
2026-09-28
Njengoqinisekisiweyo 45S5 umenzi womgubo weglasi osebenzayo, sibonelela ngokucoceka okuphezulu, izinto ezihambelana ne-ISO ze-particulate ezenzelwe ubunjineli bethambo lethambo, ukuvuselelwa kwamazinyo, kunye nokunakekelwa kwenxeba eliphezulu. Ukuqulunqwa kwethu kwe-45S5 kubambelela ngokungqongqo kwi-classic Hench composition (45% SiO₂, 24.5% Na₂O, 24.5% CaO, 6% P₂O₅), iqinisekisa i-bioactivity eqikelelweyo kunye nokuqulunqwa kwe-hydroxyapatite ngokukhawuleza. Eli phepha linika iinkcukacha ngesakhono sethu sokwenza, iiprothokholi zolawulo lomgangatho, ukwenza ubungakanani bamasuntswana ngokwezifiso, kunye neenkcukacha zobugcisa zokuthengwa kwe-B2B.
I-45S5 I-Bioglass yimathiriyeli yokuqala yokwenziwa efunyenwe ukuba idibane ngqo nethambo eliphilayo kunye nezicubu ezithambileyo. "I-45" ibhekisela kwipesenti yobunzima be-silica (SiO₂), kwaye "i-S5" ibonisa imilinganiselo ethile ye-molar ye-sodium, i-calcium, kunye ne-phosphorus. Xa evezwe kulwelo lwe-physiological, olu kwakheka lukhethekileyo lufumana uthotho lweempendulo zomphezulu ezikhokelela ekuyilweni kwe-biologically active hydroxycarbonate apatite (HCA) layer.
Lo maleko we-HCA ulingana neekhemikhali kunye nesakhiwo kwisigaba seminerali yethambo lomntu. Ivumela i-interfacial bonding eyomeleleyo, i-osteoconduction, kunye ne-osteostimulation. Njengomntu okhethekileyo 45S5 umenzi womgubo weglasi osebenzayo, sivelisa le mathiriyeli ngobukhulu obuhlukeneyo kunye ne-morphologies ukuze ihambelane neenkqubo ezahlukeneyo zonyango kunye ne-cosmetic, ukusuka kwiifayili ezitofwayo ukuya kwii-scaffolds eziprintiweyo ze-3D.
Ukusebenza kweglasi ye-45S5 ye-bioactive kuxhomekeke kwizinga elilawulwayo lokuchithwa. Ngokungafaniyo ne-inert biomaterials, i-45S5 yenzelwe ukusabela. Le nkqubo ibandakanya amanqanaba amahlanu abalulekileyo:
Olu landelelwano lwenzeka phakathi kwemizuzu ukuya kwiiyure, kuxhomekeke kubungakanani bamasuntswana kunye nommandla womphezulu. Inkqubo yethu yokwenziwa kwemveliso yongeza amandla omphezulu womgubo ukuqinisekisa ukungaguquguquki kwee-kinetics kuzo zonke iibhetshi.
Ukukhetha ethembekileyo 45S5 umenzi womgubo weglasi osebenzayo ibalulekile kubaphuhlisi bezixhobo zonyango nakumaziko ophando. Ukwahluka ekubunjweni kweekhemikhali okanye i-particle morphology inokutshintsha kakhulu ukusebenza kwebhayoloji. Iziko lethu lisebenza phantsi kwenkqubo engqongqo ye-ISO 13485 yolawulo lomgangatho, iqinisekisa ukulandeleka, ukucoceka, kunye nokuveliswa kwakhona.
