CN105288054A

CN105288054A - Medicament for treatment of spleen-kidney yang deficiency syndrome type irritable bowel syndrome

Info

Publication number: CN105288054A
Application number: CN201510875501.9A
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: 2016-02-03

Abstract

The invention provides a medicament for the treatment of spleen-kidney yang deficiency syndrome type irritable bowel syndrome, which comprises the following herbal materials: atragalus membranaceus, cdonopsis pilosula, stir-baked rhizoma dioscoreae, stir-baked white lablab bean, roasted rhizoma atractylodis macrocephalae, rhizoma atractylodis, pria cocos, rhizoma cimicifugae, radix puerariae, pericarpium citri reticulatae, magnolia officinalis, radix linderae, medicinal indianmulberry root, common fenugreek seed, desertliving cistanche, cassia bark, radix aconiti carmichaeli, radix glehniae, shisandra chinensis, semen euryales, herba portulacae, and radix glycyrrhizae preparata. Based on the TCM syndrome differentiation of the spleen-kidney yang deficiency syndrome type irritable bowel syndrome, in combination with the clinical manifestation of patients, and through the cmpatibility of prescription, the medicament achieves the effects of tonifying the spleen and the kidney, as well as regulating qi, inducing astringency and promoting salivation. Through treatment implemented by using the medicament, the medicament has a good therapeutic effect on the clinical symptoms and life quality of patients with spleen-kidney yang deficiency syndrome type irritable bowel syndrome; and the recurrence of the disease is significantly reduced, and then the occurrence of anxiety and depression is reduced.

Description

The medicine for the treatment of deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG 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.

Onset of irritable bowel syndrome 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 deficiency of spleen-YANG and kidneyYANG.

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.

Yang deficiency of spleen and stomache irritable bowel syndrome major lesions is that liver spleen kidney three is dirty, and yang deficiency of spleen and stomache is many to be transformed by due to weakness of spleen and stomach and liver-depression and spleen-insufficiency type.Because of its asthenia of both the spleen and kidney, the suitable reinforce spleen and kidney together for the treatment of, warming middle-JIAO is supporing yang, will note " treating YANG within YIN " during YANG invigorating, YANG invigorating on the basis of nourishing YIN, particularly to yang deficiency the moon also not enough person, more wants tonifying both YIN and YANG.This type of patient's course of disease is long, does not often for years on endly heal, and how effective medication is, and namely drug withdrawal recurs, and the key for the treatment of is consolidate curative effect.Form good living habit, give up tobacco and wine, keep a diet, careful food is rich, raw and cold, pungent etc. to gastrointestinal food excitatory, overcomes the unhealthy emotion such as anxiety, anxiety necessary.So the chronic diarrhea controlling this type of pattern of syndrome from spleen kidney opinion is the rule for the treatment of that effects a permanent cure, medical treatment warming and recuperating the spleen and kidney, hold concurrently to adjust liver, all diseases are all separated.

For yang deficiency of spleen and stomache irritable bowel syndrome patients, Epidemiological study finds, primary disease principal pathogenetic crowd is old people, prolonged illness, severe case, its primary disease is positive QI-insufficiency, deficiency of spleen-YANG and kidneyYANG, the prescription thinking of we and warming and recuperating the spleen and kidney, hold concurrently to regulate the flow of vital energy, astringent or styptic treatment for spontaneous sweating, raw Feng.

The present invention for deficiency of spleen-YANG and kidneyYANG 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, doctor trained in Western medicine is not yet clear and definite for the etiology and pathogenesis of this disease, and 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, 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 deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG pattern of syndrome irritable bowel syndrome, its crude drug comprises: the Radix Astragali, Radix Codonopsis, Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Atractylodis, Poria, Rhizoma Cimicifugae, Radix Puerariae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Linderae, Radix Morindae Officinalis, Semen Trigonellae, Herba Cistanches, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Glehniae, Fructus Schisandrae Chinensis, Semen Euryales, Herba Portulacae, Radix Glycyrrhizae Preparata.

