CN101810679A - Polyunsaturated fatty acid soft capsule and preparation method thereof - Google Patents
Polyunsaturated fatty acid soft capsule and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a polyunsaturated fatty acid soft capsule which comprises a soft capsule shell and content. The content comprises the following effective ingredients in percentage by weight: 7.6-8.8 percent of linolenic acid, 49.0-60.0 percent of linoleic acid, 7.0-12.9 percent of oleic acid, 0.25-0.5 percent of ganoderma triterpene and 1.6-3.0 percent of vitamin E and the balance of reagent capable of being accepted by the human body. Proved by animal functions and human body test eating experiments, the polyunsaturated fatty acid soft capsule has a health care function for improving the sleep quality, and also has a health care function of oxidation resistance.
Description
One. technical field
The present invention relates to a kind of health product, particularly relate to and a kind ofly human body is had the sleep of improvement effect, polyunsaturated fatty acid soft capsule of anti-oxidation function and preparation method thereof.
Two. background technology
In recent years, along with people to improving constantly of requiring of quality of life, health product are kept fit as disease preventing and treating, the quality of especially making the life better more and more comes into one's own.Health product kind in the market is many, but also exists deficiency miscellaneous.Improve sleep, antioxidation, the health product of slow down aging aspect become the focus that people pay close attention to.A lot of medicines, though can improve sleep, antioxidation, slow down aging, big to the human body side effect, and can't synergism, maintenance Human Physiology system stability.
In order to solve above-mentioned antioxidation, the slow down aging problem has a lot of vitamin E capsules in the market, is that the Chinese patent ZL200710068178.X on April 23rd, 2007 discloses a kind of " complex capsule of vitamin E " as the applying date.The complex capsule of this vitamin E is a raw material components by vitamin E, olive oil and rose oil, and the weight percentage ranges of each component is: vitamin E2 0%-60%, olive oil 39.9%-79.9%, rose oil 0.01%-0.1%; But the complex capsule that vitamin E is provided not only oral administration but also external that this invention provided, oral dose are 1 of every day, and one month is a course of treatment, can take throughout the year; The outer time spent it can mix use with skin care item, directly be applied in skin; Have health-care effects such as antioxidation, antiinflammatory, slow down aging, functions of removing chloasma, prevention cardiovascular and cerebrovascular disease.
Three. summary of the invention
The purpose of this invention is to provide and a kind ofly can improve the sleep effect, health product of anti-oxidation function and preparation method thereof.
A kind of polyunsaturated fatty acid soft capsule comprises soft capsule skin and content, contains the effective ingredient of following weight percent in the described content:
Linolenic acid 7.6-8.8%;
Linoleic acid 49.0-60.0%;
Oleic acid 7.0-12.9%;
Ganoderma triterpenoids 0.25-0.5%;
Vitamin E 1.6-3.0%;
Surplus is the human body acceptable agents.
Allow to contain any human body acceptable agents in the content of the present invention, as solvent or adjuvant, concrete as various saturated/unsaturated fatty acid, organic solvent etc.
Preferably, contain the effective ingredient of following weight percent in the described content: linolenic acid is 8.0%, and linoleic acid is 50.0%, and oleic acid is 8.0%, and Ganoderma triterpenoids is 0.27%, and vitamin E is 2.0%.
A kind of preparation method of described polyunsaturated fatty acid soft capsule may further comprise the steps:
1) with Fructus Cannabis oil, Ganoderma spore oil, natural Vitamin E batching, makes the soft capsule content suspension;
2) gelatin, glycerol, purified water are dropped in the peptizer according to 1: 0.4～0.6: 1 weight ratio, heating, colloidal sol are made the soft capsule skin;
3) soft capsule content suspension and soft capsule skin are carried out the filling pelleting by the automatic tire bagger of soft capsule, controlling every soft capsule content weight is 0.8～1.2g; After the soft capsule typing, wash ball, drying, lamp inspection, packing again and get product.
Preferably, in the step (2): gelatin, glycerol, purified water weight ratio are 1: 0.4: 1.
Preferably, every soft capsule content weight of control is 1.0g in the step (3).
