CN104172165A - Squalene oil and coneflower soft capsule and preparation method thereof - Google Patents
Squalene oil and coneflower soft capsule and preparation method thereof Download PDFInfo
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- CN104172165A CN104172165A CN201410404077.5A CN201410404077A CN104172165A CN 104172165 A CN104172165 A CN 104172165A CN 201410404077 A CN201410404077 A CN 201410404077A CN 104172165 A CN104172165 A CN 104172165A
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- 229960001295 tocopherol Drugs 0.000 description 1
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Classifications
-
- 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
-
- 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
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention discloses a squalene oil and coneflower soft capsule and a preparation method of the squalene oil and coneflower soft capsule. The squalene oil and coneflower soft capsule is composed of the following components in parts by weight: 50-80 parts of squalene oil, 10-40 parts of a coneflower extract, 2-6 parts of vitamin E, 1-4 parts of bee wax and 1-4 parts of soyabean lecithin. Auxiliary materials are uniformly mixed by a colloid mill to prepare the soft capsule. The health food disclosed by the invention is scientific and reasonable in formula, simple in preparation process, and safe, stable and effective; and the squalene oil and coneflower soft capsule has the function of enhancing the immunity and is suitable for people with low immunity to take.
Description
Technical field
The present invention relates to field of health care products, especially, relate to a kind of squalene oil Echinacea soft capsule and preparation method who strengthens immunity function.
Background technology
Immunity is the defense mechanism of human body self, is human body identification and any foreign matter (virus, bacterium etc.) of eliminating external intrusion; Process the ability of self cell and identification and processing vivo mutations cell and the virus infected cell of old and feeble, damage, dead, sex change.A variety of causes makes immune system normally not bring into play protective effect, in the case, very easily causes the infection such as bacterium, virus, fungi, and therefore the most directly to show be exactly liable to illness to hypoimmunity.Because of often ill, increase the weight of the consumption of body, so generally have a delicate constitution, the performance such as malnutritive, One's spirits are drooping, fatigue and weak, appetite reduction, sleep-disorder.
Squalene is a kind of lipid unsaponifiable matter, to find from the liver oil of shark at first, within 1914, be named as Squalene, its chemical name is 2,6,10,15,19,23-hexamethyl-2,6,10,14,18,22-squalene, belong to open chain triterpene, claim again Squalene, have improve in body superoxide dismutase (SOD) active, strengthen body immunity, protect liver, reducing blood lipid, anti-ageing, antifatigue, the different physiological roles such as antitumor, be a kind of avirulent marine bioactivity material with the effect of preventing and curing diseases.
Echinacea is a kind of Echinacea purpurea plant that originates in North America, be widely used at US and European, be generally considered and there is immunological enhancement, contain various active composition, comprise polysaccharide, flavones, caffeic acid derivative, polyyne, alkylamine and alkaloid etc., can stimulate the immunocyte vigor such as the interior leucocyte of human body, improve human body autoimmunity.
Beeswax is the wax of Apidae insect apis cerana or apis mellifera Linnaeus secretion.Beeswax is a kind of conventional natural suspending agent.
Vitamin E is a kind of liposoluble vitamin, claims again tocopherol, is one of the most frequently used antioxidant, is also the vitamin of needed by human.
Soybean lecithin extracts from soybean, is a kind of naturally occurring emulsifying agent.
Echinacea product is generally comparatively common with tablet, capsule etc., the absorption rate of solid dosage forms is lower, coordinated squalene oil to make soft capsule, can bring into play on the one hand the synergistic function of Echinacea and squalene oil, be more conducive to absorbing of active ingredient after making on the other hand soft capsule.
At present, there is not yet taking squalene, Echinacea as primary raw material, make soft capsule taking propolis, vitamin E, soybean lecithin as auxiliary material, as the report of health food.
Summary of the invention
The object of the invention is to for the deficiencies in the prior art, a kind of squalene oil Echinacea soft capsule and preparation method are provided, the present invention has enhancing immunity function.
The object of the invention is to be achieved through the following technical solutions: a kind of squalene oil Echinacea soft capsule that strengthens immunity function, is characterized in that: its component by following weight portion forms: squalene oil 50-80, Echinacea Purpurea Herb P.E 10-40, vitamin E2-6, beeswax 1-4, soybean lecithin 1-4.
