CN105722521B - A kind of Chinese medicine composition and preparation method thereof for treating ulcerative colitis - Google Patents
A kind of Chinese medicine composition and preparation method thereof for treating ulcerative colitis Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K36/315—Isatis, e.g. Dyer's woad
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/739—Sanguisorba (burnet)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Abstract
A kind of Chinese medicine composition for treating ulcerative colitis, the bulk pharmaceutical chemicals composition of the composition are as follows: coptis 7-11 parts by weight, baked ginger 7-11 parts by weight, kuh-seng 7-11 parts by weight, Radix Notoginseng 4-8 parts by weight, indigo naturalis 4-11 parts by weight, radix aucklandiae 4-8 parts by weight, charred RADIX SANGUISORBAE 7-11 parts by weight and radix glycyrrhizae preparata 1-5 parts by weight.The traditional Chinese medicine composition for treating ulcerative colitis effect is good, and recurrence rate is low, and side effect is unobvious, while having clear sharp enteron aisle, warming middle-JIAO and strengthening the spleen, mildly regulating cold and heat, and the effect of removing blood stasis and hemostasis mitigates disease pain, improves the quality of living, extends life span.
Description
Technical field
The invention belongs to field of traditional Chinese medicine preparations, and in particular to a kind of Chinese medicine composition for treating ulcerative colitis and its system
Preparation Method.
Background technique
Ulcerative colitis (Ulcerative colitis, UC) is a kind of colon and rectum that the cause of disease is not still fully aware of
Chronic nonspecific inflammation disease, lesion are confined to colorectal mucosa and submucosa.Lesion multidigit in sigmoid colon and rectum,
Also colon descendens or even entire colon be may extend to, the course of disease is very long, normal recurrent exerbation, can occur to be more common in 20- at any age
40 years old, men and women's disease incidence was the disease of gastroenterology without significant difference, the scopes such as Chinese medicine category " intestines Bleach ", " dysentery ".Exedens knot
The clinical manifestation of enteritis can be the important behaviour of this disease active stage there are many form, mucopurulent bloody stool, and other symptoms have abdominal pain, dislike
The heart, vomiting, weight loss, tenesmus etc., occur together periphery arthritis, episcleritis, canker sore and skin disease sometimes
The parenteral performances such as change, Medium or severe type patient activity's phase, there will be the general manifestations such as fever, anaemia.This disease table in most patient
It is in Acute onset in a few patients (accounting for about 15%) now to be chronic, low pernicious, it is accidental acute to break out onset.These patient's tables
It is now frequently hemorrhagic excrement, it can up to 30 times/day and high fever, abdominal pain.Meanwhile sign is directly related with stadium and clinical manifestation,
Patient often has weight loss and pale complexion, and in disease activity phase abdomen examination, colon site often has tenderness, may there is urgency
Abdomen disease sign occur together heat and gurgling sound reduce, toxic megacolon Shi Keyou particularly evident in acute attack or fulminant type case
Abdominal distension, fever and acute abdomen sign.Due to frequent diarrhea, anal skin can have scratch, strip off.Crissum inflammation such as anus can also occur
It splits or anal fistula, although the latter more common, digital rectal examination sense pain, skin, mucous membrane, tongue, joint and eye in Crohn`s disease
Inspection it is particularly important.The disease incidence of China's inflammatory bowel disease in the past 20 years, especially ulcerative colitis, illness rate are in gradually
Increase trend, it is rough to speculate that UC illness rate is about 11.6/10 ten thousand.
