CN108498795A - The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine - Google Patents
The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine Download PDFInfo
- Publication number
- CN108498795A CN108498795A CN201810241657.5A CN201810241657A CN108498795A CN 108498795 A CN108498795 A CN 108498795A CN 201810241657 A CN201810241657 A CN 201810241657A CN 108498795 A CN108498795 A CN 108498795A
- Authority
- CN
- China
- Prior art keywords
- plasma
- blood
- aids
- vaccine
- drug resistance
- 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.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5252—Virus inactivated (killed)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2740/00—Reverse transcribing RNA viruses
- C12N2740/00011—Details
- C12N2740/10011—Retroviridae
- C12N2740/16011—Human Immunodeficiency Virus, HIV
- C12N2740/16211—Human Immunodeficiency Virus, HIV concerning HIV gagpol
- C12N2740/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Virology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Communicable Diseases (AREA)
- Mycology (AREA)
- Immunology (AREA)
- AIDS & HIV (AREA)
- Tropical Medicine & Parasitology (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
A kind of one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine, from blood collection, blood plasma separation, blood-plasma virus killing, directly it is prepared into vaccine and the also defeated inoculation of vein, all processes are completed in enclosed disposable consumptive material, preparation process Zhong polluted dye risks can be effectively prevented from, it is ensured that the safety of vaccine preparation.Not only preparation process is simple, at low cost, and can simplify vaccine program, meets the technology requirement of large dosage of (600 800ml) blood-plasma virus killing vaccine inoculation.More importantly the viral seed culture of viruses of inactivated vaccine is patient itself, and blood plasma is also patient itself, has apparent safety, validity, feasibility.And meet the principle of Medical Ethics, and can solve the problems, such as that AIDS vaccine research and development lack animal model.It is suitable for the continual cure to the aids patient of drug resistance and treatment failure；Aids patient to not generating drug resistance is initial and conventional therapy；To the urgent blocking treatment of occupational exposure person.
Description
Technical field
The present invention relates to a kind of preparation processes of blood-plasma virus killing vaccine, the especially self blood of therapeutic type drug resistance AIDS
Starch the one-step preparation process of viral inactivation vaccine.It is suitable for AIDS preventing and controlling especially AIDS virus drug resistance and treatment failure
The treatment of patient.
Background technology
AIDS be the mankind facing newly send out health problem and public health problem special.And the whole world is all being closed
The hot spot and problem of note.It is found so far from 1981, has been known to the whole world to the calamitous harm of the mankind over 36 years.World Health Organization
Oneself causes more than 3,500 ten thousand people dead to the digital up to the present AIDS of announcement, and there be 36,700,000 HIV infection in the whole world within 2016
Person, about 1,800,000 new infections persons, has 1,000,000 people to die of AIDS for the year.Although various countries put into huge financial resources, material resources, section
Skill and social resources develop drug, and vaccine development, so far, seedling does not find the drug and means that can cure the disease completely yet,
There is no effective vaccine to come out, so, it is whole world urgency to innovate AIDS preventing and controlling strategy and prevention intervention means and method
Demand.
It is widely applied effective treatment side within the scope of our times that " cocktail ", which strengthens antiviral treatment (HAART),
Method.AIDS morbidity and mortality are made all significantly to decline, but AIDS antiviral treatment is only capable of effectively inhibiting virus
Proliferation, can not but thoroughly remove AIDS virus.The HIV/AIDS the infected for receiving treatment must take medicine on time daily, and
It cannot be discontinued throughout one's life.The toxic side effect of drug, the monopolization control of big medicine enterprise of developed country, improves the medicine valence of antiviral therapy
And medical expense and drug can and difficulty, make patient and society all feel to be difficult to bear, especially the drug resistant generation of AIDS
Criticality problem increases eager expectation of the human society to effective AIDS vaccine and new treatment, only leans on current drug,
The expectation target of the year two thousand thirty termination AIDS is all unable to reach in world wide.Therefore it is necessary to be visited from general prevention and treatment strategy
Ask new prevention and treatment technology and means.
China's AIDS antiretroviral therapy is carried out compared with Dinner, and government in 2003 proposes the policy of " four exempt from a care ", infection
Person and patient can obtain HIV antiviral first-line drug treatments, defend within 2009 and do (2009) No. 36 text notices of doctor's political affairs word and open comprehensively
Open up AIDS two wires anti-AIDS drug and treat work, so far oneself more than 8 years.