Wherein, in described medicine, the weight portion of each crude drug is respectively the Radix Astragali 20 ~ 40 parts, Radix Codonopsis 20 ~ 40 parts, Rhizoma dioscoreae (parched) 20 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 20 parts, Rhizoma Atractylodis Macrocephalae (parched) 20 ~ 30 parts, Rhizoma Atractylodis 10 ~ 20 parts, 10 ~ 20 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 10 ~ 20 parts, Pericarpium Citri Reticulatae 10 ~ 20 parts, Cortex Magnoliae Officinalis 10 ~ 20 parts, the Radix Linderae 10 ~ 20 parts, Radix Morindae Officinalis 10 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 10 ~ 20 parts, Cortex Cinnamomi 10 ~ 20 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 10 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 10 ~ 20 parts, Herba Portulacae 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Wherein, in described medicine, the weight portion of each crude drug is respectively the Radix Astragali 30 ~ 35 parts, Radix Codonopsis 30 ~ 35 parts, Rhizoma dioscoreae (parched) 25 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 ~ 30 parts, Rhizoma Atractylodis 10 ~ 15 parts, 10 ~ 15 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 15 ~ 20 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, the Radix Linderae 10 ~ 15 parts, Radix Morindae Officinalis 15 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 15 ~ 20 parts, Cortex Cinnamomi 10 ~ 15 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 15 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 15 ~ 20 parts, Herba Portulacae 10 ~ 15 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Wherein, in described medicine, the weight portion of each crude drug is respectively the Radix Astragali 30 parts, Radix Codonopsis 30 parts, Rhizoma dioscoreae (parched) 25 parts, Semen Lablab Album (parched) 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 parts, Rhizoma Atractylodis 10 parts, 10 parts, Poria, Rhizoma Cimicifugae 10 parts, Radix Puerariae 20 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, the Radix Linderae 10 parts, Radix Morindae Officinalis 20 parts, Semen Trigonellae 10 parts, Herba Cistanches 20 parts, Cortex Cinnamomi 15 parts, Radix Aconiti Lateralis Preparata 10 parts, Radix Glehniae 20 parts, Fructus Schisandrae Chinensis 15 parts, Semen Euryales 20 parts, Herba Portulacae 15 parts, Radix Glycyrrhizae Preparata 15 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 deficiency of spleen-YANG and kidneyYANG pattern of syndrome irritable bowel syndrome, its crude drug comprises the Radix Astragali, Radix Codonopsis, Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Atractylodis, Poria, Rhizoma Cimicifugae, Radix Puerariae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Linderae, Radix Morindae Officinalis, Semen Trigonellae, Herba Cistanches, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Glehniae, Fructus Schisandrae Chinensis, Semen Euryales, Herba Portulacae, 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 deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG pattern of syndrome irritable bowel syndrome, its crude drug comprises: the Radix Astragali, Radix Codonopsis, Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Atractylodis, Poria, Rhizoma Cimicifugae, Radix Puerariae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Linderae, Radix Morindae Officinalis, Semen Trigonellae, Herba Cistanches, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Glehniae, Fructus Schisandrae Chinensis, Semen Euryales, Herba Portulacae, 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 the Radix Astragali 20 ~ 40 parts, Radix Codonopsis 20 ~ 40 parts, Rhizoma dioscoreae (parched) 20 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 20 parts, Rhizoma Atractylodis Macrocephalae (parched) 20 ~ 30 parts, Rhizoma Atractylodis 10 ~ 20 parts, 10 ~ 20 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 10 ~ 20 parts, Pericarpium Citri Reticulatae 10 ~ 20 parts, Cortex Magnoliae Officinalis 10 ~ 20 parts, the Radix Linderae 10 ~ 20 parts, Radix Morindae Officinalis 10 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 10 ~ 20 parts, Cortex Cinnamomi 10 ~ 20 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 10 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 10 ~ 20 parts, Herba Portulacae 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Further preferably, in described medicine, the weight portion of each crude drug is respectively the Radix Astragali 30 ~ 35 parts, Radix Codonopsis 30 ~ 35 parts, Rhizoma dioscoreae (parched) 25 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 ~ 30 parts, Rhizoma Atractylodis 10 ~ 15 parts, 10 ~ 15 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 15 ~ 20 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, the Radix Linderae 10 ~ 15 parts, Radix Morindae Officinalis 15 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 15 ~ 20 parts, Cortex Cinnamomi 10 ~ 15 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 15 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 15 ~ 20 parts, Herba Portulacae 10 ~ 15 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

