CN105362941A

CN105362941A - Medicament for treating irritable bowel syndrome with spleen-stomach damp-heat syndrome

Info

Publication number: CN105362941A
Application number: CN201510875463.7A
Authority: CN
Inventors: 刘超
Original assignee: Qingdao Huaren Technology Incubator Co Ltd
Current assignee: Qingdao Huaren Technology Incubator Co Ltd
Priority date: 2015-12-03
Filing date: 2015-12-03
Publication date: 2016-03-02

Abstract

The invention provides a medicament for treating irritable bowel syndrome with spleen-stomach damp-heat syndrome, comprising medicinal materials: Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Tatarinowii and Radix Glycyrrhizae Preparata. The medicament is effective in clearing heat and eliminating damp, relieving spasm and pain and cooling blood and removing stasis through formulation compatibility with respect to traditional Chinese medicine differentiation of the irritable bowel syndrome with spleen-stomach damp-heat syndrome in connection with clinical manifestation of a patient. The medicament is well functional in treating a patient with the irritable bowel syndrome with spleen-stomach damp-heat syndrome in terms of clinical symptoms and living quality; can reduce recurrence of this disease, thus reducing anxiety and depression.

Description

The medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome

Technical field

The present invention relates to technical field of Chinese medicine, particularly relate to a kind of medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome.

Background technology

Irritable bowel syndrome (irritablebowelsyndrome, IBS) be a kind of functional intestinal disease (functionalbowelDisease changing into feature with stomachache or abdominal discomfort companion bowl evacuation habit, FBD), primary disease is due to the actual also NIP of intestinal, dysfunction reality is also not limited to colon, therefore is referred to as irritable bowel syndrome.Morphological change and the biochemistry of the soluble symptom of this disease shortage are abnormal, and sickness rate increases year by year, accounts for Gastroenterology Clinic 25%-50%.Find according to Epidemiological study, primary disease is mainly in women, and M-F is approximately 1: 1 ~ 1: 2, and morbidity crowd mostly is the middle age of 30 ~ 40 years old.Irritable bowel syndrome is higher in global population's prevalence, and has and increase trend year by year, and large to Quality of Life, medical expense is higher.As the typical case of functional gastrointestinal disease, irritable bowel syndrome more and more receives the concern of gastroenterologist, and due to the definite etiology unknown of irritable bowel syndrome, and clinical symptoms complexity is various, there is no any one medicine at present or psychotherapy can cure this disease.Though irritable bowel syndrome does not threaten the life of patient, have a strong impact on the life quality of patient, cause huge economy and mental burden to individual, family and society.4 hypotype: IBS-D (diarrhea-type), IBS-C (constipation type), mixed type (IBS-M) and indefinite form (IBS-U) is divided into according to RomeIII standard primary disease.Wherein common with diarrhea-type (IBS-D).Diarrhea type irritable bowel syndrome refers to the pasty state/watery stool more than 25%, is less than the hard feces of 25% bulk/quality.

Diarrhea type irritable bowel syndrome sickness rate is high, affects wide, is apt to occur in the young and the middle aged, not only affects the study of patient, live and work, and also produces negative effect in various degree to the life quality of patient.Although medical worker has carried out unremitting exploration and effort to this disease both at home and abroad at present, but because the etiology and pathogenesis of this disease is still not exclusively clear and definite, be still main mainly with symptomatic treatment in current western medical treatment method, mainly select spasmolytic, suppress the medicine of enterokinesia, the obvious person that suffers from abdominal pain can select the medicine of lax gastrointestinal smooth muscle, give psychological counseling to as required the patient of Psychological abnormal simultaneously, anxiety, antidepressant medicine can be given if desired, but clinical efficacy satisfaction is low, has repeatedly during patients symptomatic.A relatively speech, Chinese medicine has obvious advantage improving in symptom.

Chinese medicine is thought, mainly relevant with liver, spleen, stomach, renal dysfunction with the morbidity of the diarrhea type irritable bowel syndrome of principal character of having loose bowels.The liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, edema with the liver involved takes advantage of spleen, therefore all diseases of clinical appearance, and " Jing Yue's complete work is had loose bowels " is said: " have loose bowels this, invariably due to taste ", " covers with liver Wood restricts earth, the spleen being damaged and so." " hospital examines " cloud: " rush down the spleen of duty, the liver of severely rebuking, excess of the liver is insufficiency of the spleen, therefore order pain is rushed down ".It is dirty in liver spleen two that visible primary disease is mainly blamed, and " incoordination between the liver and spleen " is its main pathogenesis.In addition, spleen fortune is not normal, insufficiency of the spleen resulting in production of dampness, and damp-stagnancy heat-transformation can cause the card of spleen asthenia with dampness heat; With the passing of time insufficiency of the spleen and cause spleen YANG deficiency, and then it is also empty to affect kidney yang, the card of visible damp-heat in the spleen and stomach.

Disorder of emotion causes edema with the liver involved to take advantage of spleen to be a main cause of disease and the pathogenesis of primary disease morbidity.Diarrhea type irritable bowel syndrome has an important feature to be that it causes a disease and brings out all in close relations with emotional factors.In theory of Chinese medical science, seven emotions comprise happiness, anger, melancholy, think of, compassion, probably, shy, and wherein, liver and the angry variation relation of emotion are the closest, because liver is organ of general, are not held back strongly fragrant, main catharsis mechanism of qi, easily by feelings will is hindered.Once edema with the liver involved is ill, then mechanism of qi Buddhist is strongly fragrant, and spleen transporting is restricted.

Damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome major lesions is liver and taste, for spleen and stomach damp-heat type irritable bowel syndrome patients, Epidemiological study finds, this type of patient is mainly in the middle of colony of adolescence, wherein pathogenic factor is many because of eating and drinking without temperance, eating cold and uncooked food excessively, pungent, its body constitution also excessive phlegm wets or damp-heat constitution, or because of emotional factor cause morbidity, drinking and eating irregularly and abnormal emotion influence each other, cause liver spleen with sick, there is abdominal pain diarrhea, rush down lower urgent or not well, burning sensation of the anus, companion sees uncomfortable in chestly does not relax, excessive thirst taking fluids profusely, dry mouth with bitter taste, red tongue, yellow and greasy fur, slippery and rapid pulse.So treatment is when damp and hot with Qinghua, the spleen and stomach regulating is main, holds concurrently with smooth the liver and regulate the spleen, and harmonizing the functional activities of vital QI recovers the elevating function of internal organs.So removing damp-heat, removing dampness to restore normal function of the stomach is the rule for the treatment of that effects a permanent cure of this pattern of syndrome for the treatment of diarrhoea, requires that patient is careful in one's diet clinically, can play good therapeutical effect.

