CN100998406A - Health-care food with functions of improving immunocompetence and protecting damaged gastric mucosa and its preparing method - Google Patents
Health-care food with functions of improving immunocompetence and protecting damaged gastric mucosa and its preparing method Download PDFInfo
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Abstract
A health-care food in the form of soft-capsule, capsule, particle, tablet, or oral liquid for improving immunity and preventing and treating the injury of stomach mucosa is proportionally prepared from the oil of seabuckthorn fruit and the extract of propolis through mixing and shaping.
Description
Technical field
The present invention relates to a kind of health food, is a kind ofly to strengthen immunity, gastric mucosa injure is had health food of defencive function and preparation method thereof specifically.
Background technology
Along with the fast development of scientific and technological progress and social productive forces, the various pressure that rhythm of life at a high speed and people face cause a part of crowd's hypoimmunity; Add the rapid variation of people's dietary structure, particularly because irregular diet or take factors such as medicine is improper makes quite a few crowd's gastric mucosa sustain damage, a lot of people endure the torment of having a stomach upset for a long time to the fullest extent, suffer untold misery.What have is also untimely because of preventing and treating, and causes serious illness such as gastritis, gastric ulcer.
The cause of disease of stomach illness, mostly think for a long time relevant with multiple factors such as heredity, hyperhydrochloria, biliary regurgitation, smokings, especially think hydrochloric acid in gastric juice be the morbidity principal element.Over nearly 80 years, hydrochloric acid in gastric juice is considered to the main cause that gastric ulcer forms always, and traditional saying of " anacidity does not promptly have ulcer " is therefore arranged.
The traditional therapy of disease of stomach such as gastritis, gastric ulcer be in and the secretion of hydrochloric acid in gastric juice or gastric acid inhibitory.Continue to use alkaline drug in the past, Hz acceptor inhibitor commonly used at present or other acid secretion inhibitors.Use these and antiacidly press down sour medicine, help ulcer healing, but these medicines have a common shortcoming to be, in case drug withdrawal, just recurrence again of ulcer soon.Therefore, some patient wants discontinuity to take medicine, and what have then need take maintenance dose for a long time, also has many patient's cankers but to send out more repeatly repeatly.
By the discovery of researching and analysing to gastric juice, the duodenal ulcer disease people, gastric acid secretion is too high; But gastric ulcer philtrum gastric acid secretion enhancer only accounts for 16%, and many patient's gastric acid secretions are normal, have in addition be lower than normal.This shows what of gastric acid secretion, is not to be the key factor of gastric ulcer morbidity.Researching and analysing and find that also the gastric mucosal defense ability reduces, immunocompetence descends, thereby attack function such as hydrochloric acid in gastric juice is increased relatively, is the main cause that forms gastric ulcer.So the protective capability of enhancing gastric mucosa improves the first-selected measure that immunity is only control stomach illness.
It is many to be respectively applied for the medicine or the food that strengthen immunity or improve gastric mucosa injure at present, characteristics is respectively arranged, function singleness.But Shang Weijian integrates the health food that strengthens immunity and improve gastric mucosa injure.
Summary of the invention
The objective of the invention is at above-mentioned deficiency, a kind of health food that strengthens immunity, gastric mucosa injure is had assistant protection function that integrates is provided.
Health food of the present invention is made by the raw material of following weight portion:
Seabuckthorm Seed Oil 50-95 part,
Propolis 5-20 part.
Another object of the present invention provides the preparation method of this health food.
The preparation method that above-mentioned each raw material is made health food of the present invention is:
(1) after the propolis pulverizing with described weight portion, add 70% ethanol of 6-10 times of weight, under 60-80 ℃, lixiviate 1-3 time, each 1-2 hour, filter behind the merging extract, get filtrate;
(2) the filtrate decompression vacuum is concentrated into the thick paste that relative density is 1.30-1.33, with the thick paste drying, be ground into 120 order fine powders, propolis extract dry powder;
(3) Seabuckthorm Seed Oil with propolis extract dry powder and described weight portion mixes, promptly.
Health food of the present invention can add conventional auxiliary material required when preparing different dosage form, adopts the conventional method of Chinese medicine preparation to be prepared into any conventional oral formulations, as soft capsule, hard shell capsules, granule, tablet, oral liquid etc.
Health food of the present invention is a primary raw material with Seabuckthorm Seed Oil, propolis, makes with extra care through scientific composition with reference to the modern pharmacological research achievement to form.
Seabuckthorm Seed Oil is the vegetable oil that extracts from the seed of Elaeangnaceae hippophae plant sea-buckthorn.Seabuckthorn Oil contains active principle and medicinal ingredients such as aliphatic acid, hydro carbons, terpene, vitamin E, steroid class, flavonoids.
Experimental study shows, aspect enhancing immunity, Seabuckthorm Seed Oil can obviously strengthen E garland formation rate, the anti-SRBC antibody titer of serum, α naphthyl acetate esterase activity, and mouse humoral immune after the radiation injury and cellular immune function are recovered all to have obvious enhancement effect.
Experimental study shows that aspect the protection gastric mucosa, Seabuckthorm Seed Oil can obviously reduce gastric juice amount and free acid amount and pepsin activity, the effect with obvious suppression gastric ulcer.Experimental study also shows; Seabuckthorm Seed Oil all has the significant protection therapeutic action to big white mouse stress gastric ulcer, reserpine type gastric ulcer and chronic acetic acid type, pyloric ligation ulcers gastric ulcer etc.; its performance is that the ulcer incidence is low, and ulcer generation index reduces, and gastric secretion descends.In addition, find also after deliberation that Seabuckthorm Seed Oil can suppress the total acid output of stomach and increase gastric mucus, and can suppress the mouse gastric emptying, suppress the motion of pipe smooth muscle and have certain analgesic activity, help influence the treatment generation of gastric mucosa injure.
Propolis is the natural gum of honeybee herborization, and sneaks into its palate glandular secretion thing and beeswax and chew a kind of colloid substance that modulation forms through honeybee.Propolis contains pharmacological components such as abundant flavonoids, terpene, aromatic acid.
Aspect enhancing immunity, with mtt assay, ear swelling method, Jerne improvement slide method, blood clotting method, half intracorporal method, determination of lactate dehydrogenase method, observe mouse spleen lymphocyte conversion, delayed allergy, antibody-producting cell, serum hemolysin, huge chicken red blood cell, the NK cytoactive situation of biting in abdominal cavity respectively.The result shows that propolis extract has the effect that strengthens mouse cell immunologic function and humoral immune function.Also has the effect that strengthens macrophage phagocytosis of mice and NK cells in mice activity.
In addition, adopt hydrocortisone immunologic hypofunction mouse model (HC mouse model), complete observation propolis ethanol extract is to the influence of HC immune function of mice, show that the propolis ethanol extract can improve the humoral immune function of immunologic hypofunction mouse, strengthen antibody forming cell's function, improve serum hemolysin content, illustrate that propolis has the effect that improves the mouse humoral immune functional status.
Aspect the protection gastric mucosa, observe the effect that propolis burns type ulcer model to reserpine ulcer model and glacial acetic acid through experiment, the result shows that propolis can significantly suppress the formation of reserpine ulcer, Dichlorodiphenyl Acetate burns the type ulcer healing obvious facilitation.
In addition, observe the ulcer function of propolis ethanol extract with 5 kinds of rat ulcer models, and inquire into its mechanism, experimental result shows: ethanol extract can resist the formation of pyloric ligation ulcers ulcer, reduce total acidity and pepsin activity in the stomach, can also resist stress type ulcer formation, and can promote the acetic acid type ulcer healing.
Propolis is having fabulous clinical effectiveness aspect the protection gastric mucosa injure, is because propolis has good film forming, can form the impermeable film of one deck on mucous membrane, resists the erosion of hydrochloric acid in gastric juice, and effects such as hemostasis, the healing of promotion ulcer surface are arranged; In addition, also have the effect of sterilization and anti-inflammatory, can protect and promote the renewal of damaged tissues.
