JPH08217697A - Marker for pursuing digestive tract and its production - Google Patents

Abstract

PURPOSE: To obtain the subject readily producible marker having clear contrast in X-ray photographing, capable of alleviating pain of a patient, comprising sodium alginate and barium sulfate, etc., as main components. CONSTITUTION: This marker is obtained by dispersing (C) barium sulfate into an aqueous solution containing (A) sodium alginate or (B) sodium carboxymethyl cellulose to give a slurry, dripping the slurry on (D) an aqueous solution containing calcium ions (e.g. calcium chloride), precipitating the component A or the component B as a calcium salt, filtering, drying and coating the resultant substance with (E) an insolubilizing agent (e.g. an aminoalkyl methacrylate polymer RS). Preferably the ratio of 50-99.7wt.% component C, 0.2-49.9w.t% component A or component B and 0.1-20wt.% component E is used.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is for tracing the digestive tract for the purpose of noninvasively observing the retention status of digestive substances in the digestive tract in order to examine the function of the digestive tract in X-ray digestive tract diagnosis. Regarding the marker of. Although tracing of the gastrointestinal tract is extremely important for diagnosing gastrointestinal function, morphology, and diseases, it is not easy to perform.
Conventionally, there was no X-ray opaque marker suitable for taking when tracing the digestive tract route by X-ray. The digestive tract digests human daily food, exerts its function by passing nutrients through it to the real organs such as the pancreas, liver, and kidneys, and protects the environment from contamination. It is called a luminal organ, and its functional decline leads to malnutrition and diarrhea, and its morphological change is essential for follow-up examination of the gastrointestinal tract in order to detect constipation and disease and narrow cords.
In particular, it is important to trace the retention state of digests in the digestive tract to diagnose the function, morphology, and running state of organs.
Markers enable such X-ray tracking. Usually, these markers are taken and the retention state in the digestive tract is observed non-invasively.

[0002]

2. Description of the Related Art Cylindrical polyethylene having a diameter of 2-5 mm and containing 33% by weight of barium sulfate, which has been used as a main agent of a contrast agent generally used for diagnosis of digestive system as a radiopaque marker. A method for X-ray examination of the large intestine using a pellet as a marker has been announced (Gut. Vol. 10 No. 18).
49-847 (1969)). Further, pills in which barium sulfate is coated with polyvinyl chloride are known. However, these have low barium sulphate content in the formulation and poor contrast during X-ray photography, or require multiple X-ray photography over several days, restraining the patient and exposing the patient to several X-ray exposures in a short period of time. There was a problem that it had to be done. Further, also in the production of the marker, it is necessary to cut after the compression molding or the extrusion molding, and a mold is required only for the type of the shape of the marker. Therefore, a simpler production method has been desired.

[0003]

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and the manufacturing method is easy,
It is an object of the present invention to provide a marker which has a clear contrast during X-ray photography and reduces the pain of the patient.

[0004]

The present invention comprises (1) barium sulfate and calcium alginate or calcium carboxymethyl cellulose as main components,
A marker for tracing the digestive tract whose surface is coated with an insolubilizer. (2) Barium sulfate is dispersed in an aqueous solution containing sodium alginate or sodium carboxymethyl cellulose, the slurry is added to an aqueous solution containing calcium ions, sodium alginate or sodium carboxymethyl cellulose is precipitated as a calcium salt, filtered, and dried. After that, it is coated with an insolubilizing agent to produce a marker for tracing the digestive tract.

The barium sulphate used is pharmacological barium sulphate, and the particle size is preferably about 0.1 to 50 μm.
The ratio of barium sulfate, calcium alginate or calcium carboxymethylcellulose, and the insolubilizing agent is barium sulfate 50-99.7% by weight calcium alginate or carboxymethylcellulose calcium 0.2-49.9% by weight insolubilizing agent 0.1-20% by weight. .

When the amount of these components is less than the lower limits, the contrast of barium sulfate is lowered, the strength of calcium alginate or carboxymethyl cellulose calcium is lowered, and the insolubilizing agent causes disintegration of the preparation by digestive fluid. Occurs. If the upper limit is exceeded, the strength of the formulation will be reduced for barium sulfate, and the contrast will be reduced for calcium alginate or calcium carboxymethyl cellulose and the insolubilizer.

