Posachedwapa, Boma la Boma la Food and Drug Administration linapereka Chidziwitso pa Gulu la Management of Medical sodium hyaluronate products (No. 103 mu 2022, yomwe imatchedwa No. 103 Announcement).Zoyambira ndi zomwe zili mkati mwa kukonzanso kwa Chidziwitso No. 103 ndi izi:
I. Mbiri yakukonzanso
Mu 2009, boma la State Food and Drug Administration linapereka Chidziwitso pa Management Category of Medical Sodium hyaluronate Products (No. 81 ya 2009, yomwe imatchedwa Notice No. sodium hyaluronate) zokhudzana ndi mankhwala.Ndi chitukuko chofulumira chaukadaulo ndi mafakitale komanso kutuluka kwa zinthu zatsopano, Chilengezo 81 sichingathenso kukwaniritsa zofunikira zamakampani ndi malamulo.Choncho, State Food and Drug Administration inakonza kukonzanso kwa chilengezo cha 81.
Ii.Kubwerezanso mfundo zazikuluzikulu
(a) Pakali pano, sodium hyaluronate (sodium hyaluronate) mankhwala si ntchito mankhwala ndi zipangizo zamankhwala, komanso nthawi zambiri ntchito zodzoladzola, chakudya ndi madera ena, ndipo mankhwala ena ntchito m'mphepete mwa mankhwala, zipangizo zachipatala ndi zodzoladzola. .Kuti tiwongolere bwino kutsimikizika kwa mawonekedwe a kasamalidwe ndi magulu azinthu zofananira, Chidziwitso No. 103 chawonjezera tanthauzo la kasamalidwe kazinthu zam'mphepete ndi zida zophatikizira zamankhwala zomwe zimaphatikizapo sodium hyaluronate (sodium hyaluronate) ndi mfundo yofananira ndi chipangizo chachipatala. , ndikufotokozera za kasamalidwe ndi gulu lazinthu zokhudzana nazo.
(2) Medical sodium hyaluronate mankhwala ochizira mkodzo chikhodzodzo epithelial glucosamine zosanjikiza zosanjikiza zolakwika zavomerezedwa kuti azigulitsa ngati zida zamankhwala za Gulu lachitatu.Mtundu woterewu sunavomerezedwe molingana ndi momwe malonda akugulitsira mankhwala, kuti apitirizebe kuyang'anira, pitirizani kusunga makhalidwe oyambirira a kasamalidwe.
(3) Pamene mankhwala sodium hyaluronate ntchito jekeseni mu dermis ndi m'munsimu, ndipo ntchito ngati jekeseni kudzazidwa mankhwala kuonjezera minofu buku, ngati mankhwala alibe mankhwala zosakaniza amene amasewera pharmacological, kagayidwe kachakudya kapena immunological zotsatira, izo. idzaperekedwa ngati chipangizo chachipatala cha Class III;Ngati mankhwalawa ali ndi mankhwala oletsa kupweteka komanso mankhwala ena (monga lidocaine hydrochloride, amino acid, mavitamini), amaganiziridwa kuti ndi mankhwala osakanikirana ndi zipangizo zachipatala.
(4) Pamene mankhwala sodium hyaluronate mankhwala ndi jekeseni mu dermis kusintha khungu chikhalidwe makamaka mwa moisturizing ndi hydrating zotsatira za sodium hyaluronate, ngati mankhwala mulibe mankhwala zosakaniza amene amasewera pharmacological, kagayidwe kachakudya kapena immunological zotsatira, iwo adzakhala kuyendetsedwa molingana ndi mtundu wachitatu wa zida zamankhwala;Ngati mankhwalawa ali ndi mankhwala oletsa kupweteka komanso mankhwala ena (monga lidocaine hydrochloride, amino acid, mavitamini, ndi zina zotero), amaganiziridwa kuti ndi mankhwala osakanikirana ndi zipangizo zachipatala.
