CN104771408A - Use of notoginsenoside Ft1 - Google Patents
Use of notoginsenoside Ft1 Download PDFInfo
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- CN104771408A CN104771408A CN201410018161.3A CN201410018161A CN104771408A CN 104771408 A CN104771408 A CN 104771408A CN 201410018161 A CN201410018161 A CN 201410018161A CN 104771408 A CN104771408 A CN 104771408A
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- ulcerative colitis
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Abstract
The invention relates to the technical field of medicine, and especially relates to a use of notoginsenoside Ft1. The invention discloses the use of notoginsenoside Ft1, prodrugs and pharmaceutical salts or plant extracts containing notoginsenoside Ft1 in preparation of drugs or health-care products for prevention or treatment of ulcerative colitis. The notoginsenoside Ft1 disclosed for the first time can significantly improve the experimental ulcerative colitis mice weight reduction, bloody stool, shortening of colon, tissue pathological damage and other symptoms, provides a new choice for clinical treatment of ulcerative colitis, and has a good application prospect.
Description
Technical field
The present invention relates to medical art, particularly relate to the purposes of arasaponin Ft1.
Background technology
Ulcerative colitis (Ulcerative colitis, UC) be a kind of cause of disease coton and rectal chronic nonspecific inflammation disease still not fully aware of, be suffer from diarrhoea, mucopurulent bloody stool, stomachache and tenesmus are cardinal symptom, the digestive tract commonly encountered diseases being pathological characteristic with mucous membrane of colon chronic inflammatory disease and ulcer and difficult disease, severe patient can have the outer severe complication such as symptom and colon massive hemorrhage, perforation, canceration of the intestinal such as heating, arthritis, iritis, skin nodules erythema.Primary disease acute fulminant form mortality rate is high, the easy canceration of chronic sustained type, it is reported that its incidence rate is higher than normal person 5 ~ 20 times, average out to 3.5% ~ 7%, the above person's canceration rate of stadium 5a is 17%, and foreign statistic patient 10a canceration rate reaches 20%, more than 25a and can reach 40%, particularly the course of disease is long, extent of disease is extensive, age comparatively the lighter, is acknowledged as the precancerous lesion of colon cancer.The chronic phase rate of cancerating of primary disease is quite high, and with raw cancer of binding up one's hair of bursting, grade of malignancy is high, how namely to shift in early days, is classified as one of modern difficult treatment by World Health Organization (WHO) at present.At present, sulfasalazine, 5-aminosalicylic acid (5-ASA) slow release formulation, corticosteroid still for clinical treatment burst knot key agents, patient often needs long-term prescription to maintain, normal recurrent exerbation.
Arasaponin Ft1(Vitexin, Apigenin-8-C-β-D-glucopyranoside) be a kind of natural saponins compound, be mainly present in Radix Notoginseng.Research finds, arasaponin Ft1 has antioxidation, myocardial preservation, antitumor isoreactivity, and toxicity is extremely low.
Summary of the invention
Technical problem to be solved by this invention is for providing a kind of active medicine and pharmaceutical composition thereof for the treatment of ulcerative colitis.
For this reason, the invention discloses arasaponin Ft1, prodrug and officinal salt thereof or the purposes of plant extract in preparation prevention or treatment ulcerative colitis medicine or health product containing arasaponin Ft1.
In certain embodiments, the described plant extract containing arasaponin Ft1 is the leaf of Araliaceae or the ethanol extract of root, includes but not limited to the ethanol extract of Radix Notoginseng.
On the other hand, the invention provides a kind of pharmaceutical composition for the treatment of ulcerative colitis, described compositions contains:
A () is containing as the arasaponin Ft1 of the 1-99% weight portion of active component and officinal salt thereof;
B () weight portion is the pharmaceutically acceptable carrier of surplus.
