CN108514644B

CN108514644B - Short T2 effect rectal/vaginal cavity internal magnetic resonance imaging contrast agent and preparation method thereof

Info

Publication number: CN108514644B
Application number: CN201810317844.7A
Authority: CN
Inventors: 龚静山; 唐雪; 贾桂静; 焦月新; 周宙; 冯霞; 汪娟; 易芹芹
Original assignee: Shenzhen Peoples Hospital
Current assignee: Shenzhen Peoples Hospital
Priority date: 2018-04-10
Filing date: 2018-04-10
Publication date: 2021-07-20
Anticipated expiration: 2038-04-10
Also published as: CN108514644A

Abstract

The invention discloses a short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent and a preparation method thereof, wherein the contrast agent comprises iron dextran, an ultrasonic coupling agent and water. The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent has the beneficial effects that: the iron dextran, the ultrasonic couplant and the water are mixed according to a specified proportion to prepare the contrast agent, so that the T2 relaxation time of the ultrasonic couplant in magnetic resonance imaging is shortened, the signal intensity of the ultrasonic couplant on T2 weighted imaging is reduced, and the interference of the ultrasonic couplant on the focus display in the magnetic resonance imaging of the rectal cavity and the vaginal cavity is reduced; the contrast agent has good adhesion with cavity organs such as rectum/vagina and the like, can well fill the cavity organs such as rectum/vagina and the like, has no fluidity due to colloid, can be properly formed, does not need to be contained in a specific container, and can be directly filled in the rectum or the vagina; the contrast agent has stable components, long shelf life and convenient storage.

Description

Short T2 effect rectal/vaginal cavity internal magnetic resonance imaging contrast agent and preparation method thereof

Technical Field

The invention relates to the field of medical preparations, in particular to a short T2 effect rectal/vaginal cavity internal magnetic resonance imaging contrast agent and a preparation method thereof.

Background

Magnetic Resonance Imaging (MRI) is an Imaging technique that uses signals generated by the Resonance of atomic nuclei in a Magnetic field to reconstruct and image, and has been developed rapidly in recent years as a new medical image diagnosis technique. Not only does magnetic resonance imaging provide a greater amount of information than many other imaging techniques, but the unique information it provides has great potential advantages for diagnosing disease. In magnetic resonance imaging, good image quality is the basis of all clinical diagnoses and research development, and therefore, high-quality images are the primary condition for doctors to correctly study, judge and diagnose the focus of patients.

At present, magnetic resonance imaging diagnosis is widely applied to clinic, including the brain stem, the infratentoria, the occipital foramen area, the spinal cord, the intervertebral disc and the like, the imaging of the magnetic resonance imaging diagnosis is obviously better than that of CT (Computed Tomography), and meanwhile, the magnetic resonance imaging is also widely applied to the examination of the abdomen and the pelvic cavity, for example, the magnetic resonance imaging plays an important role in the stage and the re-stage of rectal cancer: the high-resolution T2 weighted image (T2-weighted image, T2WI for short) is the main inspection sequence of rectal cancer stage, and is important for the T stage of primary focus. Meta analysis showed that the sensitivity of magnetic resonance imaging to T-staging was 87%, specificity was 75%, and accuracy was 83% to 94%. However, since the rectum, the uterus and the vagina are hollow organs containing gas, the intestinal contents (such as feces and gas) not only affect the display of the focus, but also produce artifacts, the preparation of the intestinal tract and the good filling in the cavity are important for observing the lesion, and the filling of the intestinal cavity by using a proper contrast agent can reduce the artifacts and improve the image quality.

The filling agent commonly used in the magnetic resonance imaging examination and diagnosis process of rectum and vagina in clinic at present is an ultrasonic coupling agent, the ultrasonic coupling agent has good adhesion with cavity organs such as rectum/vagina and the like, can well fill the cavity organs such as rectum/vagina and the like, can eliminate the influence of contents in cavities and intestines to improve the display of focuses, has certain help for the magnetic resonance imaging examination and diagnosis of rectum and vagina, has no fluidity compared with water as the filling agent, can be properly formed, does not need to be filled in a specific container, and can be directly filled in the rectum or vagina; the quality guarantee period is long, the storage is convenient, however, the ultrasonic couplant is high signal on T2 weighted imaging in magnetic resonance imaging, which directly affects the display of focus, such as colorectal cancer, especially the Diffusion-weighted Image (DWI) affects the T2 penetration effect, so that the ultrasonic couplant is mixed with the human tissue lesion lump with limited Diffusion, which seriously affects the magnetic resonance imaging examination and diagnosis of rectum and vagina, and finally affects the treatment effect.

