CN112075625B - Composition for improving memory, soft capsule and preparation method thereof - Google Patents

Composition for improving memory, soft capsule and preparation method thereof Download PDF

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Publication number
CN112075625B
CN112075625B CN202010950749.8A CN202010950749A CN112075625B CN 112075625 B CN112075625 B CN 112075625B CN 202010950749 A CN202010950749 A CN 202010950749A CN 112075625 B CN112075625 B CN 112075625B
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parts
content
soft capsule
gelatin
stirring
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CN112075625A (en
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陆文岐
蒋云云
何水杰
刘连生
张蕴
伍彪
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Joincare Pharmaceutical Group Industry Co ltd
Shenzhentaitai Pharmaceutical Industry Co ltd
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Joincare Pharmaceutical Group Industry Co ltd
Shenzhentaitai Pharmaceutical Industry Co ltd
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Abstract

The invention provides a composition for improving memory, a soft capsule and a preparation method thereof, wherein the composition comprises fish oil extract, phosphatidylserine, ginkgo leaf extract, vegetable oil and beeswax, the soft capsule can rapidly pass through blood brain barrier and enter the brain, and can relieve brain capillary smooth muscle cells, increase brain blood supply, improve brain blood oxygen content and DHA content, effectively improve memory, and simultaneously can play roles in regulating emotion and improving sleep quality, and is especially suitable for brain workers and elderly people with brain function degeneration.

Description

Composition for improving memory, soft capsule and preparation method thereof
Technical Field
The invention relates to the field of health-care foods, in particular to a composition for improving memory, a soft capsule and a preparation method thereof.
Background
Memory is a response of the human brain to things that go through, and memory decline can be divided into two categories, organic memory decline and functional memory decline. The organic memory decline is caused by an organic lesion or trauma in a part of the body; whereas the decrease in functional memory is mainly manifested by a decrease in memory due to dietary conditions, nutritional conditions, bad hobbies, stress, etc.
China has entered the population aging society from the 90 th century, and the aged population has grown at a rate of 3.13% of the year. It is estimated that by 2025, the elderly population in china can reach 2.18 billion, accounting for 18.14% of the total population. Research shows that after the old people walk into the brain, the cognitive and memory functions of the old people can decline to a certain extent due to the organic function decline of brain organs. Meanwhile, as the social competition is increasingly vigorous, the modern life and the movable joint become faster, the brain labor intensity of teenagers and adults is increased in learning and working, and factors such as work and rest, irregular diet, excessive psychological stress and the like are added to enable people to be in a sub-health state, so that the memory of the people is reduced when the people are in the sub-health state for a long time, and symptoms such as insomnia and depression can be accompanied.
In view of the above, it is important to develop a health food for improving memory and simultaneously aiding sleep and resisting depression.
Phosphatidylserine is the only rare phospholipid in the phospholipid family capable of regulating and controlling the functional state of key proteins of cell membranes, and has very small content (the total amount is about 60 g) in human bodies, but can influence the transmission of chemical information in the brain, and can help brain cells store and read data, and is an important nutritional element for maintaining the normal memory, response and healthy emotion of the brain, and is called as 'brain gold element'.
However, phosphatidylserine is a phospholipid material, is insoluble in water, but is dispersible in oil and fat, and thus the phosphatidylserine material is liable to generate bubbles during the preparation of soft capsules, and becomes pasty when the concentration thereof reaches a certain level, which is also a difficult problem during the preparation of soft capsules by using phosphatidylserine as a raw material.
Disclosure of Invention
The invention provides a composition taking fish oil (rich in DHA), phosphatidylserine and ginkgo leaf extract as main raw materials, a soft capsule and a preparation method thereof, wherein the invention scientifically designs application dosage, develops a soft capsule health-care food with stable quality through a soft capsule preparation technology, has obvious effect on improving memory through human trial feeding experiments, and simultaneously has the effects of helping sleep and resisting depression.
The technical scheme for achieving the purpose is as follows:
in one aspect, the present invention provides a composition for improving memory, the composition comprising fish oil extract, phosphatidylserine, ginkgo leaf extract, vegetable oil, beeswax;
Preferably, the composition comprises 123-372 parts of fish oil extract, 52-116 parts of phosphatidylserine, 23-68 parts of ginkgo leaf extract, 50-180 parts of vegetable oil and 3-13 parts of beeswax in parts by weight.
Preferably, the composition comprises, in parts by weight, 206-312 parts of fish oil extract, 72-98 parts of phosphatidylserine, 36-52 parts of ginkgo leaf extract, 76-134 parts of vegetable oil and 4-10 parts of beeswax.
Preferably, the composition comprises, in parts by weight, 236-291 parts of fish oil extract, 80-90 parts of phosphatidylserine, 38-43 parts of ginkgo leaf extract, 85-122 parts of vegetable oil and 6-9 parts of beeswax.
Preferably, the composition comprises 269.5 parts by weight of fish oil extract, 87.5 parts by weight of phosphatidylserine, 40 parts by weight of ginkgo leaf extract, 95.5 parts by weight of vegetable oil and 7.5 parts by weight of beeswax.
Preferably, in the fish oil extract, the content of DHA is 50-70% by mass percent;
preferably, in the phosphatidylserine, the content of the active ingredients is 55% -60% by mass percent;
preferably, in the ginkgo leaf extract, the total flavonol glycoside content is 24-26%, the terpene lactone content is 6-12% and the bilobalide content is 2-4% by mass percent; more preferably, the particle size of the ginkgo leaf extract is not less than 100 meshes, preferably 100-200 meshes, and even more preferably 160 meshes;
Preferably, the vegetable oil is selected from one or more of soybean oil, linseed oil, corn oil, rapeseed oil and rice bran oil, and further preferably, the vegetable oil is soybean oil.
In another aspect, the invention also provides a soft capsule taking the composition as a content, the soft capsule comprises the content and capsule shells, wherein the content comprises fish oil extract, phosphatidylserine, ginkgo leaf extract, vegetable oil and beeswax in parts by weight;
preferably, the content comprises 123-372 parts of fish oil extract, 52-116 parts of phosphatidylserine, 23-68 parts of ginkgo leaf extract, 50-180 parts of vegetable oil and 3-13 parts of beeswax in parts by weight.
Preferably, the content comprises 206-312 parts of fish oil extract, 72-98 parts of phosphatidylserine, 36-52 parts of ginkgo leaf extract, 76-134 parts of vegetable oil and 4-10 parts of beeswax in parts by weight.
Preferably, the contents comprise, in parts by weight, 236-291 parts of fish oil extract, 80-90 parts of phosphatidylserine, 38-43 parts of ginkgo leaf extract, 85-122 parts of vegetable oil and 6-9 parts of beeswax.
Preferably, the contents comprise 269.5 parts by weight of fish oil extract, 87.5 parts by weight of phosphatidylserine, 40 parts by weight of ginkgo leaf extract, 95.5 parts by weight of vegetable oil and 7.5 parts by weight of beeswax.
