CN103393807B - A kind of treat gastrointestinal disease pharmaceutical composition and preparation method and purposes - Google Patents
A kind of treat gastrointestinal disease pharmaceutical composition and preparation method and purposes Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical composition for the treatment of gastrointestinal disease, belong to pharmaceutical technology sectors.This pharmaceutical composition is made up of following component and weight ratio: Rhizoma Atractylodis extract 5 ~ 50 weight portion, Cortex Magnoliae Officinalis extract 5 ~ 50 weight portion, Pericarpium Citri Reticulatae extract 1 ~ 30 weight portion, Radix Glycyrrhizae extract 1 ~ 30 weight portion.The present invention is combined by the effective site of natural medicinal raw material, and each herbal medicine is all nontoxic before and after extraction prescription, does not find any side effect when normal dose is taken.Pharmaceutical composition of the present invention need not decoct, and can be prepared into tablet, capsule, pill, granule, oral liquid etc., have and be easy to carry, the advantages such as taking convenience.The invention also discloses the preparation method of this pharmaceutical composition and concrete purposes.
Description
Technical field
The invention belongs to drug world, relate to a kind of pharmaceutical composition for the treatment of gastrointestinal disease, particularly relating to a kind of take traditional Chinese medicine decoction piece extract as the pharmaceutical composition being used for the treatment of gastrointestinal disease made of raw material and preparation method.
Background technology
Damp being a kind of YIN pathogen, its property is sticky deep, burnt taste then the spleen being blocked by dampness in damp retardance, and spleen can not the lucid yang sending up, and stomach can not the turbid descending, and transporting and transforming function of the spleen and stomach is neglected one's duty, and water paddy transporting can not then occur the gastrointestinal disease symptoms such as nausea and vomiting, gastral cavity painful abdominal mass abdominal distention, loose stool diarrhoea.Treatment for such disease often selects drying damp and strengthening spleen class prescription at present clinically, and wherein Pingwei San is first-selected prescription.Pingwei San comes from the Song dynasty " formulary of peaceful benevolent dispensary ", and it is monarch drug that the party adopts Rhizoma Atractylodis drying damp and strengthening spleen, and Cortex Magnoliae Officinalis dehumidifying is loose is completely ministerial drug, Pericarpium Citri Reticulatae activating QI to eliminate phlegm is adjuvant drug, Radix Glycyrrhizae, Rhizoma Zingiberis Recens, Fructus Jujubae the spleen and stomach regulating are altogether for making medicine, and above-mentioned all medicines share raises removing dampness and eliminating phlegm, effect of circulation of qi promoting spleen invigorating altogether.
Rhizoma Atractylodis begin to be loaded in Shennong's Herbal, for the herbaceous plant of Compositae [WTBX, be distributed in the ground such as Jiangsu, Hunan, Jilin, Henan, Shanxi, Sichuan, Hebei, its main chemical compositions is atisine chloride atractydin, Rhizoma Atractylodis extract, hinesol, β-eucalyptol, elemi oleyl alcohol etc.Cortex Magnoliae Officinalis begins to be loaded in Shennong's Herbal, magnolia, be distributed in the ground such as Shaanxi, Gansu, Henan, Hubei, Hunan, Sichuan, Guizhou, Guangxi, Jiangxi, its main chemical compositions is Cortex Magnoliae Officinalis extract, tetrahydrochysene Cortex Magnoliae Officinalis extract, different Cortex Magnoliae Officinalis extract, sagittol, alkaloid etc.Pericarpium Citri Reticulatae is the mature peel of rutaceae orange and variety thereof, is mainly distributed in each department on the south the Changjiang river, and its main chemical compositions is volatile oil, hesperidin, naringenin, dihydro Nobiletin etc.Radix Glycyrrhizae is leguminous plant, is distributed in the ground such as the Inner Mongol, Ningxia, Xinjiang, Gansu, and its main chemical compositions is glycyrrhizic acid, enoxolone, licoflavone, Angelica Polysaccharide etc.Modern science is studied comparatively deep at present for the chemical composition of Rhizoma Atractylodis, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae, Radix Glycyrrhizae and the pharmacological effect of each composition, but very few to the pharmacological effect research after compatibility mutual between its each chemical composition or effective site.
Summary of the invention
The object of the invention is to solve the deficiencies in the prior art, a kind of pharmaceutical composition with treatment gastrointestinal disease by the extract combination of natural medicinal raw material is provided.Another object of the present invention is the preparation method and the purposes that provide this pharmaceutical composition a kind of.
The object of the invention is to be achieved through the following technical solutions:
Treat a pharmaceutical composition for gastrointestinal disease, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 5 ~ 50 weight portion, Cortex Magnoliae Officinalis extract 5 ~ 50 weight portion, Pericarpium Citri Reticulatae extract 1 ~ 30 weight portion, Radix Glycyrrhizae extract 1 ~ 30 weight portion; Preferably, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 10 ~ 45 weight portion, Cortex Magnoliae Officinalis extract 10 ~ 45 weight portion, Pericarpium Citri Reticulatae extract 3 ~ 25 weight portion, Radix Glycyrrhizae extract 3 ~ 25 weight portion.Preferably, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 15 ~ 40 weight portion, Cortex Magnoliae Officinalis extract 15 ~ 40 weight portion, Pericarpium Citri Reticulatae extract 5 ~ 20 weight portion, Radix Glycyrrhizae extract 5 ~ 20 weight portion.Preferably, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 20 ~ 35 weight portion, Cortex Magnoliae Officinalis extract 20 ~ 35 weight portion, Pericarpium Citri Reticulatae extract 8 ~ 15 weight portion, Radix Glycyrrhizae extract 8 ~ 15 weight portion.Preferably, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 20 weight portion, Cortex Magnoliae Officinalis extract 20 weight portion, Pericarpium Citri Reticulatae extract 10 weight portion, Radix Glycyrrhizae extract 10 weight portion.Preferably, it is made up of following component and weight ratio: Rhizoma Atractylodis extract 25 weight portion, Cortex Magnoliae Officinalis extract 25 weight portion, Pericarpium Citri Reticulatae extract 12 weight portion, Radix Glycyrrhizae extract 12 weight portion.Described Rhizoma Atractylodis extract is the ethanol extraction of Chinese medicine Rhizoma Atractylodis; Described Cortex Magnoliae Officinalis extract is the ethanol extraction of Cortex Magnoliae Officinalis; Pericarpium Citri Reticulatae extract is the ethanol extraction of Chinese medicine Pericarpium Citri Reticulatae; Radix Glycyrrhizae extract is the ethanol extraction of glycyrrhiza uralensis fisch.
