A soft gelatin capsule containing algal oil DHA

Abstract

A soft capsule containing algal oil DHA, the composition comprising a capsule core and a capsule shell, wherein the capsule core contains the active ingredient and is enclosed in a vegetable capsule shell, characterized in that the capsule core comprises algal oil, lecithin and lemon oil and the capsule shell comprises vegetable starch, glycerin and purified water, wherein a stable lipid system is formed by a synergistic design of a high content of sn-2-positioned DHA (structural lipid) and lecithin as a carrier lipid in the capsule contents, which promotes the emulsification, transport and absorption of DHA in the gastrointestinal tract and thereby increases its bioavailability.

Description

Technical field

[0001] The present invention relates to a softgel capsule containing algal oil-DHA. The softgel capsule contains algal oil, lecithin, and lemon oil as its main components. The algal oil has a high proportion of DHA with an sn-2 position structure (structured lipids), and the lecithin, acting as a carrier lipid, is scientifically combined with the DHA. Water, glycerin, and edible plant gelling agents are used as excipients. The synergistic combination of DHA with a high sn-2 content (structured lipids) and lecithin (carrier lipid) forms a stable lipid system within the softgel capsule. This system promotes the emulsification, transport, and absorption of DHA in the gastrointestinal tract and increases its bioavailability. As a result, the development of brain tissue and cognitive abilities in infants and young children is effectively supported, neuronal signal transmission is improved, and normal visual development is promoted. Background technology

[0002] Docosahexaenoic acid (DHA) is an important long-chain polyunsaturated fatty acid widely distributed in tissues of the human nervous and visual systems. Studies show that DHA is an essential component of brain gray matter, nerve cell membranes, and the retina, and is of great importance during fetal and early childhood development. However, the human body's capacity for endogenous synthesis of DHA is limited. Particularly during the fetal and early childhood stages, DHA is primarily dependent on maternal supply or exogenous intake through diet. Therefore, the safe, stable, and effective delivery of DHA to fetuses and infants has long been a central focus of nutritional science and functional food technology.

[0003] The fetal phase represents a key period for the structural development and functional foundation of the central nervous system. Human brain development does not begin after birth, but rather in the early embryonic stages. From the third to fourth week of pregnancy, the neural tube forms, gradually differentiating into the brain, brainstem, and spinal cord. During the middle of pregnancy, the cerebral cortex expands rapidly, the number of neurons increases dramatically, and orderly neuronal migration occurs, giving rise to the basic functional architecture of various brain regions.

[0004] During this process, the formation of cell membranes, the development of neuronal connections, and the formation of synaptic structures are highly dependent on lipid nutrients. DHA is one of the most abundant polyunsaturated fatty acids in the brain and, during the fetal phase, is primarily involved in the synthesis of phospholipids in neuronal cell membranes. It accumulates particularly in the cerebral cortex, hippocampus, and basal ganglia—brain regions closely associated with learning, memory, and information processing.

[0005] At the molecular level, DHA contains multiple cis double bonds, which give neuronal cell membranes high fluidity and flexibility. These physical properties support the normal conformational changes of membrane proteins such as ion channels, receptors, and transporters, enabling efficient neuronal signaling. During the fetal phase, synapses are formed in large numbers; an insufficient supply of DHA can impair the structural integrity of synaptic membranes and the fine-tuning of neuronal networks.

[0006] Furthermore, the fetal phase is characterized by intensive differentiation of neural stem cells and pronounced neuronal migration. Studies show that DHA is involved in the regulation of neurogenesis and neuronal differentiation and, to some extent, influences the quality of neuronal connections. This effect is less evident in short-term functional changes, but rather in the long-term shaping of brain structure and neuronal connectivity, thus forming the basis for cognitive, learning, and behavioral abilities after birth.

