A medicine for detecting helicobacter pylori and its preparation method

Abstract

The present application relates to a kind of for detecting helicobacter pylori and its preparation method, by weight parts, its raw material includes: urea [ 13 C]10~75 portions, sodium bicarbonate 5~110 portions, lactose 15~45 portions, citric acid 1000~2500 portions, flavoring agent 50~150 portions.The flavoring agent includes at least one of stevioside, sucralose, aspartame, neotame, thaumatin, acesulfame potassium.The present application adopts the way of citric acid and tablet storage separately, effectively solves the problem of flavoring agent addition, avoids the problem of impurity generation due to citric acid addition;At the same time, mannitol is not used in medicine, reduces the risk of patient using medicine.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparations, and in particular to a drug for detecting Helicobacter pylori and its preparation method. Background Technology

[0002] Because Helicobacter pylori is closely related to the occurrence of chronic gastritis, peptic ulcers, and gastric cancer, it has been classified as a Group 1 carcinogen. Currently, the most widely used method for detecting Helicobacter pylori both domestically and internationally is the urea breath test, in which the patient orally ingests urea. 13 C] or urea [ 14 [C] If Helicobacter pylori is present in the stomach, the urease it produces can rapidly decompose urea into labeled carbon dioxide. By measuring whether the concentration of carbon-13 or carbon-14 in the patient's breath is elevated, it can be determined whether the patient is infected with Helicobacter pylori. This test is convenient and quick; therefore, urea is the most widely used breath test drug both domestically and internationally. 13 C] Breath test reagent.

[0003] The test reagent is available in various dosage forms, including capsules, powders, granules, and oral solutions. These dosage forms can be broadly categorized into two types: those that are dissolved in vitro before administration and those that are not. Dosage forms that are dissolved in vitro include powders, granules, and oral solutions; dosage forms that are not dissolved in vitro include capsules and tablets.

[0004] Patent document CN106620736A discloses a novel urea [ 13 [C] The test drug contains a high amount of mannitol in the prescription of this patent. Mannitol is a material that easily produces high permeability. Excessive dosage may cause diarrhea and affect the patient's health. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the present invention provides a drug for detecting Helicobacter pylori and a method for preparing the same. The drug of the present invention does not use mannitol, which reduces the risk of drug use for patients.

[0006] To solve the above-mentioned technical problems, one of the objectives of this invention is to provide a drug for detecting Helicobacter pylori, wherein the raw materials, by weight, include: urea [ 13 [C] 10-75 parts, sodium bicarbonate 5-110 parts, lactose 15-45 parts, citric acid 1000-2500 parts, flavoring agent 50-150 parts.

[0007] Furthermore, the flavoring agent includes at least one of steviol glycosides, sucralose, aspartame, neotame, sematrandrine, and acesulfame potassium.

[0008] Another object of the present invention is to provide a method for preparing a drug for detecting Helicobacter pylori, comprising at least the following steps:

[0009] S1, separately add urea [ 13 C], sodium bicarbonate, lactose, and flavoring agent are sieved, then the sieved powder is mixed evenly, and finally the powder is compressed into tablets.

[0010] S2. Pack the tablets in aluminum-plastic packaging or bottles;

[0011] S3. Citric acid is passed through a 20-40 mesh sieve, and the dispersed citric acid is packaged in 1-3g packages.

[0012] S4. Combine tablets in aluminum-plastic packaging or bottle packaging with citric acid in a combined packaging.

[0013] Preferably, the citric acid is dispersed and packaged in 1-1.5g portions.

[0014] Furthermore, the urea [ 13 C] After being pulverized, the urea is passed through a 60-120 mesh sieve. 13 The particle size D50 of C] is 110–250 μm.

[0015] Furthermore, the hardness of the tablet is 1 to 3.5 kg.

[0016] Furthermore, the citric acid is passed through a 20-40 mesh sieve.

[0017] Furthermore, the sodium bicarbonate, lactose, and flavoring agent are passed through a 50-120 mesh sieve.

[0018] Furthermore, each tablet weighs between 155 mg and 265 mg.

[0019] Furthermore, the citric acid is packaged in bottles or film bags.

[0020] Furthermore, the combined packaging includes: one blister pack of tablets is dotted on the top of the cap of a bottle containing citric acid, and both are placed together in a cardboard outer packaging. Before taking the tablets, place them in the bottle, add water to dissolve them, and then take the tablets; or one blister pack of tablets and one sachet of citric acid are placed together in a cardboard outer packaging. Before taking the tablets and citric acid, remove the packaging, place them in a disposable cup, add water to dissolve them, and then take the tablets; or the tablets and citric acid are placed in a bottle simultaneously, without contact between them. Before taking the tablets and citric acid, mix them together, add water to dissolve them, and then take the tablets.

