CN102551041A - Refined seal oil, seal oil soft capsules and application of seal oil soft capsules in preparing health products for improving chemical liver injury - Google Patents

Refined seal oil, seal oil soft capsules and application of seal oil soft capsules in preparing health products for improving chemical liver injury Download PDF

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Publication number
CN102551041A
CN102551041A CN2010105775183A CN201010577518A CN102551041A CN 102551041 A CN102551041 A CN 102551041A CN 2010105775183 A CN2010105775183 A CN 2010105775183A CN 201010577518 A CN201010577518 A CN 201010577518A CN 102551041 A CN102551041 A CN 102551041A
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seal oil
seal
refined
control group
soft capsules
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侯国新
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ZHEJIANG KIM NUOKANG BIO-PHARMACEUTICAL CO LTD
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ZHEJIANG KIM NUOKANG BIO-PHARMACEUTICAL CO LTD
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Abstract

The invention relates to refined seal oil, seal oil soft capsules and an application of the seal oil soft capsules in preparing health products for improving chemical liver injury. The seal oil soft capsules comprises 100 % refined seal oil as a raw material, and keep the natural anti-oxidant-squalene in the seal oil in the process of refining the raw material. There is no need to add vitamin E in the raw material. The seal oil soft capsules can be used for preparing health products for improving chemical liver injury.

Description

A kind of refined fur seal, soft capsule and the application in improving the chemical damage health products thereof
Technical field
The present invention relates to a kind of refined fur seal, soft capsule and the application in improving the chemical damage health products thereof.
Background technology
Seal oil (Seal oil) is commonly called as seal oil, is that the fat deposit of the mammal sea dog from waters, deep-sea high and cold (50 ℃) refines the oil of processing.Sea dog is with famous and precious cod; Salmon etc. are food; The thick fat deposit of enrichment in the body; Omega-3 unsaturated fatty acid EPA in the seal oil, DPA, DHA equal size be up to about 20%, the natural ecological environment of the pollution-free cleaning in the arctic in addition, and seal oil becomes the important source of optimal omega-3 unsaturated fatty acid in the Nature.It has protection liver, adjusting blood fat etc. and acts on existing report in some documents, has caused the great attention of domestic and international food circle, and has started seal oil development of functional food upsurge.
Unrighted acid is one type of extremely important aliphatic acid, and it comprises ω-3 and ω-6 series, but human body can not synthesize, must be through the biological approach picked-up, and the former is from marine animal (fish, fur seal etc.), and the latter is from vegetable oil (like peanut, soya-bean oil etc.).Find that after deliberation ω-3 and ω-6 series must keep suitable ratio just can keep the normal physiological activity of human body.WHO thinks that the optimal proportion of ω-3 and ω-6 is 1:4, and the modern diet structure often causes people's omega-3 unsaturated fatty acid insufficiency of intake, and the large-scale statistical data shows that interior this ratio substantial deviation of present human body is to 1:25, even 1:30.In view of the above, WHO and FAO (Food and Agriculture Organization of the United Nation) issue a statement: in view of the importance and the human general lacking of product itself, need promote the serial unrighted acid of ω-3 at world wide.Because the sea dog and the mankind belong to mammal together; The ω that sea dog provides-3 is identical with the chemical molecular structure of human body; Can be absorption of human body and utilization directly, and fish are rudimentary cold-blooded animals, its available ω-3 must transform the rear through liver can be absorption of human body and utilization.
The hepatic injury that is caused by the chemical Hepatoxic substance is called chemical damage.These chemical substances comprise chemical toxicant and the some drugs in alcohol, the environment.All exist some to the virose material of liver in the Nature and the human industrial processes; Be called " hepatotropic poison "; These poisonous substances are general susceptible in the crowd; Incubation period is short, and the process of pathology is directly related with the dosage of infection, can cause liver necrosis of liver cells, fatty distortion, cirrhosis and liver cancer in various degree.Along with being showing improvement or progress day by day of society, living standards of the people improve, the variation of dietary structure, because of bad eating habit (as excessively taking in high-fat food and excessive drinking etc.) dyslipidemia person increases year by year, cause liver to receive damage in various degree among the crowd.Exploitation has as soon as possible has the health food of protective effect to be necessary to chemical damage.
Summary of the invention
One of the object of the invention provides a kind of refined fur seal.
Two of the object of the invention provides a kind of seal oil soft capsule.
Three of the object of the invention provides the application of seal oil soft capsule in improving the chemical damage health products.