Most preferably, in described medicine, the weight portion of each crude drug is respectively the Radix Astragali 30 parts, Radix Codonopsis 30 parts, Rhizoma dioscoreae (parched) 25 parts, Semen Lablab Album (parched) 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 parts, Rhizoma Atractylodis 10 parts, 10 parts, Poria, Rhizoma Cimicifugae 10 parts, Radix Puerariae 20 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, the Radix Linderae 10 parts, Radix Morindae Officinalis 20 parts, Semen Trigonellae 10 parts, Herba Cistanches 20 parts, Cortex Cinnamomi 15 parts, Radix Aconiti Lateralis Preparata 10 parts, Radix Glehniae 20 parts, Fructus Schisandrae Chinensis 15 parts, Semen Euryales 20 parts, Herba Portulacae 15 parts, Radix Glycyrrhizae Preparata 15 parts.

For yang deficiency of spleen and stomache irritable bowel syndrome patients, Epidemiological study finds, primary disease principal pathogenetic crowd is old people, prolonged illness, severe case, its primary disease is positive QI-insufficiency, deficiency of spleen-YANG and kidneyYANG, the prescription thinking of we and warming and recuperating the spleen and kidney, hold concurrently to regulate the flow of vital energy, astringent or styptic treatment for spontaneous sweating, raw Feng, therefore we reuse the Radix Astragali, Radix Codonopsis, Radix Aconiti Lateralis Preparata are monarch drug group, warming and recuperating the spleen and kidney, kidney behaviour body nephroyin and nephroyang is basic, kidney yang one temperature, then warm whole body, The spleen has the function to transport and transform nutrients, and spleen sun one shakes, then whole body fortune.The medicines such as Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), the Radix Linderae, Radix Morindae Officinalis, the power of principal drug assistance, with warming and recuperating the spleen and kidney, be ministerial drug group, how long primary disease morbidity patient lets out impairment of YIN, therefore add Radix Puerariae, Fructus Schisandrae Chinensis, the raw Feng of Radix Glehniae yin fluid astringing, to recover cloudy liquid, be adjuvant drug group, Cortex Cinnamomi guiding fire to origin, for guiding drug, make medicine.Comprehensive we, the raw Feng of warming and recuperating the spleen and kidney, yin fluid astringing, has good therapeutical effect for old people, prolonged illness severe case.

Each crude drug pharmacology is as follows:

The Radix Astragali: latin name astragaliradix, sweet in the mouth, warm in nature, enter spleen, lung meridian, there is tonification spleen soil, elevate a turnable ladder yang-energy, strengthening superficial resistance to stop perspiration, the effects such as holder skin ulcer granulation promoting, are mainly used in the weak anorexia and loose stool that deficiency of both the splenic and pulmonary QI is caused, shortness of breath and palpitation, the visceroptosis of sinking of QI of middle-JIAO, the metrorrhagia of QI failing to control blood is had blood in stool, chronic diarrhea proctoptosis; The spontaneous sweating of exterior deficiency, the cards such as insufficiency of vital energy and blood.

