CN1256951C - Soft capsule of fur seal oil and application in preparing health products for dispelling chloasma, whelk, cyasma - Google Patents
Soft capsule of fur seal oil and application in preparing health products for dispelling chloasma, whelk, cyasma Download PDFInfo
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Abstract
The present invention relates to a seal's fat soft capsule and an application thereof to prepare health products for eliminating chloasma, whelks and macules in pregnancy. The seal's fat soft capsule of the present invention is composed of refined seal's fat and vitamins E according to a certain mixture ratio. The seal's fat soft capsule can be used for preparing health-care products for eliminating chloasma, whelks and macules in pregnancy and has cosmetic effect.
Description
Technical field
The present invention relates to a kind of Adeps Phocae vitulinae soft capsule and the application in the health product of preparation eliminating chloasma, comedo, cyasma thereof.
Background technology
Fur seal is being commonly called as of Phocidae animal harp sea dog (Harp seal), and perch is in the arctic and Atlantic the north.Because the protective measure that Canadian government is taked, the quantity of fur seal increases with annual 5% velocity-stabilization.For keeping the ecological balance between the fur seal and the shoal of fish, through the United Nations and Canadian government approval, can catch and kill fur seal every year slightly.
This product new Arctic Sea dog skin of hunting fat down that has drawn from through technologies such as vacuum distillinges, removes materials such as Deproteinization, carbohydrate under cryogenic conditions, obtain being the refine Adeps Phocae vitulinae of little yellow, transparency liquid shape.
Fatty acid is closed in many carbon of Ω-3 type insatiable hunger of being rich in needed by human in the Adeps Phocae vitulinae, and (Ω-3PUFA), its nutritive value is better than other edible oils.The eicosapentaenoic acid (EPA) and docosahexenoic acid (DHA) that in Adeps Phocae vitulinae, in finding fish oil, contains usually, also has the considerable clupanodonic acid (DPA) of content.Ideal conditions refines the Adeps Phocae vitulinae of processing down, and wherein the content of EPA, DHA and DPA can reach about 25%.
Because only perch is in Canadian coastal region for arctic fur seal, domestic research work about the Adeps Phocae vitulinae health-care effect is carried out seldom at present, and the report of relevant Adeps Phocae vitulinae eliminating chloasma function is then more rare.Chloasma pathogeny complexity, real pathogenic factor is still not fully aware of at present.Most scholars think, chloasma is to find expression in facial a kind of chronic functional disease because of organism endocrine functional disorder, hemorheology is unusual and reasons such as microcirculation disturbance, vivo oxidation and anti-oxidation function are unbalance, excessive sun exposure cause metabolism of pigment are disorderly.
Except that the organism endocrine dysfunction, one of major reason that chloasma forms is because the change of body blood rheological characteristic, blood viscosity increase, erythrocyte and platelet aggregation increase, microcirculation between histiocyte is obstructed and causes ischemia, cell loses blood supply and Developmental and Metabolic Disorder occurs, thereby causes that melanin increases and the mottle calmness.Motherland's traditional medicine thinks, due to chloasma system is stayed by disharmony between QI and blood, venation blood stasis, in useless turbid.Hemorheology controlled observation before and after the some cases treatment confirms, chloasma disappear take off in, hemorheology also improves thereupon.Studies show that EPA and DHA have the effect that suppresses platelet aggregation, changes viscosity of blood and erythrocyte plasticity, increase vascular permeability and blood vessel dilating.
Another major reason that chloasma forms is that may there be obstacle in oxidation and antioxidation regulating system in the body, causes the activity of oxidase system not increase and strengthen with lipid peroxide (LPO), thereby causes accumulating of lipid peroxide.Many studies show that, free radical is relevant with the formation and the pigmentation of dermal melanin.When free radical increases, can make lipid form LPO and cause lipid peroxidation, and this unsettled LPO is easy to continue to change and be decomposed into malonaldehyde (MDA) in the sebum, brings out the calm dermatosis of chromogenesis.Enzyme antioxidant such as superoxide dismutase etc. can be removed free radical in the body, suppress the formation of chloasma.Discover that LPO and MDA content obviously increase in the patient with chloasma blood, the activity of superoxide dismutase then significantly reduces.
Sun exposure is the another major reason that chloasma forms.Excessively chloasma almost all increases the weight of after the Exposure to Sunlight, avoids Exposure to Sunlight then can make chloasma alleviate and even disappear and takes off.Ultraviolet makes irradiated site melanocyte propagation as a kind of exogenous stimulation melanocyte disintegrator, and this may be that chloasma is sent out well in one of reason of face.Reported in literature is arranged, and Ω-3PUFA can obviously alleviate the Exposure to Sunlight reaction, and can improve the stimulus threshold of polymorphous light eruption.
