Munguva ichangopfuura, State Food and Drug Administration yakabudisa Chiziviso pamusoro peChikamu cheKutarisira cheMedical sodium hyaluronate products (No. 103 mu2022, inozonzi Nha. Mamiriro ezvinhu uye zviri mukati madzokororo eChiziviso Nha. 103 ndeaya anotevera:
I. Mabviro ekudzokorora
Muna 2009, iyo yaimbova State Food and Drug Administration yakabudisa Chiziviso pamusoro peManagement Category yeMedical Sodium hyaluronate Products (No. 81 ye2009, inozonzi Notice No. sodium hyaluronate) zvine hukama zvigadzirwa. Nekukurumidza kusimudzira tekinoroji uye indasitiri uye kubuda kwezvigadzirwa zvitsva, Chiziviso 81 hachichakwanisa kuzadzisa zvizere zvinodiwa neindasitiri uye mutemo. Nokudaro, State Food and Drug Administration yakaronga kudzokororwa kweNo. 81 chiziviso.
Ii. Kudzokororwa kwezviri mukati
(a) Parizvino, sodium hyaluronate (sodium hyaluronate) zvigadzirwa hazvishandiswe chete mumishonga uye zvigadzirwa zvekurapa, asi zvakare zvinowanzo shandiswa mukuzora, chikafu nemimwe minda, uye zvimwe zvigadzirwa zvinoshandiswa pamucheto wezvinodhaka, zvigadzirwa zvekurapa uye zvizorwa. . Kuitira kutungamira zvirinani kugadzwa kwehunhu hwehutungamiriri uye zvikamu zvezvigadzirwa zvine hukama, Chiziviso 103 chakawedzera iyo manejimendi tsananguro yemhando yezvigadzirwa zvemukati uye mishonga yemusanganiswa wezvigadzirwa zvinosanganisira sodium hyaluronate (sodium hyaluronate) uye inoenderana neiyo yekurapa mudziyo wechigadzirwa kupatsanura musimboti. , uye yakatsanangura manejimendi hunhu uye chikamu chezvigadzirwa zvine hukama.
(2) Zvigadzirwa zvekurapa sodium hyaluronate zvekurapa urinary bladder epithelial glucosamine inodzivirira layer defects yakatenderwa kushambadzira seKirasi III michina yekurapa. Rudzi urwu rwechigadzirwa harutenderwe zvinoenderana nemamiriro ekutengesa zvinodhaka, kuitira kuchengetedza kuenderera kwehutungamiriri, ramba uchichengeta hunhu hwekutanga hwekutarisira.
(3) Kana iyo yekurapa sodium hyaluronate chigadzirwa ichishandiswa jekiseni mudermis uye pazasi, uye inoshandiswa sechigadzirwa chekuzadza jekiseni kuti uwedzere huwandu hwematishu, kana chigadzirwa chacho chisina mishonga yemishonga inotamba pharmacological, metabolic kana immunological mhedzisiro, iyo. ichaitwa seKirasi III yekurapa mudziyo; Kana chigadzirwa chacho chiine anesthetics yemunharaunda uye mamwe madhiragi (akadai se lidocaine hydrochloride, amino acids, mavhitaminzi), inotongwa sechigadzirwa chekurapa-based based combination product.
(4) Kana mishonga yekurapa sodium hyaluronate ikaiswa mudermis kuti ivandudze mamiriro eganda kunyanya kuburikidza nekunyorovesa uye hydrating mhedzisiro yesodium hyaluronate, kana zvigadzirwa zvisina mishonga yemishonga inotamba pharmacological, metabolic kana immunological mhedzisiro, ichave. inotungamirirwa maererano nemhando yechitatu yezvigadzirwa zvemishonga; Kana chigadzirwa chacho chiine anesthetics yemunharaunda uye mamwe madhiragi (akadai se lidocaine hydrochloride, amino acids, mavhitaminzi, nezvimwewo), inotongwa sechigadzirwa chekurapa-based based combination product.
