WO2020186804A1

WO2020186804A1 - Gastrointestinal ultrasonographic developer and preparation method therefor

Info

Publication number: WO2020186804A1
Application number: PCT/CN2019/120080
Authority: WO
Inventors: 张海军; 袁坤山; 鲁手涛; 王如蒙; 刘黎明; 曹文瑞; 尹玉霞; 周超; 段翠海; 刘光
Original assignee: 山东百多安医疗器械股份有限公司
Priority date: 2019-03-19
Filing date: 2019-11-22
Publication date: 2020-09-24
Also published as: CN109745570A

Abstract

Disclosed are a gastrointestinal ultrasonographic developer and a preparation method therefor. The developer is prepared from the following components in parts by weight: 0.1-3.0 parts of a swelling material, 5-15 parts of an osmotic pressure contrast agent, 0.2-2.0 parts of a solid contrast agent, 0.005-0.1 parts of a defoamer, 0.01-0.05 parts of a flavoring agent and 79.85-94.685 parts of purified water.

Description

Gastrointestinal ultrasound inspection aid and preparation method thereof

Technical field

The invention belongs to the field of medical ultrasonic inspection, and relates to a gastrointestinal ultrasonic inspection aid and a preparation method thereof.

Background technique

The gastrointestinal tract occupies 3/4 of the abdominal cavity volume and constitutes the vast majority of the digestive tract. It is the organ with the highest incidence of the digestive system and one of the organs with a higher clinical incidence. In order to clarify the location and nature of the lesion, different inspection methods are often used to assist the diagnosis. Gastrointestinal examination methods include: upper gastrointestinal barium meal, gastroscope, stomach CT, MRI, etc. Upper gastrointestinal barium meal is simple, less painful, and easy for patients to accept, but barium meal examination is radioactive, and the examination results are affected by the barium coating, filling effect and the examiner's experience. Although barium sulfate is relatively safe, for a small number of patients, adverse reactions and complications such as allergies, barium poisoning, barium leakage, barium sulfate fecal stone incarceration, aggravation of constipation, and even death may occur, limiting its clinical application. Especially for the elderly, constipation, pregnant women and patients with barium allergy, acute upper gastrointestinal bleeding, X-ray barium meal examination is not a routine auxiliary diagnosis method. The gastroscope can visualize the shape, color, location, size, and depth of the gastric mucosa, and check the disease under direct vision to determine the nature of the disease. However, the gastroscope can only show the structure of the cavity and cannot observe the layer of the stomach wall and gastric motility. . Since gastroscopy is an interventional examination, most people feel uncomfortable, such as senile diseases that cannot tolerate gastroscopy, patients with severe cardiopulmonary disease, patients with acute upper gastrointestinal perforation, patients with acute severe throat disease, acute corrosive esophageal injury Stage patients and those with mental disorders who cannot cooperate, subjectively and objectively limit the application of gastroscopy. CT/MRI examination has high spatial resolution and clear display of anatomical structure. It is currently a common imaging method for gastric cancer staging; however, CT/MRI examination is not easy to find small lesions in the gastrointestinal cavity, and is of little value in the diagnosis of other gastrointestinal diseases. Not as a regular inspection method.

Ultrasound inspection has quickly opened the historical chapter of ultrasonic technology since the discovery of piezoelectric effect and inverse piezoelectric effect in physics in the early 20th century. Because of its noninvasiveness, painlessness, low price, good tolerance, and non-radioactivity, it has become a common and important inspection method in the substantial organs of the digestive system.

The current clinical application of gastrointestinal ultrasound examination mainly includes three methods: transabdominal gastrointestinal ultrasound examination, gastrointestinal filling ultrasound examination and endoscopic ultrasound. Trans-abdominal gastrointestinal ultrasound examination is only for preliminary screening; endoscopy, which combines the advantages of endoscopy and ultrasound, makes up for their shortcomings, and further improves the diagnostic level of endoscopy and ultrasound. However, due to its high price, complicated operation and certain trauma, it is limited to some large hospitals and is far from popular. The gastrointestinal filling ultrasound method uses a contrast agent (oral) to fill the gastrointestinal cavity and eliminate the gastrointestinal cavity. The interference of gas, content, etc. on ultrasound improves the internal environment of gastrointestinal ultrasound imaging, thereby achieving a method for clearer display of gastrointestinal wall structure and its pathological changes. This technology is the development trend of ultrasound examination of gastrointestinal diseases and can be popularized. Contrast agents are mainly in the form of non-echoic water and powder with echo. At present, the main application is the powder with echo.

