A is the same as that of the end of the flange 2 side. The liquid agent in the rear chamber 6 is formed in a shape that flows with an angle with respect to the wall surface of the syringe barrel 3. Accordingly, the flow rate of the liquid agent 12 ejected into the front chamber 9 is high, and the liquid agent 12 in the rear chamber 6 is spirally ejected with respect to the dry drug 11 in the front chamber 9. Mixing and dissolution is further promoted.

  Furthermore, as shown in the enlarged view of FIG. 4, the width A on the outlet side and the width B on the inlet side are the same, but the depth h2 on the nozzle side is changed to the depth h1 on the flange side as shown in FIG. It is formed shallower. Accordingly, since the flow rate of the liquid agent 12 ejected into the front chamber 9 is high and the liquid agent 12 is ejected downward in the drawing, the dry drug 11 is strongly stirred by the jet of the liquid agent 12, and the mixing and dissolution of both are promoted. . Of course, a combination of the embodiment shown in FIG. 3 and the embodiment shown in FIG. 2 is possible depending on the type of medicine, the shape and volume of the syringe, and the like. The number of bypasses is not limited to one and may be plural.

  In the embodiment shown in FIGS. 1 and 2, the depth (h) of the bypass 10 varies depending on the volume of the syringe barrel 3, but the depth (h) is generally 0.2 to 0.6 mm, the length (L) is 5 to 10 mm, the width A is 0.52 mm, the width B is 1.5 to 4 mm, the length (L) and the width of the intermediate piston (H ) With H / L = 0.5 to 0.8, it was found that the mixing property and solubility of the dry drug 11 and the liquid agent 12 were excellent. Further, when the intermediate piston 5 enters the bypass 10, an inlet area (a) formed by the rear end of the intermediate piston 5 and the bypass 10 and an outlet formed by the front end of the intermediate piston 5 and the bypass 10. When the ratio of the area (b) is in the relationship of a: b = 1: 0.4 to 0.8, an appropriate flow rate of the liquid agent can be obtained. When the ratio is less than 0.4, the flow resistance of the liquid in the bypass portion is increased. On the other hand, when the ratio exceeds 0.8, the flow rate of the liquid agent is not sufficient.

  Further, according to the present invention, when the intermediate piston enters the bypass, the ratio of the exit area (b) formed by the front end of the intermediate piston and the bypass and the cross-sectional area (S) in the syringe barrel is 0. It is effective when 2 ≦ b / S ≦ 1.5%. More preferably, 0.4 ≦ b / S ≦ 1.5%. That is, when the speed of pushing the plunger rod is constant, the smaller the ratio of the cross-sectional area (S) in the syringe barrel to the bypass outlet area (b) (the smaller the bypass outlet area), the more The internal pressure of the rear chamber increases when the liquid is pushed out. Therefore, when the ratio b / S is smaller than a certain value, unless the flow resistance of the liquid in the bypass portion is lowered, the intermediate piston moves before all the liquid in the rear chamber moves, and the bypass is closed. The phenomenon of ending up occurs remarkably. This value varies depending on the capacity of the syringe and the shape of the piston and bypass, but the ratio of b / S is 1.5% or less when the bypass diameter and depth are constant in the general syringe shape.

  In the above description, the dry medicine is illustrated as an example of the medicine 11 in the front chamber 9. However, the medicine 11 stored in the front chamber 9 is not limited to the dry medicine. As long as it is a drug to avoid contact, it may be a liquid, a high viscosity liquid, a high concentration liquid, an organic liquid, or any other drug. Moreover, it is more effective when the mixing property with the liquid agent in the rear chamber is low.

  The syringe barrel 3 of the two-chamber container and syringe of the present invention may be made of glass, but is preferably made of resin in consideration of the ease of molding in injection molding. The resin is not particularly limited, but cyclic polyolefin is most preferable from the viewpoints of gas barrier properties, low elution properties, and discardability. Use of such a thermoplastic resin is advantageous in terms of reducing the manufacturing cost of the syringe barrel, reducing the weight, and increasing the range of shape selection, and improves the breakage resistance of the syringe barrel.

  The various pistons, nozzle caps, and the like can be manufactured using rubber materials, vulcanizing agents, and other compounding agents conventionally used for manufacturing various rubber stoppers. It is preferable that the nozzle cap and the various pistons are covered with a fluororesin film at the wetted part. Any fluororesin film that is inactive (does not swell or dissolve) to the drug can be used. For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene-ethylene copolymer (ETFE) , Tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-fluoroalkyl vinyl ether copolymer (PFA), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), and the like. These resins are used as sheets or films.

