CN105343734A - Traditional Chinese medicine for treating spleen and stomach qi deficiency type ulcerative colitis and preparation method - Google Patents

Traditional Chinese medicine for treating spleen and stomach qi deficiency type ulcerative colitis and preparation method Download PDF

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CN105343734A
CN105343734A CN201510860965.2A CN201510860965A CN105343734A CN 105343734 A CN105343734 A CN 105343734A CN 201510860965 A CN201510860965 A CN 201510860965A CN 105343734 A CN105343734 A CN 105343734A
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马良
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Abstract

The invention provides traditional Chinese medicine for treating spleen and stomach qi deficiency type ulcerative colitis and a preparation method. The traditional Chinese medicine is prepared from ficus esquiroliana, ficus formosana roots, bilobate grewia, berchemia sinica, pimpinella thellungiana, acanthopanax obovatus hoo, cytisus scoparius, lycopodium clavatum, garden balsam stem, alpinia japonica, chervil larkspur herb, winged laggera herb, aralia apioides Hand.-Mazz. and litsea rotundifolia. The traditional Chinese medicine has an exact effect on spleen and stomach qi deficiency type ulcerative colitis and is small in toxic and side effect.

Description

A kind of Chinese medicine and preparation method for the treatment of qi-deficiency of spleen and stomach ulcerative colitis
Technical field
The present invention relates to the medicinal preparation containing deriving from plant, animal or mineral component, particularly relating to a kind of Chinese medicine and preparation method for the treatment of qi-deficiency of spleen and stomach ulcerative colitis.
Background technology
Ulcerative colitis (UC), also known as chronic nonspecific colitis, is the rectum that still imperfectly understands of a kind of cause of disease and colon chronic nonspecific inflammation disease.Pathological changes is mainly limited to colorectal mucosa and tela submucosa, and clinical manifestation is diarrhoea, mucopurulent bloody stool, stomachache.State of an illness weight not etc., many chronic courses of disease in recurrent exerbation.
Ulcerative colitis belongs to the category such as Chinese medicine " chronic dysentery ", " dysentery ", " large intestine rushes down ".The cause of disease is diseases caused by exogenous pathogenic factor six evils, injury due to diet, disorder of emotion, natural endowment is not enough, and cause in damp and accumulate large intestine, damp-heat asssociation, QI and blood blocks, and function of intestinal canal is neglected one's duty, and venation is impaired and fall ill.
Summary of the invention
Technical problem to be solved by this invention is, provide a kind of Chinese medicine and preparation method for the treatment of qi-deficiency of spleen and stomach ulcerative colitis, Chinese medicine of the present invention has definite curative effect to qi-deficiency of spleen and stomach ulcerative colitis, and toxic and side effects is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine for the treatment of qi-deficiency of spleen and stomach ulcerative colitis, its raw medicinal material comprises: Ficus fulva Reinw., Radix Fici beecheyanae, Radix grewiae bilobae, Radix Berchemiae Giraldianae, Herba Pimpinellae thellungianae, Acanthopanax obouatus Hoo, Herba Cytisi sciparii, Herba Lycopodii, Herba speranskiae tuberculatae, Rhizoma alpiniae pumilae, Herba Delphinii Anthriscifolii, Herba Laggerae Alatae, NIUJIAOQI and Corii Cuon alpini Camphor tree.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Ficus fulva Reinw. 