CN104771408B - The purposes of notoginsenoside Ft1 - Google Patents
The purposes of notoginsenoside Ft1 Download PDFInfo
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- CN104771408B CN104771408B CN201410018161.3A CN201410018161A CN104771408B CN 104771408 B CN104771408 B CN 104771408B CN 201410018161 A CN201410018161 A CN 201410018161A CN 104771408 B CN104771408 B CN 104771408B
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- notoginsenoside
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Abstract
The present invention relates to the purposes of pharmaceutical technology field more particularly to notoginsenoside Ft1.The invention discloses the plant extracts of notoginsenoside Ft1, prodrug and its officinal salt or the Ft1 containing notoginsenoside to prepare the purposes in preventing or treating ulcerative colitis drug or health products.Present invention firstly discovers that notoginsenoside Ft1 can be obviously improved, the weight loss of Experimental oral ulcer colitis mice, bloody stool, colon shortens and the symptoms such as Histopathological lesions, new selection is provided for clinical treatment ulcerative colitis, is had a good application prospect.
Description
Technical field
The present invention relates to the purposes of pharmaceutical technology field more particularly to notoginsenoside Ft1.
Background technology
Ulcerative colitis(Ulcerative colitis, UC)It is a kind of colon and rectum that the cause of disease is not still fully aware of
Chronic nonspecific inflammation disease, be with diarrhea, mucopurulent bloody stool, abdominal pain and tenesmus for cardinal symptom, it is viscous with colon
Film chronic inflammation and ulcer are formed as the alimentary canal common disease and difficult disease of pathological characteristic, and severe patient can have fever, arthritis, rainbow
The severe complications such as parenteral symptom and colon massive haemorrhage, perforation, canceration such as film inflammation, skin tag erythema.This disease is acute to be broken out
The type death rate is high, the easy canceration of chronic sustained type, it was reported that its incidence is 5~20 times higher than normal person, average out to 3.5%~7%, disease
The above person's canceration rates of phase 5a are 17%, foreign statistic patient 10a canceration rates up to 20%, 25a or more is long up to 40%, the especially course of disease,
Extent of disease extensively, the age compared with less serious case, be acknowledged as the precancerous lesion of colon cancer.The chronic phase canceration rate of this disease is quite high
, and with raw cancer of binding up one's hair of bursting, grade of malignancy is high, is mostly shifted in early stage, is classified as by the World Health Organization at present existing
For one of difficult treatment.Currently, salicylazosulfapyridine, 5-aminosalicylic acid (5-ASA) sustained-release dosage type, corticosteroid are still clinic
The key agents of the routed knot for the treatment of, patient often need long-term administration to maintain, normal recurrent exerbation.
Notoginsenoside Ft1(Vitexin, Apigenin-8-C- β-D-glucopyranoside)It is a kind of natural saponin(e
Class compound, is primarily present in Radix Notoginseng.The study found that notoginsenoside Ft1 has anti-oxidant, myocardial preservation, antitumor etc. living
Property, toxicity is extremely low.
Invention content
The technical problems to be solved by the invention are to provide a kind of active medicine and its drug for treating ulcerative colitis
Composition.
For this purpose, the invention discloses the plants of notoginsenoside Ft1, prodrug and its officinal salt or the Ft1 containing notoginsenoside to carry
Object is taken to prepare the purposes in preventing or treating ulcerative colitis drug or health products.
In some embodiments, the plant extracts of the Ft1 containing notoginsenoside is the leaf of Araliaceae or the alcohol of root
Extract, the including but not limited to alcohol extract of Roots of Panax Notoginseng.
On the other hand, the present invention provides a kind of pharmaceutical composition for treating ulcerative colitis, the composition contains
Have:
(a)Notoginsenoside Ft1 containing the 1-99% parts by weight as active constituent and its officinal salt;
(b)Parts by weight are the pharmaceutically acceptable carrier of surplus.