Disclosure of Invention

The invention mainly aims to provide a short T2 effect rectal/vaginal intracavity magnetic resonance imaging contrast agent which can avoid generating a high T2WI signal in magnetic resonance imaging and clearly display a focus.

The invention provides a short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent, which comprises iron dextran, an ultrasonic coupling agent and water.

Further, the iron content of the contrast agent is 0.125mg/g-3.75 mg/g.

Further, the ultrasonic coupling agent comprises carbomer, vitamins, a wetting agent, an antibacterial agent, a pH value regulator and water.

Further, the pH regulator includes sodium hydroxide or triethanolamine.

Further, the antibacterial agent includes trichlorohydroxydiphenyl ether or trichlorocarbanilide.

Further, the vitamin is vitamin A, vitamin C, vitamin E or vitamin B5.

Further, the humectant may include one or more of propylene glycol, glycerin and polyethylene glycol.

Further, the ultrasonic couplant comprises, by mass, 0.1% to 1.0% of the carbomer, 0% to 0.1% of the vitamin E, 0.1% to 0.5% of the sodium hydroxide, 3.0% to 8.0% of the glycerol, 0.5% to 1.0% of the trichlorohydroxydiphenyl ether, and 90.0% to 96% of the water.

Further, the contrast agent comprises 0.01-0.50% of the iron dextran, 1.50-59.50% of the water and 40.00-98.00% of the ultrasonic coupling agent by mass percentage.

A preparation method of the short T2 effect rectal/vaginal magnetic resonance imaging contrast agent comprises the following steps: respectively taking the iron dextran, the ultrasonic coupling agent and water with specified mass; mixing the iron dextran with water at a specified temperature, and putting the mixture into the ultrasonic couplant to be uniformly stirred; placing the mixture into an ultrasonic degassing tank for defoaming treatment; the radiation sterilization treatment was performed by cobalt 60.

The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent has the beneficial effects that: the iron dextran, the ultrasonic couplant and the water are mixed according to a specified proportion to prepare the contrast agent, so that the T2 relaxation time of the ultrasonic couplant in magnetic resonance imaging is shortened, the signal intensity of the ultrasonic couplant on T2 weighted imaging is reduced, and the interference of the ultrasonic couplant on the focus display in the magnetic resonance imaging of the rectal cavity and the vaginal cavity is reduced; the contrast agent has good adhesion with cavity organs such as rectum/vagina and the like, can well fill the cavity organs such as rectum/vagina and the like, has no fluidity due to colloid, can be properly formed, does not need to be contained in a specific container, and can be directly filled in the rectum or the vagina; the contrast agent has stable components, long shelf life and convenient storage.

Drawings

FIG. 1 is a schematic view of a scanning pattern of embodiments 1-8 of the present invention;

FIG. 2 is a schematic representation of the experimental procedure T2WI imaging of specific examples 1-8 of the present invention;

FIG. 3 is a schematic representation of the experimental procedure T1WI imaging of specific examples 1-8 of the present invention;

FIG. 4 is a schematic diagram of a scanning mode according to embodiment 9 of the present invention;

FIG. 5 is a schematic representation of the experimental procedure T2WI imaging of example 9 of the present invention;

FIG. 6 is a schematic representation of the experimental procedure T1WI imaging of the present invention as embodied in example 9.

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.

It should be noted that all directional indicators (such as upper, lower, left, right, front and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indicator is changed accordingly, and the connection may be a direct connection or an indirect connection.

In addition, the descriptions related to "first", "second", etc. in the present invention are for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

One embodiment of the present invention is directed to a short T2 effect endorectal/vaginal magnetic resonance imaging contrast agent comprising iron dextran, an ultrasound coupling agent, and water.

The effective components of the contrast agent are the ultrasonic couplant and the iron dextran, in magnetic resonance imaging, when the iron dextran is added into the ultrasonic couplant, the relaxation time of the ultrasonic couplant is shortened, the high signal of the ultrasonic couplant on T2 weighted imaging is inhibited, the relaxation time represents the time required by a system to approach to a certain stable fixed state from an unstable fixed state in statistics and thermodynamics, in synergetics, the relaxation time represents the influence degree of a fast variable, the faster the relaxation time is, the fast variable is not easy to eliminate, and the shorter the relaxation time is, the fast variable is easy to eliminate; in magnetic resonance, when human tissues have lesions, such as inflammation, tumor, infarction, subacute hemorrhage and the like, the position has a T2WI signal, namely, the T2 weighted imaging has a high signal; when the ultrasonic couplant is used as a contrast agent only, the ultrasonic couplant is displayed as a high signal in T2 weighted imaging in magnetic resonance imaging, which not only affects the display of lesions, such as colorectal cancer, but also, more seriously, may cause misjudgment of doctors and misjudgment of normal human tissues as lesion positions, and in a dispersion weighted image, the ultrasonic couplant may affect the T2 penetration effect to be confused with diffusion-limited human tissue lesion masses, which also affects the judgment of doctors on the condition of a detected person or the judgment of lesion positions, so that the iron dextran will reduce the influence of the ultrasonic couplant on magnetic resonance imaging, so that the ultrasonic couplant and the diseased human tissues are distinguished, the lesions are displayed clearly and independently, and the misjudgment, caused by unclear lesion display due to the T2WI high signal generated by the ultrasonic couplant, caused by the high signal generated by the ultrasonic couplant, Misdiagnosis.

In this embodiment, the iron content of the contrast agent is 0.125mg/g-3.75mg/g, in magnetic resonance imaging, when the iron dextran is added to the ultrasound couplant, the relaxation time of the ultrasound couplant is shortened, the high signal of the ultrasound couplant on T2 weighted imaging is suppressed, and in the final contrast agent obtained by mixing the ultrasound couplant and the iron dextran according to a specified ratio, when the iron content is 3.125mg/g, the high signal of the ultrasound couplant on T2 weighted imaging is just completely suppressed.

In this embodiment, the ultrasound coupling agent includes carbomer, vitamins, a wetting agent, an antibacterial agent, a pH value regulator and water, and the ultrasound coupling agent is a medical product composed of an aqueous polymer gel, is non-toxic and harmless to a human body, is not easy to dry, is not easy to rancidity, has appropriate viscosity and is not greasy, and is generally used for ultrasonic examination of moist skin and elimination of air on the surface of the skin, so that ultrasonic waves can enter the human body and the ultrasonic probe can easily slide; the contrast agent has stable components, long shelf life and convenient storage, and the carbomer is a viscosity regulator and is classified into various categories according to viscosity, including 934, 940, 980 and the like, and carbomer 980 is generally preferred; the water is preferably deionized water or purified water, and is prepared from drinking water by distillation, ion exchange, reverse osmosis or other suitable method, and contains no additives.

In this embodiment, the pH adjuster includes sodium hydroxide or triethanolamine, and the triethanolamine has an ammonia odor, and therefore, in this embodiment, the pH adjuster is preferably sodium hydroxide.

In this embodiment, the antibacterial agent includes triclosan or triclosan, and the antibacterial agent refers to a chemical substance capable of keeping the growth or reproduction of certain microorganisms, such as bacteria, fungi, yeasts, algae, viruses, and the like, below a necessary level in a certain period of time, and is a substance having bacteriostatic and bactericidal properties, and includes, but is not limited to, triclosan and triclosan.