Ifestile ye-bioactivity yeeglasi ze-silicate imxinwa. Ukuphambuka kumxholo we-sodium okanye we-calcium kunokunika i-inert yeglasi okanye kubangele ukuba inyibilike ngokukhawuleza. Sisebenzisa iisistim zokulinganisa iibhetshi ezichanekileyo ezichanekileyo kunye ne-plasma optical emission spectrometry (ICP-OES) edibeneyo yokuqinisekisa ukwakheka kwezinto. Ibhetshi nganye iyavavanywa ukuqinisekisa ukuba iyahambelana ne-45S5 stoichiometry:
| I-Oxide Component | Ipesenti yobunzima (wt%) | Ipesenti yeMolar (mol%) |
|---|---|---|
| I-Silica (SiO₂) | 45.0% | 46.1% |
| I-Sodium oxide (Na₂O) | 24.5% | 24.4% |
| I-Calcium oxide (CaO) | 24.5% | 26.9% |
| I-Phosphorus Pentoxide (P₂O₅) | 6.0% | 2.6% |
I-Bioactivity ixhomekeke kumphezulu wendawo. Amasuntswana amancinci asabela ngokukhawuleza kodwa anokudibana. Amasuntswana amakhulu anika imfezeko yesakhiwo kodwa asabela kade. Izakhono zethu zokuvelisa ziquka:
Ukungeniswa kokulawulwa (i-FDA, i-CE Mark, i-NMPA), uxwebhu olubanzi alunakuxoxwa. Sibonelela:
Njengomkhokheli 45S5 umenzi womgubo weglasi osebenzayo, sinikezela ngamabakala amaninzi alungiselelwe iimfuno ezithile zesicelo. Ukukhethwa kwebakala kuxhomekeke kusetyenziso olucetywayo, olufana nokuqinisa izinto ezidityanisiweyo, ukwakheka kwentlama, okanye ukwenziwa kwesikafula.
Eli bakala lilungele izixhobo ezingafakelwanga, ukhathalelo lwamanxeba asematheni, kunye nezicelo zamazinyo. Ibonisa ukucoceka okuphezulu kunye nokusebenza okuhambelanayo.
Yenzelwe iinkqubo ezincinci zokungena kunye nokwandisa izicubu ezithambileyo. Eli bakala lifuna ulawulo olungqongqo kwimilo yamasuntswana kunye namanqanaba e-endotoxin.
Ilungiselelwe ubuchule bokwenza okongeziweyo, kubandakanywa ijetting ye-binder kunye ne-stereolithography (SLA). Lo mgubo uhamba ngokukhululekileyo kwaye upakishe kakhulu.
Ubuninzi be-45S5 buvumela ukuba zidibaniswe kwiimveliso ezahlukeneyo zonyango kunye nezempilo zabathengi. Ukuqonda ezi zicelo kunceda abathengi ukuba bakhethe iinkcukacha ezichanekileyo kwezabo 45S5 umenzi womgubo weglasi osebenzayo.
I-45S5 powder ixutywa rhoqo kunye neepolymers (ezifana ne-PCL, i-PLGA, okanye i-collagen) ukudala i-scaffolds edibeneyo. Iglasi ibonelela nge-bioactivity kunye nokuqiniswa koomatshini, ngelixa i-polymer inikezela ukuguquguquka kunye nokulawula ukuthotywa. Ezi zidibaniso zisetyenziswa kwi:
Ubukho be-45S5 buvuselela ukwanda kwe-osteoblast kunye nokulawula izakhi zofuzo ezinxulumene nokubunjwa kwamathambo, ukukhawuleza ukuphilisa xa kuthelekiswa nokuzaliswa kwe-inert.
Kwindawo yamazinyo, iglasi ye-45S5 ye-bioactive ngumgangatho wegolide wokunyanga i-dentin hypersensitivity kunye nokukhuthaza ukuvuselelwa kwe-periodontal.
Uphononongo lwakutsha nje luqaqambisa iipropathi ze-angiogenic zeemveliso zokuchithwa kwe-45S5. I-silicon ions ekhutshwe kwiglasi ivuselela ukwanda kweeseli ze-endothelial, ikhuthaza ukwakheka komthambo wegazi omtsha.
I-porous silica-rich layer eyenziwe kwi-45S5 inokubhengeza kwaye ikhulule ii-agent zonyango. Abaphandi basebenzisa umgubo wethu ukulayisha i-antibiotics, izinto zokukhula, okanye iziyobisi ze-anticancer. Iprofayili yokukhululwa ilawulwa ngumlinganiselo we-particle kunye nesantya sokuthotywa kweglasi.
