JPH07196536A - Barium sulfate x ray contrast media - Google Patents
Barium sulfate x ray contrast mediaInfo
- Publication number
- JPH07196536A JPH07196536A JP5349106A JP34910693A JPH07196536A JP H07196536 A JPH07196536 A JP H07196536A JP 5349106 A JP5349106 A JP 5349106A JP 34910693 A JP34910693 A JP 34910693A JP H07196536 A JPH07196536 A JP H07196536A
- Authority
- JP
- Japan
- Prior art keywords
- barium sulfate
- ray contrast
- contrast media
- aqueous solution
- cps
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、硫酸バリウムＸ線造影
剤に関するものである。FIELD OF THE INVENTION The present invention relates to a barium sulfate X-ray contrast medium.
【０００２】[0002]
【従来の技術】硫酸バリウムは化学的に非常に安定で且
つ無毒な化合物であり、強力なＸ線遮蔽作用を有するた
め、Ｘ線造影剤に広く使用されている。一般に硫酸バリ
ウムＸ線造影剤は、硫酸バリウム濃度が高く、流動性、
拡散性、付着性、耐酸性及び沈降安定性に優れ、服用し
易いこと等の条件が要求されるため、硫酸バリウムＸ線
造影剤には懸濁安定剤が必要であり、トラガントガム、
アラビアガム、コンドロイチン硫酸、ペクチン、ポリア
クリル酸塩、アルギン酸ナトリウム、アルギン酸プロピ
レングリコール、カルボキシメチルセルロース等が単独
または併用して使用されている。近年、硫酸バリウム濃
度の高い造影剤が要望されており、懸濁安定剤には沈降
安定性の一層の改善が望まれている。しかし、従来使用
されて来た懸濁安定剤では流動性，耐酸性などの性能を
満足するものではあるが、長期沈降安定性を完全に満足
するものは見当たらず、粉末製剤としての使用に耐え得
るものの懸濁液製剤として充分性能を満足する懸濁安定
剤は見当らないのが現状である。Barium sulphate is a chemically very stable and non-toxic compound and has a strong X-ray shielding effect, and is therefore widely used as an X-ray contrast agent. In general, barium sulfate X-ray contrast agents have high barium sulfate concentration, fluidity,
Since conditions such as excellent diffusivity, adhesiveness, acid resistance and sedimentation stability, and ease of administration are required, a barium sulfate X-ray contrast agent requires a suspension stabilizer, tragacanth gum,
Gum arabic, chondroitin sulfate, pectin, polyacrylate, sodium alginate, propylene glycol alginate, carboxymethyl cellulose and the like are used alone or in combination. In recent years, a contrast agent having a high barium sulfate concentration has been demanded, and a suspension stabilizer is required to have further improved sedimentation stability. However, although the suspension stabilizers that have been used so far satisfy the performances such as fluidity and acid resistance, none of them completely satisfy the long-term sedimentation stability, and they cannot be used as powder formulations. At present, there is no suspension stabilizer that satisfies the required performance as a suspension formulation.
【０００３】例えば、特公平４−７６９７５号には硫酸
バリウムＸ線造影剤の懸濁安定剤としてのエーテル化度
１．２５Ｍ／Ｃ6以上、且つ２％水溶液粘度が２５℃で
２０ｃｐｓ以下のカルボキシメチルセルロースナトリウ
ム（以下、ＣＭＣと略す）を使用することが提案されて
いる。しかし、当該ＣＭＣを使用したＸ線造影剤は流動
性良好、耐酸性良好の特徴を有するものの、懸濁液製剤
に要求される長期沈降安定性に問題がある。更に特開平
１−２６１３３５号には、硫酸バリウムＸ線造影剤の懸
濁安定剤としてラムザンガム及び２％水溶液粘度が２０
ｃｐｓ以下であるＣＭＣを使用することが提案されてい
るが、低粘性、流動性良好、耐酸性良好の特徴を有する
ものの懸濁液製剤に要求される長期沈降安定性に問題が
残されている。For example, in Japanese Examined Patent Publication No. 4-76975, a carboxy having a degree of etherification of 1.25 M / C 6 or more as a suspension stabilizer of barium sulfate X-ray contrast agent and a viscosity of 2% aqueous solution of 20 cps or less at 25 ° C. It has been proposed to use sodium methyl cellulose (hereinafter abbreviated as CMC). However, although the X-ray contrast agent using the CMC has characteristics of good fluidity and good acid resistance, it has a problem in long-term sedimentation stability required for a suspension preparation. Further, JP-A-1-261335 discloses that a suspension stabilizer of barium sulfate X-ray contrast agent has a viscosity of 20% with rhamzan gum and a 2% aqueous solution.