Preferably, in the fish oil extract, the DHA content is 50-70% by mass percent;
preferably, in the phosphatidylserine, the content of the active ingredients is 55% -60% by mass percent;
preferably, in the ginkgo leaf extract, the total flavonol glycoside content is 24-26%, the terpene lactone content is 6-12% and the bilobalide content is 2-4% by mass percent; more preferably, the particle size of the ginkgo leaf extract is not less than 100 meshes, preferably 100-200 meshes, and even more preferably 160 meshes;
preferably, the vegetable oil is selected from one or more of soybean oil, linseed oil, corn oil, rapeseed oil and rice bran oil, and further preferably, the vegetable oil is soybean oil;
preferably, the capsule shell is prepared from the following components in parts by weight: 156-432 parts of gelatin, 76-265 parts of glycerol, 158-506 parts of purified water, 0.24-2.1 parts of titanium dioxide and 2.6-10.3 parts of caramel color; more preferably, the capsule shell is prepared from a glue solution comprising the following components: 262-345 parts of gelatin, 112-163 parts of glycerin, 268-344 parts of purified water, 0.62-1.82 parts of titanium dioxide and 4.6-8.8 parts of caramel color; further preferably, the capsule shell is prepared from a glue solution comprising the following components: 281-336 parts of gelatin, 121-153 parts of glycerin, 291-334 parts of purified water, 0.72-1.43 parts of titanium dioxide and 5.6-7.8 parts of caramel color; still further preferably, the capsule skin is prepared from a glue solution comprising the following components: 310 parts of gelatin, 139.5 parts of glycerin, 310 parts of purified water, 0.93 part of titanium dioxide and 6.2 parts of caramel color.
In some preferred embodiments of the invention, the formulation per 1000 soft capsules is: 123-372g of fish oil extract, 52-116g of phosphatidylserine, 23-68g of ginkgo leaf extract, 50-180g of vegetable oil, 3-13g of beeswax, 156-432g of gelatin, 76-265g of glycerol, 158-506g of purified water, 0.24-2.1g of titanium dioxide and 2.6-10.3g of caramel color; wherein the particle size of the ginkgo leaf extract is not smaller than 100 meshes.
In other preferred embodiments of the present invention, the formulation per 1000 soft capsules is: 206-312g of fish oil extract, 72-98g of phosphatidylserine, 36-52g of ginkgo leaf extract, 76-134g of vegetable oil, 4-10g of beeswax, 262-345g of gelatin, 112-163g of glycerol, 268-344g of purified water, 0.62-1.82g of titanium dioxide and 4.6-8.8g of caramel color; wherein the particle size of the ginkgo leaf extract is 100-200 meshes.
In still other preferred embodiments of the present invention, the formulation per 1000 soft capsules is: 236-291g of fish oil extract, 80-90g of phosphatidylserine, 38-43g of ginkgo leaf extract, 85-122g of soybean oil, 6-9g of beeswax, 281-336g of gelatin, 121-153g of glycerin, 291-334g of purified water, 0.72-1.43g of titanium dioxide and 5.6-7.8g of caramel color; wherein the particle size of the ginkgo leaf extract is 100-200 meshes.
In still other preferred embodiments of the present invention, wherein each 1000 of the soft capsules are formulated as follows: 269.5g of fish oil extract, 87.5g of phosphatidylserine, 40g of ginkgo leaf extract, 95.5g of soybean oil, 7.5g of beeswax, 310g of gelatin, 139.5g of glycerin, 310g of purified water, 0.93g of titanium dioxide and 6.2g of caramel color; wherein the particle size of the ginkgo leaf extract is 160 meshes.
In another aspect, the present invention also provides a method for preparing the soft capsule, wherein the method comprises the preparation of the content, and the preparation of the content comprises the following steps:
(1) Heating beeswax and the first part of vegetable oil to a temperature of T1, and stirring to dissolve the beeswax in the vegetable oil completely to obtain an oil wax mixture A;
(2) Adding the formula amount of fish oil extract and the rest vegetable oil into a stirring tank, heating to the temperature of T2, stirring uniformly, adding the formula amount of phosphatidylserine and ginkgo leaf extract, stirring uniformly, and filtering to obtain a mixture B;
(3) Adding the oil wax mixture A obtained in the step (1) into the mixture B obtained in the step (2), stirring, filtering to obtain the content, and preserving at the temperature T3 for later use;
further, the method also comprises the preparation of glue solution, and the preparation of the glue solution comprises the following steps:
(i) Mixing the formula amount of titanium dioxide with the first part of purified water, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use;
(ii) Mixing the caramel color with a second part of purified water according to the formula amount, stirring and dissolving, and filling the obtained caramel color aqueous solution into a pigment barrel II for later use;
(iii) Adding the rest purified water, the titanium dioxide suspension obtained in the step (i), the caramel color aqueous solution obtained in the step (ii) and the glycerol with the formula amount into a gelatin melting tank, starting a stirring and hot water circulating system, heating the feed liquid in the gelatin melting tank to 65-75 ℃, adding gelatin with the formula amount, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70-80 ℃, preserving heat and stirring until the gelatin is completely dissolved;
(iv) Vacuumizing again after gelatin is completely dissolved, keeping the temperature at 60-70 ℃, discharging after the gelatin solution has no bubbles and the viscosity reaches 20000-35000 mpa.s, filtering the gelatin solution by a single-layer 100-mesh filter bag in the discharging process, and pressurizing the discharged gelatin solution to be not more than 0.06MPa; the glue solution is stored in a heat preservation barrel, and kept stand for 2-24 hours at 55-70 ℃.
Still further, the method also comprises the steps of pelleting, shaping and drying the content and the glue solution by a soft capsule machine. Preferably, the thickness of the capsule skin is controlled to be 0.75-0.80mm when the capsule is pressed into pills; still more preferably, the shaping is carried out for 2-3 hours; still further preferably, the drying is performed in a clean drying chamber having a temperature of 15-25 ℃ and a relative humidity of 20% -30%; still further preferably, the capsule shell is dried to a moisture of 7% to 9%.
Preferably, in step (1) of the preparation of the content, the first portion of vegetable oil is 1/10-6/10 of the formula amount, preferably 1/5-2/5, further preferably 2/5;
preferably, in step (1) of the preparation of the content, T1 is 55-70 ℃, preferably 55-60 ℃, further preferably 60 ℃;
preferably, in step (1) of the preparation of the content, the stirring time is 20-30min, preferably 20min;
preferably, in step (2) of the preparation of the content, T2 is 35-45 ℃, preferably 40 ℃;
preferably, in step (2) of the preparation of the content, a screen is used for filtration, more preferably the screen is 60-100 mesh, even more preferably 100 mesh;
preferably, in step (3) of the preparation of the content, the stirring time is 25-30min, preferably 30 min;
preferably, in step (3) of the preparation of the content, a screen is used for filtration, more preferably the screen is 100-120 mesh, still more preferably 120 mesh.
Preferably, in step (3) of the preparation of the content, T3 is between 35 and 50 ℃, preferably between 40 and 45 ℃;
preferably, in step (3) of preparation of the content, the viscosity of the content is 200mPas-600mPas, preferably 300mPas-400mPas;
Preferably, in step (i) of the preparation of the gum solution, the mass ratio of titanium dioxide to the first portion of purified water is 1:20-30 parts;
preferably, in step (ii) of the gum preparation, the mass ratio of caramel color to the second partially purified water is 1:20-30.
In still another aspect, the present invention also provides a composition and/or soft capsule according to the present invention and/or a soft capsule prepared by the method according to the present invention for improving memory, regulating emotion, improving sleep quality.
