CN102600212B - Medicinal health product for immunity enhancement and adjuvant treatment of tumor - Google Patents
Medicinal health product for immunity enhancement and adjuvant treatment of tumor Download PDFInfo
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Abstract
The invention discloses a medicinal health composition, which comprises (by weight parts) 10-300 parts of Ganoderma lucidum extract, 100-300 parts of green tea extract EGCG (epigallocatechin gallate), and 0.015-0.1 parts of trace element selenium. The composition may be added with pharmaceutically acceptable adjuvants, and formulated into hard capsule, soft capsule, tablet, granule, and oral liquid. The composition adopts Ganoderma lucidum as immunity two-way modulator, trace element selenium as immunity enhancer and green tea extract EGCG as antioxidant, to jointly enhance immunity and cancer preventing/resisting ability, and maintain harmonic immunity system.
Description
Technical field
The invention belongs to Medicines and Health Product field, be specifically related to a kind of compositions, its preparation method and application thereof that increases the Ganoderma class health care of immunity, adjuvant therapy of tumors.
Background technology
A global investigation of World Health Organization (WHO) shows, the people of true health only accounts for population 5%, and the people who suffers from disease accounts for 20%, and 75% people is in sub-health state.2004, the cancer mortality number in the whole world was 7,400,000, accounts for 13% of all death tolls.WHO estimates that this numeral will continue to increase, and the year two thousand thirty estimation will have 1,200 ten thousand people to die from cancer.The statistics of ministry of Health of China shows: the annual newly-increased tumor patient sum of China is about 212.7 ten thousand people left and right, wherein has every year the newly-increased malignant tumor patient of 1,060,000 left and right.Immune system is the natural cover for defense of human body self, can produce antitumor etc. and maintain organism physiology balance and stable immanoprotection action, and human immune system's harmony is the main cause of cancer spontaneous regression.Permanent immunity power lowly can cause the generation of cancer, and cancer patient is the people that immunity is very low without exception.
Ganoderma is Basidiomycetes Ganoderma fungus, the title that from ancient times just has " Herba mesonae chinensis ", " Ganoderma ". be the precious Chinese medicine of traditional Chinese medical science strengthening the body resistance, strengthening by means of tonics, in China, have long medicinal history, medical value is high, is regarded as precious Chinese crude drug. and be the treasure in pools of traditional Chinese medicine.The < of Eastern Han Dynasty Sheng Nong's herbal classic > classifies Ganoderma as top grade, thinks " food, makes light of one's life by commiting suicide not old for a long time, and angle prolongs life ".Modern medicine proves: Ganoderma platform has several physiological active substances. can regulate and strengthen body immunity.Current research shows, Ganoderma also has resisting fatigue, looks improving and the skin nourishing, slow down aging and prevents and treats the effects such as acquired immune deficiency syndrome (AIDS).The < < U.S. medical herbs pharmacopeia of U.S.'s publication in 2000 and treatment summary > > have recorded Ganoderma. and this book records l0 kind Chinese medicine or medical herbs so far altogether, and Ganoderma is one of them.
Tea, is the drink of the whole nation of the Chinese nation, its production and drink the history that has experienced several thousand, and the complicated component of Folium Camelliae sinensis, comprises the necessary nutritional labeling of human body and has the composition of health care drug action.Tea polyphenols is the main bioactive ingredients in Folium Camelliae sinensis.In tea polyphenols, the strongest active composition is epigallocatechin gallate (EGCG) ((-)-Epigallocacechin-3-gal-late, EGCG).In recent years, EGCG has been done to a large amount of research extensively and profoundly both at home and abroad, found that EGCG has biological activity widely, comprised the effects such as antitumor, mutation, antioxidation, anti-inflammation.In addition, the immunoregulation effect of EGCG is also more and more paid attention to, and is used for the treatment of the experimental animal model of various autoimmune disease and diseases associated with inflammation, has obtained good effect.
Selenium is one of necessary trace element of animal and human's body, participates in biological metabolism, conversion and the adjusting of body with the functional form of glutathion peroxidase, and as relevant in tumor, cardiovascular disease, Keshan disease etc. with various diseases.
