CN105770705A - Medicinal preparation for treating functional dyspepsia of children and application of medicinal preparation - Google Patents
Medicinal preparation for treating functional dyspepsia of children and application of medicinal preparation Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention provides a medicinal preparation for treating functional dyspepsia of children and application of the medicinal preparation. The medicinal preparation is prepared from the following components in parts by weight: 10 to 20 parts of radix codonopsis, 8 to 15 parts of rhizoma dioscoreae, 20 to 30 parts of sea-buckthorn, 10 to 20 parts of fructus lycii, 20 to 30 parts of fructus tsaoko, 10 to 20 parts of rhizoma polygonati, 8 to 15 parts of fructus psoraleae, 8 to 15 parts of radix rehmanniae, 8 to 15 parts of radix angelicae dahuricae, 10 to 20 parts of flos chrysanthemi, 10 to 20 parts of herba houttuyniae, 6 to 12 parts of radix glycyrrhizae, 20 to 30 parts of medicated leaven, 20 to 30 parts of roasted fructus hordei germinatus and 20 to 30 parts of flos caryophylli. According to the medicinal preparation provided by the invention, a medicinal combination of strengthening spleen and stomach, soothing liver regulating Qi, improving appetite and promoting digestion, alleviating allergic reaction and conditioning physique is blended; in addition, chewable tablets have good mouthfeel and the appearances of the chewable tablets better accord with child psychology; the medication compliance can be improved, and a better treatment effect is played. The traditional Chinese medicine provided by the invention is novel in formula, and is reasonable in dosage form; in the aspect of treating functional dyspepsia of children, the medicinal preparation has the functions of improving the curative effects and shortening the treatment course, and has deep development value and advantages.
Description
Technical field
The invention belongs to tcm field, especially relate to one and treat the dyspeptic pharmaceutical preparation of child's function.
Background technology
Functional dyspepsia of children (fimctionaldyspePsia is called for short FD), is one of usual diseases of childhood.FD suffers from
Youngster's clinical symptoms mainly includes upper abdominal pain or discomfort, abdominal distention, early satiety, heating installation, anorexia, heartburn, acid regurgitation, nausea and vomiting etc..Disease
Shape can recurrent exerbation, it is possible to asymptomatic within the quite a while.Can be based on a certain symptom, it is possible to folding for multiple symptoms
Add.The how no positive sign of abdomen examination, losing weight occur in some infants, malnutrition, late-blooming situation, through scope,
Abdominal B type ultrasonography and every laboratory examination are without form, structure, biochemical abnormal department of pediatrics common clinical syndrome.Russia report green grass or young crops is few
Year, dyspeptic incidence rate girl was 27%, and boy is 16%；U.S.'s investigation display dyspepsia infant 62% is FD.
Functional dyspepsia of children is not a clear and definite single lysis, and its cause of disease is complicated, and the machine of symptom occurs
System fails to illustrate completely.It is probably the comprehensive function of many factors.Gastrointestinal motility is abnormal, visceral hypersensitivity is considered as FD infant
Main pathogenesis, the dependency that helicobacter pylori (Hp) infection, gut hormone, socio-psychological factors are fallen ill with FD there is also
Dispute, therefore, develops and develops medicine novel, effective, become the dyspeptic important topic of Current therapeutic child.
Domestic middle medical circles scholar thinks that children's has the feature of " the liver being liable to excess, the spleen tending to insufficiency usually ", and liver-yang hyperactivity is insufficiency of the spleen, incoordination between the liver and stomach
It it is the Etiological pathogenesis of child FD morbidity.Also scholar is had to think primary disease simulataneous insufficiency and excessive, coldheat complex, in the majority with deficiency-cold syndrome, FD
Infant morbidity food sticky with eating cold and uncooked food excessively. cause stagnation of cold-damp in middle-JIAO, stomach-QI being unable to descend normally relevant.Nervous and Mental Factors also can affect taste and be received
Transportation capabilities: as children's gets a beating anger, or required must not, or grievance of being bullied, all can make depression of liver-QI, the liver failing to maintain the normal flow of QI, perverse and unreasonable manner is violated
Stomach, stomach-QI being unable to descend normally, then diet enters less.Owing to development in children is not complete, disposition is uncertain, through correct education, can quickly recover normal.
Summary of the invention
The present invention combines the dyspeptic dialectical to child of the traditional Chinese medical science, considers Chinese prescription, has allocated a kind of invigorating the spleen and regulating the stomach,
Depressed liver-energy dispersing and QI regulating, invigorating the stomach and promoting digestion, alleviate anaphylaxis, that nurses one's health body constitution effectively treats the dyspeptic Chinese medicine preparation of child.
Specifically, the technical scheme is that and be achieved in that.
