CN1616011A - Medicinal composition for treating ulcerative colitis and its preparing method - Google Patents
Medicinal composition for treating ulcerative colitis and its preparing method Download PDFInfo
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Abstract
The medicine composition for treating ulcerative colitis has the active components from the ten kinds of Chinese medicinal materials, including pulsatillae root, ash bark, phellodendron bark, Chinese goldthread, gromwell, etc. The enema with the medicine composition as active components may be used in treating ulcerative colitis. The medicine composition has strict recipe, obvious treating effect and low cost, and it is prepared into biological adhering preparation for enema capable of acting on the disease site directly and prolonging the medicine releasing period.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of ulcerative colitis and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Ulcerative colitis is a worldwide difficult problem medically at present, and its etiology unknown does not still have final conclusion so far, in case take place, the touching delay of its course of disease often presents outbreak---alleviates alternative repeatedly variation, the healing difficulty is very big.The ulcerative colitis sickness rate is 5～12,/10 ten thousand, belongs to the sickness rate disease with high, can betide each age group, is many with 20～40 years old, men and women's sickness rate no significant difference.In the treatment of ulcerative colitis, western medical treatment focuses on eliminates symptom, control of seizures, minimizing recurrence, and medicine commonly used is SASP, hormone and immunosuppressant, but these drug side effectes are big; The surgery treatment that can undergo surgery, misery is bigger; Curative effect is not very desirable.At present clinical this disease is lacked effective treatment means, do not have specific drug to occur as yet.
Organic conception and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs are two big characteristics of Chinese medicine, and multicomponent, multipath, many target spots are brought into play the characteristic that its curative effect is a Chinese medicine, and this makes Chinese medicine embody impayable advantage in the disease treatment that the cause of disease is difficult to determine.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of ulcerative colitis.
Second purpose of the present invention is to provide a kind of bioadhesive polymer for the treatment of ulcerative colitis.
Another object of the present invention is to provide the preparation method of this pharmaceutical composition and bioadhesive polymer.
For achieving the above object, the present invention is by the following technical solutions:
A kind of pharmaceutical composition for the treatment of ulcerative colitis, its active component are made up of following raw materials according or are made up of water and/or alcohol extract that following raw materials according is made: the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Cortex Phellodendri 2～6 weight portions, Rhizoma Coptidis 1～3 weight portion, Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, Radix Rubiae 1～4 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, Indigo Naturalis 3～7 weight portions.
For reaching better effect, described active ingredient in pharmaceutical further is made up of water and/or alcohol extract that the raw material of the raw material of following parts by weight or following parts by weight is made: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 4.5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 5 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 5 weight portions, Indigo Naturalis 5 weight portions.
A kind of bioadhesive polymer for the treatment of ulcerative colitis is made up of aforementioned pharmaceutical compositions and adjuvant carbomer and sodium carboxymethyl cellulose, and adjuvant is 0.5～2 times of pharmaceutical composition gross weight, and the ratio of weight and number of carbomer and sodium carboxymethyl cellulose is 0.2～0.8.
This preparation prescription prescription science, rigorous derives from the ancient prescription Radix Pulsatillae Decoction, and year clinical syndrome differentiation treatment is repeatedly practised plus-minus and formed surplus my institute 20.
The Radix Pulsatillae is the dry root of ranunculaceae plant Radix Pulsatillae Pulsatilla chinensis (Bge.) Regel, and function heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery are used for toxic-heat and blood stasis, amebic dysentery etc.Modern study shows, its main effective ingredient is pentacyclic triterpene saponin and Anemonin, protoanemonin etc., has effects such as antibiotic, anti-ameba, anti-trichomonas vaginitis, antitumor.
Cortex Fraxini is dry branch skin or the dried bark of Oleaceae plant fraxinus rhynchophylla Hance Fraxinus rhynchophylla Hance, Chinese ash Fraxinuschinensis Roxb., sharp leaf Chinese ash Fraxinus szaboana Lingelsh., place post Chinese ash Fraxinusstylosa Lingeish., function heat clearing and damp drying, astringent therapy, make eye bright, be used for hematodiarrhoea, have loose bowels, leucorrhea with red and white discharge, conjunctival congestion and swelling pain, order give birth to nebula film etc.Modern study shows that its main effective ingredient is free Coumarins, has effects such as antibiotic, antiinflammatory, analgesia.
