CN103110100A - Korean medical healthcare food composition as well as preparation method and application thereof - Google Patents
Korean medical healthcare food composition as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a Korean medical healthcare food composition. The Korean medical healthcare food composition is a preparation prepared from the raw materials including kudzuvine root, dandelion, Chinese yam, shizandra, ophiopogon root, platycodon root, angelica root and cimicifuga foetida; and the dosage forms of the composition comprise powder, granules, tablets, chewable tablets, capsules, soft capsules, oral liquid, pastes, concentrates, ointments, soups, cakes and drinks. The composition has a healthcare function of assistant blood sugar reduction. The invention also provides a preparation method and an application of the composition. The composition has a formula which is screened out according to Chinese Korean theories of medicine on the basis of a Korean medicine clinical empirical prescription for preventing and treating diabetes, and meets requirements for healthcare foods. The composition can be used for treating the symptoms of diabetes and the like caused by phlogistic fire which fumes entrails, generates heat and dryness, causes qi flaming and secretion dryness, and makes one cannot restrain oneself by drinking due to accidental joy and anger, excessive consumption of energy, declined blood after illness, improper diet, deficiency of Yin and the like, and the aim of assistant blood sugar reduction is achieved by tonifying and astringing the lung, moistening dryness and resolving phlegm, promoting the production of body fluid to relieve exterior syndromes and clearing heat, so that a new choice is provided for the development of healthcare foods. The preparations prepared from the Korean medical healthcare food composition are experimentally proved to have the healthcare function of assistant blood sugar reduction and do not have toxic or side effect.
Description
Technical field
The present invention relates to a kind of health-care food composition, specifically refer to have auxiliary hyperglycemic function towards medical insurance health food composition and method of making the same and purposes, belong to health food development, production, use field.
Background technology
The present invention is take China towards theory of medicine as the basis, according to the regulation of " health food registration management way ", develops a kind of health-care food composition with auxiliary hyperglycemic function and preparation method thereof.Its composite formula Main Basis is used for the proved recipe of control " lunar people " diabetes in the medical science, and concrete composition derives from medicine food dual purpose plant commonly used.
Diabetes (Diabetesmellitus, DM) are to continue hyperglycaemia as one group of endocrine metabolism disease of feature.Wherein common with diabetes B, account for more than 90% of diabetes patient's sum.Diabetes B has become one of three the highest large NCDs of world's M ﹠ M, and the incidence of disease is ascendant trend year by year, especially rises the most obvious with developing countries such as China, the Indian subcontinent, Africa.Therefore, further strengthen the research to diabetes, the control of actively developing diabetes and complication thereof is the urgent task that present the world of medicine faces.The traditional Chinese medicine prevention diabetes have long history, have accumulated the experience of a large amount of preciousnesses.The anti-diabetic activity composition in Chinese medicine source particularly has gentle lasting, the characteristics such as side effect is little, can use for a long time of therapeutic action, and its mechanism of action is often many target spots, manifold effect, multi-functional comprehensive function, and the irreplaceable comprehensive advantage of Western medicine is arranged.The traditional Chinese medical science is Stages, diagnosis and treatment and specially side's treatment to the treatment major programme of DM, has obtained certain curative effect in clinical individualized treatment, but the drug development that is fit to the group feature treatment achieving no breakthrough property progress still.
China is on the basis of the intrinsic culture base of Korean nationality and east medicine towards medical science, absorbs the theory of traditional Chinese medicine and pharmacy, and in conjunction with this nationality experience of preventing and curing diseases, progressively formation and development is got up.Be take " my god, people, generation, " Overall View as theoretical direction towards medical science, take the structure of " four-quadrant of the four-dimension " as principal mode, resemble (physique, disease) and the dialectical diagnoses and treatment that combines to distinguish.Be Syndrome Differentiation of Constitution towards one of most important theories of medical science, the crowd is divided into four kinds of sun people, lunar people, few positive people, few cloudy people by physique, wherein lunar people accounts for more than 50%, and number is maximum.Lunar people easily causes suffering from diabetes because of its physique characteristic, finds towards doctor's clinical investigation, and DM patient is lunar people more than 70%.To the DM patient treatment time, towards medical science according to patient's physique characteristic in conjunction with the disease medication, prescription used is relatively stable and evident in efficacy, is particularly suitable for being developed as new drug or the health food of group feature prevention and treatment.Present clinical use represents prescription towards doctor " lunar people ", has accumulated certain experience as treatment DM such as " the civil and military soup of a thousand pieces of gold ".
This product formula is is suitably added and subtracted with reference to towards doctor's clinical proved recipe, is comprised of medicine food dual purpose plants such as the root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletops.
In formula, the root of kudzu vine, Chinese yam, balloonflower root, the root of Dahurain angelica, Dandelion are in the article that are food and medicine, and the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, rattletop are the article that can be used for health food.In formula, whole flavour of a drug form and meet health food to the requirement of raw material sources.
