CN105056080A - Traditional Chinese medicinal composition for treating infantile dyspepsia - Google Patents

Abstract

The invention discloses a traditional Chinese medicinal composition for treating infantile dyspepsia. Apple, banana, malt, carrot, lance triblema herb, iris-leaf oberonia herb, shaddock peel and Indian kalimeris herb, as monarch and ministerial drugs, are capable of promoting digestion to eliminate stagnation, and grape, fructus amomi, dried orange peel, medicinal fermented mass and hawthorn, as adjuvant drugs, are effective in stimulating appetite and tonifying spleen; and the traditional Chinese medicinal composition, as a medicine which combines various drugs and has mild administration, has functions of tonifying spleen and promoting circulation, promoting digestion to eliminate stagnation, and the like.

Description

A kind of Chinese medicine composition for the treatment of children indigestion symptom

Technical field

The present invention relates to the medicinal preparation containing deriving from plant, animal or raw mineral materials, particularly a kind of Chinese medicine composition for the treatment of children indigestion symptom and preparation method thereof.

Background technology

Stagnate and belong to the dysfunction of western medicine chronic digestible, its main clinical manifestation is: anorexia, eats without digesting, abdominal part distension, defecates uncomfortable.Because according to the saying of the traditional Chinese medical science, the reason stagnated is caused to have spleen injury and weakness of the spleen and stomach two kinds; On the other hand, the deficiency of vital energy, by TCM-related Terms, comprises vigour, pectoral qi, defends the deficient of gas, and the promotion of gas, warm, defence, the going down of astringency inducing and gasification function, thus cause the low or decline of some functional activity of body, the phenomenon that under resistance against diseases, degradation is weak.Medical education net arranges to be said by generically words, and the deficiency of vital energy may be brought: easily perspiration, malaise, down in spirits, dizzy tinnitus, abundant expectoration or have edema, the deficiency of vital energy also can cause function to go down, thus shows a series of internal organs weakness sign.Here, can find out, the deficiency of vital energy is because, internal organs weakness is fruit, internal organs weakness then causes that gastrointestinal " stagnates " etc. disease.If " deficiency of vital energy is without stagnant person ", that meaning should be have " deficiency of vital energy " this " because of " exist, but also there is no the state phenomena of " stagnating ", because the deficiency of vital energy can be have the above-mentioned phenomenon enumerated, but differ to establish a capital and reflect.

Stagnate and refer to children's's internal damage caused by infantile dyspepsia, stop poly-middle burnt, amass and do not change, a kind of gastrointestinal tract disease that the stagnation of QI is not all right formed.Not think breast food, eat without digesting, distension and fullness in the abdomen, the halitosis, the thin or constipated acid in large loose stool is smelly is feature.

Etiology and pathogenesis

The main cause causing primary disease is excess in feeding, injures taste, causes transformation and transportation of the spleen and stomach imbalance, or weakness of the spleen and stomach, and transporting of becoming thoroughly decomposed is too late, and breast food is stagnated and do not changed.Its sick position is at taste, and basic pathological changes is eaten for breast and stopped the poly-middle part of gastric cavity, and amass and do not change, the stagnation of QI is not all right.

Determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs

(1) breast food inner product

Syndrome does not think breast food, and eructating foul odor acid is turned sour or vomiting food, newborn sheet, distension and fullness in the abdomen pain, and stool acid is smelly, and agitation is cryed, and night sleeps uneasy, feverish sensation in the palms and soles, red tongue, and tongue is thick or yellow thick greasy in vain, and medical education net arranges pulse condition stringy and rolling pulse, and fingerprint purple is stagnant.

Method for the treatment of de-emulsify is eaten, and middle intestinal stasis relieving.

Main formula infantile dyspepsia person, selects the newborn ball plus-minus that disappears.Food stagnation person, selects lenitive pill to add and subtract.

(2) insufficiency of the spleen folder amasss

Syndrome shallow complexion, emaciated physique, fatigue in both spirit and physical strength, does not think breast food, eats then glutted, abdominal distention pain relieved by pressing, and loose stool acid raw meat, accompany newborn sheet or indigestion food debris, pale tongue, tongue is greasy in vain, thready and rolling pulse, and fingerprint is light stagnant.

Method for the treatment of spleen invigorating helps fortune, relieving dyspepsia.Western medicine side effect is large, and Chinese medicine is effective.