In sum, the Ω-3PUFA in the Adeps Phocae vitulinae can suppress the formation of chloasma and have to disappear to take off the effect of chloasma by improving hemorheological property and blood microcirculation, raising antioxidant ability of organism and alleviating mechanism such as skin Exposure to Sunlight reaction.Function test result confirms, takes this product for a long time and can significantly reduce chloasma colourity, reduces the area of chloasma, and does not have new chloasma generation.
Vitamin E plays an important role in removing free radical proceed as a kind of antioxidant, can suppress the generation of lipid peroxide effectively, prevents the unsaturated fatty acid oxidation deterioration in the product.
CN1378843A (open day on November 13rd, 2002) discloses a kind of Ursine seal fat softgel and production method thereof, the production method of mentioning in this documents is different fully with the present invention, what this documents was described in fact is the process for purification of Adeps Phocae vitulinae, and this documents is said nothing the application of this product in the health product of preparation eliminating chloasma.
The object of the invention provides a kind of Adeps Phocae vitulinae soft capsule, and it is made up of refined fur seal and vitamin E.
Another object of the present invention provides the application of Adeps Phocae vitulinae soft capsule in the health product of preparation eliminating chloasma, comedo, cyasma.
Summary of the invention
A kind of Adeps Phocae vitulinae soft capsule provided by the invention is characterized in that containing refined fur seal 99.5% by weight, vitamin E 0.5%.Place capsule forming machine to make soft capsule the mixed liquor of refined fur seal and vitamin E and the edible Gelatinum oxhide of heat fused, drying is washed the grain sterilization with 75% edible ethanol and is promptly got product then.
The present invention also provides the application in the health product of preparation eliminating chloasma, comedo, cyasma of the Adeps Phocae vitulinae soft capsule that contains above-mentioned component and proportioning.
Adeps Phocae vitulinae soft capsule of the present invention, its primary raw material are refined fur seal, and it is light yellow oil by Canadian import, have the intrinsic fragrance of Adeps Phocae vitulinae, free from extraneous odour, and the visible exogenous impurity of no naked eyes, physical and chemical index should meet the regulation of table 1.
The physical and chemical index of table 1 refined fur seal
| Project | Index |
| Moisture and volatile matter content, %≤ | 0.2 |
| Acid value, mg KOH/g≤ | 2.0 |
| Peroxide value, meq/Kg≤ | 6.0 |
| Impurity, %≤ | 0.1 |
The vitamin E raw material for preparing Adeps Phocae vitulinae soft capsule use of the present invention should meet the regulation of GB14756, and used gelatin should meet the regulation of GB6783.
Adeps Phocae vitulinae soft capsule color and luster of the present invention is little yellow, and content is light yellow to yellow oil, and capsule surface gloss has the intrinsic fragrance of Adeps Phocae vitulinae, free from extraneous odour, the visible exogenous impurity of no naked eyes.
The physical and chemical index of Adeps Phocae vitulinae soft capsule of the present invention is as shown in table 2, and microbiological indicator is as shown in table 3, and effective component is as shown in table 4.
The physical and chemical index of table 2 Adeps Phocae vitulinae soft capsule
| Project | Index |
| Net content, the g/ grain | 0.5 |
| The net content allowed minus deviation, %≤ | 9.0 |
| Moisture and volatile matter content, %≤ | 1.3 |
| Disintegration, min≤ | 60.0 |
| Acid value, mg KOH/g≤ | 2.0 |
| Peroxide value, meq/Kg≤ | 16.0 |
| Vitamin E, mg/100g 〉= | 350 |
| Arsenic (in As), mg/Kg≤ | 1.0 |
| Plumbous (in pb), mg/Kg≤ | 1.5 |
| Hydrargyrum (in Hg), mg.Kg≤ | 0.3 |
The microbiological indicator of table 3 Adeps Phocae vitulinae soft capsule
| Project | Index |
| Total plate count, cfu/g≤ | 1000 |
| Coliform, MPN/100g≤ | 40 |
| Mold count, cfu/g≤ | 10 |
| Yeast counts, cfu/g≤ | 10 |
| Pathogenic bacterium | Must not detect |
| Annotate: pathogenic bacterium mean salmonella, shigella, staphylococcus aureus, Hemolytic streptococcus | |
The effective component of table 4 Adeps Phocae vitulinae soft capsule
| Project | Index |
| Docosahexenoic acid (DHA), g/100g 〉= | 7.15 |
| Eicosapentaenoic acid (EPA), g/100g 〉= | 6.32 |
| Clupanodonic acid (DPA), g/100g 〉= | 3.37 |
The check of docosahexenoic acid in the table 4 (DHA), eicosapentaenoic acid (EPA), clupanodonic acid (DPA) is undertaken by the regulation of GB/T17376, GB/T17377.
The toxicological safety test of Adeps Phocae vitulinae soft capsule of the present invention is as follows:
Experimental animal: Kunming kind white mice is provided approval card number: No. [2000] 015, distant real kinoplaszm word by laboratory animal portion of Chinese Medical Sciences University.
The Wistar rat is provided by medical experiment animal portion of Chinese Medical Sciences University, approval card number: No. [2000] 015, distant real kinoplaszm word.
