CN102600212A - 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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- CN102600212A CN102600212A CN2012100913650A CN201210091365A CN102600212A CN 102600212 A CN102600212 A CN 102600212A CN 2012100913650 A CN2012100913650 A CN 2012100913650A CN 201210091365 A CN201210091365 A CN 201210091365A CN 102600212 A CN102600212 A CN 102600212A
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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 the 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 that 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 about 212.7 ten thousand people, and the newly-increased malignant tumor patient about 1,060,000 is wherein arranged every year.Immune system is the natural cover for defense of human body self, can produce antitumor etc. and keep 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 the cancer patient is the very low people of immunity without exception.
Ganoderma is a Basidiomycetes Ganoderma fungus; The title that " Herba mesonae chinensis ", " Ganoderma " are just arranged from ancient times. be the precious Chinese medicine of traditional Chinese medical science strengthening the body resistance, strengthening by means of tonics; In China long medicinal history is arranged, medical value is high, is regarded as precious Chinese crude drug. and be the treasure in the pools of traditional Chinese medicine.The Eastern Han Dynasty < Sheng Nong's herbal classic>classifies Ganoderma as top grade, thinks " eat for a long time, it is not old to make light of one's life by commiting suicide, and the angle prolongs life ".Modern medicine proves: the Ganoderma platform has several physiological active substances. can regulate and enhancing human immune.Current research shows that Ganoderma also has resisting fatigue, looks improving and the skin nourishing, slow down aging and prevents and treats effects such as AIDS." U.S.'s medical herbs pharmacopeia and treatment summary " of U.S.'s publication in 2000 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 and experienced history in several thousand, and the complicated component of Folium Camelliae sinensis comprises necessary nutritional labeling of human body and the composition with health care drug action.Tea polyphenols is the main bioactive ingredients in the Folium Camelliae sinensis.In the tea polyphenols the strongest active composition be epigallocatechin gallate (EGCG) ((-)-Epigallocacechin-3-gal-late, EGCG).In recent years, EGCG is done a large amount of researchs extensively and profoundly both at home and abroad, found that EGCG has wide biological activity, comprised effects such as antitumor, mutation, antioxidation, anti-inflammation.In addition, the immunoregulation effect of EGCG also more and more obtains paying attention to, and is used to treat the experimental animal model of various autoimmune property disease and diseases associated with inflammation, has obtained good effect.
Selenium is one of animal and human's body trace elements necessary, participates in biological metabolism, conversion and the adjusting of body with the functional form of glutathion peroxidase, and relevant with multiple disease such as tumor, cardiovascular disease, Keshan disease etc.
About green tea extract EGCG, Ganoderma extract, the selenic Combined application of trace element; Open situation is following in the prior art: Chinese patent CN1194790 discloses a kind of tea for prolonging life, is main with Folium Camelliae sinensis such as green tea, black tea, accounts for 60-80%; With the disease-resistant best Chinese herbal medicine of prolonging life be auxilliary 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, like selenium, zinc, manganese, chromium etc. and be rich in article; Account for 1-5%, specially good effect composition of the disease-resistant the best of prolonging life such as monoterpene, DADS, polysaccharide etc. account for 1-5%.
Above-mentioned composition is a main component with green tea, Ganoderma medical material, un-extracted, its complicated component; Wherein active constituent content is uncertain; Cause effect widely different, along with the continuous development of Ganoderma extractive technique, green tea extractive technique, some improved technology have appearred 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 and is selected from by in the following group that constitutes one or more 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 with the yeast that contains protein, trace element as active component, the said composition complicated component, green tea extract, Ganoderma extract effective ingredient, content are uncertain simultaneously, main effect is for to diabetes patient's blood sugar regulation.
Seeing that more than, lacking a kind of health product that are directed against the sub-health population increase immunity of hypoimmunities such as tumor patient in the prior art, not only composition is simple for it, and content is confirmed, 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 made up 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 the 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 the described compositions, 0.06 part of trace element-selenium.
Ganoderma extract of the present invention is that the ratio of 20:1 is extracted and to be obtained according to Ganoderma medical material and Ganoderma extract; Ganoderma extract has 5:1,10:1,20:1,50:1,200:1 according to Ganoderma medical material and Ganoderma extract or plurality of specifications such as puies forward certainly; The extract of all size all can be applied to compositions of the present invention; For function and the curative effect that guarantees this compositions; Ganoderma extract of the present invention is that the ratio of 20:1 is extracted and to be obtained according to Ganoderma medical material and Ganoderma extract, and other specifications are applied to compositions of the present invention after can carrying out corresponding conversion.
Preferably, the content of described green tea extract EGCG is more than or equal to 94%.
At least a forms such as trace element-selenium of the present invention can selenocarrageenan, selenocysteine, sodium selenate, sodium selenite, selenomethionine, yeast rich in selenium add.
