CN102860505A - Korean medicinal healthcare food composition with effect of assisting in protecting gastric mucosa, and preparation method and use thereof - Google Patents
Korean medicinal healthcare food composition with effect of assisting in protecting gastric mucosa, and preparation method and use thereof Download PDFInfo
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Abstract
The invention provides a Korean medicinal healthcare food composition with an effect of assisting in protecting gastric mucosa. The Korean medicinal healthcare food composition is a preparation prepared from raw materials coix seeds, dry chestnuts, radish seeds, schisandra chinensis, liriope and platycodon grandiflorum. The invention also provides a preparation method for the composition and the use of the composition. According to the composition, a formula meeting healthcare food raw material requirements is screened on the basis of a Korean medicinal proved recipe clinically for preventing and treating stomach diseases according to a Chinese Korean medicinal healthcare theory. For respiratory and digestive system diseases caused by the high lung deficiency rate and high liver abundance rate of a taiyin constitution, the aim of preventing damage to the gastric mucosa is fulfilled by tonifying the lung, regulating the stomach, driving out evil spirits and helping digestion to regulate organ function balance among the lung, the stomach and the liver, and a new choice is provided for the development of healthcare food.
Description
Technical field
The present invention relates to a kind of health-care food composition, specifically refer to have auxiliary protection gastric mucosa 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 medical science health theory as the basis, according to the regulation of " health food registration management way ", develops a kind of health-care food composition with auxiliary protection gastric mucosa function and preparation method thereof.Its composite formula Main Basis is used for preventing and treating the proved recipe of stomach trouble in medical science, concrete composition derives from medicine food dual purpose plant commonly used.
China's gastrointestinal disease incidence of disease accounts for 10%～12% of population, about 1.3 hundred million～1.6 hundred million people.Wherein about 40% patient is subjected to the puzzlement of gastrointestinal disease for a long time.Along with the increase at age, the state of an illness constantly worsens, and some patients were also canceration may occur.
Normal because the chemical factor of gastric mucosa injure (smoking, drink, strong tea, coffee and stimulate medicine such as aspirin, the indocin etc. of gastric mucosa), due to the factors such as physical factor (excessively cold, excessively boiling hot, too coarse food or eat and drink immoderately etc.), bacterium or its toxin stimulation.Which kind of invasion and attack factor no matter, the gastric mucosa injure that it causes all shows as the injury response of sequencing: at first be that coming off of top layer epithelium produces the shallow mucosa injury; Damage further develops, and microvascular endothelial cell injury will cause mucous membrane ischemic, anoxic, necrosis, thus degree of depth mucosa injury (erosion or ulcer) occurs.The infringement of gastric mucosal defense effect is the key factor that ulcer forms, and strengthens the mucous membrane protection capability, and the reparation that promotes mucous membrane is one of important step for the treatment of peptic ulcer.At present the clinical drug therapy gastric mucosa injures such as the agent of colloidal state bismuth, prostaglandin, EGF, ulcerlmin, levodopa of often selecting of doctor trained in Western medicine all have certain curative effect, but have simultaneously the problems such as easily recurrence, side effect are larger.
Traditional Chinese medicine to the understanding of gastric mucosa injure mainly based on the theory of spleen and stomach of the traditional Chinese medical science.Domestic achievement in research to the theory of spleen and stomach is verified; traditional Chinese medical science taste and digestion and immunologic function exist substantial connection; the anti-damage ability of the defense function of taste and digestive system part, particularly gastric mucosa is in close relations, and invigorating the spleen side's medicine has certain effect to the gastric mucosal protection tool.
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.Think that towards the medical knowledge opinion " lunar people " surpasses 50% in the four-quadrant people, lunar people's hepatomegaly lung is little, and disease is easily suffered from the gastral cavilty exterior cold disease of catching cold, the liver interior heat disease of being heated.This product prescription Main Basis is towards the proved recipe " lunar accent stomach soup " of the lunar people's gastrointestinal disease of doctor's control, and this prescription has tonifying lung and transfers stomach, the effect of getting rid of evils and helping digestion, and modern clinic is evident in efficacy for gastrointestinal diseases such as control gastric and duodenal ulcers.Think that towards medical science the protection gastric mucosa is that " supporting " but not " controlling ", suitable diet content and good eating habit are the important measures that prevent and treat gastric mucosa injure.Should limit the diet that gastric mucosa is had intense stimulus, and utilize diet to reduce or increase the secretion of hydrochloric acid in gastric juice, regulate the stomach function.
This product prescription is is suitably added and subtracted take towards the proved recipe " lunar accent stomach soup " of curing the lunar people's gastrointestinal disease of control as Main Basis, is raw material by the 6 flavor medicine food dual purpose plants such as coix seed, Gan Li, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root.
Do chestnut in the prescription and be bread and cheese, coix seed, radish seed, balloonflower root be food be again the article of medicine, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf are the article that can be used for health food.Whole flavour of a drug form and meet health food to the requirement of raw material sources in the prescription.
