CN104605344A - Health food for enhancing immunity and preparation method of health food - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition for enhancing immunity. The traditional Chinese medicine composition for enhancing immunity is prepared through the following steps: taking prepared rehmannia root, tortoise shell prepared with vinegar, glossy privet fruits, rhodiola rosea, mulberries, alpinia oxyphylla and gardenia as raw materials, extracting, concentrating, drying and adding auxiliary materials according to a certain ratio. The composition preparation has the function of enhancing the immunity.

Description

Health food of a kind of develop immunitypty and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition of develop immunitypty, particularly a kind of is Chinese medicine preparation composition prepared by bulk drug by prepared rhizome of rehmannia, vinegar tortoise plastron, the fruit of glossy privet, rhodiola root, fructus alpiniae oxyphyllae, mulberry fruit, cape jasmine.

Technical background

Body immunity comes in the immune system of self, and immune system is made up of immune organ, immunocyte and immune factor.Immunocyte, immune factor distribution whole body, seething, form a network mutually restricted, the immunologic function dominating human body resists bacterium, poisoning intrusion, the cell of damage sex change and aging in purged body, purged body intracellular metabolite refuse, maintains the stable of organismic internal environment.

Along with the develop rapidly of economy, the rhythm of life of people accelerates, and nervous, overtime work stays up late phenomenon generally, and shorten the length of one's sleep, the not high immunity of organisms that causes of sleep quality declines, easy catching a cold, endocrinopathy in addition.Immunocompromised patients also easily infects tuberculosis.

Modern study finds, much Chinese medicine all has immunoregulation effect.In vitro and in vivo experiment all shows, be no matter that single medicine or prescription all can affect the secretion of cell factor, the release of histamine, the synthesis of immunoglobulin (Ig) and type conversion, the expression of cell surface receptor, lymphocyte proliferation test, have therapeutic action to infection and tumour.

In the five internal organs of the traditional Chinese medical science, the relation of spleen and kidney and immunity is very close, and the kidney being the origin of congenital constitution, the root of the five internal organs, the door of life.Kidney qi foot, health is good for, and the immunologic function of body is just normal; Kidney qi declines, the positive deficiency of vital energy, and the immunologic function of body is just low.The traditional Chinese medical science proposes " the spleen being the foundation of acquired constitution, source of generating QI and blood ", and " The spleen has the function to transport and transform nutrients ", this and microecological balance have close inner link.Harmonizing the spleen and stomach and adjustment microecological balance, the immunity improving body is closely related.Modern to spleen, the experimental study of suffering from a deficiency of the kidney, confirm spleen, suffer from a deficiency of the kidney consistent with immunologic hypofunction degree, theory of traditional Chinese medical science suffer from a deficiency of the kidney most notably, be also that immunologic function damages most severe patient.

Invigorating the spleen, kidney tonifying etc. is had to the influential Chinese traditional treatment method of immunity.

In this product prescription, prepared rhizome of rehmannia has enriching yin of enriching blood, and beneficial essence fills out marrow function, and the fruit of glossy privet has nourishing liver and kidney function, fructus alpiniae oxyphyllae has warm kidney controlling nocturnal emission with astringent drugs function, and tortoise plastron has enriching yin, and nourish blood function, mulberry fruit has nourishing yin and supplementing blood function, is therefore nourished blood by replenishing vital essence to tonify kidney, and beneficial essence is filled out marrow and carried out develop immunitypty; Rhodiola root has qi and activate blood circulation function, and fructus alpiniae oxyphyllae also has warm splenic function, warm spleen qi and activate blood circulation, again can develop immunitypty; Cape jasmine can let out fiery relieving restlessness, clearing heat and promoting diuresis, removing pattogenic heat from the blood and toxic material from the body, can avoid the greasy stomach that hinders of taste in the nourishings such as prepared rhizome of rehmannia, prepared rhizome of rehmannia can be made to play nourishing yin and supplementing blood better, expel the heat-evil simultaneously and deposit the moon.This product kidney tonifying temperature spleen, the first day after tomorrow also mends, and also fills blood, reaches strengthening vital QI to eliminate pathogenic factors object, develop immunitypty.

Prepared rhizome of rehmannia: prepared rhizome of rehmannia be Scrophulariaceae herbaceos perennial glutinous rehmannia dried root through steeping in wine mix steam after drier person obtain.Prepared rhizome of rehmannia contains multiple methods of glycosides, based on iridoid glycosides, as Catalpol (catalpol), dihydro Catalpol (dihydrocatalpol), acetylcatalpol, aucubin (aucubin), single close Z-TEK glycosides (danmelittoside), martynoside A, B, C, D (rehmanniosideA, B, C, D) etc.Containing 8 kinds of saccharide compounds such as Dihuang polysaccharide RPS-b, stachyose, gossypose, glucose, sucrose, fructose, manninotrioses in prepared rhizome of rehmannia.Prepared rhizome of rehmannia is enriched blood enriching yin, and beneficial essence fills out marrow, sallow for the deficiency of blood, palpitation and severe palpitation, irregular menstruation, metrostaxis, the deficiency of liver-yin and kidney-yin, soreness and weakness of waist and knees, osteopyrexia and fever, and night sweat is passed out semen, and interior heat is quenched one's thirst, dizzy, tinnitus, poliosis.

Modern pharmacological research its on immune impact: be 18% to increment rate after white blood cell count(WBC) medication, enhance the immunologic function of body to a certain extent.Experiment proves, Dihuang polysaccharide can significantly improve the lymphocytic breeder reaction ability of normal mouse T in experiment in vitro in vivo and the long period can maintain higher level, shows obvious immunoregulatory activity.Further research finds, Dihuang polysaccharide has suppression mouse S180 function of tumor, and the generation of this tumor-inhibiting action is relevant with the decline that part improves interleukin 2 (IL-2) secretion capacity with the decline of the vigor reversing cytotoxic T lymphocyte (CTL).Research finds that prepared rhizome of rehmannia water extract and Thick many candies all significantly can promote concanavalin A, the lymphocytic propagation of mouse thymus and spleen before and after stimulating, improve supernatant interleukin 2, interferon-γ, interleukin 4, interleukin 5 level, and present dose-dependent relationship.