[0007] During mid to late pregnancy (approximately from week 24 until delivery), the rate of DHA accumulation in the fetal brain increases significantly; this period is often referred to as the "critical DHA accumulation phase." Since the fetus is hardly able to synthesize DHA itself, it is almost entirely dependent on the selective transport of DHA from the mother's body via the placenta. Insufficient maternal DHA intake can impair DHA storage in the fetal brain, potentially affecting the structural development of the nervous system. Therefore, from a nutritional perspective, providing a stable, safe, and controlled source of DHA for pregnant women is an important technical objective.

[0008] Even after birth and in early childhood, DHA plays a crucial role in the development of the brain and the visual system. This phase represents the transition from the "structural establishment" to the "functional maturation" of the brain. A newborn's brain weighs approximately 25% of an adult's, but by the age of 2 to 3 years, this figure has already reached over 80%. In addition to the rapid increase in volume, the significant rise in neuronal network complexity is particularly important.

[0009] The period from birth to the age of 2 to 3 years is considered the "golden window" of brain development. During this phase, the number of synaptic connections reaches its peak, accompanied by ongoing synaptic elimination and functional optimization. The speed and complexity of brain development are significantly higher during this period than in later childhood or adulthood.

[0010] Key features of early childhood brain development include the massive formation of synapses, the rapid increase in neuronal connections, and the subsequent synaptic selection and functional fine-tuning. The lipid composition of neuronal cell and synaptic membranes plays a crucial role in the efficiency of neuronal signal transmission and neuronal plasticity. DHA is an essential structural component of synaptic membranes and performs a fundamental function in stabilizing synapses and supporting neurotransmitter release and signal transmission.

[0011] From a functional perspective, infancy and early childhood are a key period for the development of cognition, learning ability, memory, and attention. Brain regions such as the hippocampus and the prefrontal cortex develop further during this time and are also regions with high DHA concentrations. Adequate DHA intake is considered beneficial for the maturation of neural networks and the improvement of information processing, and forms an important foundation for later language development, executive functions, and learning ability.

[0012] Besides its role in the central nervous system, DHA also plays a significant role in the development of the visual system. The outer segments of the photoreceptors in the retina have a particularly high DHA content and provide a structural basis for efficient light signal transduction. Infancy and early childhood are a phase of rapid maturation of visual pathways and functions, including visual acuity, contrast sensitivity, and visual reaction speed. DHA is considered a supporting structural component in the formation and transmission of visual signals.

[0013] In summary, DHA supports brain and visual system development during fetal, infancy, and early childhood by participating in the formation of neuronal cell membranes, synapse formation, and the structural maturation of visual tissues. This effect is long-term and fundamental, making DHA an essential nutrient in early developmental stages. It is important to note that infants' endogenous DHA synthesis capacity remains limited, and DHA status depends primarily on the DHA content of breast milk or infant formula. Insufficient DHA content in breast milk or limited dietary variety can pose a risk of inadequate DHA intake.

[0014] The expert committee of the Food and Agriculture Organization of the United Nations (FAO) points out that although DHA is formally considered a non-essential fatty acid and can be synthesized from alpha-linolenic acid, its conversion rate is low and DHA is crucial for the development of the fetal brain and retina. Therefore, DHA can be considered a "conditionally essential fatty acid" for pregnant and breastfeeding women, and supplementation is recommended during pregnancy.

[0015] Infants, toddlers, and pregnant and breastfeeding women are in special physiological phases of early development or increased physical stress and have specific, sensitive nutritional needs. DHA is an essential component of the nervous system and retina and plays a key role in the development of the fetal and early childhood brain and nervous system. At the same time, DHA is important for pregnant and breastfeeding women to maintain their own nutritional balance and meet the needs of the fetus or infant. These groups, however, place particularly high demands on the safety of exogenous dietary supplements.Unsuitable DHA sources, insufficient purity, lack of stability, or an improper formulation strategy can increase the risk of oxidation, contamination, or gastrointestinal discomfort, thus compromising the safety of long-term use. Furthermore, as a highly unsaturated fatty acid, the efficiency of DHA absorption, transport, and tissue utilization in the human body is influenced by various factors, including the structural form of the lipids, the formulation system, and the route of administration. Conventional DHA supplementation formulations still offer potential for optimization regarding bioavailability. Therefore, the development of a DHA supplement for infants, pregnant women, and breastfeeding mothers that ensures high safety while simultaneously considering DHA stability and its absorption and utilization efficiency is of considerable practical importance and high application value. Practical new product

[0016] The fundamental object of the present invention is to provide a soft capsule containing algal oil DHA, comprising a capsule core and a capsule shell. The capsule core consists of organic algal oil DHA, organic lecithin, and organic lemon oil; the capsule shell is a plant-based soft capsule shell made from organic plant starch, organic glycerin, and water, and contains no animal gelatin or carrageenan gelling agents. Encapsulating the algal oil DHA contents with plant-based capsule materials ensures that the capsule, with good shape stability and leak-proofness, meets the application requirements of infants, pregnant women, and breastfeeding mothers. The present invention achieves this object through the embodiments described in the claims.

[0017] According to the present invention, the algae oil-DHA-containing soft capsule is suitable for special groups of people such as infants, pregnant women and breastfeeding mothers.

[0018] WO2009009040A2 relates to a highly concentrated DHA / EPA fatty acid composition in which DHA and EPA from fish oil are combined in specific ratios (e.g., 3:1) in softgel capsules, with the addition of antioxidants and enteric coatings to improve absorption and stability. This composition is primarily used for cardiovascular health and disease prevention.

[0019] EP4233906NWA2 concerns nutrient compositions for infants, such as infant formula or follow-on formula. In this document, DHA is combined with phospholipid components involved in the myelination of the nervous system (e.g., sphingomyelin), as well as with iron and choline, to support the myelination process of the infant brain.

[0020] US 10,582,714 B2 discloses a DHA-containing nutrient composition for supporting the cognitive development of children and adolescents. The composition includes buttermilk, DHA, neuroassociated lipids, and prebiotics, and may optionally be combined with one or more of the following ingredients: lactoferrin, short-chain fatty acids, and vitamin B12. In certain embodiments, the composition further contains fats or lipids, carbohydrates, and proteins or protein-equivalent sources.

[0021] CN102670563A describes a soft capsule whose shell consists primarily of pullulan mixed with various biological or algal polysaccharides. After several processing steps, this mixture is formed into a film, which is then formed into soft capsules using a rotary film forming process. The resulting capsules exhibit comparable properties to gelatin capsules in terms of transparency, elasticity, and mechanical strength, and disintegrate completely within the specified time. However, the high cost of pullulan is a disadvantage, leading to high production costs and hindering the economical substitution of gelatin capsules. Furthermore, the drying time of the capsule shell is long, requiring 10–18 hours at 60–70 °C, which significantly limits production efficiency.

[0022] CN109222075A relates to a process for the production of DHA-phosphatidylserine soft capsules, wherein the capsule core comprises 60 parts algal oil DHA, 40 parts phosphatidylserine, 40 parts taurine, and 160 parts walnut oil. The capsule shell consists of 40-60 parts gelatin, 10-15 parts glycerin, 40-60 parts purified water, and 5-10 parts antioxidant powder. The invention is intended to improve memory performance and promote the visual acuity of users.

[0023] The current state of the art reveals that existing DHA formulations are either primarily geared towards the cardiovascular health of adults, predominantly use animal gelatin or biopolysaccharides as capsule material, or are limited to nutrient compositions for infants without comprehensively considering the stability of the formulation, the absorption rate in the body, or the encapsulation system. To date, no publication exists that simultaneously considers the adaptability, safety, stability, and absorption efficiency of DHA formulations for infants and develops a DHA supplement that better meets the nutritional characteristics and safety requirements of infant development.

[0024] Furthermore, most studies focus exclusively on DHA intake or on individual lipid forms, thus failing to adequately address the limited absorption and utilization efficiency of DHA in infants. By simultaneously optimizing the molecular positional distribution of DHA in the formulation, specifically positioning DHA at the sn-2 position of the triglyceride, and by introducing lecithin as a lipid carrier and emulsion system, a synergistic effect can be achieved across multiple phases, including digestive stability, micelle formation, intestinal absorption, systemic transport, and tissue utilization. This better adapts the formulation to the physiological characteristics of lipid digestion and utilization in infants.Such systematic applications of combined optimization of structured lipids and carrier lipids for DHA are still limited in the state of the art and require further improvement.

[0025] In general, DHA is primarily obtained from a diet rich in α-linolenic acid (α-LNA; 18:3 ω-3), as well as from fish and algae products. However, the conversion of α-LNA to DHA in the human body is inefficient and insufficient to meet requirements, particularly in pregnant women, individuals with liver disease, or patients with maple syrup urine disease. Clinical studies show that infants receiving only α-LNA but no DHA cannot maintain adequate DHA concentrations in the brain during the first six months of life. The conversion of α-LNA to DHA is also extremely low in newborns. In parallel, with the development of agriculture and the food industry, the population's fat intake has shifted from marine oils and α-LNA-rich oils (e.g., flaxseed oil) to ω-6-rich oils (e.g., omega-3).Soybean oil, palm olein, and corn oil) as well as saturated fats have shifted, further reducing the intake of omega-3 fatty acids and decreasing the DHA content in breast milk. For this reason, modern foods increasingly contain added fish oil, algae oil, and DHA-rich structured lipids (SL) to provide a direct source of DHA.

[0026] DHA is primarily ingested through diet or supplements. Natural sources include algae, deep-sea fish (e.g., salmon, cod, sardines), certain freshwater fish, and fortified foods such as DHA-enriched milk or eggs. Particularly stringent safety requirements apply to DHA sources for specific groups such as infants, pregnant women, and breastfeeding mothers. Currently, DHA raw materials used in food and dietary supplements are mainly derived from fish oil or algal oil, which vary considerably in terms of origin, purity, safety, and suitability for specific target groups.

[0027] Fish oil DHA is predominantly extracted from the fatty tissue of deep-sea fish, with the DHA originally derived from microalgae or phytoplankton ingested by the fish through the food chain. Algal oil DHA, on the other hand, is extracted directly from DHA-producing microalgae (e.g., Schizochytrium species) and thus represents a primary source in the food chain. This difference directly impacts the risk of potential contaminants accumulating in the final product.

[0028] Deep-sea fish can accumulate environmental contaminants such as mercury, cadmium, lead, polychlorinated biphenyls (PCBs), and dioxins through the food chain during their growth. Although modern fish oil processing technologies like molecular distillation reduce these risks, a natural exposure of the raw materials remains. In contrast, algal oil DHA is produced in controlled, closed fermentation systems, allowing for better control of raw material origin and contamination risks, and meeting stricter safety requirements for infants, pregnant women, and breastfeeding mothers.

[0029] Regarding compositional stability and formulation adjustments, fish oil DHA typically also contains eicosapentaenoic acid (EPA). While EPA is important for the cardiovascular health of adults, it is not essential for infants, and excessively high EPA levels can impair the metabolic utilization of DHA. In contrast, algal oil DHA is characterized by a high DHA content with very low or undetectable EPA levels, thus better meeting the structural requirements of infants.

[0030] Fish oil DHA often has a pronounced fishy odor and tends to develop unpleasant smells upon oxidation, which can negatively impact acceptance and compliance in infants. Algal oil DHA typically has a milder odor and better oxidative stability, making it easier to optimize the taste.

[0031] Therefore, fish oil DHA is more suitable for adult nutrition, while algal oil DHA offers greater safety and better application adaptability for infants, as well as pregnant and breastfeeding women. Taking into account the specific needs of infants aged 0-3 years and pregnant and breastfeeding women, the present invention uses highly purified algal oil as a DHA source.

