CN111567805A - Water-soluble haematococcus pluvialis astaxanthin soft capsule and preparation method thereof - Google Patents
Water-soluble haematococcus pluvialis astaxanthin soft capsule and preparation method thereof Download PDFInfo
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- CN111567805A CN111567805A CN202010549666.8A CN202010549666A CN111567805A CN 111567805 A CN111567805 A CN 111567805A CN 202010549666 A CN202010549666 A CN 202010549666A CN 111567805 A CN111567805 A CN 111567805A
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- Prior art keywords
- astaxanthin
- water
- haematococcus pluvialis
- capsule
- soft capsule
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Abstract
The invention discloses a water-soluble haematococcus pluvialis astaxanthin soft capsule and a preparation method thereof, wherein the capsule wall of the astaxanthin soft capsule comprises, by mass, 100 parts of gelatin, 6 parts of citric acid, 20 parts of glycerol, 4 parts of sodium carboxymethylcellulose, 10 parts of sorbitol and 11-13 parts of water, and the capsule core comprises, by mass, 10.0-1, 8.0 parts of haematococcus pluvialis astaxanthin oil, 10.0-8.0 parts of polyethylene glycol-40010.0-20.0 parts of monodiglycerol unsaturated fatty acid ester, 20.0-40.0 parts of sorbitol and 30.0-45.0 parts of decaglycerol monooleate. The invention completely adopts auxiliary materials used by health food according to production requirements, the emulsifier is an unsaturated fatty acid processed product, and the product is safe, non-toxic, healthy, safe and low in risk, is suitable for a human gastrointestinal aqueous nutrition absorption system, and can improve the bioavailability of the astaxanthin serving as an active ingredient.
Description
Technical Field
The invention relates to a haematococcus pluvialis astaxanthin soft capsule preparation and a preparation method thereof, in particular to a water-soluble haematococcus pluvialis astaxanthin soft capsule and a preparation method thereof.
Background
Astaxanthin (Astaxanthin) belongs to the group of oxygen-containing carotenoids (xanthophyls), a carotenoid containing a keto group. The molecular formula is C40H52O4The relative molecular mass is 596.86, and the semi-systematic name (IUPAC) is 3, 3-Dihydroxy- β -carotene-4,4 ' -dione (3,3 ' -Dihydroxy- β -carotene-4,4 ' -dione).
Astaxanthin molecule has beta end group at two ends (figure 1), contains hydroxyl and keto group, and its central polyolefin chain contains 9 double bonds, which can form various cis-trans isomers (E/Z isomer), but most of them are All trans isomers (All E-isomer) in nature. In addition, astaxanthin has a chiral center at each of the 3 and 3' positions, and thus has three optical isomers. Among astaxanthin of common sources, haematococcus pluvialis is sourced from 3S, 3 'S isomers, Phaffia rhodozyma is sourced from 3R, 3' R isomers, and artificially synthesized is a mixture of three isomers.
The melting point of the pure astaxanthin is 216 ℃, the boiling point is 774 ℃, and the density is 1.071g/mL at 25 ℃ under the condition of 100 KPa. Astaxanthin is insoluble in water, can be dissolved in most organic reagents, and has good lipid solubility. Since it is an oxygen-containing carotenoid and has a strong polarity, the saturated solubility in polar organic reagents is high. At 25 ℃ and 100KPa, the saturated solubility of astaxanthin in four solvents of dichloromethane, chloroform, dimethyl sulfoxide and acetone is respectively 30g/L, 10g/L, 0.5g/L and 0.2 g/L. The conjugated polyalkylene structure in the astaxanthin molecule is its chromophore and absorbs blue light, which makes its crystalline and dilute solution deep red under visible light.
Astaxanthin molecules contain a long conjugated unsaturated double bond structure, so that the structure of astaxanthin is easily damaged by light, heat and oxides. However, the structure also enables the astaxanthin to have strong oxidation resistance, and particularly, the astaxanthin in a free state can greatly quench active oxygen. Astaxanthin is soluble in complex lipoproteins and is partially adsorbed to fats, and the hydroxyl and keto groups on the ionone ring in the molecule allow it to form astaxanthin mono-or diesters with fatty acids and have greater lipophilicity. Astaxanthin in free form forms a blue-gray complex with proteins, and when heated, astaxanthin is liberated and appears red.
Haematococcus pluvialis contains about 40,000mg/kg astaxanthin, which is the biological resource known to have the highest level of astaxanthin accumulation in nature at present, and is the most major and best source of natural astaxanthin at present. The astaxanthin contained therein is present in the form of esters and is predominantly monoester. The dried algal powder may contain more than 40g astaxanthin per kg of dried algal powder, which accounts for more than 90% (w/w) of the total carotenoid content.
Most of the natural astaxanthin resources exist in the form of esters, so that the preparation process must include two steps of extraction and hydrolysis in order to obtain natural astaxanthin in a free state. The extraction method of astaxanthin can adopt an organic solvent extraction method or a supercritical carbon dioxide fluid extraction method. There are many reports on the research work of extracting carotenoid by using organic solvent, and the use of water-soluble polar organic solvent and water-insoluble non-polar organic solvent has both advantages and disadvantages. The hydrolysis of astaxanthin esters using ordinary saponification conditions is not satisfactory for the production. This is because astaxanthin ester is saponified under strong alkaline and aerobic conditions to produce a large amount of astacin and semiastacin, and the biological function of astacin is significantly different from that of astaxanthin. For this purpose, astaxanthin esters can be used as such. In the mammalian digestive tract, there is a set of enzyme systems that hydrolyze astaxanthin esters without producing by-products, and the resulting free astaxanthin molecules enter the transport system of the body. Therefore, people can directly take the astaxanthin ester to achieve the aim of supplementing astaxanthin. The bioavailability of astaxanthin esters is a concern during this nutritional process.
