CN104489681A - Composition with function of enhancing immunity, health product and preparation method thereof - Google Patents
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The invention relates to a composition with a function of enhancing immunity and belongs to the technical field of health products. The composition is specifically prepared from the following raw materials in parts by weight: 450-550 parts of maca powder, 120-160 parts of an astragalus extract, 40-60 parts of an American ginseng extract and 50-90 parts of a rhodiola rosea extract. According to the composition provided by the invention, four medicines are combined and jointly used in a certain proportion by means of theory of traditional Chinese medicine combined with medicating practice in in-depth studies, so that the four medicines supplement each other in function and the function of enhancing the immunity is coordinately improved. Meanwhile, the invention provides a health product preparation prepared by adding acceptable auxiliary materials on preparation into the composition and a preparation method thereof.
Description
Technical field
The invention belongs to health product technology field, be specifically related to a kind of composition, health products and preparation method thereof with develop immunitypty function.
Background technology
Along with social progress and economic development, all trades and professions develop rapidly, social competition is growing more intense, cause social crowd in the face of keen competition without physically, be mentally all in high-pressure state, a global investigation according to health organization shows, the people of true health only accounts for 5% of population, and the people suffering from disease accounts for 20%, and the people of 75% is in sub-health state.Immunity is human body
selfdefense mechanism, be human bioequivalence and eliminate any foreign matter (virus, bacterium etc.) of external intrusion; Process
old and feeble, damage, the ability of mutant cell and virus infected cell in the own cells of dead, sex change and identification and handling body.Immunology Today is thought, immunity is the physiological reaction of human bioequivalence and eliminating " dissident ".When immune function of human body imbalance, or when immune system is unsound, health is easy to infected or cancer stricken.Be in the phenomenon of colony's ubiquity hypoimmunity of sub-health state, this Ye Shi modern society human health care realizes the reason strengthened gradually.At present, the product improving immunity commercially can be found everywhere, health food of such as a kind of Maca reactive powder disclosed in CN103750298A and preparation method thereof, it is by being mixed to get product by Maca reactive powder, the Radix Astragali and American Ginseng, but the effect of its raising immunity and immunity raising degree not yet obtain efficiency test confirmation.
In view of this, need to invent a kind of develop immunitypty Be very effective, safety, composition is simple, the composite health product that content is determined.
Summary of the invention
The object of the invention is to the defect overcoming prior art, provide a kind of composition and health products of develop immunitypty Be very effective, it possesses content and determines, composition is simple, and advantage safely and effectively, provides the preparation method of above-mentioned health products simultaneously.
For achieving the above object, the concrete scheme taked of the present invention is as follows:
One aspect of the present invention provides a kind of composition with develop immunitypty function, and it is made up of following raw material:
Pueraria root powder 450 ~ 550 parts;
Astragalus Root P.E 120 ~ 160 parts;
American ginseng extract 40 ~ 60 parts;
Gadol extract 50 ~ 90 parts.
Further improve as the present invention, described composition is made up of following raw material:
Pueraria root powder 475 ~ 525 parts;
Astragalus Root P.E 130 ~ 150 parts;
American ginseng extract 45 ~ 55 parts;
Gadol extract 60 ~ 80 parts.
Further improve as the present invention, described composition is made up of following raw material:
Pueraria root powder 500 parts;
Astragalus Root P.E 140 parts;
American ginseng extract 50 parts;
Gadol extract 70 parts.
The present invention provides a kind of health products, its health products be made up of auxiliary material acceptable on above-mentioned composition and preparation process on the other hand.
Further improve as the present invention, described health products are peroral dosage form, are selected from tablet, capsule, granule, oral liquid, pulvis, medicinal tea, pill.
Further improve as the present invention, described health products are tablet, are specifically made up of the component of following weight portion:
Pueraria root powder 450 ~ 550 parts;
Astragalus Root P.E 120 ~ 160 parts;
American ginseng extract 40 ~ 60 parts;
Gadol extract 50 ~ 90 parts;
Filler 45 ~ 65 parts;
Disintegrant 20 ~ 30 parts;
Lubricant 7 ~ 9 parts;
20 ~ 30 parts, film coating powder.
Further improve as the present invention, described filler be selected from starch, soluble starch, Icing Sugar, sucrose, dextrin, lactose, amylum pregelatinisatum, microcrystalline cellulose, sweet mellow wine and starch slurry one or more; Described disintegrant be selected from sodium carboxymethylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl methylcellulose, gelatin, sodium carboxymethyl starch and Ac-Di-Sol one or more; Described lubricant be selected from dolomol, superfine silica gel powder and talcum powder one or more.
Further improve as the present invention, described filler is selected from microcrystalline cellulose, and described disintegrant is selected from sodium carboxymethyl starch, and described lubricant is selected from dolomol.
