CN102266381B - Medicinal composition for treating ulcerative colitis and preparation method and application thereof - Google Patents
Medicinal composition for treating ulcerative colitis and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for treating ulcerative colitis. The medicinal composition is a medicament prepared from the following raw materials in parts by weight: 20-30 parts of astragalus root and 4.5-9 parts of lightyellow sophora root. The invention further provides a preparation method of the medicinal composition. Compared with contents disclosed by a patent of which the application number is 200410040960.7, the medicinal composition has a better ulcerative colitis curative effect and a more reasonable formula. According to the invention, a new administration option is provided for clinical use.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of treating ulcerative colitis.Belong to drug world.
Background technology
(Ulcerative Colitis UC) claims nonspecific ulcerative colitis again to ulcerative colitis, is inflammatory bowel (Inflammato boweldisease, IBD) a kind of.The main diseases that IBD has become generally acknowledged chronic diarrhea therefore one, and be considered in the gastrointestinal tract one of disease the most serious except that cancerating.Doctor trained in Western medicine is mainly aminosallcylic acid class, adrenocortical hormones, immunomodulator etc. to the medicine of primary disease treatment, has obtained certain therapeutic effect, but because of the toxic and side effects of these medicines is bigger, can not life-time service, often cause the state of an illness repeatedly.This research is intended with the Radix Astragali, Radix Sophorae Flavescentis compatibility, and Radix Astragali replenishing QI to invigorate the spleen yang invigorating is controlled insufficiency of the spleen sinking of QI of middle-JIAO, chronic diarrhea chronic dysentery, and the Radix Sophorae Flavescentis heat clearing and damp drying is controlled hematodiarrhoea, has blood in stool.
Number of patent application: 200410040960.7; Denomination of invention: a kind of pharmaceutical composition of treating ulcerative colitis; This invention provides a kind of pharmaceutical composition of treating ulcerative colitis; It is that containing by the Radix Astragali, Radix Sophorae Flavescentis is the medicament that feedstock production forms, and wherein, the weight proportion of the Radix Astragali, Radix Sophorae Flavescentis is: Radix Astragali 2-6 part, Radix Sophorae Flavescentis 3-7 part; 4 parts of the preferred Radixs Astragali, 4 parts of Radix Sophorae Flavescentiss, this invention drug regimen raw material refining formula, drug dose is little, material base is clear and definite, determined curative effect, toxic and side effects are little; Colon targeting preparation of the present invention has dosage form novelty, medicine and directly is positioned target area (colon), makes the target area drug level be higher than other normal structure, reduces systemic side effects, and taking convenience, dose is little, material base is clear and definite, curative effect is more remarkable.Find in the effect experiment that this ratio range also fails to bring into play best drug effect.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition of treating ulcerative colitis.Another technical scheme of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition of treating ulcerative colitis, it is the medicament that is prepared from the following weight proportion raw material: 4.5～9 parts of Radix Astragali 20-30 part, Radix Sophorae Flavescentiss.
Further, it is the medicament that is prepared from the following weight proportion raw material: 30 parts of the Radixs Astragali, 7～9 parts of Radix Sophorae Flavescentiss.
Further, it is the medicament that is prepared from the following weight proportion raw material:
30 parts of the Radixs Astragali, 9 parts of Radix Sophorae Flavescentiss.
Medicine of the present invention is by the former powder of the Radix Astragali or water extract or alcohol extract, is mixed into active component with the former powder of Radix Sophorae Flavescentis or water extract or alcohol extract, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described medicament is oral formulations or external preparation.
Wherein, Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids are contained in the every preparation unit of described medicament, and its weight proportion is: Radix Astragali saponin 17.85-33.15 part, astragalus polysaccharides 30.45-56.55 part, Radix Sophorae Flavescentis total alkaloids 25.2-46.8 part.
Further preferably, the weight proportion of described Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids is: 25.5 parts of Radix Astragali saponins, 43.5 parts of astragalus polysaccharidess, 36 parts of Radix Sophorae Flavescentis total alkaloidss.
Wherein, described external preparation is: rectum is with suppository, washing liquid.
Wherein, described oral formulations is: granule, pill, powder, tablet, capsule, mixture, colon targeting preparation.