The present invention provides one to treat the dyspeptic pharmaceutical preparation of child's function, includes according to weight fraction ratio:
Radix Codonopsis 10-20 part, Rhizoma Dioscoreae 8-15 part, Fructus Hippophae 20-30 part, Fructus Lycii 10-20 part, Fructus Tsaoko 20-30 part, Rhizoma Polygonati 10-
20 parts, Fructus Psoraleae 8-15 part, Radix Rehmanniae 8-15 part, Radix Angelicae Dahuricae 8-15 part, Flos Chrysanthemi 10-20 part, Herba Houttuyniae 10-20 part, Radix Glycyrrhizae 6-12
Part, Massa Medicata Fermentata 20-30 part, Fructus Hordei Germinatus (parched) 20-30 part, Flos Caryophylli 20-30 part.
In order to obtain preferable technique effect further, one treats the dyspeptic pharmaceutical preparation of child's function, above
Each composition according to weight ratio is:
Radix Codonopsis 15 parts, Rhizoma Dioscoreae 10 parts, Fructus Hippophae 25 parts, Fructus Lycii 15 parts, Fructus Tsaoko 25 parts, Rhizoma Polygonati 15 parts, Fructus Psoraleae 10 parts, life
Radix Rehmanniae 10 parts, the Radix Angelicae Dahuricae 12 parts, Flos Chrysanthemi 15 parts, Herba Houttuyniae 15 parts, 8 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 5 parts, Fructus Hordei Germinatus (parched) 25 parts, Flos Caryophylli 25 parts.
In order to obtain preferable technique effect further, one treats the dyspeptic pharmaceutical preparation of child's function, above
Each composition according to weight ratio is:
Radix Codonopsis 10 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 20 parts, Fructus Lycii 10 parts, Fructus Tsaoko 20 parts, Rhizoma Polygonati 10 parts, Fructus Psoraleae 8 parts, life
Radix Rehmanniae 8 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 20 parts, Herba Houttuyniae 20 parts, 6 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 20 parts, Fructus Hordei Germinatus (parched) 20 parts, Flos Caryophylli 30 parts.
In order to obtain preferable technique effect further, one treats the dyspeptic pharmaceutical preparation of child's function, above
Each composition according to weight ratio is:
Radix Codonopsis 20 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 30 parts, Fructus Lycii 20 parts, Fructus Tsaoko 30 parts, Rhizoma Polygonati 20 parts, Fructus Psoraleae 15 parts, life
Radix Rehmanniae 15 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 10 parts, Herba Houttuyniae 10 parts, 12 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 30 parts, Fructus Hordei Germinatus (parched) 30 parts, Flos Caryophylli 20 parts.
One treats the dyspeptic pharmaceutical preparation of child's function, and described preparation is prepared as chewable tablet:
Effective component extracting after being cleaned by load weighted crude drug, adds 8,6,6 times of medical material amount soak by water 3 times respectively, extracts
Time is respectively filtration in 2,2,1 hour, merging filtrate, is evaporated to the clear paste of relative density 1.10-1.15 (60 DEG C), adds
Ethanol makes determining alcohol reach 65%, is sufficiently stirred for, and stands 24 hours, filters, and filtrate recycling ethanol is also evaporated to relative density
The thick paste of (1.30-1.35 80 DEG C).Add 200g dextrin, drying under reduced pressure, be ground into fine powder, add cane sugar powder appropriate, mixing, system
Grain, tabletting, to obtain final product.
One treats the dyspeptic pharmaceutical preparation of child's function, and described preparation is prepared as electuary granule:
Effective component extracting after being cleaned by load weighted crude drug, adds 8,6,6 times of medical material amount soak by water 3 times respectively, extracts
Time is respectively filtration in 2,2,1 hour, merging filtrate, is evaporated to the clear paste of relative density 1.10-1.15 (60 DEG C), adds
Ethanol makes determining alcohol reach 65%, is sufficiently stirred for, and stands 24 hours, filters, and filtrate recycling ethanol is also evaporated to relative density
The thick paste of (1.30-1.35 80 DEG C).Add 200g dextrin, drying under reduced pressure, be ground into fine powder, add cane sugar powder appropriate, mixing, system
Grain, crosses 100 mesh sieves, to obtain final product.
One treats the dyspeptic pharmaceutical preparation of child's function, and described preparation is in treatment child's digestive system disease
Application.
One treats the dyspeptic pharmaceutical preparation of child's function, and described preparation is in treatment functional dyspepsia of children
Application.
One treats the dyspeptic pharmaceutical preparation of child's function, and described Chinese medicine preparation is prepared as lotion, granule, dissipates
Agent, capsule, pill, tablet and the most acceptable dosage form.