Last aspect of the present invention provides a kind of preparation method of above-mentioned tablet, specifically comprises the following steps:
(1) pretreatment: take pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, filler, disintegrant and lubricant by described weight portion, crosses 80 mesh sieves, for subsequent use;
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtains mixed powder A; Mixed powder A is mixed with pueraria root powder, obtains mixed powder B for subsequent use;
(3) always mixed to granulate: the mixed powder B softwood that step (2) is obtained, sieve, dry and whole grain obtains particle A, by particle A and mix lubricant evenly, obtains total mixture;
(4) compressing tablet: compressing tablet is carried out to the total mixture that step (3) obtains;
(5) dressing: prepare coating solution with coating powder, carries out dressing to obtained compressing tablet coating solution.
Further improve as the present invention, described softwood is crossed 26 mesh sieves and is granulated, and the concentration of described coating solution is 6 ~ 9%.
In the present invention:
In the present invention, Astragalus Root P.E polyoses content is not less than 10%, and American ginseng extract general ginsenoside (in ginsenoside Re) content is not less than 10%, and in gadol extract, Determination of Salidroside is not less than 3%.The weight portion of composition of the present invention combines based on above-mentioned content, it will be appreciated by those skilled in the art that its constituent content can make the appropriate adjustments based on mentioned component content difference.
In the present invention, auxiliary material is not limited to above-mentioned filler, disintegrant, lubricant and film coating powder, can according to concrete dosage form selection suitable excipients as dispersant and stabilizing agent etc.
Agate coffee is rich in 55 kinds of vigor nutrients, can bring unusual vigor to humans and animals, has the good reputation of " natural vigour nutrient ".In addition protein, carbohydrate, aliphatic acid (containing more alpha-linolenic acid, linoleic acid), dietary fiber is also had, 20 seed amino acids (aspartic acid, arginine etc.), the multiple kind of bioactive ingredients such as multiple alkaloid and glucosinolate, taurine, plant polyphenol, saponin such as mineral matter (iron, manganese, copper, zinc, sodium, potassium, calcium, phosphorus, sulphur, magnesium etc.), 8 kinds of vitamins (VB1, VB2, VB5, VB6, VB12, VC, VA, VE), alkaloids (walk alone clever alkali A and B).1999, American scientist has found vegetable active composition---macamide and agate coffee alkene new containing two classes in agate coffee, they are one of core substances realizing agate coffee effect, hypothalamus and pituitary can be directly acted on after being absorbed, act on human body by polysaccharide, albumen, alkaloid and the many target position of various active material, excite internal system, recover and balance hormone secretion, activating cell, strengthens immunity.Its mechanism of action is different from supplemented with exogenous hormone, but stimulates the endogenous hormones in body needed for each organ secretion, and regulating human body internal system again to reach balance, is natural " endocrine metabolic diseases device ".
Research finds, agate coffee alkene contained in agate coffee and macamide and 20 seed amino acids, 55 kinds of pure natural active compositions such as 8 kinds of vitamin, 18 kinds of mineral matter elements, 9 kinds of secondary metabolites etc.Clinical research confirmation, agate coffee alkene and its pharmacological action of macamide are: by acting on human body body of gland (pituitary gland), can effectively make human hormone secrete and reach dynamic equilibrium, thus to alleviation climacteric metancholia, improvement function, raising sperm capacitation, improving water flood, improve blood pressure, improve sub-health state and have extraordinary effect, have the value that a lot of medicinal material cannot match in excellence or beauty.For women, can regulate endocrine, antagonism climacteric metancholia, strengthens immunologic function, antifatigue, anti-anemia action; For the male sex, then can antifatigue, strengthen energy, muscle power, improvement function, increase sperm quantity, improve sperm motility, regulate internal system, balance hormone, play the effects such as kidney tonifying, establishing-Yang, improvement dysfunction.
Rhodiola root, through the research of deep pharmacological action and Clinical practice, find that rhodiola root has to act on " adaptation former state " like ginseng, acanthopanax senticosus, and there will not be the constipating effect of be overexcited effect and the wilsonii of ginseng, health can be assisted to reply stable state.Namely rhodiola root can improve the various stimulation from chemistry, biology or physical factor of body fight.
Rhodiola root possesses antifatigue effect, by to rhodiola root in recent years document research find, rhodiola root can by regulating human body energy metabolism, removing metabolite, the nervous system regulating body and internal system, dispelling fatigue, strengthen muscle power and endurance, thus reaching the effect of resisting kinetic fatigue, the mechanism of its antifatigue is used to Sports Field resisted motion fatigue in recent years for it certain guiding value.Treat fatigue syndrome with rhodiola root, fall asleep, few dream, not easily wakes up, and weak sense disappears fast, and work and study efficiency significantly improves.
