Composition for treating skin inflammation

Abstract

The invention relates to a composition for treating scytitis, and belongs to the technical field of medicines for treating scytitis. The present application provides a composition containing one or more of human milk oligosaccharides. Preferably, the composition contains the lactose-N-trisaccharide. The mass percentage content of the lactose-N-trisaccharide in the composition is 0.5 to 2 percent. The invention provides the HMO (s)-containing composition for treating the scytitis, and the composition has the advantages of safety and effectiveness, and can well improve the scytitis and relieve the pain of a patient. The composition has the advantages of being comfortable to use, high in bioavailability, good in stability, few in adverse reaction, free of pollution to clothes and the like. The skin inflammation comprises but is not limited to dermatitis, atopic dermatitis, contact dermatitis, allergic dermatitis, seborrheic dermatitis, infectious dermatitis, acne, burn or surgical incision and the like.

Description

Technical Field

[0001] The present application relates to a composition for treating skin inflammation and belongs to the technical field of drugs for skin inflammation. Background Art

[0002] Human milk oligosaccharides (HMOs) are a unique mixture of oligosaccharides present in human milk. Among them, various HMOs such as 2'-fucosyllactose (2'-FL), 3-fucosyllactose (3-FL), and lacto-N-tetraose (LNT) have been found to exhibit excellent biological functions in aspects such as gastrointestinal barrier, enhancing immunity, anti-inflammation, and promoting brain nerve development.

[0003] Dermatitis is a general term for skin inflammatory disorders caused by various internal and external infectious or non-infectious factors. It is an inflammatory skin disease caused by multiple factors, and the etiology may be related to allergies, infections, drugs, insect bites, physical factors, etc. The clinical manifestations are diverse, and the skin lesions are polymorphic, including papulovesicles, blisters, erythema, scales, erosions, ulcers, etc. Patients may also experience discomfort such as itching, burning, and pain. Among them, atopic dermatitis (AD, also known as eczema) is a chronic / recurrent inflammatory skin disease, characterized by symptoms including intense itching (e.g., severe itching) and squamous and dry eczema-like lesions. AD usually begins in childhood before the age of 5 and may persist into adulthood.

[0004] The treatment methods for dermatitis include topical lotions and moisturizers, topical corticosteroid ointments, creams, etc. Since eczema is prone to recurrence, many patients will develop moderate to severe dermatitis, and some patients will develop resistance to topical corticosteroids. The severe itching caused by recurrence has brought confusion to the lives of patients and their families. Therefore, new compositions for treating and / or preventing dermatitis are needed. Summary of the Invention

[0005] Object of the Invention: To provide a composition that can treat / or improve / or prevent skin inflammation.

[0006] Technical Solution:

[0007] In a first aspect, the present application provides a composition containing one or more of human milk oligosaccharides, which can treat / or improve / or prevent skin inflammation.

[0008] Preferably, the composition contains lacto-N-triose.

[0009] Preferably, the mass percentage content of lacto-N-triose in the composition is 0.5 - 2%, preferably 0.8 - 1.5%, and more preferably 0.9 - 1.2%.

[0010] Chinese Patent Application No. 202411016030.1, Invention Title: "Application of HMO" discloses the application of Lacto-N-triose II (LNTII) in the preparation of moisturizing, anti-inflammatory, and soothing beauty products. The application includes the activity of inhibiting the expression of inflammatory factors, and the inflammatory factors are selected from one or more of TNF-α, IL-8, and IL-6. The entire content of the above patent is incorporated herein by reference and constitutes a part of this application. However, it should be noted that the skin inflammation described in this application is not limited to the inflammation caused by the overexpression of the above-mentioned inflammatory factors TNF-α, IL-8, and IL-6 in the above patent.

[0011] Preferably, the composition described in this application contains 5 - 20 g of lacto-N-triose per kilogram, preferably 8 - 15 g, and more preferably 9 - 12 g.