In this embodiment, the vitamins are vitamin a, vitamin C, vitamin E, or vitamin B5, and the vitamins are a generic term for a series of organic compounds, which are micronutrients required by living organisms, and generally cannot be produced by the living organisms themselves and need to be obtained by means of diet or the like. The vitamins can not generate energy and form cells like saccharides, proteins and fats, but have a regulating effect on the metabolism of organisms, wherein the vitamin A is fat-soluble alcohol substances and can participate in the synthesis of glycoprotein, and the immunoglobulin is glycoprotein, so the vitamin A can promote the synthesis of the protein and has an important influence on the immune function of the organisms; the vitamin C is also called L-ascorbic acid, is a water-soluble vitamin and mainly has the functions of improving immunity, preventing cancers, heart diseases and the like; the vitamin E is mostly dissolved in organic solvents such as fat, ethanol and the like, is insoluble in water, stable to heat and acid, unstable to alkali, sensitive to oxygen and insensitive to heat, is a fat-soluble vitamin, and a hydrolysate thereof is tocopherol which is one of the most main antioxidants; the vitamin B5, also known as pantothenic acid, has antibody-producing functions, helps to fight infectious diseases, alleviates side effects and toxicity of various antibiotics, and helps to alleviate allergic symptoms.

In this embodiment, the humectant comprises one or more of propylene glycol, glycerol and polyethylene glycol, and the main function of the humectant is to reduce the surface tension or interfacial tension of water, so that the solid surface can be wetted by water.

In this embodiment, the ultrasonic coupling agent includes, by mass, 0.1% to 1.0% of the carbomer, 0% to 1.0% of the vitamin E, 0.1% to 0.5% of the sodium hydroxide, 3.0% to 8.0% of the glycerin, 0.5% to 1.0% of the trichlorohydroxydiphenyl ether, and 90.0% to 96.0% of the water, and in this embodiment, the ultrasonic coupling agent preferably includes 0.3% of the carbomer, 0.1% of the vitamin E, 0.1% of the sodium hydroxide, 3% of the glycerin, 0.5% of the trichlorohydroxydiphenyl ether, and 96% of the purified water.

In this embodiment, the contrast agent comprises 0.01% to 0.50% of the iron dextran, 1.50% to 59.50% of the water, and 40.00% to 98.00% of the ultrasound coupling agent by mass percentage, and the iron dextran is generally an anti-anemia drug and has high biological safety, and in this embodiment, the iron dextran and the water are preferably prepared into the iron dextran solution with an iron content of 6.25mg/g by mass ratio of 1: 160.

In this embodiment, the preparation method of the contrast agent includes the steps of: respectively taking the iron dextran, the ultrasonic coupling agent and water with specified mass; mixing the iron dextran with water at a specified temperature, and putting the mixture into the ultrasonic couplant to be uniformly stirred; placing the mixture into an ultrasonic degassing tank for defoaming treatment; the cobalt 60 is used for radiation disinfection treatment, and the contrast agent is used in the rectal cavity and the vaginal cavity of a human body in magnetic resonance imaging, so that safety, sanitation and disinfection problems need to be noticed in the preparation process, and the preparation environment needs to be a sterile room; after the iron dextran solution is placed into the ultrasonic couplant, the stirring mode comprises rotary stirring and up-and-down stirring, and because air bubbles are introduced in the stirring process, the air bubbles can generate artifacts in the magnetic resonance imaging process, and influence the focus display and the doctor's judgment on the imaging result, the defoaming treatment is required, and the defoaming treatment comprises, but is not limited to, defoaming by using an ultrasonic degassing tank; the prepared contrast agent is generally filled in a plastic shell and is stored in a sealed manner at normal temperature.

The ultrasonic couplant is aqueous polymer gel, the iron dextran is preferably prepared into solution with water according to a specified proportion, so that the mixed contrast agent is liquid, is used in rectal or vaginal magnetic resonance imaging detection and treatment, and is filled in the rectal cavity and the vaginal cavity in an injection mode.

In the following specific examples 1 to 9, the ultrasonic couplant described above comprises: 0.3% of the carbomer, 0.1% of the vitamin E, 0.1% of the sodium hydroxide, 3% of the glycerol, 0.5% of the trichlorohydroxydiphenyl ether and 96% of the purified water, wherein the iron dextran and the water are prepared into the iron dextran solution with the iron content of 6.25mg/g according to the mass ratio of 1:160, clean test tubes with the uniform specification and the net weight of 2g are adopted, and 3.0TMRI scanning is adopted, and the specific condition parameters are as shown in Table 1:

TABLE 1

Specific example 1:

taking 10g of the ultrasonic couplant and pouring into the test tube, marked as A1, taking 10g of the iron dextran solution and pouring into the test tube, marked as B1, taking 0.2g of the iron dextran solution and putting into 9.8g of the ultrasonic couplant, stirring uniformly and pouring into the test tube, defoaming in the ultrasonic degassing tank and radiating and disinfecting with the cobalt 60 to obtain the contrast agent, marked as C1, with the total weight of 10g, the iron content of 1.25mg and the iron content of 0.125mg/g, and putting the A1, the B1 and the C1 under the 3.0TMRI for scanning, and repeating the test for 3-10 times.