Health food of the present invention shows through effect experiment, toxicological experiment and stability experiment; remarkable, nontoxic, the good stability of its effect; and take confirmation through majority; a kind of really the collection strengthens immunity, gastric mucosa injure had assistant protection function; strengthen immunity; improve gastric mucosa injure, and the health food that can take for a long time.Have that prescription is unique rationally, the complete maturation of preparation method, bioavilability height, easily be absorbed by the body, characteristics such as function is remarkable, taking dose is little.
The specific embodiment
Below in conjunction with embodiments of the invention the present invention is further described, but the present invention is not limited to embodiment, those of ordinary skills do some modification with technical solution of the present invention, still in protection domain of the present invention.
Embodiment 1-5: health food preparation of soft capsule of the present invention
Prepare health food soft capsule of the present invention, the weight proportion of each raw material sees Table 1 among each embodiment.
Preparing the used auxiliary material of health food soft capsule of the present invention is made by the raw material of following weight portion:
Beeswax 0.05-4 part.
The raw material weight proportioning for preparing the used capsule material of health food soft capsule of the present invention is:
Gelatin: glycerine: polyethylene glycol: water=1: (0.2-0.6): (0.6-1): (0.2-0.5).
Table 1
| Embodiment number | Seabuckthorn Oil (kg) | Propolis (kg) | Beeswax (kg) |
| 1 | 95 | 20 | 1 |
| 2 | 90 | 18 | 0.8 |
| 3 | 88 | 12 | 4 |
| 4 | 65 | 11 | 0.1 |
| 5 | 50 | 5 | 0.05 |
The source of primary raw material and quality standard are as follows among the embodiment:
1, Seabuckthorm Seed Oil Tianjin spike natural products Co., Ltd produces, and meets the specification requirement of the industry standard HB/QS002-94 of the People's Republic of China (PRC) " Seabuckthorm Seed Oil " regulation.
2, propolis Hunan Jinnong Biological Resources Co., Ltd. produces, and meets the specification requirement of the standard SB/T10096-92 of the Ministry of Commerce of the People's Republic of China (PRC) " propolis " regulation.
The preparation method is as follows: (with embodiment 3 is the example explanation, and other embodiment is substantially the same manner as Example 3 except that raw material consumption difference):
(1) chooses raw material
Choose the 88kg Seabuckthorm Seed Oil and the 12kg propolis that meet specification requirement.
(2) extract propolis
Put into multi-function extractor after the 12kg propolis broken up with the Chinese medicine collision machine, add 70% ethanol of 96kg, lixiviate is 2 times under 70 ℃ of temperature, each 1 hour time, extract is merged the back filters, filtrate and filter residue, filter residue discards; Filtrate decompression vacuum (60 ℃, 0.07Mpa) is concentrated into the thick paste that relative density is 1.30-1.33 (50 ℃ of survey); Thick paste is put into vacuum drying chamber, under 70 ℃, 0.7Mpa condition, after the drying, is ground into 120 order fine powders, propolis extract dry powder.
(3) preparation soft capsule content
88kg Seabuckthorm Seed Oil, 4kg beeswax are placed material-compound tank, after 35 ℃ of mixing of constant temperature are stirred, (2) gained propolis extract dry powder is added wherein, continue to stir 20-30 minute, make mixing of materials even, the filtration of 100 orders.Material after the filtration is squeezed in the degassing tank, is under the 60-70mmHg vacuum at 35 ℃ of constant temperature, pressure, stirs at a slow speed 30-45 minute, and the material after the degassing is squeezed in the heat-preserving container, gets soft capsule content, is incubated under 35 ℃ of conditions in order to pelleting.
(4) pill
Technology prepares the soft capsule packaging material routinely, and soft capsule content is sent into the pellet press pill, gets health food soft capsule of the present invention.
Health food soft capsule of the present invention: net content 0.5g/ grain, every contains general flavone and is no less than 800mg.
Using method: oral, every day 2 times, each 2.
Test example 1: the enhancing immunity function check of health food of the present invention
Enhancing immunity function for examination health food of the present invention, with embodiment 3 gained 0.5g/ grains * 12 * 434 plates health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send monitoring of hygiene inspection center, Jilin Province, according to " health food function assessment assessment process and method of inspection standard " (version in 2003), second portion function assessment evaluation test method one, the enhancing immunity function method of inspection check it to strengthen immunity function.Survey report is as follows:
1, materials and methods
1.1 sample: soft capsule, content are the dark oil mixture.
1.2 animal used as test: the cleaning level ICR male mice that preclinical medicine institute of Jilin University zoopery center provides, production licence number: SCXK-(Ji) 2003-0001.Feed provides production licence number by the living animal used as test feed factory of Changchun Lvyuan District benefit: SCXK-(Ji) 2003-0004.This animal housing occupancy permit number: the moving word of doctor 10-7201 number.Select 48 of healthy male mices, body weight 18-22g is divided into 4 groups, 12 every group, as immune one group, carries out internal organs/weight ratio pH-value determination pH, HD50 value (HC
50) mensuration and antibody-producting cell detect; Select 48 of healthy male mices, body weight 18-22g is divided into 4 groups, 12 every group, as immune two groups, carries out carbon and cleans up experiment; Select 48 of healthy male mices, body weight 18-22g is divided into 4 groups, 12 every group, as immune three groups, carries out mouse lymphocyte transformation experiment and NK cytoactive mensuration that ConA induces; Select 48 of healthy male mices, body weight 18-22g is divided into 4 groups, 12 every group, as immune four groups, carries out the delayed allergy experiment; Select 48 of healthy male mices, body weight 18-22g is divided into 4 groups, 12 every group, as immune five groups, carries out Turnover of Mouse Peritoneal Macrophages and engulfs the chicken red blood cell experiment.
1.3 dosage is selected: 4/day of soft capsule recommended amounts, 0.5g/ grain, be 2.0g/60kg BW, be equivalent to 0.033g/kgBW, filling stomach dosage is set to recommend 1,10 and 30 times of adult's intake day, promptly 0.03,0.33,1.0g/kgBW, each dosage group is diluted with soybean oil.With the negative control group of soybean oil, each is organized the mouse stomach amount and is 0.2mL/10kgBW, and the continuous irrigation stomach is surveyed every immune indexes after 30 days.
1.4 instrument and reagent:
Electronic balance (0.1g), assay balance, clean bench, CO2gas incubator, centrifuge, 722 spectrophotometers, water bath with thermostatic control, ELIASA, microscope etc.
Aseptic operation apparatus, slide measure (precision 0.02mm), micro syringe (25 μ L), cell counter, the flat Tissue Culture Plate in 24 holes and 96 holes, 96 hole U type Tissue Culture Plates, glass dish, gauze, test tube, slide frame, 200 eye mesh screens, timer, hemochrome suction pipe, slide etc.
Sheep red blood cell (SRBC) (SRBC), physiological saline, HanK ' s liquid (pH7.2-7.4), the RPM11640 nutrient solution, calf serum, mycillin, concanavalin A (ConA), 1% glacial acetic acid, the HCl solution of 1mol/L, acid isopropyl alcohol (the 96ml isopropyl alcohol adds 4ml hydrochloric acid), MTT, PBS buffer solution (pH7.2-7.4), complement (GPS), the SA buffer solution, agarose, Dou Shi reagent (sodium acid carbonate 1.0g, high-potassium ferricyanide 0.2g, potassium chloride 0.05g, adding distil water is to 1000ml), the YAC-1 cell, sodium lactate, the nitro tetrazolium chloride, azophenlyene dimethyl ester sulfate, oxidized coenzyme 1,0.2mol/L Tris-HCl buffer solution (pH8.2), 1%NP40, india ink, Na
2Co
3, chicken red blood cell, methyl alcohol, Giemsa dye liquor etc.
1.5 experimental technique
1.5.1 internal organs/weight ratio pH-value determination pH
Dislocation was put to death after mouse was weighed, and got spleen and thymus gland, removed most manadesma, blotted the organ surface blood stains with filter paper, weighed, and calculated spleen/body weight ratio and thymus gland/body weight ratio.