The root of kudzu vine is the dry root of legume pueraria lobata Pueraria lobata (willd.) ohwi, and spring and autumn is excavated, and removes impurity, dries.The property of medicine is sweet, hot, and is cool.Return spleen, stomach warp.Be the tcm clinical practice medicine that expels pathogenic wind from the body surface commonly used, the pharmacological actions such as hypoglycemic, antitumor, analgesic, expansion of cerebral vascular, step-down, reducing heart rate, reduction MCO, diastole smooth muscle are arranged.Think that towards the doctor root of kudzu vine is lunar people's medicine.Function is for dispersing expelling pathogenic factors from muscles and skin, and is clearing heat and detoxicating, promotes the production of body fluid to quench thirst.Be mainly used in lunar people Yang Ming, positive malicious flushing, throat disease, fever with aversion to cold, order pain nasal cavity dryness, body heat stomachache also is used for lunar people's typhoid fever from sharp person, and the more fever with less chills card is vomited and diarrhoea, cholera, difficult urination, five drench, headache, face heat waits card.Root of kudzu vine expelling pathogenic factors from muscles and skin soup in " east doctor's Longevity and Life Preservation " with clearing heat and detoxicating, is dispersed expelling pathogenic factors from muscles and skin, controls lunar people's Yangming disease; More chills and less fever soup, clearing heat and detoxicating to disperse wind-heat, control lunar people's typhoid fever, more fever with less chills card.
Dandelion is feverfew dandelion Taraxacum mongolicum Hand.-Mazz., alkali ground dandelion Taraxacum sinicum Kitag. or the dry herb that belongs to several plants together.Spend spring to autumn when just opening and excavate, remove impurity, clean, dry.The property of medicine is bitter, sweet, and is cold.Return liver, stomach warp.Be tcm clinical practice heat-clearing and detoxifying drug commonly used, resisting pathogenic microbes is arranged, protect the liver, the pharmacological actions such as cholagogic, anti-gastric-ulcer, enhancing immunologic function, diuresis.Think that towards the doctor dandelion is lunar people's medicine.Function is clearing heat and detoxicating, and dampness removing is treating stranguria, the carbuncle that disappears dissipating bind.Be mainly used in carbuncle sore, throat disease and liver kidney syndrome of dampness-heat." east doctor's Longevity and Life Preservation " more fever with less chills Tonga dandelion treatment liver kidney humidifier.
Chinese yam is the dry rhizome of Dioscoreaceae herbaceos perennial Chinese yam Dioscorea opposita Thunb..Excavate autumn, cleans, and after scraping off the processing such as tertia, dries or air-dry, running through section and using.The property of medicine is flat, and is sweet.Return spleen, lung, kidney channel.The main active of Chinese yam is Chinese yam polysaccharide.Have the protection of hypoglycemic, liver, anti-ageing, antitumor, regulate or strengthen immunologic function, oxidation resistant pharmacological action.Chinese yam polysaccharide can reduce blood sugar and lipids contents, improves liver glycogen and myocardium glycogen content, illustrates that Chinese yam has hypoglycemic activity, and can promote the blood sugar utilization.Think that towards the doctor Chinese yam is lunar people's medicine.The merit that function is kept in having for strong lung is invigorated the spleen and benefited qi.Be mainly used in having loose bowels, the consumptive disease dream is let out, and also is used for lunar people and spits blood, the diseases such as hemorrhagic vertigo.The Chinese yam soup that clears away heart-fire in " east doctor four-quadrant newly organized ", to invigorate the spleen and benefit qi, clearing away the heart fire and tranquillizing is controlled the consumptive disease dream and is let out, and abdomen is not had loose bowels bitterly, aphasia from apoplexy disease.Lung first medicine soup in mountain in " east doctor's Longevity and Life Preservation " is controlled the diseases such as haematemesis, bleeding from five sense organs or subcutaneous tissue, hemorrhagic vertigo.．
The fruit of Chinese magnoliavine is the ripening fruits of magnoliaceae schisandra Schisandra chinesis (Turcz.) Bail or schisandra chinensis Schisandra sphenanthera Rehd.et Wils..Gather during fruit maturation autumn, dries.The property of medicine is sour, sweet, warm.Return lung, the heart, kidney channel.Has convergence astringent or styptic treatment for spontaneous sweating, nourishing generate fluid, the effect of kidney calming.Be used for the treatment of nourishing generate fluid, the nourshing kidney of astringing the lung, antidiarrheal, puckery essence, calm the nerves, can control that chronic cough void is breathed heavily, the diseases such as the few dry in Tianjin, seminal emission are rushed down for a long time, forgetful insomnia.The traditional Chinese medical science thinks that the fruit of Chinese magnoliavine protects the liver, hypoglycemic, hypotensive, stimulating central nervous system system and respiratory system, kobadrin, enhancing cellular immunity, anti-oxidant, anti-ageing, resistance to compression, vasodilatory pharmacological action.Think towards the doctor: the fruit of Chinese magnoliavine is lunar people's medication, and the effect of strong lung tonifying lung is arranged.Be mainly used in lunar people's cough, thirsty hidrosis, palpitaition, insomnia, dreaminess.This product has the merit of strong lung, often joins the tuber of dwarf lilyturf, balloonflower root etc." east doctor four-quadrant newly organized " " Chinese ephedra Jinsui River soup " has the merit of the arrest sweating of promoting the production of body fluid, and often joins the tuber of dwarf lilyturf, with the arrest sweating that promotes the production of body fluid, clearing away summerheat, and treatment palpitaition, insomnia, dreaminess.Modern study thinks that the fruit of Chinese magnoliavine contains abundant organic acid, vitamin, flavonoids, phytosterol and the lignan (as schizandrin, deoxyschizandrin or fruit of Chinese magnoliavine fat element) of potent reactivation is arranged, it is also one of minority medicinal material that has concurrently essence, gas, god's three large helps, the strong liver of the beneficial gas of energy, the efficient of promoting the cells exclude refuse, supply more oxygen, construction and uses energy, raising memory and property endurance.