About green tea extract EGCG, Ganoderma extract, the use in conjunction of trace element-selenium, in prior art, open situation is as follows: Chinese patent CN1194790 discloses a kind of tea for prolonging life, with green tea, the Folium Camelliae sinensis such as black tea are main, account for 60-80%, take the disease-resistant best Chinese herbal medicine of prolonging life as auxiliary as: Cordyceps, Ganoderma, Radix Ginseng, the Radix Astragali, Fructus Lycii, Hericium erinaceus (Bull. Ex Fr.) Pers. etc., account for 15-30%, with the disease-resistant best trace element of lengthening the life, as selenium, zinc, manganese, chromium etc. and be rich in product, account for 1-5%, disease-resistant specially good effect composition of prolonging life best is as monoterpene, DADS, polysaccharide etc. account for 1-5%.
It is main component that above-mentioned composition be take green tea, Ganoderma medical material, un-extracted, its complicated component, wherein active constituent content is uncertain, cause effect widely different, along with the development of Ganoderma extractive technique, green tea extractive technique, there are some improved technology in prior art.
Chinese patent CN101658537 discloses a kind of hypoglycemic ferment compound, contain 40～60% protein, and zinc content is 50～5000mg/kg, Se content is 0.5～1000mg/kg, chromium content is 0.5～1000mg/kg, this ferment compound may further include one or more in the group of selecting free following formation simultaneously: Fructus Momordicae charantiae or its extract, Radix Puerariae or its extract, Semen Ginkgo extrac, green tea extract, Radix Ginseng or its extract, Ganoderma or its extract, Ganoderma fermented product, Ganoderma spore powder, Rhizoma Polygonati or its extract, Rhizoma Dioscoreae or its extract, Semen Coicis or its extract, Herba bromi japonici, Radix Et Rhizoma Fagopyri Tatarici, vitamin C, vitamin E, Margarita powder, calcium and ferrum.
Above-mentioned composition using contain protein, trace element yeast as active component, said composition complicated component, simultaneously green tea extract, Ganoderma extract effective ingredient, content are uncertain, main effect is for to regulate blood glucose for diabetes patient.
In view of more than, in prior art, lack the health product that a kind of sub-health population for hypoimmunities such as tumor patients increases immunity, not only composition is simple for it, content is determined, and action effect is good.
Summary of the invention
The object of the present invention is to provide the compositions of a kind of enhancing immunity, adjuvant therapy of tumors.
Compositions provided by the invention is comprised of the component of following weight fraction: 100～300 parts of Ganoderma extracts, 100～300 parts of green tea extract EGCG, 0.015～0.1 part of trace element-selenium.
Preferably, 150～250 parts of Ganoderma extracts, 100～200 parts of green tea extract EGCG in described compositions, 0.03～0.07 part of trace element-selenium.
Preferred, 200 parts of Ganoderma extracts, 170 parts of green tea extract EGCG in described compositions, 0.06 part of trace element-selenium.
The ratio that Ganoderma extract of the present invention is 20:1 according to Ganoderma medical material and Ganoderma extract is extracted and is obtained, Ganoderma extract has 5:1,10:1,20:1,50:1,200:1 according to Ganoderma medical material and Ganoderma extract or the plurality of specifications such as certainly puies forward, the extract of all size all can be applied to compositions of the present invention, in order to guarantee function and the curative effect of this compositions, the ratio that Ganoderma extract of the present invention is 20:1 according to Ganoderma medical material and Ganoderma extract is extracted and is obtained, other specifications can carry out, after corresponding conversion, being applied to compositions of the present invention.
Preferably, the content of described green tea extract EGCG is more than or equal to 94%.
At least one form such as trace element-selenium of the present invention can selenocarrageenan, selenocysteine, sodium selenate, sodium selenite, selenomethionine, yeast rich in selenium adds.
The present composition adds the adjuvant of accepting on preparation process to can be made into capsule, tablet, granule, oral liquid, powder, medicinal tea, the oral formulations such as pill, wherein adjuvant pharmaceutically comprises: starch, soluble starch, Icing Sugar, sucrose, dextrin, lactose, amylum pregelatinisatum, microcrystalline Cellulose, mannitol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, gelatin, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, citric acid, magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, glycerol, fabaceous lecithin, egg phosphatide, liquid paraffin, Cera Flava, Semen Maydis oil, soybean phospholipid, Folium Camelliae sinensis powder, Mel, xylitol etc.
Another object of the present invention is to provide said composition increases immunity or the medicine of adjuvant therapy of tumors or the application in health product in preparation.