The beneficial effects of the invention at least comprise the following aspects:
1. the invention provides a composition taking fish oil extract, phosphatidylserine and ginkgo leaf extract as main raw materials and a soft capsule preparation thereof, which can rapidly pass through blood brain barrier and enter the brain, and has the effects of relieving cerebral capillary smooth muscle cells, increasing cerebral blood supply, improving cerebral blood oxygen content and DHA content, effectively improving memory, regulating emotion and improving sleep quality, and is especially suitable for brain workers and elderly people with brain function degeneration.
2. The invention also provides a preparation method of the soft capsule, and the prepared soft capsule preparation has high stability.
Detailed Description
The invention is further illustrated by the following examples, which are given solely for the purpose of illustration and are not intended to be limiting. The raw materials used in the following examples, unless otherwise specified, were all commercially available products. Wherein, the purchase condition and quality standard of part of raw materials are as follows:
fish oil extract: is an oily liquid prepared from edible marine fish by heating, cooking, squeezing, centrifuging, purifying, decolorizing, deodorizing, etc. The quality of the fish oil and the extract thereof meet the requirements of the Ministry of health on approval of 7 kinds of articles such as tea seed oil and the like as new resource food (2009 No. 18) in the Ministry of health. In a specific embodiment of the invention, the fish oil extract is from basf, germany, wherein the DHA content is 50% -70% by mass.
Phosphatidylserine (phosphatidylserine starting material): the preparation method comprises the steps of taking soybean lecithin and L-serine as raw materials, adopting phospholipase conversion reaction, purifying and concentrating, purifying for the second time, drying and packaging to obtain pale yellow powder. The quality standard of the food meets the requirements of the health department on the phosphatidylserine in the bulletins (15 th of 2010 of the health department bulletins) for approval of 3 articles such as sucrose polyester, corn oligopeptide powder and phosphatidylserine as new resource foods. In a specific embodiment of the present invention, phosphatidylserine is derived from israel An Saike company, and has an active ingredient content of 55-60% by mass.
Ginkgo leaf extract: is prepared from ginkgo leaf through continuous extraction, concentration, sedimentation, centrifugation, filtration, resin adsorption, concentration, drying, crushing, mixing, sieving, packaging and other processes, and the quality standard of the ginkgo leaf powder meets the requirements of the pharmacopoeia of the people's republic of China. In the specific embodiment of the invention, the ginkgo leaf extract is from technical source science and technology (China) limited company, and the total flavonol glycoside content is 24-26%, the terpene lactone content is 6-12% and the bilobalide content is 2-4% by mass.
Gelatin used in specific embodiments of the invention meets the GB 6783 standard requirements, glycerol meets the GB 29950 standard requirements, soybean oil meets the GB/T1535 standard requirements, corn oil meets the GB/T19111 standard requirements, rapeseed oil meets the GB/T1536 standard requirements, rice bran oil meets the GB/T19112 standard requirements, linseed oil meets the GB/T8235 standard requirements, beeswax meets the GB 1886.87 standard requirements, caramel color meets the GB 1886.64 standard requirements, and titanium dioxide meets the GB 25577 standard requirements.
Examples 1 to 17Recipe screening
In examples 1-17 below, a composition for improving memory and a soft capsule preparation containing such a composition as a content are provided. Wherein the formula comprises: the composition of the 1000-granule formulation of the content of the soft capsule is shown in table 1; the composition of the 1000 capsule skin formulations of the soft capsules is shown in Table 2.
The preparation method comprises the following steps: the corresponding soft capsules of examples 1-17 were prepared as follows:
1. preparing glue solution:
adding titanium dioxide into purified water with the weight being 30 times that of the titanium dioxide, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use.
Adding caramel color into purified water with the weight of 30 times, stirring and dissolving, and filling the obtained caramel color aqueous solution into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color water solution and glycerol into a gelatin dissolving tank, starting a stirring and hot water circulating system, heating to 75 ℃, adding gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 80 ℃, stirring until gelatin is completely dissolved, vacuumizing again, maintaining the temperature at 70 ℃, discharging after the gelatin solution has no bubbles and the viscosity reaches 35000mpa.s, filtering by using a single-layer 100-mesh filter bag in the discharging process of the gelatin solution, and pressurizing the discharged material to be not more than 0.06MPa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 70 ℃ and standing for 24 hours.
2. Preparation of the content:
(1) Heating Cera flava and 2/5 of vegetable oil according to formula shown in Table 1 to 60deg.C, stirring for 20min to completely dissolve Cera flava in vegetable oil to obtain oil wax mixture A.
(2) Adding fish oil extract and residual vegetable oil to 40deg.C according to formula amount shown in Table 1, stirring, adding phosphatidylserine, stirring, adding folium Ginkgo extract, stirring, and filtering with 100 mesh sieve to obtain mixture B.
(3) Adding the oil wax mixture A into the mixture B, stirring for 30min, filtering with 120 mesh sieve to obtain content, measuring viscosity of 200mpas-600mpas, and storing at 40-45deg.C;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 3 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 25 ℃ and the relative humidity of 30 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Table 1: examples 1-17 content (1000) formulation (Unit: g)
Figure BDA0002676790040000091
Note that: the particle diameters of the ginkgo leaf extract are 160 meshes, 100 meshes, 200 meshes and 300 meshes in the table a, b, c, d. "/" indicates that no such material was added.
Table 2: examples 1-17 Capsule skin (1000 granules) formulation (Unit: g)
Sequence number Titanium dioxide Caramel color Purified water Glycerol Gelatin
Example 1 0.93 6.2 310 139.5 310
Example 2 1.43 7.8 334 153 336
Example 3 0.72 5.6 291 121 281
Example 4 1.82 8.8 344 163 345
Example 5 0.62 4.6 268 112 262
Example 6 2.1 10.3 506 265 432
Example 7 0.24 2.6 158 76 156
Example 8 2.1 10.3 506 265 432
Example 9 0.24 2.6 158 76 156
Example 10 2.1 10.3 506 265 432
Example 11 0.24 2.6 158 76 156
Example 12 2.1 10.3 506 265 432
Example 13 0.24 2.6 158 76 156
Example 14 2.1 10.3 506 265 432
Example 15 0.24 2.6 158 76 156
Example 16 2.1 10.3 506 265 432
Example 17 0.24 2.6 158 76 156
Example 18
The embodiment provides a composition for improving memory and a soft capsule preparation taking the composition as a content. Wherein the formula comprises: the composition of the 1000-granule formulation of the content of the soft capsule comprises 269.5g of fish oil extract, 87.5g of phosphatidylserine, 40g of ginkgo leaf extract, 95.5g of soybean oil and 7.5g of beeswax; the 1000-granule formula of the capsule skin of the soft capsule comprises 310g of gelatin, 139.5g of glycerol, 310g of purified water, 0.93g of titanium dioxide and 6.2g of caramel color. Wherein the particle size of the ginkgo leaf extract is 160 meshes.
The preparation method comprises the following steps: the soft capsule of this example was prepared as follows:
1. preparing glue solution:
0.93g of titanium dioxide is added into 18.6g of purified water, the mixture is stirred uniformly and filtered, and the obtained titanium dioxide suspension is filled into a pigment barrel I for standby.