The present invention also provides a kind of method for preparing the pharmaceutical composition of treating ulcerative colitis, and it comprises the steps:
A, take by weighing each materials of weight proportions: 30 parts of the Radixs Astragali, 4.5～9 parts of Radix Sophorae Flavescentiss:
The former powder of b, the former powder of getting the Radix Astragali or water extract or alcohol extract and Radix Sophorae Flavescentis or water extract or alcohol extract mix, and add acceptable accessories or complementary composition and are prepared into medicament pharmaceutically commonly used.
Medicine of the present invention and number of patent application: 200410040960.7 disclosed contents are compared, and it is more excellent to be used to treat the ulcerative colitis drug effect, and it is more reasonable to fill a prescription, and provide a kind of new medication to select for clinical.
Description of drawings
The colon pathological section of Fig. 1 mice ulcerative colitis * 100 normal group
The colon pathological section of Fig. 2 mice ulcerative colitis * 100 model ulcer groups
The colon pathological section of Fig. 3 mice ulcerative colitis * 100 proportioning groups 1 (fibrosis)
The colon pathological section of Fig. 4 mice ulcerative colitis * 100 proportioning groups 2 (lymph foilicie hyperplasia)
The colon pathological section of Fig. 5 mice ulcerative colitis * 100 proportioning groups 3 (erosion)
The colon pathological section of Fig. 6 mice ulcerative colitis * 100 proportioning groups 4 (table fester)
The colon pathological section of Fig. 7 mice ulcerative colitis * 100 proportioning groups 5 (lymph foilicie hyperplasia)
The colon pathological section of Fig. 8 mice ulcerative colitis * 100 proportioning groups 6 (table fester)
The colon pathological section of Fig. 9 mice ulcerative colitis * 100 proportioning groups 7 (table fester)
The colon pathological section of Figure 10 mice ulcerative colitis * 100 proportioning groups 8 (table fester)
The colon pathological section of Figure 11 mice ulcerative colitis * 100 proportioning groups 10 (inflammation)
The colon pathological section of Figure 12 mice ulcerative colitis * 100 proportioning groups 11 (table fester)
The colon pathological section of Figure 13 mice ulcerative colitis * 100 proportioning groups 9 (normally)
The positive group in the colon pathological section of Figure 14 mice ulcerative colitis * 100 is normal
The specific embodiment
The preparation of embodiment 1 medicine of the present invention
Get Radix Astragali 3000g and add 12 times of water gagings, soaked 0.5 hour, decoct three times, each 2 hours, the gained extracting solution was evaporated to relative density 1.15g/ml, got Radix Astragali concentrated solution.Other gets Radix Sophorae Flavescentis 900g and adds 6 times of amount 60% alcohol reflux 3 times, each 2h, and gained extracting solution decompression recycling ethanol, being concentrated into relative density is 1.15g/ml, gets the Radix Sophorae Flavescentis concentrated solution.Radix Astragali concentrated solution and Radix Sophorae Flavescentis concentrated solution are pressed the recipe quantity mix homogeneously, add an amount of sucrose, dextrin system soft material, cross a sieve series grain, 50 ℃ of dryings of gained wet granular are crossed the sieve granulate No. one, the packing 1000g that gets product.
Below prove beneficial effect of the present invention through pharmacodynamics.
Experimental example 1 Radix Astragali and Radix Sophorae Flavescentis various dose are studied mice ulcerative colitis therapeutical effect than prescription
1. material
1.1 animal: Kunming mouse, cleaning level, male and female half and half, body weight 18-22g, reaching large bio tech ltd by Chengdu provides, the quality certification number: scxkc (111) 2008-24.
1.2 medical material: the Radix Astragali, Radix Sophorae Flavescentis; Purchase favorable to the people prepared slices of Chinese crude drugs Co., Ltd in Sichuan; Identify through chinese medicines centre teacher Lu Xianming of pharmaceutical college of Chengdu University of Traditional Chinese Medicine; The medical material of purchasing all meets Pharmacopoeia of the People's Republic of China standard, takes by weighing medical material in the prescription ratio, the two decocting liquid fully of obtaining through refining of pure water.Mice dosage is 20 times of administrations of people's consumption proportionately.The Radix Astragali and Radix Sophorae Flavescentis are respectively organized dose ratio (with reference to Chinese Pharmacopoeia single medical material consumption per day random pair), the mouse stomach volume is seen table 1.Sulfasalazine, Shanghai Sunve Pharmaceutical Co., Ltd., product batch number: 200804C04.Mouse stomach administration volume is 0.2mL/10g.