	A1	B1	C1
				Dextran iron solution (g)	0	10	0.2
Containing iron (mg)	0	62.5	1.25
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	9.8
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	1.25:10
				Ratio (mg/g)	0	6.25	0.125

TABLE 2

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the a1, B1 and C1 all develop, the a1 and C1 are high signals, the B1 is slightly high in a ring shape, and in the result of T1 weighted imaging, the a1, B1 and C1 all develop, the a1 and C1 develop clearly, and the B1 develops a blurred edge, so that the iron content of the C1 is not sufficient to completely suppress the high signal of the ultrasonic couplant.

Specific example 2:

taking 10g of the ultrasonic couplant and pouring into the test tube, marked as A2, taking 10g of the iron dextran solution and pouring into the test tube, marked as B2, taking 0.6g of the agent A and putting into 9.4g of the ultrasonic couplant, stirring uniformly and pouring into the test tube, defoaming by the ultrasonic degassing tank and radiating and disinfecting by the cobalt 60 to obtain the contrast agent, marked as C2, with the total weight of 10g, the iron content of 3.75mg and the iron content of 0.375mg/g, and putting the A2, the B2 and the C2 under the 3.0TMRI for scanning, and repeating the test for 3-10 times.

	A2	B2	C2
				Dextran iron solution (g)	0	10	0.6
Containing iron (mg)	0	62.5	3.75
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	9.4
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	3.75:10
				Ratio (mg/g)	0	6.25	0.375

TABLE 3

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the a2, B2 and C2 all developed, the a2 and C2 still showed high signals, the B2 showed slightly high signals in a ring shape, and the T1 weighted imaging result showed that the a2, B2 and C2 all developed, the a2 and C2 developed clearly, and the B2 developed blurred edge, so that the iron content of the C2 was still insufficient to completely suppress the high signal of the ultrasonic couplant.

Specific example 3:

as shown in table 4 below, 10g of the ultrasonic couplant was poured into the test tube, which is designated as A3, 10g of the iron dextran solution was poured into the test tube, which is designated as B3, 1g of the iron dextran solution with an iron content of 6.25mg/g was placed into 9g of the ultrasonic couplant, the mixture was stirred uniformly and poured into the test tube, the mixture was degassed by the ultrasonic degassing tank and sterilized by the radiation of the cobalt 60, so that the contrast agent with a total weight of 10g, an iron content of 6.25mg and an iron content of 0.625mg/g, which is designated as C3, was obtained, and the above A3, B3 and C3 were placed under the above 3.0TMRI for scanning, and the test was repeated 3 to 10 times.

TABLE 4

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the A3, B3 and C3 all developed, the A3 and C3 still showed high signals, the B3 showed slightly high signals in a ring shape, and the T1 weighted imaging result showed that the A3, B3 and C3 all developed, the A3 and C3 developed clearly, and the B3 developed blurred edge, so that the iron content of the C3 was still insufficient to completely suppress the high signal of the ultrasonic couplant.

Specific example 4:

taking 10g of the ultrasonic couplant and pouring into the test tube, marked as A4, taking 10g of the iron dextran solution and pouring into the test tube, marked as B4, taking 2g of the iron dextran solution with the iron content of 6.25mg/g and placing into 8g of the ultrasonic couplant, uniformly stirring and pouring into the test tube, defoaming in the ultrasonic degassing tank and then radiating and disinfecting with the cobalt 60 to obtain the contrast agent with the total weight of 10g, the iron content of 12.5mg and the iron content of 1.25mg/g, marked as C4, placing the A4, the B4 and the C4 under the 3.0TMRI for scanning, and repeating the test for 3-10 times.