Refined fur seal of the present invention is the pale yellow oily liquid body, and the distinctive fishy smell of seal oil is arranged, no tapinoma-odour, free from extraneous odour, free from admixture, and each item physical and chemical index is seen table 1.
Table 1. raw material physical and chemical index
Project Requirement
Eicosapentaenoic acid (EPA)/(%) >;= 6.9
DHA (DHA)/(%) >;= 12.7
Clupanodonic acid (DPA)/(%) >;= 5.6
Squalene/(%) 1.8
Acid number/(mg/g)<= 2.0
Peroxide value (with buttermeter)/(mmol/kg)<= 3.0
Iodine number/(g/100g) >;= 10.0
The preparation method of refined fur seal of the present invention comprises the steps:
(1) be the chopping of fur seal animal tallow with natural material:
(2) under 40-45 ℃ of temperature, heat, water cleans then;
(3) in oil water separator, centrifugalize, filter then;
(4) adopt single-stage short-range molecular distillation purification process to obtain refined fur seal;
The wherein said single-stage short-range molecular distillation purification process of stating comprises the steps:
A) degassing: after system vacuum reaches 0.001-0.003mbar, 310-320 ℃ of primary heater preset temperature, 200-220 ℃ of feed heater preset temperature.
B) distillation: after the primary heater temperature reaches 200 ℃, beginning charging, charging flow velocity 80-90L/h; After the primary heater temperature reaches 310-320 ℃, charging rate 140-160L/h.
C) collect: when the parameter of whole Distallation systm reach requirement and stable after, collect the refined fur seal finished product.Refined fur seal uses heavy ends.
Parameter in the step c) comprises system vacuum degree, charging flow velocity, primary heater temperature, feed heater temperature.
The single-stage short-range molecular distillation of the preferred German UIC manufactured of above-mentioned single-stage short-range molecular distillation purifier apparatus extracts equipment, and this equipment comprises degas system, molecular still, control system and vacuum system four parts.
The present invention adopts unique single-stage short-range molecular distillation purification process refined fur seal, under high vacuum condition, separates, need not esterification.This method has kept the effective ingredient in the seal oil to greatest extent; Be particularly suitable for separating the natural products of low volatility, higher boiling, thermal sensitivity and biologically active; In the feed purification process, kept the anti-oxidant-squalene of pure natural in the seal oil, squalene has the unique raising cell oxygen content and the oxygen carrying capacity of human body hemoglobin, can strengthen cell viability; Enhance metabolism, improve the immunity of organisms function.Single-stage short-range molecular distillation The Application of Technology is that the limitation of omega-fatty acid breakthrough traditional processing technology provides powerful technical support.
Refined fur seal is processed soft capsule; Promptly in capsule machine, suppress and form by 100% refined fur seal and edible gelatin, glycerine; And through typing, dry, select ball, use 95% medicinal alcohol (carrying out the ethanol standards of 2010 editions two ones of Chinese Pharmacopoeias) to wash the ball sterilization at last after, promptly get product.
Seal oil soft capsule of the present invention, its primary raw material are refined fur seal, and raw material is slightly oily by the seal oil from the pure import of Canada, form through single-stage short-range molecular distillation technology is refining, need not fatization, no chemical residual.In the feed purification process, keep the anti-oxidant-squalene of pure natural in the seal oil, need not to add again vitamin E in the raw material.
Seal oil soft capsule of the present invention, content is the pale yellow oily liquid body, and the surface is clean and tidy, glossy, the phenomenon, the free from admixture that bond, be out of shape, break must not occur.
Seal oil soft capsule each item physical and chemical index of the present invention is carried out by the requirement of GB16740-1997 " health care (function) food universal standard ", sees table 2 for details; Each item microbiological indicator is carried out by the regulation of limiting the quantity of about microorganism among the GB16740-1997 " health care (function) food universal standard ", sees table 3 for details.