Fructus Cannabis oil of the present invention, Ganoderma spore oil, natural Vitamin E all can make by preparation method well known to those skilled in the art, also can obtain by commercial sources.
Fructus Cannabis oil is to be raw material with the Fructus Cannabis, forms through the processing refining refinement, is rich in multiple unsaturated fatty acid, and comprising: linolenic acid, linoleic acid, oleic acid have multiple pharmacological effect.Fructus Cannabis is the dry mature fruit of moraceae plants Fructus Cannabis, and property is flat, and sweet in the mouth has the effect of loosening bowel to relieve constipation, in the edible history in existing 3000 of China.Confirm that through pharmacological research Fructus Cannabis oil not only has effect to digestive system, and the human body other system is also had curative effect preferably, as the syngignoscism of defying age, antioxidation, analgesia, convulsion and enhancing and prolongation ciclobarbital soluble and time for falling asleep etc.
Ganoderma spore oil is to be raw material with the Sporoderm-broken Ganoderma Lucidum Spore powder, adopts the method for supercritical carbon dioxide extraction, through what be processed into.Ganoderma is the dry sporophore of Polyporaceae fungus Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma, and property is flat, and sweet in the mouth has invigorating QI and tranquilization, the effect of relieving cough and asthma.Ganoderma spore powder is the dark brown powder that Ganoderma discharges in growth course, finds that through scientific research spore powder is the elite part of Ganoderma, and it has concentrated the effective ingredient of Ganoderma.According to the literature, having comprised all effective ingredient such as the triterpenes in the Ganoderma spore, polysaccharide and ucleosides in the Ganoderma spore oil, is the aggregation of Ganoderma spore effective ingredient.
Natural Vitamin E is a kind of fatsoluble vitamin, also is the Natural antioxidant of the unique nontoxic oils food found up to now, and it extensively is present in the plumule of the green portion of plant and grass family seed.An amount of natural Vitamin E that replenishes can help some proteinic decaying of delaying to play a role in cell transfer and metabolic processes, thereby the protection cerebral tissue exempts from immune system and old relevant oxidation destroys.Natural Vitamin E is compared with synthesising complex E, has not only kept original physiologically active of vitamin E and natural attribute, and its trap and safety aspect also have the not available clear superiority of composite.There are the antioxidation that experiment showed, natural Vitamin E and defying age performance indications all to count and decuple synthetic vitamin E.
Polyunsaturated fatty acid soft capsule of the present invention has the health care that improves sleep, proves also have the oxidation-resisting health-care function through animal function and human feeding trial.
Four. the specific embodiment
The invention will be further described below in conjunction with embodiment, but protection scope of the present invention is not limited to this.
Embodiment 1
A kind of polyunsaturated fatty acid soft capsule, comprise soft capsule skin and content, the effective ingredient that contains following weight percent in the described content: linolenic acid is 8.0%, linoleic acid is 50.0%, oleic acid is 8.0%, Ganoderma triterpenoids is 0.27%, and vitamin E is 2.0%, and surplus is the human body acceptable agents.
A kind of preparation method of described polyunsaturated fatty acid soft capsule may further comprise the steps:
1) with Fructus Cannabis oil, Ganoderma spore oil, natural Vitamin E batching, makes the soft capsule content suspension;
2) gelatin, glycerol, purified water are dropped in the peptizer according to 1: 0.4: 1 weight ratio, heating, colloidal sol are made the soft capsule skin;
3) soft capsule content suspension and soft capsule skin are carried out the filling pelleting by the automatic tire bagger of soft capsule, controlling every soft capsule content weight is 1.0g; After the soft capsule typing, wash ball, drying, lamp inspection, packing again and get product.
Embodiment 2
A kind of polyunsaturated fatty acid soft capsule, comprise soft capsule skin and content, the effective ingredient that contains following weight percent in the described content: linolenic acid is 8.3%, linoleic acid is 55.0%, oleic acid is 12.1%, Ganoderma triterpenoids is 0.37%, and vitamin E is 2.5%, and surplus is the human body acceptable agents.