Radix Codonopsis: sweet in the mouth, property is put down, and returns lung, spleen channel, has QI invigorating strengthening the spleen, the symptoms such as nourish blood effect of raw Feng, cures mainly the fatigue and weakness of deficiency of both the splenic and pulmonary QI or QI and blood deficiency, breathes hard, cough spontaneous perspiration, spleen reinforcing nourishing the stomach is longer than by Radix Codonopsis, adjust regulating the function of middle-JIAO, have the effect of nourishing blood concurrently, its property put down, spleen invigorating fortune and not dry; Flavour is cloudy and do not wet, and can improve the immune state of body, improves resistance against diseases, and facilitating digestion absorbs, and improves metabolism, promotes that intestinal is to the absorption of nutrient substance.

Rhizoma dioscoreae (parched): latin name dioscoreaerhizoma, sweet in the mouth, property is put down, enter lung, spleen, kidney channel, there is strengthening the spleen and tonifying the lung, stomach reinforcing the kidney invigorating, benefit of reinforcing the kidney essence, hearing-improing and eyesight improving, help the five internal organs, bone and muscle strengthening, long will are calmed the nerves, effect of life lengthening, cure mainly that weakness of the spleen and stomach, lassitude, inappetence, chronic diarrhea and dysentery, insufficiency of lung-QI are dry, phlegm dyspnea cough, kidney qi loss, soreness of the waist and knees, lower limb flaccidity be weak, the red card such as swollen, fat of frequent micturition of quenching one's thirst, premature ejaculation of passing out semen, leukorrhagia nebulousurine, skin.

Semen Lablab Album (parched): sweet in the mouth, slightly warm in nature, enters spleen, stomach warp, have invigorating the spleen for eliminating dampness and in the effect of relieving summer heat, for the indigestion and loss of appetite abdominal distention of weakness of the spleen and stomach, loose stool, aqueous-grainy diarrhea, the cards such as vomiting of feeling sick.

Rhizoma Atractylodis Macrocephalae (parched): latin name atractylodismacrocephalaerhizoma, sweet in the mouth, hardship, warm in nature, enter spleen, stomach warp, there is spleen reinforcing promoting the circulation of QI, dampness diuretic, strengthening superficial resistance to stop perspiration, the effect that activating the spleen is moisturized, is mainly used in the feeling of fullness diarrhoea that dysfunction of the spleen in transportation, QI failing to transform into body fluid are caused, phlegm retention edema; The vexed lazyness speech of deficiency of QI in middle-JIAO, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, sweating due to debility spontaneous perspiration.

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.

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.

Rhizoma Cimicifugae: acrid in the mouth, micro-sweet, cold nature, enters lung, spleen, stomach, large intestine channel, has and deliver rash, heat-clearing and toxic substances removing, effect of elevate a turnable ladder yang-energy.For headache due to pathogenic wind-heat, toothache, aphtha, laryngopharynx swelling and pain, measles without adequate eruption, YANG toxin syndrome sends out speckle; Proctoptosis, the cards such as uterine prolapse.

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.

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.

The Radix Linderae: acrid in the mouth, warm in nature, enter lung, spleen, kidney, urinary bladder channel, have promoting the circulation of QI to relieve pain, effect of warming kidney for dispelling cold, vexed for fullness in the chest and hypochondrium, abdominal distention, headache, the colic of cold type pain caused by QI stagnated by cold, abdominal pain during menstruation and puerperal abdonimal pain, lower first deficiency and coldness, the frequent micturition of failure in functioning of QI, the card such as the enuresis or dysuria.

Radix Morindae Officinalis: latin name MorindaeOfficinalisRadix, acrid in the mouth, sweet, slightly warm in nature, enter liver, kidney channel, there is effect of kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, for impotence due to deficiency of the kidney, seminal emission premature ejaculation, few abdomen cold type of pain, cold womb is infertile, the cards such as the muscles and bones flaccidity caused by deficiency of the liver and kindey is soft, chills and pain of the waist and kness.