Receiving the AIDS patients for the treatment of, to show the drug resistant ratios of HIV more and more, have become influence antiviral therapy
One of the main reason for effect and treatment failure.For having generated drug resistant patient, countermeasure principle is to be replaced with sensitivity
New drug, that is to say, that if a line antiviral drugs drug resistance and treatment failure can replace two wires medicine, and in China and all
More low income developing countries, due to fund, resource and can and anti-Chinese mugwort types of drugs it is limited, if Second line Drug is resistance to again
Medicine and treatment failure, it is interchangeable without new drug to face these the infecteds, and causes the available helpless situation of no medicine.With regard to world's layer
For face, the research and development of anti-Chinese mugwort new drug also lag behind current demand and it is expected to develop AIDS vaccine safely, effectively, cheap forever
Have become global common objective.
It is known that " vaccine ", which is the mankind, fights greatest invention in virus infection history.By vaccine, the mankind eliminate
Smallpox, Eradication ridge ash is scorching, and controls the infectious diseases such as measles, and for the research and development of AIDS vaccine, respectively
State scientist is from being found that AIDS virus has been switched on comprehensive research and development, depth, range, the technology of input and fund and money
Source has been more than any vaccine in human history, and research and development in unfortunate more than 30 years suffer defeat after defeat, until the present No has effective vaccine appearance.
The research and development for making a general survey of domestic and international AIDS vaccine, fail breakthrough bottleneck and technical barrier always.Mainly existing Research idea and
Conceptual design Hai No, which are found, can overcome characteristic related with AIDS virus itself and AIDS virus pathogenesis and human body pair
The path of the immune response feature of AIDS virus and specific method.
Invention content
AIDS vaccine is divided into prevention type vaccine and therapeutic type vaccine according to purpose purposes.Preventative vaccine is suitable for not
The general health crowd of infected by HIV, it is intended that utilize the pre- preventing HIV infection of vaccine primary immune response.Therapeutic type vaccine, is suitable for
The patient and carrier infected, it is therefore an objective on the basis of oneself passes through primary immune response in the infected, carry out vaccine two again
It is secondary immune, to induce more effective specific cellular immunity and humoral immunity, achieve the purpose that Kong He Cheongju removes HIV infection.
The purpose of the present invention is to provide a kind of one-step method of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine
Preparation process.It complies with the inherent characteristic of HIV, draws domestic and international AIDS vaccine development failure or stranded lesson and experience,
Dissolve the conceptual design encountered in current AIDS vaccines research and development, work with translational medicine and the precisely innovative idea of medical treatment, " targeting "
Skill technology, Medical Ethics are various main " barrier point ", with the ripe practical technique in the country of integration and equipment, consumptive material, design
The one-step technology that excess of export simplifies is used to prepare target and has generated drug resistance for growing number of both at home and abroad, especially domestic
It is resistance to carry out the secondary active immunity therapeutic type of specificity by HIV/AIDS the infected of two wires anti-AIDS drugs drug resistance and treatment failure
Medicine AIDS self-plasma virus deactivation vaccine, for control and have dropped out treatment through HAART strengthen antiviral treatment and
And oneself is through generating HIV/AIDS the infected of drug resistance, initiative provide one kind can continue to obtain in addition to drug therapy it is effectively special
The therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine of the property immunization therapy means of services.
Specific step of preparation process is as follows：
Step 1, the separation of centrifugal plasma seed culture of viruses.
With the more filial generation HIV carried in drug resistance HIV/AIDS the infected's self blood plasma, as the specific special for treating of preparation
The seed culture of viruses of type vaccine is disposably singly adopted using DiZiPia-90 centrifugal plasmas replacing machine and matched P-1000 types
Plasma separator, anticoagulant for storage of whole blood（1）, according to procedure operation step and parameter that plasma exchange machine is set, grasped with normal sterile
Make technology, oneself is punctured by drug resistance HIV/AIDS the infected that medical institutions confirm, acquires blood plasma and separates and collects in P-
In the disposable single blood-sampling plasm separator blood plasma collecting bag of 1000 types, each 200ml of two journeys collects the blood plasma containing AIDS virus altogether
400ml completes sampled plasma as vaccine seed culture of viruses；
Step 2, closed blood-plasma virus killing.