6.2g of caramel color is added into 124g of purified water, stirred and dissolved, and the obtained caramel color aqueous solution is filled into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color water solution and 139.5g glycerol into a glue dissolving tank, starting a stirring and hot water circulating system, heating to 65 ℃, adding 310g gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70 ℃, stirring until the gelatin is completely dissolved, vacuumizing again, maintaining the temperature at 60 ℃, discharging after the glue solution has no bubbles and the viscosity reaches 20000mpa.s, filtering by using a single-layer 100-mesh filter bag in the glue solution discharging process, and discharging and pressurizing to be not more than 0.06Mpa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 55 ℃ and standing for 2 hours.
2. Preparation of the content:
(1) Heating 7.5g beeswax and 19.1g soybean oil to 60deg.C, stirring for 20min to completely dissolve beeswax in vegetable oil to obtain oil wax mixture A.
(2) Adding 269.5g of fish oil extract and the rest of vegetable oil to 40 ℃, uniformly stirring, adding 87.5g of phosphatidylserine, uniformly stirring, adding 40g of ginkgo leaf extract, uniformly stirring, and filtering by using a 100-mesh screen to obtain a mixture B for later use.
(3) Adding the oil wax mixture A into the mixture B, stirring for 30min, filtering with 120 mesh sieve to obtain content with viscosity of 345Mpas, and storing at 40-45deg.C;
3. And (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 2 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 15 ℃ and the relative humidity of 20 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Example 19
The embodiment provides a composition for improving memory and a soft capsule preparation taking the composition as a content. Wherein the formula comprises: the composition of the 1000-granule formulation of the soft capsule comprises 372g of fish oil extract, 52g of phosphatidylserine, 23g of ginkgo leaf extract, 50g of vegetable oil (10 g of soybean oil, 10g of linseed oil, 10g of corn oil, 10g of rapeseed oil, 10g of rice bran oil) and 3g of beeswax; the 1000-granule formula of the capsule skin of the soft capsule comprises 432g of gelatin, 265g of glycerol, 506g of purified water, 2.1g of titanium dioxide and 10.3g of caramel color. Wherein the particle size of the ginkgo leaf extract is 300 meshes.
The preparation method comprises the following steps: the soft capsule of this example was prepared as follows:
1. preparing glue solution:
2.1g of titanium dioxide is added into 63g of purified water, stirred evenly, filtered, and the obtained titanium dioxide suspension is filled into a pigment barrel I for standby.
10.3g of caramel color is added into 309g of purified water, stirred and dissolved, and the obtained caramel color aqueous solution is filled into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color aqueous solution and 265g glycerol into a glue dissolving tank, starting a stirring and hot water circulating system, heating to 75 ℃, adding 432g gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 80 ℃, vacuumizing again after the gelatin is completely dissolved, maintaining the temperature at 70 ℃ until the glue solution has no bubbles and the viscosity reaches 35000mpa.s, discharging, filtering by using a single-layer 100-mesh filter bag in the glue solution discharging process, and discharging and pressurizing to be not more than 0.06Mpa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 70 ℃ and standing for 24 hours.
2. Preparation of the content:
(1) Heating 3g of beeswax and 30g of vegetable oil to 70 ℃, and stirring for 30min to completely dissolve the beeswax in the vegetable oil to obtain an oil wax mixture A for later use.
(2) 372g of fish oil extract and the rest of vegetable oil are added to 45 ℃, 52g of phosphatidylserine is added after uniform stirring, 23g of ginkgo leaf extract is added after uniform stirring, and a 100-mesh screen is used for filtering to obtain a mixture B for standby.
(3) Adding the oil wax mixture A into the mixture B, stirring for 30min, filtering with 120 mesh sieve to obtain content with viscosity of 203mpas, and storing at 45-50deg.C;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 3 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 25 ℃ and the relative humidity of 30 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Example 20
The embodiment provides a composition for improving memory and a soft capsule preparation taking the composition as a content. Wherein the formula comprises: the composition of the 1000-granule formulation of the soft capsule comprises 372g of fish oil extract, 52g of phosphatidylserine, 23g of ginkgo leaf extract, 50g of vegetable oil (10 g of soybean oil, 10g of linseed oil, 10g of corn oil, 10g of rapeseed oil, 10g of rice bran oil) and 3g of beeswax; the 1000-granule formula of the capsule skin of the soft capsule comprises 432g of gelatin, 265g of glycerol, 506g of purified water, 2.1g of titanium dioxide and 10.3g of caramel color. Wherein the particle size of the ginkgo leaf extract is 300 meshes.
The preparation method comprises the following steps: the soft capsule of this example was prepared as follows:
1. Preparing glue solution:
2.1g of titanium dioxide is added into 42g of purified water, stirred uniformly, filtered, and the obtained titanium dioxide suspension is filled into a pigment barrel I for standby.
10.3g of caramel color is added into 206g of purified water, stirred and dissolved, and the obtained caramel color aqueous solution is filled into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color aqueous solution and 265g glycerol into a glue dissolving tank, starting a stirring and hot water circulating system, heating to 65 ℃, adding 432g gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70 ℃, vacuumizing again after the gelatin is completely dissolved, maintaining the temperature at 60 ℃ after the gelatin is stirred, discharging after the gelatin is bubble-free and the viscosity reaches 20000mpa.s, filtering by using a single-layer 100-mesh filter bag in the discharging process of the gelatin, and discharging and pressurizing to be not more than 0.06Mpa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 55 ℃ and standing for 2 hours.
2. Preparation of the content:
(1) Heating 3g of beeswax and 5g of vegetable oil to 55deg.C, and stirring for 20min to dissolve beeswax completely in vegetable oil to obtain oil wax mixture A.
(2) 372g of fish oil extract and the rest of vegetable oil are added to 35 ℃, 52g of phosphatidylserine is added after uniform stirring, 23g of ginkgo leaf extract is added after uniform stirring, and a 60-mesh screen is used for filtering to obtain a mixture B for standby.
(3) Adding the oil wax mixture A into the mixture B, stirring for 25min, filtering with 100 mesh sieve to obtain content with viscosity of 216mpas, and storing at 35-40deg.C for use;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 2 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 15 ℃ and the relative humidity of 20 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Example 21
The embodiment provides a composition for improving memory and a soft capsule preparation taking the composition as a content. Wherein the formula comprises: the composition of the 1000-granule formulation of the soft capsule comprises 123g of fish oil extract, 116g of phosphatidylserine, 68g of ginkgo leaf extract, 180g of vegetable oil (30 g of soybean oil, 30g of linseed oil, 40g of corn oil, 40g of rapeseed oil, 40g of rice bran oil) and 13g of beeswax; the 1000-granule formula of the capsule skin of the soft capsule comprises 156g of gelatin, 76g of glycerol, 158g of purified water, 0.24g of titanium dioxide and 2.6g of caramel color. Wherein the particle size of the ginkgo leaf extract is 100 meshes.
The preparation method comprises the following steps: the soft capsule of this example was prepared as follows:
1. Preparing glue solution:
adding 0.24g of titanium dioxide into 7.2g of purified water, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use.
2.6g of caramel color is added into 78g of purified water, stirred and dissolved, and the obtained caramel color aqueous solution is filled into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color water solution and 76g of glycerol into a glue dissolving tank, starting a stirring and hot water circulating system, heating to 75 ℃, adding 156g of gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 80 ℃, stirring until the gelatin is completely dissolved, vacuumizing again, maintaining the temperature at 70 ℃, discharging after the glue solution has no bubbles and the viscosity reaches 35000mpa.s, filtering by using a single-layer 100-mesh filter bag in the glue solution discharging process, and discharging and pressurizing to be not more than 0.06Mpa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 70 ℃ and standing for 24 hours.
