Fucoxanthin oral soluble film preparation and preparation method thereof

Abstract

The invention discloses a fucoxanthin oral soluble film preparation and a preparation method thereof, and relates to the technical field of food and drug processing. The preparation method comprises the following steps: taking the following components as raw materials: fucoxanthin, microcapsule powder, sodium carboxymethyl cellulose, maltodextrin, polyvinylpyrrolidone, esterified vitamin C, vitamin E, glycerol and strawberry powder; adding water into the raw materials, stirring, dissolving and dispersing to obtain premixed feed liquid; adding strawberry essence into the premixed material liquid; and carrying out vacuum emulsification and defoaming, coating, drying, stripping and slitting to obtain the fucoxanthin oral soluble film agent. The fucoxanthin nano-emulsion oral soluble film preparation for oral administration can rapidly and spontaneously form a nano-sized oil-in-water (O / W) nano-emulsion after being in contact with saliva and gastric juice; according to the fucoxanthin capsule, the solubility of the fucoxanthin and the stability within the shelf life are improved, the fishy smell of the fucoxanthin can be effectively encapsulated and shielded, and the fucoxanthin capsule has the excellent characteristics that the fucoxanthin capsule can be dissolved in the mouth, the taste is excellent, the dosage of additives and auxiliary materials is small, and the fucoxanthin capsule is convenient

Description

Technical Field

[0001] The invention belongs to the technical field of food and drug processing, and particularly relates to a fucoxanthin orodispersible film preparation and a preparation method thereof. Background Art

[0002] Fucoxanthin, also known as fucoxanthin, brown algae, fucoxanthin, and fucoidan, is a pigment contained in brown algae, diatoms, golden algae, and yellow-green algae. It is a carotenoid in algae and an oxygen-containing derivative of carotene, namely lutein. It is a gas-free, odorless, orange-red or reddish-brown powdery substance. It is a fat-soluble powder that is easily soluble in organic solvents such as ethanol and insoluble in water. Fucoxanthin chemical structure characteristics: It contains allene bonds, 5,6-epoxy groups, conjugated carbonyl groups, acetyl groups, conjugated polyene chains and other structures, and has strong antioxidant properties and biological activity; it is safe and has no toxic effects on the human body. Fucoxanthin is like a precise key that can open the lock of heat production and lipolysis conversion of fat cells (β3-AR and UPC1), start the combustion engine of fat cell mitochondria, and burn fat to generate heat without deliberate exercise and dieting, so as to achieve static lipid reduction and weight loss. Fucoxanthin has the function of inhibiting fat production, accelerating the burning of brown fat cells, and promoting the transformation and burning of white fat cells into brown fat cells, thereby reducing white adipose tissue in the abdomen without rebounding of fat loss; at the same time, it stimulates the liver to produce DHA, a precious core ingredient that lowers cholesterol levels and nourishes brain nerves.

[0003] According to a research report by the World Health Organization (WHO), the global obesity trend is becoming increasingly serious, and the main reasons are closely related to changes in eating habits, reduced physical activity, metabolic disorders and reduced physical exercise. In particular, with the increase in high-carb, high-fat, high-energy diets, the intake of dietary fiber, vitamins and minerals has decreased, leading to overnutrition and unbalanced nutritional intake in the human body, which is a very important reason. In order to prevent diseases caused by this unhealthy lifestyle and concerns about the side effects of drugs, functional ingredients in food have become the focus, and fucoxanthin is an important food ingredient that can prevent and improve obesity.

[0004] Currently, there are fucoxanthin products on the market, such as Advanced Nutriton, Ntri-thrive, Slimcare, etc., and multi-dimensional fucoxanthin hard capsules. The contents of the hard capsules have a strong fishy smell, poor taste, and it is not easy to accurately control the dosage; fucoxanthin itself is very active and easily oxidized. The sealing strength of the hard capsules is not enough, and it is easy to penetrate into the air, so that the active ingredients of the product are oxidized during the shelf life and the stability is poor; fucoxanthin hard capsule products need to be absorbed after disintegration in the gastrointestinal tract, and the absorption rate of fat-soluble fucoxanthin is low, and the bioavailability is not high; hard capsules generally need to be taken with water, which is not friendly to women and people with dysphagia, and the convenience and compliance of taking are poor. If processed into tablets or powders, the product's fishy smell, stability, bioavailability, and compliance cannot be solved. Summary of the invention

[0005] The present invention provides a fucoxanthin orodispersible film preparation and a preparation method thereof, aiming to provide a fucoxanthin preparation which is convenient and willing for patients to take orally, has a good oral taste and is easy to accurately control the dosage, has good product stability and high bioavailability, thereby solving the problems in the background technology.