Table 2. seal oil soft capsule physical and chemical index
Project Requirement
Net content (g/ grain) 0.75
Net content minus deviation (%)<= 4.5
Disintegration time limited (min)<= 60
Ash content (%)<= 1.0
Plumbous (mg/kg)<= 1.5
Arsenic (mg/kg)<= 1.0
Mercury (mg/kg)<= 0.3
Cadmium (mg/kg)<= 0.2
Iodine number (g/100g) >;= 10.0
Acid number (mg/g)<= 2.0
Peroxide value (with buttermeter)/(mmol/kg)<= 3.0
Table 3. seal oil soft capsule microbiological indicator
Project Requirement
Total plate count (cfu/g)<= 1000
Coliform (MPN/100g)<= 40
Mould (cfu/g)<= 25
Yeast (cfu/g)<= 25
Pathogenic bacteria (salmonella, Shigella, staphylococcus aureus, hemolytic streptococcus) Must not detect
The present invention adopts single-stage short-range molecular distillation technology refined fur seal; Kept the anti-oxidant-squalene of pure natural in the seal oil; With 100% refined fur seal is that raw material is processed soft capsule; Need not to add vitamin E in the raw material, this seal oil soft capsule improves in the health products of chemical damage in preparation to be used better.
The specific embodiment
Below in conjunction with the specific embodiment of the present invention advantage of the present invention is described:
Embodiment 1
The physical and chemical index assay of refined fur seal:
Project Assay
Eicosapentaenoic acid (EPA)/(%) 6.95
DHA (DHA)/(%) 12.81
Clupanodonic acid (DPA)/(%) 5.73
Squalene/(%) 1.88
Acid number/(mg/g) 1.12
Peroxide value (with buttermeter)/(mmol/kg) 2.46
Iodine number/(g/100g) 58.0
The preparation method:
Equipment: adopt the EA250/KD200 single-stage short-range molecular distillation of German UIC manufactured to extract equipment.
Raw material: seal oil is oil slightly.
Preparation process is following:
(1) with the thick oil chopping of seal oil:
(2) under 40 ℃ of temperature, heat, water cleans then;
(3) in oil water separator, centrifugalize, filter then;
(4) adopt single-stage short-range molecular distillation purification process refined fur seal, step is following:
A) degassing: open molecular still, when system vacuum reached 0.003mbar, setting the primary heater temperature was 318 ℃, and setting the feed heater temperature is 220 ℃.
B) distillation: after the primary heater temperature reaches 200 ℃, beginning charging, charging flow velocity 80L/h; After the primary heater temperature reaches 318 ℃, charging rate 160L/h.
C) collect: when the parameter of whole Distallation systm reach requirement and stable after, collect the refined fur seal finished product, refined fur seal uses heavy ends.
Get refined fur seal, process the seal oil soft capsule of every 0.75g with conventional method, chemical damage person oral every day 2 times, each 4, chemical damage had has assistant protection function.
Embodiment 2
The physical and chemical index assay of refined fur seal:
Project Requirement
Eicosapentaenoic acid (EPA)/(%) 7.03
DHA (DHA)/(%) 12.94
Clupanodonic acid (DPA)/(%) 5.86
Squalene/(%) 1.86
Acid number/(mg/g) 1.47
Peroxide value (with buttermeter)/(mmol/kg) 2.51
Iodine number/(g/100g) 62.0
The preparation method:
Equipment: adopt the EA250/KD200 single-stage short-range molecular distillation of German UIC manufactured to extract equipment.
Raw material: seal oil is oil slightly.
Preparation process is following:
(1) with the thick oil chopping of seal oil:
(2) under 42 ℃ of temperature, heat, water cleans then;
(3) in oil water separator, centrifugalize, filter then;
(4) adopt single-stage short-range molecular distillation purification process refined fur seal, step is following:
A) degassing: open molecular still, when system vacuum reached 0.002mbar, setting the primary heater temperature was 315 ℃, and setting the feed heater temperature is 210 ℃.
B) distillation: after the primary heater temperature reaches 200 ℃, beginning charging, charging flow velocity 90L/h; After the primary heater temperature reaches 315 ℃, charging rate 150L/h.
C) collect: when the parameter of whole Distallation systm reach requirement and stable after, collect the refined fur seal finished product, refined fur seal uses heavy ends.
Get refined fur seal, process the seal oil soft capsule of every 0.75g with conventional method, chemical damage person oral every day 2 times, each 4, chemical damage had has assistant protection function.
Embodiment 3
The physical and chemical index assay of refined fur seal:
Project Requirement
Eicosapentaenoic acid (EPA)/(%) 7.12
DHA (DHA)/(%) 13.11
Clupanodonic acid (DPA)/(%) 6.15
Squalene/(%) 1.89
Acid number/(mg/g) 1.62
Peroxide value (with buttermeter)/(mmol/kg) 2.74
Iodine number/(g/100g) 61.7
The preparation method:
Equipment: adopt the EA250/KD200 single-stage short-range molecular distillation of German UIC manufactured to extract equipment.
