CN103110889A - Traditional Chinese medicine for increasing immunity and preparation method thereof - Google Patents
Traditional Chinese medicine for increasing immunity and preparation method thereof Download PDFInfo
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- CN103110889A CN103110889A CN2013100393415A CN201310039341A CN103110889A CN 103110889 A CN103110889 A CN 103110889A CN 2013100393415 A CN2013100393415 A CN 2013100393415A CN 201310039341 A CN201310039341 A CN 201310039341A CN 103110889 A CN103110889 A CN 103110889A
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Abstract
The invention discloses a traditional Chinese medicine for increasing immunity and a preparation method thereof. The traditional Chinese medicine takes curcuma extract and lucid ganoderma extract as main materials and takes microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate as auxiliary materials, wherein the curcuma extract accounts for 10-40 percent of the total weight, and the lucid ganoderma extract accounts for 20-50 percent of the total weight. The traditional Chinese medicine is prepared into coated tablets by the processes of mixing, pelletizing, tableting, coating and the like sequentially. The curcuma extract and lucid ganoderma extract are compatible, the traditional Chinese medicine is reasonable in formula, balanced in effect, safe and low in cost, does not have a toxic or side effect, and has the functions of regulating the functions of internal organs in the whole body, improving the healthy atmosphere of a human body and finally increasing the immunity.
Description
Technical field
The present invention relates to Chinese medicine and preparation method thereof, more specifically, is a kind of Chinese medicine that helps enhancing immunity and preparation method thereof.
Background technology
Immunity generally also can be resistance.Usually the body immunity of saying be exactly health when being subject to external infringement, during such as antibacterial, poisoning intrusion human body, the ability of body resistance exotic invasive.The immunity of human body comes from immune system, immune system mainly contains the function of three aspects:, the firstth, immune defence, it to antigenic substance as: immunne response occurs in pathogenic microorganism, vaccine, toxoid, foreign protein etc., finally eliminate antigenic substance, play the effect of infection immunity.If when the generation of the defense function of body is damaged, very easily suffer from infectiousness or infectious disease; The secondth, immunological homeostasis can be removed damage, aging, dead cell, and effectively carry out immunoregulation effect, as from steady functional disorder, autoimmune disease easily occurs; It three is immune surveillance functions, its major function shows that body identifies antigen on cancerous tumor cell by immunocyte, and by special or non-specific killer cell, cancerous cell is destroyed, emerging cancerous cell namely is not eliminated before causing a large amount of propagation, diffusion, and plays antineoplastic action.As immune surveillance mistake department, normal easily Cancer.Along with the progress of society, the quickening of people's rhythm of life, the variation of living environment, and the pressure of each side is increasing, causes thus the crowd of immunity degradation also more and more.So enhancing human body immunity power is safeguarded healthy most important.
Along with social development, people's health is being faced with various threats: the diseases such as food pollution, environmental pollution, cancer, acquired immune deficiency syndrome (AIDS), SARS, bird flu, in the face of the fearful disease that pasts medical help, people more and more recognize, the power of immunity is determining that the resistance of human body is strong and weak, and it more and more has a very important role to the health degree of human body and the length of human longevity.And the power of immunity derives from strong immune system, and immune system comprises immune organ, immunocyte and immune molecule.Immunocyte mainly comprises T and bone-marrow-derived lymphocyte, monokaryon or macrophage, dendritic cell, acidophilia and basophilia polymorphonuclear cell, erythrocyte and platelet, and secreted antibody and the cytokine of these cells; Immune organ comprises liver, spleen, lymph node, thymus, bone marrow etc.Therefore, only the function of guaranteed each immune system organ, tissue, cell is normal, could improve body immunity, keeps fit.
In the medicine of existing enhancing immunity, effect is good not, because contain other expensive compositions such as propolis, cause the cost of medicine too high, these all are unfavorable for promoting the use of of enhancing immunity medicine, therefore, need a kind of successful of invention and lower-cost enhancing immunity medicine.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine that helps enhancing immunity and preparation method thereof, is suitable for the sub-health population of hypoimmunity, but is unwell to children.The experiment proved that, this product safety, effective, long-term taking has no side effect, and product stability is good, and preparation technology is simple, and cost is low, is fit to suitability for industrialized production.
The present invention realizes by following technological means:
A kind of Chinese medicine that helps enhancing immunity, take Rhizoma Curcumae Longae extract and Ganoderma extract as major ingredient, take microcrystalline Cellulose, carboxymethyl starch sodium and magnesium stearate as adjuvant, wherein, Rhizoma Curcumae Longae extract account for gross weight 10～40%, Ganoderma extract accounts for gross weight 20～50%.