Vinegar tortoise plastron: tortoise plastron another name is tortoiseshell, and being dry carapace and the plastron of Testudinidae (Tesrudinidae) animal tortoise Chinemysreevesii (Gray), is the enriching yin medicinal material commonly used simply.Its main component is amino acid.Prove through pharmacological research and Clinical practice, tortoise plastron is put down, and taste is sweet, salty; Have nourishing Yin and falling fire, replenishing kidney and strengthening bone, the function of bushing of nourishing blood.For deficiency of Yin hectic fever, hectic fever due to yin night sweat, consumption of YIN caused by febrile disease, has a dizzy spell, endogenous deficient wind, soreness and weakness of waist and knees, forgetful disease such as grade of having a guilty conscience, and has good curative effect.Xie Yangzhou etc. find that the upper first decocting liquid of tortoise can make the humoral immunity of the rat reduced and cellular immune function be recovered preferably.

The fruit of glossy privet: the fruit of glossy privet is the ripening fruits of Oleaceae Ligustrum plant glossy privet.Chemical composition puts acid, oleic acid, linoleic acid, flavonoids etc. containing polysaccharide, oleanolic acid, palm fibre.Property is sweet, bitter, cool, returns liver, kidney, the heart channel of Hang-Shaoyin.The traditional Chinese medical science tonifies the liver and kidney, black invention order, effect of mental-tranquilization.Current research finds the effects such as the fruit of glossy privet has antitumor, liver protection effect, immunity moderation function, delays senility, anti-inflammatory, reducing blood lipid.Nearest discovery, the fruit of glossy privet can increase immune organ weight, can increase Thymus and spleen index by fruit of glossy privet decoction liquor to mouse gavaging.Fructus Ligustri Lucidi polysaccharide energy regulatory T-cell function, gives mouse peritoneal injection, and SPL can be made to strengthen the breeder reaction that conA stimulates, and 3H-TdR incorporation significantly increases.Experiment in vitro shows, and the fruit of glossy privet obviously can strengthen the lymphopoiesis that suboptimal dose PHA, CO cause, and strengthens the rat local graft versus host reaction that allo-lymphocytes causes.Give S180 tumor-bearing mice and gavage Fructus Ligustri Lucidi polysaccharide every day, continuous 14 days, find that it can promote tumor-bearing mice spleen bone-marrow-derived lymphocyte and the lymphocytic propagation of T, with Yac-1 cell as target cell, find that Fructus Ligustri Lucidi polysaccharide can also improve tumor-bearing mice NK cytoactive and strengthen the phagocytic function of mononuclear macrophage.

With fruit of glossy privet water decoction can make Hemolysin to mouse gavaging, IgG content significantly increases, antagonism ring phosphorus phthalein amine is to the inhibitory action of humoral immunity.

By fruit of glossy privet decoction liquor to mouse gavaging, significantly can strengthen mononuclear macrophage and effect is cleaned up to carbon granules in blood, increase phagocytic rate and the phagocytic index of peritoneal macrophage.

Rhodiola root: be the dry herb of Crassulaceae rhodiola herbaceos perennial rhodiola.Rhodiola root mainly containing rhodioside, tyrosol and Radix Phodiolae Polyose, and contains fat, sterol, phenolic compound, organic acid, tannin, multiple micro-element and water-soluble volatile oil; In addition, 18 seed amino acids such as asparatate, threonine serine, glutamic acid, glycine, alanine, valine, leucine, tyrosine, phenylalanine, lysine, histidine, arginine, proline are also comprised; 35 kinds of inorganic elements such as magnesium, calcium, potassium, phosphorus; The macro-and trace-element iron, aluminium, zinc, cobalt, cadmium, titanium, copper, manganese etc. of 15 kinds of needed by human.Rhodiola root has and strengthens memory, improves cardio-cerebrovascular function, strengthens immunity, antifatigue, resist oxygen lack, antitumor, hypoglycemic, antiviral, resisting microwave radiation, armour from many-sided pharmacological actions such as radical damages.

Zhang Ruxue research finds that Radix Phodiolae Polyose does not make significant difference to mouse peripheral blood leucocyte and thymic weight.Human peripheral blood Hb content has reducing effect at normal mouse, then has castering action at hypoimmunity mice.Radix Phodiolae Polyose can promote that normal mouse Splenic vein hemodynamics reacts and NK cell killing activity, and immune suppressed mouse These parameters can be made again to reverse simultaneously.

Fructus alpiniae oxyphyllae: intelligence development is the ripe dry fruit of Zingiber Alpinia plants intelligence development.Its composition is containing diaryl heptane class, flavonoids, sesquiterpenoids, sterol and methods of glycosides thereof.Traditional effect of intelligence development is warming spleen and stopping diarrhaly take the photograph saliva; warm kidney controlling nocturnal emission with astringent drugs contracting urine; and modern pharmacology research shows; the pharmacological action of intelligence development is far away moreover, also have anticancer, cardiac stimulant, vasodilator, calmness, analgesia, antiallergy, anti-ageing, anti-oxidant, improve many-sided pharmacologically active such as immunity, neuroprotective.The research such as KimSH finds that the water extract part of intelligence development has stronger inhibitory action through abdominal cavity or oral administration to the allergic reaction that immunoglobulin E mediates, abdominal cavity or oral administration, fructus alpiniae oxyphyllae water extract can suppress passive cutaneous anaphylaxis to react, intravenously administrable then shows faint restrictive function, result of study shows that fructus alpiniae oxyphyllae has obvious antianaphylaxis effect, point out that this phenomenon should be relevant with the metabolic pathway of active component in human body simultaneously, this extract shows different activity according to different way of administration, may be caused by different biologically actives.

Mulberry fruit: the ripening fruits of mulberry fruit system Moraceae Morus mulberry tree.Its composition has total reducing sugar 12.00% ~ 15.00%, free acid 1.86%, crude fibre 0.91%, crude protein 0.38%, ash content 0.66%, and the composition such as carrotene, vitamin C, vitamin B1, vitamin B2, rutin, myricetin, morin, anthocyanidin rutin sophorin, tannin, Cyanidin, volatile oil (being mainly Cineole and geraniol) and phosphatide (mainly containing phosphatid ylcholine, lysophosphatidyl choline and phosphatidyl-ethanolamine etc.).

Modern pharmacology experimental study shows that it can strengthen mouse immunity: 100% mulberry fruit decocting liquid, by 10g/kg gastric infusion 10d, has no significant effect normal mouse thymus weight and serum carbonic clearance speed, obviously can increase the weight of spleen.To the body weight of asthenic symptoms mouse caused by hydrocortisone, spleen, thymic weight and serum carbonic clearance speed all have significant increasing action.After same method administration 4d, find that mulberry fruit significantly can increase the serum hemolysin (P<0.01) of asthenic symptoms mouse caused by normal mouse and hydrocortisone, illustrate that it has humidification to humoral immunity.