In the prior art, minosalicylates, drugs are clinically commonly to treat Mild and moderate ulcerative colitis at present
Drug, including salicylic acid salicylazosulfapyridine (SASP), 5-aminosalicylic acid (5-ASA), etc., adverse reaction is more, such as
Nausea and vomiting, haemolysis etc., and to some patientss unsatisfactory curative effect.Glucocorticoid medicine such as Bo Nisonglong, dexamethasone, hydrogen
Change cortisone etc., only have a preferable effect to short-term relief symptom, that there are bioavilabilities is lower for some drugs, and enteron aisle is left more
The defects of, and Long-term Hormone class drug can aggravate or induce infection, appearance and cumulant it is related it is tardy, negative attacking property is bad
Reaction etc..In the prior art about many of Ulcerative Colitis Treated with Chinese Drugs, such as " Chinese medicinal granule Coryza Treated by Syndrome Differentiation ulcer
43 observation of curative effect of property colitis " in describe Chinese traditional treatment and be generally divided into retention of damp-heat in the interior type by dialectical, mostly early stage or
The acute relapse phase has in just and holds purulence band blood under the arm, and smell dirty smelly is tenesmus, the symptoms such as burning sensation of the anus, suitable clearing heat and promoting diuresis, reconciles
Breath, the side based on baitouweng decoction;Qi stagnation and blood stasis type is the patient of chronic relapsing, has diarrhea not well, abdomen fixed pain is refused
It presses, defecates with mucus or purulence blood, dim complexion, the symptoms such as belch is eaten less close Shixiao San with bupleurum powder for relieving liver-qi;Liver-depression and spleen-insufficiency type
For chronic relapsing or sustained patient, there is borborygmus in abdomen, abdominal pain diarrhea subtracts bitterly after letting out, the symptoms such as feeling of oppression over the chest and distention of hypochondrium, liver of preferably relaxing
Invigorating the spleen, relieving QI stagnancy in the stomach close shenling baizhu powder with tongxieyao formula;Due to weakness of spleen and stomach, chronic sustained type patient, when there is half congealed during stool
It rushes down, has held mucus or indigestion under the arm, sallow complexion, the tired inability of limb, pale tongue with white fur, the symptoms such as arteries and veins is thin and delicate, suitable strengthening the spleen and replenishing qi, stomach function regulating
Dampness removing, the side based on shenling baizhu powder;Yang deficiency of spleen and stomache is chronic sustained type patient, has Diarrhoea, for very from diarrhea morning,
Afternoon then light soft stools, the symptoms such as secret anguish in abdomen, suitable tonifying spleen and kidney, relieving diarrhea with astringents are closed based on Fuzi Lizhong Wan with Sishen wan
Plus-minus;Deficiency of YIN-blood type is chronic sustained type patient, has big loose stool thin, secret anguish in abdomen, tidal fever in the afternoon, spiritlessness and weakness, and tongue is red
Less fur, suitable replenishing the vital essence and the blood, qi and solidifying intestines, based on shenling baizhu powder conjunction decoction made from radix adenophorea, tuber of dwarf lilyturf.But existing Chinese medicine acts on link
It is still unclear, differentiation of symptoms and signs for classification of syndrome disunity, and Different therapeutical effect is big in existing disclosed document.
Summary of the invention
For this purpose, technical problem to be solved by the present invention lies in the effects of Medication in Ulcerative Colitis in the prior art
Fruit is bad, and high recurrence rate, side effect is obvious, so provide it is a kind of treat that ulcerative colitis effect is good and recurrence rate is low and
Unconspicuous Chinese medicine composition of side effect and preparation method thereof.
In order to solve the above technical problems, the present invention provides a kind of for treating the Chinese medicine composition of ulcerative colitis,
The bulk pharmaceutical chemicals of the composition form are as follows: coptis 7-11 parts by weight, baked ginger 7-11 parts by weight, kuh-seng 7-11 parts by weight, Radix Notoginseng 4-8
Parts by weight, indigo naturalis 4-11 parts by weight, radix aucklandiae 4-8 parts by weight, charred RADIX SANGUISORBAE 7-11 parts by weight and radix glycyrrhizae preparata 1-5 parts by weight.
The Chinese medicine composition for being used to treat ulcerative colitis, the bulk pharmaceutical chemicals composition of the composition are as follows: the coptis 9
Parts by weight, 9 parts by weight of baked ginger, 9 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 9 parts by weight of indigo naturalis, 6 parts by weight of radix aucklandiae, 9 weight of charred RADIX SANGUISORBAE
Measure part and 3 parts by weight of radix glycyrrhizae preparata;Or
7 parts by weight of the coptis, 11 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 4 parts by weight of indigo naturalis, 8 weight of radix aucklandiae
Measure part, 5 parts by weight of 7 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
11 parts by weight of the coptis, 7 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 11 parts by weight of indigo naturalis, 4 weight of radix aucklandiae
Measure part, 1 parts by weight of 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
8 parts by weight of the coptis, 10 parts by weight of baked ginger, 8 parts by weight of kuh-seng, 7 parts by weight of Radix Notoginseng, 5 parts by weight of indigo naturalis, 7 weight of radix aucklandiae
Measure part, 4 parts by weight of 10 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
10 parts by weight of the coptis, 8 parts by weight of baked ginger, 10 parts by weight of kuh-seng, 5 parts by weight of Radix Notoginseng, 10 parts by weight of indigo naturalis, radix aucklandiae 5
2 parts by weight of parts by weight, 8 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
9 parts by weight of the coptis, 9 parts by weight of baked ginger, 9 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 8 parts by weight of indigo naturalis, 5 weight of radix aucklandiae
Part, 3 parts by weight of 7 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
8 parts by weight of the coptis, 7 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 11 parts by weight of indigo naturalis, 4 weight of radix aucklandiae
Measure part, 4 parts by weight of 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
11 parts by weight of the coptis, 11 parts by weight of baked ginger, 11 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 4 parts by weight of indigo naturalis, radix aucklandiae 4
5 parts by weight of parts by weight, 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata.
