WO2020119164A1 - Dha油脂组合物在软胶囊中的应用以及软胶囊及其制备方法 - Google Patents

Dha油脂组合物在软胶囊中的应用以及软胶囊及其制备方法 Download PDF

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WO2020119164A1
WO2020119164A1 PCT/CN2019/101031 CN2019101031W WO2020119164A1 WO 2020119164 A1 WO2020119164 A1 WO 2020119164A1 CN 2019101031 W CN2019101031 W CN 2019101031W WO 2020119164 A1 WO2020119164 A1 WO 2020119164A1
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oil
dha
soft capsule
fat composition
fat
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PCT/CN2019/101031
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English (en)
French (fr)
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梁云
王身健
曹晟
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瞿瀚鹏
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/30—Encapsulation of particles, e.g. foodstuff additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the invention relates to the technical field of food processing, in particular to the application of DHA oil and fat composition in soft capsules and a soft capsule and a preparation method thereof.
  • Docosahexaenoic acid is a long-chain polyunsaturated fatty acid. It is mainly present in the gray matter in the brain. It is the main lipid component in human brain nerve cells and the fatty acid component that brain cells preferentially absorb and utilize. .
  • the content of DHA in visual nerve cells and retinal tissue is as high as 40-47%, which plays an important role in the normal function of the photoreceptor. If DHA is lacking in food, the content of DHA in the retinal tissue can be reduced, resulting in vision and resolution decline. DHA can also reduce thrombosis and prevent cardiovascular diseases.
  • DHA also plays a significant role in delaying aging, preventing neurological diseases (such as preventing dementia, slowing down the condition of bipolar disorder, etc.), anti-cancer, inhibiting tumors, preventing osteoporosis, preventing diabetes, and anti-inflammatory.
  • neurological diseases such as preventing dementia, slowing down the condition of bipolar disorder, etc.
  • anti-cancer inhibiting tumors, preventing osteoporosis, preventing diabetes, and anti-inflammatory.
  • the World Health Organization (WHO) and the American Medical Research Institute (IOM) unanimously recommend that pregnant and lactating women receive a daily DHA intake of 200 mg, and healthy people should have a minimum daily intake of 160 mg. Children aged 4-18 years The daily intake is 90-160mg. However, the daily intake of pregnant women, lactating women, children and adults in my country is far below this level.
  • EPA can inhibit the synthesis of liver fat and lipoprotein, promote cholesterol excretion, reduce triglyceride and low-density cholesterol in the blood, and increase beneficial high-density cholesterol. Effectively prevent the occurrence of hyperlipidemia. It can inhibit platelet aggregation and reduce the formation of thrombus. At the same time dilate blood vessels, reduce blood viscosity, increase red blood cell plasticity, improve platelet membrane fluidity, and help maintain the smoothness of blood vessels. Reduce the incidence of atherosclerosis, thereby reducing the incidence of cardiovascular and cerebrovascular diseases.
  • the purpose of the present invention is to overcome the above-mentioned problems in the prior art, to provide a specific application of DHA oil and fat composition in soft capsules, as well as a soft capsule and its preparation method.
  • the first aspect of the present invention provides the use of the DHA oil and fat composition in soft capsules, the DHA oil and fat composition containing DHA oil and fat, the DHA oil and fat containing DHA and EPA;
  • the applicable objects of the soft capsule are pregnant women, infants and young people, and the content ratio of DHA to EPA in the DHA oil composition is greater than 12:1;
  • the applicable object of the soft capsule is middle-aged and elderly.
  • the content ratio of DHA and EPA is not more than 8:1.
  • the DHA oil and fat composition further contains an antioxidant.
  • the DHA oil and fat composition further contains at least one of walnut oil, perilla oil, sunflower oil, evening primrose oil, grape seed oil, soybean oil, linseed oil, rapeseed oil and olive oil.
  • a method for preparing a soft capsule includes:
  • the DHA oil and fat composition contains DHA oil and fat, and the DHA oil and fat contains DHA and EPA;
  • the applicable objects of the soft capsule are pregnant women, infants and young people, and the content ratio of DHA to EPA in the DHA oil composition is greater than 12:1;
  • the applicable object of the soft capsule is middle-aged and elderly.
  • the content ratio of DHA and EPA is not more than 8:1.
  • the DHA oil and fat composition further contains at least one of walnut oil, perilla oil, sunflower oil, evening primrose oil, grape seed oil, soybean oil, linseed oil, rapeseed oil and olive oil.
  • the DHA oil and fat composition further contains an antioxidant.
  • the DHA oil and fat composition is obtained by mixing DHA oil and antioxidant with an ambient temperature of less than 25°C and a relative humidity of less than 65%.
  • the feed liquid temperature is lower than 30°C.
  • the method further includes vacuum degassing the prepared DHA oil and fat composition.
  • the storage time of the DHA oil and fat composition is not more than 2 hours, and it is stored in a dark place under an inert gas environment.
  • the conditions of the sol include: a temperature of 60-85°C, a vapor pressure of less than 0.2 MPa, and a time of 40-50 min.
  • the obtained sol mixture is filtered and vacuum degassed under the condition of 45-75° C., and the sol mixture after filtration and vacuum degassing is kept warm.
  • the storage time of the sol mixture is not more than 48 hours.
  • the gelatin is pharmaceutical gelatin.
  • the power value of the gelatin is 180-200 Bloom.
  • the conditions for the infusion include: the ambient temperature for pelleting is 18-28°C, the relative humidity is not more than 80%, and the cooling and setting temperature of the rubber sheet is ⁇ 25°C.
  • the method further includes drying the obtained soft capsules, the drying including a primary drying and a secondary drying performed in sequence; the conditions of the primary drying include: a humidity of not more than 80%, a temperature of 26-32°C, The time is 4-8 hours; the conditions of the secondary drying include: the humidity is not more than 45%, the temperature is 30-45°C, the relative humidity is ⁇ 30%, and the time is 4-8 hours.
  • the humidity of primary drying is greater than that of secondary drying, and the temperature of primary drying is lower than the temperature of secondary drying.
  • the method includes washing the dried soft capsules with food grade petroleum ether to remove residual oil on the surface of the capsules, or the method includes drying the dried soft capsules with an oil-absorbing cloth strip The capsules are scrubbed and replaced with petroleum ether to remove residual oil on the surface of the capsules.
  • the present invention provides a soft capsule prepared by the method described above, wherein the soft capsule is applied to different consumer groups of infants, young people and middle-aged and elderly people, and the peroxide value in the soft capsule is ⁇ 15 meq/kg , Acid value ⁇ 3mg/g, Anisidine value ⁇ 15.
  • soft capsules containing DHA oil and fat compositions that meet different populations can be prepared to meet the requirements of different populations for DHA and EPA, maintain the function of the brains of infants and young people, promote the development of their brains and visual systems, and prevent It has side effects such as abnormal bleeding and precocious puberty. At the same time, it can regulate blood lipids in middle-aged and elderly people, reduce blood coagulation, and prevent senile dementia.
  • the above-mentioned antioxidant method can effectively slow down the oxidation of DHA and EPA in oils and fats, reduce the anisidine value, peroxide value and acid value of DHA oil and fat composition, control the color change of soft capsules and increase Shelf life of DHA fat softgels.
