iphepha_ibhena

iimveliso

I-REJEON PCL Filler Injection Anti-wrinkle lifting and firming

Inkcazelo emfutshane:

I-PCL inokuphucula i-contour ye-three-dimensional yobuso bonke.Inempembelelo yokuphakamisa kunye nokuqinisa ukuguga kunye nokukhululeka kwesikhumba

Ukusetyenziswa kwendawo: ibunzi, iitempile, i-brow arch, i-cheekbones, izihlathi, impumlo, i-nasolabial folds, imibimbi yomlomo, i-jawline.


Iinkcukacha zeMveliso

Iithegi zeMveliso

Imvelaphi yeREJEON PCL

Kwiminyaka engama-20 edlulileyo, ukuqonda kwethu enye yezona ndawo zintsonkothileyo emzimbeni womntu - ubuso - kuye kwaphucuka ngokumangalisayo, kunye nezakhiwo ezininzi ze-anatomical ezichongiwe.

Ngelo xesha, i-plethora ye-non-utyando
sele zikhona iinkqubo zonyango
iimpawu zokuguga kunye nokubuyisela ulutsha
ukubonakala kobuso. I-REJEON ngowokuqala, kwaye
okwangoku ekuphela kwayo, i-collagen sti mulator eyenziwe nge-polycaprolactone microspheres, enegalelo kuphuculo lobuhle bayo oluhlala ixesha elide. REJEON
iimpawu ezizodwa zithetha ukuba lukhetho olunqwenelekayo kuluhlu lweenkqubo zezicubu ezithambileyo.

a

Isishwankathelo

Ukuqulunqwa kwe REJ EO N ,
7 0% esekelwe kwi-CMC yamanzi
ophethe ijelikwaye3 0 % PCL
ukwakheka,ivumela
isiphumo sokuzaliswa kwangoko
okubangelwa yiCMC, kulandelwa kukuvuselelwa kwecollagen yomzimba (neocollagenesis).

I-CMC ifakwe kwakhona kwi-2 ukuya ku-3
iinyanga emva kwesitofukwaye ngokuqhubekayo ithathelwa indawo yeyesigulana
icollagen (ubukhulu becala uhlobo I) luvuselelwe yi
PCL microspheres. Ii-microspheres ze-PCL nazo ziyakwazi ukufumaneka kwi-bioresorbable.

I-REJEON inenani leempawu ezenza ukuba ibe lukhetho olunomtsalane njenge-dermal filler:

①Ukufakwa kwe-polymer microspheres, malunga nenyanga ye-1, kunye ne-collagen scaffold ehambelanayo ikhusela ukusabela okungaphezulu kokuvuvukala ukuba kwenzeke13
②Uhlobo lwe-collagen oluhlala luhleli kwindawo etofweyo ubukhulu becala sisikafula se-collagen 'esikhulileyo' sohlobo lwe-collagen i-I5.
a) Ukunciphisa uhlobo lwe-collagen lwe-III luthetha ukuba akukho vuselelo olungakumbi lwempendulo yokuvuvukala
③Ukuthotywa kwe-REJEON kugqitywe nge-hydrolysis, kushiya nje amanzi kunye necarbon dioxide.
④Ngenxa yokuba umthamo wokugqibela kwindawo enyangweyo mkhulu kunomthamo we-Ellansé otofweyo, akukho mfuneko yokuba 'uchukumise' unyango.
a) Umthamo wokugqibela mkhulu kunomthamo ofakwe kwi-20-30% ngenxa yokwenziwa kohlobo lwe-collagen I-fibers11
⑤Ubukho beenguqulelo ezimbini ze-REJEON ezinexesha elahlukileyo lesenzo kuthetha ukuba ubude besiphumo sonyango sinokulungelelaniswa nesigulana.
iimfuno
a) Oku kuphunyezwa ngokutshintsha ubude bemixokelelwane ye-PCL, ukuvumela ukuqikelelwa, ukulawulwa kunye nokuhlengahlengiswa kwe-bioresorption.
⑥Indlela yonyango iyafana nokuba yeyiphi imveliso yeREJEON ekhethiweyo a) Kuyafana:
● Iimpawu zeRheological

● Ubuchule

● Isirinji

● Inaliti/cannula

 

I-REJEON PCL Ukwakheka okwahlukileyo

I-REJEON PCL yenziwe yinto eyodwa, enelungelo elilodwa lomenzi wechiza
NONE
● I-7 0% ye-carboxymethyl cellulose (CMC) - i-gel carrier carrier
● I-3 0% ye-polycaprolactone (PCL) i-microspheres (Umfanekiso 1.4) 3, 4, 5