The Chinese medicine composition for being used to treat ulcerative colitis, the composition are added conventional according to common process
The clinically dosage forms such as acceptable granule, capsule, pill, suppository are made in auxiliary material.
A method of the above-mentioned Chinese medicine composition for being used to treat ulcerative colitis being prepared, this method includes following step
It is rapid:
(a) coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata are taken according to selected parts by weight,
It is ground into fine powder after mixing or mix after being respectively crushed into fine powder, it is spare to cross 100-150 mesh;
(b) take above-mentioned fine powder, be added customary adjuvant according to common process be made clinically acceptable granule, capsule,
Pill, suppository.
It further include another method for preparing the above-mentioned Chinese medicine composition for being used to treat ulcerative colitis, this method includes
Following steps:
(a) take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed according to selected parts by weight
It closes, adds water to cook secondary, the water of first time plus 8-12 times of drug weight, decoction 1.5-2.5 hours, for the second time plus 6-10 times is measured
Water decocts 1-2 hours, and filtration, merging filtrate is stood overnight, and taking supernatant to be concentrated into 60 DEG C of relative densities is 1.2-1.25's
Medicinal extract;
(b) take the medicinal extract, be added customary adjuvant according to common process be made clinically acceptable granule, capsule,
Pill, suppository.
Further, this method comprises the following steps:
(a) take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed according to selected parts by weight
It closes, adds water to cook secondary, the water of first time plus 10 times of drug weights, decoction 2 hours, for the second time plus 8 times of amount water, decoction 1.5 are small
When, filtration, merging filtrate is stood overnight, and supernatant is taken to be concentrated into the medicinal extract that 60 DEG C of relative densities are 1.2-1.25;
(b) take the medicinal extract, be added customary adjuvant according to common process be made clinically acceptable granule, capsule,
Pill, suppository.
It further include another method for preparing the above-mentioned Chinese medicine composition for being used to treat ulcerative colitis, this method includes
Following steps:
The coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed powder are taken according to selected parts by weight
It is broken into coarse powder, adds the 55-75% ethyl alcohol of 4-12 times of drug weight, dipping keeps fluid temperature after 12-48 hours, to medicine liquid heating
It is 30 DEG C~40 DEG C, forced circulation 3-4 hours, filtering obtained alcohol extract, and customary adjuvant is added, clinic is made according to common process
Upper acceptable granule, capsule, pill, suppository.
Further, this method comprises the following steps:
The coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed powder are taken according to selected parts by weight
It is broken into coarse powder, adds 60% ethyl alcohol of 8 times of drug weights, dipping is after 30 hours, and keeping fluid temperature to medicine liquid heating is 35 DEG C, by force
System circulation 3.5 hours, filtering obtain alcohol extract, and customary adjuvant is added, clinically acceptable particle is made according to common process
Agent, capsule, pill, suppository.
It is used to treat in ulcerative colitis by what above-mentioned preparation method was prepared the invention also discloses a kind of
Drug composition, and the application for treating ulcerative colitis drug is used to prepare by above-mentioned Chinese medicine composition.
Applicant is by long-term a large amount of clinical observations and practice, it is believed that the clinic of patients of ulcerative colitis is glued with diarrhea
Liquid pus and blood stool, abdominal pain, tenesmus is primary symptom, and the interpretation of the cause, onset and process of an illness is spleen deficiency for originally, enteron aisle is damp and hot to mark, and interpretation of the cause, onset and process of an illness key is cold-heat jumble,
Gut purge middle benefit gas, removing blood stasis and hemostasis are worked as in dampness and heat stasis, treatment, and mildly regulating cold and heat formulates Chinese medicine composition of the present invention, for treating
Clinical ulcerative colitis obtains good effect;The traditional chinese medicine composition of the invention is by the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, wood
Fragrant, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata form, and the coptis, kuh-seng, indigo naturalis, charred RADIX SANGUISORBAE bitter cold enter blood system in side, can gut purge hemostasis;Baked ginger is warm-natured
Not only can be warming spleen and stopping diarrha, but can manufacture-yellow even etc. all medicines bitter cold, mildly regulating cold and heat;Radix Notoginseng removing blood stasis and hemostasis, the orderly and clearly mechanism of qi of radix aucklandiae, all medicines close
The effect of clear sharp enteron aisle is damp and hot with that can get, warming middle-JIAO and strengthening the spleen, mildly regulating cold and heat, removing blood stasis and hemostasis, mitigates disease pain to reach, mentions
High quality of life extends the purpose of life span.