A kind of preparation method of described polyunsaturated fatty acid soft capsule may further comprise the steps:
1) with Fructus Cannabis oil, Ganoderma spore oil, natural Vitamin E batching, makes the soft capsule content suspension;
2) gelatin, glycerol, purified water are dropped in the peptizer according to 1: 0.5: 1 weight ratio, heating, colloidal sol are made the soft capsule skin;
3) soft capsule content suspension and soft capsule skin are carried out the filling pelleting by the automatic tire bagger of soft capsule, controlling every soft capsule content weight is 1.1g; After the soft capsule typing, wash ball, drying, lamp inspection, packing again and get product.
The test example
One, improves the sleep animal experiment
1 materials and methods
1.1 sample: polyunsaturated fatty acid soft capsule content of the present invention, content are yellow oil.The human oral recommended dose is the 1g/ grain, every day 2 times, and each 2, become body weight for humans to press 60kg and calculate, amount to dosage 0.067g/kgbw.
1.2 laboratory animal: 120 of cleaning level Kunming kind male white mouses, portion provides by the science service of Changsha laboratory animal, and body weight is 18～22kg, laboratory animal production licence number SCXK (Hunan) 2006-0001.
1.3 experimental situation condition: experiment condition is a barrier environment, 22 ℃～24 ℃ of experimental session temperature, and humidity 52%～58%, the laboratory animal occupancy permit number is SYXK (Hunan) 2005-0001 number.
1.4 dosage is selected: laboratory animal is divided into three experimental grouies, be designated as experiment I group (prolonging the pentobarbital sodium experiment length of one's sleep), II group (pentobarbital sodium sub-threshold dose hypnosis experiment), III group (barbital sodium sleep experiment incubation period) respectively, each experimental group is divided into four groups at random according to the weight of animals, 10 every group.If the basic, normal, high dosage of polyunsaturated fatty acid soft capsule is respectively 0.34g/kgbw, 0.67g/kgbw, 2.00g/kgbw (be equivalent to respectively human body recommended dose 5,10,30 times).During test, get 3.40g, 6.70g respectively, 20.00g polyunsaturated fatty acid soft capsule content, is made into corresponding dosage and is subjected to test solution to 100ml with edible vegetable oil, irritates stomach for each dosage group.Matched group gives equal-volume edible vegetable oil.Irritate stomach every day once, irritating the stomach amount is 0.1ml/10gbw, continuous 30 days.The experimental session animal drinking-water of freely ingesting.Observe activity and the growing state of animal every day.
1.5 instrument and reagent: AEU210 electronic balance, ES-C300S electronic balance, stopwatch, pentobarbital sodium, barbital sodium, normal saline.
1.6 experimental technique:
1.6.1 direct sleep experiments
Observe the given the test agent that animal gives 3 dosage, matched group give the consubstantiality food stagnation with vegetable oil after, whether the phenomenon of sleeping appears, sleep is an index with the righting reflex loss.When mice places supine position, can right the body position immediately, can not the person of righting as surpassing 30～60 seconds, promptly think righting reflex loss to enter sleep.Righting reflex recovers to be the animal awakening, and righting reflex loss is the animal sleep time to recovering during this period of time, the sleeping number of animals of record matched group and given the test agent group and the length of one's sleep.
1.6.2 prolong the pentobarbital sodium experiment length of one's sleep
The animal last is tried 15min behind the thing, press 41mg/kgbw dosage lumbar injection pentobarbital sodium for each treated animal, injection volume is 0.1ml/10gbw, serves as the sleep index with the mice righting reflex loss, observes and is tried thing to the pentobarbital sodium prolongation effect of the length of one's sleep.
1.6.3 pentobarbital sodium closes down dosage hypnosis experiment
The animal last is tried 15min behind the thing, press 32mg/kgbw dosage lumbar injection pentobarbital sodium for each treated animal, injection volume is 0.1ml/10gbw, reach more than the 1min as sleeping criterion with the mice righting reflex loss, observe and the number of animals of sleep takes place for each treated animal in the pentobarbital sodium 30min.
1.6.4 barbital sodium sleep experiment incubation period
The animal last is tried 15min behind the thing, press 295mg/kgbw dosage lumbar injection barbital sodium for each treated animal, and injection volume is 0.1ml/10g, is index with the righting reflex loss, and the observation given the test agent is to the barbital sodium preclinical influence of sleeping.