In another preference, the salt that described arasaponin Ft1 can be formed with mineral acid or organic acid, the salt such as formed with hydrochloric acid, hydrobromic acid, hydroiodic acid, sulphuric acid, nitric acid, phosphoric acid, acetic acid, maleic acid, fumaric acid, the acid of Chinese holly edge, citric acid, oxalic acid, succinic acid, tartaric acid, malic acid, mandelic acid, trifluoroacetic acid, pantothenic acid, methanesulfonic acid or p-methyl benzenesulfonic acid.
In another preference, the dosage form of described pharmaceutical composition is selected from: injection, injectable sterile powder, tablet, capsule, spirit, powder, granule, syrup, solution, tincture, aerosol, powder spray or suppository, is wherein preferably tablet or capsule.
On the other hand, the invention provides the Therapeutic Method of a kind of prevention or treatment ulcerative colitis, give the pharmaceutical composition of the present invention of patients of ulcerative colitis effective dose or the plant extract containing arasaponin Ft1.
Late Cambrian arasaponin Ft1 of the present invention obviously can improve the losing weight of Experimental oral ulcer colitis mice, hemafecia, colon shorten and the symptom such as Histopathological lesions, for clinical treatment ulcerative colitis provides new selection, have a good application prospect.
Accompanying drawing explanation
Fig. 1 arasaponin Ft1 is on the impact of ulcerative colitis Mouse Weight;
Fig. 2 arasaponin Ft1 is on the impact of ulcerative colitis mice hemafecia incidence rate;
Fig. 3 arasaponin Ft1 on the impact of ulcerative colitis mouse Colon length, Fig. 3 A mouse Colon overall appearance, Fig. 3 B mouse Colon length;
Fig. 4 arasaponin Ft1 is on the impact of ulcerative colitis mouse Colon histopathology, and Fig. 4 A mouse Colon HE dyes, and Fig. 4 B histopathology is marked;
(in above-mentioned figure: a represents Normal group, b represents model control group, and c represents SASP group, and d represents arasaponin Ft1 group)
Detailed description of the invention
The molecular formula of arasaponin Ft1 of the present invention is: C47H80O17, and molecular weight is: 917.13.
Arasaponin Ft1 of the present invention obtains from the purchase such as Chun You bio tech ltd, Shanghai, Man Site bio tech ltd, Chengdu by commercial sources.Its purity all meets medicinal standard.The purity of arasaponin Ft1 of the present invention is best with >=98%.
Reactive compound arasaponin Ft1 of the present invention from the plant extract containing arasaponin Ft1, as the leaf of Araliaceae or the ethanol extract of root, can include but not limited to the ethanol extract of Radix Notoginseng.
Term " pharmaceutically acceptable salt " refers to that above-claimed cpd can keep original biological activity and be suitable for some salt of medical usage.The pharmaceutically acceptable salt of compound of the present invention has two kinds of formation forms: one is the salt formed with acid; Another is the salt formed with alkali or alkali metal.The acid forming pharmaceutically acceptable salt with compound of the present invention comprises mineral acid and organic acid.Suitable mineral acid comprises: hydrochloric acid, sulphuric 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, propanoic acid, succinic acid, glycolic acid, gluconic acid, lactic acid, malic acid, tartaric acid, glycine, arginine, citric acid, fumaric acid, alkyl sulfonic acid etc.The alkali metal forming pharmaceutically acceptable salt with compound of the present invention comprises: lithium, sodium, potassium, magnesium, calcium, aluminum or zinc etc.
The present invention includes compound of the present invention and possible various isomery patterns thereof.Comprise: the geometric isomer etc. of non-mirror image isomer, mirror image isomer, tautomer and " E " or " Z " configurational isomer.
The present invention includes compound of the present invention and possible raceme thereof or/and mirror image isomerism thing/or/and the mixture of non-mirror image isomeric compound.
In addition, compound of the present invention also contains the solvation of this compound and non-solvated pattern in application.Therefore, various including has the specified compound constructed, and comprises its hydration and anhydrous mould assembly formula.
