CN116510042A - Contrast imaging agent for gastrointestinal tract and preparation method thereof - Google Patents
Contrast imaging agent for gastrointestinal tract and preparation method thereof Download PDFInfo
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- CN116510042A CN116510042A CN202310569633.3A CN202310569633A CN116510042A CN 116510042 A CN116510042 A CN 116510042A CN 202310569633 A CN202310569633 A CN 202310569633A CN 116510042 A CN116510042 A CN 116510042A
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- 239000012216 imaging agent Substances 0.000 title claims abstract description 47
- 210000001035 gastrointestinal tract Anatomy 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000002245 particle Substances 0.000 claims abstract description 318
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 claims abstract description 165
- 229910052788 barium Inorganic materials 0.000 claims abstract description 164
- 229920000642 polymer Polymers 0.000 claims abstract description 154
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 claims abstract description 52
- 239000002861 polymer material Substances 0.000 claims abstract description 34
- 239000002994 raw material Substances 0.000 claims abstract description 29
- 239000002775 capsule Substances 0.000 claims description 79
- 238000005303 weighing Methods 0.000 claims description 18
- 238000001746 injection moulding Methods 0.000 claims description 15
- 238000010298 pulverizing process Methods 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 10
- 238000011068 loading method Methods 0.000 claims description 9
- 238000004806 packaging method and process Methods 0.000 claims description 9
- 238000007873 sieving Methods 0.000 claims description 9
- 229920002379 silicone rubber Polymers 0.000 claims description 7
- 238000001125 extrusion Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 239000011259 mixed solution Substances 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 3
- 238000005520 cutting process Methods 0.000 claims description 3
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims description 3
- 239000000741 silica gel Substances 0.000 claims description 3
- 229910002027 silica gel Inorganic materials 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 238000002844 melting Methods 0.000 claims description 2
- 230000008018 melting Effects 0.000 claims description 2
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 239000004945 silicone rubber Substances 0.000 claims description 2
- 206010010774 Constipation Diseases 0.000 abstract description 16
- 238000011161 development Methods 0.000 abstract description 5
- 210000000936 intestine Anatomy 0.000 abstract description 5
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 14
- 230000000694 effects Effects 0.000 description 13
- 210000001072 colon Anatomy 0.000 description 12
- 230000000968 intestinal effect Effects 0.000 description 9
- 210000003384 transverse colon Anatomy 0.000 description 8
- 210000000664 rectum Anatomy 0.000 description 7
- 230000005540 biological transmission Effects 0.000 description 6
- 239000004944 Liquid Silicone Rubber Substances 0.000 description 5
- 210000001599 sigmoid colon Anatomy 0.000 description 5
- 239000002872 contrast media Substances 0.000 description 4
- 210000002429 large intestine Anatomy 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 210000001015 abdomen Anatomy 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 241001522633 Betula utilis subsp. albosinensis Species 0.000 description 1
- 239000008830 Carthamus tinctorius Honghua extract Substances 0.000 description 1
- 206010038084 Rectocele Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 206010013990 dysuria Diseases 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 230000003871 intestinal function Effects 0.000 description 1
- 239000008141 laxative Substances 0.000 description 1
- 229940125722 laxative agent Drugs 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0404—X-ray contrast preparations containing barium sulfate
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
The invention relates to the technical field of contrast imaging agents, and provides a contrast imaging agent for gastrointestinal tracts, which comprises first barium-containing polymer particles and second barium-containing polymer particles; the sizes of the first barium-containing polymer particles and the second barium-containing polymer particles are different, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 30-80 parts of high polymer material and 20-70 parts of barium sulfate. The invention also provides a preparation method of the contrast imaging agent for the gastrointestinal tract. The invention has the advantages that: the invention can judge whether the patient has constipation according to the discharge rate of the large-size particles for a certain time; the problems of the intestines of the patient can be accurately judged according to the different times and the number of the large-size particles of the different intestines and the combination of the large-range area development of the small-size particles, so that constipation is further determined; meanwhile, the developer provided by the invention has the advantages of simple preparation process and convenience in use, and is beneficial to application and popularization.
Description
Technical Field
The invention relates to the technical field of contrast imaging agents, in particular to a gastrointestinal tract contrast imaging agent and a preparation method thereof.
