CN106540019A - It is a kind of to treat Chinese medicine composition of ulcerative colitiss and its production and use - Google Patents
It is a kind of to treat Chinese medicine composition of ulcerative colitiss and its production and use Download PDFInfo
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- CN106540019A CN106540019A CN201510618217.3A CN201510618217A CN106540019A CN 106540019 A CN106540019 A CN 106540019A CN 201510618217 A CN201510618217 A CN 201510618217A CN 106540019 A CN106540019 A CN 106540019A
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- 201000006704 Ulcerative Colitis Diseases 0.000 title claims abstract description 22
- 238000004519 manufacturing process Methods 0.000 title description 4
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Abstract
The present invention provides a kind of new for treating Chinese medicine composition of ulcerative colitiss and preparation method thereof.The compositionss are mainly made up of the raw material of following weight portion：5 parts～15 parts of Radix Codonopsis, 1 part～10 parts of Radix Sophorae Flavescentiss, 1 part～10 parts of the Radix Aucklandiae, 3 parts～9 parts of terminalia flesh, 1 part～8 parts of Rhizoma Alismatis (processeded with salt).The method for preparing the Chinese medicine composition comprises the following steps：Each raw material is taken by weight, is added water to cook or is extracted using ethanol water, obtain decoction liquor or extracting solution, by the decoction liquor for obtaining or extracting solution filtration to obtain filtrate, and filtrate is concentrated to obtain clear paste.Present invention also offers purposes of the described Chinese medicine composition in the medicine for being used to treating inflammation is prepared.The Chinese medicine composition of the present invention can resist rat colon Histopathological lesions caused by trinitro-benzene-sulfonic acid, can strengthen entirety inflammatory immunoreation, hence it is evident that improve animal have blood in stool, suffer from diarrhoea, the appearance sign such as dynamic less, curative effect is obvious.
Description
Technical field
The invention belongs to Chinese medicine and pharmacy field, and in particular to a kind of for treating ulcerative colitiss
Chinese medicine composition and its production and use.
Background technology
Ulcerative colitiss (Ulcerative Colitis, UC) are a kind of rectum of autoimmunity, knot
The chronic inflammatory disease of intestinal and exedens pathological changes, the clinical difficult disease of category, are mainly shown as diarrhoea, abdomen
Bitterly, mucosanguineous fecess etc., the recurrent exerbation in chronic process, delay is up to many decades, and has carcinogenic danger
Danger, brings considerable distress and threat to patient.In recent years, with China's economic development, Ren Minqun
Many dietary structures and life style there occurs great variety, from relevant inpatient and clinical literature etc.
Data finds out that the sickness rate of UC becomes medical personal's concern in ascendant trend, its clinical treatment is continued
Emphasis.
At present, modern medicine is according to the understanding to UC etiology and pathogenesis, mainly using antiinflammatory, antibacterial, suppression
The methods such as immunoreation processed, conventional medicine have aminosalicylic acids, cortical steroid, immunity suppression
Preparation, anti-infective etc..These medicines serve positive effect to treating UC, but while and exist
High recurrence rate, therapeutic effect is undesirable and the problems such as serious toxic and side effects.
Primary disease basic pathogenesis be deficiency in origin and excess in superficiality, deficiency in origin is weakness of the spleen and kidney, mark actually wet, expectorant, heat,
The stasis of blood, poison, mainly damp are trouble.Its property of damp is deep viscous, therefore primary disease morbidity is how relatively slow, disease
Journey is longer, and difficulty heals repeatedly.The traditional Chinese medical science thinks that primary disease is more than the pathological changes of colon local, a kind of but whole body
Property disease, has substantial connection with function obstacle, imbalance between YIN and YANG.There is scholar to think the QI and blood stasis of blood
Stagnant significant in primary disease, insufficiency of the spleen, transporting and transforming nutrients from foodstuff is precise and tiny and the wet function of water is reduced, and
Cause diarrhea mucus, bloody purulent stool.
Present invention research theory of Chinese medical science, it is determined that with " invigorating the spleen and benefiting QI, clearing away heat-damp and promoting diuresis, regulating QI promoting the circulation of blood " to control
Principle is treated, present invention treatment ulcerative colitiss cause to burst to TNBS (2,4,6- trinitro-benzene-sulfonic acid)
Related biochemical indicator of ulcer colitis rat etc. is observed, to seek its curative effect and mechanism, exploitation
The Chinese patent medicine of determined curative effect, to meet clinical needs, has important practical significance.
The content of the invention
Therefore, it is an object of the present invention to provide a kind of new for treating in ulcerative colitiss
Drug composition.
It is a further object to provide a kind of prepare the new for treating exedens knot of the present invention
The method of the Chinese medicine composition of enteritis.
A further object of the present invention is to provide the new for treating in ulcerative colitiss of the present invention
The purposes of drug composition.
The purpose of the present invention is realized by providing technical scheme below.
On the one hand, the invention provides a kind of Chinese medicine composition for treating ulcerative colitiss, institute
State compositionss to be mainly made up of the raw material of following weight portion：5 parts～15 parts of Radix Codonopsis, Radix Sophorae Flavescentiss 1 part～10
Part, 1 part～10 parts of the Radix Aucklandiae, 3 parts～9 parts of terminalia flesh, 1 part～8 parts of Rhizoma Alismatis (processeded with salt).
