CN107319553A - A kind of health products of auxiliary hyperglycemic strengthen immunity and preparation method thereof - Google Patents
A kind of health products of auxiliary hyperglycemic strengthen immunity and preparation method thereof Download PDFInfo
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- CN107319553A CN107319553A CN201710554716.XA CN201710554716A CN107319553A CN 107319553 A CN107319553 A CN 107319553A CN 201710554716 A CN201710554716 A CN 201710554716A CN 107319553 A CN107319553 A CN 107319553A
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract
The invention provides a kind of health products of auxiliary hyperglycemic strengthen immunity and preparation method thereof, it is related to functional health care product technical field, often effect is poor for the medicine that can effectively overcome in correlation technique, complicated component, cost is high, and many side effects are often there is also after taking, and the medicine for the treatment of diabetes does not often improve the function of immunity, need additionally to take other drugs, increase drug cost, the defect for the effect for improving immunity and control blood glucose could be obtained simultaneously.The health products of auxiliary hyperglycemic strengthen immunity of the present invention are mainly prepared using ginseng extract, Astragalus Root P.E, mulberry-leaf extract and the ophiopogon japonicus extract of specific consumption proportion, composition is simple, raw material is easy to get, while having the remarkable efficacy for improving immunity and control blood glucose.The preparation method technique of the health products of auxiliary hyperglycemic strengthen immunity of the present invention is simple, the product of formulation needed for can obtaining as needed.
Description
Technical field
The present invention relates to functional health care product technical field, in particular to a kind of auxiliary hyperglycemic strengthen immunity
Health products and preparation method thereof.
Background technology
Immunity is the defense mechanism of human body itself, is that human bioequivalence and any foreign matter for eliminating external intrusion are (viral, thin
Bacterium etc.), processing aging, damage, death, the own cells of denaturation, and identification and processing vivo mutations cell and virus are infected
The ability of cell is human bioequivalence and excludes the physiological reaction of " dissident ".
Modern medical science finds, the factor of immune to be one have with aging substantial connection, and immunocyte decline is aging
One of most important reason.Some special cells of body immune system can by the bacterium in invasion body, virus and declined in vivo
Old dead cell, the cell being mutated and the material for causing allergy, are wholly swallowed and are eliminated, from internal ring
The stabilization in border, keeps body health.But body's immunity begun at 30 years old or so decline, it is this change be quietly, slowly,
It is continued for.In addition, the allegro life style of modern, overworked to also result in autoimmunity decline.
The body of hypoimmunity is easy to infected or cancer stricken；Immunity is extraordinary also to produce insalubrious knot
Really, allergic reaction, autoimmune disease are such as triggered.A variety of causes prevents immune system from normally playing protective effect, herein
In the case of, easily cause the infection such as bacterium, virus, fungi, therefore it is exactly liable to illness that hypoimmunity, which is most directly showed,.Cause
It is often ill, aggravated the consumption of body, so typically have a delicate constitution, malnutritive, One's spirits are drooping, fatigue and weak, appetite
Reduction, sleep-disorder etc. are showed, sick, having an injection to take medicine has become homely food.It is sick every time to be lot more time to recover,
And usually recurrent exerbation.If things go on like this body and intelligence development can be caused bad, also easily induce major disease.
Diabetes are one group of metabolic diseases being characterized with hyperglycaemia.Hyperglycaemia be due to then defect of insulin secretion or
Its biological agent is damaged, or both have concurrently and cause.Long-standing hyperglycaemia during diabetes, cause various tissues, particularly eye,
Kidney, heart, blood vessel, the chronic lesion of nerve, dysfunction.
Immunity is improved in correlation technique, can be with microelement-supplementing, vitamin etc. in addition to adjustment daily life custom
Aided in, or take some oral class medicine things.For the treatment of diabetes in correlation technique, blood glucose is mainly controlled, often
By the way of drug therapy, sulfonylurea drugs, biguanides, α glucosidase inhibitors and insulin can be used
Class medicine.But often effect is poor for medicine used in correlation technique, complicated component, cost is high, often there is also after taking
Many side effects, and the medicine for the treatment of diabetes does not often improve the function of immunity, it is necessary to additionally take other drugs,
Increase drug cost, the effect for improving immunity and control blood glucose could be obtained simultaneously.
In view of this, it is special to propose the present invention.
The content of the invention
The first object of the present invention is to provide a kind of health products of auxiliary hyperglycemic strengthen immunity, described auxiliary drop
The health products composition of blood glucose strengthen immunity is simple, and raw material is easy to get, while having the notable work(for improving immunity and control blood glucose
Effect.
The second object of the present invention is to provide a kind of preparation of the health products of described auxiliary hyperglycemic strengthen immunity
Method, this method technique is simple, the product of formulation needed for can obtaining as needed.
In order to realize the above-mentioned purpose of the present invention, spy uses following technical scheme：
A kind of health products of auxiliary hyperglycemic strengthen immunity, the health products of the auxiliary hyperglycemic strengthen immunity are main
Prepared by the raw material of following mass fraction：
10-30 parts of ginseng extract, 50-150 parts of Astragalus Root P.E, 10-30 parts of mulberry-leaf extract and ophiopogon japonicus extract 30-
90 parts.
The health products of auxiliary hyperglycemic strengthen immunity of the present invention mainly use ginseng extract, the Huang of specific consumption proportion
Stilbene extract, mulberry-leaf extract and ophiopogon japonicus extract are prepared, and composition is simple, and raw material is easy to get, while having raising immunity
With the remarkable efficacy of control blood glucose.
Preferably, the health products of the auxiliary hyperglycemic strengthen immunity are mainly prepared into by the raw material of following mass fraction
Arrive：
15-25 parts of ginseng extract, 80-120 parts of Astragalus Root P.E, 15-25 parts of mulberry-leaf extract and ophiopogon japonicus extract 45-
75 parts.
It is further preferred that the main raw material by following mass fraction of the health products of the auxiliary hyperglycemic strengthen immunity
Prepare：
63 parts of 21 parts of ginseng extract, 96 parts of Astragalus Root P.E, 21 parts of mulberry-leaf extract and ophiopogon japonicus extract.
Alternatively, the raw material of the health products of the auxiliary hyperglycemic strengthen immunity also includes pharmaceutic adjuvant.
Alternatively, the consumption of the pharmaceutic adjuvant is to extract ginseng extract, Astragalus Root P.E, mulberry-leaf extract and the tuber of dwarf lilyturf
The 20%-50% of thing gross mass, preferably 30%-40%, more preferably 34.34%.
Alternatively, the pharmaceutic adjuvant includes propellant, solubilizer, cosolvent, emulsifying agent, colouring agent, binder, disintegration
Agent, filler, lubricant, wetting agent, osmotic pressure regulator, stabilizer, glidant, flavouring, preservative, suspending agent, coating
Material, aromatic, anti-binder, integrated agent, penetration enhancer, pH value regulator, buffer, surfactant, foaming agent, disappear
In infusion, thickener, inclusion agents, NMF, absorbent, diluent, flocculant and deflocculant, filter aid and release retarding agent
One or more.
