CN114010804B - Angiography agent for corpses and preparation method thereof - Google Patents
Angiography agent for corpses and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of contrast agents, and particularly relates to an angiographic contrast agent for corpses and a preparation method thereof. The composition of the angiographic contrast agent provided by the invention comprises: iohexol, sorbitol, and water; wherein the content of the iohexol in the angiographic contrast medium is 20-60 mg/mL, and the content of the sorbitol in the angiographic contrast medium is 700-800 mg/mL. The invention can effectively avoid or reduce tissue edema or image artifacts caused by the tissue extravasation of the contrast agent by optimally designing the component formula of the angiographic contrast agent, ensures that the angiographic contrast agent has good developing effect under the condition of not influencing the histopathology, and has lower production cost and good economy.
Description
Technical Field
The invention belongs to the technical field of contrast agents, and particularly relates to an angiographic contrast agent for corpses and a preparation method thereof.
Background
The virtual dissection refers to an dissection means for acquiring internal and external positive information of a corpse and determining the death reason on the premise of not destroying or slightly destroying the integrity of the corpse by means of modern medical imaging and computer technology and by combining with the dissection principle and technical requirements, and has the greatest characteristic of non-invasiveness (or minimally invasive property) and has the advantages which are beyond the traditional gross dissection. The virtual dissection is mainly realized through post-mortem computed tomography (PMCT) and post-mortem magnetic resonance imaging (PMMRI), the PMCT has been proved to be very effective in diagnosing fractures, foreign bodies, air embolism and the like, while the PMMRI is more suitable for detecting smaller soft tissue injuries and organ abnormalities, but neither the PMCT nor the PMMRI can accurately display intravascular abnormalities. By performing contrast enhanced scanning with contrast agent, the trajectory and morphology of the blood vessel can be completely presented, and the rapid development of the corpse computer tomography angiography (PMCTA) technology largely remedies the above disadvantages. Post-mortem whole body angiography is extremely challenging due to the lack of complete blood circulation in the cadaver.
The contrast agents currently used by PMCTA are mainly classified into oily contrast agents and aqueous contrast agents, the oily solution provides a longer intravascular period (more than 72 hours), the interval between injection and imaging can be prolonged, and the extravasation phenomenon can be effectively avoided. Although the water-soluble contrast agent has a good imaging effect, tissue edema or artifacts are easily caused by tissue penetration during injection, and the difficulty of forensic identification is increased.
In the process of corpse angiography, the dosage of the contrast agent is large, hundreds of milliliters of corpse target organ angiography is needed, and a plurality of liters of corpse whole body angiography is needed. Although clinically used iodine contrast agents such as iodized oil can meet the requirements of corpse angiography, the price of the iodine contrast agents is high, and the application of the iodine contrast agents in corpse angiography is limited. The corpse angiography needs to use a contrast agent with proper viscosity, and if the viscosity of the contrast agent is too high, the contrast agent is difficult to enter small blood vessels, so that the angiography is incomplete; if the viscosity of the contrast agent is too low, the contrast agent can enter corpse microcirculation, thereby causing tissue leakage and generating artifact image quality.
Disclosure of Invention
In view of the above, the present invention provides an angiographic contrast agent for corpses and a preparation method thereof, which can not only solve the technical problem that water-soluble iodine contrast agent is easy to permeate outwards through microcirculation of corpse blood vessels to cause edema of perivascular tissues or generate artifacts, but also solve the problem that fat-soluble iodine contrast agent produces more extravasation in gastrointestinal tract regions, and improve the current situation that clinically applied contrast agents cannot be applied in large quantities due to high price when being applied to corpse angiography.
The invention provides an angiographic contrast agent for corpses, which comprises the following components: iohexol, sorbitol and water.
In the angiographic contrast agent provided by the present invention, the content of iohexol in the angiographic contrast agent is 20-60 mg/mL, specifically 20mg/mL, 25mg/mL, 30mg/mL, 35mg/mL, 40mg/mL, 45mg/mL, 50mg/mL, 55mg/mL or 60mg/mL.
In the angiographic contrast agent provided by the present invention, the sorbitol is contained in the angiographic contrast agent in a range of 700 to 800mg/mL, specifically 700mg/mL, 710mg/mL, 720mg/mL, 730mg/mL, 740mg/mL, 750mg/mL, 760mg/mL, 770mg/mL, 780mg/mL, 790mg/mL, or 800mg/mL.
In the angiographic contrast agent provided by the present invention, said angiographic contrast agent preferably consists only of iohexol, sorbitol and water.
