CN118903478A - 13C urea orally disintegrating tablet, and preparation method and application thereof - Google Patents

Abstract

The invention provides a ¹³ C urea orally disintegrating tablet and a preparation method and application thereof, and relates to the technical field of pharmaceutical preparations. The components of the ¹³ C urea orally disintegrating tablet include a raw material ¹³ C urea and an auxiliary material excipient. The raw material ¹³ C urea and the auxiliary material are used to prepare ^{the 13} C urea orally disintegrating tablet. The ¹³ C urea orally disintegrating tablet does not require water or only requires a small amount of water when taken, and does not require chewing. After rapidly disintegrating in the mouth with saliva, the drug can enter the stomach and take effect by the power of swallowing. The tablet is easy to take, has a rapid onset of effect, high bioavailability, and good compliance in clinical application.

Description

13C urea orally disintegrating tablets and their preparation method and application

Technical Field

The present invention relates to the technical field of pharmaceutical preparations, and in particular to a ¹³ C urea orally disintegrating tablet and a preparation method and application thereof.

Background Art

Helicobacter pylori is a Gram-negative bacterium that is mainly distributed in gastric mucosal tissue. Helicobacter pylori has a clear carcinogenic effect. After infection, mild cases can lead to chronic superficial gastritis. After long-term infection, it can progress to chronic atrophic gastritis. It can also form gastric ulcers and duodenal ulcers. Ulcers can be complicated by bleeding or canceration, and some people even directly develop gastric cancer or gastric mucosal lymphoma. The pathogenesis caused by Helicobacter pylori is the result of the combined action of multiple factors, such as the synergistic effects of bacterial flagella, adhesins, urease, protease, vacuolating toxins, endotoxins, etc. Among them, a large amount of highly active urease decomposes urea into ammonia and carbon dioxide. Ammonia can neutralize gastric acid, allowing this bacterium to survive in the highly acidic stomach. The accumulation of urease and ammonia can also damage the gastric mucus layer and mucosal cells, destroy the mucus-bicarbonate barrier, and cause protons to reflux to the mucosa, thereby leading to the occurrence of peptic ulcers.

The principle of the ¹³ C urea breath test is to orally take ¹³ C-labeled urea into the stomach, which is decomposed by the urease produced by Helicobacter pylori to produce ammonia and ¹³ C-carbon dioxide. Through the breath test, the collected gas is analyzed on a specific instrument, and the presence of Helicobacter pylori is determined based on the specific detection value of ¹³ C-carbon dioxide. The structural formula of ¹³ C urea is as follows:

^13C urea breath test diagnostic kits are generally available in tablets, granules, etc., which need to be dissolved in water before being distributed to subjects. The dissolution process of ordinary tablets and granules generally takes 3 to 5 minutes and requires constant stirring to completely dissolve. When there are many subjects, it takes a long time and complicated operations, which is very inconvenient.

In view of this, the present invention is proposed.

Summary of the invention

One of the purposes of the present invention is to provide a ¹³ C urea orally disintegrating tablet. The components of the ¹³ C urea orally disintegrating tablet include the raw material ¹³ C urea and the auxiliary material excipient. The ¹³ C urea orally disintegrating tablet is prepared by using the raw material ¹³ C urea and the auxiliary material. The ¹³ C urea orally disintegrating tablet does not need water or only needs a small amount of water when taken, and does not need to be chewed. After rapidly disintegrating in the mouth with saliva, the drug can enter the stomach and take effect by swallowing power. The tablet is easy to take, has a rapid onset of action, high bioavailability, and good compliance in clinical application.

The second object of the present invention is to provide a method for preparing ¹³ C urea orally disintegrating tablets, wherein the raw material ¹³ C urea and appropriate amounts of other auxiliary materials are prepared into orally disintegrating tablets by freeze drying or direct powder compression, thereby improving the stability of the raw material ¹³ C urea, simplifying the clinical preparation process, and facilitating clinical administration.

The third object of the present invention is to provide a use of ¹³ C urea orally disintegrating tablets in the preparation of products for diagnosing gastric Helicobacter pylori infection.