[0012] Preferably, the composition described in this application contains 5 - 20 g of lacto-N-triose, 4 - 10 g of carbomer, 0.7 - 2 g of sodium carboxymethyl cellulose, 80 - 120 g of glycerol, 80 - 120 g of propylene glycol, 8 - 12 g of laurocapram, 8 - 12 g of triethanolamine, and 8 - 12 g of Tween per kilogram.

[0013] Preferably, the composition described in this application contains 12 g of lacto-N-triose, 8 g of carbomer, 1 g of sodium carboxymethyl cellulose, 100 g of glycerol, 100 g of propylene glycol, 10 g of laurocapram, 10 g of triethanolamine, and 10 g of Tween per kilogram.

[0014] In a second aspect, based on the technical solution of the first aspect, the composition described in this application further contains one or more of fucosyllactose and / or Lacto-N-tetraose (LNT) and / or Lacto-N-neotetraose (LNnT).

[0015] The fucosyllactose includes but is not limited to 2'-fucosyllactose (2’-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), Lacto-N-fucopentaose I (LNFP I), Lacto-N-difucohexaose I

[0016] (Lacto-N-difucohexaose I, LNDFH I).

[0017] Patent application 202411016030.1 records that in the composition, when the mass ratio of lactose-N-trisaccharide to fucosyllactose is 1:0.7-1.5, a synergistic anti-inflammatory effect is produced.

[0018] Preferably, in the composition, the mass ratio of lactose-N-triose to fucosyllactose in the formula is 1:0.9-1.3.

[0019] Preferably, in the composition, the mass ratio of lactose-N-triose to fucosyllactose in the formula is 1:1-1.2.

[0020] Preferably, the mass ratio of lactose-N-triose to lactose-N-tetraose (Lacto-N-tetraose, LNT) and / or lactose-N-neotetraose (Lacto-N-neotetraose, LNnT) in the formula of the composition is 1:0.8-1.5.

[0021] The composition is an external medicine, and a suitable dosage form can be selected according to the formula, such as gel, etc. The composition also contains suitable pharmaceutical excipients, which can be formulated according to the requirements of the pharmacopoeia and the existing technology, and can be produced and tested according to conventional methods in the industry.

[0022] Gels are transparent, colorless, semisolid emulsions. Gels should be uniform and fine, not liquefied or dried up, and maintain a gel state with good spreadability. Hydrogels are a rapidly developing dosage form in recent years. They are widely accepted because of their beauty, comfort, high bioavailability, good stability, few adverse reactions, and no staining of clothing.

[0023] The skin inflammation described in the present application includes but is not limited to dermatitis, atopic dermatitis, contact dermatitis, hand dermatitis, allergic dermatitis, seborrheic dermatitis, infectious dermatitis, acne, acne vulgaris, burns, or wounds caused by surgical incisions or biopsies, etc.

[0024] Stability experiments have found that if the formula is not adjusted properly, the color of the prepared gel will become darker during storage, and the lactose-N-trisaccharide content will tend to decrease, affecting its use.

[0025] In a third aspect, the composition described in the present application, based on the technical solutions of the first aspect and / or the second aspect, further contains β-cyclodextrin.

[0026] Preferably, the composition further contains calcium hydrogen phosphate.

[0027] Preferably, the composition, based on the technical solutions of the first aspect and / or the second aspect, further contains 8-15 g of β-cyclodextrin per 1000 g.

[0028] Preferably, based on the technical solutions of the first aspect and / or the second aspect, the composition further contains 8-15 g of β-cyclodextrin and 1-2 g of calcium hydrogen phosphate per 1000 g.

[0029] Preferably, the composition further contains 10 g of β-cyclodextrin and 3 g of calcium hydrogen phosphate per 1000 g.

[0030] Preferably, for the preparation method of the stable gelling agent, β-cyclodextrin and / or calcium hydrogen phosphate are added in step 1 of the preparation method.