The present composition adds the adjuvant of accepting on the preparation process and can be made into capsule, tablet, granule, oral liquid; Oral formulations such as powder, medicinal tea, pill, wherein pharmaceutically adjuvant 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 provides said composition increases immunity or the medicine of adjuvant therapy of tumors or the application in the health product in preparation.
Compositions provided by the invention through Ganoderma as the two-ways regulation agent of immunologic function, trace element-selenium as immunologic function potentiator and green tea extract EGCG as antioxidant, with common human body immunity improving function, strengthen the cancer-resisting ability; In addition, Ganoderma has good blood pressure regulation blood glucose, hepatoprotective function, green tea extract EGCG be multiple drug resistance inversion agent, can improve cancerous cell to the sensitivity of chemotherapy and alleviate toxicity to heart.Full square tube is crossed three kinds of tangible functional factors compositions, from three aspect synergism enhancing human body immunity power, keeps the harmonious immune system of body.
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 the cell distortion, and anti-cancer and kill cancer action is arranged; Scarce selenium can cause human immunity, defence, and resistance against diseases descends, easy infection.Research confirms that selenium is the strong inhibitor of multiple cancers such as breast carcinoma, hepatocarcinoma, skin carcinoma, colon cancer and gastric cancer.
2) Ganoderma is treasured medical material as the Chinese tradition that has thousands of years medicinal histories, possesses very high medical value, through the modern pharmacology research confirmation of scientific research institution's many decades; Ganoderma is for enhancing human immune; Blood sugar regulation, controlling blood pressure, auxiliary tumor chemoradiotherapy; Hepatoprotective, aspects such as hypnotic all have significant curative effect.Ganoderma is best immune function controlling agents and activator, and it can significantly improve body's immunological function, strengthens patient's self anti-cancer, anti-cancer ability.
3) epigallocatechin gallate (EGCG) (EGCG) is a kind of composition that from Chinese green tea, extracts, and it is main activity of green tea and water-soluble components, and the title of " tea gold " is arranged.Because it has special stereochemical structure, EGCG has very strong antioxidant activity, is taking on the key player aspect anticancer and the cardiovascular disease.In addition, it is also as the inversion agent of the multiple drug resistance of tumor, can improve cancerous cell to the sensitivity of chemotherapy and alleviate the toxicity to heart.
The suitable crowd of product according to the invention: 1) two-ways regulation human immunologic function is fit to all groups; 2) chemotherapy tumor patient, operation back 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) chronic disease patients' such as cardiovascular disease, diabetes, chronic hepatitis, senile disease auxiliary conditioning; 8) there is the tumor high-risk group that the tumor medical history need be prevented in family; 9) take medicine for a long time crowd's 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 multiple bioactive substances 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 done further elaboration, but these embodiment do not constitute 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.
Method for preparing: take by weighing the formula ratio Semen Maydis oil, add formula ratio soybean phospholipid, Cera Flava, be heated to whole dissolvings; Placement cools to about 50 ℃; Insulation continues to stir yeast rich in selenium, Ganoderma extract, the green tea extract EGCG that adds formula ratio about 50 ℃, grinds in the rearmounted colloid mill that stirs and beat to be circulated to evenly, carries out pelleting (0.5g/ grain); Soft gelatin capsule gets soft capsule through finalizing the design, wash ball, drying, dry, pick.
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.
Method for preparing: above-mentioned composition xeraphium and microcrystalline Cellulose is evenly mixed, be binding agent system granule, drying, granulate with water, add magnesium stearate, mixing is processed the 0.25g/ grain in the capsulae vacuus of packing into.
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.
Method for preparing: get the above-mentioned composition spray drying powder, mix homogeneously adds adjuvants such as soluble starch, Icing Sugar, and mixing is even, is binding agent system granule, drying, granulate with water, obtains granule, is packaged as the 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.
Method for preparing: above-mentioned composition is pulverized, sieved, add dextrin, carboxymethyl starch sodium, mixing is even, is binding agent system granule, drying, granulate, adding magnesium stearate with hydroxyl 50% ethanol, and mix homogeneously, tabletting are processed the 0.5g/ sheet, obtain 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.
Method for preparing: above-mentioned composition is pulverized, sieved, add adjuvants such as microcrystalline Cellulose, lactose, carboxymethyl starch sodium, magnesium stearate, mixing is even, and direct powder compression is processed the 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 an amount of.
Method for preparing: with above-mentioned composition, join while stirring in the 5000ml water, be heated to dissolving, filter, water complements to 10000ml, sterilization, and 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.
Method for preparing: above-mentioned composition xeraphium and microcrystalline Cellulose is evenly mixed, be binding agent system granule, drying, granulate with water, add magnesium stearate, mixing is processed the 0.25g/ grain in the capsulae vacuus of packing into.