Coix seed is the dry mature kernal of grass seed of Job's tears Coix lacryma-jobi L.var.ma-yuan (Roman) Stapf.The property of medicine: sweet, light, cool.Return spleen, stomach, lung channel.Have inducing diuresis for removing edema, excreting dampness, invigorating the spleen are except numbness, and the clearing away heat and eliminating pus effect is to mend the body good merchantable brand.Li Shizhen (1518-1593 A.D.) is put down in writing in Compendium of Material Medica: " coix seed, positive bright medicine also can strengthening spleen and nourishing stomach.Reinforcing the mother-organ to treat deficiency is so consumptive lung disease, lung carbuncle are used it." traditional Chinese medical science think coix seed have clearing damp and promoting diuresis, invigorating the spleen to arrest diarrhea, except effects such as numbness detumescence, clearing away heat and eliminating pus.Tradition is used and is cured mainly scanty drak urine, oedema beriberi; Heating, lung carbuncle, acute appendicitis; Water retention due to hypofunction of the spleen is had loose bowels; Arthralgia due to wind-dampness, the illnesss such as muscle arteries and veins contraction.Think that towards the doctor coix seed is lunar people's key medicine, have out the stomach Qi of lung and the effect of taking food and helping digestion.Cure mainly lunar people's exterior cold syndrome, namely cold headache, bodily pain, the lossless and food ruffian that stagnates is vexed, also be used for lunar people and eat rear ruffian and stagnate, in the card such as gluttony that disappears." lunar accent stomach soup " with its expelling cold and relieving exterior syndrome, reinforcing spleen to promote digestion is controlled lunar people's exterior cold syndrome.Modern study shows that coix seed contains amino acid, Coixol, Coixenolide, triterpenoid, protein, fat, carbohydrate and multivitamin and mineral matter.The coix seed dietotherapy has enhancing metabolism and reduces the effect of stomach and intestine burdens, can be used as in the disease or the help food of weak patients after being ill.Raw pearl barley boils soup and takes to be beneficial to and dry except wind, is used for invigorating spleen and reinforcing stomach, controls splenasthenic diarrhea and then must fry edible.
Do chestnut and be the drying kind benevolence of Fagaceae chestnut Castanea mollissima BL..Being commonly called as chestnut, is China's special product, have the good reputation of " king of dry fruit ", and it also is called as " panax ginseng fruit " abroad.Record chestnut in " Mingyi Bielu ": " kidney tonifying gas makes us bearing famine for main beneficial gas, thick stomach." " food book on Chinese herbal medicine " middle record: " kidney tonifying gas makes us anti-famine for main beneficial gas, thick stomach." to do chestnut be the higher dry fruit kind of carbohydrate content, the unrighted acid that contains and multivitamin have the effect of the diseases such as pair anti-hypertension, coronary heart disease, artery sclerosis.From medicinal aspect, chestnut fruit is the kidney tonifying good merchantable brand, has strengthening the spleen and replenishing qi, clearing heat and detoxicating, antidiarrheal concurrently and controls and the effect such as cough.Think that towards the doctor doing chestnut is lunar people's common medicine, have out the stomach Qi of lung and the feed that helps digestion, tonifying spleen and stomach.The effect of hemostasis.Be mainly used in lunar people and eat stagnant ruffian completely, heel is unable, indigestion, do not feel like eating and dysentery; Also be used for insufficiency of the spleen and abdominal distension edema that cause.Record in " east doctor's four-quadrant is newly organized ": " yellow chestnut CORTEX AILANTHI soup " has tonifying spleen and stomach, clearing heat and detoxicating effect.Do the chestnut dietotherapy and can supply with the more heat energy of human body, and can help fat metabolism.Assurance body basic nutrition material is supplied, and the title of " iron crops ", " woody grain " is arranged, and has to replenish qi to invigorate the spleen the effect of Mangnolia officinalis stomach and intestine.Modern study shows that Gan Lizhong contains much starch, rich in protein, fat, B family vitamin, the inorganic salts such as calcium, phosphorus, iron, potassium, the Multiple components such as unrighted acid.
Radish seed is the mature seed of crucifer radish Raphanus sarivus L.The property of medicine: hot, sweet, flat.Return lung, spleen, stomach warp.Having and help digestion except swollen, the effect of lowering the adverse-rising QI to resolve phlegm, the traditional Chinese medical science are usually used in retention of food and drink, abdominal distention, constipation, the stagnant dysentery, phlegm of rushing down is stopped up the illness such as breath with cough.Li Shizhen (1518-1593 A.D.) is put down in writing in Compendium of Material Medica: " therapeutic method to keep the adverse qi flowing downward Dingchuan is controlled phlegm, helps digestion, and except swollen, sharp stool and urine is ended the gas pain, and is heavy behind the diarrhea, sends out the sore rash." think that radish seed has out the stomach Qi of lung and the effect of taking food and helping digestion can assist coix seed to strengthen the power that helps digestion towards the doctor.Be mainly used in that lunar people coughs, pants, chest stomachache.Ruffian is vexed after gas headache when also being used for typhoid fever, lossless, the food.Modern study shows that the compositions such as the fatty oil of radish seed, volatile oil, fat oil, raphanin have the promotion emptying to intestines and stomach.