Astaxanthin has powerful biological functions, mainly including antioxidation, light protection, anticancer, immunity enhancement, eye health maintenance, central nervous system health maintenance, etc.
In vitro experiments prove that astaxanthin is an extremely effective antioxidant and has strong quenching capacity to singlet oxygen. The research result shows that: astaxanthin quenches singlet oxygen at a rate 80 times that of vitamin E. Astaxanthin also inhibits lipid peroxidation, which is 10 times that of beta-carotene and 100 times that of vitamin E. Astaxanthin has strong antioxidant capacity, and may have positive effects on cardiovascular diseases, immune system, inflammation, nerve degeneration, etc. Astaxanthin also has potential for anti-aging, as enhancing antioxidant mechanisms and inhibiting free radical production are thought to be approaches to protecting against oxidative damage, reducing the rate of aging in biological pathways. At the same time, it can activate insulin signal channel and up-regulate FOXO3 gene.
Research has demonstrated that astaxanthin is able to protect the skin of salmon from uv damage, suggesting that astaxanthin has the potential to be an edible photoprotective agent. Meanwhile, there is a study to support a hypothesis: astaxanthin protects human tissues from oxidation and UV damage by inhibiting NF- κ B activation.
The research shows that the astaxanthin fed to rats and mice has antiproliferative effect and immunity strengthening effect on epithelial cells exposed to carcinogen, and a dose-effect relationship exists. Astaxanthin has significant inhibitory effect on mouse bladder cancer, rat oral cancer, colon cancer, and gastric cancer. Astaxanthin also has a good effect on reducing the number and volume of aflatoxin-induced liver tumor cells. Oral administration of astaxanthin also inhibits the growth of breast cancer.
Astaxanthin has obvious immunoregulation effect and can be used as immunopotentiator. When the mouse thymus is stimulated by antigen (TDAg), astaxanthin can obviously increase the quantity of mouse immunoglobulin M (IgM) and immunoglobulin G (IgG), and the effect of astaxanthin is obviously higher than that of lutein. Meanwhile, the astaxanthin also has stronger effect on enhancing the release of interleukin-I and tumor necrosis factor alpha by mice than beta-carotene and canthaxanthin. In the presence of antigen, astaxanthin can also remarkably promote spleen cells to generate antibody and increase the production of immunoglobulin of white blood cells.
When blue light acts on human retina, singlet oxygen and oxygen free radicals generated by photo-oxidation can cause peroxidative damage to polyunsaturated fatty acids contained in the retina. In clinic, supplementing carotenoid by diet can help retina quench active oxygen, resist oxidative damage and treat degenerative macular degeneration. Astaxanthin, one of carotenoids, can enter the eyeground through the blood brain barrier, effectively prevent retinal oxidation and photoreceptor cell damage, and has good effects of treating degenerative macular degeneration and protecting retinal function.
The central nervous system is rich in unsaturated fatty acid, has high metabolic activity, and is easily damaged by oxidation, thereby causing various nervous system diseases. Astaxanthin protects the central nervous system, especially the brain and the spinal column. It can be used for treating central nervous system diseases such as ischemic reperfusion injury, spinal cord injury, Parkinson's syndrome, and senile dementia.
Astaxanthin can be taken orally, has low toxicity, and has no report of toxic symptoms.
In the united states, astaxanthin has been approved by the FDA as a mixed colorant in fish feed since 2009 and has been approved for use as a single colorant in a variety of animal feeds. Haematococcus pluvialis meal (21CFR 73.185) and Rhodotorula farinosa (21CFR 73.355) were approved in 2000 for use in fish feed to color salmon. In addition, natural astaxanthin has also passed FDA's "generally safe GRAS" certification, but is severely restricted for use in animal feed.
Astaxanthin is approved as a new food resource in the European Union (ECNo.258/97) and is recognized as a raw material for dietary supplements. Since 1997, five foods have been produced in the eu with astaxanthin, and the astaxanthin raw material in each product was certified substantially equivalent to the approved astaxanthin new food source.
In China, astaxanthin was approved as a feed additive in 2009 at feed additive 10% astaxanthin (GB/T23745-2009). Haematococcus pluvialis (Haematococcus pluvialis) was approved as a new food resource by the national food and drug administration in the new resource evaluation in 2010 (No. 17 publication in 2010), and the daily recommended intake dry weight was not more than 0.8g, but the use range did not include infant food.
The addition of natural astaxanthin to the nutritional supplement is of great practical significance for improving human health. However, the property of astaxanthin that astaxanthin is easily oxidized and degraded and is insoluble in water seriously influences the bioavailability of astaxanthin, and the use of astaxanthin in medicine and food formulations is limited. Researchers have been working around the problem of improving the water solubility and stability of astaxanthin over the last 30 years to try to utilize a solution to chemically modify the water solubility of astaxanthin.
The Chinese invention patent CN 101367837B discloses a novel astaxanthin derivative, in particular to an astaxanthin phosphate derivative and a preparation method thereof. The derivative has enhanced water solubility, and can be used in the fields of medicines, health-care foods and the like.
The Chinese invention patent CN 105646869B also discloses a water-soluble astaxanthin derivative, in particular to an astaxanthin succinate PEG derivative and a preparation method thereof. The astaxanthin succinic diester PEG derivative prepared by the invention has good water solubility, greatly improves the application range of astaxanthin, can be used as a food additive to be applied to meat products and aquatic products, can be used in cosmetics and medical products due to good antioxidation, can also be used as a functional factor to be added into health-care food, and the like.
However, since the U.S. Food and Drug Administration (FDA) prohibits chemically synthesized astaxanthin from entering the food and dietary supplement market, synthetic astaxanthin and derivatives thereof are mainly used in the fields of cultivation and daily chemicals.
The physical embedding of astaxanthin by using water-soluble molecules can solve the application defects of insolubility of astaxanthin in water and poor stability, and the key point is to improve the encapsulation rate of the hydrophilic micro/nano-carrier to astaxanthin. Various micro/nano encapsulation technologies have been reported to be used for preparing astaxanthin products soluble in water, such as coacervation phase separation technology, host-guest inclusion complex technology, nano precipitation, emulsion solvent volatilization technology, supercritical fluid technology, microcapsule embedding technology, and the like.
The soft capsule is prepared by directly encapsulating a certain amount of liquid medicine, or dissolving or dispersing solid medicine in a suitable excipient to obtain a solution, suspension, emulsion or semisolid, and sealing in a spherical or elliptical soft capsule material.
Soft capsules have significant advantages: (1) the liquid oily substance can be directly encapsulated without using additives such as adsorption and encapsulation, and the soft capsule oily substance content is 60-85 wt%, and the content is below 50% like the encapsulated substance. (2) When the coating is made of thick gelatin, it can be sealed completely airtight, and the capsule has high strength and high film blocking property, and the content can be kept stable for a long period of time. The gelatin film was found to have an oxygen barrier property more than 30 times that of the polyethylene film. Is stable to oxygen in the air, and can prevent the air from oxidizing and absorbing moisture. (3) After being taken, the contents are quickly released, and the in vivo utilization rate and the absorption rate are high. (4) The content uniformity is good, and the content deviation is very low. (5) Can cover the peculiar smell and peculiar smell of some contents, and is particularly suitable for functional health foods and medicinal products. Because of its different nature from general food, it has many peculiar smell and peculiar smell components. (6) The taste, color, fragrance, transparency and glossiness of the capsule skin membrane can be freely selected, and compared with other round products, the capsule skin membrane has good appearance luster and is attractive. (7) A round airtight container is a clean type container in which foreign matter is not mixed when the container is circulated after the container is manufactured. (9) The soft capsule is made of gelatin, glycerin and water, and is edible natural product.
Chinese patent CN 106923334A, CN 108902958A, CN 109349553A and CN 109481416A both disclose an astaxanthin soft capsule. However, in these soft capsule preparations, the capsule core content is a fat-soluble composition or a fat-soluble suspension composition, which is not dispersed in water and aggregated into oil drops, thus being not beneficial to transportation and absorption of the gastrointestinal aqueous nutrition absorption system of human body.
The Chinese patent CN103011282A discloses an astaxanthin self-emulsifying soft capsule preparation and a preparation method thereof, wherein the astaxanthin self-emulsifying soft capsule preparation comprises the following components in percentage by mass: astaxanthin raw material: oil phase: emulsifier: the auxiliary emulsifier is 1: 20-60: 10-70: 0: 30; the oil phase adopts natural vegetable oil or fatty acid ester, the emulsifier adopts nonionic emulsifier, the auxiliary emulsifier adopts medium-chain alcohol or short-chain alcohol, and the self-emulsifying agent can be self-emulsified in vivo after being taken orally. The patent adopts a large amount of nonionic active agents, and auxiliary materials in the auxiliary material catalog and use regulation of health food records have large health safety risks and are not in accordance with the auxiliary material use regulation of health food, and secondly, the astaxanthin raw material is astaxanthin, so that the suspicion of using synthetic astaxanthin also exists and the method is not in accordance with the regulation.
The Chinese invention patent CN 107050066A discloses an astaxanthin-kelp self-emulsifying soft capsule and a preparation method and application thereof, and the weight percentages of the components are as follows: 0.1-5% of astaxanthin, 0.2-8% of kelp extract, 18-63% of nonionic surfactant, 2-5% of cosurfactant and 100% of olive oil supplement; the nonionic surfactant is tween 85 and nonylphenol polyoxyethylene ether np-40; the weight ratio of the two is 1: 10-10: 1; the cosurfactant is one or a mixture of two of glycerol and polyethylene glycol. The surfactant containing polyoxyethylene has the defect of hemolysis caused by the dissolution of erythrocyte membranes, is used in large amount, does not meet the regulation of 'catalogue of auxiliary materials and use regulations of health food records', and has the suspicion that astaxanthin is used as a raw material of astaxanthin, and the use of synthetic astaxanthin is illegal.
