JPH09294808A - Injection filling method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an injection filling method, by which even if autoclave sterilization is performed, the anxiety about liquid leakage of a gasket and a piston can be eliminated, and also sliding performance of the gasket and the piston will not be damaged. SOLUTION: According to the above filling method, injection 6 is liquid-tightly filled between a person 5 of an injector 1 comprising an outer cylinder 2 having an injection port 2A formed at the tip, a plunger 3 which is inserted in the outer cylinder and fitted with a gasket 4 at the tip, and the piston 5 disposed at the forward inner part in the above outer cylinder to block the injection port 2A, and the gasket 4. In this case, the piston 5 is inserted in the above outer cylinder, a designated quantity of injection is fitted in the outer cylinder, and after that, the gasket 4 is inserted in the outer cylinder 2 to autoclave sterilize the injection 6 in the above outer cylinder, and further the above gasket 4 is forced into the outer cylinder to the distance above the width of the gasket 4 or the piston 5 to complete filling of the injection 6.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe which is pre-filled with an injection agent, and more particularly, to an outer cylinder having an injection port to which an injection needle is attached at its tip and a gasket attached. And a plunger to be inserted into the outer cylinder, and a plug body is arranged at the inner end of the tip of the outer cylinder to close the injection port and liquid-tightly fill the injection agent between the plug body and the gasket. The present invention relates to a method for filling a syringe to be filled with an injection.

[0002]

2. Description of the Related Art In recent years, in order to prevent medical accidents and to prevent hospital-acquired infections and the like as much as possible, sterile or aseptic pre-filled syringes have been filled with injections such as drugs or medicinal solutions. Syringes, commonly referred to as field syringes, have been proposed. In addition, a multi-component syringe in which an injection of two or more pharmaceutical ingredients is separately filled in the prefield syringe until the injection is also proposed.

In such an injector, in addition to an outer cylinder having an injection port to which an injection needle is attached at the tip and a plunger having a gasket, the injection port disposed in the inner part of the tip of the outer cylinder is used. It has been proposed that the injection liquid is liquid-tightly filled between the plug and the gasket (Japanese Utility Model Publication No. 2-51560). In such a syringe, the outer cylinder can be liquid-tightly filled with a predetermined amount of the injection liquid almost completely (a state in which air or the like hardly enters the filling chamber). Further, in the case of an injection having two or more pharmaceutical components, a stopper is further arranged between the gasket and the stopper at the tip. The outer cylinder is generally made of glass or resin, but recently, in consideration of the convenience of incineration, most of the outer cylinder is used. As the resin for the outer cylinder, a thermoplastic resin that is easily injection-molded is used, and a relatively heat-resistant resin is used because it is subjected to an autoclave treatment, and such a resin is polypropylene, particularly, a cyclic olefin and the like. An amorphous resin containing is used. In injection molding of the outer cylinder, the inner peripheral surface of the outer cylinder is generally formed as a tapered inner wall surface whose diameter becomes smaller toward the front end because of the mold release from the outer cylinder. As the gasket and the stopper, a medical rubber stopper or the like is generally used, but a thermoplastic elastomer or the like is used as long as its liquid-tightness is guaranteed.

[0004]

However, in the case where a conventional syringe having a resin outer cylinder is filled with an injection solution and subjected to autoclave sterilization, the following problems occur. Autoclave sterilization is a heating treatment at 100 ° C or higher. When the inner wall surface of the outer cylinder is pressed and heated by the elastic force from the gasket or the plug, the resin easily undergoes thermoplastic deformation, and the contact portion between the gasket and the plug is large. The inner peripheral diameter of the outer cylinder becomes the expanded diameter. Therefore, after the sterilization is completed, the liquid tightness of the gasket and the plug is lost, and the liquid of the injection may leak. Moreover, the slidability of the gasket and the plug is also deteriorated. Such inconvenience occurs even with polypropylene having heat resistance. Therefore, an object of the present invention is to provide a method for filling an injectable solution which eliminates the fear of liquid leakage of the gasket and the plug even when autoclaved, and does not impair the slidability of the gasket and the plug. .