Preferably, the pharmaceutic adjuvant includes dextrin and/or magnesium stearate, preferably includes dextrin and magnesium stearate.
Alternatively, the consumption of the dextrin is that ginseng extract, Astragalus Root P.E, mulberry-leaf extract and ophiopogon japonicus extract are total
The 19.5%-48% of quality, preferably 29%-38.5%, more preferably 33%.
Alternatively, the consumption of the magnesium stearate is to extract ginseng extract, Astragalus Root P.E, mulberry-leaf extract and the tuber of dwarf lilyturf
The 0.5%-2% of thing gross mass, preferably 1%-1.5%, more preferably 1.34%.
Alternatively, the formulation of the health products of the auxiliary hyperglycemic strengthen immunity is one in capsule, particle and liquid
Plant or a variety of.
Alternatively, the particle includes the one or more in tablet, pill and pulvis.
A kind of preparation method of the health products of above-mentioned auxiliary hyperglycemic strengthen immunity, raw material needed for weighing in proportion,
Required formulation is prepared into, a kind of health products of auxiliary hyperglycemic strengthen immunity are obtained.
The preparation method technique of the health products of auxiliary hyperglycemic strengthen immunity of the present invention is simple, can obtain as needed
The product of required formulation.
Compared with prior art, beneficial effects of the present invention are：
The health products of auxiliary hyperglycemic strengthen immunity of the present invention mainly use ginseng extract, the Huang of specific consumption proportion
Stilbene extract, mulberry-leaf extract and ophiopogon japonicus extract are prepared, and composition is simple, and raw material is easy to get, while having raising immunity
With the remarkable efficacy of control blood glucose.The preparation method technique of the health products of auxiliary hyperglycemic strengthen immunity of the present invention is simple, energy
Enough products for obtaining required formulation as needed.
Embodiment
Technical scheme is clearly and completely described below in conjunction with embodiment, but ability
Field technique personnel will be understood that following described embodiment is a part of embodiment of the invention, rather than whole embodiments,
The present invention is merely to illustrate, and is not construed as limiting the scope of the present invention.Based on the embodiment in the present invention, the common skill in this area
The every other embodiment that art personnel are obtained under the premise of creative work is not made, belongs to the model that the present invention is protected
Enclose.Unreceipted actual conditions person in embodiment, the condition advised according to normal condition or manufacturer is carried out.Agents useful for same or instrument
Unreceipted production firm person, is the conventional products that can be obtained by commercially available purchase.
The specific embodiment of the invention provides a kind of health products of auxiliary hyperglycemic strengthen immunity, and blood drops in the auxiliary
The health products of sugared strengthen immunity are mainly prepared by the raw material of following mass fraction：
10-30 parts of ginseng extract, 50-150 parts of Astragalus Root P.E, 10-30 parts of mulberry-leaf extract and ophiopogon japonicus extract 30-
90 parts.
Ginseng extract is formed from Hydrolysis kinetics in the root, cauline leaf of Araliaceae ginseng, and it is rich in 18 kinds of ginsengs
Saponin monomer, is dissolved in 80 DEG C of water, is easily soluble in ethanol.It is primarily adapted for use in coronary heart diseases and angina pectoris, bradycardia, too fast, room property
Early rich, blood pressure imbalance, neurasthenia, climacteric metancholia, excessive fatigue, after being ill, postpartum, the postoperative symptom such as in poor health；Long
Clothes can promote longevity, and can strengthen muscle power, there is cold-and-heat resistent stress, while there is the vigor of enhancing human body surface cell,
Suppress the effect such as aging.
Astragalus Root P.E is the drying root extract of the legume Radix Astragali, and with enhancing energy, antifatigue, anti-mutation is protected
Liver, suppresses the effect of osteoclast.The astragalus polyose contained in Astragalus Root P.E has reducing blood lipid, that is, reduces cholesterol and glycerine
The effect of three esters, increasing high density lipoprotein；Cardiovascular and cerebrovascular disease can be prevented and treated, such as atherosclerosis, coronal dynamic
Arteries and veins lesion, peripheral angiopathy and hyperlipidemia etc..The Astragaloside IV contained in Astragalus Root P.E have significantly reduce blood glucose,
The effect of glycosylated hemoglobin and Urine proteins, it is possible to decrease the AGEs in cortex renis and serum, display Astragaloside IV has anti-oxidant
Effect, and have inhibitory action to aldose reductase, also suppress proliferation of mesangial cells, mitigate the effect of renal hypertrophy.
Mulberry-leaf extract is using the mulberry leaf powder of the 1-3 young leaves processing before silkworm in spring later stage or the Frost's Descent on mulberry branch as original
Material, dries in the shade, crushing, respectively with n-butanol, the heating extraction of 90% second alcohol and water, and is spray-dried and obtains, with dispelling wind and heat from the body, clearly
Lung is moisturized, the effect clear liver and improved vision, available for anemopyretic cold, cough with lung heat, headache and dizzy, the dizzy flower of hot eyes etc..
Ophiopogon japonicus extract is the liliaceous plant tuber of dwarf lilyturf (dwarf lilyturf) Ophiopogon japonicus (Thunb.) Ker-
Gawl. dried root extract, with nourishing Yin and promoting production of body fluid, effect of moistening lung clears away heart-fire, available for dryness of the lung dry cough, tuberculosis cough, Tianjin
Wound is thirsty, vexed insomnia, Heat Diabetes, the disease such as dry constipation of intestines and pharyngeal diphtheria.
The health products of auxiliary hyperglycemic strengthen immunity of the present invention mainly use ginseng extract, the Huang of specific consumption proportion
Stilbene extract, mulberry-leaf extract and ophiopogon japonicus extract are prepared, and composition is simple, and raw material is easy to get (using prior art products i.e.
Can), while having the remarkable efficacy for improving immunity and control blood glucose.
Preferably, the health products of the auxiliary hyperglycemic strengthen immunity are mainly prepared into by the raw material of following mass fraction
Arrive：
15-25 parts of ginseng extract, 80-120 parts of Astragalus Root P.E, 15-25 parts of mulberry-leaf extract and ophiopogon japonicus extract 45-
75 parts.
It is further preferred that the main raw material by following mass fraction of the health products of the auxiliary hyperglycemic strengthen immunity
Prepare：
63 parts of 21 parts of ginseng extract, 96 parts of Astragalus Root P.E, 21 parts of mulberry-leaf extract and ophiopogon japonicus extract.