[0021] In summary, this invention offers the following advantages: When citric acid and flavoring agent powder are mixed together for an extended period (e.g., 60°C, 10 days), degradation impurities of the flavoring agent are generated, leading to a decrease in either the citric acid or flavoring agent content. This invention, by storing citric acid separately from the tablets, effectively solves the problem of flavoring agent addition and avoids impurity formation due to citric acid addition. Simultaneously, mannitol is not used in the medication, reducing the risk to patients. This invention employs a direct compression process, resulting in no loss during production and effectively reducing drug costs. The tablets exhibit significantly reduced hygroscopicity, facilitating drug storage and transportation. Furthermore, the appearance and content of the tablets remain stable without impurities during room temperature storage, and the tablets can maintain stability for more than 6 months in high-temperature and high-humidity environments. This invention produces a single-dose formulation, making it convenient for patients and healthcare professionals. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the combined packaging structure in Example 1.

[0024] 1. Bottle; 2. External screw cap; 3. Perforated kit.

[0025] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0026] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0027] Unless otherwise specified, the experimental methods used in the following examples are conventional methods. Unless otherwise specified, the experimental materials and reagents used in the following examples are commercially available. All quantitative experiments in the following examples were performed in triplicate, and the data are the average of the three replicates or the average ± standard deviation.

[0028] Furthermore, the term "and / or" in the text includes three solutions. Taking A and / or B as an example, it includes technical solution A, technical solution B, and technical solution that simultaneously satisfies both A and B. In addition, the technical solutions of various embodiments can be combined with each other, but this must be based on the ability of a person skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0029] A drug for detecting Helicobacter pylori, the raw materials of which include: urea [ 13 C], sodium bicarbonate, lactose, citric acid, and flavoring agent. The mixture of urea, sodium bicarbonate, lactose, and flavoring agent is compressed into tablets.

[0030] Flavoring agents include at least one of steviol glycosides, sucralose, aspartame, neotame, sematrandrine, and acesulfame potassium.

[0031] Its preparation method is as follows:

[0032] S1. Use a grinder to grind urea [ 13 C] After the crystals are crushed, they are sieved with a 100-mesh vibrating screen to remove fine powder and coarse particles, and the intermediate powder is collected for later use.

[0033] Sodium bicarbonate, neotame, sematrandezine, and aspartame were passed through an 80-mesh sieve and the fine powders were collected separately for later use.

[0034] Lactose, sucralose, and steviol glycosides were passed through a 65-mesh sieve and collected as fine powder for later use.

[0035] Pass acesulfame potassium through a 100-mesh sieve and collect the fine powder for later use.

[0036] The collected urea [ 13 C] Sodium bicarbonate, lactose, and flavoring agent powder are mixed evenly and then compressed into tablets.

[0037] S2. Pack the tablets in bottles.

[0038] S3, citric acid, is passed through a 20-mesh sieve and packaged in 2g portions.

[0039] S4. Combine bottled tablets with citric acid in a packaged form, the structure of which is as follows: Figure 1 As shown.

[0040] like Figure 1As shown, the package includes a bottle 1 and an external screw cap 2 screwed onto the neck of bottle 1. A perforated assembly 3 is fixedly installed inside bottle 1. The perforated assembly 3 is a small, perforated, capped cylinder containing tablets. After the tablets are filled into the perforated assembly 3, the cap is pressed down to prevent the tablets from falling out. Citric acid is placed inside bottle 1 and outside the perforated assembly 3, so the tablets and citric acid do not mix. Before consumption, unscrew the external screw cap, add 100mL of water to dissolve the tablets and citric acid into a liquid, and then consume.

[0041] The tablet ingredients and dosages of the drugs in Examples 1-7 are shown in Table 1.

[0042] Table 1. Raw materials and dosage (mg / tablet) of the tablets in Examples 1-7

[0043] Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 <![CDATA[Urea 13 C]]]> 75 75 50 75 50 75 10 lactose 45 15 45 15 15 15 45 Sodium bicarbonate 5 15 15 110 50 50 50 Sucralose 50 50 15 15 / 80 / Steviosides / / 25 15 / / / Newtilla chinensis / / 10 10 / / / Somali Sweet / / / 10 / / / Acesulfame K / / / / / / 85 Aspartan / / / / 150 / /

[0044] The difference between Comparative Example 1 and Example 1 is that the tablet contains only urea. 13 C).

[0045] The difference between Comparative Example 2 and Example 1 is that, after citric acid is passed through an 80-mesh sieve, 400g of citric acid is mixed with urea, sodium bicarbonate, lactose, and flavoring agent, and the raw material powder is compressed into tablets.