Rhodiola root possesses hypoxia tolerance, has cardiac stimulant, diastole cardiovascular and cerebrovascular, oxygenating effect, contributes to purifying blood, removes refuse in blood, improves immunity and anti-fatigue ability.Also can activate cells in vivo simultaneously, improve brain tissue causes anoxic resistance to fatigue, improve working and learning efficiency, focus one's attention on, reduce miswork, increase appetite, improving water flood, regulate blood pressure, finally make internal body reach the object of balance.
Rhodiola root possesses radiation resistance, and the effect of rhodiola root to immunologic function is better than ginseng, and has the effect that the similar traditional Chinese medical science " is strengthened the body resistance to consolidate the constitution ".Namely the special regulatory function that the ill-conditioned index caused by different pathogeny changes to normal condition is impelled.Namely there is anti anoxia, antifatigue and radiation resistance, also can be anticancer, antitoxin, to nervous system and internal system, there is dual regulation.Except be applied to person in middle and old age's property disease auxiliary cure the disease except, be also widely used in the staff in the particular surroundings such as Aeronautics and Astronautics, deep-sea, down-hole, desert, as astronaut, pilot etc.For improving the adaptive capacity of body fight adverse circumstances.Therefore, be listed in " particular surroundings adaptation medicine ".Rhodiola root possesses anti-aging effects, can eliminate free radical ability, stops peroxidization, suppresses brown element herein to be formed and pile up, thus improves cell viability, delaying cell aging.Meanwhile, rhodiola root possesses cold resistance effect rhodiola root can promote systemic blood circulation, makes body excited, promotes yang-energy.
The Radix Astragali can not only coronary artery dilator, improves myocardial blood supply, improves immunity, Tumor suppression function, and can the process of delaying cell aging.The Radix Astragali, containing the various trace elements such as saponin, sucrose, polysaccharide, several amino acids, folic acid and selenium, zinc, copper, is the medicinal material for improving lung and respiratory system immunocompetence the most basic in Chinese medicine.May be used for the abnormal sweating illness because hypoimmunity causes, also may be used for tonifying Qi and enhancement spleen function and metabolic capability low.The Radix Astragali can mend the gas of the whole body.The life Radix Astragali, has effect of invigorating qi for consolidating superficies, inducing diuresis for removing edema, detoxification, myogenic, is applicable to spontaneous perspiration, night sweat, blood-arthralgia, edema, ulcer and does not burst or burst and the disease such as not hold back for a long time.Preparing astragalus membranaceus has tonifying Qi, nourishes blood, effect in benefit, is applicable to the diseases such as internal injury overstrain, splenasthenic diarrhea, the deficiency of vital energy, the deficiency of blood, laboured breathing.The Radix Astragali have reduce blood viscosity, reduce thrombosis, reduce blood pressure, cardioprotection, bidirectional modulation blood sugar, Green Tea Extract damage, anti anoxia, antitumor, strengthen body immunity, can be used to treat the diseases such as heart disease, hypertension, diabetes.The Radix Astragali can also hemangiectasis, improves skin blood circulation and nutrition condition, therefore effective to chronic ulcer disunion person of a specified duration.It can also eliminate the albuminuria of nephritis patient, and protection liver, prevents hepatic glycogen from reducing.
American Ginseng, cold in nature, bitter, micro-sweet, the thoughts of returning home, lung, kidney channel, have effect that fire, nourishing the stomach to improve the production of body fluid fall in tonifying lung.China is imported between Qing Dynasty Kangxu year, the history of existing more than 300 year, verify through tcm clinical practice, American Ginseng main component is American ginseng saponin, and containing nutriments such as several amino acids, carbohydrate and multivitamins, has multiple pharmacologically active, tonifying Qi is not got angry, improve resistance, also can nourishing Yin and promoting production of body fluid, arousing brain, raising spirit antifatigue.Generally state it, American Ginseng is superior excellent tonic product, rare medicinal herbs, has the good reputation of " green gold ".Archaism cloud: " American Ginseng is cool in nature and mend, all wish ginsengs and not by ginseng warm person all can with it ".Therefore mend and not dry be the special feature of American Ginseng.American Ginseng is as the first-selected medicinal material of health care of tonifying Qi, and can promote that haemocyanin synthesizes, bone marrow protein synthesizes, organ protein synthesizes, improve immunity of organisms, inhibition cancer cell grows, and effectively resists cancer.Informal dress American Ginseng can anti-arrhythmia, resist myocardial ischemia, anti-cardiac muscle oxidation, strengthening cardiac contractility ability, patients with coronary heart disease Symptoms is deficiency of both qi and yin, palpitation and short breath can long-term taking American Ginseng, evident in efficacy.Effect of American Ginseng is also to regulate blood pressure, effectively can reduce temporary and persistence blood pressure, contribute to the recovery of the diseases such as hypertension, arrhythmia cordis, coronary heart disease, acute myocardial infarction, cerebral thrombus.Blood sugar can also be reduced, regulate insulin secretion, promote glycometabolism and fat metabolism, have certain booster action to treatment diabetes.