The present invention for damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, suits the remedy to the case on the basis of theory of Chinese medical science, proposes a kind of novel medicine being used for the treatment of this pattern of syndrome irritable bowel syndrome.

Summary of the invention

Technical problem to be solved by this invention is, technical problem to be solved by this invention is, doctor trained in Western medicine is not yet clear and definite for the etiology and pathogenesis of this disease, treatment is only symptomatic treatment is main, for patient's persistent diarrhea, mainly select spasmolytic, suppress the medicines such as enterokinesia, but often cause patient to occur constipation, or alternating diarrhea and constipation occurs, patients ' life quality declines, and clinical efficacy satisfaction is low, in the course of time,, there is anxiety-depression morbidity tendency in patient's recurrent exerbation.And Chinese medicine provided by the invention has more specific aim, clear and definite therapeutic effect is had for damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, and somatization is improved obviously, and for doctor trained in Western medicine, Chinese medicine is natural drug, without obvious toxic-side effects, compensate for Western medicine drug not enough targetedly, there is good clinical generalization value.

For solving the problems of the technologies described above, the invention provides a kind of medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, its crude drug comprises: Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, the Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Graminei, Radix Glycyrrhizae Preparata.

Wherein, in described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 10 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 20 parts, Radix Sophorae Flavescentis 6 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 30 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 20 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 20 parts, Herba Lophatheri 10 ~ 20 parts, Rhizoma Acori Graminei 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Wherein, in described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 15 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 15 parts, Radix Sophorae Flavescentis 8 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 25 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 25 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 15 parts, Herba Lophatheri 10 ~ 15 parts, Rhizoma Acori Graminei 15 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Wherein, in described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 20 parts, Rhizoma Coptidis 15 parts, Herba Portulacae 15 parts, Radix Sophorae Flavescentis 10 parts, the Radix Pulsatillae 10 parts, Rhizoma Atractylodis 10 parts, Semen Coicis 20 parts, 10 parts, Poria, Radix Puerariae 15 parts, Radix Curcumae 15 parts, Fructus Aurantii 15 parts, Rhizoma Cyperi 10 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, Radix Notoginseng 10 parts, the Radix Paeoniae Alba 25 parts, Radix Paeoniae Rubra 15 parts, Fructus Crataegi 15 parts, Herba Lophatheri 15 parts, Rhizoma Acori Graminei 15 parts, Radix Glycyrrhizae Preparata 10 parts.

Wherein, described Chinese medicine routinely technique adds adjuvant and makes tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill or oral liquid, and described adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and substrate.

Wherein, the dosage form of described Chinese medicine is oral liquid.

Present invention also offers the preparation method of above-mentioned Chinese medicine as oral liquid, it comprises:

The first step, first rinses twice, to remove dust, pesticide, fertilizer residue with clear water by each crude drug, put into decocting container, by gross weight than the water adding 2 ~ 4 times, after boiled with big fire, be transferred to 40 minutes ~ 1.5 hours at a simmer, collecting decoction after decocting twice, filter, decoction liquor is concentrated into solid-liquid ratio 0.5 ~ 2, regulates determining alcohol to 60 ~ 85% after adding ethanol, dark place leaves standstill 20 ~ 36h, filter, reclaim ethanol, when being concentrated into 90 DEG C, relative density is the concentrated solution of 1.05 ~ 1.15;

Second step, get sucrose join relative to sucrose weight 30% ~ 50% distilled water in, heating sucrose is dissolved completely, make simple syrup, filter, for subsequent use;

3rd step, the concentrated solution that the first step of getting 30% according to mass percent obtains, 20% second step obtain simple syrup and 50% water add successively in Agitation Tank, stir 20 ~ 40min, filter, filtrate is placed in high pressure homogenizer, 65 ~ 75 DEG C, carry out twice homogenization under 20 ~ 40MPa condition, obtain homogenizing fluid;

4th step, the homogenizing fluid filling and sealing the 3rd step obtained, in the vial of cleaning, then uses flowing steam sterilizing 30min under 100 DEG C of conditions, and namely hot water injection, pouring obtain this oral liquid after doing.

The present invention also provides a kind of oral liquid being used for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, its crude drug comprises Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, the Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Graminei, Radix Glycyrrhizae Preparata;

The preparation method of described oral liquid specifically comprises,

The first step, first rinses twice, to remove dust, pesticide, fertilizer residue with clear water by each crude drug, put into decocting container, add the water of 2 ~ 4 times of crude drug quality sum, after boiled with big fire, be transferred to 40 minutes ~ 1.5 hours at a simmer, collecting decoction after decocting twice, filter, decoction liquor is concentrated into solid-liquid ratio 0.5 ~ 2, regulates determining alcohol to 60 ~ 85% after adding ethanol, dark place leaves standstill 20 ~ 36h, filter, reclaim ethanol, when being concentrated into 90 DEG C, relative density is the concentrated solution of 1.05 ~ 1.15;

Comprehensive beneficial effect of the present invention: we are for the Chinese medical discrimination of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, in conjunction with patients clinical performance, by prescription compatibility, serve and hold up spleen subduing the hyperfunction of the liver, effect of antidiarrheal in reason, also serves effect of blood circulation promoting and blood stasis dispelling, astringent therapy antidiarrheal for prolonged illness patient.

Treated by we, have good therapeutical effect to the clinical symptoms of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome patients, life quality; This disease of obvious minimizing recurs, and then reduces the generation of anxiety-depression state.

Detailed description of the invention

The invention provides a kind of medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, its crude drug comprises: Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, the Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Graminei, Radix Glycyrrhizae Preparata.

Further preferably, described medicine is only prepared from by above-mentioned raw materials medicine.