  • FIG. 1 is a flowchart of a specific embodiment of the present invention.
  • the inventors of the present invention have found that for pregnant women, infants and young people, when supplying DHA oil, the content ratio of DHA and EPA in DHA oil is greater than 12:1, further preferably greater than 20:1, More preferably, it is greater than 30:1, which can avoid the side effects of EPA on pregnant women, infants, young children, and adolescents.
  • the content of EPA in DHA oil can be appropriately increased.
  • the content ratio is not greater than 8:1, preferably not greater than 3:2, thereby preventing the incidence of atherosclerosis, thereby reducing the incidence of cardiovascular and cerebrovascular diseases.
  • the present invention provides the use of the DHA oil composition in soft capsules, the DHA oil composition containing DHA oil, the DHA oil containing DHA and EPA;
  • the applicable objects of the soft capsule are pregnant women, infants and young people, and the content ratio of DHA to EPA in the DHA oil composition is greater than 12:1;
  • the applicable object of the soft capsule is middle-aged and elderly.
  • the content ratio of DHA and EPA is not more than 8:1.
  • the applicable objects of the soft capsules are pregnant women, infants and young people
  • the content ratio of DHA to EPA is greater than 12:1, preferably greater than 20:1, and more preferably greater than 30:1.
  • the source of the DHA oil and fat can be selected within a wide range.
  • the DHA oil and fat is algae-derived DHA oil and fat.
  • the content of DHA in the algae-derived DHA oil and fat is preferably ⁇ 35% by weight and the content of EPA Preferably ⁇ 3% by weight.
  • the algae-derived DHA oil and fat can be commercially obtained through conventional channels, or can be prepared according to the existing process.
  • Examples of the algae may include, but are not limited to, Thraustochytriales, Schizochytrium, Crypthecodinium, Diatom, Spirulina, and Wuken At least one of the genus Salmonella.
  • the DHA oil and fat contains fish oil or a mixture containing fish oil and algae oil. More preferably, the DHA content in the fish oil is ⁇ 12% by weight. The content of EPA is preferably ⁇ 18% by weight.
  • the fish oil can be commercially obtained through conventional channels, or can be prepared according to the existing process.
  • DHA a long-chain polyunsaturated fatty acid
  • the existing soft capsule production technology uses ordinary oil
  • the process of production, without taking protective measures to prevent the oxidation of fat, is easy to cause the final finished soft capsule product to oxidize and deteriorate.
  • the method of the present invention adopts the following comprehensive measures for oxidation protection control: proper addition of food-grade oil and fat antioxidants, oxygen isolation, shortening of oil and fat exposure time, etc. effectively prevent the oxidative deterioration of soft capsules.
  • the DHA oil and fat composition preferably further contains an antioxidant, wherein the antioxidant may be various conventional edible antioxidants.
  • the antioxidant is at least one selected from vitamin E, lecithin, VC palmitate and rosemary, and the content is preferably 800-1500 ppm, for example, it may be 800 ppm, 900 ppm , 1000ppm, 1100ppm, 1200ppm, 1300ppm, 1400ppm, 1500ppm.
  • the DHA oil and fat composition further contains edible oil and fat, and the edible oil and fat is preferably selected from walnut oil, perilla oil, sunflower oil, evening primrose oil, grape seed oil , Soybean oil, linseed oil, rapeseed oil, and olive oil.
  • the oxidation resistance of the soft capsule will be further enhanced, so that the discoloration of the soft capsule can be further suppressed, thereby reducing the anisidine value, peroxide value, and acid value.
  • the capsule skin of the soft capsule may generally contain gelatin powder and glycerin.
  • the present invention provides a method for preparing a soft capsule, the method comprising:
  • the DHA oil and fat composition contains DHA oil and fat, and the DHA oil and fat contains DHA and EPA;
  • the applicable objects of the soft capsule are pregnant women, infants and young people, and the content ratio of DHA to EPA in the DHA oil composition is greater than 12:1;
  • the applicable object of the soft capsule is middle-aged and elderly.
  • the content ratio of DHA and EPA is not more than 8:1.
  • the DHA oil and fat composition further contains edible oil and fat, and the edible oil and fat is preferably selected from walnut oil, perilla oil, sunflower oil, evening primrose oil, grape seed oil , Soybean oil, linseed oil, rapeseed oil, and olive oil.
  • the oxidation resistance of the soft capsule will be further enhanced, so that the discoloration of the soft capsule can be further suppressed, thereby reducing the anisidine value, peroxide value, and acid value.
  • the DHA oil and fat composition further contains an antioxidant, Among them, the selection and dosage of the antioxidant have been described in detail above, and will not be repeated here.
  • the preparation of the DHA oil and fat composition can be obtained by conventional mixing of various materials.
  • the ambient temperature at which the DHA fats and antioxidants, edible fats and oils, etc. are mixed is preferably below 25°C, preferably 10-25°C, the relative humidity is less than 65%, and the temperature of the feed liquid is below 30°C.
  • the mixing can be performed under stirring conditions for 70-80 min. Further preferably, it further includes vacuum degassing the prepared DHA oil and fat composition, so as to avoid excessive contact between the DHA oil and oxygen.
  • the storage time of the DHA oil and fat composition obtained by mixing is not more than 2 hours, preferably not more than 1.5 hours, and more preferably is ready-to-use, so as to shorten the exposure time of the material in the air, and the storage process is preferably inert Under the protection of gas, the inert gas may be nitrogen.
  • the temperature of the sol is 60- 85 °C, more preferably 70-77 °C, for example, 70 °C, 71 °C, 72 °C, 73 °C, 74 °C, 75 °C, 76 °C, 77 °C
  • the steam pressure is less than 0.2MPa (for example, 0.1-0.2MPa)
  • the time is 40-50min.
  • the amount of the water, gelatin powder and glycerin can be according to the amount used in the preparation of soft capsules in the existing process.
  • the amount of gelatin powder is 80-120 parts by weight relative to 100 parts by weight of water.
  • the amount of glycerin used is 35-50 parts by weight.
  • the weight ratio of the ingredients of glycerin and gelatin is (35-50): 100, specifically, the amount of glycerin and gelatin can be adjusted according to the temperature and humidity conditions in the market to ensure the softness and hardness of the commercial capsule .
  • step (1) in order to further reduce the oxidation during the preparation of the capsule, thereby suppressing the color change of the capsule, reducing the anisidine value, the peroxide value, and the acid value, preferably, after the end of the sol, it further includes
  • the obtained sol mixture is filtered and vacuum degassed at a temperature of 45-75°C, preferably 58-62°C, and the sol mixture after filtration and vacuum degassing is kept warm for use.
  • step (1) in order to reduce the exposure time of the resulting sol mixture in the air, thereby reducing the degree of oxidation, inhibiting the color change of the capsule, and lowering the anisidine value, peroxide value and acid value, preferably,
  • the storage time of the sol mixture is not more than 48 hours, preferably not more than 40 hours, more preferably not more than 30 hours, and further preferably is ready-to-use.