Treat a preparation method for the pharmaceutical composition of gastrointestinal disease, it comprises the following steps:
S1: take raw material by aforementioned component and weight ratio;
S2: after raw material mix homogeneously, adds pharmaceutically acceptable adjuvant and is prepared into pharmaceutically conventional pharmaceutical preparation.
Treat a pharmaceutical composition for gastrointestinal disease, described dosage form is pill, powder, tablet, capsule, powder, granule, syrup, oral liquid, freeze-dried powder or injection.
The application of this pharmaceutical composition in preparation treatment retention of dampness in middle-JIAO type gastrointestinal disease medicine.
For enabling above-mentioned dosage form realize, the acceptable adjuvant of pharmacy need be added when preparing these dosage forms, such as: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are fixed, Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods; Substrate comprises: insect wax etc.
The preparation of Rhizoma Atractylodis extract: take Rhizoma Atractylodis decoction pieces and pulverize, cross 60 ~ 80 mesh sieves, add Extraction solvent, Extraction solvent is 70 ~ 95% alcoholic solution, is heated to 60 ~ 80 DEG C, reflux, extract, 2 hours, filters; Medicine residue again adds Extraction solvent 70 ~ 95% alcoholic solution and carries out second time extraction; Merge extracted twice liquid, concentratedly obtain extract extractum, by extractum through vacuum drying and get final product.Except this method prepares Rhizoma Atractylodis extract, other conventional method also can be adopted to prepare Rhizoma Atractylodis extract.
The preparation of Cortex Magnoliae Officinalis extract: take Medicinal Magnolia Bark and pulverize, cross 60 ~ 80 mesh sieves, add Extraction solvent, Extraction solvent is 70 ~ 95% alcoholic solution, is heated to 60 ~ 80 DEG C, reflux, extract, 2 hours, filters; Medicine residue again adds Extraction solvent 70 ~ 95% alcoholic solution and carries out second time extraction; Merge extracted twice liquid, concentratedly obtain extract extractum, by extractum through vacuum drying and get final product.Except this method prepares Cortex Magnoliae Officinalis extract, other conventional method also can be adopted to prepare Cortex Magnoliae Officinalis extract.
The preparation of Pericarpium Citri Reticulatae extract: take Pericarpium Citri Reticulatae decoction pieces and pulverize, cross 60 ~ 80 mesh sieves, add Extraction solvent, Extraction solvent is 70 ~ 95% alcoholic solution, is heated to 60 ~ 80 DEG C, reflux, extract, 2 hours, filters; Medicine residue again adds Extraction solvent 70 ~ 95% alcoholic solution and carries out second time extraction; Merge extracted twice liquid, concentratedly obtain extract extractum, by extractum through vacuum drying and get final product.Except this method prepares Pericarpium Citri Reticulatae extract, other conventional method also can be adopted to prepare Pericarpium Citri Reticulatae extract.
The preparation of Radix Glycyrrhizae extract: take licorice piece and pulverize, cross 60 ~ 80 mesh sieves, add Extraction solvent, Extraction solvent is 70 ~ 95% alcoholic solution, is heated to 60 ~ 80 DEG C, reflux, extract, 2 hours, filters; Medicine residue again adds Extraction solvent 70 ~ 95% alcoholic solution and carries out second time extraction; Merge extracted twice liquid, concentratedly obtain extract extractum, by extractum through vacuum drying and get final product.Except this method prepares Radix Glycyrrhizae extract, other conventional method also can be adopted to prepare Radix Glycyrrhizae extract.
Rhizoma Atractylodis extract of the present invention, Cortex Magnoliae Officinalis extract, Pericarpium Citri Reticulatae extract and Radix Glycyrrhizae extract, it is prepared extracting method and any one method conventional such as alcohol reflux, soak extraction, supersound extraction or seepage pressure effects can be selected to extract; Further, crude drug also can purified, refinement treatment after extracting, as crossed macroporous resin column.
The invention has the beneficial effects as follows:
(1) what the invention provides a kind of extract combination by natural medicinal raw material has the treatment pharmaceutical composition of gastrointestinal disease and the preparation method of this pharmaceutical composition and purposes, there is good effect, have no side effect, not easily produce toleration, taking convenience, is generally applicable to the advantages such as gastrointestinal disease patient;
(2) pharmaceutical composition of the present invention is the extract of effective ingredient, need not decoct and take, be easy to carry after being prepared into tablet, capsule, pill, granule, oral liquid, and take easily, each herbal medicine is all nontoxic before and after extraction prescription, does not find any side effect when normal dose is taken;
(3) pharmaceutical composition of the present invention has outside good therapeutical effect to gastrointestinal type disease, all has certain therapeutical effect to immunity function immunocompromised patients, selects for clinical application provides a kind of new medication.
Detailed description of the invention
Below in conjunction with embodiment, technical scheme of the present invention is described in further detail, but protection scope of the present invention is not limited to the following stated.
Embodiment 1:
Take raw material Rhizoma Atractylodis extract 5g, Cortex Magnoliae Officinalis extract 5g, Pericarpium Citri Reticulatae extract 1g, Radix Glycyrrhizae extract 1g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 2:
Take raw material Rhizoma Atractylodis extract 10g, Cortex Magnoliae Officinalis extract 10g, Pericarpium Citri Reticulatae extract 3g, Radix Glycyrrhizae extract 3g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 3:
Take raw material Rhizoma Atractylodis extract 15g, Cortex Magnoliae Officinalis extract 15g, Pericarpium Citri Reticulatae extract 5g, Radix Glycyrrhizae extract 5g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 4:
Take raw material Rhizoma Atractylodis extract 20g, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 8g, Radix Glycyrrhizae extract 8g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 5:
Take raw material Rhizoma Atractylodis extract 20g, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 6:
Take raw material Rhizoma Atractylodis extract 25g, Cortex Magnoliae Officinalis extract 25g, Pericarpium Citri Reticulatae extract 12g, Radix Glycyrrhizae extract 12g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 7:
Take raw material Rhizoma Atractylodis extract 35g, Cortex Magnoliae Officinalis extract 35g, Pericarpium Citri Reticulatae extract 15g, Radix Glycyrrhizae extract 15g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 8:
Take raw material Rhizoma Atractylodis extract 40g, Cortex Magnoliae Officinalis extract 40g, Pericarpium Citri Reticulatae extract 20g, Radix Glycyrrhizae extract 20g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 9:
Take raw material Rhizoma Atractylodis extract 45g, Cortex Magnoliae Officinalis extract 45g, Pericarpium Citri Reticulatae extract 25g, Radix Glycyrrhizae extract 25g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 10:
Take raw material Rhizoma Atractylodis extract 50g, Cortex Magnoliae Officinalis extract 50g, Pericarpium Citri Reticulatae extract 30g, Radix Glycyrrhizae extract 30g, adds conventional pharmaceutical adjuvants, evenly obtained granule, and tabletting, obtains tablet.