Except compound of the present invention, different specific embodiments comprises: pharmaceutically acceptable salt, the active metabolite of prodrug and these compounds.With the pharmaceutically acceptable salt of these metabolite.
" prodrug " is a kind of derivant of compound of the present invention, and it is become compound of the present invention in converted in vivo (such as: by hydrolysis, reduction or oxidation) by the mode by means of metabolism in vivo.Such as, compound of the present invention and acid reaction can be prepared into corresponding ester.Corresponding ester is prodrug, can be hydrolyzed to parent drug in vivo.The acid being applicable to preparing " prodrug " includes but not limited to: acetic acid, citric acid, lactic acid, tartaric acid, malonic acid, oxalic acid, salicylic acid, succinic acid, fumaric acid, maleic acid, methylene-bis-beta-hydroxyethyl base naphthoic acid, gentisic acid, hydroxyethylsulfonic acid., methanesulfonic acid, ethyl sulfonic acid, benzenesulfonic acid, p-methyl benzenesulfonic acid etc.
Purposes
Compound of the present invention or its pharmaceutically acceptable salt or prodrug or its isomer or the plant extract containing it can be used for prevention or treatment ulcerative colitis.A Therapeutic Method for prevention or treatment ulcerative colitis, gives the pharmaceutical composition of the present invention of patients of ulcerative colitis effective dose or contains its plant extract.
" effective dose " or " therapeutic dose " all refers to the amount being enough to produce curative effect.Effective dose can divide one or multiple dosing.Usually, effective dose is enough to relax, improve, stablize, slow down or postpone further developing of disease.
Usually, when the present composition is used for such use, they can make the pharmaceutical dosage form of different way of administration, as tablet, capsule, powder, granule, syrup, solution, oral liquid, spirit, tincture, aerosol, powder spray, injection, injectable sterile powder, suppository etc. with one or more pharmaceutically acceptable carriers or mixed with excipients.
Usually, pharmaceutical composition contains: (a) is containing as the reactive compound of the 0.01-99% weight portion of active component and officinal salt thereof; (b) pharmaceutically acceptable carrier.Also after can making the compound of respective pure form or the preparation of various forms of compound of the present invention, for administration.
" pharmaceutically acceptable " composition is the material being applicable to people and/or animal and namely having rational benefit/risk ratio without excessive bad side reaction (as toxicity, stimulation and allergy)." pharmaceutically acceptable carrier " is acceptable solvent, suspending agent or excipient pharmaceutically or on food for compound of the present invention or its pharmaceutically acceptable salt being sent to animal or human.Carrier can be liquid or solid.
Compound of the present invention can be passed through oral, intravenous, intramuscular or subdermal routes of administration.
In above-mentioned dosage form can the dosage form of oral administration administration be: tablet, capsule, powder, granule, syrup, solution, spirit.Solid-state carrier comprises: starch, lactose, calcium hydrogen phosphate, microcrystalline Cellulose, sucrose, kaolin, micropowder silica gel, Pulvis Talci, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, polyvinylpyrrolidone.And liquid carrier comprises: sterilized water, ethanol, Polyethylene Glycol, nonionic surfactant and edible oil (as Semen Maydis oil, Oleum Arachidis hypogaeae semen and Oleum sesami).In the process of pharmaceutical compositions, normally used adjuvant comprises: flavoring agent, coloring agent, antiseptic (as oxybenzene alkyl butyl ester, sodium benzoate, sorbic acid) and antioxidant (as vitamin E, vitamin C, sodium pyrosulfite and dibenzylatiooluene).
The dosage form that can be used for injection administration in above-mentioned dosage form comprises: injection, injectable sterile powder, and they are forms medicine and one or more pharmaceutically acceptable mixed with excipients made for drug administration by injection.Solvent comprises: sterilized water, ethanol, glycerol, propylene glycol, Polyethylene Glycol.In addition, also need to add antibacterial (as benzyl alcohol, butyl hydroxybenzoate, thimerosal), isoosmotic adjusting agent (as sodium chloride, glucose), suspending agent (as sodium carboxymethyl cellulose, methylcellulose), solubilizing agent (tween 80, lecithin), antioxidant (as vitamin E, vitamin C, sodium pyrosulfite) and filler (as lactose, mannitol).