Preferably, the Chinese medicine composition is mainly made up of the raw material of following weight portion, 10 parts of Radix Codonopsis,
5 parts of Radix Sophorae Flavescentiss, 5 parts of the Radix Aucklandiae, 6 parts of terminalia flesh, 4 parts of Rhizoma Alismatis (processeded with salt).
Preferably, the Chinese medicine composition be tablet, hard capsule, soft capsule, oral liquid,
Granule, honeyed pill, the watered pill, drop pill or unguentum.
Preferably, the Chinese medicine composition also includes pharmaceutically acceptable adjuvant, it is preferable that described
Adjuvant is selected from filler, binding agent, disintegrating agent, lubricant, wetting agent, antioxidant, preservative and rectifys
One or more in taste agent；It is highly preferred that the filler selected from Mannitol, Lactose, Polyethylene Glycol,
One or more in carboxymethyl starch sodium；Described adhesive is selected from starch and/or Microcrystalline Cellulose；It is described
Disintegrating agent is selected from carboxymethyl cellulose, low substituted hydroxypropyl cellulose and/or micropowder silica gel；The lubrication
Agent is selected from Pulvis Talci and/or magnesium stearate；The wetting agent is selected from Propylene Glycol and/or ethanol；The antioxygen
Agent is selected from sodium pyrosulfite, sodium thiosulfate and/or citric acid；The preservative selected from sodium benzoate and/
Or potassium sorbate；And/or the correctivess are selected from sucrose and/or Mannitol.
Above-mentioned pharmaceutically acceptable adjuvant is common dose, is mixed with the proportioning and extract commonly used
Close, after extract consumption determines, the proportioning between each pharmaceutic adjuvant suitably can be adjusted as needed
Section.
On the other hand, present invention also offers a kind of method of the Chinese medicine composition for preparing the present invention, described
Method comprises the following steps：
Each raw material is taken by weight, is added water to cook or is extracted using ethanol water, obtain decoction liquor or carry
Liquid is taken, by the decoction liquor for obtaining or extracting solution filtration to obtain filtrate, and filtrate is concentrated to obtain clear paste.
Preferably, wherein, will the raw material all merge after add water to cook or extracted using ethanol water,
So as to obtain decoction liquor or extracting solution, or by the raw material be divided into two groups or more add water respectively it is pan-fried
Boil or extracted using ethanol water, respectively obtain decoction liquor or extracting solution, remerge afterwards and respectively obtain
Decoction liquor or extracting solution, so as to obtain decoction liquor or extracting solution, or by the decoction liquor for respectively obtaining or
Extracting solution is filtered respectively to respectively obtain filtrate, remerges the filtrate for respectively obtaining afterwards so as to be filtered
Liquid, or the filtrate for respectively obtaining is concentrated to respectively obtain clear paste, respectively obtain clear is remerged afterwards
Cream is so as to obtaining clear paste.
It is further preferred that in the ethanol water, the volume fraction of ethanol is 30-90%；It is highly preferred that
In the ethanol water, the volume fraction of ethanol is 60%.
Preferably, wherein, it is described add water to cook or using ethanol water extract carry out twice, will twice
The extracting solution that the decoction liquor or extraction that decoction is obtained is obtained merges, and filters to obtain filtrate；Wherein, first
Secondary decoction or when extracting, 6-12 times for raw material gross weight of the weight of water or ethanol water, preferably 10
Times, decoct or reflux, extract, 1-3 hour, preferably 2 hours；Second when decocting or extracting, water or second
4-12 times for raw material gross weight of the weight of alcohol-water solution, decocts or reflux, extract, 1-3 is little by preferably 8 times
When, preferably 1.5 hours.
Preferably, the relative density of the clear paste is 1.10-1.25 at 60 DEG C.
It is further preferred that methods described is further comprising the steps of：By the decoction liquor for obtaining or extracting solution
After filtration is to obtain filtrate, and by the filtrate for obtaining concentration to obtain relative density at 60 DEG C it is being
Before the clear paste of 1.10-1.25, by the filtrate for obtaining concentration to obtain relative density at 60 DEG C it is
The clear paste of 1.18-1.23, plus ethanol makes alcohol content up to 60～70%v/v, preferred 65%v/v is stirred evenly, quiet
Put 18～48 hours, it is preferable that stand 24 hours, filter to obtain filtrate.
Preferably, in the raw material, Radix Codonopsis, Radix Sophorae Flavescentiss, the Radix Aucklandiae and Rhizoma Alismatis (processeded with salt) are added water to cook or are made as one group
Extracted with ethanol water, terminalia flesh is added water to cook as another group or extracted using ethanol water.
Preferably, methods described is further comprising the steps of：The clear paste for obtaining is dried, is crushed, obtain dry powder,
Dry powder is weighed, pharmaceutically acceptable adjuvant is added, is heated to melt temperature, makes raw material and adjuvant abundant
It is miscible, drop pill is made, or after pharmaceutically acceptable adjuvant is added, stirring is mixed and made into granule,
Will after particle drying granule or tabletted or be filled in hungry area softgel shell to obtain capsule；Or,
Methods described is further comprising the steps of：The clear paste for obtaining is weighed, pure water, preservative is added, it is fully mixed
Close, filter, oral liquid is made in filtrate fill.