[0006] In order to solve the above technical problems, the present invention is achieved through the following technical solutions:

[0007] A fucoxanthin orodispersible film preparation of the present invention comprises the following component raw materials in percentage by mass:

[0008]

[0009] Furthermore, the average particle size of the fucoxanthin microcapsule powder is ≤20 um.

[0010] A method for preparing a fucoxanthin orodispersible film preparation comprises the following steps:

[0011] S1. Weigh the following raw materials according to mass percentage: 38%-49% fucoxanthin microcapsule powder with an average particle size of ≤20um, 24%-33% sodium carboxymethyl cellulose, 15%-20 maltodextrin, 10-16% polyvinyl pyrrolidone, 1-2% esterified vitamin C, 0.01-0.06% vitamin E, 9-14% glycerol, and 0.3-1.5% strawberry powder;

[0012] S2. According to the weighed raw material: water = 1g: 10-12ml ratio, the raw material is added with water and stirred evenly, and a premix liquid is obtained by mixing and dispersing; 0.005% by weight of strawberry flavor is added to the premix liquid, and a fucoxanthin orodispersible film preparation is obtained after vacuum emulsification and degassing, coating, drying, peeling and cutting.

[0013] Furthermore, the shearing speed of the vacuum emulsification is 5000r / min to 12000r / min.

[0014] Furthermore, the shear stirring time of the vacuum emulsification is 8 min to 12 min.

[0015] Furthermore, the vacuum degree of the vacuum emulsification degassing is 0.09MPa to 0.1MPa.

[0016] Furthermore, the coating film has a thickness of 0.7 mm to 0.9 mm.

[0017] Furthermore, the drying temperature is 45°C-55°C.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] (1) The oral fucoxanthin nanoemulsion oral solution film preparation provided by the present invention can rapidly and spontaneously form a nano-sized oil-in-water (O / W) nanoemulsion after contacting saliva and gastric juice; the preparation increases the solubility of fucoxanthin, increases the stability of fucoxanthin during the warranty period, can effectively encapsulate and mask the fishy smell of fucoxanthin, has the advantages of melting in the mouth, excellent taste, small amount of additives and auxiliary materials, and convenient to carry;

[0020] (2) The orodispersible film forms a nanoemulsion in the oral saliva, which can be partially absorbed through the oral mucosa in the mouth, greatly improving the bioavailability of fucoxanthin and greatly improving the compliance of the product for women with dysphagia and middle-aged and elderly people.

[0021] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0023] Figure 1 It is a statistical line graph of the oral dissolution time of the fucoxanthin orodispersible film preparation of the technical solution taken orally in a specific embodiment; DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] A fucoxanthin orodispersible film preparation, comprising the following component raw materials in percentage by mass:

[0026]

[0027] The average particle size of fucoxanthin microcapsule powder is ≤20um.

[0028] Example 1

[0029] A method for preparing a fucoxanthin orosoluble film comprises the following steps:

[0030] S1. Weigh the following components as raw materials according to mass fraction: 40% fucoxanthin microcapsule powder with an average particle size of ≤20 μm, 28% sodium carboxymethyl cellulose, 15% maltodextrin, 3% polyvinyl pyrrolidone, 1% esterified vitamin C, 0.05% vitamin E, 11.95% glycerol, and 1% strawberry powder;

[0031] S2. Add water to the raw materials at a ratio of 1g:10ml, stir evenly, and mix and disperse to obtain a premix liquid; add 0.005% strawberry flavor to the premix liquid, vacuum emulsify and degas, apply film, dry, peel, and cut to obtain a fucoxanthin oral dissolving film agent; the shear speed of vacuum emulsification is 5000r / min; the shear stirring time of vacuum emulsification is 8min; the vacuum degree of vacuum emulsification and degassing is 0.095Pa. The film thickness of the coating is: 0.7mm; the drying temperature is 55℃; the cutting size is 3cm*2cm;

[0032] The strength and toughness of the fucoxanthin orodispersible film of this example and its dissolution time in oral saliva were observed. The results showed that the film had good strength and toughness, a smooth surface without particles, and an average dissolution and self-emulsification time of 12 seconds after the orodispersible film was taken into the mouth.

