Application of streptococcus salivarius subsp. Thermophilus Biohalo 23 tablet in preparation of product for treating otitis media

By using Biohalo23 tablets for the thermophilic subspecies of Salivary Salivary Biohalo23 tablets, combined with excipients, the problems of resistance to drug resistance and low efficiency of traditional dosage forms were solved, and significant efficacy and reduced incidence was achieved.

CN119386057AInactive Publication Date: 2025-02-07ZHIYU MEDICAL TECH (SHANDONG) CO LTD
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Patent Information

Application Number
CN202411350021.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-26
Publication Date
2025-02-07
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

There are drug resistance problems in existing treatment methods for otitis media, and traditional dosage forms such as liquid preparations quickly reach the gastrointestinal and intestines after taking them, resulting in a decrease in probiotic activity and poor treatment effect.

Method used

Biohalo23 tablets were used as probiotic preparations for the thermophilic subspecies of Streptococcus salivary. The strain was colonized in the oropharyngeal site by oral tablets, and combined with auxiliary materials such as crystalline fructose, maltodextrin, magnesium stearate and flavors to improve the probiotics. Activity and taste.

Benefits of technology

It significantly alleviates the symptoms of otitis media, reduces the incidence of otitis media, significantly reduces the number of prevalence and prevalence of young children through clinical trials, and improves middle ear effusion and improves treatment effect.

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Abstract

The invention discloses an application of a streptococcus salivarius subsp. Thermophilus Biohalo 23 tablet in preparation of a product for treating otitis media. The preservation number of the streptococcus salivarius subsp. Thermophilus Biohalo 23 is DSM34540; the streptococcus salivarius subsp. Thermophilus Biohalo 23 tablet can relieve the disease symptoms of otitis media and reduce the morbidity of the otitis media, has a remarkable curative effect on the otitis media, and particularly, through clinical tests, the number of diseases of infants can be remarkably reduced, the morbidity of the infants can be reduced, middle ear effusion can be improved, and the curative effect of the infants on the otitis media can be improved. Therefore, the streptococcus salivarius subsp. Thermophilus Biohalo 23 tablet disclosed by the invention can be used for treating the otitis media.
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Description

Technical Field

[0001] The invention relates to the technical field of probiotics, and in particular to application of a Streptococcus salivarius thermophilic subspecies Biohalo23 tablet in the preparation of a product for treating otitis media. Background Art

[0002] Otitis media is an inflammation caused by a viral or bacterial infection in the middle part of the ear, behind the eardrum. It is mainly caused by bacteria and viruses, and is often caused by diseases such as colds, flu or sinusitis. This disease is relatively common, especially in children under 10 years old, 80% of children have had otitis media at least once. Among them, the highest incidence rate is in children aged 2 and 5. There are mainly types of otitis media, such as acute otitis media, acute suppurative otitis media, chronic suppurative otitis media and secretory otitis media.

[0003] The main clinical symptoms of otitis media include ear pain, hearing loss, water discharge, pus discharge and even bleeding in the ear canal. Serous otitis media is mainly manifested by ear pain, stuffy ears, blocked ears, hearing loss or tinnitus. In addition to the classic symptoms, systemic symptoms may also occur, such as fever and headache. For children, parents need to pay close attention to whether they frequently "rub their ears".

[0004] The treatment of otitis media mainly adopts local or systemic drugs or surgical treatment. Severe otitis media that is not treated in time may cause permanent hearing loss, or cause infection in the adjacent parts of the head, resulting in serious intracranial and extracranial complications. Once symptoms such as ear pain, tinnitus, stuffy ears, hearing loss or pus in the ear canal occur, you should seek medical treatment in time.

[0005] Currently, the main clinical treatment for otitis media is drug treatment, which can be erythromycin, cefuroxime, ceftizoxime, etc. taken orally or intravenously. In the acute phase, glucocorticoids can be added, such as dexamethasone or prednisone, but long-term use of this type of drug will lead to drug resistance.

[0006] In view of this, the present invention is proposed. Summary of the invention

[0007] The object of the present invention is to provide an application of a thermophilic Streptococcus salivarius subsp. Biohalo23 tablet in the preparation of a product for treating otitis media. The thermophilic Streptococcus salivarius subsp. Biohalo23 tablet of the present invention can alleviate the symptoms of otitis media and reduce the incidence of otitis media, and has a significant therapeutic effect on otitis media.

[0008] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0009] A first aspect of the present invention provides an application of a Streptococcus salivarius thermophilus subspecies Biohalo23 tablet in the preparation of a product for treating otitis media, wherein the Streptococcus salivarius thermophilus subspecies Biohalo23 has a deposit number of DSM34540.

[0010] The second aspect of the present invention provides a probiotic tablet, which comprises the thermophilic Streptococcus salivarius subspecies Biohalo23 and auxiliary materials.

[0011] Preferably, the content of Streptococcus salivarius thermophilus subspecies Biohalo23 in each probiotic tablet is not less than 500 million cfu.