Preferably, described Rhizoma Curcumae Longae extract is to be extracted through processing by the Rhizoma Curcumae Longae raw material to obtain, and wherein, the content of curcumin is not less than 50%.
Preferably, described Ganoderma extract is to be extracted through processing by the Ganoderma raw material to obtain, and wherein, the content of crude polysaccharides is not less than 10%.
As required, can with after the coated powder coating of described Chinese medicine, make coated tablet.
A kind ofly prepare the above-mentioned method that helps the Chinese medicine of enhancing immunity, comprise the steps:
(1) mix: in proportion satisfactory Rhizoma Curcumae Longae extract, Ganoderma extract, microcrystalline Cellulose and carboxymethyl starch sodium are crossed the 70-100 mesh sieve, mix homogeneously obtains total mixed powder;
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, cross the 16-20 mesh sieve and granulate, after 16-20 mesh sieve granulate, get dried granule after drying, with described dried granule and after crossing the magnesium stearate mix homogeneously of 70-100 mesh sieve, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting, reject underproof plain sheet, obtain qualified plain sheet, more coated, obtain qualified coated tablet finished product.
Preferably, in blend step, described Rhizoma Curcumae Longae extract, Ganoderma extract, microcrystalline Cellulose and carboxymethyl starch sodium can be placed in mixer and stir and mixed in 20～30 minutes.
Preferably, described dried granule time of mixing with the magnesium stearate of crossing the 70-100 mesh sieve is 5～10 minutes.
Preferably, the moisture of described dried granule is below 5%.
Preferably, the leaching process of described Rhizoma Curcumae Longae extract is:
(1) alcohol extraction: with the Rhizoma Curcumae Longae raw material pulverizing that cleans, the edible ethanol with 95% adopts percolation to extract, and gets alcohol extract;
(2) concentrated: through distilling under reduced pressure, being concentrated into relative density is 1.20～1.25, gets concentrated solution with described alcohol extract;
(3) crystallization: described concentrated solution is carried out repeatedly crystallization with 65% edible ethanol, obtain the Rhizoma Curcumae Longae crystal;
(4) post processing: described Rhizoma Curcumae Longae crystal is carried out drying, pulverizing, obtain the Rhizoma Curcumae Longae extract finished product.
Further, in the leaching process of described Rhizoma Curcumae Longae extract, described distilling under reduced pressure is to carry out under 55～65 ℃, vacuum are the condition of 0.08MPa.
Preferably, the leaching process of described Ganoderma extract is:
(1) water extraction: the Ganoderma raw material that cleans is boiled 1 time with the decocting of 6,5,5 times of amounts respectively, and each 2 hours, merging filtrate after filtering got extracting solution;
(2) concentrated: through distilling under reduced pressure, being concentrated into relative density is 1.05～1.15, gets concentrated solution with described extracting solution;
(3) drying: described concentrated solution is carried out spray drying, get dry extract;
(4) post processing: described dry extract is pulverized, namely got the Ganoderma extract finished product.
Further, in the leaching process of described Ganoderma extract, described distilling under reduced pressure is to carry out under 70～80 ℃, vacuum are the condition of 0.08MPa.
Further, in the leaching process of described Ganoderma extract, the inlet temperature of described spray-drying process is 140～160 ℃, and leaving air temp is 70～80 ℃.
Chinese medicine thinks, the immune defense function of human body belongs to the category of healthy energy, and it had both comprised the natural defense function of body, also comprised specific immune response.If QI and blood is full, healthy energy is sufficient, QI movement being in harmonious way, and how normal immunologic function is, is difficult for being attacked by pathogens such as pathogenic microorganisms; Weak QI and blood is deficient, positive QI-insufficiency, and the many defectives of immunologic function or low are easily caused disease by the invasion and attack of the pathogens such as pathogenic microorganism.Therefore ancients have the theory of " healthy energy deposit in, heresy can not be done ", " institute of heresy gathers, and its gas must be empty ", have illustrated that the healthy energy that improves human body is enhancing human body immunity power, the key factor of preventing and curing diseases.According to the theory of immunity of above-mentioned Chinese medicine, it is the raw material prescription that the present invention selects Rhizoma Curcumae Longae extract with circulation of qi promoting removing blood stasis with potent drugs, inducing menstruation to relieve menalgia and Ganoderma extract that can tonification whole body QI of five ZANG-organs, has developed to have the Chinese medicine that strengthens immunologic function.This product Ganoderma master is in QI invigorating, and Rhizoma Curcumae Longae focuses on circulation of qi promoting, and both compatibility can make whole body healthy energy sufficient, QI movement being in harmonious way.This product function is clear and definite, and edible safety is the health-care good product that improves immunity of organisms.
