CN101053574A - Medicinal composition containing chitoser ester and preparation method and application thereof - Google Patents
Medicinal composition containing chitoser ester and preparation method and application thereof Download PDFInfo
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- CN101053574A CN101053574A CN 200610072801 CN200610072801A CN101053574A CN 101053574 A CN101053574 A CN 101053574A CN 200610072801 CN200610072801 CN 200610072801 CN 200610072801 A CN200610072801 A CN 200610072801A CN 101053574 A CN101053574 A CN 101053574A
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Abstract
The invention belongs to pharmacy technical field. In particular, the invention discloses a medical composition comprising chitosan ester and preparation and use thereof. The chitosan ester and polysaccharide in the medical composition in the present invention can produce synergia effect which can be of good effect in anti-tumour.
Description
Technical field
The invention belongs to the pharmaceutical technology field, be specifically related to a kind of pharmaceutical composition that contains chitoser ester and preparation method thereof and purposes.
Background technology
Chitoser ester is a kind of novel chitosan derivatives, chemical name is 3-O-replacement-6-O-replacement-β-1,4-D-2-amino-2-deoxidation-glucosan is to be that basic material makes it become a kind of polysaccharide compound through extraction, degraded and chemical modification with contained chitin in the marine animal Eriocheir sinensis class shell.Application number is that the patent documentation of ZL00129362.1 discloses a kind of chitoser ester and preparation method thereof and application, wherein disclose the preparation method of chitoser ester and in the application of control in the cardiovascular and cerebrovascular diseases medicament, be specially and have study of anti-atherogenic effect.Document [fourth China, etc.The research of chitoser ester study of anti-atherogenic effect.Chinese Journal of Marine Drugs, 2001,79 (1): 12] reported that also chitoser ester can suppress vascular smooth muscle cell proliferation.Chitoser ester is oral and drug administration by injection toxicity is little, all has good safety.In available data, do not see the report that the chitoser ester anti-tumor aspect is arranged.
Polysaccharide is from the natural macromolecular material in higher plant, animal cell membrane, the microbial cell, general polysaccharides Chang Youyi more than hundred in addition several thousand monosaccharide be formed by connecting by glycosidic bond.With regard to the antitumor action of polysaccharide, the antitumor polysaccharide can be divided into two big classes: a class is to have Cytotoxic polysaccharide directly to have killed tumor cell: the second class anti-tumor activity polysaccharide suppresses by enhancing body's immunological function or kill tumor cell (just the host who often says mediates anti-tumor activity) indirectly as the biological immune reaction control agent, and the most of polysaccharide with anti-tumor activity all work by this approach.
In available data, do not see the report of use in conjunction in antitumor drug relevant for chitoser ester and polysaccharide composition.
Summary of the invention
At above the deficiencies in the prior art, research worker of the present invention finds unexpectedly that in experiment chitoser ester and polysaccharide active component share, and have the effect of Synergistic, can improve the pharmacological action of polysaccharide active component greatly.
An object of the present invention is to disclose a kind of pharmaceutical composition that contains chitoser ester.
Another object of the present invention is the preparation method of open aforementioned pharmaceutical compositions.
Another purpose of the present invention is the purposes of open aforementioned pharmaceutical compositions.
The chitoser ester that contains effective dose in the pharmaceutical composition of the present invention.
Also contain the other medicines active component in the pharmaceutical composition of the present invention.
The contained chitoser ester and the weight percent content of active constituents of medicine are 50%-90%: 10%-50% in the aforementioned pharmaceutical compositions.
The contained chitoser ester and the weight percent content of active constituents of medicine are preferably 70%-80% in the aforementioned pharmaceutical compositions: 20%-30%.
