CN104208670B - A kind of pharmaceutical composition for treating hepatitis B - Google Patents
A kind of pharmaceutical composition for treating hepatitis B Download PDFInfo
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- CN104208670B CN104208670B CN201410453195.5A CN201410453195A CN104208670B CN 104208670 B CN104208670 B CN 104208670B CN 201410453195 A CN201410453195 A CN 201410453195A CN 104208670 B CN104208670 B CN 104208670B
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
A kind of pharmaceutical composition for treating hepatitis B, including, first stage medication, second stage medication and phase III medication ... N stage medications, wherein, first stage medication is:Prevention hepatitis B vaccine, haptens A and auxiliary agent;Second stage medication is prevention hepatitis B vaccine, haptens B and auxiliary agent;Phase III medication is prevention hepatitis B vaccine, haptens C and auxiliary agent, ... N stage medications are anti-use hepatitis B vaccine, haptens N and auxiliary agent, make the prevention hepatitis B vaccine in each stage from stimulating body persistently to produce antibody after corresponding different hapten conjugations.The present invention is connected using different haptens with prevention with hepatitis B vaccine, enable the antibody that produces in patient's short time long lasting for, so as to reach the purpose for thoroughly curing hepatitis B, the pharmaceutical composition convenient sources of the present invention, therapeutic effect is notable, and therapeutic process is easily operated, it is that can thoroughly cure the initiative medicine of hepatitis B, there is landmark contribution to medical field treating hepatitis B field.
Description
Technical field
The present invention relates to treating hepatitis B drug field, more particularly to a kind of pharmaceutical composition for treating hepatitis B.
Background technology
Virus B hepatitis is a kind of worldwide disease as caused by hepatitis type B virus (HBV), developing country's hair
Sick rate is high, and according to statistics, whole world Chronic asymptomatic carrier (HBsAg carrier) is more than 2.8 hundred million, and China accounts for 9300
Ten thousand, it is most asymptomatic, wherein 1/3 there is the clinical manifestation of hepatic lesion.The characteristics of there are hepatitis B patient 30,000,000, hepatitis B in current China
Relatively delay for onset, it is more typical with Subclinical and chronic type.The easy chronicity of non-icteric type HBsAg lasting masculin persons, this disease is main
By blood, mother and baby and property contact are propagated.The application of hepatitis B vaccine is prevention and the essential measure for controlling hepatitis B.
The research method of the current therapeutic type hepatitis B vaccine of China, Fudan University and Beijing Biological Product Inst.'s R & D Cooperation
Hepatitis B antigen-antibody complex vaccine " second gram " be one of them.The vaccine is to exempt from HBsAg with high-titer hepatitis B
Epidemic disease globulin is configured to antigen-antibody complex by a certain percentage, for the treatment of chronic hepatitis B, belongs to protein vaccine.Should
Project is heard beautiful plum academician by Fudan University and headed the list of signers, and system the most is studied at home and is goed deep into, nearly 20 years so far, positive at present to carry out
III clinical trial phases.
The therapeutic hepatitis B vaccine developed jointly by Third Military Medical University and Chongqing beer company is set based on molecular epitope
Principle is counted, by imitating the polypeptide biological products that some peptide chains of hepatitis B antigen are synthesized, antibody is produced with inducing cell, belongs to polypeptide
Vaccine.The project is headed the list of signers by Third Military Medical University professor Wu Yuzhang, and II clinical trial phases are also carried out at present.
Guangzhou air hospital Zhang Yijun teaches the therapeutic hepatitis B vaccine and Chen Guang with the safe biological joint study in Shenzhen
The therapeutic DNA vaccine of the Collaboration on Scientific Research group research of oolemma neck, which gets the Green Light, carries out II phase clinical researches.
But in existing technology, it is not a kind of to be produced with the medicine of permanently effective healing hepatitis B, also just because of this,
The people that the current whole world there are about 10 is just perplexed by hepatitis B, and long-term prescription can not fully recover, the body to patient
Health, economic and family all brings the loss that can not be estimated.
The content of the invention
To solve the problem of above-mentioned prior art is present, it is an object of the invention to provide a kind of medicine group for treating hepatitis B
Compound, pharmaceutical composition convenient sources of the invention, therapeutic effect is notable, and therapeutic process is easily operated, and is treating hepatitis B neck
Domain is epoch-making to create.With huge medical value and economic value.
To reach above-mentioned purpose, the technical scheme is that:
A kind of pharmaceutical composition for treating hepatitis B, the pharmaceutical composition includes, first stage medication, second stage medication and
Phase III medication ... N stage medications, wherein, first stage medication is:Prevention hepatitis B vaccine, haptens A and auxiliary agent;
Second stage medication is prevention hepatitis B vaccine, haptens B and auxiliary agent;Phase III medication is prevention hepatitis B vaccine, partly resisted
Former C and auxiliary agent ... N stage medications are anti-use hepatitis B vaccine, haptens N and auxiliary agent, make the prevention hepatitis B epidemic disease in each stage
Seedling after corresponding different hapten conjugations from stimulating body persistently to produce antibody.