The invention also provides a preparation method of the angiography agent, which comprises the following steps:
iohexol, sorbitol and water were mixed to obtain an angiographic agent for cadavers.
In the preparation method provided by the invention, the mixing mode is preferably stirring or shaking.
In the preparation method provided by the invention, the mixing temperature is preferably 20-30 ℃, and specifically can be 20 ℃, 21 ℃, 22 ℃, 23 ℃, 24 ℃, 25 ℃ (room temperature), 26 ℃, 27 ℃, 28 ℃, 29 ℃ or 30 ℃; the mixing time is preferably 1 to 2 hours, and specifically may be 1 hour, 1.1 hour, 1.2 hours, 1.3 hours, 1.4 hours, 1.5 hours, 1.6 hours, 1.7 hours, 1.8 hours, 1.9 hours or 2 hours.
In the production method provided by the present invention, in order to eliminate a small amount of gas mixed in the mixing process, it is preferable to perform defoaming treatment on the obtained mixed solution after the completion of the mixing.
In the preparation method provided by the invention, the specific mode of the defoaming treatment is preferably as follows: and sealing and standing the mixed solution under the condition of keeping out of the sun.
In the preparation method provided by the invention, the temperature for sealing and standing is preferably 20-30 ℃, and specifically can be 20 ℃, 21 ℃, 22 ℃, 23 ℃, 24 ℃, 25 ℃ (room temperature), 26 ℃, 27 ℃, 28 ℃, 29 ℃ or 30 ℃; the time for sealing and standing is preferably 12-24 h, and specifically can be 12h, 13h, 14h, 15h, 16h, 17h, 18h, 19h, 20h, 21h, 22h, 23h or 24h.
In the preparation method provided by the invention, after the angiographic contrast agent is prepared, the prepared angiographic contrast agent is preferably moved to a CT (computed tomography) for scanning, and whether the components of the angiographic contrast agent are uniformly mixed and have no bubbles is determined according to the brightness uniformity of a scanned image and the measured variance of CT values.
Compared with the prior art, the invention provides an angiographic contrast agent for corpses and a preparation method thereof. The composition of the angiographic contrast agent provided by the invention comprises: iohexol, sorbitol and water; wherein the content of the iohexol in the angiography agent is 20-60 mg/mL, and the content of the sorbitol in the angiography agent is 700-800 mg/mL. The invention can effectively avoid or reduce tissue edema or image artifacts caused by tissue extravasation of the contrast agent by optimally designing the component formula of the angiography agent, ensures that the angiography agent has good developing effect under the condition of not influencing the histopathology, and has lower production cost and good economy. More specifically, the present invention provides an angiographic contrast agent having the following technical advantages:
1) The iohexol added into the angiography agent has osmotic pressure close to that of blood plasma, moderate viscosity, good tolerance in vivo, low toxicity to a nervous system and the like, and is very suitable for angiography, myelography, urography and CT enhanced scanning;
2) Sorbitol used as a matrix in the angiographic agent has the advantages of no toxicity, moderate viscosity, moisture retention, heat stability, no deterioration and the like, is easy to dissolve in water and organic solvent, does not easily perform Maillard reaction and water retention with amino acid, protein and the like, does not have certain influence on in-vivo tissue components or structures even if being retained in a living body for a long time (for example, the influence on pathological histological examination after absorbing and dissolving fat in the tissues) and ensures the accuracy of the pathological histological examination;
3) Sorbitol used as a matrix in the angiographic agent can reach a higher CT value without adding an iodine component, so that the use amount of a precious iodine component is greatly reduced, and the production cost is reduced.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a graph of concentration versus in vitro CT value for a solution of iohexol provided in example 1 of the present invention;
FIG. 2 is a concentration-viscosity graph of a sorbitol solution provided in example 1 of the present invention;
FIG. 3 is a graph of concentration versus in vitro CT value for a sorbitol solution provided in example 1 of the present invention;
FIG. 4 is a sorbitol concentration-viscosity graph of a contrast agent provided in example 1 of the present invention;
FIG. 5 is a sorbitol concentration-in vitro CT value graph of the contrast agent provided in example 1 of the present invention;
FIG. 6 is a sorbitol concentration-in vivo CT value graph of a contrast agent provided in example 2 of the present invention;
FIG. 7 is a three-dimensional reconstruction demonstration chart provided by embodiment 3 of the present invention;
FIG. 8 is a three-dimensional reconstructed image of a contrast agent of 0% sorbitol +5% iohexol provided in example 3 of the invention;
FIG. 9 is a three-dimensional reconstructed image of a contrast agent of 10% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 10 is a three-dimensional reconstructed image of a contrast agent of 20% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 11 is a three-dimensional reconstructed image of a contrast agent of 30% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 12 is a three-dimensional reconstructed image of a contrast agent of 40% sorbitol +5% iohexol provided in example 3 of the invention;
FIG. 13 is a three-dimensional reconstructed image of a contrast agent of 50% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 14 is a three-dimensional reconstructed image of a contrast agent of 60% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 15 is a three-dimensional reconstructed image of a contrast agent of 70% sorbitol +5% iohexol provided in example 3 of the present invention;
FIG. 16 is a three-dimensional reconstructed image of a contrast agent of 80% sorbitol +5% iohexol provided in example 3 of the invention;
fig. 17 is a three-dimensional reconstructed image of a contrast agent of 90% sorbitol +5% iohexol provided in example 3 of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the following examples of the present invention, unless otherwise specified, the concentrations are mass-volume percent concentrations only, and in the case of a concentration of 5.0%, the total volume of the solution containing 5g of solute is 100mL, i.e., 5.0% =50mg/mL.