The tuber of dwarf lilyturf is liliaceous plant Ophiopogon tuber of dwarf lilyturf japonicus(Thumb.) the piece root of Ker-Gawl..Usually excavate summer, clean and remove fibrous root, dry.The property of medicine is sweet, little hardship, is slightly cold.Return stomach, lung, the heart channel of Hang-Shaoyin.Be tcm clinical practice drugs for nourishing yin commonly used, the pharmacological action of hypoglycemic, anti-ageing, antitumor, radioresistance, anti-arrhythmia, enhancing cellular immunity is arranged.The traditional Chinese medical science thinks that the tuber of dwarf lilyturf has nourishing Yin and promoting production of body fluid, the effect that moistening lung clears away heart-fire.Can be used for dryness of the lung dry cough; Lung carbuncle; Deficiency of Yin labor is coughed; Tianjin wound is thirsty; Quench one's thirst; Vexed insomnia; Have sore throat; The dry constipation of intestines; Blood-head is told the treatment of nosebleed.Think that towards the doctor tuber of dwarf lilyturf is lunar people's medicine.The moistening lung of function tonifying lung, clearing heat and moistening dryness.Be mainly used in lunar people in conditioner and heatstroke after being ill, polydipsia, summer fever is sick.Record in " eastern doctor's Longevity and Life Preservation ": " the first soup of conditioning lung " with tonifying lung and lung, fire-draining and dryness moisturizing is used for conditioner greatly after being ill.
Balloonflower root is Campanulaceae Platycodon grandiflorum(Jacq.) root of A.DC..Spring and autumn is excavated, and removes the seedling stem, cleans, and scrapes off cork, dries.The property of medicine is bitter, and suffering is flat.Return lung channel.Have a surname's lung, eliminate the phlegm, relieve sore throat, the effect of apocenosis.That balloonflower root has is hypoglycemic, protect the liver, antibechic, relaxing smooth muscle, eliminate the phlegm, oxidation resistant pharmacological action.Think that towards the doctor balloonflower root is lunar people's medication, have strong lung and outer power of pushing up is arranged.Record in " east doctor's Longevity and Life Preservation ": " balloonflower root Huangqin-Tang ", with dispersing superficial exopathogens, throat is controlled lunar people's throat disease.
The root of Dahurain angelica is the dry root of samphire root of Dahurain angelica Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. or anti-root of Dahurain angelica Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. Var. formosana (Boiss.) Shan et Yuan..Excavate when between Xia Qiu, leaf is yellow, remove fibrous root, dry.The property of medicine is hot, temperature.Return stomach, large intestine, lung channel.The main active of the root of Dahurain angelica is furocoumarin.The pharmacological actions such as analgesia, analgesic, anti-inflammatory, resisting pathogenic microbes, spasmolysis, stimulating central nervous system system are arranged.Think that towards the doctor root of Dahurain angelica is lunar people's medicine.Function for induce sweat, wind-expelling pain-stopping.Be mainly used in lunar people's headache, positive malicious flushing, sore-throat, the cards such as nasosinusitis.
Rattletop is the dry rhizome of ranunculaceae plant C.heracleifolia Cimicifuga heracleifolia Kom., Cimicifuga Dahurica Cimicifuga dahurica (Turcz.) Maxim. or rattletop Cimicifuga foetida L..Excavate autumn, removes silt, shines when doing to fibrous root, burns or remove fibrous root, dries.The property of medicine is hot, little sweet, is slightly cold.Return lung, spleen, stomach, large intestine channel.Step-down arranged, suppress cardiac muscle, the pharmacological actions such as reducing heart rate, antibiotic, calm, anticonvulsion, analgesic cooling.Think that towards the doctor rattletop is lunar people's medicine.Function is for dispersing wind-heat, detoxifcation promoting eruption, elevate a turnable ladder yang-energy.
Having no at present take China towards theory of medicine is the health food listing of compound basis, and retrieval Chinese patent and bibliographic data base have no the health food patent similar to present composition formula and study report, present composition design theory and thinking innovation.Have the health food of auxiliary hyperglycemic function take the present invention as foundational development, the market demand has a extensive future.
Summary of the invention
Technical scheme of the present invention provide a kind of take China towards medical science health theory as foundation, have the health-care food composition of auxiliary hyperglycemic function, it be by meet " health food registration management way " regulation natural material and supplementary product compatibility be prepared from.The present invention also provides preparation method and the purposes of this compound health-care food compositions.
The invention provides a kind of have auxiliary hyperglycemic towards medical insurance health food composition, it is the preparation of being made by the raw material of following weight proportioning:
Root of kudzu vine 4-60 part, dandelion 2-30 part, Chinese yam 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part, root of Dahurain angelica 1-15 part, rattletop 1-15 part.
Further preferred, it is the preparation of being made by the raw material of following weight proportioning:
20 parts of the roots of kudzu vine, 10 parts of dandelions, 10 parts of Chinese yams, 5 parts, the fruit of Chinese magnoliavine, 5 parts of the tuber of dwarf lilyturfs, 5 parts of balloonflower roots, 5 parts of the roots of Dahurain angelica, 5 parts of rattletops.
Health-care food composition of the present invention, it is to be active component by the root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop medicinal material or medicinal substances extract, adds the preparation that the acceptable auxiliary material of health food or complementary composition are prepared from.
Wherein, described preparation formulation comprises: pill, powder, granule, tablet, chewable tablets, capsule, soft capsule, oral liquid, paste, concentrate, paste, custard, cake, beverage.