Preferably, the adjuvant is selected from filler, binding agent, disintegrating agent, lubricant, wetting agent, anti-
One or more in oxygen agent, preservative and correctivess；Wherein, the filler is selected from Mannitol, breast
One or more in sugar, Polyethylene Glycol, carboxymethyl starch sodium；It is highly preferred that the Polyethylene Glycol is
Macrogol 4000 and/or polyethylene glycol 6000；Described adhesive is selected from starch and/or Microcrystalline Cellulose；
The disintegrating agent is selected from carboxymethyl cellulose, low substituted hydroxypropyl cellulose and/or micropowder silica gel；It is described
Lubricant is selected from Pulvis Talci and/or magnesium stearate；The wetting agent is selected from Propylene Glycol and/or ethanol；It is described
Antioxidant is selected from sodium pyrosulfite, sodium thiosulfate and/or citric acid；The preservative is selected from sodium benzoate
And/or potassium sorbate；The correctivess are selected from sucrose and/or Mannitol.
Preferably, the adjuvant is selected from filler, binding agent, disintegrating agent, lubricant, wetting agent, anti-
One or more in oxygen agent, preservative and correctivess；Preferably, the clear paste is done at 60 DEG C
It is dry.
Preferably, the granule is dried 2-4 hours at 60-70 DEG C.
Preferably, the granule is prepared using 12-14 mesh sieves.
Preferably, when tablet or capsule is prepared, the adjuvant is selected from filler, binding agent, disintegrate
Agent, lubricant, one or more in correctivess；When granule is prepared, the adjuvant is selected from filling
Agent, disintegrating agent, one or more in correctivess；When drop pill is prepared, the adjuvant is filler
And/or antioxidant.
Preferably, when granule or drop pill is prepared, the addition of the pharmaceutically acceptable adjuvant
For 40～90%w/w of preparation total amount.
Preferably, when drop pill is prepared, the melt temperature is 40-90 DEG C.
Water, the volume fraction can be adopted in the preparation method of the present invention for the ethanol water of 30-90% to be
Extract solvent to be extracted, extracting solution is concentrated again, makes tablet, hard capsule, flexible glue after purification
Wafer, oral liquid, granule, honeyed pill, the watered pill, drop pill, unguentum.
Another aspect, the present invention provide described Chinese medicine composition in the medicine for treating inflammation is prepared
Purposes；Preferably, the inflammation is colitis；It is highly preferred that the colitis are ulcerative colitis
It is scorching.
Applicant with the tablet of technological forming as object of study, by TNBS cause rat ulcer colon
Scorching treatment, verifies the drug activity of products formed.Experiment is divided into normal group, TNBS model group, willow nitrogen
Sulfapyridine positive group, medicine high dose group, middle dose group and low dose group.Put to death during treatment end dynamic
Thing takes colon, calculates each group rat colon intestinal weight coefficient；Determine each group rat colon myeloperoxidase (MPer)
(MPO) activity and SOD in serum and MDA levels；Spleen is taken, each group animal spleen weight coefficient is calculated；
Take segmental colonic and do microscopy, evaluate mucosa injury index.
As a result show, compared with model group, medicine high dose group, middle dose group and low dose group intestinal are again
Number significantly reduces (p<0.05)；Each administration group spleen weight coefficient has significance to raise (p<0.05)；
Each administration group colon MPO levels are reduced, and wherein medicine high dose group, positive controls have significantly
Property reduce (p<0.05) in, low dose group have reduction trend；SOD levels in each administration group serum
Significance raises (p<0.05)；Each administration group MDA level work property reduces (p<0.05), wherein high
Dosage group pole significance reduces (p<0.01)；Compared with model group, each administration group colon histology is damaged
Index is significantly reduced, and wherein medicine high dose group, positive group have pole significant difference (p<0.01).
The experiment shows that medicine can resist rat colon Histopathological lesions caused by trinitro-benzene-sulfonic acid,
Overall inflammatory immunoreation can be strengthened, hence it is evident that improve animal and the appearance sign such as have blood in stool, suffer from diarrhoea, moving less, treat
Effect is obvious.The present invention is made up of Radix Codonopsis, Radix Sophorae Flavescentiss, the Radix Aucklandiae, terminalia flesh, Rhizoma Alismatis (processeded with salt) five kinds of Chinese medicine.Radix Codonopsis benefit
Gas spleen invigorating is promoted the production of body fluid, and spleen can be helped to recover the precise and tiny function of its transporting and transforming nutrients from foodstuff, plays the effect of righting, is monarch.Radix Sophorae Flavescentiss
Heat clearing and damp drying, controls hematodiarrhoea, has blood in stool, and can remove the heresy for penting up damp-heat in the large intestine, dispels the diarrhoea, just of large intestine
The diseases such as blood, Radix Aucklandiae spleen invigorating circulation of qi promoting, dampness pain relieving enter spleen, large intestine channel, can rise and can drop, and close then with Radix Codonopsis
The effect of raw righting QI invigorating, can then let out the gas of damp, be minister with Radix Sophorae Flavescentiss.Rhizoma Alismatis (processeded with salt) promoting diuresis to eliminate damp pathogen, terminalia flesh
Relieving diarrhea with astringents is made for assistant.Five medicine fit applications work(are concentrated one's efforts grand, can reach the effect for the treatment of both the principal and secondary aspects of a disease.