Above-mentioned chitoser ester is to prepare by the method in the ZL00129362.1 patent documentation, is specially:
Chitosan is suspended in 95% isopropyl alcohol, adding solid NaOH reacts, behind the certain hour, the aqueous isopropanol that in batches adds the chlorine alkanoic acid reacted 1-2 hour down at 50 ℃-60 ℃, after sucking filtration goes out product, use 80% washed with isopropyl alcohol, with the dehydrated alcohol dehydration,, obtain intermediate at 45 ℃ of following drying under reduced pressure.Concentrated sulphuric acid is added in the reactor, slowly add chlorosulfonic acid, preparation sulfur acidizing reagent down at 0 ℃.Under agitation intermediate is added in the sulfur acidizing reagent in batches, the reinforced time of control is in 60 minutes, 0 ℃-5 ℃ reactions 60-90 minute.Stir down product is put into 95% ethanol, with 95% washing with alcohol to pH value is about 4, and water is regulated pH value to 8.0-10.0 with product dissolving and filtration with NaOH, with the aforesaid liquid molecular cut off is 1000 ultrafilter membrane ultrafiltration, removes to desalt and micromolecule.With 95% ethanol precipitation that liquid after the ultrafiltration amasss with tetraploid, the reuse dehydrated alcohol with the acetone dehydration, carries out reduced vacuum and is drying to obtain chitoser ester repeatedly under 50 ℃.
The active constituents of medicine that contains in the pharmaceutical composition of the present invention can be active component (such as polysaccharide, paclitaxel etc.) with antitumor action, also can be the active component (such as the effective ingredient in Herba Houttuyniae, the Herba Diclipterae Chinensis etc.) with antibacterial action, also can be the active component of using in the cardiovascular and cerebrovascular vessel field with blood pressure lowering, effect for reducing blood fat, also can be the active component with hypoglycemic activity.Chitoser ester all has the effect of Synergistic to it.
In the above-mentioned active constituents of medicine, be preferably active component with antitumor action.
In the active component of above-mentioned antitumor action, be preferably the polysaccharide composition.
Above-mentioned polysaccharide composition is a polyporusum bellatus, pachyman, lentinan, the ginseng polysaccharide, tremella polysaccharide, krestin, Dihuang polysaccharide, lycium barbarum polysaccharide, the Fructus actinidiae chinensis polysaccharide, astragalus polysaccharides, Radix Angelicae Sinensis polysaccharide, Herb Gynostemmae Pentaphylli polysaccharides, dictyophora fungus polysaccharide, Radix Et Caulis Acanthopanacis Senticosi polysaccharide, Inokopolyose, spirulina polysaccharide, the Folium Ginkgo polysaccharide, Ganoderma Applanatum Polysaccharides, yellow peach sarcocarp polysaccharide, Chinese yam polysaccharide, grifolan, Angelica Polysaccharide, the rheum rhabarbarum polysaccharide, the Radix Chimonanthi praecocis polysaccharide, the Radix Phytolaccae polysaccharide, Porphyra Polysaccharide, polysaccharides from morinda officinalis how, acanthopanax giraldii harms polysaccharose, the Rhizoma Dysosmae Versipellis polysaccharide, the Fructus Citri Sarcodactylis polysaccharide, Aloe polysaccharide, Carnis Haliotidis polysaccharide, the DAISHICHONGCAO polysaccharide, 4-selenium polysaccharide sulfate, the Hypoxylon polysaccharide, BCG-polysaccharide, the bacillus bifidus polysaccharide, Schizophyllum commune Fr polysaccharides, Cordyceps polysaccharides, the Tricholoma mongolicum Imai polypeptide, the beer yeast polysaccharide, the Radix Morinae Bulleyanae acid mucopolysaccharide, the Asterias amurensis Lutken polysaccharide, Sargassum polysaccharides, kelp polysaccharide sulfate, the Brown algae sulfated polysaccharide, a kind of in the Enteromorpha clathrata (Roth) Grev. Emend bliding polysaccharide etc., two kinds or several mixture.
Above-mentioned polysaccharide composition is preferably a kind of, two kinds or several the mixture in polyporusum bellatus, pachyman, lentinan, ginseng polysaccharide, the astragalus polysaccharides.
Above-mentioned pharmaceutical composition can be prepared into oral formulations and ejection preparation.
Above-mentioned oral formulations can be tablet, capsule, pill, syrup, granule, oral solution, oral suspensions or Orally taken emulsion.