Different proportioning dosage of table 1 Radix Astragali and administration volume with Radix Sophorae Flavescentis
1.3 reagent: TNB (TNBS): sigma company produces, lot number: 107K5008.Dehydrated alcohol, ether, formaldehyde are analytical pure; Myeloperoxidase (MPO) (MPO) test kit, Nanjing is built up bio-engineering research and is provided, lot number: 20090918.
2 methods and result
2.2.1 the model copy method is got mice, fasting 24h before the modeling, etherization; Insert from anus gently with the mouse stomach syringe needle, the degree of depth is 4cm, pushes TNBS solution (5%TNBS solution and dehydrated alcohol mixed by 1: 1) 80mgL/kg; Clutch anus and hold 30s, postoperative is conventional raises.
2.2 after the medication modeling the 3rd day, animal pattern is divided into model group, 11 prescription groups; Positive drug sulfasalazine group, other establishes the normal control group, and begins simultaneously by above-mentioned dosed administration; Model group and normal control group are given the equal-volume distilled water, every day 1 time, 7d continuously.
2.3 detection index
2.3.1 activity of myeloperoxidase is pressed the test kit description and is handled sample, and measures and respectively organize sample MPO activity with UV-detector (UV1700 type, the production of Tecan company) survey light absorption value at the 460nm place.
2.3.2 light microscopy checking clip colonic pathological change the most obviously locate 2cm be put in the 10% neutral buffered formalin fixing, dehydration of alcohol, FFPE, slice thickness 4-6 micron, HE dyeing, light microscopy.Pathological changes is carried out classification by following standard:
Ulcer: divide three grades, 0-does not have, 1-aphtha (less than 3mm), the big ulcer of 2-(greater than 3mm)
Inflammation: 0-does not have, and 1-is slight, 2-severe
Granulation tissue: 0-does not have, and 1-has
The pathological changes degree of depth: 0-does not have, 1-tela submucosa, 2-flesh layer, 3-placenta percreta
Fibrosis: 0-does not have, and 1-is slight, 2-severe
2.3.4 the statistical method measurement data adopts the t check.
2.4 experimental result
2.4.1 the Radix Astragali and Radix Sophorae Flavescentis high dose can significantly resist the mice colon pathology damage that TNB causes than prescription, the immunoreation of ability agents enhance overall inflammatory obviously improves animal and has blood in stool, suffers from diarrhoea, lacks outward appearance signs such as moving, and curative effect is obvious.Colon MPO active testing result shows that model group mice colon MPO obviously raises, and administration group mice MPO then is starkly lower than model group, the wherein Radix Astragali: Radix Sophorae Flavescentis=30: 9 and 30: 7 effects are the most remarkable, with other ratio groups remarkable type difference are arranged.See table 2.
Table 2 MPO active testing result
Annotate: compare with model group,
*: P＜0.01,
*: P＜0.05; Compare with proportioning group 9,
The Δ ΔP＜0.01,
ΔP＜0.05
2.4.2 the down visible ulcer of om observation model arrangement of mirrors, pathological changes is mainly in tela submucosa, and tissue edema obviously reaches massive inflammatory cells infiltrated, is main with lymph foilicie hyperplasia.The also visible ulcer of the low proportioning group prescription group of Radix Astragali Radix Sophorae Flavescentis has significantly tissue edema and a large amount of cell infiltration.Less and the visible chronic ulcer tissue that has healed of Radix Astragali Radix Sophorae Flavescentis high mixture ratio group and sulfasalazine group ulcer, tissue edema and hyperemia obviously alleviate, and cell infiltration obviously reduces.The microscopy appraisal result is relatively seen table 3.
Table 3 microscopy appraisal result relatively
Annotate: compare with model group,
*: P＜0.01,
*: P＜0.05; Compare with proportioning group 9,
The Δ ΔP＜0.01,
ΔP＜0.05
3. discuss
(Ulcerative Colitis UC) is disease under a kind of agnogenic mucous membrane of colon and the mucosa to ulcerative colitis.Think that at present UC is that multiple reason causes, unbalance or the like like heredity, environment, immunity, short inflammation and anti-inflammatory factors.2,4,6-TNB (TNBS) is a kind of hapten material; After ethanol is burnt mucous membrane of colon, close, become antigen, make T lymphocyte sensitization with the lysine epsilon-amino unity of histone; Be destroyed with animal self cell of hapten, thereby cause enteritis to take place.The O that the TNBS metabolism produces
2 -, H
2O
2 -The toxic damages intestinal tissue and the epithelial cell of isoreactivity oxygen and peroxide.This animal pattern is prone to survival, makes simply, is one of now the most frequently used UC animal model.
