CN102048909A - Callicarpa nudiflora effective part with hemostatic effect and pharmaceutical preparation thereof - Google Patents
Callicarpa nudiflora effective part with hemostatic effect and pharmaceutical preparation thereof Download PDFInfo
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- CN102048909A CN102048909A CN200910186345XA CN200910186345A CN102048909A CN 102048909 A CN102048909 A CN 102048909A CN 200910186345X A CN200910186345X A CN 200910186345XA CN 200910186345 A CN200910186345 A CN 200910186345A CN 102048909 A CN102048909 A CN 102048909A
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Abstract
The invention discloses a callicarpa nudiflora effective part extract with a hemostatic effect and a preparation method of a pharmaceutical preparation of the callicarpa nudiflora effective part extract. The effective part extract and the pharmaceutical preparation contain total flavonoids of the callicarpa nudiflora and are extracted and separated from the callicarpa nudiflora which is a traditional Chinese medicine plant, the content of the total flavonoids is not less than 50%, and the effective part extract and the pharmaceutical preparation mainly contain galuteolin, luteolin-3'-O-beta-D-glucopyranoside, luteolin-4'-O-beta-D-glucopyranoside, calliterpenone, luteolin, apigenin and cosmosiin. The effective part extract and the pharmaceutical preparation have significant hemostatic effects.
Description
Technical field
The present invention relates to a kind of have the Callicarpa nudiflora effective site of remarkable anastalsis and the preparation method of pharmaceutical preparation thereof, is that extraction separation has the preparation method of the total flavone valid target and the preparation thereof of remarkable anastalsis from medicinal plants Callicarpa nudiflora (Callicarpa nudiflora Hook.ex Am.) specifically.
Background technology
Callicarpa nudiflora (Callicarpa nudiflora Hook.ex Am.) is a Verenaceae Callicarpa plant, on China Hainan, Guangdong, Guangxi and other places distribution is arranged.Mainly be distributed in India, Vietnam and Malaysia abroad.Its root, stem, Ye Junke are used as medicine, and have antibacterial anti hemorrhagic, eliminating inflammation and expelling toxin, dissipating blood stasis for subsidence of swelling, the effect of wind-expelling and dispelling dampness cures mainly diseases such as suppurative inflammation, acute infectious hepatitis, respiratory tract and digestive tract hemorrhage, wound hemorrhage, and burn and traumatic hemorrhage etc. are controlled in external.Callicarpa nudiflora is rich in flavones ingredient, up to now, determines to isolate the effective site with anastalsis and do not appear in the newspapers from Callicarpa nudiflora.
Existing open source information shows, Callicarpa nudiflora has been become dosage forms such as tablet, capsule, suppository, vagina effervescent and injection by people's extensive exploitation, but all be that simple water is proposed decoction on its technology, perhaps precipitate with ethanol in addition again, all be lower than 30% through comparing its general flavone content, and general flavone content is more than 50% in the effective site of the present invention, the present invention has kept effective ingredient to a greater extent, remove impurity, can obviously reduce dosage.Find that in test the present invention has tangible anastalsis, and Callicarpa nudiflora preparation----the Callicarpa nudiflora capsule that obviously is better than on the market being bought.
Yan Bin discloses in CN1559451 by what Callicarpa nudiflora and Lignum et Radix Naucleae were formed has a synergistic anti-inflammatory pharmaceutical compositions, has mentioned that Callicarpa nudiflora can be the form of effective site in this invention.And the present invention different with it be to use single Callicarpa nudiflora effective site, its main component is a flavonoid, content is more than 50%, effect is hemostasis.
Summary of the invention
The present invention seeks to: the effective site that provides a kind of Callicarpa nudiflora to have anastalsis, this effective site main component is a flavonoid.
Another object of the present invention provides a kind of preparation method of Callicarpa nudiflora effective parts formulation.
