JP6551857B1 - Prefilled syringe exhibiting excellent hydrogen peroxide storage properties - Google Patents

Abstract

A syringe for suppressing the decomposition of hydrogen peroxide is provided. A syringe material for a hydrogen peroxide solution, wherein a syringe material of a portion where the syringe and the hydrogen peroxide solution are in direct contact is a resin, and the resin is contained in the hydrogen peroxide solution. Syringe with lower hydrogen peroxide resolution than glass. [Selection] Figure 1

Description

  The present invention relates to a syringe, and more particularly to a syringe in which the resolution of a hydrogen peroxide solution is lower than that of glass.

  Hydrogen peroxide solution is industrially used as a bleaching agent and in the food field as a bactericide. Oxydol containing hydrogen peroxide 2.5 to 3.5 w / v% is used for medical treatment as a disinfectant.

  A hydrogen peroxide solution can be used as a radiosensitizer by combining it with hyaluronic acid (Patent Document 1).

WO2008 / 041514

  When a hydrogen peroxide solution is used as a radiation sensitizer as in Patent Document 1, the hydrogen peroxide solution needs to be weighed out of the container at the time of use because of the characteristics of the hydrogen peroxide solution that is easily decomposed.

  In addition, if the hydrogen peroxide solution is pre-filled using a conventional glass (borosilicate glass etc.) syringe, it causes problems such as expansion during storage and pushing back of the gasket, making long-term storage impossible. there were. In order to solve this problem, the present invention provides a prefilled syringe for hydrogen peroxide solution that can be stored for a long time.

The purpose of the present invention is to
A syringe for hydrogen peroxide solution,
The syringe material of the portion where the above-mentioned syringe and the above-mentioned hydrogen peroxide solution are in direct contact is resin,
The resin is to provide a syringe in which the resolution of hydrogen peroxide in the hydrogen peroxide solution is lower than that of glass.

  By using this syringe, it is possible to suppress the decomposition of hydrogen peroxide in the hydrogen peroxide solution, and it is considered that, for example, even a syringe in which the hydrogen peroxide solution is prefilled can be stored for a long time It is done.

  According to the present invention, it is possible to provide a prefilled syringe for a radiosensitizer capable of storing hydrogen peroxide solution for a long time.

FIG. 1 shows a schematic view of a prefilled syringe filled with a hydrogen peroxide solution according to the present embodiment. FIG. 2 shows a graph of the hydrogen peroxide remaining rate of each syringe material in the example.

Definitions For convenience, certain terms used in the present application are collected here. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

  The numerical ranges and parameters indicated in the present invention are approximate, but the numerical values shown in the specific examples are described as accurately as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Also, as used herein, the term “about” generally means within 10%, 5%, 1% or 0.5% of a given value or range. Alternatively, the term “about” means within an acceptable standard error, as considered by one of ordinary skill in the art.

Syringe The syringe according to this embodiment is
A syringe for hydrogen peroxide solution,
The syringe material of the portion where the above-mentioned syringe and the above-mentioned hydrogen peroxide solution are in direct contact is resin,
The resin has lower resolution of hydrogen peroxide in the hydrogen peroxide solution than glass.

  FIG. 1 shows a schematic view of a prefilled syringe 1 filled with a hydrogen peroxide solution 50 according to the present embodiment. In the present embodiment, the shape of the syringe 10, particularly the barrel 20, is generally cylindrical, and the syringe 10 is provided with a needle mounting part 30 through which the hydrogen peroxide solution 50 is discharged at one end of the syringe 10. At the other end of the frame, an opening 80 for inserting the plunger rod 70 is provided, and around the opening 80, a flange 90 is provided. In the prefilled syringe 1 shown in FIG. 1, in order to seal the filled hydrogen peroxide solution 50, the needle mounting portion 30 is provided with a cap 40, and a plunger rod 70 provided with a gasket 60 is inserted from the opening 80. Yes.

  In this embodiment, the syringe for hydrogen peroxide solution means a syringe having a low resolution of hydrogen peroxide in the hydrogen peroxide solution. In this embodiment, the hydrogen peroxide solution means a solution in which hydrogen peroxide is dissolved in a solvent (for example, water), and may contain additives (for example, phosphoric acid and phenacetin) as necessary. Good. In the present embodiment, the syringe may be manufactured from a single material or may be composed of a plurality of materials (including a multilayer structure such as a coating). In the case of a syringe manufactured from a single material, the entire syringe is made of the resin. In the case of a syringe composed of a plurality of materials, the portion where the syringe and the hydrogen peroxide solution are in direct contact is made of the above resin, and the other portion is made of a material having high hydrogen peroxide resolution such as glass. May be. Further, it is not necessary that all the parts that come into contact with the hydrogen peroxide solution are made of the resin, and it is only necessary that the main part including the inner surface of the barrel of the syringe body is made of the resin. That is, other plunger rods, luer locks, caps, gaskets, and the like that may come into contact with the hydrogen peroxide solution need not be made of the resin. Also, a lubricant such as silicone oil that may be applied to the inner surface of the barrel of the syringe body does not need to be made of the resin.

