A biotin dispersion composition and preparation method thereof

Abstract

The present invention relates to the technical field of biotin preparations, and specifically discloses a biotin dispersion and a composition thereof, wherein the raw materials of the biotin dispersion include by weight: 1-10 parts of biotin, 80-120 parts of hydrophilic polymers, and 0.01-1 parts of disodium hydrogen phosphate. The present invention also discloses that the raw materials of the above-mentioned biotin dispersion composition include by weight: 80-135 parts of the biotin dispersion, 200-300 parts of lactose, 5-15 parts of povidone K30, 100-120 parts of enteric coating polymers, 1-5 parts of propylene glycol, and 80-100 parts of talc. The preparation process of the present invention is simple, not only the stability during the preparation process is good, but also biotin can be directly absorbed and utilized by the small intestine, which improves its absorption rate and bioavailability, and is suitable for large-scale production.

Description

Technical Field

[0001] The present invention relates to the technical field of biotin preparations, and in particular to a biotin dispersion composition and a preparation method thereof. Background Art

[0002] Biotin, also known as vitamin H and coenzyme R, is a water-soluble vitamin and also belongs to the B vitamins, specifically vitamin B7. It is a necessary substance for the synthesis of vitamin C and is an indispensable substance for the normal metabolism of fat and protein. It is a nutrient necessary to maintain the natural growth, development and normal health of the human body.

[0003] Biotin is supplied to the human body through food (egg yolk, milk, yeast, offal, fish, vegetables, grains, etc.), which generally meets the daily requirement of 50-200 micrograms of biotin. Biotin plays an important role as an essential coenzyme in carbohydrate and fat metabolism. It acts as a cofactor for the enzymatic carboxylation of pyruvate, acetyl-CoA and β-methylcrotonyl-CoA. Biotin affects the growth and differentiation of epidermal cells and is therefore important for the formation and renewal of skin, hair and nails.

[0004] The main site of biotin absorption is the proximal end of the small intestine. When the concentration is low, it is actively absorbed by carrier transport; when the concentration is high, it is absorbed in the form of simple diffusion. The absorbed biotin is transported to the liver and kidneys for storage via the portal circulation. Other cells also contain biotin, but in smaller amounts.

[0005] Biotin is currently effective in preventing hair loss and exposure to sunlight, and can also prevent the common graying of hair in modern people. Biotin is a colorless needle-shaped crystal, very slightly soluble in water, stable to heat, and can be destroyed by strong acids, strong bases and oxidants, and can also be gradually destroyed by ultraviolet rays.

[0006] Currently, most biotin products on the market are used in the form of pure products or simple mixtures of pure products with other excipients. However, they are not stable and are not resistant to strong acid. They are destroyed in gastric juice and cannot effectively reach the intestines, resulting in low bioavailability and poor hair growth effect. Summary of the invention

[0007] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a biotin dispersion composition and a preparation method thereof.

[0008] A biotin dispersion, the raw materials of which include, by weight, 1-10 parts of biotin, 80-120 parts of hydrophilic polymer, and 0.01-1 part of disodium hydrogen phosphate.

[0009] Preferably, the hydrophilic polymer is at least one of polyethylene glycol, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, povidone, and copovidone.

[0010] Preferably, the particle size D90 of the biotin dispersion is 30-100 μm.

[0011] A method for preparing a biotin dispersion comprises the following steps:

[0012] Disodium hydrogen phosphate is added to the ethanol aqueous solution and stirred evenly. Biotin and a hydrophilic polymer are then added during the stirring process. The mixture is stirred for 10-30 minutes and spray-dried to obtain a biotin dispersion.

[0013] A biotin dispersion composition, the raw materials of which include, by weight: 80-135 parts of the biotin dispersion, 200-300 parts of lactose, 5-15 parts of povidone K30, 100-120 parts of enteric coating polymer, 1-5 parts of propylene glycol, and 80-100 parts of talc.

[0014] Preferably, the enteric coating polymer is at least one of cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, acrylic acid polymer, and methacrylic acid-ethyl acrylate copolymer.

[0015] Preferably, a flavoring agent is also included.

[0016] Preferably, the flavoring agent is at least one of sucralose, acesulfame potassium and xylitol.

