CN104172165B - Squalene oil and echinacea soft capsule and preparation method thereof - Google Patents
Squalene oil and echinacea soft capsule and preparation method thereof Download PDFInfo
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- CN104172165B CN104172165B CN201410404077.5A CN201410404077A CN104172165B CN 104172165 B CN104172165 B CN 104172165B CN 201410404077 A CN201410404077 A CN 201410404077A CN 104172165 B CN104172165 B CN 104172165B
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- 238000002360 preparation method Methods 0.000 title claims abstract description 11
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- 229940069949 propolis Drugs 0.000 description 1
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- QAIPRVGONGVQAS-DUXPYHPUSA-N trans-caffeic acid Chemical class OC(=O)\C=C\C1=CC=C(O)C(O)=C1 QAIPRVGONGVQAS-DUXPYHPUSA-N 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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 echinacea soft capsule and a preparation method thereof, wherein the capsule comprises the following components in parts by weight: 50-80 parts of squalene oil, 10-40 parts of echinacea purpurea extract, 2-6 parts of vitamin E, 1-4 parts of beeswax and 1-4 parts of soybean lecithin. Mixing the adjuvants with colloid mill, and making into soft capsule. The health food has scientific and reasonable formula, simple preparation process, safety, stability and effectiveness, has the function of enhancing 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 of develop immunitypty function.
Background technology
Immunity is the defense mechanism of human body self, is human bioequivalence and any foreign matter (virus, bacterium etc.) eliminating external intrusion; Process is old and feeble, damage, the ability of mutant cell and virus infected cell in the own cells of dead, sex change and identification and handling body.A variety of causes makes immune system normally can not play protective effect, and in the case, very easily cause the infection such as bacterium, virus, fungi, therefore hypoimmunity the most directly shows is exactly liable to illness.Because of often ill, increased the weight of the consumption of body, thus generally have a delicate constitution, malnutritive, One's spirits are drooping, fatigue and weak, appetite reduction, the performance such as sleep-disorder.
Squalene is a kind of lipid unsaponifiable matter, 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, also known as Squalene, have improve superoxide dismutase (SOD) in body 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 biomaterial with the effect of preventing and curing diseases.
Echinacea is a kind of Echinacea purpurea plant originating in North America, be widely used at US and European, be generally considered and there is immunological enhancement, containing various active composition, comprise polysaccharide, flavones, caffeic acid derivative, polyyne, alkylamine and alkaloid etc., the immunocyte vigor such as leucocyte can be stimulated in human body, improves 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, and also known as tocopherol, being 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, squalene oil is coordinated to make soft capsule, the synergistic function of Echinacea and squalene oil can be played on the one hand, after making soft capsule on the other hand, be more conducive to absorbing of active ingredient.
At present, there is not yet with squalene, Echinacea for primary raw material, make soft capsule, as the report of health food with propolis, vitamin E, soybean lecithin for auxiliary material.
Summary of the invention
The object of the invention is to for the deficiencies in the prior art, provide a kind of squalene oil Echinacea soft capsule and preparation method, the present invention has develop immunitypty function.
The object of the invention is to be achieved through the following technical solutions: a kind of squalene oil Echinacea soft capsule of develop immunitypty function, is characterized in that: it is made up of the component of following weight portion: 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) squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin is got by above-mentioned weight portion; Beeswax be equivalent to its 3-6 times amount squalene oil heat fused after add agitator tank, Echinacea Purpurea Herb P.E, vitamin E, soybean lecithin and remaining squalene oil also together with add agitator tank, 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 glycerine is added, when 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 the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55-65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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 develop immunitypty function, is applicable to immunocompromised person and takes.
This product has develop immunitypty function, is applicable to immunocompromised person and takes.Human body recommended amounts is 2.0g/60kg body weight every day.
Animal Efficacy experiments is as follows: develop immunitypty functional experiment establishes basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to 5,10,15 times of the actual intake of people respectively, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, being configured to concentration is 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity presses 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Within continuous 30 days, per os gives the given the test agent of various dose.Negative control group and solvent control group give distilled water and soybean oil.Experimental result shows: compare with water control group, oily control group respectively, and given the test agent three dosage group mice spleen lymphocytes proliferation ability all strengthens, and difference all has conspicuousness (q checks, P < 0.05); Compare with water control group, oily control group respectively, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Compare with water control group respectively, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, difference all has conspicuousness (q checks, P < 0.05), illustrates that the present invention has develop immunitypty function.
The test of rat acute Oral toxicity is as follows: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female rat (180-220g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of rat, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female rat.