The present invention also provides the preparation method of this health-care food composition, and it comprises the steps:
(1) take the raw material of weight proportion: root of kudzu vine 4-60 part, dandelion 2-30 part, Chinese yam 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part, root of Dahurain angelica 1-15 part, rattletop 1-15 part;
(2) get that the root of kudzu vine, dandelion, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop add water or organic solvent extracts, get extract 1, get Chinese yam, be ground into fine powder, cross 100 mesh sieves, yam flour, or get that the root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop add water or organic solvent extracts, get extract 2;
(3) get extract 1 and yam flour mixing, add acceptable auxiliary material or complementary composition in health food, make respectively preparation by corresponding shaping technique, or get extract 2 and add acceptable auxiliary material or complementary composition in health food, make respectively preparation by corresponding shaping technique.
Health-care food composition of the present invention is that foundation is Chinese towards theory of medicine, take towards the clinical proved recipe be used to preventing and treating diabetes of doctor as the basis, filters out the formula that meets the healthy food material requirement, and concrete composition derives from medicine food dual purpose plant commonly used.Careless for the happiness anger that " lunar people " physique occurs, take up one's energy excessively, blood declines after being ill, eating and drinking without temperance, the reasons such as the element body deficiency of Yin cause the upper smoked internal organs of scorching fire, Heat of Formation is dry, dries up in gas vehement Tianjin, can not draw drink from prohibiting, become the symptom such as quench one's thirst, by tonifying lung astringe the lung, moistening dryness and resolving phlegm, promote the production of body fluid induce sweat, the merit of heat-clearing, reach the purpose of auxiliary hyperglycemic, for the exploitation health food provides a kind of new selection.
The specific embodiment
Below in conjunction with experimental example and embodiment, the present invention is described in more detail.
Embodiment 1
Health food of the present invention is to be made by the raw material of following weight: the root of kudzu vine 600 g, dandelion 300 g, Chinese yam 300 g, the fruit of Chinese magnoliavine 150 g, the tuber of dwarf lilyturf 150 g, balloonflower root 150 g, the root of Dahurain angelica 150 g, rattletop 150 g.
And health food of the present invention is by preparing as the next stage:
The root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, the rattletop boiling of (1) getting above-mentioned weight are extracted 2 times, filter, merging filtrate, get extract, get refined liquid after extract process adsorption clarification or supercentrifugation are refining, get medicinal extract after the refined liquid reduced pressure concentration, standby;
(2) get proper auxiliary materials and mix with above-mentioned medicinal extract, drying is pulverized, and crosses 100 mesh sieves, and take 50 % ethanol as wetting agent softwood processed, extrusion is crossed 14 mesh sieves and granulated, and drying is crossed the 16 whole grains of mesh sieve, gets granule.
Embodiment 2
Health food of the present invention is to be made by the raw material of following weight: the root of kudzu vine 300 g, dandelion 200 g, Chinese yam 200 g, the fruit of Chinese magnoliavine 150 g, the tuber of dwarf lilyturf 150 g, balloonflower root 150 g, the root of Dahurain angelica 150 g, rattletop 100 g.
And health food of the present invention is by preparing as the next stage:
(1) get the root of kudzu vine, the dandelion of above-mentioned weight, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop boiling are extracted 2 times, filter, merging filtrate gets extract, gets refined liquid after extract process adsorption clarification or supercentrifugation are refining, get medicinal extract after the refined liquid reduced pressure concentration, standby;
(2) get Chinese yam and be processed into powder, cross 100 mesh sieves, get yam flour, standby;
(3) get yam flour 200 g and mix with above-mentioned medicinal extract, drying is pulverized, and crosses 100 mesh sieves, and take 50 % ethanol as wetting agent softwood processed, extrusion is crossed 14 mesh sieves and granulated, and drying is crossed the 16 whole grains of mesh sieve, gets dried particle, and dried particle tablet press machine compressing tablet namely gets chewable tablets.
Embodiment 3
Health food of the present invention is to be made by the raw material of following weight: the root of kudzu vine 600 g, dandelion 300 g, Chinese yam 250 g, the fruit of Chinese magnoliavine 200 g, the tuber of dwarf lilyturf 200 g, balloonflower root 200 g, the root of Dahurain angelica 150 g, rattletop 150 g.
And health food of the present invention is by preparing as the next stage:
(1) get the root of kudzu vine, the dandelion of above-mentioned weight, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop boiling are extracted 2 times, filter, merging filtrate gets extract, gets refined liquid after extract process adsorption clarification or supercentrifugation are refining, the refined liquid reduced pressure concentration gets concentrate, and is standby;
(2) get Chinese yam and be processed into powder, cross 100 mesh sieves, get yam flour, standby;
(3) get 100g agar and put into 20 times of amount concentrates, be heated to dissolving after immersion 10h, add honey element, natural antiseptic agent, stir evenly, be heated to 80 ℃, get yam flour 250g and add, stir, pressure sterilizing lets cool to 80 ℃ of injection moldings, namely gets the custard agent.
Embodiment 4
Health food of the present invention is to be made by the raw material of following weight: the root of kudzu vine 500 g, dandelion 300 g, Chinese yam 300 g, the fruit of Chinese magnoliavine 250 g, the tuber of dwarf lilyturf 250 g, balloonflower root 200 g, the root of Dahurain angelica 150 g, rattletop 150 g.
And health food of the present invention is by preparing as the next stage:
(1) get the root of kudzu vine, the dandelion of above-mentioned weight, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop boiling are extracted 2 times, filter, and merging filtrate gets extract, get refined liquid after extract process adsorption clarification or supercentrifugation are refining, and be standby;
(2) get above-mentioned refined liquid and add appropriate flavouring, stabilizing agent, mixing filters, and adds appropriate pure water to be diluted to ormal weight, mixing, and can, sterilization namely gets beverage.