The fruit of Chinese magnoliavine is the ripening fruits of magnoliaceae schisandra Schisandra chinesis (Turcz.) Bail or schisandra chinensis Schisandra sphenanthera Rehd.et Wils..The property of medicine: sour, sweet, warm.Return lung, the heart, kidney channel.It is astringent or styptic treatment for spontaneous sweating to have convergence, nourishing generate fluid, the effect of kidney calming.Be used for the treatment of the diseases such as chronic cough void is breathed heavily, dry is lacked in Tianjin, seminal emission is rushed down for a long time, forgetful insomnia.Modern medicine thinks that the fruit of Chinese magnoliavine can be regulated excitement and the process of inhibition of central nervous system, promotes body metabolism, regulates the secretion of gastric juice and bile, and rising person has reducing effect to hepatitis convalescence transaminase.Can regulate gastric secretion, excited uterus, and promote eyesight, hearing, improve the resolving ability of skin receptor.Think that towards the doctor fruit of Chinese magnoliavine is lunar people's medication, 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.Modern study shows, the fruit of Chinese magnoliavine contains abundant organic acid, vitamin, flavonoids, phytosterol and the lignanoids of potent reactivation (such as schizandrin A, deoxyschizandrin or schisandrol) is arranged, it also is one of minority medicinal material that has concurrently essence, gas, refreshing 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 the piece root of liliaceous plant Ophiopogon tuber of dwarf lilyturf japonicus (Thumb.) Ker-Gawl..The property of medicine: sweet, little hardship is slightly cold.Return stomach, lung, the heart channel of Hang-Shaoyin.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.Record in " book on Chinese herbal medicine converges and the says ": " medicine of heart clearing, lung moistening.Main deficiency of heart-QI, the palpitation with fear palpitation, forgetful in a trance, the spirit fall; Or the lung heat dryness of the lung, cough running fire: or taste are dry dries up, empty secret just difficult." record in " book on Chinese herbal medicine newly organized ": the tuber of dwarf lilyturf, the volt fire in the purging the lung of pathogenic fire, the heat evil in the clearing stomach, the internal lesion caused by overexertion of bushing gas, tired quenching the thirst is separated in the vomiting of hemostasis man; beneficial smart reinforcing yin essence, and U.S. color is pleased skin; reducing the asthenic fever, separates the dryness of the lung, the fixed cough, what very can hold is monarch and making also for minister of can borrowing.Think towards the doctor: the tuber of dwarf lilyturf is lunar people's medication, and the effect of tonifying lung and lung, clearing heat and moistening dryness is arranged.Be mainly used in lunar people in after being ill conditioner and heatstroke, polydipsia, summer fever disease.
Balloonflower root is the root of Campanulaceae balloonflower root Platycodon grandiflorum (Jacq.) A.DC..The property of medicine: bitter, hot, flat.Return lung channel.Have a surname's lung, eliminate the phlegm, relieve sore throat, the effect of apocenosis.Put down in writing in the Shennong's Herbal: " main chest and hypochondrium such as lancination, the full borborygmus of abdomen are faint, the gas of throbbing with fear in terror." modern medicine thinks that balloonflower root contains multiple saponin(e, synanthrin, phytosterol etc.The platycodoside crude product has calmness, analgesia and the central inhibitory action such as analgesic, and anti-inflammatory and kobadrin, hemangiectasis, step-down, antiulcer action are arranged.Think that towards the doctor balloonflower root is lunar people's medication, have strong lung and outer power of pushing up arranged, can dispersing superficial exopathogens, throat.Balloonflower root also can be made into delicious dish, and is very general as edible vegetable in Korea, Korea S, Japan and China the Northeast.
Have no at present the health food listing towards medical science health theory as compound basis take China, retrieval Chinese patent and bibliographic data base have no health food patent and research report, present composition design theory and the thinking innovation similar to present composition prescription.Have the health food of auxiliary protection gastric mucosa 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; health-care food composition with auxiliary protection gastric mucosa function, it is to be prepared from by the natural material and the supplementary product compatibility that meet " health food registration management way " regulation.The present invention also provides preparation method and the purposes of this compound health-care food compositions.
The invention provides a kind of have the auxiliary protection gastric mucosa towards medical insurance health food composition, it is the preparation of being made by the raw material of following weight proportioning:
Coix seed 3-45 part, dried chestnut 3-45 part, radish seed 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part.
Further preferred, it is the preparation of being made by the raw material of following weight proportioning:
15 parts of coix seeds, 15 parts of dried chestnuts, 10 parts of radish seeds, 5 parts in the fruit of Chinese magnoliavine, 5 parts of the tuber of dwarf lilyturfs, 5 parts of balloonflower roots.
Health-care food composition of the present invention, it is to be active component by the extract of coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root and the extract doing chestnut or do chestnut, adds the preparation that the acceptable auxiliary material of health food or complementary composition are prepared from.
Wherein, described preparation is: powder, granule, tablet, chewable tablets, capsule, oral liquid, paste, concentrate, paste, custard, cake.