The above technical solution of the present invention has the following advantages over the prior art:
(1) the traditional Chinese medicine composition for treating effect of the present invention for treating ulcerative colitis is good, has clear sharp intestines
Road is damp and hot, warming middle-JIAO and strengthening the spleen, mildly regulating cold and heat, the effect of removing blood stasis and hemostasis, mitigates disease pain to reach, improves the quality of living, prolong
The purpose of long life span;
(2) Chinese medicine composition of the present invention for treating ulcerative colitis and existing drug sulfasalazine
Enteric coatel tablets are compared, the two disease activity index (desease activity index, DAI) horizontal no significant difference;For big
Mouse colonic mucosal injury index, it is viscous using the colon and surrounding tissue of the experimental colitis rat of Chinese medicine composition of the invention
Even lighter, colon surface has no the inflammatory pseudomembrane of bronzing, and congested, oedema mitigates, with existing drug sulfasalazine enteric
Colonic mucosal injury index (conlonic mucosa damage index, CMDI) horizontal no significant difference of piece;The present invention
Each dosage group colonic tissue histological scores are significantly lower than model group (P < 0.05), wherein QCWZD high of the present invention, QCWZD
Middle dose group inflammatory cell invades the degree of profit significantly lower than model group;Rat blood serum IL-6, TNF-α level have obviously compared with model group
Decline (P < 0.05), and with the horizontal no significant difference of blank group;
(3) of the present invention for treating the preparation method of the Chinese medicine composition of ulcerative colitis, pass through this method
The Chinese medicine composition for obtaining the clinically dosage forms such as acceptable granule, capsule, pill, suppository, easily facilitates and takes, protects
It deposits, stability is good, highly-safe.
Technical effect of following experimental examples to prove pharmaceutical composition of the present invention.
Experimental example 1
Purposes of the present invention in terms for the treatment of ulcerative colitis is better described below by way of basic test example.The present invention
Chinese medicine composition compared with the control group, it was demonstrated that the significant effect of traditional Chinese medicine composition for treating ulcerative colitis of the invention.
1. experimental material
Experimental animal: healthy SD rat, male 35,200 ± 20g of weight, SPF grades of rank.
Experimental drug: the drug of test group is the Chinese medicine composition prepared in the present embodiment 1, and each dosage presses mouse body
Weight is crude drug amount 1200mg/kg, crude drug amount 600mg/kg, crude drug amount 300mg/kg are divided into QCWZD high, QCWZD, QCWZD is low
Dosetest group;Control group is SASP group, i.e., drug is sulfasalazine enteric coatel tablets, and each dosage is 400mg/ by weight
kg。
Medication: stomach-filling.
2. experimental method and result:
2.1 test method
200 ± 20g of weight is taken, healthy SD rat 35, male, be randomly divided into six groups: blank group is the SD rat of health,
Pour into the deionized water of 0.6ml;Remaining each group carries out modeling according to the modeling method in existing literature, and as TNBS/ ethyl alcohol fills
The experimental colitis rat model of intestines induction: SD Rat Fast can't help water for 24 hours before modeling, 10% chloraldurate (0.3ml/
100g) intraperitoneal injection of anesthesia rat, by after latex hose lubrication of liquid paraffin by anus slowly gently be inserted into rectum about 8cm, one
Secondary property is slowly injected to be completed within TNBS solution (100mg/kg) 0.6ml, 1min containing 33.3% ethyl alcohol, keeps dorsal position buttocks
Upward 15min is put back in cage, conventinal breeding after reviving naturally, and colon group is checked in separation after taking 5 rats to put to death after 3 days immediately
It knits, there is apparent colonic mucosal injury, prompt modeling success.
Medication: blank group and model group give the 10ml/kg physiological saline of mouse weight;Control group, dosage are
400mg/kg mouse weight;The high, medium and low dosage group of QCWZD is that Chinese medicine composition prepared by the embodiment of the present invention 1 is divided by dosage
For high, medium and low amount group, each dosage be respectively crude drug amount 1200mg/kg mouse weight, crude drug amount 600mg/kg mouse weight,
Crude drug amount 300mg/kg mouse weight.Each equal gastric infusion of administration group is used in conjunction 10 days one time a day.
2.2 test result
2.2.1 to the observation of the curative effect of the experimental colitis rat of TNBS induction
2.2.1.1 to the influence of the experimental colitis rat DAI of TNBS induction
The 2nd day after modeling, there is diarrhea in model group rats, are yellow loose stools, half loose stools even bloody stool, at this time rat hair color
It tarnishes, activity is poor, delay of response, lazy move, until the 3rd day DAI reaches maximum.(DAY7) each medication group is big after medication 4 days
Mouse spirit improves, and hair color is gradually glossy, and appetite increases, and activity gradually increases, and defecates gradually normal, DAI is decreased obviously (P <
0.05), the recovery of medication 5 days (DAY8) Dao medication 10 days (DAY13) DAI is more slow, each group DAI degree DAY13 and DAY7
Without significant difference (P > 0.05).Blank group rat then changes without above-mentioned spirit, activity, hair color etc., such as table 1.Pharmaceutical intervention 10 days
Afterwards, model group DAI is still significantly higher than blank group (P < 0.05), and SASP group and each dosage group of the present invention have obviously compared with model group
Decline (P < 0.05), QCWZD senior middle school low dose group DAI level of the present invention is compared with sulfasalazine group
(salazosulfapyridine, SASP) organizes no significant difference (P > 0.05), such as table 2.