  • the gelatin in order to further reduce the influence of impurity ions in gelatin, for example, metal ions on discoloration, it is preferred that the gelatin is pharmaceutical gelatin.
  • the power value of the gelatin can be selected within a wide range, but the inventor of the present application found that the power value of the gelatin is controlled at 180-200 Bloom (for example, 180Bloom, 185Bloom, 190Bloom, 195Bloom , 200Bloom, 205Bloom, 210Bloom, 215Bloom, 220Bloom) can further suppress the color change of soft capsules.
  • the method of pouring the DHA oil and fat composition into the sol mixture may adopt the method of preparing soft capsules in the prior art, and the present invention is not particularly limited thereto.
  • the infusion conditions include: the ambient temperature of the pellet press is 18-28°C, preferably 18-24°C Relative humidity is not more than 80%, preferably not more than 65%, for example, 50-65%, rubber cooling and setting temperature ⁇ 25 °C, preferably ⁇ 14 °C, for example, 2-14 °C.
  • the method further includes drying the infused product.
  • the drying may be performed according to a conventional method in the art.
  • the inventor of the present invention found during the research that the Drying is divided into two stages of drying: primary drying and secondary drying, which can further adjust and control the degree of softness and hardness of the finished product, and control to slow down and control the cracking of the finished capsule.
  • the conditions of the primary drying include: humidity not more than 80%, preferably not more than 65% (preferably 60-65%), temperature 26-32°C, time 4-8 hours; conditions of the second drying Including: humidity not more than 45%, preferably not more than 30% (preferably 25-30%), temperature 30-45°C, relative humidity ⁇ 30%, time 4-8 hours.
  • the temperature of the primary drying is lower than the temperature of the secondary drying, preferably 2-8°C lower.
  • the soft capsule in order to further suppress the color change of the final product and avoid and slow down the oxidation of the finished capsule during the shelf life, after the soft capsule is dried, it also includes the use of food grade petroleum ether to obtain the soft The capsules are washed to remove residual oil on the surface of the capsules. Since petroleum ether is easy to volatilize, after cleaning, petroleum ether will not remain on the surface of the soft capsule.
  • the soft capsule in order to further suppress the color change of the final product and avoid and slow down the oxidation of the finished capsule during the shelf life, after the soft capsule is dried, it can also be obtained by using an oil-absorbing cloth strip.
  • the capsules are scrubbed and replaced with petroleum ether to remove residual oil on the capsule surface.
  • the oil-absorbing cloth strip is a strong oil-absorbing cloth strip.
  • the method further includes: storing the obtained soft capsules in an opaque bottle, the bottle is filled with an oxygen absorbent, and the bottle mouth is sealed with aluminum foil; Or divide the obtained soft capsules into aluminum plastic plate.
  • the present invention also provides a soft capsule prepared by the method as described above, wherein the soft capsule is applied to different consumer groups of infants, young people and middle-aged and elderly people, and the peroxide value in the soft capsule is ⁇ 15 meq /kg, acid value ⁇ 3mg/g, anisidine value ⁇ 15.
  • the microbial oil used was algal oil, with a DHA content of 45.3% by weight and an EPA content of 0.613% by weight.
  • the DHA content was 12.16% by weight and the EPA content was 18.69% by weight.
  • the soft capsule preparation equipment is a pellet maker of model MARK RJNJ-2.
  • the sol pot is steam sterilized for 15-30 minutes before production, including the inlet and outlet of the material. Then, the water (100 parts by weight) required for the preparation of the glue solution is heated to boiling into the sol pot, and stirring is started. Under the condition of stirring, glycerin (45 parts by weight) and medicinal gelatin powder (power value is 190Bloom) g) (100 parts by weight) sequentially sucked into the sol pot, stirred to dissolve, and sol for 45 min under the conditions of 75°C and steam pressure of 0.2 MPa. After the sol is finished, when the temperature is reduced to about 60°C, the sol mixture is filtered and vacuum degassed in sequence, and then kept for standby, and the storage time does not exceed 48 hours.
  • the DHA oil and fat composition in step (2) was poured into the sol in step (1) and pelletized in a pelletizer.
  • the ambient temperature for pelleting is 20°C
  • the relative humidity is 65%
  • the cooling and setting temperature of the rubber sheet is 10°C.
  • the thickness of the rubber skin of the obtained soft capsule is 0.65-0.8 mm
  • the average weight of a single soft capsule is 430 mg.
  • the obtained soft capsule was dried for 6 hours under the condition of humidity 65% and temperature 30°C; then dried under the condition of humidity 30% and temperature 32°C for 6 hours. Then, the dried soft capsules are washed with edible grade petroleum ether to obtain soft capsules.
  • the specific preparation process is shown in FIG. 1.
  • the sol pot is steam sterilized for 15-30 minutes before production, including the inlet and outlet of the material. Then, the water (100 parts by weight) required for the preparation of the glue solution is heated to boiling into the sol pot, and stirring is started. Under the condition of stirring, glycerin (42 parts by weight) and medicinal gelatin powder (power value is 180Bloom) g) (120 parts by weight) sequentially sucked into the sol pot, stirred to dissolve, and the sol under the conditions of 70 °C, steam pressure 0.1MPa for 40min. After the sol is finished, when the temperature is reduced to about 58 °C, the sol mixture is filtered and degassed in sequence, and then kept for standby, the storage time does not exceed 48 hours.
  • the temperature of the feed liquid is controlled to be less than 30°C, algal oil and lecithin are added to the ingredient container, and stirred for 75 minutes to obtain a DHA oil and fat composition, in which The content of lecithin is 800ppm. Then, the obtained DHA oil and fat composition is subjected to vacuum degassing for standby, and the storage time does not exceed 2 hours.
  • the DHA oil and fat composition in step (2) was poured into the sol in step (1) and pelletized in a pelletizer.
  • the ambient temperature of the pellet press is 18°C
  • the relative humidity is 60%
  • the cooling and setting temperature of the rubber is 14°C.
  • the thickness of the rubber skin of the obtained soft capsule is 0.65-0.8 mm
  • the average weight of a single soft capsule is 430 mg.
  • the obtained soft capsule was dried for 8 hours under the condition of humidity of 60% and temperature of 26°C; and then dried for 8 hours under the condition of humidity of 25% and temperature of 30°C. Then, the dried soft capsules are washed with edible grade petroleum ether to obtain soft capsules.
  • the specific preparation process is shown in FIG. 1.
  • the sol pot is steam sterilized for 15-30 minutes before production, including the inlet and outlet of the material. Then, the water (100 parts by weight) required for the preparation of the glue solution is heated to boiling into the sol pot, and stirring is started. Under the condition of stirring, glycerin (40 parts by weight) and medicinal gelatin powder (power value is 200Bloom) g) (80 parts by weight) sequentially sucked into the sol pot, stirred to dissolve, and the sol under the conditions of 77 °C, steam pressure 0.15MPa for 50min. After the sol is finished, when the temperature is reduced to about 62°C, the sol mixture is filtered and degassed in sequence, and then kept for standby, and the storage time does not exceed 48 hours.
  • the DHA oil and fat composition in step (2) was poured into the sol in step (1) and pelletized in a pelletizer.