Above-mentioned injection can be small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder, and its preparation method is as follows:
The preparation of injection with small volume: get above-mentioned polysaccharide composition and chitoser ester, with the water for injection dissolving, adjust pH is 6.0-7.0, and with 0.22 μ m filtering with microporous membrane, sterilization is prepared into injection with small volume.
The preparation of high-capacity injection: get above-mentioned polysaccharide composition and chitoser ester, with the water for injection dissolving, add isoosmotic adjusting agent, adjust pH is 6.0-7.0, and with 0.22 μ m filtering with microporous membrane, sterilization is prepared into high-capacity injection.
The preparation of powder injection formulation: get above-mentioned polysaccharide composition and chitoser ester, with the water for injection dissolving, add the water-soluble injection excipient, adjust pH is 6.0-7.0, and with 0.22 μ m filtering with microporous membrane, drying is prepared into powder injection formulation.
The preparation of freeze-dried powder: get above-mentioned polysaccharide composition and chitoser ester, with the water for injection dissolving, add the water-soluble injection excipient, adjust pH is 6.0-7.0, and with 0.22 μ m filtering with microporous membrane, lyophilization is prepared into freeze-dried powder.
Above-mentioned various dosage forms can add pharmaceutically acceptable additives as required, for example antioxidant, isoosmotic adjusting agent, excipient etc.
Above-mentioned antioxidant can be a kind of in sodium sulfite, sodium sulfite, the sodium thiosulfate etc.
Be used to regulate the isoosmotic adjusting agent of osmotic pressure, be usually used in intravenous injection and infusion solutions, for example, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, xylitol, sorbitol and dextran etc. are preferably sodium chloride and/or glucose.Can add excipient in the powder pin, for example a kind of, two or more the mixture in mannitol, fructose, glucosan, polyvinylpyrrolidone, the dextran etc.
In tablet, can add filler, wetting agent, binding agent, disintegrating agent, lubricant etc. as required.Filler can be starch, microcrystalline Cellulose, pregelatinized Starch etc.Wetting agent can be water and/or ethanol.Binding agent can be polyvidone, starch slurry, cellulose etc.Disintegrating agent can be polyvinylpolypyrrolidone, CC-Na, starch or CMC-Na etc.Lubricant can be Pulvis Talci, stearic acid, magnesium stearate calcium, magnesium stearate etc.
In granule, can add filler, wetting agent, binding agent etc. as required.
Can add antiseptic, the agent of tender flavor in the solution type liquid agent.
Also should add dense aqueous sucrose solution in the syrup.
Can add suspending agent, wetting agent, flocculating agent etc. as required in the suspensoid.Suspending agent can be arabic gum, sodium alginate, agar, polyvidone, cellulose family, carbopol, sodium acrylate.
Can add emulsifying agent, antiseptic, correctives etc. in the Orally taken emulsion.
Above-mentioned various dosage forms can be according to the conventional production method preparation of pharmaceutical field.
Chitoser ester in the pharmaceutical composition of the present invention and active constituents of medicine use in conjunction, effect with Synergistic, can improve the pharmacological action of active component greatly, especially the pharmacological action of polysaccharide composition aspect antitumor drug, thus make the polysaccharide composition have better antitumor action.
In the preparation process of ejection preparation, research worker of the present invention finds that unexpectedly chitoser ester can also use as excipient in the preparation process of injectable powder and lyophilized injectable powder.
Research worker of the present invention has been carried out a large amount of experiments, and the weight proportion of chitoser ester and polysaccharide has been carried out preferably.Experimental result sees Table 1.
The experiment of table 1 active component proportion optimization
| The experiment number | Chitoser ester: polysaccharide (%) | Pharmacological action |
| 1 2 3 4 5 6 7 8 9 10 | 100∶0 90∶10 80∶20 70∶30 60∶40 50∶50 40∶60 30∶70 20∶80 10∶90 | + ++ +++ ++ ++ ++ + + + + |
Annotate :+expression pharmacological action is general; ++ the expression pharmacological action is better; +++expression pharmacological action is best.