Background
Currently, clinical judgment on constipation typing generally requires colon transmission tests, and commonly used imaging agents are large-size materials such as opaque metal pellets, barium rings and barium strips. Because the imaging agent is opaque and has larger size, after entering the intestinal tract, the imaging agent can be observed after X-ray development, and the total number of residues of the imaging agent in the intestinal tract and the number of the imaging agent in each area are calculated, so that the constipation type is judged. However, since the transverse colon is an intraperitoneally located organ, the mobility is greater, and some patients with lengthy transverse colon may have the transverse colon sagged to the location of the sigmoid or rectum, and looking at the traditional visualisation product under X-rays may incorrectly calculate the visualising agent in the transverse colon as the rectocele area, resulting in a calculation error and a diagnosis error.
For this reason, medical staff tries to accurately diagnose patients using some liquid barium, but small particle barium has a disadvantage that when the liquid barium enters the colon, it is easily absorbed by the colon and is stuck to the wall of the colon, so that it cannot be moved, and it cannot be judged whether it is an intestinal canal transmission problem or that the barium is stuck to the wall.
Accordingly, there is an urgent need to design a novel imaging agent for gastrointestinal imaging.
Disclosure of Invention
The invention aims to solve the technical problems of low accuracy and high misdiagnosis rate caused by the prior art by providing a novel contrast imaging agent for gastrointestinal tracts and a preparation method thereof.
The invention adopts the following technical scheme to solve the technical problems:
a contrast imaging agent for gastrointestinal tract, comprising a first barium-containing polymer particle and a second barium-containing polymer particle; the sizes of the first barium-containing polymer particles and the second barium-containing polymer particles are different, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 30-80 parts of high polymer material and 20-70 parts of barium sulfate.
As one of the preferred modes of the invention, the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following preferred raw materials in parts by weight: 46-80 parts of high polymer material and 20-54 parts of barium sulfate.
As one of the preferable modes of the invention, the high polymer material in the raw materials comprises one or more of pp, pe, abs, pvc, tpu, PLGA, PLA, PEG and silicone rubber.
As one of the preferable modes of the invention, the liquid silicone rubber A component and the liquid silicone rubber B component are mixed according to the mass ratio of 1:1.
As one of the preferable modes of the invention, the first barium-containing polymer particles have one or more structural forms of sphere, cylinder, single-cavity ring, double-cavity ring and three-cavity ring, and the second barium-containing polymer particles have circular or quasi-circular structural forms; the first barium-containing polymer particles are large-size particles, the long diameter is 1-10 mm, and the short diameter is 1-10 mm; the second barium-containing polymer particles are small-size particles with the diameter of 0.01-0.9 mm.
As one of preferred embodiments of the present invention, regarding the first barium-containing polymeric beads:
when the first barium-containing polymer particles are in a spherical structure form, the diameter of the first barium-containing polymer particles is 1-5 mm;
when the first barium-containing polymer particles are in a cylindrical structure, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a single-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a double-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a three-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm.
As a preferred embodiment of the present invention, the contrast imaging agent to be administered at one time comprises 10 to 30 particles of a first barium-containing polymer particle having the same structural morphology and 1 to 4g of a second barium-containing polymer particle.
The preparation method of the contrast imaging agent for gastrointestinal tract comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Mixing the weighed high polymer material and barium sulfate, and melting and stirring uniformly;
(3) Pouring the mixed solution into a template with a required structural form, and placing the mixed preparation and the template together in an environment of 20-120 ℃ for curing for 2-10 h;
(4) After the mixed product is solidified, taking out the particles from the template to obtain first barium-containing silica gel particles with corresponding structural morphology;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
The preparation method of the contrast imaging agent for gastrointestinal tract comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, and performing injection molding by using an injection molding machine, wherein the injection molding temperature is 150-250 ℃ and the injection molding time is 40-58 s; during the period, the structural form of the particles is controlled by a mould; finally, first barium-containing polymer particles with corresponding structural forms are obtained;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
The preparation method of the contrast imaging agent for gastrointestinal tract comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, extruding the strip-shaped object by using an extruder, wherein the extrusion temperature is 150-250 ℃, and the extrusion time is 5-10 s;
(3) Cutting the strip-shaped object by using a granulator to obtain first barium-containing polymer particles;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
Design principle:
according to the invention, large-size particles (namely, first barium-containing polymer particles) can stay at different positions along with intestinal canal transmission, whether a patient has constipation is judged by calculating the number of the residual large-size particles in the intestinal canal, and the constipation type of the patient is judged according to the position of the intestinal canal where the large particles stay. Meanwhile, small-size particles (namely, second barium-containing polymer particles) are used for coating the whole large intestine, so that the distribution of the whole large intestine is ensured to be developed, the specific intestinal position where the large particles stay is determined, the situation that a long transverse colon can drop to a sigmoid colon or a rectum to cause the developer in the transverse colon to be counted as the sigmoid colon or the rectum is avoided, the diagnosis accuracy is improved, and misdiagnosis is avoided.
