CN105982889A - Medicinal composition capable of resisting influenza viruses and applications of medicinal composition - Google Patents
Medicinal composition capable of resisting influenza viruses and applications of medicinal composition Download PDFInfo
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- CN105982889A CN105982889A CN201510077119.3A CN201510077119A CN105982889A CN 105982889 A CN105982889 A CN 105982889A CN 201510077119 A CN201510077119 A CN 201510077119A CN 105982889 A CN105982889 A CN 105982889A
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Abstract
The invention discloses a medicinal composition capable of resisting influenza viruses and applications of the medicinal composition, belonging to the technical field of medicines. The active ingredients of the composition comprise arbidol or pharmaceutically acceptable salt of arbidol, and oseltamivir or pharmaceutically acceptable salt of oseltamivir at the weight part ratio of (1-10) to (1-5). According to the medicinal composition and the applications of the medicinal composition, through the matching of arbidol and oseltamivir, the medicinal composition can act to different action targets, so that the synergistic effect is achieved; when the medicinal composition is used for treating and preventing the cold caused by influenza viruses, the use amount of oseltamivir phosphate can be reduced, and the occurrence of drug tolerance and untoward effects can be reduced.
Description
Technical field
The present invention relates to pharmaceutical technology field, particularly relate to a kind of resisiting influenza virus pharmaceutical composition and
Application.
Background technology
Influenza (influenza is called for short influenza) is the ARI that influenza virus causes, also
It is the disease that a kind of infectiousness is strong, spread speed is fast.Patient body weakness can be made, cause multiple complications,
Simultaneously may be lethal sometimes for being hospitalized for treatment, for the more weak people of old resistance, it is easy to phase
Infect mutually, cause a range of popular.Annual influenza pandemic can cause 3 million to five million serious
Case, and cause 300,000-50 ten thousand people dead.Age is can more than 65 years old, less than the people of two years old immunity difference
Serious illness and dead people at highest risk can occur.
Causing grippal virus to be influenza virus, influenza virus is a kind of ribonucleic acid (RNA) virus,
Be divided into first, second, the third three types, pathogenic mainly before amphitypy.Influenza A virus is according to surface protein blood clotting
The structure of element and neuraminidase and genetic characteristics thereof are divided into again many hypotypes (second, the third type do not have hypotype), extremely
The blood clotting that the present has been found that have 16 hypotypes (H1-16), and 9 hypotypes (N1-9) of neuraminidase, the two is not
Being formed for a lot of hypotype with combination, popular for example in recent years H1N1virus, H5N1 influenza are sick
Poison and H7N9 influenza virus.
Influenza A virus on coating possibly together with a kind of structure, referred to as M2 ion channel.By target site,
Existing anti-influenza virus medicament has two classes:
(1) M2 ion channel blocking agents, is can not to slough shell by making virus, thus stops reproduction process.
But influenza B virus not this ionophorous protein, therefore such medicine is only effective to Flu-A.Represent medicine
Thing has amantadine and Rimantadine.M2 ion channel blocking agents problem maximum at present is that resistant rate is high.State
Starting from the Surveillance on antibiotic resistance of influenza A virus strain 1991 outward, 1994-1995, H3N2 virus is to Buddha's warrior attendant
Alkanamine and Rimantadine resistant rate are 0.4%, and 2003-2004 increases to 12.3%.Studies in China shows, H3N2
Virus 1989-1999 does not find resistance, resistance ratio 3.4% in 2002, within 2003, rises to 56.0%,
Within 2005, rise to 77.6%；Another research influenza virus in 2004 is 73.8% to amantadine resistant rate.
Serious problem is that the virus of resistance keeps good hereditary capacity, can propagate interpersonal.
(2) neuraminidase inhibitor, stops virus discharged by infected cell and invade adjacent cells, subtracts
Duplication in host for the less virus, cuts off virus diffusion chain, all has activity to first, influenza B virus.