In described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 10 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 20 parts, Radix Sophorae Flavescentis 6 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 30 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 20 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 20 parts, Herba Lophatheri 10 ~ 20 parts, Rhizoma Acori Graminei 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Further preferably, in described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 15 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 15 parts, Radix Sophorae Flavescentis 8 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 25 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 25 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 15 parts, Herba Lophatheri 10 ~ 15 parts, Rhizoma Acori Graminei 15 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Most preferably, in described medicine, the weight portion of each crude drug is respectively Radix Scutellariae 20 parts, Rhizoma Coptidis 15 parts, Herba Portulacae 15 parts, Radix Sophorae Flavescentis 10 parts, the Radix Pulsatillae 10 parts, Rhizoma Atractylodis 10 parts, Semen Coicis 20 parts, 10 parts, Poria, Radix Puerariae 15 parts, Radix Curcumae 15 parts, Fructus Aurantii 15 parts, Rhizoma Cyperi 10 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, Radix Notoginseng 10 parts, the Radix Paeoniae Alba 25 parts, Radix Paeoniae Rubra 15 parts, Fructus Crataegi 15 parts, Herba Lophatheri 15 parts, Rhizoma Acori Graminei 15 parts, Radix Glycyrrhizae Preparata 10 parts.

For spleen and stomach damp-heat type irritable bowel syndrome patients, Epidemiological study finds, this type of patient is mainly in the middle of colony of adolescence, and wherein pathogenic factor is many because of eating and drinking without temperance, eating cold and uncooked food excessively, pungent, cause damp-heat in the spleen and stomach, abdominal pain diarrhea, treatment answers clearing away heat and eliminating dampness, relieving spasm to stop pain, holds concurrently with removing heat from blood repercussive.We found, for the Etiological of this pattern of syndrome clinical, with the Radix Scutellariae of heat clearing and damp drying, Rhizoma Coptidis, Radix Sophorae Flavescentis is monarch drug group, with the Semen Coicis of invigorating spleen to remove dampness, Poria, Rhizoma Acori Graminei is ministerial drug group, during primary disease morbidity, abdominal pain diarrhea is comparatively violent, therefore be assistant with the medicine of a large amount of relieving spasm to stop pain of regulating the flow of vital energy, as Rhizoma Cyperi Radix Curcumae medicine pair, Radix Paeoniae Radix Glycyrrhizae medicine pair, play good analgesic effect, wherein Rhizoma Coptidis, Herba Portulacae, the medicines such as the Radix Pulsatillae are except having the effect of clearing away heat and cooling blood antidiarrheal, modern study finds that it has good mitigation for enteritis, the traditional Chinese medical science is thought, hot forcing blood is capable, the patient of this type of pattern of syndrome, find in clinical observation, while diarrhoea, have the red and swollen heat pain of crissum, also have at just normal discovery occult blood, so we add clearing away heat and cooling blood, activating blood circulation and dissipating blood stasis medicine, as the Radix Pulsatillae, Radix Curcumae, Radix Notoginseng, Radix Paeoniae Rubra, Herba Lophatheri etc., draw heat descending, just walk to let out from two, play and make medicine effect.Comprehensive we, play effect of clearing away heat and eliminating dampness, relieving spasm to stop pain, removing heat from blood repercussive.

Each crude drug pharmacology is as follows:

Radix Scutellariae: latin name ScutellariaeRadix, bitter in the mouth, cold in nature, enter the heart, lung, stomach, gallbladder, large intestine channel, have heat clearing and damp drying, eliminating fire and detoxication, antiabortive, the effect of hemostasis, is mainly used in damp and hot caused diarrhoea, dysentery, jaundice, pyretic stranguria; Cough due to lung-heat, thirsty pharyngalgia, also can be used for excessive fetal movement due to heat in pregnancy, and pyretic toxicity pathogenic fire invades the swollen card of carbuncle sore poison of excessive skin.

Rhizoma Coptidis: bitter in the mouth, cold in nature, enter the heart, lung, gallbladder, stomach, large intestine channel, have heat clearing and damp drying, eliminating fire and detoxication, the effect of cooling blood for improving eyesight, be usually used in the fire for the treatment of removing pathogen in the heart warp, the dysphoria and insomnia that heart-fire is prosperous, and the high fever coma of epidemic febrile disease, the symptom such as vexed, thirsty.

Herba Portulacae: latin name Portulacaeherba, sour in the mouth, cold in nature, return large intestine, Liver Channel, there is heat-clearing and toxic substances removing, diuretic dries, loose blood detumescence, dust-collection sterilization, anti-inflammatory analgetic, and effect of hemostasis removing heat from blood, cures mainly dysentery, enteritis, nephritis, puerperal, metrorrhagia, had blood in stool, the diseases such as mastitis.

Radix Sophorae Flavescentis: latin name SophoraeFlavescentisRadix, bitter in the mouth, cold in nature, enter the heart, stomach, large intestine, urinary bladder channel, there is the effect of heat clearing and damp drying, wind dispelling insecticide, be mainly used in damp-heat dysentery, jaundice, stranguria.

The Radix Pulsatillae: bitter in the mouth, cold in nature, enter stomach, large intestine channel, have the effect of heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery, being mainly used in the intestines and stomach has damp and hot stagnant heating stomachache, dysentery pus and blood, the cards such as tenesmus.

Rhizoma Atractylodis: acrid in the mouth, hardship, warm in nature, enter spleen, stomach, Liver Channel, have drying damp and strengthening spleen, expelling wind and dampness, the effect of improving eyesight, be mainly used in the stomachache dysentery of retention of dampness in middle-JIAO, the abdominal distention pain of incoordination between the spleen and stomach, vomits indigestion and loss of appetite; The abdomen side of body distending pain, the vomiting with acid regurgitation of incoordination between the liver and stomach; And the card such as the anemofrigid-damp arthralgia of the outer strongly fragrant meridians of cold-damp.

Semen Coicis: sweet in the mouth, light, cold nature, enters lung, spleen, large intestine channel, has invigorating the spleen to arrest diarrhea, diuretic eliminating impediment, and the effect of row's skin ulcer pus, is mainly used in having loose bowels of wet tired lung stomach; Damp invades the hydrosarca of stain skin, dysuria; The damp and hot numbness hindered in QI and blood passes to and the scorchingly hot card such as lung abscess, acute appendicitis pented up in lung intestinal.

Poria: sweet in the mouth, light, property is put down, and enters spleen, lung, bladder, heart channel, has the effect of eliminating dampness and diuresis, spleen invigorating mind calming, be mainly used in the edema of retention of water-damp, dysuria; The pyretic stranguria of damp-heat accumulation, the card such as anorexia and loose stool, phlegm retention stagnation, epilepsy of stagnation of dampness due to deficiency of the spleen.

Radix Puerariae: sweet in the mouth, pungent, cool in nature, enters spleen, stomach warp, has inspiration gastric qi, the raw Feng of heat clearing away, and expelling pathogenic factors from muscles is delivered, and raw sun, oozes the effect of rash, be mainly used in fever caused by exogenous pathogens, headache, stiff nape and back, and calentura is thirsty, quenches one's thirst; Diarrhea due to hypofunction of the spleen, the cards such as clear YANG failing to ascend.