Semen Trigonellae: warm in nature, bitter in the mouth, has kidney-replenishing, and effect of dispelling cold and dampness, cures mainly colic of cold type, abdomen side of body distension, the disturbance of lower legs due to pathogenic cold and dampness, the cards such as the soreness of waist, sexual impotence of suffering from a deficiency of the kidney.

Herba Cistanches: be the fleshy stem of Orobanchaceae Cistanche Hoffmgg. et Link plants Herba Cistanches and Cistanche Tubulosa, latin name herbacistanches is sweet in the mouth, salty, warm in nature, enter kidney, large intestine channel, have kidney-replenishing, benefiting essence-blood, the effect of loosening bowel to relieve constipation, for kidney yang deficiency, the impotence and premature ejaculation of asthenia of essence and blood, sterility and infertility, soreness of waist and knee joint, Hiccough and deaf, frequent micturition urine number, suffer from a deficiency of the kidney dryness of the intestine and puerperal blood deficiency, Feng liquid deficiency after being ill the card such as constipation.

Cortex Cinnamomi: extremely hot in nature, acrid in the mouth, sweet, return kidney, spleen, the heart, Liver Channel, have that to mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, effect of promoting blood circulation to restore menstrual flow, for warming the spleen and stomach, removing accumulated cold, promoting blood circulation.Control decline of the fire from the gate of life, cold extremities faint pulse, YANG-depletion is collapsed, and stomachache is had loose bowels, colic of cold type renal mass, chills and pain of the waist and kness, amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun is more floating, the cards such as heat in the upper and cold in the lower.

Radix Aconiti Lateralis Preparata: acrid in the mouth, sweet, extremely hot in nature, enter the heart, kidney, spleen channel, have recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, dispelling cold by warming the meridian, the effect of removing damp and stopping pain, for excessive YIN keeping YANG externally, loss of YANG due to profuse perspiration, vomiting and diarrhoea is fainted inverse, cold extremities faint pulse, trusted subordinate's cold type of pain, cold-dysentery, beriberi edema, anemofrigid-damp arthralgia, sexual impotence, cold womb, deficiency and coldness is vomited and diarrhoea, YIN-cold edema, yang deficiency diseases caused by exogenous pathogenic factor, the cards such as the disease of carbuncle of yin nature skin infection and all chronic diseaseses.

Radix Glehniae: cold nature, sweet in the mouth, micro-hardship, have nourishing YIN and clearing away lung-heat, effect of the raw Feng of stomach reinforcing, cures mainly the cards such as lung-heat type cough, chronic cough expectorant blood, calentura Feng wound be thirsty.

Fructus Schisandrae Chinensis: warm in nature, sour in the mouth, sweet, return lung, the heart, kidney channel, there is convergence astringent or styptic treatment for spontaneous sweating, the raw Feng of QI invigorating, effect of kidney calming, for chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Feng wound is thirsty, deficient pulse of losing heart, the cards such as interior-heat is quenched one's thirst, palpitation and insomnia.

Semen Euryales: sweet in the mouth, puckery, property is put down.Return spleen, kidney channel.Have supplementing the kidney to control the nocturnal, spleen reinforcing antidiarrheal, the function of damp eliminating leukorrhagia stopping, cures mainly emission, diarrhea due to hypofunction of the spleen, and insufficiency of the spleen nebulousurine is with inferior card.

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 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 Astragali 3000g, Radix Codonopsis 3000g, Rhizoma dioscoreae (parched) 2500g, Semen Lablab Album (parched) 1500g, Rhizoma Atractylodis Macrocephalae (parched) 2500g, Rhizoma Atractylodis 1000g, Poria 1000g, Rhizoma Cimicifugae 1000g, Radix Puerariae 2000g, Pericarpium Citri Reticulatae 2000g, Cortex Magnoliae Officinalis 2000g, Radix Linderae 1000g, Radix Morindae Officinalis 2000g, Semen Trigonellae 1000g, Herba Cistanches 2000g, Cortex Cinnamomi 1500g, Radix Aconiti Lateralis Preparata 1000g, Radix Glehniae 2000g, Fructus Schisandrae Chinensis 1500g, Semen Euryales 2000g, Herba Portulacae 1500g, 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.