At present, the imaging agents on the Chinese market are mainly prepared by grinding, mixing, and blending local existing Chinese medicines or food materials, such as the development aids prepared by the Chinese medicine formulas described in CN102441180B, CN103611173B, etc., which have certain health care and therapeutic effects. The display aid described in CN1721000A is prepared by grinding, mixing, and blending food materials. The ultrasonic image display effect is better. Before use, it needs to be directly brewed with 90-100°C boiling water, quickly stirred to form a uniform paste solution, and wait to be cooled. After reaching the appropriate temperature (generally controlled at 30-50 degrees), instruct the patient to take an ultrasound examination after drinking or taking it. The development aid described in patent CN105079829A utilizes a solid contrast to enhance the development aid effect. This patent uses osmotic pressure contrast agent and specific particle size particles with strong physical and biochemical inertia to make the distribution area of the visualization aid in the gastrointestinal area more obvious and homogeneous and high-echoic area, which has a stronger visualization aid effect. Moreover, the oligofructose, sodium hyaluronate and bioactive glass in this patent can all play a good health care effect. In addition, this patent can be used at room temperature, avoiding the cumbersome steps of high temperature dissolution.

The "Contrast ultrasonography of the digestive tract lumen. Review of the literature and personal experience" written by R. Badea et al. shows that foreign countries generally use water, polymer aqueous solutions and aqueous solutions of mixed contrast agents to enhance the contrast effect. Of the three methods, water has the worst effect, followed by aqueous polymer solutions, and finally an aqueous solution mixed with contrast agents. However, even an aqueous solution mixed with a contrast agent cannot achieve the contrast effect of the visualization aid described in this patent, because this patent uses an osmotic pressure contrast agent and a specific particle size particle with strong physical and biochemical inertness to make the distribution area of the visualization aid more uniform. The high-quality echo zone has a stronger effect. And compared with three foreign contrast solutions, the oligofructose, sodium hyaluronate and bioactive glass in this patent can all play a good health care effect.

Therefore, the visualization aid described in this patent can more effectively display the structure of the gastrointestinal body wall layer during gastrointestinal ultrasound examination, with good filling contrast, enhancing the delineation of the edges of surrounding organs, and effectively reducing and eliminating false detection areas. Shadow and interference, fully show the background and surrounding normal structures and lesions (inflammation, ulcers, tumors, stones, etc.) size and scope, and has a certain health care effect.

Summary of the invention

In view of the above-mentioned prior art, the purpose of the present invention is to provide a gastrointestinal ultrasound examination aid with a stronger effect and health-care function, which uses an osmotic pressure contrast agent and a solid contrast material with a specific particle size with strong physical and biochemical inertness. The distribution area of the visualization aid is a more obvious homogeneous and high-echo area, which has a stronger visualization effect; the biologically active substances contained in the raw materials can promote the healing of small wound diseases, regulate the balance of the intestinal flora, and have a beneficial effect on the gastrointestinal tract. Certain health effects.

In order to achieve the above objectives, the present invention adopts the following technical solutions:

A gastrointestinal ultrasound examination aid, which is made of the following components by weight: 0.1-3.0 parts of swelling substance, 5-15 parts of osmotic pressure contrast agent, 0.2-2.0 parts of solid contrast material, 0.005- 0.1 parts defoamer, 0.01-0.05 parts flavoring agent, 79.85-94.685 parts purified water.