MB- photochemistry blood-plasma virus killing technologies the most universal are applied using domestic and international safe transfusion field in recent years,
Step 1 is collected into the blood plasma 400ml containing AIDS virus, as primary product, when using standby after also defeated of blood cell
Between, the flow-stop valve of the blood plasma collecting bag is closed, the blood plasma collecting bag is removed, a concentration of 1.0-1.3 μm of ol/ of final volume is added
The dilution of the 1% injection serge blue of L after mixing well, will wait inactivating as MB photosensitizers added with the packed of MB photosensitizers
Blood plasma is lain against in the glass drawer of JY-1 type blood-plasma virus killing instrument illumination storehouse, opens blood-plasma virus killing instrument operating switch,
Under the intensity of illumination of the 35000-40000LX of setting, Continuous irradiation 30-35 minutes makes to contain HIV/AIDS in blood plasma collecting bag
The self-contained blood plasma mostly for totivirus spectrum of the infected, by MB- photochemistry blood-plasma virus killings, a step is processed into difference
Change, the ultimate product therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine of totivirus spectrum feature.
MB- photochemistry blood-plasma virus killing technologies are the appropriate technologies of safe transfusion field application and popularization, since it can
The inactivation of virus effect leaned on and safety are used by multiple developed countries and Chinese blood collecting and supplying system.The serge blue inactivation
Virus mechanism be:The G-C base-pairs and peplos of serge blue and viral nucleic acid have larger compatibility, work as serge blue
After absorbing luminous energy, it can excite and generate singlet oxygen and oxygen radical, the energy modalities of this molecular oxygen can destroy the nucleic acid of virus, especially
It is guanosint, keeps nucleic acid break and peplos damaged so as to cause the destruction of viral gene, HIV is made to be inactivated, by
HIV in blood plasma, which is inactivated, does not destroy its antigenicity, therefore is suitably applied HIV vaccine making.
Step 3, displaced type blood plasma vaccine inoculation.
After the completion of above-mentioned steps 2, closes blood-plasma virus killing instrument and take out the blood plasma collecting bag after inactivation treatment, open blood
Collecting bag flow-stop valve is starched, the also defeated program of DiZiPia-90 centrifugal plasmas replacing machine is restarted, passes through the centrifugal blood of DiZiPia-90
The also defeated channel for starching replacing machine, directly to the also defeated vaccine therapy of the drug resistant HIV/AIDS the infected, or the infusion by separately building
Pipeline is directly to the also defeated vaccine therapy of the drug resistant HIV/AIDS the infected.
Vaccine of the present invention is applied to the age more than 18 one full year of life or weight more than 30 kilograms, has regular HIV/AIDS to diagnose
It reports and meets People's Republic of China's health industry (WS293-2008)-《AIDS AIDS viral infection standard》, have just
The own report through to ART drug resistances and drug-resistant intensity of formula, and inhibition of HIV carrying capacity is 1000 copies/ml or more at present, is resistant to
By this treatment and know that the infected agreed to is personal；
It, three months or six months can be with the according to treatment restrovirus and immunological condition for drug resistance HIV/AIDS the infected
Secondary sampled plasma, blood-plasma virus killing handle-also defeated inoculation, it repeats to reinforce treatment primary.
The DiZiPia-90 centrifugal plasma replacing machines are not unique type, other centrifugal plasma replacing machines,
As long as can be general with the matching used type of the disposable single blood-sampling plasm separator of P-1000 types.
The JY-1 type blood-plasma virus killing instrument is not unique type, other modifieds such as LED light source same type machine
It is verified also can be with general.
The MB photoinactivations technology is not only available technology, other to can be used for handling single bag of blood plasma and go out
Physics living, photoinactivation technology, such as pressures cycle method, psoralea corylifolia, riboflavin, photochemical method are by verification and registration
Putting on record also can independent or combination.