[0031] The preparation method of the gelling agent comprises the following steps:

[0032] Step 1. Preparation of the gel matrix.

[0033] Add the prescribed amount of carbomer and sodium carboxymethylcellulose to an appropriate amount of distilled water to fully swell, add the prescribed amount of lacto-N-triose, the prescribed amount of β-cyclodextrin and / or the prescribed amount of calcium hydrogen phosphate, and continue to grind for 30 min. Add the prescribed amount of triethanolamine and half of the prescribed amount of propylene glycol, and grind to form a transparent gel for standby.

[0034] Step 2. Heat in a water bath at 70°C. Take the prescribed amount of other HMO(s) (if the prescription does not contain other HMO(s) except lacto-N-triose, this step is omitted), add an appropriate amount of distilled water, stir to dissolve, add the prescribed amount of Tween, the prescribed amount of laurocapram, the prescribed amount of glycerol and the remaining half of the prescribed amount of propylene glycol, and stir evenly to obtain a mixed solution.

[0035] Step 3. Add the mixed solution obtained in the above step 2 to the gel matrix obtained in step 1, stir evenly, add the remaining prescribed amount of distilled water, and continue to stir evenly to obtain the gelling agent.

[0036] Beneficial effects:

[0037] The present application provides a composition containing HMO(s). The composition has the advantages of safety and effectiveness, can well improve skin inflammation, and relieve the pain of patients. The composition has the advantages of comfortable use, high bioavailability, good stability, few adverse reactions, and no pollution to clothing. The skin inflammation includes but is not limited to dermatitis, atopic dermatitis, contact dermatitis, allergic dermatitis, seborrheic dermatitis, infectious dermatitis, acne, burns or surgical incisions, etc. Specific embodiments

[0038] The experimental methods used in the following examples are all conventional methods unless otherwise specified; all materials, reagents, etc. can be obtained from commercial channels unless otherwise specified.

[0039] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by those skilled in the art. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the scope of the present application. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, and / or combinations thereof. Generally, the nomenclature used in this specification is well-known and commonly used in the art.

[0040] In the examples, human milk oligosaccharides such as lacto-N-triose and fucosyllactose were prepared by Shandong Henglu Biotechnology Co., Ltd., and other raw materials were purchased through commercial channels.

[0041] Example 1. 5 g of lacto-N-triose, 4 g of carbomer 940, 2 g of sodium carboxymethylcellulose, 120 g of glycerol, 80 g of propylene glycol, 8 g of laurocapram, 8 g of triethanolamine, 8 g of Tween 80, 8 g of β-cyclodextrin, 2 g of calcium hydrogen phosphate, and distilled water were added to make up to 1000 g, and 1000 g of a gel was prepared according to the following method.

[0042] Step 1. Preparation of the gel matrix:

[0043] Take the prescribed amount of carbomer 940 powder and sodium carboxymethylcellulose and add them to one-third of the prescribed amount of distilled water, fully swell, add the prescribed amount of β-cyclodextrin, calcium hydrogen phosphate, and the prescribed amount of lacto-N-triose, grind for 30 min, add the prescribed amount of triethanolamine and one-half of the prescribed amount of propylene glycol, grind to form a transparent gel, sterilize, and set aside.

[0044] Step 2. Take the prescribed amount of Tween 80, the prescribed amount of laurocapram, the prescribed amount of glycerol, and the remaining one-half of the prescribed amount of propylene glycol, stir evenly to obtain a mixed solution, sterilize, and set aside.

[0045] Step 3. Add the mixed solution obtained in Step 2 above to the gel matrix obtained in Step 1, stir evenly, add the remaining prescribed amount of distilled water, and continue to stir evenly to obtain the gel.

[0046] Example 2. 20 g of lacto-N-triose, 10 g of carbomer 940, 0.5 g of sodium carboxymethylcellulose, 80 g of glycerol, 120 g of propylene glycol, 12 g of laurocapram, 12 g of triethanolamine, 12 g of Tween 80, 15 g of β-cyclodextrin, 5 g of calcium hydrogen phosphate, and distilled water were added to make up to 1000 g. 1000 g of a gel was prepared according to the method described in Example 1.