The objective of the invention is to realize by the following method:
The Callicarpa nudiflora effective site system that the present invention proposes obtains from the separation of Callicarpa nudiflora aerial parts, and its extraction process is: Callicarpa nudiflora decocts with water secondary, and each 1～3 hour, water consumption was 8～15 times of amounts (L/kg).Collecting decoction filters, and filtrate is concentrated into the clear paste of 1.10～1.20 (50～60 ℃), adds ethanol and makes that to contain alcohol be 60%～80%, reclaims ethanol, the thick solution of extract, carry out enriching and purifying then.
The method of enriching and purifying can be a solvent extraction, said extracted solution is added water make into the solution that every mL contains the 1g crude drug, use organic solvent, as chloroform, ethyl acetate, acetone, n-butyl alcohol etc., use wherein one or more mixture, extract, collect extract, reclaim solvent, the residue drying gets Callicarpa nudiflora flavone effective part extract.
The method of enriching and purifying also can be the column purification method, with technologies such as polyamide column, macroporous adsorptive resins and nonionic adsorption resin posts: the preferred polyamide post, the said extracted solution concentration is 1: 5～1: 10 (crude drug amount g: dispersion product mL), the post blade diameter length ratio is 1: 5～1: 8, applied sample amount is 100～500mg/mL (in the crude drug amount), 3～6 times of column volumes of elder generation's water eluting, 3～6 times of column volumes of the ethanol elution of reuse 30%～70%, collect eluent, reclaim solvent, residue dried gets the Callicarpa nudiflora flavone effective part.
The main component of the Callicarpa nudiflora flavone effective part that the present invention proposes comprises luteoloside, luteolin-3 '-O-β-D-pyranglucoside, luteolin-4 '-O-β-D-pyranglucoside, Folium Callicarpae Formosanae terpene ketone, luteolin, apigenin, cosmosiin.The percentage composition of contained total flavonoid composition 〉=50% (w/w) among the present invention.
The content assaying method of total flavones composition is as follows among the present invention:
1. the preparation of reference substance solution: precision takes by weighing luteoloside reference substance 5mg, puts in the 10ml measuring bottle, adds dissolve with methanol, standardize solution, promptly.
2. the preparation of standard curve: accurate reference substance solution 0.5,1.0,1.5,2.0, the 3.0ml of drawing, put respectively in the 25ml measuring bottle, respectively add water to 6ml, add 5% sodium nitrite solution 1ml, make mixing, placed 6 minutes, add 10% aluminum nitrate solution 1ml, shake up, placed 6 minutes, hydro-oxidation sodium test solution 10ml adds water to scale again, shakes up, placed 15 minutes, and, measured trap at the wavelength place of 510nm according to spectrophotography, with the trap is vertical coordinate, and concentration is abscissa, the drawing standard curve.
3. algoscopy: get this product 1g, the accurate 100ml methanol that adds claims to decide weight, and supersound process 20 minutes adds methanol and supplies weight, shakes up.Precision is measured 1ml, puts in the 10ml measuring bottle, and thin up shakes up to scale.Precision is measured 1ml, puts in the 25ml measuring bottle, and the method under the sighting target directrix curve preparation from " respectively adding water to 6ml ", is measured trap in accordance with the law, calculates general flavone content with standard curve.
The present invention further provides a kind of pharmaceutical preparation, it is characterized in that getting 1 part of above-mentioned Callicarpa nudiflora flavone effective part extract and mix, make acceptable drug preparation on the pharmaceutics with acceptable one or more carriers on the pharmaceutics.
Pharmaceutical preparation is applicable to oral cavity, rectum, nasal cavity, epidermis (comprising cheek and Sublingual), vagina or non-intestinal (comprising muscle, subcutaneous and vein) administration or is applicable to by inhalation or insufflation administration.Under suitable situation, the present invention can be the administration of divided dose unit, and can make by known method in the pharmaceutical field.