The preparation method of described squalene oil Echinacea soft capsule, is characterized in that: preparation process is as follows:
(1) get squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin by above-mentioned weight portion; Beeswax is with being equivalent to add agitator tank after squalene oil heat fused that its 3-6 doubly measures, and Echinacea Purpurea Herb P.E, vitamin E, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid;
(2) 1:0.4:1 takes purified water, glycerine and jelly powder in mass ratio, first purified water is heated to 60-70 DEG C, then add glycerine, in the time that temperature is 60-65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65-70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid;
(3) capsule liquid is placed in to the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55-65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35-45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter into setting 3-4 hour in setting rotating cage, can come out of steamer, proceed to hothouse, at drying rotating cage inner drying 10-14 hour, obtain squalene oil Echinacea soft capsule.
Ricipe for health care food of the present invention is scientific and reasonable, and preparation technology is simple, and safety and stability is effective, has enhancing immunity function, is applicable to immunocompromised person and takes.
This product has enhancing immunity function, is applicable to immunocompromised person and takes.Human body recommended amounts is 2.0g/60kg body weight every day.
Animal effect experiment is as follows: strengthen immunity function and test and establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to respectively 5,10,15 times of the actual intake of people, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, be configured to concentration and be 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity is pressed 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Continuous 30 days per os give the given the test agent of various dose.Negative control group and solvent control group give distilled water and soybean oil.Experimental result shows: respectively with water control group, oily control group comparison, given the test agent three dosage group mice spleen lymphocytes proliferation abilities all strengthen, and difference all has conspicuousness (q inspection, P < 0.05); With water control group, oily control group comparison, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).Respectively with the comparison of water control group, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises, difference all has conspicuousness (q inspection, P < 0.05), illustrates that the present invention has enhancing immunity function.
The test of rat acute Oral toxicity is as follows: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female rat (180-220g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of rat, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female rat is all greater than 20.0g/kg body weight.
The test of chmice acute Oral toxicity is as follows: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female mouse (18-22g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of mouse, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Mouse marrow cell micro nuclear test is as follows: by sample respectively with 2.5g/kg, 5.0g/kg, tri-dosage groups of 10.0g/kg, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), every group of 10 mouse (25-30g, male and female half and half), adopt interval within 24 hours, to give sample, three dosage component another name sample thiefs 2.5, 5.0 and 10.0g add edible soybean oil and be made into 0.125 to 20mL, 0.25, 0.50g/mL, press 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last to sample after 6h put to death animal, get its bone marrow of sternum film-making, methyl alcohol is fixed, Giemsa dyeing.Sample bone marrow cell micronucleus result of the test is negative.
Sperm malformation test is as follows: establish sample 2.5g/kg, 5.0g/kg, three dosage groups of 10.0g/kg body weight, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (mitomycin C 2.0mg/kg body weight), 10 every group male mices (25-30g).Three dosage components another name sample thief 2.5,5.0 and 10.0g add edible soybean oil to 20mL be made into 0.125,0.25,0.50g/mL, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 5 days.In giving first after sample the 35th day, get two side epididymis and shred, get filtrate film-making.Microscopy is observed, the lopsided number of 1000 sperms of every mouse counting.Sample sperm malformation test result feminine gender.
Salmonella reversion test is as follows: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt flat board to mix method, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.Directly on counting culture medium, returning of each bacterial strain becomes clump count.Detection repeats once.Sample Salmonella reversion test result is negative.
Within 30 days, feeding trial is as follows: establish basic, normal, high three dosage groups (0.833,1.67,3.33g/kg body weight), be equivalent to respectively 25,50,100 times of people's recommended amounts, take respectively test sample 20.0,40.0,80.0g with soybean oil to 240mL, be configured to concentration and be 0.083,0.167 and the sample of 0.333g/mL, give continuous 30 days by 10mL/kg body weight per os gavage.Separately establish negative control (distilled water), solvent control (edible soybean oil), give respectively distilled water and edible soybean oil, free diet, feeds 30 days continuously.100 of SD rats (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record weekly body weight and food-intake, and calculate food utilization, test end of term taking blood from jugular vein carries out hematological examination, broken end is got blood and is carried out blood biochemical analysis, every rat is carried out to internal organs gross examination of skeletal muscle, get liver,kidney,spleen, testis (ovary) is weighed and calculates dirty body ratio simultaneously, and get liver,kidney,spleen, stomach, intestines, testis (ovary) and carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, when histological examination result of main dirty body compared with control group, all no significant differences.