The present invention uses above-mentioned technical proposal, use value to be the innovative existing AIDS vaccine technology of preparing of breakthrough
Design route and method.Prepared for therapeutic AIDS vaccine, have found the super simplified version of a safety, general favour it is global
, particularly low income developing country conceptual design；For drug resistance HIV/AIDS the infected, especially domestic two wires medicine drug resistance
Crowd, provide the possibility for continuing to be effectively treated and feasible method；The therapeutic type drug resistance AIDS prepared by the present invention
Sick self-plasma virus deactivation vaccine and the specific active immunotherapy established by it, can be not only used for drug resistance crowd, together
Sample is also adapted for not generating drug resistance HIV/AIDS the infected, breaches current aids patient treatment and depends merely on antiretroviral agent
Object, only medicine, the situation that is covered with dust solely controlled, to realize that Comprehensive HIV/AIDS Prevention increases a policing option；It can be to People living with HIV
Active treatment is carried out, AIDS infectious degree and infection sources quantity can be effectively reduced, be likewise supplied with the value of active prevention；This hair
Bright one-step method conceptual design, the more progeny virus self-contained using the infected are as vaccine seed culture of viruses, and directly inactivation is at therapeutic
Vaccine eliminates and the AIDS virus of high standard conditions is needed to detach, cultivate, purify, identify equimolecular biological processes mistake
Journey and carrier seed culture of viruses, with seedling, adjuvant, storage and transportation, do not need experimental animal model yet, can effectively simplify preparation work
Skill process greatly reduces preparation and application charges, also breaches the skill that totivirus spectrum antigen can not be provided in research and development both at home and abroad
Art problem has and applies well and promotion prospect；The therapeutic type drug resistance AIDS self-plasma virus deactivation prepared by the present invention
The specific active immunotherapy that vaccine and inoculation are established, between the 2-8 months in 2017, by certain medical university of city, in Henan Province
Certain AIDS fixed hospital of county has carried out open double-blind study clinical verification experiment, and formal report is shown, receives this vaccine therapy
The infected of six HIV/AIDS AIDS two wires medicine drug resistances and treatment failure for the treatment of has five inhibition of HIV carrying capacity detection knots
Fruit shows that inhibition of HIV carrying capacity drops to 40copies/ml by 3442---757462copies/ml, and cd4 cell obviously rises,
With good virology and immunological effect, and safety, tolerance are good.
That is, the present invention designs the one-step method for the therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine established
Preparation process, from blood collection, blood plasma separation, blood-plasma virus killing to the also defeated inoculation of vaccine vein, all processes are all to seal
Completed in the disposable consumptive material of enclosed, preparation process Zhong polluted dye risks can be effectively prevented from, it is ensured that vaccine preparation and
The safety of inoculation.Using the also defeated vaccination ways of direct vein, vaccine program can be simplified and meet large dosage (600-
800ml) the technology requirement of blood-plasma virus killing vaccine inoculation.More importantly the viral seed culture of viruses of inactivated vaccine is patient itself
, blood plasma is also patient itself, and in clinical blood transfusion field, autotransfusion is the generally acknowledged safest blood transfusion of medical field, thus
Autologous plasma virus prepared by the one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine of the present invention
Inactivated vaccine and its inoculation method, the clear superiority with safety, validity, feasibility, and meet the original of Medical Ethics
Then, it and can solve the problems, such as to lack ideal animal model when AIDS vaccine research and development.In short, it not only preparation process was simple, but also
Manufacturing cost can be reduced, moreover it is possible to which the technical bottleneck of totivirus spectrum antigen covering can not be provided by solving HIV vaccine, be provided more completely
The totivirus spectrum antigenic virus particle being inactivated, can more effectively induce the secondary specific cellular immunity of body and body fluid to exempt from
Epidemic disease response, to obtain more effective virology, immunology and clinical therapeutic efficacy.It is suitable for losing drug resistance and treatment
The continual cure of the AIDS patients lost；AIDS patients to not generating drug resistance are initial and conventional therapy；To occupational exposure
The urgent combined occlusion treatment of person.
Description of the drawings
Attached drawing is the one-step preparation process flow chart of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine.
Specific implementation mode
Detailed description of the present invention specific implementation mode below in conjunction with the accompanying drawings.
The present invention preparation process include：To blood collection-blood plasma separation-inactivation of virus of HIV/AIDS the infected, directly
It connects and is prepared into therapeutic type AIDS self-plasma virus deactivation vaccine, and carry out also defeated inoculation self to the AIDS patient.
Specific step of preparation process is as follows：
Step 1, the separation of centrifugal plasma seed culture of viruses.