Using the ginseng extract of specific usage ratio, Astragalus Root P.E, mulberry-leaf extract and ophiopogon japonicus extract, contribute to
The health products for further improving gained auxiliary hyperglycemic strengthen immunity improve the effect of immunity and control blood glucose.
In a kind of preferred embodiment of the present invention, the raw material of the health products of the auxiliary hyperglycemic strengthen immunity
Also include pharmaceutic adjuvant.
In a kind of preferred embodiment of the present invention, the consumption of the pharmaceutic adjuvant is ginseng extract, the Radix Astragali is carried
The 20%-50% of thing, mulberry-leaf extract and ophiopogon japonicus extract gross mass, preferably 30%-40% are taken, more preferably
34.34%.
In a kind of preferred embodiment of the present invention, the pharmaceutic adjuvant include propellant, solubilizer, cosolvent,
Emulsifying agent, colouring agent, binder, disintegrant, filler, lubricant, wetting agent, osmotic pressure regulator, stabilizer, glidant,
It is flavouring, preservative, suspending agent, coating material, aromatic, anti-binder, integrated agent, penetration enhancer, pH value regulator, slow
Electuary, surfactant, foaming agent, defoamer, thickener, inclusion agents, NMF, absorbent, diluent, flocculant and anti-wadding
One or more in solidifying agent, filter aid and release retarding agent.
Using special component and the pharmaceutic adjuvant of consumption, help as needed, to improve gained auxiliary hyperglycemic enhancing and exempt from
The property of the health products of epidemic disease power.
Preferably, the pharmaceutic adjuvant includes dextrin and/or magnesium stearate, preferably includes dextrin and magnesium stearate.
When starch is decomposed and hydrolyzed under heating, acid or diastatic action, the starch of macromolecular is converted first into
For the intermediate material of small molecule, middle small-molecule substance at this moment is referred to as dextrin.Dextrin be broadly divided into white dextrin, yellow starch gum and
Britain glue or " Britain glue ", can as medicinal thickener and stabilizer, also can as tablet or electuary excipient and fill out
Fill agent.
Magnesium stearate is the light fine powder without grittiness of white；It is micro- to have special smell；Soapy feeling has been contacted with skin.This product water,
It is insoluble in ethanol or ether, it is mainly used as lubricant, antiplastering aid, glidant.The granulation of particularly suitable oils, extract medicament,
The particle being made has good mobility and compressibility.It is used as glidant in direct tablet compressing.It is alternatively arranged as filter aid, clarification
Agent and drip infusion, and liquid preparation suspending agent, thickener.It can be used as medical excipient and lubrication medicament.
In a kind of preferred embodiment of the present invention, the consumption of the dextrin is ginseng extract, Astragalus Root P.E,
The 19.5%-48% of mulberry-leaf extract and ophiopogon japonicus extract gross mass, preferably 29%-38.5%, more preferably 33%.
In a kind of preferred embodiment of the present invention, the consumption of the magnesium stearate is ginseng extract, the Radix Astragali is carried
The 0.5%-2% of thing, mulberry-leaf extract and ophiopogon japonicus extract gross mass, preferably 1%-1.5% are taken, more preferably
1.34%.
Contribute to the health products system of gained auxiliary hyperglycemic strengthen immunity using the dextrin and magnesium stearate of specific consumption
Stabilization, figuration and the lubricant effect of agent.
In a kind of preferred embodiment of the present invention, the formulation of the health products of the auxiliary hyperglycemic strengthen immunity
For the one or more in capsule, particle and liquid.
In a kind of preferred embodiment of the present invention, the particle include one kind in tablet, pill and pulvis or
It is a variety of.
The health-care product of auxiliary hyperglycemic strengthen immunity of the present invention is a kind of Orally taken product, as long as mouth can be passed through
The formulation that the mode of clothes is used can be used.
A kind of preparation method of the health products of above-mentioned auxiliary hyperglycemic strengthen immunity, raw material needed for weighing in proportion,
Required formulation is prepared into, a kind of health products of auxiliary hyperglycemic strengthen immunity are obtained.
The preparation method technique of the health products of auxiliary hyperglycemic strengthen immunity of the present invention is simple, can obtain as needed
The product of required formulation.
Each raw material can be weighed respectively in proportion, be prepared into respectively according to prior art in capsule, particle and liquid preparation
It is one or more.
For capsule preparations, after can each raw material be sufficiently mixed uniformly in proportion, direct quantitative is filling in Capsules shell
In obtain.
For granular preparation, each raw material can uniformly be mixed to specification tablet, pill or powder needed for being quantitatively prepared into proportion
Agent.
For liquid preparation, each raw material can be taken quantitatively to be dissolved in respectively in the orally available solvent such as medical water in proportion and obtained.
Raw material sources in various embodiments of the present invention are as follows：
Ginseng extract：Manufacturer is Xi'an Ze Bang bio tech ltd；
Astragalus Root P.E：Manufacturer is Xi'an Ze Bang bio tech ltd；
Mulberry-leaf extract：Manufacturer is Xi'an Quan Ao bio tech ltd；
Ophiopogon japonicus extract：Manufacturer is Xi'an four seasons bio tech ltd；
White dextrin (food-grade)：Manufacturer is Jinan De Qiao Chemical Industry Science Co., Ltd；
Magnesium stearate (food-grade)：Manufacturer is the golden riverhead bioengineering Co., Ltd in Jiangsu；
Capsules shell (gelatin)：Manufacturer is Jilin Aodong Pharmaceuticals Group Co., Ltd..
Embodiment 1
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 10g, Astragalus Root P.E 50g, mulberry-leaf extract 10g and ophiopogon japonicus extract 30g are weighed respectively, fully
After uniform mixing, gained mixed material is filled in Capsules shell, 0.45g mixing is respectively charged into each Capsules shell
Raw material, prepares a kind of health product capsule product of auxiliary hyperglycemic strengthen immunity.
Embodiment 2
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 30g, Astragalus Root P.E 150g, mulberry-leaf extract 30g and ophiopogon japonicus extract 90g are weighed respectively, are filled
Divide after uniform mixing, gained mixed material is filled in Capsules shell, 0.45g is respectively charged into each Capsules shell and is mixed
Raw material is closed, a kind of health product capsule product of auxiliary hyperglycemic strengthen immunity is prepared.
Embodiment 3
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 18g, Astragalus Root P.E 70g, mulberry-leaf extract 12g, ophiopogon japonicus extract 40g and white paste are weighed respectively
Smart 40g, after full and uniform mixing, gained mixed material is filled in Capsules shell, is filled respectively in each Capsules shell
Enter 0.45g mixed materials, prepare a kind of health product capsule product of auxiliary hyperglycemic strengthen immunity.
Embodiment 4
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 28g, Astragalus Root P.E 130g, mulberry-leaf extract 27g, ophiopogon japonicus extract 80g and hard are weighed respectively
Fatty acid magnesium 2.4g, after full and uniform mixing, gained mixed material is filled in Capsules shell, is divided in each Capsules shell
Not Zhuan Ru 0.45g mixed materials, prepare a kind of health product capsule product of auxiliary hyperglycemic strengthen immunity.