The present invention is seen by related biochemical indicator of ulcerative colitis in rats etc. is caused to TNBS
Examine, it was demonstrated that the Chinese medicine composition of the present invention is remarkably improved SOD in ulcerative colitiss animal blood
Content, suppresses MDA to generate, and shows the anti-ulcerative colitis effect of the Chinese medicine composition of the present invention
It is relevant with generation and anti-oxidation function enhancing which suppresses oxygen-derived free radicals.Additionally, it can also increase spleen
Organ weight, reduces colon's MPO contents, shows energy enhancing human body immunity reaction of the invention,
Reduce inflammatory reaction.To sum up, Chinese medicine composition of the invention can resist big caused by trinitro-benzene-sulfonic acid
Mus colon pathology damage, can strengthen overall inflammatory immunoreation, hence it is evident that improve animal have blood in stool, abdomen
The appearance sign such as rush down, move less, curative effect is obvious.
Description of the drawings
Hereinafter, with reference to accompanying drawing describing embodiment of the present invention in detail, wherein：
Colon optical microscope pictures of the Fig. 1 for rat normal group；
Optical microscopes of the Fig. 2 for rat model group colon ulcer, it is seen that ulcer, pathological changes mainly exist
Tela submucosa, tissue edema substantially and massive inflammatory cells infiltrated, based on lymph foilicie hyperplasia；
Fig. 3 is the Fibrotic optical microscope of rat model group colon, it is seen that ulcer, pathological changes are main
In tela submucosa, tissue edema substantially and massive inflammatory cells infiltrated, based on lymph foilicie hyperplasia；
Optical microscopes of the Fig. 4 for rat low dose group colon lymph foilicie hyperplasia, it is seen that ulcer,
Obvious tissue edema and a large amount of cell infiltration；
Fig. 5 is the rotten to the corn optical microscope of rat low dose group colon, it is seen that ulcer, significantly
Tissue edema and a large amount of cell infiltration；
Optical microscopes of the Fig. 6 for rat middle dose group colon table fester, it is seen that ulcer, brighter
Aobvious tissue edema and a large amount of cell infiltration；
Optical microscopes of the Fig. 7 for rat high dose group colon, ulcer is less and visible has healed
Chronic ulcer tissue, tissue edema and congested substantially mitigation, cell infiltration are significantly reduced；
Fig. 8 is the optical microscope of the positive group colon of rat, ulcer it is less and it is visible healed burst
Infectionss are organized, and tissue edema and hyperemia substantially mitigate, and cell infiltration is significantly reduced.
Specific embodiment
Below in conjunction with preferred embodiment, the present invention will be further described, to what is provided according to the present invention
Specific embodiment describes in detail as follows；For purposes of simplicity and clarity, it is hereafter appropriate to eliminate public affairs
Know the description of technology, in case those unnecessary details affect the description to the technical program.
Unless specifically stated otherwise, the rat for adopting in following examples is SPF level SD rats.
Unless specifically stated otherwise, test method used in following examples is used normal in this area
Rule method.
Unless specifically stated otherwise, reagent used in following examples is analysis pure level reagent, and can be from
Regular distributor available from.
Unless specifically stated otherwise, ethanol and adjuvant used in following examples are pharmaceutical grade, and can be from
Regular distributor available from.
Embodiment 1
Radix Codonopsis 200g, Radix Sophorae Flavescentiss 100g, Radix Aucklandiae 100g, terminalia flesh 120g, Rhizoma Alismatis (processeded with salt) 80g are taken, is added water
Decoct twice, 10 times for raw material gross weight of the weight for adding water for the first time is decocted 2 hours, second
8 times for raw material gross weight of the weight for adding water, decocts 1.5 hours, merges decoction liquor, filtration, filtrate
It is concentrated into the clear paste that relative density is 1.10-1.25 (60 DEG C).Qinghuo reagent, is dried (60 DEG C),
Crush, obtain dry powder, weigh dry powder 180g, add carboxymethyl starch sodium 100g, Microcrystalline Cellulose 90g,
Lactose 60g, micropowder silica gel 20g, are thoroughly mixed and make granule, and 2-4 hours are dried at 60-70 DEG C,
It is pressed into 1000.
Embodiment 2
Radix Codonopsis 100g, Radix Sophorae Flavescentiss 200g, Radix Aucklandiae 20g, terminalia flesh 180g, Rhizoma Alismatis (processeded with salt) 100g are taken, is added water
Decoct twice, 6 times for raw material gross weight of the weight for adding water for the first time is decocted 1 hour, added for the second time
12 times for raw material gross weight of the weight of water, decocts 3 hours, merges decoction liquor, and filtration, filtrate are dense
The clear paste that relative density is 1.18-1.23 (60 DEG C) is reduced to, plus ethanol makes alcohol content up to 65%v/v, stirs
It is even, 24 hours are stood, filtration, decompression filtrate recycling ethanol are simultaneously concentrated into relative density for 1.10-1.25
The clear paste of (60 DEG C).Qinghuo reagent, is dried (60 DEG C), crushes, obtains dry powder, weigh dry powder 130g,
Carboxymethyl starch sodium 100g, Microcrystalline Cellulose 80g, Lactose 70g, magnesium stearate 10g are added, fully
Stirring is mixed and made into granule, and 2-4 hours are dried at 60-70 DEG C, 1000 are pressed into.