Summary of the invention

Technical problem to be solved by this invention is, provides that a kind of formula is simple, processing technology is easy, the little and convenient drug administration of toxic and side effects, and medicament is easy to manufacture, with low cost, and abnormal smells from the patient does not affect patient's mouthfeel and the new drug that causes patient to resist.Chinese medicine composition relieving dyspepsia of the present invention, appetite promoting and the spleen strengthening, reaches strengthening vital QI to eliminate pathogenic factors effect, and treating both the principal and secondary aspects of a disease is treated, and clinical efficacy is excellent.The present invention adopts the Chinese crude drug of different properties, has carried out scientific compatibility, can reach desirable therapeutic effect, and safety, toxic and side effects is little, and preparation is simple, and focus of going directly, healing time is short, not easily recurs after healing.

A kind of Chinese medicine composition for the treatment of children indigestion symptom, it is the medicine that is the monarch and his subjects with Fructus Mali pumilae, Fructus Musae, Fructus Hordei Germinatus, Radix Dauci Sativae, Diplazium lanceum (Thunb), Herba Oberoniae iridifoliae, Pericarpium Citri grandis, Herba Kalimeridis, relieving dyspepsia, with Fructus Vitis viniferae, Fructus Amomi, Pericarpium Citri Reticulatae, Massa Medicata Fermentata, the medicine appetite promoting and the spleen strengthening of Fructus Crataegi for assisting a ruler in governing a country, all medicines share, medication is gentle, has spleen invigorating and helps fortune, the medicine of the effect such as relieving dyspepsia.

Treating a Chinese medicine composition for children indigestion symptom, is be made up of following raw material:

Fructus Mali pumilae 10-20 part, Fructus Musae 10-20 part, Fructus Hordei Germinatus 10-20 part, Radix Dauci Sativae 10-20 part, Diplazium lanceum (Thunb) 10-20 part, Herba Oberoniae iridifoliae 10-20 part, Pericarpium Citri grandis 10-20 part, Herba Kalimeridis 10-20 part, Fructus Vitis viniferae 5-15 part, Fructus Amomi 5-15 part, Pericarpium Citri Reticulatae 5-15 part, Massa Medicata Fermentata 5-15 part, Fructus Crataegi 5-15 part.

Treating a Chinese medicine composition for children indigestion symptom, is be made up of following raw material:

Fructus Mali pumilae 12-18 part, Fructus Musae 12-18 part, Fructus Hordei Germinatus 12-18 part, Radix Dauci Sativae 12-18 part, Diplazium lanceum (Thunb) 12-18 part, Herba Oberoniae iridifoliae 12-18 part, Pericarpium Citri grandis 12-18 part, Herba Kalimeridis 12-18 part, Fructus Vitis viniferae 6-14 part, Fructus Amomi 6-14 part, Pericarpium Citri Reticulatae 6-14 part, Massa Medicata Fermentata 6-14 part, Fructus Crataegi 6-14 part.

Treating a Chinese medicine composition for children indigestion symptom, is be made up of following raw material:

Fructus Mali pumilae 15 parts, 15 parts, Fructus Musae, 15 parts, Fructus Hordei Germinatus, 15 parts, Radix Dauci Sativae, Diplazium lanceum (Thunb) 15 parts, Herba Oberoniae iridifoliae 15 parts, Pericarpium Citri grandis 15 parts, Herba Kalimeridis 15 parts, Fructus Vitis viniferae 10 parts, Fructus Amomi 10 parts, Pericarpium Citri Reticulatae 10 parts, Massa Medicata Fermentata 10 parts, Fructus Crataegi 10 parts.

Treat a preparation method for the Chinese medicine composition of children indigestion symptom, the dosage form of described endo-medicine preparation is honey refining pill, and its preparation method comprises:

(1) by formula proportion, crude drug is added the 60-90% soak with ethanol 1-2 hour of 5-10 times amount, heating extraction 2 times, each 1-2 hour, remove supernatant, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into pasty state, mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1;

(2) medicinal residues add 5-10 times amount water soaking 1-2 hour, within 1-1.5 hour, extract 1 time, as component 2;

(3) above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.

Treat a preparation method for the Chinese medicine composition of children indigestion symptom, described agent type is capsule, and its preparation process comprises:

A, raw medicinal material is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged filtering and standing;

B, the medicinal residues refined are put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged, filtering and standing;

C, above-mentioned two kinds of filtrates to be merged, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder and incapsulate.