  • the ambient temperature for pelleting is 24°C
  • the relative humidity is 63%
  • the cooling and setting temperature of the rubber is 8°C.
  • the thickness of the rubber skin of the obtained soft capsule is 0.65-0.8 mm
  • the average weight of a single soft capsule is 430 mg.
  • the obtained soft capsules were dried under the conditions of humidity 63% and temperature 32°C for 4 hours; then dried under the conditions of humidity 28% and temperature 40°C for 4 hours. Then, the dried soft capsules are washed with edible grade petroleum ether to obtain soft capsules.
  • the specific preparation process is shown in FIG. 1.
  • the soft capsules were prepared according to the method of Example 1, except that in step (2), vitamin E was not added, that is, the DHA oil and fat composition was only algae oil, and the algae oil was not degassed in vacuum deal with.
  • the soft capsules were prepared according to the method of Example 1, except that in step (2), the ambient temperature was 30°C and the relative humidity was 70%.
  • the soft capsules were prepared according to the method of Example 1, except that in step (2), vitamin E was directly mixed with algal oil without first dissolving it into sunflower oil heated to 85°C.
  • the soft capsules are prepared according to the method of Example 1, except that in step (1), the gelatin is not medicinal gelatin, but ordinary gelatin.
  • the soft capsule is prepared according to the method of Example 1, except that in step (1), the kinetic value of the pharmaceutical gelatin is 150 Bloom.
  • the soft capsule was prepared according to the method of Example 1, except that in step (1), the kinetic value of the pharmaceutical gelatin was 250 Bloom.
  • the soft capsules were prepared according to the method of Example 1, except that in step (1), the temperature of the sol was 80° C., the vapor pressure was 0.25 MPa, and the filtration and vacuum degassing treatment were not performed after the sol was finished and cooled down.
  • the soft capsules were prepared according to the method of Example 1, except that in step (3), the ambient temperature for pelleting was 30°C and the relative humidity was 50%.
  • the soft capsules were prepared according to the method of Example 1, except that in step (3), the drying was only performed under the conditions of humidity 65% and temperature 30°C for 12 hours.
  • step (3) The preparation of soft capsules was carried out according to the method of Example 1, except that in step (3), the drying was only carried out under conditions of humidity of 30% and temperature of 32°C for 12 hours.
  • the soft capsules were prepared according to the method of Example 1, except that in step (3), the obtained soft capsules were dried under conditions of humidity 65% and temperature 30°C for 6 hours; and then at humidity 30% 1. Drying for 6h under the condition of 30°C.
  • the soft capsules were prepared according to the method of Example 1, except that in step (3), the soft capsules were dried without washing residual oil.
  • the color change is judged by observing the color change of the soft capsule. Among them, the soft capsule is light yellow and is scored 10 points, and the light reddish brown is recorded as 1 point. Among them, the lower the score, the more serious the color change.
  • the results are shown in Table 1.
  • Example 1 10 2.5 0.5 0.2
  • Example 2 10 2.3 0.8 0.3
  • Example 3 10 1.9 1.2 0.6
  • Example 4 8 5.3 5.1 2.5
  • Example 5 6 3.6 2.1 0.9
  • Example 6 7 4.2 3.2 1.4
  • Example 7 9 6.5 4.2 2.3