Further, the swelling material, osmotic pressure contrast agent, solid contrast material, defoamer, corrective agent and purified water total 100 parts by weight, wherein the mass percentage of each component is: 0.1-3.0% of the swelling material, The osmotic pressure contrast agent is 5-15%, the solid contrast material is 0.2-2.0%, the antifoaming agent is 0.005-0.1%, the flavoring agent is 0.01-0.05%, and the purified water makes up 100%.

Further, the swelling substance is a mixture of hyaluronic acid-based substances and other swelling substances, and the other swelling substances are one or more of water-soluble cellulose, gum arabic, xanthan gum and polyvinylpyrrolidone, wherein the hyaluronic acid Acidic substances account for 5%-15% (mass fraction) of all swelling substances. The swelling substance can increase the viscosity of the visualization aid, thereby prolonging the residence time. The hyaluronic acid substance can not only extend the residence time, but also promote the repair of the injured part. Hyaluronic acid can also form a protective film. Harmful substances outside the organization form a shielding effect.

Preferably, the hyaluronic acid substance is one or two of hyaluronic acid and sodium hyaluronate, and its molecular weight is 500-1800000 Da. Preferably, the water-soluble cellulose is one or more of sodium carboxymethyl cellulose, hydroxypropyl cellulose and hydroxypropyl methyl cellulose.

Further, the osmotic contrast agent is a mixture of at least one of xylitol and mannitol and fructooligosaccharides. The quality of oligofructose accounts for 2.5%-7.5% of the total mass of the osmotic contrast agent. The osmotic pressure contrast agent can increase the osmotic pressure of the visualization aid, not only can extend the residence time, but also increase the visualization aid effect. In addition to the above effects, the oligofructose can also promote the proliferation of bifidobacteria; prevent heat and get angry; Improve human metabolism, improve intestinal function, improve immunity and disease resistance; promote the body's absorption of minerals; prevent constipation and dental caries; oligofructose reduces the production of toxic metabolites in the intestine, and accelerates the metabolism of toxic substances Excreted from the body, reduce the damage of toxic metabolites to the skin, make the skin beautiful, and play the role of detoxification and beauty.

Further, the solid contrast is a mixture of at least one of calcium carbonate powder and silica powder and bioactive glass powder. The mass of the bioactive glass micropowder accounts for 0.5%-1.5% of the total mass of the solid contrast. The particle size of the solid contrast material is between 1 μm and 100 μm. The solid contrast can enhance the substantive echo of the visualization aid, thereby increasing the visualization aid effect. The bioactive glass in the body can degrade the growth factor to stimulate the growth of growth factors, repair damaged cells and tissues, and have anti-inflammatory and anti-inflammatory effects. And so on.

Further, the defoaming agent is at least one of a silicone defoaming agent such as dimethyl siloxane and a polyether defoaming agent such as polyoxypropylene oxide glycerol ether. The defoaming agent can reduce surface tension, Inhibit the production of foam or eliminate the foam that has been generated, and avoid the interference of bubbles on the help effect. The silicone-based defoaming agent may be dimethylsiloxane or the like, and the polyether-based defoaming agent may be polyoxypropylene oxide ethylene glyceryl ether or the like.

Further, the corrective agent is at least one of strawberry flavor, lemon flavor and apple flavor. The corrective agent can improve or shield the bitterness of the developing aid, present a fruity and refreshing smell, and make the drinker resistant to the developing aid. The receptivity is enhanced so that the development aid can play a better role.

The preparation method of the gastrointestinal ultrasound examination aid, which includes the following steps: slowly adding the swelling substance, the osmotic pressure contrast agent, the solid contrast material, the antifoaming agent, and the correcting agent to the purified water with rapid mechanical stirring. In order to prevent the raw materials from agglomerating into lumps, after the components are thoroughly mixed and stirred in purified water for 12 hours, they are allowed to stand for 24 hours. The resulting mixture is then divided into 100ml brown polyester bottles, which is the aid of gastrointestinal ultrasound examination.

Further, in the above preparation method, it further includes the step of irradiating and sterilizing the mixture dispensed into the brown polyester bottle under 15K-25K electron beam.