Treat a preparation method for the Chinese medicine composition of children indigestion symptom, described agent type is enema, and its preparation process is:

A, get crude drug and add water extraction 2 times, becoming extractum shape, is component 1;

B, medicinal residues add 60-90% soak with ethanol 0.5-1.5 hour, extract twice, each 1-2 hour, merge extractive liquid, filters, concentrated, 80-160 order filter, 6000-10000 rev/min centrifugal after supernatant, be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.35 extractum, heating and refluxing extraction 2 times, each 30 minutes ~ 45 minutes, extracts active ingredient, 2 extracting solution are merged and is settled into extractum shape, as component 2;

C, by concentrated for above-mentioned two kinds of extractum mixing.

Get above-mentioned enema 100mL ~ 200mL during use, retention enema, pours into 30mL ~ 50mL at every turn at every turn, and inject with No. 12 oxygen catheters and 50mL syringe, insertion depth is 15cm ~ 20cm, 2 ~ 3 times/d, 7d are 1 basic course for the treatment of, each 20min-40min.

the present invention relates to pharmacology and the property of medicine of Chinese medicine:

Fructus Mali pumilae:

[nature and flavor] property is flat, sweet, the micro-acid of sweet in the mouth.

[function] promoting the production of body fluid to quench thirst, clearing heat and relieving fidgetness, invigorating the stomach and promoting digestion, the research of Japanese hirosaki university confirms, the polyphenol in Fructus Mali pumilae can the propagation of anticancer.

Fructus Vitis viniferae:

The micro-acid of [nature and flavor] sweet in the mouth, property are put down,

[function] has invigorating the liver and kidney, replenishing QI and blood, appetizing are promoted the production of body fluid, effect of diuresis.Modern medicine study shows, Fructus Vitis viniferae also has anti-cancer, anticancer effect.

Fructus Musae:

function cures mainly: defecation, promotes enterogastric peristalsis.heat-clearing and toxic substances removing, inducing diuresis to remove edema, antiabortive. ^[3]fructus Musae contains various trace elements and vitamin, can help of flaccid muscles, makes people's body and mind joyful, and has certain effect of weight reducing.

Fructus Hordei Germinatus:

[meridian distribution of property and flavor] is sweet, flat, returns spleen, stomach warp.

[function cures mainly] promote qi circulation digestion promoting, spleen benefiting and stimulating the appetite, moves back newborn relieving distension.Do not disappear for food stagnation, abdominal distention, insufficiency of the spleen lack of appetite, newborn antiperspirant smoulders, distending pain of the breast, and women weans, Fructus Hordei Germinatus invigorating the spleen and regulating the stomach lactogenesis.For insufficiency of the spleen lack of appetite, newborn antiperspirant smoulders.The galactopoiesis of Fructus Hordei Germinatus (parched) promote qi circulation digestion promoting.Do not disappear for food stagnation, women weans.Fructus Hordei Germinatus (parched to brown) relieving dyspepsia.Do not disappear for food stagnation, abdominal distention.

Radix Dauci Sativae:

[nature and flavor] sweet in the mouth, property is put down.

[return through] enters lung, spleen channel.

[function cures mainly] strengthening the spleen to promote digestion, tonifying liver improving eyesight, heat-clearing and toxic substances removing, rash, sending down the abnormal ascending QI cough-relieving.For infantile malnutrition, measles, nyctalopia, constipation, hypertension, gastrointestinal upset, chronic dysentery, full stifling is swollen.Radix Dauci Sativae contains the nutrient such as more vitamin C, B1, B2, is described as " popular Radix Ginseng ".

Diplazium lanceum (Thunb):

[nature and flavor] are bitter; Puckery; Be slightly cold; Nontoxic

[return through] lung; Kidney channel

[function cures mainly] stops blooding treating stranguria; Heat-clearing and toxic substances removing.Main hemoptysis; Stranguria; Hematuria; Infantile malnutrition; Tinea pedis;

[each discussion]

1. " Fujian Chinese herbal medicine " clearing away heat and cooling blood, inducing diuresis for treating stranguria syndrome.

2. " Hunan medicine will ": help digestion diuresis, stop blooding.

3. " catalogue planted by Guizhou medicine ": control cough, lumbago.

4. " Wenling county drug resource register " controls conjunctival congestion and swelling pain.

[extracts] " China's book on Chinese herbal medicine " " Chinese medicine voluminous dictionary "

Herba Oberoniae iridifoliae:

Nature and flavor are light, cool.Curing mainly regulates the flow of vital energy helps digestion, clearing away heat and promoting diuresis, cough-relieving pain relieving.For dyspepsia, stomachache, enteritis, urinary tract infection, cough, bronchitis, asthma, traumatic injury, fracture, venom.