  • Example 8 5 4.8 2.5 1.1
  • Example 9 6.2 3.1 1
  • Example 10 5 7.1 4.5
  • Example 11 4 6.5 4.0 2.2
  • Example 12 6 5.1 3.6 1.8
  • Example 13 2 8.0 5.6 2.8
  • Example 14 3.9 2.6 1.1
  • Example 15 2 8.5 5.1 2.6
  • the present invention can prepare soft capsules containing DHA oil and fat compositions suitable for different people, meet the requirements of different people for DHA and EPA, maintain the function of the brains of infants and young children, and promote the brain and visual system Development, to prevent side effects such as abnormal bleeding and precocious puberty, at the same time can regulate blood lipids in middle-aged and elderly people, reduce blood coagulation, and prevent senile dementia.
  • the method of the present invention can effectively slow down the oxidation of DHA and EPA in oils and fats, reduce the anisidine value, peroxide value and acid value of DHA oil and fat compositions, control the color change of soft capsules, and increase the save time.

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Abstract

一种软胶囊及其制备方法，DHA油脂组合物含有DHA油脂，DHA油脂含有DHA和EPA；软胶囊的适用对象为孕产妇、婴幼儿和青少年，DHA与EPA的含量比大于12∶1；软胶囊的适用对象为中老年，DHA与EPA的含量比不大于8∶1。制备方法包括：将水、明胶粉和甘油混合并进行溶胶，得到溶胶混合物；将如上DHA油脂组合物灌注于溶胶混合物中，得软胶囊；所述方法可制备符合不同人群DHA软胶囊，还能够有效地减缓油脂的氧化，降低茴香胺值、过氧化物值和酸价，控制软胶囊的色变，增加DHA油脂软胶囊的保存时间。

Description

DHA油脂组合物在软胶囊中的应用以及软胶囊及其制备方法 技术领域
本发明涉及食品加工技术领域，具体涉及DHA油脂组合物在软胶囊中的应用以及一种软胶囊及其制备方法。
背景技术
二十二碳六烯酸(DHA)是一种长链多不饱和脂肪酸，在大脑中主要存在于灰质部分，是人脑神经细胞中主要的脂质成分，也是大脑细胞优先吸收利用的脂肪酸成分。DHA在视觉神经细胞及视网膜组织中的含量高达40-47％，对视感光受体的正常功能起重要作用，如果食物中缺乏DHA，可使视网膜组织中DHA含量下降，从而导致视力及分辨力下降。DHA还能够减少血栓形成，起到防止心血管疾病发生的作用。同时，DHA在延缓衰老、预防神经性疾病(如预防老年痴呆、减缓躁郁症病情等)、抗癌、抑制肿瘤，预防骨质疏松、预防糖尿病、抗炎症等方面也有明显的作用。
世界卫生组织(WHO)及美国医学研究所(IOM)一致推荐，怀孕和哺乳期妇女每日DHA摄取量为200mg，健康人每天的最低摄入量应为160mg，4岁-18岁的青少年儿童每日摄入量为90-160mg。而我国目前孕妇、哺乳期妇女、儿童及成人每日的摄入量远低于该水平。
EPA可以抑制肝脏脂肪和脂蛋白的合成，促进胆固醇排泄，降低血液中的甘油三脂和低密度胆固醇，同时增高有益的高密度胆固醇。有效防止高脂血症的发生。并可抑制血小板凝聚，减少血栓的形成。同时扩张血管，降低血液粘稠度，增加红细胞可塑性，提高血小板膜流动性，帮助维护血管的畅通。减少动脉粥样硬化的发生几率，从而减少心脑血管病的发病率。
但是发明人在研究的过程中发现，EPA的这种“血管清道夫”功效，对于婴幼儿来讲，则会产生负面的影响：并经过大量的研究表明，EPA具有降低血液粘稠度、稀释血液的作用，孕妇和婴幼儿体内积聚容易引起非正常出血现象，另外，EPA在人体内将代谢成前列腺环素PG3而有促进儿童性早熟之弊。
而目前市场上包含DHA和EPA的软胶囊中没有根据不同的人群调整DHA和EPA的比例，不利于人体对DHA和EPA的补充及人体的健康。
发明内容
本发明的目的是为了克服现有技术存在的上述问题，提供一种具体的DHA油脂组合物在软胶囊中的应用，以及一种软胶囊及其制备方法。
为了实现上述目的，本发明第一方面，提供如下的DHA油脂组合物在软胶囊中的应用，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
优选的，所述DHA油脂组合物还含有抗氧化剂。
优选的，所述DHA油脂组合物还含有核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种。
本发明第二方面，提供一种软胶囊的制备方法，该方法包括：
(1)将水、明胶粉和甘油混合并进行溶胶，得到溶胶混合物；
(2)将DHA油脂组合物灌注于所述溶胶混合物中，得到软胶囊；
其中，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
优选的，所述DHA油脂组合物还含有核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种。
优选的，所述DHA油脂组合物还含有抗氧化剂，优选的，所述DHA油脂组合物通过将DHA油脂和抗氧化剂混合得到，所述混合的环境温度低于25℃、相对湿度小于65％，料液温度低于30℃。优选的，该方法还包括将制备得到的DHA油脂组合物进行真空脱气处理。优选的，所述DHA油脂组合物的储存时间不大于2小时，并且在惰性气体环境下避光储存。
优选的，所述溶胶的条件包括：温度为60-85℃，蒸汽压力小于0.2MPa，时间为40-50min。优选的，溶胶结束后，将得到的溶胶混合物在45-75℃的条件下进行过滤和真空脱气处理，并将过滤和真空脱气处理后的溶胶混合物进行保温。优选的，所述溶胶 混合物的储存时间不大于48小时。
优选的，所述明胶为药用明胶。
优选的，所述明胶的动力值为180-200Bloom g。
优选的，所述灌注的条件包括：压丸环境温度为18-28℃，相对湿度不大于80％，胶皮冷却定型温度≤25℃。
优选的，该方法还包括将得到的软胶囊进行干燥，所述干燥包括依次进行的一次干燥和二次干燥；所述一次干燥的条件包括：湿度不大于80％，温度为26-32℃，时间为4-8小时；所述二次干燥的条件包括：湿度不大于45％，温度为30-45℃，相对湿度≤30％，时间为4-8小时。其中，一次干燥的湿度大于二次干燥的湿度，一次干燥的温度低于二次干燥的温度。
优选的，该方法包括将干燥后的软胶囊采用食品级石油醚对得到的软胶囊进行清洗，以去除胶囊表面的残油，或者，该方法包括将干燥后的软胶囊采用吸油布条对得到的胶囊进行搓洗，替代石油醚清洗以去除胶囊表面的残油。
第三方面，本发明提供了如上所述的方法制备的软胶囊，其中，所述软胶囊应用于婴幼儿、青少年和中老年不同的消费人群，所述软胶囊中过氧化值≤15meq/kg、酸价≤3mg/g、茴香胺值≤15。
通过上述技术方案，可以制备符合不同的人群的含DHA油脂组合物的软胶囊，满足不同人群对DHA和EPA的要求，维持婴幼儿和青少年大脑的机能、促进其大脑和视觉系统的发育，防止产生异常出血和性早熟等副作用，同时可以调节中老年的血脂，降低血液凝滞度，预防老年性痴呆。此外，优选的情况下，采用上述抗氧化方法能够有效地减缓油脂中DHA和EPA的氧化，降低DHA油脂组合物的茴香胺值、过氧化物值和酸价，控制软胶囊的色变，增加DHA油脂软胶囊的保存时间。