With the more filial generation HIV carried in drug resistance HIV/AIDS the infected's self blood plasma, as the specific special for treating of preparation
The seed culture of viruses of type vaccine is disposably singly adopted using DiZiPia-90 centrifugal plasmas replacing machine and matched P-1000 types
Plasma separator, anticoagulant for storage of whole blood（1）, according to procedure operation step and parameter that plasma exchange machine is set, grasped with normal sterile
Make technology, oneself is punctured by drug resistance HIV/AIDS the infected that medical institutions confirm, acquires blood plasma and separates and collects in P-
In the disposable single blood-sampling plasm separator blood plasma collecting bag of 1000 types, each 200ml of two journeys collects the blood plasma containing AIDS virus altogether
400ml completes sampled plasma as vaccine seed culture of viruses；The DiZiPia-90 centrifugal plasmas replacing machine is by Sichuan Nan Geersheng
Object Science and Technology Ltd. produces, number of registration：State eats medicine and supervises tool（It is accurate）Word 2015 the 3450501st.The P-1000 types are primary
Property single blood-sampling plasm separator by Sichuan Nan Geer biotechnologies have Ken companies production, number of registration：Medical instruments are eaten by state（It is accurate）Word 2,014
No. 3451006.
Step 2, closed blood-plasma virus killing.
MB- photochemistry blood-plasma virus killing technologies the most universal are applied using domestic and international safe transfusion field in recent years,
Step 1 is collected into the blood plasma 400ml containing AIDS virus, as primary product, when using standby after also defeated of blood cell
Between, the flow-stop valve of the blood plasma collecting bag is closed, the blood plasma collecting bag is removed, a concentration of 1.0-1.3 μm of ol/ of final volume is added
The dilution of the 1% injection serge blue of L after mixing well, will go out as MB photosensitizers added with the packed of MB photosensitizers
Promoting blood circulation slurry, lies against in the glass drawer of JY-1 type blood-plasma virus killing instrument illumination storehouse, opens blood-plasma virus killing instrument operating switch,
Under the intensity of illumination of the 35000-40000LX of setting, Continuous irradiation 30-35 minutes makes to contain HIV/ in blood plasma collecting bag
The self-contained blood plasma mostly for totivirus spectrum of AIDS the infected, by MB- photochemistry blood-plasma virus killings, a step, which is processed into, to be had
The ultimate product therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine of differentiation, totivirus spectrum feature.The JY-1 types
Blood-plasma virus killing instrument is produced by Beijing sources Kang get biotechnology development corporation, Ltd., number of registration：State eats medicine and supervises tool（It is accurate）Word
2009 No. 3451019.
Step 3, displaced type blood plasma vaccine inoculation.Therapeutic type drug resistance AIDS autologous plasma virus described in step 2 is gone out
After the completion of the ultimate product of live vaccine, closes JY-1 type blood-plasma virus killing instrument and take out the blood plasma collecting bag after inactivation treatment, beat
Blood plasma collecting bag flow-stop valve is opened, the also defeated program of DiZiPia-90 centrifugal plasmas replacing machine is restarted, is centrifuged by DiZiPia-90
The also defeated channel of formula plasma exchange machine, directly to the also defeated vaccine therapy of the drug resistant HIV/AID the infected, or it is defeated by what is separately built
Liquid pipeline is directly to the also defeated vaccine therapy of the drug resistant HIV/AID the infected.
The technical standard that the present invention applies is GB18469-2001《Whole Blood ＆ Blood Components quality requirement》
It is printed and distributed with the former Ministry of Public Health《Blood station standard》、《Blood product removal/inactivation of viruses technical method and verification guide principle》、
《Middle Country blood transfusions regulations for technical operation (blood station part)》.
The one-step preparation process of the present invention, the plasma exchange machine, disposable single blood-sampling plasm separator, blood preseration
Liquid（1）And blood-plasma virus killing instrument, it is through state's medical instruments（It is accurate）Word is registered and product is advised in widely applied conjunction, is respectively had in detail
Thin operation instruction.
Used technology is all medical service item on the regular payroll to be examined through administrative department of public health, including self blood acquires
（Project number 550000004）, inactivation of virus（Project number 5500003）, plasma exchange（Project number 310905003）.
The above, preferred embodiments, And only of the invention it is non-to the present invention in any form with substantial limitation,
It is noted that for those skilled in the art, under the premise of not Off is from the method for the present invention, can also make
Several improvement and supplement, these also should be regarded as protection scope of the present invention, all those skilled in the art, in not Off from this
In the case of the concept and content of invention, when using disclosed above content, and a little variation, modification and evolution made
Equivalent variations, be the embodiment of the present invention, meanwhile, all substantial technologicals according to the present invention, made by above-described embodiment
Any equivalent variations and change, Xiu decorations develop, within the scope of still belonging to technical scheme of the present invention,
Clinical verification testing data (- 2017 years 2016)
Between -2017 years 2016, clinical verification experiment is carried out.Using open double-blind clinical verification test, third party's detection machine
Structure is:Certain attached nosocomial infection center of certain medical university.Carry out clinical verification experiment.According to clinical test final report, now pluck
3 are lifted to be described in detail.