It has been proposed to use CMC of cps or less, but it has a problem in long-term sedimentation stability required for a suspension formulation although it has characteristics of low viscosity, good fluidity and good acid resistance. .
【０００４】[0004]
【発明が解決しようとする課題】本発明は、特に長期沈
降安定性に優れた硫酸バリウムＸ線造影剤を提供するこ
とを目的とするものである。SUMMARY OF THE INVENTION It is an object of the present invention to provide a barium sulfate X-ray contrast agent which is particularly excellent in long-term sedimentation stability.
【０００５】[0005]
【課題を解決するための手段】本発明者等は上記課題に
鑑み、硫酸バリウムＸ線造影剤の懸濁安定剤としてＣＭ
Ｃに着目して鋭意研究を重ねた結果、２％水溶液粘度が
２５℃で２０ｃｐｓ以上２００ｃｐｓ以下、且つエーテ
ル化度が１．２５Ｍ／Ｃ6以上であるＣＭＣを懸濁安定
剤として使用することにより飲用し易く、耐酸性、流動
性、長期沈降安定性に優れた硫酸バリウムＸ線造影剤が
得られることを見出し、本発明に到ったものである。In view of the above problems, the present inventors have proposed CM as a suspension stabilizer for barium sulfate X-ray contrast agents.
As a result of repeated intensive research focusing on C, the use of CMC having a 2% aqueous solution viscosity of 20 cps or more and 200 cps or less at 25 ° C. and an etherification degree of 1.25 M / C 6 or more as a suspension stabilizer It was found that a barium sulfate X-ray contrast agent which is easy to drink, and has excellent acid resistance, fluidity and long-term sedimentation stability can be obtained, and the present invention has been completed.
【０００６】本発明の硫酸バリウムＸ線造影剤は、２％
水溶液粘度が２５℃で２０ｃｐｓ以上２００ｃｐｓ以
下、且つエーテル化度が１．２５Ｍ／Ｃ6以上であるＣ
ＭＣを懸濁安定剤として使用することを特徴とするもの
である。ＣＭＣの２％水溶液粘度が２５℃で２０ｃｐｓ
未満の場合は懸濁液製剤に於ける長期沈降安定性が不充
分であり、使用に際し問題が生じ、２００ｃｐｓを超え
る場合は流動性が悪くなり、飲用する際に支障を来た
す。また、ＣＭＣのエーテル化度が１．２５Ｍ／Ｃ6未
満の場合は耐酸性が不充分となり、胃酸の作用を受けて
凝固変化若しくは粘度上昇を起こして消化管壁の状態を
正確に造影し得なくなる。ＣＭＣの添加量が０．０５％
未満の場合は懸濁液製剤に於ける長期沈降安定性，耐酸
性が低下し、使用に際し問題が生じる。また、ＣＭＣの
添加量が３％を超える場合は懸濁液製剤の流動性が低下
して飲用する際に支障を来たす。尚、本発明によれば、
飲用性、流動性、耐酸性も良好であり、粉末製剤として
の性能をも充分満足することは言うまでもない。The barium sulfate X-ray contrast agent of the present invention contains 2%.
C having an aqueous solution viscosity of 25 ℃ to 20 cps to 200 cps and an etherification degree of 1.25 M / C 6 or more
It is characterized by using MC as a suspension stabilizer. CMC 2% aqueous solution viscosity is 20 cps at 25 ° C
If it is less than 200, the long-term sedimentation stability of the suspension preparation is insufficient, and problems occur during use. If it exceeds 200 cps, the fluidity becomes poor, which causes troubles during drinking. Also, when the degree of etherification of CMC is less than 1.25 M / C 6 , the acid resistance becomes insufficient, and the state of the digestive tract wall can be accurately imaged by causing the change of coagulation or the increase of viscosity under the action of gastric acid. Disappear. The amount of CMC added is 0.05%
If it is less than the above range, long-term sedimentation stability and acid resistance of the suspension formulation are deteriorated, which causes problems during use. Further, if the amount of CMC added exceeds 3%, the fluidity of the suspension preparation is lowered, which causes troubles during drinking. According to the present invention,
Needless to say, it has good potability, fluidity, and acid resistance, and sufficiently satisfies the performance as a powder formulation.
【０００７】[0007]
【実施例】以下、本発明を実施例によって詳細に説明す
るが、本発明はこれ等によって限定されるものではな
い。EXAMPLES The present invention will now be described in detail with reference to examples, but the present invention is not limited thereto.