Raw material: seal oil is oil slightly.
Preparation process is following:
(1) with the thick oil chopping of seal oil:
(2) under 45 ℃ of temperature, heat, water cleans then;
(3) in oil water separator, centrifugalize, filter then;
(4) adopt single-stage short-range molecular distillation purification process refined fur seal, step is following:
A) degassing: open molecular still, when system vacuum reached 0.001mbar, setting the primary heater temperature was 312 ℃, and setting the feed heater temperature is 200 ℃.
B) distillation: after the primary heater temperature reaches 200 ℃, beginning charging, charging flow velocity 90L/h; After the primary heater temperature reaches 312 ℃, charging rate 140L/h.
C) collect: when the parameter of whole Distallation systm reach requirement and stable after, collect the refined fur seal finished product, refined fur seal uses heavy ends.
Get refined fur seal, process the seal oil soft capsule of every 0.75g with conventional method, chemical damage person oral every day 2 times, each 4, chemical damage had has assistant protection function.
The toxicological safety of the embodiment of the invention 3 seal oil soft capsules is tested as follows:
1 materials and methods
1.1 sample and processing: it is the product content thing that soft capsule supplies test agent, the pale yellow oily liquid body, and proportion is about 0.92.Be mixed with each dosage with edible vegetable oil as solvent during experiment and supply examination.
1.2 animal used as test and testing conditions: experiment is provided by Shanghai Slac Experimental Animal Co., Ltd. with the SD rat, and production licence number is SCXK (Shanghai) 2007-0005, cleaning level, body weight 55-80g.The animal used as test feed is provided by Zhejiang Province's Experimental Animal Center, operative norm GB14924-2001.Sense environmental conditions, the experimental animal room use certificate can the number of card be SYXK (Zhejiang) 2008-0106, temperature range 20-23 ℃, relative humidity scope 50-70%.In the Animal House environment, adapt to 3 days before the animal used as test test.
1.3 method
1.3.1 the dosage design: this product people recommended amounts is 6.0g/60kg/ day.Three dose groups and a negative control group (distilled water), a solvent control group (edible vegetable oil) are established in experiment, and basic, normal, high three dosage are respectively 2.5,5.0, the 10.0g/kg body weight, are equivalent to 25 times, 50 times and 100 times of people's recommended amounts.Experiment 2.5,5.0g/kg body weight dose groups get 60.0 respectively, the 120.0g sample with edible vegetable oil to 240ml be made into 0.25,0.50g/ml; Irritating stomach by 10ml/g body weight per os gives; 10.0g/kg the body weight dose groups is irritated stomach with product stoste by 11ml/kg body weight per os and is given continuous 30 days.Negative control group and solvent control group are irritated stomach with distilled water, edible vegetable oil respectively, irritate stomach by 10ml/kg body weight per os and give.
1.3.2 experimental technique: 100 of SD rats, divide 5 groups at random, 20 every group, male and female half and half, the single cage of rat is raised ad lib, drinking-water.Rat was observed 30 days continuously; Write down body weight and food-intake weekly and calculate food utilization; Experimental period end vein is got blood and is carried out hematological examination (measuring with the full-automatic blood counting instrument of MEK-6318KWG), and broken end is got blood and carried out blood examination and look into (getting serum with Accute TBA-40FR automatic clinical chemistry analyzer mensuration), and every rat is carried out the internal organs gross examination of skeletal muscle; Get liver,kidney,spleen simultaneously, testis (ovary) is weighed and calculate dirty body ratio; And get liver,kidney,spleen, stomach, intestines, testis (ovary) and carry out histopathologic examination's (paraffin section, H-E dyeing, light microscopy checking).
1.3.3 interpretation of result: variance analysis, rank test.
2 results
2.1 overview, experimental session, each organizes the equal no abnormality seen sings and symptoms of rat, does not also have dead.
2.2 influence to rat body weight
The result sees table 1, and initial data meets the neat requirement of variance (P>0.05), tests each time point three dose groups rat body weight and negative control group, the equal first conspicuousness of solvent control group comparing difference (variance analysis, P>0.05).
This soft capsule of table 1. to the influence of rat body weight (± SD)
Figure 887976DEST_PATH_IMAGE001
2.3 to rat week food-intake and the influence of total foodstuff utilization rate, all food utilizations
The result sees table 2, and initial data meets the neat requirement of variance (P>0.05), each in dose groups rat week food-intake and negative control group, there are no significant for the solvent control group comparing difference (variance analysis, P>0.05).