From the position being easy to preparation and administration, preferred pharmaceutical composition is solid-state composition, especially the capsule of tablet and solid-filling or liquid filling.Preferred oral administration.
The effective dose of active component used can change with the order of severity of mode of administration and disease to be treated.But, usually when plant extract of the present invention gives with the dosage of about 0.5-2000mg/kg the weight of animals every day, gratifying effect can be obtained, preferably give with the dosage that 2-4 time is separated every day, or with sustained release forms administration.Be applicable to the dosage form taken orally, comprise the plant extract of the about 0.5-2000mg mixed with solid-state or liquid pharmaceutically acceptable carrier.This therapeutic scheme of scalable is to reach optimum therapeuticing effect.Such as, can according to the needs for the treatment of situation, every day, several times separated administration, or were reduced in proportion by dosage.Usually, the scope of oral clinical dosage of being grown up is 0.5-2000mg/ day, is preferably 10-1000mg/ day.
Except making medicament, also can add the various food additive such as antioxidant, pigment, enzyme preparation in arasaponin Ft1 of the present invention, make health food by the conventional method of this area.
Below in conjunction with specific embodiment, set forth the present invention further.These embodiments are only not used in for illustration of the present invention and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, the usually conveniently conditioned disjunction condition of advising according to manufacturer.Unless otherwise indicated, otherwise all percentage ratio and number all by weight.
Embodiment 1
1, experiment material
1.1 medical material
Arasaponin Ft1(HPLC purity >=98%, Man Site bio tech ltd, Chengdu); Dextran sulfate sodium (DSS, CAS:9011-18-1, MW36-50kDa are produced by MP Biomedicals company of the U.S.); Sulfasalazine (SASP, CAS:599-79-1, molecular weight 398.39, HPLC purity >=98%, is produced by Sigma-Aldrich).
1.2 laboratory animal
The C57BL/6 female mice (8 weeks) of body weight 20 ± 2g, is provided by Shanghai Univ. of Traditional Chinese Medicine's Experimental Animal Center, the animal quality certification number: SYXK(Shanghai) 2009-0069.Be placed in conventional feeding environment, ad lib and drinking-water.
2, experimental technique
The foundation of 2.1 Ulcerative Colitis Models
The C57BL/6 female mice (20 ± 2g) of selective body weight average one, adopts international ulcerative colitis modeling method (Gastroenterology2002,123:256-70; PLoS One2012,7:e36075), research the incipient stage, make mice ad lib and drinking-water, in the early stage after adaptive phase, change water into 4%(w/v) DSS, freely drink 7 days, to cause ulcerative colitis.
2.2 grouping and medications
Normal group: 10, give normal diet.
Model control group: 10, gives 4%DSS solution and freely drinks 7 days.
SASP group: 10, while giving 4%DSS solution, gavage gives SASP(350mg/kg) continuous 7 days.
Arasaponin Ft1 group: 10, while giving 4%DSS solution, gavage gives arasaponin Ft1(50mg/kg) continuous 7 days.
Experimental session, every day is fresh prepares dosage particles, and the sodium carboxymethyl cellulose with 0.5% dissolves, and uses in 1 hour in preparation.