1.7 statistical analysis is handled: carry out data conversion and statistical analysis with Spss 11.0 softwares.Relatively the time, earlier data are carried out homogeneity test of variance with the Spss software statistics, if variance is neat, adopt one factor analysis of variance totally to compare, the reuse Dunnett method that finds differences is carried out comparing in twos between a plurality of dosage groups and matched group mean.If heterogeneity of variance, then initial data is carried out suitable variable conversion, satisfy homogeneity test of variance after, add up with the data after changing; If do not reach the neat purpose of variance yet after the variable conversion, to use rank test instead and add up, discovery is overall more variant, then adopts Tamhane ' the sT2 check that does not require homogeneity of variance to compare in twos.
2 results
2.1 polyunsaturated fatty acid flexible glue class is to the influence of the weight of animals
By table 1～3 as can be seen, each dosage group of polyunsaturated fatty acid soft capsule and matched group relatively, experimental session body weight there are no significant difference she (P＞0.05); Growth of animal is good, shows no obvious abnormalities reaction.
Table 1 polyunsaturated fatty acid soft capsule improves sleep (I) group mice body weight
Table 2 polyunsaturated fatty acid soft capsule improves sleep (II) group mice body weight
Table 3 polyunsaturated fatty acid soft capsule improves sleep (III) group mice body weight
2.2 direct sleep experiments
Table 4 polyunsaturated fatty acid soft capsule is to the influence of the direct sleep experiments of mice
| Dosage (g/kgbw) | Number of animals (only) | Sleeping number of animals (only) | Sleep incidence rate (%) | The P value |
| ??0.00 | ??10 | ??0 | ??0 | ?--- |
| ??0.34 | ??10 | ??0 | ??0 | ?--- |
| ??0.67 | ??10 | ??0 | ??0 | ?--- |
| ??2.00 | ??10 | ??0 | ??0 | ?--- |
By table 4 as seen, polyunsaturated fatty acid soft capsule each dosage group and matched group, the phenomenon of sleeping did not appear in mice after per os was irritated stomach.
2.3 prolong the inductive mouse sleep time test of pentobarbital sodium
Table 5
By table 5 as seen, each dosage group of polyunsaturated fatty acid soft capsule and matched group relatively have prolongation trend to the pentobarbital sodium inducing mouse length of one's sleep, learn check by statistics, and high dose group and matched group comparing difference have significance (P＜0.05).
2.4 pentobarbital sodium sub-threshold dose hypnosis test
Table 6 polyunsaturated fatty acid soft capsule is to closing down the influence of dosage pentobarbital sodium inducing mouse sleep incidence rate
| Dosage group (g/kgbw) | Pentobarbital sodium (mg/kgbw) | Number of animals (only) | Sleeping number of animals (only) | Sleep incidence rate (%) | The P value |
| ??0.00 | ??32 | ??10 | ??2 | ??20 | ??--- |
| ??0.34 | ??32 | ??10 | ??3 | ??30 | ??1.000 |
| ??0.67 | ??32 | ??10 | ??5 | ??50 | ??0.350 |
| ??2.00 | ??32 | ??10 | ??6 | ??60 | ??0.170 |
By table 6 as seen., polyunsaturated fatty acid soft capsule high dose group mice sleep incidence rate and matched group compare, and difference does not have significance (P＞0.05).
2.5 barbital sodium sleep real face incubation period
Table 7 polyunsaturated fatty acid soft capsule is to the barbital sodium preclinical influence of sleeping
3. brief summary
Polyunsaturated fatty acid soft capsule content with 0.34g/kgbw, 0.67g/kgbw, 2.00g/kgbw dosage is given mouse stomach 30 days, and dosage group mice body weight and matched group compare, and difference does not have significance (P＞0.05).Animal subject there is not direct sleep effect.2.00g/kgbw dosage can obviously shorten barbital sodium sleep incubation period, prolong the inductive mouse sleep time of Fujian dosage pentobarbital sodium, with the matched group comparing difference significance (P＜0.05) is arranged.The inductive mice sleep incidence rate of sub-threshold dose pentobarbital sodium there is not obvious influence.The prompting polyunsaturated fatty acid soft capsule has the sleep of improvement effect.
