Probiotic composition for improving allergic rhinitis and preparation method thereof

Abstract

The invention discloses a probiotic composition for improving allergic rhinitis and a preparation method thereof.The composition comprises anti-allergic bacteria and prebiotics, the anti-allergic bacteria are casein rhamnosus MP108, the casein rhamnosus MP108 accounts for 10-20 parts by weight, the prebiotics account for 70-75 parts by weight, the prebiotics comprise lactitol, resistant dextrin and inulin, and the anti-allergic bacteria and the prebiotics account for 10-20 parts by weight of the lactobacillus rhamnosus MP108 and 70-75 parts by weight of the prebiotics. The weight ratio of the lactitol to the resistant dextrin to the inulin is (2-3): (2-5): (1-4), through the matching of the lactitol, the resistant dextrin and the inulin, the fast planting of the anti-allergic bacteria is considered, the fermentation speed and the energy supply duration are balanced, the situation that the bacterial activity is inhibited by local acidification due to too fast fermentation or the insufficient nutrition supply is caused by too slow fermentation is avoided, and the anti-allergic bacteria can be prepared. According to the invention, a rapid proliferation-stable survival-long-acting regulation synergistic system of the lactobacillus rhamnosus MP108 in the intestinal tract is constructed, and a good and stable improvement effect on allergic rhinitis and intestinal tract balance are realized.

Description

Technical Field

[0001] This invention relates to the field of probiotic composition technology, and in particular to a probiotic composition for improving allergic rhinitis and its preparation method. Background Technology

[0002] Currently, probiotic products used for allergic rhinitis often have issues with the anti-allergy bacteria's utilization of single or compound prebiotics in their ingredients. This can lead to a situation where the main anti-allergy bacteria cannot simultaneously achieve rapid proliferation and maintain intestinal flora balance, thus affecting the proliferation of anti-allergy bacteria and the effectiveness of anti-allergy measures. Consequently, it is difficult to guarantee the stability and long-term effectiveness of the improvement. Summary of the Invention

[0003] The purpose of this invention is to overcome the shortcomings of the prior art and provide a probiotic composition that takes into account the rapid proliferation of anti-allergic bacteria, the maintenance of intestinal flora balance, and long-term improvement effects.

[0004] The objective of this invention is achieved through the following technical solution: A probiotic composition for improving allergic rhinitis includes anti-allergy bacteria and prebiotics. The anti-allergy bacteria is Lactobacillus rhamnosus MP108, with 10-20 parts by weight of Lactobacillus rhamnosus MP108 and 70-75 parts by weight of prebiotics. The prebiotics are lactitol, resistant dextrin, and inulin, with a weight ratio of (2-3):(2-5):(1-4). The remainder is excipients.

[0005] The core mechanism of this approach is that *Lactobacillus rhamnosus* MP108 regulates the intestinal immune system, reduces allergen absorption, and lowers allergic reactions in the nasal mucosa. The prebiotics, lactitol, resistant dextrin, and inulin, are used in optimized proportions to achieve synergistic effects, resulting in rapid proliferation of anti-allergic bacteria, maintenance of intestinal flora balance, and long-lasting improvement. Lactitol is preferentially utilized by *Lactobacillus rhamnosus* MP108, providing the energy needed for rapid proliferation, accelerating cell division, and shortening the colonization time of the strain in the intestine. Resistant dextrin is slowly fermented by the intestinal flora, prolonging the survival time of *Lactobacillus rhamnosus* MP108 while maintaining... The fermentation process generates short-chain fatty acids, providing a continuous energy source for Lactobacillus rhamnosus MP108 while regulating the pH value in the intestine, inhibiting inflammatory responses, and promoting mucosal cell regeneration. Inulin, as a long-chain prebiotic, can promote the symbiosis of multiple bacteria and form a stable intestinal microecology. Its fermentation also produces some short-chain fatty acids. Thus, by optimizing the ratio of the three, the rapid colonization of anti-allergy bacteria is taken into account, while the fermentation speed and energy supply duration are balanced. This avoids local acidification that inhibits bacterial activity due to excessively rapid fermentation, or insufficient nutrient supply due to excessively slow fermentation, thereby effectively improving allergic rhinitis and maintaining the improvement effect for a longer period of time.

[0006] In a preferred embodiment, the number of viable Lactobacillus rhamnosus MP108 bacteria in the probiotic composition is (1-3) × 10⁻⁶. 9 CFU / g.