[0012] Preferably, the auxiliary materials include crystalline fructose, maltodextrin, magnesium stearate and flavors.

[0013] Preferably, the auxiliary materials consist of 10-15 parts of crystalline fructose, 82-88 parts of maltodextrin, 0.8-1.2 parts of magnesium stearate and 0.2-0.8 parts of flavor.

[0014] Preferably, the flavor includes strawberry flavor, apple flavor or orange flavor.

[0015] Preferably, the mass of each probiotic tablet is 0.9-1 g.

[0016] Compared with the prior art, the beneficial effects of the present invention include at least:

[0017] The thermophilic Streptococcus salivarius subsp. Biohalo23 tablet of the present invention can relieve the symptoms of otitis media, and can reduce the incidence of otitis media, and has a significant therapeutic effect on otitis media. Specifically, through clinical trials, it can significantly reduce the number of illnesses in young children, reduce the incidence rate, and improve middle ear effusion, which further indicates that the thermophilic Streptococcus salivarius subsp. Biohalo23 tablet of the present invention can be used for the treatment of otitis media.

[0018] In addition, the thermophilic subspecies Biohalo23 tablets of Streptococcus salivarius of the present invention are easy to take and can ensure that the probiotics are stable and active for a long time. At the same time, the special tablets have a stable melting speed, melting in the mouth in about 3-5 minutes, ensuring that there is enough time for the thermophilic subspecies Biohalo23 strain of Streptococcus salivarius to colonize in the oropharynx. However, other dosage forms have poor therapeutic effects, such as liquid preparations, which quickly reach the stomach and intestines when taken, causing the death of a large number of bacteria in the gastrointestinal environment, and fewer strains are colonized in the oropharynx, resulting in failure to achieve effective therapeutic effects. DETAILED DESCRIPTION

[0019] The following embodiments of the technical solution of the present invention are described in detail in conjunction with the embodiments. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and are therefore only used as examples, and cannot be used to limit the protection scope of the present invention.

[0020] It should be noted that, unless otherwise specified, the technical terms or scientific terms used in this application should have the common meanings understood by those skilled in the art to which the present invention belongs.

[0021] The embodiment of the present invention provides an application of a Streptococcus salivarius thermophilus subspecies Biohalo23 tablet in preparing a product for treating otitis media, wherein the Streptococcus salivarius thermophilus subspecies Biohalo23 has a deposit number of DSM34540.

[0022] The preservation unit of the thermophilic Streptococcus salivarius subspecies Biohalo23 of the present invention is the German Microorganisms Preservation Center, and the strain can be purchased from the German Microorganisms Preservation Center.

[0023] The thermophilic Streptococcus salivarius subsp. Biohalo23 tablet of the present invention can relieve the symptoms of otitis media, and can reduce the incidence of otitis media, and has a significant therapeutic effect on otitis media. Specifically, through clinical trials, it can significantly reduce the number of illnesses in young children, reduce the incidence rate, and improve middle ear effusion, which further indicates that the thermophilic Streptococcus salivarius subsp. Biohalo23 tablet of the present invention can be used for the treatment of otitis media.

[0024] In addition, the thermophilic subspecies Biohalo23 tablets of Streptococcus salivarius of the present invention are easy to take and can ensure that the probiotics are stable and active for a long time. At the same time, the special tablets have a stable melting speed, melting in the mouth in about 3-5 minutes, ensuring that there is enough time for the thermophilic subspecies Biohalo23 strain of Streptococcus salivarius to colonize in the oropharynx. However, other dosage forms have poor therapeutic effects, such as liquid preparations, which quickly reach the stomach and intestines when taken, causing the death of a large number of bacteria in the gastrointestinal environment, and fewer strains are colonized in the oropharynx, resulting in failure to achieve effective therapeutic effects.

[0025] Another embodiment of the present invention provides a probiotic tablet, which includes the thermophilic Streptococcus salivarius subspecies Biohalo23 and auxiliary materials.

[0026] By adding auxiliary materials, the activity of the thermophilic subspecies of Streptococcus salivarius Biohalo23 can be better preserved, and the taste of the product can be improved, thereby improving the taste of the probiotic tablets for children.

[0027] In one embodiment, the content of Streptococcus salivarius thermophilus subspecies Biohalo23 in each probiotic tablet is not less than 500 million cfu.

[0028] By limiting the content of the thermophilic subspecies Biohalo23 of Streptococcus salivarius in probiotic tablets, the efficacy of the probiotic tablets can be better improved.

[0029] In one embodiment, the auxiliary materials include crystalline fructose, maltodextrin, magnesium stearate and flavors.

[0030] In some embodiments, the auxiliary materials are composed of 10-15 parts of crystalline fructose, 82-88 parts of maltodextrin, 0.8-1.2 parts of magnesium stearate and 0.2-0.8 parts of flavor.