1.5.2 delayed allergy (the sufficient sole of the foot thickens method DTH)
Get sheep blood, physiological saline washing 3 times, mouse is injected 0.2ml (about 1 * 10 with 2% (V/V) SRBC peritoneal immunity, every mouse
8Individual SRBC).Immunity 4 days, measure left back sufficient sole of the foot portion thickness, then at measuring point hypodermic injection 20% (V/V) SRBC, every mouse 20 μ L (about 1 * 10
8Individual SRBC), injection back 24h measures left back sufficient sole of the foot portion thickness, and same position is measured three times, averages.
1.5.3ConA the mouse lymphocyte transformation experiment (mtt assay) of inducing
The aseptic spleen of getting places the little plate that fills an amount of aseptic HanK ' s liquid, gently spleen is ground with tweezers, makes the individual cells suspension, with 4 gauzes spleen is ground, and uses HanK ' s liquid to wash 2 times, each centrifugal 10min (1000r/min).Then cell is suspended in the complete culture solution of 1ml, with the blue dyeing counting viable count of platform phenol (should more than 95%), adjusting cell concentration be 3 * 10
6Individual/ml.Again each part cell suspension is divided two holes to add in 24 well culture plates, every hole 1ml, a hole adds 75 μ L ConA liquid (being equivalent to 7.5 μ g/ml), and another hole compares, and puts 5%CO
237 ℃ of CO
2Cultivate 72h in the incubator.Cultivate and finish preceding 4h, every hole sucts clear liquid 0.7ml gently, adds the RPMI1640 nutrient solution that 0.7ml does not contain calf serum, adds MTT (5mg/ml) 50 μ L/ holes simultaneously, continues to cultivate 4h.After cultivating end, every hole adds 1ml acid isopropyl alcohol, and the piping and druming mixing dissolves purple crystal fully.Then lysate is directly moved in the 2ml cuvette, survey the OD value at ripple 570nm on 722 spectrophotometrics.
1.5.4 antibody-producting cell detects (Jerne improves slide method)
The sheep jugular vein is got blood, and sheep blood is put into the sterilization conical flask of bead, shakes towards a direction, with defiber, puts into 4 ℃ of refrigerators and preserves standbyly, can preserve for 2 weeks.
Hematocrit SRBC is made into the cell suspension of 2% (V/V) with physiological saline, and every mouse lumbar injection 0.2ml will be in putting to death with the mouse cervical vertebra dislocation of SRBC immunity after 4-5 days, get spleen, put into the little plate that fills HanK ' s liquid, gently spleen is ground, make cell suspension, then through 4 filtered through gauze, use HanK ' s liquid Xian 2 times, centrifugal at every turn (1000r/min) 10min floats over splenocyte suspension in the 5mlRPMI1640 nutrient solution at last, counting cells, and cell concentration is adjusted into 5 * 10
6Individual/ml.
After the agarose heating for dissolving, put 45-50 ℃ of water bath heat preservation, mix with HanK ' the s liquid of 2 times of concentration of equivalent pH7.2-7.4, the packing small test tube, every pipe 0.5ml, in pipe, add 10% (V/V is with the preparation of SA liquid) hematocrit SRBC50 μ L again, splenocyte suspension 20 μ L are after mixing rapidly, be poured on the slide of brushing the agarose thin layer, do parallel plate, treat that agar solidifies after, the slide level buckled be placed on the horse, put into CO2gas incubator incubation 1.5h, complement (1: 8) with the dilution of SA buffer solution joins in the slide frame groove then, behind the continuation incubation 1.5h, and the empty class of counting haemolysis number.
1.5.5 HD50 value (HC
50) mensuration
Get sheep blood, physiological saline washing 3 times, centrifugal at every turn (2000r/min) 10min, every mouse carries out immunity through lumbar injection 2% (V/V prepares with physiological saline) hematocrit SRBC 0.2ml.After 4 days, extract eyeball and get blood in centrifuge tube, place about 1h, solidification blood and tube wall are peeled off, serum is fully separated out, the centrifugal 10min of 2000r/min collects serum.With the SA buffer solution serum is diluted (400 times).Serum 1ml after the dilution is put in vitro, add 10% (V/V) SRBC 0.5ml successively, complement 1ml (diluting by 1: 8) with the SA buffer solution, other establishes the not control tube of increase serum (replacing with the SA buffer solution).After putting in 37 ℃ of waters bath with thermostatic control insulation 15-30min, the ice bath cessation reaction.The centrifugal 10min of 2000r/min gets supernatant 1ml, adds Dou Shi reagent 3ml, gets 10% (V/V) SRBC 0.25ml simultaneously, adds Dou Shi reagent to 4ml, and fully mixing behind the placement 10min, is sentenced control tube in 540nm and made blank, measures respectively and respectively manages OD value.The amount of hemolysin is with HD50 value (HC
50) expression, be calculated as follows.
HC
50OD value * the extension rate of=sample OD value/when the SRBC half is bathed in blood
1.5.6 mouse carbon is cleaned up experiment
The india ink of 1: 4 times of dilution of mouse tail vein injection treats that prepared Chinese ink injects timing immediately.Inject behind the prepared Chinese ink 2,10min, get blood 20 μ L from the angular vein clump respectively, and at once it be added to 2ml 0.1%Na
2CO
3In the solution, with 722 spectrophotometers at 600nm wavelength place's photometry density value (OD), with Na
2CO
3Solution is made negative control.Mouse is put to death, gets liver and spleen, blot the organ surface blood stains, weigh respectively, be calculated as follows phagocytic index a with filter paper:
k＝(lgOD
1-lgOD
2)/(t
2-t
1)
1.5.7 Turnover of Mouse Peritoneal Macrophages is engulfed the chicken red blood cell experiment
Mouse peritoneal injection 20% (V/V prepares with physiological saline) hematocrit chicken red blood cell (2000r/min, 10min) suspension 1ml, interval 30min, the cervical vertebra dislocation is put to death, get peritoneal macrophage washing lotion 1ml, drip on slide, put into the enamel box that is lined with wet gauze, 37 ℃ of incubator incubations of dislocation 20min.Incubate completely, rinsing in physiological saline is to remove not paster cell.Dry, fix with methyl alcohol, the dyeing of 4% (V/V) Giemsa-phosphate buffer is dried with the distilled water rinsing again.The oil mirror is counting down, 100 macrophages of every counting.
Be calculated as follows phagocytic rate and phagocytic index:
Phagocytic rate %=engulfs macrophage number * 100 of the macrophage number/counting of chicken red blood cell
The macrophage number of chicken red blood cell sum/counting that phagocytic index=quilt is engulfed
1.5.8NK cytoactive is measured (lactate dehydrogenase L DH determination method)
Testing preceding 24 hours with the target cell YAC-1 cultivation of going down to posterity, wash 3 times with HanK ' s liquid before using, is 4 * 10 with the RPMI1640 complete culture solution adjustment cell concentration that contains 10% calf serum
5Individual/ml.Being tried mouse draws neck to put to death, the aseptic spleen of getting, make splenocyte suspension, use HanK ' s liquid to wash 3 times, the centrifugal 10min of 1500r/min, it is resuspended to contain the RPMI1640 complete culture solution of 10% calf serum with 2ml again, and with the blue dyeing counting of platform phenol (viable count should more than 95%), adjusting cell concentration be 2 * 10
7Individual/ml, making and imitating the target ratio is 50: 1.Get each 100 μ L of target cell and effector cell, add in U-shaped 96 well culture plates, target cell nature release aperture adds target cell and each 100 μ L of nutrient solution, and the maximum release aperture of target cell adds target cell and each 100 μ L of 1%NP40; Above-mentioned every three parallel holes, 37 ℃, 5%CO of all establishing
2Cultivate 4h in the incubator, with the centrifugal 5min of 1500r/min, every hole is drawn supernatant 100 μ L and is put in the ELISA Plate with 96 orifice plates, add LDH matrix liquid 100 μ L, reaction 10min, every then hole adds the HCl liquid 30 μ L cessation reactions of 1mol, survey the OD value at ELIASA 490nm place, the NK activity is calculated as follows:
NK cytoactive %=(reacting hole OD-nature release aperture OD)/(maximum release aperture OD-nature release aperture OD) * 100%
The preparation of LDH matrix liquid: sodium lactate 5 * 10
-2Mol/L; Nitric acid tetrazolium chloride 6.6 * 10
-4Mol/L; Azophenlyene dimethyl ester sulfate 2.8 * 10
-4Mol/L; NAD 1.3 * 10
-3Mol/L.