[0005]

According to the present invention, there is provided an outer cylinder having an injection port formed at its tip, a plunger inserted into the outer cylinder and having a gasket attached to the tip, and an inner cylinder of the outer cylinder. In a method for filling an injectable solution liquid-tightly between an injecting agent and a gasket, the injecting agent being disposed in a deep portion of a tip and closing the injection port, in the injecting agent filling method, Insert the body, fill the outer cylinder with a predetermined amount of the injection, then insert a gasket into the outer cylinder to encapsulate the injection, and autoclave sterilize the injection in the outer cylinder, Furthermore, the above object was achieved by providing a method for filling an injectable solution, characterized in that the above-mentioned gasket is pushed into the outer cylinder to a distance equal to or larger than the width of the gasket or the plug to complete the injectable solution filling. It is a thing. According to the method for filling an injection according to the present invention, the above injection is filled in a polypropylene outer cylinder. According to the method for filling an injection according to the present invention, when sterilizing the autoclave, the deformation preventing member for preventing expansion during heating is arranged on the outer peripheral surface of the outer cylinder where the gasket and the plug are located. Is desirable.

[0006]

The outer cylinder of the syringe is usually formed to have a smaller diameter from the base end toward the tip so that the inner diameter cannot be visually observed. First, the stopper is placed in a predetermined temporary position in such an outer cylinder, then the injection is aseptically filled, and the gasket is inserted into the proximal end opening to seal the injection. Next, autoclave sterilization is performed to sterilize the injection in the outer cylinder.
After cooling, the gasket is moved further into the outer cylinder by the width of the gasket, stopped, and placed in the normal position. In the syringe filled with the injectable agent as described above, first, the gasket and the plug are arranged so as to avoid the outer cylinder portion (temporary position) that is expanded during autoclaving. For this reason, the injection in the outer cylinder maintains long-term liquid tightness. In addition, in use, when the gasket is pushed forward, the gasket will move to the part where the plug has expanded, but in this case, the liquid tightness of the gasket should be lost at the expanded part, but By making use of the fact that the outer diameter of the outer cylinder is formed to a small diameter so that it cannot be seen from the end to the tip, the gasket at a slightly larger diameter than the plug can be used to There is no loss of denseness. Therefore, it can be moved smoothly even during use.

[0007]

The preferred embodiments of the method for filling an injection according to the present invention will be described in detail below with reference to the accompanying drawings. 1 is a side sectional view of a syringe used in a method for filling an injection according to the present invention, and FIG. 2 is a sectional view of the syringe taken along the line I-I in FIG. FIG. 3 is a side sectional view of the injector of FIG. 1 during operation. FIG. 4 is a sectional view of the syringe taken along the line II-II of FIG. FIG. 5 is a side sectional view of the syringe of FIG. 1 during operation. 6 is a side sectional view of the injector of FIG. 1 during operation. FIG. 7 is a side cross-sectional view of an outer cylinder when filling an injection.

The injection method according to the present invention comprises an outer cylinder 2 having an injection port 2A formed at its tip, and a plunger 3 inserted into the outer cylinder 2 and having a gasket 4 attached at its tip.
And a gasket 4 which is disposed inside the outer cylinder 2 at the inner end of the tip and closes the injection port 2A, and the injection agent 6 is liquid-tightly filled between the stopper body 5 and the gasket 4. . Therefore, in the method for filling an injection according to the present invention, the plug 5 is inserted into the outer cylinder 2, the predetermined amount of the injection 6 is filled into the outer cylinder 2, and then the gasket 4 is inserted into the outer cylinder 2. Then, the injection 6 is enclosed, the injection 6 in the outer cylinder 2 is autoclave sterilized, and the gasket 4 is further pushed into the outer cylinder 2 to a distance equal to or larger than the width of the gasket 4 or the plug 5. The filling of 6 is completed.

First, in describing the method for filling an injection according to the present invention, the syringe 1 used in such a method will be briefly described. As shown in FIGS. 1 and 2, the outer cylinder 2 of the syringe 1 is a molded product of thermoplastic resin and is molded by injection molding. Examples of the thermoplastic resin used include polyolefins such as low-density or high-density polyethylene, polypropylene, and polybutadiene-1, polyvinyl chloride, polyvinylidene chloride, vinylidene chloride copolymer, polymethyl methacrylate, polyvinyl alcohol. ,
Examples thereof include ethylene-vinyl alcohol copolymer, acrylonitrile copolymer, and polyethylene terephthalate. In particular, polyolefins are preferable from the viewpoint of versatility and chemicals, and those having a high glass transition temperature such as an amorphous cyclic olefin copolymer and a specific gravity of 1.0 to 1.1 are desirable. . Specifically, the brand name ZEONEX (Nippon Zeon Co., Ltd.), which is recently used as a material for optical disc substrates, optical lenses, etc.,
A polyolefin resin such as the trademark Apel (Mitsui Petrochemical Industry Co., Ltd.). The outer cylinder 2 of the syringe 1 is made of heat-resistant and transparent polypropylene.