Embodiment 11:
Take raw material Rhizoma Atractylodis extract 5g, Cortex Magnoliae Officinalis extract 5g, Pericarpium Citri Reticulatae extract 1g, Radix Glycyrrhizae extract 1g, adds conventional pharmaceutical adjuvants, and evenly obtained granule, incapsulates, obtain capsule.
Embodiment 12:
Take raw material Rhizoma Atractylodis extract 10g, Cortex Magnoliae Officinalis extract 10g, Pericarpium Citri Reticulatae extract 3g, Radix Glycyrrhizae extract 3g, adds conventional pharmaceutical adjuvants, and evenly obtained granule, incapsulates, obtain capsule.
Embodiment 13:
Take raw material Rhizoma Atractylodis extract 15g, Cortex Magnoliae Officinalis extract 15g, Pericarpium Citri Reticulatae extract 5g, Radix Glycyrrhizae extract 5g, adds conventional pharmaceutical adjuvants, is conventionally prepared into pill.
Embodiment 14:
Take raw material Rhizoma Atractylodis extract 20g, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 8g, Radix Glycyrrhizae extract 8g, adds conventional pharmaceutical adjuvants, is conventionally prepared into pill.
Embodiment 15:
Take raw material Rhizoma Atractylodis extract 20g, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, adds conventional pharmaceutical adjuvants, and evenly obtained granule, is conventionally prepared into granule.
Embodiment 16:
Take raw material Rhizoma Atractylodis extract 25g, Cortex Magnoliae Officinalis extract 25g, Pericarpium Citri Reticulatae extract 12g, Radix Glycyrrhizae extract 12g, adds conventional pharmaceutical adjuvants, and evenly obtained granule, is conventionally prepared into granule.
Embodiment 17:
Take raw material Rhizoma Atractylodis extract 35g, Cortex Magnoliae Officinalis extract 35g, Pericarpium Citri Reticulatae extract 15g, Radix Glycyrrhizae extract 15g, adds conventional pharmaceutical adjuvants, is conventionally prepared into oral liquid.
Embodiment 18:
Take raw material Rhizoma Atractylodis extract 40g, Cortex Magnoliae Officinalis extract 40g, Pericarpium Citri Reticulatae extract 20g, Radix Glycyrrhizae extract 20g, adds conventional pharmaceutical adjuvants, is conventionally prepared into freeze-dried powder.
Embodiment 19:
Take raw material Rhizoma Atractylodis extract 45g, Cortex Magnoliae Officinalis extract 45g, Pericarpium Citri Reticulatae extract 25g, Radix Glycyrrhizae extract 25g, adds conventional pharmaceutical adjuvants, is conventionally prepared into injection.
Embodiment 20:
Take raw material Rhizoma Atractylodis extract 50g, Cortex Magnoliae Officinalis extract 50g, Pericarpium Citri Reticulatae extract 30g, Radix Glycyrrhizae extract 30g, adds conventional pharmaceutical adjuvants, is conventionally prepared into effervescent tablet.
Beneficial effect of the present invention is verified below by concrete pharmacy test:
The water-electrolyte metabolism test of 1 present composition
1.1 test material
1.1.1 experimental animal
Select healthy adult SD system rat 70, male and female half and half, body weight 18O ~ 250g, Chengdu University of Traditional Chinese Medicine's Experimental Animal Center provides.Weighed by animal before test, numbering, is divided into dosage group, compositions low dose group in Normal group, dampness modeling group, Pingwei San group, natural recovering group, compositions high dose group, compositions at random, often organizes 70 rats.
1.1.2 experimental apparatus and reagent
LD5-2A type centrifuge (Beijing Medical Centrifugal Machine Factory's manufacture); Numerical monitor pipettor (general headquarters of China of Lei Bo group of Finland produce); Sai Duolisi Bp-61 type electronic balance (Germany, resolution 0.1mg); Electrolyte analyser (U.S. MediaCorporation, Bedford, MA01730); Disposable hard plastic test tube (Maike Tech Co., Ltd., Sichuan Prov. provides); ADH radioimmunological kit (European diagnostic companies production); ALD, ANP radioimmunological kit (Tianjin Jiuding Medical Biological Engineering Co., Ltd's production).
1.2 test specimen preparations
(1) Pingwei San: Rhizoma Atractylodis 15g, Cortex Magnoliae Officinalis 9g, Pericarpium Citri Reticulatae 9g, Radix Glycyrrhizae 4g.After medicine being added cold water 300mL immersion 30min, add water 500mL decocting 10min, leaches medicinal liquid; Add water again 500mL decocting 15min, leaches medicinal liquid; Put 70 ~ 80 DEG C of water-baths filtrate merging by twice and concentrate to obtain 400mL, make the Chinese herbs decoction of 0.3g/mL concentration, be placed in 4 DEG C of refrigerators for subsequent use.
(2) compositions group: take raw material Rhizoma Atractylodis extract 20g according to the proportion compatibility of embodiment 5, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, add the medicinal liquid that distilled water is prepared into 1mg/mL concentration, be middle dosage, be placed in 4 DEG C of refrigerators for subsequent use.Getting 200ml concentration of liquid medicine becomes 100ml to be mixed with the medicinal liquid of 2mg/mL concentration, is high dose.Get 50ml medicinal liquid and be diluted to the medicinal liquid that 100ml is mixed with 0.5mg/mL concentration, be low dose group.
1.3 test methods and step
This experiment adopts retention of dampness in middle-JIAO model of a syndrome, after animal model success, gets 1O dampness modeling group rat at random and rats in normal control group 10 is only put to death next day, measures ADH, ALD and ANP.Remaining rat is raised in home; Pingwei San group is with crude drug dosage gavage every day 1 time of 0.6g/100g; natural recovering group every day is with the tap water gavage of room temperature equivalent; compositions high dose group is according to the dosage gavage of 2mg/100g; in compositions, dosage group is according to the dosage gavage of 1mg/100g, and compositions low dose group is according to the dosage gavage of 0.5mg/100g.Put to death after gavage in the 4th day, measure plasma A DH, ALD and ANP.Rats in normal control group is fed in home, temperature 19 ~ 25 DEG C, relative humidity 42% ~ 65%, and ad lib is drunk water.