The assessment of 2.3 enteritis
Body weight, diarrhoea, hemafecia, histopathological analysis etc. all to publish thesis (PLoS One2012,7:e36075 with reference to early-stage Study; J Pharmacol Exp Ther2013,345:473-82) described in method.Experimental session records body weight change, diarrhoea and hemafecia symptom every day.Experiment terminates rear anesthesia and cervical dislocation puts to death mice, opens abdominal cavity, takes out colon, measures the colon lengths from caecum to rectum.And get DC and make tissue slice, carry out H & E to dye, pathological score is carried out to dye colon specimen of H & E: (1) inflammatory cell ooze out standards of grading: have minute quantity inflammatory cell in 0 point-mucosa lamina propria, the inflammatory cell in more inflammatory cell or mucosa lamina propria is had to increase in 1 point-mucosa lamina propria, 2 points-inflammatory cell diffuses to Submucosa, and 3 points-holostrome all has inflammatory cell to ooze out; (2) tissue damage standards of grading: 0 point-without mucosa injury, 1 point-discrete mucosal epithelium is damaged, 2 points-top layer mucosal erosion, and 3 points-mucosa breakage widely is also expanded to intestinal wall deep layer.Oozing out of inflammatory cell is scored and tissue damage score addition, calculates histopathology scoring (1-6 divides).
2.4 statistical analysis
All experimental datas all repeat 3 times, result represents with mean+SD, adopt SPSS16.0 statistical software to adopt one way analysis of variance (One-way ANOVA) and LSD inspection to experimental data, P<0.05 is that statistically difference has significance.
3, result
3.1 arasaponin Ft1 are to the therapeutical effect of ulcerative colitis
3.1.1 on the impact of ulcerative colitis Mouse Weight
Fig. 1 embodies the impact of arasaponin Ft1 on ulcerative colitis Mouse Weight.In whole experimentation, the body weight change of Normal group mice is steady, and the body weight (19.8 ± 0.1g) of the 7th day adds 0.9%; The continued weight of model group mice declines, and body weight (18.0 ± 0.2g) rate of alleviating of the 7th day is 7.9%; The continued weight of SASP group (19.1 ± 0.2g) and arasaponin Ft1 group (18.6 ± 0.2g) mice drops to the 4th day, fall is less than model group, the rate of losing weight of the 7th day is respectively 2.2% and 4.7%, all has significant difference (P<0.001 and P<0.01) compared with model group.Illustrate that SASP and arasaponin Ft1 all obviously can improve the symptom that loses weight of the ulcerative colitis mice that DSS causes.
3.1.2 on the impact of ulcerative colitis mice hemafecia incidence rate
Fig. 2 embodies the impact of arasaponin Ft1 on ulcerative colitis mice hemafecia incidence rate.In whole experimentation, mice occurs without hemafecia Normal group.The 3rd day that adds DSS in drinking water starts, and model group and arasaponin Ft1 group mice start to occur hemafecia.Model group mice hemafecia continues to occur, and is 96.6% to the hemafecia incidence rate of the 7th day; SASP group mice add in drinking water DSS within the 4th day, start to occur hemafecia, SASP group and the arasaponin Ft1 group mice hemafecia incidence rate of the 7th day are respectively 36.7% and 40.0%, all have significant difference (P<0.001 and P<0.01) compared with model group.Illustrate that SASP and arasaponin Ft1 all obviously can improve the hemafecia symptom of the ulcerative colitis mice that DSS causes.
3.1.3 on the impact of ulcerative colitis mouse Colon length
Fig. 3 embodies the impact of arasaponin Ft1 on ulcerative colitis mouse Colon length.Compared with Normal group (12.0 ± 0.5cm), the colon swelling of model group (8.5 ± 0.5cm) mice, hemorrhage (Fig. 3 A), and obviously shorten, LVFS is 29.2%(Fig. 3 B); The colon of SASP group (11.2 ± 0.8cm) and arasaponin Ft1 group (9.1 ± 0.7cm) mice has slight swelling and hemorrhage (Fig. 3 A), LVFS be respectively 7.1% and 23.6%(Fig. 3 B), all have significant difference (P<0.001 and P<0.05) compared with model group.Illustrate that SASP and arasaponin Ft1 all obviously can improve the colon shortening symptom of the ulcerative colitis mice that DSS causes.