Table 1.DAI diurnal variation table
Note:aP < 0.05,bP > 0.05 is compared with DAY3;cP < 0.05,dP > 0.05 is compared with DAY7.
2.2.1.2 Colonic Mucosa of The Rat damage index
The visible colonic mucosa erosion weight of model group naked eyes, ulcer compared with depth and area it is larger, have obvious intestinal contents at ulcer
Insertion, is not easy to rinse;It can be seen that obvious oedema, congested, colon surface is covered with the inflammatory pseudomembrane of bronzing;Enteric cavity at colonic pathological change
Dilatating and deformable;Lesion colon and surrounding tissue adhesion are obvious, are not readily separated.Each medication group colon and surrounding tissue adhesion are lighter,
Colon surface has no the inflammatory pseudomembrane of bronzing, and congested, oedema mitigates, and ulcer is in healing sex expression.After medication 10 days, model group
Colonic mucosal injury index (colonic mucosa damage index, CMDI) is still significantly higher than blank group (P < 0.05),
SASP group and QCWZD middle dose group of the present invention are decreased obviously (P < 0.05) compared with model group, this two groups of CMD work levels are without obvious
Difference (P > 0.05), such as table 2.
Influence of 2. drug of table to TNBS Colitis rat CMDI, DAI induced
Note:eP < 0.05,fP > 0.05 is compared with blank group;gP < 0.05 is compared with model group;hP > 0.05 and SASP group
Compare.
2.2.1.3 rat colon HS
Visible mucous membrane hyperemia, oedema, massive inflammatory cells infiltrated, with lymphocyte and neutrophil leucocyte under model group light microscopic
It invades based on profit, injured depth reaches submucosa, muscle layer even placenta percreta;Goblet cell significantly reduces, ulcer peripheral part body of gland
Expansion, body of gland is disorganized, hyperplasia that glandular epithelium is slight, partially with body of gland atypical hyperplasia, it is seen that inflammatory granuloma.
Visible hyperemia, oedema mitigate under each medication group light microscopic, and inflammatory cell is invaded profit and mitigated, and based on lymphocyte, thick liquid cell, neutral grain is thin
Born of the same parents are rare, and the visible eosinophil of individual colonic tissues, inflammatory cell invades profit level and shoals, and submucosa concentrated on, such as Fig. 1
Colitis rat colon pathology figure (× the 40) (note: A- blank group, B- model of the high, medium and low dosage treatment TNBS induction of QCWZD
Group, C-SASP group, D-QCWZD high dose group, E-QCWZD middle dose group, F-QCWZD low dose group).Model group colonic tissue disease
Neo-Confucianism scoring is apparently higher than blank group (P < 0.05), and each dosage group colonic tissue histological scores of the present invention are significantly lower than
Model group (P < 0.05), wherein QCWZD high of the present invention, QCWZD middle dose group inflammatory cell invade profit (Inflammatory
Infiltration, II) degree be significantly lower than model group (P < 0.05), such as table 3.
Influence of 3. drug of table to the TNBS Colitis rat HS induced
Note:eP < 0.05,fP > 0.05 is compared with blank group;gP < 0.05 is compared with model group.
2.2.2 the influence of rat blood serum inflammatory factor TNF-α, IL-6
Model group Colitis rat blood serum IL-6, TNF-α level are obviously higher than blank group (P < 0.05);SASP group is big
Mouse blood serum IL-6, TNF-α level decreased significantly (P < 0.05) compared with model group, and with the horizontal no significant difference (P of blank group
> 0.05);QCWZD high of the present invention, QCWZD middle dose group TNF-α level decreased significantly (P < 0.05) compared with model group, with
Blank group no significant difference (P > 0.05);QCWZD low dose group IL-6 decreased significantly (P < 0.05) compared with model group, with blank
Group and notable difference (P > 0.05), such as table 4.
Influence of 4. drug of table to the TNBS Colitis rat blood serum IL-6, TNF-α induced
Note:eP < 0.05,fP > 0.05 is compared with blank group;gP < 0.05 is compared with model group.
3. conclusion
(1) Chinese medicine composition of the invention has protective effect to the Colitis rat intestinal mucosa that TNBS is induced, and can be effective
Improve colonic tissue inflammatory cell and invades profit;
(2) Chinese medicine composition of the invention can be big by the colitis for lowering blood serum IL-6, TNF-α level induces TNBS
Mouse plays anti-inflammatory effect.