Specific embodiment 2

By Radix Astragali 3300g, Radix Codonopsis 3200g, Rhizoma dioscoreae (parched) 2800g, Semen Lablab Album (parched) 1200g, Rhizoma Atractylodis Macrocephalae (parched) 2800g, Rhizoma Atractylodis 1300g, Poria 1200g, Rhizoma Cimicifugae 800g, Radix Puerariae 1700g, Pericarpium Citri Reticulatae 1800g, Cortex Magnoliae Officinalis 1800g, Radix Linderae 1200g, Radix Morindae Officinalis 1800g, Semen Trigonellae 1200g, Herba Cistanches 1800g, Cortex Cinnamomi 1300g, Radix Aconiti Lateralis Preparata 1200g, Radix Glehniae 1800g, Fructus Schisandrae Chinensis 1300g, Semen Euryales 1700g, Herba Portulacae 1200g, Radix Glycyrrhizae Preparata 1300g 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 Astragali 3500g, Radix Codonopsis 3500g, Rhizoma dioscoreae (parched) 2500g, Semen Lablab Album (parched) 1000g, Rhizoma Atractylodis Macrocephalae (parched) 2500g, Rhizoma Atractylodis 1500g, Poria 1000g, Rhizoma Cimicifugae 500g, Radix Puerariae 1500g, Pericarpium Citri Reticulatae 2000g, Cortex Magnoliae Officinalis 2000g, Radix Linderae 1000g, Radix Morindae Officinalis 2000g, Semen Trigonellae 1000g, Herba Cistanches 2000g, Cortex Cinnamomi 1500g, Radix Aconiti Lateralis Preparata 1000g, Radix Glehniae 2000g, Fructus Schisandrae Chinensis 1500g, Semen Euryales 2000g, Herba Portulacae 1000g, 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 yang deficiency of spleen and stomache irritable bowel syndrome

1, case selection

Totally 153 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 yang deficiency of spleen and kidney: abdominal part cold type of pain, obtains warm slightly easypro, and chronic diarrhea is not healed or diarrhea before dawn, and rare clearly or aqueous-grainy diarrhea of defecating, aversion to cold and cold limbs, soreness of the waist and knees, lack of appetite poor appetite, Mian Se Koushi is white.Pale tongue is fat, white, slippery and moist fur, deep-slow 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.

153 examples are clinical outpatient service and examine patient, are divided into matched group and treatment group with random digits table.Treatment group 83 example, male 46 people, women 37 people; 50 ~ 66 years old age, average (59.33) year; The course of disease 1 ~ 7 year, average 3.82.Matched group 70 example, man 40 example, female 30 example; 49 ~ 63 years old age, average (57.72) year; The course of disease 1 ~ 6 year, average 3.51.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 measurement data adopts x ± s to represent, compares employing paired-sample t test, compare employing two groups of independent samples t test between two groups before and after treatment, 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	83	55	18	8	2	97.59％
Matched group	70	18	23	16	13	81.43％

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 Few 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 .kg ^-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, vasoactive intestinal peptide VIP ( n=10)

(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 deficiency of spleen-YANG and kidneyYANG pattern of syndrome irritable bowel syndrome for one kind, it is characterized in that: crude drug comprises the Radix Astragali, Radix Codonopsis, Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Atractylodis, Poria, Rhizoma Cimicifugae, Radix Puerariae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Linderae, Radix Morindae Officinalis, Semen Trigonellae, Herba Cistanches, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Glehniae, Fructus Schisandrae Chinensis, Semen Euryales, Herba Portulacae, Radix Glycyrrhizae Preparata.