1.4 index detection method
ADH, ALD and ANP: adopt rat femoral depletion method to get fresh whole blood 4mL, EDTA anticoagulant, and add aprotinin 400U, with 4 DEG C of 2000r/min centrifugal separation plasmas ,-3O DEG C of preservation, in order to measuring ADH, ALD and ANP.By medicine box requirement with putting the concentration exempting from method mensuration plasma A DH, ALD and ANP, specifically detected by West China Center of Medical Sciences of Sichuan University basis Isotope Lab.
Na
+, K
+: in blood remaining after isolating blood plasma above being added by dibutyl phthalate 0.6mL, fully shake up, centrifugal with 4 DEG C of 2000r/min, discard separating medium and erythrocyte surface layer, draw erythrocyte 0.4mL from its bottom, in injection, have the test tube of 3.6mL deionized water, with erythrocyte crusher, erythrocyte is pulverized, obtain erythrocyte diluting fluid ,-3O DEG C of preservation, electrolyte Na to be measured
+, K
+.After erythrocyte diluting fluid is centrifugal with 2000r/min during mensuration, get supernatant 0.2mL, use electrolyte analysis-e/or determining, its result by 10 times of survey data.
1.5 statistical procedures
Use SPSS statistical software to carry out date processing, each group experimental data with
represent, between group, mean compares employing one factor analysis of variance.
1.6 experimental result
The concentration (1) respectively organizing ADH, ALD and ANP compares (
, pg/mL).The results are shown in following table 1:
The concentration that table 1 respectively organizes ADH, ALD and ANP compares (
, pg/mL)
Note: compare with Normal group, Δ P < 0.05, Δ Δ P < 0.01; ★ P < 0.05, ★ ★ P < 0.01 is compared with model group.
(2) each group electrolyte Na
+, K
+comparison (
, mmol/L).The results are shown in following table 2:
Table 2 is group electrolyte Na respectively
+, K
+comparison (
, mmol/L)
Note: compare with Normal group, Δ P < 0.05, Δ Δ P < 0.01; ★ P < 0.05, ★ ★ P < 0.01 is compared with model group.
Table 1, table 2 result display model group rat ADH compared with normal group significantly raises, and shows that model group rats distal renal tubular and collecting tubule moisture reabsorption are strengthened, is retained in vivo, have water, sodium retention phenomenon.Through Pingwei San and after combining object height, middle dosage treatment, ADH recovers normal substantially, and both explanations all by suppressing ADH release, impel the water of retention in body, sodium excretion, thus adjustment body water, electrolyte tend to balance.
Though rat model ALD compared with normal group there was no significant difference, the trend be increased significantly, shows that retention of dampness in middle-JIAO card rat ALD secretion has the trend of enhancing, promotes Na
+, the absorption of water and K
+discharge, after Pingwei San and the high, medium and low dosage treatment of compositions, ALD obviously reduces, and illustrates that above-mentioned treatment group can suppress the secretion of ALD.
Result of study also shows, Na in retention of dampness in middle-JIAO card rat cell
+compared with normal group obviously raises, K
+obvious reduction, the adjustment trend that the secretion of release and ALD that this and retention of dampness in middle-JIAO demonstrate,prove rat ADH strengthens and carries out is completely the same.After Pingwei San and medicine composite for curing, Na
+return to normal, K
+without significant change, illustrate that Pingwei San and pharmaceutical composition can promote the sodium excretion of retention in cell, meanwhile, can not potassium loss be made, play the effect protecting potassium row sodium.
2 present compositions are on the impact of immunologic function
2.1 test material
2.1.1 experimental animal
Select healthy adult SD rat 70, male and female half and half, body weight 180 ± 220g, provided by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.Weighed by animal before test, numbering, is divided into blank group, model group, dosage group, compositions low dose group in Pingwei San group, natural recovering group, compositions high dose group, compositions at random, 7 groups altogether, often organizes 10.
2.1.2 experimental apparatus and reagent
550 type microplate reader (BIORAD company), 1575 types are semi-automatic washes trigger (BIORAD company), embedding machine, microtome, optical microscope, BI2000 histomorphometric analysis system etc.Mus interleukin-6 (II-6) test kit (RapidBioI company); Rat immune globulin-G (IgG) test kit (ADRDIAGNOS-TICS company).
2.2 test specimen preparations
Refine pure lard, 0.9 normal saline, Pingwei San are first fried into conventional medicinal liquid according to clinical application decocting method, then cryoconcentration becomes the high concentration medicinal liquid containing crude drug lg/ml.
Pharmaceutical composition group takes raw material Rhizoma Atractylodis extract 20g according to the proportion compatibility of embodiment 5, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, add the medicinal liquid that distilled water is prepared into 1mg/mL concentration, be middle dosage, be placed in 4 DEG C of refrigerators for subsequent use.Getting 200ml concentration of liquid medicine becomes 100ml to be mixed with the medicinal liquid of 2mg/mL concentration, is high dose.Get 50ml medicinal liquid and be diluted to the medicinal liquid that 100ml is mixed with 0.5mg/mL concentration, be low dose group.
2.3 test methods and step
This experiment adopts retention of dampness in middle-JIAO model of a syndrome, rat is placed on the interior raising of modeling case of temperature 18 ~ 25 DEG C, humidity (9O ± 5%); The odd-numbered day fasting of modeling Mus also gives 4 DEG C of frozen water (2ml/ is only) gavage 1 time, even-numbered days in liberal supply feedstuff give Adeps Sus domestica (4ml/ only) gavage 1 time; Every day, 8:00 ~ l6:00 made rat stand in the dark water of 4cm, controlled 8 hours lengths of one's sleep.Continuous modeling 20 days, treatment group and the same model group of natural recovering group modeling method.Treatment group modeling is after 20 days, give Pingwei San gavage (concentrated original liquid adds equivalent distilled water diluting) 10ml/kg body weight (i.e. 5g crude drug/kg body weight), compositions high dose group is according to the dosage gavage of 2mg/100g, in compositions, dosage group is according to the dosage gavage of 1mg/100g, compositions low dose group according to the dosage gavage of 0.5mg/100g, totally 5 days.Blank group and natural recovering group gavage 0.9% normal saline (10ml/kg) simultaneously.Disposal after model group animal model completes for 20 days, sampling, all the other dispose sampling after respectively organizing 5 days.