Above-mentioned acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, 30 days feeding trial results show that this product safety is nontoxic.
Stability test is as follows: three batch samples are placed 3 months under 37～40 DEG C of temperature and 75% relative humidity condition by commercially available back, in 0 month, January, February, respectively three batch samples are carried out to all events detection March and (comprise organoleptic indicator, identification, squalene, Echinacea glycosides, total ash, disintegration time limited, acid value, peroxide value, plumbous arsenic mercury, BHC, DDT, net content minus deviation, total plate count, coliform, mould, saccharomycete, salmonella, Shigella, golden yellow Portugal coccus, hemolytic), testing result all meets the regulation of this target level of product quality (company standard).
The invention has the beneficial effects as follows: the present invention's squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin are made the health food that people take like a shot, reasonable recipe, had both met medicine theoretical, had again modern pharmacology and clinical research foundation; Squalene oil Echinacea soft capsule prepared by the present invention has enhancing immunity function.
Detailed description of the invention
Squalene oil Echinacea soft capsule of the present invention, its content is made up of the component of following percentage by weight: squalene oil 50-80%, Echinacea Purpurea Herb P.E 10-40%, vitamin E2-6%, beeswax 1-4%, soybean lecithin 1-4%.
The preparation method of above-mentioned squalene oil Echinacea soft capsule, comprises the steps:
(1) batching: get squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin by above-mentioned weight proportion, after the squalene oil heat fused that beeswax is doubly measured by 3-6 quality, add agitator tank, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid.
(2) change glue: 1:0.4:1 takes purified water, glycerine and gelatin in mass ratio, first purified water is heated to 60 DEG C～70 DEG C, then add glycerine, in the time that temperature is 60 DEG C～65 DEG C, add jelly powder, after jelly powder melts completely, controlling temperature is 65 DEG C～70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid;
(3) pelleting: capsule liquid is placed in to the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55 DEG C～65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35 DEG C～45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter in setting rotating cage setting 3～4 hours, can come out of steamer, proceed to hothouse, drying rotating cage inner drying 10～14 hours, obtain squalene oil Echinacea soft capsule.
Describe specific embodiments of the invention below in detail
Embodiment 1
Get squalene oil 8000g, Echinacea Purpurea Herb P.E 1000g, vitamin E 400g, beeswax 300g, soybean lecithin 300g, beeswax is with adding agitator tank after 1200g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid.Take purified water 2000g, glycerine 800g and gelatin 2000g, first purified water is heated to 60 DEG C～70 DEG C, then add glycerine, in the time that temperature is 60 DEG C～65 DEG C, add jelly powder, after jelly powder melts completely, controlling temperature is 65 DEG C～70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; The warm glue bucket that capsule liquid is placed in to pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55 DEG C～65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35 DEG C～45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter in setting rotating cage setting 3～4 hours, can come out of steamer, proceed to hothouse, drying rotating cage inner drying 10～14 hours, obtain squalene oil Echinacea soft capsule.
Animal effect experiment: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to respectively 5,10,15 times of the actual intake of people, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, be configured to concentration and be 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity is pressed 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Continuous 30 days per os give the given the test agent of various dose.Negative control group and solvent control group give distilled water and soybean oil.Data are as follows:
The impact of the mice spleen lymphocytes proliferation ability on ConA induction
| Group | Number of animals (only) | Optical density difference |
| Water control group | 10 | 0.139±0.012 |
| Oil control group | 10 | 0.147±0.015 |
| 0.167g/kg | 10 | 0.180±0.013 |
| 0.333g/kg | 10 | 0.173±0.011 |
| 0.500g/kg | 10 | 0.182±0.017 |
Turnover of Mouse Peritoneal Macrophages is engulfed to the impact of chicken red blood cell
| Group | Number of animals (only) | Phagocytic rate | Phagocytic index |
| Water control group | 10 | 28.1±4.0 | 0.59±0.09 |
| Oil control group | 10 | 30.4±4.3 | 0.64±0.11 |
| 0.167g/kg | 10 | 34.2±6.8 | 0.73±0.08 |
| 0.333g/kg | 10 | 38.4±6.0 | 0.81±0.12 |
| 0.500g/kg | 10 | 36.5±6.7 | 0.76±0.08 |
Experimental result shows: respectively with water control group, oily control group comparison, given the test agent three dosage group mice spleen lymphocytes proliferation abilities all strengthen, and difference all has conspicuousness (q inspection, P < 0.05); With water control group, oily control group comparison, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).With the comparison of water control group, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).Illustrate that this sample has enhancing immunity function.