[0032] In addition to ensuring a safe source of DHA, the other components of a brain-supporting nutritional formulation for infants must also meet high safety standards, including the capsule material. Capsules are widely used due to their ability to effectively encapsulate the product, seal it from air, and improve ease of administration. In existing capsule preparations, the capsule shell is predominantly made of gelatin, which is derived from animal hides and bones. While gelatin capsules are well-established for adults, there are limitations regarding material properties and physiological tolerability in infants.

[0033] Infants have an immature digestive and immune system with lower gastric acid secretion and reduced pepsin and trypsin activity. Therefore, the digestion of gelatin is limited, and its dissolution in the gastrointestinal tract may be delayed or incomplete, increasing the digestive burden. Furthermore, animal protein residues can pose potential immunological reactions or allergy risks.

[0034] Furthermore, animal-derived gelatin sources raise questions regarding animal disease control, traceability, and acceptance among various consumer groups. With increasing safety requirements for infant products, the use of animal-derived raw materials is being viewed with growing skepticism.

[0035] In contrast, plant-based starch capsule shells are based on polysaccharides such as tapioca, corn, or potato starch and are produced through physical or mild chemical modification. They contain no animal proteins and are enzymatically broken down in the digestive tract similarly to dietary carbohydrates, which better corresponds to the physiological needs of infants.

[0036] Regarding capsule disintegration and drug release, plant-based starch capsules exhibit gentle swelling and disintegration, thus preventing sudden high drug concentrations in the gastrointestinal tract. Gelatin capsules, on the other hand, can collapse rapidly in an acidic environment and are more dependent on individual gastric conditions.

[0037] Furthermore, infant capsules often contain lipophilic ingredients such as DHA, algae oil, or fish oil. Plant-based starch capsules exhibit less sensitivity to lipid migration and retain their physical stability better, while gelatin capsules can alter their properties upon prolonged contact with oils.

[0038] From a safety and purity perspective, the production of plant starch capsules generally does not require prolonged treatment with strong acids or alkalis, which allows for better control of impurities and residues. This increases their suitability for infant nutrition.

[0039] In summary, gelatin-based capsule shells for infant formula have limitations regarding digestibility, immunological safety, oil compatibility, and animal origin. Plant-based starch capsules offer significant advantages in this respect, although further optimization is still needed in this area.

[0040] Besides ensuring the safety of the DHA source, the absorption and utilization efficiency of DHA in infants must be guaranteed. In existing DHA preparations, DHA is usually present as triglycerides or fatty acid ethyl esters, often with a random positional distribution within the triglyceride molecule. Due to the immature digestive physiology of infants, these forms can limit actual DHA utilization.

[0041] Depending on the oil source, DHA can be present at different positions (sn-1, sn-2, or sn-3) of the triglyceride. In existing products, this distribution is mostly random. Due to physiological differences in lipid digestion in infants, there is still potential for optimization regarding absorption and utilization efficiency.

[0042] In infants, pancreatic lipase activity and bile acid secretion are reduced. Pancreatic lipase preferentially hydrolyzes fatty acids at the sn-1 and sn-3 positions, while fatty acids at the sn-2 position remain as 2-monoacylglycerol (2-MAG). This structure is efficiently absorbed, re-esterified, and transported in chylomicrons. In contrast, fatty acids from the sn-1 or sn-3 positions are released as free fatty acids, the absorption of which is limited in infants. Therefore, DHA at the sn-2 position is more bioavailable than randomly distributed DHA.

[0043] Furthermore, DHA is predominantly located at the sn-2 position in neuronal cell membranes and retinal phospholipids. In human milk fat, DHA is also present at the sn-2 position at approximately 52.63%–65.15%, which corresponds to the natural absorption physiology of infants.

[0044] However, most current recommendations only consider total DHA intake and not its positional distribution. Targeted enrichment of DHA at the sn-2 position can improve digestive stability and bioavailability without increasing the dosage, thereby better meeting the structural lipid requirements of infants.