Chu Wei observes the impact of mulberry fruit on immunologic function from cellular immunity and humoral immunity two aspect, found that: mulberry fruit is in adjustment body non-specific immune function, the phagocytic function of macrophage can be strengthened, compared with control group, its phagocytic index, phagocytic percentage all has marked difference, and (P<0.01, namely mulberry fruit has obvious humidification to Immune Function.

Cape jasmine: cape jasmine is Rubiaceae Gardenia Ellis evergreen shrubs cape jasmine, has another name called fructus gardeniae, Yellow Fructus Gardeniae, HUANGZHIZI etc., main product in Zhejiang, Fujian, Jiangxi, Hunan, Guangdong.The dry mature fruit of cape jasmine is used as medicine and claims cape jasmine.It is containing iridoids, organic acid, volatile oil, flavonoids, triterpenes, Coumarins, other classes.Iridoid constituents is its main component, has the multiple pharmacologically actives such as anti-inflammatory, anti-oxidant, cholagogic, diuresis, antitumor, antipyretic, analgesia, radiation protection, reducing blood lipid.

Summary of the invention

The object of the invention is to Chinese medicine composition of openly a kind of develop immunitypty and preparation method thereof.A kind of Chinese medicine composition of develop immunitypty, it is characterized in that: be prepared from by the Chinese medicine material medicine of following weight proportion, prepared rhizome of rehmannia 500 ~ 1000 parts, vinegar tortoise plastron 500 ~ 1000 parts, the fruit of glossy privet 200 ~ 800 parts, rhodiola root 200 ~ 800 parts, fructus alpiniae oxyphyllae 50 ~ 700 parts, 50 ~ 700 parts, mulberry fruit, cape jasmine 50 ~ 700 parts.

Described Chinese medicine composition, it is characterized in that: be prepared from by the Chinese medicine material medicine of following weight proportion, prepared rhizome of rehmannia 650 ~ 900 parts, vinegar tortoise plastron 650 ~ 900 parts, the fruit of glossy privet 300 ~ 500 parts, rhodiola root 300 ~ 500 parts, fructus alpiniae oxyphyllae 100 ~ 300 parts, 100 ~ 300 parts, mulberry fruit, cape jasmine 100 ~ 300 parts.

The Chinese medicine composition of described energy develop immunitypty, is characterized in that each component with parts by weight is: prepared rhizome of rehmannia 800 parts, vinegar tortoise plastron 800 parts, the fruit of glossy privet 480 parts, rhodiola root 480 parts, fructus alpiniae oxyphyllae 240 parts, 240 parts, mulberry fruit, cape jasmine 200 parts.

Described Chinese medicine composition, it is characterized in that, be selected from tablet, capsule, oral liquid, suck agent, granule, pill, powder, paste, sublimed preparation, supensoid agent, pulvis, solution, injection, mixture, syrup, vina, suppository, pill or patch.

Chinese medicine preparation of the present invention can be any pharmaceutically useful formulation, and these formulations comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, paste, sublimed preparation, supensoid agent, mixture, syrup, vina, pulvis, solution, injection, suppository, ointment, emplastrum, creme, spray, drops, patch.Preparation of the present invention, preferably peroral dosage form, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, paste etc.Most preferably tablet.

Chinese medicine preparation composition of the present invention, the preparation of its oral administration can containing conventional excipient, and such as adhesive, filler, diluent, tablet agent, lubricant, disintegrant, colouring agent, flavor enhancement and wetting agent, can carry out dressing to tablet if desired.

The filler be suitable for comprises microcrystalline cellulose, mannitol, lactose, calcium monohydrogen phosphate and other similar filler.Suitable disintegrant comprises starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate.Suitable lubricant comprises, such as dolomol, silica.The suitable acceptable wetting agent of medicine comprises lauryl sodium sulfate.

By mixing, fill, the method that compressing tablet etc. are conventional prepares solid oral composition.Repeatedly mix and active material can be made to be distributed in those compositions of a large amount of filler of whole use.

The form of oral liquid can be such as water-based or oily suspensions, solution, emulsion, syrup or elixir, or can be the composite dry products of a kind of available water before use or other suitable carrier.This liquid preparation can containing conventional additive, such as suspending agent, such as sorbierite, syrup, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agent, such as lecithin, sorbitan monooleate or Arabic gum; Non-aqueous carrier (they can comprise edible oil), the oily ester of the such as ester of apricot kernel oil, fractionated coconut oil, such as glycerine, propane diols or ethanol; Anticorrisive agent, such as para hydroxybenzene methyl esters or propylparaben or sorbic acid, and if need, can containing conventional flavouring agent or colouring agent.

For injection, the fluid unit dosage form of preparation contains active material of the present invention and sterile carrier.According to carrier and concentration, this compound can be suspended or dissolve.The preparation of solution, normally by being dissolved in by active material in a kind of carrier, being filtered sterilization, then being sealed before being loaded a kind of suitable bottle or ampoule.Auxiliary material such as a kind of local anesthetic, anticorrisive agent and buffer also can be dissolved in this carrier.In order to improve its stability, by freezing for this composition after loading bottle, and under vacuo water can be removed.

Chinese medicine preparation of the present invention, applicable medicine acceptable carrier is optionally added when being prepared into medicament, described medicine acceptable carrier is selected from: sweet mellow wine, sorbierite, sodium pyrosulfite, calcium monohydrogen phosphate, sodium hydrogensulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginates, gelatin, polyvinylpyrrolidone, glycerine, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, kaolin, talcum powder, calcium stearate, dolomol etc.

Preparation of the present invention according to the situation determination usage and dosage of patient, can take three every day in use, each 1-20 agent, as: 1-20 bag or grain or sheet.

The final drug preparation that of the present invention dose of finger is made, as capsule 1000 doses refers to capsule preparations 1000,1000 doses, tablet refers to 1000, tablet, is granule 1000 grams for granule.Weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.More than composition is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as large-scale production can by kilogram in units of, or in units of ton, small-scale production also can in units of milligram, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.Single medicinal material more than in composition, especially ministerial drug and adjutant, also can be replaced by the suitable Chinese medicine with the identical property of medicine, its drug effect of the Chinese medicine preparation after replacement is constant.

The preparation method of described Chinese medicine composition, is characterized in that, step is as follows: vinegar tortoise plastron is pulverized, for subsequent use; All the other Six-element medicinal materials, boiling, filters, and filtrate merges, and reduced pressure concentration, dry, pulverize, and adds vinegar tortoise plastron powder, adds filler, mix, and granulate, whole grain, adds lubricant, mixes, and compressing tablet to obtain final product.