Next, the present invention will be described more specifically with reference to examples and comparative examples.
Examples 1-3
In a syringe barrel having an inner diameter of 15 mm and a barrel length of 60 mm, the shape of the bypass is shown in FIG. 2A (Example 1), the shape shown in FIG. 2B (Example 2), and FIG. A container and syringe having the shape shown in (Example 3) was prepared. 2A (Example 1) has a bypass length (L) of 10 mm, a depth (h) of 0.4 mm, a nozzle side end width A of 1 mm, and a flange side. The end width B was set to 2 mm. 2B (Example 2) has a bypass length (L) of 10 mm, a depth (h) of 0.4 mm, a flange side end width B of 2 mm, and a bypass width constant. The length of the part was 6 mm, and the tip of the bypass was a triangle with the bypass center line bent at 45 degrees and the intersection of the center line and the point where the bypass length (L) was 10 mm as a vertex. 3 (Example 3) has a bypass length (L) of 10 mm, a bypass width (A, B) of 2 mm, a nozzle side end depth (h1) of 0.2 mm, and a flange end. The depth (h2) of the part was 0.4 mm. In addition, the contact width (H) with respect to the container wall of the intermediate piston was 7 mm in any syringe.

Comparative Examples 1 and 2
A container / syringe in which a bypass having a constant width and a constant depth was formed in the same syringe barrel as that of the example was prepared. The width was 1 mm, the depth was 0.4 mm (Comparative Example 1), the width was 2 mm, and the depth was 0.4 mm (Comparative Example 2).
Solubility test Each of the containers and syringes of Examples 1 to 3 and Comparative Examples 1 and 2 was filled with a poorly soluble protein preparation in the front chamber and the solution in the rear chamber, and the plunger rod was moved at a speed of 20 mm / sec. The solubility of the protein preparation when pressed was visually evaluated. The number of tests was 10 each. The results are shown in Table 1.

  As is clear from the above table, all of the examples were able to transfer all the lysate in the rear chamber to the front chamber. Also, no dissolution residue was observed. In contrast, in Comparative Example 1, the piston moved before the dissolved solution in the rear chamber moved to the front chamber, and the dissolved solution remained in the rear chamber. In addition, since there was not enough solution, all protein preparations in the anterior chamber were not dissolved, and a residue was observed. In Comparative Example 2, all of the lysate in the rear chamber moved to the anterior chamber, but the outflow rate to the anterior chamber was insufficient, and all protein preparations could not be dissolved only by moving the piston. . In Comparative Example 2, all of the preparation could be dissolved by applying vibration to the container and syringe.

  According to the present invention as described above, the shape of the bypass is formed so that the liquid agent ejection port is smaller than the liquid agent inlet, so that the flow rate of the liquid agent flowing into the front chamber is suppressed while suppressing the fluidity of the liquid. The mixing property of the dry drug and the liquid agent is improved by the stirring action of the liquid agent having a large flow rate, and the mixing property or solubility of the dry drug and the liquid agent is improved.

It is a figure explaining the whole two-chamber container and syringe of the present invention. It is a figure explaining the shape of the bypass of FIG. It is a figure explaining the other shape of the bypass of FIG. It is a figure explaining the other shape of the bypass of FIG. It is a figure explaining operation | movement of the two-chamber container and syringe of this invention. It is a figure explaining the whole conventional two-chamber container and syringe. It is a figure explaining the shape of the bypass of the conventional two-chamber container and syringe.

Explanation of symbols

1: Nozzle portion 2: Flange 3: Injection cylinder 4: Nozzle cap 5: Intermediate piston 6: Rear chamber 7: Rear end piston 8: Plunger rod 9: Front chamber 10: Bypass 11: Drug 12: Liquid agent 13: Inlet 14: Injection port

Claims (3)

A syringe barrel (3) having a nozzle portion (1) for attaching an injection needle to one end, a flange (2) for placing a finger on the other end, and a nozzle for sealing the nozzle portion (1) A cap (4), an intermediate piston (5) that divides the inside of the syringe barrel (3) into two chambers, a rear end piston (7) that seals the rear chamber (6) on the flange (2) side, and a rear end The plunger rod is engaged with the piston (7), and the two chambers are formed on the side wall in the front chamber (9) on the nozzle (1) side of the syringe barrel (3) across the intermediate piston (5). In the two-chamber container / syringe in which the connecting bypass (10) is formed,
The shape of the bypass (10) is, when the intermediate piston (5) has entered the upper Symbol bypass (10), the flow velocity in the the posterior chamber of the liquid in the (6) nozzle (1) side end portion, flange (2) side Ri Do to larger than the flow rate at the end, and liquid in the rear chamber (6) to flow at an angle to the horizontal wall of the barrel (3), a spiral a front chamber A two-chamber container / syringe formed so as to be ejected in a shape .   The shape of the bypass (10) is such that the depth (h1) of the end portion on the nozzle (1) side is smaller than the depth (h2) of the end portion on the flange (2) side. Two-chamber container and syringe.   The length (L) of the bypass (10) and the contact width (H) of the intermediate piston (5) with respect to the wall surface of the syringe barrel (3) are in a relationship of H / L = 0.5 to 0.8. Item 2. The two-chamber container and syringe according to item 1.

Images