2. the medicine for the treatment of deficiency of spleen-YANG and kidneyYANG 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 the Radix Astragali 20 ~ 40 parts, Radix Codonopsis 20 ~ 40 parts, Rhizoma dioscoreae (parched) 20 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 20 parts, Rhizoma Atractylodis Macrocephalae (parched) 20 ~ 30 parts, Rhizoma Atractylodis 10 ~ 20 parts, 10 ~ 20 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 10 ~ 20 parts, Pericarpium Citri Reticulatae 10 ~ 20 parts, Cortex Magnoliae Officinalis 10 ~ 20 parts, the Radix Linderae 10 ~ 20 parts, Radix Morindae Officinalis 10 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 10 ~ 20 parts, Cortex Cinnamomi 10 ~ 20 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 10 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 10 ~ 20 parts, Herba Portulacae 10 ~ 20 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

3. the medicine for the treatment of deficiency of spleen-YANG and kidneyYANG 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 the Radix Astragali 30 ~ 35 parts, Radix Codonopsis 30 ~ 35 parts, Rhizoma dioscoreae (parched) 25 ~ 30 parts, Semen Lablab Album (parched) 10 ~ 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 ~ 30 parts, Rhizoma Atractylodis 10 ~ 15 parts, 10 ~ 15 parts, Poria, Rhizoma Cimicifugae 5 ~ 10 parts, Radix Puerariae 15 ~ 20 parts, Pericarpium Citri Reticulatae 15 ~ 20 parts, Cortex Magnoliae Officinalis 15 ~ 20 parts, the Radix Linderae 10 ~ 15 parts, Radix Morindae Officinalis 15 ~ 20 parts, Semen Trigonellae 10 ~ 15 parts, Herba Cistanches 15 ~ 20 parts, Cortex Cinnamomi 10 ~ 15 parts, Radix Aconiti Lateralis Preparata 10 ~ 15 parts, Radix Glehniae 15 ~ 20 parts, Fructus Schisandrae Chinensis 10 ~ 15 parts, Semen Euryales 15 ~ 20 parts, Herba Portulacae 10 ~ 15 parts, Radix Glycyrrhizae Preparata 10 ~ 15 parts.

4. the medicine of the treatment deficiency of spleen-YANG and kidneyYANG 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 the Radix Astragali 30 parts, Radix Codonopsis 30 parts, Rhizoma dioscoreae (parched) 25 parts, Semen Lablab Album (parched) 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 25 parts, Rhizoma Atractylodis 10 parts, 10 parts, Poria, Rhizoma Cimicifugae 10 parts, Radix Puerariae 20 parts, Pericarpium Citri Reticulatae 20 parts, Cortex Magnoliae Officinalis 20 parts, the Radix Linderae 10 parts, Radix Morindae Officinalis 20 parts, Semen Trigonellae 10 parts, Herba Cistanches 20 parts, Cortex Cinnamomi 15 parts, Radix Aconiti Lateralis Preparata 10 parts, Radix Glehniae 20 parts, Fructus Schisandrae Chinensis 15 parts, Semen Euryales 20 parts, Herba Portulacae 15 parts, Radix Glycyrrhizae Preparata 15 parts.

5. the medicine of the treatment deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG 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 deficiency of spleen-YANG and kidneyYANG pattern of syndrome irritable bowel syndrome, it is characterized in that: crude drug comprises the Radix Astragali, Radix Codonopsis, Rhizoma dioscoreae (parched), Semen Lablab Album (parched), Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Atractylodis, Poria, Rhizoma Cimicifugae, Radix Puerariae, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, the Radix Linderae, Radix Morindae Officinalis, Semen Trigonellae, Herba Cistanches, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Glehniae, Fructus Schisandrae Chinensis, Semen Euryales, Herba Portulacae, Radix Glycyrrhizae Preparata;

The preparation method of described oral liquid specifically comprises,