The moulding process that medicine of the present invention prepares different dosage form only used is different with adjuvant, as effective ingredient is
, therapeutic effect is the most identical or approximates.The adjuvant of granule can be multitudinous Icing Sugar, Carboxymethyl cellulose sodium, beta-schardinger dextrin-and taste masking
Agent etc. select；Powder can select from starch, kaolin, calcium phosphate, precipitated calcium carbonate etc.；The adjuvant of capsule can be from
Silicon dioxide, sucrose, HPC, microcrystalline Cellulose, pregelatinized Starch, lactose, Icing Sugar, carboxymethylstach sodium, carmethose, hydroxyl
Third methylcellulose etc. select；The adjuvant of pill can select from starch, microcrystalline Cellulose, pregelatinized Starch etc.；
The adjuvant of tablet can be from starch, dextrin, microcrystalline Cellulose, pregelatinized Starch, magnesium stearate, lactose, Icing Sugar, carboxymethylstach sodium etc.
In select.
The pharmacological action of Chinese medicine used in the present invention:
Radix Codonopsis, the flat sweet in the mouth of property, can invigorating the spleen and replenishing QI, strengthening spleen and tonifying lung.Chemical composition contained in Radix Codonopsis is more complicated, including many
The general class of saccharide, lignin, phenolic acids, mushrooms, standby class etc..Radix Codonopsis can be obviously enhanced the function of reticuloendothelial system.Have and enrich blood
Effect, can improve the irritability of central nervous system, improves body activities ability, so its tired sense can be alleviated.Machine can be strengthened
The immunologic function of body.
Rhizoma Dioscoreae, sweet in the mouth, property is put down；Return lung, spleen, kidney channel.Spleen reinforcing；Support lung；Reinforce the kidney；Benefit essence.Main diarrhea due to hypofunction of the spleen；Lack of appetite edema；
Cough and asthma due to lung deficiency；Quench one's thirst；Seminal emission；Leukorrhagia；Suffer from a deficiency of the kidney frequent micturition；Carbuncle is controlled in external；Scrofula.Invigorating spleen and reinforcing stomach is aid digestion, kidney nourishing and replenishing vital essence.
Fructus Hippophae, sour in the mouth, puckery, warm in nature.Relieving cough and resolving phlegm；Invigorating the stomach and promoting digestion；Promoting blood circulation to remove blood stasis.Main cough with copious phlegm；Pulmonary abscess；Digestion is not
Good；Abdominal pain due to retention of food；Stomachache；Enteritis；Amenorrhea；Traumatic injury congestive edema.Nourishing the stomach, can treat gastric duodenal ulcer and dyspepsia
Deng, the diseases such as chronic superficial gastritis, atrophic gastritis, colitis are treated.
Fructus Lycii, sweet in the mouth, property is put down.Enter liver, kidney channel.Nourishing kidney, lung moistening, tonifying liver, improving eyesight.Control hepatic and renal YIN deficiency, soreness of the waist and knees, head
Dizzy, dizzy, the many tear of blurred vision, cough due to consumptive disease, quench one's thirst, seminal emission.
Fructus Tsaoko, acrid in the mouth, warm in nature, enter spleen, stomach two warp, have warming middle-JIAO, stomach invigorating, help digestion, pleasant function, cure mainly trusted subordinate pain
Bitterly, dirty distention and fullness in the abdomen, nausea and vomiting, cough with copious phlegm, malaria cold and heat etc..Volatile oil is the effective ingredient of Fructus Tsaoko.Fructus Tsaoko fruit essential oil
In, 1,8 one eucalyptol (16.19%) content is higher, has wind dispelling, calmness, antibacterial, antiviral, kills parasite and diaphoresis is made
With.Citral, α-propylene etc. have relieving asthma, eliminate the phlegm, antibacterial effect, Camphora has that stimulation is neural, clears the head flexibly
Effect, pharmacological tests shows, different Fructus Tsaokos all can antagonism caused by HAC mice stomachache, in motility of isolated ileocecal segment,
The ileum spasm that the Ileum activity suppression all having antagonism Adr to cause causes with Ach, wherein stir-baked FRUCTUS TSAOKO with rhizoma zingiberis recens juice curative effect is better than other, explanation
Stir-baked FRUCTUS TSAOKO with rhizoma zingiberis recens juice can make its pharmacological action strengthen.
Rhizoma Polygonati, property is flat, and sweet in the mouth returns lung, spleen, kidney channel, has bacteriostatic and disease prevention to improve the effect of immunity, and Rhizoma Polygonati water proposes liquid
(1:320) Bacillus typhi, staphylococcus aureus, acid-fast bacilli are had inhibitory action, 2% Rhizoma Polygonati in sabouraud culture medium to often
See that pathomycete has inhibitory action in various degree.
Fructus Psoraleae, has warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, the effect of antidiarrheal.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffer from a deficiency of the kidney
Breathe heavily, Diarrhoea；Outer for cards such as curing vitiligo, alopecia areatas.Being additionally operable to vitiligo, alopecia areata, tinea pedis on modern clinic, uterus goes out
Blood, leukopenia, leukoplakia vulvae.