2. Preparation of the content:
(1) 13g of beeswax and 108g of vegetable oil are heated to 70 ℃ and stirred for 30min, so that the beeswax is completely dissolved in the vegetable oil to obtain an oil-wax mixture A for later use.
(2) Adding 123g of fish oil extract and the rest of vegetable oil to 45 ℃, uniformly stirring, adding 116g of phosphatidylserine, uniformly stirring, adding 68g of ginkgo leaf extract, uniformly stirring, and filtering by using a 100-mesh screen to obtain a mixture B for later use.
(3) Adding the oil wax mixture A into the mixture B, stirring for 30min, filtering with 120 mesh sieve to obtain content with viscosity of 412mpas, and storing at 45-50deg.C;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 3 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 25 ℃ and the relative humidity of 30 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Example 22
The embodiment provides a composition for improving memory and a soft capsule preparation taking the composition as a content. Wherein the formula comprises: the composition of the 1000-granule formulation of the soft capsule comprises 123g of fish oil extract, 116g of phosphatidylserine, 68g of ginkgo leaf extract, 180g of vegetable oil (30 g of soybean oil, 30g of linseed oil, 40g of corn oil, 40g of rapeseed oil, 40g of rice bran oil) and 13g of beeswax; the 1000-granule formula of the capsule skin of the soft capsule comprises 156g of gelatin, 76g of glycerol, 158g of purified water, 0.24g of titanium dioxide and 2.6g of caramel color. Wherein the particle size of the ginkgo leaf extract is 100 meshes.
The preparation method comprises the following steps: the soft capsule of this example was prepared as follows:
1. Preparing glue solution:
adding 0.24g of titanium dioxide into 4.8g of purified water, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use.
2.6g of caramel color is added into 52g of purified water, stirred and dissolved, and the obtained caramel color aqueous solution is filled into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color water solution and 76g of glycerol into a glue dissolving tank, starting a stirring and hot water circulating system, heating to 65 ℃, adding 156g of gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70 ℃, stirring until the gelatin is completely dissolved, vacuumizing again, maintaining the temperature at 60 ℃, discharging after the glue solution has no bubbles and the viscosity reaches 20000mpa.s, filtering by using a single-layer 100-mesh filter bag in the glue solution discharging process, and discharging and pressurizing to be not more than 0.06Mpa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 55 ℃ and standing for 2 hours.
2. Preparation of the content:
(1) 13g of beeswax and 18g of vegetable oil are heated to 55 ℃ and stirred for 20min, so that the beeswax is completely dissolved in the vegetable oil to obtain an oil-wax mixture A for later use.
(2) Adding 123g of fish oil extract and the rest of vegetable oil to 35 ℃, uniformly stirring, adding 116g of phosphatidylserine, uniformly stirring, adding 68g of ginkgo leaf extract, uniformly stirring, and filtering by using a 60-mesh screen to obtain a mixture B for later use.
(3) Adding the oil wax mixture A into the mixture B, stirring for 25min, filtering with 100 mesh sieve to obtain content with viscosity of 429mpas, and storing at 35-40deg.C;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 2 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 15 ℃ and the relative humidity of 20 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
Comparative examples 1 to 6:
comparative examples 1-6 below provide a composition for improving memory and soft capsule formulations containing such a composition as a content and containing the combination. Wherein the formula comprises: the composition of the memory improving composition and the composition of the soft capsule per 1000 capsules are shown in table 3; the formula of the capsule skin of the soft capsule comprises 310g of gelatin, 139.5g of glycerol, 310g of purified water, 0.93g of titanium dioxide and 6.2g of caramel color.
The preparation method comprises the following steps:
the corresponding soft capsules of comparative examples 1-2 were prepared as follows:
1. preparing glue solution:
adding titanium dioxide into purified water with the weight being 30 times that of the titanium dioxide, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use.
Adding caramel color into purified water with the weight of 30 times, stirring and dissolving, and filling the obtained caramel color aqueous solution into a pigment barrel II for standby.
Adding the rest purified water, titanium dioxide suspension, caramel color water solution and glycerol into a gelatin dissolving tank, starting a stirring and hot water circulating system, heating to 75 ℃, adding gelatin, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 80 ℃, stirring until gelatin is completely dissolved, vacuumizing again, maintaining the temperature at 70 ℃, discharging after the gelatin solution has no bubbles and the viscosity reaches 35000mpa.s, filtering by using a single-layer 100-mesh filter bag in the discharging process of the gelatin solution, and pressurizing the discharged material to be not more than 0.06MPa. And storing the prepared glue solution in a heat-preserving barrel, preserving heat at 70 ℃ and standing for 24 hours.
2. Preparation of the content:
(1) Heating Cera flava and 2/5 of vegetable oil according to formula shown in Table 3 to 60deg.C, stirring for 20min to completely dissolve Cera flava in vegetable oil to obtain oil wax mixture A.
(2) Adding fish oil extract and residual vegetable oil to 40deg.C according to formula amount shown in Table 3, stirring, adding phosphatidylserine, stirring, adding folium Ginkgo extract, stirring, and filtering with 100 mesh sieve to obtain mixture B.
(3) Adding the oil wax mixture A into the mixture B, stirring for 30min, filtering with 120 mesh sieve to obtain content with viscosity of 150-700mpas, and storing at 35-50deg.C;
3. and (3) pelleting:
the soft capsule content and the glue solution are subjected to pelleting molding by a soft capsule machine, and the thickness of the capsule skin is controlled to be 0.75-0.80 mm;
4. shaping:
presetting the pressed soft capsule for 3 hours;
5. and (3) drying:
the prepared soft capsule is placed in a clean drying chamber with the temperature of 25 ℃ and the relative humidity of 30 percent for drying, and the capsule skin is dried until the moisture is 7 to 9 percent.
The corresponding soft capsules of comparative examples 3-4 were prepared as follows:
the preparation method of the soft capsule described in comparative examples 3 to 4 comprises the following steps (2) in the preparation of the content: adding the rest vegetable oil to 40deg.C according to the formula shown in Table 3, adding phosphatidylserine, stirring, adding folium Ginkgo extract, stirring, and filtering with 100 mesh sieve to obtain mixture B. The other steps were the same as in comparative examples 1-2.
The corresponding soft capsules of comparative example 5 were prepared as follows:
the preparation method of the soft capsule of the comparative example comprises the following steps of: adding fish oil extract and residual vegetable oil to 40deg.C according to formula amount shown in Table 3, stirring, adding phosphatidylserine, stirring, and filtering with 100 mesh sieve to obtain mixture B. The other steps were the same as in comparative examples 1-2.
The corresponding soft capsules of comparative example 6 were prepared as follows:
the preparation method of the soft capsule of the comparative example comprises the following steps of: adding fish oil extract and residual vegetable oil to 40deg.C according to formula shown in Table 3, stirring, adding folium Ginkgo extract, stirring, and filtering with 100 mesh sieve to obtain mixture B. The other steps were the same as in comparative examples 1-2.
Table 3: composition of 1000 granule formulations of Soft Capsule Contents of comparative examples 1-6 (Unit: g)
Figure BDA0002676790040000191
Note that: the particle sizes of the ginkgo leaf extract are 160 meshes, 100 meshes and 200 meshes respectively. "/" indicates that no such material was added.
