CN104208670B - A kind of pharmaceutical composition for treating hepatitis B - Google Patents

A kind of pharmaceutical composition for treating hepatitis B Download PDF

Info

Publication number
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
Authority
CN
China
Prior art keywords
haptens
hepatitis
vaccine
stage
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201410453195.5A
Other languages
Chinese (zh)
Other versions
CN104208670A (en
Inventor
韩自勤
何振强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CN201410453195.5A priority Critical patent/CN104208670B/en
Publication of CN104208670A publication Critical patent/CN104208670A/en
Application granted granted Critical
Publication of CN104208670B publication Critical patent/CN104208670B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

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

A kind of pharmaceutical composition for treating hepatitis B
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.
CN201410453195.5A 2014-09-09 2014-09-09 A kind of pharmaceutical composition for treating hepatitis B Active CN104208670B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201410453195.5A CN104208670B (en) 2014-09-09 2014-09-09 A kind of pharmaceutical composition for treating hepatitis B

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201410453195.5A CN104208670B (en) 2014-09-09 2014-09-09 A kind of pharmaceutical composition for treating hepatitis B

Publications (2)

Publication Number Publication Date
CN104208670A CN104208670A (en) 2014-12-17
CN104208670B true CN104208670B (en) 2017-07-28

Family

ID=52090842

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201410453195.5A Active CN104208670B (en) 2014-09-09 2014-09-09 A kind of pharmaceutical composition for treating hepatitis B

Country Status (1)

Country Link
CN (1) CN104208670B (en)

Citations (2)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
CN104208670A (en) 2014-12-17

Similar Documents

Publication Publication Date Title
Passalacqua et al. Allergen immunotherapy: history and future developments
NZ606765A (en) Combination pharmaceutical composition and methods of treating functional diseases or conditions of gastrointestinal tract
CN104208670B (en) A kind of pharmaceutical composition for treating hepatitis B
JP2009538916A5 (en)
Centers for Disease Control and Prevention (CDC Updated recommendations for use of Haemophilus influenzae type b (Hib) vaccine: reinstatement of the booster dose at ages 12-15 months
CN104000958A (en) External application ointment for treating panaritium and preparing method of external application ointment
CN102988977B (en) Multivalent vaccines
Quirke From alkaloids to gene therapy: a brief history of drug discovery in the 20th
CN101152552A (en) Traditional Chinese medicine for treating pregnancy pernicious vomiting from emptiness of spleen and stomach
Seshadri et al. Myositis in a child with murine typhus
CN101890162B (en) New use of PEG-PCL-PEG (polyethylene glycol-polycaprolactone-polyethylene glycol) and antigen-assembled mixture
CN1326567C (en) Egg yolk antibody composition for preventing and treating atypical pneumonia and its preparation method
Robinson et al. COVID-19: Vaccine and antimicrobial resistance what are the global implications?
CN101152249A (en) Traditional Chinese medicine for treating filariasis spargosis
Yim et al. Efficacy of Sorafenib Monotherapy versus Transarterial Chemoembolization (TACE)-Sorafenib Sequential Thera py in Patients with Extrahepatic Metastasis-An Interim Analysis of Randomized Controlled Trial
CN102008714B (en) Ointment for promoting rapid healing of scabby chilblain
CN108018168A (en) One kind takes care of health white wine and preparation method thereof
Lu et al. Transcontinental translational medicine collaboration: a successful Sino-Cuban Joint B-to-B program
Zhang et al. Ginseng Polysaccharide Enhances the Humoral and Cellular Immune Responses to SARS-CoV-2 RBD Protein Subunit Vaccines
Yousong An Overview of New Drugs Approved in the US, EU and Japan in March 2018
CN1265820C (en) Compound solanum lyratum injection agent for animal
Sanicas et al. COVID-19 Vaccines Authorized by Stringent Regulatory Authorities and Vaccine Candidates Expecting Approval in 2021
Lee et al. A Multicenter, Open-Label, Controlled, Randomized Study Comparing 4 g Once Daily with 2 g Two Times Daily Prolonged-Release Mesalamine for Mild to Moderate active Ulcerative Colitis.
TW202426493A (en) METHODS OF TREATMENT WITH IFNß ANTIBODIES
UA142500U (en) METHOD OF TREATMENT OF PATIENTS WITH CHRONIC TONSILITIS WITH MANIFESTATIONS OF ALLERGY

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant