JPH0428367A - Enclosing body of medicine containing bromohexine hydrochloride - Google Patents

Abstract

PURPOSE:To suppress the reduction, through the lapse of time, of the content of bromohexine hydrochloride in the medicine stored in divided envelope and improve the humidity preventing effect by forming a polyester group resin layer on the inner surface of the enclosing body which contacts with the medicine. CONSTITUTION:An enclosing body 1 has a bag body structure for sealing- accommodating a contained substance, and a bromohexine hydrochloride- containing medicine 7 is the contained substance. The enclosing body 1 is prepared by superposing two sheets of enclosing members 10 and 10 and carrying out heat seal on the peripheral edges, and a polyester group resin layer 2 is formed on the inner surface in contact with the medicine in the enclosing body. The polyester group resin layer 2 contains the crystalline or noncrystalline denatured polyethylene terephthalate resin having a glass transition temperature of 40 deg.C or more and a crystallization degree of 10% or less. Accordingly, the reduction, through the lapse of time, of bromohexine hydrochloride in the enclosed medicine can markedly be reduced.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a package for enclosing a preparation containing bromhexine hydrochloride.

[Conventional technology]

Conventionally, bromhexine hydrochloride compositions consisting of bromhexine hydrochloride, excipients such as starch and crystalline cellulose, and binders such as hydroxypropylcellulose and polyvinylpyrrolidone have been formulated into powders, fine granules, or granules for ease of use. This solid preparation is weighed in advance and stored in plastic packaging or plastic laminated aluminum packaging.

However, with conventional general plastic packaging materials,
There has been a problem that the content of bromhexine hydrochloride in the preparation decreases over time. , polyvinyl alcohol, and other packaging materials have been proposed.

[Problem to be solved by the invention]

However, the above-mentioned proposed packaging material has a high water vapor permeability and cannot be said to have a sufficient moisture-proofing effect.

In view of these circumstances, the present invention provides a package for a bromhexine hydrochloride-containing preparation that does not reduce over time the content of bromhexine hydrochloride in the preparation that is stored in separate packages and has an excellent moisture-proofing effect. It's about doing.

[Means to solve the problem]

In order to solve the above problems, the present invention provides a package for enclosing a preparation containing bromhexine hydrochloride, and is configured such that a polyester resin layer is provided on the inner surface of the package that can come into contact with the preparation.

[Effect]

Since the package for the bromhexine hydrochloride-containing preparation of the present invention has a polyester resin on the inner surface of the package that can come into contact with the preparation, the amount of bromhexine hydrochloride in the packaged preparation decreases over time very little.

It also has excellent moisture-proofing effects.

[Example] The package 1 of the bromhexine hydrochloride-containing preparation of the present invention was
This will be explained based on the figure and FIG.

As shown in FIG. 2, the package 1 of the present invention has a bag structure capable of sealingly storing the contents, and the contents are a preparation 7 containing bromhexine hydrochloride.

As shown in FIG. 2, the package 1 is generally made by stacking two sheets of packaging material (hereinafter simply referred to as packaging material) 1.0.10 and applying a heat-1 seal to the periphery. As shown in FIG.
is provided.

This polyester resin layer 2 has a glass transition temperature of 40
℃ or more, and contains an amorphous or low crystalline modified polyethylene terephthalate resin with a crystallinity of 10% or less.

Such modified polyethylene terephthalate resin has ethylene glycol and terephthalic acid as its main components, and uses a polyhydric alcohol other than ethylene glycol and/or a polyhydric carboxylic acid other than terephthalic acid as a copolymerization component for the main components. Polyester resins made of copolymers obtained by , ethylene glycol component 1
Parts are diethylene glycol, propylene glycol, 1
, 4-cyclohexane dimetatool, trimethylolpropane, etc., or a mixed resin of the modified polyethylene terephthalate resin and polyethylene terephthalate resin.