[0033] Example 2

[0034] A method for preparing a fucoxanthin orosoluble film comprises the following steps:

[0035] S1. Weigh the following components as raw materials according to mass fraction: 40% fucoxanthin microcapsule powder with an average particle size of ≤20 μm, 28% sodium carboxymethyl cellulose, 15% maltodextrin, 2% polyvinyl pyrrolidone, 1% esterified vitamin C, 0.05% vitamin E, 12.95% glycerol, and 1% strawberry powder;

[0036] S2. Add water to the raw materials at a ratio of 1g:12ml, stir evenly, and mix and disperse to obtain a premix liquid; add 0.005% strawberry flavor to the premix liquid, vacuum emulsify and degas, apply film, dry, peel, and cut to obtain a fucoxanthin oral dissolving film agent; the shear speed of vacuum emulsification is 5000r / min; the shear stirring time of vacuum emulsification is 8min; the vacuum degree of vacuum emulsification and degassing is 0.095Pa. The film thickness of the coating is: 0.7mm; the drying temperature is 55℃; the cutting size is 3cm*1cm;

[0037] The strength and toughness of the fucoxanthin orodispersible film of this example and its dissolution time in oral saliva were observed. The results showed that the film had good strength and toughness, a smooth surface without particles, and an average dissolution and self-emulsification time of 10 seconds after the orodispersible film was taken into the mouth.

[0038] Embodiment 3:

[0039] A method for preparing a fucoxanthin orosoluble film comprises the following steps:

[0040] S1. Weigh the following components as raw materials according to mass fraction: 38% fucoxanthin microcapsule powder with an average particle size of ≤20 μm, 30% sodium carboxymethyl cellulose, 15% maltodextrin, 2% polyvinyl pyrrolidone, 1% esterified vitamin C, 0.05% vitamin E, 12.95% glycerol, and 1% strawberry powder;

[0041] S2. Add water to the raw materials at a ratio of 1g:10ml, stir evenly, and mix and disperse to obtain a premix liquid; add 0.005% strawberry flavor to the premix liquid, vacuum emulsify and degas, apply film, dry, peel, and cut to obtain a fucoxanthin oral dissolving film agent; the shear speed of vacuum emulsification is 5000r / min; the shear stirring time of vacuum emulsification is 8min; the vacuum degree of vacuum emulsification and degassing is 0.095Pa. The film thickness of the coating is: 0.7mm; the drying temperature is 55℃; the cutting size is 3cm*3cm;

[0042] The strength and toughness of the fucoxanthin orodispersible film of this example and its dissolution time in oral saliva were observed. The results showed that the film had good strength and toughness, and the surface was flat, smooth and free of particles. After the orodispersible film was taken into the mouth, the average dissolution and self-emulsification time was 13 seconds.

[0043] Embodiment 4:

[0044] A method for preparing a fucoxanthin orosoluble film comprises the following steps:

[0045] S1. Weigh the following components as raw materials according to mass fraction: 38% fucoxanthin microcapsule powder with an average particle size of ≤20 μm, 30% sodium carboxymethyl cellulose, 16% maltodextrin, 1% polyvinyl pyrrolidone, 2% esterified vitamin C, 0.05% vitamin E, 11.95% glycerol, and 1% strawberry powder;

[0046] S2. Add water to the raw materials at a ratio of 1g:10ml, stir evenly, and mix and disperse to obtain a premix liquid; add 0.005% strawberry flavor to the premix liquid, vacuum emulsify and degas, apply film, dry, peel, and cut to obtain a fucoxanthin oral dissolving film agent; the shear speed of vacuum emulsification is 5000r / min; the shear stirring time of vacuum emulsification is 8min; the vacuum degree of vacuum emulsification and degassing is 0.095Pa. The film thickness of the coating is: 0.7mm; the drying temperature is 55℃; the cutting size is 3cm*2cm;

[0047] The strength and toughness of the fucoxanthin orodispersible film of this example and its dissolution time in oral saliva were observed. The results showed that the film had good strength and toughness, a smooth surface without particles, and an average dissolution and self-emulsification time of 11 seconds after the orodispersible film was taken into the mouth.

[0048] Embodiment 5:

[0049] A method for preparing a fucoxanthin orosoluble film comprises the following steps:

[0050] S1. Weigh the following components as raw materials according to mass fraction: 38% fucoxanthin microcapsule powder with an average particle size of ≤20 μm, 30% sodium carboxymethyl cellulose, 15% maltodextrin, 2% polyvinyl pyrrolidone, 1% esterified vitamin C, 0.05% vitamin E, 12.95% glycerol, and 1% strawberry powder;

[0051] S2. Add water to the raw materials at a ratio of 1g:10ml, stir evenly, and mix and disperse to obtain a premix liquid; add 0.005% strawberry flavor to the premix liquid, vacuum emulsify and degas, apply film, dry, peel, and cut to obtain a fucoxanthin oral dissolving film agent; the shear speed of vacuum emulsification is 5000r / min; the shear stirring time of vacuum emulsification is 8min; the vacuum degree of vacuum emulsification and degassing is 0.095Pa. The film thickness of the coating is: 0.7mm; the drying temperature is 55℃; the cutting size is 3cm*3cm;

[0052] The strength and toughness of the fucoxanthin orodispersible film of this example and its dissolution time in oral saliva were observed. The results showed that the film had good strength and toughness, a smooth surface without particles, and an average dissolution and self-emulsification time of 12 seconds after the orodispersible film was taken into the mouth.