Pericarpium Citri grandis:

It is pungent, sweet, bitter, temperature.Return spleen, kidney, urinary bladder channel.Have reduce phlegm, help digestion, effect of the therapeutic method to keep the adverse QI flowing downwards, fast diaphragm.Be usually used in the stagnation of QI uncomfortable in chest, coldness and pain in the epigastrium, dyspepsia, cough with asthma, hernia.

Herba Kalimeridis:

[meridian distribution of property and flavor] acrid in the mouth, cold nature.Return liver, kidney, stomach, large intestine channel.

[effect] relieves internal heat anticancer, removing heat from blood scattered silt, clearing away heat-damp and promoting diuresis, reducing swelling and alleviating pain.

Energy heat-clearing and toxic substances removing, dissipating blood stasis stops blooding, and dampness removing, helps digestion, removing food stagnancy.For cat fever, cough, acute pharyngitis, tonsillitis, mumps, infectious hepatitis, taste-blindness rate, infantile malnutrition, enteritis, dysentery, spits blood, metrorrhagia, menoxenia; External is controlled furuncle and is swollen and ache, mastitis, traumatic hemorrhage; Dysentery or damp-heat diarrhea; Laryngopharynx swelling and pain, carbuncle skin infection; Heat in blood epistaxis, to have blood in stool; Jaundice due to damp-heat; Or edema, dysuria; Eating accumulation, distension and fullness in the abdomen.

Fructus Amomi:

[nature and flavor] are warm in nature, acrid in the mouth,

During [function] circulation of qi promoting is adjusted, stomach function regulating, is amusing, and be applicable to breast gastral cavity painful abdominal mass vexed, abdominal distention is eaten less, and the stomachache caused due to Deficiency and coldness of spleen and stomach is had loose bowels.

Pericarpium Citri Reticulatae:

[meridian distribution of property and flavor] is bitter, pungent, temperature; Return lung, spleen channel.

[function cures mainly] regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.

Massa Medicata Fermentata:

[nature and flavor] are bitter, temperature; 1. the property of medicine is examined: micro-bitter fragrant sweet; 2. detailed outline is picked up any lost article from the road: sweet light, delicate fragrance.

[function] removing dampness by means of aromatics, dispelling wind to relieve the exterior syndrome, digesting and appetizing.For Common Cold, summertime heatstroke, autumn catches a cold, heating of being afraid of cold, headache general pain, vomiting and diarrhoea, dyspepsia, abdominal distention uncomfortable in chest.

Fructus Crataegi:

[nature and flavor] sour in the mouth, sweet, slightly warm in nature.

[function cures mainly] appetite-stimulating indigestion-relieving, change stagnant removing food stagnancy, promoting blood circulation to remove blood stasis, circulation of qi promoting of reducing phlegm.For meat stagnant long-pending, lump in the abdomen, abdominal distention feeling of fullness, stasis blocking stomachache, phlegm retention, have loose bowels, discharging fresh blood stool etc.

Detailed description of the invention

embodiment 1 formula:

Fructus Mali pumilae 10g, Fructus Musae 10g, Fructus Hordei Germinatus 10g, Radix Dauci Sativae 10g, Diplazium lanceum (Thunb) 10g, Herba Oberoniae iridifoliae 10g, Pericarpium Citri grandis 10g, Herba Kalimeridis 10g, Fructus Vitis viniferae 5g, Fructus Amomi 5g, Pericarpium Citri Reticulatae 5g, Massa Medicata Fermentata 5g, Fructus Crataegi 5g.

Preparation method comprises:

By formula proportion, crude drug is added the 60-90% soak with ethanol 1-2 hour of 5-10 times amount, heating extraction 2 times, each 1-2 hour, remove supernatant, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into pasty state, mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1; Medicinal residues add 5-10 times amount water soaking 1-2 hour, within 1-1.5 hour, extract 1 time, as component 2; Above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.

Usage and dosage: warm water takes, 3 times/day, 3 tablets/time, 4.5g/ grain.

Case:

Patient 18 months, usually anorexia, eat flatulence at most, food often can not be stagnated any more, normal fatigue and weakness, and how half congealed thin defecate, body of the tongue is slightly red, and tongue is slightly rotten greasy, and deep pulse is cunning slightly.See its body partially thin, shallow complexion.Oral Chinese medicine of the present invention after three days symptom alleviate, recovery from illness after a week.

embodiment 2 formula:

Fructus Mali pumilae 12g, Fructus Musae 12g, Fructus Hordei Germinatus 12g, Radix Dauci Sativae 12g, Diplazium lanceum (Thunb) 12g, Herba Oberoniae iridifoliae 12g, Pericarpium Citri grandis 12g, Herba Kalimeridis 12g, Fructus Vitis viniferae 6g, Fructus Amomi 6g, Pericarpium Citri Reticulatae 6g, Massa Medicata Fermentata 6g, Fructus Crataegi 6g.