[0047] Example 3. 12 g of lacto-N-triose, 8 g of carbomer 940, 1 g of sodium carboxymethylcellulose, 100 g of glycerol, 100 g of propylene glycol, 10 g of laurocapram, 10 g of triethanolamine, 10 g of Tween 80, 10 g of β-cyclodextrin, 3 g of calcium hydrogen phosphate, and distilled water was added to make up to 1000 g. 1000 g of the gel was prepared according to the method described in Example 1.

[0048] Example 4. 12 g of lacto-N-triose, 8 g of carbomer 940, 1 g of sodium carboxymethylcellulose, 100 g of glycerol, 100 g of propylene glycol, 10 g of laurocapram, 10 g of triethanolamine, 10 g of Tween 80, 10 g of β-cyclodextrin, and distilled water was added to make up to 1000 g. 1000 g of the gel was prepared with reference to the method described in Example 1.

[0049] Step 1 of the preparation method: Preparation of the gel matrix:

[0050] The prescribed amount of carbomer 940 powder and sodium carboxymethylcellulose were added to an appropriate amount of distilled water and fully swollen, the prescribed amount of β-cyclodextrin and the prescribed amount of lacto-N-triose were added and ground for 30 min, the prescribed amount of triethanolamine and half of the prescribed amount of propylene glycol were added, and ground to form a transparent gel for standby.

[0051] Other steps were the same as in Example 1.

[0052] Examples 5 - 11. Samples of Examples 5 - 11 were prepared according to the formula shown in Table 1.

[0053] Table 1

[0054]

[0055] The gel compositions of Examples 5 - 11 were prepared according to the following method:

[0056] Step 1. Operate according to Step 1 described in Example 1.

[0057] Step 2. At 70 °C in a water bath, take the prescribed amount of fucosyllactose / or lacto-N-tetraose / or lacto-N-neotetraose, add an appropriate amount of distilled water, stir to dissolve, add the prescribed amount of Tween, the prescribed amount of laurocapram, the prescribed amount of glycerol and the remaining half of the prescribed amount of propylene glycol, and stir evenly to obtain a mixed solution.

[0058] Step 3. Add the mixed solution obtained in Step 2 above to the gel matrix obtained in Step 1, stir evenly, add the remaining prescribed amount of distilled water, and continue to stir evenly to obtain the gel.

[0059] Control Examples 1 - 3. Refer to the formulas and preparation methods described in Examples 1 - 3 respectively, but without adding β-cyclodextrin and calcium hydrogen phosphate, and complete the following Control Examples 1 - 3 respectively.

[0060] Comparative Example 1. 5 g of lactose-N-trisaccharide, 4 g of carbomer 940, 2 g of sodium carboxymethyl cellulose, 120 g of glycerol, 80 g of propylene glycol, 8 g of laurocapram, 8 g of triethanolamine, 8 g of Tween 80, add distilled water to make up to 1000 g, and prepare 1000 g of gel as follows.

[0061] Step 1. Preparation of gel matrix:

[0062] Add the prescribed amount of Carbomer 940 powder and sodium carboxymethyl cellulose into an appropriate amount of distilled water to fully swell, add the prescribed amount of lactose-N-trisaccharide and grind, add the prescribed amount of triethanolamine and one-half of the prescribed amount of propylene glycol to form a transparent gel matrix for use.

[0063] Step 2. Stir evenly the prescribed amount of Tween 80, the prescribed amount of laurocapram, the prescribed amount of glycerin and the remaining half of the prescribed amount of propylene glycol to obtain a mixed solution.

[0064] Step 3. Add the mixed solution obtained in step 2 above to the gel matrix obtained in step 1, stir evenly, add the remaining amount of distilled water, continue to stir evenly, and obtain a gel.

