A DHA algae oil bird's nest acid orally dissolving film preparation and preparation method thereof

Abstract

The present invention discloses a DHA algae oil and bird's nest acid orally disintegrating film and a preparation method thereof. The preparation method comprises the following steps: (1) taking the following components as raw materials: bird's nest acid, DHA algae oil powder with an average particle size of less than 10 μm, hydroxypropyl methylcellulose, pullulan, esterified vitamin C, glycerin, and sunset yellow; (2) adding water to the raw materials and stirring to obtain a second slurry; adding orange essence to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil and bird's nest acid orally disintegrating film. The present invention uses DHA algae oil powder with an average particle size of less than 10 μm and bird's nest acid as main raw materials to prepare the orally disintegrating film. The preparation increases the solubility of DHA algae oil and reduces the fishy smell of DHA algae oil. The preparation has excellent characteristics such as melting in the mouth, good taste, low amount of auxiliary materials, and portability. The orally disintegrating film dissolves in the oral cavity and is partially absorbed by the oral mucosa, greatly improving the compliance of pregnant women and infants.

Description

Technical Field

[0001] The present invention belongs to the field of pharmaceutical preparations, and in particular relates to a DHA algae oil and bird's nest acid orally dissolving film preparation and a preparation method thereof. Background Art

[0002] DHA, or docosahexaenoic acid, commonly known as brain gold, is a key element for the growth and maintenance of nervous system cells. It is an essential fatty acid for the human body and a key component of the brain and retina. It is crucial for the intellectual and visual development of infants and young children. Studies have shown that mothers consuming DHA during pregnancy or using DHA-enriched formula can help increase DHA levels in infants, leading to better visual and brain development. DHA is primarily derived from deep-sea fish and algae, while algal oil is extracted from marine microalgae. It is not passed through the food chain and has a very low EPA content, making it particularly suitable for infants and young children.

[0003] Bird's nest acid, also known as sialic acid, is a naturally occurring carbohydrate compound found throughout biological systems. It is the general name for a family of derivatives based on the nine-carbon sugar neuraminic acid. Sialic acid is an essential nutrient for cognitive development in the human brain, with the highest concentration found in breast milk. Previous studies on sialic acid have primarily linked it to conditions such as infections, tumors, and coronary heart disease. However, studies in healthy individuals have highlighted its relationship with nervous system development, which has become a hot topic. Exogenous sialic acid has been shown to increase the concentration of gangliosides in the brains of animals and improve learning ability. This suggests that sialic acid plays a crucial role in promoting nervous system development. From a nutritional perspective, sialic acid represents a novel nutrient in human nutrition. In human studies, supplementing infants aged 0-6 months with high-sialic acid formula has been shown to increase serum ganglioside levels and promote cognitive development, such as hand-eye coordination and performance skills.

[0004] Whether given to pregnant mothers or infants, DHA and bird's nest acid can promote the neural development of the infant's cerebral cortex and retina, promote memory and intellectual development, improve the intestinal absorption capacity of vitamins and minerals, and enhance resistance and immunity. Studies have shown that DHA and bird's nest acid are positively correlated and are beneficial to the early brain development of infants.

[0005] Currently, most DHA supplements on the market come in the form of DHA soft capsules. These dosage forms are often cut open for infants and young children, and the contents of the soft capsules have a strong fishy odor, poor taste, and difficulty controlling dosage. DHA algae oil itself is easily oxidized and has a certain algae-like odor. Tablets or powders, on the other hand, require swallowing with water or dissolving in water, making them less compliant for pregnant women and infants.

[0006] Therefore, there is an urgent need for a DHA algae oil bird's nest acid preparation that is easy for patients to use, has low fishy smell, is easy to control the dosage, and has good patient compliance. Summary of the Invention

[0007] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a DHA algae oil and bird's nest acid orally dissolving film preparation.

[0008] The second object of the present invention is to provide a method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent.