Embodiment 3
Take Radix Codonopsis 300g, Radix Sophorae Flavescentiss 20g, Radix Aucklandiae 200g, terminalia flesh 60g, Rhizoma Alismatis (processeded with salt) 20g, plus 60%v/v
Twice, the weight of the ethanol water for adding for the first time is raw material gross weight to ethanol water reflux, extract,
10 times of amounts, heat 2 hours, and the weight of the ethanol water of second addition is the 8 of raw material gross weight
Measure again, heat 1.5 hours, united extraction liquid, filtration, filtrate are concentrated into relative density for 1.10-1.25
The clear paste of (60 DEG C).Qinghuo reagent, is dried (60 DEG C), crushes, obtains dry powder, weigh dry powder 195g,
Carboxymethyl starch sodium 100g, Microcrystalline Cellulose 40g, Lactose 45g, Pulvis Talci 10g are added, is fully stirred
Mix and be mixed and made into granule, 2-4 hours are dried at 60-70 DEG C, be pressed into 1000 tablets.
Embodiment 4
Take Radix Codonopsis 200g, Radix Sophorae Flavescentiss 100g, Radix Aucklandiae 40g, terminalia flesh 100g, Rhizoma Alismatis (processeded with salt) 160g, the above
The five tastes, take Radix Sophorae Flavescentiss, the Radix Aucklandiae and merge, add 60%v/v ethanol waters reflux, extract, twice, for the first time
The weight of the ethanol water of addition is 8 times of Radix Sophorae Flavescentiss and Radix Aucklandiae gross weight, is heated 2 hours, second
The weight of the ethanol water of addition is 6 times of Radix Sophorae Flavescentiss and Radix Aucklandiae gross weight, is heated 1.5 hours, is merged
Extracting solution, filtration, filtrate are concentrated into the clear paste that relative density is 1.10-1.25 (60 DEG C), standby；Will
Radix Codonopsis, terminalia flesh, Rhizoma Alismatis (processeded with salt) are added water to cook twice, and the weight of the water for adding for the first time is above-mentioned three kinds former
12 times of material gross weight, decoct 1 hour, and the weight of the water of second addition is that above-mentioned three kinds of raw materials are total
8 times of weight, decoct 3 hours, merge decoction liquor, and filtration, filtrate are concentrated into relative density for 1.10-1.25
The clear paste of (60 DEG C), it is standby；Merge two kinds of clear paste.Above-mentioned clear paste is taken, (60 DEG C) are dried,
Crush, obtain dry powder, weigh dry powder 138g, add carboxymethyl starch sodium 80g, Microcrystalline Cellulose 70g,
Micropowder silica gel 16g, it is thoroughly mixed and makes granule, 2-4 hours is dried at 60-70 DEG C, is pressed into
1000 tablets.
Embodiment 5
The formula and extraction process of embodiment 5 is identical with embodiment 1, and qinghuo reagent is dried
(60 DEG C), crush, obtain dry powder, weigh dry powder 180g, add carboxymethyl starch sodium 100g, Lactose 70g,
Magnesium stearate 10g, is thoroughly mixed and makes granule, 2-4 hours is dried at 60-70 DEG C, is then filled
Capsule is obtained in entering hungry area softgel shell.
Embodiment 6
The formula and extraction process of embodiment 6 is identical with embodiment 2, and qinghuo reagent is dried
(60 DEG C), crush, obtain dry powder, weigh dry powder 130g, add carboxymethyl starch sodium 90g, crystallite fine
Dimension element 40g, Lactose 50g, Pulvis Talci 15g, are thoroughly mixed and make granule, in 60-70 DEG C of drying
2-4 hours, are obtained capsule in being then filled into hungry area softgel shell.
Embodiment 7
The formula and extraction process of embodiment 7 is identical with embodiment 3, and qinghuo reagent is dried
(60 DEG C), crush, obtain dry powder, weigh dry powder 195g, add carboxymethyl starch sodium 190g, crystallite fine
Dimension element 80g, Lactose 70g, magnesium stearate 10g, are thoroughly mixed and make granule, dry at 60-70 DEG C
Dry 2-4 hours, are obtained capsule in being then filled into hungry area softgel shell.
Embodiment 8
The formula and extraction process of embodiment 8 is identical with embodiment 4, and qinghuo reagent is dried
(60 DEG C), crush, obtain dry powder, weigh dry powder 138g, add carboxymethyl starch sodium 140g, Lactose 120g,
Micropowder silica gel 16g, is thoroughly mixed and makes granule, and 2-4 hours are dried at 60-70 DEG C, at 60-70 DEG C
2-4 hours are dried, in being then filled into hungry area softgel shell, capsule are obtained.
Embodiment 9
The formula and extraction process of embodiment 9 is identical with embodiment 4, and qinghuo reagent is dried
(60 DEG C), crush, obtain dry powder, weigh dry powder 138g, and 100g dry powder adds Macrogol 4000 184g,
Polyethylene glycol 6000 92g, heating melt temperature (40-90 DEG C), makes raw material and adjuvant fully miscible, drips
Make drop pill.
Embodiment 10
The formula and extraction process of embodiment 10 is identical with embodiment 4, qinghuo reagent, and 100g adds water
1000ml, sodium benzoate 5g, after stirring evenly rear static placement 12 hours, filtration, filtrate fill are made
Oral liquid.
Embodiment 11
The Chinese medicine composition of the present invention has therapeutical effect to ulcerative colitiss, is illustrated such as by the test of pesticide effectiveness
Under：
Experiment purpose research medicine causes the therapeutical effect of ulcerative colitis in rats to TNBS.
