JPH06154290A - Prefilled syringe dissolvable on use - Google Patents

Abstract

PURPOSE:To perform freeze-drying of a drug liq. in a prefilled syringe dissolvable on use after it is filled by constituting the prefilled syringe with a drug dissolvable on use of a powder drug storing part and a dissolving liq. storing part and filling the drug in a glass container having a projected by-pass and being to be a pushing element in the powder drug storing part. CONSTITUTION:A drug liq. 17 is fed into a glass container 1 by standing it up and after the opening of the glass container 1 is temporarily stopped with a gasket 3, it is freeze-dried to make the drug liq. to a powder drug 18. After freeze-drying is finished and it is tightly closed by pushing the gasket 3 therein, the gasket is pushed just before a projected by-pass 2 and a dissolving liq. 19 is fed and a gasket 4 connected with a stopper valve 8 by using a connecting member 9 is pushed into a glass container 1 and the upper part of the dissolving liq. 19 is tightly closed. Then, a glass container 1 is inserted between an inner pipe 6 and an outer pipe 5 of the syringe cylinder 7 and a stopper valve 8 is fitted to the inner pipe 6 to close tightly and a rear cap 15 is sheathed on the glass container 1 to fit it on the outer cylinder 5 of the syringe cylinder 7.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pre-filled syringe which is a dissolution type before use, which is one of the medical kit products for injections in which a drug and an administration system are combined.

[0002]

2. Description of the Related Art In a non-kit administration system such as an ampoule and a vial formulation, the content drug solution varies in the amount sucked into a syringe, and it is difficult to accurately collect the indicated amount with a viscous drug solution. , Foreign matter such as glass fragments when cutting ampoules or coring when threading a rubber stopper.
On the other hand, injectable medical kit products that combine a drug and an administration system can reduce the risk of microbial contamination, prevent errors during drug administration, and provide quick response during an emergency compared to non-kit administration systems. It has many medical advantages such as improvement of quality, waste of chemicals, reduction of property cost by simplifying inventory management, convenience and safety, and reduction of workload.

For this reason, many medical kit products have been recently developed and sold. Among pre-filled disposable syringes (pre)
filled disposable syring
e, hereinafter referred to as a prefilled syringe) is a system that provides a drug solution in a form that is pre-filled in a syringe, and has excellent responsiveness in an emergency. In recent years, a solid-state drug and an attached solution are provided in a single syringe. A ready-to-use prefilled syringe that has been filled in is developed and is widely sold. As shown in FIG. 4, a needle-dissolving type pre-filled syringe used for mixing a solid-state drug and an attachment liquid or two kinds of liquid medicines at the time of use is a needle mounting portion 33 of an injection cylinder 32 having a bypass portion 31. After tightening with luer tip 34 through packing 35, freeze-dried preparation 3 with needle mounting portion 33 facing down
6 into the syringe barrel 32 and the gasket 37 into the syringe barrel 3
After pressing the plug up to just before the bypass part 31 of 2 and sealing it,
There is a commercially available pre-filled syringe in which a solution 38 is injected, and a gasket 40 having a pusher mounting screw hole 39 is pushed again to be tightly plugged.

When the dissolution type prefilled syringe is used, the gasket 40 of the injection cylinder 32 is used as shown in FIG.
When the pusher 41 is screwed into the pusher mounting screw hole 39 of No. 3, and the pusher 41 is pushed in as it is, the gasket 37 moves to reach the bypass section 31, and the dissolution liquid 38 passes through the bypass section 31.
Flows into the sealed portion of the freeze-dried preparation 36. Pusher 4
When 1 is pushed in, the gasket 40 comes into contact with the gasket 37, and all of the solution 38 flows into the lyophilized formulation 36 enclosing portion to dissolve the lyophilized formulation 36. Thereafter, a double-point injection needle is passed through the packing and inserted into the aluminum luer tip 34 to complete the preparation for administration.

[0005]

The above-mentioned dissolution-type prefilled syringe is mechanically complicated as compared with the case of charging a drug solution because the freeze-dried preparation is charged into the syringe barrel. However, it has the drawback of requiring a lot of time and low productivity. Therefore, in reality, there is a strong demand for the development of a ready-to-use prefilled syringe in which a drug solution is lyophilized.