1, acute toxicity test in mice: select 40 of healthy Kunming kind white mice for use, each 20 of male and female are tested.The mice body weight is 18.1-22.0g.21.50,10.00,4.64,2.15g/Kg.bw each sex mice is divided into four dosage groups at random, is respectively:, each dosage group is prepared with vegetable oil.Observed 14 days continuously behind the mouse stomach.Record poisoning manifestations and death condition, result of the test is as shown in table 5.
Table 5 acute toxicity test in mice result
| Dosage group (g/kg.bw) | Male | Female | ||
| The laboratory animal number | The dead animal number | The laboratory animal number | The dead animal number | |
| 21.50 10.00 4.64 2.15 | 5 5 5 5 | 0 0 0 0 | 5 5 5 5 | 0 0 0 0 |
Manufacturer's recommended adult (body weight is in 60kg) day absorption approved product maximum 0.033g/kg.bw, the maximum dose level group is tried thing 21.50g/kg.bw, converts to be equivalent to 652 times of Coming-of-Age Day absorption approved product amount.14 days each dosage groups of laboratory observation are not seen poisoning symptom, and death toll is zero.Tried the acute toxicity LD of thing to two kinds of sex mices
50All,, belong to nontoxic level according to toxicity grading greater than 15.00g/kg.bw.LD
50Greater than 10 times of manufacturer's recommended Coming-of-Age Day intakes, can enter the next stage toxicological experiment.
2, genetic toxicity test:
1. Salmonella reversion test: adopt through identifying that satisfactory Salmonella typhimurium histidine defect type TA97, TA98, TA100, four test strains of TA102 test.Adopt the inductive rat liver homogenate of Polychlorinated biphenyls (PCB) as external metabolism activation system.Test establishes 0.313,0.625,1.250,2.500,5 dosage of 5.000mg/ ware, each dosage group is diluted with dimethyl sulfoxide (DMSO), (TA97 of disactivation system, TA98, TA102 are fenaminosulf 50.0 μ g/ wares, and TA100 is sodium azide 1.5 μ g/ wares to establish blank, solvent control, negative control (distilled water) and positive control simultaneously.Activation system adopts N-2-Fluorenylamine 10.0 μ g/ wares).Adding 0.1mL test strain enrichment liquid, 0.1mL are tried thing solution in top agar, add the 0.5mLS9 mixed liquor during metabolism activation, pour into behind the mixing on the bottom culture medium flat plate.Cultivated 48 hours at 37 ℃, count every ware and return the change clump count.If being tried the change clump count that returns of thing is to become clump count more than 2 times from beaming back, and has dosage--reaction relation person then is decided to be the positive.Each dosage do three parallel.A whole set of test repeats under the same conditions to do twice and adds up respectively, and result of the test is shown in table 6,7.
Table 6Ames result of the test (for the first time)
| Dosage (mg/ ware) | TA97 | TA98 | TA100 | TA102 | ||||
| -S 9 | +S 9 | -S 9 | +S 9 | -S 9 | +S 9 | -S 9 | +S 9 | |
| 5.000 2.500 1.250 0.625 0.313 blank solvent control negative control positive controls | 139.3±36.7 122.0±32.2 130.7±20.7 145.0±6.9 152.7±13.0 127.7±28.4 141.7±28.9 122.7±15.8 2037.7±78.9 | 135.7±28.7 122.7±13.2 114.3±17.6 119.3±25.5 125.0±18.7 117.3±28.7 140.0±27.2 148.0±30.3 1162.7±162.1 | 41.0±4.4 36.3±4.9 44.7±2.5 42.7±6.0 45.3±2.3 46.0±3.6 47.0±2.6 38.0±7.2 909.0±60.8 | 41.0±7.0 40.0±6.6 39.0±6.6 42.7±6.7 38.7±7.6 37.3±6.7 35.7±1.5 36.7±7.6 2482.7±204.1 | 122.3±7.5 173.0±25.6 162.0±25.0 162.3±20.8 137.3±18.1 144.3±48.0 170.0±34.8 159.7±32.3 1763.3±40.3 | 144.7±20.6 142.0±13.2 143.3±43.0 129.7±15.0 131.0±27.2 153.0±44.5 141.3±32.1 169.0±20.0 2479.3±215.1 | 293.3±29.1 274.0±28.6 258.7±9.5 297.7±24.4 290.7±22.9 301.7±10.5 285.7±26.1 255.3±7.1 895.0±3.0 | 277.3±26.1 271.0±18.3 273.3±22.1 291.3±8.7 292.3±21.9 279.7±17.0 279.7±30.0 287.0±40.1 267.3±13.5 |
Table 7Ames result of the test (for the second time)
| Dosage (mg/ ware) | TA97 | TA98 | TA100 | TA102 | ||||
