CN107812190A - A kind of light power kit and preparation method for rectal neoplasm treatment - Google Patents
A kind of light power kit and preparation method for rectal neoplasm treatment Download PDFInfo
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- CN107812190A CN107812190A CN201711106205.8A CN201711106205A CN107812190A CN 107812190 A CN107812190 A CN 107812190A CN 201711106205 A CN201711106205 A CN 201711106205A CN 107812190 A CN107812190 A CN 107812190A
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- suppository
- ala
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
- A61K41/0057—Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
- A61K41/0061—5-aminolevulinic acid-based PDT: 5-ALA-PDT involving porphyrins or precursors of protoporphyrins generated in vivo from 5-ALA
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0613—Apparatus adapted for a specific treatment
- A61N5/062—Photodynamic therapy, i.e. excitation of an agent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0601—Apparatus for use inside the body
- A61N5/0603—Apparatus for use inside the body for treatment of body cavities
- A61N2005/0608—Rectum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/065—Light sources therefor
- A61N2005/0651—Diodes
- A61N2005/0652—Arrays of diodes
Abstract
The invention discloses a kind of light power kit and preparation method for rectal neoplasm treatment.The kit of the present invention includes:5 aminolevulinic acids (5 Aminolevulinic acid, ALA) suppository, suppository type LED light source.Wherein 5 aminolevulinic acid suppositorys are in bullet-shaped, and the content of 5 aminolevulinic acids is 20%;Suppository type LED light source is that the profile of transparent epoxy resin encapsulation LED unit, lithium battery, normally closed type magnetic switch and constant-current drive circuit composition is the midget plant of bullet-shaped suppository and supporting magnet ring.Noninvasive chronic optical dynamic therapy can be carried out to rectal neoplasm patient using the PDT suppositorys kit, do not limit the position of patient over the course for the treatment of, while reduce medical expense.
Description
Technical field
The present invention relates to a kind of kit and preparation method of photic chemical effect, especially one kind by rectally and to shine
The photochemical effect kit and preparation method that the carcinoma of the rectum is treated using photodynamic effect of light.
Background technology
Photodynamic therapy (Photodynamic Therapy, PDT) be later 1970s come out and near several
The one kind developed rapidly over year is directed to the selective therapy new technology of (blood vessel) proliferative lesion tissue, and the therapy is complete
Studied different from another after operation, radiotherapy, chemotherapy and immunization therapy, the brand-new therapy in fast development, light moves
Power therapy is a kind of new disease treatment means based on the interaction of light, sensitising agent and oxygen, it has also become world's tumour
One of most active research field in preventing and treating science.
Increasing hospital starts using PDT as conventional therapy means, as clinical research deepens continuously and related skill
Art reaches its maturity, and application is also increasingly extensive, increasingly shows vigorous vigor and vitality.Because malignant tumour has wellability
The characteristics of fast-growth, easily transfer, recurrence.Any treatment means are depended merely on, want the life that tumor eradication takes into account patient again
Quality is deposited, is all difficult to.Photodynamic therapy will be examined due to the advantages of its is unique and good compatibility as tumour
A new fresh combatants in disconnected and treatment, play a significant role in the complex treatment of tumour.
Traditional photodynamic therapy (acute photodynamic therapy, aPDT) passes through relative high-energy (50-
500mW) laser short time (within 30min) irradiation tumour excites the sensitising agent in it, and tumour is killed for major way with necrosis.
But because sensitising agent and tumour are non-specific binding, the normal structure of surrounding can also be damaged by certain PDT.Chronic light
Dynamic therapy (metronamic photodynamic therapy, mPDT), passes through the lasting small of sensitising agent 5-ALA
Dosage is administered and long-time (a few houres were to several days) low energy (1-10mW) irradiated lesion position, makes normal structure from PDT's
Influence, while using apoptosis as major way killing tumor cell, reach treatment tumour and the purpose to reduce inflammation.Although mPDT
It is with the obvious advantage in narrow fixed lacuna oncotherapy, but it is not corresponding as the sensitising agent and light source of therapy mechanism using mPDT
And give birth to.This is relevant with the long-irradiated operation difficulties of slow release formulation and light source of sensitising agent.Solving the two problems is
MPDT is in the clinical emphasis for playing useful effect.