[0065] Comparative Example 2. 20 g lactose-N-trisaccharide, 10 g carbomer 940, 0.7 g sodium carboxymethylcellulose, 80 g glycerol, 120 g propylene glycol, 12 g laurocapram, 12 g triethanolamine, 12 g Tween 80, add distilled water to make up to 1000 g. 1000 g of gel was prepared according to the method described in Comparative Example 1.

[0066] Comparative Example 3. Lactose-N-triose 12g, 8g Carbomer 940, 1g sodium carboxymethylcellulose, 100g glycerol, 100g propylene glycol, 10g laurocapram, 10g triethanolamine, 10g Tween 80, add distilled water to make up to 1000g. Prepare 1000g of gel according to the method described in Comparative Example 1.

[0067] Comparative Example 4. Based on the formulation of Example 3, β-cyclodextrin and calcium hydrogen phosphate were added in step 2, as follows:

[0068] Step 1. Preparation of gel matrix:

[0069] Add the prescribed amount of Carbomer 940 powder and sodium carboxymethyl cellulose into an appropriate amount of distilled water to fully swell, add the prescribed amount of lactose-N-triose to grind, add the prescribed amount of triethanolamine and one-half of the prescribed amount of propylene glycol to form a transparent gel matrix for use.

[0070] Step 2. Take the prescribed amount of Tween 80, the prescribed amount of laurocapram, the prescribed amount of glycerol, and the remaining half of the prescribed amount of propylene glycol, and the prescribed amount of β-cyclodextrin and calcium hydrogen phosphate, and stir evenly to obtain a mixed solution.

[0071] Step 3. Add the mixed solution obtained in Step 2 above to the gel matrix obtained in Step 1, stir evenly, add the remaining prescribed amount of distilled water, and continue to stir evenly to obtain a gel.

[0072] Example 12. Efficacy experiment

[0073] Take the samples of Examples 1-11 and the samples of Control Examples 1-3 respectively, and conduct skin inflammation tests.

[0074] (1) Grouping: Select 105 Kunming mice (SPF grade, male), randomly divide them into 15 groups, with 7 mice in each group, and record them as the model group, the groups of Examples 1-11, and the groups of Control Examples 1-3 respectively.

[0075] (2) Establishment of inflammatory model animals: After anesthetizing the mice in the model group, the groups of Examples 1-11, and the groups of Control Examples 1-3 with ether, apply 0.03 mL / rat of xylene inflammatory solution on the front and back sides of the right ear of the mice.

[0076] (3) 30 minutes after applying xylene, apply 0.1 g of the composition of Example 1-11 or Control Example 1-3 to the inflamed part of the right ear of each mouse in the groups of Examples 1-11 and the groups of Control Examples 1-3 respectively. After 3 hours, apply 0.1 g of the composition of the respective group to each group of mice again.

[0077] No treatment is given to the left ears of the mice in the above-mentioned model group, the groups of Examples 1-11, and the groups of Control Examples 1-3.

[0078] (4) 4 hours after the last application, dislocate and sacrifice the mice in the model group, the groups of Examples 1-11, and the groups of Control Examples 1-3. Immediately cut off both ears along the auricle baseline, use a punch with a diameter of 8 mm to take ear pieces from the same part, accurately weigh them on an analytical balance (accurate to one ten-thousandth of a gram) respectively. The weight of the right ear piece minus the weight of the left ear piece is used as the swelling degree, and the swelling inhibition rate is calculated according to the following formula, and the results are recorded in Table 1.

[0079] Swelling inhibition rate = [1 - (average swelling degree of the sample / average swelling degree of the model group)] × 100%.

[0080] For easy comparison, the evaluation results of the above-mentioned model group, the groups of Examples 1-11, and the groups of Control Examples 1-3 are listed in Table 2.