Representing medicine has Oseltamivir phosphate, zanamivir and Peramivir etc..Wherein, Oseltamivir phosphate
(Oseltamivir) trade name Tamiflu (Tamiflu), its structure is as follows:
Oseltamivir is the nerve of the novel resisiting influenza virus being developed listing by Gilead company and Roche company
Propylhomoserin enzyme inhibitor, molecular formula is C16H28N2O4·H3PO4, chemistry entitled (3R, 4R, 5S)-4 acetamide
Base-5 amino-3 (1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester phosphate (Novel selective inhibitors
of viral or bacterial neuraminidases,WO9626933).Oseltamivir phosphate acts on influenza virus
Surface glycoprotein-neuraminidase (NA), thus suppress virus replication and the propagation in respiratory tract, it is one
Plant high selective influenza virus NA inhibitor.Oseltamivir phosphate, was used in Switzerland's listing in 1999
(Oseltamivir phosphate can effectively be treated for the A type of people and 1 years old and more than 1 years old children and influenza B treatment
A type and influenza B, but the clinical practice data of influenza B are still few).Can also be used for being grown up and 13 years old
And the prevention of more than 13 years old teen-age A type and influenza B.But, with the popularization applied clinically,
Virus continues to bring out (Influenza Neuraminidase Inhibitors as Antiviral to its drug resistance phenomenon
Agents.ANNUAL REPORTS IN MEDICINAL CHEMISTRY,2006(41):287-297；In
Vitro Generation of Neuraminidase Inhibitor Resistance in A(H5N1)Influenza
Viruses.Antimicrob.Agents Chemother., 2009 (53): 4433-4440), will cause for control virus
Replicate and be continuously increased dosage.Further, Oseltamivir phosphate also has certain bad reaction, main
Bad reaction is: gastral discomfort, including nausea,vomiting,diarrhea, stomachache etc., next to that breathe system
The bad reaction of system, including bronchitis, cough etc., in addition with the bad reaction of central nervous system,
Such as dizziness, headache, insomnia, fatigue etc..
Abiduoer (Arbidol) is a kind of antiviral drugs, and molecular formula is C22H25BrN2O3S, chemical name
For 6-bromo-5-hydroxyl-1-methyl-4-((dimethylamino) methyl)-2-(phenylthiomethyl)-1H-indole-3-carboxylic acid second
Ester.Its structure is as follows:
First Abiduoer was approved listing in Russia in 1993, in the clinical practice of conventional 20 years,
By the spy such as its determined curative effect being had, side effect are little, patient should not produce resistance and medical expense is low
Property, be widely used in adult and more than 6 years old pediatric population, the bronchitis concurrent as influenza, influenza and
The prevention of pneumonia and medicine for treatment thing.Abiduoer is also respectively by Chinese Pharmacopoeia Commission of Russia and Russia
Federal health care and development division be recommended as " the treatment and prevention medication of adult and children's first, influenza B ",
And " types of drugs of the prescription medicine of free medical rescue and first aid office indispensability ", and Chinese in 2010
The Ministry of Public Health is recommended as " medicine for the treatment of Influenza A H1N1 ".And the bad reaction of Abiduoer is mainly and dislikes
The heart, diarrhoea, dizziness and serum transaminase increase.
Although existing at present several Tamiflu, a preferable medicine that effectively can prevent in the flu outbreak phase
Still have to be developed.A nearest meta-analysis to current curative effect of medication is reached a conclusion, amantadine or gold
Firm ethamine is because its significant side reaction and the rapid of virus drug resistance occur, it should do not encourage to use.And it is refreshing
Then can cause virus drug resistance, and price more expensive compared with Abiduoer through propylhomoserin enzyme inhibitor.
Content of the invention
Based on this, it is an object of the invention to provide the pharmaceutical composition of a kind of resisiting influenza virus, said composition
In Abiduoer and Oseltamivir phosphate coordinate, act on different action target spots, play Synergistic
Effect, when for treating and preventing flu that influenza virus causes, can reduce the use of Oseltamivir phosphate
Amount, reduces the generation of drug resistance and bad reaction.