Laser is the conventional light source of optical dynamic therapy.It is tens of thousands of at least but laser is not only expensive, at most tens
Ten thousand, and volume is larger, it is not easily shifted.Semiconductor laser even developed in recent years can only also be accomplished to control by bed
Treat.With LED development, it all plays the effect for the property changed in the various aspects of human lives.In the neck of photodynamic therapy
Domain, research have confirmed that under identical optical parameter the photodynamic effect of LED and laser mediation is very close.Cost is cheap, volume
It is following irreversible trend that small LED, which substitutes effect of the laser in photodynamic therapy,.Most of all, LED can root
According to it is different need to be designed to it is wearable and can built-in type equipment, the treatment of complexity is simplified.But it so far, there is no phase
The report of pass and license.
Sensitising agent is another key element of photodynamic therapy.The sensitising agent that China possesses Bureau of Drugs Supervision's lot number at present only has two kinds, and one
Kind is hematoporphyrin derivative, and trade name happiness pool is fragrant, is that Huading Modern Biopharmaceutical Co., Ltd., Chongqing City produces, for note
Medication is penetrated, is adapted to vascular diseases and most of oncotherapy;One kind is 5-ALA, i.e. ALA, trade name Chinese mugwort draw, be on
Extra large Fudan University's Zhangjiang Biomedics Inc. production.ALA is externally applied drug, and commodity packaging is pulvis, clinical at present to adapt to
Disease is condyloma acuminatum.Because ALA is small-molecule drug, transdermal characteristic is strong, is adapted to skin and SM tumour particularly enteron aisle to swell
Knurl.But it is not adapted to the ALA formulations of enteron aisle at present, simple pulvis can not meet Clinical practice demand.
Most importantly, photodynamic therapy is a kind for the treatment of method of two-step method, i.e., first uses sensitising agent, then with light source
Excite.Sensitising agent belongs to medicine category, and light source then belongs to medicine equipment category, is limited by national examination & approval mechanism, Liang Zhe
When applying for Clinical practice qualification, often isolate what is come, but both uses must be supporting, the wavelength of light source is necessary
Match the absorption peak of sensitising agent.This has resulted in the confusion of clinical practice and harm.There is no light source and sensitising agent still at present
Supporting equipment.
The content of the invention
In order to solve problems of the prior art, the present invention provides a kind of light power examination for rectal neoplasm treatment
Agent box and preparation method, overcome optical dynamic therapy intestinal canal tumour light source in the prior art and sensitising agent to select difficulty, is arranged without matching somebody with somebody
The problem of standby.
The technical scheme is that:A kind of light power kit for rectal neoplasm treatment, including sample holder, institute
State and 5-ALA (5-Aminolevulinic acid, ALA) suppository (ALA suppositorys) and suppository are provided with sample holder
Type LED light source (LED suppositorys), shell is provided with outside sample holder.
5-ALA suppository and suppository the type LED light source is the bullet-shaped suppository of same volume, and LED suppositorys are
Transparent epoxy resin encapsulation is made up of LED unit, fin, lithium battery, normally closed type magnetic switch and constant-current drive circuit
Midget plant, bottom is provided with supporting magnet ring.
The 5-ALA suppository is made up of 5-ALA pulvis, azone and fat-soluble matrix, wherein, 5-
Aminolevulinic acid suppository weight accounts for every bolt and weighs 20%.
The fat-soluble matrix is 36 type fatty glycerides.
The preparation method of a kind of light power kit for rectal neoplasm treatment, it is characterised in that comprise the following steps:
(1) preparation of 5-ALA suppository:5-ALA is crossed into 100 mesh sieves fine powder is made, add water for injection
Dissolving, the azone of recipe quantity is added, mixed standby;Taking 36 type fatty glyceride heating water baths, 2/3rds dissolve to 60 DEG C
Stop heating afterwards, it is melted completely with waste heat, be slowly added to the 5-ALA aqueous solution, stirring while adding, stirring is equal
After even, it is quickly poured into advance with the bolt mould of glycerine lubrication, 2 DEG C of coolings, scrapes off redundance, be stripped and produce;
(2) preparation of LED suppositorys:Four sheet-shaped LED light sources are subjected to quadrate array arrangement on lithium battery surface top,
Constant-current drive circuit is distributed in lithium battery surface lower portions, and connection is carried out according to the circuit of design;Circuit uses closed type magnetic
Control switch control, during preparation and storage, LED suppositorys are in magnetic field, using holding circuit as open circuit;In magnetic field environment
Under, whole light source body is put into bullet-shaped plastic mould, injects epoxy resin, mould is removed after solidification, you can is obtained entirely
Light supply apparatus.