Ukungafihli kwimveliso kwakha ukuthembana. Njengengcali 45S5 umenzi womgubo weglasi osebenzayo, sisebenzisa indlela yokunyibilika, esemgangathweni woshishino wokuvelisa iglasi ye-bioactive ye-homogeneous.
Izinto eziluhlaza ezicocekileyo (SiO₂, Na₂CO₃, CaCO₃, CaHPO₄) zilinganiswa ngokuchanekileyo. ICarbonates isetyenziswa endaweni yeeoksidi zesodium kunye necalcium ukuququzelela ukubola kunye nokukhutshwa kwegesi ngexesha lokunyibilika. Umxube u-homogenized kwi-mixer yeplanethi ukuqinisekisa ukusabalalisa okufanayo.
Ibhetshi inyibilika kwi-platinum-rhodium crucible kumaqondo obushushu aphakathi kwe-1300 ° C kunye ne-1400 ° C. Eli qondo lokushisa liphezulu liqinisekisa ukuchithwa okupheleleyo kwe-silica kunye nokuphelisa amaqamza. Ukuzinza kweqondo lokushisa kubalulekile ukukhusela i-crystallization (i-devitrification) ngaphakathi kwe-melt, eya kuphazamisa i-bioactivity.
Iglasi etyhidiweyo igalelwa kwiipleyiti zentsimbi engatyiwayo okanye emanzini ukuze zicime. Ukupholisa ngokukhawuleza kuthintela i-crystal nucleation, okubangelwa isakhiwo seglasi ye-amorphous. Le meko ye-amorphous ibalulekile kwi-reactivity ephezulu ye-45S5.
Isiphumo seglasi yefrit siyatyunyuzwa kwaye emva koko sigutywe kusetyenziswa imidiya ye-ceramic ukuphepha ukungcoliswa kwesinyithi. Sisebenzisa i-jet mills okanye iibhola zebhola ngokuxhomekeke kubukhulu besuntswana ekujoliswe kulo. Iilayini zeCeramic kunye neendaba ziqinisekisa ukuba akukho ntsimbi okanye ezinye izinto ezingcolileyo zetsimbi ezingeniswayo.
Umgubo ocoliweyo ugqithiswa kwizihluzi zomoya ukuze zahlule amasuntswana ngokobukhulu. Amasuntswana amakhulu abuyiselwa kwindawo yokusila. Le nkqubo ivaliweyo iqinisekisa isivuno esiphezulu kunye nolawulo oluchanekileyo lwePSD.
Iisampulu zokugqibela zivavanywa ngokuqatha ukwakheka kweekhemikhali, ubungakanani bamasuntswana, kunye nobunyumba. Iibhetshi ezivunyiweyo zipakishwe kwiindawo ezicocekileyo zokugcina imigangatho yococeko.
Ngelixa iinkcukacha zobugcisa ze-45S5 zizonke, ukuthembeka kwekhonkco lakho lokubonelela kubaluleke kakhulu. IJinan Meiyi Biotechnology Co., Ltd., ikomkhulu eJinan, kwiPhondo laseShandong, isebenza njengebhulorho ebalulekileyo phakathi kwemveliso yebhayoloji ephucukileyo kunye neemfuno zentengiso yehlabathi. Njenge-subsidiary ye-Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd., sigxile kuphando, ukuxhasa uphuhliso, kunye nokuthengiswa kwe-bioactive technologies, ngokugxininisa kakhulu kwizicelo kwi-cosmetics, i-aesthetics yonyango, kunye neyeza lokuvuselela.
Ngokungafaniyo nabavelisi bemveli, iJinan Meiyi Biotechnology isebenza njengeqhinga lokufumana kunye neqabane lokuhambisa eliqinisekisiweyo. Asizibandakanyi kwimveliso yemathiriyeli ekrwada ngokuthe ngqo; endaweni yoko, sixhasa uthungelwano olusekwe kakuhle lwekhonkco lonikezelo lwehlabathi ukuze sibe neqabane kunye nabavunyiweyo bamazwe ngamazwe, abavelisi abaqinisekisiweyo be-ISO. Lo mzekelo usivumela ukuba silawule iphothifoliyo yezinto eziphezulu zokusebenza-ezifana neglasi ye-45S5 ye-bioactive echazwe kweli nqaku-ukuqinisekisa ukuba ibhetshi nganye ihlangabezana nokusebenza ngokungqongqo, ukuzinza, kunye nemigangatho yokulawula.