The conditions for the production of these are as follows: an aqueous solution of sodium alginate or sodium carboxymethyl cellulose at 5 to 100 g / L and barium sulfate 10
0 to 1700 g / L is dispersed, and an amount of a calcium ion source necessary for converting sodium alginate or sodium carboxymethyl cellulose in the slurry into a calcium salt, for example, 10 to 500 g of calcium chloride.
The slurry is added as a 1 / L aqueous solution to obtain a coprecipitation product of barium sulfate and calcium alginate or calcium carboxymethyl cellulose. Next, filtration, washing with water and drying are performed to obtain granules. The obtained product is coated by a known method using a known insolubilizing agent such as aminoalkyl methacrylate copolymer RS, ethyl cellulose or chitosan. The insolubilizing agent prevents dissolution in digestive juices.

[0008]

[Examples] Specific examples will be described below. Example 1 100 g of a 2% sodium alginate aqueous solution was vigorously stirred to add 100 g of barium sulfate to form a suspension. This suspension is dropped into a 10% calcium chloride solution with a syringe (0.7 mm needle) at a pressure of 1 kg / cm ² and left for 24 hours to exchange sodium ion and calcium ion. The finished granules are washed with distilled water. Then, it is dried by ventilation at 80 ° for about 5 hours. The obtained granules are treated with 5% Eudragit RS (ethanol solution)
Coating in the usual way. The average particle size of the obtained pills was about 2 mm.

Example 2 100 g of a 2% sodium alginate aqueous solution was vigorously stirred to add 100 g of barium sulfate to form a suspension. This suspension is dropped into a 10% calcium chloride solution with a syringe (0.7 mm needle) at a pressure of 3 kg / cm ² and left for 24 hours to exchange sodium ion and calcium ion. The finished granules are washed with distilled water. After that, it is dried by ventilation at 80 ° for about 5 hours. The obtained granules are coated with 5% Eudragit RS (ethanol solution) by a usual method. The average particle size of the obtained pills was about 1.3 mm.

Example 3 As a result of performing a test according to the disintegration test method described in the Japanese Pharmacopoeia, it was found that the first liquid and the second liquid did not disintegrate,
Further, after the test with the first liquid, the test with the second liquid did not cause disintegration. The details of the test are shown below. First liquid preparation method To 2.0 g of sodium chloride, 7.0 mL of hydrochloric acid and water are added and dissolved to make 1000 mL. This solution is colorless and transparent,
Its pH is about 1.2. Second liquid preparation method 0.2 M in 0.2 M potassium dihydrogen phosphate test solution 250 mL
Add 10 mL of N-sodium hydroxide test solution and water to add 10
Make up to 00 mL. This liquid is colorless and transparent, and its pH is about 6.8. Test method Attach the tester to the receiving shaft, put in a beaker, and 2 minutes for 1 minute.
9 to 32 reciprocations, and an amplitude of 53 to 57 mm are adjusted so as to perform a smooth vertical movement. When the tester is at the lowest position, the bottom mesh surface should be 25mm from the bottom of the beaker. To do so. The temperature of the liquid is kept at 37 ± 2 °. The test time was 3 hours regardless of which test solution was used.

Example 4 When the pills obtained in Examples 1 and 2 were taken and X-ray photographed, the contrast was clear.

[0012]

As described above, the marker for tracing the digestive tract according to the present invention does not easily collapse even when the patient takes it, and a clear contrast can be obtained by X-ray photography.

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Claims (2)

[Claims] 1. A marker for tracing the digestive tract, which comprises barium sulfate, calcium alginate or calcium carboxymethyl cellulose as the main component, and the surface of which is coated with an insolubilizing agent. 2. Barium sulfate is dispersed in an aqueous solution containing sodium alginate or sodium carboxymethylcellulose, and the slurry is added dropwise to an aqueous solution containing calcium ions to precipitate sodium alginate or sodium carboxymethylcellulose as a calcium salt, followed by filtration, A method for producing a marker for tracing a digestive tract by drying and coating with an insolubilizing agent.