Summary of the invention
The purpose of this invention is to provide a kind ofly at middle-aged and old immunity degradation, failure of memory has the health food of functions of prevention and health care, and its preparation method.
Health food of the present invention is formulated by following weight portion raw material, pilose antler 2-6, American Ginseng 2-6, Radix Astragali 20-60, Radix Angelicae Sinensis 3-12, fruit of Chinese wolfberry 3-12 and sealwort 5-18.
The best proportioning of above-described health food is: (weight portion): pilose antler 3, American Ginseng 3, the Radix Astragali 30, Radix Angelicae Sinensis 6, the fruit of Chinese wolfberry 6, sealwort 9.
Use above-mentioned raw materials, be equipped with suitable auxiliary material and can be made into capsule, soft capsule, tablet or other oral formulations.
The preparation method of health food of the present invention may further comprise the steps:
1) with the pilose antler crushed after being dried, cross 80~200 mesh sieves, standby;
2) with the American Ginseng crushed after being dried, cross 80~200 mesh sieves, standby;
Perhaps: with American Ginseng 70-80% alcohol extract 2-4 time, each 1-4 hour, extracting liquid filtering, filtrate recycling ethanol concentrates, and drying under reduced pressure was pulverized the 80-200 mesh sieve to dry extract, and was standby;
3) Radix Astragali, Radix Angelicae Sinensis, the fruit of Chinese wolfberry and sealwort were soaked 1-3 hour, added hot reflux 2-4 time, and each 1-4 hour, to filter while hot, filtrate merges, and is evaporated to the medicinal extract that density is 1.2-1.3;
4) by 3) step gained medicinal extract adds the microcrystalline cellulose auxiliary material, mixing continues to be evaporated to dried, pulverizes, with 1) step and 2) step gained powder, 70-90% ethanol system particle, according to a conventional method compacting in flakes, the bag film-coating gets Film coated tablets.
Perhaps: by 3) the thick medicinal extract of step gained adds auxiliary materials such as microcrystalline cellulose, and mixing continues to be evaporated to dried, pulverizes, with 1) and 2) step gained powder, capsule made.
Perhaps: by 3) 80 ℃ of drying under reduced pressure of gained medicinal extract to water content less than 3%, add 1) gained powder and 2) gained American Ginseng extract powder, behind the mixing, add in the soybean oil-beeswax-soybean lecithin mixture of 40-60 ℃ of insulation, the weight ratio of soybean oil, beeswax, soybean lecithin is 5-30: 1: 0.05-0.3, the weight proportion of the medicinal powder behind the mixing and soybean oil-beeswax-soybean lecithin mixture is 1: 0.5-4, stir, ground 10-30 minute, cross 100~200 mesh sieves, 30-60 ℃ is pressed into soft capsule.
The present invention has the health care that strengthens immunity, improves memory, and to hypoimmunity, old degenerative illness such as failure of memory has prevention and supplemental treatment effect.Chinese medicine of the present invention truly has the effect that strengthens immunity and improve memory through clinical confirmation for many years.The inventor has also carried out toxicology test, function assessment test to capsule, and its result also confirms to have and strengthens immunity and improve memory impairments, and safe toxicological test confirmation this product is taken safety for a long time.Because for Chinese medicine preparation (being the integration of drinking and medicinal herbs medicine), action temperature and, side effect is little, can take for a long time, to hypoimmunity and failure of memory, prevention and treatment double action is arranged.
Below be the experimental data of function and effect:
One, capsule function assessment animal test results of the present invention
1. dosage
Everyone (by the 60kg batheroom scale) recommended intake every day is capsule 's content 5g (being equivalent to pilose antler 1g American Ginseng 1g Radix Astragali 10g Radix Angelicae Sinensis 2g fruit of Chinese wolfberry 2g sealwort 3g).Being converted into every day kg body weight dosage is 0.083g/kg.b.w, presses 5 times of human body recommended intakes, 10 times, 25 times designs basic, normal, high 3 dosage groups, i.e. 0.415,0.830,2.075 g/kg.b.w respectively.
2. enhancing immunity function
Test basis: carry out according to " health food check and assessment technique standard " (version in 2003).Experiment is with cleaning level ICR mouse.Get the healthy mice that body weight is 18~22g, random packet, 12 every group experimentize.