[0017] A method for preparing the biotin dispersion composition comprises the following steps:

[0018] S1, mixing the biotin dispersion and lactose evenly and sending them into a fluidized bed, top-spraying the polyvidone K30 aqueous solution in the fluidized bed for granulation, drying to a moisture content of <2%, and removing large particles with a sieve to obtain a biotin complex;

[0019] S2, adding the enteric coating polymer, propylene glycol, talcum powder and flavoring agent into water and mixing them evenly to obtain a coating solution;

[0020] S3. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 17-27°C, and dry until the moisture content is less than 2%.

[0021] Preferably, the biotin is stabilized biotin, and its raw materials include: biotin, hydrogenated lecithin, cholesterol, Tween, gelatin, and glutamine transaminase, and the mass ratio of biotin, hydrogenated lecithin, cholesterol, Tween, gelatin, and glutamine transaminase is 1-10:1-2:1-2:0.1-1:1-2:0.1-1;

[0022] Among them, the specific activity of glutamine transaminase is 3000-4000U / g;

[0023] Among them, hydrogenated lecithin is an amphoteric surfactant obtained by hydrogenating natural lecithin. It can form a liquid crystal structure in water or as an emulsifier in an emulsion system. This emulsifier has high safety. Compared with emulsifiers from non-natural sources, the safety of emulsions prepared from hydrogenated lecithin is also effectively guaranteed.

[0024] During the preparation process: biotin, hydrogenated lecithin, cholesterol and Tween are added to edible oil and stirred at 30-40° C. for 1-2 hours to obtain pretreated biotin;

[0025] Dissolve gelatin in water, add pretreated biotin under stirring, high-speed shear for 10-30s, the shear rate is 1000-5000r / min, adjust the pH value of the system to 4-5, add glutamine aminotransferase and stir for 1-2h, filter, wash and dry to obtain stabilized biotin.

[0026] A method for preparing the biotin dispersion composition comprises the following steps:

[0027] S1. Add biotin, hydrogenated lecithin, cholesterol and Tween into edible oil, and stir at 30-40° C. for 1-2 h to obtain pretreated biotin;

[0028] S2, dissolving gelatin in water, adding pretreated biotin thereto under stirring, high-speed shearing for 10-30s, the shear rate is 1000-5000r / min, adjusting the pH value of the system to 4-5, adding glutamine aminotransferase and stirring for 1-2h, filtering, washing, and drying to obtain stabilized biotin;

[0029] S3, adding disodium hydrogen phosphate to the ethanol aqueous solution and stirring evenly, adding stabilizing biotin and hydrophilic polymer during stirring, stirring for 10-30 minutes, and spray drying to obtain a biotin dispersion;

[0030] S4, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, the polyvidone K30 aqueous solution is top-sprayed in the fluidized bed for granulation, and dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0031] S5, adding the enteric coating polymer, propylene glycol, talcum powder and flavoring agent into water and mixing them evenly to obtain a coating solution;

[0032] S6. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 17-27°C, and dry until the moisture content is less than 2%.

[0033] Preferably, in S1, the edible oil is at least one of palm oil, corn oil and olive oil.

[0034] Preferably, in S3, the mass fraction of the ethanol aqueous solution is 40-60%.

[0035] Preferably, in S3, the particle size D90 of the biotin dispersion is 30-100 μm.

[0036] Preferably, in S3, the mass fraction of the povidone K30 aqueous solution is 14-24%. Beneficial Effects

[0037] 1. The biotin dispersion of the present invention has good structural stability and good crystal structure, which can not only improve the solubility and dissolution rate of biotin and increase bioavailability, but also control the release in the intestine with good effect.

[0038] 2. In the present invention, the special structure of hydrogenated lecithin, in combination with cholesterol, effectively enhances the stability of biotin in edible oil, and effectively improves the efficiency of direct absorption and utilization of biotin by the small intestine. The gelatin wall material is further coated on its surface, which is not only safe to use and stable in nature, but also can isolate or reduce the contact between the core material and oxygen, greatly improving the storage time.