In another preferred example, the salt that the notoginsenoside Ft1 can be formed with inorganic acid or organic acid, for example, with salt
Acid, hydrobromic acid, hydroiodic acid, sulfuric acid, nitric acid, phosphoric acid, acetic acid, maleic acid, fumaric acid, Chinese holly edge acid, citric acid, oxalic acid, succinic acid,
The salt that tartaric acid, malic acid, mandelic acid, trifluoroacetic acid, pantothenic acid, methanesulfonic acid or p-methyl benzenesulfonic acid are formed.
In another preferred example, the dosage form of described pharmaceutical composition is selected from:Injection, injection sterile powder, tablet, glue
Wafer, spirit, powder, granule, syrup, solution, tincture, aerosol, powder spray or suppository, wherein preferably tablet or
Capsule.
On the other hand, the present invention provides a kind of therapy prevented or treat ulcerative colitis, gives exedens knot
The pharmaceutical composition of the present invention of enteritis patient's effective dose or the plant extracts of the Ft1 containing notoginsenoside.
Present invention firstly discovers that the weight that notoginsenoside Ft1 can be obviously improved Experimental oral ulcer colitis mice subtracts
Gently, the symptoms such as bloody stool, colon shortening and Histopathological lesions, new selection is provided for clinical treatment ulcerative colitis, is had
There is good application prospect.
Description of the drawings
Influences of Fig. 1 notoginsenosides Ft1 to ulcerative colitis mouse weight;
Influences of Fig. 2 notoginsenosides Ft1 to ulcerative colitis mouse bloody stool incidence;
Influences of Fig. 3 notoginsenosides Ft1 to ulcerative colitis mouse Colon length, Fig. 3 A mouse Colon overall appearances,
Fig. 3 B mouse Colon length;
Influences of Fig. 4 notoginsenosides Ft1 to ulcerative colitis mouse Colon histopathology, Fig. 4 A mouse Colons HE dyes
Color, the scoring of Fig. 4 B histopathologies;
(In above-mentioned figure:A indicates that Normal group, b indicate that model control group, c indicate that SASP groups, d indicate notoginsenoside
Ft1 groups)
Specific implementation mode
The molecular formula of notoginsenoside Ft1 of the present invention is:C47H80O17, molecular weight are:917.13.
The notoginsenoside Ft1 of the present invention can be by commercial sources from the Shanghai bio tech ltd Chun You, the graceful think of in Chengdu
Special bio tech ltd etc. purchase obtains.Its purity meets medicinal standard.The purity of the notoginsenoside Ft1 of the present invention
It is best with >=98%.
The reactive compound notoginsenoside Ft1 of the present invention can be planted from the plant extracts of the Ft1 containing notoginsenoside, such as Araliaceae
The leaf of object or the alcohol extract of root, the including but not limited to alcohol extract of Roots of Panax Notoginseng.
Term " pharmaceutically acceptable salt ", which refers to above compound, can keep original bioactivity and be suitable for medicine
Certain salts of purposes.There are two types of form form for the pharmaceutically acceptable salt of compound of the present invention:First, being formed with acid
Salt;Another is the salt formed with alkali or alkali metal.The acid of pharmaceutically acceptable salt is formed with compound of the present invention
Including inorganic acid and organic acid.Suitable inorganic acid includes:Hydrochloric acid, sulfuric acid and phosphoric acid.Suitable organic acid can be selected from aliphatic,
Cycloaliphatic, armaticity, heterocyclic carboxylic acid and sulfonic classes of organic acids;The example includes but not limited to:Formic acid, acetic acid, propionic acid, amber
Acid, Glycolic acid, gluconic acid, lactic acid, malic acid, tartaric acid, glycine, arginine, citric acid, fumaric acid, alkyl sulphur
Acid etc..With compound of the present invention formed pharmaceutically acceptable salt alkali metal include:Lithium, sodium, potassium, magnesium, calcium, aluminium or zinc
Deng.
The present invention includes compound of the present invention and its possible various isomery patterns.Including:Non-mirror image isomer, mirror
The geometric isomer etc. of conformational isomer, tautomer and " E " or " Z " configurational isomer.
The present invention includes compound of the present invention and its possible raceme or/and mirror image isomerism object/or/and non-mirror image
The mixture of isomeric compound.