Mentioned reagent is dissolved in the Tris-HCL buffer solution of 0.2mol/L (pH8.2).
1.6 experimental data is carried out variance analysis with SPSS10.0 software.
2 results
2.1 soft capsule, the results are shown in examination 1 table 1-to the influence of mouse body weight and tries 1 table 4.
Try of the influence of 1 table 1 soft capsule to immune one group of mouse body weight
| Group | Number of animals (only) | Starting weight (g) | Eventually heavy (g) | Weightening finish (g) | p |
| Negative control | 12 | 19.0±0.6 | 37.5±1.0 | 18.5±1.1 | --- |
| Low dose group | 12 | 19.1±0.9 | 38.3±1.5 | 19.1±1.4 | 0.284 |
| Middle dosage group | 12 | 19.3±0.5 | 37.2±1.0 | 17.9±1.3 | 0.384 |
| High dose group | 12 | 19.1±0.7 | 37.9±1.8 | 18.8±2.0 | 0.576 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 1 as seen, learn by statistics and handle, the initial body weight of mouse compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, the initial body weight that is mouse is comparatively balanced between each group, through giving soft capsule 30 days, there was no significant difference (p＞0.05) is compared in each dosage group mouse weightening finish between basic, normal, high dosage group and negative control group, promptly soft capsule does not have influence to the mouse weight gain.
Try of the influence of 1 table 2 soft capsule to immune two groups of mouse body weight
| Group | Number of animals (only) | Starting weight (g) | Eventually heavy (g) | Weightening finish (g) | p |
| Negative control | 12 | 18.7±0.5 | 37.1±1.2 | 18.4±1.2 | --- |
| Low dose group | 12 | 18.9±0.7 | 37.4±1.4 | 18.5±1.5 | 0.931 |
| Middle dosage group | 12 | 18.4±0.4 | 37.4±1.8 | 19.0±1.9 | 0.418 |
| High dose group | 12 | 18.6±0.8 | 37.8±1.5 | 19.1±1.9 | 0.304 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 2 as seen, learn by statistics and handle, the initial body weight of mouse compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, the initial body weight that is mouse is comparatively balanced between each group, through giving soft capsule 30 days, there was no significant difference (p＞0.05) is compared in each dosage group mouse weightening finish between basic, normal, high dosage group and negative control group, promptly soft capsule does not have influence to the mouse weight gain.
Try of the influence of 1 table 3 soft capsule to immune three groups of mouse body weight
| Group | Number of animals (only) | Starting weight (g) | Eventually heavy (g) | Weightening finish (g) | p |
| Negative control | 12 | 19.0±0.7 | 36.6±0.8 | 17.6±1.2 | --- |
| Low dose group | 12 | 19.1±0.5 | 36.9±1.7 | 17.8±1.7 | 0.681 |
| Middle dosage group | 12 | 18.9±0.6 | 37.1±1.4 | 18.2±1.6 | 0.280 |
| High dose group | 12 | 19.1±0.9 | 37.0±1.2 | 17.9±1.6 | 0.543 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 4 as seen, learn by statistics and handle, the initial body weight of mouse compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, the initial body weight that is mouse is comparatively balanced between each group, through giving soft capsule 30 days, there was no significant difference (p＞0.05) is compared in each dosage group mouse weightening finish between basic, normal, high dosage group and negative control group, promptly soft capsule does not have influence to the mouse weight gain.
2.2 soft capsule is to the influence of mouse internal organs/body weight ratio
Try of the influence of 1 table 4 soft capsule to mouse internal organs/body weight ratio
| Group | Number of animals (only) | Spleen/body weight ratio (mg/g) | p 1 | Thymus gland/body weight ratio (mg/g) | p 2 |
| Negative control | 12 | 5.02±0.24 | --- | 2.96±0.60 | --- |
| Low dose group | 12 | 5.05±0.21 | 0.813 | 2.85±0.17 | 0.395 |
| Middle dosage group | 12 | 5.09±0.25 | 0.533 | 2.89±0.08 | 0.568 |
| High dose group | 12 | 5.14±0.31 | 0.280 | 2.94±0.17 | 0.844 |
Spleen/body weight ratio p
1Value: each experimental group and negative control group are relatively
Thymus gland/body weight ratio p
2Value: each experimental group and negative control group are relatively
By examination 1 table 4 as seen, soft capsule through giving the mouse various dose 30 days, learn by statistics and handle, its spleen/body weight ratio and thymus gland/body weight ratio compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, and promptly soft capsule does not have influence to the internal organs proportion of mouse.
2.3 soft capsule is to the mouse cell Immune Effects
2.3.1 soft capsule, the results are shown in examination 1 table 5 to the influence of mouse body weight and delayed allergy (DTH).
Try of the influence of 1 table 5 soft capsule to mouse body weight and delayed allergy (DTH)
| Group | Number of animals (only) | Starting weight (g) | Eventually heavy (g) | Weightening finish (g) | p 1 | Swelling degree of the paw | p 2 |
| Negative control | 12 | 19.2±0.8 | 37.1±0.9 | 17.9±1.3 | --- | ± | --- |
| Low dose group | 12 | 19.8±0.9 | 37.8±1.1 | 18.0±1.0 | 0.911 | ± | 0.695 |
| Middle dosage group | 12 | 20.3±0.8 | 38.2±1.7 | 18.2±1.9 | 0.672 | ± | 0.033 |
| High dose group | 12 | 20.2±1.0 | 38.3±1.6 | 18.1±2.0 | 0.794 | ± | 0.007 |
p
1Value: each experimental group and negative control group are relatively
p
2Value: each experimental group and negative control group are relatively
*P＜0.05
*P＜0.01
By examination 1 table 5 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, each dosage group mouse weightening finish there was no significant difference (p＞0.05) relatively between basic, normal, high dosage group and negative control group; Its swelling degree of the paw compares there was no significant difference (p＞0.05) between low dose group and negative control group; Significant difference (p＜0.05) is relatively arranged between middle dosage group and negative control group; Highly significant difference (p＜0.01) is relatively arranged between high dose group and negative control group, and promptly the soft capsule of middle and high dosage can strengthen the delayed allergy of mouse.
2.3.2 the influence of the mouse lymphocyte transformation experiment that soft capsule is induced ConA the results are shown in examination 1 table 6.
Try the influence of the mouse lymphocyte transformation experiment that 1 table 6 soft capsule induces ConA
| Group | Number of animals (only) | Lymphopoiesis ability (OD difference) | p |
| Negative control | 12 | 0.152±0.032 | --- |
| Low dose group | 12 | 0.159±0.036 | 0.647 |
| Middle dosage group | 12 | 0.156±0.040 | 0.810 |
| High dose group | 12 | 0.165±0.041 | 0.414 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 6 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, its lymphocytic multiplication capacity compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, promptly soft capsule does not have influence to the mouse lymphocyte conversion capability that ConA induces.
2.4 soft capsule is to the influence of humoral immunity
2.4.1 the influence of soft capsule antagonist cellulation number the results are shown in examination 1 table 7.
Try of the influence of 1 table 7 soft capsule to mouse antibodies cellulation number
| Group | Number of animals (only) | Hemolysis plaque number (* 10 3/ full spleen) | p |
| Negative control | 12 | 169.5±10.1 | --- |
| Low dose group | 12 | 177.0±11.2 | 0.136 |
| Middle dosage group | 12 | 177.8±14.0 | 0.098 |
| High dose group | 12 | 180.3±12.7 * | 0.035 |
The p value: each experimental group and negative control group are relatively
*P＜0.05
By examination 1 table 7 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, its antibody-producting cell number there was no significant difference (p＞0.05) relatively between low, middle dosage group and negative control group; Significant difference (p＜0.05) is relatively arranged between high dose group and negative control group, and promptly the soft capsule of high dose has tangible influence to the antibody-producting cell number of mouse.