Above-mentioned four traditional Chinese medicine, by theory of traditional Chinese medical science, in conjunction with medication reality, by deep research, share and with certain proportion conbined usage, effect of four traditional Chinese medicine can be made to complement each other by the present invention, collaborative effect improving develop immunitypty.Agate coffee directly acts on hypothalamus and pituitary, acts on human body, excite internal system by polysaccharide, albumen, alkaloid and the many target position of various active material, and recover and balance hormone secretion, activating cell, strengthens immunity.Rhodiola root strengthens the adaptability of body, strengthens the nonspecific resistance of body to the various destructive stimulus such as physics, chemistry and biology and damage, disorderly functional recovery is acted on normally.The Radix Astragali can mend the gas of the whole body, improves myocardial blood supply, improves immunity.American Ginseng can promote that haemocyanin synthesizes, bone marrow protein synthesizes, organ protein synthesizes, and improve immunity of organisms, inhibition cancer cell grows.Full side is made up of four different function factors, strengthens immunity of organisms, maintain and strengthen immunity of organisms from four aspects synergies.
The present invention possesses compatibility science, definite ingredients, and natural safety, has no side effect, and strengthens the feature of immunity of organisms definite effect.
Detailed description of the invention
Below in conjunction with specific embodiment, detailed further describing is carried out to the present invention.
In following examples, gadol extract is purchased from Jiahe, Shaanxi plant chemical industry responsibility Co., Ltd; American ginseng extract is purchased from Ningbo LiHua Pharmaceutical Co., Ltd; Astragalus Root P.E is purchased from Zhejiang Huisong Pharmaceuticals Co., Ltd; Pueraria root powder is purchased from ANDINA FOODS EXPORT E.I.R.L.; Film coating powder is purchased from Wenzhou Xiaolun Coating Technology Co., Ltd., and main component is hydroxypropyl methylcellulose, titanium dioxide, talcum powder, Macrogol 6000, Brilliant blue aluminum lake, Ponceau 4R aluminum lake.
embodiment 1
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 140g;
American ginseng extract 50g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: the mixed powder B that step (2) obtains is added the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step (3) is placed in tablet press machine and carries out compressing tablet, and compressing tablet quantity is 1000, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
Tablet obtained by the present embodiment, every 100g, containing protein 4.5g, Thick many candies 1.5g, total saposins 3g, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 2
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 130g;
American ginseng extract 55g;
Gadol extract 40g;
Microcrystalline cellulose 45g;
Sodium carboxymethyl starch 30g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 3
Prescription:
Pueraria root powder 525g;
Astragalus Root P.E 140g;
American ginseng extract 50g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 4
Prescription:
Pueraria root powder 550g;
Astragalus Root P.E 120g;
American ginseng extract 40g;
Gadol extract 50g;
Microcrystalline cellulose 45g;
Sodium carboxymethyl starch 20g;
Dolomol 7g;
Film coating powder 20g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: the mixed powder B that step (2) obtains is added the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step (3) is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 5
Prescription:
Pueraria root powder 450g;
Astragalus Root P.E 160g;
American ginseng extract 60g;
Gadol extract 90g;
Microcrystalline cellulose 65g;
Sodium carboxymethyl starch 30g;
Dolomol 9g;
Film coating powder 30g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 6
Prescription:
Pueraria root powder 525g;
Astragalus Root P.E 140g;
American ginseng extract 45g;
Gadol extract 60g;
Microcrystalline cellulose 45g;
Sodium carboxymethyl starch 20g;
Dolomol 7g;
Film coating powder 20g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 7
Prescription:
Pueraria root powder 475g;
Astragalus Root P.E 130g;
American ginseng extract 45g;
Gadol extract 60g;
Microcrystalline cellulose 45g;
Sodium carboxymethyl starch 20g;
Dolomol 7g;
Film coating powder 20g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 8
Prescription:
Pueraria root powder 475g;
Astragalus Root P.E 140g;
American ginseng extract 50g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 9
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 120g;
American ginseng extract 60g;
Gadol extract 90g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 10
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 160g;
American ginseng extract 40g;
Gadol extract 60g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 11
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 150g;
American ginseng extract 50g;
Gadol extract 80g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 12
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 130g;
American ginseng extract 60g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: mixed powder B step 2 obtained adds the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) compressing tablet: the total mixture obtained step 3 is placed in tablet press machine and carries out compressing tablet, the heavy 0.85g of sheet, tablet weight variation controls ± 5%.
(5) dressing: the concentration preparing coating powder with 75% ethanol is 8%, obtains coating solution, the plain sheet suppressed is put into coating pan, dressing wraps one deck coating membrane, coating weight gain about 3% to plain sheet surface uniform.
The tablet that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 13 capsule
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 140g;
American ginseng extract 50g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: the mixed powder B that step (2) obtains is added the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating, and namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, wet granular carries out drying, about temperature 50 C, and moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, mixed with dolomol by particle A, the time is about about 10min, obtains total mixture;
(4) encapsulated, make 0.85g/ grain.