By above-mentioned experimental result as can be seen: when the weight percent content of chitoser ester and polysaccharide is 50%-90%: during 10%-50%, pharmacological action is better; When the weight percent content of chitoser ester and polysaccharide is 70%-80%: 20%-30%, pharmacological action is best.
Research worker of the present invention has been carried out following pharmacodynamic experiment to the pharmaceutical preparation that contains chitoser ester of the present invention.
1, to the influence of mice S180 sarcoma
Get health, the vigorous sarcoma S180 tumor-bearing mice of tumor growth, put to death the back and take out the tumor piece, add normal saline in homogenizer, make the tumor homogenate, again with normal saline dilution in 1: 3, getting 0.2ml then, to inject oxter, a mice left side subcutaneous, weighed in 24 hours.Mice is divided into model control group, chitoser ester group, polysaccharide medicine group and medicine group of the present invention, 10 every group at random.Treating excess syndrome is tested medicine, and chitoser ester group injection gives chitoser ester 30mg/kg, and the injection of polysaccharide medicine group gives polysaccharide 50mg/kg, and medicine group injection of the present invention gives medicine 80mg/kg (wherein chitoser ester 30mg, polysaccharide 50mg).Every day the mouse peritoneal drug administration by injection once, model control group injection gives isopyknic normal saline, successive administration 10 days.Next day is put to death mice in drug withdrawal, weighs and carefully peels off the subcutaneous tumors piece, and it is heavy to take by weighing tumor in electronic balance.The results are shown in Table 2.
The growth inhibited effect of table 2 couple murine sarcoma S180
| Group | Tumor body weight (g) | Suppression ratio (%) |
| Model control group | 2.18 | - |
| The chitoser ester group | 2.02 | 7.3 |
| Polysaccharide medicine group medicine group of the present invention | 1.47 1.03 | 32.6 ** 52.8 **# |
Annotate: compare with model control group:
*P＜0.01; To the polysaccharide medicine group relatively: #P＜0.05.
2, to the tumor-inhibiting action of transplanted hepatoma H22
The 7th day the H22 lotus tumor male mice ascites in aseptic extraction inoculation back, add 4 times of amount normal saline mixings, it is subcutaneous to be inoculated in mice right fore axillary fossa place, every inoculation 0.2ml, inoculate back 24 hours mice is divided into model control group, chitoser ester group, polysaccharide medicine group and medicine group of the present invention, 10 every group at random.Intraperitoneal injection, dosage is the same, administration every day 1 time, successive administration 10 days took off neck execution mice in 24 hours after the last administration, strip tumor and weigh, according to formula: (the average tumor of the average tumor weight-administration of matched group group is heavy) * 100%/matched group tumor is heavy, obtains tumour inhibiting rate.The results are shown in Table 3.
The tumor-inhibiting action of table 3 couple transplanted hepatoma H22
| Group | Tumor body weight (g) | Suppression ratio (%) |
| The normal control group | 2.77 | - |
| The chitoser ester group | 2.49 | 10.1 |
| Polysaccharide medicine group medicine group of the present invention | 1.76 1.24 | 36.5 55.2 |
Annotate: compare with model control group: * * P＜0.01; To the polysaccharide medicine group relatively: #P＜0.05.
By above-mentioned pharmacodynamic experiment result as can be seen, under above-mentioned dosage, chitoser ester has antineoplastic action hardly; The polysaccharide composition has antitumor action; When chitoser ester and polysaccharide composition drug combination, the antitumor action of polysaccharide composition obviously strengthens, and illustrates that chitoser ester and polysaccharide composition share the effect that has Synergistic really.
Specific embodiment
Further describe the present invention with embodiment below, help understanding the present invention and advantage thereof, better effects if; Described embodiment is also non exhaustive, only is used to illustrate the present invention rather than restriction the present invention.
Embodiment 1
Get lentinan 90g and chitoser ester 10g, add dextrin, granulate, drying is pressed into tablet.