Described Chinese medicine composition preparation method, it is characterized in that, step is as follows: vinegar tortoise plastron boiling three times, and decocting liquid filters, and filtrate merges, stand for standby use; All the other Six-element medicinal materials, boiling secondary, filters, and filtrate merges, and add above-mentioned filtrate for subsequent use, reduced pressure concentration, dry, pulverize, and adds filler, mixes, and granulates, and dry, whole grain, adds lubricant, mixes, compressing tablet, and dressing to obtain final product.

Described Chinese medicine composition preparation method, is characterized in that: by extraction, concentrated, dry, mixing, fill, the method that compressing tablet etc. are commonly used prepares solid oral composition; The preparation of its oral administration can containing conventional excipient; The filler be suitable for comprises microcrystalline cellulose, mannitol, lactose, calcium monohydrogen phosphate and other similar filler; Suitable disintegrant comprises starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate; Suitable lubricant comprises dolomol, silica etc.

Chinese medicinal composition preparation of the present invention, being that the Chinese medicine material by being formed by above-mentioned formula is processed through extraction or other modes, making pharmaceutically active substance, subsequently, with this material for raw material, when needing, add medicine acceptable carrier, make according to the routine techniques of galenic pharmacy.Described active material can obtain by extracting Chinese medicine material respectively, also can be obtained by the common Chinese medicine material that extracts, also can obtain by other means, as: by pulverizing, squeezing, calcine, grind, sieve, diacolation, extraction, water extraction, alcohol extracting, ester carry, the material that method obtains, these active materials can be medicinal extract form such as ketone is carried, chromatography, can be dry extract also can be liquid extract, need to determine to make different concentration according to the difference of preparation.

Pharmaceutically active substance in Chinese medicinal composition preparation of the present invention, its in the formulation shared percentage by weight can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical preparation of the present invention, exists in a unit, and described unit dosage form refers to the unit of preparation, as every sheet of tablet, and every capsules of capsule, every bottle of oral liquid, granule every bag etc.

Described Chinese medicine composition can be applied in the medicine preparing develop immunitypty or health products.

Detailed description of the invention:

Further illustrate the present invention below by embodiment, but do not show limiting to the claimed invention.

Prepared by embodiment 1, a kind of Chinese medicine composition

Instrument and reagent

Instrument lambda25 spectrophotometry instrument;

Reagent prepared rhizome of rehmannia, the fruit of glossy privet, rhodiola root, vinegar tortoise plastron, fructus alpiniae oxyphyllae, mulberry fruit, cape jasmine

Reagent glucose control product (Nat'l Pharmaceutical & Biological Products Control Institute provides, for assay); Sulfuric acid, anthrone are pure for analyzing, and water is ultra-pure water.

Method and result

Preparation method of the present invention is through screening acquisition, and screening process is as follows:

1. the research of vinegar tortoise plastron extraction process: with dry extract yield and extract polyoses content for inspection target, experiment investigation is carried out to the extraction process in extraction process.By 3 factors (amount of water, decoction number of times, decocting time) 3 levels, design orthogonal test table L ₉(3 ⁴), carry out orthogonal test with this table, experimental result as table 1,2,3.

Table 1 vinegar tortoise plastron extracts research and design

Table 1 orthogonal test gauge outfit L ₉(3 ⁴)

Get vinegar tortoise plastron, be ground into most meal, test by orthogonal test arrangement, filter, filtrate reduced in volume, dry, obtain 9 groups of sample dry extracts.

Table 2 orthogonal experiments

The variance analysis of table 3 yield of extract

Results and analysis: experimentally result can be found out, extraction time has remarkable impact to yield of extract, according to intuitive analysis result, optimised process is 10 times amount that add water, and extracts 3 times, each 2 hours, because extraction time and amount of water affect not quite, vinegar tortoise plastron extraction process determines that getting vinegar tortoise plastron powder becomes most meal, extracting in water 3 times, add 6 times of water gagings at every turn, extract 1.5 hours.

2. other 6 taste medicinal material extract technical studies

According to literature search, polysaccharide has stronger enhancing immunization, and in the medicines such as rhodiola root, mulberry fruit, the fruit of glossy privet, prepared rhizome of rehmannia, polysaccharide all has the effect strengthening immunity, take polysaccharide as Testing index, investigate extraction time, amount of water, extraction time to the impact of polysaccharide, determine best extraction process.The results are shown in Table 4, table 5, table 6.

Table 4 orthogonal test gauge outfit L ₉(3 ⁴)

Get fructus alpiniae oxyphyllae fragmentation, merge other medicinal materials, test by orthogonal test arrangement, filter, filtrate reduced in volume, dry, obtain 9 groups of sample dry extracts.Measure polysaccharide total amount in medicinal extract according to Thick many candies content assaying method in " health food functional component detection method ", the results are shown in Table 5.

Table 5 orthogonal experiments

The variance analysis of table 6 polysaccharide

α＝0.05

Results and analysis: experimental result display extraction time has remarkable impact to Polyose extraction, extraction time and amount of water do not make significant difference to Polyose extraction under the condition of design, and according to intuitive analysis, optimum extraction condition is for getting medicinal material extract 3 times, each extraction 2 hours, adds 10 times of water gagings.

According to variance analysis, self 2 times of water gaging can be absorbed from the saving energy and medicinal material itself and consider, extraction process is modified to: all the other Six-element medicinal materials, boiling secondary, first time adds the soak by water 1.5 hours of 8 times amount, and second time adds 6 times amount soak by water 1 hour, filter, merging filtrate.

3. drying process research: adopt oven drying method, boulton process, micro-wave drying method three kinds of drying means to carry out comparative study respectively.Oven drying method, boulton process carry out the dry comparison of 3 kinds of different temperatures (60 DEG C, 75 DEG C, 90 DEG C) respectively.Using drying time and Determination of Gardenoside as observation index, determine to select boulton process to carry out drying under not higher than 90 DEG C of conditions.

Table 7 drying condition screens

	Vacuum drying	Microwave drying	Constant pressure and dry
				Baking temperature	60	60	60
Dry cream rate (%)	49.3	49.5	49.6
				Polysaccharide total amount (g)	3.25	3.23	3.20
Drying time (h)	4	1.6	6

Results and analysis: experimental result shows drying mode on polyoses content without impact, but microwave drying is fastest, from the viewpoint of production control and energy-conservation, is decided to be microwave drying by drying mode.

4. Study on Forming: because this product is pure Chinese medical extract, have stronger hygroscopicity, considers that adding suitable auxiliary material granulates, to increase the mobility of material, improves the stability of preparation.Ethanol is that wetting agent is granulated, with mouldability, mobility, disintegration time limited for inspection target.Investigate the auxiliary materials such as sodium carboxymethyl starch, HPMC, microcrystalline cellulose (102), calcium monohydrogen phosphate, dolomol, design prescription also investigates disintegration time, specifically in table 8.