In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

In a first aspect, the present invention provides a ¹³ C urea orally disintegrating tablet, wherein the components of the ¹³ C urea orally disintegrating tablet include a raw material ¹³ C urea and auxiliary excipients.

Furthermore, the unit dose of the ¹³ C urea orally disintegrating tablet comprises 50-150 mg of the raw material ¹³ C urea and auxiliary excipients.

Further, the weight ratio of the ¹³ C urea to the excipient is 1:0.3-1:15;

Preferably, the excipient comprises at least one of povidone K30, polyethylene glycol 4000, polyethylene glycol 6000, citric acid, sodium citrate, mannitol, sorbitol, xylitol, lactose, gelatin, glycine and glutathione.

Furthermore, the components of the ¹³ C urea orally disintegrating tablets also include auxiliary flavoring agents;

Preferably, the weight of the flavoring agent is less than or equal to 1% of the total weight of the ¹³ C urea orally disintegrating tablet;

Preferably, the flavoring agent comprises at least one of aspartame, sodium cyclamate, sodium saccharin, steviol glycoside and sucralose.

Furthermore, the components of the ¹³ C urea orally disintegrating tablet also include auxiliary preservatives;

Preferably, the weight of the preservative is less than or equal to 1% of the total weight of the ¹³ C urea orally disintegrating tablet;

Preferably, the preservative includes at least one of methylparaben and its sodium salt, ethylparaben and its sodium salt, propylparaben and its sodium salt, benzoic acid and its sodium salt, and sorbic acid and its potassium salt.

In a second aspect, the present invention provides a method for preparing the ¹³ C urea orally disintegrating tablet, the method for preparing ^{the 13} C urea orally disintegrating tablet comprising the following steps:

The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and the orally disintegrating tablets are prepared by freeze drying or direct powder compression.

Furthermore, the ¹³ C urea, the excipient, the flavoring agent and the preservative in a formula amount are dissolved in a solvent, and an orally disintegrating tablet is prepared by freeze drying or direct powder compression;

Preferably, the solvent comprises water, and the excipient, the flavoring agent and the preservative are all water-soluble;

Preferably, the concentration of the mixture of the drug substance and the excipients in water is 40-250 g/L.

Furthermore, the freeze-drying method is used to prepare the ¹³ C urea orally disintegrating tablet, which comprises the following steps:

The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and then filling, freeze-drying and sealing are performed in sequence to prepare ¹³ C urea orally disintegrating tablets.

In a third aspect, the present invention provides a use of the ¹³ C urea orally disintegrating tablet in the preparation of a product for diagnosing gastric Helicobacter pylori infection.

Furthermore, when the ¹³ C urea orally disintegrating tablet is used, the ¹³ C urea orally disintegrating tablet is placed in the oral cavity or in 1-2 ml of water to disintegrate or dissolve.

Compared with the prior art, the present invention has at least the following beneficial effects:

The ¹³ C urea orally disintegrating tablet provided by the present invention uses ¹³ C urea as a raw material drug, and an auxiliary material excipient is added. The excipient serves as a freeze-dried skeleton material, and water sublimates during the freeze-drying process to form a porous block solid in an amorphous state, which can improve the solubility of the tablet and make it dissolve quickly in the oral cavity. The ¹³ C urea orally disintegrating tablet provided by the present invention has the characteristics of rapid disintegration in the oral cavity or rapid disintegration with only a very small amount of water, is easy to take, and improves compliance in clinical use.

The preparation method of ¹³ C urea orally disintegrating tablets provided by the present invention adopts freeze drying or powder direct compression to prepare a tablet that can disintegrate in a small amount of water with the raw material ¹³ C urea and a suitable amount of other auxiliary materials, thereby improving the stability of the raw material ¹³ C urea, simplifying the clinical preparation process, and facilitating clinical administration.

The ¹³ C urea orodisintegrating tablet provided by the present invention is clinically used for diagnosing gastric Helicobacter pylori infection. When the ¹³ C urea orodisintegrating tablet is used, the orodisintegrating tablet is placed in the oral cavity or in 1-2 ml of water, and can be rapidly disintegrated or dissolved within 30 seconds. The tablet is convenient to take, has a rapid onset of action, and has good compliance in clinical application.