| -S 9 | +S 9 | -S 9 | +S 9 | -S 9 | +S 9 | -S 9 | +S 9 | |
| 5.000 2.500 1.250 0.625 0.313 blank solvent control negative control positive controls | 138.0±19.7 154.7±17.6 152.7±25.0 121.7±18.8 136.3±8.7 150.0±26.5 114.3±27.7 133.7±37.2 2088.3±92.5 | 136.7±17.6 147.9±15.5 150.9±39.2 144.0±6.5 145.8±12.7 154.5±40.4 134.2±27.1 141.3±40.5 1414.3±168.3 | 39.3±4.9 41.7±6.7 43.3±5.0 38.3±2.1 36.0±5.3 38.3±7.0 44.7±5.9 38.3±2.3 913.3±29.2 | 37.7±8.1 37.3±3.8 37.3±4.5 40.7±4.7 38.0±7.0 35.3±4.5 41.0±7.0 44.0±4.4 2492.3±423.4 | 128.0±10.1 152.3±41.9 150.7±28.3 159.3±27.6 161.3±31.6 139.0±46.0 128.3±1.2 153.7±20.8 2071.3±122.8 | 131.0±45.9 147.7±36.3 129.3±19.7 139.7±42.2 152.0±23.6 165.0±18.5 107.7±3.2 162.0±13.7 2803.3±406.4 | 282.3±26.6 258.0±25.2 293.3±6.5 282.3±27.3 278.3±28.7 274.3±37.9 267.7±22.0 281.3±16.5 822.0±21.9 | 270.0±28.9 258.0±17.4 292.3±23.9 283.3±35.4 284.3±27.8 288.7±18.7 272.3±25.8 272.0±24.1 277.3±6.4 |
By table 6,7 as seen, each dosage group is returned change bacterium colony number average and is returned two times that become clump count above negative control group, does not also have dosage--reaction relation.Illustrate that this is tried thing to Salmonella typhimurium histidine defect type TA97, TA98, TA100, TA102 four bacterial strains, add and do not add S9, all do not present genetoxic.
2. PCEMNR micronucleus test: adopt at interval 24 hours twice per os administration by gavage to test, irritate stomach amount 0.2mL/10g body weight.With body weight 25.6-30.0g white mice, by the body weight random packet, 10 every group, male and female half and half.With the positive contrast of cyclophosphamide (CP) of 40mg/kg.bw dosage, the negative contrast of ripe Oleum Glycines is tried the agent amount and is 0.94,1.88,3.75,7.50g/kg.bw, is assigned to desired concn with ripe Oleum Glycines.After the last administration 6 hours, animal was put to death in the cervical vertebra dislocation, gets femur bone marrow and dilutes smear with calf serum, and methanol is fixed, Giemsa dyeing.Under optical microscope, every animal counting 1000 polychromatic erythrocytes (PCE), microkernel incidence is to contain the PCE permillage of micronucleus, and result of the test is as shown in table 8.
Table 8 mouse bone marrow cells PCE micronucleus test result
| Sex | Dosage group (g/kg.bw) | Number of animals (only) | Check PCE number (individual) | Contain micronucleus PCE number (individual) | Micronucleus number (‰) |
| Male | 7.50 the positive group of 3.75 1.88 0.94 negative groups | 5 5 5 5 5 5 | 5×1000 5×1000 5×1000 5×1000 5×1000 5×1000 | 5 8 7 8 9 124 | 1.0 1.6 1.4 1.6 1.8 24.8 |
| Female | 7.50 the positive group of 3.75 1.88 0.94 negative groups | 5 5 5 5 5 5 | 5×1000 5×1000 5×1000 5×1000 5×1000 5×1000 | 7 5 6 7 6 111 | 1.4 1.0 1.2 1.4 1.2 22.2 |
Through X 2 test, each dosage group micronuclear rates and negative control group comparing difference do not have significance (P＞0.05), and positive controls and negative control group relatively have highly significant difference (P＜0.01).It is negative that this is tried thing PCEMNR micronucleus test.
3. mouse sperm deformity test: with the sexual maturity male mice of body weight 26.5-30.0g, by the body weight random packet.Tried the agent amount and be 1.88,3.75,7.50g/kg.bw, be assigned to desired concn with ripe Oleum Glycines.With the positive matched group of 40mg/kg.bw cyclophosphamide (CP), the negative matched group of distilled water, ripe Oleum Glycines are solvent control.More than each test group irritate stomach once every day, continuous 5 days, irritate stomach amount 0.2mL/10g body weight, put to death animal on the 30th day behind the last filling stomach, get the epididymis film-making, Yihong dyeing, several 5 animals of every batch total, the sperm of 1000 structural integrities of every animal counting calculates distortion spermatogenesis rate, and result of the test is as shown in table 9.