In addition, compound of the present invention is above also covered by the solvation of the compound and non-solvated pattern in application.Cause
This, various includes the compound for having specified construction, including its hydration and anhydrous mould assembly formula.
Other than compound of the present invention, different specific embodiments include:Pharmaceutically acceptable salt, prodrug and should
Etc. compounds active metabolite.With the pharmaceutically acceptable salt of such metabolin.
" prodrug " is a kind of derivative of compound of the present invention, by means of the mode that is metabolized in vivo by it in live body
Interior conversion(Such as:By hydrolysis, reduction or oxidation)At compound of the present invention.For example, can be by chemical combination of the present invention
Object is prepared into corresponding ester with acid reaction.Corresponding ester is prodrug, can in vivo be hydrolyzed to parent drug.It is suitble to make
Include but not limited to for the acid of " prodrug ":It is acetic acid, citric acid, lactic acid, tartaric acid, malonic acid, oxalic acid, salicylic acid, succinic acid, anti-
Butene dioic acid, maleic acid, methylene-bis-beta-hydroxyethyl base naphthoic acid, gentianic acid, isethionic acid, methanesulfonic acid, ethanesulfonic acid, benzene sulphur
Acid, p-methyl benzenesulfonic acid etc..
Purposes
Compound of the present invention or its pharmaceutically acceptable salt or prodrug or its isomers are carried containing its plant
Object is taken to can be used for preventing or treat ulcerative colitis.A kind of therapy prevented or treat ulcerative colitis, gives routed
The pharmaceutical composition of the present invention of ulcer colitis patient's effective dose or the plant extracts containing it.
" effective dose " or " therapeutic dose " each means the amount for being enough to generate curative effect.Effective quantity can divide to be administered one or more times.It is logical
Often, effective quantity is enough to mitigate, improve, stablize, slow down or postpone the further development of disease.
In general, when the present composition is used for such use, they can be with one or more pharmaceutically acceptable loads
Body or excipient are mixed and made into the pharmaceutical dosage form of different way of administration, such as tablet, capsule, powder, granule, syrup, solution
Agent, oral solution, spirit, tincture, aerosol, powder spray, injection, injection sterile powder, suppository etc..
In general, pharmaceutical composition contains:(a)Reactive compound containing the 0.01-99% parts by weight as active constituent and
Its officinal salt;(b)Pharmaceutically acceptable carrier.The compound or various forms of hairs of respective pure form can also be made
After the preparation of the bright compound, for being administered.
" pharmaceutically acceptable " ingredient is suitable for people and/or animal and without excessive bad side reaction(Such as toxicity, stimulation
And allergy)Have rational benefit/risk than substance." pharmaceutically acceptable carrier " is for will be of the present invention
Compound or its pharmaceutically acceptable salt send to the acceptable solvent pharmaceutically or on food of animal or people, suspending agent or
Excipient.Carrier can be liquid or solid.
The compound of the present invention can pass through oral, intravenous, intramuscular or subdermal routes of administration.
In above-mentioned dosage form can the dosage form of oral administration be:Tablet, capsule, powder, granule, syrup, solution, fine wine
Agent.Solid-state carrier includes:It is starch, lactose, calcium monohydrogen phosphate, microcrystalline cellulose, sucrose, white bole, superfine silica gel powder, talcum powder, low
Replace hydroxypropyl cellulose, sodium carboxymethyl starch, polyvinylpyrrolidone.And liquid carrier includes:Sterile water, ethyl alcohol, poly- second
Glycol, nonionic surface active agent and edible oil (such as corn oil, peanut oil and sesame oil).In the mistake for preparing pharmaceutical composition
Usually used adjuvant includes in journey:Flavoring agent, colorant, preservative (such as oxybenzene alkyl butyl ester, sodium benzoate, sorbic acid) and
Antioxidant (such as vitamin E, vitamin C, sodium pyrosulfite and dibutyl hydroxy toluene).