Results and analysis: can find out according to 5 prescriptions and disintegration time, the disintegration in medicinal extract sheet of sodium carboxymethyl starch, HPMC is limited in one's ability, the calcium monohydrogen phosphate of cellulose and the mineral matter easily collapsed is adopted obviously to reduce the disintegration time of medicinal extract sheet, experimentally prescription 5 meets this product requirement, therefore adopts prescription 5 as this product prescription.

This product formulation and technology is decided to be: the extraction dried cream powder of recipe quantity medicinal material, microcrystalline cellulose 88g, calcium monohydrogen phosphate 64g, mixing, and the alcohol granulation of 45-85%, 65 DEG C ~ 70 DEG C oven dryings, whole grain, adds 0.5% dolomol, compressing tablet, dressing.

The preparation of embodiment 2, a kind of Chinese medicine composition tablet

Get vinegar tortoise plastron 8 parts (800g), prepared rhizome of rehmannia 8 parts (800g), the fruit of glossy privet 4.8 parts (480g), rhodiola root 4.8 parts (480g), fructus alpiniae oxyphyllae 2.4 parts (240g), 2.4 parts, mulberry fruit (240g), cape jasmine 2 parts (200g), wherein 1 part is 100g.

1) vinegar Carapax Et Plastrum Testudinis extract is prepared:

Vinegar tortoise plastron, be ground into most meal, adding 6 times amount water extractions gets 3 times, each 1.5 hours, releases extract, and merge extract, reduced pressure concentration, obtains vinegar tortoise plastron thick paste for subsequent use.

2) other Six-element medicinal substances extracts are prepared:

Prepared rhizome of rehmannia, the fruit of glossy privet, rhodiola root, fructus alpiniae oxyphyllae, Sang San, cape jasmine are dropped in extractor, add the water of 8 times amount, boil and extract 1.5h, release extract.Add the water of 6 times amount again, boil and extract 1h, release extract, merge aqueous extract, reduced pressure concentration, obtains other Six-element medicinal material thick pastes for subsequent use.

3) merge above-mentioned thick paste, microwave drying, pulverize 80 orders for subsequent use.Extract powder is added microcrystalline cellulose, calcium monohydrogen phosphate to mixer, mix 20 ~ 30 minutes.Add the appropriate amount of ethanol softwood of 45-85%.Make wet granular, be placed in clean pallet.65 DEG C ~ 70 DEG C oven dryings, whole grain.Add dolomol mixing 15 ~ 20 minutes, for subsequent use.Compressing tablet, film coating.

The preparation of embodiment 3, a kind of Chinese medicinal composition granules

Get vinegar tortoise plastron 8 parts (800g), prepared rhizome of rehmannia 8 parts (800g), the fruit of glossy privet 4.8 parts (480g), rhodiola root 4.8 parts (480g), fructus alpiniae oxyphyllae 2.4 parts (240g), 2.4 parts, mulberry fruit (240g), cape jasmine 2 parts (200g).

Wherein 1 part is 100g, prepares vinegar Carapax Et Plastrum Testudinis extract and other Six-element medicinal substances extracts, be prepared into granule according to galenic pharmacy routine techniques according to the method for embodiment 1.

Embodiment 3: the preparation of capsule

Get vinegar tortoise plastron 8 parts (800g), prepared rhizome of rehmannia 8 parts (800g), the fruit of glossy privet 4.8 parts (480g), rhodiola root 4.8 parts (480g), fructus alpiniae oxyphyllae 2.4 parts (240g), 2.4 parts, mulberry fruit (240g), cape jasmine 2 parts (200g).

Wherein 1 part is 100g, prepares vinegar Carapax Et Plastrum Testudinis extract and other Six-element medicinal substances extracts, be prepared into capsule according to galenic pharmacy routine techniques according to the method for embodiment 1.

The preparation of embodiment 4, a kind of Chinese medicine composition oral liquid

Get vinegar tortoise plastron 8 parts (800g), prepared rhizome of rehmannia 8 parts (800g), the fruit of glossy privet 4.8 parts (480g), rhodiola root 4.8 parts (480g), fructus alpiniae oxyphyllae 2.4 parts (240g), 2.4 parts, mulberry fruit (240g), cape jasmine 2 parts (200g).

Wherein 1 part is 100g, prepares vinegar Carapax Et Plastrum Testudinis extract and other Six-element medicinal substances extracts, be prepared into oral liquid according to galenic pharmacy routine techniques according to the method for embodiment 1.

The preparation II of embodiment 5, a kind of Chinese medicine composition tablet

Get vinegar tortoise plastron 8 parts (800g), prepared rhizome of rehmannia 8 parts (800g), the fruit of glossy privet 4.8 parts (480g), rhodiola root 4.8 parts (480g), fructus alpiniae oxyphyllae 2.4 parts (240g), 2.4 parts, mulberry fruit (240g), cape jasmine 2 parts.Wherein 1 part is 100g.

1) vinegar Carapax Et Plastrum Testudinis extract is prepared:

80 orders pulverized by vinegar tortoise plastron, for subsequent use;

2) other Six-element medicinal substances extracts are prepared:

Prepared rhizome of rehmannia, the fruit of glossy privet, rhodiola root, fructus alpiniae oxyphyllae, Sang San, cape jasmine, boiling secondary, first time adds the soak by water 1.5 hours of 8 times amount, second time adds 6 times amount soak by water 1 hour, filter, filtrate merges, and reduced pressure concentration becomes relative density to be the thick paste of 1.05 ~ 1.1 (60 DEG C), 55 DEG C ~ 60 DEG C microwave dryings.

3) extract dried cream powder is broken, adds the vinegar tortoise plastron powder crushed, adds microcrystalline cellulose and calcium monohydrogen phosphate, mix, add 45-85% ethanol 40g, granulate with 24 mesh sieves, 65 DEG C ~ 70 DEG C oven dryings, the whole grain of 20 mesh sieve, add silica, dolomol, mix, compressing tablet, film coating, to obtain final product.

The develop immunitypty function test of experimental example 6, a kind of Chinese medicine composition tablet

Sample: the tablet of energy develop immunitypty of the present invention in Example 2,0.65g/ sheet, after removing dressing, content is sepia, and preparation pharmaceutical composition of the present invention improves immunity function experimental study.Human oral's RD is every day 2 times, each 2, and adult's body weight press 60kg calculating, amounts to dosage 0.0433g/kgbw.

Animal used as test: SPF level ICR mouse 200, female, body weight 18 ~ 22g, the animal used as test quality certification number: No.43004700008193.