[0081] Table 2

[0082] Group Average swelling degree, mg Swelling inhibition rate, % Model group 15.6 N / A Example 1 group 12.7 18.59 Example 2 group 10.6 32.05 Example 3 group 11.1 28.85 Example 4 group 11.0 29.49 Example 5 group 9.9 36.54 Example 6 group 9.2 41.02 Example 7 group 9.8 37.18 Example 8 group 9.7 37.82 Example 9 group 9.7 37.82 Example 10 group 9.4 39.74 Example 11 group 9.1 41.67 Control example 1 group 12.8 17.95 Control example 2 group 10.6 32.05 Control example 3 group 11.0 29.49

[0083] Table 2 Data Description: The compositions of Examples 1 to 11 and Comparative Examples 1-3 have an obvious effect of inhibiting skin inflammation.

[0084] Example 13. Inhibition experiment on skin inflammation after mosquito bites on human skin.

[0085] Twenty-four voluntary subjects aged 20 to 50 were collected and randomly divided into 3 groups, with 8 people in each group, and were divided into a blank group, an Example 3 group, and an Example 8 group, respectively.

[0086] When feeling the mosquito bite and skin itching, the blank group applied blank gel; the Example 3 group and the Example 8 group applied the compositions of Example 3 or Example 8 to the affected area, respectively.

[0087] Preparation of blank gel: Referring to the formula of Example 3, blank gel was prepared. The formula is as follows: 8 g of carbomer 940, 1 g of sodium carboxymethylcellulose, 100 g of glycerol, 100 g of propylene glycol, 10 g of laurocapram, 10 g of triethanolamine, 10 g of Tween 80, 10 g of β-cyclodextrin, 3 g of calcium hydrogen phosphate, and distilled water was added to make up to 1000 g. 1000 g of gel was prepared according to the method described in Example 1 (the addition operation of lactose-N-trisaccharide was not carried out in step 1).

[0088] The results are recorded in Table 3.

[0089] Table 3

[0090]

[0091] Example 14.

[0092] Eight subjects with mild eczema were randomly divided into a control group and an experimental group, with 4 people in each group, and local treatment was carried out on them respectively.

[0093] Control group: First, mometasone furoate cream was applied, and then tacrolimus ointment was applied 5 minutes later, 3 times a day. During this period, seafood and spicy foods were avoided.

[0094] Experimental group: First, mometasone furoate cream was applied, then tacrolimus ointment was applied 5 minutes later, and then the composition of Example 3 was applied 5 minutes later. During this period, seafood and spicy foods were avoided.

[0095] The disappearance time of eczema was observed, and the results were recorded in Table 4.

[0096] Table 4

[0097]

[0098] Example 15. Stability experiment.

[0099] Take 5 g (accurate to one ten-thousandth) of the samples of Examples 1-11 and the samples of Comparative Examples 1-4 respectively in petri dishes, cover the lids, place them in a constant temperature and humidity chamber at 45 °C and a relative humidity of 70%, take them out on the 60th day, observe the appearance, measure the change in gel quality and the change in the content of lacto-N-triose (LNT II), and record the results in Table 5.

[0100] Table 5

[0101]

[0102] Explanation of the data in Table 5: During the stability investigation, the gel obtained in this application has stable quality; while for the samples of the comparative examples, the content of lacto-N-triose shows a downward trend, and the color of the product gradually deepens, and water droplets appear on the surface. It shows that the technical solution of this application obtains a gel product with stable quality.

[0103] The above are only the preferred embodiments of this application and are not used to limit this application. Although this application has been described in detail with reference to the foregoing embodiments, for those skilled in the art, they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of this application shall be included within the protection scope of this application.

Claims

1. A composition, characterized in that The composition contains lactose-N-triose, Preferably, the mass percentage of lactose-N-trisaccharide in the composition is 0.5-2%, preferably 0.8-1.5%, and further preferably 0.9-1.2%. Preferably, the composition is an external medicine. Preferably, the dosage form of the composition is selected from a gel.