Rhizoma Curcumae Longae extract is that tuber or the rhizome of zingiberaceous plant Rhizoma Curcumae Longae makes with extra care through extracting crocus crystallization or the powder that obtains, and its active component mainly is comprised of curcumin, demethoxycurcumin, Bisdemethoxycurcumin etc.The hot temperature of Rhizoma Curcumae Longae property, return spleen, Liver Channel, have the removing blood stasis circulation of qi promoting, the effect of inducing menstruation to relieve menalgia; Also have simultaneously the functions such as antioxidation, infection, antiinflammatory, anticoagulant, blood fat reducing, atherosclerosis and inhibition tumor growth.Water insoluble and the ether of curcumin is dissolved in ethanol, glacial acetic acid, propylene glycol, to thermally-stabilised, but unstable in illumination and alkali liquor, be widely used in the industry such as food, article of everyday use and pharmacy, safety non-toxic, having no side effect, is one of a kind of natural pigment that has DEVELOPMENT PROSPECT.
Ganoderma extract is that Ganoderma is through the extract of processing.Ganoderma is Basidiomycetes, and Polyporaceae belongs to fungus.Ancient Chinese medicine doctor thinks that Ganoderma is strengthening the body resistance, the treasure of strengthening by means of tonics.Its property is flat, sweet in the mouth, GUIXIN, lung, liver, kidney channel.The Compendium of Material Medica record, Ganoderma can " be controlled knot in the heart, the motive of hanging ", " enter the heart being responsible for production of blood, help the heart to fill arteries and veins ", " calming the nerves ", " protecting god ", and " lung benefiting, spleen, vital essence ", " tonifying liver gas " etc. all has benefiting action to the whole body QI of five ZANG-organs.Modern study shows that Ganoderma contains polysaccharide, aminoacid, protein, polypeptide, steroid class, terpenoid, organic acid and volatilization wet goods composition, wherein ganoderan is main biological activity, has the growth regulating immunologic function, suppress real tumor body in Mice Body, stimulates insulin secretion, promotes the effect such as synthetic of nucleic acid and protein.Pharmacological testing shows, Ganoderma can increase body Thymus and spleen weight, increases the phagocytic function of macrophage, promotes the generation of T lymphocyte transformation and hemolysin, the effect with obvious enhancing human body immunity power.Ganoderma is healthy food material commonly used, is widely used in clinically, and its safety is confirmed.
A key character of the present invention is the compatibility of Rhizoma Curcumae Longae extract and two kinds of raw materials of Ganoderma extract, take curcumin as significant composition, function is clear and definite, bring into play integrally-regulated advantage, regulate each function of whole body, improve the healthy energy of human body, finally reach the effect of improving body constitution, enhancing immunity.
The safety evaluatio result of the test shows, this product safe without toxic side effect; The functional trial result shows, this product has the good enhancing immunity effect that helps; The study on the stability result shows, this product steady quality before the deadline is reliable.
Formula of the present invention is reasonable, effect is balanced, is a kind of good health care Chinese medicine that helps enhancing immunity, and does not adopt a large amount of expensive compositions, and greatly reduce the use cost of medicine, such product will have wide market prospect.
Description of drawings
Fig. 1 is the flow chart of the described preparation method of the embodiment of the present invention, and wherein, each step all requires 300,000 grades of cleanliness factors.
The specific embodiment
Below describe the preferred embodiment of the present invention, but be not to limit the present invention.
Embodiment 1:
Be prepared as follows the described Chinese medicine that helps enhancing immunity:
(1) mix: with satisfactory Rhizoma Curcumae Longae extract 45g, Ganoderma extract 150g, microcrystalline Cellulose 78g and carboxymethyl starch sodium 24.9g, cross respectively 70 mesh sieves, be placed in mixer and stirred 30 minutes, make its mix homogeneously, obtain total mixed powder;
Wherein, the leaching process of described Rhizoma Curcumae Longae extract is: with the Rhizoma Curcumae Longae raw material pulverizing that cleans, the edible ethanol with 95% adopts percolation to extract, and gets alcohol extract; Be under the condition of 0.08MPa at 55～65 ℃, vacuum, described alcohol extract is carried out distilling under reduced pressure, being concentrated into relative density is 1.20～1.25, gets concentrated solution, and the ethanol with evaporation reclaims simultaneously; Described concentrated solution is carried out repeatedly crystallization with 65% edible ethanol, obtain the Rhizoma Curcumae Longae crystal; Described Rhizoma Curcumae Longae crystal is carried out drying, pulverizing, obtain the Rhizoma Curcumae Longae extract finished product, extract yield and be about 5%, wherein the content of curcumin is not less than 50%.