[0045] To improve the actual absorption efficiency and utilization stability of DHA in the bodies of infants and young children, in addition to optimizing the structural position of DHA in the triglyceride molecule during the manufacturing process and synthesis of oils with a high content of sn-2-positioned DHA, suitable carrier lipids can also be sought to further increase the absorption and utilization of DHA.

[0046] As a highly hydrophobic, long-chain fatty acid, the digestion and absorption of DHA in the gastrointestinal tract depends not only on the activity of lipases, but also to a large extent on the emulsification state of the lipids in the digestive juices and the efficiency of mixed micelle formation. With insufficient emulsification or low micelle formation efficiency, DHA is often present as larger fat droplets, which restricts contact with digestive enzymes and bile salts, thus impairing its solubility and subsequent absorption. In existing DHA preparations, it is difficult to effectively improve the physical dispersion of DHA in the intestinal environment without a suitable lipid carrier system.

[0047] Lecithin is a group of natural phospholipids whose main component is phosphatidylcholine. Due to its amphiphilic molecular structure with hydrophilic head groups and hydrophobic fatty acid chains, lecithin exhibits excellent surface-active properties. During intestinal absorption, the formation of mixed micelles is a crucial step for lipid uptake. Lecithin can bind to the surface of DHA fat droplets, reducing the oil-water interfacial tension and thus forming an emulsion system with smaller and more uniformly distributed droplet sizes. This increases the contact area between the fat droplets and the lipases and bile salts, which promotes the formation of mixed micelles.Furthermore, lecithin, together with bile salts, monoacylglycerides and fatty acids, can be involved in the structuring of mixed micelles, increasing their stability and lipid carrying capacity, thus enabling DHA in dissolved form to more easily reach the intestinal epithelial cells and be absorbed.

[0048] Furthermore, lecithin, as an essential structural component of cell membranes and lipoproteins, plays a crucial role in transmembrane lipid transport and intracorporeal transport. After lipids are absorbed by intestinal epithelial cells, fatty acids and monoacylglycerides must be reassembled into triglycerides and packaged into chylomicrons. As a key component of the phospholipid layer of chylomicrons, lecithin can contribute to its structural stability and formation, thereby promoting the lipoprotein transport of DHA in the body. This pathway allows DHA to enter the bloodstream more efficiently and participate in further tissue distribution.

[0049] From a tissue utilization perspective, DHA is primarily involved in the formation of cell membrane phospholipids, with lecithin itself being a significant source of membrane phospholipids. In systems where DHA is present alongside lecithin, it can be more readily integrated into phospholipid metabolism, creating favorable conditions for its involvement in cell membrane repair. This synergistic effect results in the body's utilization pathway more closely resembling natural physiological lipid metabolism.

[0050] Therefore, the present invention not only increases the absorption rate of DHA by increasing the proportion of sn-2-positioned DHA structural lipid in the algal oil, but also introduces lecithin as a carrier lipid into the DHA capsule formulation to achieve a scientifically sound combination with DHA. This positively influences the digestive and intracorporeal utilization process of DHA at several levels, including emulsification and dispersion, mixed micelle formation, intestinal absorption, lipoprotein transport, and cell membrane phospholipid metabolism, and provides an effective technical approach for improving the absorption adaptation and utilization stability of DHA in existing preparations.

[0051] According to the present invention, the soft capsule product comprises a capsule core and a capsule shell, wherein the capsule core is enclosed in the plant-based capsule shell. The capsule core comprises the following raw materials: DHA algal oil, lecithin, and lemon oil; the capsule shell comprises the following raw materials: plant starch, glycerin, and purified water.

[0052] As is known to those skilled in the art, a suitable dosage depends on various factors, such as body weight, age, sex, and stage of growth and development. The dosage regimen also depends on the dose, the user's general state of health, and any other medications taken concurrently. Therefore, taking these factors into account, a suitable dosage regimen for the composition according to the invention can be determined by consulting a physician.