Animal used as test is originated: Hunan Si Laike Jing Da animal used as test Co., Ltd, animal used as test production licence number: SCXK (Hunan) 2013-0004.

Regular grade Hartley cavy 30, female, body weight 300 ~ 350g, the animal used as test quality certification number: 2007000702555.

Animal used as test is originated: Shanghai raw prosperous animal used as test cultivation Co., Ltd, animal used as test production licence number: SCXK (Shanghai) 2012-0007.

Feeding environment: barrier environment, room temperature is (20 ~ 25) DEG C, and relative humidity is (40 ~ 70) %.Animal used as test occupancy permit number: SYXK (Jiangxi) 2013-0005.

Feed resource: Beijing Australia of section pulls together feed corporation,Ltd; Feed Manufacturing credit number: SCXK (capital) 2009-0012, SCXK (capital) 2014-0010.

Dosage choice and tested material give mode

Be high, medium and low three dosage groups and negative control group with 30 of human oral's recommended amounts times, 20 times and 10 times, dose design is respectively 1.300g/kgbw, 0.867g/kgbw, 0.433g/kgbw, sample thief 26.00g, 17.34g, 8.66g distilled water is settled to 400ml respectively, give mouse stomach respectively, once a day, gavage volume is 0.2ml/10gbw, and negative control group gives equal-volume distilled water, continuous 30 days.Test method

Above-mentioned tested material gives by body weight every day, continuous 30-45 days, in administration simultaneously, observes the state of animal every day,

Take weekly a weight of animals, and measure indices by the following method.

(1) internal organs/weight ratio pH-value determination pH: after mouse weights record, dislocation is put to death, and gets spleen and thymus gland, removes most manadesma, weigh.Calculate spleen/body weight ratio and thymus gland/body weight ratio.

(2) the mouse spleen lymphocyte transformation experiment (mtt assay) of ConA induction: experiment mice dislocation is put to death, immerse in 75% medicinal alcohol, asepticly get spleen, be placed in the aseptic little mortar filling Hank's liquid, rapidly spleen is ground, make splenocyte suspension, aseptic Hank ' s liquid is used to filter in test tube by cell permeable 6 layers of sterile gauze, 1000rpm, centrifugal 2 times of 10min, abandons supernatant and is upspring by cell, and it is resuspended containing the RPMI1640 complete culture solution of 10% calf serum to add 2mL, spleens cell number is measured, by cell number furnishing experiment desired concn with cell counter.Add in 24 well culture plates by the cell suspension point holes adjusting cell concentration, every hole 1mL, add 50 μ l ConA solution (being equivalent to 5 μ g/ml) wherein in a hole, (5%CO in incubator in contrast, is put in another hole ₂, 37 DEG C) cultivate 72 hours.Cultivation terminates first 4 hours, every hole sucks supernatant 0.7mL gently, add 0.7mL not containing the RPMI1640 nutrient solution of calf serum and the MTT/RPMI1640 (5mg/ml) of 50 μ l, continue cultivation 4 hours, cultivate after terminating, every hole adds 1mL acid isopropyl alcohol, purple crystal is dissolved completely, and then moved into by this liquid in 96 hole ELISA Plates, packing 4 holes in each hole are as Duplicate Samples, colorimetric on ELIASA, result represents with the OD value at wavelength 570nm place.Lymphocytic multiplication capacity deducts by the OD value adding ConA hole the OD value not adding ConA hole and represents.

(3) delayed allergy (the sufficient sole of the foot thickens method): every mouse is through lumbar injection 2% (with normal saline) hematocrit SRBC suspension 0.2mL.After immunity 4d, with the left back sufficient sole of the foot thickness (background values) of kind of calliper, same position duplicate measurements three times, calculating mean value.Then at measuring point hypodermic injection 20% hematocrit SRBC, every mouse 20 μ L.After injection, 24h measures left back sufficient sole of the foot thickness again.Pedal swelling degree is represented by the difference of attacking the twice sufficient sole of the foot one-tenth-value thickness 1/10 in front and back.

(4) antibody-producting cell detects: cavy femoral artery (30) is taken a blood sample, isolate serum, it is mixed by 1:5 with hematocrit SRBC, place 30min, frequently shake, 2000rpm for 4 DEG C, 10min centrifuging and taking supernatant, packing ,-30 DEG C of preservations, the used time presses 1:10 dilution with SA buffer solution.Agarose distilled water is mixed with 1% solution, and water-bath is boiled, and makes it to melt completely, is applied on clean slide, for subsequent use in film releasing box after dry.Every mouse is through lumbar injection 2% (preparing with physiological salt liquid) hematocrit SRBC suspension 0.2mL.By immunity 5 days after mouse dislocation put to death, take out spleen, be placed on fill Hank ' s liquid little mortar in, grind, filtered in 10ml test tube by cell with 2 layers of gauze, 1000rpm, 10min are centrifugal, abandon supernatant, wash 1 time with Hank ' s liquid, splenocyte is suspended in 10mLHank ' s liquid for subsequent use.Agarose is mixed with 1% aqueous solution, water-bath is boiled, make it to melt completely, mix with equivalent double Hank ' s liquid, packing small test tube, often pipe 0.5mL, in pipe, add 10% (using SA buffer) hematocrit SRBC suspension 50 μ L, splenocyte suspension 10 μ L again, rapidly after mixing, be poured on agarose thin layer slide, after agar solidification, slide level being buckled is placed on horse, puts into 37oC incubator and hatches 1.5 hours, is then joined by complement in slide frame groove, after continuing to hatch 1.5 hours, counting hemolysis plaque number.Draw 20ul splenocyte suspension, add 10ml cell diluent, fully mix, counting spleens cell number.With plaque number/10 ⁶splenocyte represents.

(5) mensuration (Hemagglutination Method) of serum hemolysin: mouse is through lumbar injection 2% hematocrit SRBC (with normal saline) suspension 0.2mL.Mouse after immune 4-5 days is extractd eyeball, gets whole blood in microcentrifugal tube, leave standstill 1h, 2000r/min, 10min centrifugal, collect serum.With physiological saline by serum doubling dilution, dilution for difference serum is placed in Microhemagglutination brassboard respectively, every hole 100 μ l, add the SRBC suspension of 100 μ l 0.5% (v/v) again, mixing, be loaded in moistening square position and add a cover, in 37 DEG C of incubation 3h, observe hemagglutination degree.

Result antibody product represents.In antibody horizontal=(S1+2S2+3S3nSn) formula 1,2,3n represents the index of two-fold dilution, S represents the rank of aggegation degree, and antibody product is about large, represents that serum antibody is higher.