Comparative example 7
The comparative example provides a composition for improving memory and soft capsule preparation containing the composition as content. Wherein the formula comprises: the memory improving composition and the soft capsule comprise the following components in per 1000 capsules: 68g of ginkgo leaf extract with the particle size of 60 meshes and the other components being the same as in example 7; the formulation composition of the capsule skin of the soft capsule is the same as that of example 7.
In the preparation method of the soft capsule according to this comparative example, in the preparation step (3) of the content, filtration was performed using a 60 mesh sieve, and the other steps were the same as in example 7.
Comparative example 8
The comparative example provides a composition for improving memory and soft capsule preparation containing the composition as content. Wherein the formula comprises: the composition of the memory improving composition and the composition of the soft capsule per 1000 capsules are the same as in example 7; the formulation composition of the capsule skin of the soft capsule is the same as that of example 7.
In the preparation method of the soft capsule according to this comparative example, in the preparation step (2) of the content, the temperature was heated to 80℃and the other steps were the same as in example 7.
Comparative example 9
The comparative example provides a composition for improving memory and soft capsule preparation containing the composition as content. Wherein the formula comprises: the composition of the memory improving composition and the composition of the soft capsule per 1000 capsules are the same as in example 7; the formulation composition of the capsule skin of the soft capsule is the same as that of example 7.
The preparation method comprises the following steps: the corresponding soft capsules of this comparative example were prepared as follows:
1. preparing glue solution:
adding glycerol, purified water and gelatin into a gelatin dissolving tank, heating to 75deg.C to obtain gelatin solution, adding titanium dioxide and caramel into the gelatin solution, stirring at constant temperature for 45 min to obtain gelatin solution mixture, vacuumizing the gelatin solution mixture, controlling vacuum degree to above-0.06 Mpa, closing vacuum, opening exhaust valve, detecting gelatin solution viscosity at 2.8 ten thousand mPas, filtering the gelatin solution with 90 mesh filter bag, and keeping the temperature of the gelatin solution at 58deg.C for use;
2. Preparation of the content:
adding fish oil extract, phosphatidylserine, folium Ginkgo extract, soybean oil, and Cera flava into a mixing tank, stirring for 22 min to obtain total mixture of the contents, grinding, and filtering;
3. and (3) pelleting:
pressing the total mixture of the contents and the glue solution into soft capsules in a rolling mode soft capsule machine, wherein the dosage of the composition is 500 mg/granule;
4. shaping:
setting the pressed soft capsule at the controlled temperature of 21 ℃ and relative humidity of 28% for 3.5 hours;
5. and (3) drying:
and (3) carrying out ventilation drying on the shaped capsules at the temperature of 21 ℃ and the relative humidity of 25%.
Test example 1: soft capsule content test
The soft capsules prepared in examples 1 to 22 and comparative examples 1 to 9 were taken, and the properties, flowability, viscosity (viscosity of the content measured at normal temperature by a viscometer) and sedimentation ratio (measured according to the edition 2015 annex of the "chinese pharmacopoeia") of the contents were measured and recorded, while the soft capsules prepared in examples 1 to 22 and comparative examples 1 to 6 were examined for appearance and difference in the contents (measured according to the edition 2015 annex of the "chinese pharmacopoeia") and the test results were shown in table 4.
Table 4: soft capsule contents and test results of Soft capsules prepared in examples 1 to 22 and comparative examples 1 to 9
Figure BDA0002676790040000211
Figure BDA0002676790040000221
And (3) injection: in the table "/" indicates that the soft capsule cannot be produced because the content cannot meet the production requirements, "#" indicates that the content has too many bubbles to perform the sedimentation ratio test, and "×" indicates that the content is divided into multiple layers to perform the sedimentation ratio test.
Test example 2:stability test
Testing the specification of a sample: 0.5 g/grain, 60 grains/bottle
Inspection item: DHA, total flavonol glycoside and phosphatidylserine
Acceleration test conditions: temperature: 37±2 ℃, relative humidity: 75% ± 5%
Detection result: as shown in table 5.
Table 5: stability detection result (measurement unit: g/100 g) of marker ingredient in prepared soft capsule for improving memory
Figure BDA0002676790040000222
Conclusion: from Table 5, it can be seen that the content of the marking components DHA, total flavonol glycosides and phosphatidylserine in the soft capsule provided by the invention is changed within a controllable range under the conditions of high temperature and high humidity. Therefore, the compatibility stability between the raw materials and the auxiliary materials of the soft capsule provided by the invention is higher, and the product quality meets the requirements.
Test example 3:human body test food test for assisting in improving memory function
1. Sample: the soft capsules prepared in examples 1, 6, 7 and 18 and comparative examples 2, 4, 5 and 6 and placebo (control group) which are substantially identical in package, appearance and taste were administered 1 time a day, 3 tablets each time, and orally.
2. A subject: age 18-65 years, unlimited sex, good physical health condition, no long-term medicine taking history, no test of memory quotient, no medicine or health care product for improving memory, and 90 subjects in total are ensured to cooperate in voluntary test.
3. The test method comprises the following steps: a control, double-blind, random design method was used. The test diet group and the control group were randomly divided according to the memory quotient, 10 persons each were continuously taken for 30 days, and then a memory-related test was performed.
4. And (3) observing the indexes:
(1) Safety index: general conditions, blood routine, urine routine, fecal routine, blood biochemical tests, electrocardiography, abdominal B-ultrasound, chest radiography, and the like.
(2) Efficacy index: testing the original score using a clinical memory scale, testing the original score with each score after testing: direction memory, associative learning, free recall of images, recall of nonsensical images, and associative recall of portrait features. The total amount of the test amounts are added, and the memory quotient is checked by the total amount.
5. Data statistics: the SPSS statistical software is adopted to carry out statistical processing analysis on the data obtained by the research, the measurement data is represented by mean value +/-standard deviation, the t test is adopted, the counting data is tested by chi-square, and when P is less than 0.05, the difference is obvious, so that the statistical significance is realized.
6. Results:
after subjects took the soft capsules for 30 consecutive days to improve memory, the test panel image recall scale and memory quotient were both higher than the pre-test and post-test control (tables 6 and 7), with the differences of examples 1, 6, 7, 18 being "very significant" (P < 0.01) and the differences of comparative examples 2, 4, 5, 6 being "significant" (P < 0.05). After the test, the safety indexes of blood, urine, stool, blood biochemistry, electrocardiogram, B ultrasonic and the like are not obviously changed abnormally, and obvious adverse reactions are not found during the test. According to the evaluation standard of "health food inspection and evaluation technical Specification" (2003 edition), the soft capsule for improving memory provided by the invention is suggested to have the function of assisting in improving memory, and examples 1, 6, 7 and 18 have stronger assisting in improving memory than comparative examples 2, 4, 5 and 6.