Radix Rehmanniae, clearing away heat and cooling blood, yin nourishing, promote the production of body fluid.For calentura crimson tongue excessive thirst, yin asthenia generating intrinsic heat, hectic fever due to YIN-deficiency consumptive fever, interior-heat disappears
Yearningly, spit blood, epistaxis, send out speckle dermexanthesis.
The Radix Angelicae Dahuricae, warm in nature, acrid in the mouth, lung, stomach, large intestine channel can be entered, there is relieving exterior syndrome and dispelling cold, wind-expelling pain-stopping, select clearing the nasal passage, dampness
Leukorrhagia stopping, effect of detumescence and apocenosis.
Flos Chrysanthemi, taste is micro-pungent, sweet, bitter, cold nature.Energy dispelling wind and heat pathogens, liver heat removing and eyesight improving, suppressing the hyperactive liver sun, removing toxic substances.For wind of catching a cold
Heat, heating giddy；Liver Channel has heat；The many tear of conjunctival congestion, or the hepatic and renal YIN deficiency, eyes is dim-sighted；Excessive rising of liver-YANG, dizziness and headache；Skin infection swells and ache.
Flos Chrysanthemi is a kind of nerve tonic, can strengthen the resistance of blood capillary, delaying sanility.
Herba Houttuyniae, acrid in the mouth, cold.Can heat-clearing and toxic substances removing, row pain detumescence treatment skin ulcer, promoting urination to remove dampness, invigorating the stomach and promoting digestion.With controlling reality
Heat, pyretic toxicity, damp, disease heat are the lung abscess of trouble, sore swollen toxin, hemorrhoidal hemorrhage, retention of heat in the spleen and stomach etc..
Radix Glycyrrhizae, Radix Glycyrrhizae have removing toxic substances, eliminate the phlegm, pain relieving, spasmolysis, invigorating the spleen and replenishing QI, grow and cough lung moistening, emergency is detoxified, and is in harmonious proportion hundred
Medicine.The Radix Astragali, for exterior deficiency spontaneous perspiration, night sweat due to yin deficiency, has effect of benefiting QI for strengthening the superficies, inducing diuresis to remove edema, detoxification, granulation promoting.
Massa Medicata Fermentata, sweet, acrid, warm.Enter spleen, stomach two warp.Strengthening the spleen to promote digestion, regulating QI to expel dampness, induces sweat.Cure the wound the food feeling of stuffiness in chest, and stomachache is vomited and diarrhoea,
Dysentery, headache due to common cold, children's hinders hungry mistake and satisfies.
Fructus Hordei Germinatus (parched), abnormal smells from the patient is the thinnest, and kind generation gas, to help gastric qi to rise, moves temper and provides strong fortune, therefore the de-swelling that can help digestion, alleviating distention in middle-JIAO
The therapeutic method to keep the adverse QI flowing downwards, appetizing of being amusing, QI invigorating qi-restoratives.Having the non-defective unit of benefit in, profit favourable for invigorating middle warmer, the most preferably disappear rice and flour food stagnation.
Flos Caryophylli, warming middle-JIAO, warming the kidney, sending down the abnormal ascending QI.Control singultus, vomiting, regurgitation, dysentery, trusted subordinate's cold type of pain, mass beside the umbilicus, hernia, ringworm.
The present invention has allocated a kind of invigorating the spleen and regulating the stomach, depressed liver-energy dispersing and QI regulating, invigorating the stomach and promoting digestion, alleviates anaphylaxis, the medicine of conditioning body constitution
Thing combines, and chewable tablet is the most in good taste and outward appearance the most more meets infantile psychology, can improve drug compliance, play more preferably
Therapeutic effect；On the other hand owing to using pure Chinese medicinal preparation oral taking chewy sheet or electuary particle delivery, medicine is through chewing/gastrointestinal
After can preferably be absorbed, it is ensured that effective ingredient fast onset effect, improve bioavailability.Similar medicine existing with on market
Comparing, the Chinese prescription of the present invention is novel, and dosage form is reasonable, in terms for the treatment of child's dyspepsia, can improve curative effect, shorten and treat
Journey, has the value and advantage deeply developed.
Detailed description of the invention
The detailed description of the invention of the following stated, the only present invention, protection scope of the present invention is not limited thereto, any ripe
Know those skilled in the art in the technical scope that the invention discloses, the change that can readily occur in or replacement, all should contain
Cover within protection scope of the present invention.
Embodiment 1
One treats the dyspeptic pharmaceutical preparation of child's function, includes according to weight fraction ratio:
Radix Codonopsis 10 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 20 parts, Fructus Lycii 10 parts, Fructus Tsaoko 20 parts, Rhizoma Polygonati 10 parts, Fructus Psoraleae 8 parts, life
Radix Rehmanniae 8 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 20 parts, Herba Houttuyniae 20 parts, 6 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 20 parts, Fructus Hordei Germinatus (parched) 20 parts, Flos Caryophylli 30 parts.