Radix Astragali replenishing QI to invigorate the spleen yang invigorating is controlled insufficiency of the spleen sinking of QI of middle-JIAO, chronic diarrhea chronic dysentery, and astragalus polysaccharides and Radix Astragali saponin are the main extracts in the Radix Astragali, and the ability enhancing human body immunity is the material base of Radix Astragali performance pharmacological action; The Radix Sophorae Flavescentis heat clearing and damp drying is controlled hematodiarrhoea, has blood in stool, and Radix Sophorae Flavescentis alkaloid can be the material base of Radix Sophorae Flavescentis performance pharmacological action to anti-inflammatory response.This experiment is passed through to MPO active unit mensuration with to the interpretation of result of colon histopathology microscopy; The Radix Astragali: Radix Sophorae Flavescentis=30: 9 and 30: 7 o'clock curative effects are the most obvious; With other each groups significant difference is arranged relatively, as the Radix Astragali and kuh-seng formulation treatment ulcerative colitis optimal dose ratio.
Experimental example 2 Radixs Astragali and Radix Sophorae Flavescentis various dose are studied mice ulcerative colitis therapeutical effect than prescription
1. material
1.1 animal: Kunming mouse, cleaning level, male and female half and half, body weight 18-22g, reaching large bio tech ltd by Chengdu provides, the quality certification number: scxkc (111) 2008-24.
1.2 medical material: the Radix Astragali, Radix Sophorae Flavescentis; Purchase favorable to the people prepared slices of Chinese crude drugs Co., Ltd in Sichuan; Identify through chinese medicines centre teacher Lu Xianming of pharmaceutical college of Chengdu University of Traditional Chinese Medicine; The medical material of purchasing all meets Pharmacopoeia of the People's Republic of China standard, takes by weighing medical material in the prescription ratio, the two decocting liquid fully of obtaining through refining of pure water.Mice dosage is 20 times of administrations of people's consumption proportionately.The Radix Astragali and Radix Sophorae Flavescentis are respectively organized dose ratio (with reference to Chinese Pharmacopoeia single medical material consumption per day random pair), the mouse stomach volume is seen table 4.Sulfasalazine, Shanghai Sunve Pharmaceutical Co., Ltd., product batch number: 200804C04, proportionately 20 times of administrations of people's consumption of mice, i.e. 1g/kg, medicine is made into 0.05g/mL with distilled water, and mouse stomach administration volume is 0.2mL/10g.
Different proportioning dosage of table 4 Radix Astragali and administration volume with Radix Sophorae Flavescentis
1.3 reagent: glacial acetic acid: sigma company produces.Dehydrated alcohol, ether, formaldehyde are analytical pure; Myeloperoxidase (MPO) (MPO) test kit, Nanjing is built up bio-engineering research and is provided, lot number: 20090918.
2 methods and result
2.1 the model copy method is got mice, fasting 24h before the modeling, and etherization inserts from anus with the mouse stomach syringe needle gently, and the degree of depth is 4cm, pushes glacial acetic acid solution 80mL/kg, clutches anus and holds 30s, and postoperative is conventional raises.
2.2 after the medication modeling the 3rd day, animal pattern is divided into model group, 11 prescription groups; Positive drug sulfasalazine group, other establishes the normal control group, and begins simultaneously by above-mentioned dosed administration; Model group and normal control group are given the equal-volume distilled water, every day 1 time, 7d continuously.
2.3 detection index
2.3.1 activity of myeloperoxidase is pressed the test kit description and is handled sample, and measures and respectively organize sample MPO activity with UV-detector (UV1700 type, the production of Tecan company) survey light absorption value at the 460nm place.
2.3.2 light microscopy checking clip colonic pathological change the most obviously locate 2cm be put in the 10% neutral buffered formalin fixing, dehydration of alcohol, FFPE, slice thickness 4-6 micron, HE dyeing, light microscopy.Pathological changes is carried out classification by following standard:
Ulcer: divide three grades, 0-does not have, 1-aphtha (less than 3mm), the big ulcer of 2-(greater than 3mm)
Inflammation: 0-does not have, and 1-is slight, 2-severe
Granulation tissue: 0-does not have, and 1-has
The pathological changes degree of depth: 0-does not have, 1-tela submucosa, 2-flesh layer, 3-placenta percreta
Fibrosis: 0-does not have, and 1-is slight, 2-severe
2.3.4 the statistical method measurement data adopts the t check.