The test of chmice acute Oral toxicity is as follows: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female mouse (18-22g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of mouse, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Mouse marrow cell micro nuclear test is as follows: by sample respectively with 2.5g/kg, 5.0g/kg, 10.0g/kg tri-dosage groups, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), often organize 10 mouse (25-30g, male and female half and half), interval is adopted to give sample in 24 hours, 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, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last puts to death animal to 6h after sample, and get its bone marrow of sternum film-making, methyl alcohol is fixed, and Giemsa dyes.Sample Bone Marrow cell micronucleus test result is negative.
Sperm malformation test is as follows: establish sample 2.5g/kg, 5.0g/kg, 10.0g/kg body weight three dosage groups, 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), often organize 10 male mices (25-30g).Three dosage component another name sample thiefs 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 after sample the 35th day first, getting two side epididymis and shredding, getting filtrate film-making.Microscopy is observed, and every mouse counts the lopsided number of 1000 sperms.Sample sperm malformation test result is negative.
Salmonella reversion test is as follows: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt dull and stereotyped incorporation methods, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.On direct 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 25,50,100 times of people's recommended amounts respectively, take respectively test sample 20.0,40.0,80.0g with soybean oil to 240mL, be configured to the sample that concentration is 0.083,0.167 and 0.333g/mL, give by 10mL/kg body weight per os gavage, continuous 30 days.Separately establish negative control (distilled water), solvent control (edible soybean oil), give distilled water and edible soybean oil respectively, free diet, feed 30 days continuously.SD rat 100 (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record body weight and food-intake weekly, 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 bio-chemistry checking, internal organs gross examination of skeletal muscle is carried out to every rat, gets liver,kidney,spleen simultaneously, testis (ovary) weighs and calculate dirty body ratio, and get liver,kidney,spleen, stomach, intestines, testis (ovary) carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, main dirty body when histological indications compared with control group, equal no significant difference.
Above-mentioned acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, that 30 days feeding trial results show this product safety is nontoxic.
Stability test is as follows: three batch samples are pressed commercially available back and place 3 months at 37 ~ 40 DEG C of temperature and 75% relative humidities, in 0 month, January, February, respectively all events detection is carried out to three batch samples 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 make the health food that people take like a shot, reasonable recipe, both met medicine theoretical, had again modern pharmacology and clinical research foundation; Squalene oil Echinacea soft capsule prepared by the present invention has develop immunitypty 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) prepare burden: get squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin by above-mentioned weight proportion, agitator tank is added after the squalene oil heat fused of beeswax 3-6 quality times amount, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil also together with add agitator tank, after being uniformly mixed, mix through colloid mill, obtain feed liquid.
(2) glue is changed: 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 glycerine is added, when temperature is 60 DEG C ~ 65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65 DEG C ~ 70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid;
(3) pelleting: warm glue bucket capsule liquid being placed in pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55 DEG C ~ 65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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.
The following detailed description of specific embodiments of the invention
Embodiment 1
Get squalene oil 8000g, Echinacea Purpurea Herb P.E 1000g, vitamin E 400g, beeswax 300g, soybean lecithin 300g, agitator tank is added after beeswax 1200g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil also together with add agitator tank, 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 glycerine is added, when temperature is 60 DEG C ~ 65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65 DEG C ~ 70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; Capsule liquid is placed in the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55 DEG C ~ 65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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 Efficacy experiments: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to 5,10,15 times of the actual intake of people respectively, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, being configured to concentration is 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity presses 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Within continuous 30 days, per os gives 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:
On the impact of the mice spleen lymphocytes proliferation ability of 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: compare with water control group, oily control group respectively, and given the test agent three dosage group mice spleen lymphocytes proliferation ability all strengthens, and difference all has conspicuousness (q checks, P < 0.05); Compare with water control group, oily control group respectively, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Compare with water control group respectively, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Illustrate that this sample has develop immunitypty function.
Rat acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female rat (180-220g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of rat, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Chmice acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female mouse (18-22g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of mouse, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, 10.0g/kg tri-dosage groups, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), often organize 10 mouse (25-30g, male and female half and half), interval is adopted to give sample in 24 hours, 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, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last puts to death animal to 6h after sample, and get its bone marrow of sternum film-making, methyl alcohol is fixed, and Giemsa dyes.Sample Bone Marrow cell micronucleus test result is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, 10.0g/kg body weight three dosage groups, 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), often organize 10 male mices (25-30g).Three dosage component another name sample thiefs 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 after sample the 35th day first, getting two side epididymis and shredding, getting filtrate film-making.Microscopy is observed, and every mouse counts the lopsided number of 1000 sperms.Sample sperm malformation test result is negative.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt dull and stereotyped incorporation methods, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.On direct 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 25,50,100 times of people's recommended amounts respectively, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to the sample that concentration is 0.063,0.125 and 0.25g/mL, give by 10mL/kg body weight per os gavage, continuous 30 days.Separately establish negative control (distilled water), solvent control (edible soybean oil), give distilled water and edible soybean oil respectively, free diet, feed 30 days continuously.SD rat 100 (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record body weight and food-intake weekly, 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 bio-chemistry checking, internal organs gross examination of skeletal muscle is carried out to every rat, gets liver,kidney,spleen simultaneously, testis (ovary) weighs and calculate dirty body ratio, and get liver,kidney,spleen, stomach, intestines, testis (ovary) carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, main dirty body when histological indications compared with control group, equal no significant difference.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, that 30 days feeding trial results show this secure sample is nontoxic.
Stability test: three batch samples are pressed commercially available back and place 3 months at 37 ~ 40 DEG C of temperature and 75% relative humidities, in 0 month, January, February, respectively all events detection is carried out to three batch samples 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, agitator tank is added after beeswax 2400g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil also together with add agitator tank, 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 glycerine is added, when temperature is 60 DEG C ~ 65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65 DEG C ~ 70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; Capsule liquid is placed in the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55 DEG C ~ 65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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 Efficacy experiments: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to 5,10,15 times of the actual intake of people respectively, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, being configured to concentration is 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity presses 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Within continuous 30 days, per os gives 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:
On the impact of the mice spleen lymphocytes proliferation ability of 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: compare with water control group, oily control group respectively, and given the test agent three dosage group mice spleen lymphocytes proliferation ability all strengthens, and difference all has conspicuousness (q checks, P < 0.05); Compare with water control group, oily control group respectively, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Compare with water control group respectively, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Illustrate that this sample has develop immunitypty function.
Rat acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female rat (180-220g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of rat, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Chmice acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female mouse (18-22g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of mouse, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, 10.0g/kg tri-dosage groups, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), often organize 10 mouse (25-30g, male and female half and half), interval is adopted to give sample in 24 hours, 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, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last puts to death animal to 6h after sample, and get its bone marrow of sternum film-making, methyl alcohol is fixed, and Giemsa dyes.Sample Bone Marrow cell micronucleus test result is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, 10.0g/kg body weight three dosage groups, 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), often organize 10 male mices (25-30g).Three dosage component another name sample thiefs 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 after sample the 35th day first, getting two side epididymis and shredding, getting filtrate film-making.Microscopy is observed, and every mouse counts the lopsided number of 1000 sperms.Sample sperm malformation test result is negative.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt dull and stereotyped incorporation methods, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.On direct 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 25,50,100 times of people's recommended amounts respectively, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to the sample that concentration is 0.063,0.125 and 0.25g/mL, give by 10mL/kg body weight per os gavage, continuous 30 days.Separately establish negative control (distilled water), solvent control (edible soybean oil), give distilled water and edible soybean oil respectively, free diet, feed 30 days continuously.SD rat 100 (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record body weight and food-intake weekly, 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 bio-chemistry checking, internal organs gross examination of skeletal muscle is carried out to every rat, gets liver,kidney,spleen simultaneously, testis (ovary) weighs and calculate dirty body ratio, and get liver,kidney,spleen, stomach, intestines, testis (ovary) carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, main dirty body when histological indications compared with control group, equal no significant difference.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, that 30 days feeding trial results show this secure sample is nontoxic.
Stability test: three batch samples are pressed commercially available back and place 3 months at 37 ~ 40 DEG C of temperature and 75% relative humidities, in 0 month, January, February, respectively all events detection is carried out to three batch samples 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, agitator tank is added after beeswax 1600g squalene oil heat fused, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin and remaining squalene oil also together with add agitator tank, 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 glycerine is added, when temperature is 60 DEG C ~ 65 DEG C, add jelly powder, after jelly powder melts completely, control temperature is 65 DEG C ~ 70 DEG C, open vavuum pump, carry out vacuumize degassing bubble, obtain capsule liquid; Capsule liquid is placed in the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55 DEG C ~ 65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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 Efficacy experiments: establish basic, normal, high three dosage groups (0.167,0.333,0.500g/kg body weight), be equivalent to 5,10,15 times of the actual intake of people respectively, take respectively test sample 1.67,3.33,5.00g with soybean oil to 100mL, being configured to concentration is 0.0167,0.0333 and 0.0500g/mL sample, mouse stomach, gavage capacity presses 0.1mL/10g batheroom scale.Establish negative control group (distilled water) and solvent control group (soybean oil) simultaneously.Within continuous 30 days, per os gives 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:
On the impact of the mice spleen lymphocytes proliferation ability of 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: compare with water control group, oily control group respectively, and given the test agent three dosage group mice spleen lymphocytes proliferation ability all strengthens, and difference all has conspicuousness (q checks, P < 0.05); Compare with water control group, oily control group respectively, the phagocytic index that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Compare with water control group respectively, the phagocytic percentage that given the test agent three dosage group Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell all raises, and difference all has conspicuousness (q checks, P < 0.05).Illustrate that this sample has develop immunitypty function.
Rat acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female rat (180-220g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of rat, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Chmice acute Oral toxicity is tested: adopt maximum tolerated dose method, is contaminated by sample with 20.0g/kg body weight dose to each 10 the per os gavages of male and female mouse (18-22g).Take sample and be made into 0.5g/mL, give by 20mL/kg body weight secondary gavage, interval 4h.After contamination, observe the general status of mouse, poisoning symptom and death condition, observe two weeks time limits.Result of the test: sample is all greater than 20.0g/kg body weight to the maximum tolerated dose of the acute oral of male and female mouse.
Mouse marrow cell micro nuclear test: by sample respectively with 2.5g/kg, 5.0g/kg, 10.0g/kg tri-dosage groups, configure with edible soybean oil, separately establish negative control (distilled water), solvent control (edible soybean oil) and positive controls (endoxan 60mg/kg body weight), often organize 10 mouse (25-30g, male and female half and half), interval is adopted to give sample in 24 hours, 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, by 20mL/kg body weight, respectively to each treated animal gavage.Once a day, continuous 2 days.Last puts to death animal to 6h after sample, and get its bone marrow of sternum film-making, methyl alcohol is fixed, and Giemsa dyes.Sample Bone Marrow cell micronucleus test result is negative.
Sperm malformation test: establish sample 2.5g/kg, 5.0g/kg, 10.0g/kg body weight three dosage groups, 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), often organize 10 male mices (25-30g).Three dosage component another name sample thiefs 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 after sample the 35th day first, getting two side epididymis and shredding, getting filtrate film-making.Microscopy is observed, and every mouse counts the lopsided number of 1000 sperms.Sample sperm malformation test result is negative.
Salmonella reversion test: select histidine auxotroph salmonella typhimurium TA
97, TA
98, TA
100, TA
102, adopt dull and stereotyped incorporation methods, proof load is 40 μ g/ wares, 200 μ g/ wares, 1000 μ g/ wares, 5000 μ g/ wares.On direct 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 25,50,100 times of people's recommended amounts respectively, take respectively test sample 15.0,30.0,60.0g with soybean oil to 240mL, be configured to the sample that concentration is 0.063,0.125 and 0.25g/mL, give by 10mL/kg body weight per os gavage, continuous 30 days.Separately establish negative control (distilled water), solvent control (edible soybean oil), give distilled water and edible soybean oil respectively, free diet, feed 30 days continuously.SD rat 100 (55-80g), male and female half and half, random packet, single cage is raised.Continuous Observation 30 days, record body weight and food-intake weekly, 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 bio-chemistry checking, internal organs gross examination of skeletal muscle is carried out to every rat, gets liver,kidney,spleen simultaneously, testis (ovary) weighs and calculate dirty body ratio, and get liver,kidney,spleen, stomach, intestines, testis (ovary) carry out histopathologic examination.Result: animal used as test growing state is good, hematological examination, biochemical analysis, main dirty body when histological indications compared with control group, equal no significant difference.
Acute toxicity test, micronucleus test, sperm malformation test, Salmonella reversion test, that 30 days feeding trial results show this secure sample is nontoxic.
Stability test: three batch samples are pressed commercially available back and place 3 months at 37 ~ 40 DEG C of temperature and 75% relative humidities, in 0 month, January, February, respectively all events detection is carried out to three batch samples 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 make the present invention and change, all fall into protection scope of the present invention.
Claims (1)
1. a squalene oil Echinacea soft capsule, is characterized in that: it is made up of the component of following weight portion: 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, step is as follows:
(1) squalene oil, Echinacea Purpurea Herb P.E, vitamin E, beeswax, soybean lecithin is got by above-mentioned weight portion; Beeswax be equivalent to its 3-6 times amount squalene oil heat fused after add agitator tank, Echinacea Purpurea Herb P.E, vitamin E, soybean lecithin and remaining squalene oil also together with add agitator tank, 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 glycerine is added, when 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 the warm glue bucket of pellet press, feed liquid is placed in the feed liquid bucket be connected with sprinkler body; The temperature setting warm glue bucket is 55-65 DEG C; Start main frame and the air-cooler of pellet press, prepare adhesive tape and sent into by adhesive tape 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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| Publication number | Priority date | Publication date | Assignee | Title |
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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 |
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| 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 |
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