Detailed description of the invention
In order to make the content of the present invention more clearly understood, it below according to specific embodiments of the present invention and combines
Attached drawing, the present invention is described in further detail, wherein
Fig. 1 is the Colitis rat colon pathology figure of traditional Chinese medicine composition for treating TNBS induction prepared by the embodiment of the present invention 1
(×40)。
Specific embodiment
1 bead dosage form of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 7g, baked ginger 11g, kuh-seng 7g, Radix Notoginseng 8g, indigo naturalis 4g, radix aucklandiae 8g, charred RADIX SANGUISORBAE 7g and radix glycyrrhizae preparata 5g.
Granule is prepared according to the following steps into the Chinese medicine composition:
(a) take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed according to selected parts by weight
It closes, adds water to cook secondary, the water of first time plus 570ml, decoction 1.5 hours, second plus 456ml of water, decoction 1 hour, filter
It crosses, merging filtrate is stood overnight, and supernatant is taken to be concentrated into the medicinal extract that 60 DEG C of relative densities are 1.2-1.25;
(b) medicinal extract is taken, is made clinically acceptable according to the customary adjuvant that common process is added in pharmacy
Granula.
2 capsule formulation of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 11g, baked ginger 7g, kuh-seng 7g, Radix Notoginseng 8g, indigo naturalis 11g, radix aucklandiae 4g, charred RADIX SANGUISORBAE 11g and radix glycyrrhizae preparata 1g.
Granule is prepared according to the following steps into the Chinese medicine composition:
(a) coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and toast are taken according to the bulk pharmaceutical chemicals of above-mentioned selected weight
Radix Glycyrrhizae mixing adds water to cook secondary, the water of first time plus 12 times of drug weights, decoction 2 hours, second plus 10 times of drug weights
Water decocts 1.5 hours, and filtration, merging filtrate is stood overnight, and taking supernatant to be concentrated into 60 DEG C of relative densities is 1.2-1.25's
Medicinal extract;
(b) medicinal extract is taken, clinically acceptable glue is made according to the customary adjuvant that common process is added in pharmacy
Wafer.
3 pill-type of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 9g, baked ginger 9g, kuh-seng 9g, Radix Notoginseng 6g, indigo naturalis 9g, radix aucklandiae 6g, charred RADIX SANGUISORBAE 9g and radix glycyrrhizae preparata 3g.
Pill is prepared according to the following steps into the Chinese medicine composition:
(a) according to the bulk pharmaceutical chemicals of above-mentioned selected weight, take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and
Radix glycyrrhizae preparata mixing adds water to cook secondary, the water of first time plus 8 times of drug weights, decoction 1.5 hours, second plus 6 times of drug weights
Water is measured, is decocted 2 hours, filtration, merging filtrate is stood overnight, and taking supernatant to be concentrated into 60 DEG C of relative densities is 1.2-1.25's
Medicinal extract;
(b) medicinal extract is taken, the customary adjuvant in pharmacy is added according to common process, pill is dry, selects ball, it packs,
Clinically acceptable pill is made.
4 suppository type of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 8g, baked ginger 10g, kuh-seng 8g, Radix Notoginseng 7g, indigo naturalis 5g, radix aucklandiae 7g, charred RADIX SANGUISORBAE 10g and radix glycyrrhizae preparata 4g.
Suppository is prepared according to the following steps into the Chinese medicine composition:
(a) according to the bulk pharmaceutical chemicals of above-mentioned selected weight, take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and
Radix glycyrrhizae preparata mixing adds water to cook secondary, the water of first time plus 10 times of drug weights, decoction 2.5 hours, second plus 8 times of drugs
Weight water decocts 1.5 hours, and filtration, merging filtrate is stood overnight, and taking supernatant to be concentrated into 60 DEG C of relative densities is 1.2-
1.25 medicinal extract;
(b) medicinal extract is taken, clinically acceptable bolt is made according to the customary adjuvant that common process is added in pharmacy
Agent.
5 bead dosage form of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 7g, baked ginger 11g, kuh-seng 7g, Radix Notoginseng 8g, indigo naturalis 4g, radix aucklandiae 8g, charred RADIX SANGUISORBAE 7g and radix glycyrrhizae preparata 5g.
Granule is prepared according to the following steps into the Chinese medicine composition:
(a) coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata are taken according to selected parts by weight,
It is ground into fine powder after mixing or mix after being respectively crushed into fine powder, it is spare to cross 120 meshes;
(b) above-mentioned fine powder is taken, customary adjuvant is added according to common process, clinically acceptable granule is made.
6 capsule formulation of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 11g, baked ginger 7g, kuh-seng 7g, Radix Notoginseng 8g, indigo naturalis 11g, radix aucklandiae 4g, charred RADIX SANGUISORBAE 11g and radix glycyrrhizae preparata 1g.