Embodiment 5
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 10g, Astragalus Root P.E 50g, mulberry-leaf extract 10g, ophiopogon japonicus extract 30g, white paste are weighed respectively
Smart 19.5g and magnesium stearate 0.5g, after full and uniform mixing, gained mixed material is filled in Capsules shell, Mei Gekong
0.45g mixed materials are respectively charged into heart-soothing capsule shell, a kind of health product capsule of auxiliary hyperglycemic strengthen immunity is prepared
Product.
Embodiment 6
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 30g, Astragalus Root P.E 150g, mulberry-leaf extract 30g, ophiopogon japonicus extract 90g, white paste are weighed respectively
Smart 144g and magnesium stearate 6g, after full and uniform mixing, gained mixed material is filled in Capsules shell, each hollow glue
0.45g mixed materials are respectively charged into softgel shell, a kind of health product capsule product of auxiliary hyperglycemic strengthen immunity is prepared.
Embodiment 7
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 15g, Astragalus Root P.E 80g, mulberry-leaf extract 15g, ophiopogon japonicus extract 45g, white paste are weighed respectively
Smart 44.95g and magnesium stearate 1.55g, after full and uniform mixing, gained mixed material is filled in Capsules shell, each
0.45g mixed materials are respectively charged into Capsules shell, a kind of health products glue of auxiliary hyperglycemic strengthen immunity is prepared
Capsule product.
Embodiment 8
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 25g, Astragalus Root P.E 120g, mulberry-leaf extract 25g, ophiopogon japonicus extract 75g, white paste are weighed respectively
Smart 98.175g and magnesium stearate 3.825g, after full and uniform mixing, gained mixed material is filled in Capsules shell, often
0.45g mixed materials are respectively charged into individual Capsules shell, a kind of health products of auxiliary hyperglycemic strengthen immunity are prepared
Capsule product.
Embodiment 9
A kind of preparation method of the health product capsule of auxiliary hyperglycemic strengthen immunity, comprises the following steps：
Ginseng extract 21g, Astragalus Root P.E 96g, mulberry-leaf extract 21g, ophiopogon japonicus extract 63g, white paste are weighed respectively
Smart 66.33g and magnesium stearate 2.69g, after full and uniform mixing, gained mixed material is filled in Capsules shell, each
0.45g mixed materials are respectively charged into Capsules shell, a kind of health products glue of auxiliary hyperglycemic strengthen immunity is prepared
Capsule product.
Enhancing is carried out using the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 immune
(detection side is Health Food Function Detection Center, Applied Literature and Science College, B to the zoopery of power function, is directly used
The health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 removes the drug ingedient after capsule shells),
Foundation《Health food is examined and assessment technique specification》(2003 editions), function assessment evaluation test method：First, strengthen immunity function
The method of inspection is carried out.
From Beijing HFK Bio-Technology Co., Ltd.'s [credit number：SCXK (capital) 2014-0004] breeding
16g~19g cleaning grades Kunming kind female mice 192, is divided into four batches and is tested, and every batch is randomly divided into 4 groups, every group 12
Only.Experiment it is a collection of progress internal organs/body weight ratio measurement, delayed allergy experiment, the measure of half hemolytic value (HCso) and
The measure of antibody-producting cell number；Two batches of progress carbonic clearance experiments of experiment；Three batches of progress Turnover of Mouse Peritoneal Macrophages phagocytosiss of experiment
Chicken red blood cell is tested；The mouse lymphocyte transformation experiment and NK cytoactive detections of four batches of progress ConA inductions of experiment.Experiment
Animal feeding is in Health Food Function Detection Center, Applied Literature and Science College, B SPF grades of animal housing.Experimental animal makes
Use credit number：SYXK (capital) 2012-0031.Feed is maintained to be pulled together feed corporation,Ltd's [credit number by Beijing Australia of section：SCXK
(capital) 2014-0010] production.
The recommended dose of the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 is adult
(pressing 60kg batheroom scales) daily 2.7g, equivalent to 0.045g/kgBW/d.Experiment sets 5 times, 10 times, 30 times of human body recommended amounts, i.e.,
Daily 0.22g/kgBW, 0.45g/kgBW, 1.35g/kgBW are basic, normal, high dosage group.High dose tested material：Weigh 8.1Og samples
Product add sterilized water to 60.OmL.Middle dosage tested material：2.70g samples plus sterilized water are weighed to 60.OmL.Low dosage tested material：Claim
1.35g plus sterilized water are taken to 60.OmL.After tested material orally administration once a day, continuous gavage 31d, indices are surveyed.Mouse
Gavage volume is 1OmL/kgBW.A blank control group (Og/kgBW) is set simultaneously, tested material, daily gavage body are replaced with sterilized water
Product is identical with each tested material group.Each dosage group gives maintenance feed.
Data processing is carried out with SPSS softwares.Using variance analysis, but it is neat first to carry out variance by the program of variance analysis
Property examine, variance is neat, calculates F values, F values<F0.05, conclusion：No significant difference between each group mean；F values >=F0.05, P≤0.05,
Counted with the comparative approach two-by-two of mean between multiple experimental groups and a control group；To the data of abnormal or heterogeneity of variance
Appropriate variable conversion is carried out, after normal state or the neat requirement of variance is met, is counted with the data after conversion；If variable is changed
Normal state or the neat purpose of variance are still not up to afterwards, are used rank test instead and are counted.
《Health food is examined and assessment technique specification》(2003 editions) regulations：Cellular immune function, humoral immune function,
Any two aspect results of the macrophage function of monokaryon one, four aspects of NK cytoactives are positive, can determine that the given the test agent has
Strengthen immunity function.Two experimental results wherein in cellular immune function assay project are the positive, or any one
Two dosage group results of experiment are positive, can determine that cellular immune function assay result is positive.Humoral immune function determines project
In two experimental results be the positive, or two dosage group results of any one experiment are positive, can determine that humoral immune function
Measurement result is positive.Two experimental results in the macrophage function measure project of monokaryon one are the positive, or any one experiment
Two dosage group results it is positive, can determine that the macrophage function result of monokaryon one is positive.The one of NK cytoactive detections experiment
Individual above dosage group result is positive, can determine that NK cytoactives result is positive.
Related test results are as follows：
The original body mass of each group mouse of table 1
From table 1, the original body mass of mouse is compared in four batches of each dosage groups of experimental animal between Og/kgBW groups, difference
There are no significant (P>0.05).I.e. the original body mass of mouse is more balanced between each group.
