CN107714673A - Ropivacaine mesopore bioactive glass complex microsphere preparation technology - Google Patents
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
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Abstract
Present invention relates to Ropivacaine mesopore bioactive glass complex microsphere preparation technology, comprise the following steps：Step 1：The preparation of SiO2 colloid crystal templates；Step 2：The preparation of anti-Colloidal crystals carbon template；Step 3：MBGs preparation；Step 4：Load of the medicine in MBGs；Step 5：The preparation of complex microsphere；In steps of 5, MBGs and load medicine MBGs powder are uniformly dispersed first, it is laid in smooth bright and clean and enough surface strength plane, another smooth bright and clean and enough hardness surface is pressed in MBGs and carried again and is pressurizeed on medicine MBGs powder, adjust moulding pressure, then it is added dropwise PEG and PLA PEG chloroformic solution around medicine MBGs powder in MBGs and carrying dropwise, wetting keeps under normal temperature being vented to chloroform volatilization and finished.
Description
Technical field
That be originally related to is Ropivacaine mesopore bioactive glass complex microsphere preparation technology.
Background technology
Limbs postoperative pain produces significant negative impact to patient's post-operative recovery quality and functional training.Continued postoperative
Pain, the problem of analgesia time deficiency is grasped with dosage being present by single injection local anaesthetics, analgesia pump infusion needs to put pipe, and
Many relevant issues such as catheter displacement and infection can be produced.The three-dimensional ordered macroporous carbon template combination colloidal sol of this problem plan use-solidifying
The method that glue process and block copolymer template replicate, prepares small size single dispersing Ropivacaine (Ropi)/mesopore bioactive
Glass microsphere（MBGMs）/ ethylene glycol lactic acid copolymer（PEG-PLA）Complex microsphere, and optimization formulation and technique.
Bioactivity glass (BG) causes people widely to be closed after professor Hench by the U.S. in 1971 has found
Note.Compared with traditional biological activity glass, mesopore bioactive glass (MBG) shows more preferable bone remoulding ability and biofacies
Capacitive.MBG has mesoporous phase (2 ~ 50 nm), larger specific surface area and a pore volume, and abundant surface silanol group can then provide compared with
More avtive spot, so as to reach higher drug loading.Researcher releases also by experimental study extension MBG in medicine
Put and the application of biomedical sector.MBG is as the advantage of pharmaceutical carrier：Carrier has nontoxicity, lived without physiology in itself
Property and more preferable biological degradability, biocompatibility；The integrality of medicines structure can be kept after drug assemble；Mesopore molecular sieve
The abundant silicone hydroxyl in surface can make drug molecule be easy to equably load to as the avtive spot with drug molecule interaction
Have an effect on the surface in duct and duct so that drug molecule is firmly loaded into duct.By adjust assembling condition and
The parameters of mesopore molecular sieve, not only can with the size of regulating drug assembling amount, meanwhile, can effectively control drug molecule
Rate of release, so as to reach the purpose for making medicament slow release or controlled release.But up to the present sieve piperazine card using MBG as carrier
Because Atrigel does not have correlative study also.2017, team of Ji Li armies reports could using three-dimensional ordered macroporous carbon template
Highly monodispersed magnetic MBGMs is synthesized with accurate control.And by itself and the compound preparation magnetic of PEG-PLA block copolymers
MBGMs/PEG-PLA complex microspheres, while the medicines such as arsenic trioxide, Anastrozole and brufen are have studied in MBGMs/PEG-
Load and release behavior in this new material of PLA complex microspheres, determine that the complex microsphere is adapted to carrying medicament.Research finds,
The release behavior of medicine can pass through the hydrophilic and hydrophobic and thickness control of polymer covering layer.PEG-PLA hydrophilic and hydrophobic is because of the two
Molecular weight it is different and different, therefore by using the PEG-PLA clads with different molecular weight medicine can be controlled to release
Let pass and be.
But the release behavior of PEG-PLA clads control medicine receives PEG-PLA concentration, molecular weight, coating thickness
Deng the influence of many factors, therefore, in laboratory need to find a kind of PEG-PLA clads control medicine that can quickly adjust
The method of rate of release, in favor of studying under different pharmaceutical rate of release, Ropivacaine mesopore bioactive glass is compound micro-
The property of ball.