DETAILED DESCRIPTION

Unless otherwise defined herein, scientific and technical terms used in conjunction with the present invention shall have the meanings commonly understood by those of ordinary skill in the art. The meaning and scope of the terms should be clear, however, in the case of any potential ambiguity, the definitions provided herein take precedence over any dictionary or external definitions. In this application, unless otherwise stated, the use of "or" means "and/or". In addition, the use of the term "including" and other forms is non-limiting.

The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

In a first aspect, the present invention provides a ¹³ C urea orally disintegrating tablet, wherein the components of the ¹³ C urea orally disintegrating tablet include a raw material ¹³ C urea and auxiliary excipients.

In the present invention, ¹³ C urea is used as a raw material, and an auxiliary material excipient is added. The excipient is used as a freeze-dried skeleton material. During the freeze-drying process, water sublimates to form a porous block solid in an amorphous state, which can improve the solubility of the tablet and make it dissolve quickly in the oral cavity. The ¹³ C urea orally disintegrating tablet provided by the present invention has the characteristics of rapid disintegration in the oral cavity or rapid disintegration with only a very small amount of water, is easy to take, and improves compliance in clinical use.

Furthermore, the unit dose of the ¹³ C urea orally disintegrating tablet comprises 50-150 mg of the raw material ¹³ C urea and auxiliary excipients.

Taking the unit dose of ¹³ C urea orodisintegrating tablets as an example, the content of the raw material ¹³ C urea in each orodisintegrating tablet is 50-150 mg, for example, it can be 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 134 mg, 140 mg, 145 mg, 150 mg, etc.;

The content of ¹³ C urea in the orally disintegrating tablet is more preferably 75 mg/tablet.

Further, the weight ratio of the ¹³ C urea to the excipient is 1:0.3-1:15, for example, 1:0.3, 1:0.5, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:3.5, 1:4, 1:4.5, 1:5, 1:5.5, 1:6, 1:6.5, 1:7, 1:7.5, 1:8, 1:8.5, 1:9, 1:9.5, 1:10, 1:10.5, 1:11, 1:11.5, 1:12, 1:12.5, 1:13, 1:13.5, 1:14, 1:14.5, 1:15, etc.;

Preferably, the excipient comprises at least one of povidone K30, polyethylene glycol 4000, polyethylene glycol 6000, citric acid, sodium citrate, mannitol, sorbitol, xylitol, lactose, gelatin, glycine and glutathione.

In the present invention, the excipients are used as freeze-dried skeleton materials. As the water sublimates during the freeze-drying process, a porous block solid is formed, which is in an amorphous state and can improve the solubility of the tablets and make them dissolve quickly in the oral cavity. Among them, excipients such as povidone K30, polyethylene glycol 4000, polyethylene glycol 6000, gelatin, etc. have a certain adhesive effect, and only a small amount is needed to make the tablets maintain a certain structural strength and not easily broken into powder.

Furthermore, the components of the ¹³ C urea orally disintegrating tablets also include auxiliary flavoring agents;

Preferably, the weight of the flavoring agent is less than or equal to 1% of the total weight of the ¹³ C urea orodisintegrating tablet, for example, it can be 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, etc.;

Preferably, the flavoring agent comprises at least one of aspartame, sodium cyclamate, sodium saccharin, steviol glycoside and sucralose.

In the present invention, the flavoring agent is added to improve the taste of the orodisintegrating tablet, and only a small amount is needed to improve the taste of the orodisintegrating tablet and improve the adaptability of clinical application. The amount does not exceed 1% of the total weight of the orodisintegrating tablet.

Furthermore, the components of the ¹³ C urea orally disintegrating tablet also include auxiliary preservatives;

Preferably, the weight of the preservative is less than or equal to 1% of the total weight of the ¹³ C urea orally disintegrating tablet, for example, it may be 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, etc.;

Preferably, the preservative includes at least one of methylparaben and its sodium salt, ethylparaben and its sodium salt, propylparaben and its sodium salt, benzoic acid and its sodium salt, and sorbic acid and its potassium salt.

In the present invention, the preservatives are mainly added to sugars, amino acids, proteins and other excipients that are easy for microbial growth, which can inhibit the growth of microorganisms in these excipients, improve the stability of the product, and ensure the quality of the product within the validity period. The amount used is relatively low and does not exceed 1% of the total weight of the orally disintegrating tablet.