Radix Curcumae: acrid in the mouth, hardship, cold in nature, return liver, the heart, lung meridian, have promoting blood circulation and stopping pain, promoting QI circulation for relieving depression, clear away heart-fire removing heat from blood, and effect of promoting the function of the gallbladder to alleviate jaundice cures mainly amenorrhea dysmenorrhea, chest and abdomen swelling and pain, twinge, calentura coma, the cards such as epilepsy is gone mad, jaundice dark coloured urine.

Fructus Aurantii: bitter in the mouth; Acid; Cold nature returns lung; Spleen; Liver; Stomach; Large intestine channel, cures mainly: septum pectorale feeling of fullness; Distending pain over the hypochondrium; Accumulation of food in the stomach and intes tine due to indigestion; Distension and fullness in the abdomen; Heavy after dysentery; Proctoptosis; The cards such as uterine prolapse.

Rhizoma Cyperi: acrid in the mouth, sweet, micro-hardship, property is put down, and returns liver, tri-jiao channel; Have gas perfume row loose, can rise and can fall, resolving depression of regulating the flow of vital energy, effect of menstruction regulating and pain relieving, cures mainly stagnation of QI due to depression of the liver, breast side of body feeling of fullness, abdominal distention, hernia pain, menoxenia, abdominal pain during menstruation, amenorrhea, bleeding not during menses, the cards such as frequent fetal movement.

Pericarpium Citri Reticulatae: warm in nature, acrid in the mouth, hardship; Return spleen, lung meridian, for diseases such as distension and fullness of the chest and abdomen.The pungent loose logical temperature of Pericarpium Citri tangerinae, fragrant odour, is longer than and regulates the flow of vital energy, spleen lung can be entered, therefore can go loose sluggishness of lung-QI, again can promoting the circulation of QI to alleviate the stagnation in middle-JIAO, gather around stagnant, chest and diaphragm feeling of fullness and the disease such as stagnation of QI in spleen and stomach, distension and fullness in the abdomen for lung qi, for retention of dampness in middle-JIAO, gastral cavity abdomen painful abdominal mass is swollen, have loose bowels in loose stool, and the card such as abundant expectoration cough.

Cortex Magnoliae Officinalis: bitter in the mouth, pungent, warm in nature, returns spleen channel; Stomach warp; Large intestine channel, has circulation of qi promoting removing food stagnancy; Dampness is except full; Effect of lowering the adverse QI to relieve asthma, cures mainly stagnation of QI due to dyspepsia; Abdominal distention constipation; Retention of dampness in middle-JIAO, gastral cavity painful abdominal mass is vomited and diarrhoea; Expectorant stops up QI rising in reverse order; Fullness in the chest such as to be breathed with cough at the card.

Radix Notoginseng: latin name notoginsengradixetrhizoma is the dry root welding technology of panax araliaceae plant: warm in nature, sweet in the mouth, micro-hardship, return liver, stomach warp, and have dissipating blood stasis hemostasis, effect of subduing swelling and relieving pain, cures mainly to fall and flutter congestive edema, thoracic obstruction angor, lump in the abdomen; Blood stasis amenorrhea; Dysmenorrhea; Puerperal, stasis of blood the moon was suffered from abdominal pain; The cards such as sore, carbuncle and painful swelling.

The Radix Paeoniae Alba: latin name PaeoniaeRadixAlba, bitter in the mouth, acid, cool in nature, enter liver, spleen channel, there is nourishing blood to suppress the hyperactive liver, pain relieving in slow, yin fluid astringing receives effect of antiperspirant, cures mainly the breast abdomen pain over the hypochondriac region, and dysentery is suffered from abdominal pain, cold sweating night sweat, fever due to yin deficiency, menoxenia, metrorrhagia, is with inferior card.

Radix Paeoniae Rubra: bitter in the mouth, cold nature, returns Liver Channel, has removing fire from the liver, clearing away heat and cooling blood, effect of stasis-dispelling and pain-killing, cures mainly the conjunctival congestion and swelling pain of high liver fire, has a dizzy spell, pain in chest and hypochondrium, the fever of the body crimson tongue of the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, and macule is hemorrhage, and blood stasis amenorrhea; The haematemesis hematuria of the absurd row of burning hot flourishing forcing blood; The trip of women's heat in blood is through too much; Various pain caused by blood retardance; The cards such as the furuncle carbuncle of heat in blood poison Sheng.

Fructus Crataegi: sour in the mouth, sweet, slightly warm in nature, returns spleen, stomach, Liver Channel, for promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis, be mainly used to treat accumulation of food in the stomach and intes tine due to indigestion, have loose bowels, dysentery, Fructus Crataegi be the staple for the treatment of dyspepsia, and Fructus Crataegi can increase the secretion of peptic digestion enzyme, facilitating digestion; To dysentery bacterium, escherichia coli, bacillus pyocyaneus, staphylococcus aureus etc., there is obvious inhibitory action, the effect that the effective ingredient Fructus Crataegi total flavones in Fructus Crataegi and Fructus Crataegi total triterpene acids have good blood fat reducing, reduce cholesterol, increase Gastric juice digestion enzyme.

Herba Lophatheri: sweet in the mouth, light, cold in nature, enters the heart, lung, stomach warp, has the effect of clearing heat and relieving fidgetness, inducing diuresis for treating stranguria syndrome, be mainly used in the cards such as fever caused by exogenous pathogenic factors, restlessness and thirst, heart stomach-fire Sheng, aphtha of the mouth and tongue, dark coloured urine stranguria with turbid discharge.

Rhizoma Acori Graminei: acrid in the mouth, warm in nature, enter the heart, stomach warp, has refreshment of having one's ideas straightened out, effect of removing dampness to restore normal function of the stomach, and be used for the treatment of expectorant and cover clear key, coma is demented, dizzy, and insomnia is forgetful, tinnitus, retention of dampness in middle-JIAO, the cards such as abdominal distention.

Radix Glycyrrhizae Preparata: sweet in the mouth, property is put down, and returns 12 warps, has the mediation property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak, to alleviate in abdomen the cards such as contracture pain.

Described Chinese medicine routinely technique adds adjuvant and makes tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill or oral liquid, and described adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and substrate.

Further preferably, the dosage form of described Chinese medicine is oral liquid.

Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.