2.4 experimental result
2.4.1 the Radix Astragali and Radix Sophorae Flavescentis high dose can significantly resist the mice colon pathology damage that glacial acetic acid causes than prescription, the immunoreation of ability agents enhance overall inflammatory obviously improves animal and has blood in stool, suffers from diarrhoea, lacks outward appearance signs such as moving, and curative effect is obvious.Colon MPO active testing result shows that model group mice colon MPO obviously raises, and administration group mice MPO then is starkly lower than model group, and proportioning group 9MPO activity significantly is lower than all the other each proportioning groups (P＜0.05) and sees table 5.
Table 5 MPO active testing result
Annotate: compare with model group,
*: P＜0.01,
*: P＜0.05; Compare with proportioning group 9,
The Δ ΔP＜0.01,
ΔP＜0.05
2.4.2 the down visible ulcer of om observation model arrangement of mirrors, the down visible ulcer of model arrangement of mirrors, pathological changes is mainly in tela submucosa, and tissue edema obviously reaches massive inflammatory cells infiltrated, is main with lymph foilicie hyperplasia.The also visible ulcer of administration group has significantly tissue edema and a large amount of cell infiltration, wherein assembly than group 9 and sulfasalazine group ulcer the less and visible chronic ulcer tissue that has healed, tissue edema and hyperemia obviously alleviate, cell infiltration obviously reduces.Each organizes pathological section as follows.The microscopy appraisal result is relatively seen table 6, Fig. 1
Table 6 microscopy appraisal result relatively
Annotate: compare with model group,
*: P＜0.01,
*: P＜0.05; Compare with proportioning group 9,
The Δ ΔP＜0.01,
ΔP＜0.05
Conclusion: this experiment causes the therapeutical effect research of mice ulcerative colitis to glacial acetic acid through the different proportioning prescriptions of Radix Astragali Radix Sophorae Flavescentis; To MPO active unit mensuration with to the interpretation of result of colon histopathology microscopy; The Radix Astragali: Radix Sophorae Flavescentis=30: 9 and 30: 7 o'clock curative effects are the most obvious, can the immunoreation of agents enhance overall inflammatory, improve obviously that animal is had blood in stool, suffers from diarrhoea, few outward appearance sign such as moving; Curative effect is obvious, as the Radix Astragali and kuh-seng formulation treatment ulcerative colitis optimal dose.
Experimental example 3 Radix Astragali saponins, astragalus polysaccharides, three kinds of active components of Radix Sophorae Flavescentis total alkaloids are united the therapeutical effect research to the rat ulcer colitis
1. material
1.1 medical material: the Radix Astragali, Radix Sophorae Flavescentis, purchase favorable to the people prepared slices of Chinese crude drugs Co., Ltd in Sichuan, identify that with identifying professor Pei Jin the medical material of purchasing all meets Pharmacopoeia of the People's Republic of China standard through pharmaceutical college of Chengdu University of Traditional Chinese Medicine Chinese medicine medicinal plant cultivation.The extraction of Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids, separation and purifying process are provided by Chinese drugs agentia laboratory professor Yang Ming of Chengdu University of Traditional Chinese Medicine.
1.2 reagent: TNB (TNBS): sigma company produces, lot number: 107K5008.Dehydrated alcohol, ether, formaldehyde are analytical pure; Myeloperoxidase (MPO) (MPO) test kit builds up bio-engineering research by Nanjing provides lot number: 20090918.
1.3 laboratory animal grouping and administration SD rat are divided into 6 groups by body weight, 15 every group after adapting to week raising at random.
Normal group: irritate stomach and give normal saline, 1 time/day, each 2mL/100g rat.
Model group: irritate stomach and give normal saline, 1 time/day, each 2mL/100g rat.
Positive controls: 0.6g/kg irritates stomach and gives sulfasalazine solution.
Mixed active component high dose group: contain Radix Astragali saponin 25.5mg, astragalus polysaccharides 43.5mg, Radix Sophorae Flavescentis total alkaloids 36mg respectively in the every 1ml medicinal liquid of mixed active component high dose group, press 20ml/kg dosage gastric infusion for every.