Amandla ethu angundoqo alele kwindlela yethu yogcino olucwangcisiweyo kunye nobuchule bobugcisa. Sisebenzela iilabhoratri ze-R&D, ii-CDMO, kunye neekliniki zobuhle kulo lonke elase-Asiya, iYurophu, kunye noMntla Melika, sibonelela kungekuphela nje izixhobo, kodwa iidosi zobugcisa ezibanzi, ubukrelekrele bolawulo, kunye nokusombulula iingxaki ngentsebenziswano. Ngokugcina ulawulo olungqongqo kwisiqinisekiso somthengisi, ukulandeleka kwamaxwebhu, kunye nolungiselelo, senza ukuba abathengi bethu banciphise ukuntsonkotha kokukhangela ngelixa begcina intembeko epheleleyo yokungaguquguquki kwezinto kunye nokulungela ukulawula.

Xa kufunwa izinto, abaphathi bokuthengwa kwempahla bahlala bethelekisa i-45S5 kunye nezinye izinto ezithatha indawo yethambo. Le theyibhile ilandelayo ibalaselisa iingenelo ezikhethekileyo ze-45S5 bioactive glass powder.
| Uphawu | 45S5 Bioactive Glass | IHydroxyapatite (HA) | I-Beta-Tricalcium Phosphate (β-TCP) | Inert Bioceramics (Alumina) |
|---|---|---|---|---|
| Uhlobo lweBioactivity | Ukudibanisa (Osteoproductive) | I-Osteoconductive | I-Osteoconductive | Inert |
| Amandla oBonding | Phezulu (Ibhondi yeekhemikhali ngokuthe ngqo) | Phakathi | Phakathi | Akukho (I-Fibrous encapsulation) |
| Ireyithi yokupheliswa | Ukulawulwa, kukhulula iiyoni zonyango | Ucotha kakhulu | Ukukhawuleza | Ayinamsebenzi |
| I-Angiogenesis | Ivuselela ukukhula kwemithambo yegazi | Ilinganiselwe | Ilinganiselwe | Akukho nanye |
| I-Antimicrobial Effect | Ewe (ngokuphakama kwe-pH) | Hayi | Hayi | Hayi |
| Amandla oomatshini | Brittle (idla ngokudibanisa) | Phezulu | Phantsi | Phezulu kakhulu |
Ngelixa i-HA kunye ne-TCP zibalaseleyo zokuzaliswa kwendawo, i-45S5 ivuselela ngokusebenzayo iimpendulo zezinto eziphilayo. Oku kwenza ukuba kube phezulu kwizicelo apho ukudibanisa ngokukhawuleza kunye nokudibanisa izicubu ezithambileyo zifunekayo.
Ukukhetha iinkcukacha ezichanekileyo kwi-a 45S5 umenzi womgubo weglasi osebenzayo ibandakanya ukulinganisa i-reactivity, ukuphatha, kunye neemfuno zokulawula. Qwalasela ezi nkalo zilandelayo:
NgeeNdibaniselwano: Sebenzisa amaqhekeza amakhulu (45-90 µm) ukugcina amandla omatshini kunye nokunciphisa i-viscosity.
Ngezitofu: Sebenzisa amasuntswana e-micronized (<10 µm) ukuqinisekisa ukukhutshwa okugudileyo ngeenaliti zokulinganisa kakuhle.
Ngeencanyatheliswa: Ukusasazwa kwe-bimodal (umxube weengqungquthela ezinkulu kunye ezincinci) zihlala zibonelela ngobuninzi bokupakisha kunye nokusebenza.
Qinisekisa ukuba umenzi usebenzisa izixhobo ezine-ceramic-lined. Ukungcola kwesinyithi (i-Fe, i-Cr, i-Ni) ingaba yi-cytotoxic kwaye iphazamise i-bioactivity mechanism. Cela idatha ye-ICP-MS ukuqinisekisa amanqanaba okulandela umkhondo.