It is an object of the present invention to provide a pre-filled syringe which can be lyophilized after it has been charged with a drug solution.

[0007]

[Means for Solving the Problems] The inventors of the present invention have made extensive studies to achieve the above object. As a result, since the conventional pre-filled syringe that is dissolved before use is placed in the syringe barrel, it is difficult to stand the freeze-dried barrel containing the drug solution and freeze-dry it.Therefore, the freeze-dried preparation was placed in the syringe barrel. If you put the drug solution in the pusher instead of the syringe,
Establishing that it is easy to stand and freeze-dry,
This invention was reached.

That is, according to the present invention, in a pre-filled syringe of a dissolving type at the time of use, a glass container serving as a pusher having a powder drug container and a solution container and having a convex bypass in the powder drug container, and an inner surface of the glass container A gasket that tightly seals between the powder medicine storage unit and the dissolution liquid storage unit that can be in close contact with each other, and a stopper valve that has a hole for guiding the chemical solution to the stopper valve from the surroundings, and the other of the dissolution liquid storage unit that is connected to the stopper valve. Gasket, double-tube injection cylinder whose tip is sealed with packing, lure tip, cap, etc., glass container with stopper valve fitted and fixed to inner tube by inserting upper end of glass container between inner tube and outer tube of the injection cylinder A pre-filled syrup that is made up of a rear cap with an activator for protecting the glass container that is fitted on the outside of the syringe barrel. Di.

Further, in the pre-filled syringe of the dissolving type at the time of use, it comprises a powder medicine storing section and a dissolving solution storing section,
A glass container serving as a pusher having a convex bypass in the powder drug storage part, a gasket for tightly plugging between the powder drug storage part and the solution storage part that can be slidably attached to the inner surface of the glass container, and the other of the glass containers Stopper piston valve connected to the gasket
Double-tube injection cylinder sealed with lure tip, cap, etc.
A glass container in which a stopper piston valve provided in the inner tube of the syringe barrel guides a drug solution flowing in, a glass container upper end is inserted between the inner tube of the syringe barrel and the outer tube, and the stopper piston valve is fitted and fixed to the inner tube. The pre-filled syringe is a pre-filled syringe, which is composed of a rear cap with an activator for protecting a glass container, which is fitted over the outer periphery of the syringe barrel and is externally fitted.

[0010]

In operation, the pre-filled syringe of the dissolving type according to the present invention is composed of a powder drug storage portion and a solution storage portion, instead of the conventional filling of the injection cylinder with the drug, and a pusher having a convex bypass in the powder drug storage portion. Since the child glass container is filled with the drug, it is possible to fill the glass container with the drug solution and freeze-dry, and the powder drug is not required to be filled, and the productivity is greatly improved. Also, since the drug solution is introduced into the inner tube of the double tube of the injection cylinder through the hole drilled from around the gasket that tightly plugs the other of the solution storage part, the remaining amount of the drug solution at the time of administration should be reduced. You can

When the pre-filled syringe of the present invention is filled with a drug, a glass container comprising a powder drug storage part and a solution storage part is charged with a drug solution for producing a powder drug, and a gasket is temporarily placed in the glass container. If plugged and used for freeze-drying, it can be stood upright and stored during freeze-drying, which facilitates filling and improves productivity. When the powdered drug is filled by freeze-drying, push the gasket to the front of the convex bypass of the glass container and seal it, then fill the solution with the solution and seal the other side of the solution container with the gasket.
If it is pushed into the glass container, the other part of the solution storage part is sealed. And, between the inner tube and the outer tube of the double-tube injection cylinder whose tip is sealed with packing, lure tip, cap, etc.,
The upper end of the glass container is inserted, the stopper valve is fitted and fixed to the inner tube, the rear cap with an activator for protecting the glass container is covered on the glass container, and the outer tube is externally fitted to the syringe cylinder, and the filling of the drug is completed.