Specific examples of the modified polyethylene terephthalate resin are:
Ethylene glycol, isophthalic acid, and terephthalic acid, 1
．． Polyester resins made of co-condensation polymers of combinations of 4-cyclohexane dimetatool, nyletine glycol, terephthalic acid, propylene glycol, isophthalic acid, terephthalic acid, etc., and polyester resins made from the aforementioned terephthalic acid and ethylene glycol as base materials. When polymerizing, a trivalent carboxylic acid such as trimellitic acid is used as part of the acid component, or a trivalent alcohol such as trimethylolpropane is used as part of the alcohol component, Furthermore, it is a copolymerized polystyl resin obtained by using a trivalent carboxylic acid and a trivalent alcohol in one part of the alcohol component and one part of the acid component.

In addition, the aliphatic dicarboxylic acid component in the acid component is 10% by weight.
A resin layer formed of the modified polyethylene terephthalate resin as described above is not preferable because the non-absorption of bromhexine hydrochloride is reduced. The thickness of the polyester resin layer 2 of the present invention containing such modified polyethylene terephthalate resin is preferably 20 to 40 μm, more preferably 5 to 50 μm. If this value is less than 5 μm, a resin layer with a uniform thickness and high precision cannot be obtained, resulting in the inconvenience that stable heat sealing cannot be obtained.
If this value exceeds 50 μm, there will be disadvantages in that the cost will be high and the film will also become stiff and have an undesirable texture.

A barrier layer 4 is provided on (outside) the resin layer 2 as shown in FIG. The barrier layer 4 is mainly made of aluminum foil or the like having gas barrier properties and water vapor barrier properties. The thickness is usually about 7 to 20 μm.

A support layer 6 is provided on (outside) such a barrier layer 4. The support layer 6 is mainly used to give strength to the packaging material or to be used for printing paper, etc. Specifically, the support layer 6 is made of oriented polyester (O-PET), oriented polypropylene (
o-pp) or cellophane.

Note that it is preferable to provide an intermediate layer as shown below between the resin layer 2 and the barrier layer 4. That is, a polybutylene terephthalate resin (or a polycarbonate resin layer, or an adhesive polyolefin resin layer and a polyolefin resin layer, or,
It is preferable to provide a polyolefin resin layer having carboxyl groups on the side of the contact surface with the resin layer 2 that has been previously subjected to a corona discharge treatment.

When such an intermediate layer is provided, the sealing strength and impact resistance of the heat-sealed portion where the resin layers 2 are thermally bonded to each other are significantly improved when forming the package of the present invention.

The present invention described above will be explained in further detail based on specific examples shown below.

Experimental Example Biaxially stretched polyester film (1
A laminated material obtained by dry laminating a film (5 μm) and an AI foil (9 μm) as the barrier layer 4 with a urethane adhesive was prepared as a base material for a packaging agent (hereinafter referred to as base material a).

Various resin layers constituting the inner surface of the packaging body as shown below were provided on the AI foil surface of this base material a to produce various packaging material samples (hereinafter referred to as packaging material samples).

Packaging material sample 1 (present invention) After applying a urethane adhesive to the A/foil side of the base material a, apply a modified polyethylene terephthalate resin (Mitsui DuPont Chemical Co., Ltd.) with a glass transition temperature of 71°C to the applied surface. Co., Ltd.: Sealer PTX207) was provided as the polyester resin layer 2.

The thickness of the resin layer 2 was 40 μm.

Packaging material sample 2 (present invention) The material of the polyester resin layer 2 of the packaging sample 1 was modified polyethylene terephthalate resin (Eastman Kodak Company: PETG 67) with a glass transition temperature of 81°C.
63).

Other than that, the same procedure as Sample 1 was carried out.

Packaging material sample 3 (comparative example) The material of the polyester resin layer 2 of the packaging sample 1 was modified polyethylene terephthalate resin (Toyobo Co., Ltd.: Hiron GM 900) with a glass transition temperature of -20°C.
) changed to

Other than that, the same procedure as Sample 1 was carried out.