[0031] In one embodiment, the flavor includes strawberry flavor; in other embodiments, the flavor may be strawberry flavor, apple flavor or orange flavor.

[0032] In one embodiment, the mass of each probiotic tablet is 0.9-1 g.

[0033] The technical scheme of the present invention is further described in detail below through specific examples. The various materials and reagents used in the following specific examples are commonly used materials and reagents in the field and can be obtained through regular commercial channels; the methods used are conventional methods known to those skilled in the art.

[0034] Example 1

[0035] This embodiment is a probiotic tablet, which includes the thermophilic Streptococcus salivarius subspecies Biohalo23 and auxiliary materials;

[0036] The content of Streptococcus salivarius thermophilus subspecies Biohalo23 in each probiotic tablet is 1 billion cfu, and the mass of each probiotic tablet is 0.95g;

[0037] The auxiliary materials consist of 10 parts of crystalline fructose, 88 parts of maltodextrin, 0.8 parts of magnesium stearate and 0.2 parts of flavor, wherein the flavor is strawberry flavor.

[0038] Example 2

[0039] This embodiment is a probiotic tablet, which includes the thermophilic Streptococcus salivarius subspecies Biohalo23 and auxiliary materials;

[0040] The content of Streptococcus salivarius thermophilus subspecies Biohalo23 in each probiotic tablet is 1 billion cfu, and the mass of each probiotic tablet is 0.95g;

[0041] The auxiliary materials consist of 15 parts of crystalline fructose, 82 parts of maltodextrin, 1.2 parts of magnesium stearate and 0.8 parts of flavor, wherein the flavor is strawberry flavor.

[0042] Example 3

[0043] This embodiment is a probiotic tablet, which includes the thermophilic Streptococcus salivarius subspecies Biohalo23 and auxiliary materials;

[0044] The content of Streptococcus salivarius thermophilus subspecies Biohalo23 in each probiotic tablet is 1 billion cfu, and the mass of each probiotic tablet is 0.95g;

[0045] The auxiliary materials consist of 12 parts of crystalline fructose, 85.5 parts of maltodextrin, 1 part of magnesium stearate and 0.5 parts of flavor, wherein the flavor is strawberry flavor.

[0046] Experimental example

[0047] This experimental example is a study on the effect of Streptococcus salivarius thermophilus subspecies Biohalo23 (German strain library deposit number DSM34540) on otitis media;

[0048] The probiotic tablets used in the following experiments are the probiotic tablets prepared in Example 3.

[0049] 1. Among the healthy children who entered kindergarten in the first year, 120 children took one probiotic tablet sublingually every day for 6 consecutive months, and the other 120 children did not take probiotic tablets as the control group, and were followed up for 3 months.

[0050] Experimental results:

[0051] Compared with the control group, the incidence of acute otitis media decreased by 47% during the period when children took probiotic tablets (P<0.01);

[0052] During the follow-up period, the incidence of acute otitis media decreased by 65% ​​(P<0.05).

[0053] 2. A total of 32 children with secretory otitis media were treated. Children with secretory otitis media took probiotic tablets sublingually for 30 days, 1 tablet per day;

[0054] Experimental results:

[0055] The incidence of acute otitis media decreased by 69% compared with before taking the drug (P<0.01);

[0056] The left and right otoscopy scores decreased by 66% and 63%, respectively (P<0.05);

[0057] The middle ear effusion in the left and right ears was improved by 88% and 75%, respectively (P<0.05).

[0058] In summary, by taking the probiotic tablets, the symptoms of otitis media during the onset period are significantly improved, and the incidence of otitis media can be reduced, indicating that the probiotic tablets of the present invention can treat otitis media.

[0059] 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 by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and specification of the present invention.

Claims

1. Application of Streptococcus salivarius thermophilus subspecies Biohalo23 tablets in the preparation of products for treating otitis media, characterized in that: The deposit number of the thermophilic Streptococcus salivarius subspecies Biohalo23 is DSM34540.

2. A probiotic tablet, characterized in that: The probiotic tablet comprises the thermophilic Streptococcus salivarius subspecies Biohalo23 according to claim 1 and auxiliary materials.

3. The probiotic tablet according to claim 2, characterized in that The content of the thermophilic Streptococcus salivarius subspecies Biohalo23 in each probiotic tablet is not less than 500 million cfu.

4. The probiotic tablet according to claim 2, characterized in that The auxiliary materials include crystalline fructose, maltodextrin, magnesium stearate and flavors.

5. The probiotic tablet according to claim 2, characterized in that: The auxiliary material consists of 10-15 parts of crystal fructose, 82-88 parts of maltodextrin, 0.8-1.2 parts of magnesium stearate and 0.2-0.8 parts of flavor.

6. The probiotic tablet according to claim 4, characterized in that: The flavor includes strawberry flavor, apple flavor or orange flavor.

7. The probiotic tablet according to claim 2, characterized in that: The mass of each probiotic tablet is 0.9-1g.