Influence of the table 2 to mouse weight
From table 2, the health products glue of the auxiliary hyperglycemic strengthen immunity of the present invention of orally administration mouse various dose
After capsule product 31d, the body weight of mouse is compared in four batches of each dosage groups between 0g/kgBW groups, difference there are no significant (P>0.05),
The health product capsule product of auxiliary hyperglycemic strengthen immunity i.e. of the present invention has no adverse effects to mouse weight.
Influence of the table 3 to mice organs/body weight ratio
From table 3, the health products glue of the auxiliary hyperglycemic strengthen immunity of the present invention of orally administration mouse various dose
After capsule product 31d, each dosage group spleen/body weight ratio is compared with Og/kgBW groups, difference there are no significant (P>0.05).I.e. originally
The health product capsule product of invention auxiliary hyperglycemic strengthen immunity is on spleen/body weight ratio of mouse without influence.
Influence of the table 4 to mouse thymus/body weight ratio
From table 4, the health products glue of the auxiliary hyperglycemic strengthen immunity of the present invention of orally administration mouse various dose
After capsule product 31d, each dosage group thymus gland/body weight ratio is compared with Og/kgBW groups, difference there are no significant (P>0.05).I.e. originally
The health product capsule product of invention auxiliary hyperglycemic strengthen immunity is on thymus gland/body weight ratio of mouse without influence.
The influence of the mouse delayed allergy of table 5
*:Being compared with 0g/kgBW groups has significant difference
From table 5, the health products glue of the auxiliary hyperglycemic strengthen immunity of the present invention of orally administration mouse various dose
After capsule product 31d, compared with Og/kgBW groups, 0.45g/kgBW group mouse swelling degree of the paw is improved, and has significant difference (P<
0.05)；1.35g/kgBW group mouse swelling degree of the paw is improved, and has significant difference (P<0.01) it is that auxiliary hyperglycemic of the present invention increases
The health product capsule product of strong immunity can improve mouse delayed allergy journey in 0.45g/kgBW groups, 1.35g/kgBW groups
Degree.
Influence of the table 6 to mouse lymphocyte transformation experiment
From table 6, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, each dosage group mouse lymphocyte multiplication capacity is compared with Og/kgBW groups, difference there are no significant (P>
0.05).I.e. the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity is to mouse lymphocyte multiplication capacity
Without influence.
Influence of the table 7 to mouse antibodies cellulation number
*:Being compared with 0g/kgBW groups has significant difference
From table 7, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, compared with Og/kgBW groups, 1.35g/kgBW group mouse hemolysis plaque number is improved, and has significant difference (P
<0.05).That is the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity can improve small in 1.35g/kgBW groups
Mouse antibody-producting cell number.
Influence of the table 8 to mouse half hemolytic value
*:Being compared with 0g/kgBW groups has significant difference
From table 8, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, compared with Og/kgBW groups, 1.35g/kgBW group mouse half hemolytic value is improved, and has significant difference (P
<0.05).That is the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity can improve small in 1.35g/kgBW groups
Mouse half hemolytic value.
Influence of the table 9 to mouse carbonic clearance ability
From table 9, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, each metering group mouse phagocytic index is compared with Og/kgBW groups, difference there are no significant (P>0.05)；I.e.
The health product capsule product of gained auxiliary hyperglycemic strengthen immunity of the invention is on the carbonic clearance ability of mouse without influence.
Table 10 swallows the influence of chicken red blood cell phagocytic rate to mouse macrophage
*:Being compared with 0g/kgBW groups has significant difference
From table 10, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, compared with Og/kgBW groups, 0.45g/kgBW groups mouse macrophage phagocytosis chicken red blood cell phagocytic rate is carried
Height, there is significant difference (P<0.05)；1.35g/kgBW groups mouse macrophage phagocytosis chicken red blood cell phagocytic rate is improved, and is had significantly
Sex differernce (P<O.OO1).I.e. the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity is in 0.45g/kgBW
Group, 1.35g/kgBW groups can improve mouse macrophage phagocytosis chicken red blood cell phagocytic rate.
Table 11 swallows the influence of chicken red blood cell phagocytic index to mouse macrophage
*:Being compared with 0g/kgBW groups has significant difference
From table 11, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, compared with Og/kgBW groups, 0.45g/kgBW groups mouse macrophage phagocytosis chicken red blood cell phagocytic index
Improve, there is significant difference (P<0.01)；1.35g/kgBW groups mouse macrophage phagocytosis chicken red blood cell phagocytic index is improved, and is had
Sunlight writes sex differernce (P<O.OO1).I.e. the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity is in 0.45g/
KgBW groups, 1.35g/kgBW groups can improve mouse macrophage phagocytosis chicken red blood cell phagocytic index.
Influence of the table 12 to NK cells in mice activity
From table 12, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 31d, each dosage group NK cytoactives are compared with Og/kgBW groups, difference there are no significant (P>0.05).I.e. originally
The health product capsule product of invention gained auxiliary hyperglycemic strengthen immunity is on NK cells in mice activity without influence.
As a result show, the health products of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After capsule product 31d, compared with 0g/kgBW control groups, tested material can improve mouse swelling degree of the paw (P in 0.45g/kgBW groups
＜ 0.05), improve mouse macrophage phagocytosis chicken red blood cell phagocytic rate (P ＜ 0.05) and phagocytic index (P ＜ 0.01)；Tested material
0.45g/kgBW groups can improve mouse toes swelling (P ＜ 0.01), improve mouse antibodies cellulation number (P ＜ 0.05),
Mouse half hemolytic value (P ＜ 0.05) is improved, mouse macrophage phagocytosis chicken red blood cell phagocytic rate (P ＜ 0.001) is improved and gulps down
Bite index (P ＜ 0.001).Tested material increases to mouse weight to have no adverse effects, according to《Health food is examined advises with assessment technique
Model》(2003 editions) understand to criterion of strengthen immunity health food, the guarantor of auxiliary hyperglycemic strengthen immunity of the present invention
Strong product capsule product has the function of strengthen immunity.
Auxiliary drop blood is carried out using the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9
(detection side is Health Food Function Detection Center, Applied Literature and Science College, B, is directly used for sugared function zoopery
The health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 removes the drug ingedient after capsule shells),
According to state of State Food and Drug Administration food medicine prison guarantorization [2012] 107, annex 3：Auxiliary hyperglycemic function evaluation side
Method (scheme one) is carried out.
From Beijing HFK Bio-Technology Co., Ltd.'s [credit number：SCXK (capital) 2014-0004] breeding
The healthy cleaning grade female mice totally 120 of (18-22) g Kunming kind, the batch mouse basal plasma glucose value is (6.6 ± 0.5) mmol/
L, is divided into three batches and is tested.Experiment is a collection of to carry out that normal mouse fasting blood-glucose is influenceed to test；Experiment two batches is carried out to height
The influence experiment of blood glucose model mice fasting blood-glucose；Three batches of progress hyperglycemia model glucose tolerance in mice experiments of experiment.Experimental animal is raised
Support in Health Food Function Detection Center, Applied Literature and Science College, B SPF grades of animal housing, experimental animal uses license
Card number is SYXK (capital) 2012-0031.Feed is maintained to be pulled together feed corporation,Ltd's [credit number by Beijing Australia of section：SCXK (capital)
2014-0010] production.