The present invention also provides the preparation method of this health-care food composition, and it comprises the steps:
(1) takes by weighing the raw material of weight proportion: coix seed 3-45 part, do chestnut 3-45 part, radish seed 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part;
(2) get that coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root add water or organic solvent extracts, get extract 1, get and do chestnut, be ground into fine powder, cross 100 mesh sieves, must do the chestnut powder, or get that coix seed, Gan Li, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root add water or organic solvent extracts, get extract 2;
(3) get extract 1 and dried chestnut powder mixing, add acceptable auxiliary material or complementary composition in the health food, make respectively preparation by corresponding shaping technique, or get acceptable auxiliary material or complementary composition in the extract 2 adding health foods, make respectively preparation by corresponding shaping technique.
Health-care food composition of the present invention is theoretical towards the medical science health according to China, take towards the clinical proved recipe be used to preventing and treating stomach trouble of doctor as the basis, filters out the prescription that meets the healthy food material requirement, and concrete composition derives from medicine food dual purpose plant commonly used.The weak liver of lung occurs easily for " lunar people " physique and contain breathing and the disease of digestive system that causes, by tonifying lung transfer stomach, getting rid of evils helps digestion, the organ function balance reaches the purpose of prevention gastric mucosa injure between adjustment lung, stomach, the liver, 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: coix seed 300g, dried chestnut 300g, radish seed 200g, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, each 100g of balloonflower root.
And health food of the present invention is by preparing such as the next stage:
Coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, the balloonflower root boiling of (1) getting above-mentioned weight are extracted 2 times, filter, merging filtrate gets extract, gets refined liquid after extract process adsorption clarification or supercentrifugation are refining, 80 ℃ of vacuum drying behind the refined liquid reduced pressure concentration, get dry extract, pulverize, cross 100 mesh sieves, get extract powder, for subsequent use;
(2) get dried chestnut and be processed into powder, cross 100 mesh sieves, must do the chestnut powder, for subsequent use;
(3) get dried chestnut powder 300g and above-mentioned extract powder mixing, adding an amount of lactose is filler, mixing, and the softwood processed take 50% ethanol as wetting agent, extrusion is crossed 18 mesh sieves and is granulated, and drying is crossed the whole grain of 16 mesh sieves, namely gets granule.
Embodiment 2
Health food of the present invention is to be made by the raw material of following weight: coix seed 300g, dried chestnut 200g, radish seed 150g, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, each 100g of balloonflower root.
And health food of the present invention is by preparing such as the next stage:
Coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, the balloonflower root boiling of (1) getting above-mentioned weight are extracted 2 times, filter, merging filtrate gets extract, gets refined liquid after extract process adsorption clarification or supercentrifugation are refining, 80 ℃ of vacuum drying behind the refined liquid reduced pressure concentration, get dry extract, pulverize, cross 100 mesh sieves, get extract powder, for subsequent use;
(2) get dried chestnut and be processed into powder, cross 100 mesh sieves, must do the chestnut powder, for subsequent use;
(3) get dried chestnut powder 200g and above-mentioned extract powder mixing, adding an amount of lactose is filler, mixing, the softwood processed take 2.5% starch slurry as wetting agent, extrusion is crossed 18 mesh sieves and is granulated, and drying is crossed the whole grain of 16 mesh sieves, must do particle, 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: coix seed 300g, dried chestnut 100g, radish seed 100g, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, each 100g of balloonflower root.
And health food of the present invention is by preparing such as the next stage:
Coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, the balloonflower root 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, the refined liquid reduced pressure concentration gets concentrate, and is for subsequent use;
(2) get dried chestnut and be processed into powder, cross 100 mesh sieves, must do the chestnut powder, for subsequent use;
(3) get 50g agar and put into 20 times of amount concentrates, be heated to dissolving behind the immersion 10h, add honey element, natural antiseptic agent, stir evenly, be heated to 80 ℃, get dried chestnut powder 100g 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: coix seed 200g, dried chestnut 250g, radish seed 150g, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, each 100g of balloonflower root.
And health food of the present invention is by preparing such as the next stage:
Coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root, the boiling of dried chestnut of (1) getting above-mentioned weight are extracted 2 times, filter, merging filtrate gets extract, gets refined liquid after extract process adsorption clarification or supercentrifugation are refining, 80 ℃ of vacuum drying behind the refined liquid reduced pressure concentration, get dry extract, pulverize, cross 100 mesh sieves, get extract powder, for subsequent use;
(2) getting above-mentioned extract powder, to add an amount of dextrin be filler, and mixing take 60% ethanol as wetting agent, adopts marumerization to granulate, and gets dried particle, does particles filled capsule, namely gets capsule.
The discriminating of experimental example 1 chewable tablets Chinese medicine
(1) fruit of Chinese magnoliavine thin layer is differentiated and is got this product powder 10g, adds chloroform 80mL, adds hot reflux 30 minutes, filters, and filtrate evaporate to dryness, residue add chloroform 1mL makes dissolving, as need testing solution.Get fruit of Chinese magnoliavine control medicinal material 2g, be made in the same way of control medicinal material solution.Get again the schizandrin A reference substance, add chloroform and make the solution that every 1mL contains 1mg, in contrast product solution.Get the preparation 2g that lacks the fruit of Chinese magnoliavine, be made in the same way of negative control solution.According to thin-layered chromatography (10 editions appendix VIB of Chinese Pharmacopoeia) test, draw above-mentioned four kinds of solution, put in same silica G F respectively
254On the lamellae, take the upper solution of benzinum (30-60 ℃)-ethyl acetate-formic acid (15: 5: 1) as solvent, launch, take out, dry, put under the ultraviolet lamp (254nm) and inspect.The 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 then without corresponding spot.