The second aspect of the present invention provides a method for preparing the ¹³ C urea orally disintegrating tablet, and the method for preparing ^{the 13} C urea orally disintegrating tablet comprises the following steps:

The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and the orally disintegrating tablets are prepared by freeze drying or direct powder compression.

In the present invention, the raw material ¹³ C urea and appropriate amounts of other auxiliary materials are made into a tablet that can disintegrate in a small amount of water by freeze drying or direct powder compression, thereby improving the stability of the raw material ¹³ C urea, simplifying the clinical preparation process, and facilitating clinical administration.

Furthermore, the ¹³ C urea, the excipient, the flavoring agent and the preservative in a formula amount are dissolved in a solvent, and an orally disintegrating tablet is prepared by freeze drying or direct powder compression;

Preferably, the solvent comprises water, and the excipient, the flavoring agent and the preservative are all water-soluble;

Preferably, the concentration of the mixture of the drug substance and the excipients in water is 40-250 g/L.

In the present invention, water is used as a solvent to prepare a freeze-dried intermediate solution, and the concentration of the total amount of solid matter of raw and auxiliary materials in water is 4% to 25% (w/v).

Furthermore, the freeze-drying method is used to prepare the ¹³ C urea orally disintegrating tablet, which comprises the following steps:

The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and then filling, freeze-drying and sealing are performed in sequence to prepare ¹³ C urea orally disintegrating tablets.

In the present invention, the freeze-drying process of the ¹³ C urea orally disintegrating tablet is as follows: ¹³ C urea and water-soluble excipients, flavoring agents and preservatives are dissolved in water in a certain proportion, filled into aluminum-plastic blisters, freeze-dried, and after drying, the aluminum-plastic blisters and aluminum foils are hot-pressed and sealed to prepare orally disintegrating tablets.

The third aspect of the present invention provides a use of the ¹³ C urea orally disintegrating tablet in the preparation of a product for diagnosing gastric Helicobacter pylori infection.

Furthermore, when the ¹³ C urea orally disintegrating tablet is used, the ¹³ C urea orally disintegrating tablet is placed in the oral cavity or in 1-2 ml of water to disintegrate or dissolve.

In the present invention, when the ¹³ C urea orodisintegrating tablet is used, the orodisintegrating tablet is placed in the oral cavity or in 1-2 ml of water, and can be rapidly disintegrated or dissolved within 30 seconds. The tablet is convenient to take, has a rapid onset of effect, and has good compliance in clinical application.

The present invention is further described below by way of examples. Unless otherwise specified, the materials in the examples are prepared according to existing methods or directly purchased from the market.

Example 1

This embodiment provides a ¹³ C urea orally disintegrating tablet, the formula of which is shown in Table 1 below.

Table 1

The preparation method of the ¹³ C urea orally disintegrating tablet comprises the following steps:

(1) Measure 3000 ml of purified water;

(2) Weigh the prescribed amount of ¹³ C urea and lactose, add them to the purified water, stir to dissolve, and then add purified water to make up to 4000 ml;

(3) Fill the above solution into aluminum-plastic blisters, with 3 ml in each blister;

(4) Transfer to a freeze dryer for freeze drying. The freeze drying parameters are shown in Table 2.

Table 2

(5) Seal the freeze-dried sample with aluminum foil by heat pressing.

Example 2

This embodiment provides a ¹³ C urea orally disintegrating tablet. In the formula, the dosage of ¹³ C urea is 150 g and the dosage of lactose is 45 g. During the preparation process, after the raw materials and auxiliary materials are dissolved, purified water is added to make the volume to 3000 ml.

The rest is consistent with Example 1.

Example 3

This embodiment provides a ¹³ C urea orally disintegrating tablet. In the formula, the dosage of ¹³ C urea is 70 g and the dosage of lactose is 81 g. During the preparation process, after the raw materials and auxiliary materials are dissolved, purified water is added to make the volume to 3000 ml.

The rest is consistent with Example 1.

Example 4

This embodiment provides a ¹³ C urea orally disintegrating tablet, in which the excipient is povidone K30.