1. the pharmaceutical preparation that is applicable to oral administration can be dispersive unit, as capsule, pellet, tablet, powder, granule, the oral liquid of the Callicarpa nudiflora total flavones that respectively contains scheduled volume respectively.The tablet of oral administration and capsule can contain conventional excipient such as binding agent, filler, lubricant, disintegrating agent or wetting agent, and tablet can be by method coating commonly known in the art.Oral liquid can be the form of suspensoid, solution, Emulsion, syrup or the tincture of water or oil, also can be that the form of dry product provides, and prepares with water or other suitable vehicle with preceding again.This liquid preparation comprises conventional additive such as suspensoid, emulsifying agent, non-water vehicle (can comprise edible oil) or antiseptic.
2. the local administration preparation that is applicable to epidermis can be ointment, cream or lotion or is the transdermal patch.Can constitute by adding suitable thickening in aqueous or the oleaginous base such as ointment and cream.Lotion can be made of aqueous or oleaginous base, and generally contains one or more emulsifying agents, stabilizing agent, dispersant, suspending agent, thickening agent or toner.
3. be applicable to the pharmaceutical preparation of rectally, the suppository of preferred unit dosage, suitable carriers comprises cocoa butter and other common used material of the prior art.Suppository can be by mixing Callicarpa nudiflora flavone effective part extract with soft or meltability carrier, cooling forming in mould and making.
4. the preparation that is applicable to vagina administration is vaginal suppository, tampon, cream, colloid, paste, infusion or spray.
5. be applicable to nasal-cavity administration, be liquid spray or dispersible powder or drop form.Drop can be made of aqueous or non-aqueous substrate, and contains more than one dispersant, lytic agent or suspensoid.Liquid spray can come administration easily by pressure bottle.
6. the preparation that is applicable to oral cavity local medication is collutory, lozenge and pastille.Lozenge is made of Callicarpa nudiflora flavone effective part extract and sucrose, arabic gum or tragakanta fragrance substrate; Pastille is made of inert bases such as Callicarpa nudiflora flavone effective part extract and gelatin, glycerol, sucrose and arabic gums, and collutory is made of Callicarpa nudiflora flavone effective part extract and suitable liquid-carrier.
7. be used for inhalation, can pass through insufflator, aerosol apparatus or pressure bottle administration.
Beneficial effect of the present invention is:
Show that through pharmacological evaluation the present invention has tangible anastalsis:
1. to the influence of clotting time of mice
Get 40 of KM kind mices, male and female half and half property by the body weight random packet, is respectively blank group, YUNNAN BAIYAO 0.333g/kg group, Callicarpa nudiflora effective site 0.667 and 1.333g/kg group, 10 every group.By the mice body weight, to remove the blank group and give isopyknic distilled water, other groups give this product and the YUNNAN BAIYAO of corresponding dosage, equal ig, 0.2ml/10g body weight, administration every day 1 time, successive administration 7d.1h after the last administration measures blood coagulation time with slide method and capillary tube method.And organize a T and check.
The result: Callicarpa nudiflora effective site has the effect of shortening clotting time of mice, and its high dose group and YUNNAN BAIYAO group all have the effect of shortening clotting time, compares with the blank group respectively, and difference all has significance meaning (p＜0.05), sees Table 1.
Table 1 Callicarpa nudiflora effective part extract to the influence of clotting time of mice (
N=10)
Compare * p＜0.05 with the blank group
The influence in 2 pairs of mice bleeding times
Get 40 of above-mentioned mices,, be respectively blank group, YUNNAN BAIYAO group, Callicarpa nudiflora effective site group, 10 every group by the body weight random packet.By the mice body weight, to remove matched group and model group and give isopyknic distilled water, other groups give relative medicine, administration every day 1 time, successive administration 7d.1h after the last administration is used in apart from the terminal 2mm of mouse tail place and cuts off, and timing is immediately inhaled the section drop of blood once every 30s gently with filter paper, until hemorrhage stop naturally till, be the mice bleeding time.Organize a T check.