Peasant, man 29 years old, WB confirmations , And start to take a line medicine ART within 2010, and therapeutic scheme is: AZT+3TC+NVP.
In the end of the year 2015, because virology therapeutic effect is bad, on January 16th, 2016, change therapeutic scheme was:TDF+3TC+LVP/r,
After treatment 13 months, screening CD4+ 17325, VL 173452copies/ml, AZT/TDF/EFV/NVP drug resistances belong to treatment and lose
It loses.On 2 19th, 2017, enters group progress therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine specific active immunity and control
It treats, by standard design procedures, acquisition and MB- photochemistry blood-plasma virus killings, processing blood plasma 200ml * 3, total 600ml, through blood plasma
The blood sampling also defeated inoculation in channel of replacing machine original, treats restrovirus and immunology detection shows good efficacy.On March 30th, 2017
547.49, CD4+ cells are detected, 305 copies/ml of VL detect CD4+ 646.3, VL TND on June 2nd, 2017 again,
August detects again on the 12nd within 2017, and CD4+513.11, VL is less than 40copies/ml.
Example 2, BLZH, peasant, 48 years old, WB confirmations , And in 2003 started to take a line medicine ART treatments, resist until changing within 2010 and taking two wires
Viral medicine is treated 6 years, and therapeutic scheme is:TDF+3TC+LPV/r detects the equal drug resistances of whole NRTl/NNRTi, CD4+ before entering group
136.21, cell, 14640 copies of VL/ml.Row self-plasma virus deactivation treatment on 2 19th, 2017, according to standard
Program Cai Ji And handle 600 ml of blood plasma, and after separately building the also defeated vaccine therapy of infusion channel, virology, immunological effect are good.
It is detected within 12nd in August in 2017,163.82, CD4+ cells, VL is less than 40copies/ml.
Example 3, HPQI, peasant, 53 years old, WB confirmations , And took a line medicine ART and treat nearly 10 years, and the property followed is good, immunologic mjury
Seriously, CD4+ cells spy is low, enters detection CD4+ Fine born of the same parents only 16.52 before group, VL 84386 copies/ml, 2 months 2017
19, carry out self-plasma virus deactivation vaccine specific active immunity treatment.It acquires, inactivate, going back vaccinating transfusion slurry 600ml,
Patient status improves apparent.After 24 weeks, CD4+ cells increase nearly 7 times, and VL declines apparent.August detects on the 12nd within 2017, CD4+
110.4, cell, VL（Virus load）, TND, immunology and virology all show good efficacy.Patient's readme:It treated
Journey no pain is willing to accept treatment, feel after treatment with energetically, Long meat, have no interest, clinical efficacy is clearly visible.
Claims (3)
1. a kind of one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine, which is characterized in that packet
Include following processing step:
Step 1, the separation of centrifugal plasma seed culture of viruses are made with the more filial generation HIV carried in drug resistance HIV/AIDS the infected's self blood plasma
To prepare the seed culture of viruses of specific special for treating type vaccine, matched using DiZiPia-90 centrifugal plasmas replacing machine and with it
The disposable single blood-sampling plasm separator of P-1000 types, anticoagulant for storage of whole blood（1）, according to the procedure operation step of plasma exchange machine setting
And parameter is punctured oneself by drug resistance HIV/AIDS the infected that medical institutions confirm, is acquired with normal sterile operating technology
Blood plasma simultaneously separates and collects in the disposable single blood-sampling plasm separator blood plasma collecting bag of P-1000 types, and each 200ml of two journeys is collected altogether
Contain the blood plasma 400ml of AIDS virus as vaccine seed culture of viruses, completes sampled plasma；
Step 2, closed blood-plasma virus killing apply MB- light the most universal in recent years using domestic and international safe transfusion field
Step 1 is collected the blood plasma 400ml containing AIDS virus by chemical blood-plasma virus killing technology, as primary product, profit
With stand-by time of the blood cell after also defeated, the flow-stop valve of the blood plasma collecting bag is closed, the blood plasma collecting bag is removed, final body is added
The dilution of the 1% injection serge blue of a concentration of 1.0-1.3 μm of ol/L of product, will be added with after mixing well as MB photosensitizers
The packed blood plasma to be inactivated of MB photosensitizers is lain against in the glass drawer of JY-1 type blood-plasma virus killing instrument illumination storehouse, opens blood plasma
Virus inactivation instrument operating switch, under the intensity of illumination of the 35000-40000LX of setting, Continuous irradiation 30-35 minutes makes blood plasma
Containing the blood plasma mostly for totivirus spectrum that HIV/AIDS the infected is self-contained in collecting bag, gone out by MB- photochemistry plasma virals
Living, a step, which is processed into, has the characteristics that differentiation, the ultimate product therapeutic type drug resistance AIDS autologous plasma virus of totivirus spectrum are gone out
Live vaccine；
Step 3, displaced type blood plasma vaccine inoculation after the completion of above-mentioned steps 2, close blood-plasma virus killing instrument and simultaneously take out inactivation treatment
Blood plasma collecting bag afterwards opens blood plasma collecting bag flow-stop valve, restarts the also defeated program of DiZiPia-90 centrifugal plasmas replacing machine, leads to
The also defeated channel for crossing DiZiPia-90 centrifugal plasma replacing machines is controlled directly to the also defeated inoculation of the drug resistant HIV/AIDS the infected
It treats, or the infusion pipeline by separately building is directly to the also defeated vaccine therapy of the drug resistant HIV/AIDS the infected.