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.
Method for preparing: above-mentioned composition xeraphium and microcrystalline Cellulose is evenly mixed, be binding agent system granule, drying, granulate with water, add magnesium stearate, mixing is processed the 0.25g/ grain in the capsulae vacuus of packing into.
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.
Method for preparing: above-mentioned composition xeraphium and microcrystalline Cellulose is evenly mixed, be binding agent system granule, drying, granulate with water, add magnesium stearate, mixing is processed the 0.25g/ grain in the capsulae vacuus of packing into.
Instructions of taking: every day 2 times, each 2.
Simultaneously, the present invention has carried out toxicological experiment and has cured mainly relevant Pharmacodynamic test of active extract with function through setting up animal model.
Embodiment 10: toxicological test
Test objective: whether the check product has toxicity
The capsule that test material: embodiment 2 makes
Sample: the oral recommended amounts of human body is the 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 makes an experiment
Laboratory animal: cleaning 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 in this liquid one day at interval and to irritate stomach to its mouse oral in 4 hours, irritates stomach altogether 2 times, irritates at every turn that body of stomach is long-pending to be 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, are 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 simultaneously) from beaming back change, solvent control and the contrast of positive mutagens
The 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 that embodiment 2 makes, 25.0g, 12.5g adding distil water to 100mL, are made into the test solution that receives of corresponding dosage; Irritate stomach to its mouse oral, irritate the long-pending 0.2mL/10gbw of being of body of stomach)
The 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 that embodiment 2 makes, 25.0g, 12.5g adding distil water to 100mL, are made into the test solution that receives of corresponding dosage; Irritate stomach to its mouse oral, irritate the long-pending 0.2mL/10gbw of being of body of stomach)
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 the equal-volume distilled water; Irritate stomach once to rat oral every day, continuous 30 days).
Result of the test:
1, anxious poisons mouth toxicity test result:
The maximum tolerated dose (MTD) of female, male mice in kunming all greater than 20.0 g/ kgbw, is belonged to nontoxic level;
2, three genetic toxicity test results:
The result is all negative for three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test);
3,30 days feeding trial results:
Give rat oral gavage 30 days with 0.42g/ kgbw, 0.83 g/ kgbw, 1.70 g/ kgbw dosage (be equivalent to human body RD 25,50,100 times); Duration of test; Animal growth is good; Each dose groups 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 compare, no significant difference (P>0.05).Gross anatomy is not seen the abnormal change relevant with sample with tissue pathology checking.
Embodiment 11: function test
Test objective: whether the 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 the 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 makes an experiment
Experimental animal: 200 of cleaning 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 (be equivalent to respectively human body RD 5,10,30 times).Basic, normal, high dosage receives test solution when configuration, gets capsule 0.8g, 1.7g, 5.0g adding distil water respectively and is settled to 200mL, and matched group is given isopyknic distilled water; Give animal subject respectively and irritate stomach; Irritate stomach every day once, irritate the long-pending 0.2mL/kgbw of being of body of stomach, 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, ELIASA, microscope etc.
Test method: clean up the determination experiment that experiment, Turnover of Mouse Peritoneal Macrophages engulf chicken red blood cell experiment, NK cytoactive through internal organs/weight ratio pH-value determination pH, delayed allergy, the inductive mouse lymphocyte transformation experiment of ConA, antibody-producting cell detection, the mensuration of half hemolysis value, mice carbon and carry 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 the 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, raising mice serum half hemolysis value that mouse monokaryon-macrophage carbon is cleaned up, P < 0.05.The ability of weight of mice, spleen/body weight ratio, thymus/body weight ratio, macrophage phagocytic chicken red blood cell is not seen obvious influence (P>0.05).Under this experiment condition, point out this sample to have the function of enhancing immunity.
Concrete result of the test data see the following form:
The capsule that table 1: embodiment 2 makes is to the influence of mice delayed allergy (DTH)
Can be known that by table 1 per os gives the capsule 30 days of mice various dose, middle and high dose groups swelling degree of the paw is apparently higher than matched group, and difference has significance (P < 0.05).
The capsule that table 2: embodiment 2 makes is to the influence of the inductive mouse lymphocyte conversion capability experiment of mice ConA
Can be known that by table 2 per os gives the capsule 30 days of mice various dose, high dose group mouse lymphocyte conversion capability is apparently higher than matched group, and difference has significance (P < 0.05).
The capsule that table 3: embodiment 2 makes is to the influence of mouse antibodies cellulation number
Can be known that by table 3 per os gives the capsule 30 days of mice various dose, middle and high dose groups 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) influence
Can be known that by table 4 per os gives the capsule 30 days of mice various dose, high dose group mice half hemolysis value is apparently higher than matched group, and difference has significance (P < 0.05).