The outer cylinder 2 is a molded product which is injection-molded in a state in which a cutting die is arranged, and the inner diameter of the inner part is formed to be small from the base end to the tip. That is, the inner wall surface is formed in a taper shape from the base end of the outer cylinder 2 toward the tip thereof, but is inclined so that it cannot be visually observed. Further, four convex ribs 11 are formed to extend in the axial direction on the inner peripheral wall of the outer end of the outer cylinder 2, and the length of the rib 11 is formed to be longer than the width of the plug body 5. The height of the rib 11 is also formed in a taper shape, and the height is such that a bypass-shaped void is formed between the inner peripheral wall of the outer cylinder 2 and the plug body 5 when the plug body 5 rides up. There is. Further, a protrusion 14 is formed on the inner wall surface of the shoulder portion 13 of the outer tube 2 so that the plug body 5 does not adhere to the inner wall surface of the shoulder portion 13.

A plug 5 is arranged in the middle of the outer cylinder 2,
The plug body 5 maintains the liquid tightness with the inner wall surface of the outer cylinder 2 and has elasticity so that it can slide. Further, a gasket 4 is arranged in the outer cylinder 2 at a predetermined distance from the plug body 5, and the gasket 4 has liquid elasticity and slidable elasticity with respect to the inner wall surface of the outer cylinder 2. Although rubber plugs are specifically used as these materials, the present invention is not limited to rubber as long as it has such an elastic force. An injection 6 is filled between the gasket 4 and the stopper 5, and the injection 6 is aseptically filled and autoclaved together with the outer cylinder 2. As the injection 6, a drug that does not undergo heat denaturation or the like is used, and a solution of the drug or a diluent may be used.
The injection needle 7 may be attached to the tip of the ejection port 2A in advance, or the injection needle 7 may be attached at the time of use.

Next, a method for filling the injection 1 with the injection 6 will be described in detail. As shown in FIG. 7, first, the plug body 5 is inserted and arranged at a predetermined position in the outer cylinder 2. Next, with the base end of the outer cylinder 2 facing upward and the tip facing downward, the injection agent 6 sterilized using a sterilizing filter or the like is filled from the base end opening to a substantially full amount. In this state, the gasket 4 is inserted to make the injection 6 liquid-tight. A restriction ring 21 is arranged outside the gasket 4 and the plug body 5 in the circumferential direction via the wall of the outer cylinder 2. The restriction ring 21 is made of a member such as a ceramic having a heat deformation resistance and a low thermal expansion property. With the restriction ring 21 arranged, the injection needle 7 is attached to the ejection port 2A as necessary,
Perform autoclave sterilization. In the autoclave sterilization treatment, sterilization is performed at 100 ° C. or higher, particularly in the range of 105 ° C. to 130 ° C. considering that the resin outer cylinder 2 is used. Then, after sterilization, attach the plunger 3 to the gasket 4,
With the plunger 3, the gasket 4 is pushed into the outer cylinder 2 more than the width of the plug 5 or the gasket 4,
The plug body 5 is rearranged. Then, the syringe 1 is aseptically packaged with a packaging material (not shown) or the like.

The syringe 1 thus filled with the injection agent 6
If used, it is operated according to FIGS.
From the state of the syringe of FIG. 1, as shown in FIG.
When is pushed, the gasket 4 and the plug body 5 are pushed to the injection port 2A side in conjunction with this. As shown in FIGS. 4 and 6, the convex ribs 11 bite into the outer peripheral wall of the plug 5 to deform the outer peripheral wall of the plug 5. Due to the deformation of the outer peripheral wall of the stopper 5,
A gap is formed between the outer peripheral wall of the stopper 5 and the inner wall of the outer cylinder 2, and the injection agent 6 between the stopper 5 and the gasket 4 bypasses the gap and flows into the injection port 2A side. Next, in this state, the air in the outer cylinder 2, the ejection port 2A and the injection needle 7 is expelled, and then the injection needle is punctured into the patient. Then, when the plunger 3 is further pushed in, the gasket 4 is positioned at the portion L2 expanded by the plug body 5 during autoclave sterilization, as shown in FIG. In this case, the liquid-tightness of the gasket 4 should be lost at the bulging portion L2, but the outer cylinder 2 is formed to have a small diameter so that the inner diameter cannot be seen from the base end portion toward the tip end portion. Since the gasket 4 is formed to have a slightly larger diameter than the plug body 5,
The sliding is performed in a state where the liquid tightness in the bulging portion is not lost. As shown in FIG. 6, the gasket 4 and the stopper 5 are brought into contact with each other, and the injection 6 is completely injected into the patient. Further, in this case, since the plug body 5 does not come into close contact with the protrusion 14 of the shoulder portion 13 of the outer cylinder 2, there is no possibility of blocking the flow path of the injection 6.