  The resolution of hydrogen peroxide is the ratio of the concentration of hydrogen peroxide in the hydrogen peroxide solution after a specific storage period under specific temperature conditions to the concentration of hydrogen peroxide in the hydrogen peroxide solution before storage begins ( It can be determined from the hydrogen peroxide residual rate). Storage is performed in a closed state. Temperature conditions may be, but are not limited to, 35 ° C, 37 ° C, 40 ° C, or 60 ° C. The storage period is not limited, but may be 1 week, 2 weeks, 3 weeks or 4 weeks, or 4 weeks or more. The concentration of hydrogen peroxide in the hydrogen peroxide solution before the start of storage may be tested at any concentration in the range of 0.01 to 40% (v / v), for example. In the embodiment, it is sufficient that the resolution of hydrogen peroxide of the resin is lower than that of glass. The residual hydrogen peroxide ratio of the resin is 70% or more, preferably 75% or more, more preferably 78%, under the condition that a solution containing hydrogen peroxide 2.5 to 3.5 w / v% is hermetically stored at 60 ° C. for 4 weeks. % Or more, more preferably 80% or more. The amount of hydrogen peroxide in the hydrogen peroxide solution can be determined by titration with a potassium permanganate solution according to the Japanese Pharmacopoeia oxidol determination method.

  In the present embodiment, the resin can be exemplified by cycloolefin polymer (COP), cycloolefin copolymer (COC) and polypropylene, but if the resin has lower hydrogen peroxide resolution than glass Not limited to these.

  The syringe of the present embodiment may be provided as a syringe in which a hydrogen peroxide solution is prefilled. The syringe with the hydrogen peroxide solution pre-filled comprises a slidably mounted gasket of the syringe. Moreover, the needle mounting part of the syringe prefilled with the hydrogen peroxide solution is sealed (for example, with a cap or the like).

  In the present embodiment, the concentration of hydrogen peroxide in the hydrogen peroxide solution in the prefilled syringe is, for example, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.5, 1, 5 , 10, 15, 20, 25, 30, 35 or 40%, and may be in the range between any two of the numerical values exemplified herein, for example, 0.01 to 40% (v / v), Preferably, it is 0.05 to 30% (v / v).

Stability Test of Hydrogen Peroxide Solution The stability test of the hydrogen peroxide solution was conducted using a glass syringe, a COP syringe and a COC syringe. 1 mL of hydrogen peroxide solution was added to each syringe and sealed, and stored at 60 ° C. for 4 weeks. The residual ratio of hydrogen peroxide in the hydrogen peroxide solution after storage was measured. As the hydrogen peroxide solution, Oxole “KENA” (containing 2.5 to 3.5 w / v% hydrogen peroxide, containing phosphoric acid and phenacetin) manufactured by Kenei Pharmaceutical Co., Ltd. was used. The amount of hydrogen peroxide in the hydrogen peroxide solution was detected by titration with a potassium permanganate solution according to the oxydol determination method of the Japanese Pharmacopoeia.

  The results are shown in FIG. In the case of glass, COP and COC were 70% or more while hydrogen peroxide residual rate was less than 70%. As a result of the above, COP and COC syringes were able to suppress the decomposition of hydrogen peroxide more than glass syringes.

1 Prefilled syringe
10 syringe
20 barrels
30 Needle mount
40 cap
50 Hydrogen peroxide solution
60 Gasket
70 Plunger rod
80 opening
90 flange

Claims (2)

A syringe for hydrogen peroxide solution with hydrogen peroxide solution prefilled,
The syringe material of the portion where the syringe and the hydrogen peroxide solution are in direct contact with each other is cycloolefin polymer (COP) or cycloolefin copolymer (COC),
The syringe , wherein the hydrogen peroxide solution is a solution in which hydrogen peroxide is dissolved in water, and can optionally contain an additive . The syringe according to claim 1 , wherein the concentration of hydrogen peroxide in the hydrogen peroxide solution is 0.01 to 40% (v / v).