Above Chinese medicine preparation is prepared as chewable tablet, and preparation method is as follows:
Effective component extracting after being cleaned by load weighted crude drug, adds 8,6,6 times of medical material amount soak by water 3 times respectively, extracts
Time is respectively filtration in 2,2,1 hour, merging filtrate, is evaporated to the clear paste of relative density 1.10-1.15 (60 DEG C), adds
Ethanol makes determining alcohol reach 65%, is sufficiently stirred for, and stands 24 hours, filters, and filtrate recycling ethanol is also evaporated to relative density
The thick paste of (1.30-1.35 80 DEG C).Add 200g dextrin, drying under reduced pressure, be ground into fine powder, add cane sugar powder appropriate, mixing, system
Grain, tabletting, to obtain final product.
Embodiment 2
One treats the dyspeptic pharmaceutical preparation of child's function, and each composition according to weight ratio is:
Radix Codonopsis 15 parts, Rhizoma Dioscoreae 10 parts, Fructus Hippophae 25 parts, Fructus Lycii 15 parts, Fructus Tsaoko 25 parts, Rhizoma Polygonati 15 parts, Fructus Psoraleae 10 parts, life
Radix Rehmanniae 10 parts, the Radix Angelicae Dahuricae 12 parts, Flos Chrysanthemi 15 parts, Herba Houttuyniae 15 parts, 8 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 5 parts, Fructus Hordei Germinatus (parched) 25 parts, Flos Caryophylli 25 parts.
Above Chinese medicine preparation is prepared as electuary granule, and preparation method is as follows:
Effective component extracting after being cleaned by load weighted crude drug, adds 8,6,6 times of medical material amount soak by water 3 times respectively, extracts
Time is respectively filtration in 2,2,1 hour, merging filtrate, is evaporated to the clear paste of relative density 1.10-1.15 (60 DEG C), adds
Ethanol makes determining alcohol reach 65%, is sufficiently stirred for, and stands 24 hours, filters, and filtrate recycling ethanol is also evaporated to relative density
The thick paste of (1.30-1.35 80 DEG C).Add 200g dextrin, drying under reduced pressure, be ground into fine powder, add cane sugar powder appropriate, mixing, system
Grain, crosses 100 mesh sieves, to obtain final product.
Embodiment 3
One treats the dyspeptic pharmaceutical preparation of child's function, each composition according to weight ratio is:
Radix Codonopsis 20 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 30 parts, Fructus Lycii 20 parts, Fructus Tsaoko 30 parts, Rhizoma Polygonati 20 parts, Fructus Psoraleae 15 parts, life
Radix Rehmanniae 15 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 10 parts, Herba Houttuyniae 10 parts, 12 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 30 parts, Fructus Hordei Germinatus (parched) 30 parts, Flos Caryophylli 20 parts.
Above Chinese medicine preparation is prepared as capsule, and preparation method is as follows:
The Chinese medicine taking above amount decocts, and decocts rear medicinal liquid and concentrates, and (proportion is that 1:1 is left to be concentrated into finite concentration
Right), 1.1 times of ethanol put of cold rear addition, fully mix, stand overnight so that it is precipitation, take its supernatant next day and (filter if desired
Cross), precipitate with a small amount of 52% ethanol clean, washing liquid merges with filtrate, after decompression recycling ethanol, to be concentrated to finite concentration time
Adding a certain amount of water. mixing stands certain time, makes precipitation complete, rate mistake, filtrate low-temperature evaporation to paste, powdered extract powder
The suitable dextrin of middle addition, pregelatinized Starch adjuvant, after mixing, add and be pressed into the most whole to satisfactory granularity, load hungry area
Softgel shell, obtains capsule.
Embodiment 4
One treats the dyspeptic pharmaceutical preparation of child's function, and each composition according to weight ratio is:
Radix Codonopsis 18 parts, Rhizoma Dioscoreae 12 parts, Fructus Hippophae 28 parts, Fructus Lycii 18 parts, Fructus Tsaoko 26 parts, Rhizoma Polygonati 20 parts, Fructus Psoraleae 15 parts, life
Radix Rehmanniae 15 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 10 parts, Herba Houttuyniae 10 parts, 12 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 30 parts, Fructus Hordei Germinatus (parched) 28 parts, Flos Caryophylli 22 parts.