Table 6: influence of soft capsule for improving memory on free recall of images
Group of Before the test After the test
Control group 10.84±6.67 12.20±5.75
Example 1 group 10.65±6.52 15.82±5.14 **##
Example 18 group 10.21±5.93 15.46±5.75 **##
Example 6 group 10.68±6.82 14.21±4.84 **##
Example 7 group 10.35±6.31 14.13±5.01 **##
Comparative example 2 group 10.95±6.53 12.96±4.06 *#
Comparative example 4 group 10.92±6.27 12.89±5.04 *#
Comparative example 5 group 10.87±6.13 13.03±5.21 *#
Comparative example 6 group 10.85±6.62 12.95±5.11 *#
TABLE 7 influence of memory improving Soft capsules on memory quotient
Group of Before the test After the test
Control group 75.78±20.41 82.58±17.80
Example 1 group 75.48±18.21 92.12±15.93 **##
Example 18 group 74.48±17.81 91.63±16.23 **##
Example 6 group 75.94±18.41 90.08±15.43 **##
Example 7 group 74.98±18.01 90.13±16.17 **##
Comparative example 2 group 75.12±17.08 88.6±15.17 *#
Comparative example 4 group 74.12±16.78 87.5±15.27 *#
Comparative example 5 group 75.36±17.09 88.2±15.62 *#
Comparative example 6 group 75.85±17.34 88.6±15.23 *#
Note that: compared with the control group, P is less than 0.01, compared with the control group before self-trial feeding, the # P is less than 0.01,
p < 0.05 compared to control group and #p < 0.05 compared to self-test diet.
Test example 4:human body test food test with sleep aiding function
1. Sample: the soft capsules prepared in examples 1, 6, 7 and 18 and comparative examples 2, 4, 5 and 6 and placebo (control group) which are substantially identical in package, appearance and taste were administered 1 time a day, 3 tablets each time, and orally.
2. A subject: age 18-65 years, unlimited sex, good physical health condition, no long-term medicine taking history, evaluation score of > 7 points through Pittsburgh sleep quality index scale (Pittsburgh Sleep Quality Index, PQSI) and no sedative hypnotic medicine is taken recently.
3. The test method comprises the following steps: a control, double-blind, random design method was used. The animals were divided into a control group and a test diet group according to a random number method, and each group was taken for 30 days by 10 persons.
4. And (3) observing the indexes:
the improvement of sleep quality before and after treatment in the control group and the test group was evaluated by the pittsburgh sleep quality index scale (PQSI scale).
5. Data statistics: the SPSS statistical software is adopted to carry out statistical processing analysis on the data obtained by the research, the measurement data is represented by mean value +/-standard deviation, the t test is adopted, the counting data is tested by chi-square, and when P is less than 0.05, the difference is obvious, so that the statistical significance is realized.
6. Results:
the PQSI scores of the post-treatment observations were significantly reduced compared to the control and pre-treatment scores, the differences of examples 1, 6, 7, 18 were "very significant" (P < 0.01), the differences of comparative examples 2, 4, 5, 6 were "significant" (P < 0.05), the differences of the group comparisons were statistically significant (P < 0.05), and the improvement of sleep performance of examples 1, 6, 7, 18 was greater than that of comparative examples 2, 4, 5, 6, suggesting that the product had better sleep performance improvement, as specified in table 8 below.
Table 8:
group of Before the test After the test
Control group 7.96±2.16 7.65±2.19
Example 1 group 8.12±2.25 4.13±1.23**##
Example 18 group 7.99±2.15 4.15±1.47**##
Example 6 group 7.86±2.08 4.82±1.36*##
Example 7 group 8.06±2.23 4.86±1.38*##
Comparative example 2 group 7.85±2.21 6.46±1.43
Comparative example 4 group 8.15±2.01 6.51±1.53
Comparative example 5 group 8.28±2.13 6.69±1.41
Comparative example 6 group 8.10±2.18 6.78±1.38
Note that: compared with the control group, P is less than 0.01, compared with the control group before self-trial feeding, the # P is less than 0.01,
p < 0.05 compared to control group and #p < 0.05 compared to self-test diet.
Test example 5 : human body test food test with antidepressant function
1. Sample: the soft capsules prepared in examples 1, 6, 7 and 18 and comparative examples 2, 4, 5 and 6 and placebo (control group) which are substantially identical in package, appearance and taste were administered 1 time a day, 3 tablets each time, and orally.
2. A subject: the age is 18-65 years old, the sex is unlimited, the physical health condition is good, the long-term medicine taking history is avoided, the diagnosis of the Chinese mental disorder classification and diagnosis standard is confirmed by relevant examination, the grade of the Hamd of the Hamiltonian depression scale is more than or equal to 20 minutes, and the antipsychotic medicine is not used.
3. The test method comprises the following steps: a control, double-blind, random design method was used. The animals were divided into a control group and a test diet group according to a random number method, and each group was taken for 30 days by 10 persons.
4. And (3) observing the indexes:
the hamiltonian depression scale (HAMD scale) was performed to evaluate the symptoms of depression in the control group and the test group. This scale contains 4 factors, respectively: the higher the score, the more severe the symptoms of depression are suggested to be sleep, cognitive disorders, mood and anxiety.
5. Data statistics: the SPSS statistical software is adopted to carry out statistical processing analysis on the data obtained by the research, the measurement data is represented by mean value +/-standard deviation, the t test is adopted, the counting data is tested by chi-square, and when P is less than 0.05, the difference is obvious, so that the statistical significance is realized.
6. Results:
the observed after treatment had significantly reduced scores compared to the control and pre-treatment, the differences of examples 1, 6, 7, 18 were "very significant" (P < 0.01), the differences of comparative examples 2, 4, 5, 6 were "significant" (P < 0.05), the differences of the comparisons between groups were all statistically significant (P < 0.05), and the antidepressant function of examples 1, 6, 7, 18 was stronger than that of comparative examples 2, 4, 5, 6, suggesting that the product had better antidepressant function, as specified in table 9 below.
Table 9:
Figure BDA0002676790040000261
Figure BDA0002676790040000271
note that: compared with the control group, P is less than 0.01, compared with the control group before self-trial feeding, the # P is less than 0.01,
p < 0.05 compared to control group and #p < 0.05 compared to self-test diet.
The present invention includes, but is not limited to, the embodiments described above, and any products, methods, and so forth that are consistent with the description of the claims fall within the scope of the invention.

Claims (42)

1. A soft capsule comprising a content and a capsule shell, wherein the content comprises, in parts by weight: 206-312 parts of fish oil extract, 72-98 parts of phosphatidylserine, 36-52 parts of ginkgo leaf extract, 76-134 parts of vegetable oil and 4-10 parts of beeswax;
the capsule skin is prepared from the following glue solution: 156-432 parts of gelatin, 76-265 parts of glycerol, 158-506 parts of purified water, 0.24-2.1 parts of titanium dioxide and 2.6-10.3 parts of caramel color;
The glue solution is prepared by a method comprising the following steps:
(i) Mixing the formula amount of titanium dioxide with the first part of purified water, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use;
(ii) Mixing the caramel color with a second part of purified water according to the formula amount, stirring and dissolving, and filling the obtained caramel color aqueous solution into a pigment barrel II for later use;
(iii) Adding the rest purified water, the titanium dioxide suspension obtained in the step (i), the caramel color aqueous solution obtained in the step (ii) and the glycerol with the formula amount into a gelatin melting tank, starting a stirring and hot water circulating system, heating the feed liquid in the gelatin melting tank to 65-75 ℃, adding gelatin with the formula amount, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70-80 ℃, preserving heat and stirring until the gelatin is completely dissolved;
(iv) Vacuumizing again after gelatin is completely dissolved, keeping the temperature at 60-70 ℃, discharging after the gelatin solution has no bubbles and the viscosity reaches 20000-35000 mpa.s, filtering the gelatin solution by a single-layer 100-mesh filter bag in the discharging process, and pressurizing the discharged gelatin solution to be not more than 0.06MPa; the glue solution is stored in a heat preservation barrel, and kept stand for 2-24 hours at 55-70 ℃.