This soft capsule of table 2. to the influence of rat week food-intake (± SD)
Figure 756706DEST_PATH_IMAGE002
2.4 influence to rat blood
The result sees table 3; Numerical value is all in normal range (NR); Remove male and female property rat hemoglobin and red blood cell count(RBC) initial data and do not meet the neat requirement of variance (P < 0.05); Data still do not meet the homogeneity of variance requirement through conversion, and each dose groups male and female property rat hemoglobin, red blood cell count(RBC) and negative control group, solvent control group comparing difference do not have conspicuousness outer (rank test, P>0.05).The white blood cell count(WBC) initial data meets the neat requirement of variance (P>0.05), and each dose groups rat leukocyte counting and negative control group, solvent control group comparing difference do not have conspicuousness (variance analysis, P>0.05).
This soft capsule of table 3. to the influence of rat HB, RBC, WBC (± SD)
2.5 influence to rat WBC
The result sees table 4, and initial data meets the neat requirement of variance (P>0.05).Numerical value is all in normal range (NR).The classification of each dose groups rat leukocyte lymph, monokaryon, granulocyte and negative control group, there are no significant for the solvent control group comparing difference (variance analysis, P>0.05).
This soft capsule of table 4. to the influence of rat WBC (± SD)
Figure 621949DEST_PATH_IMAGE004
2.6 influence to blood biochemistry of rats
The result sees table 5, table 6, and numerical value is all in normal range (NR).Remove female rats serum glutamic pyruvic transminase, urea nitrogen; Male rat serum flesh liver initial data does not meet the neat requirement of variance (P < 0.05); Data still do not meet the homogeneity of variance requirement through conversion; That there are no significant is outer for each dose groups female rats serum urea nitrogen and male rat serum creatinine and negative control group, solvent control group comparing difference (rank test, P>0.05), and all the other initial data meet the neat requirement of variance (P>0.05).Each dose groups rat blood serum glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease, urea nitrogen, creatinine, T-CHOL, triglycerides and negative control group, there are no significant for the solvent control group comparing difference (variance analysis, P>0.05).
Table 6 numerical value is all in normal range (NR).Initial data meets the neat requirement of variance (P>0.05).Each dose groups rat blood serum blood sugar, total protein, albumin, globulin, white/ball than and negative control group, there are no significant for the solvent control group comparing difference (variance analysis, P>0.05).
This soft capsule of table 5. to the influence of blood biochemistry of rats (± SD)
Figure 83017DEST_PATH_IMAGE005
This soft capsule of table 6. to the influence of blood biochemistry of rats (± SD)
Figure 450545DEST_PATH_IMAGE006
2.7 the influence of and dirty body ratio heavy to Rats Organs and Tissues
The result sees table 7, and initial data meets the neat requirement of variance (P>0.05).The heavy liver,spleen,kidney of each dose groups Rats Organs and Tissues, testis (ovary) and dirty body compare than liver/body, spleen/body, kidney/body, testis (ovary)/body ratio and negative control group, solvent control group, there are no significant for difference (variance analysis, P>0.05).
This soft capsule of table 7. is given birth to by Rats Organs and Tissues and the influence of dirty body ratio (± SD)
Figure 629853DEST_PATH_IMAGE007
2.8 rat histopathologic examination
Gross anatomy is not found obviously unusual, and mirror inspection is down found: liver: the liver tunicle is complete, the lobuli hepatis clear in structure, and the liver plate is arranged not disorderly, the karyon regular shape, the little bile duct in portal area, blood vessel, lymphatic vessel are visible, and Kupffer is not different from; A small amount of slight extravasated blood of rat central veins of hepatic lobules (negative control: male rat 2 examples, female rats 1 example, this treated animal adds up to 20, sketches 1/20 example into ♂ 2 ♀; Solvent control group: male rat 2 examples, female rats 2 examples, sketch 2/20 example into ♂ 2 ♀; High dose group: male rat 3 examples, female rats 2 examples, sketch 2/20 example) into ♂ 3 ♀.A small amount of slight dilatation and congestion of rat liver blood sinus, strip distribution (negative control: ♀ 1/20 example; Solvent control group: ♂ 1/20 example; High dose group: ♂ 1 ♀ 2/20 example). visible circular cavity in a small amount of rat liver cell cytosol, strip is dispersed in distribution (negative control: 0/20 example; Solvent control group: ♀ 2/20 example; High dose