The recommended dose of the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 is adult
(pressing 60kg batheroom scales) daily 2.7g, equivalent to 0.045g/kgBW/d.Experiment sets 5 times, 10 times, 30 times of human body recommended dose,
0.22g/kgBW, 0.45g/kgBW, 1.35g/kgBW are often said for basic, normal, high three dosage groups, hyperglycemia model control is separately set
Group (Og/kgBW).1.35g/kgBW group：13.50g samples plus sterilized water are weighed to 1OO.OmL；0.45g/kgBW groups：Weigh
4.50g samples add sterilized water to 1OO.OmL：0.22g/kgBW groups：2.20g samples plus sterilized water are weighed to 1OO.OmL；Daily one
Indices are surveyed after secondary orally administration, continuous gavage 30d.Mouse stomach volume is 1OmL/kgBW.Hyperglycemia model control group is used
Sterilized water replaces tested material, and daily gavage volume is identical with each tested material group.Each dosage group gives maintenance feed.It is another to set normal
High dose group (1.35g/kgBW) and Normal group (Og/kgBW) carry out tested material influences real to normal mouse fasting blood-glucose
Test.
Data processing is carried out with SPSS softwares.Using variance analysis, but it is neat first to carry out variance by the program of variance analysis
Property examine, variance is neat, calculates F values, F values<F0.05, conclusion：No significant difference between each group mean；F values >=F0.05, P≤0.05,
Counted with the comparative approach two-by-two of mean between multiple experimental groups and a control group；To the data of abnormal or heterogeneity of variance
Appropriate variable conversion is carried out, after normal state or the neat requirement of variance is met, is counted with the data after conversion；If variable is changed
Normal state or the neat purpose of variance are still not up to afterwards, are used rank test instead and are counted.Influence to normal mouse fasting blood-glucose is real
Test to examine using the t of independent sample and counted.
An index positive in fasting blood-glucose and sugar tolerance binomial index, and on intact animal fasting blood-glucose without influence, i.e.,
It can determine that the auxiliary merit function of blood sugar reduction results of animal of the given the test agent is positive.
Related test results are as follows：
The original body mass of each group mouse of table 13
From table 13, the original body mass of mouse is compared in three batches of each dosage groups of experimental animal between Og/kgBW groups, difference
There are no significant (P>0.05).I.e. the original body mass of mouse is more balanced between each group.
Influence of the table 14 to mouse weight
From table 14, the health care of the present invention gained auxiliary hyperglycemic strengthen immunity of orally administration mouse various dose
After product capsule product 30d, the body weight of mouse is compared in three batches of each dosage groups of experimental animal between Og/kgBW groups, and difference is without aobvious
Work property (P>0.05).The health product capsule product of gained auxiliary hyperglycemic strengthen immunity i.e. of the invention is to mouse weight without shadow
Ring.
Influence of the table 15 to normal mouse fasting blood-glucose
From table 15, before normal mouse experiment and decline percentage to fasting blood sugar after tested material 30d and blood glucose and exist
Compared between 1.35g/kgBW groups and Og/kgBW groups, no significant difference (P>0.05), i.e. present invention gained auxiliary hyperglycemic enhancing
The health product capsule product of immunity is on normal mouse fasting blood-glucose without influence.
Influence of the table 16 to hyperglycemia model mouse fasting blood-glucose
From table 16, the present invention gained auxiliary hyperglycemic enhancing of orally administration hyperglycemia model mouse various dose is exempted from
After the health product capsule product 30d of epidemic disease power, individual dosage group fasting blood sugar, blood glucose decline percentage and compared with Og/kgBW groups, poor
It is different without conspicuousness (P>0.05), i.e. the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity is to hyperglycaemia mould
Type mouse fasting blood-glucose is without influence.
Influence of the table 17 to hyperglycemia model mouse to blood sugar level after glucose
*:Being compared with 0g/kgBW groups has significant difference
From table 17, the present invention gained auxiliary hyperglycemic enhancing of orally administration hyperglycemia model mouse various dose is exempted from
After the health product capsule product 30d of epidemic disease power, compared with Og/kgBW groups, 1.35g/kgBW groups drop to 0.5h blood glucose values after glucose
It is low, there is significant difference (P<0.05).That is the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity exists
1.35g/kgBW groups can reduce hyperglycemia model mouse to 0.5h blood sugar levels after glucose.
Influence of the table 18 to hyperglycemia model mouse to 0-2h Area under the curve of blood glucose after glucose
From table 18, the present invention gained auxiliary hyperglycemic enhancing of orally administration hyperglycemia model mouse various dose is exempted from
After the health product capsule product 30d of epidemic disease power, compared with Og/kgBW groups, each dosage group is to after glucose below 0-2h blood glucose curves
Product moment is different there are no significant (P>0.05).I.e. the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity is to height
Blood glucose model mice is to 0-2h Area under the curve of blood glucose after glucose without influence.
As a result show, the present invention gained auxiliary hyperglycemic enhancing of orally administration hyperglycemia model mouse various dose is immune
After the health product capsule product 30d of power, compared with model control group (Og/kgBW), the tested material can drop in 1.35g/kgBW groups
Low hyperglycemia model mouse is to 0.5h blood sugar levels (P after glucose<0.05).The tested material is to mouse weight and to normal mouse
Fasting blood-glucose has no adverse effects.According to state of State Food and Drug Administration food medicine prison [2012] No. 107 annexes 3 of guarantorization：
Knowable to the criterion of auxiliary hyperglycemic function evaluation method (scheme one), present invention gained auxiliary hyperglycemic strengthen immunity
Health product capsule product auxiliary hyperglycemic function results of animal is positive.
Security poison is carried out using the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9
Neo-Confucianism evaluates zoopery, and (detection side is Health Food Function Detection Center, Applied Literature and Science College, B, is directly made
With the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 remove the medicine after capsule shells into
Point), foundation《Health food is examined and assessment technique specification》(2003 editions) toxicology method of inspection is carried out.
Beijing Vital River Experimental Animals Technology Co., Ltd. is selected in experiment respectively【Credit number：SCXK (capital) 2012-
0001】The SPF level Kunming mouses of breeding and SD rats.Feed is maintained to be pulled together feed corporation,Ltd by Beijing Australia of section【Licensing
Number：SCXK (capital) 2014-OOlO】Production.Each dosage group gives maintenance feed.