40 ~ 60 parts, Radix Fici beecheyanae 30 ~ 50 parts, Radix grewiae bilobae 20 ~ 30 parts, Radix Berchemiae Giraldianae 30 ~ 50 parts, Herba Pimpinellae thellungianae 5 ~ 15 parts, Acanthopanax obouatus Hoo 15 ~ 30 parts, Herba Cytisi sciparii 10 ~ 20 parts, Herba Lycopodii 10 ~ 20 parts, Herba speranskiae tuberculatae 5 ~ 15 parts, Rhizoma alpiniae pumilae 15 ~ 25 parts, Herba Delphinii Anthriscifolii 5 ~ 15 parts, Herba Laggerae Alatae 15 ~ 25 parts, NIUJIAOQI 15 ~ 30 parts and Corii Cuon alpini Camphor tree 40 ~ 60 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Ficus fulva Reinw. 40 ~ 50 parts, Radix Fici beecheyanae 30 ~ 40 parts, Radix grewiae bilobae 20 ~ 25 parts, Radix Berchemiae Giraldianae 30 ~ 40 parts, Herba Pimpinellae thellungianae 5 ~ 10 parts, Acanthopanax obouatus Hoo 15 ~ 25 parts, Herba Cytisi sciparii 10 ~ 15 parts, Herba Lycopodii 10 ~ 15 parts, Herba speranskiae tuberculatae 5 ~ 10 parts, Rhizoma alpiniae pumilae 15 ~ 20 parts, Herba Delphinii Anthriscifolii 5 ~ 10 parts, Herba Laggerae Alatae 15 ~ 20 parts, NIUJIAOQI 15 ~ 25 parts and Corii Cuon alpini Camphor tree 40 ~ 50 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Ficus fulva Reinw. 48 parts, Radix Fici beecheyanae 34 parts, Radix grewiae bilobae 22 parts, Radix Berchemiae Giraldianae 32 parts, Herba Pimpinellae thellungianae 6 parts, Acanthopanax obouatus Hoo 19 parts, Herba Cytisi sciparii 12 parts, Herba Lycopodii 14 parts, Herba speranskiae tuberculatae 7 parts, Rhizoma alpiniae pumilae 16 parts, Herba Delphinii Anthriscifolii 8 parts, Herba Laggerae Alatae 17 parts, NIUJIAOQI 21 parts and Corii Cuon alpini Camphor tree 45 parts.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 80 ~ 90%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.5 times, the starch of 0.1 ~ 0.5 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 1 ~ 3 times in the micropowders obtained by second step, mixing, obtains powder.
Beneficial effect of the present invention: Chinese medicine of the present invention has definite curative effect to qi-deficiency of spleen and stomach ulcerative colitis, and toxic and side effects is little.
Detailed description of the invention
The invention provides a kind of Chinese medicine for the treatment of qi-deficiency of spleen and stomach ulcerative colitis, its raw medicinal material comprises: Ficus fulva Reinw., Radix Fici beecheyanae, Radix grewiae bilobae, Radix Berchemiae Giraldianae, Herba Pimpinellae thellungianae, Acanthopanax obouatus Hoo, Herba Cytisi sciparii, Herba Lycopodii, Herba speranskiae tuberculatae, Rhizoma alpiniae pumilae, Herba Delphinii Anthriscifolii, Herba Laggerae Alatae, NIUJIAOQI and Corii Cuon alpini Camphor tree.
In described Chinese medicine, the pharmacology of each raw medicinal material is as follows:
Ficus fulva Reinw.: [source] is the root bark of moraceae plants Ficus fulva Reinw..[nature and flavor] are sweet, and property is put down.[function cures mainly] replenishing QI to invigorate the spleen, expelling wind and removing dampness.The main deficiency of vital energy, the prolapse of the uterus, proctoptosis, loose stool, edema, rheumatic arthralgia.
Radix Fici beecheyanae: [source] is the root of moraceae plants Fructus Fici Beecheyanae.[nature and flavor] are sweet, pungent, temperature.[return through] returns lung, spleen, kidney channel.[function cures mainly] replenishing QI to invigorate the spleen, promoting blood circulation to remove obstruction in the collateral, expelling wind and removing dampness.Main overstrain is weak, lack of appetite, agalactia, insufficiency of the spleen leucorrhea, proctoptosis, menoxenia, wind syndrome of head pain, traumatic injury, rheumatic arthralgia.