附图说明
图1是本发明一种具体实施方式的流程图。
具体实施方式
在本文中所披露的范围的端点和任何值都不限于该精确的范围或值，这些范围或值应当理解为包含接近这些范围或值的值。对于数值范围来说，各个范围的端点值之间、各个范围的端点值和单独的点值之间，以及单独的点值之间可以彼此组合而得到一个或 多个新的数值范围，这些数值范围应被视为在本文中具体公开。
本发明的发明人在研究的过程中发现，对于孕产妇、婴幼儿和青少年，在供给DHA油脂时，将DHA油脂中的DHA与EPA的含量比大于12:1，进一步优选大于20:1，更进一步优选大于30:1，可避免EPA对孕产妇、婴幼儿和青少年产生的副作用，而对于中老年，可适当提高DHA油脂中EPA的含量，其含量比不大于8:1，优选不大于3:2，从而预防动脉粥样硬化的发生几率，从而减少心脑血管病的发病率。
基于如上的发现，第一方面，本发明提供了如下的DHA油脂组合物在软胶囊中的应用，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
(1)所述软胶囊的适用对象为孕产妇、婴幼儿和青少年
优选的，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1，优选大于20:1，更优选为大于30:1。
其中，所述DHA油脂的来源可以在较宽的范围内进行选择，优选的，DHA油脂为藻类来源的DHA油脂，所述藻类来源的DHA油脂中DHA的含量优选≥35重量％，EPA的含量优选≤3重量％。其中，所述藻类来源的DHA油脂可以通过常规的途径商购获得，也可以按照现有工艺制备得到。
其中，所述藻类的实例可以包括但并不限于破囊壶菌(Thraustochytriales)、裂殖壶菌(Schizochytrium)、隐甲藻(Crypthecodinium)、硅藻(diatom)、螺旋藻(Spirulina)和吾肯氏菌属中的至少一种。
(2)所述软胶囊的适用对象为中老年
优选的，所述DHA油脂含有鱼油或者含有鱼油和藻油的混合物，更优选的，所述鱼油中DHA含量≥12重量％。EPA的含量优选≥18重量％。其中，所述鱼油可以通过常规的途径商购获得，也可以按照现有工艺制备得到。
本发明的发明人在研究的过程中发现，DHA这一长链多不饱和脂肪酸，因为含双键导致氧化稳定性不好，极易氧化导致品质差，现有的软胶囊生产技术采用普通油脂的工艺生产，没有采取防止油脂氧化的保护措施，极易导致最终的成品软胶囊产品氧化变质。而本发明的方法采用如下的氧化保护控制的综合措施：适当添加食品级油脂抗氧化 剂、隔绝氧、缩短油脂暴露时间等有效防止了软胶囊的氧化变质。
根据本发明，为了防止DHA油脂组合物中的进一步氧化，所述DHA油脂组合物还优选含有抗氧化剂，其中，所述抗氧化剂可以为现有常规的各种可食用的抗氧化剂。根据本发明一种优选的实施方式，所述抗氧化剂选自维生素E、卵磷脂、VC棕榈酸酯和迷迭香中的至少一种，含量优选为800-1500ppm，例如，可以为800ppm、900ppm、1000ppm、1100ppm、1200ppm、1300ppm、1400ppm、1500ppm。
根据本发明一种优选的实施方式，所述DHA油脂组合物中还含有可食用油脂，所述可食用油脂优选选自核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种。在该优选的情况下，所述软胶囊的抗氧化性会进一步增强，从而能够进一步抑制软胶囊的变色，从而降低茴香胺值、过氧化值和酸价。
根据本发明，所述软胶囊的胶囊皮中通常可以含有明胶粉和甘油。
根据本发明的第二方面，本发明提供了一种软胶囊的制备方法，该方法包括：
(1)将水、明胶粉和甘油混合并进行溶胶，得到溶胶混合物；
(2)将DHA油脂组合物灌注于所述溶胶混合物中，得到软胶囊；
其中，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
根据本发明，不同适用对象的油脂的选择已经在如上第一方面进行了详细的介绍，此处不再重复赘述。
根据本发明一种优选的实施方式，所述DHA油脂组合物中还含有可食用油脂，所述可食用油脂优选选自核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种。在该优选的情况下，所述软胶囊的抗氧化性会进一步增强，从而能够进一步抑制软胶囊的变色，从而降低茴香胺值、过氧化值和酸价。
根据本发明，为了进一步提高制备过程中的抗氧化性，抑制得到的软胶囊的变色，从而降低茴香胺值、过氧化值和酸价，优选的，所述DHA油脂组合物还含有抗氧化剂，其中，所述抗氧化剂的选择和用量已经在如上进行了详细的介绍，此处不再重复赘述。
根据本发明，DHA油脂组合物的制备可以通过将各物料进行常规的混合得到，为了进一步抑制软胶囊制备过程中的氧化反应，抑制软胶囊的变色，从而降低茴香胺值、 过氧化值和酸价，优选的，将所述DHA油脂和抗氧化剂、如上的可食用油脂等物质进行混合的环境温度优选低于25℃，优选10-25℃，相对湿度小于65％，料液的温度低于30℃。其中，所述混合可以在搅拌的条件下进行70-80min。进一步优选的，还包括将制备得到的DHA油脂组合物进行真空脱气处理，从而避免DHA油脂和氧气的过多接触。更进一步优选的，混合得到的DHA油脂组合物的储存时间不大于2小时，优选不大于1.5小时，更优选为现用现配，从而缩短物料在空气中的暴露时间，并且储存过程优选在惰性气体的保护下进行，所述惰性气体可以为氮气。
根据本发明，步骤(1)中，为了进一步降低胶囊制备过程中的氧化，从而抑制胶囊的色变，降低茴香胺值、过氧化值和酸价，优选的，所述溶胶的温度为60-85℃，更优选为70-77℃，例如，70℃、71℃、72℃、73℃、74℃、75℃、76℃、77℃，蒸汽压力小于0.2MPa(例如，0.1-0.2MPa)，时间为40-50min。
本发明中，所述水、明胶粉和甘油用量可以按照现有工艺中制备软胶囊时的用量，优选的，相对于100重量份的水，明胶粉的用量为80-120重量份、甘油的用量为35-50重量份。进一步的优选的，甘油与明胶的配料重量比为(35-50)：100，具体可以根据市场所处的温度与湿度条件调整甘油与明胶的用量配比，以此保障商品胶囊的软硬度。
根据本发明，步骤(1)中，为了进一步降低胶囊制备过程中的氧化，从而抑制胶囊的色变，降低茴香胺值、过氧化值和酸价，优选的，在溶胶结束后，还包括将得到的溶胶混合物在45-75℃，优选58-62℃的温度下进行过滤和真空脱气处理，并将过滤和真空脱气处理后的溶胶混合物进行保温备用。
根据本发明，步骤(1)中，为了降低得到的溶胶混合物在空气中的暴露时间，从而降低氧化程度，抑制胶囊的色变，降低茴香胺值、过氧化值和酸价，优选的，所述溶胶混合物的储存时间不大于48小时，优选不大于40小时，更优选不大于30小时，进一步优选为现用现配。
根据本发明，为了进一步降低明胶中的杂质离子，例如，金属离子对变色的影响，优选的，所述明胶为药用明胶。其中，所述明胶的动力值可以在较宽的范围内选择，但是本申请的发明人发现，将明胶的动力值控制在180-200Bloom g(例如，180Bloom g、185Bloom g、190Bloom g、195Bloom g、200Bloom g、205Bloom g、210Bloom g、215Bloom g、220Bloom g)能够进一步抑制软胶囊的色变。
根据本发明，步骤(2)中，将DHA油脂组合物灌注于所述溶胶混合物中的方法可以采用现有技术中制备软胶囊的方法，本发明对此并没有特别的限定。
优选的，为了降低得到的溶胶混合物在空气中的暴露时间，从而降低氧化程度，抑制胶囊的色变，所述灌注的条件包括：压丸环境温度为18-28℃，优选为18-24℃，相对湿度不大于80％，优选不大于65％，例如，50-65％，胶皮冷却定型温度≤25℃，优选≤14℃，例如，2-14℃。