Capsule, preparation process comprises:

1) raw medicinal material is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged filtering and standing; 2) medicinal residues refined are put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged, filtering and standing;

3) above-mentioned two kinds of filtrates are merged, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder and incapsulate.

Usage and dosage: warm water takes, 3 times/day, 3 tablets/time, 4.5g/ grain.

Case:

Patient 15 months, usually anorexia, dare not polyphagia, eats flatulence anorexia at most, xerostomia, red tongue with a little fluid, the micro-Huang of tongue, thready and rapid pulse.Oral Chinese medicine of the present invention is anorexia improvement after three days, and xerostomia, flatulence alleviate, recovery from illness after a week.

embodiment 3 formula:

Fructus Mali pumilae 15g, Fructus Musae 15g, Fructus Hordei Germinatus 15g, Radix Dauci Sativae 15g, Diplazium lanceum (Thunb) 15g, Herba Oberoniae iridifoliae 15g, Pericarpium Citri grandis 15g, Herba Kalimeridis 15g, Fructus Vitis viniferae 10g, Fructus Amomi 10g, Pericarpium Citri Reticulatae 10g, Massa Medicata Fermentata 10g, Fructus Crataegi 10g.

The preparation process of enema is:

A, get crude drug and add water extraction 2 times, becoming extractum shape, is component 1;

B, medicinal residues add 60-90% soak with ethanol 0.5-1.5 hour, extract twice, each 1-2 hour, merge extractive liquid, filters, concentrated, 80-160 order filter, 6000-10000 rev/min centrifugal after supernatant, be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.35 extractum, heating and refluxing extraction 2 times, each 30 minutes ~ 45 minutes, extracts active ingredient, 2 extracting solution are merged and is settled into extractum shape, as component 2;

C, by concentrated for above-mentioned two kinds of extractum mixing.

Get above-mentioned enema 100mL ~ 200mL during use, retention enema, pours into 30mL ~ 50mL at every turn at every turn, and inject with No. 12 oxygen catheters and 50mL syringe, insertion depth is 15cm ~ 20cm, 2 ~ 3 times/d, 7d are 1 basic course for the treatment of, each 20min-40min.

Case:

Patient 15 months, usually anorexia, dare not polyphagia, eats flatulence anorexia at most, xerostomia, red tongue with a little fluid, the micro-Huang of tongue, thready and rapid pulse.Use herbal enema of the present invention anorexia improvement after three days, xerostomia, flatulence alleviate, recovery from illness after a week.

embodiment 4 formula:

Fructus Mali pumilae 18g, Fructus Musae 18g, Fructus Hordei Germinatus 18g, Radix Dauci Sativae 18g, Diplazium lanceum (Thunb) 18g, Herba Oberoniae iridifoliae 18g, Pericarpium Citri grandis 18g, Herba Kalimeridis 18g, Fructus Vitis viniferae 14g, Fructus Amomi 14g, Pericarpium Citri Reticulatae 14g, Massa Medicata Fermentata 14g, Fructus Crataegi 14g.

Capsule, its preparation process comprises:

1) raw medicinal material is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged filtering and standing;

2) medicinal residues refined are put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged, filtering and standing;

3) above-mentioned two kinds of filtrates are merged, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder and incapsulate.

Usage and dosage: warm water takes, 3 times/day, 3 tablets/time, 4.5g/ grain.

Case:

Patient 3 one full year of life, enter kindergarten and occur emaciation and sallow complexion after one week, brittle hair, diet is unusual, and belly becomes large, and defecation taste is smelly, and the mental status is not good, and oral Chinese medicine of the present invention is diet improvement after three days, and xerostomia, flatulence alleviate, and defecation is normal, recovery from illness after a week.

embodiment 5 formula:

Fructus Mali pumilae 20g, Fructus Musae 20g, Fructus Hordei Germinatus 20g, Radix Dauci Sativae 20g, Diplazium lanceum (Thunb) 20g, Herba Oberoniae iridifoliae 20g, Pericarpium Citri grandis 20g, Herba Kalimeridis 20g, Fructus Vitis viniferae 15g, Fructus Amomi 15g, Pericarpium Citri Reticulatae 15g, Massa Medicata Fermentata 15g, Fructus Crataegi 15g.