Two, anti-oxidation function animal experiment
1 material and method
1.1 sample: polyunsaturated fatty acid soft capsule content of the present invention, content are yellow oil.The human oral recommended dose is the 1g/ grain, every day 2 times, and each 2, become body weight for humans to press 6okg and calculate, amount to dosage 0.067g/kgbw.
1.2 laboratory animal: cleaning level Kunming kind male 12 the monthly age 40 of mices, body weight is 50.62 ± 2.38g.Technical Services Division provides by the Changsha laboratory animal, laboratory animal production licence number SCXK (Hunan) 2006-0001, and feedstuff is provided by same unit.
1.3 experimental situation condition: experiment condition is a barrier environment, 22 ℃～24 ℃ of experimental session experimental situation temperature, humidity 52%～58%.The laboratory animal occupancy permit number is SYXK (Hunan) 2005-0001.1.4 dosage is selected and sample treatment:, establish the basic, normal, high dosage of sample and be respectively 0.34g/kgbw, 0.67g/kgbw, 2.00g/kgbw (be equivalent to respectively human body recommended dose 5,10,30 times) according to the oral recommended amounts of human body.Basic, normal, high dosage be subjected to test solution when preparation respectively sample thief 0.34g/kgbw, 0.67g/kgbw, 2.00g/kgbw be settled to the 100ml mixing with edible vegetable oil, standby.
1.5 key instrument and reagent: animal platform balance, constant water bath box, 722 type spectrophotometers, centrifuge: malonaldehyde (MDA), superoxide dismutase (SOD), glutathion peroxidase (GSH-Px) testing cassete builds up bio-engineering research by Nanjing is provided.
1.6 experimental technique:
Before the test, after mice was weighed, tail point blood sampling 20 μ l added the 0.48mL distilled water and make 4% hemolysate, press the MDA level in the test kit description mensuration hemolysate.By the MDA level aged mouse is divided into matched group and three dosage groups.Each dosage group mice is irritated the test solution that is subjected to that stomach gives variable concentrations by the dosage design in 1.4, and matched group gives isopyknic edible vegetable oil, irritates stomach every day once, irritates the long-pending 0.1ml/10gbw of being of body of stomach, continuous 30 days.The 31st day, mice is as above adopted tail point blood and prepares 4% hemolysate, measures MDA, and plucks the eyeball blood sampling, and was centrifugal, gets serum, presses the test kit description and measures serum superoxide dismutases (SOD) and glutathion peroxidase (GSH-Px) vigor.
1.7 experimental data statistics: carry out statistical analysis with Excel, Spssl1.0 software.During with the Spss software analysis, earlier data are carried out homogeneity test of variance, if variance is neat, adopt one factor analysis of variance totally to compare, the reuse Dunnett method that finds differences is carried out comparing in twos between a plurality of dosage groups and matched group mean.If heterogeneity of variance then carries out the conversion of suitable variable to initial data, satisfy homogeneity test of variance after, add up with the data after changing; If do not reach the neat purpose of variance yet after the variable conversion, to use rank test instead and add up, discovery is overall more variant, then adopts Tamhane ' the sT2 check that does not require homogeneity of variance to compare in twos.
2 results
2.1 polyunsaturated fatty acid soft capsule is to the influence of aged mouse body weight
Table 1 polyunsaturated fatty acid soft capsule is to the influence of aged mouse body weight
By table 1 as seen, mid-term is tested initially, tested to each dosage group, experiment end mice body weight is compared there was no significant difference (P＞0.05) with matched group.
2.2 polyunsaturated fatty acid soft capsule is to the influence of aged mouse lipid peroxide
Influence the results are shown in Table 2.Per os gave the sample of various dose after 30 days, and each dosage group is tested last hemolysate MDA level and matched group relatively has reduction trend, and high dose group and matched group comparing difference have significance (P＜0.05).
Table 2 polyunsaturated fatty acid soft capsule is to the influence of aged mouse MDA content
2.3 polyunsaturated fatty acid soft capsule sees Table 3 to the influence of aged mouse serum superoxide dismutases (SOD) vigor.Per os gave the sample of various dose after 30 days, and each dosage group serum activity of SOD and matched group relatively have rising trend, and high dose group and matched group comparing difference have significance (P＜0.05).