2.4.2 soft capsule is to mouse HD50 value (HC
50) influence, the results are shown in the examination 1 table 8.
Try 1 table 8 soft capsule to mouse HD50 value HC
50Influence
| Group | Number of animals (only) | Sample HC 50 | p |
| Negative control | 12 | 156±11 | --- |
| Low dose group | 12 | 159±8 | 0.467 |
| Middle dosage group | 12 | 161±12 | 0.238 |
| High dose group | 12 | 166±12 * | 0.024 |
The p value: each experimental group and negative control group are relatively
*P＜0.05
By examination 1 table 8 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, its HD50 value compares there was no significant difference (p＞0.05) between low, middle dosage group and negative control group, explicitly difference (p＜0.05) is relatively arranged between high dose group and negative control group, and promptly the soft capsule of high dose can improve mouse HD50 value.
2.5 soft capsule is to the influence of mouse monokaryon-macrophage phagocytic function
2.5.1 soft capsule is cleaned up the influence of function to mouse monokaryon-macrophage carbon, the results are shown in examination 1 table 9.
Try 1 table 9 soft capsule mouse monokaryon-macrophage carbon is cleaned up the influence of function
| Group | Number of animals (only) | Phagocytic index (a) | p |
| Negative control | 12 | 5.64±0.33 | --- |
| Low dose group | 12 | 5.86±0.59 | 0.341 |
| Middle dosage group | 12 | 5.98±0.69 | 0.137 |
| High dose group | 12 | 6.07±0.52 | 0.065 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 9 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, its carbon is cleaned up function and compare there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, and promptly soft capsule is cleaned up ability to the carbon of mouse monokaryon-macrophage does not have influence.
2.5.2 soft capsule, the results are shown in examination 1 table 10 to the influence of the ability of mouse body weight and macrophage phagocytic chicken red blood cell.
Try of the influence of 1 table 10 soft capsule to the ability of mouse body weight and macrophage phagocytic chicken red blood cell
| Group | Number of animals (only) | Starting weight (g) | Eventually heavy (g) | Weightening finish (g) | p 1 | Phagocytic rate (%) | p 2 | Phagocytic index | p 3 |
| Negative control | 12 | 19.1±0.9 | 37.0±1.4 | 17.9±1.5 | --- | 33±7 | --- | 0.42±0.08 | --- |
| Low dose group | 12 | 19.3±0.7 | 37.6±1.4 | 18.3±1.6 | 0.575 | 35±5 | 0.322 | 0.45±0.06 | 0.363 |
| Middle dosage group | 12 | 19.4±1.1 | 37.7±1.6 | 18.2±1.9 | 0.617 | 36±5 | 0.247 | 0.46±0.07 | 0.162 |
| High dose group | 12 | 19.7±0.9 | 38.0±1.7 | 18.3±1.7 | 0.527 | 38±7 | 0.064 | 0.47±0.06 | 0.092 |
p
1Value: each experimental group and negative control group are relatively
Phagocytic rate (%) p
2Value: each experimental group and negative control group are relatively
Phagocytic index p
3Value: each experimental group and negative control group are relatively
By examination 1 table 10 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, there was no significant difference (p＞0.05) is compared in each dosage group mouse weightening finish between basic, normal, high dosage group and negative control group, its phagocytic rate relatively there are no significant between basic, normal, high dosage group and negative control group difference (p＞0.05), promptly soft capsule is engulfed erythrocytic ability to mouse macrophage does not have influence.
2.6 soft capsule, the results are shown in examination 1 table 11 to the influence of NK cells in mice activity.
Try of the influence of 1 table 11 soft capsule to the NK cells in mice activity
| Group | Number of animals (only) | NK cytoactive (%) | p |
| Negative control | 12 | 6.7±2.1 | --- |
| Low dose group | 12 | 6.9±2.0 | 0.826 |
| Middle dosage group | 12 | 7.0±2.2 | 0.680 |
| High dose group | 12 | 7.6±2.3 | 0.283 |
The p value: each experimental group and negative control group are relatively
By examination 1 table 11 as seen, give the soft capsule 30 days of mouse various dose, learn by statistics and handle, its NK cytoactive compares there was no significant difference (p＞0.05) between basic, normal, high dosage group and negative control group, and promptly soft capsule does not have influence to the NK cytoactive of mouse.
3 brief summaries
Soft capsule through giving the mouse various dose 30 days can improve the HD50 value of mouse, and mouse antibodies cellulation number can strengthen the delayed allergy of mouse; To the growth of mouse body weight, internal organs/body weight ratio, ability that mouse monokaryon-macrophage carbon is cleaned up, mouse lymphocyte conversion capability, Turnover of Mouse Peritoneal Macrophages that ConA induces engulf erythrocytic ability, the NK cytoactive does not have influence.Judge that thus soft capsule has the effect of the immunity function of enhancing.
Test example 2: health food of the present invention has the check of assistant protection function to gastric injury
For examination health food of the present invention has assistant protection function to gastric injury; with embodiment 3 gained 2kg (0.5g/ grain) health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send Shandong Center for Disease Control ﹠ Prevention; the method prison is sent out (2003) No. 42 " health food check and assessment technique standard " function assessment evaluations and the method for inspection has assistant protection function to gastric injury according to defending, and checks it that gastric injury is had assistant protection function.Survey report is as follows:
1 material and method
1.1 sample: health food of the present invention, content are the dark oil mixture.
1.2 animal used as test: (credit number is SCXK-(capital)-2002-0003) to 40 of SPF level healthy SD male rats selecting for use Beijing Vital River Experimental Animals Technology Co., Ltd. to breed, body weight 160-180g.
1.3 dosage is selected: it is 2g/60kg body weight every day that the human body of soft capsule is recommended consumption, three dosage groups are established in experiment: promptly 0.17g/kg body weight group (low), 0.33g/kg body weight group (in) and 0.99g/kg body weight group (height), the dosage of basic, normal, high three groups is respectively 5 times, 10 times, 30 times of human body recommended amounts, with 1% sodium carboxymethylcellulose sample is prepared to desired concn, promptly get 0.68g, 1.32g, the 3.96g sample is assigned to 40ml with 1% sodium carboxymethylcellulose, set up 1% sodium carboxymethylcellulose control group simultaneously, press the 1ml/100g body weight and irritated stomach 30 days.
1.4 instrument and reagent: digimatic calipers, absolute ethyl alcohol, formaldehyde.
1.5 experimental technique: get 40 of rats, be divided into 4 groups at random, the dosage group is irritated the stomach soft capsule, and control group is irritated stomach 1% sodium carboxymethylcellulose, and continuous 30 days, water 24h was can't help in the animal fasting before dissecting.Experiment finishes the same day irritates stomach and is tried only to irritate stomach absolute ethyl alcohol 1ml/ again behind the thing 1h.Put to death animal behind the 1h, getting stomach fixedly cuts off along greater curvature behind the 20min in 10% formalin, clean content,, calculate the hyperemia of every mouse and the gross area of diffuse hemorrhage band with vernier caliper measurement its length and wide (being accurate to 0.01m) congested and the diffuse hemorrhage band.
1.6 test data is set up database with Excel software, carries out variance analysis with SPSS software, uses the tournament method (Dunnett method of inspection) of mean between a plurality of experimental group and control group to carry out statistical analysis again
2 results
2.1 soft capsule, the results are shown in examination 2 tables 1 to the influence of rat body weight.
Try 2 tables 1 respectively organize the initial body weight of rat, mid-term body weight and latter stage body weight
| Group (g/kg body weight) | Number of animals (only) | Initial body weight (g) | Body weight in mid-term (g) | Body weight in latter stage (g) | The p value |
| 0.00 | 10 | 168±5 | 232±9 | 326±21 | |
| 0.17 | 10 | 173±4 | 233±14 | 325±20 | ＞0.05 |
| 0.33 | 10 | 166±4 | 228±20 | 314±14 | ＞0.05 |
| 0.99 | 10 | 168±4 | 228±14 | 306±18 | ＞0.05 |
By examination 2 tables 1 as seen, give soft capsule after 30 days, the body weight there was no significant difference of each treated animal (p＞0.05)
2.2 the influence of the rat pipe film injury that soft capsule causes absolute ethyl alcohol the results are shown in examination 1 table 2.