Kwizixhobo ezifakelwayo, umgubo kufuneka ube yinyumba. Buza malunga nendlela yokuvala inzala. I-Gamma irradiation iqhelekile kodwa ngamanye amaxesha inokuchaphazela izongezo zepolymer ukuba zixutywe ngaphambili. I-ethylene oxide (EtO) yenye inketho kodwa ifuna ukuphefumla ngononophelo ukususa iintsalela.
Ngaba umenzi ubonelela ngeFayile eyiNtloko yeziyobisi (DMF) okanye inkxaso yeFayile yobuGcisa? Kubhaliso lwezixhobo zonyango, ukufikelela kwiirekhodi ezineenkcukacha zokwenziwa kunye notshintsho lwezaziso zolawulo kubalulekile.

Ukusebenza ngeglasi ye-bioactive kufuna iiprothokholi ezithile zokuphatha. Nantsi imiba eqhelekileyo ejongene namaqela e-R&D kunye nendlela yokuyilungisa.
Ingxaki: I-45S5 i-hygroscopic kwaye isabela ngokufuma kwe-atmospheric, ekhokelela ekuhlanganiseni kunye nokulahlekelwa kwe-bioactivity ngaphambi kokusetyenziswa.
Isisombululo: Gcina umgubo kwi-desiccator okanye ibhokisi eyomileyo. Sebenzisa ukupakishwa komqobo womswakama (i-aluminium foil bags kunye ne-desiccant). Inkqubo kwiindawo eziphantsi zomswakama (<40% RH).
Ingxaki: Amasuntswana amahle athande ukuba agglomerate kwi-viscous polymer melts, ukudala amanqaku abuthathaka kwi-composite.
Isisombululo: Sebenzisa i-surface-modified 45S5 powder kunye ne-silane coupling agents. Lungiselela ukuxuba amaxabiso okucheba ukuqhekeza amaqela ngaphandle kokuthoba isidima sepolymer.
Ingxaki: Inkqubo yokutshintshiselana nge-ion ikhupha i-Na⁺ kunye ne-OH⁻, iphakamisa i-pH yendawo. Kwiindawo ezivaliweyo, oku kunokuba yi-cytotoxic.
Isisombululo: Buffer inkqubo okanye sebenzisa ugxininiso olusezantsi lweglasi. Qinisekisa ukutshintshiselana ngolwelo okwaneleyo kwi-vivo. Kuvavanyo lwe-in vitro, sebenzisa imidiya ye-buffered kunye notshintsho oluqhelekileyo.
Ukuzinikela kwethu kumgangatho ubonakaliswa ngovavanyo olungqongqo. Yonke ibhetshi ye-45S5 yomgubo weglasi esebenzayo iphantsi kolu vavanyo lulandelayo:
Ewe, iglasi eyi-45S5 ye-bioactive isetyenziswe eklinikhi ukusukela ngoo-1980. I-biocompatible, ayinayo ityhefu, kunye ne-non-carcinogenic. Izifundo ezininzi zexesha elide ziqinisekisa ukhuseleko lwayo kwizicelo zamathambo kunye namazinyo. Nangona kunjalo, ukuvala inzala ngendlela eyiyo kunye nokuphathwa kuyafuneka ukuthintela usulelo.
Xa igcinwe kwindawo epholileyo, eyomileyo kwindawo engavulwanga, kwipakethe enobungqina bokufuma, i-45S5 powder inobomi beshelufu ye-2-3 iminyaka. Emva kokuba ivulwe, kufuneka isetyenziswe ngokukhawuleza okanye igcinwe kwi-desiccator ukukhusela ukuchithwa kwangaphambi kwexesha.
Ewe, i-45S5 inokufakwa ngamayeza okubulala iintsholongwane afana ne-gentamicin okanye i-vancomycin. I-silica gel layer ene-porous eyenziwe ngexesha lokuchithwa inokubhengeza iziyobisi, inika ukukhululwa kwendawo. Nangona kunjalo, ukugqabhuka kokuqala okuphezulu kwe-pH kufuneka kuthathelwe ingqalelo xa kukhethwa amayeza okubulala iintsholongwane angeva nge-pH.