Example 1
In vitro testing of varying concentrations of iohexol and sorbitol contrast agent
(1) The purpose is as follows: the effect of iohexol and sorbitol concentrations on the CT value (HU value) and viscosity of the solution and the corresponding trend were determined.
(2) Materials: iohexol, sorbitol, single distilled water, CT machine.
(3) The experimental method comprises the following steps:
(3.1) formulation of agent I to investigate the effect of variations in iohexol concentration on the physical properties of the contrast agent:
taking a proper amount of iohexol, dissolving in single distilled water, respectively preparing 11 solutions with iohexol concentrations of 0%, 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5% and 5.0%, respectively preparing 50mL of each solution, placing the solutions into a 50mL centrifuge tube, standing for 24 hours in a dark place at room temperature, performing CT scanning and recording corresponding numerical values, wherein the result is shown in figure 1, and figure 1 is a concentration-in-vitro CT value curve chart of the iohexol solution provided by the embodiment 1 of the invention.
As can be seen from fig. 1, the CT value of iohexol solution increases with the increase of its concentration and is linearly related, and the linear fitting equation is y =101.78x +30.464.
(3.2) formulation reagent II to examine the effect of sorbitol concentration variation on the physical properties of the contrast agent:
taking a proper amount of sorbitol to dissolve in single distilled water, respectively preparing 10 solutions with sorbitol concentrations of 0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%, respectively, placing 50mL of each solution in a 50mL centrifuge tube, standing for 24h in a dark place at room temperature, performing viscosity measurement and CT scanning, and recording corresponding numerical values, wherein the results are shown in figures 2 and 3, figure 2 is a concentration-viscosity curve graph of the sorbitol solution provided by the invention in the example 1 (note: the viscosity of water is 1 mPas, and the measurement result of the viscosity of the sorbitol solution less than 5 mPas is omitted according to the relevant principle of the experiment), and figure 3 is a concentration-in-vitro CT value curve graph of the sorbitol solution provided by the invention in the example 1.
As can be seen from fig. 2, the viscosity of the sorbitol solution increases with increasing concentration, and is parabolic.
As can be seen from fig. 3, the CT value of the sorbitol solution increases with the increase of its concentration and is linearly related, and the linear fitting equation is y =2.7038x +10.539.
(3.3) after determining the CT value of iohexol or sorbitol at each concentration, reagent III was prepared to examine the effect of mixing the two components on the physical properties of the contrast agent:
appropriate amounts of iohexol and sorbitol are dissolved in single distilled water to prepare 10 solutions with sorbitol concentrations of 0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%, wherein each solution is prepared into 50mL, and the iohexol concentration is unchanged (5%), after the solution is prepared, the solution is placed into a 50mL centrifuge tube and is placed in a dark place at room temperature for 24h, viscosity determination and CT scanning are performed, and corresponding values are recorded, and the results are shown in fig. 4 and 5, fig. 4 is a sorbitol concentration-viscosity curve diagram of the contrast agent provided in embodiment 1 of the present invention, and fig. 5 is a sorbitol concentration-in vitro CT value curve diagram of the contrast agent provided in embodiment 1 of the present invention.
As can be seen from fig. 4, the viscosity of the sorbitol mixed iohexol contrast agent increases with increasing sorbitol concentration, and is parabolic. And the addition of iohexol increases the overall viscosity of the contrast agent.
