CN106421818A - Contrast agent applied to diagnosis of gastrointestinal tract dynamic transportation and preparation - Google Patents

Contrast agent applied to diagnosis of gastrointestinal tract dynamic transportation and preparation Download PDF

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Publication number
CN106421818A
CN106421818A CN201610542750.0A CN201610542750A CN106421818A CN 106421818 A CN106421818 A CN 106421818A CN 201610542750 A CN201610542750 A CN 201610542750A CN 106421818 A CN106421818 A CN 106421818A
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CN
China
Prior art keywords
bar
preparation
contrast agent
contrast
section
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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.)
Pending
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CN201610542750.0A
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Chinese (zh)
Inventor
金黑鹰
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Nanjing Pu Pai Medical Science And Technology Co Ltd
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Nanjing Pu Pai Medical Science And Technology Co Ltd
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Priority to CN201610542750.0A priority Critical patent/CN106421818A/en
Publication of CN106421818A publication Critical patent/CN106421818A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/04X-ray contrast preparations
    • A61K49/0404X-ray contrast preparations containing barium sulfate

Abstract

The invention provides a contrast agent applied to diagnosis of gastrointestinal tract dynamic transportation. Metal salts with high atomic numbers are used as a contrast agent; the contrast agent and a molding material are prepared into a long-strip-shaped contrast agent, namely a contrast agent strip; cross sections of the contrast agent strip are round, oval, triangular, rectangular, pentagonal and hexagonal respectively; capsules are filled with a plurality of contrast agent strips with the same cross section shape; the capsules filled with two to four contrast agent strips with different cross section shapes are packaged in sets. The maximum width of the cross section of the contrast agent strips is 1.3mm to 3mm and the long diameter is 14mm to 20mm. Barium strips with different cross section shapes, which enter a human body at different time, can be distinguished; basic gastrointestinal tract disease conditions can be accurately judged through one-time X-ray radiography.