Further, the hepatitis B vaccine is Hepatitis B Vaccine Prepared From Yeast Recombinanted or recombinant C HO hepatitis B vaccines.
Further, in the pharmaceutical composition, haptens A, haptens B, haptens C... haptens N contain in molecule
Have carboxyl or can carboxylation haptens, containing amino or reducible nitro haptens, haptens containing sulfydryl, hydroxyl it is half anti-
Former, ketone group containing or ketone group haptens, other haptens such as penicillin, biotin, digoxin, fluorescein.
Further, in the pharmaceutical composition, haptens A, haptens B, it is many that haptens C... haptens N is selected from BCG vaccine
Ribosomal ribonucleic acid, prodigiosin, typhoid bacillus lipopolysaccharides etc..
Further, each haptens in the medication stage, used is differed, and medication stage N is not less than 17 times.
Further, the auxiliary agent is poly IC.
Further, the prevention is 30mg with the consumption of hepatitis B vaccine, and haptens N consumption is respectively:Typhoid bacillus
Lipopolysaccharides 1ml, 50 units/2ml prodigiosin 2ml, BCG vaccine polysaccharide nucleic acid 0.5mg.
Further, haptens N and the 2ml poly IC by 30mg preventions hepatitis B vaccine and the consumption is in 10ml
Be sufficiently mixed in container, after preserving 24h under 4 DEG C of constant temperature, afterwards by first stage medication, second stage medication ... N ranks
Section medication, carries out intramuscular injection, each stage injection interval is not less than 28 days successively.
Further, it is necessary to reduce internal hepatitis B number using medicine before using pharmaceutical composition of the present invention
Amount.
Further, used medicine is Aldoforwe ester, and Time of Administration is one month.
The present invention drug mechanism be:Innovative utilization haptens of the invention is theoretical, for being produced to hepatitis B vaccine
The patient of raw tolerance, by hepatitis B vaccine as a haptens, makes it be combined with another conventional haptens, to be produced in patient's body
Raw reactionogenicity, so as to produce hbv antibody, but during actual therapeutic, finds just with same haptens, resists
Body is difficult to long lasting for because after body produces antibody to the haptens, the antibody of the haptens is directed in later stage body
The haptens can be neutralized, so that being returned to the shape of the only remaining hepatitis B vaccine that can not produce reactionogenicity in patient's body again
State, because patient is resistant to no longer persistently produce antibody to hepatitis B vaccine, therefore, the present invention program innovative use stage
Property, different haptens and hepatitis B vaccine drug combination, so as to stimulate body persistently to produce hbv antibody, fundamentally reach healing
The purpose of hepatitis B.
Relative to prior art, beneficial effects of the present invention are:
The present invention is theoretical according to haptens, is connected using different haptens with prevention with hepatitis B vaccine, makes patient in short-term
The interior antibody produced can be long lasting for so as to reach the purpose for thoroughly curing hepatitis B, pharmaceutical composition of the invention is originated
Convenient, therapeutic effect is notable, and therapeutic process is easily operated, and is the epoch-making creation in treating hepatitis B field.With huge doctor
Treat value and economic value.It is that can thoroughly cure the initiative medicine of hepatitis B, to medical field treating hepatitis B to patient's non-hazardous
Field has landmark contribution.According to clinical verification, this method therapeutic effect significantly, has no side effect.
Embodiment
The present invention program is described in further detail with reference to specific embodiment:
A kind of pharmaceutical composition for treating hepatitis B, the pharmaceutical composition includes, first stage medication, second stage medication and
Phase III medication ... N stage medications, wherein, first stage medication is:Prevention hepatitis B vaccine, haptens A and auxiliary agent;
Second stage medication is prevention hepatitis B vaccine, haptens B and auxiliary agent;Phase III medication is prevention hepatitis B vaccine, partly resisted
Former C and auxiliary agent ... N stage medications are anti-use hepatitis B vaccine, haptens N and auxiliary agent, make the prevention hepatitis B epidemic disease in each stage
Seedling after corresponding different hapten conjugations from stimulating body persistently to produce antibody.
Further, the hepatitis B vaccine is Hepatitis B Vaccine Prepared From Yeast Recombinanted or recombinant C HO hepatitis B vaccines.
Further, in the pharmaceutical composition, haptens A, haptens B, haptens C... haptens N contain in molecule
Have carboxyl or can carboxylation haptens, containing amino or reducible nitro haptens, haptens containing sulfydryl, hydroxyl it is half anti-
Former, ketone group containing or ketone group haptens, other haptens such as penicillin, biotin, digoxin, fluorescein.