(2) tuber of dwarf lilyturf, this product powder 4g was got in the thin layer discriminating, added chloroform-methane (7: 3) mixed solution 40mL, soaked 3 hours, and ultrasonic processing 30 minutes lets cool, and filtered, and filtrate evaporate to dryness, residue add chloroform 0.5mL makes dissolving, as need testing solution.Get the control medicinal material 2g tuber of dwarf lilyturf, be made in the same way of control medicinal material solution.Get the preparation 2g that lacks 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 gel g thin-layer plate, take toluene-methyl alcohol-glacial acetic acid (80: 5: 0.1) as solvent, launch, take out, dry, spray the H with 10%
2SO
4The solution colour developing is inspected under the fluorescent lamp.The 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 then without corresponding spot.
(3) the balloonflower root thin layer is differentiated and is got this product powder 4g, add 7% sulfuric acid alcohol-water (7: 3) mixed solution 50mL, refluxed 3 hours, let cool, extract 2 times with the chloroform jolting, each 30mL discards washing lotion, chloroform liquid anhydrous sodium sulfate dehydration, filter, filtrate evaporate to dryness, residue add methyl alcohol 1mL makes dissolving, as need testing solution.Get balloonflower root control medicinal material 2g, be made in the same way of control medicinal material solution.Other gets the preparation 2g that lacks balloonflower root, is 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, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the spot colour developing at 105 ℃.The 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 then without corresponding spot.
(4) the radish seed thin layer is differentiated and is got this product powder 10g, and the 100mL that adds diethyl ether added hot reflux 1 hour, discarded ether solution, and the dregs of a decoction volatilize, and add methyl alcohol 100mL, add hot reflux 1 hour, filters, and filtrate evaporate to dryness, residue add methyl alcohol 2mL makes dissolving, as need testing solution.Get radish seed control medicinal material 1g, be made in the same way of control medicinal material solution.Get scarce radish seed preparation 2g, be made in the same way of negative control solution.Get again sinapine cyanate reference substance, add methyl alcohol and make the solution that every 1mL contains 1mg, in contrast product solution.According to the thin-layered chromatography test, draw each 3～5 μ l of above-mentioned four kinds of solution, put respectively on same silica gel g thin-layer plate, take the upper solution of ethyl acetate-formic acid-water (10: 2: 3) as solvent, launch, take out, dry, put under the ultraviolet lamp (365nm) and inspect.In the test sample chromatogram, with the corresponding position of control medicinal material chromatogram on, the fluorescence spot of aobvious same color.Spray is with 10% ethanol solution of sulfuric acid of 1% vanillic aldehyde, and it is clear to be heated to the spot colour developing.The 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 then without corresponding spot.
(5) coix seed is got this product powder 10g, adds benzinum (60-90 ℃) 50mL, and ultrasonic extraction 30min filters, and filtrate evaporate to dryness, residue add benzinum (60-90 ℃) 1mL makes dissolving, as need testing solution.Get coix seed control medicinal material 2g, be made in the same way of control medicinal material.Get without coix seed " lunar accent stomach soup " particle 2g, be made in the same way of negative control solution.According to the thin-layered chromatography test, draw each 10 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, take petroleum ether-ethyl acetate-acetic acid (10: 3: 0.1) as solvent, launch, take out, dry, put under the ultraviolet lamp (365nm) and inspect.The 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 then without corresponding spot.
(6) do chestnut and get this product powder 4g, add chloroform 40mL, add hot reflux 30min, filter, filtrate evaporate to dryness, residue add chloroform 1mL makes dissolving, as need testing solution.Get and do chestnut control medicinal material 2g, be made in the same way of control medicinal material solution.Get without " the lunar accent stomach particle " 2g that does chestnut, be made in the same way of negative control solution.Draw above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, take the upper solution of benzinum (30-60 ℃)-ethyl acetate-formic acid (15: 5: 1) as solvent, launch, take out, dry, spray is with 10% sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃.The 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 then without corresponding spot.
The mensuration of general flavone in experimental example 2 chewable tablets
Adopt ultraviolet spectrophotometry, measure general flavone content in the chewable tablets.
The preparation of 1 solution
1.1 sample solution
Get this product porphyrize, precision takes by weighing 0.5g,, add ethanol and be settled to 25mL, after shaking up, ultrasonic 20min leaves standstill, and miillpore filter filters, and gets sample solution.
1.2 need testing solution
Precision is measured sample solution 1mL in evaporating dish, adds the absorption of 1g Silon, flings to ethanol in water-bath or insulating box, then changes chromatographic column over to, use first 20mL benzinum wash-out, discard benzinum liquid, use again methanol-eluted fractions, collect methanol solution, evaporated under reduced pressure, the methyl alcohol dissolving is settled to 25mL and get final product.