The capsule that table 5: embodiment 2 makes is to influence that mouse monokaryon-macrophage carbon is cleaned up
Can be known that by table 5 per os gives the capsule 30 days of mice various dose, high dose group mice phagocytic index is apparently higher than matched group, and difference has significance (P < 0.05).
The capsule that table 6: embodiment 2 makes is to the active influence of NK cells in mice
Can be known that by table 6 per os gives the capsule 30 days of mice various dose, middle and high dose groups 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 the check product has the auxilliary function that suppresses tumor growth
Test material:
The capsule that sample: embodiment 2 makes, the oral recommended amounts of human body is the 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 makes an experiment
[0067]Experimental animal: 100 of cleaning 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: with H22 tumor cell suspension (1 * 10
5) to be inoculated in animal forelimb axillary fossa subcutaneous, 0.2ml/ only inoculates 70 altogether.Weigh behind the 24h and be divided into 7 groups at random: negative control group (giving isopyknic distilled water), model group (giving isopyknic distilled water), receive reagent group (capsule 0.08 g/kgbw, 0.50g/kgbw that embodiment 2 makes), receive 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, 10 every group; Administration after dividing into groups; Receive reagent to irritate stomach, once a day, continuous 10 days; Positive drug lumbar injection, administration every other day.Observe every day and respectively organize the mice general state.Each treated animal is weighed next day after the drug withdrawal, puts to death mice and also peels off the tumor piece, weighs and calculates tumour inhibiting rate.
Result of the test:
Behind the inoculated tumour, model group, positive controls mice animal activity number of times obviously reduce, cutis laxa, and hair is holded up, and state is relatively poor.It is normally movable to receive the reagent group merely and share cyclophosphamide group mice, and fur is smooth, weight increase.The positive control drug group can significantly suppress tumor growth, but the weight of animals increase slowly, and state is relatively poor.And receiving the independent use of reagent that the effect that suppresses the H22 tumor growth is just arranged, tumor control rate is 29.6%; Share the back effect with the 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 spleen and the thymus 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 that the immune organ of chemotherapy tumor-bearing mice is had protective effect, the effect of share efficacy enhancing and toxicity reducing with chemotherapeutic.Under this experiment condition, point out this sample to have the auxiliary function that suppresses tumor growth.
Concrete result of the test data see the following form:
The capsule that table 7: embodiment 2 makes is to the inhibitory action of mice H22 tumor
Annotate: compare *＜0.05 with the tumor matched group, * *＜0.01; Compare △＜0.05, △ △＜0.01 with the cyclophosphamide group.
Claims (10)
1. the compositions with health care is characterized in that, is made up of the component of following weight portion meter:
100～300 parts of Ganoderma extracts
100～300 parts of green tea extract EGCG
0.015～0.1 part of trace element-selenium.
2. compositions as claimed in claim 1 is characterized in that, is made up of the component of following weight portion meter:
150～250 parts of Ganoderma extracts
100～200 parts of green tea extract EGCG
0.03～0.07 part of trace element-selenium.
3. compositions as claimed in claim 2 is characterized in that, is made up of the component of following weight portion meter:
200 parts of Ganoderma extracts
170 parts of green tea extract EGCG
0.06 part of trace element-selenium.
4. compositions as claimed in claim 1 is characterized in that, described Ganoderma extract is that the ratio of 20:1 is extracted and to be obtained according to Ganoderma medical material and Ganoderma extract.
5. compositions as claimed in claim 1 is characterized in that, the content of described green tea extract EGCG >=94%.
6. compositions as claimed in claim 1 is characterized in that, described trace element-selenium adds with at least a form in selenocarrageenan, selenocysteine, sodium selenate, sodium selenite, selenomethionine, the yeast rich in selenium.
7. increase immunity or the medicine of adjuvant therapy of tumors or the application in the health product like the described arbitrary compositions of claim 1 to 6 in preparation.
8. the preparation with health care is characterized in that processing by adding the adjuvant of accepting on the preparation process like the described arbitrary compositions of claim 1 to 6.
9. the preparation with health care as claimed in claim 8 is characterized in that said adjuvant is selected from one or more in 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, the xylitol.
10. preparation as claimed in claim 8 is characterized in that being oral formulations, preferred hard capsule, soft capsule, tablet, granule or oral liquid.
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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 |
| CN113197916A (en) * | 2021-04-28 | 2021-08-03 | 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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Effective date of registration: 20170621 Address after: 225300 No. 816, drug city road, Jiangsu, Taizhou Patentee after: Shijiazhuang Pharmaceutical Group Pharmaceutical (Taizhou) Co., Ltd. CHINO Address before: 050035 the Yellow River Road, Hebei, Shijiazhuang, No. 226 Patentee before: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. of CSPC Group |