When the drug solution is to be administered by a pre-filled syringe that dissolves at the time of use, the activator provided on the rear cap is pushed to push the glass container into the syringe barrel.
The gasket that closes the space between the powder drug storage unit and the solution storage unit slides up to the convex bypass of the powder drug storage unit, and the dissolution liquid falls into the powder drug storage unit through the convex bypass and the powder drug dissolves. To be done. In addition, remove the rear cap with activator, attach a double-point injection needle to the tip of the syringe barrel, push the glass container into the syringe barrel, and seal the other side of the solution storage compartment with a gasket located on the convex bypass of the powder drug storage compartment. Then, the drug solution flows through the convex bypass from the piston valve connected to the gasket to the inner pipe of the double pipe or the stopper piston valve into the conduit, and is guided to the tip of the injection cylinder to complete the preparation for administration.

In another in-use dissolution type prefilled syringe of the present invention, a glass tube is inserted between an inner tube and an outer tube of a double-tube injection cylinder whose tip is sealed with a packing, a luer tip, a cap or the like when a drug is filled. The upper end of the container is inserted, the stopper piston valve is fitted and fixed to the inner tube, the rear container with an activator for protecting the glass container is put on the glass container, and the outer tube is fitted on the outer tube of the injection cylinder to complete the drug filling. Also, when administering a drug solution, if the gasket that tightly plugs the other of the solution storage parts of the glass container is located in the convex bypass of the powder drug storage part, the stopper where the drug solution is connected to the gasket via the convex bypass It flows through the piston valve into the conduit in the inner tube of the double tube and is guided to the tip of the injection cylinder.

[0014]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The details of the present invention will be described below with reference to FIGS. FIG. 1 is a block diagram showing the order of filling drugs into a pre-use dissolution type prefilled syringe of the present invention, FIG. 2 is a block diagram showing an operation sequence when using a pre-use dissolution type prefilled syringe, and FIG. 3 is another example of the present invention. It is a sectional view of the dissolving prefilled syringe before use. In FIG. 1, 1 is a glass container for containing a powdered medicine and a solution, 2 is a convex bypass provided in the powdered medicine enclosing portion of the glass container 1, 3 is a gasket for tightly sealing the space between the powdered medicine and the solution, 4 Is a gasket that tightly plugs the mouth of the glass container 1. The gasket 4 is connected by a connecting member 9 to a stopper valve 8 that is inserted into an inner tube 6 of an injection cylinder 7 composed of an outer tube 5 and an inner tube 6. The hole 10 drilled from the periphery and the hole 11 drilled from the stopper valve 8 to the connecting member 9 communicate with each other, and the hole 11 is opened to the inner pipe 6. Reference numeral 12 denotes a needle mounting portion of the injection cylinder 7, which is wound and squeezed with an aluminum luer tip 13 through a packing, and a cap 1
It is sealed by 4. Reference numeral 15 is a rear cap with an activator 16 for protecting the glass container 1.

In the case of filling the above-mentioned dissolving type prefilled syringe with a drug, the drug solution 17 to be a powder drug is charged with the glass container 1 standing upright, and the gasket 3 is temporarily plugged in the mouth of the glass container 1 and then frozen. When dried, the drug solution 17 becomes a powder drug 18. After the freeze-drying is completed, the gasket 3 is pushed in and tightly plugged, then taken out from the freeze-dryer, and the gasket 3 is pushed in immediately before the convex bypass 2,
The dissolution liquid 19 is charged, and the stopper valve 8 and the connecting member 9
The gasket 4 connected by is pushed into the glass container 1 and the upper portion of the solution 19 is sealed. Then, the glass container 1 is inserted between the inner tube 6 and the outer tube 5 of the injection cylinder 7 composed of the outer tube 5 and the inner tube 6, and the stopper valve 8 is fitted into the inner tube 6 to seal it. Then, the rear cap 15 with the activator 16 is externally fitted to the glass container 1 and fitted to the outer cylinder 5 of the injection cylinder 7, and the filling of the medicine is completed.