Capsule is prepared according to the following steps into the Chinese medicine composition:
The coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata mixed powder are taken according to selected parts by weight
It is broken into coarse powder, adds 75% ethyl alcohol of 360ml, dipping is after 12 hours, and keeping fluid temperature to medicine liquid heating is 30 DEG C~40 DEG C, by force
System circulation 3.5 hours, filtering obtain alcohol extract, and customary adjuvant is added, clinically acceptable capsule is made according to common process
Agent.
7 pill-type of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 9g, baked ginger 9g, kuh-seng 9g, Radix Notoginseng 6g, indigo naturalis 9g, radix aucklandiae 6g, charred RADIX SANGUISORBAE 9g and radix glycyrrhizae preparata 3g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and pill is made.
8 suppository type of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 8g, baked ginger 10g, kuh-seng 8g, Radix Notoginseng 7g, indigo naturalis 5g, radix aucklandiae 7g, charred RADIX SANGUISORBAE 10g and radix glycyrrhizae preparata 4g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and suppository is made.
9 granule of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 10g, baked ginger 8g, kuh-seng 10g, Radix Notoginseng 5g, indigo naturalis 10g, radix aucklandiae 5g, charred RADIX SANGUISORBAE 8g and radix glycyrrhizae preparata 2g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and granule is made.
10 capsule of embodiment
The Chinese medicine composition of the treatment treatment ulcerative colitis of the present embodiment, is formulated as follows:
Coptis 9g, baked ginger 9g, kuh-seng 9g, Radix Notoginseng 6g, indigo naturalis 8g, radix aucklandiae 5g, charred RADIX SANGUISORBAE 7g and radix glycyrrhizae preparata 3g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and capsule is made.
11 pill of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 8g, baked ginger 7g, kuh-seng 7g, Radix Notoginseng 6g, indigo naturalis 11g, radix aucklandiae 4g, charred RADIX SANGUISORBAE 11g and radix glycyrrhizae preparata 4g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and pill is made.
12 suppository of embodiment
The Chinese medicine composition of the treatment ulcerative colitis of the present embodiment is formulated as follows:
Coptis 11g, baked ginger 11g, kuh-seng 11g, Radix Notoginseng 8g, indigo naturalis 4g, radix aucklandiae 4g, charred RADIX SANGUISORBAE 11g and radix glycyrrhizae preparata 5g.
The Chinese medicine composition is added pharmaceutically customary adjuvant according to common process and suppository is made.
Obviously, the above embodiments are merely examples for clarifying the description, and does not limit the embodiments.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of variation or
It changes.There is no necessity and possibility to exhaust all the enbodiments.And it is extended from this it is obvious variation or
It changes still within the protection scope of the invention.
Claims (10)
1. a kind of for treating the Chinese medicine composition of ulcerative colitis, which is characterized in that the bulk pharmaceutical chemicals of the composition form
Are as follows: coptis 7-11 parts by weight, baked ginger 7-11 parts by weight, kuh-seng 7-11 parts by weight, Radix Notoginseng 4-8 parts by weight, indigo naturalis 4-11 parts by weight,
Radix aucklandiae 4-8 parts by weight, charred RADIX SANGUISORBAE 7-11 parts by weight and radix glycyrrhizae preparata 1-5 parts by weight.
2. according to claim 1 for treating the Chinese medicine composition of ulcerative colitis, which is characterized in that the composition
Bulk pharmaceutical chemicals composition are as follows:
9 parts by weight of the coptis, 9 parts by weight of baked ginger, 9 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 9 parts by weight of indigo naturalis, 6 parts by weight of radix aucklandiae,
3 parts by weight of 9 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
7 parts by weight of the coptis, 11 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 4 parts by weight of indigo naturalis, 8 parts by weight of radix aucklandiae,
5 parts by weight of 7 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
11 parts by weight of the coptis, 7 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 11 parts by weight of indigo naturalis, 4 weight of radix aucklandiae
Part, 1 parts by weight of 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
8 parts by weight of the coptis, 10 parts by weight of baked ginger, 8 parts by weight of kuh-seng, 7 parts by weight of Radix Notoginseng, 5 parts by weight of indigo naturalis, 7 parts by weight of radix aucklandiae,
4 parts by weight of 10 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
10 parts by weight of the coptis, 8 parts by weight of baked ginger, 10 parts by weight of kuh-seng, 5 parts by weight of Radix Notoginseng, 10 parts by weight of indigo naturalis, 5 weight of radix aucklandiae
Part, 2 parts by weight of 8 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
9 parts by weight of the coptis, 9 parts by weight of baked ginger, 9 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 8 parts by weight of indigo naturalis, 5 parts by weight of radix aucklandiae,
3 parts by weight of 7 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
8 parts by weight of the coptis, 7 parts by weight of baked ginger, 7 parts by weight of kuh-seng, 6 parts by weight of Radix Notoginseng, 11 parts by weight of indigo naturalis, 4 parts by weight of radix aucklandiae,
4 parts by weight of 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata;Or
11 parts by weight of the coptis, 11 parts by weight of baked ginger, 11 parts by weight of kuh-seng, 8 parts by weight of Radix Notoginseng, 4 parts by weight of indigo naturalis, 4 weight of radix aucklandiae
Part, 5 parts by weight of 11 parts by weight of charred RADIX SANGUISORBAE and radix glycyrrhizae preparata.