[0039] 3. The present invention adopts stabilized biotin in combination with hydrophilic polymer and disodium hydrogen phosphate to prepare biotin dispersion, which can not only improve the solubility of biotin and protect biotin from being destroyed by strong acid in the gastrointestinal tract, so that biotin can effectively reach the small intestine for effective absorption, thereby enhancing the bioavailability of biotin, but also has excellent dispersion stability, thereby extending the storage time of the biotin active ingredient.

[0040] 4. The preparation process of the present invention is simple. Not only is the stability during the preparation process good, but biotin can also be directly absorbed and utilized by the small intestine, thereby improving its absorption rate and bioavailability, and is suitable for large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This is a graph showing the change in biotin retention rate of the biotin dispersion composition obtained in Example 5 and Comparative Examples 1-2 after being irradiated with ultraviolet light.

[0042] Figure 2 This is a graph showing the change in biotin retention rate of the biotin dispersion composition obtained in Example 5 and Comparative Examples 1-2 after being treated with oxygen and high temperature.

[0043] Figure 3 The graph is a graph showing the change in biotin retention rate of the biotin dispersion composition obtained in Example 5 and Comparative Examples 1-2 in simulated gastric fluid. DETAILED DESCRIPTION

[0044] The present invention will be further explained below in conjunction with specific embodiments. Example 1

[0045] A biotin dispersion, whose raw materials include: 1kg of biotin, 80kg of hydrophilic polymer and 0.01kg of disodium hydrogen phosphate.

[0046] The preparation method thereof comprises the following steps:

[0047] Disodium hydrogen phosphate was added to the ethanol aqueous solution and stirred evenly. Biotin and a hydrophilic polymer were added during the stirring process. The mixture was stirred for 10 minutes and spray-dried to obtain a biotin dispersion. Example 2

[0048] A biotin dispersion, whose raw materials include, by weight: 10 kg of biotin, 120 kg of hydrophilic polymer, and 1 kg of disodium hydrogen phosphate.

[0049] The preparation method thereof comprises the following steps:

[0050] Disodium hydrogen phosphate was added to the ethanol aqueous solution and stirred evenly. Biotin and a hydrophilic polymer were added during the stirring process. The mixture was stirred for 30 minutes and spray-dried to obtain a biotin dispersion. Example 3

[0051] A biotin dispersion composition, whose raw materials include: 2kg of stabilized biotin, 85kg of Kollidon VA 64, 0.05kg of disodium hydrogen phosphate, 215kg of lactose, 7kg of povidone K30, 105kg of Kollicoat MAE 30DP, 2kg of propylene glycol, 85kg of talc and 1.2kg of sucralose.

[0052] The raw materials of stabilized biotin include: 7kg biotin, 1.2kg hydrogenated lecithin, 1.7kg cholesterol, 0.2kg Tween 800, 1.8kg gelatin, 0.3kg glutamine aminotransferase with specific activity of 3000U / g;

[0053] The method for preparing the biotin dispersion composition comprises the following steps:

[0054] S1. Add biotin, hydrogenated lecithin, cholesterol and Tween 80 to 28 kg of olive oil, stir at 33° C. for 100 min at a stirring speed of 1100 r / min to obtain pretreated biotin;

[0055] S2, dissolving gelatin into 90 kg of water, adding pretreated biotin thereto under stirring, high-speed shearing for 15 seconds at a shear rate of 4000 r / min, adjusting the pH value of the system to 4-5, adding glutamine aminotransferase, stirring at a speed of 700 r / min for 100 minutes, filtering, washing, and drying to obtain stabilized biotin;

[0056] S3, adding disodium hydrogen phosphate to 25 kg of 55% ethanol aqueous solution and stirring evenly at a stirring speed of 1200 r / min, adding stabilized biotin and Kollidon VA 64 during stirring, stirring for 25 min, and spray drying at a temperature of 64°C to obtain a biotin dispersion;

[0057] S4, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, a 21% mass fraction of povidone K30 aqueous solution is top-sprayed for granulation in the fluidized bed, dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0058] S5, adding Kollicoat MAE 30DP, propylene glycol, talc and sucralose to 330 kg of water and mixing evenly to obtain a coating solution;

[0059] S6. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 20-24°C, and dry until the moisture content is less than 2%. Example 4

[0060] A biotin dispersion composition comprises raw materials: 9 kg of stabilized biotin, 112 kg of Kollidon VA 64, 0.4 kg of disodium hydrogen phosphate, 280 kg of lactose, 12 kg of povidone K30, 118 kg of Kollicoat MAE 30DP, 4 kg of propylene glycol, 95 kg of talc and 1.5 kg of sucralose.