Preparation method comprises:

By formula proportion, crude drug is added the 60-90% soak with ethanol 1-2 hour of 5-10 times amount, heating extraction 2 times, each 1-2 hour, remove supernatant, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into pasty state, mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1; Medicinal residues add 5-10 times amount water soaking 1-2 hour, within 1-1.5 hour, extract 1 time, as component 2; Above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.

Usage and dosage: warm water takes, 3 times/day, 3 tablets/time, 4.5g/ grain.

Case:

Patient 4 one full year of life, the situation same with case three, there is emaciation and sallow complexion, brittle hair after boarding at the nursery one week in kindergarten, diet is unusual, and belly becomes large, and defecation taste is smelly, and the mental status is not good, oral Chinese medicine of the present invention is diet improvement after three days, and xerostomia, flatulence alleviate, and defecation is normal, recovery from illness after a week.

pharmacological experiment

Pharmacology pharmacodynamic is tested:

1, cumulative toxicity test report

Test method: select 20 healthy mices, female, each 10 of hero, with capsule of the present invention, dose design is first phase in every 5 days, each issue dosage is respectively 0.10LD50,0.15LD50,0.22LD50,0.34LD50,0.50LD50, the LD50 that is female, male mice of this sample be 5000m part/k part BW (five dosage is 500,750,1100,1700,2500m part/k part BW).Within every 5 days, weigh once, adjustment dosage, by 0.1ml/10 part BW per os gavage.After 20 days, animal occurs without death condition, off-test, and by ascending-dose to tested material after 20 days, female, buck all occurs without death condition.

2, acute toxicity test: give white mouse large enteral dispensing with 200 times of the clinical consumption per day of this product honey refining pill, observe 5.The all animals of result are strong deposits, and its activity, diet, hair, Excreta are no abnormal, have no toxic reaction.Irritation test is carried out to white mouse vagina and damaged skin, there are no irritative response and other untoward reaction.Toxicity test proves, the not toxic effect of this medicine and untoward reaction, clinical practice is safe and reliable.

3, to the bacteriostasis of common bacterial strain

Solid process antibacterial action: line on blood ware or ordinary nutrient agar plate so that various test organisms is intensive, punch with 8mm card punch, every hole adds aseptic reagent and is about 0.2ml, cultivate 18 ~ 24 hours at 37 DEG C, observe the size of inhibition zone, for inventive gel agent, judge that its responsive result is as following table.

Antibacterial circle diameter < 9mm., drug resistance-; Antibacterial circle diameter >=10 ~ 14mm, slight sensitive+; Antibacterial circle diameter >=15 ~ 19mm, medium sensitivity ++; Antibacterial circle diameter >=20 ~ 29mm, extremely sensitive +++; Antibacterial circle diameter >=30mm, special extremely sensitive ++++.

Above extracorporeal bacteria inhibitor test shows, this product truly has obvious inhibitory action to common antibacterial.

4. hypersensitive test:

Get healthy albino guinea-pig 18, body weight 250-300g, male and female dual-purpose, reject both sides dorsal body setae before test, every side 3 × 3cm, is divided into test group, blank group (substrate) and positive controls at random.Positive controls DNFB, sensitization 1% concentration, excites and uses 0.1% concentration.Get enema 0.1g of the present invention and be applied to unhairing district, back, the next day 1 time, totally 3 times.In latter 14 days of last contact, at back, the same area smeared this product 0.1g, at once observes after removing medicine after 6h, and in 24,48,72h observes with or without anaphylaxis.Blank group and positive controls excite by same method and contact and observe.Result of the test: namely positive controls animal skin occurs localized erythema and slight edema in sensitization after 1 hour, within 24 hours, symptoms of allergic increases the weight of, and have scleroma to be formed, sensitization rate is 100%, all there is not any symptoms of allergic in test group and blank treated animal skin, sensitization rate is 0%.

Pharmacological experiment

Get capsule of the present invention, drugs compared is some, mice, rabbit is provided by biology department of Shandong University.

1, medicine group mice charcoal end propelling rate of the present invention compares with Normal group and presents remarkable inhibitory action; Can the intestinal smooth muscle spasm that causes of antagonism neostigmine, resist the intestinal function caused by atropine and suppress, play the effect regulating intestinal function; Blood D-xylose concentration is apparently higher than Normal group; Of the present invention group of suppression ratio to rabbits infestines smooth muscle, antagonistic rate all have significant difference apparently higher than matched group; Mouse death rate in 3 hours all makes moderate progress;

Medicine group of the present invention can obviously antagonism intestinal function be hyperfunction, improves intestinal function and suppresses, play and regulate intestinal function effect, has spasmolytic and the effect promoting intestinal absorption; Rehabilitation effect is had to spleen-deficient mice; Mouse monokaryon macrophage phagocytic function, enhancing human body immunity can be promoted.

