JP2003024439A - Syringe outer cylinder, prefilled syringe and medical fluid administration kit - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a syringe outer cylinder, a prefilled syringe and a medical fluid administration kit capable of saving the labor before and after use, preventing a piercing accident and smoothly and precisely performing a dripping work. SOLUTION: In this syringe outer cylinder, a synthetic resin-made syringe cylinder is integrally molded with a synthetic resin-made medical fluid injection needle provided with an injection port on the side wall.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe outer cylinder body, particularly an outer cylinder body suitable for a prefilled syringe to be put on the market in a state of being pre-filled with a liquid medicine and a prefilled syringe using the outer cylinder body. A drug administration kit.

[0002]

2. Description of the Related Art Conventionally, an outer barrel of a syringe is merely provided with a protrusion for mounting an injection needle at its front end. Therefore, in the past, when the drug solution was directly administered to a patient using a prefilled syringe, or when the drug solution was mixed and injected into a drip bag or the like, it was naturally indispensable to attach an injection needle.

However, the mounting operation of the injection needle is a troublesome preparatory work for a medical staff with a large amount of processing and sometimes causes a problem such as a puncture accident to a finger or the like. It was In particular, since the conventional injection needle is a metal needle, after use, it must be removed from the non-metallic syringe outer cylinder and sorted and discarded, and the complexity and risk of a puncture accident cannot be overlooked. It was a problem. In addition, there is a possibility that various bacteria and the like may be mixed during the above-mentioned operation of mounting the injection needle, and it is the actual situation that the improvement is required in the medical field.

[0004]

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned conventional problems and actual circumstances, and it is not necessary to attach an injection needle each time, and a sealing system is held,
There is no fear of contamination by miscellaneous bacteria, and it is possible to immediately insert a mixed bag by piercing it into a drip bag, etc., and there is no need to separate and dispose of it even after it has been used. It is an object to provide a prefilled syringe and a drug solution administration kit.

[0005]

The syringe outer cylinder of the present invention achieves the above object by integrally forming a synthetic resin pharmaceutical liquid injection needle having a spout on the side wall at the front end portion of a synthetic resin syringe outer cylinder. It has been achieved.

Further, the prefilled syringe of the present invention achieves the above-mentioned object by preliminarily filling and sealing the liquid medicine into the syringe outer cylinder.

The drug solution administration kit of the present invention achieves the above object by including the prefilled syringe and the plunger.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a schematic sectional explanatory view of the prefilled syringe of the present invention. In FIG. 1, reference numeral 10 denotes a synthetic resin syringe outer cylinder, and a chemical solution injection needle 20 also made of synthetic resin is formed integrally with the syringe outer cylinder 10 at the front end portion thereof.

As a concrete molding method of such an integrally molded body, injection molding is simple and desirable. In addition, the syringe outer cylinder 10
It is preferable that the liquid medicine injection needle 20 be transparent or semi-transparent so that the state of the liquid medicine 50 can be observed from outside.
Furthermore, it is preferable that the syringe outer cylinder 10 and the drug solution injection needle 20 have heat resistance such that the resin component thereof does not elute into the drug solution during heat sterilization after filling the drug solution.

As a synthetic resin that can be used to obtain the syringe outer cylinder 10 and the chemical liquid injection needle 20 that meet the above conditions, for example, cycloolefin polymer (CO
P), polypropylene (PP), polyethylene (P
E), polymethylpentene (TPX), polycarbonate (PC), polyethylene terephthalate (PET) and the like are mentioned as preferable ones.

The chemical injection needle 20 has a spout 21 on its side wall.
Is formed, and its tip is sharp without a spout being provided.

The outer diameter and length of the drug solution injection needle 20 are the same as those of any commercially available injection needle, winged needle, three-way stopcock or other medical device,
It is advantageous to set a size that does not fit other needles for direct administration in order to prevent erroneous administration, and the specific outer diameter is 4 mm or less at the maximum diameter part and 15 mm or more at the length. Is desirable. Further, the tip angle of the chemical liquid injection needle 20 is preferably set to 30 to 45 ° in order to reduce the resistance of the drip container to pierce the rubber stopper and to enable a smooth piercing operation.

The opening area of the spout 21 should be made larger than the opening area of the thickest injection needle (18G) that is generally used, so that the load at the time of injection into the drip container is small and a smooth injection operation is possible. It is preferable in that it is possible.

The number of such spouts 21 to be formed is not particularly limited, but usually 1 to 3 is preferable in terms of moldability and strength.