[0061] The raw materials of stabilized biotin include: 3kg biotin, 1.8kg hydrogenated lecithin, 1.3kg cholesterol, 0.8kg Tween 80, 1.2kg gelatin, 0.7kg glutamine aminotransferase with specific activity of 3000U / g;

[0062] The method for preparing the biotin dispersion composition comprises the following steps:

[0063] S1. Add biotin, hydrogenated lecithin, cholesterol and Tween 80 to 22 kg of olive oil, stir at 37° C. for 80 min at a stirring speed of 1300 r / min to obtain pretreated biotin;

[0064] S2, dissolving gelatin into 70 kg of water, adding pretreated biotin thereto under stirring, high-speed shearing for 25 seconds at a shear rate of 2000 r / min, adjusting the pH value of the system to 4-5, adding glutamine aminotransferase, stirring at a speed of 900 r / min for 80 minutes, filtering, washing, and drying to obtain stabilized biotin;

[0065] S3, adding disodium hydrogen phosphate to 35 kg of 45% ethanol aqueous solution and stirring evenly at a stirring speed of 1800 r / min, adding stabilized biotin and Kollidon VA 64 during stirring, stirring for 15 min, and spray drying at a temperature of 66°C to obtain a biotin dispersion;

[0066] S4, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, a 17% mass fraction of povidone K30 aqueous solution is top-sprayed for granulation in the fluidized bed, dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0067] S5, adding Kollicoat MAE 30DP, propylene glycol, talc and sucralose to 370 kg of water and mixing evenly to obtain a coating solution;

[0068] S6. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 20-24°C, and dry until the moisture content is less than 2%. Example 5

[0069] A biotin dispersion composition comprises raw materials: 5 kg of stabilized biotin, 100 kg of Kollidon VA 64, 0.5 kg of disodium hydrogen phosphate, 250 kg of lactose, 10 kg of povidone K30, 110 kg of Kollicoat MAE 30DP, 3 kg of propylene glycol, 90 kg of talc and 1.5 kg of sucralose.

[0070] The raw materials of stabilized biotin include: 5kg biotin, 1.5kg hydrogenated lecithin, 1.5kg cholesterol, 0.5kg Tween 800, 1.5kg gelatin, 0.5kg glutamine aminotransferase with specific activity of 3000U / g;

[0071] The method for preparing the biotin dispersion composition comprises the following steps:

[0072] S1. Add biotin, hydrogenated lecithin, cholesterol and Tween 80 to 25 kg of olive oil, stir at 35° C. for 90 min at a stirring speed of 1200 r / min to obtain pretreated biotin;

[0073] S2, dissolving gelatin into 80 kg of water, adding pretreated biotin thereto under stirring, high-speed shearing for 20 seconds at a shear rate of 3000 r / min, adjusting the pH value of the system to 4-5, adding glutamine aminotransferase, stirring at a speed of 800 r / min for 90 minutes, filtering, washing, and drying to obtain stabilized biotin;

[0074] S3, adding disodium hydrogen phosphate to 30 kg of 50% ethanol aqueous solution and stirring evenly at a stirring speed of 1500 r / min, adding stabilized biotin and Kollidon VA 64 during stirring, stirring for 20 min, and spray drying at a temperature of 65°C to obtain a biotin dispersion;

[0075] S4, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, a 19% mass fraction of povidone K30 aqueous solution is top-sprayed for granulation in the fluidized bed, dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0076] S5, adding Kollicoat MAE 30DP, propylene glycol, talc and sucralose to 350 kg of water and mixing well to obtain a coating solution;

[0077] S6. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 20-24°C, and dry until the moisture content is less than 2%.

[0078] Comparative Example 1

[0079] A biotin dispersion composition comprises raw materials: 5 kg of stabilized biotin, 100 kg of Kollidon VA 64, 0.5 kg of disodium hydrogen phosphate, 250 kg of lactose, 10 kg of povidone K30, 110 kg of Kollicoat MAE 30DP, 3 kg of propylene glycol, 90 kg of talc and 1.5 kg of sucralose.