Compared with the prior art, the invention has the advantages that:
(1) The invention can judge whether the patient has constipation according to the discharge rate of the large-size particles for a certain time; the problems of the intestines of the patient can be accurately judged according to the different times and the number of the large-size particles of the different intestines and the combination of the large-range area development of the small-size particles, so that constipation is further determined;
(2) The two barium-containing polymer particles are respectively prepared from 30-80 parts of polymer materials and 20-70 parts of barium sulfate serving as raw materials, wherein the proportion is the result of multiple experimental verification optimization; based on the above proportion of the particle combination, the composition has the best developing effect when in use;
(3) The invention has simple preparation process and convenient use, and is beneficial to application and popularization;
(4) The two barium-containing polymer particles respectively have one or more structural forms of sphere, cylinder, single-cavity ring, double-cavity ring and three-cavity ring; when corresponding particles with different structural forms are swallowed in different time periods, counting errors when the conventional spherical and cylindrical particles are completely overlapped in the intestines can be further avoided;
(5) If the large-size particles are bigger, the particles are not easy to swallow, and if the particles are smaller, the particles are mixed with the small-size particles; if the small-sized particles are smaller, the developing effect is poor, and if the small-sized particles are larger, the large-sized particles are confused with the large-sized particles.
Drawings
FIG. 1 is a schematic structural view of spherical, cylindrical, single-cavity annular, double-cavity annular and three-cavity annular structural morphology particles of the present invention;
FIG. 2 is a graph showing the effect of contrast agent in example 1 of the present invention;
FIG. 3 is a graph showing the effect of contrast agent in comparative example 3 of the present invention;
FIG. 4 is a graph showing the effect of contrast agent in comparative example 4 of the present invention.
Detailed Description
The following describes in detail the examples of the present invention, which are implemented on the premise of the technical solution of the present invention, and detailed embodiments and specific operation procedures are given, but the scope of protection of the present invention is not limited to the following examples.
Example 1
The contrast imaging agent for gastrointestinal tract of the embodiment comprises first barium-containing polymer particles and second barium-containing polymer particles with different sizes and capsules for accommodating the first barium-containing polymer particles and the second barium-containing polymer particles respectively. The first barium-containing polymer particles are large-size particles, the second barium-containing polymer particles are small-size particles, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 50 parts of high polymer material and 40 parts of barium sulfate.
Specifically, in this embodiment, the polymer material is liquid silicone rubber.
Specifically, in this embodiment, the large-size particles are in a cylindrical structure (see fig. 1), the long diameter is 2-5 mm, and the short diameter is 1-3 mm; preferably, the long diameter is 2-3 mm, and the short diameter is 1.5-2.5 mm.
The small-size particles are in a circular or quasi-circular structure form, and the diameter is 0.01-0.9 mm; preferably, the diameter is 0.1 to 0.6mm.
Specifically, in this embodiment, in the capsules corresponding to the large-size particles, each capsule contains 10 to 30 large-size particles, preferably 20 particles; in the capsules corresponding to the small-sized particles, each capsule contains 0.3-1 g of small-sized particles, preferably 0.625g.
The preparation method comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, extruding the strip-shaped object by using an extruder, wherein the extrusion temperature is 150 ℃, and the extrusion time is 8s;
(3) Cutting the strip-shaped object by using a granulator to obtain first barium-containing polymer particles;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer to pulverize, and sieving the pulverized large particles to obtain small particles;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
Example 2
A contrast imaging agent for gastrointestinal tract of this embodiment is basically the same as that of embodiment 1, and is mainly different in that: (1) The first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 30 parts of high polymer material and 20 parts of barium sulfate. And (2) selecting pp as a polymer material. (3) And S1, extruding at 250 ℃ for 6S.
Example 3
A contrast imaging agent for gastrointestinal tract of this embodiment is basically the same as that of embodiment 1, and is mainly different in that: (1) The first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 80 parts of high polymer material and 70 parts of barium sulfate. And (2) selecting a high polymer material pe. (3) And S1, extruding at 200 ℃ for 5S.
Example 4
The contrast imaging agent for gastrointestinal tract of the embodiment comprises first barium-containing polymer particles and second barium-containing polymer particles with different sizes and capsules for accommodating the first barium-containing polymer particles and the second barium-containing polymer particles respectively. The first barium-containing polymer particles are large-size particles, the second barium-containing polymer particles are small-size particles, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 65 parts of high polymer material and 35 parts of barium sulfate.
Specifically, in this embodiment, the polymer material is TPU.
Specifically, in this embodiment, the large-sized particles are in the form of a sphere (see fig. 1) with a diameter of 1 to 5mm.
The small-size particles are in a circular or quasi-circular structure form, and the diameter is 0.01-0.9 mm, preferably 0.1-0.6 mm.
Specifically, in this embodiment, in the capsules corresponding to the large-size particles, each capsule contains 10 to 30 large-size particles, preferably 20 particles; in the capsules corresponding to the small-sized particles, each capsule contains 0.3-1 g of small-sized particles, preferably 0.625g.
The preparation method comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, and performing injection molding by using an injection molding machine at the injection molding temperature of 200 ℃ for 40s; during the period, the structural form of the particles is controlled by a mould; finally, first barium-containing polymer particles with corresponding structural forms are obtained;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer to pulverize, and sieving the pulverized large particles to obtain small particles;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
Example 5
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 4, and is mainly different in that: (1) The first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 46 parts of high polymer material and 20 parts of barium sulfate. (2) Polymer material PLGA is selected. (3) S1, injection molding temperature is 150 ℃ and injection molding time is 58S.
Example 6
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 4, and is mainly different in that: (1) The first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 80 parts of high polymer material and 54 parts of barium sulfate. And (2) selecting ABS as the high polymer material. (3) S1, injection molding temperature is 250 ℃, and injection molding time is 45S.
Example 7
The contrast imaging agent for gastrointestinal tract of the embodiment comprises first barium-containing polymer particles and second barium-containing polymer particles with different sizes and capsules for accommodating the first barium-containing polymer particles and the second barium-containing polymer particles respectively. The first barium-containing polymer particles are large-size particles, the second barium-containing polymer particles are small-size particles, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 50 parts of high polymer material and 40 parts of barium sulfate.
Specifically, in this embodiment, the polymer material is liquid silicone rubber; the liquid silicone rubber is prepared by mixing a liquid silicone A component (HT 9860A) and a liquid silicone B component (HT 9860B) of Shenzhen Honghua silicone technology Co., ltd. According to a mass ratio of 1:1.
Specifically, in this embodiment, the large-size particles are in a single-cavity annular structure (see fig. 1), with a short diameter of 1-3 mm and a long diameter of 2-5 mm. The small-size particles are in a circular or quasi-circular structure form, and the diameter is 0.01-0.9 mm; preferably, the diameter is 0.1 to 0.6mm.
Specifically, in this embodiment, in the capsules corresponding to the large-size particles, each capsule contains 10 to 30 large-size particles, preferably 20 particles; in the capsules corresponding to the small-sized particles, each capsule contains 0.3-1 g of small-sized particles, preferably 0.625g.
The preparation method comprises the following steps:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Mixing the weighed polymer material and barium sulfate, and uniformly stirring;
(3) Pouring the mixed solution into a template with a required shape, and placing the mixed preparation and the template together in an environment of 70 ℃ for curing for 5 hours;
(4) After the mixed product is solidified, taking out the particles from the template to obtain first barium-containing silica gel particles with corresponding structural forms;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer to pulverize, and sieving the pulverized large particles to obtain small particles;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
Example 8
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 7, and is mainly different in that: s1, pouring the mixed solution into a template with a required cylindrical shape, and placing the mixed preparation and the template together in an environment of 20 ℃ for curing for 10 hours.
Example 9
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 7, and is mainly different in that: s1, pouring the mixed solution into a template with a required cylindrical shape, and placing the mixed preparation and the template together in an environment of 120 ℃ for curing for 2 hours.
Example 10
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 7, and is mainly different in that: the large-size particles are in a double-cavity annular structure (see figure 1), the short diameter is 1-3 mm, and the long diameter is 2-5 mm.
Example 11
A contrast imaging agent for gastrointestinal tract of this embodiment is substantially the same as that of embodiment 7, and is mainly different in that: the large-size particles are in a three-cavity annular structure (see figure 1), the short diameter is 1-3 mm, and the long diameter is 2-5 mm.
Design principle of contrast imaging agent in the above embodiment:
according to the invention, large-size particles (namely, first barium-containing polymer particles) can stay at different positions along with intestinal canal transmission, whether a patient has constipation is judged by calculating the number of the residual large-size particles in the intestinal canal, and the constipation type of the patient is judged according to the position of the intestinal canal where the large particles stay. Meanwhile, small-size particles (namely, second barium-containing polymer particles) are used for coating the whole large intestine, so that the distribution of the whole large intestine is ensured to be developed, the specific intestinal position where the large particles stay is determined, the situation that a long transverse colon can drop to a sigmoid colon or a rectum to cause the developer in the transverse colon to be counted as the sigmoid colon or the rectum is avoided, the diagnosis accuracy is improved, and misdiagnosis is avoided.
Administration method and notice:
laxatives and other drugs affecting bowel function were taken 3 days prior to examination. Checking that the gastrointestinal tract contrast imaging agent capsules are taken along with standard dining on the same day, and shooting 1 abdomen X-ray flat tablet for 6, 24, 48 and 72 hours after taking the marker (1) recording the total number of large particle residues in each time period and the number of large particle residues in each partition of colon of the abdomen flat tablet; the discharge rate of large particles is more than 80 percent and is normal in colon transmission, and the discharge rate is less than or equal to 80 percent and is abnormal in colon transmission; (2) The number of residual large particles in the right half colon region, the left half colon region and the rectum sigmoid colon region is recorded according to the colon region, the transportation index is calculated, and the chronic constipation is classified according to the transportation index (the transportation index is more than 0.5 and is the constipation with dysuria, the transportation index is less than 0.5 and is the slow transportation type constipation, and the transportation index=0.5 and is the mixed type constipation). Transport index = SRm/(rcm+lcm+srm), where SRm is the number of large colorectal particles in the sigmoid rectum, RCm is the number of large right-half colon particles, LCm is the number of large left-half colon particles.
The practical application shows that the contrast imaging agent for gastrointestinal tract has obvious developing effect, and whether constipation exists in a patient can be judged according to the discharge rate of large-size particles for a certain time; and according to the number of large-size particles of different intestinal tracts at different times and by combining with the development of large-range areas of small-size particles, the problems of the intestinal tracts of the patient can be accurately judged, so that constipation can be further determined. Taking example 1 as an example, the application effect is shown in fig. 2.
In addition, in order to verify the influence of the addition proportion of each raw material in the first barium-containing polymer particles and the second barium-containing polymer particles on the use effect, the following comparative examples were further set, and the practical application effects of the contrast imaging agents of the comparative examples were respectively tested.
Comparative example 1
A contrast imaging agent for gastrointestinal tract of this comparative example is substantially the same as in example 1, and differs mainly in that: the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 10 parts of high polymer material and 40 parts of barium sulfate.
Comparative example 2
A contrast imaging agent for gastrointestinal tract of this comparative example is substantially the same as in example 1, and differs mainly in that: the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 15 parts of high polymer material and 40 parts of barium sulfate.
Comparative example 3
A contrast imaging agent for gastrointestinal tract of this comparative example is substantially the same as in example 1, and differs mainly in that: the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 170 parts of high polymer material and 40 parts of barium sulfate.
Comparative example 4
A contrast imaging agent for gastrointestinal tract of this comparative example is substantially the same as in example 1, and differs mainly in that: the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 200 parts of high polymer material and 40 parts of barium sulfate.