Amancinci amancinci anomlinganiselo ophezulu we-surface-area-to-volume ratio, okhokelela ekukhululweni kwe-ion ngokukhawuleza kunye nokwakheka kweHCA ngokukhawuleza. Nangona kunjalo, amasuntswana acoleke ngokugqithisileyo asenokunyibilika ngokukhawuleza kakhulu, abeke esichengeni isidima solwakhiwo. Ibhalansi kufuneka yenziwe ngokusekwe kwixesha lokuphilisa lesicelo.
I-45S5 yenza iqhina elomeleleyo elinezicubu ezithambileyo kunye nethambo kodwa linyibilika ngokukhawuleza. I-13-93 inomxholo ophezulu we-silica kunye nezilungisi ezahlukeneyo, okwenza kube yinto ehlala ixesha elide kwaye ifaneleke kwizicelo ezithwala umthwalo apho ukuthotywa okucothayo kufunwayo. I-45S5 ikhethwa ukuphiliswa ngokukhawuleza kunye nokunxibelelana kwezicubu ezithambileyo.
Njengomhlaba jikelele 45S5 umenzi womgubo weglasi osebenzayo, sithobela imigangatho yolawulo lwamazwe ngamazwe. Amaziko ethu aphicothwa rhoqo ukuqinisekisa ukuthotyelwa:
Sixhasa abathengi bethu ekulungiseleleni amaxwebhu obugcisa be-FDA 510 (k) yokungeniswa kunye nokuMakisha kwe-CE phantsi koMgaqo weMedical Device (MDR). Ikhonkco lethu lobonelelo oluselubala liqinisekisa ukuba zonke izinto ezikrwada zifumaneka kubathengisi abavunyiweyo ngokulandeleka ngokupheleleyo.
Siyaqonda ukuba izisombululo ezingaphandle kweshelufu azifanelanga zonke iinguqulelo ezintsha. Iqela lethu le-R&D lisebenza ngokusondeleleneyo namaqabane ukuphuhlisa iifomyula ezilungiselelweyo ze-45S5.
Sinokubandakanya i-ion zonyango ezifana ne-Strontium (Sr), i-Magnesium (Mg), i-Zinc (Zn), okanye i-Copper (Cu) kwinethiwekhi yeglasi. Ezi dopants zomeleza imisebenzi ethile yebhayoloji:
Kubenzi beesamente zamathambo okanye i-putty, sinikezela ngokuxutywa kwangaphambili kwe-45S5 powder kunye ne-biopolymers. Oku kunciphisa amanyathelo okucubungula kwaye kuqinisekise ukusasazwa okulinganayo.
I-45S5 iglasi ye-bioactive ihlala iyinto esisiseko kwiyeza lokuvuselela. Ikhono layo elikhethekileyo lokuzimanya kunye nezicubu eziphilayo kunye nokuvuselela ukuphiliswa kwenza kube yinto eyimfuneko kwizixhobo zonyango zesizukulwana esilandelayo. Nangona kunjalo, umgangatho we powder uchaphazela ngokuthe ngqo kwiziphumo zekliniki. Ukwahlukahlukana ekubunjweni okanye ubungakanani beengqungquthela kunokukhokelela ekusebenzeni okungahambelaniyo.
Ngokukhetha indawo yethu eqinisekisiweyo ye-ISO, ufumana ufikelelo ku:
Nokuba wenza intlama yamazinyo entsha, indawo yokufakela amathambo, okanye ukunxitywa kwenxeba, iqela lethu likulungele ukuxhasa iprojekthi yakho ukusuka kwiprototype ukuya kwintengiso.
Qhagamshelana neqela lethu leentengiso zobuchwephesha namhlanje ukuze ucele isampulu, uphonononge iphepha lethu leenkcukacha ezipheleleyo, okanye uxoxe ngeemfuno zakho zokwenza isiko. Masikuncede ukhawulezise uphuhliso lwemveliso yakho ngezinto ezinokuthenjwa, ezisebenza kakhulu.
Phonononga uluhlu lwethu olupheleleyo lwezinto ezisebenzayo kunye nezixhobo zobugcisa