Table 9 mouse sperm deformity result of the test
| Dosage group (g/kg.bw) | Number of animals (only) | Observe sperm count (individual) | The sperm deformity type | Teratospermia number (individual) | Abnormal rate (‰) | |||||||
| Amorphous | Wugou | Fat head | Banana-shaped | Double end | Two tails | Tail is folding | Other | |||||
| 7.50 3.75 1.88 negative control group solvent control group positive controls | 5 5 5 5 5 5 | 5×1000 5×1000 5×1000 5×1000 5×1000 5×1000 | 52 36 62 54 45 163 | 20 33 25 31 29 132 | 17 29 15 21 25 123 | 29 24 23 18 15 112 | 0 0 0 0 0 0 | 0 0 0 0 0 0 | 2 0 0 1 2 36 | 0 0 0 0 0 0 | 120 122 125 125 116 566 | 240 24.4 25.0 25.0 23.2 113.2 |
Through the Wilconson rank test, each dosage group rate of teratosperm and negative control group comparing difference do not have significance (P＞0.05), and positive controls and negative control group relatively have highly significant difference (p＜0.01).The mouse sperm deformity test is negative.
3,30 days feeding trials
Experimental animal: select body weight 55.2-69.9g Wistar rat for use.
Test method: rat is divided into matched group and three is at random tried the thing group, it is 2.000g/60kg.bw (press content calculating) that the manufacturer's recommended adult takes in the approved product maximum (body weight is in 60kg) every day.The maximum dose level group is a B group in Coming-of-Age Day 100 times of maximum intake, be 3.333g/kg.bw, below in, low dose group successively decreases with 1/5, be C group 0.667g/kg.bw, 20 times of maximum intake are equivalent to be grown up, D organizes 0.133g/kg.bw, 4 times of the maximum intake that is equivalent to be grown up, every group of 10 rats.B, C, three test group of D are tried thing evenly mix in the normal feedstuff, content is 3.333%, 0.667%, 0.133% according to this.Matched group (A group) feed arm's length basis feedstuff.The rat feed intake is calculated by body weight 10%, and single cage is fed, free diet, and record rats eating amount, body weight were observed 30 days continuously.
Clinical observation: the general performance of animal, behavior, poisoning symptom, and death condition, claim body weight, intake weekly, calculate the food overall utilization.
Survey routine blood test and biochemical indicator: get blood in the 31st day tail vein of test, adopt Japanese CA-300 blood cell automatic counter for counting, measure hemoglobin (HGB), erythrocyte (RBC), from cell (WBC).Femoral artery is got blood, and the test kit, the Dutch VITALAB-MICRO biochemistry analyzer that adopt Beijing Zhongsheng Biological Engineering High Technology Company to provide are measured glutamate pyruvate transaminase (GPT), glutamic oxaloacetic transaminase, GOT (GOT), blood urea nitrogen (BUN), creatinine (CR), blood glucose (GLU), total protein (Tp), albumin (ALB), cholesterol (CHO), triglyceride (TG).
Pathological anatomy: gross examination of skeletal muscle, organ coefficient, pathological tissue inspection (liver,kidney,spleen, stomach and duodenum)
Result of the test is shown in table 10,11,12,13,14.
1, as shown in table 10 to the influence of rat body weight:
30 days feeding trial rat body weights of table 10 measurement result
| The dosage group | Number of animals (only) | Starting weight (g) | The 1st all body weight (g) | The 2nd all body weight (g) | The 3rd all body weight (g) | The 4th all body weight (g) | |
| Male | A B C D | 10 10 10 10 | 64.6±4.0 62.4±5.3 65.4±4.7 63.0±5.1 | 95.3±6.8 91.7±7.4 94.2±5.9 97.0±8.2 | 128.9±10.7 135.6±8.8 124.2±10.4 133.7±11.2 | 174.7±16.8 182.6±13.4 170.0±18.2 175.2±11.5 | 209.6±22.9 220.4±14.3 207.3±19.5 209.9±11.4 |
| Female | A B C D | 10 10 10 10 | 60.7±4.1 62.9±4.1 65.9±4.3 61.2±4.6 | 86.6±7.2 87.4±6.6 91.7±6.6 86.1±7.4 | 127.0±13.0 128.7±11.4 129.8±12.4 126.6±9.7 | 160.4±16.9 160.1±14.9 166.0±15.5 155.8±12.6 | 186.4±17.1 186.5±15.8 194.2±17.4 181.5±13.8 |
By table 10 as seen, each treated animal vegetative activity is normal.Each dosage treated animal body weight and matched group compare, and difference does not have significance (P＞0.05).
2, as shown in table 11 to the influence of rat total foodstuff utilization rate:
30 days feeding trial total foodstuffs of table 11 utilization rate measurement result
| Sex | The dosage group | Number of animals (only) | Weight gain (g) | Food-intake (g) | Food utilization (%) |
| Male | A B C D | 10 10 10 10 | 145.0±22.3 158.0±15.1 141.9±16.7 146.9±12.1 | 517.2±58.0 547.0±46.0 514.1±54.4 534.2±39.1 | 28.0 28.9 27.6 27.6 |
| Female | A B C D | 10 10 10 10 | 125.7±17.7 123.6±16.0 128.3±16.3 120.3±13.0 | 479.0±50.1 484.2±46.0 504.9±45.6 475.6±33.9 | 26.2 25.5 25.4 25.2 |
By table 11 as seen, tried thing and mixed in the feedstuff feed rat 30 days, the refusing to eat phenomenon does not appear in animal, and each dosage treated animal food utilization and matched group comparing difference do not have significance (P＞0.05).