[0046] The difference between Comparative Example 3 and Example 1 is that the tablets do not contain sodium bicarbonate.

[0047] The difference between Comparative Example 4 and Example 1 is that the sodium bicarbonate content in the tablet is 150 mg.

[0048] The difference between Comparative Example 5 and Example 1 is that the tablet contains 50 mg of lactose.

[0049] The difference between Comparative Example 6 and Example 1 is that the tablet contains 10 mg of lactose.

[0050] The tableting process results of the tablets in Examples 1-7 and Comparative Examples 1-6 are shown in Table 2.

[0051] Table 2

[0052]

[0053]

[0054] Table 2 shows that lactose helps with tablet formation, increases tablet hardness, and reduces tablet friability. Although pure urea can be compressed into tablets, the tablets are relatively friable. Adding ≥15mg of lactose significantly reduces tablet friability.

[0055] The disintegration of the tablets in Examples 1-7 and Comparative Examples 1-6 after being combined with citric acid is shown in Table 3.

[0056] Table 3

[0057]

[0058]

[0059] Table 3 shows that tablets containing sodium bicarbonate have significantly shorter disintegration times, making them more convenient for patients to take and reducing waiting time. However, when the amount of sodium bicarbonate exceeds 110 mg, the amount of citric acid is reduced after dissolution, which may decrease the efficacy of the formulation. When the lactose content is below 50 mg, the disintegration is clearer and the sensory acceptance is better.

[0060] The tablets of Examples 1-7 and Comparative Examples 1-6 were placed in an environment of 40°C and 75% RH and an environment of 30°C and 65% RH to examine their quality stability. The results are shown in Tables 4, 5 and 6.

[0061] Table 4

[0062]

[0063] Table 5

[0064]

[0065] Table 6

[0066]

[0067]

[0068] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0069] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A drug for detecting Helicobacter pylori, characterized in that, By weight, its raw materials include: urea [ 13 C] 10~75 parts, sodium bicarbonate 5~50 parts, lactose 15~45 parts, citric acid 1000~2500 parts, flavoring agent 50~150 parts; The drug is packaged in a combination form, comprising component A and component B: (1) Component A is a tablet, made from the urea [ 13 It is composed of [C], sodium bicarbonate, lactose, and flavoring agents, compressed into tablets; wherein, the urea [ 13 The particle size of C] meets the requirement of passing through a 60-120 mesh sieve, and the urea [ 13 C] granularity D 50 The particle size is 110~250μm; the particle size of the sodium bicarbonate, lactose, and flavoring agent all meet the requirement of passing through a 50~120 mesh sieve; the hardness of the tablet is 1~4kg, and the weight of each tablet is 155mg~265mg; (2) Component B is composed of citric acid and is individually packaged in 1~3g specifications.

2. The drug for detecting Helicobacter pylori according to claim 1, characterized in that, The flavoring agent includes at least one of steviol glycosides, sucralose, aspartame, neotame, sematrandrine, and acesulfame potassium.

3. A method for preparing a drug for detecting Helicobacter pylori as described in claim 1, characterized in that, At least the following steps are included: S1, separately add urea [ 13 C], sodium bicarbonate, lactose, and flavoring agent are sieved, then the sieved powder is mixed evenly, and finally the powder is compressed into tablets. S2. Pack the tablets in aluminum-plastic packaging or bottles; S3. Citric acid is passed through a 20-40 mesh sieve, and the dispersed citric acid is packaged in 1-3g packages. S4. Combine tablets in aluminum-plastic packaging or bottle packaging with citric acid in a combined packaging.

4. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The urea [ 13 C] After being pulverized, the urea is passed through a 60-120 mesh sieve. 13 C] granularity D 50 The value is 110~250μm.

5. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The hardness of the tablets is 1~3.5 kg.

6. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The citric acid passed through a 20-40 mesh sieve.

7. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The sodium bicarbonate, lactose, and flavoring agent are passed through a 50-120 mesh sieve.

8. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, Each tablet weighs between 155 mg and 265 mg.

9. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The citric acid is packaged in bottles or film bags.

10. A method for preparing a drug for detecting Helicobacter pylori according to claim 3, characterized in that, The combined packaging includes: one blister pack of tablets with a dot on the top of the cap of a bottle containing citric acid, both placed together in a cardboard box. Before taking the tablets, place them in the bottle, add water to dissolve them, and then take the tablets; or one blister pack of tablets and one sachet of citric acid are placed together in a cardboard box. Before taking the tablets and citric acid, remove the packaging, place them in a disposable cup, add water to dissolve them, and then take the tablets; or the tablets and citric acid are placed in a bottle simultaneously, without contact between them. Before taking the tablets and citric acid, mix them together, add water to dissolve them, and then take the tablets.

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