2.4 index detection method
2.4.1 spleen, thymus weight in wet base and organ coefficient
All animals sample after disposing, and taken out by the organ such as spleen, thymus, weigh immediately on electronic balance after sacrifice of animal, and record numerical value also calculates organ coefficient.
2.4.2 spleen, thymus pathological observation
All animals sample after disposing, and open abdominal cavity, spleen, thymus are taken out respectively, are soaked in the formalin of 10% fixing immediately.Conventional H E dyes, and observes and measure thymic cortex thickness and spleen central artery lymph sheath diameter under optical microscope.
2.4.3 blood serum IL-6 and IgG content measure
Before all animals are disposed, adopt femoral artery depletion method blood sampling 5ml, be placed in test tube, not anticoagulant, left at room temperature 1 hour, 2000 revs/min centrifugal 5 minutes, and separation of serum, puts-20 DEG C of Refrigerator stores, test serum IL-6 and IgG content.
2.5 statistical procedures
Use SPSS statistical software to carry out date processing, each group experimental data with
represent, between group, mean compares employing one factor analysis of variance.
2.6 experimental result
2.6.1 respectively organize the change of Rats Spleen, thymus weight in wet base and organ coefficient to compare in table 3.
Table 3 each group Rats Spleen and index of spleen change are compared (
)
Note: compare with blank group, ★ P<0.01; Compare with model group, △ P<0.05.
Table 4 each group rat chest gland weight in wet base and organ coefficient change are compared (
)
Note: compare with blank group, ★ P<0.01; Compare with model group, △ P<0.05.
Shown in table 3, table 4, animal model builds up rear model treated animal spleen, thymus weight in wet base declines to a great extent (P<0.01), has certain rising after clear-cutting forestland, but recovers more obvious after present composition treatment.Model group animal spleen, thymus organ coefficient are lower than blank group, and after present composition treatment, its effect is better than Pingwei San group, natural recovering group, but two group differences are without significant.
2.6.2 respectively group Mouse Thymic Cortex thickness and the change of spleen central artery lymph sheath diameter are compared
Table 5 each group Mouse Thymic Cortex thickness and the change of spleen central artery lymph sheath diameter are compared (um,
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.01; Compare with model group, △ P<0.01.Natural recovering group is due to dead 1 of gavage, therefore number of animals is 9.
Table 5 shows, model group animal thymus cortical thickness and spleen central artery lymph sheath diameter obviously diminish (P<0.01), but have obvious recovery after medicine composite for curing, wherein the therapeutical effect of high, the middle dosage group of the present composition is better than Pingwei San group (P<0.01).
2.6.3 respectively group rat blood serum IL-6 and IgG content change are compared
Table 6 each group rat blood serum IL-6 and IgG content change are compared (
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.01; Compare with model group, △ P<0.01.Natural recovering group is due to dead 1 of gavage, therefore number of animals is 9.
Table 6 shows, model group animal serum IL-6 content obviously raises (P<0.01), after medicine composite for curing, IL-6 reduces (P<0.01), has significant (P<0.01) with model group comparing difference; Model group animal serum IgG content obviously reduces (P<0.05), and after medicine composite for curing, IgG raises, and effect is better than natural recovering group, in medicine dosage group and Pingwei San group curative effect close, but no significant difference.
Experimental study shows that Pingwei San and compositions group are all significantly improved the immunologic dysfunction tool of the spleen and stomach being stranded by dampness card rat model in sum, and wherein the curative effect of pharmaceutical composition of the present invention is slightly better than the curative effect of Pingwei San.
3 present compositions adjust the impact of hormone to water
3.1 test material
3.1.1 experimental animal
Select healthy adult SD rat 70, male and female half and half, body weight 180 ± 220g, provided by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.Weighed by animal before test, numbering, is divided into blank group, model group, dosage group, compositions low dose group in Pingwei San group, natural recovering group, compositions high dose group, compositions at random, 7 groups altogether, often organizes 10.
3.1.2 experimental apparatus and reagent
Ethylenediaminetetraacetic acid (EDTA) and aprotinin, ALD, ANP, NT, AVP radioimmunology analysis test kit, provides by West China Center of Medical Sciences of Sichuan University basis Isotope Lab.
3.2 test specimen preparations
Pingwei San medicine forms: Rhizoma Atractylodis 15g, Cortex Magnoliae Officinalis 9g, Pericarpium Citri Reticulatae 9g, Radix Glycyrrhizae Preparata 4g (being purchased from Beijing Tongrentang Chengdu Fen Tang).Medicine is made the Chinese herbs decoction of 0.3g/mL concentration, be placed in 4 DEG C of refrigerators for subsequent use.
Pharmaceutical composition group takes raw material Rhizoma Atractylodis extract 20g according to the proportion compatibility of embodiment 5, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, add the medicinal liquid that distilled water is prepared into 1mg/mL concentration, be middle dosage, be placed in 4 DEG C of refrigerators for subsequent use.Getting 200ml concentration of liquid medicine becomes 100ml to be mixed with the medicinal liquid of 2mg/mL concentration, is high dose.Get 50ml medicinal liquid and be diluted to the medicinal liquid that 100ml is mixed with 0.5mg/mL concentration, be low dose group.
3.3 test methods and step
This experiment adopts retention of dampness in middle-JIAO model of a syndrome, rat is placed on the interior raising of modeling case of temperature 18 ~ 25 DEG C, humidity (9O ± 5%); Simulation " occupy wetland for a long time, exogenous damp crosses Sheng "; The odd-numbered day fasting of modeling rat also gives 4 DEG C of frozen water (2mL/ is only) gavage 1 time, even-numbered days in liberal supply feedstuff give Adeps Sus domestica (4mL/ only) gavage 1 time, simulation " eating and drinking without temperance, irregular diet "; Every day, 8:00 ~ l6:00 made rat stand in the dark water of 4cm, controlled the 8h length of one's sleep, upset its biological clock, simulation " feelings will is unsuccessful ".30 modeling group rats are divided into model by continuous modeling 20d at random.Pingwei San treatment group, natural recovering group (often organizing 10).Blank group rat is fed in home, temperature l9 ~ 25 DEG C, and relative humidity 42% ~ 65%, ad lib is drunk water.Model group and blank group rat are put to death in modeling next day.Remaining 20 rats are raised in home; and Pingwei San group is with 0.6g/100g crude drug dosage gavage every day 1 time; compositions high dose group is according to the dosage gavage of 2mg/100g; in compositions, dosage group is according to the dosage gavage of 1mg/100g, and compositions low dose group is according to the dosage gavage of 0.5mg/100g.Natural recovering group every day is with the tap water gavage of room temperature equivalent.Put to death after 4d gavage.