Packaging material sample 4 (comparative example) The material of the polyester resin layer 2 of the packaging sample 1 was a low-density polyethylene resin (Mitsui Petrochemical Industries, Ltd.):
I changed it to Miraran 16P). Other than that, the same procedure as Sample 1 was carried out.

Packaging material sample 5 (present invention) The thickness of the polyester resin layer 2 of the packaging material sample 1 was 20 μm, and polybutylene terephthalate resin (Polyplastics Co., Ltd.) was used as an intermediate layer between this resin layer 2 and the AI foil.・Duranetx PF600) was provided to a thickness of 20 μm.

The resin layer 2 and the intermediate layer were formed into a co-extruded film by co-extrusion processing, and then dry laminated and laminated with a urethane adhesive so that the intermediate layer was in contact with the surface of the AI foil.

Packaging material sample 6 (present invention) The middle layer of the packaging material sample 5 is made of polycarbonate resin (
Mitsubishi Gas Chemical Co., Ltd. Kneepilon 5200).

The rest was the same as in Sample 5.

Packaging material sample 7 (present invention) The middle layer of the packaging material sample 4 was made of adhesive polyolefin resin (Mitsui Petrochemical Industries, Ltd.: Ad?-3F-600) with a thickness of 1-0 μm and polyolefin with a thickness of 110 μm. It was changed to a laminate with a base resin (Mitsui Petrochemical Industries, Ltd.: Miralan 16P). The rest was the same as in Sample 5. Note that the surface to be bonded to the AI foil surface was made of Mirason 16P.

Packaging material sample 8 (present invention) The laminated film was applied to the AI foil surface of the base material a of the laminated material described above, and the AA foil surface and a polyolefin resin having a carboxyl group (Mitsui DuPont Polychemical Co., Ltd., Nucleol) were applied. A laminate was obtained by laminating AN4213C) 20 μm thick films by an extrusion coating method and then bonding them under heat and pressure.

Next, one side of the polyolefin resin film having carboxyl groups was subjected to corona discharge treatment, and a modified polyethylene terephthalate resin (Mitsui DuPont Polychemical Co., Ltd.
A 20 μm thick resin layer made by Sealer PTX207) was directly extruded and laminated to obtain packaging material sample 8.

Using such various packaging material samples 1 to 8, three-sided sill pouches of 50 mm x 40 mm were formed by heat sealing.

After filling the resulting three-sided sealed pouch with the bromhexine hydrochloride-containing preparation Log, the opening was sealed by heat sealing to obtain a sealed package sample.

These various sealed package samples were opened after being left in an atmosphere at 37°C for 60 days, and the retention rate of the initial concentration of bromhexine hydrochloride contained in the formulation was determined by liquid chromatography.

The results are shown in Table 1 below.

〔Effect of the invention〕

Table 1 above. The effects of the present invention are clear from the results.

That is, since the package of the bromhexine hydrochloride-containing preparation of the present invention has a polyester resin on the inner surface of the package that can come into contact with the preparation, the decrease in bromhexine hydrochloride in the packaged preparation over time is extremely small. It also has excellent moisture-proofing effects and productivity.

[Brief explanation of drawings]

FIG. 1 is a partial cross-sectional view of the packaging material, and FIG. 2 is a longitudinal cross-section of the package. ]... Packaging body, 2... Polyester resin layer, 4... Barrier layer, 6... Support layer, 7... Bromhexine hydrochloride-containing preparation, 10... Packaging material.

Claims (1)

[Scope of Claims] 1. A package for enclosing a preparation containing bromhexine hydrochloride, characterized in that a polyester resin layer is provided on the inner surface of the package that can come into contact with the preparation. packaging. 2. The polyester resin layer has a glass transition temperature of 4.
Claim 1 characterized in that it contains an amorphous or low crystalline modified polyethylene terephthalate resin having a temperature of 0°C or higher.
A package of the bromhexine hydrochloride-containing preparation described above. 3. The package of a bromhexine hydrochloride-containing preparation according to claim 1 or 2, wherein the polyester resin layer has a thickness of 5 to 50 μm.