[0053] Comparative Example:

[0054] Commercially available fucoxanthin multi-dimensional fucoxanthin hard capsules such as advanced Nutriton, Ntri-thrive, Slimcare, etc. were used as comparative examples; the following taste evaluation table was obtained by directly taking it orally to determine whether there was a fishy smell:

[0055] Example Bad review (strong fishy smell) Medium rating (average smell) Good (good smell) Excellent (no fishy smell) 1 √ 2 √ 3 √ 4 √ 5 √ Comparative Example √

[0056] Table 1: Taste evaluation table;

[0057] The products corresponding to Examples 1-5 and the products of the comparative example were directly orally taken and eaten immediately to obtain a time chart of each product dissolving in the oral cavity, as shown in FIG. Figure 1 As shown; among them, the multi-dimensional fucoxanthin hard capsule will take more than 60 seconds to dissolve, which is generally swallowed and is not included in the line graph; the vertical axis unit in this table is time: s;

[0058] It can be seen that the obvious advantage of the product of the embodiment of the technical solution over the multi-dimensional fucoxanthin hard capsule product is that it can self-emulsify and dissolve quickly in the oral cavity and be partially absorbed by the oral mucosa; the fishy smell of the product is completely encapsulated and has a good taste. It is obviously different from the hard capsule products on the market now; the strength and toughness of a fucoxanthin oral dissolving film of this embodiment and the dissolution time in oral saliva are observed. The result shows that the strength and toughness of the film are good, the surface is smooth and free of particles, and the average dissolution self-emulsification time is 12s after the oral dissolving film enters the mouth; therefore, the product of the technical solution has the characteristics of dissolving in the mouth, excellent taste, and the oral dissolving film forms a nanoemulsion in the oral saliva, which can be partially absorbed in the oral mucosa in the mouth, greatly improving the bioavailability of fucoxanthin, and the compliance of the product for women with dysphagia and middle-aged and elderly people has been greatly improved.

[0059] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific implementation methods described. Obviously, many modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and use the present invention well. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A fucoxanthin orodispersible film preparation, characterized in that: It includes the following raw materials by mass percentage:

2. The fucoxanthin orodispersible film preparation according to claim 1, characterized in that: The average particle size of the fucoxanthin microcapsule powder is ≤20um.

3. The method for preparing a fucoxanthin orodispersible film preparation according to any one of claims 1 to 2, characterized in that: The steps include: S1. Weigh the following raw materials according to mass percentage: 38%-49% fucoxanthin microcapsule powder with an average particle size of ≤20um, 24%-33% sodium carboxymethyl cellulose, 15%-20 maltodextrin, 10-16% polyvinyl pyrrolidone, 1-2% esterified vitamin C, 0.01-0.06% vitamin E, 9-14% glycerol, and 0.3-1.5% strawberry powder; S2. According to the weighed raw material: water = 1g: 10-12ml ratio, the raw material is added with water and stirred evenly, and a premix liquid is obtained by mixing and dispersing; 0.005% by weight of strawberry flavor is added to the premix liquid, and a fucoxanthin orodispersible film preparation is obtained after vacuum emulsification and degassing, coating, drying, peeling and cutting.

4. The method for preparing a fucoxanthin orodispersible film preparation according to claim 3, characterized in that: The shearing speed of the vacuum emulsification is 5000 r / min to 12000 r / min.

5. The method for preparing a fucoxanthin orodispersible film preparation according to claim 3, characterized in that: The shear stirring time of the vacuum emulsification is 8 minutes to 12 minutes.

6. The method for preparing a fucoxanthin orodispersible film preparation according to claim 3, characterized in that: The vacuum degree of the vacuum emulsification degassing is 0.09MPa to 0.1MPa.

7. The method for preparing a fucoxanthin orodispersible film preparation according to claim 3, characterized in that: The coating film has a film thickness of 0.7 mm to 0.9 mm.

8. The method for preparing a fucoxanthin orodispersible film preparation according to claim 3, characterized in that: The drying temperature is 45°C-55°C.

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