Cortex Phellodendri is the dry bark of rutaceae wampee Phellodendron chinense Schneid. or Cortex Phellodendri Phellodendronamurense Rupr., function heat clearing and damp drying, pathogenic fire purging remove steams, detoxifies and treat skin ulcer, is used for damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, eczema pruritus etc.Modern study shows that its main effective ingredient is alkaloidss such as berberine, phellodendrine, has effects such as antibiotic, antiviral, antiinflammatory.
Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao Coptis deltoideaC.Y.Cheng et Hsiao or Coptis teeta Coptis teeta Wall., function heat clearing and damp drying, eliminating fire and detoxication are used for damp and hot feeling of fullness, vomiting acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, dysphoria and insomnia, carbuncle furuncle etc.Modern study shows that its main effective ingredient is a free Coumarins etc., has effects such as antibiotic, anti-inflammatory and antalgic.
Radix Arnebiae (Radix Lithospermi) is the dry root of comfrey lithospermum euchromum Royle Arnebia euchroma (Royle) Johnst., Radix Arnebiae (Radix Lithospermi) Lithospermum erythrorhizon Sieb.et Zucc. or arnebia guttata Bunge Arnebia guttata Bunge, function removing heat from blood and promoting blood circulation, detoxifcation rash are used for that heat in blood poison is contained, purple black, the measles without adequate eruption of macule, skin infection, eczema, burn due to hot liquid or fire etc.Modern study shows that its main effective ingredient is naphthoquinone class pigment, lithosperman etc., has antibiotic, antiinflammatory, antiviral, hemostasis and regulates effect such as immunity.
Herba Agrimoniae is the dry aerial parts of rosaceous plant Radix Agrimoniae Agrimonia pilosa Ledeb., function astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving, detoxifcation, strong are used for hemoptysis, haematemesis, metrostaxis, malaria, dysentery, take off power impairment caused by overstrain, carbuncle sore tumefacting virus, pudendal pruritus leukorrhagia.Modern study shows that its main effective ingredient is agrimophol, agrimonolide, hyperin etc., has antibiotic, antitumor, antiviral and effect such as strong.
The Fructus Chebulae is the dry mature fruit of Combretum Racemosum plant Fructus Chebulae Terminalia chebula Retz. or fine hair Fructus Chebulae Terminaliachebula Retz.var.tomentella Kurt., the function astringing intestine to stop diarrhea is astringed the lung, the pathogenic fire reducing sore-throat relieving, is used for the chronic diarrhea chronic dysentery, the proctoptosis of having blood in stool, the deficiency of the lung are breathed with cough, chronic cough more than, the pharyngalgia hoarseness.Modern study shows that its main effective ingredient is a tannin etc., has effects such as antibiotic, antitumor and astringing to arrest diarrhea.
Radix Rubiae is dry root and the rhizome of Maguireothamnus speciosus Radix Rubiae Rubia cordifolia L., and function cooling blood for hemostasis, blood stasis dispelling stimulate the menstrual flow, and is used for haematemesis, epistaxis, metrorrhagia, traumatic hemorrhage, the resistance of the amenorrhea stasis of blood, arthralgia, tumbling and swelling.Modern study shows that its main effective ingredient is Rubidate, anthraquinone pigments etc., has effects such as hemostasis, antibiotic, antitumor.
Pseudobulbus Bletillae (Rhizoma Bletillae) is the dry tuber of orchid Pseudobulbus Bletillae (Rhizoma Bletillae) Bletilla striata (Thunb.) Reichb.f., function astringing to arrest bleeding, detumescence and promoting granulation are used for hemoptysis haematemesis, traumatic hemorrhage, sore swollen toxin, chapped skin, hemoptysis of pulmonary tuberculosis, digestive ulcerative bleeding.Modern study shows that its main effective ingredient is a Rhizoma Bletillae gel, and bletilla polysaccharide etc. have hemostasis, effect such as antibiotic.