First, laboratory animal packet and administration
SPF level SD rats, after adapting to raise for one week, are randomly divided into 6 groups by body weight, 15 per group.Just
Often group and model group gavage give normal saline, 1 times/day, each 2mL/100g rats；Positive control
Group 0.6g/kg gavages give sulfasalazine solution；It is by the tablet disintegrating of the embodiment of the present invention 1 plus raw
Reason saline is into 2g/ml drug suspensions；Medicine high dose group presses 20ml/kg dosage gastric infusions, in
Dosage group is per only pressing 10ml/kg dosage gastric infusions；Medicine low dose group is per only being given by 5ml/kg dosage gavages
Medicine.
Model copy method:Before experiment, by all Rat Fasts 24 hours.After 24 hours, in addition to normal group,
Other group 20% urethane solution of rats by intraperitoneal injection (6ml/kg) anesthesia, a diameter about 2mm is about
By the light and slow slotting people of anus, depth is 8cm to the rubber tube for transfusion of 12cm, pushes 2%TNBS solution
100mg/kg, allow animal keep lie low nature regain consciousness.The 2nd day after modeling, treat that animal revives, by animal
It is random to be grouped, administration, once a day, continuous 7 days.
2nd, Testing index
Intestinal weight coefficient：Per colon is only taken rapidly, from anus 2cm, colon 8cm is taken upwards,
Enteric cavity is cut off longitudinally along mesentery, perusal inflammation and ulcer occur with normal saline flushing totally
Situation, subsequently weighs, using colon weight (g)/rat body weight (kg) as intestinal weight coefficient.
Spleen weight coefficient：Each group animal spleen is taken, using dirty heavy (mg)/body weight (g) as spleen weight coefficient.
Myeloperoxidase (MPO) (MPO) activity：Sample is processed by kit specification, and determines each group sample
This MPO is active, surveys light absorption value with UV-detector at 460nm.
SOD in serum, MDA levels：Rat femoral is taken a blood sample, and, in test tube, room temperature is quiet for collect blood
After putting natural coagulation contraction, in 37 DEG C of water-baths, 20min is incubated, 10min is centrifuged with 4000r/min,
Serum is separated, -20 DEG C of preservations are detected by test kit prescriptive procedure.
Light microscopy checking：Clip colonic pathological change is most substantially located to consolidate during 2cm is put in 10% neutral buffered soap aldehyde solution
It is fixed, dehydration of alcohol, paraffin embedding, 4-6 μm of slice thickness, HE dyeing, light microscopy.
Statistical method：Data are usedRepresent, the comparison between two groups is checked with Dunnett t.
3rd, experimental result
Occur within the 2nd day after appearance sign each group animal model having blood in stool, diarrhoea situation, most animals
There is anorexia, lazy move phenomenon.Compared with model group, each administration group is had blood in stool, diarrhoea degree is lighter, continues
Time shorten, its positives group and medicine high dose group animal integrality it is best.
Compared with model group, each administration group can reduce MPO contents in leukocyte to MPO activity, wherein
Medicine high dose group, positive controls have significance to reduce (p<0.05) high dose group and the positive, are shown
Group medicine can reduce colonic crypt cells inflammatory reaction, and MPO active testings the results are shown in Table 1.
1 MPO active testing results Ug of table-1
Note：Compare with model group, * *:P<0.01, *:P<0.05；
SOD, MDA test result is compared with normal group, SOD poles in model group rats colon
Significance is reduced, and MDA levels pole significance raises (p<0.01), show colon's local free radical
System is in imbalance state.Compared with model group, in each administration group serum, the horizontal significances of SOD are raised
(p<0.05), the horizontal significances of MDA reduce (p<0.05).The results are shown in Table 2.
2 rat colon tissue SOD of table, MDA level determination results
Note：Compare with model group, * *:P<0.01, *:P<0.05；Compare with positive group,ΔΔP<0.01,ΔP<0.05
Spleen weight coefficient：Compare with model group, each administration group spleen weight coefficient has significance to raise (p<0.05)
Each group spleen weight coefficient is shown in Table 3.
3 each group animal spleen of table weight coefficient
Note：Compare with model group, * *:P<0.01, *:P<0.05
Colon intestinal weight coefficient：Compared with model group, positive controls, medicine high dose, low dose group intestinal
Weight coefficient pole significantly reduces (P<0.01), middle dose group significance reduces (P<0.05).This index
Test result shows that medicine group has hamartoplasia effect caused by good antagonism colon inflammatory reaction.Intestinal
Weight coefficients comparison the results are shown in Table 4.
Om observation：Visible ulcer under model group mirror, mainly in tela submucosa, tissue edema is obvious for pathological changes
And massive inflammatory cells infiltrated, based on lymph foilicie hyperplasia, figure is shown in 2 and 3.Low dose group in medicine
It can be seen that ulcer, has obvious tissue edema and a large amount of cell infiltration, figure is shown in 4,5 and 6.Medicine is high
Dosage group and sulfasalazine group ulcer is less and the visible chronic ulcer tissue for having healed, tissue edema and fills
Blood substantially mitigates, and cell infiltration is significantly reduced, and figure is shown in 7 and 8.Microscopy appraisal result is relatively shown in Table 4.