Try the influence of the rat pipe film injury that 2 table 2 soft capsules cause absolute ethyl alcohol
| Group (g/kg body weight) | Number of animals (only) | The gastric bleeding zone face amasss (mm 2) | The p value |
| 0.00 | 10 | 134.87±71.15 | |
| 0.17 | 10 | 86.81±33.73 | ＞0.05 |
| 0.33 | 10 | 55.98±40.12 | ＜0.01 |
| 0.99 | 10 | 66.81±47.84 | ＜0.01 |
By examination 2 tables 2 as seen, give soft capsule after 30 days, the gastric mucosa injure area of the middle and high dosage group of soft capsule illustrates that significantly less than control group (p＜0.01, p＜0.05) rat pipe film injury that soft capsule causes absolute ethyl alcohol has the certain protection effect.
3 conclusions
Experimental result proves, with 0.17,0.33, the soft capsule of 0.99g/kg body weight gave rat oral gavage 30 days, the gastric mucosa injure area of middle and high dosage group is significantly less than control group (p＜0.01, p＜0.05).Show that the rat pipe film injury that soft capsule of the present invention causes absolute ethyl alcohol has certain auxiliary protection function.
Test example 3: health food of the present invention has the assistant protection function human feeding trial to gastric injury
For examination health food of the present invention has assistant protection function to gastric injury; with 1000 of embodiment 3 gained, 0.5g/ grain health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send the Shandong ProvinceQianfoshan Hospital; carry out that according to " health food check and assessment technique standard " gastric injury is had the assistant protection function human feeding trial, survey report is as follows:
1 materials and methods
1.1 sample: soft capsule, 0.5g/ grain.
1.2 the experimenter selects
1.2.1 standard of including in: meet the chronic superficial gastritis diagnostic criteria, and part is screened the volunteer who is diagnosed as chronic superficial gastritis through gastroscope.
1.2.2 the diagnostic criteria of chronic superficial gastritis: course of disease delay, clinical symptoms such as the indigestion, epigastric pain of distinct program, heartburn, belch, sour regurgitation, abdominal distension are arranged, the upper abdomen mild tenderness can be arranged.Meet chronic superficial gastritis gastrofiberscope diagnostic criteria and biopsy diagnostic criteria, get rid of the gastric ulcer patient.
1.2.3 get rid of experimenter's standard: the age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution and to this sample allergy sufferers; Secondary cases chronic gastritis person; Be associated with cardiovascular, the cerebrovascular, liver, kidney and the serious systemic disease person of hemopoietic system; Symptom, sign are classified as severe person; Often medication, be addicted to drink, a large amount of smoker; The patient that digestive system ulcer is arranged; Taking the other treatment medicine or accepting the other treatment person; Take the article relevant with being tried function in a short time, influence is to result's judgement person; Do not take sample in accordance with regulations, can't judge effect, or data is not congruent influences effect or security judgement person.Participating in the health check-up number is 136 people, and qualified number is 104 people, and the actual count number is 104 people.
1.3 test-meal method:
104 routine experimenters are divided into two groups at random, every group 52 people.Control group is not taken the similar medicine of this product or is influenced the medicine that this product result judges, is blank.Be subjected to the examination group to take soft capsule, each is edible once before every day lunch and the dinner, each 2, is used for the article of chronic gastropathy at inactive other of duration of test.All observed 30 days, and extended to 45 days in case of necessity for two groups.Duration of test does not change original eating habit.Each group adopts the own control design, is control design between group between two groups.
1.4 instrument and reagent:
F-820 type blood cell numeration instrument, ten analyzers of MIDIRON urine (Germany produces), Olympus automatic clinical chemistry analyzer model AU600 (Japan produces), the biochemical reagents box is all provided by middle living company.
1.5 statistical method:
Experimental data is a measurement data, adopts the t check.Own control adopts paired t-test, and two groups of means relatively adopt t check in groups, and the latter carries out homogeneity test of variance.
2 observation index
2.1 safety indexes
Ordinary circumstance: comprise spirit, sleep, diet, stool and urine, blood pressure etc.; Blood, urine, just routine inspection; Hepatic and renal function is checked; Chest X-rays, electrocardiogram, Abdominal B type ultrasonography inspection (before on-test, checking 1 time).
2.2 effect index
2.2.1 symptom is observed: clinical symptoms such as stomachache, belch, sour regurgitation, abdominal distension, few foods.By symptom weight statistics integration (severe 3 minutes, moderate 2 minutes, slight 1 minute).
2.2.2 sign is observed: the tenderness degree is checked under the xiphoid-process, according to the pain program be divided into gently (1 minute), in (2 minutes), weight (3 minutes).
2.2.3 gastroscopic observation: press gastric mucosal lesion kind and degree score under the gastroscope, comprise erosion, hemorrhage, congested, oedema etc., severe 3 minutes, moderate 2 minutes, slight 1 minute.Respectively select 15 examples to carry out the gastroscope check at random in test-meal group and control group.
3 results judge:
Test-meal group self relatively reaches after the test-meal between test-meal group and control group relatively before and after the test-meal, and clinical symptoms, sign integration obviously reduce, and this given the test agent of decidable has auxiliary protection function to gastric mucosa injure.
4 results
4.1 physical data:
Test-meal group 52 examples, male 27 examples, women 26 examples, 44.37 ± 8.64 years old mean age, average course of disease 5.29 years; Control group 52 examples, male 29 examples, women 23 examples, 45.12 ± 8.35 years old mean age, average course of disease 5.35 years.
4.2 observe last as situation relatively, see examination 3 tables 1, examination 3 tables 2.
Try 3 tables 1 observe last as situation relatively
| Grouping | Example number (example) | Age (year) | Sex | The course of disease (year) | |
| The man | The woman | ||||
| The test-meal group | 52 | 44.37±8.64 | 27 | 25 | 5.29±2.46 |
| Control group | 52 | 45.12±8.35 | 29 | 23 | 5.35±2.37 |
Try to take drug condition before 3 table 2 test-meals
| Grouping | The example number | Digestive tract power reinforcing medicine | Mucosa protective agent | Acid inhibitor | Not medication |
| The test-meal group | 52 | 12 | 19 | 29 | 7 |
| Control group | 52 | 15 | 22 | 26 | 5 |
By examination 3 tables 1, examination 3 tables 2 as seen, test-meal group and the every index no significant difference of control group have comparativity before the test-meal.
4.3 effect is observed
4.3.1 two groups of doing well,improving situations after the test-meal are seen examination 3 tables 3.
Try the improvement of two groups of symptoms after 3 table 3 test-meals
| The test-meal group | Control group | |||||||||
| The example number | Produce effects | Effectively | Invalid | Improvement rate (%) | The example number | Produce effects | Effectively | Invalid | Improvement rate (%) | |
| Stomachache | 26 | 7 | 15 | 4 | 84.62 | 25 | 2 | 6 | 17 | 32.00 |
| Belch | 34 | 6 | 11 | 17 | 50.00 | 35 | 1 | 9 | 25 | 28.57 |
| Sour regurgitation | 30 | 7 | 12 | 11 | 63.33 | 27 | 1 | 6 | 20 | 35.00 |
| Abdominal distension | 19 | 5 | 9 | 5 | 73.68 | 25 | 2 | 7 | 16 | 36.00 |
| Few food | 16 | 3 | 6 | 7 | 56.25 | 15 | 1 | 3 | 11 | 26.67 |
Improving aspect the symptom, two groups have notable difference.
4.3.2 examination 3 tables 4 are seen in the contrast of two groups of test-meal front and back symptom integrations.
The contrast that tries symptom integration before and after the test-meal of 3 tables 4 liang group (divides X ± SD)
| Grouping | The example number | The symptom integration | Difference | Rate of descent (%) | |
| Before the test-meal | After the test-meal | ||||
| The test-meal group | 52 | 8.31±1.22 | 5.96±1.24 | 2.35±0.52 * | 28.28 |
| Control group | 52 | 8.74±1.49 | 8.01±1.35 | 0.73±0.68 # | 8.35 |
Own control
*P＜0.01 contrasts p＜0.01 between the # group, observes after 30 days, and test-meal group symptom integration obviously reduces, with the control group significant difference.