根据本发明一种优选的实施方式，该方法还包括将灌注后的产品进行干燥，所述干燥可以按照本领域常规的方法进行，然而本发明的发明人在研究的过程中发现，将所述干燥分为一次干燥和二次干燥两个阶段的干燥，能够进一步地调整与控制成品的软硬程度，控制减缓与控制成品胶囊的龟裂问题。其中，所述一次干燥的条件包括：湿度不大于80％，优选不大于65％(优选60-65％)，温度为26-32℃，时间为4-8小时；所述二次干燥的条件包括：湿度不大于45％，优选不大于30％(优选为25-30％)，温度为30-45℃，相对湿度≤30％，时间为4-8小时。其中，一次干燥的温度低于二次干燥的温度，优选低2-8℃。
根据本发明一种优选的实施方式，为了进一步抑制终产品的色变，避免与减缓成品胶囊在保质期里的氧化，在将所述软胶囊干燥后，还包括采用食品级石油醚对得到的软胶囊进行清洗，以去除胶囊表面的残油。由于石油醚易于挥发，因此，清洗结束后，石油醚基本上不会残留在软胶囊的表面。
根据本发明另一种优选的实施方式，为了进一步抑制终产品的色变，避免与减缓成品胶囊在保质期里的氧化，在将所述软胶囊干燥后，也可以通过使用吸油布条对得到的胶囊进行搓洗，替代石油醚清洗以去除胶囊表面的残油。其中，所述吸油布条为强吸油布条。
其中，为了进一步防止软胶囊中DHA油脂的氧化，该方法还包括：将得到的软胶囊储藏于不透光的瓶子中，所述瓶子中装有吸氧剂，且瓶口采用铝箔纸密封；或将得到的软胶囊分装于铝塑板中。
第三方面，本发明还提供了如上所述的方法制备得到的软胶囊，其中，所述软胶囊应用于婴幼儿、青少年和中老年不同的消费人群，所述软胶囊中过氧化值≤15meq/kg、酸价≤3mg/g、茴香胺值≤15。
以下将通过实施例对本发明进行详细描述。以下实施例中，
以下实施例和对比例中，
所用的微生物油脂为藻油，DHA含量为45.3重量％，EPA含量为0.613重量％。
所用的鱼油中，DHA含量为12.16重量％，EPA含量为18.69重量％。
软胶囊制备设备为型号MARK Ⅱ RJNJ-2的制丸机。
实施例1
本实施例用于说明本发明提供的软胶囊及其制备方法
(1)溶胶
溶胶锅在生产前进行15-30分钟蒸汽杀菌，包括进出料管口。然后将胶液制备所需的水(100重量份)加热至沸腾吸入溶胶锅内，并开启搅拌，在搅拌的条件下，将甘油(45重量份)和药用明胶粉(动力值为190Bloom g)(100重量份)依次吸入溶胶锅，搅拌溶解，并在75℃、蒸汽压力0.2MPa的条件下溶胶45min。溶胶结束后，待温度降低至约60℃时，将溶胶混合物依次进行过滤和真空脱气，然后进行保温备用，保存时间不超过48小时。
(2)DHA油脂组合物的制备
在环境温度低于25℃，相对湿度小于65％的条件下，将藻油加入到配料容器中，同时将维生素E加入到适量并加热到85℃的葵花籽油中溶解，待料液温度降低至低于30℃后将其倒入配料器中，搅拌75min得到DHA油脂组合物，其中，维生素E的含量为1200ppm。然后将得到的DHA油脂组合物进行真空脱气备用，保存时间不超过2小时。
(3)软胶囊制备
在制丸机中将步骤(2)中的DHA油脂组合物灌注于步骤(1)的溶胶并进行压丸。其中，压丸环境温度为20℃，相对湿度为65％，胶皮冷却定型温度10℃。得到的软胶囊的胶皮的厚度为0.65-0.8mm，单个软胶囊的平均重量为430mg。
将得到的软胶囊在湿度为65％、温度为30℃的条件下干燥6h；然后再在湿度为30％、温度为32℃的条件下干燥6h。之后使用食用级石油醚对干燥后的软胶囊进行清洗，得到软胶囊，具体制备流程如图1所示。
实施例2
本实施例用于说明本发明提供的软胶囊及其制备方法
(1)溶胶
溶胶锅在生产前进行15-30分钟蒸汽杀菌，包括进出料管口。然后将胶液制备所需 的水(100重量份)加热至沸腾吸入溶胶锅内，并开启搅拌，在搅拌的条件下，将甘油(42重量份)和药用明胶粉(动力值为180Bloom g)(120重量份)依次吸入溶胶锅，搅拌溶解，并在70℃、蒸汽压力0.1MPa的条件下溶胶40min。溶胶结束后，待温度降低至约58℃时，将溶胶混合物依次进行过滤和真空脱气，然后进行保温备用，保存时间不超过48小时。
(2)DHA油脂组合物的制备
在环境温度低于25℃，相对湿度小于65％的条件下，将料液的温度控制在低于30℃，将藻油和卵磷脂加入到配料容器中，搅拌75min得到DHA油脂组合物，其中，卵磷脂的含量为800ppm。然后将得到的DHA油脂组合物进行真空脱气备用，保存时间不超过2小时。
(3)软胶囊制备
在制丸机中将步骤(2)中的DHA油脂组合物灌注于步骤(1)的溶胶并进行压丸。其中，压丸环境温度为18℃，相对湿度为60％，胶皮冷却定型温度14℃。得到的软胶囊的胶皮的厚度为0.65-0.8mm，单个软胶囊的平均重量为430mg。
将得到的软胶囊在湿度为60％、温度为26℃的条件下干燥8h；然后再在湿度为25％、温度为30℃的条件下干燥8h。之后使用食用级石油醚对干燥后的软胶囊进行清洗，得到软胶囊，具体制备流程如图1所示。
实施例3
本实施例用于说明本发明提供的软胶囊及其制备方法
(1)溶胶
溶胶锅在生产前进行15-30分钟蒸汽杀菌，包括进出料管口。然后将胶液制备所需的水(100重量份)加热至沸腾吸入溶胶锅内，并开启搅拌，在搅拌的条件下，将甘油(40重量份)和药用明胶粉(动力值为200Bloom g)(80重量份)依次吸入溶胶锅，搅拌溶解，并在77℃、蒸汽压力0.15MPa的条件下溶胶50min。溶胶结束后，待温度降低至约62℃时，将溶胶混合物依次进行过滤和真空脱气，然后进行保温备用，保存时间不超过48小时。
(2)DHA油脂组合物的制备
在环境温度低于25℃，相对湿度小于65％的条件下，将鱼油加入到配料容器中，同时将VC棕榈酸酯加入到适量并加热到85℃的葵花籽油中溶解，待料液温度降低至低 于30℃后倒入到配料器中，搅拌75min得到DHA油脂组合物，其中，VC棕榈酸酯的含量为1500ppm。然后将得到的DHA油脂组合物进行真空脱气备用，保存时间不超过2小时。
(3)软胶囊制备
在制丸机中将步骤(2)中的DHA油脂组合物灌注于步骤(1)的溶胶并进行压丸。其中，压丸环境温度为24℃，相对湿度为63％，胶皮冷却定型温度8℃。得到的软胶囊的胶皮的厚度为0.65-0.8mm，单个软胶囊的平均重量为430mg。
将得到的软胶囊在湿度为63％、温度为32℃的条件下干燥4h；然后再在湿度为28％、温度为40℃的条件下干燥4h。之后使用食用级石油醚对干燥后的软胶囊进行清洗，得到软胶囊，具体制备流程如图1所示。
实施例4
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(2)中，不加入维生素E，也即，所述DHA油脂组合物仅为藻油，并且不对该藻油进行真空脱气处理。
实施例5
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(2)中，环境温度为30℃，相对湿度为70％。
实施例6
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(2)中，直接将维生素E与藻油混合，而不先溶解至加热到85℃的葵花籽油中。
实施例7
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(1)中，所述明胶不是药用明胶，而是普通的明胶。
实施例8
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(1)中，所述药用明胶的动力值为150Bloom g。
实施例9
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(1)中，所述药用明胶的动力值为250Bloom g。
实施例10
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(1)中，溶胶的温度为80℃，蒸汽压力为0.25MPa，且溶胶结束并降温后不进行过滤和真空脱气处理。
实施例11
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(3)中，压丸环境温度为30℃，相对湿度为50％。
实施例12
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(3)中，所述干燥仅在湿度为65％、温度为30℃的条件下干燥12h。
实施例13
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(3)中，所述干燥仅在湿度为30％、温度为32℃的条件下干燥12h。
