Niki Lidocaine Yatewe na Dermal Yuzuza Nimpamvu Ihinduka Clinical Standard

Kugura kwisi yose mubyubuvuzi bwiza bwiza Kwimura L idocaine Yuzuza , Guhinduka Ibyingenzi bikoreshwa mubuvuzi.

Uruganda rukora ubuvuzi bwiza cyane ku isi rwabonye impinduka zikomeye mu myaka icumi ishize: kuzuza aside ya hyaluronike gakondo idafite imiti igabanya ubukana irimo kugenda buhoro buhoro biva mu bubiko rusange bw’amavuriro. Ibicuruzwa bya aside Hyaluronic hamwe na lidocaine ubu bingana na 62% byuzuza ibicuruzwa byuzuye ku masoko yo mu Burayi, Amerika, Uburasirazuba bwo hagati na Aziya y'Amajyepfo. Ku mavuriro meza, abadandaza bakomeye hamwe n’abakwirakwiza ibicuruzwa mu karere, hashyizwemo ivuriro ryemejwe 'ububabare bwuzuye dermal yuzuza 'mubicuruzwa portfolio ntibikiri amahitamo ahubwo ni ingamba zifatika zo guhuza ningeso zikoreshwa zabarwayi ba estetique no kunoza imikorere.

Hamwe nuburambe bwimyaka 25 mubucuruzi mpuzamahanga bwuzuza ubwiza bwubuvuzi, dukwirakwiza mubihugu birenga 120 kwisi, twateje imbere ibicuruzwa byabigenewe ibicuruzwa birenga 580 byaho byuburanga mu mahanga. Duhereye ku bwinshi bwibitekerezo twakira kubakoresha amaherezo ya clinique, turashobora kwerekana neza inyungu zamafaranga zituruka kubisubiramo. Kurugero, i Dubai, impuzandengo yubunini bwuburanga bwiza bwasimbuye 80% yububiko bwuzuye HA yuzuza lidocaine mu gihembwe cya mbere cya 2025. Nyuma y’amezi atandatu, hiyongereyeho 41% by’igipimo cyo gusurwa n’abarwayi bashya ndetse no kugabanuka kwa 28% by’ibiciro bifitanye isano n’ibikoreshwa mu gutera anesthetike y’ibanze yakoreshejwe mbere yuburyo bukurikizwa. Iyi mibare nyayo yunguka kwisi niyo mpamvu rwose lidocaine yuzuza ibyuzuye byihuta byahindutse urwego rwibanze rukoreshwa mubikorwa byubuvuzi kwisi yose. Iyi ngingo igabanyijemo iyi ngingo mubice bitanu byingenzi - amahame yo gushyiraho, agaciro k’ubucuruzi ku ivuriro, umurongo w’ibicuruzwa, kubahiriza amabwiriza n’ubufatanye bwa OEM / abikorera ku giti cyabo - guha abaguzi ku isi amakuru akenewe kugira ngo bafate icyemezo kiboneye kandi gishingiye ku makuru ku kugura byinshi.

Ihame rya siyansi yibanze: R&D ishingiro ryuburyo butagira ububabare

Kugirango tumenye impamvu abuzuza dermal bafite lidocaine baruta 'ibya kera ', tugomba guhindukirira ubuvanganzo bw’isi ku isi ndetse n’ibisabwa kugira ngo habeho ibiyobyabwenge byemewe n’inzego zemeza ibyemezo bya CE hamwe n’ubuyobozi bugenzura iburayi na Amerika. Ubwinshi bwiyi nyongeramusaruro ni 0.3% lidocaine, niyo nganda yinganda, kandi byemejwe nigeragezwa ryamavuriro menshi yo mu mavuriro kugira ngo bigire ingaruka nziza kuri analgesie yibanze idahinduye imiterere ya fiziki ya chimique ya acide ya hyaluronike cyangwa kongera ibibazo bya allergique ku barwayi.