3.4 index detection method
Adopt rat femoral depletion method to get blood 6mL and be placed in disposable EDTA anticoagulant test tube I, II, III, each two milliliters, and add aprotinin 400U, shake up gently.Get test tube I 4 DEG C of centrifuges with 2000r/min centrifugation 5min, get upper plasma 0.5mL with suction pipe, be placed in-3O DEG C of refrigerator and preserve, index to be measured.
By test kit requirement with putting the concentration exempting from method mensuration plasma A LD, ANP, NT and AVP, detected by West China Center of Medical Sciences of Sichuan University Isotope Lab.Getting test tube II adopts routine clinical detection method to measure.Get test tube III, add separating medium dibutyl phthalate 0.3mL again, fully shake up, with 4 DEG C of centrifuges with 2000r/min centrifugation 5min, discard separating medium and erythrocyte surface layer, draw erythrocyte 0.2mL with suction pipe from wherein bottom, have the test tube of 1.8mL deionized water in injection, with cell pulverization instrument, erythrocyte is pulverized completely, obtain erythrocyte diluting fluid, then with 2000r/min centrifugation 5min, get supernatant 0.1mL, use electrolyte analysis-e/or determining.
3.5 statistical procedures
Use SPSS13.0 statistical software to carry out date processing, each group experimental data with
represent, between group, mean compares employing one factor analysis of variance.
3.6 experimental result
(1) the concentration change situation of each group plasma A LD, ANP, NT, AVP is in table 7.
Table 7 respectively group plasma A LD, ANP, NT, AVP concentration change (
)
Note: compare ★ ★ P<0.01 with model group, ★ P<0.05, compares Δ Δ P<O.01, Δ P<0.05 with blank group
Result shows, after modeling, all more blank group of ALD, ANP, NT, AVP concentration has rising, is declined all in various degree by indices after the treatment of medicine group.
(2) mensuration of plasma electrolyte is in table 8.
The change of table 8 plasma electrolyte (
)
Note: compare ★ ★ P<0.01 with model group, ★ P<0.05, compares Δ Δ P<0.01, Δ P<0.05 with blank group
(3) change of erythrocyte Inner electrolysis matter is in table 9.
The change of table 9 erythrocyte Inner electrolysis matter (
)
Note: compare ★ ★ P<0.01 with model group, ★ P<0.05, compares Δ Δ P<0.01, Δ P<0.05 with blank group.
Above-mentioned result of the test shows that erythrocyte Inner electrolysis matter measures, and model group compares with blank group, K
+more blank group of concentration reduction (P<0.05).Natural recovering group, Pingwei San group, pharmaceutical composition senior middle school low dose group compare with model group, there was no significant difference, compare have statistical significance (P<0.01) with blank group.Model group compares with blank group, Na
+concentration raises, but not statistically significant.Natural recovering group, Pingwei San group, pharmaceutical composition group compared with model group, Na
+concentration significantly reduces (P<0.05).
In sum, pharmaceutical composition group can reduce ALD, NT, AVP concentration, increases ANP concentration and stops intraor extracellular sodium potassium ion to continue loss effect, thus reach the object dispelling damp.
4 present compositions are on the impact of intestinal mucosa
4.1 test material
4.1.1 experimental animal
Select healthy adult SD rat 70, male and female half and half, body weight 180 ± 220g, provided by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.Weighed by animal before test, numbering, is divided into blank group, model group, dosage group, compositions low dose group in Pingwei San group, natural recovering group, compositions high dose group, compositions at random, 7 groups altogether, often organizes 10.
4.1.2 experimental apparatus and reagent
D-ALPHA-Hydroxypropionic acid testing cassete (Beijing Rui Xinnong scientific & trading Co., Ltd., 200809), (Science and Technology Ltd. is built up in Nanjing to diamine oxidase (DAO) testing cassete, 20080706), glutathione peroxidase (CsH-PX) testing cassete (Bioengineering Research Institute 20070529 is built up in Nanjing), (Bioengineering Research Institute is built up in Nanjing to superoxide dismutase (SOD) testing cassete, 20070528), (Bioengineering Research Institute is built up in Nanjing to malonaldehyde (MDA) testing cassete, 20070614), (Bioengineering Research Institute is built up in Nanjing to Coomassie brilliant blue testing cassete, 20070714).
4.2 test specimen preparations
Pingwei San: take Rhizoma Atractylodis 24g, Cortex Magnoliae Officinalis 18g, Pericarpium Citri Reticulatae 12g, Radix Glycyrrhizae Preparata 6g, the 500ml that first added water by medicine soaks 1h, then together decocts to about 300ml with Fructus Jujubae 1Og, Rhizoma Zingiberis Recens 6g, and reconcentration becomes concentration to be the deposit medicinal liquid of 1g crude drug ml.
Pharmaceutical composition group takes raw material Rhizoma Atractylodis extract 20g according to the proportion compatibility of embodiment 5, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, add the medicinal liquid that distilled water is prepared into 1mg/mL concentration, be middle dosage, be placed in 4 DEG C of refrigerators for subsequent use.Getting 200ml concentration of liquid medicine becomes 100ml to be mixed with the medicinal liquid of 2mg/mL concentration, is high dose.Get 50ml medicinal liquid and be diluted to the medicinal liquid that 100ml is mixed with 0.5mg/mL concentration, be low dose group.
4.3 test methods and step
This experiment adopts retention of dampness in middle-JIAO model of a syndrome, after animal model success, rat is placed on the interior raising of modeling case of temperature 18 ~ 25 DEG C, humidity (9O ± 5%).Model group terminates execution on the same day in modeling and draws materials, and puts to death and draw materials after other three groups of 3d.Femoral artery gets blood, leaves standstill about 2h, the centrifugal 2000rmin of refrigerated centrifuge
-1, 5min, gets supernatant, subpackage, and-80 DEG C of refrigerators are frozen, D-ALPHA-Hydroxypropionic acid content to be measured and DAO activity.Get each 100mg of jejunal tissue on ice, frozen water homogenate.
GSH-Px, MDA: prepare 10% homogenate, 4 DEG C of 3000rmin
-1, 1Omin, centrifuging and taking supernatant ,-80 DEG C of stored frozen are to be measured.SOD: prepare 1% homogenate, 4 DEG C of 10000rmin
-1, 15min, centrifuging and taking supernatant ,-80 DEG C of stored frozen are to be measured; Coomassie brilliant blue measures protein content: be mixed with 2% homogenate, 4 DEG C of 1500rmin
-1, 10min, centrifuging and taking supernatant ,-8O DEG C of stored frozen is to be measured.