Radix grewiae bilobae: [source] is the Herb of Tiliaceae plant bilobed grewia.[nature and flavor] are sweet, bitter, temperature.[return through] returns liver, spleen, stomach warp.[function cures mainly] invigorating the spleen and benefiting QI, expelling wind and removing dampness, treating spontaneous emission and leukorrhagia.Main insufficiency of the spleen lack of appetite, proctoptosis, infantile malnutrition, ascariasis, rheumatic arthralgia, seminal emission, metrorrhagia, leukorrhagia, uterine prolapse.
Radix Berchemiae Giraldianae: [source] is the root of Rhamnaceae plant Nasus Bovis seu Bubali fist.[nature and flavor] are micro-puckery, and property is put down.[function cures mainly] wind-damp dispelling, promoting blood circulation to remove obstruction in the collateral, relieving cough and resolving phlegm, invigorating the spleen and benefiting QI.Dispelling the wind and dampness pathogens arthralgia, lumbago, dysmenorrhea, pulmonary tuberculosis, scrofula, infantile malnutrition, hepatitis, biliary tract ascarid, venom, traumatic injury.
Herba Pimpinellae thellungianae: the root that [source] is samphire thellung pimpinella herb or herb.[nature and flavor] sweet in the mouth, pungent, warm in nature.[function cures mainly] invigorating the spleen and benefiting QI, tranquilizing by nourishing the heart, eliminating phlegm and stopping cough.Main Keshan disease, the heart is reconstructed, and breathes hard, cough with asthma.
Acanthopanax obouatus Hoo: the root that [source] is Araliaceae Acanthopanax obouatus Hoo or stem.[nature and flavor] sweet in the mouth, micro-hardship, warm in nature.[function cures mainly] invigorating the spleen and benefiting QI, kidney calming, relaxing muscles and tendons and activating QI and blood in the collateral.Main body void is weak, inappetence, soreness of the waist and knees, sexual impotence, and insomnia and dreamful sleep is forgetful, anemofrigid-damp arthralgia.
Herba Cytisi sciparii: the flower that [source] is leguminous plant Herba Cytisi sciparii or branch top.[nature and flavor] are sweet, temperature.[return through] GUIXIN warp.The diuresis of [function cures mainly] heart tonifying, yang invigorating is delivered.Main heart disease edema, arrhythmia, rash is sent out not saturating, traumatic injury.
Herba Lycopodii: [source] is the whole herb with root of lycopsid Lycopodium clavatum.[nature and flavor] are bitter, pungent, temperature.[return through] returns liver, spleen, kidney channel.[function cures mainly] expelling wind and cold, dehumidifying detumescence, relaxing muscles and tendons to promote blood circulation.Control anemofrigid-damp arthralgia, joint aches, skin numbness, tetraparesis, edema, traumatic injury.
Herba speranskiae tuberculatae: [source] is the herb of euphorbia plant Herba speranskiae tuberculatae.[nature and flavor] are pungent, warm in nature.[return through] returns lung, Liver Channel.[function cures mainly] expelling wind and removing dampness, relaxing muscles and tendons to promote blood circulation, dissipating blood stasis for subsidence of swelling, removing toxic substances pain relieving.Main air pain of dampness syndrome, muscles and bones contracture, the disturbance of lower legs due to pathogenic cold and dampness, lumbar strain, paralysis, amenorrhea, eczema scrotum, furuncle toxic swelling.
Rhizoma alpiniae pumilae: [source] is the rhizome of zingiberaceous plant Alpinia pumila Hook. F..[nature and flavor] acrid in the mouth, micro-hardship, warm in nature.[return through] returns spleen, stomach warp.[function cures mainly] expelling wind and removing dampness, promoting the circulation of QI to relieve pain.Main air pain of dampness syndrome, diarrhoea, stomachache, traumatic injury.
Herba Delphinii Anthriscifolii: [source] is the herb of ranunculaceae plant Herba Delphinii Anthriscifolii.[nature and flavor] acrid in the mouth is bitter, warm in nature.[return through] GUIXIN, liver, kidney channel.[function cures mainly] expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, relieving dyspepsia, removing toxic substances.Main air pain of dampness syndrome, hemiplegia, dyspeptic abdominal distention, urticaria, carbuncle skin ulcer tinea leprosy.