Embodiment 2
Get cactus polyoses 10g and chitoser ester 90g, add starch, fill, be prepared into capsule.
Embodiment 3
Get polyporusum bellatus 50g and chitoser ester 50g, with the water for injection dissolving, adjust pH is 6.0, and with 0.22 μ m filtering with microporous membrane, sterilization is prepared into injection with small volume.
Embodiment 4
Get pachyman, lentinan 80g and chitoser ester 20g, the water for injection dissolving adds glucose, and adjust pH is 6.5, and with 0.22 μ m filtering with microporous membrane, sterilization is prepared into high-capacity injection.
Embodiment 5
Get ginseng polysaccharide 60g and chitoser ester 40g, with the water for injection dissolving, add mannitol and glucosan, adjust pH is 7.0, and with 0.22 μ m filtering with microporous membrane, drying is prepared into powder injection formulation.
Embodiment 6
Get lentinan 30g and chitoser ester 70g, with the water for injection dissolving, add polyvinylpyrrolidone, dextran, adjust pH is 6.5, and with 0.22 μ m filtering with microporous membrane, lyophilization is prepared into freeze-dried powder.
Claims (10)
1, a kind of pharmaceutical composition that contains chitoser ester is characterized in that, contains the chitoser ester and the other medicines active component of effective dose in the pharmaceutical composition.
2, pharmaceutical composition according to claim 1 is characterized in that, the wherein contained chitoser ester and the weight percent content of active constituents of medicine are 50%-90%: 10%-50%.
3, pharmaceutical composition according to claim 2 is characterized in that, the wherein contained chitoser ester and the weight percent content of active constituents of medicine are 70%-80%: 20%-30%.
According to the described pharmaceutical composition of one of claim 1-3, it is characterized in that 4, described active constituents of medicine is the polysaccharide effective ingredient.
5, pharmaceutical composition according to claim 4, it is characterized in that described polysaccharide composition is a polyporusum bellatus, pachyman, lentinan, the ginseng polysaccharide, cactus polyoses, ganoderan, tremella polysaccharide, krestin, Dihuang polysaccharide, lycium barbarum polysaccharide, the Fructus actinidiae chinensis polysaccharide, astragalus polysaccharides, Radix Angelicae Sinensis polysaccharide, Herb Gynostemmae Pentaphylli polysaccharides, dictyophora fungus polysaccharide, Radix Et Caulis Acanthopanacis Senticosi polysaccharide, Inokopolyose, spirulina polysaccharide, the Folium Ginkgo polysaccharide, Ganoderma Applanatum Polysaccharides, yellow peach sarcocarp polysaccharide, Chinese yam polysaccharide, grifolan, Angelica Polysaccharide, the rheum rhabarbarum polysaccharide, the Radix Chimonanthi praecocis polysaccharide, the Radix Phytolaccae polysaccharide, Porphyra Polysaccharide, polysaccharides from morinda officinalis how, acanthopanax giraldii harms polysaccharose, the Rhizoma Dysosmae Versipellis polysaccharide, the Fructus Citri Sarcodactylis polysaccharide, Aloe polysaccharide, Carnis Haliotidis polysaccharide, the DAISHICHONGCAO polysaccharide, 4-selenium polysaccharide sulfate, the Hypoxylon polysaccharide, BCG-polysaccharide, the bacillus bifidus polysaccharide, Schizophyllum commune Fr polysaccharides, Cordyceps polysaccharides, the Tricholoma mongolicum Imai polypeptide, the beer yeast polysaccharide, the Radix Morinae Bulleyanae acid mucopolysaccharide, the Asterias amurensis Lutken polysaccharide, Sargassum polysaccharides, kelp polysaccharide sulfate, the Brown algae sulfated polysaccharide, a kind of in the Enteromorpha clathrata (Roth) Grev. Emend bliding polysaccharide etc., two kinds or several mixture.
6, pharmaceutical composition according to claim 5 is characterized in that, described polysaccharide composition is a kind of, two kinds or several the mixture in polyporusum bellatus, pachyman, lentinan, ginseng polysaccharide, the astragalus polysaccharides.