4.4 statistical procedures
Use SPSS13.0 statistical software to carry out date processing, each group experimental data with
represent, between group, mean compares employing one factor analysis of variance or non parametric tests.
4.5 experimental result
(1) serum D-ALPHA-Hydroxypropionic acid content and diamine oxidase activity, the results are shown in Table 10.
Table 10 respectively group D-ALPHA-Hydroxypropionic acid and DAO result (
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.1; Compare with model group, Δ P<0.05, Δ Δ P<0.01.
From table 10 experimental result, model group rats serum D-ALPHA-Hydroxypropionic acid content obviously increases, and comparing with blank group has statistical significance (P<0.01), and after giving Drug therapy, content reduces, and successful is better than clear-cutting forestland.Model group rats diamine oxidase activity reduces, but more meaningless with blank group (P>0.05); After the treatment of compositions high, medium and low dosage group, activity has and increases trend, but more meaningless with model group (P>0.05); Natural recovering group compares with model group without significant change (P>0.05).
(2) jejunum GSH-Px vigor, SOD vigor, MDA changes of contents, the results are shown in Table 11.
Table 11 jejunum GSH-Px vigor, SOD vigor, MDA changes of contents (
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.01; Compare with model group, Δ P<0.05, Δ Δ P<0.01
As described in Table 11, after modeling, jejunum GSH-Px vigor significantly declines (P<0.01), has to a certain degree take a turn for the better through clear-cutting forestland, but compares with blank group and still have gap (P<0.05); After compositions treatment, vigor significantly recovers (P<0.01).After modeling, jejunum SOD vigor significantly declines (P<0.01), does not substantially recover (comparing with model group, P>0.05) under naturalness; After Pingwei San, compositions high dose, middle dosage, low dose therapy, vigor significantly recovers (comparing with model group, P<0.01), and wherein in Pingwei San group and compositions, dosage group is tending towards normal.After modeling MDA concentration raise (P<0.01), have under naturalness and to a certain degree fall after rise, the high, medium and low dosage group of Pingwei San group, composition dosage has downward trend, but with blank group and the more equal not statistically significant of model group.
To sum up described in test, pharmaceutical composition of the present invention can improve SOD and GSH-Px vigor, has and removes intestinal free radical, anti peroxidation of lipid, the effect of protection Antioxidant Enzyme Systems, thus improves the impaired intestinal mucosal barrier of rat model.
5 present compositions are on the impact of gastrointestinal function
5.1 test material
5.1.1 experimental animal
Select healthy adult SD rat 70, male and female half and half, body weight 180 ± 220g, provided by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.Weighed by animal before test, numbering, is divided into blank group, model group, dosage group, compositions low dose group in Pingwei San group, natural recovering group, compositions high dose group, compositions at random, 7 groups altogether, often organizes 10.
5.1.2 experimental apparatus and reagent
GastrinIEnzymeImmunoAssay，ADRDIAGNOSTICS，BatchNo．：050504。Motilin (MTL) radioimmunoassay kit, the immunity of East Asia, PLA General Hospital Science and Technology Development Center provided, lot number: 0506.
5.2 test specimen preparations
Pingwei San: Rhizoma Atractylodis 12g, Cortex Magnoliae Officinalis 9g, Pericarpium Citri Reticulatae 6g, Radix Glycyrrhizae Preparata 3g, all purchased from branch, Tongrentang Chengdu.Medicinal liquid is prepared by Drug Manufacturing Room, is first brewed into conventional medicinal liquid according to clinical application decocting method, then cryoconcentration becomes the high concentration medicinal liquid containing 1g crude drug/ml.
Pharmaceutical composition group takes raw material Rhizoma Atractylodis extract 20g according to the proportion compatibility of embodiment 5, Cortex Magnoliae Officinalis extract 20g, Pericarpium Citri Reticulatae extract 10g, Radix Glycyrrhizae extract 10g, add the medicinal liquid that distilled water is prepared into 1mg/mL concentration, be middle dosage, be placed in 4 DEG C of refrigerators for subsequent use.Getting 200ml concentration of liquid medicine becomes 100ml to be mixed with the medicinal liquid of 2mg/mL concentration, is high dose.Get 50ml medicinal liquid and be diluted to the medicinal liquid that 100ml is mixed with 0.5mg/mL concentration, be low dose group.
5.3 test methods and step
This experiment adopts retention of dampness in middle-JIAO model of a syndrome model, rat is placed on the interior raising of modeling case of temperature 18 ~ 25 DEG C, humidity (9O ± 5%).The odd-numbered day fasting of modeling rat also gives 4 DEG C of frozen water (2ml/ is only) gavage 1 time, even-numbered days in liberal supply feedstuff give Adeps Sus domestica (4ml/ only) gavage 1 time; Every day, 8:00 ~ 16:00 made rat stand in the dark water of 4cm, controlled the 8h length of one's sleep.Continuous modeling 20d.After treatment group modeling 2Od, the gavage side for the treatment of medicine (10ml/kg), compositions high dose group is according to the dosage gavage of 2mg/100g, and in compositions, dosage group is according to the dosage gavage of 1mg/100g, compositions low dose group, according to the dosage gavage of 0.5mg/100g, is total to 5d.Blank group and natural recovering group gavage 0.9% normal saline (10ml/kg) simultaneously.
5.4 Indexs measure
5.4.1 the observation of general signs
The general state of close observation rat in experimentation, as: situation, growing state, body weight, the fur color and lusters etc. of ingesting of drinking water, modeling and treatment terminate rear measurement difference group rat body weight, 24h food ration (Metabolic cage method) and Abdominal girth index.
5.4.2 the mensuration of gastrointestinal index of correlation
Gastric emptying and intestinal propulsion experiment adopt semi-solid nutrition to stick with paste method, semi-solid nutrition is stuck with paste: get carboxymethyl cellulose 5g, be dissolved in 125ml distilled water, then add milk powder 8g successively, white sugar 6g, starch 6g, and often add 1 stirring 1 time, after stirring, add a small amount of Yihong dyestuff again, stir, be finally made into the red mixture that 150ml sticks with paste containing 150g nutrition, put into 4 DEG C of refrigerator storages.Use front 2h to take out, return to room temperature.