The leaching process of described Ganoderma extract is: the Ganoderma raw material that cleans is boiled 1 time with the decocting of 6,5,5 times of amounts respectively, and each 2 hours, merging filtrate after filtering got extracting solution; Be under the condition of 0.08MPa at 70～80 ℃, vacuum, described extracting solution is carried out distilling under reduced pressure, being concentrated into relative density is 1.05～1.15, gets concentrated solution; Described concentrated solution is carried out spray drying, and wherein, inlet temperature is 140～160 ℃, and leaving air temp is 70～80 ℃, gets dry extract; Described dry extract is pulverized, namely got the Ganoderma extract finished product, extract yield and be about 15%, wherein the content of crude polysaccharides is not less than 10%.
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, crossing 16 mesh sieves granulates, after drying after 16 mesh sieve granulate, obtain moisture and be the dried granule below 5%, described dried granule was mixed 10 minutes with the magnesium stearate that 2.1g crosses 70 mesh sieves, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting by the specification of 0.3g/ sheet, reject underproof plain sheet, obtain qualified plain sheet, recycling 9g coating powder coordinates coating solution to carry out coating, obtains qualified coated tablet finished product 1.
Embodiment 2:
Be prepared as follows the described Chinese medicine that helps enhancing immunity:
(1) mix: with satisfactory Rhizoma Curcumae Longae extract 75g, Ganoderma extract 120g, microcrystalline Cellulose 79g and carboxymethyl starch sodium 23.9g, cross respectively 80 mesh sieves, be placed in mixer and stirred 28 minutes, make its mix homogeneously, obtain total mixed powder;
Wherein, the acquisition methods of described Rhizoma Curcumae Longae extract and Ganoderma extract is in the same manner as in Example 1.
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, crossing 18 mesh sieves granulates, after drying after 18 mesh sieve granulate, obtaining moisture is must do granule below 5%, described dried granule was mixed 8 minutes with the magnesium stearate that 2.1g crosses 80 mesh sieves, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting by the specification of 0.3g/ sheet, reject underproof plain sheet, obtain qualified plain sheet, recycling 9g coating powder coordinates coating solution to carry out coating, obtains qualified coated tablet finished product 2.
Embodiment 3:
Be prepared as follows the described Chinese medicine that helps enhancing immunity:
(1) mix: with satisfactory Rhizoma Curcumae Longae extract 105g, Ganoderma extract 90g, microcrystalline Cellulose 80g and carboxymethyl starch sodium 22.9g, cross respectively 90 mesh sieves, be placed in mixer and stirred 20 minutes, make its mix homogeneously, obtain total mixed powder;
Wherein, the acquisition methods of described Rhizoma Curcumae Longae extract and Ganoderma extract is in the same manner as in Example 1.
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, crossing 18 mesh sieves granulates, after drying after 18 mesh sieve granulate, obtaining moisture is must do granule below 5%, described dried granule was mixed 6 minutes with the magnesium stearate that 2.1g crosses 90 mesh sieves, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting by the specification of 0.3g/ sheet, reject underproof plain sheet, obtain qualified plain sheet, recycling 9g coating powder coordinates coating solution to carry out coating, obtains qualified coated tablet finished product 3.
Embodiment 4:
Be prepared as follows the described Chinese medicine that helps enhancing immunity:
(1) mix: with satisfactory Rhizoma Curcumae Longae extract 120g, Ganoderma extract 75g, microcrystalline Cellulose 81g and carboxymethyl starch sodium 21.9g, cross respectively 100 mesh sieves, be placed in mixer and stirred 25 minutes, make its mix homogeneously, obtain total mixed powder;
Wherein, the acquisition methods of described Rhizoma Curcumae Longae extract and Ganoderma extract is in the same manner as in Example 1.
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, crossing 20 mesh sieves granulates, after drying after 20 mesh sieve granulate, obtain moisture and be the dried granule below 5%, described dried granule was mixed 5 minutes with the magnesium stearate that 2.1g crosses 100 mesh sieves, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting by the specification of 0.3g/ sheet, reject underproof plain sheet, obtain qualified plain sheet, recycling 9g coating powder coordinates coating solution to carry out coating, obtains qualified coated tablet finished product 4.
For further proving effect and the performance that helps the Chinese medicine of enhancing immunity of the present invention, the qualified coated tablet finished product 2 (become body weight for humans to press 60kg and calculate, amounting to dosage is 20mg/kg BW) of choosing in embodiment 2 carries out following test:
Toxicological test
Test objective: whether the check product has toxicity.