[0053] According to the present invention, the capsule core of the soft capsule comprises the following raw materials in mass proportions: 200-300 parts DHA algae oil, 10-50 parts lecithin and 5-20 parts lemon oil; The capsule shell comprises the following raw materials in mass proportions: 100-200 parts vegetable starch, 20-70 parts glycerin and 10-50 parts purified water.

[0054] In a further preferred embodiment, the capsule core according to the present invention comprises 240-260 parts DHA algal oil, 10-20 parts lecithin and 5-10 parts lemon oil; The capsule shell comprises the following raw materials in mass proportions: 140-160 parts vegetable starch, 40-70 parts glycerin and 10-30 parts purified water.

[0055] According to the present invention, the active ingredients include, but are not limited to, the components mentioned above.

[0056] According to the present invention, the content of the aforementioned active components corresponds to the amount provided by a minimal independent packaging unit of the product. The typical daily intake is 1-2 such minimal independent units.

[0057] According to the present invention, the algal oil must be obtained from Schizochytrium, wherein the proportion of sn-2-DHA in the total 2-monoacyl fatty acids is above 80%.

[0058] According to the present invention, the lecithin must be sunflower lecithin and not soy lecithin in order to avoid the risk of soy allergens.

[0059] According to the present invention, the starch used for the capsule shell must be of vegetable origin and be selected from one or a combination of the following starches: rice starch, maize starch, tapioca starch, sweet potato starch, wheat starch and mung bean starch, with maize starch or tapioca starch being preferred.

[0060] In one embodiment, the manufacturing steps of the soft capsule comprise the following steps: Step 1: Production of the capsule core The raw materials for the capsule core are weighed according to the recipe ratio and mixed completely to obtain a ready-to-use capsule core. Step 2: Production of the capsule shell Vegetable starch, glycerin, and purified water are weighed in the specified ratio, placed in a container, and heated to 45–75 °C with intensive stirring to obtain a gel-like mass. This is then degassed under a vacuum of -0.05 to -0.1 MPa, followed by filtration to obtain a gel mass, which is stored at 50–70 °C for further use. Step 3: Shaping, fixing and drying The prepared filling solution and gel mass are processed using a capsule press, producing soft capsules by roll forming. The formed soft capsules are then dried and fixed in a fixing drum unit using hot air. Afterwards, the soft capsules are placed on drying trays and dried at a temperature of ≤30 °C and a relative humidity of ≤50% for 8–24 hours, during which time the water content of the capsule shell is adjusted to 15–25% to obtain the finished soft capsule product. Cited patent literature WO2009009040A2

[0018] EP4233906NWA2

[0019] US 10,582,714 B2

[0020] CN102670563A

[0021] CN109222075A

[0022] Cited non-patent literature [1] “Expert Consensus on DHA Supplementation for Pregnant Women and Infants in China”. [2] Relative content of sn-2: Enzymatic synthesis of the sn-2 position rich in DHA in medium and long chain structural lipids. „Research on Nutritional Components of Maternal Plasma and Breast Milk“. [3] Christensen M S .Intestinal absorption and lymphatic transport of eicosapentaenoic (EPA), docosahexaenoic (DHA), and decanoic acids: dependence on intramolecular triacylglycerol structure.[J].Am. J. Clin. Nutr, 1995, 61(1):56. [4] Sugasini D , Yalagala P , Goggin A ,et al.Enrichment of brain docosahexaenoic acid (DHA) is highly dependent upon the molecular carrier of dietary DHA: lysophosphatidylcholine is more efficient than either phosphatidylcholine or triacylglycerol.[J].The Journal of nutritional biochemistry, 2019, 74:108231. [5] Suzanne J ,Meldrum,Nina,et al.Effects of high-dose fish oil supplementation during early infancy on neurodevelopment and language: a randomised controlled trial.[J].The British journal of nutrition, 2012. [6] Visual Acuity and Fatty Acid Status of Term Infants Fed Human Milk and Formulas with and without Docosahexaenoate and Arachidonate from Egg Yolk Lecithin [7] Ryan AS , Nelson EB .Assessing the Effect of Docosahexaenoic Acid on Cognitive Functions in Healthy, Preschool Children: A Randomized, Placebo-Controlled, Double-Blind Study[J].Clinical Pediatrics, 2008, 47(4):355-62. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2009009040A2 [0018, 0060] EP 4233906 [0019, 0060] US 10,582,714 B2 [0020, 0060] CN 102670563A [0021, 0060] CN 109222075A [0022, 0060] Zitierte Nicht-Patentliteratur