Iimicrosphere zePCL zibanjelwe ngaphakathi
ukunqunyanyiswa homogeneous kwi-CMC-based gel carrier. I-PCL kunye ne-CMC zombini zineprofayili egqwesileyo kwaye eqinisekisiweyo ye-biocompatibility.

a
b
d

IREJEON PCL imathiriyeli eluhlaza ivela eGemany

I-PCL MICROSPHERES

I-PCL yipolyester yonyango engenatyhefu, eyaqala ukwenziwa ekuqaleni koo-1930s4, oko kukuthi.
ekhangayo ukuba isetyenziswe kwii-dermal fillers ngenxa yokulula kwayo i-bioresorption; ngokwemvelo ifakwe kwi-hydrolyzed kwi-carbon dioxide kunye namanzi ngaphakathi komzimba5.

Iimicrosphere zePCL ezisetyenziswa kwi
I-RE JEON yenzelwe ukunika
eyona biocompatibility6. Zinobuso obugudileyo, a
imilo engqukuva kunye nobukhulu be
malunga nama-25–50 μm

I-PCL ineprofayili egqwesileyo yokhuseleko3 kwaye isetyenziswe kwintsimi ye-biomedical iminyaka engaphezu kwe-70 kuluhlu lwezicelo, ukusuka kwi-sutures ukuya kwi-tissue kunye nokutshintshwa kwamalungu ngokuprintwa kwe-3D (Umfanekiso 1.6)4. Ikwasetyenziswa kwi-CE-ephawulwe kunye ne-US Food and
Ulawulo lweziyobisi (FDA)- iimveliso ezivunyiweyo.

a
b

IIPROPATI ZE-CMC
I-CMC yinto yendalo evela kwiselulosi; ayidityaniswanga, kwaye ayinayo ityhefu. Ezinye iipropati zayo ziquka (Umfanekiso 1.7)4 :
● Yinto eyaziwayo encedisa amayeza
● I-hygroscopic
● Ichongwe yi-FDA njengeyaziwa ngokubanzi njengekhuselekile ( GRAS)
● Ukubuyisela kwakhona kwenzeka kwiinyanga ezi-2 ukuya kwezi-3

Iingenelo eziphambili zeREJEON PCL Filler

I-REJEON PCL ine-microsphere ekhethekileyo kunye negqibeleleyo, kunye nobukhulu beengqungquthela ezihlangabezana nemigangatho yokhuseleko lwamazwe ngamazwe kunye nomgangatho ogudileyo onokuqhubeka nokukhuthaza ukukhula kwe-collagen.

a

Ukuvuselelwa kweCollagen nguREJEON: Ubungqina besayensi

REJEON uye waba
kuvavanywa kwisilwanyana
imodeli apho imivundla yatofwa ngayo
nokuba yiREJEON S
(PCL-1) okanye i-REJEON M (PCL-2) ukuphanda i-neocollagenesis5.

Kwiinyanga ezilithoba emva kokutofa kwe-PCL-1,
I-neocollagenesis yenzekile kwaye i-PCL microspheres ye-PCL-1 yayihlaziywe ngokupheleleyo (Umfanekiso 1. 1 1) 5.
Okwangoku, nge-PCL-2 kwiinyanga ze-9,
bekukho ubungqina bokusekwa kwe
uhlobo I kwaye uchwetheze III collagen ngeenxa zonke
PCL microspheres. Kwiinyanga ze-2 ze-post-injection, i-PCL-2 i-microspheres yayisekho kwi-tissue injected5.

Kuphononongo olulingwayo lwe-RE JEO N ebantwini, izigulana zabhaliswa ukuba zifumane i-Ellansé etofelwe nge-intradermally etempileni.
ummandla9. Uhlalutyo lwe-Histological lwezicubu ezifunyenwe kwii-biopsies zityhiliwe
ukubunjwa kwe-collagen malunga neengqungquthela ze-PCL ezijojowe (Umfanekiso 1. 12) 9, ukuxhasa iziphumo ezifanayo eziboniswe ngaphambili
izicubu zomvundla5.

b

REJEON indlela yokusebenza

I-REJEON inezigaba ezibini ezahlukeneyo zomsebenzi (Umfanekiso 1.9)1,4 :
● Inyathelo loku-1: Ngokukhawuleza emva kokutofa, icandelo le-CMC libonelela ngevolumu yethutyana,
ethi iyancipha ngokuthe ngcembe kwiinyanga ezi-2-3
● Inyathelo lesi-2: I-PCL microspheres induce
I-neocollagenesis yeentlobo ze-I kunye ne-III collagen, kunye nohlobo oluqhubekayo oluqhubekayo lwe-collagen
Ulwakhiwo lwanda ngokuthe ngcembe kwiinyanga ezi-1 ukuya kwezi-3 kunye ne-PCL microspheres
ukuba ifakwe kuhlobo lwe-collagen
isikafula. Isiphumo somthamo we-collagen
ithatha indawo yokunyuka kwevolumu yokuqala okubangelwa yijeli yeCMC

I-collagen scaffold ekhuthazwa yi-PCL
iimicrospheres ziyaqhubeka emva kokuba ziphinde zafakwa, okukhokelela ekonyusweni kwevolumu ehlala ixesha elide ebonwa ngeREJEON.