Dose groups in the mixed active component: contain Radix Astragali saponin 12.75mg, astragalus polysaccharides 21.75mg, Radix Sophorae Flavescentis total alkaloids 18mg respectively in the every 1ml medicinal liquid of dose groups in the mixed active component, press 20ml/kg dosage gastric infusion for every.
Mixed active component low dose group: contain Radix Astragali saponin 6.375mg, astragalus polysaccharides 10.875mg, Radix Sophorae Flavescentis total alkaloids 9mg respectively in the every 1ml medicinal liquid of mixed active component low dose group, press 20ml/kg dosage gastric infusion for every.
2 methods and result
2.1 before the experiment of model copy method, with all rat fasting 24 hours.After 24 hours, except that normal group, other group rats by intraperitoneal injection 20% urethane solution (6ml/kg) anesthesia; The rubber tube for transfusion that the about 2mm of one diameter is about 12cm is by the light and slow insertion of anus; The degree of depth is 8cm, pushes 2%TNBS solution 100mg/kg, makes the animal nature that keeps lying low clear-headed.
2.2 after the medication modeling the 2nd day, treat that animal revives, and is divided into model group with animal pattern; Positive drug sulfasalazine group, dose groups, mixed active low dose group in mixed active component high dose group, the mixed active component, other establishes the normal control group; And begin dosed administration simultaneously by 20ml/kg; Model group and normal control group are given the equal-volume normal saline, every day 1 time, 7d continuously.
2.3 detection index
2.3.1 activity of myeloperoxidase is pressed the test kit description and is handled sample, and mensuration is respectively organized, and sample MPO is active to survey light absorption value with UV-detector at the 460nm place.
2.3.2 light microscopy checking clip colonic pathological change the most obviously locate 2cm be put in the 10% neutral buffered soap aldehyde solution fixing, dehydration of alcohol, FFPE, slice thickness 4-6 micron, HE dyeing, light microscopy.
Pathological changes is carried out classification by following standard:
Ulcer: divide three grades, 0-does not have, 1-aphtha (less than 3mm), the big ulcer of 2-(greater than 3mm)
Inflammation: 0-does not have, and 1-is slight, 2-severe
Granulation tissue: 0-does not have, and 1-has
The pathological changes degree of depth: 0-does not have, 1-tela submucosa, 2-flesh layer, 3-placenta percreta
Fibrosis: 0-does not have, and 1-is slight, 2-severe
2.3.4 statistical method metering material adopts the t check.
2.4 experimental result
2.4.1 the observed result of outward appearance sign
All occurred having blood in stool in the 2nd day after each treated animal modeling, the diarrhoea situation, anorexia, lazy moving phenomenon appear in most of animals.Compare with model group, each administration group is had blood in stool, the diarrhoea degree is lighter, and the persistent period shortens, and wherein positive group and mixed active component high dose group integral animal are in the best state.
2.4.2MPO active testing interpretation of result
Mixed active component high dose group can significantly be resisted the mice colon pathology damage that TNB causes, and the immunoreation of ability agents enhance overall inflammatory obviously improves animal and has blood in stool, suffers from diarrhoea, lacks outward appearance signs such as moving, and curative effect is obvious.Compare with model group, each the administration group MPO of colon level all significantly reduces, and wherein mixed active component high dose group, positive controls have significance to reduce (p＜0.05), and MPO active testing result sees table 7.
Table 7 MPO active testing is Ug as a result
-1(
N=8)
Annotate: compare with model group,
*: P＜0.01,
*: P＜0.05; Compare with positive group,
The Δ ΔP＜0.01,
ΔP＜0.05 time with.
2.4.3 the heavy coefficient of colon intestinal
Compare with model group, positive controls, mixed active component high dose, the heavy coefficient of low dose group intestinal extremely significantly reduce (P＜0.01), and middle dose groups significance reduces (P＜0.05).This index test result shows that the mixed active composition has the hamartoplasia that good antagonism colon inflammatory reaction causes.
2.4.4 the down visible ulcer of om observation model arrangement of mirrors, pathological changes is mainly in tela submucosa, and tissue edema obviously reaches massive inflammatory cells infiltrated, is main with lymph foilicie hyperplasia, and figure sees Figure 1B and C.In the mixed active component, the also visible ulcer of low dose group, significantly tissue edema and a large amount of cell infiltration are arranged, figure sees Fig. 1 D, E and F.Less and the visible chronic ulcer tissue that has healed of mixed active component high dose group and sulfasalazine group ulcer, tissue edema and hyperemia obviously alleviate, and cell infiltration obviously reduces, and figure sees G and H.The microscopy appraisal result is relatively seen table 8.