3, hematological examination result is as shown in table 12:
Table 12 feeding trial hematological examination in 30 days result
| Sex | The dosage group | Number of animals (only) | Hemoglobin (g/dL) | Red blood cell count(RBC) (* 10 12/L) | Numeration of leukocyte (* 10 9/L) |
| Male | A B C | 10 10 10 | 15±3 14±2 13±4 | 10.37±1.29 10.59±1.42 10.02±1.31 | 9.7±2.0 9.7±1.5 9.2±1.7 |
| D | 10 | 14±4 | 9.88±0.95 | 9.4±2.0 | |
| Female | A B C D | 10 10 10 10 | 14±4 15±3 14±4 13±3 | 9.67±1.34 9.92±1.47 9.39±1.45 9.49±1.26 | 9.1±1.5 9.8±1.5 8.9±2.1 9.9±1.5 |
By table 12 as seen, the hemoglobin of each dosage group (HGB), erythrocyte (RBC), leukocyte (WBC) do not have significance (P＞0.05) with the matched group comparing difference.
4,30 days feeding trial biochemical investigation results are as shown in table 13:
Table 13 feeding trial biochemical investigation in 30 days result
| Sex | The dosage group | Number of animals (only) | GPT (U/L) | BUN (mmol/L) | GOT (U/L) | CR (μmol/L) | GLU (mmol/L) | TP (g/dL) | AIB (g/L) | CHO (mmol/L) | TG (mmol/L) |
| Male | A B C D | 10 10 10 10 | 86±15 77±26 90±23 79±21 | 6.336±0.704 6.756±0.885 6.439±0.869 6.210±0.752 | 180±45 223±136 185±43 196±33 | 110.0±6.3 115.2±7.2 108.7±12.1 102.1±8.0 | 9.80±1.06 9.31±0.86 9.65±1.17 9.30±1.16 | 10.4±0.7 10.9±0.5 10.4±0.5 10.1±0.8 | 44.9±4.1 44.0±2.1 44.4±2.4 47.3±4.0 | 2.89±0.64 2.69±0.57 2.50±0.53 2.47±0.58 | 1.19±0.34 1.19±0.39 1.36±0.54 1.36±0.45 |
| Female | A B C D | 10 10 10 10 | 73±14 71±21 85±19 77±20 | 6.565±0.690 6.436±0.666 6.740±0.596 6.069±0.485 | 202±39 221±134 196±35 176±30 | 101.4±8.3 107.8±12.5 102.7±13.2 106.6±12.7 | 9.39±1.34 9.12±1.17 10.12±1.09 9.09±0.51 | 10.4±0.7 10.9±0.7 10.5±0.7 10.1±0.5 | 44.4±3.8 45.1±2.8 46.2±3.7 46.1±3.1 | 2.91±0.58 2.91±0.45 2.75±0.47 2.88±0.79 | 1.45±0.53 1.22±0.54 1.38±0.50 1.48±0.54 |
By table 13 as seen, the glutamate pyruvate transaminase of each dosage group (GPT), glutamic oxaloacetic transaminase, GOT (GOT), blood urea nitrogen (BUN), creatinine (CR), blood glucose (GLU), total protein (TP), albumin (ALB), cholesterol (CHO), triglyceride (TG) do not have significance (P＞0.05) with the matched group comparing difference.
5, tried the influence of thing to the dirty body ratio of rat:
The measurement result of 30 days dirty body ratios of feeding trial rat of table 14
| Sex | The dosage group | Number of animals (only) | Liver/body (%) | Spleen/body (%) | Kidney/body (%) |
| Male | A B C D | 10 10 10 10 | 3.74 3.47 3.71 3.76 | 0.24 0.25 0.25 0.25 | 0.78 0.75 0.73 0.78 |
| Female | A B C D | 10 10 10 10 | 3.69 3.72 3.75 3.65 | 0.25 0.26 0.24 0.22 | 0.78 0.78 0.76 0.75 |
By table 14 as seen, each dosage group and matched group comparing difference do not have significance (P＞0.05).
6, histopathologic examination:
Each treated animal gross examination of skeletal muscle is no abnormal, and when dissected is not also found bladder, common hepatic duct calculus, and liver,spleen,kidney, stomach, duodenum that mirror is observed animal down there is no significant pathological change.
Result of the test shows that this is tried thing and mixed in the feedstuff feed rat 30 days, and every indexs such as each dosage treated animal body weight gain, food utilization, routine blood test, blood biochemistry index, organ coefficient be there is no harmful effect.Histopathology is observed, and liver,spleen,kidney, stomach, duodenum there is no significant pathological change.