The dosage form that can be used for injection administration in above-mentioned dosage form includes:Injection, injection sterile powder, they be by
Drug is mixed and made into the form for drug administration by injection with one or more pharmaceutically acceptable excipient.Solvent includes:It is sterile
Water, ethyl alcohol, glycerine, propylene glycol, polyethylene glycol.In addition, also need be added bacteriostatic agent (such as benzyl alcohol, butyl hydroxybenzoate, thimerosal),
Ooze conditioning agent (such as sodium chloride, glucose), suspending agent (such as sodium carboxymethylcellulose, methylcellulose), solubilizer (Tween-80,
Lecithin), antioxidant (such as vitamin E, vitamin C, sodium pyrosulfite) and filler (such as lactose, mannitol).
In terms of easily prepared and administration position, preferred pharmaceutical composition is solid-state composition, especially tablet and solid
Body is filled or the capsule of liquid filling.It is preferred that being administered orally.
The effective dose of active constituent used can change with mode of administration and the severity of disease to be treated.So
And it can usually be enabled when the plant extracts of the present invention is given with the dosage of about 0.5-2000mg/kg the weight of animals daily
The effect of people's satisfaction, is preferably given with 2-4 separated dosage, or be administered with sustained release forms daily.Suitable for agent for oral administration
Amount form includes the plant extracts of the about 0.5-2000mg mixed with solid-state or liquid pharmaceutically acceptable carrier.It is adjustable
This therapeutic scheme is saved to reach optimum therapeuticing effect.For example, can be separately administered several times daily according to the needs for the treatment of situation,
Or dosage is proportionally reduced.In general, adult takes orally ranging from 0.5-2000mg/ days of clinical dosage, preferably 10-
1000mg/ days.
Other than medicament is made, antioxidant, pigment, enzyme preparation can also be added in the notoginsenoside Ft1 of the present invention
Etc. various food additives, health food is made by the conventional method of this field.
Below in conjunction with specific embodiment, the present invention is further explained.These embodiments are merely to illustrate the present invention and do not have to
In limiting the scope of the invention.In the following examples, the experimental methods for specific conditions are not specified, usually according to normal condition or presses
According to the condition proposed by manufacturer.Unless otherwise stated, otherwise all percentage and number is by weight.
Embodiment 1
1, experiment material
1.1 medicinal material
Notoginsenoside Ft1(HPLC purity >=98%, the Chengdu bio tech ltd Man Site);Dextran sulfate sodium
(DSS, CAS:9011-18-1, MW36-50kDa are produced by MP Biomedicals companies of the U.S.);Salicylazosulfapyridine
(SASP, CAS:599-79-1, molecular weight 398.39, HPLC purity >=98% are produced by Sigma-Aldrich).
1.2 experimental animal
The C57BL/6 female mices of 20 ± 2g of weight(8 weeks), provided, moved by Shanghai Univ. of Traditional Chinese Medicine's Experimental Animal Center
Object quality certification number:SYXK(Shanghai)2009-0069.It is placed in conventinal breeding environment, ad lib and drinking-water.
2, experimental method
The foundation of 2.1 Ulcerative Colitis Models
The C57BL/6 female mices for selecting weight uniform(20±2g), using international ulcerative colitis modeling
Method(Gastroenterology2002,123:256-70;PLoS One2012,7:e36075), in the research incipient stage, make
Mouse ad lib and drinking-water after the laundering period in the early stage, change water into 4%(w/v)DSS, freely drink 7 days, to cause to burst
Ulcer colitis.
2.2 groupings and medication
Normal group:10, give normal diet.
Model control group:It 10, gives 4%DSS solution and freely drinks 7 days.
SASP groups:10, gavage gives SASP while giving 4%DSS solution(350mg/kg)Continuous 7 days.
Notoginsenoside Ft1 groups:10, gavage gives notoginsenoside Ft1 while giving 4%DSS solution(50mg/kg)Even
It is 7 days continuous.
It is fresh daily to prepare dosage particles during experiment, it is dissolved with 0.5% sodium carboxymethylcellulose, and small preparing 1
When interior use.