【０００８】実施例１ 水７１０ｇにＣＭＣ（２％水溶液粘度３３ｃｐｓ，エー
テル化度１．４０Ｍ／Ｃ6）を所定量溶解し、日局硫酸
バリウム１３００ｇを添加して混合撹拌し、１３０％
（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Example 1 A predetermined amount of CMC (2% aqueous solution viscosity 33 cps, etherification degree 1.40 M / C 6 ) was dissolved in 710 g of water, and 1300 g of JP Barium Sulfate was added and mixed with stirring to obtain 130%.
A barium sulfate sol of (W / V) was obtained.
【０００９】実施例２ 実施例１と同様にＣＭＣ（２％水溶液粘度２３ｃｐｓ，
エーテル化度１．４０Ｍ／Ｃ6）を添加し、１３０％
（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Example 2 As in Example 1, CMC (2% aqueous solution viscosity 23 cps,
Etherification degree 1.40M / C 6 ) was added, 130%
A barium sulfate sol of (W / V) was obtained.
【００１０】実施例３ 実施例１と同様にＣＭＣ（２％水溶液粘度２３ｃｐｓ，
エーテル化度１．２７Ｍ／Ｃ6）を添加し、１３０％
（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Example 3 As in Example 1, CMC (2% aqueous solution viscosity 23 cps,
Etherification degree 1.27M / C 6 )
A barium sulfate sol of (W / V) was obtained.
【００１１】実施例４ 実施例１と同様にＣＭＣ（２％水溶液粘度１５０ｃｐ
ｓ，エーテル化度１．４５Ｍ／Ｃ6）を添加し、１３０
％（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Example 4 Same as Example 1, CMC (2% aqueous solution viscosity 150 cp
s, degree of etherification 1.45 M / C 6 ),
% (W / V) barium sulfate sol was obtained.
【００１２】参考例１ 実施例１と同様にＣＭＣ（２％水溶液粘度１４ｃｐｓ，
エーテル化度１．４０Ｍ／Ｃ6）を添加し、１３０％
（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Reference Example 1 As in Example 1, CMC (2% aqueous solution viscosity 14 cps,
Etherification degree 1.40M / C 6 ) was added, 130%
A barium sulfate sol of (W / V) was obtained.
【００１３】参考例２ 実施例１と同様にＣＭＣ（２％水溶液粘度２６ｃｐｓ，
エーテル化度１．００Ｍ／Ｃ6）を添加し、１３０％
（Ｗ／Ｖ）の硫酸バリウムゾルを得た。Reference Example 2 As in Example 1, CMC (2% aqueous solution viscosity 26 cps,
Etherification degree 1.00M / C 6 ) is added, 130%
A barium sulfate sol of (W / V) was obtained.
【００１４】上記で得られた硫酸バリウムゾルを粘度測
定、耐酸性試験及び沈降試験に供試した。結果を表１に
示す。The barium sulfate sol obtained above was subjected to viscosity measurement, acid resistance test and sedimentation test. The results are shown in Table 1.
【００１５】粘度測定 Ｂ型粘度計（東京計器社製）で２５℃、６０ｒｐｍにて
測定した。 耐酸性試験 ガラス製試験管に人工胃液（ｐＨ１．１）３０ｍｌを入
れ、硫酸バリウムゾル１滴を滴下し、滴下直後および３
０分放置後の状態を肉眼で観察し、凝固性を判定した。 （−）滴下と同時に煙状に分散し、液は均一に濃く白濁
する。 （±）極く弱い凝固を起こした数個の粒子が落下し、他
は（−）と同じ。 （＋）凝固した荒い粒子となって浮遊しながら分散し、
液は白濁する。 （＋＋）凝固を起こした多くの塊となって落下し、液は
透明。 （＋＋＋）滴下したままの塊で瞬間的に落下し、液は全
く濁らない。 沈降試験 硫酸バリウムゾルを１００ｍｌメスシリンダーに入れ、
１年間静置してその上澄液量（ｍｌ）を測定した。Viscosity measurement The viscosity was measured with a B-type viscometer (manufactured by Tokyo Keiki Co., Ltd.) at 25 ° C. and 60 rpm. Acid resistance test 30 ml of artificial gastric juice (pH 1.1) was placed in a glass test tube, 1 drop of barium sulfate sol was dropped, immediately after dropping and 3 times.