Chinese patent CN 109893513A the invention discloses a composite Haematococcus pluvialis astaxanthin self-emulsifying soft capsule, a preparation method and application thereof. The soft capsule comprises a capsule core and a capsule wall, wherein the capsule core contains haematococcus pluvialis astaxanthin or an extract thereof, vegetable oil, an emulsifier, an auxiliary emulsifier and an antioxidant. This patent adopts haematococcus pluvialis astaxanthin as the astaxanthin monomer, and the astaxanthin monomer is unstable, probably has the pollution of isomerism, oxidation or degradation product, adopts haematococcus pluvialis extract, and the impurity is more, still has great health safety risk.
The use of the auxiliary materials of the health food record product should meet the relevant national standards and regulations, and the following principles must be followed: does not cause any health hazard to human body; does not aim at covering the putrefaction and deterioration of the product; the purposes of covering up the product or quality defects in the processing process or doping, adulteration and counterfeiting are not taken; the health care function and the nutritional value of the product are not reduced; the usage amount in the product is reduced as much as possible on the premise of achieving the expected effect; the processing aid is used according to the national food additive use standard of food safety (GB2760) and relevant regulations.
The use of the food form product auxiliary materials is in accordance with the relevant regulations of national food additive use Standard for food safety (GB2760) and the like; the use of "available auxiliary materials for health food records" and the food raw materials included in the use regulations (trial) thereof is allowed.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a safe, nontoxic and compliant water-soluble haematococcus pluvialis astaxanthin soft capsule which can be dispersed into oil-in-water emulsion in water and a preparation method thereof.
In order to achieve the purpose, the invention provides the following technical scheme:
a water-soluble haematococcus pluvialis astaxanthin soft capsule comprises a capsule wall and a capsule core, wherein the capsule wall is a water-soluble composition consisting of gelatin, a plasticizer and water, the capsule core is a self-emulsifying composition consisting of haematococcus pluvialis astaxanthin oil, mono-diglycerol fatty ester, polyglycerol fatty acid ester, polyethylene glycol-400 and sorbitol, an oil-in-water emulsion can be spontaneously formed in the water, the haematococcus pluvialis astaxanthin oil contains astaxanthin monoester and diester, the astaxanthin is mainly all-trans levorotation astaxanthin, the water-soluble composition plasticizer for the capsule wall is a composition consisting of glycerol, sorbitol, citric acid and sodium carboxymethylcellulose, and the water-soluble composition for the capsule wall comprises the following components in parts by weight:
the capsule core self-emulsifying composition is characterized in that the mono-diglycerol fatty ester of the capsule core self-emulsifying composition is a mono-diglycerol unsaturated fatty ester with an HLB value of 4-6, the polyglycerol fatty ester of the capsule core self-emulsifying composition is decaglycerol monooleate with an HLB value of more than 13, and the capsule core self-emulsifying composition comprises the following components in percentage by mass:
in order to enable the capsule core self-emulsifying composition to spontaneously form transparent nano emulsion in water, the components and the mass percentages thereof are preferably as follows:
the haematococcus pluvialis astaxanthin oil is preferably haematococcus pluvialis astaxanthin oil prepared by physically refining, purifying and blending artificially cultured haematococcus pluvialis extracts, wherein the mass percent of monoester in astaxanthin ester is 70-75, the mass percent of diester in astaxanthin ester is 25-30, and more than 90% of astaxanthin in occurrence state is all-trans-levorotatory astaxanthin.
Furthermore, one or more of fat-soluble vitamins, fat-soluble pigments or animal and vegetable oil with health care function can be added into the haematococcus pluvialis extract in the physical refining, purifying and blending processes to prepare haematococcus pluvialis astaxanthin oil, so that the physiological effects of the haematococcus pluvialis astaxanthin can be benefited.
The above-mentioned monodiglycerol unsaturated fatty acid ester is preferably monodiglycerol unsaturated fatty acid ester whose monoglyceride mass percentage is greater than or equal to 90.0, including one or more of monodiglycerol oleate, monodiglycerol linoleate and monodiglycerol linolenate.
The soft capsule of the water-soluble haematococcus pluvialis astaxanthin can be applied to gel candies, and is prepared by firstly preparing a soft capsule wall skin, flatly laying the soft capsule wall skin on a groove die, injecting a capsule core self-emulsifying composition, then coating another layer of soft capsule wall skin, and rolling and combining to prepare the sandwich type gel candies.
The preparation method of the water-soluble haematococcus pluvialis astaxanthin soft capsule comprises the steps of gelatin melting, pelleting, shaping, pill washing, drying, pill inspection, inspection and packaging, and also comprises the step of preparing the capsule core self-emulsifying composition under the protection of nitrogen, and the step of preparing the capsule core self-emulsifying composition sequentially comprises the following operations: firstly, accurately weighing the required components according to the requirements of the formula of the mass percent of the components, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing, then transferring the components into a high-pressure homogenizer for homogenization, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance after the homogenization, and preparing the soft capsule for use in the step of preparing the pill.
In the step of preparing the capsule-core self-emulsifying composition, the preferable process conditions are that the mixing temperature is 25-35 ℃, the mixing time is 20-30 min, the pressure of a first-stage valve of a homogenizer is 25-30 MPa, the pressure of a second-stage valve is 5-10 MPa, the homogenization is carried out for 2 times, the homogenization pressure is 25-30 MPa, the homogenization is carried out for 2 times, and the oxygen partial pressure in a mixing kettle and a storage tank is 200-300 Pa.
Compared with the prior art, the invention has the following beneficial effects:
1. the plasticizer in the soft capsule wall water-soluble composition is a composition of glycerol, sorbitol, citric acid and sodium carboxymethylcellulose, the mass parts of the plasticizer relative to 100 parts of dry gelatin are 20:10:6:4, the plasticizer composition can remarkably improve the disintegration rate of the soft capsule wall, the disintegration rate is kept within 30 minutes, the composition is similar to that of a common hollow hard capsule, the water solubility of the soft capsule wall is enhanced, meanwhile, a disintegrated substance is weakly acidic in water, the gelatin is positively charged, the transportation and absorption of a human body small intestine charged system are facilitated, the bioavailability of an active component astaxanthin in the soft capsule is improved, all components of the soft capsule wall are proper auxiliary materials used according to production requirements in health food record products and use regulations thereof, and the soft capsule wall water-soluble composition is safe, non-toxic, small in health safety risk and compliance regulations.
2. The capsule core self-emulsifying composition of the soft capsule can be self-emulsified into an oil-in-water emulsion in water, can be emulsified into a transparent nano solution by an improved scheme, is suitable for a human gastrointestinal aqueous nutrition absorption system, improves the bioavailability of the active ingredient astaxanthin of the soft capsule, is a proper amount of auxiliary materials used according to production requirements in 'available auxiliary materials for health food records and use regulations thereof', and is safe, non-toxic, low in health safety risk and compliance.
3. The capsule core self-emulsifying composition of the soft capsule adopts haematococcus pluvialis astaxanthin oil as haematococcus pluvialis astaxanthin oil prepared by physically refining and purifying artificially cultured haematococcus pluvialis extracts, wherein the mass percent of monoester in astaxanthin ester is 70-75, the mass percent of diester is 25-30, more than 90% of astaxanthin in occurrence state is all-trans-levorotation astaxanthin, deep processed astaxanthin monomers and primarily processed haematococcus pluvialis extracts are not adopted, possible isomerization, oxidation and degradation pollution in the deep processing process of astaxanthin monomers are avoided, excessive impurity influence in the primarily processed haematococcus pluvialis extracts is also avoided, the soft capsule is healthier and safer, and the biological activity of astaxanthin is more favorably exerted. The emulsifier adopted in the capsule core self-emulsifying composition is a deep-processed product of unsaturated fatty acid such as oleic acid, linoleic acid and linolenic acid, can promote the transportation and absorption of fat-soluble astaxanthin, is a high-quality source of the unsaturated fatty acid, has less dosage of the emulsifier in the narrow sense of the capsule core self-emulsifying composition, is only a co-emulsifier with the content of less than 20 percent, and has low health and safety risks.
4. According to the preparation method of the water-soluble haematococcus pluvialis astaxanthin soft capsule, the capsule core self-emulsifying composition is subjected to homogeneous mixing under the protection of nitrogen and is temporarily stored under the protection of nitrogen, and a measure of adding an antioxidant is not adopted, so that the balance of an astaxanthin oil antioxidant system is favorably maintained.
Drawings
FIG. 1 shows the molecular structure of all-trans astaxanthin.
FIG. 2 shows the molecular structures of astaxanthin monoester and diester of Haematococcus pluvialis.
Detailed Description
The invention discloses a water-soluble haematococcus pluvialis astaxanthin soft capsule, which comprises a capsule wall and a capsule core, wherein the capsule wall is a water-soluble composition consisting of gelatin, a plasticizer and water, the capsule core is a self-emulsifying composition consisting of haematococcus pluvialis astaxanthin oil, a monoglyceride and diglyceride fatty ester, a polyglycerol fatty acid ester, polyethylene glycol-400 and sorbitol, an oil-in-water emulsion can be spontaneously formed in the water, the haematococcus pluvialis astaxanthin oil contains astaxanthin monoester and diester, the astaxanthin is mainly all-trans astaxanthin, the plasticizer of the water-soluble composition on the capsule wall is a composition of glycerol, sorbitol, citric acid and sodium carboxymethylcellulose, the monoglyceride and diglyceride fatty ester of the self-emulsifying composition on the capsule core is a monoglyceride with an HLB value of 4-6, the polyglycerol fatty acid ester of the self-emulsifying composition on the capsule core is decaglycerol monooleate with an HLB value of more than 13, and the capsule wall and the capsule core components are both available auxiliary materials for health-care food record products and use regulations thereof The production needs proper amount of auxiliary materials, and the method is safe, non-toxic, low in health and safety risk and compliant with the compliance method.
The haematococcus pluvialis astaxanthin oil is preferably haematococcus pluvialis astaxanthin oil prepared by physically refining, purifying and blending artificially cultured haematococcus pluvialis extracts, wherein the mass percent of monoester in astaxanthin ester is 70-75, the mass percent of diester in astaxanthin ester is 25-30, and more than 90% of astaxanthin in occurrence state is all-trans astaxanthin. The properties are the basic characteristics of haematococcus pluvialis astaxanthin oil astaxanthin which is different from astaxanthin of other sources, such as crab leftover materials, phaffia rhodozyma and astaxanthin of an artificial synthetic source and deep-processed astaxanthin monomers, and the molecular structures of haematococcus pluvialis astaxanthin mono-ester and di-ester are shown in the attached figure 2 in detail. The astaxanthin of the haematococcus pluvialis astaxanthin oil source exists in an esterified state, is stable and easily obtained relative to an astaxanthin monomer, and has the same physiological effect.
In order to further tonify the physiological effect of haematococcus pluvialis astaxanthin, one or more mixtures of fat-soluble vitamins, fat-soluble pigments or animal and vegetable oil with health care function can be added in the physical refining, purifying and blending process of the haematococcus pluvialis extract to prepare the haematococcus pluvialis astaxanthin oil.
In order to further improve the emulsifying property of the astaxanthin oil, the mass percent of the monoglyceride in the monodiglycerol unsaturated fatty acid ester is more than or equal to 90.0.
The water soluble haematococcus pluvialis astaxanthin soft capsule can also be applied to sandwich type gel candies, and the soft capsule wall skin is prepared firstly, is laid on a groove die, is injected with a capsule core self-emulsifying composition, is then coated with another layer of soft capsule wall skin, and is rolled and combined to prepare the sandwich type gel candies.
The preparation method of the water-soluble haematococcus pluvialis astaxanthin soft capsule comprises the steps of preparing the conventional soft capsule, namely, melting gelatin, pelleting, shaping, washing, drying, detecting, inspecting and packaging, wherein the steps of melting gelatin are firstly carried out, water with the mass 0.7-1.4 times of that of dry gelatin is measured, heating is carried out, a plasticizer is added, the gelatin is completely dissolved, stirring and dissolving are carried out, negative pressure degassing is carried out, and impurities are filtered and removed, so that a gelatin solution is obtained; then making into pills by adopting a mould pressing method or a dropping method; shaping and washing the soft capsule, and drying until the water content is below 9.0 wt%; then, checking the pills and removing unqualified products; and finally, inspecting and packaging according to the product execution standard.
Because the capsule core of the water-soluble haematococcus pluvialis astaxanthin soft capsule is a self-emulsifying composition consisting of haematococcus pluvialis astaxanthin oil, mono-diglycerol fatty ester, polyglycerol fatty acid ester, polyethylene glycol-400 and sorbitol and has super oxidation resistance, the capsule core self-emulsifying composition needs to be prepared by homogenizing under the protection of nitrogen. Accurately weighing the required components according to the requirements of the formula of the mass percent of the components, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing, then putting the components into a high-pressure homogenizer for homogenization, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance after the homogenization, and preparing the soft capsule for pill making.
The present invention will be described in more detail with reference to specific examples.
Examples
Example 1
Preparing a water-soluble haematococcus pluvialis astaxanthin soft capsule
1) Capsule wall component formula (quality meter)
100 parts of gelatin, 20 parts of glycerol, 10 parts of sorbitol, 6 parts of citric acid, 4 parts of sodium carboxymethylcellulose and 110 parts of water.
2) Capsule core component formula (quality percentage)
10.0 percent of haematococcus pluvialis and shrimp freshwater vegetable oil, 20.0 percent of mono-diglycerol oleate (the mass percent of the mono-glyceride is more than or equal to 90.0 percent), 45.0 percent of decaglycerol monooleate, polyethylene glycol-40020.0 percent and 5.0 percent of sorbitol.
3) Chemical glue
Weighing water with the mass 1.1 times of that of the dry gelatin, heating, adding glycerol, sorbitol, citric acid and sodium carboxymethylcellulose required by the formula, dissolving completely, adding the gelatin required by the formula, stirring for dissolving, degassing under negative pressure, and filtering to remove impurities to obtain a gelatin solution.
4) Preparation of the core
Firstly, accurately weighing required components according to the requirements of a formula of the components by mass percent, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing the components for 25min at 30 ℃, then putting the components into a high-pressure homogenizer for homogenization, wherein the pressure of a primary valve is 25MPa, the pressure of a secondary valve is 10MPa, homogenizing the components for 2 times, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance, and the oxygen partial pressure in the storage tank is 300Pa to obtain the capsule core composition.
5) Making into pill, shaping, washing, drying, inspecting, packaging, and making into soft capsule with conventional method to obtain water soluble Haematococcus pluvialis astaxanthin soft capsule.
Randomly extracting 1 soft capsule, cutting the capsule wall, dripping the capsule core content into 150mL warm water of 35-40 ℃, and shaking lightly to obtain red emulsion.
Randomly extracting 1 soft capsule, directly putting into 150mL of warm water with the temperature of 35-40 ℃, completely disintegrating in 25 minutes, and slightly shaking to obtain red emulsion, wherein the pH of the emulsion is 4.50, 10% of Arabic gum solution is dripped into the red emulsion, the red emulsion has coacervate floccules, and the Arabic gum solution is electronegative colloid, which indicates that the emulsion is positively charged.
Example 2
Preparing a water-soluble haematococcus pluvialis astaxanthin soft capsule
1) Capsule wall component formula (quality meter)
100 parts of gelatin, 20 parts of glycerol, 10 parts of sorbitol, 6 parts of citric acid, 4 parts of sodium carboxymethylcellulose and 100 parts of water.
2) Capsule core component formula (quality percentage)
18.0 percent of haematococcus pluvialis and shrimp freshwater vegetable oil, 40.0 percent of mono-diglycerol linoleate (the mass percent of monoglyceride is more than or equal to 90.0), 30.0 percent of decaglycerol monooleate, polyethylene glycol-40010.0 percent and 2.0 percent of sorbitol.
3) Chemical glue
Weighing water with the mass of 1.0 time of that of the dry gelatin, heating, adding glycerol, sorbitol, citric acid and sodium carboxymethylcellulose required by the formula, completely dissolving, adding the gelatin required by the formula, stirring for dissolving, degassing under negative pressure, and filtering to remove impurities to obtain a gelatin solution.
4) Preparation of the core
Firstly, accurately weighing required components according to the requirements of a formula of the components by mass percent, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing the components for 30min at 30 ℃, then putting the components into a high-pressure homogenizer for homogenization, wherein the pressure of a primary valve is 30MPa, the pressure of a secondary valve is 10MPa, homogenizing the components for 2 times, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance, and the oxygen partial pressure in the storage tank is 200Pa to obtain the capsule core composition.
5) Making into pill, shaping, washing, drying, inspecting, packaging, and making into soft capsule with conventional method to obtain water soluble Haematococcus pluvialis astaxanthin soft capsule.
Randomly extracting 1 soft capsule, cutting the capsule wall, dripping the capsule core content into 150mL warm water of 35-40 ℃, and shaking lightly to obtain red emulsion.
Randomly extracting 1 soft capsule, directly putting into 150mL warm water of 35-40 ℃, completely disintegrating in 27 minutes, and slightly shaking to obtain red emulsion, wherein the pH of the emulsion is 4.60, 10% Arabic gum solution is dripped into the red emulsion, the red emulsion has coacervate floccules, and the Arabic gum solution is electronegative colloid, which indicates that the emulsion is positively charged.
Example 3
Preparing a water-soluble haematococcus pluvialis astaxanthin soft capsule
1) Capsule wall component formula (quality meter)
100 parts of gelatin, 20 parts of glycerol, 10 parts of sorbitol, 6 parts of citric acid, 4 parts of sodium carboxymethylcellulose and 120 parts of water.
2) Capsule core component formula (quality percentage)
15.0 percent of haematococcus pluvialis and shrimp freshwater vegetable oil, 16.0 percent of mono-diglycerol oleate (the mass percent of monoglyceride is more than or equal to 90.0), 16.0 percent of mono-diglycerol linoleate (the mass percent of monoglyceride is more than or equal to 90.0), 35.0 percent of decaglycerol monooleate, polyethylene glycol-40014.0 percent and 4.0 percent of sorbitol.
3) Chemical glue
Weighing water with the mass 1.2 times of that of the dry gelatin, heating, adding glycerol, sorbitol, citric acid and sodium carboxymethylcellulose required by the formula, dissolving completely, adding the gelatin required by the formula, stirring for dissolving, degassing under negative pressure, and filtering to remove impurities to obtain a gelatin solution.
4) Preparation of the core
Firstly, accurately weighing required components according to the requirements of a formula of the components by mass percent, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing the components for 25min at 30 ℃, then putting the components into a high-pressure homogenizer for homogenization, wherein the pressure of a primary valve is 25MPa, the pressure of a secondary valve is 5MPa, homogenizing the components for 2 times, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance, and the oxygen partial pressure in the storage tank is 250Pa to obtain the capsule core composition.
5) Making into pill, shaping, washing, drying, inspecting, packaging, and making into soft capsule with conventional method to obtain water soluble Haematococcus pluvialis astaxanthin soft capsule.
Randomly extracting 1 soft capsule, cutting the capsule wall, dripping the capsule core content into 150mL warm water of 35-40 ℃, and slightly shaking to obtain a red transparent solution, wherein the water-in-oil emulsion is transparent, the particle size of the emulsion is nano-scale, and the emulsion is nano-emulsion.
Randomly extracting 1 soft capsule, directly putting into 150mL of warm water with the temperature of 35-40 ℃, completely disintegrating in 30 minutes, and slightly shaking to obtain a red semitransparent emulsion, wherein the pH of the emulsion is 4.50, 10% of Arabic gum solution is dripped into the red semitransparent emulsion, the red semitransparent emulsion has coacervate floccules, and the Arabic gum solution is a negative colloid, which indicates that the emulsion is positively charged.
Example 4
Preparing a water-soluble haematococcus pluvialis astaxanthin soft capsule
1) Capsule wall component formula (quality meter)
100 parts of gelatin, 20 parts of glycerol, 10 parts of sorbitol, 6 parts of citric acid, 4 parts of sodium carboxymethylcellulose and 140 parts of water.
2) Capsule core component formula (quality percentage)
13.0 percent of haematococcus pluvialis freshwater vegetable oil, 12.0 percent of mono-diglycerol oleate (the mass percent of monoglyceride is more than or equal to 90.0), 12.0 percent of mono-diglycerol linoleate (the mass percent of monoglyceride is more than or equal to 90.0), 3.0 percent of mono-diglycerol linolenic acid ester (the mass percent of monoglyceride is more than or equal to 90.0), 40.0 percent of decaglycerol monooleate, polyethylene glycol-40014.0 percent and 4.0 percent of sorbitol.
3) Chemical glue
Weighing water with the mass 1.4 times of that of the dry gelatin, heating, adding glycerol, sorbitol, citric acid and sodium carboxymethylcellulose required by the formula, dissolving completely, adding the gelatin required by the formula, stirring for dissolving, degassing under negative pressure, and filtering to remove impurities to obtain a gelatin solution.