The result (
n=8) of heavy coefficient of each treated animal colon intestinal of table 8 and degree of tissue damage
Compare with model group, the heavy coefficient of dose groups intestinal significantly reduces (p＜0.05) in positive controls, mixed active component high dose group, the mixed active component; Each the administration group MPO of colon level all significantly reduces, and wherein mixed active component high dose group, positive controls have significance to reduce (p＜0.05), in, low dose group has treatment trend; Compare with model group, each administration group colon learns damage index and all significantly reduces, and wherein mixed active component high dose group, positive group have utmost point significant difference (p＜0.01).
Conclusion Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids synergy can resist the rat colon histopathology damage that TNB causes, and the immunoreation of ability agents enhance overall inflammatory obviously improves animal and has blood in stool, suffers from diarrhoea, lacks outward appearance signs such as moving, and curative effect is obvious.
Claims (2)
1. pharmaceutical composition of treating ulcerative colitis, it is characterized in that: it is the medicament that is prepared from the following weight proportion raw material: 30 parts of the Radixs Astragali, 7～9 parts of Radix Sophorae Flavescentiss.
2. the pharmaceutical composition of treatment ulcerative colitis according to claim 1 is characterized in that: it is the medicament that is prepared from the following weight proportion raw material:
30 parts of the Radixs Astragali, 9 parts of Radix Sophorae Flavescentiss.
3, the pharmaceutical composition of treatment ulcerative colitis according to claim 1 and 2; It is characterized in that: it is by the former powder of the Radix Astragali or water extract or alcohol extract; Be mixed into active component with the former powder of Radix Sophorae Flavescentis or water extract or alcohol extract, add the medicament that acceptable accessories or complementary composition are prepared from.
4, the pharmaceutical composition of treatment ulcerative colitis according to claim 3 is characterized in that: described medicament is oral formulations or external preparation.
5, the pharmaceutical composition of treatment ulcerative colitis according to claim 4; It is characterized in that: Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids are contained in the every preparation unit of described medicament, and its weight proportion is: Radix Astragali saponin 17.85-33.15 part, astragalus polysaccharides 30.45-56.55 part, Radix Sophorae Flavescentis total alkaloids 25.2-46.8 part.
6, the pharmaceutical composition of treatment ulcerative colitis according to claim 5 is characterized in that: the weight proportion of described Radix Astragali saponin, astragalus polysaccharides, Radix Sophorae Flavescentis total alkaloids is: 25.5 parts of Radix Astragali saponins, 43.5 parts of astragalus polysaccharidess, 36 parts of Radix Sophorae Flavescentis total alkaloidss.
7, according to the pharmaceutical composition of any described treatment ulcerative colitis of claim 4-6, it is characterized in that: described external preparation is: rectum is with suppository, washing liquid.
8, the pharmaceutical composition of treatment ulcerative colitis according to claim 4 is characterized in that: described oral formulations is: granule, pill, powder, tablet, capsule, mixture, colon targeting preparation.
9, a kind of method for preparing the pharmaceutical composition of treating ulcerative colitis, it comprises the steps:
A, take by weighing each materials of weight proportions: 30 parts of the Radixs Astragali, 7～9 parts of Radix Sophorae Flavescentiss:
The former powder of b, the former powder of getting the Radix Astragali or water extract or alcohol extract and Radix Sophorae Flavescentis or water extract or alcohol extract mix, and add acceptable accessories or complementary composition and are prepared into medicament pharmaceutically commonly used.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110212265 CN102266381B (en) | 2010-07-29 | 2011-07-27 | Medicinal composition for treating ulcerative colitis and preparation method and application thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010239467.3 | 2010-07-29 | ||
| CN201010239467 | 2010-07-29 | ||
| CN 201110212265 CN102266381B (en) | 2010-07-29 | 2011-07-27 | Medicinal composition for treating ulcerative colitis and preparation method and application thereof |
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| 盛艳梅，等.中药新复方愈肠宁的组方研究.《医药导报》.2008,第27卷(第3期),第259页"2 实验方法与结果". |
| 盛艳梅,等.中药新复方愈肠宁的组方研究.《医药导报》.2008,第27卷(第3期),第259页"2 实验方法与结果". * |
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