Herba Laggerae Alatae: [source] is the herb of feverfew Laggera alata (Roxb.) Sch.-Bip..[nature and flavor] are pungent, temperature.[return through] returns lung, spleen, urinary bladder channel.[function cures mainly] dispels the wind, and dehumidifying, changes stagnant, dissipating blood stasis, detumescence, removing toxic substances.Cure cold cough body pain, stomachache dysentery, rheumatic arthritis, women's amenorrhea, traumatic injury, furuncle carbuncle scrofula, noxious dampness pruritus.
NIUJIAOQI: [source] is the root of Araliaceae Radix Araliae apioidis.[nature and flavor] bitter in the mouth, pungent, slightly warm in nature.[function cures mainly] expelling wind and removing dampness, promoting blood circulation and detumescence.Main air pain of dampness syndrome, traumatic injury, fracture, stomachache, lumbago, lymphadenitis.
Corii Cuon alpini Camphor tree: the root that [source] is canella Corii Cuon alpini Camphor tree and bark.[nature and flavor] are pungent, temperature.[return through] returns liver, stomach, spleen, kidney channel.[function cures mainly] circulation of qi promoting, invigorates blood circulation, pain relieving, wind-damp dispelling.Main stomachache, stomachache, dysentery, diarrhoea, dysmenorrhea, rheumatic arthralgia, traumatic injury.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Ficus fulva Reinw. 40 ~ 60 parts, Radix Fici beecheyanae 30 ~ 50 parts, Radix grewiae bilobae 20 ~ 30 parts, Radix Berchemiae Giraldianae 30 ~ 50 parts, Herba Pimpinellae thellungianae 5 ~ 15 parts, Acanthopanax obouatus Hoo 15 ~ 30 parts, Herba Cytisi sciparii 10 ~ 20 parts, Herba Lycopodii 10 ~ 20 parts, Herba speranskiae tuberculatae 5 ~ 15 parts, Rhizoma alpiniae pumilae 15 ~ 25 parts, Herba Delphinii Anthriscifolii 5 ~ 15 parts, Herba Laggerae Alatae 15 ~ 25 parts, NIUJIAOQI 15 ~ 30 parts and Corii Cuon alpini Camphor tree 40 ~ 60 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Ficus fulva Reinw. 40 ~ 50 parts, Radix Fici beecheyanae 30 ~ 40 parts, Radix grewiae bilobae 20 ~ 25 parts, Radix Berchemiae Giraldianae 30 ~ 40 parts, Herba Pimpinellae thellungianae 5 ~ 10 parts, Acanthopanax obouatus Hoo 15 ~ 25 parts, Herba Cytisi sciparii 10 ~ 15 parts, Herba Lycopodii 10 ~ 15 parts, Herba speranskiae tuberculatae 5 ~ 10 parts, Rhizoma alpiniae pumilae 15 ~ 20 parts, Herba Delphinii Anthriscifolii 5 ~ 10 parts, Herba Laggerae Alatae 15 ~ 20 parts, NIUJIAOQI 15 ~ 25 parts and Corii Cuon alpini Camphor tree 40 ~ 50 parts.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Ficus fulva Reinw. 48 parts, Radix Fici beecheyanae 34 parts, Radix grewiae bilobae 22 parts, Radix Berchemiae Giraldianae 32 parts, Herba Pimpinellae thellungianae 6 parts, Acanthopanax obouatus Hoo 19 parts, Herba Cytisi sciparii 12 parts, Herba Lycopodii 14 parts, Herba speranskiae tuberculatae 7 parts, Rhizoma alpiniae pumilae 16 parts, Herba Delphinii Anthriscifolii 8 parts, Herba Laggerae Alatae 17 parts, NIUJIAOQI 21 parts and Corii Cuon alpini Camphor tree 45 parts.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 80 ~ 90%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.5 times, the starch of 0.1 ~ 0.5 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 1 ~ 3 times in the micropowders obtained by second step, mixing, obtains powder.