For achieving the above object, the present invention takes techniques below scheme:
The pharmaceutical composition of a kind of resisiting influenza virus, the active component of described composition is by compound of formula I or its medicine
Acceptable salt and Formula II compound or its pharmaceutically acceptable salt composition on:
Wherein, compound of formula I or its pharmaceutically acceptable salt and Formula II compound or it is pharmaceutically acceptable
The weight part ratio of salt is 1-10:1-5.
Oseltamivir shown in Abiduoer shown in Formulas I and Formula II is combined by the pharmaceutical composition of the present invention,
Wherein, Abiduoer is by activation 2,5-oligoadenylate synthetase, specifically stops influenza virus cyst membrane and place
The contact of chief cell cell membrane, stick and merge, thus blocking the duplication of influenza virus, and cell can be penetrated
Core directly suppresses the synthesis of viral RNA, also by generation and the phagocytosis assisting macrophage of inducing interferon
Effect, thus strengthen cellular immune function, improve the ability that body resistance infects.Oseltamivir then acts on
Neuraminidase, the neuraminidase activity of suppression virus, stop virus discharged and invaded by infected cell
Adjacent cells, reduces duplication in host for the virus, cuts off virus diffusion chain.The two cooperates, and makees
For different action target spots, play the effect of Synergistic.
In one of them embodiment, described compound of formula I pharmaceutically acceptable salt is selected from: hydrochloride, hydrogen bromine
Hydrochlorate, tartrate, citrate, sulfate or acetate.
Wherein in an embodiment, described compound of formula I pharmaceutically acceptable salt is hydrochloride.
Wherein in an embodiment, described Formula II compound pharmaceutically acceptable salt is phosphate.
Wherein in an embodiment, the hydrochloride of described compound of formula I is phosphatic heavy with Formula II compound
Amount part ratio is for 1-8:1-3.
Wherein in an embodiment, the hydrochloride of described compound of formula I is phosphatic heavy with Formula II compound
Amount part ratio is for 4:1.
The invention also discloses the pharmaceutical composition of a kind of above-mentioned resisiting influenza virus at preparation prevention and treatment stream
Application in the medicine of sense.
When the pharmaceutical composition of above-mentioned resisiting influenza virus being used for prevent and treat the flu that influenza virus causes,
Both Abiduoer and Oseltamivir cooperate, and act on different action target spots, play Synergistic
Effect, can reduce the consumption of Oseltamivir phosphate, reduces the generation of drug resistance and bad reaction.
Wherein in an embodiment, described influenza is for by caused by influenza A virus or influenza B virus
Influenza.
Wherein in an embodiment, the formulation of described medicine be oral liquid, hard shell capsules, soft capsule, tablet,
Pill, pill or granule.
Above-mentioned formulation can be prepared according to the conventional production process of pharmaceutical field, for example, make active component and one
Or the mixing of multiple pharmaceutically acceptable auxiliary material, it is then made into required formulation.Wherein, pharmaceutically may be used
The auxiliary material accepting includes but is not limited to: diluent, disintegrant, wetting agent, adhesive, lubricant, flavoring
The common medicinal supplementary material etc. of agent, coating agent and other necessity.Diluent includes but is not limited to: starch, breast
Sugar, sucrose, microcrystalline cellulose, dextrin etc..Disintegrant includes but is not limited to: dried starch, CMS
Sodium, low-substituted hydroxypropyl cellulose, PVPP, Ac-Di-Sol etc..Profit
Humectant or adhesive include but is not limited to: water, 30%-70% ethanol, sodium carboxymethylcellulose, hydroxypropyl are fine
Dimension element etc..Lubricant includes but is not limited to: magnesium stearate, superfine silica gel powder, talcum powder etc..Flavouring includes
But it is not limited to: sucrose, fructose, aspartame, stevioside etc..Coating agent includes but is not limited to: hydroxypropyl
Cellulose, hydroxypropyl methyl cellulose, PVP, acrylic resin etc..