In addition, in the method of filling the injection 6 as described above, the outer cylinder 2 having an expanded diameter at the time of autoclaving as shown in FIG.
The gasket 4 and the plug 5 are arranged so as to avoid the bulging portions L1 and L2. Therefore, the injection 6 in the outer cylinder 2 is kept liquid-tight for a long time. In the above-described embodiment, the bypass structure for allowing the injection 6 to slip through the stopper 5 is the rib 11 provided on the inner peripheral surface of the outer cylinder 2. However, in the method of filling an injection according to the present invention, the gasket 4
It can be applied as long as it is a syringe having a structure including the plug body 5 and the plug body 5. For example, as shown in FIG. 8, instead of the bypass structure of the rib 11, a conventionally used bypass groove portion 15 may be used. Further, the stopper 5 is not limited to one, but a plurality of stoppers may be provided in the outer cylinder 2 to form a two-component injection. Then, as long as at least one liquid injection is present in the outer cylinder 2, the solid medicine may be filled in the outer cylinder 2 in advance.

[0015]

As described above, in the method for filling an injection according to the present invention, the plug is inserted into the outer cylinder,
A predetermined amount of the injection is filled in the outer cylinder, then a gasket is inserted into the outer cylinder to encapsulate the injection, and the injection in the outer cylinder is sterilized by autoclave, and the gasket is further attached. Since the injection is completed by pushing the gasket or stopper into the outer cylinder to a distance more than the width of the gasket or stopper, anxiety about liquid leakage of the gasket and stopper is eliminated even after autoclave sterilization. There is no loss of mobility.

[Brief description of drawings]

FIG. 1 is a side sectional view of a syringe used in a method for filling an injection according to the present invention.

FIG. 2 is a cross-sectional view taken along line I-I in FIG.

FIG. 3 is a side sectional view showing a state where the plunger of the syringe of FIG. 1 is pushed in halfway.

4 is a sectional view taken along the line II-II in FIG.

5 is a side sectional view of the syringe of FIG. 1 in use.

6 is a side sectional view of the syringe of FIG. 1 in use.

FIG. 7 is a side sectional view of the outer cylinder of the syringe showing the steps of the method for filling an injection according to the present invention.

FIG. 8 is a side sectional view different from the injector of FIG. 1 used in the method for filling an injection according to the present invention.

[Explanation of symbols]

 1, 21 Syringe 2 Outer cylinder 2A Outlet of outer cylinder 3 Plunger 4 Gasket 5 Plug 6 Injection 7 Injection needle 11 Convex rib 15 Bypass groove

Claims (3)

[Claims] 1. An outer cylinder having an injection port formed at its tip, a plunger inserted into the outer cylinder and having a gasket attached to the tip, and arranged in the inner part of the tip of the outer cylinder. In a method of filling an injectable solution, which comprises liquid-tightly filling an injectable agent between a stopper and a gasket of a syringe including a stopper for closing the injection port, the outer tube is inserted into the outer cylinder, A predetermined amount of the above injection is filled therein, and then a gasket is inserted into the outer cylinder to enclose the injection, and the injection in the outer cylinder is autoclave sterilized, and the gasket is replaced with the gasket or A method for filling an injectable agent, characterized in that the injectable agent is filled by pushing it into the outer cylinder to a distance equal to or larger than the width of the stopper. 2. The method for filling an injection according to claim 1, wherein the polypropylene is filled with the injection. 3. The sterilization of the autoclave is performed by disposing a deformation preventing member for preventing expansion during heating on the outer peripheral surface of the outer cylinder where the gasket and the plug are located. 2. The method for filling an injection as described in 2.