3.1.4 on the impact of ulcerative colitis mouse Colon histopathology
Fig. 4 embodies the injury repairing effect of arasaponin Ft1 to ulcerative colitis mouse Colon tissue.The colon of model group mice is the performance of exemplary inflammatory mucosa, and visible mucosa, Submucosa be muscle layer massive inflammatory cells infiltrated even, and organizational structure is disorderly, fracture, and Submucosa is hemorrhage, edema, telangiectasis; Colon's lesions visible of SASP group mice and arasaponin Ft1 group mice alleviates, ulcer healing, and Submucosa is hemorrhage to be alleviated (Fig. 4 A).
According to the 1-6 point of standards of grading representing inflammatory tissue damage, the score of Normal group mice is 0; Model group mice score (5.7 ± 0.3 points) significantly increases; SASP group (2.2 ± 0.8 points) and the score of arasaponin Ft1 group (4.1 ± 0.7 points) mice all reduce, and all have significant difference (P<0.001 and P<0.05) (Fig. 4 B) compared with model group.
To sum up colon's pathological analysis result shows, SASP and arasaponin Ft1 all significantly can improve colonic mucosal tissue pathology damage and the inflammatory cell infiltration symptom of the ulcerative colitis mice that DSS causes.
To sum up result of study shows, arasaponin Ft1 obviously can improve the losing weight of ulcerative colitis mice, hemafecia, colon shorten and the symptom such as Injured colonic mucosa.
The preparation of embodiment 2 tablet
Utilize routine techniques, mix following component, then direct compression, prepare the pharmaceutical composition of tablet form, its formula is as follows:
Scope of the present invention is not by the restriction of described specific embodiments, and described embodiment only for as the single example of illustrating various aspects of the present invention, also comprises method and the component of functional equivalent in the scope of the invention.In fact, except content as herein described, those skilled in the art can easily grasp multiple improvement of the present invention with reference to description above and accompanying drawing.Described improvement also falls within the scope of appended claims.Every section of list of references mentioned above is listed in herein as a reference all in full.
Claims (8)
1. arasaponin Ft1, prodrug and officinal salt thereof or the purposes of plant extract in preparation prevention or treatment ulcerative colitis medicine or health product containing arasaponin Ft1.
2. purposes according to claim 1, is characterized in that the described plant extract containing arasaponin Ft1 is the leaf of Araliaceae or the ethanol extract of root.
3. purposes according to claim 2, is characterized in that the described plant extract containing arasaponin Ft1 is the ethanol extract of Radix Notoginseng.
4. purposes according to claim 1, is characterized in that its officinal salt described is the salt that described arasaponin Ft1 and mineral acid or organic acid are formed.
5. purposes according to claim 4, is characterized in that described salt is the salt that described arasaponin Ft1 and hydrochloric acid, hydrobromic acid, hydroiodic acid, sulphuric acid, nitric acid, phosphoric acid, acetic acid, maleic acid, fumaric acid, the acid of Chinese holly edge, citric acid, oxalic acid, succinic acid, tartaric acid, malic acid, mandelic acid, trifluoroacetic acid, pantothenic acid, methanesulfonic acid or p-methyl benzenesulfonic acid are formed.
6. treat a pharmaceutical composition for ulcerative colitis, described compositions contains:
A () is containing as the arasaponin Ft1 of the 0.01-99% weight portion of active component and officinal salt thereof;
B () weight portion is the pharmaceutically acceptable carrier of surplus.
7. pharmaceutical composition according to claim 6, is characterized in that the dosage form of described pharmaceutical composition is injection, injectable sterile powder, tablet, capsule, spirit, powder, granule, syrup, solution, tincture, aerosol, powder spray or suppository.
8. pharmaceutical composition according to claim 6, is characterized in that the dosage form of described pharmaceutical composition is tablet or capsule.
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Cited By (2)
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CN107468701A (en) * | 2016-10-21 | 2017-12-15 | 云南农业大学 | The application of (R) the notoginsenoside Ft1 of compound 20 and its pharmaceutical composition in anti-inflammatory drug is prepared |
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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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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