JPH08157393A - Barium sulfate granular preparation for internal use - Google Patents

Abstract

PURPOSE: To obtain the subject preparation suitable for functional diagnosis of digestive canal, not causing aggregation precipitation in the digestive canal even after administration, mobile without obstructing motion of digestive canal due to maintenance of granular state, by using a specific copolymer as a binder or a coating agent. CONSTITUTION: This preparation is obtained by using a copolymer of ethyl acrylate and methyl methacrylate as a binder or a coating agent. The preparation is preferably obtained by adding (B) barium sulfate powder to (B) an emulsion prepared by dispersing the copolymer of ethyl acrylate and methyl methacrylate to water, kneading, granulating and drying. The particle diameter of the component A is preferably 500μm to 5mm. When the component B is used as the binder, 5-15 pts.wt. of the component B is used based on 100 pts.wt. of the component A. When the component B is used as the coating agent, 0.2-3 pts.wt. of the component B is preferably used based on 100 pts.wt. of the component A.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a barium sulfate granular preparation to be taken as a contrast agent for examination of the digestive tract by radiography.

[0002]

2. Description of the Related Art Conventionally, as a method for examining the digestive tract, a method in which a subject is allowed to drink a suspension of barium sulfate and X-ray photography is widely used.

However, recently, in addition to simply taking a picture of the digestive tract, it may be necessary to examine the function of the digestive tract, for example, the examination of the peristaltic movement ability of the stomach and intestines.

[0004]

As a method for examining such digestive tract function, there has been no suitable means in the past. Therefore, it has been attempted to examine the migration over time using a small amount of barium sulfate, which is a conventional gastrointestinal X-ray contrast agent. However, conventional barium sulfate is not suitable for diagnosing digestive tract function because it rapidly precipitates and aggregates after administration.

An object of the present invention is to provide a contrast medium which can be used for diagnosing the function of the digestive tract by keeping its shape even after taking, moving without disturbing the movement of the digestive tract.

[0006]

Means for Solving the Problems As a result of intensive studies to achieve the above object, the present inventors have found that ethyl acrylate / methyl methacrylate copolymer often uses barium sulfate particles as a non-toxic binder. It was found that they can be bound to maintain a granular state in the digestive tract, and the present invention has been completed based on this finding.

That is, the present invention relates to a barium sulfate granular preparation in which an ethyl acrylate / methyl methacrylate copolymer is used as a binder or a coating agent.

This barium sulfate granular preparation has a mode in which an ethyl acrylate / methyl methacrylate copolymer is used as a binder for barium sulfate particles, and a coating agent for barium sulfate particles bonded with another binder. There is also a mode used as both a binder and a coating agent.

As for the shape, in addition to granular shape, spherical shape, triangular shape,
The shape can be any shape such as a quadrangle, a column, and a short tube. The advantage of making it easier to determine the time course of gastrointestinal motility is obtained by changing the shape and administering the compounds one by one.

The average particle size of the barium sulfate particles is about 50 μm to 8 mm, preferably 500 μm to 3 mm.
The degree is appropriate.

As the ethyl acrylate / methyl methacrylate copolymer, a known binder may be used.
For example, the content of methoxyl group is about 7 to 10%, and the content of ethoxyl group is about 21 to 33%.

When an ethyl acrylate / methyl methacrylate copolymer is used as a binder, its blending amount is 0.5 to 100 parts by weight of barium sulfate in dry weight.
About 30 parts by weight, preferably about 5 to 15 parts by weight is suitable. On the other hand, when it is used as a coating agent, it may be about 0.2 to 3 parts by weight with respect to 100 parts by weight of barium sulfate.

When using the ethyl acrylate / methyl methacrylate copolymer as a coating agent, other binders can be used to granulate the barium sulfate particles. In this case, other binders include polyvinylpyrrolidone, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose phthalate and the like, and the compounding amount thereof is 0.5 to 2 parts by weight in terms of dry weight with respect to 100 parts by weight of barium sulfate. The degree is appropriate.

As the method for producing the granular preparation of the present invention, barium sulfate powder may be added to an emulsion of an ethyl acrylate / methyl methacrylate copolymer, and the mixture may be kneaded, granulated or tableted, and dried. . This kneading, granulation or tableting,
A known mixing type granulator, tableting machine or the like can be used for drying. The emulsion of the ethyl acrylate / methyl methacrylate copolymer may use an organic solvent as a dispersion medium, but it is preferable to use water as a dispersion medium from the viewpoint of handleability. It is preferable to use a dispersant for stabilizing the dispersion, and polyoxyethylene nonylphenyl ether is preferably used for this dispersant. The concentration of the emulsion may be set in consideration of handleability, and for example, the viscosity may be about 1 to 20 centistokes (20 ° C.). After granulating, it is screened if necessary before use.

The barium sulfate granular preparation of the present invention may be given to a subject by using an appropriate amount of water immediately before the examination of the digestive tract by X-ray photography or projection. Drinking dose is about 1 to 10 g, especially 2 to 1 when performing gastrointestinal function test.
About 6g is suitable.

[0016]

The barium sulfate granule preparation of the present invention has high fluidity because the granule state is maintained in the digestive tract without agglomeration and sedimentation even after the subject drinks it. As a result, the peristaltic movement of the digestive tract causes fluidization, so that the motor function of the digestive tract can be tested.

[0017]

[Examples] To 850 parts by weight of barium sulfate (Japanese Pharmacopoeia), an ethyl acrylate / methyl methacrylate copolymer emulsion ("Eudragit NE30D", manufactured by Laem Pharma Co., solid content 30%) was added. The mixture was kneaded, granulated, and dried to prepare a granule having an average particle diameter of 1.5 mm.

After administration of 2 g of this granule, an examination by X-ray photography was carried out over time. As a result, the motility state of the digestive tract of the subject was ascertained, and the administered barium sulfate granules kept their original shape. It was excreted as it was.

[0019]

EFFECT OF THE INVENTION By using the preparation of the present invention, it is possible to test the motor function of the digestive tract of a subject.

Further, this preparation can be subjected to a higher degree of examination by making several kinds of shapes and continuously administering it over time.

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Claims (1)

[Claims] 1. A barium sulfate granular preparation in which an ethyl acrylate / methyl methacrylate copolymer is used as a binder or a coating agent.