2. the one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine as described in claim 1,
It is characterized in that, vaccine of the present invention is applied to, the age was more than for 18 one full year of life or weight is more than 30 kilograms, there is regular HIV/
AIDS diagnosis reports, and meet People's Republic of China's health industry (WS293-2008)-《AIDS AIDS viral infection mark
It is accurate》, have it is formal oneself through the report to ART drug resistances and drug-resistant intensity, and at present inhibition of HIV carrying capacity be 1000 copies/ml with
On, it is resistant to this treatment and knows that the infected agreed to is personal；For drug resistance HIV/AIDS the infected, according to treatment restrovirus
And immunological condition, three months or six months can second of sampled plasma, blood-plasma virus killing handle-also defeated inoculation, repeat
It is primary to reinforce treatment.
3. the one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine as described in claim 1,
It is characterized in that, the DiZiPia-90 centrifugal plasma replacing machines are not unique type, other centrifugal plasma displacements
Machine, as long as can be general with the matching used type of the disposable single blood-sampling plasm separator of P-1000 types;The JY-1 types
Blood-plasma virus killing instrument is not unique type, and other modifieds such as LED light source same type machine is verified also can be with general;Institute
It is not only available technology to state MB photoinactivation technologies, other physics that can be used for handling single bag of Plasma Inactivation,
Photoinactivation technology, such as pressures cycle method, psoralea corylifolia, riboflavin, photochemical method are put on record by verification and registration also may be used
Individually or it is combined.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810241657.5A CN108498795A (en) | 2018-03-22 | 2018-03-22 | The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810241657.5A CN108498795A (en) | 2018-03-22 | 2018-03-22 | The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108498795A true CN108498795A (en) | 2018-09-07 |
Family
ID=63378116
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810241657.5A Pending CN108498795A (en) | 2018-03-22 | 2018-03-22 | The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108498795A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108578693A (en) * | 2018-04-23 | 2018-09-28 | 北京铂鑫天然生物技术有限公司 | Photochemical method for preparation for the autologous plasma inactivated vaccine for treating AIDS |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2803274Y (en) * | 2005-06-27 | 2006-08-09 | 李金城 | Disposable machine extrating and blood plasma virus deactivating hemostix |
| CN102389595A (en) * | 2011-07-14 | 2012-03-28 | 郑州飞龙医疗设备有限公司 | Non-drug treatment system for inactivation of HIV (human immunodeficiency virus) and other viruses |
| CN102397538A (en) * | 2011-10-27 | 2012-04-04 | 上海市血液中心 | Application of viral vaccine prepared by using methylene blue photochemical virus inactivating method |
-
2018
- 2018-03-22 CN CN201810241657.5A patent/CN108498795A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2803274Y (en) * | 2005-06-27 | 2006-08-09 | 李金城 | Disposable machine extrating and blood plasma virus deactivating hemostix |
| CN102389595A (en) * | 2011-07-14 | 2012-03-28 | 郑州飞龙医疗设备有限公司 | Non-drug treatment system for inactivation of HIV (human immunodeficiency virus) and other viruses |
| CN102397538A (en) * | 2011-10-27 | 2012-04-04 | 上海市血液中心 | Application of viral vaccine prepared by using methylene blue photochemical virus inactivating method |
Non-Patent Citations (2)
| Title |
|---|
| 张耀等: "亚甲基蓝光化学法对全血中任免疫缺陷I型病毒的灭活研究", 《第三军医大学学报》 * |