Indigo Naturalis is the leaf of acanthaceous vegetable acanthaceous indigo Baphicacanthus cusia (Nees) Bremek., polygonaceae plant polygonum tinctorium ait. Polygonum tinctorium Ait. or cruciferae isatis Isatis indigotica Fort. or dried powder or the agglomerate that stem and leaf makes through processing.Function heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion are used for maculae caused by violent heat pathogen, heat in blood is told nosebleed, chest pain spitting of blood, aphtha, mumps, sore throat, pediatric epilepsy scared.Modern study shows, its main effective ingredient is an indirubin, indigo etc., has antitumor, effect such as antibiotic.
A kind of preparation method for the treatment of the pharmaceutical composition and the bioadhesive polymer of ulcerative colitis, this method may further comprise the steps:
(1) get the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get Rhizoma Coptidis 1～3 weight portion, Cortex Phellodendri 2～6 weight portions, Radix Rubiae 1～4 weight portion, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get Indigo Naturalis 3～7 weight portions and add.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer and sodium carboxymethyl cellulose again, makes bioadhesive polymer.Adjuvant is 0.5～2 times of pharmaceutical composition gross weight, and carbomer and sodium carboxymethyl cellulose parts by weight scope ratio are 0.2～0.8.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
A kind of preparation method for the treatment of the pharmaceutical composition and the bioadhesive polymer of ulcerative colitis, this method may further comprise the steps:
(1) get the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Rhizoma Coptidis 1～3 weight portion, Cortex Phellodendri 2～6 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, with 50% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, Radix Rubiae 1～4 weight portion, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get Indigo Naturalis 3～7 weight portions and add.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer and sodium carboxymethyl cellulose again, makes bioadhesive polymer.Adjuvant is 0.5～2 times of pharmaceutical composition gross weight, and carbomer and sodium carboxymethyl cellulose parts by weight scope ratio are 0.2～0.8.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Choice of preservatives and dosage are this area routine techniques, and so non-main points of the present invention are not superfluous stating.
Advantage of the present invention is: this product be under instruction of Chinese Medicine theory prescription, be prepared from by natural Chinese medicinal herb, the simple YAOJING in side, merit is specially imitated work, is used for ulcerative colitis treatment, clinical efficacy is definite, and is rapid-action, transference cure is fast, and is safe in utilization.Adopt modern means of science and technology, make the biologic adhesion preparation of slow release after, make drug release rate slow down, duration of efficacy is long, clinical efficacy is more remarkable.
The invention will be further described below in conjunction with the specific embodiment, but enforcement of the present invention is not subjected to the restriction of embodiment.
The specific embodiment
Embodiment 1
Prescription: the Radix Pulsatillae 7 weight portions, Cortex Fraxini 5 weight portions, Cortex Phellodendri 5 weight portions, Rhizoma Coptidis 2 weight portions, Radix Arnebiae (Radix Lithospermi) 3 weight portions, Herba Agrimoniae 4 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 4 weight portions, Indigo Naturalis 4 weight portions.
(1) get 7 parts of the Radix Pulsatillaes, 5 parts of Cortex Fraxinis, 4 parts of Herba Agrimoniaes, 3 parts of Fructus Chebulaes, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 2 parts of Rhizoma Coptidis, 5 parts of Cortex Phellodendris, 3 parts in Radix Rubiae, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 3 parts of Radix Arnebiae (Radix Lithospermi)s, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 4 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1. 03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 4 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 1: 2, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 2
Prescription: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 6 weight portions, Cortex Phellodendri 4 weight portions, Rhizoma Coptidis 1 weight portion, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 4 weight portions, Fructus Chebulae's 2 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 5 weight portions, Indigo Naturalis 5 weight portions.
(1) get 5 parts of the Radix Pulsatillaes, 6 parts of Cortex Fraxinis, 4 parts of Herba Agrimoniaes, 2 parts of Fructus Chebulaes, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 1 part of Rhizoma Coptidis, 4 parts of Cortex Phellodendris, 3 parts in Radix Rubiae, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 5 parts of Radix Arnebiae (Radix Lithospermi)s, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 5 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 5 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 2: 3, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 3
Prescription: the Radix Pulsatillae 3 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 4 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 4 weight portions, Herba Agrimoniae 4 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 2 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 6 weight portions, Indigo Naturalis 5 weight portions.
(1) get 3 parts of the Radix Pulsatillaes, 4 parts of Cortex Fraxinis, 4 parts of Herba Agrimoniaes, 3 parts of Fructus Chebulaes, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 3 parts of Rhizoma Coptidis, 4 parts of Cortex Phellodendris, 2 parts in Radix Rubiae, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 4 parts of Radix Arnebiae (Radix Lithospermi)s, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 6 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 5 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 1: 1, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 4
Prescription: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 4.5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 5 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 6 weight portions, Indigo Naturalis 5 weight portions.
(1) get 5 parts of the Radix Pulsatillaes, 4 parts of Cortex Fraxinis, 5 parts of Herba Agrimoniaes, 3 parts of Fructus Chebulaes, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 3 parts of Rhizoma Coptidis, 4.5 parts of Cortex Phellodendris, 3 parts in Radix Rubiae, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 5 parts of Radix Arnebiae (Radix Lithospermi)s, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 6 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 5 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 1: 3, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 5
Prescription: the Radix Pulsatillae 4 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 6 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 4 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 6 weight portions, Indigo Naturalis 5 weight portions.
(1) get 4 parts of the Radix Pulsatillaes, 4 parts of Cortex Fraxinis, 5 parts of Cortex Phellodendris, 3 parts of Rhizoma Coptidis, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 6 parts of Herba Agrimoniaes, 3 parts of Fructus Chebulaes, with 50% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 5 parts of Radix Arnebiae (Radix Lithospermi)s, 4 parts in Radix Rubiae, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 6 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 5 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 1: 3, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 6
Prescription: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 3 weight portions, Cortex Phellodendri 5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 6 weight portions, Herba Agrimoniae 5 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 4 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 5 weight portions, Indigo Naturalis 5 weight portions.
(1) get 5 parts of the Radix Pulsatillaes, 3 parts of Cortex Fraxinis, 5 parts of Cortex Phellodendris, 3 parts of Rhizoma Coptidis, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation.The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby.
(2) get 5 parts of Herba Agrimoniaes, 3 parts of Fructus Chebulaes, with 50% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged.Filtrate decompression is condensed into concentrated solution, and is standby.
(3) get 6 parts of Radix Arnebiae (Radix Lithospermi)s, 4 parts in Radix Rubiae, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby.
(4) get 5 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged.Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby.
(5) above concentrated solution is mixed, get 5 parts of addings of Indigo Naturalis.
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds carbomer, sodium carboxymethyl cellulose again, and two adjuvant ratios are 2: 3, and pharmaceutical composition is 1: 1 with total adjuvant ratio, makes bioadhesive polymer.
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
Embodiment 7. clinical pharmacology researchs
1. case: select patients of ulcerative colitis 107 examples, adopt the randomized controlled trial method, be divided into two groups, 65 examples are organized in treatment, matched group 42 examples.Treat the comparison of preceding two groups of patients at aspects such as age, sex, the course of disease, diseased regions, all credit is analysed by statistics, has comparability.
2. method: the only oral sulfasalazine of matched group patient, every day 3g, divide 3 times oral, 30 days is 1 course of treatment.
Treatment group patient uses " Ke Lao " (i.e. enema of making by embodiment 4) retention enema merely, earlier this medicine is heated to 40～46 ℃, front row 1 property retention enema after an action of the bowels of sleeping every night, get a buttocks high position during coloclysis, coloclysis Chinese medicine should prolong the time of reservation at enteral as far as possible, at least keep 2h, herbal enema 30 days was 1 course of treatment, but 2 courses of treatment of logotype.
Efficacy assessment standard:, be divided into following criterion of therapeutical effect according to national ulcerative colitis diagnosis and criterion of therapeutical effect.Cure in the recent period: clinical symptoms, sign disappear, and intestinal fiberscopy normally or roughly normal.Effectively: clinical symptoms, sign disappear substantially or take a turn for the better, and intestinal fiberscopy mucous hyperemia, edema or petechia, ulcer, erosion etc. disappear or take a turn for the better.Invalid: the equal no change of clinical symptoms, sign and intestinal fiberscopy.
3. result
Treatment ulcerative colitis efficacy result sees Table 1.
Table 1 liang group patient's curative effect relatively
The total routine number of group is cured enabledisable total effective rate (%)
Treatment organizes 65 32 28 5 92.61
Matched group 42 14 21 7 83.33
Compare with matched group, P＜0.05, treatment group curative effect is better than matched group, property that there were significant differences.
Prescription compatibility of medicines of the present invention is rigorous, and merit is specially imitated work, and the crude drug wide material sources are with low cost.Make bioadhesive polymer simultaneously and be used for coloclysis, both directly acted on the disease target position, drug slow is discharged, prolonged effective drug duration.Through the checking of the drug effect of clinical principium, determined curative effect, rapid-action, transference cure is fast, and is safe in utilization.
Claims (6)
1. pharmaceutical composition for the treatment of ulcerative colitis, it is characterized in that: its active component is made up of following raw materials according or is made up of water and/or alcohol extract that following raw materials according is made: the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Cortex Phellodendri 2～6 weight portions, Rhizoma Coptidis 1～3 weight portion, Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, Radix Rubiae 1～4 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, Indigo Naturalis 3～7 weight portions.
2. a kind of pharmaceutical composition for the treatment of ulcerative colitis according to claim 1, it is characterized in that: described raw materials in part by weight is respectively: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 4.5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 5 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 5 weight portions, Indigo Naturalis 5 weight portions.
3. bioadhesive polymer for the treatment of ulcerative colitis, it is characterized in that: it is made up of claim 1 or 2 described pharmaceutical compositions and adjuvant carbomer and sodium carboxymethyl cellulose, total adjuvant is 0.5～2 times of pharmaceutical composition gross weight, and carbomer and sodium carboxymethyl cellulose ratio are 0.2～0.8.
4. preparation method for the treatment of the pharmaceutical composition and the bioadhesive polymer of ulcerative colitis, this method may further comprise the steps: (1) gets the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, carry 2 times with decocting, each 1～2 hour, the water extract filters, and merges; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation; The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby;
(2) get Rhizoma Coptidis 1～3 weight portion, Cortex Phellodendri 2～6 weight portions, Radix Rubiae 1～4 weight portion, with 70% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged; Filtrate decompression is condensed into concentrated solution, and is standby;
(3) get Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby;
(4) get Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby;
(5) above concentrated solution is mixed, get Indigo Naturalis 3～7 weight portions and add;
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer, sodium carboxymethyl cellulose again, and the adjuvant ratio is 0.2～0.8, and total adjuvant is 0.5～2 times of pharmaceutical composition weight, makes bioadhesive polymer;
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
5. preparation method for the treatment of the pharmaceutical composition and the bioadhesive polymer of ulcerative colitis, this method may further comprise the steps: (1) gets the Radix Pulsatillae 3～7 weight portions, Cortex Fraxini 2～6 weight portions, Rhizoma Coptidis 1～3 weight portion, Cortex Phellodendri 2～6 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filters, and merges; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, standing over night, elimination precipitation; The alcohol deposit fluid concentrating under reduced pressure becomes concentrated solution, and is standby;
(2) get Herba Agrimoniae 3～7 weight portions, Fructus Chebulae's 1～3 weight portion, with 50% (V/V) ethanol extraction 2 times, each 1～2 hour, alcohol extract filtered, and merged; Filtrate decompression is condensed into concentrated solution, and is standby;
(3) get Radix Arnebiae (Radix Lithospermi) 3～7 weight portions, Radix Rubiae 1～4 weight portion, with 90% (V/V) ethanol percolate extraction, the percolate concentrating under reduced pressure becomes concentrated solution; Medicinal residues are carried 2 times with decocting, and each 1～2 hour, the water extract filtered, and merged, and concentrating under reduced pressure becomes concentrated solution; Standby;
(4) get Pseudobulbus Bletillae (Rhizoma Bletillae) 3～7 weight portions, carry 2 times with decocting, each 1～2 hour, the water extract filtered, and merged; Filtrate decompression is concentrated into relative density 1.03～1.13 (60 ℃), and it is 70% (V/V) to containing the alcohol amount that concentrated solution is put cold back adding 95% (V/V) ethanol, and standing over night keeps the precipitation Rhizoma Bletillae gel, and is standby;
(5) above concentrated solution is mixed, get Indigo Naturalis 3～7 weight portions and add;
(6) Rhizoma Bletillae gel of the above-mentioned preparation of adding adds adjuvant carbomer, sodium carboxymethyl cellulose again, and the adjuvant ratio is 0.2～0.8, and total adjuvant is 0.5～2 times of pharmaceutical composition weight, makes bioadhesive polymer;
(7) this bioadhesive polymer is added antiseptic, packing, sterilization.
6. according to claim 4 or the 5 described a kind of pharmaceutical composition of ulcerative colitis and preparation methoies of bio-adhesive agent for the treatment of, it is characterized in that: described raw materials in part by weight is respectively: the Radix Pulsatillae 5 weight portions, Cortex Fraxini 4 weight portions, Cortex Phellodendri 4.5 weight portions, Rhizoma Coptidis 3 weight portions, Radix Arnebiae (Radix Lithospermi) 5 weight portions, Herba Agrimoniae 5 weight portions, Fructus Chebulae's 3 weight portions, Radix Rubiae 3 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 5 weight portions, Indigo Naturalis 5 weight portions.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632746B (en) * | 2009-08-14 | 2011-02-16 | 扬州大学 | Medicament for treating ulcerative colitis and preparation method thereof |
| CN104491418A (en) * | 2014-11-21 | 2015-04-08 | 中国人民解放军总医院 | Traditional Chinese medicinal preparation for treating ulcerative colitis |
| CN104491417A (en) * | 2014-11-21 | 2015-04-08 | 中国人民解放军总医院 | Traditional Chinese medicinal preparation for treating ulcerative colitis and preparation method thereof |
| CN105168399A (en) * | 2015-09-21 | 2015-12-23 | 青岛金智高新技术有限公司 | Clysis fluid for treating chronic non-specific ulcerative colitis |
| CN105395975A (en) * | 2015-12-23 | 2016-03-16 | 方晓华 | Enema traditional Chinese medicine composition treating ulcerative colitis and preparation method thereof |
| CN110812396A (en) * | 2019-11-26 | 2020-02-21 | 广州中医药大学第一附属医院 | Traditional Chinese medicine composition for treating ulcerative colitis and preparation method and application thereof |
Families Citing this family (1)
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| CN101229251B (en) * | 2008-01-24 | 2010-11-03 | 侯占海 | Chinese traditional medicine for treating diarrhoea, bacillary dysentery and colonitis |
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2004
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632746B (en) * | 2009-08-14 | 2011-02-16 | 扬州大学 | Medicament for treating ulcerative colitis and preparation method thereof |
| CN104491418A (en) * | 2014-11-21 | 2015-04-08 | 中国人民解放军总医院 | Traditional Chinese medicinal preparation for treating ulcerative colitis |
| CN104491417A (en) * | 2014-11-21 | 2015-04-08 | 中国人民解放军总医院 | Traditional Chinese medicinal preparation for treating ulcerative colitis and preparation method thereof |
| CN104491418B (en) * | 2014-11-21 | 2017-08-18 | 中国人民解放军总医院 | A kind of Chinese medicine preparation for treating ulcerative colitis |
| CN104491417B (en) * | 2014-11-21 | 2017-08-25 | 中国人民解放军总医院 | It is a kind of to treat Chinese medicine preparation of ulcerative colitis and preparation method thereof |
| CN105168399A (en) * | 2015-09-21 | 2015-12-23 | 青岛金智高新技术有限公司 | Clysis fluid for treating chronic non-specific ulcerative colitis |
| CN105395975A (en) * | 2015-12-23 | 2016-03-16 | 方晓华 | Enema traditional Chinese medicine composition treating ulcerative colitis and preparation method thereof |
| CN110812396A (en) * | 2019-11-26 | 2020-02-21 | 广州中医药大学第一附属医院 | Traditional Chinese medicine composition for treating ulcerative colitis and preparation method and application thereof |
| CN110812396B (en) * | 2019-11-26 | 2024-06-25 | 广州中医药大学第一附属医院 | Traditional Chinese medicine composition for treating ulcerative colitis as well as preparation method and application thereof |
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