Adeps Phocae vitulinae soft capsule of the present invention has the effect of eliminating chloasma, specifically tests as follows:
1, detailed medical history-taking, the main observation: chloasma area, shade, have or not new chloasma to occur, determination of colority adopts the brown card Bn (C+M+Y) (Institute of Geography, Academia Sinica's development, Mapping Press's publication) in the practical chromatograph card.With the major diameter and the wide footpath of same chloasma before and after the tape measure amount experimenter test-meal, reference area (mm
2).
2, carrying out safety observes:
1. blood and routine urianlysis: hemoglobin, red blood cell count(RBC), numeration of leukocyte, routine urinalysis.
2. blood biochemistry index is measured: T-CHOL, triglyceride, paddy third change nitrogen enzyme, total bile pigments, blood urea nitrogen, creatinine, blood glucose.
3. Chest X-rays, electrocardiogram, Abdominal B type ultrasonography.
3, effect is judged:
Record chloasma faciei situation before and after the test-meal has significant difference at aspects such as the area of chloasma and shades, and does not increase new chloasma, and promptly decidable is tried the effect that thing has functions of removing chloasma.
4, result of the test:
35 routine chloasma experimenter's faces all have differ in size, the different planar chloasma of point, the experimenter is the women, age is at 28-50 between year, experimenter's test-meal " Adeps Phocae vitulinae soft capsule " every day 2 times, each 2, after taking 30 days continuously, there is not obvious change at aspects such as diet, sleep, defecation, the mental status.
1. the variation of chloasma area
Table 15 Adeps Phocae vitulinae soft capsule is to chloasma area (mm
2) influence
| The example number | Before the test-meal | After the test-meal | The P value |
| 35 | 2333.43±859.91 | 2200.86±826.11 | ＜0.01 |
By table 15 as seen, take the Adeps Phocae vitulinae soft capsule after 30 days, can obviously reduce the area (P＜0.01) of chloasma.
2. the variation of chloasma colourity
Table 16 Adeps Phocae vitulinae soft capsule is to the influence of chloasma colourity
| The example number | Before the test-meal | After the test-meal | The P value |
| 35 | 1.66±0.29 | 1.29±0.28 | ＜0.01 |
By table 16 as seen, take the Adeps Phocae vitulinae soft capsule after 30 days, can obviously reduce the colourity (P＜0.01) of chloasma.
3. doing well,improving situation
Table 17 cardinal symptom is improved situation
| Cardinal symptom | The example number | Effectively | Invalid | Effective percentage (%) |
| The irritated distending pain in the chest and hypochondrium constipation of insomnia feeling of fatigue | 4 3 2 2 4 | 1 0 2 2 1 | 3 3 0 0 3 | 25.00 0.00 100.00 100.00 25.00 |
4. safety indexes detects
Table 18 safety indexes testing result
| Observation item | The example number | Before taking | After taking |
| T-CHOL (mg/dl) triglyceride (mg/dl) glutamic-pyruvic transaminase (U/L) total bilirubin (mg/dl) creatinine (mg/dl) urea nitrogen (mg/dl) blood sugar (mg/dl) hemoglobin (g/d1) red blood cell (* 1012/ l) leukocyte (* 10 8/l) | 35 35 35 35 35 35 35 35 35 35 | 175.97±19.35 117.23±42.51 17.56±6.08 0.54±0.16 0.62±0.14 14.50±4.09 91.06±11.53 13.28±0.64 4.20±0.30 5.91±1.14 | 177.89±19.73 116.04±39.08 17.74±5.35 0.54±0.14 0.64±0.13 15.50±4.67 90.74±10.43 13.35±0.73 4.21±0.31 6.06±1.14 |
Table 18 shows that all experimenters took the Adeps Phocae vitulinae soft capsule after 30 days, and routine blood test, routine urinalysis, blood biochemistry index are all in normal range.
5. Chest X-rays, electrocardiogram, Abdominal B type ultrasonography all belong to normally.
Conclusion:
35 examples are taken the Adeps Phocae vitulinae soft capsule on request through the chloasma volunteer of medical fitness, every day 2 times, each 2, continuous 30 days.The result shows: the Adeps Phocae vitulinae soft capsule can significantly reduce chloasma colourity (P＜0.01), reduces the area (P＜0.01) of chloasma, and does not observe new chloasma generation.Routine blood test and blood biochemistry index all do not have obvious change after experimenter's test-meal, and do not have allergy and untoward reaction.