Above Chinese medicine preparation is prepared as powder, and preparation method is as follows:
The Chinese medicine more than measured conventionally decocts, and decoct rear medicinal liquid carrying out being concentrated into proportion is the dense of 1:1.2
Degree, 1.5 times of ethanol put of cold rear addition, fully mix, stand overnight so that it is precipitation, take its supernatant next day, precipitate is with few
Measuring 50% ethanol to clean, washing liquid merges with filtrate, after decompression recycling ethanol, to be concentrated to finite concentration time shift storing cold place standing
Certain time, make precipitation complete, rate mistake, filtrate low-temperature evaporation to paste, powdered extract powder adds suitable starch and
Calcium phosphate adjuvant, after mixing, crosses 200 mesh sieves, obtains powder.
Embodiment 5: animal pharmacodynamics test
5.1, animal modeling
60 Kunming system male mices, body weight 20 scholar 2g, it is randomly divided into 6 groups: blank group, model group, fourth beautiful jade group,
Chinese medicine basic, normal, high dosage group, often group 10.Use the irregular diet L mono-comprehensive molding method of Arg, in addition to blank group remaining
Each group mice implements modeling: irregular diet method: 2 natural feets are eaten, fasting in 1 day, circulation is implemented, totally 15 days.L mono-Arg method: irregular diet
The 11st day lumbar injection L-Arg3.79/kg that method is implemented, the 12-15 days lumbar injection 1.859/kg, comprehensive modeling totally 15 days.
After modeling terminates, water 24h is can't help in fasting, and often group randomly draws each 10 mices, and gavage semisolid sticks with paste 0.59/, de-after 15min
Neck puts to death mice, surveys gastric residual rate, prepares pathological section and carry out the detection of histopathology, and each remaining mice record of group is general
State and body weight change.
5.2, it is grouped and is administered
Blank group: the sufficient feedstuff of supply and cleaning tap water.
Model group: 0.2ml/l0g body weight distilled water, day 2 gavages 10d.
Fourth beautiful jade group: give fourth beautiful jade every day；Suspension 2.88mg/kg, day 2 gavages 10d.
Chinese medicine low dose group: the medicine gavage of the present invention being 1.0g/ml according to crude drug, day 2 gavages 10d.
Dosage group in Chinese medicine: the medicine gavage of the present invention being 1.5g/ml according to crude drug, day 2 gavages 10d.
Chinese medicine high dose group: the medicine gavage of the present invention being 2.0g/ml according to crude drug, day 2 gavages 10d.
Within every 7 days, claim a body weight, adjust by the body weight after change and be administered volume.
5.3, observation index
5.3.1 the detection of Mouse Stomach emptying
Water 24h is can't help in fasting, and gavage semisolid sticks with paste 0.59/, and after 15min, de-neck puts to death mice.Cut abdominal cavity open, ligature stomach
Cardia and pylorus, take stomach, wipes with filter paper and claims full weight after doing, cuts off body of stomach along greater gastric curvature, and 4 DEG C of normal saline flushings go.Gastric holds
Wipe dry after thing, claim stomach net weight, with the difference of stomach full weight stomach function regulating net weight for stomach residue weight, with this with giving the percentage ratio sticking with paste weight be
Gastric residual rate.
5.3.2 the detection of mice serum gastrin GAS
After taking blood, it is centrifuged IOmin with 4000r/min, leaves and takes serum, in-20 DEG C of preservations.Test tube is numbered, and uses during detection
The method of enzyme linked immunological, specifically selects ELISA kit, and by specification operates.
5.4, experimental result
Respectively group modeling group and treatment group Mouse Stomach in residual rate compare with blank group statistically significant (P >
0.05).The results are shown in Table 1, the gastric residual rate of blank group is below other each group, and the gastric emptying ability of model group is worst,
After motilium Drug therapy, gastric emptying ability improves, and each medicine group is the most all improved through treatment gastric emptying ability, with height
The effect of dosage group is best.
Mouse Stomach emptying testing result respectively organized by table 1.
| Group (effective experiment mice number) | Gastric residual rate (%) |
| Blank group (10) | 59.42±11.48 |
| Model group (9) | 73.46±12.59* |
| Motilium group (9) | 67.56±11.31# |
| Chinese medicine low dose group (10) | 69.05±11.96## |
| Dosage group (10) in Chinese medicine | 65.19±10.49# |
| Chinese medicine high dose group (9) | 63.87±10.30# |
Note:
* model group compares P < 0.05, * * P < 0.01 with blank group.
# each treatment group compares P < 0.05, ##P < 0.01 with model group.
5.4.2
Detecting mice serum gastrin by ELISA, the results are shown in Table 2, model group has significantly compared with blank group
Statistical significance (P < 0.01), Chinese medicine high dose group and motilium group, with blank group ratio, have close serum gastrin
Level, illustrates that both are the most fine for the effect of regulation serum gastrin.
Mice serum gastrin testing result respectively organized by table 2.
| Group (effective experiment mice number) | Serum gastrin (pg/ml) |
| Blank group (10) | 35.98±5.18 |
| Model group (9) | 30.46±3.52** |
| Motilium group (10) | 34.50±4.91# |
| Chinese medicine low dose group (10) | 32.05±5.16## |
| Dosage group (10) in Chinese medicine | 34.17±4.47# |
| Chinese medicine high dose group (9) | 35.35±5.01## |
Note:
* model group compares P < 0.05, * * P < 0.01 with blank group.