As can be seen from fig. 5, the CT value of the sorbitol mixed iohexol contrast agent increases with increasing sorbitol concentration and is linearly related, and the linear fitting equation is y =2.6972x +502.47.
As can be seen by comparing the linear fitting equations of fig. 3 and fig. 5, the values of a in the two equations are approximate, i.e., 2.6972 and 2.7038, respectively, which indicates that the addition of sorbitol to iohexol contrast agent does not affect its development ability under CT, and the predicted CT values of the contrast agent after mixing different concentrations of iohexol and sorbitol can be simply calculated by the equation.
Example 2
In vivo testing of different concentrations of sorbitol contrast agent
(1) The purpose is as follows: and measuring the change trend of the CT value of the sorbitol contrast agent with different concentrations in the animal body after injection.
(2) Materials and grouping: selecting 30 adult rabbits (female and male are not limited), and carrying out CT; the rabbits are divided into 10 groups by completely random sampling, and each group contains 3 rabbits; each group of rabbits was injected with 1 of the reagents III prepared according to the method used in example 1.
(3) The experimental method comprises the following steps: preparing each 60ml of reagent III, and standing for 24 hours at room temperature in a dark place; rabbits were anesthetized by 20% chloral hydrate by intravenous injection into the ear, each injection amounting to about 5mL; injecting 1 group of rabbits with 20mL of each contrast agent through a common carotid artery cannula at the flow rate of 0.2mL/s by a high-pressure injector at room temperature, and respectively carrying out in-situ CT scanning before and after injection; the post-processing workstation selects CT values of 3 random equal-size regions of interest (ROI) in the aortic arch lumen of each rabbit as a measurement index (the aortic arch lumen is wide, the filling degree is good, and the detection is easy), and compares the CT values with the in-vitro CT value of the reagent III in the embodiment 1.
(4) The experimental results are as follows: as shown in fig. 6, fig. 6 is a graph of sorbitol concentration versus CT value in vivo of the contrast medium provided in embodiment 2 of the present invention, and it can be seen from fig. 6 that the CT value of the contrast medium in vivo changes to a certain extent due to the influence of blood volume, but the contrast medium generally has a linear rising trend.
Example 3
Tissue leakage testing of contrast agents in animals
(1) The purpose is as follows: the leakage in dead animal carcasses was examined after the addition of varying concentrations of sorbitol to the iohexol contrast agent.
(2) Materials: adult rabbits 30 (female and male not limited) had reagent III, CT, example 1.
(3) The experimental method comprises the following steps: dividing 30 rabbits into 10 groups by completely random sampling; rabbits were euthanized by intravenous injection of 20% chloral hydrate into the ear, approximately 5mL each, and the time of death was recorded; after 24h of death of the rabbits (increase of vascular permeability in order to detect leakage), the rabbits were injected by high-pressure syringe at room temperature with 20mL per injection through common carotid artery cannula at 0.2mL/s, and in-situ CT scans were performed before and after injection, respectively; and (4) transmitting the data to a post-processing workstation for three-dimensional reconstruction, searching for a leakage region (with unclear and regular boundaries and discontinuous and symmetrical shape) for measurement, and evaluating the leakage condition of the contrast agent by the method.
(4) The experimental results are as follows: fig. 7 to 17 show the results, where fig. 7 is a three-dimensional reconstruction demonstration diagram provided in embodiment 3 of the present invention, in fig. 7, the left figure is the three-dimensional reconstruction situation when no contrast agent is injected, and the right figure is the three-dimensional reconstruction situation after the contrast agent is injected, where the reference numeral 1 is: the boundary is clear, the shape is continuous, the contrast agent in the normal blood vessel shows the condition, and no leakage exists; region No. 2: irregular shape, discontinuous display, being a leakage area of the contrast agent in vivo, and mostly a gastrointestinal tract area (rich blood and dense small blood vessels); region No. 3: the kidney region is spherical, and the coating of the kidney shows that the kidney region is not a leakage region. FIGS. 8 to 17 are three-dimensional reconstructed images of contrast agents of different sorbitol concentrations provided in example 3 of the present invention; as is apparent from fig. 8 to 17, the leakage in the gastrointestinal region of rabbits injected with sorbitol of 70% or more concentration is significantly reduced from that of rabbits injected with sorbitol of 70% or less (the reason for the significant difference should be related to the viscosity of sorbitol of different concentrations in a curve rising trend, the viscosity difference is not great at low concentration, and the viscosity rises rapidly after reaching a certain concentration), which indicates that the leakage of the contrast medium in the tissue is significantly reduced after reaching a certain concentration, and proves that the leakage in the tissue is reduced after adding sorbitol of a certain concentration into the iodine contrast medium.
Through experimental studies of the above examples, the following conclusions can be drawn:
1) The addition of sorbitol in the contrast agent can reduce the tissue extravasation of the contrast agent, which is mainly because the increase of the liquid viscosity after the addition of sorbitol in the iodine contrast agent forms the effect similar to fat embolism in tiny blood vessels and capillary vessels, so that the main blood vessels can be clearly displayed without being influenced by the increase of the CT value caused by the contrast agent flowing into the tissue capillary vessels; the experimental results and practical experience are combined to determine that the sorbitol concentration is proper when reaching 70-80%, the extravasation reduction effect is not obvious when the concentration is too low, and manual injection is difficult due to too high viscosity when the concentration is too high, so that the sorbitol injection is not beneficial to popularization and use.
2) The CT value of the contrast agent provided by the invention is more than 400HU, and the contrast agent can meet the requirement of examination (the suitable range of CT chest enhancement examination: the descending aorta CT value is more than or equal to 300HU, and the pulmonary artery CTA pulmonary trunk is more than or equal to 250 HU); meanwhile, the CT value of the contrast agent is less than 900HU, and the three-dimensional reconstruction requirement can be met (the CT value of bones in a human body is large and can reach 1000HU or even higher, and certain artifacts can be generated when the CT value of the contrast agent is too high, so that the image quality is influenced, and the CT value is close to the bones during three-dimensional reconstruction, so that the automatic reconstruction difficulty and quality of a machine are increased, the manual workload is increased, and the image quality is reduced).
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and amendments can be made without departing from the principle of the present invention, and these modifications and amendments should also be considered as the protection scope of the present invention.
Claims (9)
1. An angiographic agent for use on cadavers comprising: iohexol, sorbitol and water; wherein the content of iohexol in the angiographic contrast medium is 20-50 mg/mL, and the content of sorbitol in the angiographic contrast medium is 700-800 mg/mL.
2. The angiographic contrast agent according to claim 1, wherein the iohexol is present in the angiographic contrast agent in an amount of 20mg/mL, 25mg/mL, 30mg/mL, 35mg/mL, 40mg/mL, 45mg/mL or 50mg/mL.
3. The angiographic contrast agent according to claim 1, wherein the sorbitol is present in the angiographic contrast agent in an amount of 700mg/mL, 710mg/mL, 720mg/mL, 730mg/mL, 740mg/mL, 750mg/mL, 760mg/mL, 770mg/mL, 780mg/mL, 790mg/mL or 800mg/mL.
4. A method for preparing the angiographic contrast agent according to any one of claims 1 to 3, comprising the steps of:
iohexol, sorbitol and water were mixed to obtain an angiographic agent for cadavers.
5. The method according to claim 4, wherein the mixing is performed by stirring or shaking.
6. The method according to claim 4, wherein the mixing temperature is 20 to 30 ℃; the mixing time is 1-2 h.
7. The method of claim 4, further comprising: after the mixing is finished, defoaming treatment is performed on the obtained mixed liquid.
8. The preparation method according to claim 7, wherein the defoaming treatment is carried out in a specific manner: and sealing and standing the mixed solution under the condition of keeping out of the sun.
9. The preparation method of claim 7, wherein the temperature of the sealed standing is 20-30 ℃; the sealing and standing time is 12-24 h.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100021389A1 (en) * | 2006-09-18 | 2010-01-28 | Forim-X-AG | Radiographic contrast agent for postmortem, experimental and diagnostic angiography |
| CN111840580A (en) * | 2020-07-24 | 2020-10-30 | 北京迪安法润鉴定技术有限公司 | Special angiographic agent for corpses and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100021389A1 (en) * | 2006-09-18 | 2010-01-28 | Forim-X-AG | Radiographic contrast agent for postmortem, experimental and diagnostic angiography |
| CN111840580A (en) * | 2020-07-24 | 2020-10-30 | 北京迪安法润鉴定技术有限公司 | Special angiographic agent for corpses and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| Go Inokuchi等.The utility of postmortem computed tomography selective coronary angiography in parallel with autopsy.《Forensic Sci Med Pathol》.2013,第506-514页，尤其是第507页左侧倒数的第10-21行，第508页左侧第16-18行. * |
| The utility of postmortem computed tomography selective coronary angiography in parallel with autopsy;Go Inokuchi等;《Forensic Sci Med Pathol》;20131231;第506-514页，尤其是第507页左侧倒数的第10-21行，第508页左侧第16-18行 * |
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