Acide Hyaluronic ni kimwe mu bigize dermis z'umubiri w'umuntu. Nubunini busimbuza ingirabuzimafatizo zoroshye mugufata amazi hagati yimyenda. Ikoreshwa mu koroshya iminkanyari ihagaze, kuvugurura isura yo mumaso nkikiraro cyizuru, umurongo wurwasaya, umusaya wa pome n umusaya, nibindi. Ibi bikemura ububabare buterwa nuburyo busanzwe bwo kuzuza nko gutobora inshinge binyuze mu ruhu no gutera inshinge. Bitandukanye nuburyo bwabanjirije uburyo bwo gukoresha amavuta yo kubabaza mbere yuburyo bukoreshwa, igisubizo kibanziriza kuvanga anesthetic gishobora gukurikiza aside ya hyaluronike kugirango ikwirakwize ibice ku bice bitandukanye bya dermal, bikoroshe neza. uburambe bwumurwayi wumurwayi muburyo bwose.

Itsinda ryabafatanyabikorwa bacu R&D ryitangiye guhuza aside ya hyaluronike ihuza imyaka irenga 20, kandi igenzura neza urwego rwose rutanga ibikoresho. Acide ya hyaluronike ni isuku yimiti ya farumasi itumizwa mu mahanga, igiciro cyamasoko ni $ 45,000 kuri kilo. Ikorerwa mu cyumba cy’isuku cya GMP cyo mu cyiciro cya 100 binyuze mu ntambwe 27 zinyuranye zo kweza osmose ukoresheje amazi yo gutera inshinge. Ubu buryo bukuraho ibibyimba byose nyuma yibikorwa biterwa numwanda kandi bigatanga ikwirakwizwa rya lidocaine muri monofasike cyangwa biphasic hyaluronic acide gel matrix. Ubushakashatsi bwemewe bw’amavuriro bwerekanwe muri NCBI bwemeza ko kuba lidocaine iri mu kigereranyo cyujuje ibisabwa bitagira ingaruka ku rwego rwo guhuza imipaka, umuvuduko wa metabolike w’umubiri hamwe n’ibisubizo by’uburanga. Ubusanzwe isura ya 1ml na 2ml ifite ibisubizo bimara amezi 9-12, na 10ml na 20ml byuzuye umubiri wuzuye byuzuza ibisubizo bimara amezi 12-18 - ugereranije no kuramba kuranga mpuzamahanga mpuzamahanga nka Restylane na Juvéderm.

Inyungu enye zingenzi zubuvuzi nubucuruzi byuzuza Lidocaine kuzuza inganda zikurikira? (Isesengura riva mubitekerezo bya Clinic nabatanga inyungu)

Ibikurikira bikurikira bishingiye ku byukuri-byukuri, ibitekerezo byukuri biva mumiryango yacu yisi yose yibigo byubuvuzi byuburanga bwiza hamwe nabakiriya bagura byinshi kandi bifitanye isano itaziguye no kuzamura inyungu no guhatanira isoko kubaguzi bacu.

Gutezimbere kuburyo butangaje ububiko bushya bwo guhindura abakiriya no gusubiramo igiciro

Ubushakashatsi bwakozwe mu nganda bugaragaza ko hejuru ya 61% by’abarwayi b’uburanga bwiza birinda kugirwa inama kubera gutinya ububabare bujyanye no gutera inshinge. Amavuriro yagiye mu kuzuza lidocaine yagize igabanuka rya 50% mugipimo cyabakiriya bayo. Urunigi rwo muri Berezile rwamavuriro yuburanga (umukiriya umaze igihe kinini) rwongereye igipimo cyabakiriya bashya 37% mugihe cyamezi atatu nyuma yo guhindukira rwose mubicuruzwa byuzuye birimo lidocaine. Byongeye kandi, 89% by’abarwayi bahawe imiti yuzuye bagarutse gukoraho, guhuza cyangwa ubundi buryo bwo kurwanya gusaza mu mezi icumi, bigatuma amafaranga yinjira kandi yizewe kandi arambye.

Kugabanya itangwa ryamavuriro nigiciro cyakazi, no koroshya akazi mbere yo gutangira

Uburyo busanzwe bwo kuzuza dermal busaba mbere yo kuvura igihe cyo guta umutwe kuminota 20 kugeza kuri 40 akenshi bikubiyemo gukoresha imyambarire idasanzwe. Ibi bitwara amavuta menshi ya cream anesthetic hamwe nabakozi baforomo. Ariko hamwe nuwuzuza mbere yo kuvangwa na lidocaine, usiba ibyo byose bitesha umutwe hanyuma ukazigama 22% kugeza 30% byibikoreshwa nakazi kuri buri gikorwa. 'Ibi biganisha ku kuzigama kwinshi mubikorwa byumwaka mugihe cyamavuriro manini manini yuburanga akora amajana yuzuza buri munsi.