The beneficial effects of the present invention are:

The swelling substance in the visualization aid can effectively increase the viscosity of the visualization aid and prolong its residence time in the gastrointestinal cavity, and the antifoaming agent can effectively eliminate the interference of gas in the cavity. Osmotic contrast agent and solid contrast material can make the gastrointestinal tract show a uniformly distributed interface area with strong echo. It can understand the peristalsis and emptying function of the gastrointestinal tract. At the same time, it can clear the interference of mucus, effectively reduce and eliminate the examination The artifacts and interference in the region can clearly show the hierarchical structure, thickness and pathological changes of the gastrointestinal tract, and make the diagnosis and differential diagnosis of gastrointestinal mucosal lesions, submucosal and extra-intestinal lesions, and play a stronger effect.

The hyaluronic acid in the visualization aid can not only increase the residence time, but also promote the migration of cells to the wound tissue. The bioactive glass in the solid contrast can speed up cell metabolism and stimulate the secretion of wound healing factors. Both of these substances can Promote the healing of small wound diseases such as gastrointestinal ulcers; Fructooligosaccharide in the osmotic pressure contrast agent can significantly improve the proportion of microbial populations in the intestine, reduce and inhibit the production of spoilage in the intestine, inhibit the growth of harmful bacteria, and regulate the bacteria in the intestine Group balance. Therefore, the gastrointestinal ultrasound examination aid of the present invention has a certain health-care effect on the gastrointestinal tract and has a good application prospect in medical ultrasound examination.

Description of the drawings

Figure 1 is a flow chart of the preparation process of the aids for gastrointestinal ultrasound examination.

Figure 2 shows a sample of the aids for gastrointestinal ultrasound examination.

detailed description

The present invention will be further described in conjunction with the embodiments. It should be noted that the following description is only for explaining the present invention and does not limit its content.

Example 1

Slowly add flavoring agent, defoaming agent, osmotic pressure contrast agent, solid contrast material and swelling substance to the purified water with rapid mechanical stirring in order, avoiding the raw materials from agglomeration during the adding process, and wait until the raw materials are fully mixed in the purified water Evenly, dilute the sample to 100ml, then continue to stir with a powerful mechanical stirrer for 12h, and let it stand for 24h after the stirring is completed, and finally divide it into 100ml brown polyester bottles, box them, and perform 15K electron beam irradiation sterilization. Obtain the aid of gastrointestinal ultrasound examination. The corrective agent is strawberry flavor 0.01g, the antifoaming agent is polyoxypropylene oxide ethylene glyceryl ether 0.005g, the osmotic pressure contrast agent is xylitol 4.75g, oligofructose 0.25g, and the solid contrast material has a particle size of 50μm. 0.198 g of calcium carbonate powder, 0.002 g of bioactive glass powder with a particle size of 50 μm, and swelling substances of 1.35 g of sodium carboxymethyl cellulose, 1.35 g of hydroxypropyl cellulose and 0.30 g of sodium hyaluronate.

Example 2

According to the method of Example 1, the difference is that the flavoring agent is 0.025g strawberry flavor, the antifoaming agent is 0.05g polyoxypropylene oxide ethylene glycerol, and the osmotic pressure contrast agent is wood. Sugar alcohol 7.125g, oligofructose 0.375g, solid contrast is 30μm calcium carbonate powder 0.99g, 70μm particle size bioactive glass powder 0.01g, swelling material is hydroxypropyl methylcellulose 0.09g, hyaluronic acid Sodium acid 0.01g.

Example 3

According to the method of Example 1, the difference is that the flavoring agent is 0.05g of strawberry essence, the antifoaming agent is 0.1g of polyoxypropylene oxide ethylene glycerol, and the osmotic pressure contrast agent is wood. Sugar alcohol 14.25g, oligofructose 0.75g, solid contrast is 1.98g calcium carbonate powder with a particle size of 1μm, bioactive glass powder with a particle size of 30μm 0.02g, swelling material is gum arabic 1.35g, sodium hyaluronate 0.15g .