[0009] The technical solution of the present invention is summarized as follows:

[0010] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0011] (1) Weigh the following components by mass as raw materials: 20%-26% swalnic acid, 18%-22% DHA algae oil powder with an average particle size of less than 10 μm, 26%-34% hydroxypropyl methylcellulose, 12%-16.788% pullulan, 0.5%-1.2% esterified vitamin C, 8%-12% glycerol, and 0.008%-0.012% sunset yellow;

[0012] The DHA algae oil powder with an average particle size of less than 10 μm is prepared by the following steps:

[0013] 24 parts by mass of β-cyclodextrin are dissolved in 72 parts by mass of water at 50-55°C to obtain an aqueous phase; 4 parts by mass of DHA algae oil are added to the aqueous phase and stirred at 10,000-12,500 r / min for 3-5 minutes; the mixture is homogenized at 20-25 MPa to obtain a slurry, which is then spray-dried in an airflow spray dryer at a slurry flow rate of 80-100 mL / h, an inlet air temperature of 195°C, and an outlet air temperature of 90±5°C to obtain DHA algae oil powder with an average particle size of less than 10 μm;

[0014] (2) adding water to the raw material at a ratio of 1 g: 8-10 mL and stirring evenly to obtain a uniform second slurry; adding orange essence equivalent to 0.01% of the mass of the raw material to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0015] The vacuum degree of the vacuum emulsification degassing is 0.09-0.1 MPa.

[0016] The coating film has a thickness of 0.6-0.8 mm.

[0017] The drying temperature in step (2) is 50-60°C.

[0018] A DHA algae oil and bird's nest acid orally dissolving film-forming agent prepared by the above preparation method.

[0019] Advantages of the present invention:

[0020] The present invention uses DHA algae oil powder with an average particle size of less than 10 μm and swalconolactone as the main raw materials to prepare a DHA algae oil and swalconolactone orally disintegrating film preparation. This preparation increases the solubility of the DHA algae oil and reduces its fishy smell. It has excellent characteristics such as melting in the mouth, good taste, low auxiliary material content, and portability. The orally disintegrating film preparation dissolves in the mouth and is partially absorbed by the oral mucosa, greatly improving the compliance of pregnant women and infants. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a bar chart of the fishy smell sensory evaluation of Examples 4-8. DETAILED DESCRIPTION

[0022] The present invention will be further described below with reference to specific examples.

[0023] DHA algae oil, commercially available.

[0024] Example 1

[0025] DHA algae oil powder with an average particle size of less than 10 μm is prepared by the following steps:

[0026] 24 g of β-cyclodextrin was dissolved in 72 g of water at 53°C to obtain an aqueous phase; 4 g of DHA algae oil was added to the aqueous phase and stirred at 11,000 r / min for 4 min; then homogenized at 23 MPa to obtain a slurry, which was then spray-dried in an airflow spray dryer at a slurry flow rate of 90 mL / h, an inlet air temperature of 195°C, and an outlet air temperature of 90°C to obtain DHA algae oil powder with an average particle size of less than 10 μm.

[0027] Example 2

[0028] DHA algae oil powder with an average particle size of less than 10 μm is prepared by the following steps:

[0029] 24 g of β-cyclodextrin was dissolved in 72 g of water at 50°C to obtain an aqueous phase; 4 g of DHA algae oil was added to the aqueous phase and stirred at 10,000 r / min for 5 minutes; then homogenized at 20 MPa to obtain a slurry, which was then spray-dried in an air flow spray dryer at a slurry flow rate of 80 mL / h, an inlet air temperature of 195°C, and an outlet air temperature of 85°C to obtain DHA algae oil powder with an average particle size of less than 10 μm.

[0030] Example 3

[0031] DHA algae oil powder with an average particle size of less than 10 μm is prepared by the following steps:

[0032] 24 g of β-cyclodextrin was dissolved in 72 g of water at 55°C to obtain an aqueous phase; 4 g of DHA algae oil was added to the aqueous phase and stirred at 12,500 r / min for 3 min; the mixture was homogenized at 25 MPa to obtain a slurry, which was then spray-dried in an air flow spray dryer at a slurry flow rate of 100 mL / h, an inlet air temperature of 195°C, and an outlet air temperature of 95°C to obtain DHA algae oil powder with an average particle size of less than 10 μm.

[0033] Example 4

[0034] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0035] (1) The following components were weighed as raw materials according to mass fraction: 23% swalnic acid, 20% DHA algae oil powder with an average particle size of less than 10 μm prepared in Example 1, 30% hydroxypropyl methylcellulose, 14% pullulan, 1% esterified vitamin C, 11.99% glycerol, and 0.01% sunset yellow;

[0036] (2) adding water to the raw material at a ratio of 1 g: 9 mL and stirring evenly to obtain a uniform second slurry; adding orange essence equivalent to 0.01% of the mass of the raw material to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0037] The vacuum degree of vacuum emulsification degassing is 0.096MPa.

[0038] The film thickness of the coating film was 0.7 mm.

[0039] The drying temperature in step (2) is 60°C.

[0040] The cutting size is 2cm*1cm, 2cm*2cm or 2cm*3cm.

[0041] The strength and toughness of the DHA algae oil and bird's nest acid orally dissolving film of this embodiment were observed. The results showed that the film had good strength and toughness and no snowflake-like particles.

[0042] Example 5

[0043] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0044] (1) The following components were weighed as raw materials according to mass fraction: 20% swalnic acid, 22% DHA algae oil powder with an average particle size of less than 10 μm prepared in Example 2, 29.492% hydroxypropyl methylcellulose, 16% pullulan, 0.5% esterified vitamin C, 12% glycerol, and 0.008% sunset yellow;

[0045] (2) adding water to the raw material at a ratio of 1 g: 8 mL and stirring evenly to obtain a uniform second slurry; adding orange essence equivalent to 0.01% of the mass of the raw material to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0046] The vacuum degree of vacuum emulsification degassing is 0.09MPa.

[0047] The film thickness of the coating film was 0.6 mm.

[0048] The drying temperature in step (2) is 55°C.

[0049] The cutting size is 2cm*1cm, 2cm*2cm or 2cm*3cm.

[0050] The strength and toughness of the DHA algae oil and bird's nest acid orally disintegrating film of this embodiment were observed. The results showed that the film had good strength and toughness and no snowflake-like particles.

[0051] Example 6

[0052] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0053] (1) The following components were weighed as raw materials according to mass fraction: 26% swalnic acid, 18% DHA algae oil powder with an average particle size of less than 10 μm prepared in Example 3, 34% hydroxypropyl methylcellulose, 12% pullulan, 1.2% esterified vitamin C, 8.788% glycerol, and 0.012% sunset yellow;

[0054] (2) adding water to the raw material at a ratio of 1 g: 10 mL and stirring evenly to obtain a uniform second slurry; adding orange essence equivalent to 0.01% of the mass of the raw material to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0055] The vacuum degree of vacuum emulsification degassing is 0.1 MPa.

[0056] The film thickness of the coating film was 0.8 mm.

[0057] The drying temperature in step (2) is 50°C.

[0058] The cutting size is 2cm*1cm, 2cm*2cm or 2cm*3cm.

[0059] The strength and toughness of the DHA algae oil and bird's nest acid orally dissolving film of this embodiment were observed. The results showed that the film had good strength and toughness and no snowflake-like particles.

[0060] Example 7

[0061] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0062] (1) The following components were weighed as raw materials according to mass fraction: 26% swalnic acid, 22% DHA algae oil powder with an average particle size of less than 10 μm prepared in Example 1, 26% hydroxypropyl methylcellulose, 16.788% pullulan, 1.2% esterified vitamin C, 8% glycerol, and 0.012% sunset yellow;

[0063] (2) adding water to the raw material at a ratio of 1 g: 9 mL and stirring evenly to obtain a uniform second slurry; adding orange essence equivalent to 0.01% of the mass of the raw material to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0064] The vacuum degree of vacuum emulsification degassing is 0.096MPa.

[0065] The film thickness of the coating film was 0.7 mm.

[0066] The drying temperature in step (2) is 60°C.

[0067] The cutting size is 2cm*1cm, 2cm*2cm or 2cm*3cm.

[0068] The strength and toughness of the DHA algae oil and bird's nest acid orally dissolving film of this embodiment were observed. The results showed that the film had good strength and toughness and no snowflake-like particles.