Kugabanya ingaruka mbi nyuma yo kubagwa no kugabanya amakimbirane yubuvuzi

Gukoresha cyane amavuta ya anesthetic kuruhu birashobora gutuma byoroshye ingaruka mbi kubarwayi bafite uruhu rworoshye, nko gutukura, guhinda no kubyimba gutinda. Dukurikije imibare y’ibarurishamibare yatanzwe n’abaterankunga bacu bo mu mahanga, isosiyete yacu yubahirije formulaire yihariye ifite 0.3% yibikoresho bikora bihuza cyane n’ibipimo by’ubuvuzi ku isi, kandi ibyo byatumye igabanuka rikabije ry’imyumvire ya allergique.

Gushoboza abadandaza gutandukanya ibicuruzwa byabo no kumenyekanisha isoko ryabo

Intara yihariye yo mukarere hamwe nabacuruzi benshi barashobora kubika urutonde rwuzuye rwujuje ibyangombwa, ivuriro-ryuzuye ryuzuza harimo urwego rwuzuye rwa CE yemewe na dermal yuzuza ibicuruzwa, kugirango yunguke neza kurushanwa kurenza ibyujuje ibyangombwa, bitujuje ubuziranenge byuzuza isoko. Twageze ku isoko rirenga 30% mumasoko yo hagati y’ibicuruzwa byuzuza ibicuruzwa byo mu burasirazuba bwo hagati no mu Burayi bwi Burasirazuba tubikesha abafatanyabikorwa bacu benshi bafite uburenganzira bw’ibigo byihariye ku bikoresho byuzuye bya lidocaine.

Ibintu bitandukanye byuzuza lidocaine byashyizwe mubikorwa ukurikije amavuriro akoreshwa

Dermal yuzuye yuzuye ya lidocaine yuzuye igwa mumirongo ibiri yingenzi yibicuruzwa, itandukanijwe no gutandukana kwinshi kwa acide ya hyaluronike, guhuza ubwuzuzanye no kuzuza ingano, bikubiyemo ibyiciro byose bikenerwa mubuvuzi, kuva gukosora imirongo myiza kugeza kubishushanyo no kongera amagufwa:

Urukurikirane rwiza rwo gutunganya umurongo (1ml / 2ml): Guhuza kwinshi, acide biphasic hyaluronic aside + 0.3% Lidocaine

Nibyiza kuvura ibirenge byinkongoro, imirongo myiza yumurongo hamwe no kwiheba amarira no kwongera iminwa. Gele iroroshye kandi irashobora gukwirakwira byoroshye kandi bingana. Hariho kubyimba gake nyuma yuburyo bukurikira. Uru ruhererekane ni ibendera 'igeragezwa ryibicuruzwa ' kumavuriro mato mato mato mato kandi aringirakamaro mugutwara abakiriya no kwishora mubikorwa.

Ibishushanyo mbonera byimbitse (1ml / 2ml): Umuvuduko mwinshi, uhuza cyane aside hyaluronic + Lidocaine

Igicuruzwa cyibanze kubigo byubuvuzi byubuvuzi byumwuga, kugirango bivurwe byimbitse ya nasolabial hamwe nu murongo wuruhanga, kimwe na rinoplasti, kongera urusaku, urusengero rwinshi hamwe nubusobanuro bwa jawline. Gele ifite ubufasha bwiza bwimiterere no kurwanya kwimuka, bigatuma biba byiza gutera inshinge zimbitse cyangwa supraperiosteal.

Turatanga kandi PLLA-igizwe no kuvugurura ibyuzuzo hamwe nuburyo bwo kwihitiramo kugiti cye. Bitewe nibisabwa buri muntu ku giti cye, arashobora gutegurwa na lidocaine cyangwa idafite kandi akifashisha imbaraga zo kongera umusaruro wa kolagen yumubiri kugirango atange ibisubizo birambye, kandi bimara imyaka irenga ibiri. Ibi bituma bahitamo neza kurwego rwohejuru, bespoke anti-gusaza paki.

Lidocaine OEM yuzuza uruhushya rwuzuzanya hamwe nuwuzuza formulaire yo guhitamo Kwibanda kubakora ibicuruzwa byisi yose hamwe nabaguzi ba label

Bitandukanye nabandi batanga ibikoresho byibanze byujuje ibyangombwa, dufite uburambe bwimyaka 25 muruganda, isomero ryibisobanuro birenga igihumbi byemejwe, hamwe nitsinda ryabajyanama b'inzobere, barimo abahanga mu kuvura dermatologue bemewe baturutse mu Burayi, Amerika, Koreya y'Epfo, na UAE, kugira ngo batange serivisi zuzuye z’ibicuruzwa byihariye mu bice bine by'ingenzi:

Guhindura formulaire: Duhindura ingano ya lidocaine murwego rwubuvuzi kandi twongeramo ibintu nka kolagen, PDRN, PLLA tubisabwe. Acide ya Hyaluronic irashobora guhindurwa kuburyo bworoshye hagati ya 20mg / ml na 25mg / ml, mugihe gel viscosity hamwe ninkunga yimiterere ijyanye nibyiza bya buri soko.

Gupakira ibicuruzwa: Ibirango byihariye byabakiriya bikoreshwa kuri syringes, agasanduku ko hanze na vial. Siringes iza mubunini busanzwe bwa 1ml, 2ml, 10ml na 20ml hamwe ninshinge kuva 26G kugeza 30G ahantu hatandukanye.

Igishushanyo mbonera: Abashushanya batandatu bafite uburambe bunini mubipimo byuburanga bwisoko ryubuvuzi bwubuvuzi bwisi yose batanga ibishushanyo mbonera byubusa kubakiriya-label yihariye.

Umusaruro wizewe ： Iyo formulaire yawe hamwe nugupakira birangiye, ibicuruzwa byigenga byigenga byarangiye mubyumweru 2-3. Turemeza ko tuzatanga ibicuruzwa binini ku isi ku gihe kandi tukagira ubushobozi bwo gukora buri kwezi bwa 500.000 syringes.

Twatangije neza ibicuruzwa byigenga byamamaza ibicuruzwa birenga 580 byubuvuzi bwiza byubuvuzi byumugabane wa gatanu kugeza ubu, kandi twafashije benshi mubafatanyabikorwa bacu kuba abatanga isoko ryuzuza dermal mukarere kabo.

Umwanzuro: Korana nuburyo bukwiye bwa lidocaine yuzuza ibicuruzwa kugirango ukoreshe isoko ryagutse ryubuvuzi bwiza.

Ukurikije icyerekezo cy’ubuvuzi bw’ubuvuzi ku isi, umugabane w’isoko wuzuza aside hyaluronic idafite ububabare hamwe na lidocaine uzagenda wiyongera buhoro buhoro mu myaka 3-5 iri imbere. Biteguye gusimbuza burundu kuzuza gakondo nta miti igabanya ubukana no guhinduka bisanzwe bikoreshwa muburyo bwiza bwo gutera ubwiza. Imbaraga zitera impinduka ni izamuka ry’abarwayi bakeneye ubunararibonye bwo kwivuza kimwe n’inganda zifuza inyungu nyinshi.

Niba uri urunigi rwibitaro byo kubaga plastike cyangwa ivuriro rimwe ryiza ryo mu rwego rwo hejuru cyangwa uri umugabuzi ushaka kubona uburenganzira bwihariye bwaho, wongeyeho kubahiriza, byemejwe nubuvuzi lidocaine yuzuza ibicuruzwa byawe portfolio ni ingamba zifatika zo kuzamuka kwigihe kirekire. Amatsinda yo kugurisha hamwe na tekiniki arahari kugirango atange ibiciro byinshi, ibyitegererezo byubusa hamwe na progaramu yihariye-label igenamigambi, niba ubishaka. Urashobora kutwandikira ukoresheje urubuga rwacu rwemewe kugirango wakire urutonde rwibicuruzwa byuzuye hamwe nubushakashatsi bwakozwe mubisabwa ku isi.