Table 1 medicine of the present invention is on the impact (X ± SD) of small intestine movement of mice propulsion functions

* P < 0.05**P < 0.01 compares with Normal group

Experimental result shows: in medicine of the present invention, dosage group has demonstrated the inhibitory action to intestinal propulsion, high dose group then has significant differences (P < 0.01) compared with Normal group, medicine of the present invention advances small intestine movement of mice as can be seen here obvious inhibitory action, and strengthens to some extent along with the increase inhibitory action of dosage.

Impact (X ± SD) n=12 that table 2 medicine of the present invention is hyperfunction on neostigmine induced mice intestinal propulsion

△ P < 0.05, compares * P < 0.05**P0.01 and compares with model control group with Normal group

Result shows: mice is after injection neostigmine, its Intestinal propulsive rate has obvious rising (p < 0.05), after drug administration of the present invention, each administration group mouse small intestine propelling rate all has certain decline, wherein, heavy dose of group compares with model control group significant difference (P < 0.05, p < 0.01), and medicine of the present invention has obvious antagonism to neostigmine induced mice intestinal propulsion is hyperfunction as can be seen here.

The impact (X ± SD, n=10) that table 3 medicine of the present invention suppresses atropine induced mice intestinal propulsion

△ P < 0.05, compares * * P < 0.01 and compares with model control group with Normal group

Atropine makes the intestinal propulsion of mice be suppressed (atropine group compares with Normal group significant difference p < 0.05), medication result shows medicine of the present invention can resist atropinic small intestinal inhibitory action, its Intestinal propulsive rate is apparently higher than atropine group (p < 0.01), and medicine of the present invention suppresses there is obvious antagonism to atropine induced mice intestinal propulsion as can be seen here.

Table 4 medicine of the present invention is on the impact (X ± SD, n=5) of small intestinal peristalsis amplitude

Note: compare * p < 0.05, * * p < 0.01 with before dosing

Experimental data shows: medicine of the present invention is wriggled in obvious inhibitory action to rabbit jejunum, and with the increase of dosage, inhibitory action strengthens.

clinical data

1 data and method

1.1 physical data: the children indigestion symptom selecting in March, 2013 ~ 2015 my institute's diagnosis and treatment in year June is totally 200 examples, all meet Chinese children in 1998 and to stagnate disease diagnostic criteria.Wherein man 118 example, female 82 example, age <6 month person 30 example, 6 months ~ 2 years old person 148 example, >2 year 22 examples.

Be divided into two groups at random, treatment group 128 example, matched group 72 example, two groups of infants comparing difference not statistically significant in age, sex, state of an illness weight, has comparability, and is in hospital or out-patient treatment according to the weight of the state of an illness.

1.2 Therapeutic Method: two groups of cases all give conventional fluid infusion, electrolyte supplement, antiviral and "Xingpi Yanger Granule" symptomatic treatment, treatment group adds with Chinese medicinal formulae enema of the present invention on this basis, get above-mentioned enema 100mL ~ 200mL during use at every turn, retention enema, pours into 30mL ~ 50mL at every turn, injects with No. 12 oxygen catheters and 50mL syringe, insertion depth is 15cm ~ 20cm, 2 ~ 3 times/d, 7d are 1 basic course for the treatment of, each 20min-40min.Also can pulverize, with vinegar furnishing pulpiness, be affixed on SHENQUE acupoint, gauze external application, adhesive tape is fixed, indwelling 8 ~ 12h, 1 time/d, and continuous 3 ~ 5d is 1 course for the treatment of.

1.3 efficacy determinations: the curative effect determinate standard of the disease diagnoses and treatment scheme revision that stagnates according to Chinese children

Effective: in treatment 72h, feces character and number of times recover normal, and General Symptoms disappears; Effective: in treatment 72h, feces character and number of times are clearly better, and General Symptoms improves; Invalid: in treatment 72h, feces character, number of times and General Symptoms are without improvement, even worsen.

2 results

Two groups of comparitive study: observation group's total effective rate 96.1%; Apparently higher than matched group total effective rate 76.3%, through statistical procedures, two groups of total effective rate comparing differences have statistical significance (P<0.01), in table 5.

A table 5 liang group therapeutic effect compares (example)

Group	Number of cases	Effective	Effectively	Invalid	Total effective rate (%)
						Treatment group	128	102	21	5	96.09
Matched group	72	37	18	17	76.39

Note: compare with matched group, P<0.01.