Example 4

The gastrointestinal ultrasound examination aid was prepared according to the method of Example 1. The difference is that the correcting agent is lemon essence 0.01g, the antifoaming agent is dimethylsiloxane 0.005g, and the osmotic pressure contrast agent is mannitol. 4.75g, 0.25g of oligofructose, solid contrast is 0.198g of silica powder with a particle size of 100μm, 0.002g of bioactive glass powder with a particle size of 70μm, the swelling substance is 0.09g of sodium carboxymethylcellulose, xanthan gum 1.41g and sodium hyaluronate 0.15g; the sterilization dose of electron beam irradiation is 20K.

Example 5

The gastrointestinal ultrasound examination aid was prepared according to the method of Example 1. The difference is that the flavoring agent is lemon flavor 0.025g, the antifoaming agent is dimethylsiloxane 0.05g, and the osmotic pressure contrast agent is mannitol. 7.125g, oligofructose 0.375g, solid contrast is 0.99g particle size 80μm silica powder, 90μm particle size bioactive glass powder 0.01g, swelling material is polyvinylpyrrolidone 2.70g, sodium hyaluronate 0.30g; electronic The beam irradiation sterilization dose is 20K.

Example 6

The gastrointestinal ultrasound examination aid was prepared according to the method of Example 1. The difference is that the flavoring agent is 0.05g lemon essence, the antifoaming agent is 0.1g dimethylsiloxane, and the osmotic pressure contrast agent is mannitol. 14.25g, 0.75g oligofructose, solid contrast is 1.98g of silica micropowder with particle size of 10μm, 0.02g of bioactive glass powder with particle size of 20μm, swelling material is acacia 0.68g, polyvinylpyrrolidone 0.67 and hyaluronic acid Sodium 0.15g; the sterilization dose of electron beam irradiation is 20K.

Example 7

According to the method of Example 1, the difference is that: the flavoring agent is 0.01g of apple flavor, the defoaming agent is 0.025g of polyoxypropylene oxide ethylene glyceryl ether, dimethylsiloxane 0.025g, the osmotic pressure contrast agent is xylitol 3.55g, mannitol 3.55g, oligofructose 0.375g, solid contrast is 40μm calcium carbonate powder 0.495g, particle size 60μm silica powder 0.495g and The bioactive glass powder with a particle size of 1μm is 0.01g, the swelling material is 0.04g of xanthan gum, 0.05g of polyvinylpyrrolidone and 0.01g of sodium hyaluronate; the sterilization dose of electron beam irradiation is 25K.

Example 8

According to the method of Example 1, the difference is that: the flavoring agent is 0.01g of apple flavor, the defoaming agent is 0.025g of polyoxypropylene oxide ethylene glyceryl ether, dimethylsiloxane 0.025g, the osmotic pressure contrast agent is xylitol 3.55g, mannitol 3.55g, oligofructose 0.375g, solid contrast is 30μm calcium carbonate powder 0.495g, 70μm silicon dioxide powder 0.495g and The bioactive glass powder with a particle size of 90μm is 0.01g, the swelling material is 0.04g of sodium carboxymethylcellulose, 0.05g of acacia and 0.01g of sodium hyaluronate; the sterilization dose of electron beam irradiation is 25K.

Example 9

According to the method of Example 1, the difference is that: the flavoring agent is 0.01g of apple flavor, the defoaming agent is 0.025g of polyoxypropylene oxide ethylene glyceryl ether, dimethylsiloxane 0.025g, the osmotic pressure contrast agent is xylitol 3.55g, mannitol 3.55g, oligofructose 0.375g, solid contrast is 10μm calcium carbonate powder 0.495g, particle size 50μm silica powder 0.495g and The bioactive glass powder with a particle size of 80μm is 0.01g, the swelling material is hydroxypropylcellulose 0.01g, hydroxypropylmethylcellulose 1.35 xanthan gum 1.25 and sodium hyaluronate 0.30g; electron beam irradiation sterilization dose is 25K .