Animal subject: the healthy Kunming mouse of SPF level; SPF level healthy SD kind rat.
Experimental enviroment: laboratory animal room is barrier system, and temperature is 22～25 ℃, and relative humidity is 55～70%.
Test method:
According in Ministry of Public Health " health food check with assessment technique standard " (version in 2003) about toxicological assessment test requirements document test, specifically comprise the test of chmice acute Oral toxicity, pollutant mutagenicity detection (Salmonella reversion test), mouse marrow cell micro nuclear test, mouse sperm deformity test, 30 days feeding trials of rat, wherein, the healthy Kunming mouse of SPF level is all adopted in the test of chmice acute Oral toxicity, mouse marrow cell micro nuclear test and mouse sperm deformity test, and 30 days feeding trials of rat adopt SPF level healthy SD kind rat.
The toxicity test result is as follows:
Table 1-1 chmice acute Oral toxicity result of the test
Through table 1-1 as can be known, after giving mouse stomach with the sample of 30000mg/kg BW dosage, growth of animal is good, has no body weight and is affected.Tested mice has been showed no poisoning symptom, observes 14 days without animal dead.Animal, gross examination of skeletal muscle are dissected in off-test, the main organs such as liver,kidney,spleen, the heart, lung, stomach, intestinal are showed no obvious abnormalities change, according to the acute toxicity grading criteria in " health food check and assessment technique standard " (version in 2003), the acute oral toxicity of this sample belongs to nontoxic level.
Table 1-2Ames result of the test (for the first time)
Table 1-3Ames result of the test (for the second time)
Annotate: 1, TA97a, TA98, TA100, TA102 are four kinds of bacterial strains of Salmonella typhimurium histidine defect type.
2, S
-9The rat liver microsomes enzyme of inducing for Polychlorinated biphenyls is as Metabolic Activation of Cyclophosphamide.
3, the result (clump count) of above table 1-2,1-3 is the means standard deviation of 3 plates.
4, positive control: TA97a+S
-9, TA98+S
-9, TA100+S
-9Adopt 2-aminofluorene (dosage is 10 μ g/ wares); TA98-S
-9Adopt daunorubicin (dosage is 6 μ g/ wares); TA97a-S
-9, TA102-S
-9Adopt fenaminosulf (dosage is 50 μ g/ wares); TA100-S
-9Adopt sodium azide (dosage is 1.5 μ g/ wares); TA102+S
-9Adopt 1,8-dihydroxyanthraquinone (dosage is 50 μ g/ wares).
From table 1-2, table 1-3 as seen, to TA97a, TA98, TA100, four kinds of test strains of TA102, no matter whether add S-9, returning of each dosage group of sample becomes the bacterium colony number average over certainly beaming back the twice that becomes clump count, also without dose-response relationship, show that this tested material mutagenesis testing result is negative.
Table 1-4 mouse Bone marrow cells micronucleus incidence rate result of the test
Annotate: PCE is polychromatic erythrocyte, and PEC/NCE is the ratio of polychromatic erythrocyte and mature erythrocyte; * and negative control group compare, P＜0.01; Cp is cyclophosphamide.
From table 1-4 as seen, the bone marrow cell micronucleus rate of each dosage group mice of sample and negative control group compare, and there are no significant for difference (P＞0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P＜0.01).Having no this sample has damage the medullary cell of mice.
Table 1-5 Sperm Abnormalities of Mice result of the test
Annotate: * * and negative control group compare, P＜0.01; Cp is cyclophosphamide.
From table 1-5 as seen, sample does not produce obvious change to Sperm Abnormalities of Mice, the rate of teratosperm of each dosage group of sample and negative control group are relatively, there are no significant for difference (P＞0.05), and cyclophosphamide positive controls and negative control group comparing difference have utmost point significance (P＜0.01).Have no this sample mouse sperm is produced the distortion effect.
In addition, 30 days feeding trial results show: with the sample of 2000mg/kg BW, 1500mg/kg BW, a 1000mg/kg BW3 dosage (be equivalent to respectively human body and recommend consumption 100,75,50 times) continuously to rat oral gavage 30 days, the experimental session animal growth is good, and the body weight of each dosage group rat, gain in weight, food-intake, food utilization, routine blood test index, blood parameters, organ weights and internal organs/body weight ratio etc. all is not significantly affected; The gross anatomy observation has no the abnormal change relevant with sample with histopathological examination.Have no this sample in tested dosage range the every observation index of rat is produced toxic and side effects.