Emptying test: by formulae discovery stomach residual percentage: Stomach residue rate (%)=(the stomach net weight that the stomach gross weight-of the 1st time is 2 times)/2 × 100%.
Intestinal propulsion is tested: the percentage ratio stuck with paste by the nutrition of formulae discovery intestinal propulsion: advance distance (the cm)/small intestinal total length (cm) × 100% in small intestinal is stuck with paste in Intestinal propulsive rate (%)=nutrition
Gut hormone measures: before all treated animals are disposed, and adopts femoral artery depletion method blood sampling 5ml, is placed in test tube, not anticoagulant, left at room temperature 1h, centrifugal 5min, rotating speed 2000r/min, is separated and gets serum, put-20 DEG C of Refrigerator stores, gastrin to be measured, motilin.
5.4.3 gastrointestinal tissue's morphological observation
All treated animals sample after disposing, and open abdominal cavity, perusal gastrointestinal tissue form, then Stomach duodenum, jejunum, colon are taken out respectively, are soaked in the formalin solution of 10% fixing immediately.Conventional H E dyes, tissue visualization form under optical microscope.
5.5 statistical procedures
Use SPSS13.0 statistical software to carry out date processing, each group experimental data with
represent, between group, mean compares employing one factor analysis of variance or non parametric tests.
5.6 experimental result
5.6.1 the observation of general signs
After modeling there is inappetence in model group rats, and dietary amount reduces, large loose stool, and the dark and gloomy jaundice of fur color and luster, becomes thin, abdominal distention, and the symptom such as lose weight, modeling the 18th day dead 1 rat of natural recovering group.After administration, treatment group rat symptom turns for the better by and large, and natural recovering group rat sign is improved not obvious.After experiment, body weight, 24h food ration and Abdominal girth index are in table 12.
Table 12 body weight, 24h food ration and Abdominal girth index (
)
Note: compare with blank group, ★ ★ P<0.O1; Compare with model group, Δ P<0.05.
Build up rear body weight by table 12 visual animal model to decline to a great extent, have certain clear-cutting forestland, but weight recovery is more remarkable after Pingwei San and compositions treatment.After modeling, animal 24h food ration obviously reduces, and progressively recovers after treatment.After modeling, animal Abdominal girth index obviously raises, and has reduction trend after treatment.
5.6.2 the measurement result of gastric emptying and Intestinal propulsive rate is in table 13.
Table 13 gastrointestinal motility changes of function (
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.01; Compare with model group, Δ P<0.05, Δ Δ P<0.01.
After being built up by the visible model of table 13, model group animal Stomach residue rate raises, and gastric emptying ability reduces, and continue in clear-cutting forestland process to reduce, Pingwei San group and combination group are slightly better than natural recovering group, and wherein the curative effect of the high, medium and low dosage group of compositions is better than Pingwei San; Model group gastrointestinal propulsive movement declines, and obviously improves after compositions treatment.
5.6.3 the measurement result of serum gastrin and motilin content is in table 14.
Table 14 gastrin and motilin changes of contents (
)
Note: compare with blank group, ★ P<0.05, ★ ★ P<0.01; Compare with model group, Δ P<0.05, Δ Δ P<0.01.
Build up rear serum gastrin content by table 14 visual animal model to reduce, after Pingwei San, compositions high dose, middle dosage and low dose therapy, serum gastrin content is on the rise, and wherein the curative effect of compositions high dose, middle dosage and low dose group is better than Pingwei San group.After modeling, motilin content raises, and clear-cutting forestland process relaying height of continuing rising, after Pingwei San group and each dosage group of compositions are treated, compares with model group, have downward trend, but not statistically significant.
5.6.4 gastrointestinal tissue's pathological observation
Have 1 rats death in modeling process, find after dissecting, flatulence is obvious, and gastrointestinal wall is obviously thinning, and coat of the stomach blood vessel exposes, and gastric mucosa has and is dispersed in petechia on a small quantity.Found by model group rats when dissected, most animals flatulence is obvious, and gastric remains nutrition and sticks with paste more, and nutrition is stuck with paste shorter at little enteral advance distance.After HE dyeing, observe under ordinary optical microscope and find, model group animal intestines and stomach tissue adherence defect, mucous layer has a small amount of congestion and edema, and be dispersed in a small amount of inflammatory cell of distribution, tela submucosa has a large amount of inflammatory cell.Pingwei San group, compositions each dosage treated animal pathological changes is recovered substantially, and natural recovering group is without obvious change.
Pharmaceutical composition of the present invention is that each herbal medicine " formulary of peaceful benevolent dispensary " being recorded classic prescriptions Pingwei San extracts, extract is carried out dosage ratio as effective ingredient, proved by above-mentioned experiment, therapeutical effect after extract combination is better than the raw material not carrying out extracting, and is better than traditional Pingwei San curative effect.In addition, pharmaceutical composition of the present invention, except extremely having except good therapeutical effect gastrointestinal disease and gastrointestinal function, also has regulating action for immunologic dysfunction.
Claims (4)
1. treat the pharmaceutical composition of gastrointestinal disease for one kind, it is characterized in that: it is made up of following component and weight ratio: Rhizoma Atractylodis extract 20 weight portion, Cortex Magnoliae Officinalis extract 20 weight portion, Pericarpium Citri Reticulatae extract 10 weight portion, Radix Glycyrrhizae extract 10 weight portion, described Rhizoma Atractylodis extract is the ethanol extraction of Chinese medicine Rhizoma Atractylodis; Described Cortex Magnoliae Officinalis extract is the ethanol extraction of Cortex Magnoliae Officinalis; Pericarpium Citri Reticulatae extract is the ethanol extraction of Chinese medicine Pericarpium Citri Reticulatae; Radix Glycyrrhizae extract is the ethanol extraction of glycyrrhiza uralensis fisch.
2. prepare a kind of preparation method for the treatment of the pharmaceutical composition of gastrointestinal disease according to claim 1, it is characterized in that: it comprises the following steps:
s1:raw material is taken by aforementioned component and weight ratio;
s2:after raw material mix homogeneously, add pharmaceutically acceptable adjuvant and be prepared into pharmaceutically conventional pharmaceutical preparation.
3. the pharmaceutical composition for the treatment of gastrointestinal disease according to claim 1, is characterized in that: described dosage form is pill, powder, tablet, capsule, powder, granule, syrup, oral liquid, freeze-dried powder or injection.
4. the application of pharmaceutical composition as claimed in claim 1 in preparation treatment retention of dampness in middle-JIAO type gastrointestinal disease medicine.
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Granted publication date: 20151202 Termination date: 20180813 |