Further, in the pharmaceutical composition, haptens A, haptens B, it is many that haptens C... haptens N is selected from BCG vaccine
Ribosomal ribonucleic acid, prodigiosin, typhoid bacillus lipopolysaccharides etc..
Further, each haptens in the medication stage, used is differed, and medication stage N is not less than 17 times.
Further, the auxiliary agent is poly IC.
Further, the prevention is 30mg with the consumption of hepatitis B vaccine, and haptens N consumption is respectively:Typhoid bacillus
Lipopolysaccharides 1ml, 50 units/2ml prodigiosin 2ml, BCG vaccine polysaccharide nucleic acid 0.5mg.
Further, haptens N and the 2ml poly IC by 30mg preventions hepatitis B vaccine and the consumption is in 10ml
Be sufficiently mixed in container, after preserving 24h under 4 DEG C of constant temperature, afterwards by first stage medication, second stage medication ... N ranks
Section medication, carries out intramuscular injection, each stage injection interval is not less than 28 days successively.
Further, it is necessary to reduce internal hepatitis B number using medicine before using pharmaceutical composition of the present invention
Amount.
Further, used medicine is Aldoforwe ester, and Time of Administration is one month.
The present invention drug mechanism be:Innovative utilization haptens of the invention is theoretical, for being produced to hepatitis B vaccine
The patient of raw tolerance, by hepatitis B vaccine as a haptens, makes it be combined with another conventional haptens, to be produced in patient's body
Raw reactionogenicity, so as to produce hbv antibody, but during actual therapeutic, finds just with same haptens, resists
Body is difficult to long lasting for because after body produces antibody to the haptens, the antibody of the haptens is directed in later stage body
The haptens can be neutralized, so that being returned to the shape of the only remaining hepatitis B vaccine that can not produce reactionogenicity in patient's body again
State, because patient is resistant to no longer persistently produce antibody to hepatitis B vaccine, therefore, the present invention program innovative use stage
Property, different haptens and hepatitis B vaccine drug combination, so as to stimulate body persistently to produce hbv antibody, fundamentally reach healing
The purpose of hepatitis B.
Test example 1:
Patient Lee X, man, 36 years old, hepatitis B great three positive 3 years, with nausea, low fever, liver ascites is invalid through multi-treatment, profit
With the inventive method, Aldoforwe ester is taken one month, it is the first stage, 30mg preventions hepatitis B vaccine and typhoid bacillus fat is more
Sugared 1ml and 2ml poly ICs are sufficiently mixed in 10ml containers, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection is produced in vivo
Hbv antibody, after 28 days, row second stage medication, by 30mg preventions hepatitis B vaccine and 50 units/2ml prodigiosin 2ml and
2ml poly ICs are sufficiently mixed in 10ml containers, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection, after 28 days, the rank of row the 3rd
Section medication, 30mg preventions hepatitis B vaccine and BCG vaccine polysaccharide nucleic acid 0.5mg and 2ml poly IC are fully mixed in 10ml containers
Close, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection ... it is anti-using prevention hepatitis B vaccine and not of the same race half through 17 stages
Original coupling makes body continue to produce antibody symptom disappearance after 16 months, and anti-HbsAg is the positive, and five displays of check have been cured, arrived
06 months mesh the previous years did not recurred.
Test example 2
Guo patient XX, man, 43 years old, hepatitis B "small three positive", with nausea, low fever is invalid through multi-treatment, utilizes present invention side
Method, takes Aldoforwe ester one month, the first stage, by 30mg preventions hepatitis B vaccine and typhoid bacillus lipopolysaccharides 1ml and 2ml
Poly IC is sufficiently mixed in 10ml containers, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection produces hbv antibody in vivo,
After 28 days, by 30mg preventions hepatitis B vaccine and 50 units/2ml prodigiosin 2ml and 2ml poly IC in 10ml containers fully
Mixing, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection, through 17 stages using prevention hepatitis B vaccine and not homologous hapten
Coupling makes body continue to produce antibody symptom disappearance after 16 months, and anti-HbsAg is the positive, and five displays of check have been cured, to mesh
The first half did not recurred.
Test example 3:
Patient Zhao XX, female, 51 years old, hepatitis B great three positive 4 years, with nausea, low fever, hepatic sclerosis is tormented by slight illness for a long time,
Using the inventive method, Aldoforwe ester is taken one month, the first stage, by 30mg preventions hepatitis B vaccine and typhoid bacillus fat
Polysaccharide 1ml and 2ml poly IC are sufficiently mixed in 10ml containers, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection, in vivo production
Raw hbv antibody, after 28 days, row second stage medication, by 30mg preventions hepatitis B vaccine and 50 units/2ml prodigiosin 2ml
And 2ml poly ICs are sufficiently mixed in 10ml containers, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection, after 28 days, row the 3rd
Stage medication, by 30mg preventions hepatitis B vaccine and BCG vaccine polysaccharide nucleic acid 0.5mg and 2ml poly IC in 10ml containers fully
Mixing, after preserving 24h under 4 DEG C of constant temperature, intramuscular injection, through 20 stages using prevention hepatitis B vaccine and not homologous hapten
Coupling makes body continue to produce antibody symptom disappearance after 18 months, and anti-HbsAg is the positive, and five displays of check have been cured, to mesh
The first two years did not recurred for 03 months.