Function test
Test objective: whether the check product efficacy is obvious.
Animal subject: 200 of the healthy elder brother's Male Kunming strain mice of SPF level, body weight is 18～22 grams.Every 40 mices are one group, totally 5 groups.Immunity I group is carried out mouse spleen lymphocyte transformation experiment, NKT (NK) cytoactive detection that ConA induces; Immunity II group is carried out the delayed allergy experiment; Immunity III group is carried out dirty/body ratio measurement, and serum hemolysin is measured and the antibody-producting cell number is measured; Immunity IV group is carried out carbon and is cleaned up experiment; Immunity V group is carried out Turnover of Mouse Peritoneal Macrophages and is engulfed the chicken red blood cell experiment.
Experimental enviroment: temperature is 22～25 ℃, and relative humidity is 55～70%.
Dosage is selected to give mode with tested material: recommend consumption according to human oral, if the basic, normal, high dosage group of sample is respectively 100mg/kg BW, 200mg/kg BW, 400mg/kg BW (be equivalent to respectively human body and recommend 5,10,20 times of consumption), if a negative control group, every group of 10 animals.Take respectively the qualified coated tablet 0.5g of the present invention, 1.0g, 2.0g, respectively add pure water to 100mL, be made into respectively 5mg/mL, 10mg/mL, 20mg/mL concentration solution, give respectively corresponding dosage treated animal gavage, the gavage amount is 0.2mL/10g BW, matched group gives isopyknic pure water, every day gavage once, continuously gavage is 30 days.
test method: according to testing about the requirement of enhancing immunity functional check method in Ministry of Public Health " health food check and assessment technique standard " (version in 2003), specifically comprise internal organs/weight ratio pH-value determination pH, the mouse spleen lymphocyte transformation experiment (mtt assay) that ConA induces, the mouse DTH experiment (ear swelling method) that dinitrofluorobenzene is induced, antibody-producting cell detects (Jerne improves slide method), the mensuration of serum hemolysin (Hemagglutination Method), mice carbon is cleaned up experiment, Turnover of Mouse Peritoneal Macrophages is engulfed chicken red blood cell experiment (half intracorporal method), NK cytoactive detection (LDH algoscopy).
The function test result is as follows:
1. the impact of sample on Mouse Weight
Table 2-1 sample affects result to Mouse Weight
(immune I group)
Annotate: each dosage group experiment is initial, Mouse Weight and the weightening finish and matched group comparison in mid-term and latter stage, and there are no significant for difference (P＞0.05).
Table 2-2 sample affects result to Mouse Weight
(immune II, III, IV, V group)
Immunity II group
Immunity III group
Immunity IV group
Immunity V group
Annotate: each dosage group experiment is initial, Mouse Weight and the weightening finish and matched group comparison in mid-term and latter stage, and there are no significant for difference (P＞0.05).
By table 2-1, table 2-2 as seen, per os gives the sample 30 days of mice various dose, compare between experiment initial stage, the Mouse Weight of testing mid-term, experiment each dosage group in latter stage and experimental session weight of mice and negative control group, there are no significant for difference (P＞0.05), shows that this sample has no significant effect the body weight gain of mice.
2. the impact of sample on mouse immune organ internal organs/body weight ratio
The immune organ internal organs of table 2-3 mice/body weight ratio
Test result
By table 2-3 as seen, per os gives the sample 30 days of mice various dose, thymus/body weight of mice and spleen/body weight ratio and negative control group compare, and difference that there are no significant (P＞0.05) shows that this sample has no significant effect the immune organ weight of mice.
3. the impact of sample on mouse immune organ internal organs/body weight ratio
3.1 the impact of the mouse spleen lymphocyte conversion capability that sample is induced ConA
Table 2-4 mouse lymphocyte transformation experiment result
From table 2-4 as seen, the lymphocyte transformation ability of each dosage group mice of sample is all higher than negative control group, and the difference of high dose group and negative control group has very significant (P＜0.01), shows that this sample has the lymphopoiesis that promotes mice, the effect of conversion capability.
3.2 the impact of sample on mice delayed allergy (DTH)
Table 2-5 mice delayed allergy (DTH) experimental result
From table 2-5 as seen, sample is high, the left and right auricle weight difference of middle dosage group mice is higher than negative control group, high dose group wherein and the difference of negative control group have significance (P＜0.05), show that this sample has the effect that promotes delayed allergy.
4. the impact of sample on the humoral immunization of mice
4.1 the impact of sample on the antibody-producting cell number of mice
Table 2-6 antibody-producting cell test experience result
From table 2-6 as seen, the antibody-producting cell number average of each dosage group mice of sample is higher than negative control group, and the difference of high dose group and negative control group has significance (P＜0.05), shows that this sample has the effect of the antibody-producting cell propagation that promotes mice.