Compositions provided by the invention by Ganoderma as the two-ways regulation agent of immunologic function, trace element-selenium as immunologic function potentiator and green tea extract EGCG as antioxidant, jointly to improve body's immunity, strengthen cancer-resisting ability; In addition, Ganoderma has good adjusting blood pressure and blood sugar, hepatoprotective function, green tea extract EGCG be multi-medicament drug resistance inversion agent, can improve cancerous cell to the sensitivity of chemotherapy and alleviate the toxicity to heart.Full square tube is crossed three kinds of obvious functional factors and is formed, and from three aspect synergism enhancing human body immunity power, maintains the immune system of body harmony.
1) selenium can promote cells in vivo and natural killer cell activity obviously to strengthen, and is the reinforcing agent of immunologic function; Selenium has antioxidation, removes free radical and repairs biomembranous damage, prevents cell aberration, has anti-cancer and kill cancer action; Scarce selenium can cause human immunity, defence, and resistance against diseases declines, easy infection.Studies confirm that selenium is the strong inhibitor of the kinds cancers such as breast carcinoma, hepatocarcinoma, skin carcinoma, colon cancer and gastric cancer.
2) Ganoderma is treasured medical material as the China's tradition that has thousands of years medicinal histories, possesses very high medical value, modern pharmacology through scientific research institution's many decades studies confirm that, Ganoderma is for strengthening body immunity, regulate blood glucose, control blood pressure, auxiliary tumor chemoradiotherapy, hepatoprotective, the aspects such as hypnotic all have significant curative effect.Ganoderma is best immune function controlling agents and activator, and it can significantly improve the immunologic function of body, strengthens patient's self anti-cancer, anti-cancer ability.
3) epigallocatechin gallate (EGCG) (EGCG) is a kind of composition extracting from Chinese green tea, and it is the main activity of green tea and water-soluble components, has the title of " tea gold ".Because it has special stereochemical structure, EGCG has very strong antioxidant activity, aspect anticancer and cardiovascular disease, is taking on key player.In addition, it also, as the inversion agent of tumor multi-medicament drug resistance, can improve cancerous cell to the sensitivity of chemotherapy and alleviate the toxicity to heart.
The suitable crowd of product of the present invention: 1) two-ways regulation human immunologic function, is applicable to all groups; 2) chemotherapy tumor patient, hands postoperative patient, health invigorating, improves symptom; 3) Combined with Radiotherapy, chemotherapy comprehensive prophylaxis of tumours relapse and metastasis that heightens the effect of a treatment; 4) auxiliary tumor growth, the cancer-resisting of suppressing; 5) valetudinarian, the person of just recovering from a dangerous illness; 6) middle-aged and elderly people, prevention various diseases, slow down aging; 7) the auxiliary conditioning of the patients with chronic diseases such as cardiovascular disease, diabetes, chronic hepatitis, senile disease; 8) there is the tumor high-risk that tumor medical history need be prevented in family; 9) Long-term taking medicine crowd hepatoprotective, prevent chemical liver injury etc.
Product described in the present invention has following characteristics: 1) compatibility science: Ganoderma elite+tea gold+trace element organic selenium, science compatibility.2) clear and definite, the definite effect of composition: be rich in the various bioactivators such as triterpenes Ganodenic acid, ganoderan, EGCG, trace element-selenium, organic germanium, definite effect.3) natural, safely, have no side effect.
The specific embodiment
Below in conjunction with embodiment, the present invention is further elaborated, but these embodiment do not form any restriction to the present invention.
embodiment 1: soft capsule
Prescription: yeast rich in selenium 20g(trace element-selenium: 40mg), Ganoderma extract (Ganoderma medical material 20:1) 300g, green tea extract EGCG 100g
Adjuvant: Semen Maydis oil 800g, soybean phospholipid 250g, Cera Flava 30g.
Preparation method: take formula ratio Semen Maydis oil, add formula ratio soybean phospholipid, Cera Flava, be heated to whole dissolvings, placement cools to 50 ℃ of left and right, insulation continues 50 ℃ of left and right to stir yeast rich in selenium, Ganoderma extract, the green tea extract EGCG that adds formula ratio, grinds and beat to be circulated to evenly in the rearmounted colloid mill that stirs, and carries out pelleting (0.5g/ grain), soft gelatin capsule, through shaping, wash ball, drying, dry, pick, obtains soft capsule.