(6) mouse carbonic clearance test: in the india ink 0.2ml of mouse tail vein injection dilution, treat that prepared Chinese ink injects, immediately timing.Respectively at 2,10 minutes, get blood 20 μ l from left side angular vein clump, and be added to 2mL Na ₂cO ₃in solution.With Na ₂cO ₃solution makes blank, with ultraviolet-uisible spectrophotometer at 600nm wavelength place densitometric value (OD).After mouse weights, cervical dislocation is put to death, and gets liver and spleen, removes most manadesma, weigh (g).Calculate phagocytic index.

(7) Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cells experiment (half intracorporal method): mouse peritoneal injects 20% chicken erythrocyte suspension 1ml, interval is after 30 minutes, inject Hank's liquid 2ml again, mouse is put to death with cervical dislocation, rub belly gently 30 times, fully to wash out peritoneal macrophage, then stomach wall is cut off an osculum, draw abdominal cavity washing lotion 0.5ml with syringe, drip on the slide being decorated with circle.Slide is put into the enamel box being lined with wet gauze, dislocation 37 DEG C of incubator incubations 30 minutes.Hatch after terminating and with Hank's liquid, non-attached cell is washed out rapidly, dry.In methanol solution, fix 5 minutes, Giemsa liquid dyes 20 minutes.Under oily mirror, 100 macrophages are counted to every mouse, engulf in record macrophage the macrophage numbers of chicken red blood cell and macrophage engulf the sum of chicken red blood cell.Be calculated as follows phagocytic index and phagocytic rate:

The macrophage of the sum/counting of chicken red blood cell is engulfed in phagocytic index=macrophage

Macrophage number × 100% of phagocytic rate (%)=the engulf macrophage number/counting of chicken red blood cell

(8) NK cytoactive detection (LDH method): test and target cell YAC-1 was carried out Secondary Culture in first 24 hours, before application, is 1 × 10 with the RPMI1640 complete culture solution adjustment cell concentration containing 10% calf serum ⁵individual/mL.Mouse cervical dislocation is put to death, and asepticly gets spleen, is placed in the aseptic little mortar filling Hank's liquid, is ground by spleen rapidly, makes splenocyte suspension, with the washing of Hank ' s liquid, and centrifugal 2 times of 1000rpm, 10min.Abandon supernatant to be upspring by sedimentation cell, it is resuspended containing the RPMI1640 complete culture solution of 10% calf serum to add 2mL, measures spleens cell number with cell counter.By cell number furnishing 5 × 10 ⁶individual/ml, makes effect (splenocyte) target (YAC-1) cell than being 50:1.Get target cell and each 100 μ L of effector cell, add in U-shaped 96 porocyte culture plate; Target cell Spontaneous release hole adds target cell and each 100 μ L of nutrient solution, and the maximum release aperture of target cell adds target cell and each 100 μ L of 1%NP40; Above-mentionedly everyly all establish three parallel holes, 37 DEG C, 5%CO ₂cultivate 4 hours in incubator.At the end of cultivation, by 96 porocyte culture plates with 1500rpm centrifugal 5 minutes, every hole was drawn supernatant 100 μ L and is put in 96 hole ELISA Plates, add LDH matrix liquid 100 μ L, room temperature reaction 3 minutes, then every hole adds the HCl solution 30 μ L cessation reaction of 1mol/L, surveys OD value at 490nm place with ELIASA.

NK cytoactive %=(reacting hole OD-Spontaneous release hole OD)/(maximum release aperture OD-Spontaneous release hole OD) × 100%

The medicine that Experimental agents uses the embodiment of the present invention 2 to prepare, is called: a kind of Chinese medicine composition alleviating physical fatigue preparation

Experimental result

(1) a Chinese medicine composition develop immunitypty preparation observation that the weight of animals is changed, in table 1,2,3,4,5:

Table 1 Chinese medicine composition develop immunitypty preparation is on the impact of immune I group Mouse Weight:

Table 2 Chinese medicine composition develop immunitypty preparation is on the impact of immune II group Mouse Weight:

Table 3 Chinese medicine composition develop immunitypty preparation is on the impact of immune III group Mouse Weight:

Table 4 Chinese medicine composition develop immunitypty preparation is on the impact of immune IV group Mouse Weight:

Table 5 Chinese medicine composition develop immunitypty preparation is on the impact of immune V group Mouse Weight:

From table 1-5, each dosage group experiment initial stage, experiment mid-term, experiment Mouse Weight in latter stage and the growth of experimental session Mouse Weight are compared with negative control group, there was no significant difference (P>0.05).

(2) a kind of Chinese medicine composition develop immunitypty preparation must affect, in table 6 mouse thymus/weight ratio and spleen/weight ratio:

Table 6 Chinese medicine composition develop immunitypty preparation is on the impact of mouse immune organ internal organs/weight ratio

From table 6: per os gives a kind of Chinese medicine composition develop immunitypty of each dosage group of mouse preparation 30 days, affects (P>0.05) on mouse spleen/body weight ratio and thymus gland/body weight ratio without conspicuousness.

(3) Chinese medicine composition develop immunitypty preparation is on an impact for mouse cell immunologic function,

In table 7,8:

A: the impact that a kind of Chinese medicine composition develop immunitypty preparation is tested mouse ConA induction of lymphocyte conversion capability, in table 7

Table 7 Chinese medicine composition develop immunitypty preparation is to mouse lymphocyte conversion capability experimental result (lymphopoiesis ability)

From table 7: high, medium and low three the dosage groups of a kind of Chinese medicine composition develop immunitypty preparation all can significantly improve mouse lymphocyte conversion capability, have pole significant difference (P<0.01) with the mouse lymphocyte conversion capability of negative control group.

B Chinese medicine composition develop immunitypty preparation on the impact of mouse delayed allergy, in table 8:

Table 8 Chinese medicine composition develop immunitypty preparation is on mouse delayed allergy (the sufficient sole of the foot thickens method) impact (sufficient sole of the foot thickness difference mm)

From table 8: the difference of high, medium and low three dosage groups foot sole of the foot thickness is significantly higher than the difference of negative control group foot sole of the foot thickness, compares P<0.01, P<0.01, P<0.05 respectively with negative control group.

Cellular immune function assay result: mouse lymphocyte transformation experiment result is positive; Delayed allergy (the sufficient sole of the foot thickens method) result is for positive.Cellular immune function assay result is positive.

(4) Chinese medicine composition develop immunitypty preparation is on an impact for humoral immune function, in table 9,10:

A Chinese medicine composition develop immunitypty preparation on the impact of mouse antibodies cellulation, in table 9:

Table 9 Chinese medicine composition develop immunitypty preparation is on mouse antibodies cellulation number impact (plaque number/106 splenocyte)

From table 9: each dosage group plaque number compares with negative control group plaque number, there was no significant difference (P>0.05).