The rest is consistent with Example 3.

Example 5

This embodiment provides a ¹³ C urea orally disintegrating tablet, in which the excipients are 75 g lactose and 6 g povidone K30.

The rest is consistent with Example 3.

Example 6

This embodiment provides a ¹³ C urea orally disintegrating tablet, in the formula of which 0.75 g of aspartame, a flavoring agent, and 74.25 g of lactose are added.

The rest is consistent with Example 5.

Example 7

This embodiment provides a ¹³ C urea orally disintegrating tablet. The formula thereof is shown in Table 3 below. In the formula, 0.75 g of sodium benzoate and 73.5 g of lactose as preservatives are added. The remaining steps are consistent with those of Example 6.

Table 3

Example 8

This embodiment provides a ¹³ C urea orally disintegrating tablet, the formula of which is shown in Table 4 below.

Table 4

The preparation method of the ¹³ C urea orally disintegrating tablet comprises the following steps:

(1) Take 1800 ml of purified water and heat it to 80°C;

(2) Weigh the prescribed amount of methylparaben and propylparaben, stir to dissolve, and cool to 60°C;

(3) Add gelatin, stir to dissolve, and let stand to defoam;

(4) Add ¹³ C urea, sorbitol and sucralose, stir to dissolve, and add purified water to make up to 2500 ml;

(5) Fill the above solution into aluminum-plastic blisters, with each blister filled with 2.5 ml;

(6) Transfer to a freeze dryer for freeze drying. The freeze drying parameters are as follows:

Table 5

(7) Seal the freeze-dried sample with aluminum foil by heat pressing.

Example 9

This embodiment provides a ¹³ C urea orally disintegrating tablet, the formula of which is shown in Table 6 below.

Table 6

The preparation method of the ¹³ C urea orally disintegrating tablet comprises the following steps:

(1) Take 4000 ml of purified water;

(2) Weigh the prescribed amount of citric acid and sodium citrate and stir to dissolve;

(3) Add 13C urea, mannitol and steviol glycoside, stir to dissolve, and add purified water to make up to 5000 ml;

(4) Fill the above solution into aluminum-plastic blisters, with 5 ml in each blister;

(5) Transfer to a freeze dryer for freeze drying. The freeze drying parameters are as follows:

Table 7

(6) Seal the freeze-dried sample with aluminum foil by heat pressing.

Comparative Example 1

This comparative example is a tablet containing ¹³ C urea, and its formula is shown in Table 8 below.

Table 8

The preparation process of the tablet containing ¹³ C urea is as follows:

(1) Crush the raw and auxiliary materials, pass through an 80-mesh sieve, and weigh them for later use;

(2) mixing ¹³ C urea and magnesium stearate uniformly;

(3) Press into tablets to obtain the product.

Comparative Example 2

This comparative example is a granular preparation containing ¹³ C urea, and its formula is shown in Table 9 below.

Table 9

The preparation process of granules containing ¹³ C urea is as follows:

(1) Crush the raw and auxiliary materials, pass through an 80-mesh sieve, and weigh them for later use;

(2) adding ¹³ C urea, mannitol, citric acid, sodium citrate and steviol glycoside to a wet granulator, mixing evenly, and adding 70% ethanol for granulation;

(3) the wet granules are granulated by a swing granulator with a sieve size of 16 meshes;

(4) drying the prepared particles in a vacuum drying oven at 60° C. for 3 hours;

(5) Sieve the dried granules through a 14-mesh sieve and remove fine powder through an 80-mesh sieve;

(6) Fill into bottles at a filling volume of 5 g/bottle and seal.

Test Example 1

Test samples: The performance of the ¹³ C urea orally disintegrating tablets prepared in Examples 1-14 and the ¹³ C urea agents prepared in Comparative Examples 1-2 were compared. The specific results are shown in Table 10 below.