	A4	B4	C4
				Dextran iron solution (g)	0	10	2
Containing iron (mg)	0	62.5	12.5
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	8
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	12.5:10
				Ratio (mg/g)	0	6.25	1.25

TABLE 5

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the a4, B4 and C4 develop, the a4 and C4 still have high signals, but the C4 signal is slightly lower than the a4 signal, the B4 has a slightly higher annular signal, and the T1 weighted imaging result shows that the a4, B4 and C4 develop, the a4 and C4 develop clearly, and the B4 develops a blurred edge, so the iron content of the C4 is still not enough to completely suppress the high signal of the ultrasonic couplant.

Specific example 5:

taking 10g of the ultrasonic couplant and pouring into the test tube, marked as A5, taking 10g of the iron dextran solution and pouring into the test tube, marked as B5, taking 3g of the iron dextran solution with the iron content of 6.25mg/g and placing into 7g of the ultrasonic couplant, uniformly stirring and pouring into the test tube, defoaming in the ultrasonic degassing tank and then radiating and disinfecting with the cobalt 60 to obtain the contrast agent with the total weight of 10g, the iron content of 18.75mg and the iron content of 1.875mg/g, marked as C5, placing the A5, the B5 and the C5 under the 3.0TMRI for scanning, and repeating the test for 3-10 times.

	A5	B5	C5
				Dextran iron solution (g)	0	10	3
Containing iron (mg)	0	62.5	18.75
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	7
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	18.75:10
				Ratio (mg/g)	0	6.25	1.875

TABLE 6

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the a5, B5 and C5 develop, the a5 is a high signal, the B5 and C5 have slightly high annular signals, and in the result of T1 weighted imaging, the a5, B5 and C5 develop, the a5 and C5 develop clearly, and the B5 develops a blurred edge, so that the iron content of the C5 significantly reduces the high signal of the ultrasonic couplant, but is still insufficient to completely suppress the high signal of the ultrasonic couplant.

Specific example 6:

taking 10g of the ultrasonic couplant and pouring into the test tube, marked as A6, taking 10g of the iron dextran solution and pouring into the test tube, marked as B6, taking 4g of the iron dextran solution with the iron content of 6.25mg/g and placing into 6g of the ultrasonic couplant, uniformly stirring and pouring into the test tube, defoaming in the ultrasonic degassing tank and then radiating and disinfecting with the cobalt 60 to obtain the contrast agent with the total weight of 10g, the iron content of 25mg and the iron content of 2.5mg/g, marked as C6, placing the A6, the B6 and the C6 under the 3.0TMRI for scanning, and repeating the test for 3-10 times.

TABLE 7

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the A6, B6 and C6 develop, the A6 is a high signal, the B6 and C6 have slightly high annular signals, and in the result of T1 weighted imaging, the A6, B6 and C6 develop, the A6 and C6 develop clearly, and the B6 develops a blurred edge, so that the iron content of the C6 significantly reduces the high signal of the ultrasonic couplant, but is still insufficient to completely suppress the high signal of the ultrasonic couplant.

Specific example 7:

as shown in table 8 below, 10g of the ultrasonic couplant was poured into the test tube, which is designated as a7, 10g of the iron dextran solution was poured into the test tube, which is designated as B7, 5g of the iron dextran solution with an iron content of 6.25mg/g was placed into 5g of the ultrasonic couplant, the mixture was stirred uniformly and poured into the test tube, the mixture was degassed by the ultrasonic degassing tank and sterilized by the radiation of the cobalt 60, so that the contrast agent with a total weight of 10g, an iron content of 31.25mg and an iron content of 3.125mg/g, which is designated as C7, was obtained, and the a7, B7 and C7 were placed under the 3.0TMRI for scanning, and the test was repeated 3 to 10 times.

	A7	B7	C7
				Dextran iron solution (g)	0	10	5
Containing iron (mg)	0	62.5	31.25
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	5
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	31.25:10
				Ratio (mg/g)	0	6.25	3.125

TABLE 8

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the above-mentioned a7, B7 and C7 all develop, the above-mentioned a7 is a high signal, the above-mentioned C7 develops a low signal identical to the background, the above-mentioned B7 is a slightly high signal in a ring shape, and in the result of T1 weighted imaging, the above-mentioned a7, B7 and C7 all develop, the above-mentioned a7 and C7 develop clearly, and the above-mentioned B7 develops a blurred edge, so that the iron content of the above-mentioned C7 has completely suppressed the high signal of the above-mentioned ultrasonic couplant, and T1WI develops clearly.