[0080] The raw materials of stabilized biotin include: 5kg biotin, 1.5kg lecithin, 1.5kg cholesterol, 0.5kg Tween 80, 1.5kg gelatin, 0.5kg glutamine aminotransferase with specific activity of 3000U / g;

[0081] The method for preparing the biotin dispersion composition comprises the following steps:

[0082] S1. Add biotin, lecithin, cholesterol and Tween 80 to 25 kg of olive oil, stir at 35° C. for 90 min at a stirring speed of 1200 r / min to obtain pretreated biotin;

[0083] S2, dissolving gelatin into 80 kg of water, adding pretreated biotin thereto under stirring, high-speed shearing for 20 seconds at a shear rate of 3000 r / min, adjusting the pH value of the system to 4-5, adding glutamine aminotransferase, stirring at a speed of 800 r / min for 90 minutes, filtering, washing, and drying to obtain stabilized biotin;

[0084] S3, adding disodium hydrogen phosphate to 30 kg of 50% ethanol aqueous solution and stirring evenly at a stirring speed of 1500 r / min, adding stabilized biotin and Kollidon VA 64 during stirring, stirring for 20 min, and spray drying at a temperature of 65°C to obtain a biotin dispersion;

[0085] S4, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, a 19% mass fraction of povidone K30 aqueous solution is top-sprayed for granulation in the fluidized bed, dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0086] S5, adding Kollicoat MAE 30DP, propylene glycol, talc and sucralose to 350 kg of water and mixing well to obtain a coating solution;

[0087] S6. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 20-24°C, and dry until the moisture content is less than 2%.

[0088] Comparative Example 2

[0089] A biotin dispersion composition comprises raw materials: 2.38 kg of biotin, 100 kg of Kollidon VA 64, 0.5 kg of disodium hydrogen phosphate, 250 kg of lactose, 10 kg of povidone K30, 110 kg of Kollicoat MAE 30DP, 3 kg of propylene glycol, 90 kg of talc and 1.5 kg of sucralose.

[0090] The method for preparing the biotin dispersion composition comprises the following steps:

[0091] S1. Add disodium hydrogen phosphate to 30 kg of 50% ethanol aqueous solution and stir evenly at a stirring speed of 1500 r / min. Add biotin and Kollidon VA 64 during stirring, stir for 20 min, and spray dry at a temperature of 65°C to obtain a biotin dispersion.

[0092] S2, the biotin dispersion and lactose are mixed evenly and sent into a fluidized bed, a 19% mass fraction of povidone K30 aqueous solution is top-sprayed for granulation in the fluidized bed, dried to a moisture content of <2%, and large particles are removed by a sieve to obtain a biotin complex;

[0093] S3, adding Kollicoat MAE 30DP, propylene glycol, talc and sucralose to 350 kg of water and mixing well to obtain a coating solution;

[0094] S4. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 20-24°C, and dry until the moisture content is less than 2%.

[0095] The biotin dispersion compositions obtained in Example 5 and Comparative Examples 1-2 were respectively placed in sealed colorless transparent vials and placed in a UV aging test chamber (irradiance 2 W / m 2 , 25℃), and oxygenated filling (80℃) conditions for 30 days, and samples were taken at 0 day, 10 day, 20 day, and 30 day respectively. The biotin content in each sample was detected by high performance liquid chromatography to characterize the effects of ultraviolet irradiation and oxygenated high temperature environment on the biotin content (stability) in the sample.

[0096] The change of biotin retention rate after ultraviolet irradiation is shown in the figure Figure 1 As shown in the figure, the change of biotin retention rate after oxygenation and high temperature treatment is shown in Figure 2 As shown, after the biotin dispersion composition obtained in Example 5 was subjected to ultraviolet irradiation and oxygenated high temperature treatment, the biotin content did not drop significantly, but the biotin content of the biotin dispersion composition obtained in Comparative Examples 1-2 dropped significantly, indicating that the biotin dispersion composition obtained by the present invention has good stability and can extend the shelf life of the biotin effective ingredient.