Specific embodiment 1

By Radix Scutellariae 2000g, Rhizoma Coptidis 1500g, Herba Portulacae 1500g, Radix Sophorae Flavescentis 1000g, Radix Pulsatillae 1000g, Rhizoma Atractylodis 1000g, Semen Coicis 2000g, Poria 1000g, Radix Puerariae 1500g, Radix Curcumae 1500g, Fructus Aurantii 1500g, Rhizoma Cyperi 1000g, Pericarpium Citri Reticulatae 2000g, Cortex Magnoliae Officinalis 2000g, Radix Notoginseng 1000g, Radix Paeoniae Alba 2500g, Radix Paeoniae Rubra 1500g, Fructus Crataegi 1500g, Herba Lophatheri 1500g, Rhizoma Acori Graminei 1500g, Radix Glycyrrhizae Preparata 1000g first rinses twice, to remove dust with clear water, pesticide, fertilizer residue, put into decocting container, add the water of 3 times of crude drug quality sum, be transferred to 1 hour at a simmer after boiled with big fire, collecting decoction after decocting twice, filter, decoction liquor is concentrated into solid-liquid ratio 0.5, regulate determining alcohol to 80% after adding ethanol, dark place leaves standstill 36h, filters, reclaim ethanol, when being concentrated into 90 DEG C, relative density is the concentrated solution of 1.05, get sucrose join relative to sucrose weight 40% distilled water in, heating makes sucrose dissolve completely, make simple syrup, filter, for subsequent use, the concentrated solution obtained before 30% is got according to mass percent, the simple syrup obtained before 20% and the water of 50% add in Agitation Tank successively, stir 40min, filter, filtrate are placed in high pressure homogenizer, at 70 DEG C, carry out twice homogenization under 30MPa condition, obtain homogenizing fluid, by the homogenizing fluid filling and sealing that obtains in the vial of cleaning, then use flowing steam sterilizing 30min under 100 DEG C of conditions, hot water injection, drench after doing and namely obtain this oral liquid.

Specific embodiment 2

By Radix Scutellariae 1500g, Rhizoma Coptidis 1000g, Herba Portulacae 1000g, Radix Sophorae Flavescentis 800g, Radix Pulsatillae 1000g, Rhizoma Atractylodis 1000g, Semen Coicis 2000g, Poria 1000g, Radix Puerariae 1000g, Radix Curcumae 1000g, Fructus Aurantii 1000g, Rhizoma Cyperi 1000g, Pericarpium Citri Reticulatae 1500g, Cortex Magnoliae Officinalis 1500g, Radix Notoginseng 500g, Radix Paeoniae Alba 2500g, Radix Paeoniae Rubra 1000g, Fructus Crataegi 1000g, Herba Lophatheri 1000g, Rhizoma Acori Graminei 1500g, Radix Glycyrrhizae Preparata 1000g first rinses twice, to remove dust with clear water, pesticide, fertilizer residue, put into decocting container, add the water of 3 times of crude drug quality sum, be transferred to 1 hour at a simmer after boiled with big fire, collecting decoction after decocting twice, filter, decoction liquor is concentrated into solid-liquid ratio 0.5, regulate determining alcohol to 80% after adding ethanol, dark place leaves standstill 36h, filters, reclaim ethanol, when being concentrated into 90 DEG C, relative density is the concentrated solution of 1.05, get sucrose join relative to sucrose weight 40% distilled water in, heating makes sucrose dissolve completely, make simple syrup, filter, for subsequent use, the concentrated solution obtained before 30% is got according to mass percent, the simple syrup obtained before 20% and the water of 50% add in Agitation Tank successively, stir 40min, filter, filtrate are placed in high pressure homogenizer, at 70 DEG C, carry out twice homogenization under 30MPa condition, obtain homogenizing fluid, by the homogenizing fluid filling and sealing that obtains in the vial of cleaning, then use flowing steam sterilizing 30min under 100 DEG C of conditions, hot water injection, drench after doing and namely obtain this oral liquid.

Specific embodiment 3

By Radix Scutellariae 2000g, Rhizoma Coptidis 1500g, Herba Portulacae 1500g, Radix Sophorae Flavescentis 1000g, Radix Pulsatillae 1500g, Rhizoma Atractylodis 1500g, Semen Coicis 2500g, Poria 1500g, Radix Puerariae 1500g, Radix Curcumae 1500g, Fructus Aurantii 1500g, Rhizoma Cyperi 1500g, Pericarpium Citri Reticulatae 2000g, Cortex Magnoliae Officinalis 2000g, Radix Notoginseng 1000g, Radix Paeoniae Alba 3000g, Radix Paeoniae Rubra 1500g, Fructus Crataegi 1500g, Herba Lophatheri 1500g, Rhizoma Acori Graminei 2000g, Radix Glycyrrhizae Preparata 1500g first rinses twice, to remove dust with clear water, pesticide, fertilizer residue, put into decocting container, add the water of 3 times of crude drug quality sum, be transferred to 1 hour at a simmer after boiled with big fire, collecting decoction after decocting twice, filter, decoction liquor is concentrated into solid-liquid ratio 0.5, regulate determining alcohol to 80% after adding ethanol, dark place leaves standstill 36h, filters, reclaim ethanol, when being concentrated into 90 DEG C, relative density is the concentrated solution of 1.05, get sucrose join relative to sucrose weight 40% distilled water in, heating makes sucrose dissolve completely, make simple syrup, filter, for subsequent use, the concentrated solution obtained before 30% is got according to mass percent, the simple syrup obtained before 20% and the water of 50% add in Agitation Tank successively, stir 40min, filter, filtrate are placed in high pressure homogenizer, at 70 DEG C, carry out twice homogenization under 30MPa condition, obtain homogenizing fluid, by the homogenizing fluid filling and sealing that obtains in the vial of cleaning, then use flowing steam sterilizing 30min under 100 DEG C of conditions, hot water injection, drench after doing and namely obtain this oral liquid.

Embodiment 4 the present invention treats the clinical observation research of spleen and stomach damp-heat type irritable bowel syndrome

1, case selection

Totally 236 examples, all meet diagnostic criteria in " irritable bowel syndrome combination of Chinese and Western medicine diagnosis and treatment scheme ".Chinese medical discrimination meets syndrome of dampness-heat of spleen and stomach: abdominal pain diarrhea, rushes down lower urgent or not well, burning sensation of the anus, and companion sees uncomfortable in chestly does not relax, excessive thirst taking fluids profusely, dry mouth with bitter taste, red tongue, yellow and greasy fur, slippery and rapid pulse.The eliminating age is less than 18 years old or is greater than the patient of 60 years old person and other system serious disease.