[0007] In a preferred embodiment, the probiotic composition further includes a synergistic component, which includes at least one immune-enhancing component and an auxiliary synergistic component, wherein the immune-enhancing component is at least one of an enhancing microbial community and an immune polysaccharide.

[0008] In a preferred embodiment, the synergistic microbial community is one or more of Lactobacillus reuteri, Bifidobacterium, Lactobacillus paracasei, Saccharomyces boulardii, and Lactobacillus acidophilus, and the immunopolysaccharide includes one or more of Astragalus polysaccharide, Poria cocos polysaccharide, Lentinus edodes polysaccharide, Salvia miltiorrhiza polysaccharide, Taraxacum mongolicum polysaccharide, Bupleurum chinense polysaccharide, or Anemarrhena asphodeloides polysaccharide.

[0009] In a preferred embodiment, the auxiliary synergistic component is one or more of sea buckthorn fruit powder, blueberry fruit powder, cherry fruit powder, and grape fruit powder.

[0010] In a preferred embodiment, the probiotic composition is a microencapsulated powder.

[0011] The present invention also provides a method for preparing the above-mentioned probiotic composition for improving allergic rhinitis, comprising the following steps: S1 The components of the composition are prepared into a uniform mud according to the ratio, and then a protective agent is added and freeze-dried into bacterial powder; S2 Prepare the encapsulation material solution and sterilize it for later use; S3. The freeze-dried bacterial powder is slowly added to the capsule material solution and homogenized to form a uniform suspension.

[0012] S4 involves slowly dripping the suspension into a cross-linking agent solution to form microcapsules encapsulating the bacterial powder using a composite encapsulating material. The mixture is then stirred until the microcapsules solidify, and the microcapsules are filtered, washed, and collected.

[0013] S5 freeze-dry the microcapsules obtained in S4 to obtain a powdered product.

[0014] In a preferred embodiment, the protective agent is skim milk powder, the encapsulating material is sodium alginate, and the cross-linking agent is calcium chloride. Compared with the prior art, the present invention has at least the following advantages: The probiotic composition of this invention mainly focuses on the combination and optimization of prebiotics for single anti-allergy bacteria. By adjusting the ratio of lactitol, resistant dextrin, and inulin, it balances the rapid colonization of anti-allergy bacteria with the fermentation speed and energy supply duration, avoiding local acidification that inhibits bacterial activity due to excessively rapid fermentation or insufficient nutrient supply due to excessively slow fermentation. This constructs a synergistic system for the rapid proliferation, stable survival, and long-term regulation of Lactobacillus rhamnosus MP108 in the intestine. Compared with single anti-allergy bacteria, it can achieve a good and stable improvement effect on allergic rhinitis and intestinal balance.

[0015] The probiotic composition of the present invention, with the ratio of anti-allergy bacteria and prebiotics of the present invention, and with the addition of certain specific synergistic components, can also maintain a good effect on improving allergic rhinitis. Detailed Implementation

[0016] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0017] It should be noted that the main components involved in the embodiments of the present invention are derived from: Lactobacillus rhamnosus MP108, with accession number SHBCC D28306, was cultured and collected, with an effective viable count of 5 × 10⁸. 9 CFU / g; Bifidobacterium animalis subsp. lactis was purchased from Shandong Pingao Pharmaceutical Co., Ltd., 1×10 10 CFU / g; Lactobacillus reuteri was purchased from Xi'an Tianhe Pharmaceutical Co., Ltd., 5×10 9 CFU / g; Lactitol, resistant dextrin, inulin, maltodextrin, lentinan, and astragalus polysaccharide are all commercially available food-grade powders.

[0018] The following examples and comparative examples were prepared according to the following methods: S1 prepares the composition components of each example according to the proportions in Table 1-1, makes them into a uniform paste, adds skim milk powder, and freeze-dries them into bacterial powder; S2 Prepare a 2g / 100mL sodium alginate solution, and sterilize it according to the ratio of bacterial powder mass (g) to sodium alginate solution volume (mL) of 1:10. S3. The freeze-dried bacterial powder was slowly added to a sodium alginate solution and homogenized at 5000 rpm / min to form a uniform suspension. The volume ratio of sodium alginate solution to crosslinking agent solution was 1:3-1:5. S4 The suspension is slowly added dropwise to a 2% calcium chloride solution at a rate of 2-4 mL / min to form microcapsules encapsulating the bacterial powder. The mixture is stirred until the microcapsules solidify, then filtered, washed, and collected.

[0019] S5 freeze-dry the microcapsules obtained in S4 to obtain a powdered product.