[0097] 5 g of the biotin dispersion composition obtained in Example 5 and Comparative Examples 1-2 were added to 200 mL of simulated gastric juice (the pH value of 0.5% NaCl solution was adjusted to 2.0 with 1 mol / L hydrochloric acid, pepsin was added to make the final concentration of the enzyme in the solution 3.0 g / L, and then filtered and sterilized with a 0.22 μm aqueous phase filter membrane), and the mixture was shaken at 160 rpm in a constant temperature shaker at 37±0.5°C for 3 h. Samples were taken at 0, 30 min, 60 min, 90 min, 120 min, and 180 min, respectively, to detect the biotin content in each sample, and the biotin retention rate was calculated.

[0098] like Figure 3 As shown, the biotin dispersion composition obtained in Example 5 still has a high biotin retention rate in simulated gastric fluid for 3 hours, while the biotin dispersion composition obtained in Comparative Examples 1-2 has a large loss of biotin content in a strong acid environment and cannot effectively reach the small intestine, thereby reducing bioavailability.

[0099] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A biotin dispersion composition, characterized in that The raw materials include, by weight: 80-135 parts of biotin dispersion, 200-300 parts of lactose, 5-15 parts of povidone K30, 100-120 parts of enteric coating polymer, 1-5 parts of propylene glycol, and 80-100 parts of talc; The raw materials of the biotin dispersion include, by weight: 1-10 parts of stabilized biotin, 80-120 parts of hydrophilic polymer, and 0.01-1 parts of disodium hydrogen phosphate; The raw materials for stabilizing biotin include: biotin, hydrogenated lecithin, cholesterol, Tween, gelatin, and transglutaminase, wherein the mass ratio of biotin, hydrogenated lecithin, cholesterol, Tween, gelatin, and transglutaminase is 1-10: 1-2: 1-2: 0.1-1: 1-2: 0.1-1; Among them, the specific activity of glutamine transaminase is 3000-4000U / g; In the preparation process of the stabilized biotin, biotin, hydrogenated lecithin, cholesterol and Tween are added to edible oil and stirred at 30-40° C. for 1-2 hours to obtain pretreated biotin; Dissolve gelatin in water, add pretreated biotin under stirring, high-speed shear for 10-30s, the shear rate is 1000-5000r / min, adjust the pH value of the system to 4-5, add glutamine aminotransferase and stir for 1-2h, filter, wash and dry to obtain stabilized biotin.

2. The biotin dispersion composition according to claim 1, characterized in that The hydrophilic polymer is at least one of polyethylene glycol, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, povidone, and copovidone.

3. The biotin dispersion composition according to claim 1, characterized in that The particle size D90 of the biotin dispersion is 30-100 μm.

4. The biotin dispersion composition according to any one of claims 1 to 3, characterized in that The preparation method of the biotin dispersion comprises the following steps: adding disodium hydrogen phosphate to an ethanol aqueous solution and stirring evenly, adding stabilizing biotin and a hydrophilic polymer during the stirring process, stirring for 10-30 minutes, and spray drying to obtain the biotin dispersion.

5. The biotin dispersion composition according to claim 1, characterized in that The enteric coating polymer is at least one of cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, and acrylic acid polymer.

6. The biotin dispersion composition according to claim 5, characterized in that The enteric coating polymer is methacrylic acid-ethyl acrylate copolymer.

7. The biotin dispersion composition according to claim 1, characterized in that Flavoring agents are also included.

8. The biotin dispersion composition according to claim 7, characterized in that The flavor corrector is at least one of sucralose, acesulfame potassium, and xylitol.

9. A method for preparing the biotin dispersion composition according to any one of claims 1 to 8, characterized in that: The steps include: S1, mixing the biotin dispersion and lactose evenly and sending them into a fluidized bed, top-spraying the polyvidone K30 aqueous solution in the fluidized bed for granulation, drying to a moisture content of <2%, and removing large particles with a sieve to obtain a biotin complex; S2, adding the enteric coating polymer, propylene glycol, talcum powder and flavoring agent into water and mixing them evenly to obtain a coating solution; S3. Send the biotin complex into the fluidized bed, spray the coating liquid on the bottom of the fluidized bed for coating, the system temperature is 17-27°C, and dry until the moisture content is less than 2%.

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