Rat acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female rat (180-220g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of rat, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Chmice acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female mouse (18-22g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of mouse, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, tri-dosage groups of 10.0g/kg, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), every group of 10 mouse (25-30g, male and female half and half), adopt interval within 24 hours, to give sample, three dosage component another name sample thiefs 2.5, 5.0 and 10.0g add edible soybean oil and be made into 0.125 to 20mL, 0.25, 0.50g/mL, press 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last to sample after 6h put to death animal, get its bone marrow of sternum film-making, methyl alcohol is fixed, Giemsa dyeing.Sample bone marrow cell micronucleus result of the test is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, three dosage groups of 10.0g/kg body weight, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (mitomycin C 2.0mg/kg body weight), 10 every group male mices (25-30g).Three dosage components another name sample thief 2.5,5.0 and 10.0g add edible soybean oil to 20mL be made into 0.125,0.25,0.50g/mL, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 5 days.In giving first after sample the 35th day, get two side epididymis and shred, get filtrate film-making.Microscopy is observed, the lopsided number of 1000 sperms of every mouse counting.Sample sperm malformation test result feminine gender.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt flat board to mix method, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.Directly on counting culture medium, returning of each bacterial strain becomes clump count.Detection repeats once.Sample Salmonella reversion test result is negative.
30 days feeding trials: establish basic, normal, high three dosage groups (0.625,1.25,2.5g/kg body weight), be equivalent to respectively 25,50,100 times of people's recommended amounts, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to concentration and be 0.063,0.125 and the sample of 0.25g/mL, give continuous 30 days by 10mL/kg body weight per os gavage.Separately establish negative control (distilled water), solvent control (edible soybean oil), give respectively distilled water and edible soybean oil, free diet, feeds 30 days continuously.100 of SD rats (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record weekly body weight and food-intake, and calculate food utilization, test end of term taking blood from jugular vein carries out hematological examination, broken end is got blood and is carried out blood biochemical analysis, every rat is carried out to internal organs gross examination of skeletal muscle, get liver,kidney,spleen, testis (ovary) is weighed and calculates dirty body ratio simultaneously, and get liver,kidney,spleen, stomach, intestines, testis (ovary) and carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, when histological examination result of main dirty body compared with control group, all no significant differences.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, 30 days feeding trial results show that this secure sample is nontoxic.
Stability test: three batch samples are placed 3 months under 37～40 DEG C of temperature and 75% relative humidity condition by commercially available back, in 0 month, January, February, respectively three batch samples are carried out to all events detection March and (comprise organoleptic indicator, identification, squalene, Echinacea glycosides, total ash, disintegration time limited, acid value, peroxide value, plumbous arsenic mercury, BHC, DDT, net content minus deviation, total plate count, coliform, mould, saccharomycete, salmonella, Shigella, golden yellow Portugal coccus, hemolytic), testing result all meets the regulation of this target level of product quality (company standard).
Embodiment 2
Get squalene oil 5000g, Echinacea Purpurea Herb P.E 4000g, vitamin E2 00g, beeswax 400g, soybean lecithin 400g, beeswax is with adding agitator tank after 2400g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid.Take purified water 2000g, glycerine 800g and gelatin 2000g, first purified water is heated to 60 DEG C～70 DEG C, then add glycerine, in the time that temperature is 60 DEG C～65 DEG C, add jelly powder, after jelly powder melts completely, controlling temperature is 65 DEG C～70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; The warm glue bucket that capsule liquid is placed in to pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55 DEG C～65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35 DEG C～45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter in setting rotating cage setting 3～4 hours, can come out of steamer, proceed to hothouse, drying rotating cage inner drying 10～14 hours, obtain squalene oil Echinacea soft capsule.