# each treatment group compares P < 0.05, ##P < 0.01 with model group.
Embodiment 6: clinical experiment
6.1, physical data
Disappear because the intestines and stomach is uncomfortable medical and is defined as function at Pediatric Clinic during accepting in December, 2015 in January, 2014 to for medical treatment
Changing bad patient, in age 3-14 year, 150 examples, all patients meet the standard-required of Western medicine diagnose child FD, all meet Chinese and Western
Doctor's diagnostic criteria, and coordinate observer voluntarily, all enter group treatment, get rid of other substantive gastrointestinal disease etc.；Patient is divided at random
For experimental group 75 example and matched group 75 example.Experimental group boy 38 example, girl 37 example, year mean age (7.2 ± 6.3), the course of disease 5 days
～3 years, average course of disease (2.1 ± 1.4) year；Matched group male 39 example, women 36 example, year mean age (9.3 ± 7.5), the course of disease 6
It～5 years, average course of disease (3.3 ± 2.1) moon.
Western medicine diagnose standard foundation: the RomeⅢdiagnostic criteria of child FD, it is necessary to include the following: 1. continue or repeatedly
Upper abdominal pain or discomfort；2. defecation is not alleviated, and times of defecation, shape are without changing；3. can not be with inflammation, dissection, metabolism or tumor solution
Release infant symptom.Symptom at least 1 time weekly, the course of disease just can make diagnosis in more than 2 months.
Tcm diagnosis standard, TCM Syndrome Type diagnostic criteria: FD belong to Chinese medicine anorexia, stagnate, suffer from abdominal pain, the category such as vomiting.
TCM Syndrome Type and CM syndrome differentiation criterion thereof, with reference to " Chinese and Western of functional dyspepsia combines diagnosis and treatment National Consensus (2010) " defined.
6.2, therapeutic scheme
Patient in this clinical trial is divided into 2 groups, respectively experimental group and matched group, wherein packet and the choosing of pharmaceutical dosage form
Selecting is the wish according to patient, is a course for the treatment of with 1 week.
Experimental group, use the chewable tablet of the present embodiment 1, or the peening particle of embodiment 2 add embodiment 3 or embodiment 4
Chinese medicine preparation；
Matched group, takes oral drugs seven-star tea and child's JIANWEI XIAOSHI PIAN.
6.3, criterion of therapeutical effect
Efficacy assessment standard
With reference to " combination of Chinese and Western medicine diagnosis and treatment National Consensus (2010) of functional dyspepsia " defined.1. Syndrome Scale:
With the disease feature of children's FD as foundation, formulate with reference to this diagnosis and treatment project.It is shown in Table 3.2. therapeutic index: therapeutic index=(treatment
Surplus mark after front syndrome total score-treatment) front syndrome total score × 100% of/treatment.
Therapeutic index ＜ 25% is invalid；
26%～50% for taking a turn for the better；
51%～85% is effective；
＞ 86% is clinical cure；
Take a turn for the better, effective, clinical cure adds up to effectively.
Total effective rate: (clinical cure+effective+improvement)/ill total individuality
Table 3 Syndrome Scale grade form
6.4, therapeutic outcome
The results are shown in Table 4, through statistical analysis, two groups compare, and it is right that the obvious effective rate (94.6%) of experimental group is significantly higher than
According to the obvious effective rate (84%) of group, there is significant difference (P < 0.05).
The therapeutic outcome of 4 liang of table group medicine
| Group (patient's number) | Cure | Effective | Effectively | Invalid | Obvious effective rate |
| Experimental group (75 example) | 45 | 18 | 8 | 4 | 94.6% |
| Matched group (75 example) | 29 | 27 | 9 | 10 | 86.7% |
6.5 model case
Case 1: Zhao, 8 years old, because eating before 2 weeks after meat eats and cause fever more, just brought down a fever with second day, but afterwards
Two weeks in all there is no appetite, abdominal distention after having a meal less and having a meal, morning every day defecate, constant shapeless, period ate stomach invigorating and disappeared
Food sheet and massage treatment, all do not have obvious effect, and through having a medical check-up, hematuria routine is all normal, and other routine examinations are also at normal model
In enclosing, there is no otherwise problem, through understanding Chinese medicine of the present invention, agree to into group to experimental group.Treatment is taken the present invention real
Execute example 1 chewable tablet be careful in one's diet simultaneously, do not eat raw food stimulation food, after one week check, symptom substantially alleviates, appetite increase
By force, and the most uncomfortable after having a meal, continue to strengthen, recover normal after taking again one week, go out without malaise symptoms during treatment
Existing, it is determined that for curing.