4) Preparation of the core
Firstly, accurately weighing required components according to the requirements of a formula of the components by mass percent, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing the components for 25min at 35 ℃, then putting the components into a high-pressure homogenizer for homogenization, wherein the pressure of a primary valve is 25MPa, the pressure of a secondary valve is 10MPa, homogenizing the components for 2 times, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance, and the oxygen partial pressure in the storage tank is 200Pa to obtain the capsule core composition.
5) Making into pill, shaping, washing, drying, inspecting, packaging, and making into soft capsule with conventional method to obtain water soluble Haematococcus pluvialis astaxanthin soft capsule.
Randomly extracting 1 soft capsule, cutting the capsule wall, dripping the capsule core content into 150mL warm water of 35-40 ℃, and slightly shaking to obtain a red transparent solution, wherein the water-in-oil emulsion is transparent, the particle size of the emulsion is nano-scale, and the emulsion is nano-emulsion.
Randomly extracting 1 soft capsule, directly putting into 150mL warm water of 35-40 ℃, completely disintegrating in 28 minutes, and slightly shaking to obtain red semitransparent emulsion, wherein the pH of the emulsion is 4.40, 10% Arabic gum solution is dripped into the emulsion, and the emulsion has coacervate floccules, and is a negative colloid, which indicates that the emulsion is positively charged.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (8)
1. A water-soluble haematococcus pluvialis astaxanthin soft capsule comprises a capsule wall and a capsule core, wherein the capsule wall is a water-soluble composition consisting of gelatin, a plasticizer and water, the capsule core is a self-emulsifying composition consisting of haematococcus pluvialis astaxanthin oil, mono-diglycerol fatty ester, polyglycerol fatty acid ester, polyethylene glycol-400 and sorbitol, an oil-in-water emulsion can be spontaneously formed in the water, the haematococcus pluvialis astaxanthin oil contains astaxanthin monoester and diester, the water-soluble composition plasticizer for the capsule wall is a composition consisting of glycerol, sorbitol, citric acid and sodium carboxymethylcellulose, and the water-soluble composition for the capsule wall comprises the following components in parts by mass:
the capsule core self-emulsifying composition comprises the following components in percentage by mass:
2. the water-soluble haematococcus pluvialis astaxanthin soft capsule according to claim 1, characterized in that the capsule core self-emulsifying composition comprises the following components in percentage by mass:
3. the water-soluble haematococcus pluvialis astaxanthin soft capsule according to claim 1 or 2, characterized in that the haematococcus pluvialis astaxanthin oil is the haematococcus pluvialis astaxanthin oil prepared by physically refining, purifying and blending an artificially cultured haematococcus pluvialis extract, wherein the mass percent of monoester in astaxanthin ester is 70-75, the mass percent of diester is 25-30, and more than 90% of astaxanthin in an occurrence state is all-trans astaxanthin.
4. The water-soluble haematococcus pluvialis astaxanthin soft capsule according to claim 3, wherein the haematococcus pluvialis extract is subjected to physical refining, purification and blending, and one or more of fat-soluble vitamins, fat-soluble pigments and animal and vegetable fats and oils with health care functions are added to prepare the haematococcus pluvialis astaxanthin oil.
5. The soft capsule of water-soluble haematococcus pluvialis astaxanthin according to claim 1 or 2, characterized in that the mass percentage of monoglycerides in the monodiglycerol unsaturated fatty acid esters is equal to or more than 90.0, comprising a mixture of one or more of mono-diglycerol oleate, mono-diglycerol linoleate, and mono-diglycerol linolenate.
6. The use of a soft capsule of water-soluble haematococcus pluvialis astaxanthin according to claim 1, wherein the gel candy is prepared by first preparing a soft capsule wall skin, laying a layer of the soft capsule wall skin on a groove die, injecting the core self-emulsifying composition, then laying a layer of the soft capsule wall skin, and rolling and combining the layers.
7. The method for preparing the water-soluble haematococcus pluvialis astaxanthin soft capsule of claim 1, comprising the steps of gelatin melting, pelleting, sizing, pill washing, drying, pill inspection, inspection and packaging of conventional soft capsule preparation, and further comprising the step of preparing the capsule core self-emulsifying composition under the protection of nitrogen, wherein the step of preparing the capsule core self-emulsifying composition comprises the following operations: accurately weighing the required components according to the requirements of the formula of the mass percent of the components, sequentially putting the components into a stirring and mixing kettle which is filled with nitrogen in advance, mixing, then putting the components into a high-pressure homogenizer for homogenization, transferring the qualified capsule core self-emulsifying composition into a stirring storage tank which is filled with nitrogen in advance after the homogenization, and preparing the soft capsule for pill making.
8. The method for preparing a soft capsule of water-soluble haematococcus pluvialis astaxanthin according to claim 7, wherein in the step of preparing the capsule core self-emulsifying composition, the mixing temperature is 25-35 ℃, the mixing time is 20-30 min, the pressure of a first-stage valve of a high-pressure homogenizer is 25-30 MPa, the pressure of a second-stage valve of the high-pressure homogenizer is 5-10 MPa, the homogenization is carried out for 2 times, and the oxygen partial pressure in a mixing kettle and a storage tank is 200-300 Pa.
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