4.1 the impact of sample on the mice serum hemolysin
Table 2-7 mice hemolysin test result
From table 2-7 as seen, the antibody product of each dosage mice of sample is all higher than negative control group, and the difference of high dose group and negative control group has very significant (P＜0.01), shows that this sample has the effect of the serum hemolysin of raising mice.
5. the impact of sample on the monocytes/macrophages phagocytic function of mice
5.1 the impact that sample is cleaned up the monocytes/macrophages carbon of mice
Table 2-8 mice carbon is cleaned up experimental result
From table 2-8 as seen, the phagocytic index of each dosage mice of sample is all higher than negative control group, and high, middle dosage group has significance (P＜0.05) with the difference of negative control group, shows that this sample has the effect that the monocytes/macrophages carbon of promotion mice is cleaned up function.
5.2 sample is engulfed the impact of chicken red blood cell ability on the peritoneal macrophage of mice
Table 2-9 Turnover of Mouse Peritoneal Macrophages is engulfed the chicken red blood cell experimental result
From table 2-9 as seen, the peritoneal macrophage of each dosage group mice of sample to the phagocytic rate of chicken red blood cell and phagocytic index all higher than negative control group, and the difference of the phagocytic rate of high dose group and phagocytic index and negative control group has significance (P＜0.05 or P＜0.01), shows that this sample has the effect of the Peritoneal Macrophage Phagocytosis that promotes mice.
6. the impact of sample on the NK cytoactive of mice
Table 2-10 NK cells in mice determination of activity result
From table 2-10 as seen, the NK cytoactive of each dosage group mice of sample is all higher than negative control group, but the difference of each dosage group and negative control group there are no significant (P＞0.05), show that this sample has no significant effect the NK cells in mice activity.
brief summary: per os gives mice 100mg/kg BW, 200mg/kg BW, 400mg/kg BW (is equivalent to human body and recommends consumption 5, 10, 20 times) the qualified coated tablet of the present invention of dosage 30 days, can promote the spleen lymphocyte proliferation of mice, transformation, promote the delayed allergy of mice, promote the antibody-producting cell propagation of mice, improve the serum hemolysin of mice, promote the phagocytic activity of the monocytes/macrophages of mice, body weight gain to mice, thymus/body weight ratio, spleen/body weight ratio and NK cytoactive have no significant effect, point out this sample to have the enhancing immunity function.
Separately show through the study on the stability result, this product steady quality before the deadline is reliable.
In sum, Chinese medicine of the present invention has the effect of obvious enhancing immunity, have no side effect, steady quality is reliable, and preparation method is simple, component is cheap and easy to get, cost is relatively low, has a extensive future.
Claims (13)
1. Chinese medicine that helps enhancing immunity, it is characterized in that: take Rhizoma Curcumae Longae extract and Ganoderma extract as major ingredient, take microcrystalline Cellulose, carboxymethyl starch sodium and magnesium stearate as adjuvant, wherein, Rhizoma Curcumae Longae extract account for gross weight 10～40%, Ganoderma extract accounts for gross weight 20～50%.
2. the Chinese medicine that helps enhancing immunity according to claim 1 is characterized in that: described Rhizoma Curcumae Longae extract is to be extracted through processing by the Rhizoma Curcumae Longae raw material to obtain, and wherein, the content of curcumin is not less than 50%.
3. the Chinese medicine that helps enhancing immunity according to claim 1 is characterized in that: described Ganoderma extract is to be extracted through processing by the Ganoderma raw material to obtain, and wherein, the content of crude polysaccharides is not less than 10%.
4. the Chinese medicine that helps enhancing immunity according to claim 1, it is characterized in that: described Chinese medicine is coated tablet.
5. one kind prepares the method that helps the Chinese medicine of enhancing immunity as claimed in claim 1, it is characterized in that, comprises the steps:
(1) mix: in proportion satisfactory Rhizoma Curcumae Longae extract, Ganoderma extract and microcrystalline Cellulose, carboxymethyl starch sodium are crossed the 70-100 mesh sieve, mix homogeneously obtains total mixed powder;
(2) granulate: described total mixed powder is made soft material with 95% ethanol mixing moistening, cross the 16-20 mesh sieve and granulate, after 16-20 mesh sieve granulate, get dried granule after drying, with described dried granule and after crossing the magnesium stearate mix homogeneously of 70-100 mesh sieve, obtain hybrid particles;
(3) finished product: described hybrid particles is carried out tabletting, reject underproof plain sheet, obtain qualified plain sheet, more coated, obtain qualified coated tablet finished product.
6. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 5 is characterized in that: described Rhizoma Curcumae Longae extract, Ganoderma extract, microcrystalline Cellulose and carboxymethyl starch sodium are placed in mixer stir and mixed in 20～30 minutes.
7. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 5 is characterized in that: described dried granule is 5～10 minutes with the time that the magnesium stearate of crossing the 70-100 mesh sieve is mixed.
8. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 5, it is characterized in that: the moisture of described dried granule is below 5%.
9. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 5, is characterized in that, the leaching process of described Rhizoma Curcumae Longae extract is:
(1) alcohol extraction: with the Rhizoma Curcumae Longae raw material pulverizing that cleans, the edible ethanol with 95% adopts percolation to extract, and gets alcohol extract;
(2) concentrated: through distilling under reduced pressure, being concentrated into relative density is 1.20～1.25, gets concentrated solution with described alcohol extract;
(3) crystallization: described concentrated solution is carried out repeatedly crystallization with 65% edible ethanol, obtain the Rhizoma Curcumae Longae crystal;
(4) post processing: described Rhizoma Curcumae Longae crystal is carried out drying, pulverizing, obtain the Rhizoma Curcumae Longae extract finished product.
10. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 9 is characterized in that: in the leaching process of described Rhizoma Curcumae Longae extract, described distilling under reduced pressure is to carry out under 55～65 ℃, vacuum are the condition of 0.08MPa.
11. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 5 is characterized in that, the leaching process of described Ganoderma extract is:
(1) water extraction: the Ganoderma raw material that cleans is boiled 1 time with the decocting of 6,5,5 times of amounts respectively, and each 2 hours, merging filtrate after filtering got extracting solution;
(2) concentrated: through distilling under reduced pressure, being concentrated into relative density is 1.05～1.15, gets concentrated solution with described extracting solution;
(3) drying: described concentrated solution is carried out spray drying, get dry extract;
(4) post processing: described dry extract is pulverized, namely got the Ganoderma extract finished product.
12. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 11 is characterized in that: in the leaching process of described Ganoderma extract, described distilling under reduced pressure is to carry out under 70～80 ℃, vacuum are the condition of 0.08MPa.
13. the method that is prepared with the Chinese medicine that helps enhancing immunity according to claim 11 is characterized in that: in the leaching process of described Ganoderma extract, the inlet temperature of described spray-drying process is 140～160 ℃, and leaving air temp is 70～80 ℃.
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| CN103800390A (en) * | 2014-01-20 | 2014-05-21 | 天津铸源健康科技集团有限公司 | Health-care product with immunity-reinforcing and liver-protecting functions, preparation method and application thereof |
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| CN104623541A (en) * | 2015-01-20 | 2015-05-20 | 北京东方红航天生物技术股份有限公司 | Traditional Chinese medicine conductive to enhancing immunity and preparation method thereof |
| CN105561215A (en) * | 2016-03-03 | 2016-05-11 | 湖北省中医院 | Poria cocos-lucid ganoderma-rhizoma curcumae longae compound preparation |
| CN105770727A (en) * | 2016-03-03 | 2016-07-20 | 湖北省中医院 | Preparation technology of poria cocos and glossy ganoderma health-care compound preparation |
| CN105999096A (en) * | 2016-07-07 | 2016-10-12 | 天津天狮生物发展有限公司 | Composition for enhancing immunity and application |
| CN107136510A (en) * | 2017-07-12 | 2017-09-08 | 延边韩工坊健康制品有限公司 | One kind improves immunity health food and preparation method thereof |
| CN108576819A (en) * | 2018-04-24 | 2018-09-28 | 北京中和鸿业医药科技有限公司 | A kind of liver-protecting combination, health food, preparation method and applications |
| CN110250516A (en) * | 2019-07-11 | 2019-09-20 | 中国科学院烟台海岸带研究所 | It is a kind of with relieving stress with the composition of strengthen immunity and preparation method thereof |
| CN111549084A (en) * | 2020-05-12 | 2020-08-18 | 营家健康科技(广东)有限公司 | Method for preparing protein small molecule peptide by simulating human body digestive tract enzymolysis |
| CN111549084B (en) * | 2020-05-12 | 2020-12-25 | 营家健康科技(广东)有限公司 | Method for preparing protein small molecule peptide by simulating human body digestive tract enzymolysis |
| CN113713075A (en) * | 2021-09-16 | 2021-11-30 | 江苏盛世康禾生物技术有限公司 | Chinese medicinal preparation with immunity enhancing function and preparation method thereof |
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