Case 2: Wei, 15 years old, existing nearly 3 years of gastrointestinal upset, frequent belch, abdominal distention, often to suffer from abdominal pain, appetite is poor, body
Become thin, regular nauseating, especially feel sick morning serious, loose stool, every day 1-2 time, through having a medical check-up, without other diseases, include reality in
Test group to observe.Taking the electuary granule of the present invention, three times on the one, one after each meal, after taking one week, abdominal distention, colic symptoms is obvious
Alleviating, other, without significant change, continue to take one week after conditioning consumption, major part transference cure, and appetite strengthens, and abdominal distention stomachache is existing
As disappearing, feel sick and simply have once in a while, defecate shapeless, continue to take 2 weeks, abdominal pain and distension, nausea and vomiting and loose stool of defecating
Phenomenon all disappears, and doctor's advice drug withdrawal is careful in one's diet, and checks, do not have rebound phenomenon after two weeks, it is determined that cure.
Claims (9)
1. the treatment dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described pharmaceutical preparation is according to weight portion
Number ratio includes: Radix Codonopsis 10-20 part, Rhizoma Dioscoreae 8-15 part, Fructus Hippophae 20-30 part, Fructus Lycii 10-20 part, Fructus Tsaoko 20-30 part, Rhizoma Polygonati 10-
20 parts, Fructus Psoraleae 8-15 part, Radix Rehmanniae 8-15 part, Radix Angelicae Dahuricae 8-15 part, Flos Chrysanthemi 10-20 part, Herba Houttuyniae 10-20 part, Radix Glycyrrhizae 6-12
Part, Massa Medicata Fermentata 20-30 part, Fructus Hordei Germinatus (parched) 20-30 part, Flos Caryophylli 20-30 part.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Thing preparation according to weight ratio is: Radix Codonopsis 15 parts, Rhizoma Dioscoreae 10 parts, Fructus Hippophae 25 parts, Fructus Lycii 15 parts, Fructus Tsaoko 25 parts, Rhizoma Polygonati 15 parts, benefit
Bone fat 10 parts, Radix Rehmanniae 10 parts, the Radix Angelicae Dahuricae 12 parts, Flos Chrysanthemi 15 parts, Herba Houttuyniae 15 parts, 8 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 5 parts, Fructus Hordei Germinatus (parched) 25 parts,
Flos Caryophylli 25 parts.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Thing preparation according to weight ratio is: Radix Codonopsis 10 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 20 parts, Fructus Lycii 10 parts, Fructus Tsaoko 20 parts, Rhizoma Polygonati 10 parts, benefit
Bone fat 8 parts, Radix Rehmanniae 8 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 20 parts, Herba Houttuyniae 20 parts, 6 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 20 parts, Fructus Hordei Germinatus (parched) 20 parts, fourth
Fragrant 30 parts.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Thing preparation according to weight ratio is: Radix Codonopsis 20 parts, Rhizoma Dioscoreae 15 parts, Fructus Hippophae 30 parts, Fructus Lycii 20 parts, Fructus Tsaoko 30 parts, Rhizoma Polygonati 20 parts, benefit
Bone fat 15 parts, Radix Rehmanniae 15 parts, the Radix Angelicae Dahuricae 15 parts, Flos Chrysanthemi 10 parts, Herba Houttuyniae 10 parts, 12 parts of Radix Glycyrrhizae, Massa Medicata Fermentata 30 parts, Fructus Hordei Germinatus (parched) 30
Part, Flos Caryophylli 20 parts.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Preparation is prepared as lotion, granule, powder, capsule, pill, tablet and the most acceptable dosage form.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Preparation is preferably prepared to chewable tablet.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Preparation is prepared as electuary granule.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Preparation application in the medicine of preparation treatment child's digestive system disease.
The most according to claim 1, one treats the dyspeptic pharmaceutical preparation of child's function, it is characterised in that: described medicine
Preparation application in preparation treatment functional dyspepsia of children medicine.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106387902A (en) * | 2016-09-20 | 2017-02-15 | 王晓临 | Health care food capable of improving digestive tract disease symptoms |
| CN108783166A (en) * | 2018-06-08 | 2018-11-13 | 丁申 | A kind of children's drink and its preparation method and application |
-
2016
- 2016-05-10 CN CN201610308808.5A patent/CN105770705A/en not_active Withdrawn
Non-Patent Citations (1)
| Title |
|---|
| 刁志光等: "运脾通肝方加减治疗功能性消化不良疗效观察", 《辽宁中医杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106387902A (en) * | 2016-09-20 | 2017-02-15 | 王晓临 | Health care food capable of improving digestive tract disease symptoms |
| CN108783166A (en) * | 2018-06-08 | 2018-11-13 | 丁申 | A kind of children's drink and its preparation method and application |
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Application publication date: 20160720 |