group: ♂ 1 ♀ 4/20 example).Visible point kitchen range shape cell infiltration (negative control group: ♂ 1 ♀ 1/20 example in a small amount of rat liver leaflet; Solvent control group: ♂ 2 ♀ 2/20 example; High dose group: ♂ 2 ♀ 2/20 example), visible cell infiltration (negative control: ♂ 1 ♀ 2/20 example that is dispersed in a small amount of rat liver portal area; Solvent control group: ♂ 1 ♀ 2/20 example; High dose group: ♂ 2 ♀ 2/20 example), rat liver visible point kitchen range shape necrosis of liver cells is accompanied cell infiltration (negative control: ♂ 1 ♀ 1/20 example on a small quantity; Solvent control group: ♂ 1 ♀ 3/20 example; High dose group: ♂ 2 ♀ 3/20 example).Kidney: tunicle is complete, and it is clear that cortical area and medullary substance are distinguished layer, no proliferation of fibrous tissue.Changes such as that glomerulus is not seen is full, atrophy, necrosis.The renal plevis mucous membrane is complete, and nothingization is given birth to and waited abnormal change.A small amount of rat kidney part renal cells mild swelling (negative control: ♂ 1 ♀ 1/20 example; Solvent control group: ♀ 2/20 example; High dose group: ♂ 1 ♀ 1/20 example), the slight dilatation and congestion of matter blood vessel (negative control: ♂ 1 ♀ 2/20 example between the local cortex renis of a small amount of rat kidney; Solvent control group: ♂ 2 ♀ 2/20 example; High dose group: ♂ 2 ♀ 2/20 example).The visible special mess shape cell infiltration (negative control: 0/20 example in a small amount of kidney of rats cortical area; Solvent control group: 0/20 example; High dose group: ♂ 2/20 example.Indivedual kidney of rats ductus papillaris epithelial cell focal necrosis companion cell infiltration (negative controls: 0/20 example; Solvent control group: 0/20 example; High dose group: ♂ 1/20 example).Spleen: spleen is organized no abnormality seen, and is red in visible with white pulp, and visible arterial sheath in the white pulp is red in interior visible lymphocyte and the red blood cell that is dispersed in, red, the white pulp ratio is normal basically.The a small amount of slight dilatation and congestion of rat splenic sinusoid (negative control: ♂ 2/20 example; Solvent control group: ♂ 2/20 example; High dose group: ♀ 1/20 example).Stomach and intestines (small intestine, duodenum): mucomembranous epithelial cell form no abnormality seen, lamina propria, submucosa, flesh layer and placenta percreta are not seen cell infiltration, and gastric gland, enteraden all do not have atrophy, and hyperplasia sexually revises.Indivedual gastric mucosa of rat lower floors blood vessel mild hyperaemia (negative control: 0/20 example; Solvent control group: ♀ 1/20 example; High dose group: 0/20 example).Testis: androgone reduces in indivedual rat testicle convoluted seminiferous tubules, does not see androgone in the part convoluted seminiferous tubule, interstitial cell hyperplasia (negative control: 0/20 example; Solvent control group: 0/20 example; High dose group: ♂ 1/20 example).All the other not atrophys of rat testicle convoluted seminiferous tubule, androgones at different levels are arranged not disorderly, and a matter no abnormality seen changes.Ovary: visible growing follicles at different levels, a matter no abnormality seen.
Result of the test shows: 30 days feeding trial three dose groups each item indexs of this soft capsule rat are not all seen the overt toxicity reaction.
The functional test of seal oil soft capsule of the present invention is following:
1 animal used as test and testing conditions:
The animal used as test occupancy permit number is SYXK (Zhejiang) 2008-0106.Experiment is provided by west, Shanghai pul-Bi Kai animal used as test Co., Ltd with the ICR mouse, and the animal used as test production licence is SCXK (Shanghai) 2008-0016, and the cleaning level is male, body weight 20 ± 2g.Feed is provided by Zhejiang Province's Experimental Animal Center, operative norm GB14924.1-2001.Sense environmental conditions, temperature 20-24 ℃, relative humidity 40-70%.Animal adapts to 3 days in the Animal House environment before test.
The design of 2 dosage:
Three dose groups are established in experiment: normal control group, model control group (distilled water) and solvent control group (soybean oil).Basic, normal, high three dosage are respectively 0.5,1.0, the 3.0g/kg body weight, are equivalent to 5,10 and 30 times (people's recommended amounts is 6.0g/60kg/ day) of people's recommended amounts.Three dose groups take by weighing respectively supply test agent 3.0,6.0 and 18.0g with soybean oil to 60ml, be mixed with concentration and be 0.005,0.100 and the 0.300g/ml sample, irritate stomach and give sample, irritate gastric capacity and press the 0.1ml/10g batheroom scale.