Compared with prior art, the method have the advantages that
The pharmaceutical composition of the resisiting influenza virus of the present invention, by Abiduoer shown in Formulas I or it is pharmaceutically acceptable
Salt and Formula II shown in Oseltamivir or its pharmaceutically acceptable salt combine, by the two phase interworking
Close, act on different action target spots, play the effect of Synergistic, be used for treating and preventing influenza disease
During the flu that poison causes, while reaching same result for the treatment of, the consumption of Oseltamivir phosphate can be reduced,
Reduce the generation of drug resistance and bad reaction.
Brief description
Fig. 1 is H274Y-PR8 virus infected mice survival rate figure in embodiment 6.
Detailed description of the invention
Describe the present invention in detail below in conjunction with the drawings and specific embodiments, but the present invention is not caused any
Limit.
Embodiment 1
A kind of granule of resisiting influenza virus, prescription is as follows:
Preparation method: pulverize arbidol HCl and Oseltamivir phosphate respectively in advance, with lactose, stevia rebaudianum
Sugar and dried starch are crossed 100 mesh sieves and are mixed, and with suitable quantity of water wetting softwood processed, cross 12 mesh sieves and pelletize, 50 DEG C
Dry, cross the 10 whole grains of mesh sieve, then sift out fine powder with 60 mesh sieves, still by suitable quantity of water wetting softwood processed, mistake 12
Mesh sieve is pelletized, 50 DEG C of drying, the whole grain of mistake 10 mesh sieve；Merge particle twice, to obtain final product.
Embodiment 2
A kind of tablet of resisiting influenza virus, prescription is as follows:
Preparation method: pulverize arbidol HCl and Oseltamivir phosphate respectively in advance, with sucrose and 35g
Dried starch is crossed 100 mesh sieves and is mixed, and with appropriate 30% ethanol wet softwood, crosses 18 mesh sieves and pelletizes, 45 DEG C
Dry, the whole grain of mistake 16 mesh sieve, then sift out fine powder with 60 mesh sieves, still with appropriate 30% ethanol wet softwood,
Cross 18 mesh sieves to pelletize, 45 DEG C of drying, the whole grain of mistake 16 mesh sieve；Merge particle twice, with 15g dried starch and
Magnesium stearate mixes, compressing tablet, to obtain final product.
Embodiment 3
A kind of tablet of resisiting influenza virus, prescription is as follows:
Preparation method: arbidol HCl and Oseltamivir phosphate are pulverized respectively in advance, with microcrystalline cellulose,
Sucrose and 10g low-substituted hydroxypropyl cellulose are crossed 100 mesh sieves and are mixed, and soak softwood processed by suitable quantity of water,
Cross 18 mesh sieves to pelletize, 55 DEG C of drying, the whole grain of mistake 16 mesh sieve, then sift out fine powder with 60 mesh sieves, still with in right amount
Water-wet softwood, excessively 18 mesh sieves are pelletized, 55 DEG C of drying, the whole grain of mistake 16 mesh sieve；Merge particle twice,
Mix with 5g low-substituted hydroxypropyl cellulose and magnesium stearate, compressing tablet, to obtain final product.
Embodiment 4
A kind of tablet (coating tablet) of resisiting influenza virus, prescription is as follows:
Preparation method: pulverize arbidol HCl and Oseltamivir phosphate respectively in advance, with starch and 25g
Sodium carboxymethyl starch is crossed 100 mesh sieves and is mixed, and with appropriate 70% ethanol wet softwood, crosses 18 mesh sieve systems
Grain, 45 DEG C of drying, the whole grain of mistake 16 mesh sieve, then sift out fine powder with 60 mesh sieves, still by appropriate 70% ethanol profit
Wet softwood processed, excessively 18 mesh sieves are pelletized, 45 DEG C of drying, the whole grain of mistake 16 mesh sieve；Merge particle twice, with 10g
Sodium carboxymethyl starch and talcum powder mix, compressing tablet.Above-mentioned tablet is put in coating pan, heats and keep
45 DEG C, 15g hydroxypropyl methyl cellulose is made into the ethanol solution that concentration is 15%, is coated, to obtain final product.