In the case of using the pre-filled syringe that dissolves before use, as shown in FIG. 2, when the activator 16 of the rear cap 15 is pushed to push the glass container 1 into the syringe barrel 7, the stopper valve 8 of the syringe barrel 7 is inserted. Since it is in contact with the inner tube 6, the gasket 3 is pressed and slid to be positioned in the convex bypass 2, and the dissolution liquid 19 flows into and mixes with the powder medicine 18 storage section to dissolve the powder medicine 18 and dissolve the medicine solution. Twenty. After that, the rear cap 15 is removed, and the glass container 1 is further pushed into the injection cylinder 7 to position the gasket 4 in front of the convex bypass 2. And the syringe 7
After removing the cap 14 of the needle mounting portion, the packing is pierced and mounted by the pull point injection needle 21, and the preparation for administration is completed. When administering the drug solution 20, the injection needle 2
1 is pierced by the patient, and the glass container 1 is further inserted into the injection cylinder 7
When pushed in, the drug solution 20 is administered through the hole 10 drilled from the periphery of the gasket 4, the hole 11 drilled in the connecting member 9, the inner cylinder 6 and the injection needle 21.

FIG. 3 shows another pre-filled syringe that dissolves before use. The drug solution 20 is provided in the inner cylinder 6 through a radial orifice 23 from a hole formed in the stopper piston valve 22 around the gasket 4. Conduit 24
Is supplied to the injection needle 21 via.

[0018]

As described above, the in-use prefilled syringe according to the present invention is made into a powdered drug by filling the presser with a glass container instead of the conventional syringe and filling it with a drug solution and freeze-drying. Therefore, the drug can be filled only by filling the drug solution and can be rapidly performed, and the productivity is significantly improved.

[Brief description of drawings]

FIG. 1 is a configuration diagram showing an order of filling medicines into a pre-use dissolution type prefilled syringe of the present invention.

FIG. 2 is a configuration diagram showing an operation sequence when using a dissolution-type prefilled syringe before use.

FIG. 3 is a cross-sectional view of another in-use dissolution type prefilled syringe of the present invention.

FIG. 4 is a sectional view of a conventional in-use dissolution type prefilled syringe.

[Explanation of symbols]

 1 Glass Container 2 Convex Bypass 3, 4, 37, 40 Gasket 5 Outer Tube 6 Inner Tube 7, 32 Injection Cylinder 8 Stopper Valve 9 Connecting Member 10, 11 Hole 12, 33 Needle Mounting Section 13, 34 Almyr Tip 14 Cap 15 Rear Cap 16 Activator 17 Drug Solution 18 Powdered Drug 19 Dissolved Solution 20 Drug Solution 21 Injection Needle 22 Stopper Piston Valve 23 Radial Orifice 24 Conduit 31 Bypass 35 Packing 36 Lyophilized Formulation 38 Dissolved Solution 39 Pusher Screw Hole 41 Pusher

Claims (2)

[Claims] 1. A pre-filled syringe that dissolves at the time of use, comprising a powder medicine container and a solution container, and a glass container serving as a pusher having a convex bypass in the powder medicine container, and closely contacting the inner surface of the glass container. Gasket that tightly plugs between the slidable powder medicine storage part and the dissolution liquid storage part, a gasket that seals the other of the dissolution liquid storage part connected to the stopper valve that has a hole for guiding the chemical solution to the stopper valve from the surroundings, the tip A double-tube injection cylinder sealed with packing, lure tip, cap, etc., and insert the upper end of the glass container between the inner tube and the outer tube of the injection tube to cover the glass container with the stopper valve fitted and fixed to the inner tube. A pre-filled syringe that dissolves before use and consists of a rear cap with an activator for protecting the glass container that is fitted onto the rear end of the syringe barrel. 2. A pre-filled syringe that dissolves before use, comprising a powder drug container and a solution container, which is a pusher having a convex bypass in the powder drug container, and adheres closely to the inner surface of the glass container. A gasket that seals between the slidable powder medicine storage part and the dissolution liquid storage part, a stopper piston valve that is connected to a gasket that seals the other of the glass container, and a double pipe with the tip sealed with packing, luer tip, cap, etc. Injection tube, a conduit for guiding a drug solution flowing from a stopper piston valve provided in the inner tube of the injection tube, an upper end of a glass container is inserted between the inner tube and the outer tube of the injection tube, and the stopper piston valve is fitted to the inner tube. To consist of a rear cap with an activator for protecting the glass container that is fitted on the fixed glass container and externally fitted on the rear end of the syringe barrel. Dissolvable prefilled syringe.