The foregoing is only a specific embodiment of the invention, but protection scope of the present invention is not limited thereto, any
The change or replacement expected without creative work, should all be included within the scope of the present invention.Therefore, it is of the invention
Protection domain should be determined by the scope of protection defined in the claims.
Claims (8)
1. a kind of pharmaceutical composition for treating hepatitis B, it is characterised in that the pharmaceutical composition includes, first stage medication, second
Stage medication and phase III medication are to N stage medications, and medication stage N is not less than 17 times, wherein, first stage medication is:
Prevention hepatitis B vaccine, haptens A and auxiliary agent;Second stage medication is prevention hepatitis B vaccine, haptens B and auxiliary agent;3rd
Stage medication is prevention hepatitis B vaccine, haptens C and auxiliary agent, is prevention hepatitis B vaccine, haptens N to N stage medications
And auxiliary agent, each haptens in the medication stage, used differs, and makes prevention hepatitis B vaccine and the stage in each stage
Hapten conjugation after so as to stimulating body persistently to produce antibody.
2. pharmaceutical composition according to claim 1, it is characterised in that the hepatitis B vaccine is Hepatitis B Vaccine Prepared From Yeast Recombinanted
Or recombinant C HO hepatitis B vaccines.
3. pharmaceutical composition according to claim 2, it is characterised in that in the pharmaceutical composition, haptens A, haptens
B, haptens C to haptens N in molecule containing carboxyl or can carboxylation haptens, anti-containing amino or reducible nitro half
Original, the haptens of the haptens of haptens containing sulfydryl, hydroxyl, ketone group containing.
4. pharmaceutical composition according to claim 3, it is characterised in that in the pharmaceutical composition, haptens A, haptens
B, haptens C are to haptens N selected from BCG vaccine polysaccharide nucleic acid, prodigiosin, typhoid bacillus lipopolysaccharides.
5. pharmaceutical composition according to claim 2, it is characterised in that the auxiliary agent is poly IC.
6. pharmaceutical composition according to claim 4, it is characterised in that the prevention is with the consumption of hepatitis B vaccine
30mg, haptens N consumption is respectively:Typhoid bacillus lipopolysaccharides 1ml, 50 units/2ml prodigiosin 2ml, BCG vaccine polysaccharide core
Sour 0.5mg.
7. the pharmaceutical composition according to any claim in claim 1-6, it is characterised in that using the medicine
, it is necessary to reduce internal hepatitis B quantity using medicine before composition.
8. pharmaceutical composition according to claim 7, it is characterised in that used medicine is Aldoforwe ester, is taken
Time is one month.
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CN201410453195.5A CN104208670B (en) | 2014-09-09 | 2014-09-09 | A kind of pharmaceutical composition for treating hepatitis B |
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CN201410453195.5A CN104208670B (en) | 2014-09-09 | 2014-09-09 | A kind of pharmaceutical composition for treating hepatitis B |
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CN104208670B true CN104208670B (en) | 2017-07-28 |
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1300222A (en) * | 1998-02-12 | 2001-06-20 | 免疫合成物公司 | Strategically modified hepatitis b core proteins and their derivatives |
CN101125202A (en) * | 2006-08-15 | 2008-02-20 | 马胜录 | Protein vaccine used for processing immune tolerant treatment to hepatitis B |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1814285A (en) * | 2005-11-22 | 2006-08-09 | 广州市恺泰生物科技有限公司 | Vaccine composition for treating B-type hepatitis and preparing method |
CN100389823C (en) * | 2005-12-29 | 2008-05-28 | 中国人民解放军第三军医大学第三附属医院 | Preparation method of hepatitis vaccine and its use |
KR100900837B1 (en) * | 2007-12-07 | 2009-06-04 | (주)두비엘 | A powerful vaccine composition comprising lipopeptide and poly(i:c) as an adjuvant |
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- 2014-09-09 CN CN201410453195.5A patent/CN104208670B/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1300222A (en) * | 1998-02-12 | 2001-06-20 | 免疫合成物公司 | Strategically modified hepatitis b core proteins and their derivatives |
CN101125202A (en) * | 2006-08-15 | 2008-02-20 | 马胜录 | Protein vaccine used for processing immune tolerant treatment to hepatitis B |
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