Data processing is carried out using SPSS11.0 softwares.One-way analysis of variance is used to measurement data, but need to be by variance
The program of analysis first carries out homogeneity test of variance, if variance is neat, carries out overall comparison using one-way analysis of variance, finds differences
Again being compared two-by-two between multiple dosage groups and a control group mean is carried out with Dunnett.Data to heterogeneity of variance are fitted
When variable conversion, wait meet homogeneity of variance requirement after, counted with the data after conversion；If being still not up to after variable conversion
Homogeneity of variance, uses rank test instead and is counted.χ is used to enumeration data2Examine.
Related test results are as follows：
The acute toxicity test in mice result of table 19
From the result of table 19, to 2 tested materials of mouse stomach of two kinds of sexes, given low is 18.OOg/kgBW,
During the 14d of observation, animal state is normal, the abnormal conditions such as no poisoning sign and death.Animal subject is put to death and carried out by 15d
Gross anatomy checks that major organs are shown no obvious abnormalities.Tested material is equal to the oral maximum tolerated dose (MTD) of female, male mouse
More than 15g/kgBW.According to acute toxicity grading criteria, the health product capsule of present invention gained auxiliary hyperglycemic strengthen immunity
Product belongs to nontoxic level.
Table 20 first time Salmonella reversion test result unit：Individual/ware
Note：Result above is the means standard deviation of three plates.
Second of the Salmonella reversion test result unit of table 21：Individual/ware
Note：Result above is the means standard deviation of three plates.
From table 20, the result of table 21, each dosage group of tested material, which is returned, becomes clump count not less than solvent control group, untreated
Control group, which is returned, becomes clump count more than 2 times, also without dosage --- reaction relation.
Conclusion：The health product capsule product of gained auxiliary hyperglycemic strengthen immunity of the invention is adding and is being not added with hepatomicrosome
Under enzyme activation system situation, Salmonella reversion test result is feminine gender.
The female mice Micronucleus result of the test of table 22
Note#：Positive controls are compared with solvent control group, there is pole significant difference (P ＜ 0.01)
The Male mouse bone marrow polychromatic erythrocyte micronucleus test result of table 23
Note#：Positive controls are compared with solvent control group, there is pole significant difference (P ＜ 0.01)
From table 22, the result of table 23, each dose of test thing is to the proliferation of bone marrow cells of two kinds of sex mouse without obvious suppression
Make and use, basic, normal, high three dosage groups PCEfNCE ratios illustrate tested material no cytotoxicity.Two kinds of each dosage groups of sex mouse
Difference (P ＞ 0.05) that Micronucleus is compared that there are no significant with solvent control group.Positive controls mouse
Micronucleus is significantly higher than solvent control group (P ＜ 0.01), illustrates that animal subject is sensitive, experiment is reliable.
Conclusion：In the range of study dosage, the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity
Mice bone marrow micronucleus is negative.
The mouse inbred strain result of table 24
Note#：Positive controls are compared with solvent control group, there is pole significant difference (P ＜ 0.01)
From table 24, it is poor that each dosage group Sperm Abnormalities of Mice of tested material is compared no conspicuousness with solvent control group
Different (P ＞ 0.05).Positive controls Sperm Abnormalities of Mice is significantly higher than solvent control group (P ＜ 0.01), illustrates tested
Animal is sensitive, and experiment is reliable.
Conclusion：In the range of study dosage, the health product capsule product of present invention gained auxiliary hyperglycemic strengthen immunity
Mouse inbred strain is negative.
The female rats body weight of table 25, weight gain, food ration, food utilization inspection result
The male rat body weight of table 26, weight gain, food ration, food utilization inspection result
From table 25, table 26, give after the tested material 30d of rat various dose, rat body weight, weight gain, ingest
Amount, food utilization are compared in each dosage group of experimental animal between solvent control group, there are no significant difference (p>0.05), i.e., originally
The health product capsule product of invention gained auxiliary hyperglycemic strengthen immunity is to the weight gain of rat, food ration, food use
Rate etc. has no significant effect.
The Rat Fast body weight of table 27
The Rats Organs and Tissues coefficient inspection result -1 of table 28
The Rats Organs and Tissues coefficient inspection result -2 of table 29
From table 27,28,29, give after the tested material 30d of rat various dose, Rats Organs and Tissues coefficient is in experimental animal
Each dosage group between solvent control group with being compared, there are no significant difference (P>0.05), i.e. present invention gained auxiliary hyperglycemic enhancing
The health product capsule product of immunity has no significant effect to Rats Organs and Tissues.
The rat biochemical analysis result -1 of table 30
The rat biochemical analysis result -2 of table 31
The rat biochemical analysis result -3 of table 32
The rat blood inspection result -1 of table 33
The rat blood inspection result -2 of table 34
From table 30 to 34, give after the tested material 30d of rat various dose, the every biochemical and physiochemical indice of rat exists
Each dosage group of experimental animal between solvent control group with being compared, there are no significant difference (P>0.05), i.e., present invention gained auxiliary drops
The health product capsule product of blood glucose strengthen immunity is to the physiochemical indice of rat, hepatic and renal function, and fat, sugar, protein metabolism are without bright
Development rings.
Table feeds hepatic pathology microscopy result in 35 30 days
Liver：Solvent control group female rats liver cell sees 2 spotty necrosis.High dose group is female, male rat liver cell
Respectively see 1 spotty necrosis.
Table feeds Pathological microscopy result in 36 30 days
Kidney：Solvent control group and high dose group is female, male rat kidney is normal.
Table feeds gastroenteric pathology microscopy result in 37 30 days
Stomach and intestine：Solvent control group and high dose group is female, male rat stomach and intestine are normal.
Table feeds spleen pathology microscopy result in 38 30 days
Spleen：Solvent control group and high dose group is female, male rat spleen is normal.
Table feeds orchiopathology microscopy result in 39 30 days
Testis：Solvent control group and high dose rat testicle are normal.
Table feeds ovary pathology microscopy result in 40 30 days
Ovary：Solvent control group and high dose rat ovary are normal.
From table 35 to 40：Solvent control group and the indivedual sample liver cell spotty necrosis of high dose group.Solvent control group
Notable difference is had no with high dose group pathological change.The health product capsule product of gained auxiliary hyperglycemic strengthen immunity of the invention
The obvious pathological change of test group of animals is not caused.
As a result show, the health product capsule product of the gained auxiliary hyperglycemic strengthen immunity of the embodiment of the present invention 9 is to two kinds
The maximum tolerated dose (MTD) of its mouse oral of sex is all higher than 15g/kgBW, belongs to nontoxic level by acute toxicity classification.Through Ames
Experiment, mice bone marrow micronucleus, mouse inbred strain, result are feminine gender, in study dosage model
Mutagenicity is had no in enclosing.30 days feeding trials of rat, rat body weight, weightening, food ration, food utilization, internal organs inspection,
Organ weights, dirty/body ratio, hematology and blood biochemical analysis inspection result show that each dosage group is compared with solvent control group, respectively
Inspection project is without significant difference (P>0.05).Histopathologic examination's result shows, solvent control group and high dose group is female, hero
Property rats'liver, kidney, stomach, intestines, spleen, ovary and testis do not find obvious damaging pathological change.Feeding trial is not found within 30 days
The health product capsule product of gained auxiliary hyperglycemic strengthen immunity of the invention has obvious toxic action.
Although illustrate and describing the present invention with specific embodiment, but it will be appreciated that various embodiments above is only used
To illustrate technical scheme, rather than its limitations；It will be understood by those within the art that：Without departing substantially from this hair
In the case of bright spirit and scope, the technical scheme described in foregoing embodiments can be modified, or to wherein
Some or all of technical characteristic carries out equivalent substitution；And these modifications or replacement, do not make the essence of appropriate technical solution
Depart from the scope of various embodiments of the present invention technical scheme；It is, therefore, intended that including belonging to the present invention in the following claims
In the range of all these substitutions and modifications.
Claims (10)
1. a kind of health products of auxiliary hyperglycemic strengthen immunity, it is characterised in that the auxiliary hyperglycemic strengthen immunity
Health products are mainly prepared by the raw material of following mass fraction：
10-30 parts of ginseng extract, 50-150 parts of Astragalus Root P.E, 10-30 parts of mulberry-leaf extract and ophiopogon japonicus extract 30-90
Part.
2. a kind of health products of auxiliary hyperglycemic strengthen immunity according to claim 1, it is characterised in that the auxiliary
The health products of hypoglycemic strengthen immunity are mainly prepared by the raw material of following mass fraction：
15-25 parts of ginseng extract, 80-120 parts of Astragalus Root P.E, 15-25 parts of mulberry-leaf extract and ophiopogon japonicus extract 45-75
Part.
3. a kind of health products of auxiliary hyperglycemic strengthen immunity according to claim 2, it is characterised in that the auxiliary
The health products of hypoglycemic strengthen immunity are mainly prepared by the raw material of following mass fraction：
63 parts of 21 parts of ginseng extract, 96 parts of Astragalus Root P.E, 21 parts of mulberry-leaf extract and ophiopogon japonicus extract.
4. a kind of health products of auxiliary hyperglycemic strengthen immunity according to claim 1, it is characterised in that the auxiliary
The raw material of the health products of hypoglycemic strengthen immunity also includes pharmaceutic adjuvant.
5. the health products of a kind of auxiliary hyperglycemic strengthen immunity according to claim 4, it is characterised in that described medicinal
The consumption of auxiliary material is the 20%-50% of ginseng extract, Astragalus Root P.E, mulberry-leaf extract and ophiopogon japonicus extract gross mass, excellent
Elect 30%-40%, more preferably 34.34% as.
6. the health products of a kind of auxiliary hyperglycemic strengthen immunity according to claim 4, it is characterised in that described medicinal
Auxiliary material includes propellant, solubilizer, cosolvent, emulsifying agent, colouring agent, binder, disintegrant, filler, lubricant, wetting
Agent, osmotic pressure regulator, stabilizer, glidant, flavouring, preservative, suspending agent, coating material, aromatic, anti-binder,
Integrated agent, penetration enhancer, pH value regulator, buffer, surfactant, foaming agent, defoamer, thickener, inclusion agents, guarantor
One or more in humectant, absorbent, diluent, flocculant and deflocculant, filter aid and release retarding agent.
7. the health products of a kind of auxiliary hyperglycemic strengthen immunity according to claim 6, it is characterised in that described medicinal
Auxiliary material includes dextrin and/or magnesium stearate, preferably includes dextrin and magnesium stearate.
8. a kind of health products of auxiliary hyperglycemic strengthen immunity according to claim 7, it is characterised in that the dextrin
Consumption be ginseng extract, Astragalus Root P.E, the 19.5%-48% of mulberry-leaf extract and ophiopogon japonicus extract gross mass, preferably
For 29%-38.5%, more preferably 33%；
Preferably, the consumption of the magnesium stearate is that ginseng extract, Astragalus Root P.E, mulberry-leaf extract and ophiopogon japonicus extract are total
The 0.5%-2% of quality, preferably 1%-1.5%, more preferably 1.34%.
9. according to a kind of health products of any described auxiliary hyperglycemic strengthen immunities of claim 1-8, it is characterised in that institute
The formulation for stating the health products of auxiliary hyperglycemic strengthen immunity is the one or more in capsule, particle and liquid；
Preferably, the particle includes the one or more in tablet, pill and pulvis.
10. a kind of preparation method of the health products of auxiliary hyperglycemic strengthen immunity as described in claim 1-9 is any, it is special
Levy and be, raw material needed for weighing in proportion is prepared into required formulation, obtains a kind of health care of auxiliary hyperglycemic strengthen immunity
Product.
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| CN108578544A (en) * | 2018-06-20 | 2018-09-28 | 西安巨子生物基因技术股份有限公司 | A kind of Chinese medicine composition and the preparation method and application thereof with blood sugar reducing function |
| CN110464757A (en) * | 2019-08-16 | 2019-11-19 | 云南绿华食品有限公司 | A kind of composition and preparation method thereof reducing blood glucose using Guava Leaf |
| CN114848748A (en) * | 2022-06-08 | 2022-08-05 | 河北御芝林生物科技有限公司 | Composition with blood sugar reducing effect and preparation method thereof |
| CN115120684A (en) * | 2021-03-24 | 2022-09-30 | 杭州秋禾健康管理有限公司民康街诊所 | Traditional Chinese medicine formula for treating diabetes and processing method thereof |
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| CN102068625A (en) * | 2010-12-30 | 2011-05-25 | 蚌埠丰原涂山制药有限公司 | Traditional Chinese medicinal composition for reducing blood sugar and blood pressure and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108578544A (en) * | 2018-06-20 | 2018-09-28 | 西安巨子生物基因技术股份有限公司 | A kind of Chinese medicine composition and the preparation method and application thereof with blood sugar reducing function |
| CN110464757A (en) * | 2019-08-16 | 2019-11-19 | 云南绿华食品有限公司 | A kind of composition and preparation method thereof reducing blood glucose using Guava Leaf |
| CN115120684A (en) * | 2021-03-24 | 2022-09-30 | 杭州秋禾健康管理有限公司民康街诊所 | Traditional Chinese medicine formula for treating diabetes and processing method thereof |
| CN115120684B (en) * | 2021-03-24 | 2023-08-08 | 杭州秋禾健康管理有限公司民康街诊所 | Chinese medicinal composition for treating diabetes and its preparation method |
| CN114848748A (en) * | 2022-06-08 | 2022-08-05 | 河北御芝林生物科技有限公司 | Composition with blood sugar reducing effect and preparation method thereof |
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