Results: the contrast agents of comparative examples 1 and 2 are difficult to form and cannot be made into finished products; example 1 the effect of application is shown in figure 2; the effects of the comparative examples 3 and 4 are shown in fig. 3 and 4, respectively. From the above results, it is clear that the addition ratio of each raw material in the first barium-containing polymer particles and the second barium-containing polymer particles has an important influence on the use effect, and that the particle combination based on the ratio of the present invention has an optimal development effect when used.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (8)
1. A contrast imaging agent for gastrointestinal tract, which is characterized by comprising first barium-containing polymer particles and second barium-containing polymer particles; the sizes of the first barium-containing polymer particles and the second barium-containing polymer particles are different, and the first barium-containing polymer particles and the second barium-containing polymer particles respectively comprise the following raw materials in parts by weight: 30-80 parts of high polymer material and 20-70 parts of barium sulfate.
2. The contrast imaging agent for gastrointestinal tract according to claim 1, wherein the polymer material in the raw material comprises one or more of pp, pe, abs, pvc, tpu, PLGA, PLA, PEG and silicone rubber.
3. The contrast imaging agent for gastrointestinal tract according to claim 1, wherein the first barium-containing polymer particles have one or more of a spherical, cylindrical, single-cavity annular, double-cavity annular, and triple-cavity annular structure morphology, and the second barium-containing polymer particles have a circular or quasi-circular structure morphology; the first barium-containing polymer particles are large-size particles, the long diameter is 1-10 mm, and the short diameter is 1-10 mm; the second barium-containing polymer particles are small-size particles with the diameter of 0.01-0.9 mm.
4. A contrast imaging agent for the gastrointestinal tract according to claim 3, characterized in that, in relation to the first barium-containing polymeric particles:
when the first barium-containing polymer particles are in a spherical structure form, the diameter of the first barium-containing polymer particles is 1-5 mm;
when the first barium-containing polymer particles are in a cylindrical structure, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a single-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a double-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm;
when the first barium-containing polymer particles are in a three-cavity annular structure form, the short diameter is 1-3 mm, and the long diameter is 2-5 mm.
5. The contrast imaging agent for gastrointestinal tract according to any one of claims 1 to 4, wherein the contrast imaging agent for one administration comprises 10 to 30 particles of the first barium-containing polymer particles having the same structural morphology and 1 to 4g of the second barium-containing polymer particles.
6. A method of preparing a contrast imaging agent for the gastrointestinal tract according to any one of claims 1 to 5, comprising the steps of:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Mixing the weighed high polymer material and barium sulfate, and melting and stirring uniformly;
(3) Pouring the mixed solution into a template with a required structural form, and placing the mixed preparation and the template together in an environment of 20-120 ℃ for curing for 2-10 h;
(4) After the mixed product is solidified, taking out the particles from the template to obtain first barium-containing silica gel particles with corresponding structural forms;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
7. A method of preparing a contrast imaging agent for the gastrointestinal tract according to any one of claims 1 to 5, comprising the steps of:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, and performing injection molding by using an injection molding machine, wherein the injection molding temperature is 150-250 ℃ and the injection molding time is 40-58 s; during the period, the structural form of the particles is controlled by a mould; finally, first barium-containing polymer particles with corresponding structural forms are obtained;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
8. A method of preparing a contrast imaging agent for the gastrointestinal tract according to any one of claims 1 to 5, comprising the steps of:
s1, preparing first barium-containing polymer particles:
(1) Weighing the raw materials respectively;
(2) Uniformly mixing the weighed high polymer material and barium sulfate, extruding the strip-shaped object by using an extruder, wherein the extrusion temperature is 150-250 ℃, and the extrusion time is 5-10 s;
(3) Cutting the strip-shaped object by using a granulator to obtain first barium-containing polymer particles;
s2, preparing second barium-containing polymer particles:
taking out a part of large particles from the prepared first barium-containing polymer particles, putting the large particles into a pulverizer for pulverization, and sieving the pulverized large particles after pulverization to obtain small particles with the particle size of 0.01-0.9 mm;
s3, encapsulating:
10 to 30 first barium-containing polymer particles are put into a capsule to form a capsule containing large-size particles; weighing 1-4 g of second barium-containing polymer particles, and evenly loading the second barium-containing polymer particles into four capsules to form a capsule containing small-size particles;
s4, packaging:
one "capsule containing large-sized particles" and four "capsules containing small-sized particles" are combined into one developer capsule unit and contained in one package.
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