Instructions of taking: every day 3 times, each 1.
embodiment 2: capsule
Prescription: yeast rich in selenium 30g(trace element-selenium: 60mg), Ganoderma extract (Ganoderma medical material 20:1) 200g, green tea extract EGCG 170g
Adjuvant: microcrystalline Cellulose 590g, magnesium stearate 10g.
Preparation method: by above-mentioned composition xeraphium and microcrystalline Cellulose, be mixed evenly, take water as binding agent granule processed, dry, granulate, add magnesium stearate, mix, pack into and make 0.25g/ grain in capsulae vacuus.
Instructions of taking: every day 2 times, each 2.
embodiment 3: granule
Prescription: yeast rich in selenium 50g(trace element-selenium: 100mg), Ganoderma extract (Ganoderma medical material 20:1) 300g, green tea extract EGCG 300g
Adjuvant: soluble starch 400g, Icing Sugar 450g.
Preparation method: get above-mentioned composition spray drying powder, mix homogeneously, adds the adjuvants such as soluble starch, Icing Sugar, mixes evenly, take water as binding agent granule processed, dry, granulate, obtains granule, is packaged as 1.5g/ bag.
Instructions of taking: every day 1 time, each 1 bag.
embodiment 4: tablet
Prescription: yeast rich in selenium 7.5g(trace element-selenium: 15mg), Ganoderma extract (Ganoderma medical material 20:1) 100g, green tea extract EGCG 100g
Adjuvant: dextrin 280g, carboxymethyl starch sodium 7.5g, magnesium stearate 5g.
Preparation method: above-mentioned composition is pulverized, is sieved, add dextrin, carboxymethyl starch sodium, mix evenly, take hydroxyl 50% ethanol as binding agent granule processed, be dried, granulate, add magnesium stearate, mix homogeneously, tabletting, make 0.5g/ sheet, obtains tablet.
Instructions of taking: every day 1 time, each 1.
embodiment 5: tablet
Prescription: selenocarrageenan 1.5g(trace element-selenium: 15mg), Ganoderma extract (Ganoderma medical material 10:1) 200g, green tea extract EGCG 300g
Adjuvant: microcrystalline Cellulose 170g, lactose 200g, carboxymethyl starch sodium 16.5g, magnesium stearate 12g.
Preparation method: above-mentioned composition is pulverized, sieved, add the adjuvants such as microcrystalline Cellulose, lactose, carboxymethyl starch sodium, magnesium stearate, mix evenly, direct powder compression, makes 0.45g/ sheet, obtains tablet.
Instructions of taking: every day 1 time, each 2 or every day 2 times, each 1.
embodiment 6: oral liquid
Prescription: yeast rich in selenium 50g(trace element-selenium: 100mg), Ganoderma extract (Ganoderma medical material 50:1) 80g, green tea extract EGCG 170g,
Adjuvant: Mel 600g, xylitol 120g, water are appropriate.
Preparation method: by above-mentioned composition, join while stirring in 5000ml water, be heated to dissolve, filter, water complements to 10000ml, sterilizing, fill becomes 10ml/ to prop up, and obtains oral liquid.
Instructions of taking: every day 1 time, each 1.
embodiment 7: capsule
Prescription: sodium selenite 0.16g(trace element-selenium: 70mg), Ganoderma extract (Ganoderma medical material 20:1) 150g, green tea extract EGCG 200g
Adjuvant: microcrystalline Cellulose 620g, magnesium stearate 10g.
Preparation method: by above-mentioned composition xeraphium and microcrystalline Cellulose, be mixed evenly, take water as binding agent granule processed, dry, granulate, add magnesium stearate, mix, pack into and make 0.25g/ grain in capsulae vacuus.
Instructions of taking: every day 2 times, each 2.
embodiment 8: capsule
Prescription: selenomethionine 0.075g(trace element-selenium: 30mg), Ganoderma extract (Ganoderma medical material 20:1) 250g, green tea extract EGCG 100g
Adjuvant: microcrystalline Cellulose 640g, magnesium stearate 10g.
Preparation method: by above-mentioned composition xeraphium and microcrystalline Cellulose, be mixed evenly, take water as binding agent granule processed, dry, granulate, add magnesium stearate, mix, pack into and make 0.25g/ grain in capsulae vacuus.
Instructions of taking: every day 2 times, each 2.
embodiment 9: capsule
Prescription: selenocysteine 0.15g(trace element-selenium: 67mg), Ganoderma extract (Ganoderma medical material 20:1) 200g, green tea extract EGCG 170g
Adjuvant: microcrystalline Cellulose 620g, magnesium stearate 10g.
Preparation method: by above-mentioned composition xeraphium and microcrystalline Cellulose, be mixed evenly, take water as binding agent granule processed, dry, granulate, add magnesium stearate, mix, pack into and make 0.25g/ grain in capsulae vacuus.
Instructions of taking: every day 2 times, each 2.
Meanwhile, the present invention, by setting up animal model, has carried out toxicological experiment and has cured mainly relevant Pharmacodynamic test of active extract with function.
embodiment 10: toxicological test
Test objective: whether check product has toxicity
The capsule that test material: embodiment 2 makes
Sample: the oral recommended amounts of human body is 0.25g/ grain, every day 2 times, each 2.Become body weight for humans to press 60kg and calculate, amount to dosage 0.017g/kgbw.Getting capsule 's content tests
Laboratory animal: clean level Kunming mouse, SD rat and feedstuff
Experimental situation condition: temperature 22-24 ℃, humidity 52-58 ℃.
Test method:
Acute toxicity test in mice (get the capsule 25g that embodiment 2 makes, adding distil water is to 50mL, gets interval in this liquid one day and amounts to gavage 2 times to its mouse oral gavage in 4 hours, and each gavage volume is 0.2mL/10gbw, and cumulative measurement is 20.0g/kgbw)
Salmonella reversion test (is got the capsule 1.25g that embodiment 2 makes, adding distil water 25mL, be the dosage of 5000 μ g/ wares, five dosage are established in test, be respectively 5000 μ g/ wares, 1000 μ g/ wares, 200 μ g/ wares, 40 μ g/ wares, 8 μ g/ wares, add strain culturing, establish from beaming back change, solvent control and the contrast of positive mutagens simultaneously)
PCEMNR micronucleus test is (with the positive contrast of cyclophosphamide of 40mg/ kgbw dosage, the negative contrast of distilled water, 3 dosage of test group are respectively 10.0g/ kgbw, 5.0g/ kgbw, 2.5g/ kgbw, get capsule 50.0g, 25.0g that embodiment 2 makes, 12.5g adding distil water to 100mL, be made into the test solution that is subject to of corresponding dosage, give its mouse oral gavage, gavage volume is 0.2mL/10gbw)
Mouse sperm deformity test is (with the positive contrast of cyclophosphamide of 40mg/ kgbw dosage, the negative contrast of distilled water, 3 dosage of test group are respectively 10.0g/ kgbw, 5.0g/ kgbw, 2.5g/ kgbw, get capsule 50.0g, 25.0g that embodiment 2 makes, 12.5g adding distil water to 100mL, be made into the test solution that is subject to of corresponding dosage, give its mouse oral gavage, gavage volume is 0.2mL/10gbw)
30 days feeding trials (are got capsule 4.2 g, 8.3g, the 17.0 g adding distil waters that embodiment 2 makes and are settled to 100mL, 3 dosage of test group are respectively 0.42 g/ kgbw, 0.83 g/ kgbw, 1.70 g/ kgbw, matched group is given and equal-volume distilled water, every day to rat oral gavage once, continuous 30 days).
Result of the test:
1, anxious poisons mouth toxicity test result:
Maximum tolerated dose (MTD) female, male mice in kunming is all greater than to 20.0 g/ kgbw, belongs to nontoxic level;
2, three genetic toxicity test results:
Three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test) result is all negative;
3,30 days feeding trial results:
With 0.42g/ kgbw, 0.83 g/ kgbw, 1.70 g/ kgbw dosage (be equivalent to human body recommended dose 25,50,100 times) to rat oral gavage 30 days, duration of test, animal growth is good, each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, internal organs weight in wet base and internal organs/body weight ratio and matched group comparison, no significant difference (P>0.05).Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking.
embodiment 11: function test
Test objective: whether check product has the function of this enhancing immunity
Test material:
The capsule that sample: embodiment 2 makes, the oral recommended amounts of human body is 0.25g/ grain, every day 2 times, each 2.Become body weight for humans to press 60kg and calculate, amount to dosage 0.017g/kgbw.Getting capsule 's content tests
Experimental animal: 200 of clean level Kunming kind female mices, body weight is 18-22g
Experimental enviroment condition: barrier system.Temperature 22-24 ℃, humidity 52-58%
Dosage is selected and sample treatment: establish the basic, normal, high dosage of capsule that embodiment 2 makes and be respectively 0.08g/kgbw, 0.17g/kgbw, 0.50g/kgbw(and be equivalent to respectively 5,10,30 times of human body recommended dose).Basic, normal, high dosage is subject to test solution when configuration, gets respectively capsule 0.8g, 1.7g, 5.0g adding distil water is settled to 200mL, and matched group gives isopyknic distilled water, give respectively animal subject gavage, every day gavage once, gavage volume is 0.2mL/kgbw, continuous 30 days
Key instrument and reagent: animal platform balance, analytical balance, clean bench, CO2 gas incubator, autoclave, filter, centrifuge, 722 spectrophotometers, constant water bath box, microplate reader, microscope etc.
Test method: clean up experiment, Turnover of Mouse Peritoneal Macrophages by mouse lymphocyte transformation experiment, antibody-producting cell detections, the mensuration of half hemolysis value, the mice carbon of internal organs/weight ratio pH-value determination pH, delayed allergy, ConA induction and engulf that chicken red blood cell is tested, the determination experiment of NK cytoactive carries out assessment of function.
Result of the test:
Per os gives the capsule 30 days that the embodiment 2 of mice 0.08 g/kgbw, 0.17 g/kgbw, 0.50 g/kgbw dosage makes, 0.17 g/kgbw, 0.50 g/kgbw dosage can strengthen mice delayed allergy, improve the antibody-producting cell number of mice, improve the NK cytoactive of mice, 0.50 g/kgbw dosage can improve ability, raising mouse lymphocyte conversion capability, the raising mice serum half hemolysis value that mouse monokaryon-macrophage carbon is cleaned up, P<0.05.Ability on weight of mice, spleen/body weight ratio, thymus/body weight ratio, macrophage phagocytic chicken red blood cell has no obvious impact (P>0.05).Under this experiment condition, point out this sample to there is the function of enhancing immunity.
Concrete result of the test data see the following form:
The impact of the capsule that table 1: embodiment 2 makes on mice delayed allergy (DTH)
As shown in Table 1, per os gives the capsule 30 days of mice various dose, and middle and high dosage group swelling degree of the paw is apparently higher than matched group, and difference has significance (P<0.05).
The impact of the capsule that table 2: embodiment 2 makes on the mouse lymphocyte conversion capability experiment of mice ConA induction
As shown in Table 2, per os gives the capsule 30 days of mice various dose, and high dose group mouse lymphocyte conversion capability is apparently higher than matched group, and difference has significance (P<0.05).
The impact of the capsule that table 3: embodiment 2 makes on mouse antibodies cellulation number
As shown in Table 3, per os gives the capsule 30 days of mice various dose, and middle and high dosage group antibody-producting cell number is apparently higher than matched group, and difference has significance (P<0.05).
The capsule that table 4: embodiment 2 makes is to mice half hemolysis value (HC
50) impact
As shown in Table 4, per os gives the capsule 30 days of mice various dose, and high dose group mice half hemolysis value is apparently higher than matched group, and difference has significance (P<0.05).
The impact that the capsule that table 5: embodiment 2 makes is cleaned up mouse monokaryon-macrophage carbon
As shown in Table 5, per os gives the capsule 30 days of mice various dose, and high dose group mice phagocytic index is apparently higher than matched group, and difference has significance (P<0.05).
The impact of the capsule that table 6: embodiment 2 makes on NK cells in mice activity
As shown in Table 6, per os gives the capsule 30 days of mice various dose, and middle and high dosage group NK cells in mice activity is apparently higher than matched group, and difference has significance (P<0.05).
embodiment 12: function test
Test objective: whether check product has the function of auxiliary inhibition tumor growth
Test material:
The capsule that sample: embodiment 2 makes, the oral recommended amounts of human body is 0.25g/ grain, every day 2 times, each 2.Become body weight for humans to press 60kg and calculate, amount to dosage 0.017g/kgbw.Getting capsule 's content tests
[0067]experimental animal: 100 of clean level Male Kunming strain mice, body weight is 18-22g
Experimental enviroment condition: barrier system.Temperature 22-24 ℃, humidity 52-58%
Key instrument: animal platform balance, analytical balance, clean bench, CO2 gas incubator, autoclave, centrifuge, microscope etc.