Below adopt embodiment to describe embodiments of the present invention in detail, fully understand how application technology means solve technical problem in the present invention whereby, reach technique effect and implement according to this.
Embodiment 1: capsule
Get Ficus fulva Reinw. 480g, Radix Fici beecheyanae 340g, Radix grewiae bilobae 220g, Radix Berchemiae Giraldianae 320g, Herba Pimpinellae thellungianae 60g, Acanthopanax obouatus Hoo 190g, Herba Cytisi sciparii 120g, Herba Lycopodii 140g, Herba speranskiae tuberculatae 70g, Rhizoma alpiniae pumilae 160g, Herba Delphinii Anthriscifolii 80g, Herba Laggerae Alatae 170g, NIUJIAOQI 210g and Corii Cuon alpini Camphor tree 450g;
Prepare according to the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 4 times is the ethanol of 80%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 times again, reflux 1 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 2 hours, pulverize and sieve acquisition 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.4 times, the starch of 0.4 times, the magnesium stearate of 0.02 times, carry out mixing process, namely obtain capsule 's content, described Capsule content is incapsulated in housing, namely obtain capsule finished product.
Embodiment 2: powder
Get Ficus fulva Reinw. 430g, Radix Fici beecheyanae 390g, Radix grewiae bilobae 240g, Radix Berchemiae Giraldianae 370g, Herba Pimpinellae thellungianae 90g, Acanthopanax obouatus Hoo 230g, Herba Cytisi sciparii 150g, Herba Lycopodii 110g, Herba speranskiae tuberculatae 60g, Rhizoma alpiniae pumilae 180g, Herba Delphinii Anthriscifolii 60g, Herba Laggerae Alatae 180g, NIUJIAOQI 170g and Corii Cuon alpini Camphor tree 480g;
Prepare according to the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 85%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 times again, reflux 1 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 hour, pulverize, sieve, obtain 100 object micropowders;
3rd step: add the starch relative to its quality 3 times in the micropowders obtained by second step, mixing, obtains powder.
Toxicity test:
Acute toxicity testing: application mice 60, male and female half and half, body weight 30-40g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicine capsules prepared by embodiments of the invention 1, (concentration is 8.54g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 42.7 crude drugs/kg), and matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage capsule LD50>42.7 crude drug/kg of the present invention, every day, maximum dosage-feeding was 85.4 crude drugs/kg/ day.Chinese medicine clinical application amount of the present invention be 8.2g crude drug/day/people, adult body weight in 60KG, average dosage is 0.137g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 35g) oral administration gavage Chinese medicine of the present invention is 623 times of quantity.Therefore Chinese medicine acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: Chinese medicine embodiment 1 capsule of the present invention to three groups of mices (often organize 20) by 13.63,22.68 and 43.54g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Clinical data:
Case selection: whole 100 routine cases are my Out-patient Department patient.All be diagnosed as ulcerative colitis, TCM Syndrome Type is qi-deficiency of spleen and stomach.Patient is divided into treatment group and matched group at random, wherein treatment group 55 example, male 35 example, women 20 example; 35 ~ 64 years old age, average (46.8 ± 5.5) year; The course of disease 3 ~ 40 months, average (22.2 ± 8.4) individual month; Histopathology histological grading: I grade of 20 example, II grade of 25 example, III grade of 10 example; Diseased region: total colectomy 7 example, left hemicolon 18 example, proctosigmoid 20 example, 10 examples on rectum.Matched group 45 people, male 28 example, women 17 example; 35 ~ 62 years old age, average (44.6 ± 4.9) year; The course of disease 3 ~ 38 months, average (20.8 ± 6.5) individual month; Histopathology histological grading: I grade of 17 example, II grade of 20 example, III grade of 8 example; Diseased region: total colectomy 6 example, left hemicolon 15 example, proctosigmoid 18 example, 6 examples on rectum.Two groups in age, sex, the course of disease, symptom, diseased region and coincident with severity degree of condition etc. through statistical analysis there was no significant difference (p>0.05).