The discriminating of experimental example 1 granule of the present invention
(1) thin layer of the root of kudzu vine is differentiated and is got this product powder 6 g, adds methyl alcohol 10 mL, places 2 h, filters, and filtrate evaporate to dryness, residue add methyl alcohol 0.5 mL makes dissolving, as need testing solution.Get root of kudzu vine control medicinal material 1 g, be made in the same way of control medicinal material solution.Get preparation 1 g that lacks the root of kudzu vine, be made in the same way of negative control solution.Get the Puerarin reference substance, add methyl alcohol and make the solution that every 1 mL contains 1mg, product solution in contrast.According to the thin-layered chromatography test, draw above-mentioned four kinds of solution, put respectively on same silica gel g thin-layer plate, take chloroform-methanol-water (7.5:2:0.25) as solvent, launch, take out, dry, put under ultraviolet lamp (365nm) and inspect.Result with reference substance chromatogram and control medicinal material chromatogram relevant position on, the spot of the aobvious same color of test sample chromatogram, negative control solution is without corresponding spot.
(2) thin layer of dandelion is differentiated and is got this product powder 10g, adds methyl alcohol 50ml, adds hot reflux 30 minutes, filter, filtrate evaporate to dryness, residue add water 10ml makes dissolving, filters, filtrate is extracted 2 times with the ethyl acetate jolting, each 10ml, combined ethyl acetate liquid, evaporate to dryness, residue adds methyl alcohol 1ml makes dissolving, as need testing solution.Separately get the caffeic acid reference substance, add methyl alcohol and make the solution that every 1ml contains 0.5mg, in contrast product solution.According to the thin-layered chromatography test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take the upper solution of butyl acetate-formic acid-water (7:2.5:2.5) as solvent, launch, take out, dry, put under ultraviolet lamp (365nm) and inspect.In the test sample chromatogram, with reference substance chromatogram corresponding position on, the fluorescence spot of aobvious same color.
(3) thin layer of Chinese yam is differentiated and to be got this product powder 10 g, and 30 mL that add methylene chloride add hot reflux 2 h, filters, and filtrate evaporate to dryness, residue 1 mL that adds methylene chloride makes dissolving, as need testing solution.Get Chinese yam control medicinal material 5 g, be made in the same way of control medicinal material solution.Get preparation 5 g that lack Chinese yam, be made in the same way of negative control solution.Test according to thin-layered chromatography (10 editions appendix VI B of Chinese Pharmacopoeia), draw above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-methyl alcohol-strong ammonia solution (9:1:0.5) as solvent, launch, take out, dry, spray is heated to the spot colour developing with 10% phosphomolybdic acid ethanol solution at 105 ℃.Result with control medicinal material chromatogram relevant position on, the spot of the aobvious same color of test sample chromatogram, the negative control product are without corresponding spot.
(4) fruit of Chinese magnoliavine thin layer is differentiated and is got this product powder 10 g, adds chloroform 30 mL, adds hot reflux 30 min, filters, and filtrate evaporate to dryness, residue add chloroform 1 mL makes dissolving, as need testing solution.Get fruit of Chinese magnoliavine control medicinal material 1 g, be made in the same way of control medicinal material solution.Get preparation 10 g that lack the fruit of Chinese magnoliavine, be made in the same way of negative control solution.Get the schizandrin A reference substance, add chloroform and make the solution that every 1 mL contains 1mg, product solution in contrast.Test according to thin-layered chromatography (10 editions appendix VI B of Chinese Pharmacopoeia), draw above-mentioned four kinds of solution, put respectively on same silica GF254 lamellae, take the upper solution of benzinum (30-60 ℃)-ethyl acetate-formic acid (15:5:1) as solvent, launch, take out, dry, put under ultraviolet lamp (254nm) and inspect.Result with reference substance chromatogram and control medicinal material chromatogram relevant position on, the spot of the aobvious same color of test sample chromatogram, the negative control product are without corresponding spot.
(5) tuber of dwarf lilyturf, this product powder 10 g were got in the thin layer discriminating, added chloroform-methane (7:3) mixed solution 30 mL, soaked 3 h, and ultrasonic processing 30 min let cool, and filtered, and filtrate evaporate to dryness, residue add chloroform 0.5 mL makes dissolving, as need testing solution.Get the control medicinal material 2 g tuber of dwarf lilyturf, be made in the same way of control medicinal material solution.Get preparation 5 g that lack the tuber of dwarf lilyturf, be made in the same way of negative control solution.According to the thin-layered chromatography test, draw above-mentioned three kinds of solution, put respectively on same silica GF254 lamellae, take toluene-methyl alcohol-glacial acetic acid (80:5:0.1) as solvent, launch, take out, dry, put under ultraviolet lamp (254nm) and inspect.Result with control medicinal material chromatogram relevant position on, the test sample chromatogram is the spot of aobvious same color all, the negative control product are without corresponding spot.
(6) the balloonflower root thin layer is differentiated and is got this product powder 10 g, adds 7% sulfuric acid alcohol-water (1:3) and mixes molten 30 mL, and 3 h reflux, let cool, extract 2 times each 30 mL with the chloroform jolting, merge chloroform liquid, add water washing 2 times, each 30 mL, discard washing lotion, chloroform liquid anhydrous sodium sulfate dehydration filters the filtrate evaporate to dryness, residue adds methyl alcohol 1 mL makes dissolving, as need testing solution.Get balloonflower root control medicinal material 5 g, be made in the same way of control medicinal material solution.Get preparation 5 g that lack balloonflower root, be made in the same way of negative control solution.According to the thin-layered chromatography test, draw above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, take chloroform-ether (2:1) as solvent, launch, take out, to dry, spray is heated to the spot colour developing at 105 ℃ clear with 10% ethanol solution of sulfuric acid.Result with control medicinal material chromatogram relevant position on, the spot of the aobvious same color of test sample chromatogram, the negative control product are without corresponding spot.
(7) thin layer of the root of Dahurain angelica is differentiated and is got this product powder 10 g, and 20 mL that add diethyl ether soak 2 h, and jolting constantly filters, and filtrate volatilizes, and residue adds ethyl acetate 1 mL makes dissolving, as need testing solution.Get root of Dahurain angelica control medicinal material 0.5 g, be made in the same way of control medicinal material solution.Get preparation 5 g that lack the root of Dahurain angelica, be made in the same way of negative control solution.Get Imperatorin, Isomperatorin reference substance, add ethyl acetate and make the solution that every 1 mL contains 1mg, product solution in contrast.According to thin-layered chromatography (10 editions appendix VI B of Chinese Pharmacopoeia) test, draw above-mentioned five kinds of solution, put respectively on same silica gel g thin-layer plate, take benzinum (30-60 ℃)-ether (3:2) as solvent, launch, take out, dry, put under ultraviolet lamp (365nm) and inspect.Result with reference substance chromatogram and control medicinal material chromatogram relevant position on, the spot of the aobvious same color of test sample chromatogram, the negative control product are without corresponding spot.
(8) thin layer of rattletop is differentiated and is got this product powder 10g, adds ethanol 150ml, adds hot reflux 1 hour, filters, and filtrate evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Separately get forulic acid reference substance, isoferulic acid reference substance, add ethanol and make the solution that every 1ml contains 1mg, in contrast product solution.According to thin-layered chromatography (appendix VI B) test, draw each 10 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, take benzene-chloroform-glacial acetic acid (6:1:0.5) as solvent, launch, take out, dry, put under ultraviolet lamp (365nm) and inspect.In the test sample chromatogram, with reference substance chromatogram corresponding position on, the fluorescence spot of aobvious same color.
The assay of general flavone in experimental example 2 granule of the present invention
Adopt ultraviolet spectrophotometry, measure general flavone content in preparation.
The preparation of 1 solution
1.1 sample solution
Get granule, cross 60 mesh sieves after pulverizing, precision takes powder 2 g, adds ultrasonic 30 min of ethanol, is settled to 25 mL, and after shaking up, miillpore filter filters to get sample solution.
1.2 need testing solution
Precision measures sample solution 4 mL and is placed in evaporating dish, add 1 g Silon absorption, fling to ethanol in water-bath or insulating box, then change chromatographic column over to, first wash with 30 mL benzinums, benzinum liquid discards, use the methanol-eluted fractions flavones, collect methanol solution, evaporated under reduced pressure, be settled to 25 mL with the methyl alcohol dissolving again, and get final product.
1.3 reference substance solution
Precision takes control substance of Rutin 5 mg, and with the methyl alcohol dissolving, ultrasonic letting cool with methanol constant volume to 100 mL, namely gets 50 μ g ﹒ mL
-1Reference substance solution.
2 linear relationships are investigated
Get respectively reference substance solution 0,1,2,3,4,5 mL add methyl alcohol to scale in 10 mL volumetric flasks, shake up, and measure absorbance in 360 nm places.Carry out linear regression with reference substance solution concentration (X) and absorbance (Y), getting regression equation is Y=0.0263X-0.0485, r=0.9992(n=6).Result shows, at 0-25 μ g ﹒ mL
-1Scope internal reference product concentration and absorbance are good linear relationship.
3 precision are investigated
Precision measures reference substance solution, and replication 5 times the results are shown in Table 1, shows that instrument precision is good.
Table 1 precision is investigated result
4 study on the stability
The accurate need testing solution of drawing, respectively at 0,2,4,8,12,24 h measure absorbance, the results are shown in Table 2.Result shows, need testing solution is stable in 24 h.
Table 2 study on the stability result
5 repeatability are investigated
Precision takes same batch sample, presses 5 parts of test samples of preparation under the need testing solution item, measures absorbance.The results are shown in Table 3.Result shows, this law repeatability is good.
Table 3 repeatability is investigated result
6 average recoveries are investigated
Precision measures totally 6 parts of the sample solutions of known content, and precision adds reference substance appropriate respectively, and by preparing under the need testing solution item, calculate recovery rate the results are shown in Table 4.This law average recovery rate is 95.14 % as a result, and RSD=1.42 % shows that this law degree of accuracy is better, and method is feasible.
Table 4 average recovery is investigated result
7 sample sizes are measured
By the said determination method, 3 batch samples are measured, calculated content, the results are shown in Table 5.
Table 5 sample size measurement result
The assay of Puerarin in experimental example 3 granule of the present invention
Adopt high performance liquid chromatography, measure the content of Puerarin in preparation.
1 chromatographic condition chromatographic column is ODS-2 HYPERSIL(250 mm * 4.6 mm, 5 μ m), mobile phase is methanol-water (90: 10), flow velocity 1 mLmin
-1Detect wavelength 250 nm, 30 ℃ of column temperatures.
The preparation of 2 solution
Reference substance solution: it is appropriate that precision takes the Puerarin reference substance, and being mixed with concentration with 30% ethanol is 80 μ gmL
-1Solution, and get final product.
Need testing solution: get approximately 0.5 g of this product powder (cross No. three sieve), accurately weighed, precision adds 30% ethanol 50 ml, and weighed weight adds hot reflux 30 min, lets cool, and weighed weight is supplied the weight of less loss with 30% ethanol, shake up, and filtration is got subsequent filtrate, and be get final product.
Negative control solution: get approximately 0.5 g of this product powder of not containing the root of kudzu vine (crossing sieve No. three), with test sample preparation method preparation, and get final product.
3 system suitabilities are got respectively each 10 μ L of reference substance solution, need testing solution and negative sample solution, and injecting chromatograph is measured, and theoretical cam curve is calculated by puerarin peak and is not less than 4000 as a result.Under this chromatographic condition, composition to be measured can be separated preferably, and test sample is having identical chromatographic peak with reference substance chromatographic retention corresponding position, and negative control is noiseless.
The investigation precision of 4 linear relationships measures reference substance solution 1,2,3,4,5 mL put respectively in 5 ml volumetric flasks, add 30% ethanol constant volume, each sample introduction 10 μ L, measure peak area, with peak area (Y), sample size (X) is returned, getting regression equation is Y=184098X+10
6, r=0.9992 shows, in 16 ~ 80 μ g scopes, Puerarin sample size and peak area are good linear relationship.
5 precision are investigated precision and are measured above-mentioned reference substance solution, and each sample introduction 10 μ L repeat sample introduction 5 times, and recording RSD is 0.39 %, shows, instrument precision is good.
Table 6 precision is investigated result
6 study on the stability precisions measure same need testing solution, respectively at 0,2, and 4,8,12,24 h, sample introduction 10 μ L measure, and RSD is 2.10%, shows, and need testing solution is stable in 24 h.
Table 7 study on the stability result
7 reappearances are investigated precision and are taken 5 parts of same batch samples, and by preparing under the need testing solution item, sample introduction 10 μ L measure, and calculating RSD is 1.77 %, shows, this law reappearance is good.
Table 8 reappearance is investigated result
8 average recoveries are investigated totally 6 parts of the accurate sample solutions that measures known content, precision adds reference substance appropriate respectively, by preparing under the need testing solution item, sample introduction 10 μ L measure, calculate recovery rate, the results are shown in Table 9, show that this law average recovery rate is 106.70%, RSD=1.68%, show that this law degree of accuracy is better, method is feasible.
Table 9 average recovery is investigated result
The assay of 9 samples carries out assay by the said determination method to 3 batch samples, calculates with external standard method, the results are shown in Table 10, shows, in granule, puerarin content is 1.5 mg ﹒ g
-1
According to the assay result of 3 batch samples, the tentative every 1g of this product contains Puerarin and must not be less than 1.2mg (1.5 mg * 80%).
Puerarin content measurement result in table 10 3 batch samples
Functional evaluation, the toxicologic study of experimental example 4 preparations
1 has the auxiliary hyperglycemic function evaluation experimental
1.1 the sample sample is the granule of this product, this experiment adopts 5,10,20 times of taking doses as tested material.
1.2 animal used as test is selected adults, (26 ± 2g) single sexes, every group of 10-15 only to select mouse.
1.3 dosage grouping and given the test agent give the time experiment and establish three dosage groups, a model control group.Take 10 times of human body recommended amounts as one of them dosage group, separately establish two dosage groups.Establish simultaneously the intact animal group that gives the given the test agent high dose.It is 30 days that given the test agent gives the time.
1.4 the fasting of hyperglycemia model animal gave the Streptozotocin modeling after 24 hours, and after 5-7 days fasting 3-5 hour, survey blood sugar, blood glucose value 10-25mmol/L is hyperglycemia model success animal.
Select the hyperglycemia model animal to divide into groups by the blood sugar level of fasting 3-5 hour 1.4.1 reduce the fasting blood-glucose experiment, select at random 1 model control group and 3 dosage groups (the poor 1.1mmol/L that is not more than between group).The dosage group gives the variable concentrations given the test agent, and model control group gives solvent, continuous 30 days, surveys fasting blood sugar (fasting is front with experiment), relatively each treated animal blood glucose value and blood sugar decline percentage.Blood glucose value * 100% before blood sugar decline percentage=(blood glucose value after blood glucose value before experiment-experiment)/experiment.Select the healthy adult animal to divide into groups by the blood sugar level of fasting 3-5 hour, select at random 1 control group and 1 given the test agent group (high dose), remaining operation is the same.
1.4.2 sugar tolerance experiment hyperglycemia model animal fasting 3-5 hour, the dosage group gives the variable concentrations given the test agent, model control group gives with the volume solvent, gave glucose 2.0g/kg by mouth in 15-20 minute, mensuration to glucose after 0,0.5,2 hour blood glucose value or give medical starch after the blood glucose value of 0,1,2 hour, observe model control group and given the test agent group to glucose after the variation of each time point Area under the curve of blood glucose.
Area under the curve of blood glucose :=1/2 * (0 hours blood glucose value+0.5 hours blood glucose value) * 0.5+1/2 * (2 hours blood glucose values+0.5 hours blood glucose value) * 1.5=0.25 * (0 hours blood glucose value+4 * 0.5 hours blood glucose values+3 * 2 hours blood glucose values)
1.6 data are processed and result is judged
Data can be used variance analysis, but need first to carry out homogeneity test of variance by the program of variance analysis, and variance is neat, calculates the F value, F value＜F
0.05, conclusion: each organizes no significant difference between mean; The F value〉F
0.05, P＜0.05 is added up with the comparative approach in twos that all belongs between a plurality of experimental group and control group.
Fall the fasting blood-glucose experiment: under the prerequisite that model is set up, given the test agent dosage group and control group compare, and the fasting blood-glucose measured value reduces or blood sugar decline percentage has statistical significance, can judge that the fasting blood-glucose experimental result positive falls in this given the test agent.
Sugar tolerance experiment: under the prerequisite that model is set up, given the test agent dosage group and control group are relatively, 0,0.5,2 hours blood glucose TG-AUCs reduce after giving glucose or medical starch statistical significance, can judge that this given the test agent sugar tolerance experimental result is positive.
1.7 result
Per os gives the granule of the present invention 30 days of mouse various dose, and middle and high dosage experiments group mouse blood sugar decline percentage and model control group relatively have significant difference (P＜0.05), and present dose-effect relationship; Each experimental mice Area under the curve of blood glucose and model control group be there was no significant difference (P＞0.05) relatively; On the intact animal group fasting blood-glucose that gives the given the test agent high dose without impact.Experimental result can be judged, the granule auxiliary hyperglycemic function results of animal positive of the present invention.
2 toxicologic studies
Measurement result shows, mouse takes granule per os acute toxicity testing LD of the present invention
50Greater than 15.0 g/kg.bw, belong to nontoxic level according to toxicity grading.Micronuclei in mice, mouse sperm deformity are tested, Salmonella reversion test is all negative.30d feeds experiment the indices such as routine blood test, blood biochemistry index, organ coefficient and body weight, weightening finish, food-intake, food utilization is showed no harmful effect.Histopathology is observed, and liver,spleen,kidney, Stomach duodenum, testis, ovary are showed no significant pathological change.
Experimental example 5 human experiment experiments
Select selection state of an illness after diet control or OHA treatment more stable, do not need to change types of drugs and dosage, only take the adult Patients with NIDDM of maintenance dose, Kong abdomen Xue Tang＞=7.8 mmol/L (140 mg/dl) or 2h Xue Tang＞=11.1 mmol/L (200 mg/dl) after the meal; After also can selecting 7.8 mmol/L＞=empty abdomen blood sugar＞=6.7 mmol/L (120 mg/dl) or 11.1 mmol/L＞=meal＞=hyperglycemia population of 2 h blood sugar＞=7.8 mmol/L.Viewing duration, the experimenter stops using and treats diabetes medicament and other relevant health foods, and the time is 2 months.The result of test-meal shows, after patients with NIDDM was taken health food of the present invention, the main clinic symptoms such as thirsty many drinks, polyorexia, lassitude hypodynamia, diuresis all were improved.
Above-mentioned functions evaluation experimental and human experiment are tested and are shown, health food of the present invention has auxiliary hyperglycemic function, and has no side effect.
Protection scope of the present invention can not be thought and is confined to the above-mentioned specific embodiment and instantiation.Concerning the person of an ordinary skill in the technical field, under the basic premise that does not break away from the present invention's design, can also make some simple deductions or be equal to replacement, these are equal to alternative and still will be regarded as within protection scope of the present invention.
Claims (6)
1. one kind towards medical insurance health food composition, and it is characterized in that: it is the preparation of being made by the raw material of following weight proportioning:
Root of kudzu vine 4-60 part, dandelion 2-30 part, Chinese yam 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part, root of Dahurain angelica 1-15 part, rattletop 1-15 part.
2. according to claim 1 towards medical insurance health food composition, it is characterized in that: it is the preparation of being made by the raw material of following preferred weight proportioning:
20 parts of the roots of kudzu vine, 10 parts of dandelions, 10 parts of Chinese yams, 5 parts, the fruit of Chinese magnoliavine, 5 parts of the tuber of dwarf lilyturfs, 5 parts of balloonflower roots, 5 parts of the roots of Dahurain angelica, 5 parts of rattletops.
3. according to claim 1-2 any one are described towards medical insurance health food composition, it is characterized in that: it is to be active component by the root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop medicinal material or medicinal substances extract, adds the preparation that the acceptable auxiliary material of health food or complementary composition are prepared from.
4. according to claim 3 towards medical insurance health food composition, it is characterized in that: described preparation formulation comprises: pill, powder, granule, tablet, chewable tablets, capsule, soft capsule, oral liquid, paste, concentrate, paste, custard, cake, beverage.
5. prepare the method towards medical insurance health food composition claimed in claim 1, it is characterized in that: it comprises the steps:
(1) take the raw material of weight proportion: root of kudzu vine 4-60 part, dandelion 2-30 part, Chinese yam 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part, root of Dahurain angelica 1-15 part, rattletop 1-15 part;
(2) get that the root of kudzu vine, dandelion, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop add water or organic solvent extracts, get extract 1, get Chinese yam, be ground into fine powder, cross 100 mesh sieves, yam flour, or get that the root of kudzu vine, dandelion, Chinese yam, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the root of Dahurain angelica, rattletop add water or organic solvent extracts, get extract 2;
(3) get extract 1 and yam flour mixing, add acceptable auxiliary material or complementary composition in health food, make respectively preparation by corresponding shaping technique, or get extract 2 and add acceptable auxiliary material or complementary composition in health food, make respectively preparation by corresponding shaping technique.
6. the described composition of claim 1-5 any one has purposes in the health food of auxiliary hyperglycemic function in preparation.
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| CN108553584A (en) * | 2018-06-19 | 2018-09-21 | 延边大学 | A kind of composition of auxiliary hyperglycemic and its application |
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| CN108553584A (en) * | 2018-06-19 | 2018-09-21 | 延边大学 | A kind of composition of auxiliary hyperglycemic and its application |
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