The weight of the 5-ALA pulvis, azone and 36 type fatty glycerides is respectively:5- amino ketones penta
Sour pulvis 160mg, azone 15mg, 36 type fatty glyceride 625mg.
Beneficial effects of the present invention are:The present invention utilizes the light for being used for rectal neoplasm treatment using chronic photodynamic effect to move
Power suppository kit, ALA suppositorys and LED suppositorys are contained, i.e., sensitising agent and the irradiation of matching are equipped with same reagent box
Light source, optical dynamic therapy can be directly carried out, more convenient accurately approach is provided for the clinical practice of photodynamic therapy.It is described
Effective photosensitizer compositions are the ALA pulvis for having obtained clinical lots in ALA suppositorys, are on pharmaceutical dosage form in the kit
Change, clinic approval application it is simpler.The LED suppositorys replace the laser in traditional photodynamic therapy using LED light source
Light source, cost is greatly reduced, and to be disposable, it is convenient and healthy.Smooth power suppository kit of the present invention will
Promote application of the photodynamic therapy in the carcinoma of the rectum.
Brief description of the drawings
Fig. 1 is a kind of schematic diagram of light power suppository kit for rectal neoplasm treatment provided by the invention;
In figure, 1-ALA suppositorys;2-LED suppositorys;3- magnet rings;4- sample holders;5- shells;
Fig. 2 is the LED suppositorys described in a kind of light power suppository kit for rectal neoplasm treatment provided by the invention
Structure chart;
Fig. 3 is the LED suppositorys described in a kind of light power suppository kit for rectal neoplasm treatment provided by the invention
Circuit diagram;VCC:Lithium battery power supply pin;KR:Magnetic switch;VDD:LED power supply pin;ISET:Continuous current sets pin;LEDG:
LED negative poles;GND:Ground;CN5611:LED constant current driving chip;
Fig. 4 PDT kits are used for the therapeutic effect of rabbit rectum tumour;A:Control group;B:PDT groups.
Embodiment
The present invention is described in further detail below in conjunction with the accompanying drawings.
A kind of light power suppository kit for rectal neoplasm treatment, including sample holder 4, set on sample holder 4
There are 5-ALA suppository 1 and suppository type LED light source 2, shell 5 is provided with outside sample holder 4.The ALA suppositorys 1 are matter
Measure fraction 20%ALA rectal plug;The LED suppositorys 2 are the integrated LED light source of transparent epoxy resin encapsulation.Wherein, every bolt
Heavy 800mg, ALA 160mg, azone 15mg, the semi-synthetic fatty glyceride 625mg of 36 types.
ALA suppositorys and LED suppositorys are ordinary suppository size, and kit overall volume is small, beneficial to the reality of photodynamic therapy
Apply.ALA suppositorys are the ALA pulvis by having obtained clinical lots, are dispersed in fat-soluble matrix and are formed, and have certain sustained release
Effect.ALA suppositorys with the addition of azone to improve mucous membrane penetrability.
LED suppositorys are integrated equipment, and whole equipment volume is consistent with ALA suppositorys, are the rectum property inserted equipment, can do noninvasive
Phototherapy.The peak wavelength of LED suppositorys is 630nm, is matched with ALA absorption peak, can effectively carry out optical dynamic therapy.LED
The built-in lithium battery of suppository, capacitance 80mAh, it is available for 4 20mA LED units (2 strings 2 and mode) to continue with luminous power 10mW
Irradiation 1 hour, meets the needs of mPDT long-time irradiations.LED suppositorys use normally closed magnetic switch, during preparation and storage
Magnetic field state is in, holding circuit is open circuit, removes kit and starts working, LED suppositorys itself are hermetically sealed, can pacify in vivo
It is complete to use.
Present invention also offers the preparation method of ALA suppositorys and LED suppositorys.
The preparation method of ALA suppositorys is:160mg ALA are crossed into 100 mesh sieves fine powder are made, add appropriate water for injection to dissolve,
15mg azones are added, are mixed standby.The type fatty glyceride heating water baths of 625mg 36 are taken to 60 DEG C, range estimation 2/3rds is dissolved
Stop heating afterwards, it is melted completely with waste heat, be slowly added to the ALA aqueous solution, it is stirring while adding, after stirring, quickly
Pour into advance with the bolt mould of glycerine lubrication, 2 DEG C of coolings, scrape off redundance, be stripped and produce.