The assessment of 2.3 enteritis
Weight, diarrhea, bloody stool, histopathological analysis etc. publish thesis with reference to early-stage study(PLoS One2012,7:
e36075;J Pharmacol Exp Ther2013,345:473-82)The method.Weight change is recorded during experiment daily
Change, diarrhea and bloody stool symptom.It is anaesthetized after experiment and cervical dislocation puts to death mouse, opened abdominal cavity, take out colon, measure from blind
Colon lengths of the intestines to rectum.And terminal colon is taken to do histotomy, H&E dyeing is carried out, disease is carried out to H&E dyeing colon samples
Reason scoring:(1)The exudation standards of grading of inflammatory cell:There are minute quantity inflammatory cell, 1 point-mucous membrane solid in 0 point-mucosa lamina propria
Having has the inflammatory cell in more inflammatory cell or mucosa lamina propria to increase in layer, 2 points-inflammatory cell diffuses under mucous membrane
Layer, 3 points-holostrome have inflammatory cell exudation;(2)Tissue damage standards of grading:0 point-without mucosa injury, 1 point-discrete glutinous
Film epithelial lesions, 2 points-surface layer mucosal erosion, 3 points-extensive mucous membrane is damaged and is extended to intestinal wall deep layer.By oozing for inflammatory cell
Go out score to be added with tissue damage score, calculates histopathology scoring(1-6 points).
2.4 statistical analysis
All experimental datas are repeated 3 times, and are as a result indicated with mean+SD, using SPSS16.0 statistical softwares pair
Experimental data uses One-way ANOVA(One-way ANOVA)And LSD is examined, P<0.05 has significantly for statistically difference
Property.
3, result
Therapeutic effects of the 3.1 notoginsenoside Ft1 to ulcerative colitis
3.1.1 to the influence of ulcerative colitis mouse weight
Fig. 1 embodies influences of the notoginsenoside Ft1 to ulcerative colitis mouse weight.In the entire experiment process, just
The changes of weight of normal control group mice is steady, the 7th day weight(19.8±0.1g)Increase 0.9%;The weight of model group mouse
It continues to decline, the 7th day weight(18.0±0.2g)Mitigation rate is 7.9%;SASP groups(19.1±0.2g)With notoginsenoside Ft1
Group(18.6±0.2g)The continued weight of mouse drops to the 4th day, and fall is smaller than model group, the 7th day weight loss rate
Respectively 2.2% and 4.7%, the significant difference compared with model group(P<0.001 and P<0.01).Illustrate SASP and Radix Notoginseng soap
Glycosides Ft1 can significantly improve the weight loss symptom of ulcerative colitis mouse caused by DSS.
3.1.2 to the influence of ulcerative colitis mouse bloody stool incidence
Fig. 2 embodies influences of the notoginsenoside Ft1 to ulcerative colitis mouse bloody stool incidence.In whole experiment process
In, Normal group mouse occurs without bloody stool.Starting for the 3rd day for DSS, model group and notoginsenoside Ft1 groups are added in drinking water
Mouse starts bloody stool occur.Model group mouse bloody stool persistently occurs, and is 96.6% to the 7th day bloody stool incidence;SASP group mouse
DSS is added in drinking water starts bloody stool occur on the 4th day, and SASP groups and notoginsenoside Ft1 groups the 7th day bloody stool of mouse occur
Rate is respectively 36.7% and 40.0%, the significant difference compared with model group(P<0.001 and P<0.01).Illustrate SASP and three
Seven saponin(e Ft1 can significantly improve the bloody stool symptom of ulcerative colitis mouse caused by DSS.
3.1.3 to the influence of ulcerative colitis mouse Colon length
Fig. 3 embodies influences of the notoginsenoside Ft1 to ulcerative colitis mouse Colon length.With Normal group
(12.0±0.5cm)It compares, model group(8.5±0.5cm)Colon swelling, the bleeding of mouse(Fig. 3 A), and be obviously shortened, shorten
Rate is 29.2%(Fig. 3 B);SASP groups(11.2±0.8cm)With notoginsenoside Ft1 groups(9.1±0.7cm)The colon of mouse has gently
Micro- swelling and bleeding(Fig. 3 A), shortening rate is respectively 7.1% and 23.6%(Fig. 3 B), the significant difference compared with model group(P
<0.001 and P<0.05).Illustrate that SASP and notoginsenoside Ft1 can significantly improve ulcerative colitis mouse caused by DSS
Colon shortens symptom.