The capsule that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 14 particle
Prescription:
Pueraria root powder 500g;
Astragalus Root P.E 140g;
American ginseng extract 50g;
Gadol extract 70g;
Microcrystalline cellulose 56g;
Sodium carboxymethyl starch 25.5g;
Dolomol 8.5g;
Film coating powder 25.5g.
Preparation method is as follows:
(1) pretreatment: pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, microcrystalline cellulose, sodium carboxymethyl starch, dolomol cross 80 mesh sieves respectively, weighs, for subsequent use.
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtain mixed powder A, the time is about 15min; Mixed with pueraria root powder by mixed powder A, the time is about 30min, obtains mixed powder B for subsequent use;
(3) total mixed granulation: the mixed powder B that step (2) obtains is added the ethanol softwood of 95%, stir about 15min, with " have gentle hands is held agglomerating; namely that pinches falls apart " for degree, softwood is crossed 26 mesh sieves and is granulated, and wet granular carries out drying, about temperature 50 C, moisture≤5%, dried particles is crossed the whole grain of 26 mesh sieve and is obtained particle A, is packaged as 0.85g/ bag.
The particle that the present embodiment obtains, through Function detection, possesses the effect strengthening immunity of organisms.
embodiment 15 acute toxicity test
Sample: the tablet that embodiment 1 is obtained.
Animal used as test: select the cleaning grade ICR healthy mice that Yangzhou University's comparative medicine center is bred.
Test method: carry out acute toxicity test in mice by maximal tolerance dose method, selects cleaning grade ICR healthy adult mouse 20, and female, each 10 of hero, quarantine 3 days, body weight is 18.7 ~ 21.5g.Test front animal fasting 16 hours, freely drink water.Given the test agent sterilized water is prepared, and maximum dose concentration is 0.5g/mL, and give sample 2 times by gavage amount 20mL/kgbw mono-day, 4 hours, interval, it is 20.0g/kgbw that tested material gives dosage.Continuous Observation 14 days, record poisoning manifestations and death condition.
Result of the test: during experimental observation, embodiment 1 tablet on Mouse Weight without impact.Normally, well-grown, has no any poisoning manifestations for each treated animal diet and activity, without dead.Therefore, female, the male mice acute oral MTD of embodiment 1 tablet are greater than 20.0g/kgbw, belong to nontoxic level.Concrete data are in table 1.
Table 1 embodiment 1 tablet chmice acute Oral toxicity (
± SD)
embodiment 16 30 days feeding trials
Sample: the tablet that embodiment 1 is obtained.
Animal used as test: the healthy weanling rat of the SPF level SD selecting Shanghai western pul-Bi Kai animal used as test Co., Ltd to breed.
Test method: select the healthy weanling rat 80 of SPF level SD, after animal is bought, quarantine 4 days in the room of quarantine in this Animal House, is divided into 4 groups at random by body weight, often organizes 20, female, hero half and half.The human body RD 3.4g/ people/day (with 60kg batheroom scale) of embodiment 1 tablet, by 30,65 and 100 times of human body RD establish 1.70,3.68,5.67g/kgbw/d tri-dosage groups are (low, in, high), separately establish a blank group 0g/kgbw/d.Given the test agent mixes in basal feed to feed raises rat, low, in, the percentage composition that high each dosage group sample mixes basal feed is respectively 1.70%, 3.68%, 5.67%.The content mixing feed because of high dose group sample is greater than 5%, and separately adding casein 1.42%, to adjust protein content identical with control group.Control group is fed and is raised basal feed.Continuous nursing 30 days.Animal ad lib is drunk water, and claims 1 body weight and 2 food intake doses weekly, calculates weekly and total food utilization, observes animal ordinary circumstance every day, with or without poisoning manifestations and death.
Result of the test: embodiment 1 tablet gives rat 30d with 1.70g/kgbw/d, 3.68g/kgbw/d, 5.67g/kgbw/d tri-dosage, animal subject ordinary circumstance is good, the change all without exception of body weight, food utilization, organ weights, organ coefficient; Hematological indices and the display of biochemical indicator result, indices is all in normal range (NR); Each internal organs histopathologic examination is showed no the pathological change relevant with given the test agent.30 days feeding trial results according to the Ministry of Public Health " health food inspection and assessment technical specification " (version in 2003) judge, the maximum illeffects dosage (NOAEL) of not observing of embodiment 1 tablet is 5.67g/kgbw/d.
embodiment 17 mutagenicity test
Sample: the tablet that embodiment 1 is obtained.
Animal used as test: the cleaning grade ICR healthy mice that micronucleus test selects Yangzhou University's comparative medicine center to breed; The cleaning grade ICR healthy mice that mouse inbred strain selects Yangzhou University's comparative medicine center to breed.