The content of the invention
In view of this, in order to solve the above problems, it is compound that the present invention provides a kind of Ropivacaine mesopore bioactive glass
Microspheres.
Ropivacaine mesopore bioactive glass complex microsphere preparation technology, comprises the following steps：
Step 1：The preparation of SiO2 colloid crystal templates；
Step 2：The preparation of anti-Colloidal crystals carbon template；
Step 3：MBGs preparation；
Step 4：Load of the medicine in MBGs；
Step 5：The preparation of complex microsphere；Characterized in that, in steps of 5, it is first that MBGs and load medicine-MBGs powder is scattered equal
It is even, it is laid in smooth bright and clean and enough surface strength plane, then another smooth bright and clean and enough hardness surface is pressed
Pressurizeed on MBGs and load medicine-MBGs powder, adjust moulding pressure, then dropwise in MBGs and load medicine-MBGs powder
Around be added dropwise PEG and PLA-PEG chloroformic solution, wetting keeps under normal temperature being vented to chloroform volatilization and finished.
Further, in steps of 5, after the volatilization of first time chloroform, the chloroform for repeating to be added dropwise PEG and PLA-PEG is molten
Liquid is to being covered to complete.
Further, planar pressing surfaces are made from diamond, ceramics or glass, but hard alloy can not be used to make.
Further, planar pressing surfaces Mohs' hardness is more than 6.0.
Further, in step 1, the preparation of single dispersing SiO2 microballoons：Pass through orthosilicic acid second using St ber method
Ester（TEOS）Basic hydrolysis process prepare single dispersing SiO2 microsphere suspension liquids.251.2 g absolute ethyl alcohols are weighed, 118.25 g are gone
Ionized water and 34 g NH3H2O are placed in conical flask, after being well mixed under magnetic stirring, are added 27.7 g TEOS, are continued
The h of magnetic agitation 3, obtains the suspension of SiO2 particles；
The preparation of SiO2 colloid crystal templates：It is first that the suspension of SiO2 particles obtained above is more to remove by rotary evaporation
Remaining solvent, is then placed in Flat bottom container, is centrifuged off unnecessary solvent, forms the unordered SiO2 Colloidal crystals moulds of bulk
Plate, then sintered under 1000 DEG C of high temperature and SiO2 colloid crystal templates are made.
Further, in step 2, SiO2 colloids crystal template obtained above is immersed in and made with urotropine
For the phenolic resin of crosslinking agent, methenamine:mPF=1:10, ethanol solution in.After alcohol solvent volatilization, it will be wrapped in
PF SiO2 colloid crystal templates are put into box atmosphere furnace, are warming up to 1000oC, programming rate 3oC/ under nitrogen protection
Min, PF is set to complete carbonisation, so as to obtain SiO2/C composites.Soaked after above-mentioned composite material surface is polished smooth
To remove SiO2 in mass fraction is 40% hydrofluoric acid, with deionized water, soaking flushing to remove the HF of residual, is dried repeatedly afterwards
Ordered big hole carbon template is obtained after dry
Further, in step 3, Si75Ca25-MBGs, Si/Ca=75:25, mol ratio, preparation process, it is specific as follows
It is described.2.7 g TEOS, 1.18 g Ca (NO3) 24H2O, the 4.2 g F127 and M HNO3 of 0.08 g 2 are added into 8 g
Stirred in the mixed liquor of absolute ethyl alcohol, stir 3 h at room temperature.Ordered big hole carbon template in step 2 is immersed into gained colloidal sol and put
Enter in vacuum drying chamber and carry out sol-gel process at 50 DEG C, after collosol and gel drying, sintered in Muffle furnace at 600 DEG C
Template is removed, produces MBGs.Then gained MBGs is ground into uniform powder, it is standby.
Further, in step 4, the saturated solution of two kinds of medicines is prepared first, is loaded to using perfusion
In MBGs, specific implementation method is as follows：With the MBGs powder of certain density drug solution infiltration known quality, it is placed on true
In empty drying box, its rapid draing is made under vacuum condition, completion once irrigates the cycle.Perfusion is repeated several times and can adjust its load medicine
Measure, after the completion of most rear bearing medicine, be placed in drying box, it is standby.Record perfusion number, calculates theoretical drugloading rate.