3 experimental techniques:
3.1 each dose groups per os every day is irritated stomach and tried thing, normal control group and model control group give distilled water, and solvent control group gives edible soybean oil.Animal weighs twice weekly, is tried the dosage of thing with adjustment.In the experiment the 45th day with model control group, solvent control group; Being tried each dose groups animal of thing once irritates stomach and gives 50% ethanol 14ml/kg body weight; The normal control treated animal is given distilled water; Fasting 16h puts to death animal, gets detection (10% hepatic homogenate is centrifugal with 10000 rev/mins) and histopathologic examination that liver carries out each item index.
3.2 detection index: the MDA in the hepatic tissue (MDA), reduced glutathione (GSH) and triglycerides (TG) content.
3.3 hepatic pathology histological examination is done the cross section from mouse liver lobus sinister middle part and is drawn materials, frozen section, oil red dyeing.The pathological change that microscopy is looked closely wild opening entry cell from one of liver is observed whole histotomy continuously with 40 times of object lens, mainly observes distribution, scope and area that fat drops in liver.
3.4 data: homogeneity of variance through variance test of homogeneity homogeneity of variance or after carrying out appropriate data conversion, then adopt variance analysis.If after data transaction, do not reach normal state or homogeneity of variance requirement yet, then use rank test instead and add up.Experimental result is added up with the SPSS11.5 statistical software.
4 experimental results:
4.1 tried the influence of thing to the experiment mice body weight:
The result sees table 1.Through the variance test of homogeneity, initial data meets sends out the difference homogeneous.The initial body weight of basic, normal, high three dose groups mouse, mid-term body weight, final body weight and weight gain and normal control group, model control group, solvent control group relatively, the equal not statistically significant of difference (variance analysis, P>0.05).
Table 1. is tried the influence of thing to the mouse body weight
Figure 341195DEST_PATH_IMAGE008
4.2 tried the influence of thing to murine liver tissue MDA, GSH, TG content:
The result sees table 2, with the normal control group relatively, MDA, TG obviously raise in the model control group murine liver tissue, GSH obviously reduces, difference all has statistical significance (t check, P < 0.05), and the establishment of ethanol liver injury model be described.With model control group and solvent control group relatively, TG obviously reduces in the high dose group murine liver tissue, GSH obviously raises, difference all has statistical significance (q check, P < 0.05); With model control group relatively, GSH obviously raises in the low dose group murine liver tissue, difference has statistical significance (q check, P < 0.05); With solvent control group relatively, TG obviously reduces in the low dose group murine liver tissue, difference has statistical significance (q check, P < 0.05).
Table 2. is tried the influence of thing to murine liver tissue MDA, GSH, TG content
Figure 922349DEST_PATH_IMAGE009
Annotate: a. and normal control group compare, the t check, and P < 0.05; B. compare with model control group, the q check, P < 0.05; C. compare with solvent control group, the q check, P < 0.05.
4.3 the hepatic pathology histology changes:
The microscopy result sees table 3, and model control group and each dose groups animal's liver pathological change are main with hepatic cell fattydegeneration, and pathology unit sees with the leaflet peripheral band more.With the normal control group relatively, model control group mouse liver cellular fat sex change scoring obviously raises, through statistical procedures, difference has statistical significance (t check, P < 0.01), explains that model sets up successfully.With model control group and solvent control group relatively, high dose group mouse liver cellular fat sex change scoring average obviously reduces, difference all has statistical significance (q check, P < 0.05).
Table 3. is tried thing to murine liver tissue Histopathology variable effect
Figure 195199DEST_PATH_IMAGE010
Annotate: a. and normal control group compare, the t check, and P < 0.01; B. compare with model control group, the q check, P < 0.05; C. compare with solvent control group, the q check, P < 0.05.
Result of the test shows: this soft capsule has assistant protection function to the chemical damage of mouse.
Advanced technological means development and use seal oil resource is adopted in this research; Be made into and have the functional food that chemical damage is had defencive function; Have functional component content height, little, the eutherapeutic characteristics of dose, this product will bring good social benefit and economic benefit.

Claims (7)

1. a refined fur seal is characterized in that containing in the seal oil eicosapentaenoic acid >=6.9g/100g, DHA >=12.7g/100g, clupanodonic acid >=5.6g/100g, squalene >=1.8 g/100g.