Description

One kind is applied to gastrointestinal tract dynamia and transports diagnostic contrast agents and preparation
Technical field:
The present invention relates to a kind of medical contrast medium, it is that one kind is applied to gastrointestinal tract dynamia and transports diagnostic contrast agents, especially The shaping barium bar of combination and preparation, under intestines and stomach X-ray radiography, measure GI power and transport situation.
Background technology:
A kind of gastrointestinal function check mark thing of CN 200910014491, the high atom not being absorbed by the body with nonhazardous and The metallic salt [A] of ordinal number has high-expansion, high viscosity for adding to have in the contrast preparation of main material in production process Low absorption x-ray material [B] and a solidification, the material of cementation and water [D] composition, the weight ratio of each component is as follows:Plateau The metallic salt [A] of sub- ordinal number:50~99% high-expansions, high viscosity low absorption x-ray material [B]:0.5~10% solidification, The material [C] of cementation:0.5~5% water [D]:1~40%.A kind of transporting marker for gastrointestinal tract of CN201110447570 and Its preparation method, it is made up of following weight parts material:Medicinal barium sulfate 3-5 part, self-curing tooth acrylic 2-3 part, solid dioxy Change carbon 2-3 part, artificial tooth base resin 3-4 part.This mark material therefor is medical material does not have toxicity;The ratio of mark Focus between 0.98-1.04, may float on the water surface.
Wherein typically it is applied to gastrointestinal tract dynamia and transports diagnostic contrast agents system using barium sulfate x-ray imaging, barium agent is not Molten water, is not absorbed, especially roentgenopaque feature, is always used as gastrointestinal imaging.Existing X-ray gastrointestinal contrast agent master If using the metallic salt high-selenium corn X-ray of nonhazardous in intestines and stomach such as barium sulfate fine material powder end be material, auxiliary it With the powdery agent of the seasonings such as flavouring agent (or even Chinese medicine etc. quite a few see), it is tuned into that pulpous state is drunk or bowel lavage uses.
CN1078911A adopts medical grade silicon rubber, ethylene methacrylic polysiloxanes, methyl phenyl silicone oil, medicinal barium sulfate, gas Phase method silica, 2,5- dimethyl -2,5- di-t-butyl ethane peroxide prepares particle and loads use, X-ray in capsule Lower image definition.The mark composition granule that the method is obtained easily is assembled in vivo in actual applications, skewness, inconvenience meter Number, thus lead to gastroenteritic power assessment inaccurate or difficult.The geometry to label of colonic transportation test for the CN2212392Y Improved, its geometry has spheroid, multi-angular body and the interior lamellar body having through hole.The barium ball mark that above method is obtained Thing, due to due to single spheroid weight, internal intestine evacuation velocity too fast it is impossible to accurate evaluation gastroenteritic power situation.
CN101773674A proposes a kind of gastrointestinal motivity marker capsule, and it is to be filled with mark in medicinal hollow capsule Thing, label includes barium sulfate, medical grade silicon rubber and montmorillonite.5-15 label is filled, preferably wherein in each capsule 10 labels;Wherein it is based on label gross weight, barium sulfate content is 15%-40%, medical grade silicon rubber content is 50%- 80%, montmorillonite content is 5%-10%.Wherein label is ring, and the cross section of described ring is annulus.This annulus Outer diameter D 1 be 4-5mm, preferably 4.4-4.6mm, most preferably 4.5mm.The internal diameter D2 of this annulus is 3.0-3.5mm, preferably For 3.2-3.4mm, most preferably 3.3mm.Using method is:Patient is administered orally two capsules containing label, and (each capsule contains Have 10 labels), the 5th after taking day carries out x-ray imaging inspection.And inform that patient disables any defaecation in 5 days Medicine, enema, suppository etc..Carry out belly radiography to determine label distributing position and scope within 5th day.If patient excretes At least 80% (16 or more) illustrate that colon transport function is normal.If still remaining 4 or more multi-tracer in patient's enteron aisle, In ensuing several days, (as the second to five day) needs to carry out x-ray imaging inspection.Rectosigmoid knot is flocked on for label In intestines or label exists in colon in a large number, need the disposal of second step.As five days if it exceeds 20% (4-6 piece) still suffers from In vivo.Patient is allowed to take bulking agent 1-2 week daily.Within this 1-2 week, then allow the clothes for patients capsule of two labels, taking With after carry out within the 5th day x-ray imaging come check mark thing distributing position and scope.
Prior art is used for medical circles' diagnosis gastrointestinal tract disease needs the result of colonic transit test.Patient's oral, non-toxic in stomach and intestine The mark that interior insoluble, impermeable X-ray, development clearly shaping barium agent label, the passage according to the time and colon retain The quantity of thing is judging the function of colonic peristalsis.Its weak point is need to be every 24 hours after those who are investigated take barium agent label Clap an X-ray film, until label is discharge all of only, this not only makes troubles to patient, and also add excessive X Light intake.Modern times, it is generally accepted that the intake of X-ray crosses multipole damages evil, especially can not judge basic stomach and intestine by an X-ray Illness situation.
Colonic transit test is a kind of detection technique clinically commonly used, and is frequently used barium agent bar in clinical position (obtain the barium agent of harmless and health license however not excluded that in the future new X-ray developer using) replacing, barium agent bar system Cumbersome when making (CN101773674A adopt vulcanization process prepare) and not ten sectional specification, clinically using effect wait to carry High and be restricted.
Content of the invention:
It is an object of the invention to, provide one kind to be applied to gastrointestinal tract dynamia and transport diagnostic contrast agents, especially a kind of one-tenth What the development effect that set uses improved transports more obvious barium marker capsule to gastrointestinal motivity.May also include diagnostic contrast agents barium The method of bar preparation and die plate equipment, propose one kind not only patient's taking convenience, and also reduce X-ray intake, or even energy X-ray check, can accurately judge basic gastrointestinal tract disease situation.
The technical scheme is that:One kind is applied to gastrointestinal tract dynamia and transports diagnostic contrast agents, it is characterized in that using high The metallic salt of atomic number is contrast preparation, and it is contrast preparation bar that contrast preparation is prepared into strip contrast preparation together with moulding material, The cross section of contrast preparation bar is respectively circle, ellipse, triangle, rectangle, pentagon and hexagon, with some horizontal strokes filling in capsule Cross sectional shape identical contrast preparation bar;The capsule of the contrast preparation bar of two to four varying cross-section shapes is packaging kit.Every time A set of diagnostic contrast agents use for those who are investigated;Must complete first use.