Adeps Phocae vitulinae soft capsule Detection of Stability result of the present invention is shown in table 19:
Table 19 Adeps Phocae vitulinae soft capsule Detection of Stability result
| Lot number | 20010520 | 20010601 | 20010610 |
| 0th month stability test | |||
| Total plate count, the cfu/g coliform, MPN/100g pathogenic bacterium mold count, cfu/g yeast counting, the cfu/g eicosapentaenoic acid, the % docosahexenoic acid, the % clupanodonic acid, % acid value peroxide value, the meq/kg vitamin E, mg/100g lead, mg/kg arsenic, mg/kg hydrargyrum, the mg/kg moisture and volatile matter content, % | ＜10＜30 do not detect＜10＜10 6.47 7.49 3.62 1.25 15.62 398＜0.12＜0.1＜0.003 1.11 | ＜10＜30 do not detect＜10＜10 6.75 7.66 3.43 1.24 15.57 392＜0.12＜0.1＜0.003 1.16 | ＜10＜30 do not detect＜10＜10 6.32 7.15 3.37 1.22 15.31 402＜0.12＜0.1＜0.003 1.09 |
| 1st month stability test preservation condition: 37 ℃ of relative humidity 75% temperature | |||
| Total plate count, the cfu/g coliform, MPN/100g pathogenic bacterium mold count cfu/g yeast counting, the cfu/g eicosapentaenoic acid, the % docosahexenoic acid, the % clupanodonic acid, % acid value peroxide value, the meq/kg vitamin E, mg/100g lead, mg/kg arsenic, mg/kg hydrargyrum, the mg/kg moisture and volatile matter content, % | ＜10＜30 do not detect＜10＜10 6.48 7.52 3.68 1.23 15.67 420＜0.12＜0.1＜0.003 1.13 | ＜10＜30 do not detect＜10＜10 6.85 7.73 3.57 1.21 15.53 390＜0.12＜0.1＜0.003 1.16 | ＜10＜30 do not detect＜10＜10 6.44 7.26 3.49 1.24 15.38 397＜0.12＜0.1＜0.003 1.10 |
| 2nd month stability test preservation condition: 37 ℃ of relative humidity 75% temperature | |||
| Total plate count, cfu/g coliform, MPN/100g | 10 ＜30 | 30 ＜30 | 10 ＜30 |
| The pathogenic bacterium mold count, cfu/g yeast counting, the cfu/g eicosapentaenoic acid, the % docosahexenoic acid, the % clupanodonic acid, % acid value peroxide value, the meq/kg vitamin E, mg/100g lead, mg/kg arsenic, mg/kg hydrargyrum, the mg/kg moisture and volatile matter content, % | Do not detect＜10＜10 6.52 7.49 3.52 1.26 15.68 389＜0.12＜0.1＜0.003 1.16 | Do not detect＜10＜10 6.43 7.27 3.72 1.24 15.43 389＜0.12＜0.1＜0.003 1.19 | Do not detect＜10＜10 6.66 7.48 3.75 1.25 15.40 398＜0.12＜0.1＜0.003 1.11 |
| 3rd month stability test preservation condition: 37 ℃ of relative humidity 75% temperature | |||
| Total plate count, the cfu/g coliform, MPN/100g pathogenic bacterium mold count, cfu/g yeast counting, the cfu/g eicosapentaenoic acid, the % docosahexenoic acid, the % clupanodonic acid, % acid value peroxide value, the meq/kg vitamin E, mg/100g lead, mg/kg arsenic, mg/kg hydrargyrum, the mg/kg moisture and volatile matter content, % | 20＜30 do not detect＜10＜10 6.74 7.81 3.64 1.27 15.74 395＜0.12＜0.1＜0.003 1.16 | 50＜30 do not detect＜10＜10 6.80 7.64 3.47 1.26 15.52 396＜0.12＜0.1＜0.003 1.22 | 20＜30 do not detect＜10＜10 6.79 7.39 3.65 1.25 15.48 396＜0.12＜0.1＜0.003 1.15 |
The specific embodiment:
Following embodiment is in order to further specify the present invention
Embodiment 1
Get Canadian import refined fur seal 99.5kg, vitamin E 0.5kg, make 200000 of the capsules of every 0.5g, wherein every 100g contains effective composition: docosahexenoic acid (DHA) 7.15g, eicosapentaenoic acid (EPA) 6.32g, clupanodonic acid (DPA) 3.37g, to chloasma person oral every day 2 times is arranged, each 2, took 30 days, and had obvious eliminating chloasma, comedo, cyasma effect.
Claims (1)
1, the application of Adeps Phocae vitulinae soft capsule in the health product of preparation eliminating chloasma, the effective ingredient of described Adeps Phocae vitulinae soft capsule is made up of by weight 99.5% refined fur seal and 0.5% vitamin E.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031007554A CN1256951C (en) | 2003-01-21 | 2003-01-21 | Soft capsule of fur seal oil and application in preparing health products for dispelling chloasma, whelk, cyasma |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031007554A CN1256951C (en) | 2003-01-21 | 2003-01-21 | Soft capsule of fur seal oil and application in preparing health products for dispelling chloasma, whelk, cyasma |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1518990A CN1518990A (en) | 2004-08-11 |
| CN1256951C true CN1256951C (en) | 2006-05-24 |
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|---|---|---|---|
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| CN (1) | CN1256951C (en) |
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| 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 |
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2003
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