2. refined fur seal according to claim 1 is characterized in that the preparation method comprises the steps:
(1) the fur seal animal tallow is shredded:
(2) under 40-45 ℃ of temperature, heat, water cleans then;
(3) in oil water separator, centrifugalize, filter then;
(4) adopt single-stage short-range molecular distillation purification process refining.
3. refined fur seal according to claim 2, wherein said single-stage short-range molecular distillation purification process comprises the steps:
A) degassing: after system vacuum reaches 0.001-0.003mbar, 310-320 ℃ of primary heater preset temperature, 200-220 ℃ of feed heater preset temperature;
B) distillation: after the primary heater temperature reaches 200 ℃, beginning charging, charging flow velocity 80-90L/h; After the primary heater temperature reaches 310-320 ℃, charging rate 140-160L/h;
C) collect: when the parameter of whole Distallation systm reach requirement and stable after, collect the refined fur seal finished product.
4. refined fur seal according to claim 3, wherein said single-stage short-range molecular distillation purification process are selected the single-stage short-range molecular distillation equipment of German UIC company for use.
5. a seal oil soft capsule is characterized in that adopting arbitrary described 100% refined fur seal by weight of claim 1-4.
6. seal oil soft capsule according to claim 5 improves the application in the chemical damage health products in preparation.
7. application according to claim 6, dosage are the 6g/60kg body weight/day.
CN2010105775183A 2010-12-08 2010-12-08 Refined seal oil, seal oil soft capsules and application of seal oil soft capsules in preparing health products for improving chemical liver injury Pending CN102551041A (en)

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CN104068402A (en) * 2014-06-29 2014-10-01 宁波市成大机械研究所 Soft seal oil capsule containing gamma-linolenic acid
CN104082752A (en) * 2014-06-29 2014-10-08 宁波市成大机械研究所 Squalene containing seal oil soft capsules
CN104172151A (en) * 2014-06-29 2014-12-03 宁波市成大机械研究所 Seal oil soft capsules containing coenzyme Q10
CN104544104A (en) * 2015-02-11 2015-04-29 昆明轿子雪山玛卡生物科技开发有限公司 Maca-seal oil composite soft capsule
CN105132121A (en) * 2015-08-24 2015-12-09 广西北部湾海皇生物科技有限公司 Refining method for seal oil and application of seal oil in preventing and treating fatty liver and prostatic hyperplasia

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CN101177649A (en) * 2006-11-10 2008-05-14 浙江医药股份有限公司新昌制药厂 Method for enriching active ingredient of seal oil
CN101530425A (en) * 2009-04-29 2009-09-16 刘威 Application of refined seal oil to preparation of medicines for treating chronic renal failure

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CN1435186A (en) * 2003-03-11 2003-08-13 刘威 Use of refined fur seal oil for preparing medicine for preventing and treating senile dementia and apoplexy sequela
CN1679626A (en) * 2004-04-09 2005-10-12 刘威 Use of testiset and its composition in health-care products for preventing liver from chemical damage
WO2006097806A1 (en) * 2005-03-14 2006-09-21 Aldivia Antioxidants based on anacardiaceae species, methods for obtaining same and uses thereof
CN1951399A (en) * 2005-10-18 2007-04-25 天津贝特药业有限公司 A refined fur seal enriched in OMEGA-3 polyunsaturated fatty acid and preparation thereof
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104068402A (en) * 2014-06-29 2014-10-01 宁波市成大机械研究所 Soft seal oil capsule containing gamma-linolenic acid
CN104082752A (en) * 2014-06-29 2014-10-08 宁波市成大机械研究所 Squalene containing seal oil soft capsules
CN104172151A (en) * 2014-06-29 2014-12-03 宁波市成大机械研究所 Seal oil soft capsules containing coenzyme Q10
CN104544104A (en) * 2015-02-11 2015-04-29 昆明轿子雪山玛卡生物科技开发有限公司 Maca-seal oil composite soft capsule
CN105132121A (en) * 2015-08-24 2015-12-09 广西北部湾海皇生物科技有限公司 Refining method for seal oil and application of seal oil in preventing and treating fatty liver and prostatic hyperplasia
CN105132121B (en) * 2015-08-24 2019-01-01 广西北部湾海皇生物科技有限公司 The refining methd of seal oil and its prevention and treatment fatty liver and hyperplasia of prostate application

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