实施例14
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(3)中，将得到的软胶囊在湿度为65％、温度为30℃的条件下干燥6h；然后再在湿度为30％、温度为30℃的条件下干燥6h。
实施例15
本实施例用于说明本发明提供的软胶囊及其制备方法
按照实施例1的方法进行软胶囊的制备，不同的是，步骤(3)中，将软胶囊干燥后不进行残油的清洗。
测试例1
(1)色变
通过观察软胶囊的颜色变化来判断色变情况，其中，软胶囊为浅黄色记为10分，浅红褐色记为1分，其中，分值越低表明色变越严重，结果见表1。(2)将实施例1-15制备的软胶囊从包装中去除后，获得包裹的DHA油脂组合物，进行过氧化值(通过紫外分光光度计，按GB/T24304-2009方法进行测定)、茴香胺值(通过GB/T 24304-2009方法进行测定)和酸价(通过GB 5009.229-2016方法进行测定)的测定，结果见表1。
表1
编号 色变 茴香胺值 过氧化值(meq/kg) 酸价(mg/g)
实施例1 10 2.5 0.5 0.2
实施例2 10 2.3 0.8 0.3
实施例3 10 1.9 1.2 0.6
实施例4 8 5.3 5.1 2.5
实施例5 6 3.6 2.1 0.9
实施例6 7 4.2 3.2 1.4
实施例7 9 6.5 4.2 2.3
实施例8 5 4.8 2.5 1.1
实施例9 7 6.2 3.1 1
实施例10 5 7.1 4.5 2.5
实施例11 4 6.5 4.0 2.2
实施例12 6 5.1 3.6 1.8
实施例13 2 8.0 5.6 2.8
实施例14 8 3.9 2.6 1.1
实施例15 2 8.5 5.1 2.6
由表1可以看出，本发明可以制备符合不同的人群的含DHA油脂组合物的软胶囊，满足不同人群对DHA和EPA的要求，维持婴幼儿和青少年大脑的机能、促进其大脑和视觉系统的发育，防止产生异常出血和性早熟等副作用，同时可以调节中老年的血脂，降低血液凝滞度，预防老年性痴呆。此外，采用本发明的方法能够有效地减缓油脂中DHA和EPA的氧化，降低DHA油脂组合物的茴香胺值、过氧化物值和酸价，控制软胶囊的色变，增加DHA油脂软胶囊的保存时间。
以上详细描述了本发明的优选实施方式，但是，本发明并不限于此。在本发明的技术构思范围内，可以对本发明的技术方案进行多种简单变型，包括各个技术特征以任何其它的合适方式进行组合，这些简单变型和组合同样应当视为本发明所公开的内容，均属于本发明的保护范围。

Claims (11)

  1. 如下的DHA油脂组合物在软胶囊中的应用，其特征在于，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
    所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
    所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
  2. 根据权利要求1所述的应用，其中，所述DHA油脂组合物还含有抗氧化剂；
    优选的，所述抗氧化剂选自维生素E、卵磷脂、VC棕榈酸酯和迷迭香中的至少一种；
    优选的，在所述DHA油脂组合物中，所述抗氧化剂的含量为800-1500ppm；
    优选的，所述DHA油脂组合物还含有可食用油脂，所述可食用油脂优选选自核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种。
  3. 根据权利要求1或2所述的应用，其中，所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂为微生物油脂，优选的，所述微生物油脂中DHA含量≥35重量％，优选的，所述微生物油脂为藻类来源的DHA油脂；
    所述软胶囊的适用对象为中老年，所述DHA油脂含有鱼油或者含有鱼油和藻油的混合物，优选的，所述鱼油中DHA含量≥12重量％。
  4. 一种软胶囊的制备方法，该方法包括：
    (1)将水、明胶粉和甘油混合并进行溶胶，得到溶胶混合物；
    (2)将DHA油脂组合物灌注于所述溶胶混合物中，得到软胶囊；
    其中，所述DHA油脂组合物含有DHA油脂，所述DHA油脂含有DHA和EPA；
    所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂组合物中，DHA与EPA的含量比大于12:1；
    所述软胶囊的适用对象为中老年，所述DHA油脂组合物中，DHA与EPA的含量比不大于8:1。
  5. 根据权利要求4所述的方法，其中，所述DHA油脂组合物还含有抗氧化剂；
    优选的，所述抗氧化剂选自维生素E、卵磷脂、VC棕榈酸酯和迷迭香中的至少一种；
    优选的，在所述DHA油脂组合物中，所述抗氧化剂的含量为800-1500ppm；
    优选的，所述DHA油脂组合物还含有可食用油脂，所述可食用油脂优选选自核桃油、紫苏油、葵花籽油、月见草油、葡萄籽油、大豆油、亚麻籽油、菜籽油和橄榄油中的至少一种；
    优选的，所述DHA油脂组合物通过将DHA油脂和抗氧化剂混合得到，所述混合的环境温度低于25℃、相对湿度小于65％，料液温度低于30℃；
    优选的，将制备得到的DHA油脂组合物进行真空脱气处理；
    优选的，所述DHA油脂组合物的储存时间不大于2小时，并且在惰性气体环境下避光储存。
  6. 根据权利要求4或5所述的方法，其中，所述软胶囊的适用对象为孕产妇、婴幼儿和青少年，所述DHA油脂为微生物油脂，优选的，所述微生物油脂中DHA含量≥35重量％，优选的，所述微生物油脂为藻类来源的DHA油脂；
    所述软胶囊的适用对象为中老年，所述DHA油脂含有鱼油或者含有鱼油和藻油的混合物，优选的，所述鱼油中DHA含量≥12重量％。
  7. 根据权利要求4所述的方法，其中，步骤(1)中，所述溶胶的条件包括：温度为60-85℃，蒸汽压力小于0.2MPa，时间为40-50min；
    优选的，溶胶结束后，将得到的溶胶混合物在45-75℃的条件下进行过滤和真空脱气处理，并将过滤和真空脱气处理后的溶胶混合物进行保温；
    优选的，所述溶胶混合物的储存时间不大于48小时；
    优选的，所述明胶为药用明胶；
    优选的，所述明胶的动力值为180-200Bloom g。
  8. 根据权利要求4所述的方法，其中，步骤(2)中，所述灌注的条件包括：压丸环境温度为18-28℃，相对湿度不大于80％，胶皮冷却定型温度≤25℃；
    优选的，该方法还包括将得到的软胶囊进行干燥，所述干燥包括依次进行的一次 干燥和二次干燥；
    所述一次干燥的条件包括：湿度不大于80％，温度为26-32℃，时间为4-8小时；
    所述二次干燥的条件包括：湿度不大于45％，温度为30-45℃，时间为4-8小时；
    其中，一次干燥的湿度大于二次干燥的湿度，一次干燥的温度低于二次干燥的温度；
    优选的，该方法包括将干燥后的软胶囊采用食品级石油醚对得到的软胶囊进行清洗，以去除胶囊表面的残油；
    优选地，该方法包括将干燥后的软胶囊采用吸油布条对得到的胶囊进行搓洗，替代石油醚清洗来除胶囊表面的残油。
  9. 根据权利要求4所述的方法，其中，步骤(1)中，相对于100重量份的水，明胶粉的用量为80-120重量份、甘油的用量为35-50重量份，甘油与明胶的配料重量比为(35-50)：100。
  10. 根据权利要求4-8中任意一项所述的方法，其中，该方法还包括：将得到的软胶囊分装于不透光的包装瓶中，所述包装瓶中装有吸氧剂，且瓶口采用铝箔纸密封；或将得到的软胶囊分装于铝塑板中。
  11. 权利要求4-10中任意一项所述的方法制备得到的软胶囊，其中，所述软胶囊应用于婴幼儿、青少年和中老年不同的消费人群，所述软胶囊中过氧化值≤15meq/kg、酸价≤3mg/g、茴香胺值≤15。
PCT/CN2019/101031 2018-12-10 2019-08-16 Dha油脂组合物在软胶囊中的应用以及软胶囊及其制备方法 WO2020119164A1 (zh)

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