The state after being left for 0 minutes was visually observed to determine the coagulability. (-) Disperses into a smoke at the same time as dropping, and the liquid becomes uniformly thick and cloudy. (±) Several particles that have undergone extremely weak coagulation fall, and the others are the same as (-). (+) Coagulated rough particles are dispersed while floating,
The liquid becomes cloudy. (++) Many lumps that have solidified and fall, and the liquid is transparent. (+++) It drops instantly as a lump as it is dropped, and the liquid does not become cloudy at all. Sedimentation test Put barium sulfate sol in a 100 ml graduated cylinder,
The solution was allowed to stand for 1 year and the amount of supernatant (ml) was measured.
【００１６】[0016]
【表１】 [Table 1]
【００１７】[0017]
【発明の効果】長期沈降安定性に特に優れた硫酸バリウ
ムＸ線造影剤であって、飲用性、流動性、耐酸性もＸ線
造影剤として要求される性能を満足するものである。INDUSTRIAL APPLICABILITY A barium sulfate X-ray contrast agent which is particularly excellent in long-term sedimentation stability, and also satisfies the performance required as an X-ray contrast agent in terms of drinkability, fluidity and acid resistance.
Claims (2)
ｐｓ以上２００ｃｐｓ以下で且つエーテル化度が１．２
５Ｍ／Ｃ6以上であるカルボキシメチルセルロースナト
リウムを懸濁安定剤として使用することを特徴とする硫
酸バリウムＸ線造影剤。1. A 2% aqueous solution having a viscosity of 20 c at 25 ° C.
ps to 200 cps and etherification degree is 1.2
A barium sulfate X-ray contrast medium, characterized by using sodium carboxymethylcellulose having a concentration of 5 M / C 6 or more as a suspension stabilizer.
ースナトリウムの添加率が硫酸バリウムに対して０．０
５〜３ｗｔ％であることを特徴とする硫酸バリウムＸ線
造影剤。2. The addition ratio of sodium carboxymethyl cellulose according to claim 1 is 0.0 with respect to barium sulfate.
Barium sulfate X-ray contrast agent, characterized in that it is 5 to 3 wt%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP5349106A JP2937731B2 (en) | 1993-12-28 | 1993-12-28 | Barium sulfate X-ray contrast agent with excellent long-term stability |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP5349106A JP2937731B2 (en) | 1993-12-28 | 1993-12-28 | Barium sulfate X-ray contrast agent with excellent long-term stability |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH07196536A true JPH07196536A (en) | 1995-08-01 |
| JP2937731B2 JP2937731B2 (en) | 1999-08-23 |
Family
ID=18401535
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP5349106A Expired - Fee Related JP2937731B2 (en) | 1993-12-28 | 1993-12-28 | Barium sulfate X-ray contrast agent with excellent long-term stability |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2937731B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100665234B1 (en) * | 2005-07-27 | 2007-01-04 | 주식회사태준제약 | Peroral x-ray small bowel contrast media |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5276417A (en) * | 1975-12-22 | 1977-06-27 | Otsuka Pharma Co Ltd | Fluidifying method of balium sulfate |
| JPS55127322A (en) * | 1979-03-26 | 1980-10-02 | Otsuka Pharmaceut Factory Inc | Barium sulfate contrast medium for x-ray radiography |
| JPH01261335A (en) * | 1988-04-11 | 1989-10-18 | Dai Ichi Kogyo Seiyaku Co Ltd | Barium sulfate contrast medium for x ray |
| JPH0476975A (en) * | 1990-07-18 | 1992-03-11 | Nec Corp | Laser oscillator |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3236735A (en) | 1962-09-14 | 1966-02-22 | Mallinckrodt Chemical Works | Barium sulfate and low viscosity monosaccharide polymer x-ray contrast media |
-
1993
- 1993-12-28 JP JP5349106A patent/JP2937731B2/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5276417A (en) * | 1975-12-22 | 1977-06-27 | Otsuka Pharma Co Ltd | Fluidifying method of balium sulfate |
| JPS55127322A (en) * | 1979-03-26 | 1980-10-02 | Otsuka Pharmaceut Factory Inc | Barium sulfate contrast medium for x-ray radiography |
| JPH01261335A (en) * | 1988-04-11 | 1989-10-18 | Dai Ichi Kogyo Seiyaku Co Ltd | Barium sulfate contrast medium for x ray |
| JPH0476975A (en) * | 1990-07-18 | 1992-03-11 | Nec Corp | Laser oscillator |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100665234B1 (en) * | 2005-07-27 | 2007-01-04 | 주식회사태준제약 | Peroral x-ray small bowel contrast media |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2937731B2 (en) | 1999-08-23 |
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