Table 3 polyunsaturated fatty acid soft capsule is to the influence of aged mouse serum activity of SOD
2.4 polyunsaturated fatty acid soft capsule sees Table 4 to the influence of aged mouse serum glutathion peroxidase (GSH-Px) vigor.Per os gave the sample of various dose after 30 days, and each dosage group serum GSH-Pox vigor and matched group be there was no significant difference (P＞0.05) relatively.
Table 4 polyunsaturated fatty acid soft capsule is to the influence of aged mouse serum GSH-Px vigor
3 conclusions
Per os is irritated the polyunsaturated fatty acid soft capsule content 30 days that stomach gives aged mouse 0.34g/kgbw, 0.67g/kgbw, 2.00g/kgbw dosage, 2.00g/kgbw dosage can significantly reduce lipid peroxide in the blood (MDA) content, improve serum superoxide dismutases (SOD) vigor (P＜0.05), each dosage does not have obvious influence to serum glutathion peroxidase (GSH-Px) vigor.The prompting given the test agent has anti-oxidation function.
Three, anti-oxidation function human experiment experiment
1 material and method
1.1 sample
Adopt polyunsaturated fatty acid soft capsule No. 1, No. 2, the two is basically identical on packing, outward appearance, color and luster and mouthfeel, and wherein No. 1 is polyunsaturated fatty acid soft capsule of the present invention, and No. 2 is placebo, human oral every day 2 times, each 2.
1.2 the experimenter selects
1.2.1 standard of including in: experimenter's male or female.Age 45-65 year, physical condition is good, does not have obvious brain, the heart, liver, lung, kidney, blood illness, does not have the volunteer of the history of taking medicine for a long time and guarantees to cooperate.
1.2.2 experimenter's exclusion standard: gestation or women breast-feeding their children; To the health food allergy sufferers; Merge to have the inclination, serious disease patients such as liver, kidney and hemopoietic system; Take the article relevant in a short time, have influence on judgement person as a result with being tried function; Do not meet the standard of including in, edible in accordance with regulations given the test agent can't be judged effect or data not umbra sound effect or safety judgement person.
1.3 experimental design and grouping
Adopt two kinds of control design between self and group.Be divided into test-meal group and placebo group at random by experimenter's serum malonaldehyde (MDA), superoxide dismutase (SOD), glutathion peroxidase (GSH-Px) level.And consider influence result's principal element such as age, sex etc. as far as possible, and carry out harmony and check, with the comparability between the assurance group, carry out test-meal by double-blind method and test.
1.4 test method
To meet the standard of including in and guarantee the volunteer of compatibility test, be divided into test-meal group and matched group at random according to 1.3.In beginning on 01 26th, 2008, test-meal group and matched group were taken sample or placebo by recommended dose, continuous 175 days.Duration of test does not change original dietary habit, normal diet.
2 observation index
Each measures once every observation index when test-meal on-test and end.
2.1 safety indexes
2.1.1 general physical examination: perquisition experimenter health status before the test, situations such as understanding experimenter's spirit, sleep, diet, defecation, and measure body weight, blood pressure, heart rate.All experimenters are carried out conventional physical examination and necessary lab testing.
2.1.2 routine blood test: red blood cell count(RBC), numeration of leukocyte, content of hemoglobin mensuration etc.
2.1.3 routine urinalysis: pH value, leukocyte, glucose in urine etc.
2.1.4 stool for routine: worm's ovum inspection etc.
2.1.5 biochemistry detection: total serum protein (TP), albumin (ALB), glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), cholesterol (CHOL), glycerol three cruel (TG), blood urea nitrogen (BUN), flesh are joined (Cr), uric acid (UA), blood is warded off (GLU) and measured.
2.1.6 inspections such as electrocardiogram, Abdominal B type ultrasonography, Chest X-rays.
2.1.7 untoward reaction is observed.
2.2 effect index
2.2.1 lipid peroxide content: variation and the MDA rate of descent of MDA before and after the viewing test.
MDA * 100% before MDA rate of descent=(MDA-test back MDA before the test)/test
2.2.2 superoxide dismutase: the variation of SOD and the rate of rise of SOD before and after the viewing test.
SOD * 100% before SOD rate of rise=(SOD before the SOD-test of test back)/test
2.2.3 glutathion peroxidase: the variation of GSH-Px and the rate of rise of GSH-Px before and after the viewing test.GSH-Px * 100% before GSH-Px rate of rise=(GSH-Px before the GSH-Px-test of test back)/test
3. the result judges
3.1 between group statistical significance is arranged more all after each effect observation index test front and back self comparison and the test-meal, can judge this index positive;
3.2 each experimental result positive in lipid peroxide content, superoxide dismutase, three experiments of glutathion peroxidase, the decidable given the test agent has the anti-oxidation function effect.
4. statistical procedures
Data result represents with mean scholar standard deviation, self paired data adopts paired t-test, between test group and the matched group under the prerequisite of homogeneity of variance, mean relatively adopts t check in groups, otherwise adopt the t check after carrying out satisfying homogeneity of variance after variable transforms, if variance is still uneven, adopt rank test.
5. result
Double-blind method is observed and is finished to make known: take No. 1 person and be polyunsaturated fatty acid soft capsule, take No. 2 persons and be placebo.
5.1 ordinary circumstance: initial trial crowd's test group 51 examples, matched group 51 examples, through 175 days the test after, test group have 0 routine experimenter because of data not all or none method determine effect screened out, matched group have 0 routine experimenter because of data not all or none method determine effect screened out.Last efficiency test crowd test group 51 examples, matched group 51 examples.Before and after the test-meal, experimenter's spirit, sleep, diet, defecation situation no abnormality seen.Matched group: man/woman is 24/27, and the age is 51.90 ± 5.86 years old; The test-meal group: man/woman is 26/25, and the age is 51.98 ± 6.33 years old.
5.2 safety is observed
5.2.1 body weight, blood pressure, heart rate, routine urinalysis, stool routine examination, routine blood test and biochemistry detection see Table 1,2.Eat and tried thing after 175 days, test-meal group and matched group body weight, blood pressure, heart rate, routine blood test, routine urinalysis, stool routine examination and biochemical indicator show no obvious abnormalities change, and the prompting polyunsaturated fatty acid soft capsule does not have obvious damage to body health.
Body weight, blood pressure, heart rate, routine blood test, routine urinalysis, stool routine examination situation of change before and after table 1 test-meal
Changes of biochemical indexes situation before and after table 2 test-meal
5.2.2 electrocardiogram, Abdominal B type ultrasonography, Chest X-rays inspection show no obvious abnormalities.
5.2.3 do not see the untoward reaction relevant during the test-meal with sample.
5.3 effect is observed
Serum MDA, the horizontal situation of change of SOD, GSH-Px see Table 3,4 before and after the test-meal test.Before the test, matched group and test-meal group serum MDA, SOD, GSH-Px level compare, and the P value is pointed out between two groups to have comparability all greater than 0.05.Test after back test-meal group serum activity of SOD and the matched group test-meal and before self testing and compare, difference has significance (P＜0.05).Compare before test-meal group serum GSH-Px, MDA and matched group and self test after the test-meal, difference does not have significance (P＞0.05).The test group SOD in serum raises 21.17% before the test, and serum MDA reduces by 6.11% before the test, and serum GSH-Px vigor raises 6.67% before the test.
Serum MDA, SOD, GSH-Px level are relatively before and after table 3 test-meal
Annotate:, compare #P＜0.05 with matched group with comparison * P＜0.05 before the test-meal
Serum MDA, SOD, GSH-Px rate of change before and after table 4 test-meal
| Index | Matched group | The test-meal group |
| MDA reduction rate (%) | ??2.88 | ??6.11 |
| SOD rate of rise (%) | ??8.63 | ??21.17 |
| GSH-Px rate of rise (%) | ??2.73 | ??6.67 |
6. brief summary
The experimenter takes and is tried thing after 175 days, the result shows: test-meal group SOD in serum, GSH-Px vigor improve 21.17%, 6.67% before the test respectively after the test-meal, serum MDA reduces by 6.11% before the test, wherein compare after SOD vigor and the matched group test-meal and before self testing, difference all has significance (P＜0.05).Safety indexes such as body weight, blood pressure, heart rate, routine blood test, routine urinalysis, stool routine examination, biochemistry detection, electrocardiogram, B ultrasonic, Chest X-rays show no obvious abnormalities change before and after the test-meal.Do not see the untoward reaction relevant during the test-meal with sample.The above results prompting submitted sample has anti-oxidation function.