1.3 reference substance solution
Precision takes by weighing control substance of Rutin 5mg, uses the methyl alcohol ultrasonic dissolution, is settled to 100mL, namely gets 0.05mgmL
-1Reference substance solution.
2 linear relationships are investigated and are measured respectively reference substance solution 1,2,3,4,5,6, and 7mL adds methyl alcohol to scale in the 10mL volumetric flask, shake up, and measure absorbance in the 256nm place.Carry out linear regression with reference substance solution concentration (X) and absorbance (Y), getting regression equation is Y=0.013X-0.0171, r=0.9996 (n=7).The result shows, at 0.05-0.35mgmL
-1Scope internal reference product concentration and absorbance are good linear relationship.
3 precision investigation precision is measured 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 the result
4 study on the stability precisions are measured need testing solution, respectively at 0,2,4,6,8,10,12h, measure absorbance, the results are shown in Table 2.The result shows that need testing solution is stable in 12h.
Table 2 study on the stability result
5 repeatability are investigated precision and are taken by weighing same batch sample, press 5 parts of test samples of preparation under the need testing solution item, measure absorbance.The results are shown in Table 3.The result shows that this law repeatability is good.
Table 3 repeatability is investigated the result
6 average recoveries are investigated totally 6 parts of accurate sample solutions of measuring known content, and the accurate reference substance that adds is an amount of 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 99.67%, RSD=1.27% as a result, shows that this law degree of accuracy is better, and method is feasible.
7 sample sizes are measured and by the said determination method 3 batch samples are measured, and calculate content, the results are shown in Table 5.
According to the assay result of 3 batch samples, the tentative every 1g of this product contains general flavone and must not be less than 84.56mg (93.95mg * 90%), and every sheet heavily is 2g, must not be less than 169.12mg so tentative every of this product contains general flavone.
Table 4 average recovery is investigated the result
Table 5 sample size measurement result
The mensuration of Sinapine Thiocyanate in experimental example 3 chewable tablets
Adopt high performance liquid chromatography, measure the content of Sinapine Thiocyanate in the preparation.
1 chromatographic condition chromatographic column is Yi Lite Kromasil 100-5PHENYL (4.6mm * 250mm, 5 μ m), and mobile phase is acetonitrile-water (60: 40), flow velocity 1mLmin
-1Detect wavelength 326nm, 30 ℃ of column temperatures.
The preparation of 2 solution
Reference substance solution: it is an amount of that precision takes by weighing the Sinapine Thiocyanate reference substance, places brown volumetric flask, and being mixed with concentration with methyl alcohol is 40 μ gmL
-1Solution, and get final product.
Need testing solution: get chewable tablets porphyrize powdered (crossing sieve No. three), precision takes by weighing 0.5g and places brown measuring bottle, adds 70% methyl alcohol, and ultrasonic processing (power 250W, frequency 50kHz) 30min is settled to 50mL.Shake up, filter, get subsequent filtrate, place brown bottle, and get final product.
Negative control solution: get the chewable tablets 0.5g that does not contain radish seed, 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 sees Fig. 1,2,3, and theoretical cam curve is calculated by the Sinapine Thiocyanate peak and is not less than 5000.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 is measured reference substance solution 2,6,10,16,20 μ L, injecting chromatograph is measured peak area, with peak area (Y) sample size (X) is returned, getting regression equation is Y=372054X-11685, r=0.9995, and the result shows, in 0.08～0.72 μ g scope, Sinapine Thiocyanate sample size and peak area are good linear relationship.The results are shown in Figure 4.
5 precision investigation precision is measured above-mentioned reference substance solution, and each sample introduction 10 μ L repeat sample introduction 5 times, and recording RSD is 0.72%, illustrates that instrument precision is good.
Table 5 precision is investigated the result
6 study on the stability precisions are measured same need testing solution, and respectively at 0,2,4,6,8h, sample introduction 10 μ L measure, and RSD is 0.86%, show that need testing solution is stable in 8h.
Table 6 study on the stability result
7 reappearances are investigated precision and are taken by weighing 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 1.57%, shows that this law reappearance is good.
Table 7 repeatability is investigated the result
8 average recoveries are investigated totally 6 parts of accurate sample solutions of measuring known content, the accurate reference substance that adds is an amount of respectively, by preparing under the need testing solution item, sample introduction 10 μ L measure, calculate recovery rate, the results are shown in Table 8, show that this law average recovery rate is 99.56%, RSD=0.70%, show that this law degree of accuracy is better, method is feasible.
Table 8 average recovery is investigated the result
The assay of 9 samples is measured 3 batch samples by the said determination method, calculates with external standard method, the results are shown in Table 9, shows that Determination of Sinapine Thiocyanate is 130.60 μ g/g. in the chewable tablets
According to the assay result of 3 batch samples, the tentative every 1g of this product contains Sinapine Thiocyanate and must not be less than 117.54 μ g (130.60 μ g * 90%), and every sheet heavily is 2g, must not be less than 235.08 μ g so tentative every of this product contains Sinapine Thiocyanate.
Determination of Sinapine Thiocyanate measurement result in table 9 batch sample
Functional evaluation, the toxicologic study of experimental example 4 preparations
1 has auxiliary protection gastric mucosa functional evaluation experiment
1.1 the sample sample is the chewable tablets of this product, this experiment adopts 2,5,10 times of taking doses as tested material.