236 examples are clinical outpatient service and examine patient, are divided into matched group and treatment group with random digits table.Treatment group 120 example, male 55 people, women 65 people; 20 ~ 38 years old age, average (32.68) year; The course of disease 1 ~ 5 year, average 3.15.Matched group 116 example, man 52 example, female 64 example; 21 ~ 36 years old age, average (31.95) year; The course of disease 1 ~ 4 year, average 2.92.Two groups of sexes, age, courses of disease etc. compare there was no significant difference (P > 0.05), have comparability.

2, Therapeutic Method

The oral liquid that treatment group is prepared by the embodiment of the present invention 1, oral, 200ml/ time, 2 times/day.Matched group dicetel (Su Wei pharmaceutical manufacturing) 50mg, oral, 3 times/day.Two groups of courses for the treatment of are 4 weeks, and treatments period is stopped using other drug, and avoid pungent food plump and ice-cold food.

3 observational techniques

Symptom and sign comprises diarrhoea, abdominal distention stomachache, inappetence, borborygmus, belch, tongue pulse condition etc.According to " new Chinese medicine treats the guideline of clinical investigations of having loose bowels " Syndrome Scale quantization table, symptom degree is divided into slightly, moderate, severe 3 grades, and the integration of 3 grades is respectively 1 point, 2 points, 3 points.Terminate the biochemical analysis such as check blood, urine, stool routine and hepatic and renal function the course for the treatment of.

Statistical procedures adopts the analysis of SPSS19.0 statistical package, and enumeration data adopts X ²inspection.

4 criterions of therapeutical effect

According to " new Chinese medicine treats the guideline of clinical investigations of having loose bowels " therapeutic effect of syndrome criterion, therapeutic index=[before (before treatment the rear symptom integral of symptom integral-treatment)/treatment symptom integral] * 100%.Recovery from illness: therapeutic index >=95%; Effective: 70%≤therapeutic index < 95%; Effective: 30%≤therapeutic index < 70%; Invalid: therapeutic index < 30%.

5 therapeutic outcomes

Two groups of Clinical efficacy comparisons, the results are shown in Table 1.

Table 1 liang group Clinical efficacy comparison

Group	n	Recovery from illness	Effective	Effectively	Invalid	Total effective rate
							Treatment group	120	73	29	14	4	96.67％
Matched group	116	35	46	19	16	86.21％

Table 1 can be found out, treatment group total effective rate is better than matched group.By clinical application, before after treatment group medication, clinical symptoms total mark is starkly lower than medication, clinical symptoms is improved significantly.By summing up a point statistical analysis to two groups, two groups have significant difference.Treatment group is better than matched group.Having no obvious adverse reaction after two groups of patient treatments, all there is not abnormal change in blood, routine urinalysis and biochemical indicator.

Embodiment 5 pharmacological toxicity is tested

1, experiment material:

Laboratory animal: SPF level NIH mice 60,18 ~ 22g, male and female half and half, are provided by shanghai Medicine Experimental Animal Center, and check and affirm word 2015A018, animal quality quality certification N for Experimental Establishment quality certification SCXK (Shanghai) 2015-0013, Shanghai ₀0037518.This experiment feeding environment is SPF level Animal Lab., facility occupancy permit SYXK (Shanghai) 2015-0052.

Test medicine

1, medicine of the present invention: the oral liquid that embodiment 1 is made: 3 times/day, be mixed with high concentration medicinal liquid with deionized water, graduated cylinder measures, and is 592.5mL, and calculating crude drug concentration is 0.7324g/ml.

2, blank group: gavage deionized water, all the other conditions are with medicine group of the present invention.

Experimental technique

Get SPF level NIH mice 60, male and female half and half, under experimental situation, adaptability raises 3d, is divided into 2 groups at random, is respectively matched group 24, oral liquid group of the present invention 36, male and female half and half, male and female sub-cage rearing.Before experiment, water 8h is can't help in the fasting of each group mice, weighs in after fasting, matched group with 3 times/day of gavage distilled water 40mL/kg, oral liquid group mice of the present invention 3 times/day of gavages oral liquid 0.7324g/ml of the present invention, dosing interval 4h.The free diet of mice is recovered, simultaneously observed and recorded mice response situation after administration.After administration 24h, the upper and lower noon respectively observes 1 time every day, Continuous Observation 14d, and 7d, 14d claim each group of Mouse Weight 1 time after administration.Viewing duration, if any dead mouse, then carry out immediately cuing open inspection, administration 14d, not dead mice is all put to death and cuts open inspection

Result of the test

(1) general state is observed

Control group mice 3 times/day, gavage gives steaming and sautes water 40mL/kg, and 24 mice behaviors are observed all normal, 14d viewing duration, and mice is all movable normal, and behavior is active, and hair is smooth, and Excreta is without exception, and drinking-water of ingesting is all normal, and mice is without death.

Oral liquid group mice 3 times/day of the present invention, gavage oral liquid 0.7324g/ml of the present invention, by body weight 40mL/kg administration, 11 mice activities reduce (one-level), quiet.After administration 24h, mice behavioral activity recovers normal, without dead.Continuous Observation 14d, mice behavioral activity Non Apparent Abnormality phenomenon, each natural vestibule secretions without exception, drinking-water of ingesting is all normal, and urine feces is normal, and mice is without death.

(2) body weight

With matched group with compared with sex Mouse Weight, before administration two groups all basically identical with sex Mouse Weight, no significant difference (P > 0.05); After administration 7d two groups with sex Mouse Weight, no significant difference (P > 0.05); After administration 14d two groups with sex Mouse Weight numerical value, there was no significant difference (P > 0.05).

(3) inspection is cutd open

Viewing duration is without dead mouse, and therefore empirically requirement, when observing 14d, puts to death all mices, carry out cuing open inspection.The MAIN OUTCOME MEASURES such as outward appearance sign, main organs of the visible two groups of mices of perusal is basically identical, each natural animal vestibule, by hair and outward appearance sign no abnormality seen.Natural vestibule secretions without exception.Main organs arrangement is normal, and without hydrops, without adhesion, secretions without exception, shows no obvious abnormalities.Respectively organize internal organs perusal smooth surface, chromaticness is normal, and Non Apparent Abnormality changes.

