JPS63162452A - Plastic vessel for fluid supplementation - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] +8) Industrial Field of Application This invention mainly relates to medical liquid containers, and when storing liquid drugs used for dripping, injection, administration, etc., such as Ringer's solution, glucose solution, amino acid solution, etc. This relates to a plastic container to be stored during use.

(bl Conventional Technology) Conventionally, infusion containers used for the above purpose have been made of glass (vials), polyolefin resins (bottles) made by blow molding or other methods, and plasticizer-containing polyvinyl chloride (bottles).
However, glass vials are easily damaged by impact, are heavy, and have problems such as the infiltration of germs through the air holes, while polyolefin bottles have low heat resistance and are susceptible to leakage from the air needles. There are disadvantages such as penetration, and soft PV
The C bag had drawbacks such as poor plasticizer elution, poor heat resistance, and poor barrier properties against water vapor and other elements.

In addition, special film laminates have been proposed to improve the above-mentioned shortcomings of conventional containers, especially heat resistance and prevention of bacterial infiltration through air needles, but hygiene due to adhesive leaching There are problems with surface defects, delamination, and high cost.

(C1 Problem to be Solved by the Invention) This invention solves the problem of conventional plastic containers for infusions, since the material is hard and the volume does not shrink when draining the contents, requiring an air needle. There is a risk of bacteria infiltration due to the inflow of water, and due to low heat resistance, there are major problems such as changes in capacity due to deformation and rupture during high-pressure steam sterilization. The purpose of this invention is to provide a plastic container for infusions that has excellent heat resistance and low production costs.

Means for solving the fd1 problem and its operation In order to solve the above-mentioned drawbacks, this invention allows the liquid content to be discharged in a stable state until the end without an air needle, and prevents deformation, rupture, etc. even during high-pressure steam sterilization. This container is manufactured by blow molding, which is inexpensive to manufacture.

That is, as a molding material, the surface hardness measured according to the ASTM standard is 95 or less in Shore A, and the temperature conditions during high-pressure steam sterilization (usually carried out at 110 ° C to 130 ° C)
The plastic container for infusion according to this invention is characterized by being molded by blow molding using a synthetic resin having a tensile strength of 13 kg/c+J or more in hardness and tensile strength when heated. This can only be achieved by using a resin that is simultaneously filled and blow moldable.

In addition, it can be applied to the currently widely used multilayer blowing method, which can improve water vapor and gas barrier properties, hygiene, etc., and can also be applied to high-temperature storage, which is the most problematic with soft and soft resins. Strength can be increased.

In the case of multilayer blow molding, the main objective of this invention is to
In order for the liquid content to be discharged in a stable state until the end without an air needle and to prevent deformation or rupture even during high-pressure steam sterilization, the surface hardness according to ASTM D2250 mentioned above must be 95 or less in Shore A, and high-pressure steam sterilization must be performed. It is required that resin with a tensile strength of 13 kg/cd or more under the same temperature conditions as during the sterilization process accounts for 60% or more of the thickness,
and the total thickness proportion ratio of the tensile strength under the same conditions as the temperature during sterilization of the films constituting each layer is 13
It is necessary to weigh more than kg.

Further, even better results can be obtained if the surface hardness is 87 or less in Shore A and the tensile strength when heated is 17 kg/cj or more.

Further, the shape of the container is preferably an elliptical cylinder rather than a regular cylinder, and the major axis of the ellipse is 1.5 times or more the minor axis,
The content liquid can be drained more smoothly.

The thickness of the container, excluding the mouth and bottom where the rubber stopper is attached, is
It is preferable that the wall thickness is uniform, and if the tensile strength when heated is 13 to 16 kg/cd, the minimum wall thickness is 25 kg/cd.
It is necessary to mold the material so that the thickness is 0μ or more, and the tensile strength -hf of 17 kg/cIi or more can be handled by making the minimum wall thickness 180μ or more.

The resin that is the material for this plastic container for infusions, whether it is a single layer or multilayer, must pass the Japanese Pharmacopoeia test for plastic containers for infusions if it is the inner layer, and the plastic expressed using Shore A is , which falls into the category of elastomers, such as MK resin manufactured by Dainippon Plastics, etc., is suitable.

(e) Example Blow molded using each resin used in the comparative test.The major axis is approximately 9 cm (IJ, short axis is 6 cm), and the total height is 22 cm.
500m in a bottle-shaped container with an internal capacity of 750cc using CAE.
1 was filled with water, a butyl rubber stopper was fitted to the mouth, and the bottle was heat-sealed and fixed with a resin cap (ring shape) made of the same material as the bottle body (inner layer in case of multi-layer).

The minimum thickness of the side of the bottle, excluding the mouth and bottom, is 250μ.
Comparative tests were conducted using containers made of resins of various materials molded to give a diameter of 1.1 mm, and the results were as shown in the table below.

Elastomer in the table: MK resin manufactured by Dainippon Plastics ■ Sterilization method: High-pressure steam sterilization, sterilization time 20ml Deformation degree after sterilization: Items with dents, bulges, and overall bends of 5μwI11 or more are deformed (Yes) was displayed.

Amount of liquid content flowing out after sterilization: Using a 15G (standard needle for coring) manufactured by Top Co., Ltd., the needle was inserted so that it protruded approximately 5 +n from the inner wall of the rubber stopper, and the outflow amount was measured by inverting the container. The volume of the thick walled portion (approximately in) near the mouth was approximately 12o+1.

Table (1) shows the test results for single-layer blow-molded products, and Table (2) shows the test results for multi-layer blow-molded products.

Table-1 Table-2 In the table, / means adhesive stroke 2 means adhesive resin history 5μ) (f) Effect of the invention The plastic container according to the present invention can be used without using an air needle when taking out liquid. The container also has the flexibility to allow all liquid to be drained, thereby eliminating the infiltration of bacteria into the treatment room, etc., and does not cause rupture or deformation even when steam sterilized at high temperatures. This is a new and practical plastic container for infusions that can be manufactured at low cost using a molding machine.

Claims (3)

[Claims] (1) Surface hardness according to ASTM D2240 is Shore A
95 or less and whose tensile strength is 13 kg/cm^2 or more under the same temperature conditions as the high-pressure steam sterilization process, or this resin covers 60% or more of the thickness. 1. A plastic container for infusion, characterized in that it is obtained by blow molding a multi-layered body. (2) In the case of multilayer blow molding, the total thickness proportion ratio of the tensile strength under the same temperature conditions as during the high-pressure steam sterilization process of the films constituting each layer is 13 kg/cm^2 or more, Claim 1 Plastic containers for infusion as described in Section 1. (3) The plastic container for infusion according to claim 1, wherein the transverse cross section when filled with infusion is elliptical, and the major axis is 1.5 times or more the minor axis.