It is strip that described gastrointestinal tract dynamia transports contrast preparation, the cross section Breadth Maximum 1.3-3mm of contrast preparation bar, especially 1.6-2mm, major diameter are 14 20mm, especially 15 17mm;Capsule interimage agent is strip, such as referred to as barium bar, using circle Strip(8-14 root) is typically a kind of.
In contrast preparation, than for 20-70%, moulding material is with medical for the weight of the metallic salt (as barium sulfate) of atomic number Silicon rubber, PE, PMMA or PA, PS, PET etc., and other pluronic polymer, the preparation method of contrast preparation of the present invention is:Extrusion molding Cut-out, injection or sulfidization molding, including interpolation barium sulfate, polymeric retention aid in medical grade silicon rubber, PE, PMMA or PA, PS or PET Agent and (attapulgite, montmorillonite etc.) filler, in contrast preparation, the slaine of atomic number is typically barium sulfate, pluronic polymer With filler montmorillonite by macromolecular material mixing aftershaping, obtain the described diagnostic contrast agents (label) of various sectional areas, will Some (as 10) diagnostic contrast agents with section are placed in medicinal hollow capsule.In capsule, equipment diagnostic contrast agents are barium Bar-cross section is circular or other shapes of strip, and when circle, every capsule is built-in(8-14 root).
As follows using process:The complete use of palpus, by the barium of a set of three kinds (can be two kinds or four kinds) different cross section shapes Bar loads different capsules, takes within three days respectively to patient for a set of three kinds, takes one daily, take and record certain section daily The barium bar capsule of shape, three days is the barium bar capsule of three different cross section shapes, then after after 24h an X take the photograph film developing imaging, three The barium bar of it three kinds of different cross section shapes all can be resolved;Doctor knows every kind of section shape according to the situation that those who are investigated take The barium bar of shape time, the emptying ability of situation acquisition stomach of internal position, distribution and emptying or disease in those who are investigated's body The situations such as trouble.
Beneficial effect:A kind of present invention convenient oral of offer, smooth surface, nontoxic non-stimulated, with intestines and stomach frictional resistance Little gastrointestinal motivity marker capsule.Will not digested, can easily measure and exactly reflection stomach and intestine solid row Gastrointestinal motivity diagnostic contrast agents (label) capsule with mouth-anus time between space-time.The development effect of list structure of the present invention Improve, the power situation (being much better than spherical) of stomach and intestine can be reflected, improve the decentralization of the contrast preparation such as barium sulfate, strengthen development Effect.Development is clear.After certain time, an X-ray takes the photograph film developing imaging, and the barium bar of different cross section shape all can be resolved;Very Take the photograph piece to X-ray of energy and accurately judge basic gastrointestinal tract disease situation.The complete information being obtained using rear inspection is the abundantest, and X As long as light takes the photograph piece once, the impact that X-ray takes the photograph film developing imaging inspection person is minimum.Condition preparation can be selected for extremely simple convenient side Method, low cost.
Brief description:
Fig. 1 is equipped with the schematic diagram of diagnostic contrast agents capsule (label).
The schematic diagram of Fig. 2-7 difference capsule cross section, the diagnostic contrast agents cross section of the strip of capsule dress correspond to respectively Ellipse, circle, square, rectangle, pentagon and triangle (six kinds), any two to the four kinds capsule dress diagnosis for complete use Contrast preparation.
Specific embodiment:
Embodiment 1 present invention is the sulfurizing mould that application and preparation is made using barium bar in Gl transit test, sulfuration system Standby, there is number row's shape to be respectively linear, the shape of trigonometric sum circle above, thickness is 1mm, and upper and lower two faces are respectively cover plate; When using, mould is placed on lower cover, after barium agent powder (30% weight ratio) is disperseed, directly pours mould into polymer, Put into upper cover plate full of after three rounds, barium bar takes out upper and lower cover plates after sulfuration of heating, by three kinds of varying cross-sections in Fig. 2-7 The diagnostic contrast agents barium bar of shape loads different capsules, and every capsule fills ten diagnostic contrast agents barium bars, divides three to person to be checked It takes the photograph piece through 24 hours X-rays after taking again.
Embodiment 2 is applied to the template that Gl transit test is made using diagnostic contrast agents barium bar, with extrusion process system Standby;When using, mould is placed on lower cover, after barium agent powder (40% weight ratio) is disperseed with PE or pet polymer and After auxiliary agent extrusion molding, extruded mould has the diagnostic contrast agents barium bar in the different section such as Fig. 2-7, by any three kinds in Fig. 2-7 not Cut into the length of needs, such as 16mm with the barium bar of shape of cross section, load the capsule of different three kinds of colors, every capsule dress Article ten, diagnostic contrast agents barium bar divide three days to person to be checked take after take the photograph piece through 24 hours X-rays again.A set of three three kinds of colors For using, each color represents a kind of shape of cross section to capsule.A set of two to four different colours can also be adopted when needing Capsule.
The diagnostic contrast agents barium bar in the different section such as Fig. 2-7 is prepared in embodiment 3 injection, and each section identical 10 is examined Disconnected contrast preparation barium bar label loads in a capsule for medicine, and packaging, sterilization are standby.A set of two glue to four different colours Capsule uses.
The forming agent of contrast preparation barium bar adopts PMMA resin, nylon, PET, can be molded or extrusion molding, all can be using routine Squeeze or Shooting Technique, silicon rubber needs sulfuration preparation, and process conditions are relevant with the performance of material and the composition of dispensing, material choosing With medical grade, process also meets health and medical requires.
Those of ordinary skill in the art should be understood:The foregoing is only the specific embodiment of the present invention, and It is not used in the restriction present invention, all any modification, equivalent substitution and improvement within the spirit and principles in the present invention, done etc., all Should be included within protection scope of the present invention.

Claims (5)

1. one kind is applied to gastrointestinal tract dynamia and transports diagnostic contrast agents, it is characterized in that being to make using the metallic salt of high atomic number Shadow agent, it is contrast preparation bar that contrast preparation is prepared into strip contrast preparation together with moulding material, and the cross section of contrast preparation bar is respectively Circle, ellipse, triangle, rectangle, pentagon and hexagon, with some sliver transvers section shape identical contrast preparation filling in capsule Bar;The capsule of the contrast preparation bar of two to four varying cross-section shapes is packaging kit.
2. diagnostic contrast agents according to claim 1, is characterized in that the cross section Breadth Maximum 1.3-3mm of contrast preparation bar, Major diameter is 14 20mm.
3. diagnostic contrast agents according to claim 1, is characterized in that the cross section Breadth Maximum 1.6-2mm of contrast preparation bar, Major diameter is 15 17mm.
4. it is applied to the preparation method that gastrointestinal tract dynamia transports diagnostic contrast agents according to one of claim 1-3, its feature Be the weight of the metallic salt of atomic number in contrast preparation than for 20-70%, moulding material with medical grade silicon rubber, PE, PMMA or PA, PS, PET, separately plus pluronic polymer, with extrusion molding cut-out, injection or sulfidization molding, obtain the described contrast preparation of various sectional areas Bar, the 8-14 root contrast preparation bar in same section is placed in medicinal hollow capsule, the contrast preparation of two to four varying cross-section shapes The capsule of bar is packaging kit.
5. preparation method according to claim 4, is characterized in that the built-in 10 contrast preparation bars of every capsule.
CN201610542750.0A 2016-07-11 2016-07-11 Contrast agent applied to diagnosis of gastrointestinal tract dynamic transportation and preparation Pending CN106421818A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107233580A (en) * 2017-07-27 2017-10-10 上海安翰医疗技术有限公司 Mark capsule for target area Dynamic testing and preparation method thereof
CN110064060A (en) * 2019-04-23 2019-07-30 焦俊 A kind of barium agent label of colonic transportation test and preparation method thereof
CN110522927A (en) * 2019-09-03 2019-12-03 安徽萍聚德医疗科技股份有限公司 A kind of gastroenteritic power marker capsule

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2212392Y (en) * 1995-01-20 1995-11-15 李继明 Colon transporting test marker with multiple geometric shapes
CN101496905A (en) * 2009-02-27 2009-08-05 莱芜钢铁集团有限公司医院 Marker for function check of stomach and intestine and preparation method thereof
CN102091335A (en) * 2011-02-11 2011-06-15 张发明 Gastrointestinal transit disorder diagnosis composition and use thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2212392Y (en) * 1995-01-20 1995-11-15 李继明 Colon transporting test marker with multiple geometric shapes
CN101496905A (en) * 2009-02-27 2009-08-05 莱芜钢铁集团有限公司医院 Marker for function check of stomach and intestine and preparation method thereof
CN102091335A (en) * 2011-02-11 2011-06-15 张发明 Gastrointestinal transit disorder diagnosis composition and use thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
王锦萍等: "应用不透X线标志物法诊断糖尿病性胃病", 《影像诊断与介入放射学》 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107233580A (en) * 2017-07-27 2017-10-10 上海安翰医疗技术有限公司 Mark capsule for target area Dynamic testing and preparation method thereof
CN107233580B (en) * 2017-07-27 2021-03-02 上海安翰医疗技术有限公司 Marking capsule for target area dynamic detection and preparation method thereof
US11000244B2 (en) * 2017-07-27 2021-05-11 Ankon Medical Technologies (Shanghai) Co., Ltd. Capsule for measuring motility of a target area and a method for making the capsule
CN110064060A (en) * 2019-04-23 2019-07-30 焦俊 A kind of barium agent label of colonic transportation test and preparation method thereof
CN110522927A (en) * 2019-09-03 2019-12-03 安徽萍聚德医疗科技股份有限公司 A kind of gastroenteritic power marker capsule

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