Claims (6)

1. treat a Chinese medicine composition for children indigestion symptom, it is characterized in that: be made up of following raw material:

Fructus Mali pumilae 10-20 part, Fructus Musae 10-20 part, Fructus Hordei Germinatus 10-20 part, Radix Dauci Sativae 10-20 part, Diplazium lanceum (Thunb) 10-20 part, Herba Oberoniae iridifoliae 10-20 part, Pericarpium Citri grandis 10-20 part, Herba Kalimeridis 10-20 part, Fructus Vitis viniferae 5-15 part, Fructus Amomi 5-15 part, Pericarpium Citri Reticulatae 5-15 part, Massa Medicata Fermentata 5-15 part, Fructus Crataegi 5-15 part.

2. a kind of Chinese medicine composition for the treatment of children indigestion symptom according to claim 1, is characterized in that: be made up of following raw material:

Fructus Mali pumilae 12-18 part, Fructus Musae 12-18 part, Fructus Hordei Germinatus 12-18 part, Radix Dauci Sativae 12-18 part, Diplazium lanceum (Thunb) 12-18 part, Herba Oberoniae iridifoliae 12-18 part, Pericarpium Citri grandis 12-18 part, Herba Kalimeridis 12-18 part, Fructus Vitis viniferae 6-14 part, Fructus Amomi 6-14 part, Pericarpium Citri Reticulatae 6-14 part, Massa Medicata Fermentata 6-14 part, Fructus Crataegi 6-14 part.

3. a kind of Chinese medicine composition for the treatment of children indigestion symptom according to claim 1, is characterized in that: be made up of following raw material:

Fructus Mali pumilae 15 parts, 15 parts, Fructus Musae, 15 parts, Fructus Hordei Germinatus, 15 parts, Radix Dauci Sativae, Diplazium lanceum (Thunb) 15 parts, Herba Oberoniae iridifoliae 15 parts, Pericarpium Citri grandis 15 parts, Herba Kalimeridis 15 parts, Fructus Vitis viniferae 10 parts, Fructus Amomi 10 parts, Pericarpium Citri Reticulatae 10 parts, Massa Medicata Fermentata 10 parts, Fructus Crataegi 10 parts.

4. a kind of Chinese medicine composition for the treatment of children indigestion symptom according to claim 1-3 any one, is characterized in that: the dosage form of thing preparation is honey refining pill, and its preparation method comprises:

By formula proportion, crude drug is added the 60-90% soak with ethanol 1-2 hour of 5-10 times amount, heating extraction 2 times, each 1-2 hour, remove supernatant, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into pasty state, mass continues heating and is concentrated into extractum shape, stand for standby use, becomes component 1;

Medicinal residues add 5-10 times amount water soaking 1-2 hour, within 1-1.5 hour, extract 1 time, as component 2;

(3) above-mentioned two kinds of extractum are condensed into pasty state, add Mel and be twisted into pill.

5. a kind of Chinese medicine composition for the treatment of children indigestion symptom according to claim 1-3 any one, is characterized in that: described agent type is capsule, and its preparation process comprises:

Raw medicinal material is put into 10 times amount ethanol, heating and refluxing extraction 2 times, each 1 ~ 2 hour, extract active ingredient, 2 extracting solution are merged filtering and standing;

The medicinal residues refined are put into 10 times of water gagings, heating and refluxing extraction 3 times, each 45 minutes ~ 1 hour, 3 extracting solution are merged, filtering and standing;

Above-mentioned two kinds of filtrates are merged, decompression recycling ethanol to be concentrated into liquor strength be 0.4g crude drug/mL, after sucking filtration, when the relative density of filtrate is about 20 DEG C 1.06; Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first uses deionized water or the distilled water eluting of 10 times of resin column volumes, then uses 95% ethanol elution of 5 times of resin column volumes, collects ethanol elution, removes solvent, obtains raw material medicated powder and incapsulate.

6. a kind of Chinese medicine composition for the treatment of children indigestion symptom according to claim 1-3 any one, is characterized in that: described agent type is enema, and its preparation process is:

A, get crude drug and add water extraction 2 times, becoming extractum shape, is component 1;

B, medicinal residues add 60-90% soak with ethanol 0.5-1.5 hour, extract twice, each 1-2 hour, merge extractive liquid, filters, concentrated, 80-160 order filter, 6000-10000 rev/min centrifugal after supernatant, be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.35 extractum, heating and refluxing extraction 2 times, each 30 minutes ~ 45 minutes, extracts active ingredient, 2 extracting solution are merged and is settled into extractum shape, as component 2;

C, by concentrated for above-mentioned two kinds of extractum mixing.