Embodiment 5
A kind of capsule of resisiting influenza virus, prescription is as follows:
Operation: pulverize arbidol HCl and Oseltamivir phosphate respectively in advance, low with lactose and 10g takes
Cross 100 mesh sieves for hydroxypropyl cellulose to mix, with appropriate 70% ethanol wet softwood, cross 18 mesh sieves
Pelletize, 45 DEG C of drying, the whole grain of mistake 16 mesh sieve, then sift out fine powder with 60 mesh sieves, still with appropriate 70% ethanol
Soaking softwood processed, 18 mesh sieves excessively are pelletized, 45 DEG C of drying, the whole grain of mistake 16 mesh sieve；Merge particle twice, with
Magnesium stearate mixes, and loads capsulae vacuus, to obtain final product.
Embodiment 6
The present embodiment compares the arbidol hydrochloride of Different Weight part ratio and Oseltamivir phosphate composition (i.e.
The pharmaceutical composition of the resisiting influenza virus of the present invention) be used alone arbidol hydrochloride and be used alone phosphoric acid
The inhibitory activity of Oseltamivir infected by influenza, tests as follows:
First, experiment material
Influenza virus: A/PR8/8/34 (H1N1) (PR8), source: Guangzhou Inst. of Respiratory Diseases.
Arbidol hydrochloride (Arb), purity is 97.5%, source: laboratory is made by oneself, through mass spectrum, infrared light
Spectrum, proton nmr spectra, carbon-13 nmr spectra carry out structural identification.
Oseltamivir phosphate (Osel), purity is 98.0%, source: laboratory is made by oneself, through mass spectrum, infrared light
Spectrum, proton nmr spectra, carbon-13 nmr spectra carry out structural identification.
Mouse: 6-8 is all, female, Balb/c, average weight 20g.
2nd, viral infectious process
With PBS by PR8 viral dilution to 200pfu/40 μ l (2MLD50), mouse after isoflurane anesthesia,
The PR8 virus having diluted with 100 μ l pipettors absorption 40 μ l instills in mouse nasal cavity through nostril, both sides.
3rd, experimental technique
According to following table dosage, compound is dissolved in the PBS of 200 μ l pH7.2 administration, according to following table packet,
Often organizing 10 mouse, wherein, Viral interference control group only infects with virus, is not administered, Normal group
Neither infecting with virus, not also being administered, remaining respectively organizes 2 gastric infusions every day, successive administration 5 days.Its
In, first administration infects front 4h for virus, is spaced 12h subsequently and is administered (i.e. every day is administered for 2 times).
In an experiment, mouse weighed every day, observe the death rate.And by the mouse quantity of survival in the 10th day
Calculate 10 days survival rates.
Table 1 dosage
Four, result of the test: result is as shown in Fig. 1 and Biao 2.
Table 2 H274Y-PR8 virus infected mice survival condition
From the above results, Normal group mouse all survives, and Viral interference control group mice is whole
Death, illustrates modeling success.
It is administered composition A group and the administration 200 μ g (Arb/Osel of 20mg (Arb/Osel weight ratio is 4/1)
Weight ratio is 4/1) composition B group, be administered 2mg arbidol HCl D group, be administered 2mg and
The H group being administered 200 μ g Oseltamivir phosphates is similar with I group, has a same resisiting influenza virus effect, and 10
Its survival rate is 100%.