4.3.3 examination 3 tables 5 are seen in the comparison of each symptom integration of test-meal group before and after the test-meal.
The comparison that tries each symptom integration of test-meal group before and after 3 table 5 test-meals (divides X ± SD)
| Grouping | The example number | Stomachache | Belch | Sour regurgitation | Abdominal distension | Few food |
| The test-meal group | 52 | 1.75±0.24 | 1.55±0.36 | 1.66±0.46 | 1.84±0.50 | 1.68±0.32 |
| Control group | 52 | 1.13±0.30 * | 1.38±0.29 | 1.05±0.17 * | 1.19±0.26 * | 1.51±0.24 |
Own control
*P＜0.01, the symptom of stomachache after the test-meal of test-meal group, sour regurgitation, abdominal distension have clear improvement before than test-meal, belch, eat symptom less and make moderate progress, but with test-meal before relatively, there was no significant difference.
4.3.4 examination 3 tables 6 are seen in the comparison of two groups of each symptoms after the test-meal.
The comparison that tries two groups of each symptoms after 3 table 6 test-meals (divides X ± SD)
| Grouping | The example number | Stomachache | Belch | Sour regurgitation | Abdominal distension | Few food |
| The test-meal group | 52 | 1.69±0.26 | 1.54±0.18 | 1.58±0.33 | 1.69±0.20 | 1.70±0.18 |
| Control group | 52 | 1.13±0.30 * | 1.38±0.29 | 1.05±0.17 * | 1.19±0.26 * | 1.51±0.24 |
Contrast between group
*P＜0.01 was observed after 30 days, and each symptom integration of test-meal group has obvious decline than control group.
4.3.5 two groups of signs are improved situation before and after the test-meal, see examination 3 tables 7.
Two groups of signs are improved situation before and after trying 3 table 7 test-meals
| Grouping | The example number | Produce effects | Effectively | Invalid | Improvement rate (%) |
| The test-meal group | 52 | 15 | 23 | 15 | 73.08 |
| Control group | 52 | 4 | 15 | 34 | 36.54 |
Observe after 30 days, tenderness takes an evident turn for the better under the test-meal group xiphoid-process.
4.3.6 examination 3 tables 8 are seen in the contrast of two groups of sign integrations before and after the test-meal.
The contrast that tries two groups of sign integrations before and after 3 table 8 test-meals (divides X ± SD)
| Grouping | The sign integration | Improvement rate (%) | ||
| Before the test-meal | After the test-meal | Difference | ||
| The test-meal group | 1.92±0.45 | 1.02±0.47 | 0.90±0.39 * | 46.88 |
| Control group | 1.89±0.52 | 1.71±0.49 | 0.18±0.24 ** | 9.52 |
Own control
*P＜0.01,
*Contrast between group
*P＜0.01, test-meal group sign integration obviously descends after the test-meal, has compared significant difference with control group
4.3.7 two groups of gastrocopy situations are relatively seen examination 3 tables 9 before and after the test-meal.
Try the two groups of gastrocopy situations in 3 table 9 test-meals front and back
| Grouping | Before the test-meal | After the test-meal | ||
| The example number | Integration | The example number | Integration | |
| The test-meal group | 15 | 2.32±1.27 | 15 | 1.91±1.11 |
| Control group | 15 | 2.20±1.29 | 15 | 2.01±1.48 |
Test-meal group stomach lining inflammation integration descends to some extent after the test-meal, but compares no significant difference with control group.
4.4 the observation of safety index
4.4.1 two groups of index detection case such as hematology before and after the test-meal are seen examination 3 tables 10.
Try the two groups of index detection case such as hematology in 3 table 10 test-meals front and back
| Test-meal group (n=52) | Control group (n=52) | |||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| TP(g/L) | 71.25±3.74 | 71.48±4.12 | 72.09±3.91 | 73.20±4.11 |
| ALB(g/L) | 43.72±7.47 | 45.00±7.62 | 45.36±6.77 | 46.15±7.84 |
| ALT(u/L) | 20.92±6.65 | 19.30±6.09 | 18.96±8.02 | 19.20±8.75 |
| AST(u/L) | 23.76±8.40 | 21.62±7.21 | 22.68±7.55 | 21.90±8.03 |
| UREA(mmol/L) | 5.57±2.34 | 5.65±2.07 | 5.05±2.55 | 5.60±2.31 |
| Cr(μmol/L) | 90.70±17.93 | 92.10±14.07 | 93.00±15.49 | 93.69±13.90 |
| HGB(g/L) | 135.63±17.02 | 137.99±17.26 | 137.25± 20.87 | 136.94±20.97 |
| RBC(×1012/L) | 4.41±0.64 | 4.30±0.63 | 4.33±0.66 | 4.47±0.62 |
| WBC(×109/L) | 6.12±1.37 | 6.52±1.50 | 6.12±1.83 | 5.64±1.92 |
| Routine urinalysis | Normally | Normally | Normally | Normally |
| Just conventional | Normally | Normally | Normally | Normally |
Before and after two groups of test-meals, blood and urine, just the every index of conventional detection all in normal range (NR).
4.4.2 Chest X-rays, electrocardiogram, ultrasound diagnosis: two groups of experimenters are all in normal range (NR).
5. sum up
5.1 soft capsule can obviously improve symptoms such as chronic superficial gastritis patient's clinical symptoms, especially stomachache, sour regurgitation, abdominal distension.
5.2 soft capsule is the sign of tenderness under the reduction of patient xiphoid-process preferably.
5.3 gastrocopy finds that soft capsule has some improvement to chronic superficial gastritis patient stomach lining inflammation.
5.4 after taking soft capsule, hemoglobin, red blood cell, leucocyte, total serum protein, albumin, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease, flesh liver, urea and urine, just every inspection index such as routine is all in normal range (NR), and this product is described, and the trencherman is healthy has no adverse effects to examination.
6.3 soft capsule is not observed allergy and other bad reaction in the test-meal process.
Conclusion:
Statistics shows: soft capsule has significant protective effect to gastric mucosa; the clinical shape integration of test-meal group obviously descends before than the test-meal group, and tenderness obviously alleviates under the xiphoid-process, and the improvement rate reaches 73.08%; and control group is 36.54%, two group significant difference (p＜0.01) is arranged.Test-meal group gastroscope makes moderate progress before descending the observation pathology than test-meal after the test-meal, hemoglobin, red blood cell, leucocyte, total serum protein, albumin, glutamic-oxalacetic transaminease, glutamic-pyruvic transaminase, urea nitrogen, creatinine and routine urinalysis before and after the test-meal soft capsule, just every clinical indices such as routine shows that all in normal range (NR) soft capsule has no adverse effects to examination the healthy of trencherman.
Claims (5)
1, a kind ofly strengthen immunity, gastric mucosa injure is had the health food of defencive function, it is characterized in that it is a raw material by following weight portion, Seabuckthorm Seed Oil 50-95 part, propolis 5-20 part, and make as follows,
(1) after the propolis pulverizing with described weight portion, add 70% ethanol of 6-10 times of weight, under 60-80 ℃, lixiviate 1-3 time, each 1-2 hour, filter behind the merging extract, get filtrate;
(2) the filtrate decompression vacuum is concentrated into the thick paste that relative density is 1.30-1.33, with the thick paste drying, be ground into 120 order fine powders, propolis extract dry powder;
(3) Seabuckthorm Seed Oil with propolis extract dry powder and described weight portion mixes, promptly.
2, enhancing immunity according to claim 1, gastric mucosa injure is had the health food of defencive function, it is characterized in that said health food can be made into soft capsule, hard shell capsules, granule, tablet, oral liquid.
3, according to claim 1,2 described enhancing immunity, gastric mucosa injure is had the health food soft capsule of defencive function, it is characterized in that preparing the used auxiliary material of soft capsule is the raw material of following weight portion:
Beeswax 0.05-4 part.