Animal effect experiment: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to respectively 5,10,15 times of the actual intake of people, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, be configured to concentration and be 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity is pressed 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Continuous 30 days per os give the given the test agent of various dose.Negative control group and solvent control group give distilled water and soybean oil.Data are as follows:
The impact of the mice spleen lymphocytes proliferation ability on ConA induction
| Group | Number of animals (only) | Optical density difference |
| Water control group | 10 | 0.147±0.010 |
| Oil control group | 10 | 0.152±0.013 |
| 0.167g/kg | 10 | 0.182±0.019 |
| 0.333g/kg | 10 | 0.173±0.012 |
| 0.500g/kg | 10 | 0.188±0.017 |
Turnover of Mouse Peritoneal Macrophages is engulfed to the impact of chicken red blood cell
| Group | Number of animals (only) | Phagocytic rate | Phagocytic index |
| Water control group | 10 | 28.5±4.0 | 0.56±0.10 |
| Oil control group | 10 | 31.4±4.3 | 0.61±0.12 |
| 0.167g/kg | 10 | 34.5±6.0 | 0.80±0.16 |
| 0.333g/kg | 10 | 40.5±6.4 | 0.82±0.12 |
| 0.500g/kg | 10 | 41.6±5.0 | 0.89±0.06 |
Experimental result shows: respectively with water control group, oily control group comparison, given the test agent three dosage group mice spleen lymphocytes proliferation abilities all strengthen, and difference all has conspicuousness (q inspection, P < 0.05); With water control group, oily control group comparison, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).With the comparison of water control group, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).Illustrate that this sample has enhancing immunity function.
Rat acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female rat (180-220g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of rat, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Chmice acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female mouse (18-22g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of mouse, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, tri-dosage groups of 10.0g/kg, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), every group of 10 mouse (25-30g, male and female half and half), adopt interval within 24 hours, to give sample, three dosage component another name sample thiefs 2.5, 5.0 and 10.0g add edible soybean oil and be made into 0.125 to 20mL, 0.25, 0.50g/mL, press 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last to sample after 6h put to death animal, get its bone marrow of sternum film-making, methyl alcohol is fixed, Giemsa dyeing.Sample bone marrow cell micronucleus result of the test is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, three dosage groups of 10.0g/kg body weight, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (mitomycin C 2.0mg/kg body weight), 10 every group male mices (25-30g).Three dosage components another name sample thief 2.5,5.0 and 10.0g add edible soybean oil to 20mL be made into 0.125,0.25,0.50g/mL, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 5 days.In giving first after sample the 35th day, get two side epididymis and shred, get filtrate film-making.Microscopy is observed, the lopsided number of 1000 sperms of every mouse counting.Sample sperm malformation test result feminine gender.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt flat board to mix method, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.Directly on counting culture medium, returning of each bacterial strain becomes clump count.Detection repeats once.Sample Salmonella reversion test result is negative.
30 days feeding trials: establish basic, normal, high three dosage groups (0.625,1.25,2.5g/kg body weight), be equivalent to respectively 25,50,100 times of people's recommended amounts, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to concentration and be 0.063,0.125 and the sample of 0.25g/mL, give continuous 30 days by 10mL/kg body weight per os gavage.Separately establish negative control (distilled water), solvent control (edible soybean oil), give respectively distilled water and edible soybean oil, free diet, feeds 30 days continuously.100 of SD rats (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record weekly body weight and food-intake, and calculate food utilization, test end of term taking blood from jugular vein carries out hematological examination, broken end is got blood and is carried out blood biochemical analysis, every rat is carried out to internal organs gross examination of skeletal muscle, get liver,kidney,spleen, testis (ovary) is weighed and calculates dirty body ratio simultaneously, and get liver,kidney,spleen, stomach, intestines, testis (ovary) and carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, when histological examination result of main dirty body compared with control group, all no significant differences.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, 30 days feeding trial results show that this secure sample is nontoxic.
Stability test: three batch samples are placed 3 months under 37～40 DEG C of temperature and 75% relative humidity condition by commercially available back, in 0 month, January, February, respectively three batch samples are carried out to all events detection March and (comprise organoleptic indicator, identification, squalene, Echinacea glycosides, total ash, disintegration time limited, acid value, peroxide value, plumbous arsenic mercury, BHC, DDT, net content minus deviation, total plate count, coliform, mould, saccharomycete, salmonella, Shigella, golden yellow Portugal coccus, hemolytic), testing result all meets the regulation of this target level of product quality (company standard).