The preparation method of LED suppositorys is:By the LED light source (type that 4 centre wavelengths according to square profile are 630nm
Number 3528 paster LED lamp beads) 80mAh lithium batteries (poly-lithium battery of model 350926) surface top by 2 strings 2 and in a manner of square
Shape array arrangement, constant-current drive circuit are distributed in lithium battery surface lower portions, and closed type magnetic switch is distributed in lithium battery output end,
Connection is carried out according to the sense of current.Whole light source body is put into the bullet-shaped plastic moulds of long 3cm, diameter about 1cm, is noted
Enter medical transparent epoxy resin, mould is removed after solidification, you can obtain whole light supply apparatus.LED light source, power supply and radiating is integrated
Into the transparent material of normal suppository size, small volume, without additionaling power.Built-in type equipment is may be used as, carries out noninvasive light
Treat.LED suppositorys use magnetic switch, depart from magnetic field and start working, no external circuit contacts with tissue.
Experimental example
Photodynamic therapy treatment rectum is carried out to the light power suppository kit of the present invention for rectal neoplasm treatment
The effect of cancer, is assert, it was demonstrated that the kit can realize that mPDT is treated, and reach the purpose of tumors destroyed.Laboratory report is as follows:
First, make a summary
Light power suppository kit of the present invention for rectal neoplasm treatment, one time a day, ALA suppositorys 1 tablet each time,
LED suppositorys irradiate 1h, continuous 3 times, can reach and effectively eliminate tumour under Japan large ear rabbit mucous membrane of rectum.
2nd, purpose
Tumour is moved with the light of the present invention treated for rectal neoplasm under observation Japan large ear rabbit mucous membrane of rectum
After power suppository kit implements 3 optical dynamic therapies, the suppression situation of tumour.
3rd, study subject
1st, study subject:Light power suppository kit of the present invention for rectal neoplasm treatment
The 2nd, unit is provided:Inst. of Biomedicine Engineering Chinese Academy of Medicine's laser medicine laboratory
4th, reference substance
Blank medicine bolt, in blank medicine bolt in addition to without ALA, other formulas are consistent.LED suppositorys are the same as of the present invention.
5th, animal model
1st, source:Japan large ear rabbit is provided by Beijing HFK Bio-Technology Co., Ltd..
2nd, body weight:2kg
3rd, sex:Male
4th, modeling:Use 1*107Individual VX2 cells are inoculated with rabbit rectum mucous membrane, and diameter 1cm or so tumor mass is grown up to after 14 days
As modeling success.
5th, every group of number of animals:6
6th, dosage
1st, PDT groups and control group are set to
2nd, every Japan large ear rabbit, 1 times/day, 1 ALA suppository/time, LED suppositorys irradiation 1h, continuous 3 times.
7th, approach
Rectally, it is consistent with clinical administration approach.
8th, method
Male Japan large ear rabbit 12, under mucous membrane of rectum after tumour modeling success, it is randomly divided into PDT groups and control
Group.PDT groups, ALA suppositorys pick a small amount of glycerine lubrication, are gently sent into rectum, and position is defined by submucous tumor position, Ran Houyong
Hand gently compresses rabbit anus 15 minutes.Treat that suppository melts after half an hour, animal light anesthesia is allowed to be in rest state.Will
LED suppositorys take out from box, and LED is bright, are sent into rectum same position in the same way, gently press anus with hand, prevent from discharging,
Irradiation 1 hour.After irradiation, Japan large ear rabbit discharges LED suppositorys in its natural state.Same treatment is given for three days on end.Control
Group gives blank drug suppository, and the use of LED suppositorys is the same as PDT groups.
9th, observation index
Tumour growth:Tumor size is determined with MRI at the 7th day and the 14th day.
Tenth, result
As a result as shown in figure 4, A is control group, tumour continued propagation, reaches after blank drug suppository and the irradiation of LED suppositorys
To 3 to 4 times of original volumes.B is PDT groups, and after ALA suppositorys and LED suppositorys implement PDT, 60% animal tumor obtains
Effectively suppress, tumour substantially eliminates.
11, conclusion
PDT suppositorys kit of the present invention can effectively reach the effect for eliminating the carcinoma of the rectum.