1

I-REJEON PCL Filler ineziphumo ezilungileyo

I-REJEON PCL Filler yi-ejenti yokuzalisa ehlala ixesha elide enokuthi igudise umkhondo oshiywe lixesha kwaye ibuyisele imbonakalo yobutsha kunye neyobutsha ebusweni.

a

IREJEON PCL FILLER IMPENDULO YOMTHENGI

1

Sizimisele ukwabelana ngobuchule bethu kunye
ulwazi xa kunye nendlela yokudibanisa i-r ej eon ekusebenzeni kweklinikhi. Ndiyathemba ukuba iyakunceda umfundi ngendlela enye endisebenzele ngayo kule minyaka ili-10 idlulileyo: ukunika unyango olukhuselekileyo oluneziphumo ezingcono kunye neziphumo ezihlala ixesha elide. I-RE JEON sisixhobo esisisiseko ekusebenzeni kwam kwaye indenze i-injector engcono! ”

UGqr Francisco de Melo
UGqirha wePlastiki, e-UAE

2

“ IRE JEON ibiyeyona nto ndiyithandayo yokugcwalisa idermal
Iminyaka eyi-7. Le ncwadi iza kukunceda ukwazi ukuyisebenzisa kakuhle
RE JEON kwaye uya kuyithanda. ”

UGqr Shang- Lin
Ugqirha wesikhumba, eTaiwan

3

“Ukuphuculwa kolwakhiwo kunye nolusu
umgangatho ophuma kwi RE JOE N 's unique
I-neocollagenesis ayifani. Ngokungathandabuzekiyo esinye sezona zixhobo zingcono kwiiklinikhi ezifuna ukusebenza kakuhle kunye nokhuseleko kwimveliso etofwayo. I-REJ EO N ine
amandla okubonelela ngokuphakamisa okuhlala ixesha elide kunye nokwakhiwa kobuso okwandisiweyo ngeseshoni enye nje. ”
UGqr Ingrid Ló pez- Gehrke
Ugqirha wesikhumba, eMexico

4

“Ndifumana uyolo olukhulu ekusebenziseni iRE JEON ngenxa yesiphumo sayo sokucula sevol umi. Oku kuvumela ngaphantsi
imveliso eza kusetyenziswa, kwaye ngemveliso yokwenyani yohlobo lwe-collagen I, inomthamo wokwenyani wesikhumba
ukuzalwa ngokutsha. Izigulana ezininzi zithi kum: ‘Siyaqala ngqa
Ndinento ehlala ihleli', okanye 'Jonga umgangatho wolusu lwam'. Ngokuqinisekileyo ifayile yam endiyithandayo. ”
UGqr Pierre Nicolau
UGqirha wePlastiki, eSpain

REJEON IIMBALASANA EZINGUNDOQO

Ukulandela uphando olubanzi kunye nophuhliso, kunye neklinikhi
uvavanyo, iREJEON ifumene isatifikethi se-ISO 13485 yeNkqubo yoLawulo loMgangatho kwi
20081 (Umfanekiso 1.2). Ngo-2009, ukuvunywa kwamanqaku e-European Conformity (CE) kwaba
kunikwe, ukukhokela

kuphehlelelo olunempumelelo kakhulu lwe
imveliso e-UK, eJamani naseSpain. Kwalandela okunye ukuqaliswa, ngokubhaliswa ngaphezulu kwama-69
amazwe ngo 2018. Nge 2019, i
Isikhumbuzo seminyaka eyi-10 sokulahlwa, ngaphezulu

iisirinji ezingaphezulu kwesigidi ezithengisiweyo
kwihlabathi jikelele. Kodwa ibali lempumelelo alizange liphelele apho, kunye nesiza esitsha sokwenza eNetherlands siqala
imveliso ngo-2020

a

REJEON PCL PRODUCT Iinkcukacha

1 (2)

1ml/iqhekeza
Yamkela ukupakishwa okulungiselelwe kwe-OEM


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