Comparative example 1

According to the method of Example 1, the difference is that: the flavoring agent is strawberry flavor 0.025g, the antifoaming agent is polyoxypropylene oxide ethylene glyceryl ether 0.025g, dimethylsiloxane 0.025g, the osmotic pressure contrast agent is xylitol 7.125g, oligofructose 0.375g, the solid contrast is 0.99g of silica powder with a particle size of 50μm and 0.01g of bioactive glass powder with a particle size of 50μm, no added Swelling substance; the sterilization dose of electron beam irradiation is 20K.

Comparative example 2

According to the method of Example 1, the difference is that: the flavoring agent is lemon flavor 0.025g, the antifoaming agent is polyoxypropylene oxide ethylene glyceryl ether 0.025g, dimethylsiloxane 0.025g, without adding osmotic pressure contrast agent, solid contrast is 0.99g of calcium carbonate powder with particle size of 50μm, 0.01g of bioactive glass powder with particle size of 50μm, swelling material is polyvinylpyrrolidone 1.35, sodium hyaluronate 0.15; electronic The beam irradiation sterilization dose is 20K.

Comparative example 3

According to the method of Example 1, the difference is that: the flavoring agent is 0.025g of apple flavor, the defoaming agent is 0.025g of polyoxypropylene oxide ethylene glyceryl ether, dimethylsiloxane 0.025g, the osmotic pressure contrast agent is mannitol 7.125g, oligofructose 0.375g, no solid contrast is added, and the swelling material is gum arabic 1.35 and sodium hyaluronate 0.15. The sterilization dose of electron beam irradiation is 20K.

The biological performance parameters of the gastrointestinal ultrasound examination aids prepared in Examples 1-9 were tested as follows:

1. Cytotoxicity test: According to the method specified in GB/T 16886.5-2003, it is rated according to the United States Pharmacopoeia.

2. Oral mucosal irritation test: According to the method specified in GB/T 16886.10-2005.

3. Sensitization test: According to the maximum dose sensitization test method specified in GB/T 16886.10-2005.

4. Acute systemic toxicity test: According to the method specified in GB/T 16886.11-2011, the dose is 50ml/kg orally administered once orally.

The specific results are shown in Table 1.

Table 1 Results of biological performance of aids for gastrointestinal ultrasound examination

It can be seen from Table 1: that the cytotoxicity of the products of Examples 1-9 is not greater than Grade 2, none of the oral mucosa irritation, none of the sensitization and no acute systemic toxicity.

The fullness of the gastrointestinal ultrasound examination aids prepared in Examples 1-9 and Comparative Examples 1-3 was tested. The specific methods are as follows:

Osmotic pressure: Take samples to determine the method in accordance with the general rule 0632 of the Pharmacopoeia of the People’s Republic of China (2015 edition). The osmotic pressure of the sample is directly related to its residence time in the gastrointestinal cavity. The greater the osmotic pressure, the longer the residence time and the longer the filling effect.

Filling degree: prepare 500ml sample, experimental animal is Beagle, 200ml is given by gavage 1h before imaging examination, 150ml is given by enema 30min before the machine check, and continue by gavage before the machine Administer 150ml. Ultrasonic examination was used to observe the filling of the small intestine to the colon and the continuity in the intestinal cavity.

The specific results are shown in Table 2 below.

Table 2 Results of filling effect test

It can be seen from Table 2 that compared with Comparative Examples 1-3, the gastrointestinal ultrasound examination aids provided in Examples 1-9 have better filling degree, and the filling degree decreases slowly with time, and the osmotic pressure is higher. , It shows that the gastrointestinal ultrasound examination aids provided in Examples 1-9 have better manifestation aids and strong persistence.

Secondly, the filling degree of Comparative Example 1 decreased the fastest, indicating that the swelling material played a key role in extending the residence time. The filling degree of Comparative Examples 1-3 is much lower than that of Examples 1-9, indicating that the swelling material, the osmotic pressure contrast agent and the solid contrast material are the key factors to improve the filling degree.

In summary, the beneficial effects of a gastrointestinal ultrasound examination aid and its preparation method proposed by the present invention are:

1. The swelling material, osmotic pressure contrast agent and solid contrast material are used together to effectively increase the residence time of the visualization aid in the gastrointestinal cavity, and at the same time, remove the interference of gas and mucus in the cavity and eliminate artifacts.