3. according to claim 1 or claim 2 for treating the Chinese medicine composition of ulcerative colitis, which is characterized in that in described
Drug composition is added customary adjuvant according to common process and clinically acceptable granule, capsule, pill, suppository is made.
4. a kind of method prepared as described in claim 1-3 is any for treating the Chinese medicine composition of ulcerative colitis,
It is characterized in that, this method comprises the following steps:
(a) coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata are taken according to selected parts by weight, respectively
It is ground into fine powder after mixing or mix after being ground into fine powder, it is spare to cross 100-150 mesh;
(b) take above-mentioned fine powder, be added customary adjuvant according to common process be made clinically acceptable granule, capsule, pill,
Suppository.
5. a kind of method prepared as described in claim 1-3 is any for treating the Chinese medicine composition of ulcerative colitis,
It is characterized in that, this method comprises the following steps:
(a) it takes the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata to mix according to selected parts by weight, adds
Water decocts secondary, the water of first time plus 8-12 times of drug weight, and decoction 1.5-2.5 hours, for the second time plus 6-10 times is measured water, decoction
1-2 hours, filtration, merging filtrate was stood overnight, and supernatant is taken to be concentrated into the medicinal extract that 60 DEG C of relative densities are 1.2-1.25;
(b) take the medicinal extract, be added customary adjuvant according to common process be made clinically acceptable granule, capsule, pill,
Suppository.
6. according to the method described in claim 5, it is characterized in that, this method comprises the following steps:
(a) it takes the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata to mix according to selected parts by weight, adds
Water decocts secondary, the water of first time plus 10 times of drug weights, decoction 2 hours, second plus 8 times of amount water, decoction 1.5 hours, filter
It crosses, merging filtrate is stood overnight, and supernatant is taken to be concentrated into the medicinal extract that 60 DEG C of relative densities are 1.2-1.25;
(b) take the medicinal extract, be added customary adjuvant according to common process be made clinically acceptable granule, capsule, pill,
Suppository.
7. a kind of method prepared as described in claim 1-3 is any for treating the Chinese medicine composition of ulcerative colitis,
It is characterized in that, this method comprises the following steps:
According to selected parts by weight take the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata co-grinding at
Coarse powder adds the 55-75% ethyl alcohol of 4-12 times of drug weight, and for dipping after 12-48 hours, keeping fluid temperature to medicine liquid heating is 30
DEG C~40 DEG C, forced circulation 3-4 hours, filtering obtained alcohol extract, and customary adjuvant is added, is made according to common process and clinically may be used
Granule, capsule, pill, the suppository of receiving.
8. the method according to the description of claim 7 is characterized in that this method comprises the following steps: according to selected parts by weight
It takes the coptis, baked ginger, kuh-seng, Radix Notoginseng, indigo naturalis, radix aucklandiae, charred RADIX SANGUISORBAE and radix glycyrrhizae preparata co-grinding at coarse powder, adds 8 times of drug weights
60% ethyl alcohol, dipping is after 30 hours, and keeping fluid temperature to medicine liquid heating is 35 DEG C, and forced circulation 3.5 hours, filtering obtained alcohol
Extract is added customary adjuvant, clinically acceptable granule, capsule, pill, suppository is made according to common process.
9. the Chinese medicine composition being prepared according to any method of claim 4-8.
10. Chinese medicine composition described according to claim 1 or 2 or 3 or 9 is used to prepare answering for treatment ulcerative colitis drug
With.
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CN107335029B (en) * | 2017-06-19 | 2021-01-19 | 南京海陵中药制药工艺技术研究有限公司 | Preparation method of intestine-clearing and middle-warming granules |
CN112190681A (en) * | 2020-10-29 | 2021-01-08 | 北京中医药大学东方医院 | Traditional Chinese medicine composition for treating ulcerative colitis and preparation method thereof |
CN115708862B (en) * | 2022-08-23 | 2023-12-19 | 李毅 | Traditional Chinese medicine composition for treating colonitis |
CN116211992B (en) * | 2023-03-22 | 2023-11-21 | 重庆市中医院 | Traditional Chinese medicine composition for treating ulcerative colitis-induced depression-like behavior |
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