The result: Callicarpa nudiflora effective site has the effect of shortening the mice bleeding time, and its high dose group and YUNNAN BAIYAO 0.333g/kg group all can obviously shorten the mice bleeding time, compare with the blank group respectively, and difference all has significance meaning (p＜0.05); High dose group and YUNNAN BAIYAO 0.333g/kg group relatively have identical result.See Table 2.
Table 2 Callicarpa nudiflora effective part extract is to the influence in mice bleeding time (X ± SD)
Compare * p＜0.05 with the blank group
The influence of 3 pairs of rats in vitro platelet aggregations
This experiment is formed 3 groups of test groups by blank group, Callicarpa nudiflora capsule, Callicarpa nudiflora effective site, tests 10 examples for every group.Test with the intelligent blood agglutometer of TYXN-96, the observation curve of platelet aggregation changes, and test index is the platelet aggregation rate in the 5min, and test index is organized a T check, judges group difference.
Result: in the test of external antiplatelet aggregation, Callicarpa nudiflora effective site and Callicarpa nudiflora capsule all have the effect of the external rat platelet maximum agglutination rate of tangible increase, all have highly significant and significance meaning (p＜0.01 and p＜0.05) with blank group comparing difference, see Table 3
Table 3 Callicarpa nudiflora effective part extract is induced the influence of rats in vitro platelet aggregation to ADP
Compare * P＜0.05, * * p＜0.01 with matched group
By zoopery, Callicarpa nudiflora flavone effective part extract is through carrying out tests such as clotting time, bleeding time and platelet aggregation to mice, the result shows that Callicarpa nudiflora flavone effective part extract has significant anastalsis, can be used as a kind of hemorrhage active drug in inside and outside for the treatment of.
Embodiment 1:
Get Callicarpa nudiflora and decoct with water secondary, each 1.5 hours, water consumption was 8 times of amounts (L/kg).Collecting decoction filters, and filtrate is concentrated into the clear paste of 1.20 (50 ℃), adds ethanol and makes that to contain alcohol be 70%, reclaim ethanol, add water and make into the solution that every mL contains the 1g crude drug, use ethyl acetate extraction, reclaim solvent, residue dried gets Callicarpa nudiflora flavone effective part extract.
Embodiment 2:
Callicarpa nudiflora decocts with water secondary, and each 2 hours, water consumption was 12 times of amounts (L/kg).Collecting decoction filters, and filtrate is concentrated into the clear paste of 1.10 (60 ℃), add ethanol and make and contain alcohol 65%, reclaim ethanol, solution concentration is 1: 8 (crude drug amount g: dispersion product mL), the polyamide column blade diameter length ratio is 1: 7, applied sample amount is 100～500mg/mL (in the crude drug amount), 4 times of column volumes of first water eluting, 5 times of column volumes of the ethanol elution of reuse 50%, collect eluent, reclaim solvent, residue dried gets Callicarpa nudiflora flavone effective part extract.
Embodiment 3:
Get 1 part of Callicarpa nudiflora effective part extract, 2 parts of starch mix, 95% alcohol granulation, and drying, granulate, encapsulated, promptly get capsule.
Embodiment 4:
Get 1 part of Callicarpa nudiflora effective part extract, 1.5 parts of microcrystalline Cellulose mix, granulate with 5%PVP, and drying, granulate, the magnesium stearate of adding 0.5%, tabletting promptly gets tablet.
Embodiment 5:
Get 1 part of Callicarpa nudiflora effective part extract, 5 parts of Mel, 1.5 parts of glycerol, sodium benzoate is an amount of, mixes, and stirs, and filters, and adds water, and fill promptly gets oral liquid.
Embodiment 6:
Get 4 parts of polyethylene glycol 6000s, 5 parts of polyethylene glycol 1500s, be heated to 65 ℃ of fusings, stir evenly, as substrate, get 1 part of Callicarpa nudiflora effective part extract, it is an amount of to add water, grinds to form thick paste, stir to add in the substrate, and 65 ℃ of insulations, moulding, cooling promptly gets suppository.