Although above in conjunction with accompanying drawing, invention has been described, and the invention is not limited in above-mentioned specific implementation
Mode, above-mentioned embodiment is only schematical, is not restricted, one of ordinary skill in the art is at this
Under the enlightenment of invention, in the case of present inventive concept and scope of the claimed protection is not departed from, many shapes can also be made
Formula, these are belonged within protection scope of the present invention.
Claims (6)
1. a kind of light power kit for rectal neoplasm treatment, including sample holder, it is characterised in that the sample holder
On be provided with 5-ALA suppository and suppository type LED light source, be provided with shell outside sample holder.
2. the light power kit according to claim 1 for rectal neoplasm treatment, it is characterised in that the 5- amino
Ketone valeric acid suppository and the bullet-shaped suppository that suppository type LED light source is same volume, LED suppositorys are transparent epoxy resin encapsulation
The midget plant being made up of LED unit, fin, lithium battery, normally closed type magnetic switch and constant-current drive circuit, bottom is provided with
Supporting magnet ring.
3. the light power kit according to claim 1 for rectal neoplasm treatment, it is characterised in that the 5- amino
Ketone valeric acid suppository is made up of 5-ALA pulvis, azone and fat-soluble matrix, wherein, 5-ALA suppository weight
Account for every bolt and weigh 20%.
4. the light power kit according to claim 3 for rectal neoplasm treatment, it is characterised in that described fat-soluble
Matrix is 36 type fatty glycerides.
5. the preparation method of a kind of light power kit for rectal neoplasm treatment, it is characterised in that comprise the following steps:
(1) preparation of 5-ALA suppository:5-ALA is crossed into 100 mesh sieves fine powder is made, be dissolved in water for injection,
The azone of recipe quantity is added, is mixed standby;36 type fatty glyceride heating water baths are taken to 60 DEG C, 2/3rds dissolve after stop
Only heat, it is melted completely with waste heat, be slowly added to the 5-ALA aqueous solution, it is stirring while adding, after stirring, soon
Speed is poured into advance with the bolt mould of glycerine lubrication, 2 DEG C of coolings, is scraped off redundance, is stripped and produces;
(2) preparation of LED suppositorys:Four sheet-shaped LED light sources are subjected to quadrate array arrangement, constant current on lithium battery surface top
Drive circuit is distributed in lithium battery surface lower portions, and connection is carried out according to the circuit of design;Circuit is opened using closed type magnetic control
Control is closed, during preparation and storage, LED suppositorys are in magnetic field, using holding circuit as open circuit;Under magnetic field environment,
Whole light source body is put into bullet-shaped plastic mould, injects epoxy resin, mould is removed after solidification, you can obtains whole light source
Device.
6. the preparation method of the light power kit according to claim 5 for rectal neoplasm treatment, it is characterised in that
The weight of the 5-ALA pulvis, azone and 36 type fatty glycerides is respectively:5-ALA pulvis
160mg, azone 15mg, 36 type fatty glyceride 625mg.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2023109694A1 (en) * | 2021-12-17 | 2023-06-22 | 北京大学 | Method for enhancing activity of photosensitizer by means of magnetic field |
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CN101896203A (en) * | 2007-12-12 | 2010-11-24 | 光治疗Asa公司 | Use of 5-aminolevulinic acid and derivatives in a solid form for photodynamic treatment and diagnosis |
CN106902468A (en) * | 2015-12-22 | 2017-06-30 | 中国医学科学院生物医学工程研究所 | A kind of rectal plug LED light source for carcinoma of the rectum optical dynamic therapy |
-
2017
- 2017-11-10 CN CN201711106205.8A patent/CN107812190A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101896203A (en) * | 2007-12-12 | 2010-11-24 | 光治疗Asa公司 | Use of 5-aminolevulinic acid and derivatives in a solid form for photodynamic treatment and diagnosis |
CN106902468A (en) * | 2015-12-22 | 2017-06-30 | 中国医学科学院生物医学工程研究所 | A kind of rectal plug LED light source for carcinoma of the rectum optical dynamic therapy |
Non-Patent Citations (1)
Title |
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王春燕 等主编, 重庆大学出版社 * |
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WO2023109694A1 (en) * | 2021-12-17 | 2023-06-22 | 北京大学 | Method for enhancing activity of photosensitizer by means of magnetic field |
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