2. The composition according to claim 1, characterized in that Each kilogram contains 5-20g, preferably 8-15g, and more preferably 9-12g of lactose-N-triose.

3. The composition according to claim 1, characterized in that Each kilogram contains 5-20g of lactose-N-trisaccharide, 4-10g of carbomer, 0.7-2g of sodium carboxymethyl cellulose, 80-120g of glycerol, 80-120g of propylene glycol, 8-12g of laurocapram, 8-12g of triethanolamine, and 8-12g of Tween.

4. The composition according to claim 1, characterized in that Each kilogram contains 12g of lactose-N-triose, 8g of carbomer, 1g of sodium carboxymethyl cellulose, 100g of glycerol, 100g of propylene glycol, 10g of laurocapram, 10g of triethanolamine, and 10g of Tween.

5. The composition according to claim 1, characterized in that It also contains one or more of fucosyllactose and / or lacto-N-tetraose (Lacto-N-tetraose, LNT) and / or lacto-N-neotetraose (LNnT).

6. The composition according to claim 5, characterized in that The fucosyllactose includes but is not limited to 2'-fucosyllactose (2'-fucosyllactose, 2'-FL), 3-fucosyllactose (3-FL), difucosyllactose (Difucosyllactose, DFL), lactose-N-fucopentaose I (Lacto-N-fucopentaose I, LNFPI), lactose-N-difucohexaose I (Lacto-N-difucohexaose I, LNDFH I), lactose-N-tetraose (Lacto-N-tetraose, LNT) and / or lactose-N-neotetraose (LNnT).

7. The composition according to claim 5, characterized in that in, The mass ratio of lactose-N-triose to fucosyllactose is 1:0.7-1.5, Preferably, the mass ratio of lactose-N-triose to lactose-N-tetraose (Lacto-N-tetraose, LNT) and / or lactose-N-neotetraose (Lacto-N-neotetraose, LNnT) in the formula of the composition is 1:0.8-1.

5.

8. The composition according to claim 5, characterized in that in, The mass ratio of lactose-N-triose to fucosyllactose and / or lactose-N-tetraose and / or lactose-N-neotetraose is 1:0.9-1.3, Preferably, the mass ratio of lactose-N-triose to fucosyllactose and / or lactose-N-tetraose and / or lactose-N-neotetraose is 1:1-1.

2.

9. The composition according to claim 1, characterized in that Also contains beta-cyclodextrin, Preferably, the composition further contains calcium hydrogen phosphate, Preferably, the composition further contains 8-15 g of β-cyclodextrin per 1000 g. Preferably, the composition further contains 8-15g of β-cyclodextrin and 2-5g of calcium hydrogen phosphate per 1000g. Preferably, the composition further contains 10 g of β-cyclodextrin and 3 g of calcium hydrogen phosphate per 1000 g.

10. The method for preparing the gel composition according to claim 1, comprising the following steps: Step 1. Preparation of gel matrix, Add appropriate amount of distilled water to fully swell the prescribed amount of carbomer and sodium carboxymethyl cellulose, add the prescribed amount of lactose-N-trisaccharide, the prescribed amount of β-cyclodextrin and / or the prescribed amount of calcium hydrogen phosphate and continue grinding for 30 minutes, add the prescribed amount of triethanolamine and one-half of the prescribed amount of propylene glycol and grind to form a transparent gel for use. Step 2. Place the mixture in a water bath at 70°C, take the prescribed amount of other HMO(s) (if the prescription does not contain other HMO(s) except lactose-N-triose, this step can be ignored), add an appropriate amount of distilled water, stir to dissolve, add the prescribed amount of Tween, the prescribed amount of laurocapram, the prescribed amount of glycerol and the remaining half of the prescribed amount of propylene glycol, stir evenly to obtain a mixed solution. Step 3. Add the mixed solution obtained in step 2 above to the gel matrix obtained in step 1, stir evenly, add the remaining amount of distilled water, continue to stir evenly, and obtain a gel.

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