Conclusion

It is generally acknowledged maximum tolerated dose be equivalent to the clinical daily dosage more than 100 times of people and animal without death, when occurring without overt toxicity response situation, this medicine is safe.The clinical plan consumption of oral liquid of the present invention is 15.624g crude drug/day, and calculate according to mice maximum tolerated dose 87.888g crude drug/kg, the daily intaking amount being converted to clinical people is 676.062g/kg, and this dosis tolerata is 337.51 times of the clinical plan consumption of capsule of the present invention.Therefore, can affirm, the application of this clinical drug is safe.

Rat chronic toxicity test of the present invention

1, experiment material

Test medicine with make up a prescription

The oral liquid that the invention process is made, gavage, 3 times/day, being configured to crude drug concentration is 1.302g/ml, and 4 DEG C save backup, and take in total amount every day and are equivalent to 15.624g/ml, and medicine is prepared by Shanghai Univ. of Traditional Chinese Medicine Drug Manufacturing Room.

(2) laboratory animal

SPF level SD rat, in 6 ~ 7 week age, male and female half and half, are provided by shanghai Medicine Experimental Animal Center, and check and affirm word 2015A018, Quality of Experimental Animals quality certification N20100055 for Experimental Establishment quality certification SCXK (Shanghai) 2015-0013, Shanghai; Zoopery environment: SPF level Animal Lab., this experiment feeding environment is SPF level Animal Lab., facility occupancy permit SYXK (Shanghai) 2015-0052.

(3) experimental technique

(1) grouping and route of administration

6 ~ 7 week age SPF level SD rat 80, male and female half and half, are divided into dosage group, oral liquid low dose group of the present invention in matched group, oral liquid high dose group of the present invention, oral liquid of the present invention at random by body weight, corresponding dosage is 15.624g/kg/d, 7.812g/kg/d, 3.906g/kg/d

Each administration group according to dosage gastric infusion 20mL/kg, matched group gives distilled water 20mL/kg with method gavage, and test adopts gastric infusion, and route of administration is consistent with clinical oral administration route of administration.

(2) medication

Oral liquid of the present invention each dosage group administration 1 times/day, empirically require gastric infusion, by volume 20mL/kg respectively when the morning 8, blank group gavage deionized water, by 20mL/kg gavage.Claim 1 body weight weekly, and according to body weight adjustment dosage, drug withdrawal after successive administration 6 weeks (clinical application 1 course for the treatment of be 7 ~ 14 days), the recovery observation period is after drug withdrawal 2 weeks.

(4) experimental result

Rat oral gavage gives oral liquid high dose 15.624g/kg/d of the present invention, (clinical adult intends with dosage 60.00 times), dosage 7.812g/kg/d in oral liquid of the present invention, (clinical adult intends with dosage 30.00 times), oral liquid low dosage 3.906g/kg/d of the present invention, (clinical adult intends with dosage 15.00 times), 1 times/day, after successive administration 6 weeks with the more every Testing index of matched group as general state, body weight, food-intake, amount of drinking water, urine, hematology, blood biochemical analysis, organ coefficient and histopathology etc., have no obvious toxicity sensitive indicator and toxicity target organ, after drug withdrawal recovers 2 weeks, the every Testing index of oral liquid of the present invention high, medium and low dosage group rat all belongs to normal, has no oral liquid of the present invention and produces Delayed onset toxic reaction and cumulative toxicity reaction.Result of the test illustrates oral liquid prolonged application of the present invention to rat without obvious toxic-side effects, clinical adult's plan dosage and be in safety range the course for the treatment of.

Embodiment 6 oral liquid of the present invention is on the impact of diarrhea type irritable bowel syndrome rat model

1. modeling and grouping

This experiment rat model of irritable bowel syndrome forms with transformation on acetic acid-balloon expandable method modeling basis.Get SD rat 70, male and female half and half, body weight 180 ~ 220g: blank group 10, model group 60.Modeling method: 1 times/day, the morning 9 point, Rat-rectum injects 0.5% acetic acid 1.0ml, injects 14d continuously, causes acetic acid inflammatory damage.Recover 7d, 28d to start to carry out balloon expandable, fasting 8h before balloon expandable.Under rat waking state, insert 3-4cm with homemade sacculus per anum, in sacculus, water filling makes it expansion, water injection rate 0.5ml, and each stimulation continues 1min, stimulates 2 every day, interval 30min, continued stimulus 14d.Occur that the loose stool of continous-stable is modeling success.Random packet, model control group 10, berberine hydrochloride group 10, compound recipe glutamic acid group 10, oral liquid high dose group of the present invention 10, dosage group 10 in oral liquid of the present invention, oral liquid low dose group of the present invention 10.

2. administration and dosage

Each administration group according to dosage gastric infusion, berberine hydrochloride group dosage is 81.00mg medicated powder/kg, compound glutamine Capsules group dosage is 0.81/kg, and the high, medium and low dosage of oral liquid of the present invention is respectively 2.812g crude drug/kg, 1.406g crude drug/kg, 0.703g crude drug/kg.Administration volume is 10mL/kg, 1 times/day, continuous 14d, and blank group, model control group same way gavage give distilled water 10mL/kg, and meanwhile, except Normal group, all the other each modeling groups are with the modeling of foregoing continuous balloon expandable.

(1) compared with Normal group, model control group rat (male, female) body weight all significantly alleviates (P < 0.01); Compare with model control group, oral liquid of the present invention high, normal, basic 3 dosage group male rats, female rats weight averages significantly increase (P < 0.05); Compare with berberine hydrochloride group, compound glutamine Capsules group, male, the female rats tuple value of oral liquid of the present invention each dosage group and positive controls zero difference after administration, but average is all higher than two matched groups (P > 0.05).

Table 2 the present invention on male rat body weight impact (g) ( n=5)

Note: 1. berberine hydrochloride group dosage unit is g medicated powder .kg ^-1, compound glutamine group dosage unit is grain .kg ^-1, treatment group dosage unit is g crude drug .kg ^-1, compared with Normal group, ^*p < 0.01, compared with model control group, ^#p < 0.05, ^##p < 0.01

Table 3 the present invention to female rats ghost image ring (g) ( n=5)

(2) compared with Normal group, model control group rat kind just weight in wet base obviously increases (P < 0.01), and class just water content significantly raises (P < 0.01).Compare with model control group, high, normal, basic 3 the dosage group rat feces weight in wet bases of capsule of the present invention significantly reduce (P < 0.01), and feces water content significantly reduces (P < 0.01); Compared with two positive controls, capsule of the present invention each dosage group rat Ji is weight in wet base, feces water content there are no significant difference (P > 0.05) just.Capsule of the present invention significantly reduces irritable bowel syndrome in rats stool weight in wet base and feces water content, and has pronounced amount effect relationship.