[0020] Table 1-1 lists the components of each embodiment and comparative example as follows: The total viable count was determined by diluting and coating the product using the plate count method. To ensure better release of viable bacteria from the microencapsulated product, except for the control example, the products in the examples and comparative examples were measured after adding the microcapsule powder to 0.85% NaCl, treating it with ultrasound, and then diluting it. The test results are shown in Tables 1-2. Table 1-2 Results of viable bacteria count detection As can be seen from Tables 1-2, within the formulation range provided by this invention, the probiotic composition (Examples 1-6) can achieve a viable count of 10. 9 -10 10 The CFU / g concentration, without the addition of other synergistic bacteria, can reach 3.12 × 10⁻⁶. 9 The CFU / g of the compound probiotics (comparative examples 3-5) that does not fall within the mass ratio range of this invention has a viable count of 10. 7 -10 8 CFU / g. It is evident that the compound probiotics provided by this invention significantly increase the total number of live probiotics, helping to effectively reduce the effectiveness of the probiotic composition. Compared to Example 3, in Comparative Examples 1-2, the proportion of *Lactobacillus rhamnosus* MP108 was too high, increasing the difficulty of microcapsule encapsulation or resulting in insufficient bacterial cells. This enhanced intercellular interactions led to increased viscosity of the composition, bacterial aggregation, and reduced survival rate. Conversely, the proportion of *Lactobacillus rhamnosus* MP108 was too low, causing the bacteria to be tightly encapsulated and difficult to release. In Comparative Examples 3-5, due to the prebiotic ratio, the proportion of a certain component was either too high or too low, leading to uneven mixing of the bacterial powder and sodium alginate solution during microencapsulation, excessively high viscosity causing uneven bacterial distribution, and the formation of localized high-concentration areas. This affected the bacterial release efficiency, or the prepared microcapsule structure was loose, making it difficult to effectively block the external environment, resulting in a decrease in the number of live bacteria.

[0021] For the above examples, four volunteers with allergic rhinitis were randomly selected for each example to undergo improvement testing. The selection criteria for volunteers were as follows: (1) Those aged between 20 and 60 (excluding pregnant and lactating women) who currently have at least one allergy symptom, such as nasal itching (scratching the nose more than 8 times / day), nasal congestion (nasal congestion time more than 10 hours), continuous sneezing, or runny nose, and who will not be in an environment with obvious pollen, dust, or fluff in the next month. (2) No serious systemic diseases, no immunodeficiency or autoimmune diseases, and no high level of physical fitness; (3) Has not used hormone drugs or immunosuppressants in the past month; (4) Those who have not participated in other clinical trials in the past three months.

[0022] Test method: Each group of volunteers used 10g of the above sample three times a day for 15 consecutive days. The condition of each patient was observed, and the following records were kept for each patient: (1) Did you feel any improvement after using it for 7 days? (2) After 15 days of use, evaluate the improvement of allergy symptoms on a scale of 0-10. Significant improvement is 10 points, and no improvement or worsening of symptoms is 0 points. (3) Whether the allergy symptoms have improved or been relieved within 15 days after discontinuation is scored on a scale of 0-1. If the symptoms worsen after 15 days of use, it is scored on 0 points; if the symptoms remain or improve further, it is scored on 1 point.

[0023] (4) Evaluate the side effects on a scale of 0-5 based on actual feelings during use. No side effects are 0 points, while abdominal distension, severe diarrhea (>3 times / day), unbearable abdominal pain, and constipation are 5 points. Record the side effects.