Embodiment 7:
Get 1 part of Callicarpa nudiflora effective part extract, pour in the container under 1 part of room temperature of Arlacel-85, adorn press then and be pressed into propellant, promptly get spray.
Embodiment 8:
Get 2 parts of triethanolamine, 5 parts of glycerol, 50 parts of distilled water are heated to more than 80 ℃, are water; With 10 parts of stearic acid, 2 parts of lanolines, heating and melting adds above-mentioned aqueous phase gradually together, and the limit edged stirs, and makes substrate; After grinding 1 part of liquid Paraffin of Callicarpa nudiflora effective part extract evenly, add mix homogeneously in the above-mentioned substrate, promptly get ointment with equal portions.
Claims (8)
1. one kind has anastalsis Callicarpa nudiflora effective part extract, it is characterized in that it being the flavones ingredient that extraction separation obtains from Callicarpa nudiflora, wherein mainly comprise luteoloside, luteolin-3 '-O-β-D-pyranglucoside, luteolin-4 '-O-β-D-pyranglucoside, Folium Callicarpae Formosanae terpene ketone, luteolin, apigenin, cosmosiin.
2. Callicarpa nudiflora effective part extract according to claim 1 is characterized in that percentage composition summation 〉=50% of total flavonoid composition.
3. according to the described Callicarpa nudiflora effective part extract of claim 1～2, it is characterized in that having significant anastalsis.
4. according to described any extract of claim 1～3, it is characterized in that with pharmaceutics on acceptable auxiliary, make acceptable preparation on the pharmaceutics;
5. preparation according to claim 4 is characterized in that: said preparation is an oral formulations, as capsule, pellet, tablet, powder, granule and oral administration solution preparation.
6. preparation according to claim 4 is characterized in that: said preparation is the epidermis local administration preparation, as ointment, cream, liniment, lotion and the agent of transdermal patch.
7. preparation according to claim 4 is characterized in that: said preparation is oral cavity and nasal cavity portion drug-delivery preparation, as collutory, lozenge, pastille, spray, powder and drop.
8. preparation according to claim 4 is characterized in that: said preparation is rectum and portio vaginalis drug-delivery preparation, as suppository, tampon agent, cream, colloid, paste, effervescent or spray.
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| CN103272260A (en) * | 2013-06-13 | 2013-09-04 | 海南医学院 | Chitosan composite medical dressing comprising callicarpa nudiflora extract and preparation method thereof |
| CN103566055A (en) * | 2013-09-26 | 2014-02-12 | 许力宏 | Callicarpa nudiflora pellet capsule as well as preparation method thereof |
| CN103585357A (en) * | 2013-11-21 | 2014-02-19 | 海南医学院 | Callicarpa nudiflora slow release pellet, and preparation method and application of slow release pellet |
| CN103893412A (en) * | 2013-12-24 | 2014-07-02 | 深圳市仙湖植物园管理处 | Anti-tumor callicarpa nudiflora extract and preparation method and application thereof |
| CN113318162A (en) * | 2016-11-07 | 2021-08-31 | 海南医学院 | Preparation method of Li medicine Callicarpa nudiflora scald ointment |
| CN113350427A (en) * | 2014-09-04 | 2021-09-07 | 九芝堂股份有限公司 | Suppository for treating gynecological inflammation and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103272260A (en) * | 2013-06-13 | 2013-09-04 | 海南医学院 | Chitosan composite medical dressing comprising callicarpa nudiflora extract and preparation method thereof |
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| CN103893412A (en) * | 2013-12-24 | 2014-07-02 | 深圳市仙湖植物园管理处 | Anti-tumor callicarpa nudiflora extract and preparation method and application thereof |
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| CN113350427A (en) * | 2014-09-04 | 2021-09-07 | 九芝堂股份有限公司 | Suppository for treating gynecological inflammation and preparation method thereof |
| CN113318162A (en) * | 2016-11-07 | 2021-08-31 | 海南医学院 | Preparation method of Li medicine Callicarpa nudiflora scald ointment |
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Application publication date: 20110511 |