B: a kind of Chinese medicine composition develop immunitypty preparation on the impact of mice serum hemolysin, in table 10:

Table 10 Chinese medicine composition develop immunitypty preparation is on the impact (antibody product) of mice serum hemolysin

From table 10: the antibody product of low dose group is significantly higher than negative control antibody product (P<0.01).Other dosage groups and negative control group there was no significant difference (P>0.05).

Humoral immune function measurement result: antibody-producting cell test experience result is negative, the low dose group result of the mensuration of serum hemolysin is positive.Humoral immune function measurement result is negative.

(5) Chinese medicine composition develop immunitypty preparation is on mouse monokaryon--an impact for macrophage function, see 11,12:

A: a kind of Chinese medicine composition develop immunitypty preparation is on mouse monokaryon--the impact of macrophage carbonic clearance, in table 11:

Table 11 Chinese medicine composition develop immunitypty preparation is on mouse monokaryon--the impact (phagocytic index) of macrophage carbonic clearance

From table 11: high and low two dosage groups can significantly improve mouse carbonic clearance ability, compare with negative control group respectively, P<0.05, P<0.01, middle dosage group compares there was no significant difference (P>0.05) with negative control group.

B: the impact of chicken red blood cell ability engulfed by a kind of Chinese medicine composition develop immunitypty preparation on Turnover of Mouse Peritoneal Macrophages, in table 12:

The impact of chicken red blood cell phagocytic rate engulfed by table 12 Chinese medicine composition develop immunitypty preparation on Turnover of Mouse Peritoneal Macrophages

From table 12: high, medium and low three dosage group phagocytic percentages, phagocytic index compare with negative control group phagocytic percentage, phagocytic index, there was no significant difference (P>0.05).

Monokaryon-macrophage function measurement result: high and low two dosage group results of mouse carbonic clearance experiment are positive.Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell experimental result for negative.Monokaryon-macrophage function measurement result is positive.

(6) Chinese medicine composition develop immunitypty preparation is on an impact for NK cells in mice activity, in table 13:

Table 13 Chinese medicine composition develop immunitypty preparation is on the impact of NK cells in mice activity

From table 13: the NK cytoactive of low dose group compares with negative control group NK cytoactive, have significant difference (P<0.05), all the other are group and negative control group there was no significant difference (P>0.05) respectively.

NK cytoactive detection result: in NK cytoactive detection experiment (LDH method), low dose group is positive, and result is positive.NK cytoactive detection result is positive.Result shows:

1. each dosage group compares with negative control group, on Mouse Weight, mouse spleen/body weight and thymus gland/body weight ratio without impact;

2. each dosage group significantly can strengthen mouse delayed allergy and mouse lymphocyte conversion capability;

3. high and low dose group significantly can strengthen mouse carbonic clearance ability;

4. low dose group can significantly improve the content of mice serum hemolysin;

5. low dose group significantly can strengthen the activity of NK cell;

6. each dosage group antagonist cellulation, Turnover of Mouse Peritoneal Macrophages engulf chicken red blood cell function all without impact.

According to develop immunitypty function evaluation regulation in the Ministry of Public Health " health food inspection and assessment technical specification " (version in 2003), comprehensive every result of the test judges, a kind of Chinese medicine composition develop immunitypty sheet has develop immunitypty function.

Claims (8)

1. the Chinese medicine composition of a develop immunitypty, it is characterized in that: be prepared from by the Chinese medicine material medicine of following weight proportion, prepared rhizome of rehmannia 500 ~ 1000 parts, vinegar tortoise plastron 500 ~ 1000 parts, the fruit of glossy privet 200 ~ 800 parts, rhodiola root 200 ~ 800 parts, fructus alpiniae oxyphyllae 50 ~ 700 parts, 50 ~ 700 parts, mulberry fruit, cape jasmine 50 ~ 700 parts.

2. Chinese medicine composition according to claim 1, it is characterized in that: be prepared from by the Chinese medicine material medicine of following weight proportion, prepared rhizome of rehmannia 650 ~ 900 parts, vinegar tortoise plastron 650 ~ 900 parts, the fruit of glossy privet 300 ~ 500 parts, rhodiola root 300 ~ 500 parts, fructus alpiniae oxyphyllae 100 ~ 300 parts, 100 ~ 300 parts, mulberry fruit, cape jasmine 100 ~ 300 parts.

3. the Chinese medicine composition of energy develop immunitypty according to claim 2, is characterized in that each component with parts by weight is: prepared rhizome of rehmannia 800 parts, vinegar tortoise plastron 800 parts, the fruit of glossy privet 480 parts, rhodiola root 480 parts, fructus alpiniae oxyphyllae 240 parts, 240 parts, mulberry fruit, cape jasmine 200 parts.

4. Chinese medicine composition according to claim 1, it is characterized in that, be selected from tablet, capsule, oral liquid, suck agent, granule, pill, powder, paste, sublimed preparation, supensoid agent, pulvis, solution, injection, mixture, syrup, vina, suppository, pill or patch.

5. the preparation method of Chinese medicine composition according to claim 1, is characterized in that, step is as follows: vinegar tortoise plastron is pulverized, for subsequent use; All the other Six-element medicinal materials, boiling, filters, and filtrate merges, and reduced pressure concentration, dry, pulverize, and adds vinegar tortoise plastron powder, adds filler, mix, and granulate, whole grain, adds lubricant, mixes, and compressing tablet to obtain final product.

6. Chinese medicine composition preparation method according to claim 1, it is characterized in that, step is as follows: vinegar tortoise plastron boiling three times, and decocting liquid filters, and filtrate merges, stand for standby use; All the other Six-element medicinal materials, boiling secondary, filters, and filtrate merges, and add above-mentioned filtrate for subsequent use, reduced pressure concentration, dry, pulverize, and adds filler, mixes, and granulates, and dry, whole grain, adds lubricant, mixes, compressing tablet, and dressing to obtain final product.

7. Chinese medicine composition preparation method according to claim 1, is characterized in that: by extraction, concentrated, dry, mixing, fill, the method that compressing tablet etc. are commonly used prepares solid oral composition; The preparation of its oral administration can containing conventional excipient; The filler be suitable for comprises microcrystalline cellulose, mannitol, lactose, calcium monohydrogen phosphate and other similar filler; Suitable disintegrant comprises starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate; Suitable lubricant comprises dolomol, silica etc.

8. the application of Chinese medicine composition in the medicine preparing develop immunitypty or health products of the develop immunitypty of claim 1.