Embodiment 3
Get squalene oil 6000g, Echinacea Purpurea Herb P.E 3000g, vitamin E 300g, beeswax 400g, soybean lecithin 300g, beeswax is with adding agitator tank after 1600g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid.Take purified water 2000g, glycerine 800g and gelatin 2000g, first purified water is heated to 60 DEG C～70 DEG C, then add glycerine, in the time that temperature is 60 DEG C～65 DEG C, add jelly powder, after jelly powder melts completely, controlling temperature is 65 DEG C～70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; The warm glue bucket that capsule liquid is placed in to pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55 DEG C～65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35 DEG C～45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter in setting rotating cage setting 3～4 hours, can come out of steamer, proceed to hothouse, drying rotating cage inner drying 10～14 hours, obtain squalene oil Echinacea soft capsule.
Animal effect experiment: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to respectively 5,10,15 times of the actual intake of people, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, be configured to concentration and be 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity is pressed 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Continuous 30 days per os give the given the test agent of various dose.Negative control group and solvent control group give distilled water and soybean oil.Data are as follows:
The impact of the mice spleen lymphocytes proliferation ability on ConA induction
| Group | Number of animals (only) | Optical density difference |
| Water control group | 10 | 0.147±0.016 |
| Oil control group | 10 | 0.153±0.012 |
| 0.167g/kg | 10 | 0.189±0.012 |
| 0.333g/kg | 10 | 0.172±0.013 |
| 0.500g/kg | 10 | 0.190±0.019 |
Turnover of Mouse Peritoneal Macrophages is engulfed to the impact of chicken red blood cell
| Group | Number of animals (only) | Phagocytic rate | Phagocytic index |
| Water control group | 10 | 28.6±4.0 | 0.59±0.09 |
| Oil control group | 10 | 31.2±4.5 | 0.64±0.13 |
| 0.167g/kg | 10 | 37.1±5.9 | 0.71±0.05 |
| 0.333g/kg | 10 | 39.9±6.6 | 0.82±0.11 |
| 0.500g/kg | 10 | 40.4±5.0 | 0.83±0.08 |
Experimental result shows: respectively with water control group, oily control group comparison, given the test agent three dosage group mice spleen lymphocytes proliferation abilities all strengthen, and difference all has conspicuousness (q inspection, P < 0.05); With water control group, oily control group comparison, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).With the comparison of water control group, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages are engulfed chicken red blood cell all raises respectively, and difference all has conspicuousness (q inspection, P < 0.05).Illustrate that this sample has enhancing immunity function.
Rat acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female rat (180-220g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of rat, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Chmice acute Oral toxicity test: adopt maximum tolerated dose method, sample is contaminated to each 10 the per os gavages of male and female mouse (18-22g) with 20.0g/kg body weight dosage.Take sample and be made into 0.5g/mL, give interval 4h by 20mL/kg body weight secondary gavage.After contamination, observe general status, poisoning symptom and the death condition of mouse, observe two weeks time limits.Result of the test: the maximum tolerated dose of the acute oral of sample to male and female mouse is all greater than 20.0g/kg body weight.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, tri-dosage groups of 10.0g/kg, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), every group of 10 mouse (25-30g, male and female half and half), adopt interval within 24 hours, to give sample, three dosage component another name sample thiefs 2.5, 5.0 and 10.0g add edible soybean oil and be made into 0.125 to 20mL, 0.25, 0.50g/mL, press 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last to sample after 6h put to death animal, get its bone marrow of sternum film-making, methyl alcohol is fixed, Giemsa dyeing.Sample bone marrow cell micronucleus result of the test is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, three dosage groups of 10.0g/kg body weight, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (mitomycin C 2.0mg/kg body weight), 10 every group male mices (25-30g).Three dosage components another name sample thief 2.5,5.0 and 10.0g add edible soybean oil to 20mL be made into 0.125,0.25,0.50g/mL, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 5 days.In giving first after sample the 35th day, get two side epididymis and shred, get filtrate film-making.Microscopy is observed, the lopsided number of 1000 sperms of every mouse counting.Sample sperm malformation test result feminine gender.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt flat board to mix method, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.Directly on counting culture medium, returning of each bacterial strain becomes clump count.Detection repeats once.Sample Salmonella reversion test result is negative.
30 days feeding trials: establish basic, normal, high three dosage groups (0.625,1.25,2.5g/kg body weight), be equivalent to respectively 25,50,100 times of people's recommended amounts, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to concentration and be 0.063,0.125 and the sample of 0.25g/mL, give continuous 30 days by 10mL/kg body weight per os gavage.Separately establish negative control (distilled water), solvent control (edible soybean oil), give respectively distilled water and edible soybean oil, free diet, feeds 30 days continuously.100 of SD rats (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record weekly body weight and food-intake, and calculate food utilization, test end of term taking blood from jugular vein carries out hematological examination, broken end is got blood and is carried out blood biochemical analysis, every rat is carried out to internal organs gross examination of skeletal muscle, get liver,kidney,spleen, testis (ovary) is weighed and calculates dirty body ratio simultaneously, and get liver,kidney,spleen, stomach, intestines, testis (ovary) and carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, when histological examination result of main dirty body compared with control group, all no significant differences.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, 30 days feeding trial results show that this secure sample is nontoxic.
Stability test: three batch samples are placed 3 months under 37～40 DEG C of temperature and 75% relative humidity condition by commercially available back, in 0 month, January, February, respectively three batch samples are carried out to all events detection March and (comprise organoleptic indicator, identification, squalene, Echinacea glycosides, total ash, disintegration time limited, acid value, peroxide value, plumbous arsenic mercury, BHC, DDT, net content minus deviation, total plate count, coliform, mould, saccharomycete, salmonella, Shigella, golden yellow Portugal coccus, hemolytic), testing result all meets the regulation of this target level of product quality (company standard).
Above embodiment is used for explaining the present invention, instead of limits the invention, and in the protection domain of spirit of the present invention and claim, any amendment and change that the present invention is made, all fall into protection scope of the present invention.
Claims (2)
1. a squalene oil Echinacea soft capsule, is characterized in that: its component by following weight portion forms: squalene oil 50-80, Echinacea Purpurea Herb P.E 10-40, vitamin E2-6, beeswax 1-4, soybean lecithin 1-4.
2. the preparation method of squalene oil Echinacea soft capsule according to claim 1, is characterized in that: preparation process is as follows:
(1) get squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin by above-mentioned weight portion; Beeswax is with being equivalent to add agitator tank after squalene oil heat fused that its 3-6 doubly measures, and Echinacea Purpurea Herb P.E, vitamin E, soybean lecithin and remaining squalene oil add agitator tank together with also, after being uniformly mixed, mix through colloid mill, obtain feed liquid;
(2) 1:0.4:1 takes purified water, glycerine and jelly powder in mass ratio, first purified water is heated to 60-70 DEG C, then add glycerine, in the time that temperature is 60-65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65-70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid;
(3) capsule liquid is placed in to the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket being connected with sprinkler body; The temperature of setting warm glue bucket is 55-65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape adhesive tape is sent in the middle of two moulds of pellet press, fall sprinkler body, set sprinkler body temperature is 35-45 DEG C simultaneously, starts pelleting; Open rotating cage switch and air-supply switch, open conveyer belt, make capsule and pill enter into setting 3-4 hour in setting rotating cage, can come out of steamer, proceed to hothouse, at drying rotating cage inner drying 10-14 hour, obtain squalene oil Echinacea soft capsule.
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| US20060105005A1 (en) * | 2002-01-08 | 2006-05-18 | Michael Marenick | Skin care formulation containing whole egg powder |
| CN101279049A (en) * | 2007-04-06 | 2008-10-08 | 王洪飞 | Soft capsules for resisting altitude stress |
| CN101810336A (en) * | 2010-04-30 | 2010-08-25 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
| CN101869589A (en) * | 2010-07-07 | 2010-10-27 | 郭景龙 | Medicinal composition for improving immunity |
| JP2013169153A (en) * | 2012-02-17 | 2013-09-02 | Shefco Co Ltd | Hydrogen-containing drink including functional ingredient |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060105005A1 (en) * | 2002-01-08 | 2006-05-18 | Michael Marenick | Skin care formulation containing whole egg powder |
| CN101279049A (en) * | 2007-04-06 | 2008-10-08 | 王洪飞 | Soft capsules for resisting altitude stress |
| CN101810336A (en) * | 2010-04-30 | 2010-08-25 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
| CN101869589A (en) * | 2010-07-07 | 2010-10-27 | 郭景龙 | Medicinal composition for improving immunity |
| JP2013169153A (en) * | 2012-02-17 | 2013-09-02 | Shefco Co Ltd | Hydrogen-containing drink including functional ingredient |
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