| 李瑞玲等: "非药物HIV-CD4+融合阻断疗法的临床免疫效果观察", 《中华预防医学杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108578693A (en) * | 2018-04-23 | 2018-09-28 | 北京铂鑫天然生物技术有限公司 | Photochemical method for preparation for the autologous plasma inactivated vaccine for treating AIDS |
| CN108578693B (en) * | 2018-04-23 | 2019-03-12 | 北京铂鑫天然生物技术有限公司 | For treating the photochemical method for preparation of the autologous plasma inactivated vaccine of AIDS |
| WO2019205921A1 (en) * | 2018-04-23 | 2019-10-31 | 北京铂鑫天然生物技术有限公司 | Photochemical preparation method for autologous plasma inactivated vaccine for treating aids |
| US11197924B2 (en) | 2018-04-23 | 2021-12-14 | Beijing Boxin Nature Biotech Ltd. | Photochemical preparation method for autologous plasma inactivated vaccine for treating AIDS |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Kumar et al. | Analysis of reasons for discarding blood and blood components in a blood bank of tertiary care hospital in central India: A prospective study | |
| Piyush et al. | Convalescent plasma therapy: a promising coronavirus disease 2019 treatment strategy | |
| Rentas et al. | Inactivation of Orientia tsutsugamushi in red blood cells, plasma, and platelets with riboflavin and light, as demonstrated in an animal model | |
| Gugerell et al. | Viral safety of APOSECTM: a novel peripheral blood mononuclear cell derived-biological for regenerative medicine | |
| CN108498795A (en) | The one-step preparation process of therapeutic type drug resistance AIDS self-plasma virus deactivation vaccine | |
| RU2207876C1 (en) | Method for complex- individualized impact upon body at slow viral infection and method for preparing laboratory animal for testing the method of such impact | |
| US20030108543A1 (en) | Photophoretic auto immune stimulation | |
| US11197924B2 (en) | Photochemical preparation method for autologous plasma inactivated vaccine for treating AIDS | |
| Wagner et al. | Photoinactivation of Leishmania donovani infantum in red cell suspensions by a flexible thiopyrylium sensitizer | |
| Fatima et al. | Seroprevalence of Transfusion Transmissible Infections among Blood Donors in Nizamabad District of Telangana State—A Six Years Study | |
| Tegnell et al. | Smallpox—eradicated, but a growing terror threat | |
| CN112107683A (en) | Photochemical inactivation method of coronavirus and vaccine | |
| Swetha et al. | A review on infectious diseases and their importance in developing biological databases | |
| Karim et al. | Seroprevalence of Hepatitis B, Hepatitis C and Human Immunodeficiency Virus Among Multitransfused Thalassaemic Children in Dhaka, Bangladesh | |
| Erhabor et al. | The risk of transfusion–transmissible hepatitis c infection among blood donors in sokoto, north western nigeria | |
| Joshi et al. | The Ebola menace: Epidemic, evidence and expectations | |
| RU2359269C2 (en) | Method for making tick-borne encephalitis diagnosticum | |
| Rubi et al. | CLINICAL EFFICACY OF CONVALESCENT PLASMA TREARMENT IN COVID-19 PATIENTS | |
| Momoh et al. | MODELING THE IMPACT OF DRUG RESISTANCE AND SENSITIVITY ON TRANSMISSION DYNAMICS OF TUBERCULOSIS INCORPORATING CASE DETECTION | |
| Maindad et al. | HIV Prevalence among Voluntary Blood Donors in Mumbai | |
| Tehseen | Transfusion Medicine Practice in a Pandemic; Use of Convalescent Plasma in the Management of COVID-19 | |
| Santra et al. | A Mini Review on the Corona Various-A Universal Long Standing Problem: T-Cell Therapy Might Show Some Light in New Vaccine Development | |
| Gupta et al. | Risk and safe practice pattern for ophthalmologists in seropositives | |
| Do | A 24-Year-Old Woman from Uganda With Fever and Shock | |
| Gdanski | COVID-19 Antibodies Post Infection: An Analysis of the benefits and the Effect of Antibodies during the COVID-19 pandemic |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |