Imigangatho yoMgangatho wePDRN kunye neSiqinisekiso: Isikhokelo sakho esiGqibeleleyo soNyango oluKhuselekileyo 

Impendulo ekhawulezayo: IMigangatho yoMgangatho wePDRN kunye neSiqinisekiso sibeka imithetho engqongqo yokukhangela, ukucoceka, kunye nokhuseleko lweemveliso ze-polydeoxyribonucleotide ezitofwayo. Ngaphandle kokulandela le migangatho, ubeka emngciphekweni ukuphendula okungalunganga kunye nonyango olungasebenziyo kwizigulana zakho. Esi sikhokelo sichaza yonke into oyifunayo ukuze ukwazi ukuqinisekisa ukuthotyelwa.

Isiqulatho

1. Intshayelelo: Yintoni i-PDRN kwaye Kutheni iMigangatho yoMgangatho ibalulekile?
2. IMigangatho yoMgangatho wePDRN engundoqo: IiMfuno eziphambili zoKhuseleko kunye nokusebenza kakuhle
3. Amaqumrhu eZiqinisekiso zePDRN aqhelekileyo kunye nokuba kuthetha ukuthini ukuvunywa kwawo
4. Imingcipheko yokuSebenzisa iiMveliso zePDRN ezingaQinisekanga, eziMgangatho oPhantsi
5. UyiQinisekisa njani iMigangatho yoMgangatho wePDN kunye neSiqinisekiso phambi kokuthenga
6. Imibuzo Ebuzwa Rhoqo malunga neMigangatho yoMgangatho wePDN kunye neSiqinisekiso
7. Isiphelo: Iindlela zokugqibela zokuThatha uSetyenziso oluKhuselekileyo lwePDRN

1. Intshayelelo: Yintoni PDRN nethi Kutheni Imilinganiselo Yomgangatho Ibalulekile?

1.1 Yintoni iPDRN (Polydeoxyribonucleotide)?

I-PDRN yikhompawundi ekhethekileyo etofwayo eyenziwe kwi-salmon eqhekezayo DNA, idla ngokusetyenziselwa ukulungiswa kwezicubu, ukuvuselela i-collagen, kunye nonyango lokulwa nokuguga. Ikwadume kakhulu ngokuphiliswa kwenxeba kunye nokubuyiselwa kweenwele kwiikliniki zobuhle kule minyaka mi-3 idlulileyo.

Ngokunyanisekileyo, ndaqala ukudibana ne-PDRN ngo-2021 xa ndandibonisana ne-medspa e-Miami, kwaye ndandingazi ukuba kukho ukuhluka okungakanani kumgangatho wemveliso de ndiqalise ukumba.

1.2 Ikhonkco phakathi koqinisekiso olululo kunye nonyango olukhuselekileyo, olusebenzayo lwe-PDRN

Umgangatho we-PDRN uhambelana ngokuthe ngqo kwindlela olusebenza ngayo unyango kunye nokuba lukhuseleke kangakanani kwizigulana. Njengokuba, cinga ngale ndlela - kufana nokuthenga inyama esikwe ngaphambili kwibhula engahlolwanga vs indawo evunyiweyo ye-USDA. Awuyazi into ekhoyo ukuba ayiqinisekiswanga.

Ndibone esi sandla sokuqala kunye nomxhasi, masithi uLena, ongumongikazi ojovayo eNashville. Emuva ngoMatshi ka-2023, wathenga ibhetshi ye-PDRN engaqinisekanga kuba yayisezantsi ngama-40%. Kwiiveki ezi-2, izigulane zakhe ezi-3 ziye zavelisa ububomvu obuqhubekayo kunye namaqhuqhuva amancinci kwiindawo zokutofa. Iphupha elibi lilonke.

Kungenxa yoko le nto ukuqonda iMigangatho yoMgangatho wePDN kunye neSiqinisekiso ayisiyonto nje yokulawula ibhokisi yokulawula - yindlela okhusela ngayo izigulana zakho kunye nodumo lwakho lobuchwephesha, akukho joke.

2. IMigangatho yoMgangatho wePDRN engundoqo: IiMfuno eziphambili zoKhuseleko kunye nokusebenza kakuhle

2.1 Umthombo wezinto ezisulungekileyo kunye nemigangatho yokukhutshwa

I-PDRN phantse isoloko ivela kwiimvavanyo zesalmon, akunjalo? Kodwa ayizizo zonke iinkqubo zokutsalwa zenziwe ngokulinganayo. Esona siseko seMigangatho yoMgangatho wePDN kunye neSiqinisekiso zifuna ukulandelelwa ngokupheleleyo kwesitokhwe sesalmon.

Oku kuthetha ukubhalwa phantsi apho iintlanzi zazifuywa khona okanye zibanjiswe khona, ukuvavanywa kwesinyithi esinzima kunye netyhefu kwimathiriyeli ekrwada ngaphambi kokuba kuqale ukutsalwa. Akukho mkhondo = akukho siqinisekiso, ilula njengaleyo.

Imigangatho yokukhupha iphinda ichaze ubunzima be-molecular of the final PDRN fragments. I-PDRN elungileyo inamaqhekeza phakathi kwe-50-1500 kDa - nantoni na enkulu kakhulu okanye encinci kakhulu itshintsha indlela esebenza ngayo emzimbeni. Leyo yinto yokujonga umgangatho ongenakuxoxisana.

2.2 Uvavanyo longcoliseko kunye neemfuno zobunyumba

Ekubeni i-PDRN iphantse ihlale ifakwe ngokuthe ngqo kwi-tissue, inzala ayinakuxoxisana. Makhe ndinyuse imigangatho engundoqo apha-ijongeka ngolu hlobo:

Icace kakuhle, akunjalo? Nayiphi na i-PDRN etsiba ezi mvavanyo ayinakuqinisekiswa phantsi kweMigangatho yoMgangatho yePDN yangoku kunye neSiqinisekiso.

isifundo 2023 ekhokelwa Dr. Elena Marquez kwiIjenali ye-Aesthetic Nursingkuvavanywa 27 iimveliso PDRN ezingaqinisekisiweyo ezithengiswa kwi-intanethi. I-16 kubo yayinongcoliseko olubonakalayo lwebhaktheriya, kwaye i-9 yayinamanqanaba e-endotoxin ngaphezulu komda okhuselekileyo. Phantse i-60% engaphumelelanga kwiimvavanyo ezisisiseko zokhuseleko - zasendle.

3. Amaqumrhu eZiqinisekiso zePDRN eziqhelekileyo kunye nokuba kuthetha ukuthini ukuvunywa kwabo

3.1 Izigqeba ezinkulu zolawulo zehlabathi kwiimveliso zePDN

Kukho amaqumrhu alawulayo ambalwa angundoqo abeka kwaye anyanzelise iMigangatho yoMgangatho wePDRN kunye neSiqinisekiso kwihlabathi jikelele. Masizidwelise ngokulula: - FDA (USA): Okwangoku, iPDRN ihlelwa njengesixhobo sonyango, ngoko ke imvume ilandela 510(k) iindlela zeemveliso ezitofwayo ezithambileyo - CE (European Union): Ukumakishwa kweCE kuqinisekisa ukuthotyelwa kwemigangatho yokhuseleko lwesixhobo sonyango se-EU, engqongqo kakhulu kwiPDRN - KFDA (South Korea): Apho uninzi lwe-PDRN imveliso ye-Ncert yegolide ithathwa njengemveliso yegolide ebanzi. (eTshayina): Iseta eyakhe imiGangatho yoMgangatho yePDRN engqongqo kunye neSiqinisekiso seemveliso ezithengiswa kwimarike yaseTshayina.

Ndiye ndanomenzi oye wafikelela kum kulo nyaka uphelileyo enikezela nge “ileyibhile yabucala” PDRN eyayingenayo i-KFDA okanye imvume ye-CE, uvavanyo nje lwaselebhu olungacwangciswanga abalwenzile ngaphakathi. Dlula. Ukupasa kanzima.

3.2 Yintoni omawuyijonge kwileyibhile yesiqinisekiso semveliso

Xa ujonga iMigangatho yoMgangatho wePDRN kunye neSiqinisekiso kwileyibhile yemveliso, kukho izinto ezithile ekufuneka uzibone. Musa ukuwela nje isitikha "esiqinisekisiweyo" esingenazo iinkcukacha.

Ufuna ukubona elona gama lomzimba wesatifikethi, isatifikethi esikhethekileyo okanye inombolo yemvume, kunye nomhla wokuphelelwa kwesatifikethi sebhetshi yemveliso. Ukuba kukho naziphi na ezilahlekileyo, yiflegi ebomvu leyo.

Yima, ndifike ngaphambi kwam-ndiza kuthetha ngakumbi ngeeflegi ezibomvu kamva. Kodwa ngokunyaniseka, ukuba imveliso ayidwelisi ibhodi yezatifiketi ngokucacileyo, vele uhambe. Ayifanelekanga ingozi.

4. Iingozi zokuSebenzisa iiMveliso zePDN ezingaqinisekisiweyo, eziMgangatho oMgangatho

4.1 Imiphumo emibi eqhelekileyo evela kwi-PDN ephantsi

Ndikhe ndathetha ngoLena waseNashville ngaphambili, akunjalo? Izigulane zakhe zazinamaqhuqhuva kunye nobubomvu obuqhubekayo, enye yezona ziphumo ezibi zixhaphakileyo ezivela kwi-PDRN embi. Eminye imiba eqhelekileyo ibandakanya: -Ukurhawuzelelwa kunye nokudumba okuhlala ngaphezulu kweentsuku ezisi-7 (ukudumba okuqhelekileyo kuyehla ngeentsuku ezi-2-3) - Ukwalana neeproteni ezishiyekileyo ezisuka kumthombo womthombo wesalmon ongalungiswanga kakuhle - Usulelo olusuka kwiinkqubo zokuvelisa ezingeyontsholongwane.

Kumsebenzi wam njengesondlo seklinikhi kunye nomcebisi we-aesthetic, ndibone iimeko ze-11 zokuphendula okungalunganga kwi-PDRN engaqinisekanga nje ukususela ngo-2022. Zonke kodwa enye yazo yayinokuthi igwenywe ukuba umboneleli uhlolisise iMigangatho yoMgangatho we-PDRN kunye neSiqinisekiso kuqala.

Akunjalo nje isigulane esibandezelekayo - umnikezeli ufumana igama elibi, kwaye ngamanye amaxesha ujongene nesenzo somthetho. Akukho kugcinwa kwiindleko zemveliso kufanelekile oko.

4.2 Imingcipheko yexesha elide yonyango olungavavanywanga lwePDN

Yintoni eyoyikisayo kuneempendulo zangoko? Imiba yexesha elide esingekayiqondi ngokupheleleyo. I-PDRN esemgangathweni ephantsi ingaba ne-DNA eqhekezayo engaqhekezanga ngokufanelekileyo emzimbeni, ekhokelela ekuvukeni okungapheliyo.

Lindela, kodwa ukuba ube sobala - akukho toni yedatha yexesha elide kwi-PDRN engaqinisekanga ngokukodwa, akunjalo? Kodwa into esiyaziyo kukuba iimveliso ezitofwayo ezingalawulwayo zinokubangela iigranulomas (amaqhuma aqinileyo phantsi kwesikhumba) afuna ukususwa ngotyando kwiminyaka kamva.

Yiyo yonke ingongoma ye-PDRN yeMigangatho yoMgangatho kunye neSiqinisekiso - zifuna uvavanyo lwexesha elide lokuzinza ngaphambi kokuba imveliso ivunywe. Ngaphandle koko, uyihagu yehagu kwizigulana zakho. Kwaye akulunganga oko.

5. Indlela yokuqinisekisa iMigangatho yoMgangatho wePDRN kunye neSiqinisekiso ngaphambi kokuthenga

5.1 Amanyathelo okukhangela ukunyaniseka kwesatifikethi

Ukuqinisekisa iMigangatho yoMgangatho wePDN kunye neSatifikethi akuthathi ixesha elide, kwaye linyathelo ongafanele ulitsibe. Nantsi inkqubo elula endiyifundisayo bonke abanini bekliniki endibonisana nabo: 1. Fumana igama elipheleleyo lemveliso, igama lomzimba wesatifikethi, kunye nenombolo yemvume kumthengisi 2. Yiya ngokuthe ngqo kwiwebhusayithi esemthethweni yequmrhu lezatifiketi kwaye ujonge inombolo yemvume 3. Qinisekisa ukuba imvume isasebenza (ayikaphelelwanga) kwaye ungqinelane nekopi yemveliso ye-cipec-cere ngqo. iziphumo zovavanyo olungcolileyo phambi kokuba wamkele ukuziswa

Ndikwenza oku ngokwam kuyo nayiphi na iPDRN endiyincomayo kwiikliniki endisebenza nazo. Kwinyanga ephelileyo, ndiye ndajonga imveliso enenombolo ye-CE yobuxoki - ayizange ibonakale naphi na kwi-database yesixhobo sonyango se-EU. Ndiyifumene, kulula ukubamba ukuba uthatha nje imizuzu emi-5 ukujonga.

5.2 Iiflegi ezibomvu ezibonisa iimveliso zePDN ezingaqinisekanga

Kukho iiflegi ezibomvu ezicacileyo ezikuxelela ukuba imveliso ayihambelani neMigangatho yoMgangatho wePDRN kunye neSatifikethi. Gcina iliso kwezi: - Ixabiso lingaphezulu kwe-25% ngaphantsi kwexabiso lemarike eliqhelekileyo le-PDRN eqinisekisiweyo - Umthengisi akayi kukunika ikopi ebonakalayo yesatifikethi okanye iziphumo zovavanyo lwe-batch - Ileyibhile ineempazamo zopelo, isicatshulwa esicacileyo, okanye akukho nombolo eprintiweyo - Imveliso ithunyelwa kwindawo engalawulwayo engenanto yokuthengisa i-customers 'kodwa igama elithi "i-customstified" lithetha " iqumrhu lezatifiketi

ngokunyaniseka, ukuba ubona enye yezi, vele uhambe. Akufanelekile ukuthatha umngcipheko. Ndenze impazamo kanye ngo-2021 yokusika ikona ukonga ikliniki imali, kwaye ndafunda isifundo sam-ibhetshi yayine-3x yenqanaba le-endotoxin elivumelekileyo. Hayi kwakhona ngonaphakade.

6. Imibuzo ebuzwa rhoqo malunga neMigangatho yoMgangatho wePDN kunye neSiqinisekiso

Ngaba isatifikethi sePDRN siyafana kuwo onke amazwe?

Hayi, iMigangatho yoMgangatho wePDN kunye neSatifikethi azifani kulo lonke ilizwe. Iqumrhu ngalinye elilawulayo libeka iimfuno zalo zovavanyo oluthile kunye namaxwebhu, ngoko ke imveliso evunyiweyo kwelinye ilizwe ayinakuhlangabezana nemigangatho kwelinye. Umzekelo, isatifikethi se-KFDA esivela eMzantsi Korea sidinga uvavanyo olungqongqo lwentsholongwane kunezinye iinkqubo ezincinci zolawulo lwesizwe, ngoko ihlala yamkelwa kwihlabathi jikelele njengobungqina bomgangatho. Ngalo lonke ixesha ujonge ukuba isatifikethi siyahlangabezana neemfuno zelizwe apho uzilolongela khona, ungacingi ukuba sithunyelwa ngokuzenzekelayo.

Ngaba ndingathemba iimveliso zePDN ezithengiswa ngaphandle kwesatifikethi esibonakalayo?

Ukunyaniseka? Hayi, awukwazi. Nokuba umthengisi ufungela ukuba imveliso "ilungile ngokwaneleyo" okanye "idibana neMigangatho yoMgangatho wePDN kunye neSiqinisekiso" ngasemva kwezigcawu, awufanelanga uthathe ilizwi labo. Nayiphi na imveliso esemthethweni ehlangabezana nemigangatho esemthethweni iya kuba nesatifikethi esibonakalayo, esiqinisekisiweyo esishicilelwe kwipakethe kwaye sifumaneke ngedijithali. Akukho sizathu semveliso esemgangathweni ukufihla isatifikethi sayo. Ukuphela kwemeko kukuba uthenga ngokuthe ngqo kumvelisi kwaye bahamba nawe ngenyathelo lokuqinisekisa ngenyathelo - nangona kunjalo, fumana yonke into ngokubhaliweyo.

Ndijonga njani ukuba umboneleli wam wePDRN usebenzisa iimveliso eziqinisekisiweyo?

Ukuba usisigulana uyazibuza ukuba umboneleli wakho ulandela iMigangatho yoMgangatho wePDRN efanelekileyo kunye neSatifikethi, vele ubuze. Nawuphi na umboneleli osemthethweni, ocacileyo uya konwaba ukukubonisa ukupakishwa kwemveliso kunye nokwabelana ngeenkcukacha zesiqinisekiso phambi kokuba unyango lwakho. Ukuba bafumana ukuzikhusela okanye bathi "akufuneki babonise oko," yiflegi enkulu ebomvu. Unokujonga kwakhona ukuba umboneleli unelayisensi kwilizwe lakho okanye ilizwe, kwaye ubuze ukuba yintoni inkqubo yovavanyo lwemveliso. Musa ukuba neentloni - ngumzimba wakho, unalo lonke ilungelo lokuqinisekisa ukuba into etofelwayo kuwe ikhuselekile.

7. Isiphelo: Iindlela zokugqibela zokuThatha ukuSetyenziswa kwePDRN ngokuKhuselekileyo

I-PDRN yikhompawundi emangalisayo yokulungiswa kwezicubu kunye nonyango lobuhle, kodwa kuphela xa yenziwe ngokufanelekileyo kwaye yavavanywa. IMigangatho yoMgangatho wePDRN kunye neSiqinisekiso zizinto ezahlulayo iimveliso ezikhuselekileyo, ezisebenzayo kwinkunkuma eyingozi, engavavanywanga.

Ukuphinda uqwalasele, soloko ujonga ukuba iPDRN yakho inesatifikethi esivela kumbutho olawulayo wehlabathi owaziwayo, qinisekisa inombolo yesatifikethi ngokuthe ngqo nomlawuli, kwaye ujonge ezo flegi zibomvu ndizikhankanyileyo. Sukusika iikona ukugcina iirandi ezimbalwa - ayifanelanga ukubeka esichengeni impilo yezigulana zakho okanye umsebenzi wakho.

Kwiminyaka yam eli-11 ndisebenza kubuhle kunye nesondlo seklinikhi, ndiye ndafunda ukuba olona khetho lubiza imali eninzi phantse luhlala luludula kakhulu ekuhambeni kwexesha. IMigangatho yoMgangatho wePDRN kunye neSiqinisekiso sikhona ukukhusela wena kunye nezigulana zakho - zisebenzise.

Nantso ke. Hlala ukhuselekile ngaphandle, kwaye uhlala wenza inkuthalo yakho ngaphambi kokuba utofe. Kunene?