2.1 capsule is to mouse immune organ weight's influence
The continuous gastric infusion of each dosage group mouse 10 days, the 10th, 12 day intraperitoneal injection of cyclophosphamide (60mg/kg) respectively except that the normal control group continues to be administered to the 15 day, after the last administration 1 hour, wins and respectively organizes mouse thymus and spleen.Be thymus gland or spleen index with thymus gland or spleen weight (mg) with likening to of body weight (g), experimental result sees Table 1.
Table 1 capsule to mouse immune organ weight's influence (x ± SD, n=12)
Group |
Dosage (g/kg.b.w) |
Thymus index |
Spleen index |
Dosage group capsule in high dose group in Normal group Herb Gynostemmae Pentaphylli total glycosides tablet model group (endoxan) the capsule low dose group capsule |
NS 0.02 - 0.415 0.830 2.075 |
2.53±0.65 2.33±0.61 1.65±0.69
* 2.02±0.84 2.35±0.88 2.65±0.67
△△ |
3.82±0.96 3.64±0.63 2.89±0.62
* 3.03±0.49 3.56±0.94 3.76±0.77
△ |
Compare with control group,
*P<0.05,
*Compare with model group P<0.01,
△P<0.05,
△ △P<0.01 (as follows) is the result show, with model group relatively, the thymus index of the high agent group of capsule mouse is significantly increased (P<0.01), mouse spleen index also has and significantly improves (P<0.05).
2.2 the influence (mtt assay) that capsule transforms ConA inducing mouse SPL
Each dosage treated animal continuous irrigation stomach 30d presses mtt assay, gets spleen, carries out cell and cultivates, handles the back in 570nm wavelength place ELIASA mensuration optical density, the results are shown in Table 2.
The influence that table 2 capsule transforms ConA inducing mouse SPL (x ± SD, n=12)
Group |
Dosage (g.kg
-1.b.w)
|
Add ConA hole and the difference that does not add ConA hole absorbance |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
0.007±0.003 0.016±0.005
** 0.014±0.009
* 0.017±0.006
** 0.019±0.008
** |
2.3 capsule is to the influence of dinitrofluorobenzene (DNFB) inducing mouse delayed allergy
Each dosage treated animal continuous irrigation stomach 30d presses the ear swelling method, the weight of weighing auricle, and capsule sees Table 3 to the influence of DNFB inducing mouse delayed allergy.
Table 3 capsule to the influence of DNFB inducing mouse DTH (x ± SD, n=12)
Group |
Dosage (g.kg
-1.b.w)
|
Auricular concha weightening finish (mg) |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
6.5±3.0 11.3±4.1
** 7.5±1.5 9.6±2.6
** 11.5±3.6
** |
2.4 capsule is to the plain (HC that forms of mice serum HD50
50) influence
Each dosage treated animal continuous irrigation stomach 30d gets blood, and separation of serum is pressed the blood clotting method and observed the hemagglutination degree, and the calculating antibody product sees Table 4.
Table 4 capsule is to mice serum HD50 element (HC
50) form influence (x ± SD, n=12)
Group |
Dosage (g.kg
-1.b.w)
|
HC
50 |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
46±14 70±32
* 51±25 60±27
* 66±23
* |
2.5 the influence that the capsule antagonist generates
Each dosage treated animal continuous irrigation stomach 30d gets blood, with defiber sheep red blood cell (SRBC) immunity 5d, puts to death, and counting splenocyte hemolysis plaque number the results are shown in Table 5
Table 5 capsule to the influence of mouse haemolysis spot number (x ± SD, n=12)
Group |
Dosage (g.kg
-1.b.w)
|
Hemolysis plaque number (10
6Splenocyte)
|
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
136±40 190±46
* 159±51 176±57 202±43
* |
2.6 capsule is cleaned up the influence of effect to mouse carbon
Each dosage treated animal continuous irrigation stomach 30d, through intravenous injection dilution prepared Chinese ink, blood is got from intraocular corner of the eyes veniplex in the back, through 0.1mlNaCO
3After the dilution, measure OD value in 600nm.With blood concentration of carbon logarithm the time is mapped.Straight slope K represents with phagocytic index a calibrated back, the results are shown in Table 6.
Table 6 capsule to mouse carbon clean up effect influence (x ± SD, n=12)
Group |
Dosage (g/kg.b.w) |
Phagocytic index a |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
5.23±0.69 5.19±0.57 5.02±0.91 5.22±0.73 5.08±0.65 |
2.7 capsule is engulfed each dosage treated animal continuous irrigation stomach 30d of influence (half intracorporal method) of chicken red blood cell to Turnover of Mouse Peritoneal Macrophages, measures macrophage phagocytic function by half intracorporal method, the results are shown in Table 7.
Table 7 capsule to Turnover of Mouse Peritoneal Macrophages engulf the phagocytic rate of chicken red blood cell and the influence of phagocytic index (x ± SD, n=12)
Group |
Dosage (g/kg.b.w) |
Phagocytic rate |
Phagocytic index |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
25.4±5.9 26.5±7.5 26.2±4.9 27.1±6.3 28.5±5.7 |
0.33±0.09 0.34±0.10 0.31±0.07 0.34±0.05 0.36±0.11 |
2.8 capsule is to the influence (LDH method) of NK cytoactive
Each dosage treated animal continuous irrigation stomach 30d measures the NK cytoactive according to determination of lactate dehydrogenase method (LDH), the results are shown in Table 8.
Table 8 capsule to the influence of NK cytoactive (x ± SD, n=12)
Group |
Dosage (g/kg.b.w) |
NK cytoactive (%) |
Dosage group capsule in high dose group in the normal control group Herb Gynostemmae Pentaphylli total glycosides tablet capsule low dose group capsule |
NS 0.02 0.415 0.830 2.075 |
52.2±16.6 72.5±18.6
* 63.0±22.4 71.9±18.8
* 79.5±26.4
** |
According to above-mentioned preparation scheme, the capsule with Chinese traditional medicine composition of the present invention is prepared into confirms that through zoopery mouse immune power is had humidification.
3. improve the effect of memory
3.1 diving tower method
Irritate stomach with 30% ethanol and cause mouse memory reproduction obstacle, observe capsule of the present invention, the results are shown in Table 9 the influence that mouse memory reproduces obstacle.
Table 9 diving tower method is measured capsule reproduces obstacle to mouse memory influence
Group |
Dosage (g/kg.b.w) |
Errors number in 5 minutes (n) |
Diving tower test after 24 hours |
Incubation period (n) |
Mistake percentage (%) |
Dosage group capsule in high dose group in the normal control group capsule low dose group capsule |
NS 0.415 0.830 2.075 |
5.6±1.3 4.4±2.1 4.3±1.8
* 3.2±1.4
** |
94.5±29.4 123.8±37.1
* 146.1±44.0
** 153.8±48.7
** |
101.4±39.6 75.6±24.2
* 52.8±24.3
** 42.5±16.9
** |
By Biao Kede, give the basic, normal, high dosage group of medicine of the present invention, the school grade of mouse all presents raising in various degree, and wherein high dose group school grade and memory achievement are compared with model control group and significant difference are all arranged (P<0.001, P<0.05).Point out medicine of the present invention that certain nootropic effect is arranged.
3.2 darkness avoidance test
The results are shown in Table 10.
Table 10 darkness avoidance test is investigated the influence of capsule to mouse memory
Group |
Dosage (g/kg.b.w) |
Errors number in 5 minutes (n) |
Diving tower test after 24 hours |
Incubation period (n) |
Mistake percentage (%) |
Dosage group capsule in high dose group in the normal control group capsule low dose group capsule |
NS 0.415 0.830 2.075 |
6.8±2.3 5.4±2.0 4.3±1.6
* 3.5±1.4
** |
103.8±35.2 119.4±44.4 134.1±39.5
* 145.3±38.4
** |
102.5±42.7 68.9±28.9
* 55.6±22.1
** 32.5±14.8
** |
3.3 water maze test
The results are shown in Table 11,12.