2. The product does not require a complicated heating process and can be drunk directly, eliminating the complicated preparation process of grain gastrointestinal tract aids and providing patients with more convenient services.

3. The sodium hyaluronate contained in the product can promote cell migration to wound tissues, and bioactive glass can accelerate cell metabolism and stimulate the secretion of wound healing factors. Both of these substances can promote the healing of gastrointestinal ulcers and other minor wound diseases; oligomerization Fructose can promote the proliferation of bifidobacteria; prevent heat and get angry; increase human metabolism, improve intestinal function, improve immunity and disease resistance; promote the absorption of minerals by the human body; prevent constipation and dental caries; oligofructose Reduce the generation of toxic metabolites in the intestine, and accelerate the excretion of toxic metabolites from the body, reduce the damage of toxic metabolites to the skin, make the skin beautiful, and play the role of detoxification and beauty. Therefore, the gastrointestinal ultrasound examination aid described in this patent has a certain health effect on the gastrointestinal tract.

The embodiments described above are part of the embodiments of the present invention, but not all of the embodiments. The detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, and secondly, it merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

Claims

A gastrointestinal ultrasound examination aid, which is characterized in that it is made of the following components by weight: 0.1-3.0 parts of swelling substance, 5-15 parts of osmotic pressure contrast agent, 0.2-2.0 parts of solid contrast , 0.005-0.1 parts of defoamer, 0.01-0.05 parts of flavoring agent, 79.85-94.685 parts of purified water; the swelling substance is a mixture of hyaluronic acid substances and other swelling substances, and other swelling substances are water-soluble One or more of cellulose, gum arabic, xanthan gum and polyvinylpyrrolidone, wherein hyaluronic acid substances account for 5wt%-15wt% of all swelling substances; the osmotic contrast agent is xylitol and mannose A mixture of at least one of alcohol and oligofructose, wherein oligofructose accounts for 2.5%-7.5% of the total mass of the osmotic contrast agent; the solid contrast is at least one of calcium carbonate powder and silica powder A mixture of micropowder with bioactive glass, wherein the micropowder bioactive glass accounts for 0.5%-1.5% of the total mass of the solid contrast, and the particle size of the solid contrast is between 1 μm and 100 μm.
The gastrointestinal ultrasound examination aid according to claim 1, wherein the hyaluronic acid substance is one or two of hyaluronic acid and sodium hyaluronate, and its molecular weight is 500-1800000 Da.
The gastrointestinal ultrasound examination aid of claim 1, wherein the water-soluble cellulose is one of sodium carboxymethyl cellulose, hydroxypropyl cellulose and hydroxypropyl methyl cellulose Or multiple.
The gastrointestinal ultrasound examination aid of claim 1, wherein the antifoaming agent is at least one of a silicone antifoaming agent and a polyether antifoaming agent.
The gastrointestinal ultrasound examination aid of claim 3, wherein the silicone antifoaming agent is dimethylsiloxane, and the polyether antifoaming agent is polyoxypropylene oxide. Glyceryl ether.
The gastrointestinal ultrasound examination aid according to claim 1, wherein the correcting agent is one or more of strawberry flavor, lemon flavor and apple flavor.
A preparation method of a gastrointestinal ultrasound examination aid according to any one of claims 1 to 6, characterized in that it comprises the following steps: combining the swelling substance, the osmotic pressure contrast agent, the solid contrast material, and the antifoaming agent , The flavoring agent is slowly added to the purified water with rapid mechanical stirring to prevent the raw materials from coagulating into lumps. After the components are thoroughly mixed in the purified water and stirred for 12 hours, they are allowed to stand for 24 hours. The resulting mixture is divided into brown polyester bottles. It is the aid of gastrointestinal ultrasound examination.
The preparation method according to claim 7, characterized in that it further comprises the step of irradiating and sterilizing the mixture dispensed into the brown polyester bottle under electron beam 15K-25K.