[0069] Example 8 (control)

[0070] A method for preparing a DHA algae oil and bird's nest acid orally dissolving film-forming agent comprises the following steps:

[0071] (1) The following components were weighed as raw materials according to mass fraction: 26% swalnic acid, 22% commercially available DHA algae oil, 26% hydroxypropyl methylcellulose, 16.788% pullulan, 1.2% esterified vitamin C, 8% glycerol, and 0.012% sunset yellow;

[0072] (2) adding water to the raw material in a ratio of 1 g: 9 mL and stirring evenly to obtain a uniform second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

[0073] The vacuum degree of vacuum emulsification degassing is 0.096MPa.

[0074] The film thickness of the coating film was 0.7 mm.

[0075] The drying temperature in step (2) is 60°C.

[0076] The cutting size is 2cm*1cm, 2cm*2cm or 2cm*3cm.

[0077] The strength and toughness of the orally disintegrating film containing DHA algae oil and bird's nest acid of this embodiment were observed. The results showed that the film was brittle and had poor demoulding properties.

[0078] Sensory evaluation method:

[0079] Take 10 pieces of 2cm*1cm DHA algae oil bird's nest acid orally dissolving film prepared in Example 4-8, select 10 people to participate as tasters, and use a ten-point system to conduct sensory evaluation on the algae smell of the DHA algae oil bird's nest acid orally dissolving film. The score represents the strength of the sensory organ. The sensory evaluation results are as follows: Figure 1 As shown:

[0080] Depend on Figure 1 It can be seen that there is no significant difference in the fishy smell sensory evaluation scores of Examples 4-7. Example 8 has a stronger fishy smell because commercially available DHA algae oil is directly used without encapsulation and without adding orange flavor for taste masking.

[0081] In summary, the DHA algae oil and bird's nest acid orally disintegrating film prepared by the present invention uses β-cyclodextrin as the wall material, DHA algae oil as the core material, spray drying for microencapsulation treatment and adding orange essence to achieve a good taste-masking effect on the fishy smell of DHA algae oil. At the same time, it can be dissolved and absorbed in the mouth, does not require drinking water, is easy to use, has a good taste, and greatly improves the compliance of pregnant women and children.

Claims

1. A method for preparing a DHA algae oil bird's nest acid orally dissolving film agent, characterized in that The steps include: (1) Weigh the following components by mass as raw materials: 20%-26% swalnic acid, 18%-22% DHA algae oil powder with an average particle size of less than 10 μm, 26%-34% hydroxypropyl methylcellulose, 12%-16.788% pullulan, 0.5%-1.2% esterified vitamin C, 8%-12% glycerol, and 0.008%-0.012% sunset yellow; The DHA algae oil powder with an average particle size of less than 10 μm is prepared by the following steps: 24 parts by mass of β-cyclodextrin are dissolved in 72 parts by mass of water at 50-55°C to obtain an aqueous phase; 4 parts by mass of DHA algae oil are added to the aqueous phase and stirred at 10,000-12,500 r / min for 3-5 minutes; the mixture is homogenized at 20-25 MPa to obtain a slurry, which is then spray-dried in an airflow spray dryer at a slurry flow rate of 80-100 mL / h, an inlet air temperature of 195°C, and an outlet air temperature of 90±5°C to obtain DHA algae oil powder with an average particle size of less than 10 μm; (2) The raw material and water are stirred evenly in a ratio of 1 g: 8-10 mL to obtain a uniform second slurry; orange essence equivalent to 0.01% of the mass of the raw material is added to the second slurry; vacuum emulsification and degassing, coating, drying, peeling, and cutting are performed to obtain a DHA algae oil bird's nest acid orally dissolving film agent.

2. The preparation method according to claim 1, wherein The vacuum degree of the vacuum emulsification degassing is 0.09-0.1 MPa.

3. The preparation method according to claim 1, wherein The coating film has a thickness of 0.6-0.8 mm.

4. The preparation method according to claim 1, wherein The drying temperature in step (2) is 50-60°C.

5. A DHA algae oil and bird's nest acid orally dissolving film preparation prepared by the preparation method according to any one of claims 1 to 4.

Images