According to the described pharmaceutical composition of one of claim 1-6, it is characterized in that 7, this pharmaceutical composition can be prepared into oral formulations and ejection preparation; Wherein oral formulations comprises tablet, capsule, pill, syrup, granule, oral solution, oral suspensions or Orally taken emulsion; Wherein injection comprises small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder.
8, pharmaceutical composition according to claim 7 is characterized in that, this pharmaceutical composition is an ejection preparation.
9, according to claim 7 or 8 described pharmaceutical compositions, it is characterized in that, also contain pharmaceutically acceptable pharmaceutic adjuvant in the described pharmaceutical preparation.
10, the application of the described pharmaceutical composition of one of claim 1-9 in the preparation antitumor drug.
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101361774B (en) * | 2008-09-01 | 2012-01-25 | 北京世纪博康医药科技有限公司 | Combination containing brown alga polysaccharide sulfuric ester and panax ginseng and use thereof |
| CN102641284A (en) * | 2012-05-03 | 2012-08-22 | 昆明振华制药厂有限公司 | Application of spirulina platensis polysaccharide |
| CN103330718A (en) * | 2013-06-20 | 2013-10-02 | 广西大学 | Preparation method of gynostemma pentaphyllum polysaccharide-iron complex |
| CN103893213A (en) * | 2012-12-29 | 2014-07-02 | 佳木斯大学 | Nano yam polysaccharide biostime colon-targeted microecological modulator |
| CN105664140A (en) * | 2016-01-15 | 2016-06-15 | 上海荣神生物化学有限公司 | Glycopeptide composition as well as preparation method and application thereof |
| CN106954855A (en) * | 2017-02-17 | 2017-07-18 | 江苏宇鸿生物科技有限责任公司 | A kind of anticancer composite fungi amylose and preparation method thereof |
| CN108783465A (en) * | 2018-05-22 | 2018-11-13 | 湖北和格复合骨胶原生物科技有限公司 | A kind of nutrition formula product with oncotherapy function |
| CN113424954A (en) * | 2021-07-30 | 2021-09-24 | 江西正和大健康产业有限公司 | Edible fungus composition preparation and preparation method thereof |
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2006
- 2006-04-10 CN CN 200610072801 patent/CN101053574A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101361774B (en) * | 2008-09-01 | 2012-01-25 | 北京世纪博康医药科技有限公司 | Combination containing brown alga polysaccharide sulfuric ester and panax ginseng and use thereof |
| CN102641284A (en) * | 2012-05-03 | 2012-08-22 | 昆明振华制药厂有限公司 | Application of spirulina platensis polysaccharide |
| CN102641284B (en) * | 2012-05-03 | 2014-10-22 | 昆明振华制药厂有限公司 | Application of spirulina platensis polysaccharide |
| CN103893213A (en) * | 2012-12-29 | 2014-07-02 | 佳木斯大学 | Nano yam polysaccharide biostime colon-targeted microecological modulator |
| CN103330718A (en) * | 2013-06-20 | 2013-10-02 | 广西大学 | Preparation method of gynostemma pentaphyllum polysaccharide-iron complex |
| CN103330718B (en) * | 2013-06-20 | 2015-04-08 | 广西大学 | Preparation method of gynostemma pentaphyllum polysaccharide-iron complex |
| CN105664140A (en) * | 2016-01-15 | 2016-06-15 | 上海荣神生物化学有限公司 | Glycopeptide composition as well as preparation method and application thereof |
| CN106954855A (en) * | 2017-02-17 | 2017-07-18 | 江苏宇鸿生物科技有限责任公司 | A kind of anticancer composite fungi amylose and preparation method thereof |
| CN108783465A (en) * | 2018-05-22 | 2018-11-13 | 湖北和格复合骨胶原生物科技有限公司 | A kind of nutrition formula product with oncotherapy function |
| CN113424954A (en) * | 2021-07-30 | 2021-09-24 | 江西正和大健康产业有限公司 | Edible fungus composition preparation and preparation method thereof |
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