Diagnostic criteria: adopt digestive system disease Professional Committee of (Suzhou) CAIM (Chinese Association Of Integrative Medicine) in 2010 to formulate " ulcerative colitis combination of Chinese and Western medicine diagnosis and treatment common recognition ":
1. clinical manifestation: have lasting or recurrent exerbation diarrhoea, mucopurulent bloody stool, companion's stomachache, tenesmus and General Symptoms in various degree.The course of disease is many more than 4 ~ 6 weeks.Joint, skin, eye, mouth and liver, gallbladder etc. can be had outside the venue to show.
2. colonoscopy: pathological changes is many from rectum, in seriality, diffusivity distribution.Show as that (1) mucosa vascular lake is fuzzy, disorderly, congested, edema, embrittlement, hemorrhage and purulent secretion attachment.Also common mucosa is coarse, in fine particulate.(2) pathological changes obviously locates visible diffusivity, multiple erosion or ulcer.(3) the visible colon pouch of catabasis patient shoal, rust or disappearance, pseudopolyp, bridge type mucosa etc.
3. mucosal tissue checks: (1) active stage: 1. have diffusivity, chronic inflammatory cell, neutrophilic granulocyte, eosinophils in lamina propria.2. crypts has acute inflammatory cells to infiltrate, and especially has neutrophil infiltration and cryptitis between epithelial cell, even forms crypt abscess, and abscess can be burst into lamina propria.3. crypts epithelial proliferation, goblet cell reduces.4. visible mucosal surface is rotten to the corn, ulcer and granulation tissue hyperplasia.(2) catabasis: 1. neutrophilic granulocyte disappears, chronic inflammatory cell reduces.2. crypts size, form are irregular, arrangement disorder.3. glandular epithelium and muscular layer of mucosa gap broadening, or see intrinsic body of gland atrophy.4. paneth's cellization is raw.
4. excision specimens pathological checks: the These characteristics of naked eyes and the upper visible UC of histology.
Can by following standard diagnostics on the disease basis such as infectious colitis and Crohn disease (CD), ischemic colitis, radiation colitis such as eliminating bacillary dysentery, amebic dysentery, chronic schistosomiasis, tuberculosis of intestine etc.: among possessing above-mentioned 1,2, any one can intend examining into primary disease simultaneously, and the characteristic performance as added pathologic finding in the 3rd or the 4th then can be made a definite diagnosis.
Histopathology grade scale: adopt Truelove-Richards staging.I grade: without obvious inflammation.The structural change of chronic disease may be had, and little lymphatic infiltration stove, but NAI, crypt abscess or mucous epithelium destroy.II grade: slight to moderate inflammation.Have disorderly, the acute and chronic inflammatory cell of congestion and edema, vascular lake to increase, but mucous epithelium is complete.III grade: hyperphlogosis.Acute and chronic inflammatory cell obviously infiltrates, and has crypt abscess, mucosal surface ulcer, purulence to ooze out.
Syndrome Differentiation of Traditional Chinese Medicine standard: qi-deficiency of spleen and stomach: 1. main disease: (1) diarrhoea loose stool, has mucus or a small amount of pus and blood; (2) lack of appetite poor appetite; (3) abdominal distention after meal; (4) pale tongue is fat or have indentation, white and thin fur; (5) thready and weak pulse or slow.2. secondary disease: (1) abdominal swelling; (2) abdominal part dull pain pain relieved by pressing; (3) limbs asthenia; (4) spiritlessness and sparing of words; (5) shallow complexion.3. pattern of syndrome is determined: possess primary symptom 2 ((1) item is indispensable, as follows) and add time disease 2, or primary symptom (1) Xiang Jiaci disease 3.
Therapeutic Method:
Matched group: take sulfasalazine tablet, initial dose 2 ~ 3g/d, points 3 ~ 4 times are oral, if without significant discomfort after medication, dose can be increased to 4 ~ 6g/d, after enteropathy remission gradually decrement to maintenance dose 1.5 ~ 2g/d.
Treatment group: adopt Chinese medicine embodiment 1 capsule of the present invention, each 4, every day 3 times.
Two groups are 30 days 1 courses for the treatment of.Two groups of patients all want diet light at treatments period, a series of irritable foods such as fasting is pungent, wine, encourage patient to keep the good positive partner treatment of phychology simultaneously.
Curative effect judging standard: with reference to the standard of " ulcerative colitis combination of Chinese and Western medicine diagnosis and treatment common recognition " that digestive system disease Professional Committee of combination of Chinese and Western medicine association formulates in Suzhou for 2010.1. complete incidence graph: clinical cardinal symptom disappears, secondary disease disappears or substantially disappears, and tongue, arteries and veins recover normal substantially, and intestinal mirror check mucosa infection recovers normal, or ulcer focus forms cicatrix, and stool routine examination 3 is subnormal.2. effective: clinical cardinal symptom disappears substantially, secondary disease is improved degree and is reached more than secondary, and tongue arteries and veins is often answered substantially, and intestinal mirror check mucosa infection recovery extent reaches more than secondary, and stool routine examination inspection is normal.3. effective: clinical cardinal symptom improvement reaches more than one-level, intestinal mirror check mucosa infection recovery extent reaches more than one-level, and stool routine examination inspection is red, leukocyte count <5 individual/H.4. invalid: after treatment, clinical symptoms, scope and pathologic finding are without improvement.
Therapeutic outcome: see the following form.
Group n Complete incidence graph Effective Effectively Invalid Effectively total
Treatment group 55 13 25 13 4 51(92.73%)
Matched group 45 5 10 17 13 32(71.11%)
Treatment group compares with matched group: treatment group curative effect is better than matched group, and two groups of Different therapeutical effects have statistical significance (P<0.05).
Concrete case: Lee, male, 47 years old.Ulcerative colitis has 2 years 8 months medical histories.Diarrhoea loose stool, have mucus, lack of appetite poor appetite, abdominal distention after meal, limbs asthenia, shallow complexion, pale tongue is fat, white and thin fur, thready and weak pulse.TCM Syndrome Type is qi-deficiency of spleen and stomach.Give Chinese medicine embodiment 1 capsule of the present invention every day 3 times, each 4, treat 30 days, complete incidence graph, follows up a case by regular visits to and does not recur half a year.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (8)

1. treat a Chinese medicine for qi-deficiency of spleen and stomach ulcerative colitis, it is characterized in that, each raw medicinal material of described Chinese medicine comprises: Ficus fulva Reinw., Radix Fici beecheyanae, Radix grewiae bilobae, Radix Berchemiae Giraldianae, Herba Pimpinellae thellungianae, Acanthopanax obouatus Hoo, Herba Cytisi sciparii, Herba Lycopodii, Herba speranskiae tuberculatae, Rhizoma alpiniae pumilae, Herba Delphinii Anthriscifolii, Herba Laggerae Alatae, NIUJIAOQI and Corii Cuon alpini Camphor tree.
2. Chinese medicine as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Ficus fulva Reinw. 40 ~ 60 parts, Radix Fici beecheyanae 30 ~ 50 parts, Radix grewiae bilobae 20 ~ 30 parts, Radix Berchemiae Giraldianae 30 ~ 50 parts, Herba Pimpinellae thellungianae 5 ~ 15 parts, Acanthopanax obouatus Hoo 15 ~ 30 parts, Herba Cytisi sciparii 10 ~ 20 parts, Herba Lycopodii 10 ~ 20 parts, Herba speranskiae tuberculatae 5 ~ 15 parts, Rhizoma alpiniae pumilae 15 ~ 25 parts, Herba Delphinii Anthriscifolii 5 ~ 15 parts, Herba Laggerae Alatae 15 ~ 25 parts, NIUJIAOQI 15 ~ 30 parts and Corii Cuon alpini Camphor tree 40 ~ 60 parts.
3. Chinese medicine as claimed in claim 1 or 2, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Ficus fulva Reinw. 40 ~ 50 parts, Radix Fici beecheyanae 30 ~ 40 parts, Radix grewiae bilobae 20 ~ 25 parts, Radix Berchemiae Giraldianae 30 ~ 40 parts, Herba Pimpinellae thellungianae 5 ~ 10 parts, Acanthopanax obouatus Hoo 15 ~ 25 parts, Herba Cytisi sciparii 10 ~ 15 parts, Herba Lycopodii 10 ~ 15 parts, Herba speranskiae tuberculatae 5 ~ 10 parts, Rhizoma alpiniae pumilae 15 ~ 20 parts, Herba Delphinii Anthriscifolii 5 ~ 10 parts, Herba Laggerae Alatae 15 ~ 20 parts, NIUJIAOQI 15 ~ 25 parts and Corii Cuon alpini Camphor tree 40 ~ 50 parts.
4. the Chinese medicine as described in claims 1 to 3, is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Ficus fulva Reinw. 48 parts, Radix Fici beecheyanae 34 parts, Radix grewiae bilobae 22 parts, Radix Berchemiae Giraldianae 32 parts, Herba Pimpinellae thellungianae 6 parts, Acanthopanax obouatus Hoo 19 parts, Herba Cytisi sciparii 12 parts, Herba Lycopodii 14 parts, Herba speranskiae tuberculatae 7 parts, Rhizoma alpiniae pumilae 16 parts, Herba Delphinii Anthriscifolii 8 parts, Herba Laggerae Alatae 17 parts, NIUJIAOQI 21 parts and Corii Cuon alpini Camphor tree 45 parts.
5. the Chinese medicine as described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 80 ~ 90%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.5 times, the starch of 0.1 ~ 0.5 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
6. the Chinese medicine as described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 1 ~ 3 times in the micropowders obtained by second step, mixing, obtains powder.
7. a preparation method for Chinese medicine described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 80 ~ 90%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 80 ~ 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;
3rd step: the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.5 times, the starch of 0.1 ~ 0.5 times, the magnesium stearate of 0.005 ~ 0.05 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.
8. a preparation method for Chinese medicine described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is powder, and its preparation method comprises the following steps:
The first step: each for described Chinese medicine raw medicinal material is mixed in proportion, adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 3 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step obtains is placed in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 100 order ~ 200 object micropowders;
3rd step: add the starch relative to its quality 1 ~ 3 times in the micropowders obtained by second step, mixing, obtains powder.
CN201510860965.2A 2015-11-29 2015-11-29 Traditional Chinese medicine for treating spleen and stomach qi deficiency type ulcerative colitis and preparation method Pending CN105343734A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106063810A (en) * 2016-07-30 2016-11-02 宋富利 A kind of Chinese medicine preparation treating chronic ulcerative colitis

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104706844A (en) * 2013-12-15 2015-06-17 戴绍波 Traditional Chinese medicine for treating ulcerative colitis
CN104825847A (en) * 2015-04-24 2015-08-12 繁昌县智融中药材专业合作社 Traditional Chinese medicine decoction for treating ulcerative colitis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104706844A (en) * 2013-12-15 2015-06-17 戴绍波 Traditional Chinese medicine for treating ulcerative colitis
CN104825847A (en) * 2015-04-24 2015-08-12 繁昌县智融中药材专业合作社 Traditional Chinese medicine decoction for treating ulcerative colitis

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106063810A (en) * 2016-07-30 2016-11-02 宋富利 A kind of Chinese medicine preparation treating chronic ulcerative colitis

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