Claims (5)
1. a polyunsaturated fatty acid soft capsule comprises soft capsule skin and content, it is characterized in that containing in the described content effective ingredient of following weight percent:
Linolenic acid 7.6-8.8%;
Linoleic acid 49.0-60.0%;
Oleic acid 7.0-12.9%;
Ganoderma triterpenoids 0.25-0.5%;
Vitamin E 1.6-3.0%;
Surplus is the human body acceptable agents.
2. according to the described polyunsaturated fatty acid soft capsule of claim 1, it is characterized in that: the effective ingredient that contains following weight percent in the described content: linolenic acid is 8.0%, and linoleic acid is 50.0%, and oleic acid is 8.0%, Ganoderma triterpenoids is 0.27%, and vitamin E is 2.0%.
3. the preparation method of the described polyunsaturated fatty acid soft capsule of claim 1 is characterized in that may further comprise the steps:
1) with Fructus Cannabis oil, Ganoderma spore oil, natural Vitamin E batching, makes the soft capsule content suspension;
2) gelatin, glycerol, purified water are dropped in the peptizer according to 1: 0.4～0.6: 1 weight ratio, heating, colloidal sol are made the soft capsule skin;
3) soft capsule content suspension and soft capsule skin are carried out the filling pelleting by the automatic tire bagger of soft capsule, controlling every soft capsule content weight is 0.8～1.2g; After the soft capsule typing, wash ball, drying, lamp inspection, packing again and get product.
4. according to the preparation method of the described polyunsaturated fatty acid soft capsule of claim 3, it is characterized in that in the step (2): gelatin, glycerol, purified water weight ratio are 1: 0.4: 1.
5. according to the preparation method of claim 3 or 4 described polyunsaturated fatty acid soft capsules, it is characterized in that every soft capsule content weight of control is 1.0g in the step (3).
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| CN201010146733A CN101810679A (en) | 2010-04-14 | 2010-04-14 | Polyunsaturated fatty acid soft capsule and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101965971A (en) * | 2010-07-26 | 2011-02-09 | 广西润达制药股份有限公司 | Walnut hemp oil health food |
| CN103005427A (en) * | 2012-11-23 | 2013-04-03 | 浙江华立生命科技有限公司 | Improved health care product composite containing hemp seed oil and preparation method of improved health care product composite |
| CN104664208A (en) * | 2015-03-03 | 2015-06-03 | 深圳市妍倩科技有限公司 | Food with blood fat reduction assisting function |
| CN108402439A (en) * | 2018-02-06 | 2018-08-17 | 天津阿尔康生物科技有限公司 | A kind of alpha-linolenic acid salt and preparation method thereof |
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2010
- 2010-04-14 CN CN201010146733A patent/CN101810679A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101965971A (en) * | 2010-07-26 | 2011-02-09 | 广西润达制药股份有限公司 | Walnut hemp oil health food |
| CN101965971B (en) * | 2010-07-26 | 2013-04-03 | 广西润达制药股份有限公司 | Walnut hemp oil health food |
| CN103005427A (en) * | 2012-11-23 | 2013-04-03 | 浙江华立生命科技有限公司 | Improved health care product composite containing hemp seed oil and preparation method of improved health care product composite |
| CN103005427B (en) * | 2012-11-23 | 2013-11-27 | 浙江华立生命科技有限公司 | Improved health care product composite containing hemp seed oil and preparation method of improved health care product composite |
| CN104664208A (en) * | 2015-03-03 | 2015-06-03 | 深圳市妍倩科技有限公司 | Food with blood fat reduction assisting function |
| CN108402439A (en) * | 2018-02-06 | 2018-08-17 | 天津阿尔康生物科技有限公司 | A kind of alpha-linolenic acid salt and preparation method thereof |
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Application publication date: 20100825 |