Table 11 capsule to young rat/mouse labyrinth test effect relatively
Group |
Dosage (g/kg.b.w) |
Mistake percentage (%) |
Dosage group capsule in high dose group in the normal control group capsule low dose group capsule |
NS 0.415 0.830 2.075 |
22.0±4.5 17.4±4.7 16.2±3.4
* 15.3±2.9
* |
Table 12 capsule to adult mice maze test effect relatively
Group |
Dosage (g/kg.b.w) |
Mistake percentage (%) |
Dosage group capsule in high dose group in the normal control group capsule low dose group capsule |
NS 0.415 0.830 2.075 |
46.1±16.3 31.6±12.7
* 24.9±13.4
** 24.3±11.9
** |
Zoopery shows that this product is to effect blue or green, that adult mice all has obvious promotion learning and memory function.To sum up, capsule of the present invention has tangible effect to strengthening mouse immune power and improving memory.
Two, safe toxicological test
Test basis: carry out according to " health food check and assessment technique standard " (version in 2003).Experiment is with cleaning level Kunming mouse and cleaning level WISTAR rat.
1. 30 days feeding trials of rat
Assay and evaluation: the pellet that WISTAR kind healthy rat is contained 0.50%, 1.00%, 2.00% capsule every day, dosage is 2.075,4.150,8.300g/kg.b.w, be equivalent to 25,50,100 times of human body recommended amounts, test period totally 30 days, result of the test is:
1) the general physiology sign of rat, behavior, stool and urine, fur etc. are all no abnormal.
2) body weight and food utilization index are normal
3) the blood routine index is normal
4) biochemical indicator is no abnormal
5) each organ coefficient index is normal
6) inspection substantially of organs such as each rat heart, liver,spleen,kidney, small intestine, testis is no abnormal; The liver of control group and high dose group rat, kidney and the pathological observation result of small intestine are basic identical, do not see special pathological change.
2. its mouse oral acute toxicity test (LD
50)
Male, female mice per os LD50>30g/kg.b.w are tried thing capsule of the present invention and are belonged to nontoxic level material.
3. mouse bone marrow cells micronucleus test
1.50 the micronucleus result of~10.0g/kg.b.w dosage is negative, is tried thing capsule of the present invention body cell is not had mutagenesis.
4. mouse sperm deformity test
The spermatic aberration test result of 50~10.0g/kg.b.w dosage is negative, is tried thing capsule of the present invention reproduction cell is not had mutagenesis.
5.Ames test
8-5000 μ g/ ware is tried thing salmonella typhimurium strain TA97, TA98, TA1000, TA102 is carried out the plate infiltration test, no matter when adding and do not add the S9 mixed liquor, each dosage group does not cause that all the back mutation bacterium colony of test strain significantly increases, the Salmonella reversion test result is negative, is tried thing capsule of the present invention and does not have direct or indirect mutagenesis.
Above presentation of results, capsule of the present invention does not have obvious toxic and side effects.
Three, capsule is to strengthening body immunity and improving the clinical efficacy of remembering
1. research object
The young people who (contains 40 years old) below 40 years old more than 18 years, main suit are hypoimmunity, easy catching a cold, every month once or more than, or troubles respiratory tract infection in a year is more than twice.
The elderly more than 40 years old, failure of memory, hypoimmunity or multiple chronic disease.
2. method of administration
The adult, each 5, every day 2 times.
Above research object was a course of treatment with one month all, treated 1-3 the course of treatment.
3, observational technique:
Carry out blood, urine, just routine test and the heart, pulmonary function test, and observe: heating, aversion to cold, sniffle, pharyngeal symptom and whole body situation and the temperature of having a medical check-up, pharyngeal tonsils, tongue picture and resembling, therapeutic evaluation is carried out in variations such as fingerprint respectively.
4, therapeutic evaluation
Observe 319 routine patients altogether, 102 young people wherein, 217 the elderly, its clinical effectiveness sees Table 13:
The clinical observation on the therapeutic effect of table 13 capsule
Project |
The example number |
Obviously improve |
Improve |
Invalid |
Total improvement rate (%) |
Strengthen immunity and improve memory |
Young 102 |
57 48 |
32 35 |
13 19 |
88.2 81.4 |
Strengthen immunity and improve memory |
In old 217 years |
71 56 |
31 34 |
0 12 |
100 88.3 |
Side effect of the present invention: outside the period in a medicine small number of patients dry, all do not have any bad reaction, stop using or decrement the dry transference cure.
Clinical research shows, capsule of the present invention to the immunity that strengthens youth and person in middle and old age's human body body, to improve the memory effect obvious, toxic and side effect is little.
The specific embodiment
Embodiment 1
Get parts by weight of raw materials (kilogram): pilose antler 3, American Ginseng 3, the Radix Astragali 20, Radix Angelicae Sinensis 3, the fruit of Chinese wolfberry 3 and sealwort 5, and auxiliary material.
Preparation by the following method:
1) with pilose antler oven dry, pulverize, 100 mesh sieves (80-200 mesh sieve all can), the pilose antler powder;
2) American Ginseng is shone or oven dry, pulverizes, cross 100 mesh sieves (80-200 mesh sieve all can), ginseng powder;
3) Radix Astragali, Radix Angelicae Sinensis, sealwort, the fruit of Chinese wolfberry are added 8 times of water gagings and soaked 1 hour, added hot reflux 2 hours, add 6 times of water gagings again, added hot reflux 2 hours, filter while hot, filtrate merges, and concentrates, and 80 ℃ of drying under reduced pressure are to thick medicinal extract (density is about 1.3);
4) by 3) gained medicinal extract adding microcrystalline cellulose right amount of auxiliary materials (suitable) to viscosity, mixing continues to be evaporated to dried, pulverize, with 1) and 2) the gained powder, with 70-90%7 ethanol system particle, compacting is wrapped film-coating in flakes according to a conventional method, gets Film coated tablets.
Embodiment 2
Get parts by weight of raw materials (kilogram): pilose antler 3, American Ginseng 3, the Radix Astragali 30, Radix Angelicae Sinensis 6, the fruit of Chinese wolfberry 6, sealwort 9, and auxiliary material.
Preparation by the following method:
1) with pilose antler oven dry, pulverize, 100 mesh sieves (80-200 mesh sieve all can), the pilose antler powder;
2) with American Ginseng section, with 8 times of amount 70% alcohol immersion 1 hour, refluxing extraction 2 hours added 6 times of amount 70% alcohol refluxs extraction 2 times, each 1.5 hours again; Filter, filtrate merges, and reclaims ethanol, concentrates, and drying under reduced pressure is to dry extract, pulverizes 100 mesh sieves (80-200 mesh sieve all can), the American Ginseng extract powder;
3) this step is identical with embodiment 1;
4) the microcrystalline cellulose right amount of auxiliary materials being added 3) in the thick medicinal extract such as the step gained Radix Astragali, mixing continues to be evaporated to dry extract, 100 mesh sieves (80-200 mesh sieve all can) were pulverized in cooling, added 1) the pilose antler powder and 2 of step) the American Ginseng extract powder of step, mix, encapsulated, promptly.
Embodiment 3
Get parts by weight of raw materials (kilogram): pilose antler 4, American Ginseng 5, the Radix Astragali 60, Radix Angelicae Sinensis 9, the fruit of Chinese wolfberry 12 and sealwort 18, and auxiliary material.
Make soft capsule:
1) preparation of pilose antler powder, ginseng powder or thick medicinal extract such as the American Ginseng extract powder and the Radix Astragali is with above-mentioned embodiment.
2) 80 ℃ of thick medicinal extract such as the Radix Astragali are continued drying under reduced pressure to water content less than 3%, cooling, pulverized 100 mesh sieves (80-200 mesh sieve all can), add pilose antler powder and ginseng powder or American Ginseng extract powder, behind the mixing, again in the soybean oil-beeswax-soybean lecithin mixture auxiliary material (weight ratio of soybean oil, beeswax, soybean lecithin is 22: 1: 0.2) of 50 ℃ of insulations of weight portion such as adding proportioning, stir, grind 15 minutes (10-30 minute all can), 40 ℃ (30-60 ℃ all can) be pressed into soft capsule, promptly.
Above embodiment and experimental example just illustrate of the present invention, and purpose is to illustrate implementation method of the present invention, and those skilled in the art in conjunction with the various changes that the general knowledge of this area is done, will fall into the protection domain of invention according to enlightenment of the present invention.