2. The soft capsule of claim 1, wherein the contents comprise, in parts by weight, 236-291 parts of fish oil extract, 80-90 parts of phosphatidylserine, 38-43 parts of ginkgo leaf extract, 85-122 parts of vegetable oil, and 6-9 parts of beeswax.
3. The soft capsule of claim 2, wherein the contents comprise 269.5 parts by weight of fish oil extract, 87.5 parts of phosphatidylserine, 40 parts of ginkgo leaf extract, 95.5 parts of vegetable oil, and 7.5 parts of beeswax.
4. The soft capsule of claim 1, wherein the content of DHA in the fish oil extract is 50% -70% by mass.
5. The soft capsule according to claim 1, wherein the content of the effective component in the phosphatidylserine is 55% -60% by mass.
6. The soft capsule of claim 1, wherein the ginkgo leaf extract has a total flavonol glycoside content of 24-26% by mass, a terpene lactone content of 6% -12% and a bilobalide content of 2% -4%.
7. The soft capsule of claim 1, wherein the ginkgo leaf extract has a particle size of not less than 100 mesh.
8. The soft capsule of claim 7, wherein the ginkgo leaf extract has a particle size of 100-200 mesh.
9. The soft capsule of claim 8, wherein the ginkgo leaf extract has a particle size of 160 mesh.
10. The soft capsule of claim 1, wherein the vegetable oil is one or more selected from soybean oil, linseed oil, corn oil, rapeseed oil and rice bran oil.
11. The soft capsule of claim 10, wherein the vegetable oil is soybean oil.
12. The soft capsule of claim 1, wherein the capsule skin is prepared from a gum solution comprising, in parts by weight: 262-345 parts of gelatin, 112-163 parts of glycerin, 268-344 parts of purified water, 0.62-1.82 parts of titanium dioxide and 4.6-8.8 parts of caramel color.
13. The soft capsule of claim 12, wherein the capsule skin is prepared from a gum solution comprising, in parts by weight: 281-336 parts of gelatin, 121-153 parts of glycerin, 291-334 parts of purified water, 0.72-1.43 parts of titanium dioxide and 5.6-7.8 parts of caramel color.
14. The soft capsule of claim 13, wherein the capsule shell is prepared from a gum solution comprising, in parts by weight: 310 parts of gelatin, 139.5 parts of glycerin, 310 parts of purified water, 0.93 part of titanium dioxide and 6.2 parts of caramel color.
15. A method of preparing the soft capsule of any one of claims 1-14, wherein the method comprises the preparation of a content comprising the steps of:
(1) Heating beeswax and the first part of vegetable oil to a temperature of T1, and stirring to dissolve the beeswax in the vegetable oil completely to obtain an oil wax mixture A;
(2) Adding the formula amount of fish oil extract and the rest vegetable oil into a stirring tank, heating to the temperature of T2, stirring uniformly, adding the formula amount of phosphatidylserine and ginkgo leaf extract, stirring uniformly, and filtering to obtain a mixture B;
(3) And (3) adding the oil wax mixture A obtained in the step (1) into the mixture B obtained in the step (2), stirring, filtering to obtain the content, and storing at the temperature T3 for later use.
16. The preparation method according to claim 15, wherein the method further comprises the preparation of a glue solution comprising the steps of:
(i) Mixing the formula amount of titanium dioxide with the first part of purified water, uniformly stirring, filtering, and filling the obtained titanium dioxide suspension into a pigment barrel I for later use;
(ii) Mixing the caramel color with a second part of purified water according to the formula amount, stirring and dissolving, and filling the obtained caramel color aqueous solution into a pigment barrel II for later use;
(iii) Adding the rest purified water, the titanium dioxide suspension obtained in the step (i), the caramel color aqueous solution obtained in the step (ii) and the glycerol with the formula amount into a gelatin melting tank, starting a stirring and hot water circulating system, heating the feed liquid in the gelatin melting tank to 65-75 ℃, adding gelatin with the formula amount, vacuumizing, stopping vacuumizing after the vacuum degree reaches-0.08 Mpa, continuously heating to 70-80 ℃, preserving heat and stirring until the gelatin is completely dissolved;
(iv) Vacuumizing again after gelatin is completely dissolved, keeping the temperature at 60-70 ℃, discharging after the gelatin solution has no bubbles and the viscosity reaches 20000-35000 mpa.s, filtering the gelatin solution by a single-layer 100-mesh filter bag in the discharging process, and pressurizing the discharged gelatin solution to be not more than 0.06MPa; the glue solution is stored in a heat preservation barrel, and kept stand for 2-24 hours at 55-70 ℃.
17. The preparation method according to claim 15, wherein the method further comprises the steps of pelleting, shaping and drying the content and the glue solution by a soft capsule machine.
18. The method of claim 15, wherein in step (1) of preparing the contents, the first portion of vegetable oil is 1/10 to 6/10 of the formula amount.
19. The method of claim 18, wherein in step (1) of preparing the contents, the first portion of vegetable oil is 1/5-2/5 of the formula amount.
20. The method of claim 19, wherein in step (1) of preparing the contents, the first portion of vegetable oil is 2/5 of the formula amount.
21. The method of claim 15, wherein in step (1) of the content preparation, T1 is 55-70 ℃.
22. The method of claim 21, wherein in step (1) of the content preparation, T1 is 55-60 ℃.
23. The method of claim 22, wherein in step (1) of the content preparation, T1 is 60 ℃.
24. The method of claim 15, wherein in the step (1) of preparing the contents, the stirring time is 20-30min.
25. The method of claim 24, wherein in step (1) of the preparation of the contents, the stirring time is 20min.
26. The method of claim 15, wherein in step (2) of the content preparation, T2 is 35-45 ℃.
27. The method of claim 26, wherein in step (2) of the content preparation, T2 is 40 ℃.
28. The method of claim 15, wherein in step (2) of the content preparation, screen filtration is used.
29. The method of claim 28, wherein the screen is 60-100 mesh.
30. The method of claim 29, wherein the screen is 100 mesh.
31. The method of claim 15, wherein in the step (3) of preparing the contents, the stirring time is 25-30min.
32. The method of claim 31, wherein in the step (3) of preparing the contents, the stirring time is 30 minutes.
33. The method of claim 15, wherein in step (3) of the content preparation, screen filtration is used.
34. The method of claim 33, wherein the screen is 100-120 mesh.
35. The method of claim 34, wherein the screen is 120 mesh.
36. The method of claim 15, wherein in step (3) of the content preparation, T3 is 35-50 ℃.
37. The method of claim 36, wherein in step (3) of the content preparation, T3 is 40-45 ℃.
38. The method of claim 15, wherein in step (3) of preparing the content, the viscosity of the content is 200mPas-600mPas.
39. The method of claim 38, wherein in the step (3) of preparing the content, the viscosity of the content is 300mPas to 400mPas.
40. The method of claim 16, wherein in step (i) of the dope preparation, the mass ratio of titanium dioxide to the first portion of purified water is 1:20-30.
41. The method of claim 16, wherein in step (ii) of the gum preparation, the mass ratio of caramel color to the second partially purified water is 1:20-30.
42. Use of a soft capsule according to any one of claims 1-14 or prepared according to the method of any one of claims 15-41 for improving memory, regulating emotion, improving sleep quality.
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