Specific example 8:

as shown in table 9 below, 10g of the ultrasonic couplant was poured into the test tube, which is designated as A8, 10g of the iron dextran solution was poured into the test tube, which is designated as B8, 6g of the iron dextran solution with an iron content of 6.25mg/g was placed into 4g of the ultrasonic couplant, the mixture was stirred uniformly and poured into the test tube, the mixture was degassed by the ultrasonic degassing tank and sterilized by the radiation of the cobalt 60, so that the contrast agent with a total weight of 10g, an iron content of 37.5mg and an iron content of 3.75mg/g, which is designated as C8, was obtained, and the A8, B8 and C8 were placed under the 3.0TMRI for scanning, and the test was repeated 3 to 10 times.

	A3	B3	C3
				Dextran iron solution (g)	0	10	1
Containing iron (mg)	0	62.5	6.25
				Test tube weight (g)	2	2	2
Coupling agent (g)	10	0	9
				Total weight about (g)	10	10	10
Ratio (mg: g)	0：10	62.5:10	6.25:10
				Ratio (mg/g)	0	6.25	0.625

TABLE 9

Referring to fig. 1, 2 and 3, in the result of T2 weighted imaging under the 3.0TMRI scan, the a8, B8 and C8 all developed, the a8 was a high signal, the C8 developed as a low signal equal to the background, the B8 developed as a ring-shaped high signal, and the a8, B8 and C8 all developed, the a8 developed clearly, and the B8 and C8 developed blurred edges in the result of T1 weighted imaging, so that the iron content of the C8 completely suppressed the high signal of the ultrasonic couplant, but the T1WI developed not clearly.

Referring to fig. 1, 2 and 3, the developing conditions of a1-A8 and B1-B8 are consistent, the machine of the current scanning is judged to be normal, and the influence of the scanning machine on the current experiment is eliminated.

The C1-C8 formulation data are as follows in Table 10:

watch 10

Referring to fig. 1, 2 and table 10, in the 3.0TMRI scan, as a result of T2 weighted imaging, the cuvettes of C1-C8 were developed and the development signal gradually decreased, the signals of C7 and C8 decreased to the same low signal as the background, and it was found that when the ultrasonic couplant was mixed with the iron dextran solution at different ratios, i.e., different iron contents of the contrast agent, the T2 signal was different and the T2 signal was gradually decreased as the iron content of the contrast agent increased in the 3.0TMRI scan.

Referring to fig. 1 and 3, in the results of T1 weighted imaging under the 3.0TMRI scan, the C1-C8 images, wherein the C1-C7 images are clear in the range of development and the development edge is not blurred compared to the a1-A8 pure ultrasound couplant, and the C8 image is blurred, which is consistent with the development of the B1-B8 pure iron dextran solution, indicating that when the iron content of the short T2 effect mri contrast agent is too high, the development image will be greatly disturbed.

Therefore, the effective concentration of the iron content of the contrast agent is 1.25-3.75mg/g, namely, the contrast agent comprises 40.0-80.0% of the ultrasonic couplant, 0.1-0.5% of the iron dextran and 19.5-59.5% of the water, and the proportion of the specific example 7 is determined for the first time, namely, the contrast agent is the best contrast agent when the contrast agent is 3.125mg/g, namely, the contrast agent comprises 50.00% of the ultrasonic couplant, 0.31% of the iron dextran and 49.69% of the water.

Specific example 9:

as shown in table 11 below, 5g of the iron dextran solution with an iron content of 6.25mg/g was placed in 5g of the ultrasonic couplant, the mixture was stirred uniformly and poured into the test tube, after deaeration in the ultrasonic degassing tank, the mixture was sterilized by radiation with the cobalt 60 to obtain the contrast agent with a total weight of 10g, an iron content of 31.25mg and an iron content of 3.125mg/g, i.e., C7, 10g of the pure ultrasonic couplant was placed in the test tube, denoted as a, and the a and C7 were scanned under the 3.0TMRI, and the test was repeated for 3-10 times.