Test method:
(1) Salmonella reversion test method
By " health food inspection and assessment technical specification " version in 2003, adopt dressing plate incorporation methods, select salmonella typhimurium saltant TA97, TA98, TA100, TA102, test after qualified.Activation system is the rats'liver S-9 of Polychlorinated biphenyls induction, and S-9 protein content is 37.8mg/mL, and its vigor has good metabolic activation ability to 2-aminofluorene.10mL S-9 is added in every 100mL S-9 mixed liquor.Positive thing: do not add S-9 person for fenaminosulf (TA97, TA98, TA102), Sodium azide (TA100), add S-9 person for 2-aminofluorene (TA97, TA98, TA100), 1,8-dihydroxy anthraquinone (TA102), establishes negative control group (sterile distilled water and methyl-sulfoxide) simultaneously.Test with 5000,1000,200,40 and 8 μ g/ ware dosage with when not adding S-9 mixed liquor when adding, each dosage group makees 3 plates.Sample is placed in high-temperature sterilization 20min under 0.103Mpa condition, aseptically, weigh given the test agent and be mixed with solution, given the test agent methyl-sulfoxide is mixed with 50mg/mL, i.e. high dose group, 4 dosage methyl-sulfoxides are mixed with 10,2,0.4,0.08 mg/mL by certain multiple proportions stepwise dilution below, and application of sample amount is 0.1mL/ ware.0.1mL test strain enrichment liquid, 0.1mL given the test agent solution and 0.5mLS-9 mixed liquor (when needs metabolism activation) is added in 2mL top agar.Pour on bottom culture medium flat plate after mixing, cultivate 48 hours, count every ware and return change clump count for 37 DEG C.If the change clump count that returns of given the test agent group is that negative control group returns change clump count more than 2 times, and has dose-response relationship then for positive.Whole test repeats to do once under the same conditions.
(2) mouse marrow cell micro nuclear test
Select body weight 25 ~ 30g ICR kind cleaning grade mouse 50, animal conforms after buying and tests for 3 days.Be divided into 5 groups at random by body weight, often organize 10, male and female half and half.The possible intake of embodiment 1 tablet people: 3.4g/ people/day, 100 times of the possible intake of people are: 5667mg/kgbw, maximum dose level is set to 10000mg/kgbw, if 10000,5000,2500mg/kgbw 3 dosage groups, negative control group (sterilized water), positive controls (endoxan 40mg/kgbw).Dissolubility per sample selects sterilized water as solvent.Given the test agent sterilized water is prepared, high, medium and low dosage component not Han given the test agent concentration be 500,250,125mg/mL, with 20mL/kgbw gavage, adopt 30h to tested material method.Give given the test agent interval 24h twice, within 6 hours, animal is put to death after second time gives given the test agent, get the conventional film-making of breastbone, microscopy, every mouse counts 1000 Polychromatic erythrocyte (PCE), observe the polychromatic erythrocyte number containing micronucleus and calculate microkernel incidence, in permillage, result adopts Poisson distribution U inspection to carry out statistical disposition.Viewed mature erythrocyte number when every mouse counts 200 polychromatic erythrocytes, and calculate polychromatic erythrocyte and mature erythrocyte ratio (PCE/RBC).
(3) mouse inbred strain
Select body weight 25 ~ 35g ICR kind cleaning grade sexal maturity male mice 25, animal conforms after buying and tests for 3 days.Be divided into 5 groups at random by body weight, often organize 5.The possible intake of embodiment 1 tablet people: 3.4g/ people/day, 100 times of the possible intake of people are: 5667mg/kgbw, maximum dose level is set to 10000mg/kgbw, if 10000,5000,2500mg/kgbw 3 dosage groups, negative control group (sterilized water), positive controls (endoxan 40mg/kgbw).Dissolubility per sample selects sterilized water as solvent.Given the test agent sterilized water is prepared, high, medium and low dosage component not Han given the test agent concentration be 500,250,125mg/mL, with 20mL/kgbw gavage, every day 1 time, continuous 5d.Within the 35th day after giving given the test agent first, put to death animal, get the film-making routinely of both sides epididymal sperm filtrate, microscopy.Every mouse counts the sperm of 1000 structural integrities, calculates Sperm malformation rate (with percentage), and result adopts rank test to carry out statistical disposition.
Result of the test:
(1) the aseptic test result of Salmonella reversion test method: given the test agent solution, solvent control, buffer solution and S9 mixture all do not observe contaminated bacterium colony on aseptic flat board.
(2) mouse marrow cell micro nuclear test test result: each dosage group micronuclear rates there was no significant difference (P>0.05) compared with negative control group of embodiment 1 tablet, positive controls is then significantly higher than negative control group (P<0.01).Have no embodiment 1 tablet to have an impact to the formation of PCEMNR micronucleus and PCE/RBC ratio.