[0024] The results are recorded as follows: Table 1-3 Results of the Allergic Rhinitis Improvement Trial As shown in Tables 1-3, Examples 1-6 showed significantly better improvement effects on allergic rhinitis symptoms than Comparative Examples 1-5 and the control, with virtually no side effects. This indicates that within the component ratio range of this invention, they exhibited better improvement effects, played a better role in intestinal balance, and maintained a longer-lasting improvement effect. Compared to Example 3, the *Lactobacillus rhamnosus* MP108 in Comparative Examples 1 and 2 was outside the specified ratio range. In Comparative Example 1, when the proportion of *Lactobacillus rhamnosus* MP108 was insufficient, the fermented prebiotics could not be fully utilized. After entering the colon, the prebiotics were utilized by other harmful bacteria, producing harmful metabolites. Insufficient short-chain fatty acid production prevented effective reduction of intestinal pH and inhibition of pathogens, increasing the risk of infection and impairing intestinal barrier function, leading to diarrhea. In Comparative Example 2, the excessively high proportion of *Lactobacillus rhamnosus* MP108 accelerated the fermentation of prebiotics, causing a sharp drop in the prebiotic concentration in the local intestinal environment. Other beneficial bacteria, lacking a carbon source, were unable to thrive. Limited growth can disrupt gut microbiota diversity, leading to microbiota imbalance and reduced improvement effects. The ratio of the three prebiotic components aims to achieve synergy. As oligosaccharide prebiotics, lactitol can be preferentially utilized by *Lactobacillus rhamnosus* MP108, providing it with the energy needed for rapid proliferation and shortening the colonization time of the strain in the gut. Resistant dextrin and inulin regulate intestinal pH and mucus layer thickness, creating a suitable living environment for *Lactobacillus rhamnosus* MP108, thereby jointly promoting the proliferation of beneficial bacteria in the gut, regulating gut microbiota balance, increasing the production of short-chain fatty acids, lowering intestinal pH, and inhibiting the growth of harmful bacteria. An imbalance in the ratio of these components weakens the overall function. In Comparative Examples 3-5, the ratio of lactitol, resistant dextrin, and inulin resulted in an excessively high or low proportion of one or two prebiotic components, leading to a poorer improvement effect on allergic rhinitis compared to Example 3, and causing gastrointestinal discomfort and abnormal bowel movements, with a poorer sustained improvement effect. For example, in Comparative Example 3, the excessive proportion of lactitol and insufficient proportion of inulin weakened the gut health effect and made diarrhea more likely. In Comparative Example 4, the excessive proportion of resistant dextrin increased the burden on the gastrointestinal tract. In Comparative Example 5, the excessive proportion of inulin easily caused over-fermentation, leading to an imbalance of gut microbiota.

[0025] 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 probiotic composition for improving allergic rhinitis, characterized in that, It includes anti-allergy bacteria and prebiotics. The anti-allergy bacteria is Lactobacillus rhamnosus MP108, with 10-20 parts by weight of Lactobacillus rhamnosus MP108. The prebiotics are 70-75 parts by weight, and the prebiotics are lactitol, resistant dextrin, and inulin. The weight ratio of lactitol, resistant dextrin, and inulin is (2-3): (2-5): (1-4), with the remainder being excipients.

2. The probiotic composition for improving allergic rhinitis according to claim 1, characterized in that, The probiotic composition contains (1-3) × 10⁸ live bacteria of Lactobacillus rhamnosus MP108. 9 CFU / g.

3. The probiotic composition for improving allergic rhinitis according to claim 1, characterized in that, It also includes synergistic components, which include at least one immune-enhancing component and an auxiliary synergistic component, wherein the immune-enhancing component is at least one of an enhancing microbial community and an immune polysaccharide.

4. The probiotic composition for improving allergic rhinitis according to claim 3, characterized in that, The synergistic microbial community is one or more of Lactobacillus reuteri, Bifidobacterium, Lactobacillus paracasei, Saccharomyces boulardii, and Lactobacillus acidophilus.

5. The probiotic composition for improving allergic rhinitis according to claim 3, characterized in that, The immunopolysaccharides include one or more of the following: Astragalus polysaccharide, Poria polysaccharide, Lentinus edodes polysaccharide, Salvia miltiorrhiza polysaccharide, Taraxacum mongolicum polysaccharide, Bupleurum chinense polysaccharide, or Anemarrhena asphodeloides polysaccharide.

6. The probiotic composition for improving allergic rhinitis according to claim 3, characterized in that, The auxiliary synergistic components are one or more of sea buckthorn fruit powder, blueberry fruit powder, cherry fruit powder, and grape fruit powder.

7. The probiotic composition for improving allergic rhinitis according to claim 3, characterized in that, The probiotic composition is a microcapsule powder.

8. A method for preparing the probiotic composition for improving allergic rhinitis as described in any one of claims 1-7, characterized in that, Includes the following steps: S1 The components of the composition are prepared into a uniform mud according to the ratio, and then a protective agent is added and freeze-dried into bacterial powder; S2 Prepare the encapsulation material solution and sterilize it for later use; S3. The freeze-dried bacterial powder is slowly added to the encapsulation material solution and homogenized to form a uniform suspension; S4 involves slowly dripping the suspension into a cross-linking agent solution to form microcapsules encapsulating the bacterial powder using a composite encapsulating material. The mixture is stirred until the microcapsules solidify, then filtered, washed, and collected. S5 freeze-dry the microcapsules obtained in S4 to obtain a powdered product.

9. The preparation method according to claim 8, characterized in that, The protective agent is skim milk powder, the capsule material is sodium alginate, and the crosslinking agent is calcium chloride.

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