But, in B group, when the weight of arbidol HCl and Oseltamivir phosphate is than for 4:1, i.e. combine
In thing, the content of arbidol HCl is 160 μ g, and the content of Oseltamivir phosphate is only 40 μ g, within 10 days, deposits
Motility rate reaches 100%, and entirely by the F group of 160 μ g arbidol HCls with entirely with 40 μ g phosphoric acid department difficult to understand when being administered
The J group of his Wei, within 10 days, survival rate is respectively 40% and 40%, from the above results, Abiduoer and Austria
The produced synergistic corrosion virus effect of two kinds of drug regimen application of Si Tawei, is far longer than both and is used alone phase
With antiviral effect during dosage.
And Arb/Osel weight ratio is for the L group of 10:1 and 1:5 and M group, even if total dosage is 200 μ g,
Owing to the proportioning between Abiduoer and Oseltamivir is different, its effect is not as Arb/Osel weight ratio is for 4:1
B group.
Therefore, Abiduoer and Oseltamivir are used in combination by the present invention, reduce the use of Oseltamivir phosphate
Amount, while reaching same result for the treatment of, both can reduce treatment cost, can reduce again it bad instead
The generation answered.
Embodiment described above only have expressed the several embodiments of the present invention, and it describes more concrete and detailed,
But therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that, for this area
Those of ordinary skill for, without departing from the inventive concept of the premise, can also make some deformation and
Improving, these broadly fall into protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be with appended
Claim is as the criterion.
Claims (9)
1. the pharmaceutical composition of a resisiting influenza virus, it is characterised in that the active component of described composition by
Compound of formula I or its pharmaceutically acceptable salt form with Formula II compound or its pharmaceutically acceptable salt:
Wherein, compound of formula I or its pharmaceutically acceptable salt and Formula II compound or it is pharmaceutically acceptable
The weight part ratio of salt is 1-10:1-5.
2. the pharmaceutical composition of resisiting influenza virus according to claim 1, it is characterised in that described formula
I pharmaceutically acceptable salt is selected from: hydrochloride, hydrobromate, tartrate, citrate, sulphur
Hydrochlorate or acetate.
3. the pharmaceutical composition of resisiting influenza virus according to claim 2, it is characterised in that described formula
I pharmaceutically acceptable salt is hydrochloride.
4. the pharmaceutical composition of the resisiting influenza virus according to any one of claim 1-3, it is characterised in that
Described Formula II compound pharmaceutically acceptable salt is phosphate.
5. the pharmaceutical composition of resisiting influenza virus according to claim 4, it is characterised in that described formula
The hydrochloride of I is 1-8:1-3 with the phosphatic weight part ratio of Formula II compound.
6. the pharmaceutical composition of resisiting influenza virus according to claim 5, it is characterised in that described formula
The hydrochloride of I is 4:1 with the phosphatic weight part ratio of Formula II compound.
7. the pharmaceutical composition of the resisiting influenza virus described in any one of claim 1-6 is in preparation prevention and treatment
Application in the medicine of influenza.
8. application according to claim 7, it is characterised in that described influenza is for by influenza A virus
Or the influenza caused by influenza B virus.
9. application according to claim 7, it is characterised in that the formulation of described medicine be oral liquid,
Hard shell capsules, soft capsule, tablet, pill, pill or granule.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641266A (en) * | 2012-04-13 | 2012-08-22 | 石家庄中硕药业集团有限公司 | Medicament composite for treating viral influenza |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641266A (en) * | 2012-04-13 | 2012-08-22 | 石家庄中硕药业集团有限公司 | Medicament composite for treating viral influenza |
Non-Patent Citations (3)
| Title |
|---|
| QIANG LIU等: "Antiviral and anti-inflammatory activity of arbidol hydrochloride in influenza A (H1N1) virus infection", 《ACTA PHARMACOLOGICA SINICA》 * |
| 刘强等: "盐酸阿比朵尔胶囊抗甲型H1N1流感病毒的体外实验研究", 《中国药学杂志》 * |
| 张兴权等: "盐酸阿比朵尔体外抑制2009 新型流感病毒A (H1N1) 的作用", 《中国医学科学院学报》 * |
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