1.2 animal used as test is selected the Wistar healthy rat.
1.3 dosage grouping and given the test agent give the time experiment and establish 3 dosage groups, 1 negative control group.Take 2 times, 5 times, 10 times of human body recommended amounts as 3 dosage groups.The modeling of chronic ulcer model elder generation, operation is divided into groups next day again.It is 9 days that given the test agent gives the time.
1.4 the acute gastric mucosal lesion model is divided into 5 groups at random with female Wistar rats, each 5 of model group, negative control group, every group each 6 of high, medium and low dosage groups.Model group, negative control group are only filled with physiological saline 1mL/ every day, and experiment establishes 160,320,3 dosage groups of 640mg/kg.BW (be equivalent to 2,5,10 times of human body recommended intake, be respectively low dose group, middle dosage group, high dose group).Every day, gavage was 1 time, and continuous 10 days, the animal fasting be can't help water 24 hours before dissecting, and tested the 10th day, and animal gavage tested material gavage absolute ethyl alcohol 1.01mL/ only (except the negative control group) again after 1 hour causes the acute alcohol damage model.Put to death animal behind the etherization after 1 hour, round stomach and be fixed in 20min in 10% methanol solution, stomach after fixing is cut off along greater curvature, clean gastric content, gastric mucosa is launched, gastric mucosa injure shows as strip hyperemia or the diffuse hemorrhage of glandular stomach district mucous membrane, goes out the area (being accurate to 0.01mm) of hyperemia or diffuse hemorrhage band with vernier caliper measurement, with the gross area of hyperemia band and the diffuse hemorrhage evaluation index as degree of injury.
1.5 data are processed and the result judges
1.5.1 the significance test of data difference uses the SPSS16.0 statistical software to carry out the one-way analysis of variance processing between the statistical procedures group, take P＜0.05 as difference conspicuousness is arranged.
1.5.2 single-bolus high-dose gives the rat absolute ethyl alcohol and causes gastric mucosa injure very obvious as a result, can show strip hyperemia or diffuse hemorrhage, naked eyes can be observed, compare with the absolute ethyl alcohol control group, the lunar accent stomach of each dosage group of experimental group chewable tablets all obviously alleviates absolute ethyl alcohol to the damage of gastric mucosa, and bleeding alleviates.
Hemorrhage area all is higher than negative control group in the absolute ethyl alcohol model control group gastric mucosa of rat observation index, and through one-way analysis of variance, difference has statistical significance (P＜0.05) to show this model success, and experimental system is reliable.The hemorrhage area of testing set high, medium and low three dosage groups all is lower than control group and along with the increase of dosage, ulcer area has the trend of minimizing, and difference has statistical significance.
2 toxicologic studies
2.1 the sample sample is the chewable tablets of this product, this experiment adopts 5,10,20 times of taking doses as tested material.
2.2 animal used as test is selected Kunming mouse.
2.3 the acute toxicological experiment experimental technique adopts horn method.40 of mouse, 10 every group, female, male half and half, 4 dosage groups are established in experiment, take 21.5,10.0,4.64,2.15g/kg BW is as 4 dosage groups.Adopt the per os gavage to give tested material, every day, gavage was 2 times, and continuous 10 days, the animal fasting be can't help water 24 hours before dissecting, and tested the 14th day, mainly observed the central nervous system of mouse and somatic movement and had that posture, cry are unusual in changing, ataxia etc.; Autonomic nerve has acorea to zoom in or out, shed tears etc.; Respiratory system has or not rhinorrhea, Chao Shi breathing etc.; Gastronintestinal system has or not inflatable, diarrhoea or constipation etc., and the time of poisoning symptom appears in record.If animal has death, record death toll, death time, dead animal is done gross anatomy, and weighed at the 14th day, calculate weightening finish.
2.4 micronucleus test is selected each 25 of female, male mouse by the body weight requirement, weigh, the number of dying is divided into 3 dosage groups and feminine gender and positive controls at random, every group 10, male and female half and half, take the human body recommended amounts 10.0,5,2.5g/kg BW is as 3 dosage groups, negative control group gives equivalent distilled water, and positive controls gives the equivalent endoxan.6h after second time gavage, mouse is put to death in the cervical vertebra dislocation, gets femur and dilutes smear with calf serum, and methyl alcohol is fixed, Giemsa dyeing.Under light microscope, every animal counting 1000 polychromatic erythrocytes (PCE), polychromatic erythrocyte (PCE) permillage of microkernel incidence to contain micronucleus, every animal counting 200 polychromatic erythrocytes (PCE), calculate polychromatic erythrocyte (PCE) and mature erythrocyte (RBC) ratio, and carry out statistical analysis.