The present invention on the impact of rat feces water content ( n=10)

Note: 1. berberine hydrochloride group dosage unit is g medicated powder .kg ^-1, compound glutamine group dosage unit is grain .kg ^-1, treatment group dosage unit is g crude drug .k ^-1, compared with Normal group, ^*p < 0.01, compared with model control group, ^##p < 0.01

(3) compared with Normal group, model control group rat SS, vasoactive peptide content all significantly raise (P < 0.01).Compare with model control group, capsule of the present invention high, normal, basic 3 dosage group rat SS SS, vasoactive intestinal peptide VIP content all significantly reduce (P < 0.01); Compare with two positive drug control groups, capsule of the present invention each dosage group rat SS, vasoactive intestinal peptide numerical value no difference of science of statistics (P > 0.05).

The present invention on the impact of rat SS SS, blood vessel living-article intestinal peptide VIP ( n=10)

Note: 1. berberine hydrochloride group dosage unit is g medicated powder .kg ^-1, compound glutamine group dosage unit is grain .kg ^-1, treatment group dosage unit is g crude drug .kg ^-1, compared with Normal group, ^*p < 0.01, compared with model control group, ^##p < 0.01

(4) oral liquid of the present invention is on the impact of irritable bowel syndrome in rats rectum morphosis

Blank group, model control group group rectum form microexamination (under light microscopic): epithelial cell marshalling under blank group Rat-rectum section light microscopic, mucosa is complete, tela submucosa has no hemorrhage, fibre modification, inflammatory cell ooze out, the interior visible size of intestinal wall is comparatively consistent, the lymph node of clear in structure, intestinal wall smooth muscle can be divided into two-layer, vertical shape flesh and circular muscle are demarcated clear, contractile fiber cells has no fracture, fibrosis, degeneration, necrosis, swelling, pyknosis, Lay film is complete to be shown no obvious abnormalities, without inflammatory cell infiltration.

See that epithelial cell arrangement is not whole under model control group Rat-rectum section light microscopic, goblet cell significantly reduces, Mild edema under mucosa, massive inflammatory cells infiltrated, and vertical shape flesh and circular muscle are demarcated unclear, and aphtha focus appears in local.

Oral liquid group each dosage group of the present invention and two positive drug group Rat-rectums section light microscopic under basically identical with Normal group, mucosa form is intact, epithelial cell marshalling, the nearly normal condition of goblet cell showed increased, without obvious edema or inflammatory cell infiltration phenomenon, morphosis has no obvious pathological change.

3. result

Oral liquid of the present invention experimental studies have found that irritable bowel syndrome; there is certain therapeutic effect; to rat, there is antidiarrheal, analgesic effect; protective effect is had to intestinal; its every day dosage and be all in safety range the course for the treatment of; overall merit its have therapeutical effect to irritable bowel syndrome, and effectively improve simultaneous phenomenon, be applicable to clinical expansion.

All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.

The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims

1. treat the medicine of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome for one kind, it is characterized in that: crude drug comprises Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, the Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Graminei, Radix Glycyrrhizae Preparata.

2. the medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome as claimed in claim 1, it is characterized in that: the weight portion of each crude drug is respectively Radix Scutellariae 10 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 20 parts, Radix Sophorae Flavescentis 6 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 30 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 20 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 20 parts, Herba Lophatheri 10 ~ 20 parts, Rhizoma Acori Graminei 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

3. the medicine for the treatment of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome as claimed in claim 1 or 2, it is characterized in that: the weight portion of each crude drug is respectively Radix Scutellariae 15 ~ 20 parts, Rhizoma Coptidis 10 ~ 15 parts, Herba Portulacae 10 ~ 15 parts, Radix Sophorae Flavescentis 8 ~ 10 parts, the Radix Pulsatillae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Semen Coicis 20 ~ 25 parts, 10 ~ 15 parts, Poria, Radix Puerariae 10 ~ 15 parts, Radix Curcumae 10 ~ 15 parts, Fructus Aurantii 10 ~ 15 parts, Rhizoma Cyperi 10 ~ 15 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, Radix Notoginseng 5 ~ 10 parts, the Radix Paeoniae Alba 25 ~ 30 parts, Radix Paeoniae Rubra 10 ~ 15 parts, Fructus Crataegi 10 ~ 15 parts, Herba Lophatheri 10 ~ 15 parts, Rhizoma Acori Graminei 15 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

4. the medicine of the treatment damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome as described in claims 1 to 3, it is characterized in that: the weight portion of each crude drug is respectively Radix Scutellariae 20 parts, Rhizoma Coptidis 15 parts, Herba Portulacae 15 parts, Radix Sophorae Flavescentis 10 parts, the Radix Pulsatillae 10 parts, Rhizoma Atractylodis 10 parts, Semen Coicis 20 parts, 10 parts, Poria, Radix Puerariae 15 parts, Radix Curcumae 15 parts, Fructus Aurantii 15 parts, Rhizoma Cyperi 10 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, Radix Notoginseng 10 parts, the Radix Paeoniae Alba 25 parts, Radix Paeoniae Rubra 15 parts, Fructus Crataegi 15 parts, Herba Lophatheri 15 parts, Rhizoma Acori Graminei 15 parts, Radix Glycyrrhizae Preparata 10 parts.

5. the medicine of the treatment damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome as described in Claims 1-4, it is characterized in that: described medicine routinely technique adds adjuvant and makes tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill or oral liquid, and described adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and substrate.

6. the medicine of the treatment damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome as described in claim 1 to 5, is characterized in that: the dosage form of described medicine is oral liquid.

7. Chinese medicine described in claim 1 to 6 is as the preparation method of oral liquid, it is characterized in that, comprising:

8. one kind is used for the treatment of the oral liquid of damp-heat in the spleen and stomach pattern of syndrome irritable bowel syndrome, it is characterized in that: crude drug comprises Radix Scutellariae, Rhizoma Coptidis, Herba Portulacae, Radix Sophorae Flavescentis, the Radix Pulsatillae, Rhizoma Atractylodis, Semen Coicis, Poria, Radix Puerariae, Radix Curcumae, Fructus Aurantii, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Crataegi, Herba Lophatheri, Rhizoma Acori Graminei, Radix Glycyrrhizae Preparata;

The preparation method of described oral liquid specifically comprises,