[0000] Expert Consensus on DHA Supplementation for Pregnant Women and Infants in China

[0060] Relative content of sn-2: Enzymatic synthesis of the sn-2 position rich in DHA in medium and long chain structural lipids. „Research on Nutritional Components of Maternal Plasma and Breast Milk

[0060] Christensen M S .Intestinal absorption and lymphatic transport of eicosapentaenoic (EPA), docosahexaenoic (DHA), and decanoic acids: dependence on intramolecular triacylglycerol structure.[J].Am. J. Clin. Nutr, 1995, 61(1):56

[0060] Sugasini D , Yalagala P , Goggin A ,et al.Enrichment of brain docosahexaenoic acid (DHA) is highly dependent upon the molecular carrier of dietary DHA: lysophosphatidylcholine is more efficient than either phosphatidylcholine or triacylglycerol.[J].The Journal of nutritional biochemistry, 2019, 74:108231

[0060] Suzanne J ,Meldrum,Nina,et al.Effects of high-dose fish oil supplementation during early infancy on neurodevelopment and language: a randomised controlled trial.[J].The British journal of nutrition, 2012

[0060] Visual Acuity and Fatty Acid Status of Term Infants Fed Human Milk and Formulas with and without Docosahexaenoate and Arachidonate from Egg Yolk Lecithin

[0060] Ryan A S , Nelson E B .Assessing the Effect of Docosahexaenoic Acid on Cognitive Functions in Healthy, Preschool Children: A Randomized, Placebo-Controlled, Double-Blind Study[J].Clinical Pediatrics, 2008, 47(4):355-62

[0060]

Claims

A soft capsule containing algal oil DHA, the composition comprising a capsule core and a capsule shell, wherein the capsule core contains the active ingredient and is enclosed in a vegetable capsule shell, characterized in that the capsule core comprises algal oil, lecithin and lemon oil and the capsule shell comprises vegetable starch, glycerin and purified water, wherein a stable lipid system is formed by a synergistic design of a high content of sn-2-positioned DHA (structural lipid) and lecithin as a carrier lipid in the capsule contents, which promotes the emulsification, transport and absorption of DHA in the gastrointestinal tract and thereby increases its bioavailability. Soft capsule containing algal oil-DHA according to claim 1, characterized in that the capsule core comprises the following raw materials in mass fractions: 200-300 parts DHA algal oil, 10-50 parts lecithin and 5-20 parts lemon oil; and that the capsule shell comprises the following raw materials in mass fractions: 100-200 parts vegetable starch, 20-70 parts glycerin and 10-50 parts purified water. Soft capsule containing algal oil-DHA according to claim 1, characterized in that the capsule core comprises the following raw materials in mass fractions: 240-260 parts DHA algal oil, 10-20 parts lecithin and 5-10 parts lemon oil; and that the capsule shell comprises the following raw materials in mass fractions: 140-160 parts vegetable starch, 40-70 parts glycerin and 10-30 parts purified water. Soft capsule containing algal oil DHA according to claim 1, characterized in that the algal oil is obtained from Schizochytrium and the proportion of sn-2-DHA is more than 80% of the total 2-monoacyl fatty acids. Soft capsule containing algal oil DHA according to claim 1, characterized in that the lecithin is sunflower lecithin and does not contain soy lecithin in order to avoid the risk of soy allergens. Soft capsule containing algal oil DHA according to claim 1, characterized in that the starch used for the capsule shell is either corn starch or tapioca starch.