Table 10

It can be seen from the data of each embodiment in Table 10 that in embodiments 1-4, the product of embodiment 1 has a relatively prolonged dissolution time due to its large density, and the product of embodiment 4 has a relatively prolonged dissolution time due to the formation of micelles caused by the dissolution of a large amount of polyvidone; the gelatin in the product of embodiment 8 forms a gel, resulting in a relatively slightly prolonged dissolution time; according to experiments, the products in embodiments 7-9 have stronger stability and are more convenient to carry and transport; in terms of clinical use, compared with the comparative example, the orodisintegrating tablets containing ¹³ C urea in the embodiments of the present invention only require a small amount of water to dissolve quickly, and can be dissolved in the oral cavity by saliva or a small amount of water for clinical oral administration, are easy to take, and have good compliance; the comparative example needs to be stirred in a large amount of warm water for several minutes to dissolve before it can be taken; it can be seen that the orodisintegrating tablets containing ¹³ C urea in the embodiments of the present invention are easy to take, do not need to be dissolved and prepared for clinical use, reduce the burden on medical staff, have good patient compliance, and have obvious advantages.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. A ¹³ C urea orally disintegrating tablet, characterized in that the components of the ¹³ C urea orally disintegrating tablet include a raw material ¹³ C urea and auxiliary excipients. 2 . The ¹³ C urea orally disintegrating tablet according to claim 1 , wherein a unit dose of the ¹³ C urea orally disintegrating tablet comprises 50 to 150 mg of the raw material ¹³ C urea and auxiliary excipients. 3. The ¹³ C urea orally disintegrating tablet according to claim 1, characterized in that the weight ratio of the ¹³ C urea to the excipient is 1:0.3-1:15; Preferably, the excipient comprises at least one of povidone K30, polyethylene glycol 4000, polyethylene glycol 6000, citric acid, sodium citrate, mannitol, sorbitol, xylitol, lactose, gelatin, glycine and glutathione. 4. The ¹³ C urea orally disintegrating tablet according to claim 1, characterized in that the components of the ¹³ C urea orally disintegrating tablet further include an auxiliary flavoring agent; Preferably, the weight of the flavoring agent is less than or equal to 1% of the total weight of the ¹³ C urea orally disintegrating tablet; Preferably, the flavoring agent comprises at least one of aspartame, sodium cyclamate, sodium saccharin, steviol glycoside and sucralose. 5. The ¹³ C urea orally disintegrating tablet according to claim 1, characterized in that the components of the ¹³ C urea orally disintegrating tablet further include an auxiliary preservative; Preferably, the weight of the preservative is less than or equal to 1% of the total weight of the ¹³ C urea orally disintegrating tablet; Preferably, the preservative includes at least one of methylparaben and its sodium salt, ethylparaben and its sodium salt, propylparaben and its sodium salt, benzoic acid and its sodium salt, and sorbic acid and its potassium salt. 6. A method for preparing the ¹³ C urea orally disintegrating tablet according to any one of claims 1 to 5, characterized in that the method for preparing ^{the 13} C urea orally disintegrating tablet comprises the following steps: The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and the orally disintegrating tablets are prepared by freeze drying or direct powder compression. 7. The method for preparing ¹³ C urea orally disintegrating tablets according to claim 6, characterized in that the formulated amount of ¹³ C urea, excipients, flavoring agents and preservatives are dissolved in a solvent, and the orally disintegrating tablets are prepared by freeze drying or direct powder compression; Preferably, the solvent comprises water, and the excipient, the flavoring agent and the preservative are all water-soluble; Preferably, the concentration of the mixture of the drug substance and the excipients in water is 40-250 g/L. 8. The method for preparing the ¹³ C urea orally disintegrating tablet according to claim 6, characterized in that the freeze-drying method is used to prepare ^{the 13} C urea orally disintegrating tablet, comprising the following steps: The formulated amount of the raw material ¹³ C urea and the auxiliary materials are dissolved in a solvent, and then filling, freeze-drying and sealing are performed in sequence to prepare ¹³ C urea orally disintegrating tablets. 9. Use of the ^13C urea orodisintegrating tablet according to any one of claims 1 to 5 in the preparation of a product for diagnosing gastric Helicobacter pylori infection. 10 . The use of the ¹³ C urea orally disintegrating tablet according to claim 9 , characterized in that when the ¹³ C urea orally disintegrating tablet is used, the ¹³ C urea orally disintegrating tablet is placed in the oral cavity or in 1-2 ml of water to disintegrate or dissolve.