The result of 4 each group animal colon intestinal of table weight coefficient and degree of tissue damage
Note：Compare with model group, * *:P<0.01, *:P<0.05；
Test with the tablet of technological forming as object of study, by causing ulcerative colitis in rats to TNBS
Treatment, verify products formed drug activity.Experiment is divided into normal group, TNBS model group, willow nitrogen sulphur
Amine pyridine positive group, medicine high dose group, middle dose group and low dose group.Animal is put to death during treatment end
Colon is taken, each group rat colon intestinal weight coefficient is calculated；Determine each group rat colon myeloperoxidase (MPer) (MPO)
Activity and SOD in serum and MDA levels；Spleen is taken, each group animal spleen weight coefficient is calculated；Take part
Colon does microscopy, evaluates mucosa injury index.
As a result show, compared with model group, medicine high dose group, middle dose group and low dose group intestinal are again
Number significantly reduces (p<0.05)；Each administration group spleen weight coefficient has significance to raise (p<0.05)；
Each administration group colon MPO levels are reduced, and wherein medicine high dose group, positive controls have significantly
Property reduce (p<0.05) in, low dose group have reduction trend；SOD levels in each administration group serum
Significance raises (p<0.05)；Each administration group MDA level work property reduces (p<0.05), wherein high
Dosage group pole significance reduces (p<0.01)；Compared with model group, each administration group colon histology is damaged
Index is significantly reduced, and wherein medicine high dose group, positive group have pole significant difference (p<0.01).
The experiment shows that medicine can resist rat colon Histopathological lesions caused by trinitro-benzene-sulfonic acid,
Overall inflammatory immunoreation can be strengthened, hence it is evident that improve animal and the appearance sign such as have blood in stool, suffer from diarrhoea, moving less, treat
Effect is obvious.
This experiment probes into the Chinese medicine composition of the present invention by the therapeutical effect to TNBS cause rat ulcers
Therapeutical effect of the thing to ulcerative colitiss.Experimental result shows that the Chinese medicine composition of the present invention can be notable
SOD contents in ulcerative colitiss animal blood are improved, is suppressed MDA to generate, is shown the present invention's
The generation and anti-oxidation function that the effect of Chinese medicine composition anti-ulcerative colitis suppresses oxygen-derived free radicals with which increases
It is strong relevant.Additionally, it can also increase spleen organ weight, colon's MPO contents are reduced, is shown
The Chinese medicine composition energy enhancing human body immunity reaction of the present invention, reduces inflammatory reaction.To sum up, it is of the invention
Chinese medicine composition can resist rat colon Histopathological lesions caused by trinitro-benzene-sulfonic acid, can strengthen overall
Inflammatory immunoreation, hence it is evident that improve animal and the appearance sign such as have blood in stool, suffer from diarrhoea, moving less, curative effect is obvious.
Claims (10)
1. a kind of Chinese medicine composition for treating ulcerative colitiss, the compositionss are mainly by following heavy
The raw material of amount part is made：5 parts～15 parts of Radix Codonopsis, 1 part～10 parts of Radix Sophorae Flavescentiss, 1 part～10 parts of the Radix Aucklandiae, scold
3 parts～9 parts of sub- meat, 1 part～8 parts of Rhizoma Alismatis (processeded with salt)；
Preferably, the Chinese medicine composition is mainly made up of the raw material of following weight portion, 10 parts of Radix Codonopsis,
5 parts of Radix Sophorae Flavescentiss, 5 parts of the Radix Aucklandiae, 6 parts of terminalia flesh, 4 parts of Rhizoma Alismatis (processeded with salt).
2. Chinese medicine composition according to claim 1, wherein, the Chinese medicine composition be tablet,
Hard capsule, soft capsule, oral liquid, granule, honeyed pill, the watered pill, drop pill or unguentum.
3. Chinese medicine composition according to claim 1 and 2, wherein, the Chinese medicine composition is also wrapped
Include pharmaceutically acceptable adjuvant；
Preferably, the adjuvant is selected from filler, binding agent, disintegrating agent, lubricant, wetting agent, anti-
One or more in oxygen agent, preservative and correctivess；
It is highly preferred that the filler is in Mannitol, Lactose, Polyethylene Glycol, carboxymethyl starch sodium
One or more；
Described adhesive is selected from starch and/or Microcrystalline Cellulose；
The disintegrating agent is selected from carboxymethyl cellulose, low substituted hydroxypropyl cellulose and/or micropowder silica gel；
The lubricant is selected from Pulvis Talci and/or magnesium stearate；
The wetting agent is selected from Propylene Glycol and/or ethanol；
The antioxidant is selected from sodium pyrosulfite, sodium thiosulfate and/or citric acid；
The preservative is selected from sodium benzoate and/or potassium sorbate；And/or
The correctivess are selected from sucrose and/or Mannitol.