(3) mouse inbred strain test result: each dosage group rate of teratosperm compares with negative control group, there was no significant difference (P>0.05), and positive controls mouse sperm deformity rate compares with negative control group be significantly increased (P<0.01).Therefore embodiment 1 tablet does not have an impact to mouse sperm deformity rate.
embodiment 18 function test
Sample: the tablet that embodiment 1 is obtained.
Animal used as test: the cleaning grade F1 generation Healthy female mouse 200 selecting Shanghai Slac Experimental Animal Co., Ltd. to breed, body weight is 19.0 ~ 22.9g.
Dosage choice and packet transaction: establish 0.28g/kgbw/d, 0.57g/kgbw/d, 1.70g/kgbw/d tri-dosage groups (being equivalent to 5 times of given the test agent human body recommended intake, 10 times, 30 times respectively), separately establish 0g/kgbw/d group to replace tested material with sterilized water.Given the test agent sterilized water is prepared, and basic, normal, high dosage formulation concentration is respectively 28mg/mL, 57mg/mL, 170mg/mL, and per os gives the tested material of mouse corresponding dosage once a day, and mouse stomach amount is 0.1mL/10gbw.Continuous gavage measures every develop immunitypty functional parameter after one month.
Mouse by body weight be divided at random I, II, III, IV, V 5 large group, every large group 40 mouse, are divided into 4 dosage groups, each dosage group 10.Wherein I group mouse carries out mouse spleen lymphocyte conversion, the NK cell activity assays of ConA induction; II group mouse carries out auricle edema test; III group of mouse carries out antibody-producting cell and detects and HD50 value HC
50mensuration; IV group of mouse carries out the test of mouse carbonic clearance; V group of mouse carries out Turnover of Mouse Peritoneal Macrophages and engulfs chicken red blood cell test.
Test method: undertaken by the develop immunitypty functional check method of " health food inspection and assessment technical specification " (version in 2003).
ConA inducing mouse Splenic vein hemodynamics is tested---mtt assay; DNFB inducing mouse delayed allergy (DTH)---ear swelling method; Antibody-producting cell detects---and Jerne improves slide method; Serum hemolysin measures---HD50 value (HC
50).
Result of the test:
(1) in the mouse spleen lymphocyte conversion test that cellular immune function: ConA induces, 0.28g/kgbw/d, 0.57g/kgbw/d, 1.70g/kgbw/d group adds ConA hole and compares with 0g/kgbw/d group with the difference not adding ConA hole absorbance, no significant difference (P ﹥ 0.05); During DNFB inducing mouse DTH tests, the weightening finish of 0.28g/kgbw/d, 0.57g/kgbw/d, 1.70g/kgbw/d group auricular concha is compared with 0g/kgbw/d group, no significant difference (P ﹥ 0.05).This is negative.
(2) humoral immune function: in antibody-producting cell detection experiment, 1.70g/kgbw/d group hemolysis plaque number is higher than 0g/kgbw/d group, and difference has statistical significance (P ﹤ 0.05); In the test of mice serum HD50 value, 1.70g/kgbw/d group mice serum HD50 value is higher than 0g/kgbw/d group, and difference has statistical significance (P ﹤ 0.05).This is positive.
(3) monocytes/macrophages function: in carbonic clearance test, 1.70g/kgbw/d group carbonic clearance index is higher than 0g/kgbw/d group, and difference has statistical significance (P ﹤ 0.05); In chicken red blood cell phagocytosis test, 1.70g/kgbw/d group phagocytic percentage, phagocytic index are higher than 0g/kgbw/d group, and difference has statistical significance (P ﹤ 0.05).This is positive.
(4) NK cytoactive: in NK cells in mice active determination test, 1.70g/kgbw/d group NK cytoactive is higher than 0g/kgbw/d group, and difference has statistical significance (P ﹤ 0.05).This is positive.
Conclusion: the result according to the develop immunitypty function test of " health food inspection and assessment technical specification " judges, the tablet that embodiment 1 obtains under this experimental condition has develop immunitypty function.
Concrete test data is as follows:
Table 2 embodiment 1 tablet on the impact of Mouse Weight (
± SD)
Table 3 embodiment 1 tablet on the impact of mouse thymus, spleen organ (
± SD)
Impact that table 4 embodiment 1 tablet transforms mouse spleen lymphocyte (
± SD)
Table 5 embodiment 1 tablet on the impact of DNFB inducing mouse DTH (
± SD)
Table 6 embodiment 1 tablet on the impact of mouse hemolysis plaque number (
± SD)
Table 7 embodiment 1 tablet on the impact of mouse HC50 (
± SD)
Table 8 embodiment 1 tablet on the impact of mouse carbonic clearance ability (
± SD)
Table 9 embodiment 1 tablet engulfs chicken red blood cell phagocytic rate to Turnover of Mouse Peritoneal Macrophages
And the impact of phagocytic index (
± SD)
Table 10 embodiment 1 tablet on the impact of NK cells in mice activity (
± SD)
The above embodiment is only the preferred embodiments of the present invention, and and the feasible enforcement of non-invention exhaustive.For persons skilled in the art, to any apparent change done by it under the prerequisite not deviating from the principle of the invention and spirit, all should be contemplated as falling with within claims of the present invention.