Further, as a concretely formed portion of the spout 21, a rubber stopper of the drip container is located at a position 4 mm or more away from the tip in the direction of the root and a position 11 mm or more away from the root in the direction of the tip. This is advantageous in that the liquid medicine 50 can be smoothly injected into the drip container by completely piercing the urine and the rubber dust or the like is prevented from being mixed in when the rubber stopper is pierced.

Reference numeral 30 denotes a protective cap made of rubber or the like, which is attached to the medicinal solution injection needle 20 by being crowned. This protective cap 30
As a result, a needle stick accident can be prevented, and a sealed system can be secured before use to prevent invasion of various bacteria and the like.

Reference numeral 40 denotes a gasket made of rubber or the like, which seals the drug solution 50 filled in the syringe outer cylinder 10, thereby ensuring a sealed system. A lubricant such as silicone oil may be applied to the inner wall of the syringe to improve the slidability of the gasket. The gasket is preferably coated or laminated with a material such as plastic.

The liquid 50 filled in the syringe outer cylinder 10 is not particularly limited, but it is used for treatment, prevention or diagnosis of various diseases, specifically cisplatin, ifosfamide, etoposide, carboplatin, nedaplatin, Antineoplastic drugs such as irinotecan hydrochloride, paclitaxel, docetaxel, tegafur, fluorouracil,
Amrinone, dopamine hydrochloride, dobutamine hydrochloride, arrhythmic agents such as pilsicanide hydrochloride, argatroban, ozagrel sodium, alprostadil, anticoagulants such as batroxobin, blood substitutes such as Ringer's solution, fructose, glucose,
Examples thereof include sugars such as maltose, various proteins, various amino acids, and various vitamins.

Reference numeral 60 denotes a shrink label on the surface of which a drug name and the like are appropriately printed and displayed, and is covered on the outer circumference of the syringe outer cylinder 10 and the outer circumference of the base of the protective cap 30 to prevent erroneous administration by confirming the drug name. It is like this.

The prefilled syringe according to the above-mentioned embodiment is appropriately packaged together with a plunger (not shown), and is put on the market as a drug solution administration kit.

[0022]

According to the present invention, since the drug solution injection needle and the syringe outer cylinder are integrally formed, it is possible to immediately pierce and use a rubber stopper such as a drip container without directly attaching the injection needle. As a result, it is possible to save the troublesome labor of the related art, prevent a puncture accident, and greatly contribute to the reduction of the preparatory work of the medical staff. In particular, the convenience is extremely great in that the drip work can be smoothly and accurately performed in an emergency when the time is critical.

Moreover, according to the present invention, since it is not necessary to attach an injection needle, the hermetically sealed system for the chemical liquid is maintained until the time of use, and as a result, contamination by various bacteria is prevented. In addition, since the drug solution injection needle is also made of the same synthetic resin as the syringe cylinder, it is not necessary to remove it separately after use like the metal needle and separate and dispose of it. The risk of accidents is also greatly reduced.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional explanatory view of a prefilled syringe of the present invention.

[Explanation of symbols]

10: Syringe cylinder 20: Chemical injection needle 21: outlet 30: Protective cap 40: Gasket 50: drug solution 60: Shrink label

Continued front page    (72) Inventor Satoshi Ichinose             4-38 Akita-cho, Takatsuki-shi, Osaka Daiichi Pharmaceutical Co., Ltd.             Pharmaceutical Technology Research Center, Osaka Pharmaceutical Technology Center             Within F-term (reference) 4C066 BB01 CC01 DD08 EE14 FF05                       HH13

Claims (8)

[Claims] 1. A syringe outer cylinder body, characterized in that a synthetic resin pharmaceutical liquid injection needle having a side wall with a spout is integrally formed at the front end of the synthetic resin syringe outer cylinder. 2. The syringe outer cylinder body according to claim 1, wherein the syringe outer cylinder body is an integrally molded body formed by injection molding. 3. The syringe outer cylinder body according to claim 1, which is transparent or translucent. 4. The syringe outer cylinder body according to claim 1, which has heat resistance corresponding to heat sterilization conditions. 5. The syringe outer cylinder body according to claim 1, wherein a protective cap is attached to the drug solution injection needle. 6. A prefilled syringe characterized in that the syringe outer cylinder body according to any one of claims 1 to 5 is filled and sealed with a drug solution in advance. 7. The prefilled syringe according to claim 6, wherein the outer peripheral portion is covered with a shrink label. 8. A drug solution administration kit comprising the prefilled syringe according to claim 6 or 7, and a plunger.