4. a kind of method of the Chinese medicine composition prepared according to any one of claims 1 to 3, described
Method comprises the following steps：
Each raw material is taken by weight, is added water to cook or is extracted using ethanol water, obtain decoction liquor or carry
Liquid is taken, by the decoction liquor for obtaining or extracting solution filtration to obtain filtrate, and filtrate is concentrated to obtain clear paste；
Preferably, wherein,
Add water to cook or extracted using ethanol water after the raw material is all merged, so as to be decocted
Liquid or extracting solution, or
The raw material is divided into two groups or more to add water to cook respectively or extract using ethanol water,
Decoction liquor or extracting solution are respectively obtained, the decoction liquor or extracting solution for respectively obtaining is remerged afterwards, so as to
To decoction liquor or extracting solution, or the decoction liquor for respectively obtaining or extracting solution are filtered to respectively obtain respectively
Filtrate, remerges the filtrate for respectively obtaining afterwards so as to obtain filtrate, or will be the filtrate for respectively obtaining dense
Contracting remerges the clear paste for respectively obtaining so as to obtain clear paste afterwards to respectively obtain clear paste；
It is further preferred that in the ethanol water, the volume fraction of ethanol is 30-90%；It is highly preferred that
In the ethanol water, the volume fraction of ethanol is 60%.
5. method according to claim 4, wherein, it is described to add water to cook or use ethanol water
Extraction is carried out twice, is decocted the extracting solution that the decoction liquor that obtains or extraction obtain twice and is merged, filter with
Obtain filtrate；Wherein, when decocting for the first time or extract, the weight of water or ethanol water is raw material gross weight
6-12 times of amount, decocts or reflux, extract, 1-3 hour, preferably 2 hours by preferably 10 times；Second
When decocting or extracting, 4-12 times for raw material gross weight of the weight of water or ethanol water, preferably 8 times,
Decoct or reflux, extract, 1-3 hour, preferably 1.5 hours；
Preferably, the relative density of the clear paste is 1.10-1.25 at 60 DEG C；
It is further preferred that methods described is further comprising the steps of：By the decoction liquor for obtaining or extracting solution
After filtration is to obtain filtrate, and by the filtrate for obtaining concentration to obtain relative density at 60 DEG C it is being
Before the clear paste of 1.10-1.25, by the filtrate for obtaining concentration to obtain relative density at 60 DEG C it is
The clear paste of 1.18-1.23, plus ethanol makes alcohol content up to 60～70%v/v, preferred 65%v/v is stirred evenly, quiet
Put 18～48 hours, it is preferable that stand 24 hours, filter to obtain filtrate；
Preferably, in the raw material, Radix Codonopsis, Radix Sophorae Flavescentiss, the Radix Aucklandiae and Rhizoma Alismatis (processeded with salt) are added water to cook or are made as one group
Extracted with ethanol water, terminalia flesh is added water to cook as another group or extracted using ethanol water.
6. the method according to claim 4 or 5, wherein,
Methods described is further comprising the steps of：The clear paste for obtaining is dried, is crushed, obtained dry powder, weigh
Dry powder, adds pharmaceutically acceptable adjuvant, is heated to melt temperature, makes raw material and adjuvant fully miscible,
Drop pill is made, or after pharmaceutically acceptable adjuvant is added, stirring is mixed and made into granule, general
Grain be dried after granule or tabletted or be filled in hungry area softgel shell to obtain capsule；Or
Methods described is further comprising the steps of：The clear paste for obtaining is weighed, pure water, preservative is added, is filled
Divide mixing, filter, oral liquid is made in filtrate fill.
7. method according to claim 6, wherein, the adjuvant selected from filler, binding agent,
One or more in disintegrating agent, lubricant, wetting agent, antioxidant, preservative and correctivess；
Wherein, the filler in Mannitol, Lactose, Polyethylene Glycol, carboxymethyl starch sodium one
Plant or various；
Described adhesive is selected from starch and/or Microcrystalline Cellulose；
The disintegrating agent is selected from carboxymethyl cellulose, low substituted hydroxypropyl cellulose and/or micropowder silica gel；
The lubricant is selected from Pulvis Talci and/or magnesium stearate；
The wetting agent is selected from Propylene Glycol and/or ethanol；
The antioxidant is selected from sodium pyrosulfite, sodium thiosulfate and/or citric acid；
The preservative is selected from sodium benzoate and/or potassium sorbate；
The correctivess are selected from sucrose and/or Mannitol.
8. method according to claim 6, wherein, the clear paste is dried at 60 DEG C；
Preferably, the granule is dried 2-4 hours at 60-70 DEG C；
Preferably, the granule is prepared using 12-14 mesh sieves；
Preferably, when tablet or capsule is prepared, the adjuvant is selected from filler, binding agent, disintegrate
Agent, lubricant, one or more in correctivess；When granule is prepared, the adjuvant is selected from filling
Agent, disintegrating agent, one or more in correctivess；When drop pill is prepared, the adjuvant is filler
And/or antioxidant；
Preferably, when granule or drop pill is prepared, the addition of the pharmaceutically acceptable adjuvant
For 40～90%w/w of preparation total amount；
Preferably, when drop pill is prepared, the melt temperature is 40-90 DEG C.
9. the Chinese medicine composition any one of claims 1 to 3 is used for treating the medicine of inflammation in preparation
Purposes in thing.
10. purposes according to claim 9, wherein, the inflammation is colitis；Preferably,
The colitis are ulcerative colitiss.
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Effective date of registration: 20231017 Address after: 4th Floor, Building B1, No. 306 Huiren Road, Binhai Science and Technology Park, Binhai New Area, Tianjin, 300451 Patentee after: Heguang Traditional Chinese Medicine Technology (Tianjin) Co.,Ltd. Address before: 300193 Tianjin City, Nankai District Anshan West Road No. 308 Patentee before: Tianjin Institute of Pharmaceutical Research Co.,Ltd. |