3.1.4 to the influence of ulcerative colitis mouse Colon histopathology
Fig. 4 embodies notoginsenoside Ft1 and acts on the injury repair of ulcerative colitis mouse Colon tissue.Model group is small
The colonic tissue of mouse shows for exemplary inflammatory mucous membrane, it is seen that mucous membrane, submucosa even muscle layer massive inflammatory cells infiltrated, tissue
Structure disturbance, fracture, submucosa bleeding, oedema, telangiectasis;SASP groups mouse and notoginsenoside Ft1 group mouse
Colonic tissue lesions visible mitigates, ulcer healing, and submucosa bleeding mitigates(Fig. 4 A).
According to 1-6 points of standards of grading for representing inflammatory tissue damage, the score of Normal group mouse is 0;Model group mouse
Score(5.7 ± 0.3 points)It dramatically increases;SASP groups(2.2 ± 0.8 points)With notoginsenoside Ft1 groups(4.1 ± 0.7 points)Mouse meter
Divide and reduces, the significant difference compared with model group(P<0.001 and P<0.05)(Fig. 4 B).
To sum up colonic tissue pathological analysis the result shows that, SASP and notoginsenoside Ft1 can be significantly improved and be burst caused by DSS
The colonic mucosal tissue pathology damage and inflammatory cell infiltration symptom of ulcer colitis mouse.
To sum up result of study shows that notoginsenoside Ft1 can be obviously improved the weight loss of ulcerative colitis mouse, blood
Just, the symptoms such as colon shortening and Injured colonic mucosa.
The preparation of 2 tablet of embodiment
Using routine techniques, following components is mixed, then direct tablet compressing, prepares the pharmaceutical composition of tablet form, match
Side is as follows:
The scope of the present invention is not limited by the specific embodiments described, and the embodiment is only intended to as illustrating the present invention
The single example of various aspects further includes function equivalent method and component in the scope of the invention.In fact, in addition to described herein
Content outside, those skilled in the art with reference to described above and attached drawing can easily grasp to the present invention a variety of improvement.
The improvement is also fallen within the scope of the appended claims.Every bibliography mentioned above is all included in full to be made herein
For reference.
Claims (3)
1. the plant extracts of notoginsenoside Ft1 or the Ft1 containing notoginsenoside are preparing prevention or treatment ulcerative colitis drug
In purposes.
2. purposes according to claim 1, it is characterised in that the plant extracts of the Ft1 containing notoginsenoside is Araliaceae
The leaf of plant or the alcohol extract of root.
3. purposes according to claim 2, it is characterised in that the plant extracts of the Ft1 containing notoginsenoside is Roots of Panax Notoginseng
Alcohol extract.
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CN114306354A (en) * | 2021-11-18 | 2022-04-12 | 广东中诚生物科技有限公司 | Plant monomer with anti-dengue virus type 2 effect and application thereof |
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CN102100711A (en) * | 2005-12-07 | 2011-06-22 | 昆明制药集团股份有限公司 | Application of pseudoginseng root total saponins and preparations thereof in adjuvant treatment of 'systemic inflammatory response syndrome' |
CN103446169A (en) * | 2012-06-01 | 2013-12-18 | 上海中医药大学 | New use of notoginsenoside R1 |
CN103908459A (en) * | 2013-01-09 | 2014-07-09 | 上海中医药大学 | Medicinal use of notoginsenoside Ft1 |
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CN102100711A (en) * | 2005-12-07 | 2011-06-22 | 昆明制药集团股份有限公司 | Application of pseudoginseng root total saponins and preparations thereof in adjuvant treatment of 'systemic inflammatory response syndrome' |
CN103446169A (en) * | 2012-06-01 | 2013-12-18 | 上海中医药大学 | New use of notoginsenoside R1 |
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Granted publication date: 20181030 Termination date: 20220115 |