Claims (10)
1. have a composition for develop immunitypty function, it is characterized in that, it is made up of following raw material:
Pueraria root powder 450 ~ 550 parts;
Astragalus Root P.E 120 ~ 160 parts;
American ginseng extract 40 ~ 60 parts;
Gadol extract 50 ~ 90 parts.
2. a kind of composition with develop immunitypty function according to claim 1, it is characterized in that, described composition is made up of following raw material:
Pueraria root powder 475 ~ 525 parts;
Astragalus Root P.E 130 ~ 150 parts;
American ginseng extract 45 ~ 55 parts;
Gadol extract 60 ~ 80 parts.
3. a kind of composition with develop immunitypty function according to claim 1, it is characterized in that, described composition is made up of following raw material:
Pueraria root powder 500 parts;
Astragalus Root P.E 140 parts;
American ginseng extract 50 parts;
Gadol extract 70 parts.
4. the health products be made up of acceptable auxiliary material on the composition described in any one of claim 1-3 and preparation process.
5. a kind of health products according to claim 4, is characterized in that, it is peroral dosage form, are selected from tablet, capsule, granule, oral liquid, pulvis, medicinal tea or pill.
6. a kind of health products according to claim 4, is characterized in that, formulation is tablet, is specifically made up of the component of following weight portion:
Pueraria root powder 450 ~ 550 parts;
Astragalus Root P.E 120 ~ 160 parts;
American ginseng extract 40 ~ 60 parts;
Gadol extract 50 ~ 90 parts;
Filler 45 ~ 65 parts;
Disintegrant 20 ~ 30 parts;
Lubricant 7 ~ 9 parts;
20 ~ 30 parts, film coating powder.
7., according to a kind of health products according to claim 4, it is characterized in that, described filler be selected from starch, soluble starch, Icing Sugar, sucrose, dextrin, lactose, amylum pregelatinisatum, microcrystalline cellulose, sweet mellow wine and starch slurry one or more; Described disintegrant be selected from sodium carboxymethylcellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl methylcellulose, gelatin, sodium carboxymethyl starch and Ac-Di-Sol one or more; Described lubricant be selected from dolomol, superfine silica gel powder and talcum powder one or more.
8. according to a kind of health products according to claim 7, it is characterized in that, described filler is microcrystalline cellulose, and described disintegrant is sodium carboxymethyl starch, and described lubricant is dolomol.
9. a preparation method for health products as claimed in claim 6, is characterized in that, specifically comprises the following steps:
(1) pretreatment: take pueraria root powder, Astragalus Root P.E, American ginseng extract, gadol extract, filler, disintegrant and lubricant by described weight portion, crosses 80 mesh sieves, for subsequent use;
(2) premixed: Astragalus Root P.E, American ginseng extract, gadol extract, filler and disintegrant are mixed, obtains mixed powder A; Mixed powder A is mixed with pueraria root powder, obtains mixed powder B for subsequent use;
(3) always mixed to granulate: the mixed powder B softwood that step (2) is obtained, sieve, dry and whole grain obtains particle A, by particle A and mix lubricant evenly, obtains total mixture;
(4) compressing tablet: compressing tablet is carried out to the total mixture that step (3) obtains;
(5) dressing: prepare coating solution with coating powder, carries out dressing to obtained compressing tablet coating solution.
10. a preparation method for tablet as claimed in claim 9, is characterized in that, described softwood is crossed 26 mesh sieves and granulated, and the concentration of described coating solution is 6 ~ 9%.
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| CN105614847A (en) * | 2015-12-23 | 2016-06-01 | 太仓东浔生物科技有限公司 | Anti-fatigue lozenge and preparation method therefor |
| CN105661510A (en) * | 2016-01-19 | 2016-06-15 | 陕西嘉禾生物科技股份有限公司 | Preparation method of immunity-improving Maca compound tablets |
| CN105943596A (en) * | 2016-06-01 | 2016-09-21 | 谢晓亮 | Composite containing maca and improving immunity and preparation method and application thereof |
| CN106942749A (en) * | 2017-03-28 | 2017-07-14 | 北京创立科创医药技术开发有限公司 | A kind of health food of strengthen immunity and preparation method thereof |
| CN107137443A (en) * | 2017-04-26 | 2017-09-08 | 丽江久康生物科技有限公司 | A kind of composition for relieving fatigue, preparation method and applications |
| CN107319553A (en) * | 2017-07-10 | 2017-11-07 | 溧阳市天目湖保健品有限公司 | A kind of health products of auxiliary hyperglycemic strengthen immunity and preparation method thereof |
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