CN101698105A - Gastrointestinal tract contrast medium - Google Patents
Gastrointestinal tract contrast medium Download PDFInfo
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- CN101698105A CN101698105A CN200910224879A CN200910224879A CN101698105A CN 101698105 A CN101698105 A CN 101698105A CN 200910224879 A CN200910224879 A CN 200910224879A CN 200910224879 A CN200910224879 A CN 200910224879A CN 101698105 A CN101698105 A CN 101698105A
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Abstract
The invention discloses a gastrointestinal tract contrast medium and the contrast medium comprises the following components in parts by weight: 1000 parts of purified water, 0.3-20 parts of one or more of pure iodine and iodides in the purified water, and 1-8 parts of edible liquid paraffin, wherein the weight of iodine and iodides is calculated by 100% of pure iodine. The gastrointestinal tract contrast medium has the advantage that the contrast medium is safe and effective and has no toxic and side effects, the contrast medium can be fast filled in the part of body which is needed to imaged, and the contrast medium filled in the intracavity can form imaging oral contrast medium with a certain threshold specific density on the adjacent organ and lesion (nidus). After drunken, the contrast medium of the invention is not easy to absorb and can be discharged fast; the physiochemical performance of the contrast medium is stable, the comparison is obvious, the image is clear, the effective diagnosis rate reaches above 97%, the detecting ability is excellent especially for the observation of midabdomen, lower abdomen and pelvic cavity and the diagnosis of the small lesion (nidus), and the sensitivity and specificity for detecting early tumors and lesions in the gastrointestinal tract can be increased.
Description
Technical field:
The present invention relates to a kind of gastrointestinal tract contrast medium, be used for the clinical CT of development, MRI abdominal part imaging examination.Subject range: oral or coloclysis was full before abdominal part and pelvic cavity CT, MRI checked prepares, is used for CT, the video picture of MRI gastrointestinal imaging.
Background technology:
Tumor early discovery early treatment is the routine clinical employing methods in present various countries, utilizes CT, MRI tomography technology, and carrying out the gastrointestinal tract imaging diagnosis is International Development research focus.If carry out the contrast agent that CT, MRI gastrointestinal examination then at first will solve full intracavity.
Present clinical gastrointestinal examination is still based on barium meal stomach function regulating, intestinal endoscopy etc., and comparing them with CT, MRI all can't the outer pathological changes of observation chamber, as the infiltration of surrounding organ, and lymphatic metastasis etc.Adopt conventional CT, the scanning of MRI stomach, accurately show lymph node size, position and metamorphosis, the information of metastasis is provided effectively, but can not better show normal coat of the stomach structure and pathological changes, little membrane changing can't be diagnosed especially, and demonstration mucosa that can not be comprehensive and whole itself and pathological changes are closed on the metamorphosis of district's mucosa; As bridge shape mucosal fold etc.Colonoscope is a kind of unusual effective ways of knot rectal mucosa of diagnosing, but checking process is uncomfortable, the patient often need take tranquilizer and analgesic, particularly because the tediously long or narrow sexually transmitted disease (STD) of colon becomes existence, has the patient of 10%-20% can not finish colonoscopy.Though barium coloclysis relative low price, but the intrinsic characteristic of patient's uncomfortable property and projection in the checking process (cause overlapping intestinal song be difficult to assessment) has limited the application of barium coloclysis as the generaI investigation instrument in the past few decades, and it is very high to operator's dependency, between veteran doctor and the general doctor, the focus recall rate differs bigger.
Domestic and international clinical employing contrast agent carries out CT at present, the MRI gastrointestinal examination mainly contains:
1, gadolinium agent: a kind of paramagnetism used for intravenous injection contrast agent, injection is made gadolinium agent aqueous solution after blending the water dilution, be used for the inspection of MRI gastrointestinal imaging after oral administration or the coloclysis.Optium concentration 10mmol/L with gadolinium agent imaging is an example, and the 1.5L gadolinium agent aqueous solution of preparation standard will need the gadolinium agent 30ml of 0.5mol/L, with the calculation of price of domestic market gadolinium agent, needs cost 700-800 unit.Therefore domestic any one tame hospital is difficult to gadolinium agent aqueous solution coloclysis MRC as colorectal carcinoma patient common method.
2, barium sulfate: canel barium meal contrast examination agent, the interior inspection method that under the X line, shows the video picture of digestive tract pathological changes of full gastrointestinal cavity.Gulp down barium or the video picture of barium coloclysis only can be seen gastral profile, and the gastrointestinal image that is full of the barium agent is often covered small focus, therefore often by oral foaming agent or to the intestinal gas injection, make existing highdensity barium agent in the gastrointestinal tract, low-density gas shadow is arranged again, form gas barium contrast radiography, checking process causes positive findings easily.The radiography of barium agent simultaneously can't finish that pathological changes is observed and overlapping intestinal is bent differentiates in the chamber outside, and the patient reflects that generally barium sulfate hypopharynx occurs being difficult to when full and vomits drinking.
3, gasgraphy agent (air or CO
2): be to be used for clinical research in recent years, but never be widely used that reason is exactly that gas has the pseudo-shadow of apparent in view magnetosensitive sense, and in the scanning process, need the patient to hold one's breath 2-5 time,, may cause the position, boundary of gradation scanning misregister to occur if it is discontinuous to hold one's breath.
4, hospital's self-control diodone: employing is blended into the 10%-30% Reno-M with water and makes the method that contrast agent is used for the CT gastrointestinal examination.This method for making comes from 87 years and begins the science introduction that we research and develop contrast agent.Hospital's self-control diodone mouthfeel is poor, lacks contrast standard, and untoward reaction is many, and there is medical safety hidden danger in very easily cross infection disease.
A term electronic computer human body fault imaging (CT), MRT (MRI).
B term gastrointestinal imaging contrast medium medical image/diagnosis auxiliary agent.
A patent application is formerly also arranged at present, a kind of CT gastrointestinal tract contrast medium is disclosed, adopt in this patent application and help cathartic, purpose is for emptying body interimage agent as early as possible and shortens the holdup time, but the shortcoming of this gastrointestinal tract contrast medium is that disease patient should not use for mechanical intestinal obstruction, the intestines and stomach is hemorrhage etc.
Summary of the invention:
The object of the present invention is to provide a kind of safe, effective, side effect is low, can fill the contrast agent that needs radiography position, full intracavity fast and adjoin organ and pathological changes (kitchen range) and form certain threshold comparison density and the oral type contrast agent of video picture.Difficult absorption of this product drink rear intestinal and emptying are fast; Physicochemical property is stable, and the video picture contrast is clear, and the efficient diagnosis rate reaches more than 97%; Especially in, that lower abdomen and the little occupying lesion contrast of pelvic cavity detect ability is superior, can improve sensitivity and specificity that gastrointestinal tract infantile tumour and pathological changes detect.
Purpose of the present invention is implemented by following technical scheme: gastrointestinal tract contrast medium includes forming of following weight portion: in 1000 parts of purified water, contain any or several combinations of the iodine of pure iodine of 0.3-20 part and iodide, wherein iodine and iodide are that 100% pure iodine calculates food grade liquid paraffin 1-8 part by purity.
Described iodine and iodide are water soluble or the iodide that are dissolved in oil.
Described iodide are sodium iodide, potassium iodide, calcium iodide, iodate, amidotrizoic acid, sodium amidotrizoate, cardiografin, iohexol (iohexol), Iopromide (iopromide) and B-15000 (iopamidol), iotrolanvist (iotrolan), fatty acid iodide.
A kind of gastrointestinal tract contrast medium also includes stabilizing agent, and wherein in 1000 parts the purified water, described by weight stabilizing agent is 0.1-1 part.Described stabilizing agent is an arabic gum.
A kind of gastrointestinal tract contrast medium also includes fruit flavors, and wherein in 1000 parts the purified water, described by weight fruit flavors is 0.5-8 part, and described fruit flavors is aspartame, xylitol or sweetener.
Operation principle: the more absorption X line of the present invention's energy, full intracavity contrast agent and surrounding tissue organ form the density contrast and video picture under X-ray.Medical practitioner is by contrast images, to digestive tract with adjoin organ and carry out that pathological changes is observed and diagnostic comments is made in discriminating.
Advantage of the present invention: transparency liquid, mouthfeel is good, and side effect is low, does not have taboo, and contrast agent can fill fast needs the radiography position.Physicochemical property is stable, contrast obviously, clear picture is beneficial to the doctor and observes and differentiate little pathological changes (kitchen range), especially in, that lower abdomen and pelvic cavity pathological changes detect ability is superior.Emptying is quick, and liquid paraffin acts on mainly that to impel the intestines and stomach not absorb in line, utilizes paraffin to be difficult for by the gastrointestinal absorption characteristic, and short its contrast agent arrives fast and examined the position, can reduce doctors and patients' waiting time to be checked.The present invention fills up CT gastrointestinal examination application blank, for doctor, patient start new diagnostic mode.Differentiating in the imaging, clear picture, contrast obviously, the doctor to the shallow pathological changes, that little occupying lesion detects ability is superior, can improve sensitivity and specificity that gastrointestinal tract infantile tumour and pathological changes detect.
The specific embodiment:
Embodiment 1: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, get mass percent and be 0.31 kilogram of 98% iodine (is that 100% pure iodine is calculated as 0.3 kilogram pure iodine by purity), get 1 kilogram food grade liquid paraffin.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 2: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, get mass percent and be 0.2 kilogram of 98% 0.2 kilogram of 0.3 kilogram of iodine, sodium iodide, sodium iodate (is that 100% pure iodine is calculated as 0.59 kilogram pure iodine by purity), get 3 kilograms food grade liquid paraffin.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 3: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, get mass percent and be 0.6 kilogram of 98% 0.1 kilogram of 0.3 kilogram of iodine, sodium amidotrizoate, cardiografin (is that 100% pure iodine is calculated as 0.64 kilogram pure iodine by purity), get 5 kilograms food grade liquid paraffin.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 4: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, get 0.4 kilogram of 0.4 kilogram of sodium iodide, potassium iodide (is that 100% pure iodine is calculated as 0.64 kilogram pure iodine by purity), get 4 kilograms food grade liquid paraffin.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 5: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, (0.6 kilogram of 300mg iodine/ml) 0.5 kilogram, iotrolanvist (is that 100% pure iodine is calculated as 0.43 kilogram pure iodine by purity) are got 3 kilograms food grade liquid paraffin to get B-15000.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 6: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, (0.6 kilogram of 300mg iodine/ml) 0.5 kilogram, iotrolanvist (is that 100% pure iodine is calculated as 0.43 kilogram pure iodine by purity) are got 3 kilograms food grade liquid paraffin to get Iopromide.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 7: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, 29.7 kilograms of 10 kilograms of sodium amidotrizoate, cardiografin (is that 100% pure iodine is calculated as 20 kilograms pure iodine by purity), get 8 kilograms food grade liquid paraffin, get 1 kilogram arabic gum, get 5 kilograms fruit flavors, fruit flavors can be aspartame.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 8: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, 15 kilograms of 6 kilograms of sodium amidotrizoate, cardiografin (is that 100% pure iodine is calculated as 10.66 kilograms pure iodine by purity), get 6 kilograms food grade liquid paraffin, get 0.5 kilogram arabic gum, get 3 kilograms fruit flavors, fruit flavors can be xylitol.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Embodiment 9: prepare a kind of gastrointestinal tract contrast medium, wherein get 1000 kilograms of purified water, get 0.5 kilogram of 0.51 kilogram of sodium iodide, potassium iodide (is that 100% pure iodine is calculated as 0.81 kilogram pure iodine by purity), get 2 kilograms food grade liquid paraffin, get 0.1 kilogram arabic gum, get 0.5 kilogram fruit flavors, fruit flavors can be sweetener.Preparing process: accurately measure each raw-material quality, fully dissolve the back with a small amount of purified water and mix, be diluted to the necessary requirement volume, carry out ultra-clean after the emulsifying and filter, sterilization, packing with purified water.
Pharmacodynamics embodiment:
The performance indications of the gastrointestinal tract contrast medium that obtains according to embodiment 1-9:
1, sense organ state: colourless transparent liquid.
2, TPER: the inspection in 20 minutes of harmonization of the stomach upper abdomen, lower abdomen and inspection in pelvic cavity 45-50 minute.
3, reduced density: even, the anti-pH value of 256 ± 67Hu video picture density is no pseudo-shadow down.
Clinical verification: (with ten thousand routine tracing records)
1, untoward reaction: oral back person under inspection stomachache, diarrhoea occur, feels sick in one week, vomiting and General Symptoms.Safe and reliable untoward reaction, the efficient and convenient no pain of patient process, the biological assessment: no sensitization, no mucous membrane irritation, the no abnormal variation of histopathological examination etc. do not found.
2, toleration: all the person under inspection thinks that all the product taste is fragrant and sweet, makes the full ideal effect that reaches.
3, arrive terminal ileum: the contrast agent emptying is difficult for absorbing dynamically down at intestinal, and oral back 45-50 ± 5 minutes product arrives or by terminal ileum, can obviously shorten the time before the patient, improves checking efficiency.
4, contrast medium distributes: person under inspection's abdominal part small intestinal product of accepting the abdominal CT inspection is evenly distributed; Person under inspection's pelvic cavity small intestinal product of accepting the pelvic cavity CT examination is evenly distributed; Person under inspection's abdomen group and the basin group small intestinal product of accepting abdomen pelvic cavity CT examination are evenly distributed.
5, the contrast of contrast medium and surrounding tissue: gastrointestinal tract imaging key is to need the favorable tissue contrast or the contrast medium of gastrointestinal tract intracavity and the density contrast of gastrointestinal tract wall to reach certain threshold value clinically.Pseudo-shadow does not appear in CT value 256 ± 67Hu fine demonstration gastrointestinal tract wall of energy and soft tissue piece shadow.
6, density contrast: the imaging key of clinical gastrointestinal tract image is that contrast agent needs the favorable tissue contrast, and the contrast agent of intracavity and the density contrast of gastrointestinal tract wall reach certain threshold value.This contrast agent determines that with vast amount of clinical best reduced density is CT value 256 ± 67Hu.The contrast of this contrast agent down can clear demonstration gastrointestinal tract wall and soft tissue piece shadow, exposes cryptomorphic little pathological changes focus in Zou's wall easily, is convenient to radiate the doctor pathological changes details is observed and discriminating.Reduced density is uniform and stable, and adopt double blinding to observe down: video picture is clear, does not have pseudo-shadow.Can improve the accuracy by stages of the recall rate and the gastrointestinal cancer of gastrointestinal tract early lesion, and the pathological changes that can show the outer abdominal viscera of gastrointestinal tract, especially it is superior shallow pathological changes and little pathological changes (kitchen range) to be detected ability, can allow the doctor increase the confidence and the confidence of correct diagnosis.
Claims (7)
1. gastrointestinal tract contrast medium, it is characterized in that, it includes the composition of following weight portion: in 1000 parts of purified water, contain any or several combinations of the iodine of pure iodine of 0.3-20 part and iodide, wherein iodine and iodide are for being that 100% pure iodine calculates food grade liquid paraffin 1-8 part by purity.
2. a kind of gastrointestinal tract contrast medium according to claim 1 is characterized in that, described iodine and iodide are water soluble or the iodide that are dissolved in oil.
3. a kind of gastrointestinal tract contrast medium according to claim 2, it is characterized in that described iodide are sodium iodide, potassium iodide, calcium iodide, iodate, amidotrizoic acid, sodium amidotrizoate, cardiografin, iohexol, Iopromide, B-15000, iotrolanvist or fatty acid iodide.
4. a kind of gastrointestinal tract contrast medium according to claim 1 is characterized in that it also includes stabilizing agent, and described by weight stabilizing agent is 0.1-1 part.
5. a kind of gastrointestinal tract contrast medium according to claim 4 is characterized in that, described stabilizing agent is an arabic gum.
6. a kind of gastrointestinal tract contrast medium according to claim 1 and 2 is characterized in that it also includes fruit flavors, and described by weight fruit flavors is 0.5-8 part.
7. a kind of gastrointestinal tract contrast medium according to claim 6 is characterized in that, described fruit flavors is aspartame, xylitol or sweetener.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009102248797A CN101698105B (en) | 2009-11-23 | 2009-11-23 | Gastrointestinal tract contrast medium |
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| CN2009102248797A CN101698105B (en) | 2009-11-23 | 2009-11-23 | Gastrointestinal tract contrast medium |
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| CN101698105A true CN101698105A (en) | 2010-04-28 |
| CN101698105B CN101698105B (en) | 2012-02-22 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770913A (en) * | 2016-03-25 | 2016-07-20 | 上海世正医学影像诊断中心有限公司 | Compound meglumine diatrizoate injection and use method thereof |
| CN107115534A (en) * | 2017-05-27 | 2017-09-01 | 山东赛克赛斯生物科技有限公司 | A kind of intestines and stomach diagnostic imaging imaging assistant and preparation method thereof |
| CN114288427A (en) * | 2022-03-01 | 2022-04-08 | 福建宸润生物科技有限公司 | Gastrointestinal tract oral CT contrast agent |
| CN114652902A (en) * | 2022-03-10 | 2022-06-24 | 上海市第六人民医院 | 3D printing intravascular absorbable stent visualized under X-ray and preparation method thereof |
| CN115192736A (en) * | 2022-08-22 | 2022-10-18 | 内蒙古爱众医学影像有限公司 | Coal-made light white oil nano-emulsion type low-density contrast agent and preparation method thereof |
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2009
- 2009-11-23 CN CN2009102248797A patent/CN101698105B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105770913A (en) * | 2016-03-25 | 2016-07-20 | 上海世正医学影像诊断中心有限公司 | Compound meglumine diatrizoate injection and use method thereof |
| CN107115534A (en) * | 2017-05-27 | 2017-09-01 | 山东赛克赛斯生物科技有限公司 | A kind of intestines and stomach diagnostic imaging imaging assistant and preparation method thereof |
| CN114288427A (en) * | 2022-03-01 | 2022-04-08 | 福建宸润生物科技有限公司 | Gastrointestinal tract oral CT contrast agent |
| CN114652902A (en) * | 2022-03-10 | 2022-06-24 | 上海市第六人民医院 | 3D printing intravascular absorbable stent visualized under X-ray and preparation method thereof |
| CN115192736A (en) * | 2022-08-22 | 2022-10-18 | 内蒙古爱众医学影像有限公司 | Coal-made light white oil nano-emulsion type low-density contrast agent and preparation method thereof |
| CN115192736B (en) * | 2022-08-22 | 2023-08-15 | 内蒙古爱众医学影像有限公司 | Coal light white oil nanoemulsion type low-density contrast agent and preparation method thereof |
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| CN101698105B (en) | 2012-02-22 |
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Owner name: INNER MONGOLIA AIZHONG MEDICAL IMAGING CO., LTD. Free format text: FORMER OWNER: HOU SHUJUN Effective date: 20141016 Free format text: FORMER OWNER: PENG WEIJUN TIAN CUN Effective date: 20141016 |
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Effective date of registration: 20141016 Address after: 010051 No. 214 West Hailar Road, Hui District, Hohhot, the Inner Mongolia Autonomous Region Patentee after: Inner Mongolia love medical imaging Co., Ltd. Address before: 010051 No. 214 West Hailar Road, Hohhot Hui Autonomous Region, the Inner Mongolia Autonomous Region Patentee before: Hou Shujun Patentee before: Peng Weijun Patentee before: Tian Cun |