4, enhancing immunity according to claim 3, gastric mucosa injure is had the health food soft capsule of defencive function, it is characterized in that the raw material weight proportioning for preparing the used capsule material of soft capsule is:
Gelatin: glycerine: polyethylene glycol: water=1: (0.2-0.6): (0.6-1): (0.2-0.5).
5, the enhancing immunity of claim 1, gastric mucosa injure is had the preparation method of the health food of defencive function, it is characterized in that comprising the steps:
(1) after the propolis pulverizing with described weight portion, add 70% ethanol of 6-10 times of weight, under 60-80 ℃, lixiviate 1-3 time, each 1-2 hour, filter behind the merging extract, get filtrate;
(2) the filtrate decompression vacuum is concentrated into the thick paste that relative density is 1.30-1.33, with the thick paste drying, be ground into 120 order fine powders, propolis extract dry powder;
(3) Seabuckthorm Seed Oil with propolis extract dry powder and described weight portion mixes, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101632875A CN100435663C (en) | 2006-12-18 | 2006-12-18 | Health-care food with functions of improving immunocompetence and protecting damaged gastric mucosa and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101632875A CN100435663C (en) | 2006-12-18 | 2006-12-18 | Health-care food with functions of improving immunocompetence and protecting damaged gastric mucosa and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN100998406A true CN100998406A (en) | 2007-07-18 |
| CN100435663C CN100435663C (en) | 2008-11-26 |
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| CNB2006101632875A Expired - Fee Related CN100435663C (en) | 2006-12-18 | 2006-12-18 | Health-care food with functions of improving immunocompetence and protecting damaged gastric mucosa and its preparing method |
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| CN101878870A (en) * | 2010-06-22 | 2010-11-10 | 江西汪氏蜜蜂园有限公司 | Preparation method of propolis all-components soft capsule |
| CN101664531B (en) * | 2009-09-07 | 2011-12-21 | 北京同仁堂健康药业股份有限公司 | Food and medicament with assistant protecting function for stomach mucosa and preparation method |
| CN102763845A (en) * | 2012-07-31 | 2012-11-07 | 新疆伊犁州惠华酒业有限责任公司 | Seabuckthorn fruit oil and propolis soft capsule |
| CN103519172A (en) * | 2013-10-17 | 2014-01-22 | 新疆天海绿洲农业科技股份有限公司 | Soft capsule containing jujube, American ginseng and sea buckthorn seed oil |
| CN104306554A (en) * | 2014-09-29 | 2015-01-28 | 中国科学院西北高原生物研究所 | Food, health product or medicine composition for treating gastric ulcer |
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| CN105343465A (en) * | 2015-11-16 | 2016-02-24 | 无锡瑞盈生命科学有限公司 | A compound tuber onion seed oil health-care spray and a preparing method |
| CN105394750A (en) * | 2015-11-16 | 2016-03-16 | 无锡瑞盈生命科学有限公司 | Seabuckthorn seed oil compound functional health product |
| CN105410921A (en) * | 2015-12-16 | 2016-03-23 | 蜂乃宝本铺（南京）保健食品有限公司 | Baccharis dracunculifolia DC. propolis and seabuckthorn soft capsule and preparation method thereof |
| CN106420860A (en) * | 2016-12-13 | 2017-02-22 | 南京中科药业有限公司 | Medicine composition containing sea buckthron oil and propolis |
| CN106420834A (en) * | 2016-11-03 | 2017-02-22 | 汤臣倍健股份有限公司 | Deep processing preparation and quality control method of propolis composite |
| CN106418386A (en) * | 2016-08-31 | 2017-02-22 | 成都润馨堂药业有限公司 | Soft capsule capable of protecting gastric mucosa, and preparation method thereof |
| CN106511396A (en) * | 2016-11-03 | 2017-03-22 | 汤臣倍健股份有限公司 | Deep processing preparation and quality control method for propolis compound |
| CN107495366A (en) * | 2017-08-17 | 2017-12-22 | 内蒙古兰太药业有限责任公司 | There is the Ricipe for health care food of assistant protection function to gastric mucosa damage |
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| CN113499393A (en) * | 2021-08-13 | 2021-10-15 | 河北御芝林生物科技有限公司 | Composition with gastric mucosa injury protection effect and preparation method thereof |
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| CN101664531B (en) * | 2009-09-07 | 2011-12-21 | 北京同仁堂健康药业股份有限公司 | Food and medicament with assistant protecting function for stomach mucosa and preparation method |
| CN101878870A (en) * | 2010-06-22 | 2010-11-10 | 江西汪氏蜜蜂园有限公司 | Preparation method of propolis all-components soft capsule |
| CN102763845A (en) * | 2012-07-31 | 2012-11-07 | 新疆伊犁州惠华酒业有限责任公司 | Seabuckthorn fruit oil and propolis soft capsule |
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| CN105285980A (en) * | 2015-10-14 | 2016-02-03 | 李红 | Compound health-care safflower oil spraying agent and preparation method thereof |
| CN105343465A (en) * | 2015-11-16 | 2016-02-24 | 无锡瑞盈生命科学有限公司 | A compound tuber onion seed oil health-care spray and a preparing method |
| CN105394750A (en) * | 2015-11-16 | 2016-03-16 | 无锡瑞盈生命科学有限公司 | Seabuckthorn seed oil compound functional health product |
| CN105410921B (en) * | 2015-12-16 | 2018-04-24 | 蜂乃宝本铺（南京）保健食品有限公司 | A kind of water wally propolis sea-buckthorn soft capsule and preparation method thereof |
| CN105410921A (en) * | 2015-12-16 | 2016-03-23 | 蜂乃宝本铺（南京）保健食品有限公司 | Baccharis dracunculifolia DC. propolis and seabuckthorn soft capsule and preparation method thereof |
| CN106418386A (en) * | 2016-08-31 | 2017-02-22 | 成都润馨堂药业有限公司 | Soft capsule capable of protecting gastric mucosa, and preparation method thereof |
| CN106420834A (en) * | 2016-11-03 | 2017-02-22 | 汤臣倍健股份有限公司 | Deep processing preparation and quality control method of propolis composite |
| CN106511396A (en) * | 2016-11-03 | 2017-03-22 | 汤臣倍健股份有限公司 | Deep processing preparation and quality control method for propolis compound |
| CN106420834B (en) * | 2016-11-03 | 2019-11-12 | 汤臣倍健股份有限公司 | A kind of deep processing preparation of propolis compound and method of quality control |
| CN106420860A (en) * | 2016-12-13 | 2017-02-22 | 南京中科药业有限公司 | Medicine composition containing sea buckthron oil and propolis |
| CN107495366A (en) * | 2017-08-17 | 2017-12-22 | 内蒙古兰太药业有限责任公司 | There is the Ricipe for health care food of assistant protection function to gastric mucosa damage |
| CN108185423A (en) * | 2018-03-22 | 2018-06-22 | 合肥仙之峰农业科技有限公司 | A kind of health food that can improve immunity |
| CN112704223A (en) * | 2019-12-30 | 2021-04-27 | 汤臣倍健股份有限公司 | Composition with auxiliary gastric mucosa protection effect, application thereof and health food |
| CN113499393A (en) * | 2021-08-13 | 2021-10-15 | 河北御芝林生物科技有限公司 | Composition with gastric mucosa injury protection effect and preparation method thereof |
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Owner name: JILIN XINKEQI HEALTH-CARE FOOD CO., LTD. Free format text: FORMER OWNER: DONGBEIHU PHARMACEUTICAL CO., LTD. Effective date: 20111231 |
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Effective date of registration: 20111231 Address after: 132013 Jilin high tech Zone, Jilin Province Road No. three, No. 4 Patentee after: Jilin Xinkeqi Health-care Food Co., Ltd. Address before: 132013 No. 2, No. 3, hi tech Zone, Jilin, Jilin Patentee before: Dongbeihu Pharmaceutical Co., Ltd. |
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Address after: 132000 Jilin high tech Zone, Jilin Province Road No. three, No. 4 Patentee after: Jilin cloud Health Food Co., Ltd. Address before: 132013 Jilin high tech Zone, Jilin Province Road No. three, No. 4 Patentee before: Jilin Xinkeqi Health-care Food Co., Ltd. |
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