(5) Chiziviso Nhamba 81 inotaura kuti "kurapwa kwe ... Zvigadzirwa zvine mhedzisiro yemishonga yakadai semaronda eganda zvichagadziriswa zvinoenderana nekutonga kwezvinodhaka". Nekudaro, nekuvandudzwa kwesainzi uye tekinoroji uye nekunzwisisa kwakadzika kwesodium hyaluronate, zvinowanzo davirwa munharaunda yekutsvagisa yesainzi kuti kana sodium hyaluronate ichishandiswa mukupfeka kwekurapa, yakakwira molecular uremu sodium hyaluronate yakaiswa pamaronda eganda anogona kunamatira kumusoro. yemaronda eganda uye kutora nhamba huru yemamorekuru emvura. Kupa nzvimbo yekunyorova yekuporesa kwechironda chepamusoro, kuitira kuti zvive nyore kupora kwepamusoro peronda, musimboti wekuita kwayo unonyanya kusimba. Zvigadzirwa izvi zvinodzorwa semidziyo yekurapa muUnited States neEuropean Union. Nokudaro, zvipfeko zvezvokurapa zvinotsanangurwa muBulletin 103 zvine sodium hyaluronate zvinogadziriswa semidziyo yezvokurapa kana isina mishonga yemishonga ine pharmacological, metabolic kana immunological effects; Kana ichigona kubatwa zvishoma kana kunyudzwa zvachose nemuviri kana kushandiswa kune maronda asingaperi, inofanirwa kutarisirwa zvinoenderana nerudzi rwechitatu rwechigadzirwa chekurapa. Kana iyo isingakwanisi kubatwa nemuviri uye inoshandiswa kune maronda asingagumi, inofanira kutarisirwa maererano nemhando yechipiri yemishonga yekurapa.
(6) Sezvo mavanga ekugadzirisa zvinhu zvinobatsira mukuvandudza nekudzivirira kuumbwa kwedermatologic rational scars zvakanyorwa mu "Classification of Medical Devices" 14-12-02 Scar kugadzirisa zvinhu, zvichave zvichitungamirirwa maererano neChikamu II michina yezvokurapa. Kana zvigadzirwa zvakadaro zvine sodium hyaluronate, maitiro avo ekutungamira uye manejimendi mapoka haachinje.
(7) Sodium hyaluronate (sodium hyaluronate) inowanzotorwa kubva munyama yemhuka kana kugadzirwa nekuvirisa kwemicrobial, ine dzimwe njodzi dzinogona kuitika. Kuchengetedzeka uye kushanda kweChikamu I michina yekurapa haigone kuvimbiswa nematanho ekudzora. Naizvozvo, chikamu chekutungamira chezvekurapa sodium hyaluronate (sodium hyaluronate) zvigadzirwa pasi pekutarisirwa kwemidziyo yekurapa haifanirwe kunge yakaderera pane Chikamu II.
(8) Sodium hyaluronate, sechinhu chinonyorovesa uye hydrating, yakashandiswa muzvizoro.Zvigadzirwa zvine sodium hyaluronateIyo inoshandiswa paganda, bvudzi, zvipikiri, miromo nedzimwe nzvimbo dzevanhu kuburikidza nekukwesha, kupfapfaidza kana dzimwe nzira dzakafanana nechinangwa chekuchenesa, kuchengetedza, kugadzirisa kana kushongedza, uye hazviitwe semishonga kana michina yekurapa. Zvigadzirwa zvakadaro hazvifanirwe kunzi kushandiswa kwekurapa.
(9) lotions, disinfectants uyedonje padsine mishonga inouraya utachiona inoshandiswa chete kuuraya utachiona hweganda rakakuvadzwa nemaronda haizopiwe semishonga kana michina yekurapa.
(10) Kana iyo yemuviri, kemikari uye zvipenyu zvimiro zvemodified sodium hyaluronate zvichienderana neiyo sodium hyaluronate mushure mekuongororwa, hunhu hwehutungamiriri uye mapoka ekutungamira anogona kuitwa nekureva kuChiziviso ichi.
(11) Kuti ujekese zvinodiwa zvekushandisa, nyaya dzakakodzera dzekunyorera chikumbiro pasi pemamiriro akasiyana dzinotaurwa. Kune mamiriro anosanganisira shanduko yemaitiro ekugadzirisa zvigadzirwa kana zvikamu, iyo nguva yekushandura yeanosvika makore maviri inopihwa kuve nechokwadi chekuchinja kwakanaka.
HEALTHSILEzvichanyatsorongwa maererano nemitemo yenyika. Zvinoenderana nemusimboti wekuve nebasa kune vatengi, Hyaluronate icharamba ichigadzira zvigadzirwa zvitsva kusimudzira hutano hweganda.
Nguva yekutumira: Nov-23-2022