Further, in steps of 5, PEG (6000,10000,20000) and PLA-PEG is selected（15000）For MBGs's
Surface coating material, using chloroform as reaction dissolvent.
PEG-PLA clads are fine and close and surface porosities, and solution is dense when the speed of its release internal drug is wrapped up with it
Degree（Molecular weight）It is relevant with integument thickness.In order to obtain the integument of different rate of release, conventional art needs to adjust solution
Molecular weight repeatedly is repeatedly carried out wrapping up.Often obtain once the integument of different rate of release, it is necessary to carry out once complete
From step 1 to step 5（Delete pressure process）Technique.It is and undesirable（Rate of release）Experiment product can only lose
Abandon, lose time and medicine.And chloroform is poisonous, the technique of integument thickness is adjusted using multiple parcel, to experimenter not
Safety.After technique using the pressurized control rate of release of the application, moulding pressure size only need to be adjusted in steps of 5, i.e.,
Can quick regulation integument thickness.When needing to configure the integument of different rate of release, it is only necessary to make in a collection of step 4
MBGs and load medicine-MBGs powder, then use different moulding pressures in steps of 5, unified only to wrap up a PEG-PLA solution
（Now chloroform is only using once）The integument of different rate of release can be produced.
After the coating mesoporous bioactivity glass complex microspheres of PEG-PLA, complex microsphere structure to be spherical, its pressurization with
Afterwards, combine closely from each other, surface is overlapping from each other, and overlapping degree and moulding pressure are substantially linear.Work as leaching
After profit is in PEG and PLA-PEG chloroformic solution, the underlapped surface of microballoon superscribes PEG and PLA-PEG layers, overlapping table
Do not wrap up in face.After air-drying, form surface and be uneven, it is local wrap up PEG and PLA-PEG layers, it is local do not wrap up PEG and
The microballoon of PLA-PEG layers.Drug releasing rate and PEG and PLA-PEG layer solution molecule amounts and the microsphere surface parcel of the microballoon
Degree is relevant.When constant of PEG and PLA-PEG layers solution molecule amount, drug releasing rate and moulding pressure（Microsphere surface exists
During pressurization, overlapping degree from each other）It is relevant.Therefore by the technical program, PEG-PLA can quickly be adjusted in laboratory
The rate of release of clad control medicine is in favor of studying under different pharmaceutical rate of release, Ropivacaine mesopore bioactive glass
The property of glass complex microsphere.
Embodiment
Step 1：The preparation of SiO2 colloid crystal templates
The preparation of single dispersing SiO2 microballoons：Method using St ber passes through ethyl orthosilicate（TEOS）Basic hydrolysis process system
Standby single dispersing SiO2 microsphere suspension liquids.251.2 g absolute ethyl alcohols are weighed, 118.25 g deionized waters and 34 g NH3H2O are put
In conical flask, after being well mixed under magnetic stirring, 27.7 g TEOS are added, continues the h of magnetic agitation 3, obtains SiO2
The suspension of grain.
The preparation of SiO2 colloid crystal templates：First by the suspension of SiO2 particles obtained above by rotary evaporation with except
Unnecessary solvent is removed, is then placed in Flat bottom container, is centrifuged off unnecessary solvent, forms the unordered SiO2 colloids of bulk
Crystal template, then sintered under 1000 DEG C of high temperature and SiO2 colloid crystal templates are made.
Step 2：The preparation of anti-Colloidal crystals carbon template
SiO2 colloids crystal template obtained above is immersed in urotropine（Methenamine）Phenol as crosslinking agent
Urea formaldehyde（PF）（M methenamines:mPF=1:10）Ethanol solution in.After alcohol solvent volatilization, it will be wrapped in PF's
SiO2 colloid crystal templates are put into box atmosphere furnace, are warming up to 1000oC under nitrogen protection（Programming rate is 3oC/min）Make
PF completes carbonisation, so as to obtain SiO2/C composites.Quality is immersed in after above-mentioned composite material surface is polished smooth
Fraction is to remove SiO2 in 40% hydrofluoric acid, and with deionized water, soaking flushing is to remove the HF of residual repeatedly afterwards, after drying i.e.