Test method: by H22 tumor cell suspension (1 * 10
5) to be inoculated in animal forelimb axillary fossa subcutaneous, 0.2ml/ only, inoculates 70 altogether.After 24h, weigh and be divided at random 7 groups: negative control group (giving isopyknic distilled water), model group (giving isopyknic distilled water), be subject to reagent group (capsule 0.08 g/kgbw, 0.50g/kgbw that embodiment 2 makes), be subject to reagent (capsule 0.08 g/kgbw, 0.50g/kgbw that embodiment 2 makes) to add cyclophosphamide (CY, 0.03g/kgbw) and positive control (CY, 0.03g/kgbw) group, every group 10, administration after grouping, be subject to reagent gavage, once a day, continuous 10 days, positive drug lumbar injection, every other day administration.Observe every day and respectively organize mice general state.After drug withdrawal, each treated animal is weighed next day, puts to death mice and also peels off tumor piece, weighs and calculates tumour inhibiting rate.
Result of the test:
After inoculated tumour, model group, positive controls mice animal activity number of times obviously reduce, cutis laxa, and hair is holded up, and state is poor.Be subject to merely reagent group and Irradiation Combined with Cyclophosphamide group mice movable normal, fur is smooth, and body weight increases.Positive control drug group can significantly suppress tumor growth, but the weight of animals increase slowly, and state is poor.And the only use of tested prescription just has the effect that suppresses H22 tumor growth, tumor control rate is 29.6%; Share rear effect with chemotherapeutic cyclophosphamide and strengthen, tumor control rate is 64.8%, and cyclophosphamide is 59.8% to the suppression ratio of H22 tumor.Simultaneously; this sample can also increase the Thymus and spleen index of tumor-bearing mice, promotes weight of mice, and more all there were significant differences with tumor matched group and cyclophosphamide group; point out this sample to have protective effect to the immune organ of chemotherapy tumor-bearing mice, the effect of share efficacy enhancing and toxicity reducing with chemotherapeutic.Under this experiment condition, point out this sample to there is the auxiliary function that suppresses tumor growth.
Concrete result of the test data see the following form:
The inhibitory action of the capsule that table 7: embodiment 2 makes to mice H22 tumor
Note: compare * < 0.05 with tumor matched group, * * < 0.01; Compare △ < 0.05, △ △ < 0.01 with cyclophosphamide group
Claims (2)
1. a capsule with health care, described capsule consists of the following composition according to parts by weight meter:
200 parts of Ganoderma extracts
170 parts of green tea extract EGCG
0.06 part of trace element-selenium
590 parts of microcrystalline Cellulose
10 parts of magnesium stearate;
Wherein, the ratio that described Ganoderma extract is 20:1 according to Ganoderma medical material and Ganoderma extract is extracted and is obtained;
Wherein, content >=94% of described green tea extract EGCG;
Wherein, described trace element-selenium adds with the form of yeast rich in selenium, and in yeast rich in selenium, the content of trace element-selenium is 2mg selenium/g yeast rich in selenium;
Wherein, described capsule is prepared from by following steps:
1. take Ganoderma extract, green tea extract, yeast rich in selenium, the microcrystalline Cellulose of recipe quantity, mix homogeneously, take water as binding agent granulation;
2. dry, granulate
3. the magnesium stearate that adds recipe quantity, mixes,
4. capsule-filling, obtains capsule.
2. capsule as claimed in claim 1 increases immunity or the medicine of adjuvant therapy of tumors or the application in health product in preparation.
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| CN201210091365.0A CN102600212B (en) | 2012-03-31 | 2012-03-31 | Medicinal health product for immunity enhancement and adjuvant treatment of tumor |
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| CN106617031A (en) * | 2016-12-26 | 2017-05-10 | 南京糖防生物科技有限公司 | Immunomodulatory Chinese river deer milk composition and preparation method thereof |
| CN107753514A (en) * | 2017-11-23 | 2018-03-06 | 铜陵市东方矿冶机械有限责任公司 | Liquid paraffin breast and preparation method thereof |
| CN113197916B (en) * | 2021-04-28 | 2022-05-10 | 武汉轻工大学 | Nano-selenium composite gel, preparation method thereof and selenium supplement |
| CN113171380A (en) * | 2021-04-30 | 2021-07-27 | 浙江育康清生物医药有限公司 | Traditional Chinese medicine composition and application thereof |
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