	A	C7
			Dextran iron solution (g)	0	5
Containing iron (mg)	0	31.25
			Test tube weight (g)	2	2
Coupling agent (g)	10	5
			Total weight about (g)	10	10
Ratio (mg: g)	0：10	31.25:10
			Ratio (mg/g)	0	3.125

TABLE 11

Referring to fig. 4, 5 and 6, in the 3.0TMRI scan, T2 weighted imaging results, a is a high signal; the C7 is a low signal same as the background, that is, in the C7, the iron dextran solution completely suppresses the T2 high signal of the ultrasonic couplant, and in the result of T1-weighted imaging, both the a and C7 are developed and are clearly developed, and the a constitutes a good contrast, and it is further verified that the iron dextran solution of the C7 shortens the T2 effect of the ultrasonic couplant, completely suppresses the T2 signal of the ultrasonic couplant, and does not affect the development effect.

In summary, when the iron content of the contrast agent prepared by mixing the ultrasonic coupling agent and the iron dextran solution reaches 3.125mg/g, the contrast agent is an optimal mixture ratio, namely, the contrast agent comprises 50.00% of the ultrasonic coupling agent, 0.31% of the iron dextran solution and 49.69% of the water.

The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent has the beneficial effects that: the iron dextran, the ultrasonic couplant and the water are mixed according to a specified mass ratio to prepare the contrast agent, so that the T2 relaxation time of the ultrasonic couplant in magnetic resonance imaging is shortened, the signal intensity of the ultrasonic couplant on T2 weighted imaging is reduced, and the interference of the ultrasonic couplant on focus display in the magnetic resonance imaging of the rectal cavity and the vaginal cavity is reduced; the contrast agent has good adhesion with cavity organs such as rectum/vagina and the like, can well fill the cavity organs such as rectum/vagina and the like, has no fluidity due to colloid, can be properly formed, does not need to be contained in a specific container, and can be directly filled in the rectum or the vagina; the contrast agent has stable components, long shelf life and convenient storage.

The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by using the contents of the present specification and the accompanying drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. A short T2 effect rectal/vaginal cavity internal magnetic resonance imaging contrast agent is characterized in that the contrast agent consists of 0.01-0.50% of iron dextran, 1.50-59.50% of water and 40.00-98.00% of ultrasonic coupling agent by mass percentage; wherein the iron content of the contrast agent is 3.125mg/g-3.75 mg/g; the ultrasonic couplant consists of carbomer, vitamins, a wetting agent, an antibacterial agent, a pH value regulator and water.

2. The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent according to claim 1, wherein the pH adjusting agent is sodium hydroxide or triethanolamine.

3. The short T2 effect rectal/vaginal endocavity magnetic resonance imaging contrast agent according to claim 2, wherein the antibacterial agent is triclosan or triclocarban.

4. The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent according to claim 3, wherein the vitamin is vitamin A, vitamin C, vitamin E or vitamin B5.

5. The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent according to claim 4, wherein the wetting agent is one or more of propylene glycol, glycerol and polyethylene glycol.

6. The short T2 effect rectal/vaginal cavity magnetic resonance imaging contrast agent according to claim 5, wherein the ultrasound coupling agent comprises, in mass percent, 0.1% -1.0% of the carbomer, 0-1.0% of the vitamin E, 0.1% -0.5% of the sodium hydroxide, 3.0% -8.0% of the glycerol, 0.5% -1.0% of the trichlorohydroxydiphenyl ether, and 90.0% -96.0% of the water.

7. A method for preparing a short T2 effect endorectal/vaginal magnetic resonance imaging contrast agent according to any one of claims 1-6, comprising the steps of:

respectively taking the iron dextran, the ultrasonic coupling agent and the water with specified mass;

mixing the iron dextran with water at a specified temperature, and putting the mixture into the ultrasonic couplant to be uniformly stirred;

placing the mixture into an ultrasonic degassing tank for defoaming treatment;

the radiation sterilization treatment was performed by cobalt 60.