Obtain ordered big hole carbon template
Step 3：MBGs preparation
Si75Ca25-MBGs（Si/Ca = 75:25, mol ratio）Preparation process, it is described in detail below.By 2.7 g TEOS,
1.18 g Ca (NO3) 24H2O, 4.2 g F127 and the M HNO3 of 0.08 g 2 are added in the mixed liquor of 8 g absolute ethyl alcohols
Stirring, stirs 3 h at room temperature.Ordered big hole carbon template in step 2 is immersed into gained colloidal sol and is put into vacuum drying chamber 50
DEG C carry out sol-gel process, after collosol and gel drying after, in Muffle furnace at 600 DEG C sintering remove template, produce
MBGs.Then gained MBGs is ground into uniform powder, it is standby.
Step 4：Load of the medicine in MBGs
The saturated solution of two kinds of medicines is prepared first, is loaded to using perfusion in MBGs, specific implementation method is as follows：With
The MBGs powder of certain density drug solution infiltration known quality, is placed in vacuum drying chamber, makes it under vacuum condition
Rapid draing, completion once irrigate the cycle.It is repeated several times to irrigate and can adjust its drugloading rate, after the completion of most rear bearing medicine, is placed in drying
It is standby in case.Record perfusion number, calculates theoretical drugloading rate.
Step 5：The preparation of complex microsphere
Select PEG (6000,10000,20000) and PLA-PEG（15000）It is anti-using chloroform for MBGs Surface coating material
Answer solvent.MBGs and load medicine-MBGs powder are uniformly dispersed first, are laid in smooth bright and clean and enough surface strength plane
On, then another smooth bright and clean and enough hardness surface is pressed in MBGs and carried and is pressurizeed on medicine-MBGs powder, adjust
Moulding pressure.Planar pressing surfaces are made from diamond, ceramics or glass, but hard alloy can not be used to make.Then exist dropwise
MBGs and the chloroformic solution that PEG and PLA-PEG is added dropwise around medicine-MBGs powder is carried, wetting, keep under normal temperature being vented to chlorine
Imitative volatilization finishes.After first time chloroform volatilizees, repeat to be added dropwise PEG and PLA-PEG chloroformic solution to being covered to complete.
Claims (9)
1. Ropivacaine mesopore bioactive glass complex microsphere preparation technology, comprises the following steps：
Step 1：The preparation of SiO2 colloid crystal templates；
Step 2：The preparation of anti-Colloidal crystals carbon template；
Step 3：MBGs preparation；
Step 4：Load of the medicine in MBGs；
Step 5：The preparation of complex microsphere；
Characterized in that, in steps of 5, MBGs and load medicine-MBGs powder are uniformly dispersed first, are laid in smooth bright and clean and table
In the enough planes of surface intensity, then another smooth bright and clean and enough hardness surface is pressed in MBGs and carries medicine-MBGs powder
On pressurizeed, adjust moulding pressure, then in MBGs and carry PEG and PLA-PEG is added dropwise around medicine-MBGs powder dropwise
Chloroformic solution, wetting keep under normal temperature being vented to chloroform volatilization and finished.
2. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 1, it is characterized in that：In step
In rapid 5, after first time chloroform volatilizees, repeat to be added dropwise PEG and PLA-PEG chloroformic solution to being covered to complete.
3. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 2, it is characterized in that：Pressurization
Plane is made from diamond, ceramics or glass, but hard alloy can not be used to make.
4. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 3, it is characterized in that：Pressurization
Plane Mohs' hardness is more than 6.0.
5. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 4, it is characterized in that：In step
In rapid 1, the preparation of single dispersing SiO2 microballoons：Method using St ber passes through ethyl orthosilicate（TEOS）Basic hydrolysis process
Prepare single dispersing SiO2 microsphere suspension liquids；Weigh 251.2 g absolute ethyl alcohols, 118.25 g deionized waters and 34 g NH3H2O
It is placed in conical flask, after being well mixed under magnetic stirring, adds 27.7 g TEOS, continue the h of magnetic agitation 3, obtain SiO2
The suspension of particle；
The preparation of SiO2 colloid crystal templates：It is first that the suspension of SiO2 particles obtained above is more to remove by rotary evaporation
Remaining solvent, is then placed in Flat bottom container, is centrifuged off unnecessary solvent, forms the unordered SiO2 Colloidal crystals moulds of bulk
Plate, then sintered under 1000 DEG C of high temperature and SiO2 colloid crystal templates are made.
6. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 5, it is characterized in that：In step
In rapid 2, SiO2 colloids crystal template obtained above is immersed in the phenolic resin using urotropine as crosslinking agent, crow
Lip river tropine:mPF=1:10, ethanol solution in；After alcohol solvent volatilization, the SiO2 colloid crystal templates for being wrapped in PF are put
Enter in box atmosphere furnace, be warming up to 1000oC, programming rate 3oC/min under nitrogen protection, PF is completed carbonisation, from
And obtain SiO2/C composites；Mass fraction is immersed in after above-mentioned composite material surface is polished smooth as in 40% hydrofluoric acid
To remove SiO2, with deionized water, soaking flushing to remove the HF of residual, obtains ordered big hole carbon mould repeatedly after drying afterwards
Plate.
7. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 6, it is characterized in that：In step
In rapid 3, Si75Ca25-MBGs, Si/Ca=75:25, mol ratio, preparation process, it is described in detail below, by 2.7 g
TEOS, 1.18 g Ca (NO3) 24H2O, 4.2 g F127 and the M HNO3 of 0.08 g 2 add the mixing of 8 g absolute ethyl alcohols
Stirred in liquid, stir 3 h at room temperature；Ordered big hole carbon template in step 2 is immersed into gained colloidal sol and is put into vacuum drying chamber
Sol-gel process is carried out at 50 DEG C, after collosol and gel drying, sintering removes template at 600 DEG C in Muffle furnace, i.e.,
Obtain MBGs；Then gained MBGs is ground into uniform powder, it is standby.
8. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 7, it is characterized in that：In step
In rapid 4, the saturated solution of two kinds of medicines is prepared first, is loaded to using perfusion in MBGs, specific implementation method is as follows：
With the MBGs powder of certain density drug solution infiltration known quality, it is placed in vacuum drying chamber, makes under vacuum condition
Its rapid draing, completion once irrigate the cycle, are repeated several times and irrigate its adjustable drugloading rate, after the completion of most rear bearing medicine, are placed in dry
It is standby in dry case, record perfusion number, calculate theoretical drugloading rate.
9. Ropivacaine mesopore bioactive glass complex microsphere preparation technology as claimed in claim 8, it is characterized in that：In step
In rapid 5, PEG (6000,10000,20000) and PLA-PEG is selected（15000）For MBGs Surface coating material, using chloroform as
Reaction dissolvent.
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| CN201810563656.2A CN108721247B (en) | 2017-10-23 | 2018-06-04 | Preparation process of ropivacaine mesoporous bioactive glass composite microspheres |
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| CN108721247A (en) * | 2017-10-23 | 2018-11-02 | 无锡市锡山人民医院 | Ropivacaine mesopore bioactive glass complex microsphere preparation process |
| CN109364041A (en) * | 2018-11-14 | 2019-02-22 | 高雄 | The Pain relief agents and its preparation method of ultrasonic mediation and the drug release of acidity sensitivity and application |
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| CN103342453B (en) * | 2013-07-09 | 2015-12-02 | 扬州大学 | The method of the monodisperse mesoporous bioactivity glass microballoon of template synthesis |
| CN107714673A (en) * | 2017-10-23 | 2018-02-23 | 无锡市锡山人民医院 | Ropivacaine mesopore bioactive glass complex microsphere preparation technology |
| CN107595781A (en) * | 2017-10-23 | 2018-01-19 | 锡山区东港晓鸣电子产品经营部 | The MBGs for the quick adjustment drug releasing rate that pack of pressurizeing makes |
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| CN108721247A (en) * | 2017-10-23 | 2018-11-02 | 无锡市锡山人民医院 | Ropivacaine mesopore bioactive glass complex microsphere preparation process |
| CN108721247B (en) * | 2017-10-23 | 2021-08-31 | 无锡市锡山人民医院 | Preparation process of ropivacaine mesoporous bioactive glass composite microspheres |
| CN109364041A (en) * | 2018-11-14 | 2019-02-22 | 高雄 | The Pain relief agents and its preparation method of ultrasonic mediation and the drug release of acidity sensitivity and application |
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