2.5 50 of teratospermia experiment small white mouses, every group 10, female, hero half and half, 3 dosage groups and feminine gender and positive controls are established in experiment, take 10.0,5,2.5g/kg BW is as 3 dosage groups, negative control group give equivalent distilled water, positive controls gives equivalent endoxan (get the 200mg endoxan and add physiological saline to the abundant mixing of 10mL, dilute 10 times and be 40mg/kg BW dosage group).Adopt the per os gavage to give tested material, every day, gavage was 2 times, continuous 10 days, the animal fasting be can't help water 24 hours before dissecting, and tested the 14th day, 30h puts to death mouse after the last gavage, get the epididymis film-making, Yihong dyeing, the sperm of 1000 structural integrities of several 5 animals countings of every batch total, calculate distortion spermatogenesis rate, and carry out statistical analysis.
2.6 the experimental result mouse takes this product per os acute toxicity testing LD
50Greater than 15.0g/kg BW, belong to nontoxic level according to toxicity grading.Micronuclei in mice, mouse sperm deformity are tested 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.
The experiment of experimental example 5 human experiments
Select through gastroscope and be diagnosed as chronic superficial gastritis, experience qualified experimenter's 30 examples (male 20 examples, women 10 examples), viewing duration, medicine and other relevant health foods that the experimenter stops using and treats chronic gastritis, the time is one month.The result of test-meal shows, after chronic gastritis test-meal thing person took health food of the present invention, pain, poor appetite, sour regurgitation were heartburn, all being improved of abdominal distension, belch.Health food of the present invention can be fast in and hydrochloric acid in gastric juice, stop hydrochloric acid in gastric juice to erosion, the digestion of injured of gastric mucosa and body of stomach, quickly alleviating pain, in and effective time of hydrochloric acid in gastric juice long, be conducive to self-healing and the regeneration of gastric mucosa, taking rear afterbody has obvious comfort sense, and can obviously delay various stomach trouble recurrence periods.
Above-mentioned functions evaluation experimental and human experiment experiment show that health food of the present invention has auxiliary protection gastric mucosa 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)
- One kind have auxiliary protection gastric mucosa function towards medical insurance health food composition, it is characterized in that: it is the preparation of being made by the raw material of following weight proportioning:Coix seed 3-45 part, dried chestnut 3-45 part, radish seed 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part.
- According to claim 1 have auxiliary protection gastric mucosa function 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:15 parts of coix seeds, 15 parts of dried chestnuts, 10 parts of radish seeds, 5 parts in the fruit of Chinese magnoliavine, 5 parts of the tuber of dwarf lilyturfs, 5 parts of balloonflower roots.
- 3. according to claim 1-2 any one described have auxiliary protection gastric mucosa function towards medical insurance health food composition; it is characterized in that: it is to be active component by the extract of coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root and the extract doing chestnut or do chestnut, adds the preparation that the acceptable auxiliary material of health food or complementary composition are prepared from.
- According to claim 3 have auxiliary protection gastric mucosa function towards medical insurance health food composition, it is characterized in that: described preparation is: powder, granule, tablet, chewable tablets, capsule, oral liquid, paste, concentrate, paste, custard, cake.
- One kind prepare claimed in claim 1 have auxiliary protection gastric mucosa function towards medical insurance health food composition, it is characterized in that: it comprises the steps:(1) takes by weighing the raw material of weight proportion: coix seed 3-45 part, do chestnut 3-45 part, radish seed 2-30 part, fruit of Chinese magnoliavine 1-15 part, tuber of dwarf lilyturf 1-15 part, balloonflower root 1-15 part;(2) get that coix seed, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root add water or organic solvent extracts, get extract 1, get and do chestnut, be ground into fine powder, cross 100 mesh sieves, must do the chestnut powder, or get that coix seed, Gan Li, radish seed, the fruit of Chinese magnoliavine, the tuber of dwarf lilyturf, balloonflower root add water or organic solvent extracts, get extract 2;(3) get extract 1 and dried chestnut powder mixing, add acceptable auxiliary material or complementary composition in the health food, make respectively preparation by corresponding shaping technique, or get acceptable auxiliary material or complementary composition in the extract 2 adding health foods, 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 protection gastric mucosa function in preparation.
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| CN103110100A (en) * | 2013-02-05 | 2013-05-22 | 郭建鹏 | Korean medical healthcare food composition as well as preparation method and application thereof |
| CN103141831A (en) * | 2013-01-17 | 2013-06-12 | 延边大学 | Korean medicine health care food composition with liver protecting function and preparation method and application thereof |
| CN107259559A (en) * | 2017-05-02 | 2017-10-20 | 江苏大学 | Rapeseed peptides and fruit of Chinese magnoliavine water extract and the method for cooperateing with improvement to sleep |
| CN109589379A (en) * | 2019-02-18 | 2019-04-09 | 中国农业科学院特产研究所 | Protect liver tune stomach composition and its preparation method and application |
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| CN107259559A (en) * | 2017-05-02 | 2017-10-20 | 江苏大学 | Rapeseed peptides and fruit of Chinese magnoliavine water extract and the method for cooperateing with improvement to sleep |
| CN107259559B (en) * | 2017-05-02 | 2020-12-18 | 江苏大学 | Rapeseed polypeptide and schisandra chinensis aqueous extract and method for synergistically improving sleep |
| CN109589379A (en) * | 2019-02-18 | 2019-04-09 | 中国农业科学院特产研究所 | Protect liver tune stomach composition and its preparation method and application |
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