(5) Chidziwitso No. 81 chimanena kuti "pochiza ... Zogulitsa zomwe zili ndi zotsatira zenizeni za mankhwala monga zilonda zapakhungu ziyenera kuyang'aniridwa molingana ndi kasamalidwe ka mankhwala ".Komabe, ndi chitukuko cha sayansi ndi teknoloji komanso kumvetsetsa kwakuya kwa sodium hyaluronate, anthu ambiri amakhulupirira kuti pamene sodium hyaluronate imagwiritsidwa ntchito muzovala zachipatala, hyaluronate yapamwamba ya sodium hyaluronate yogwiritsidwa ntchito pa zilonda zapakhungu imatha kumamatira pamwamba. zilonda zapakhungu ndi kuyamwa kuchuluka kwa mamolekyu amadzi.Kupereka chonyowa machiritso chilengedwe kwa chilonda pamwamba, kuti atsogolere machiritso a bala pamwamba, mfundo yake zochita ndi makamaka thupi.Zogulitsazi zimayendetsedwa ngati zida zamankhwala ku United States ndi European Union.Choncho, zovala zachipatala zomwe zafotokozedwa mu Bulletin 103 zomwe zili ndi sodium hyaluronate zimayendetsedwa ngati zipangizo zamankhwala ngati zilibe mankhwala omwe ali ndi zotsatira za pharmacological, metabolic kapena immunological;Ngati itha kutengeka pang'ono kapena kwathunthu m'thupi kapena kugwiritsidwa ntchito ngati zilonda zosakhalitsa, iyenera kuyang'aniridwa motsatira mtundu wachitatu wa chipangizo chachipatala.Ngati sichingatengedwe ndi thupi ndipo chimagwiritsidwa ntchito pa mabala osachiritsika, chiyenera kuyang'aniridwa motsatira mtundu wachiwiri wa chipangizo chachipatala.
(6) Popeza zipangizo zopangira zipsera zomwe zimathandiza kukonza ndi kuteteza mapangidwe a dermatologic rational scars zalembedwa mu "Classification of Medical Devices" 14-12-02 Zipangizo zopangira Scar, zidzayendetsedwa molingana ndi zida zachipatala za Gulu II.Pamene mankhwala amenewa ali ndi sodium hyaluronate, kasamalidwe katundu ndi kasamalidwe magulu sasintha.
(7) Sodium hyaluronate (sodium hyaluronate) nthawi zambiri imachokera ku nyama zanyama kapena kupangidwa ndi fermentation ya tizilombo, yomwe imakhala ndi zoopsa zina.Chitetezo ndi mphamvu ya zida zachipatala za Gulu I sizingatsimikizidwe ndi malamulo.Choncho, gulu la kasamalidwe la mankhwala sodium hyaluronate (sodium hyaluronate) pansi kasamalidwe zipangizo zachipatala sayenera kutsika Gulu II.
(8) Sodium hyaluronate, monga chopangira chonyowa komanso chopatsa mphamvu, chagwiritsidwa ntchito muzodzola.Mankhwala okhala ndi sodium hyaluronatezomwe zimagwiritsidwa ntchito pakhungu, tsitsi, misomali, milomo ndi malo ena aumunthu popaka, kupopera mankhwala kapena njira zina zofananira ndi cholinga choyeretsa, kuteteza, kusintha kapena kukongoletsa, ndipo sizimaperekedwa ngati mankhwala kapena zipangizo zamankhwala.Zogulitsa zotere siziyenera kunenedwa kuti zimagwiritsidwa ntchito pachipatala.
(9) mafuta odzola, ophera tizilombo toyambitsa matenda ndimapepala a thonjeokhala ndi mankhwala ophera tizilombo tomwe amagwiritsidwa ntchito popha tizilombo towonongeka pakhungu ndi mabala sayenera kuperekedwa ngati mankhwala kapena zida zamankhwala.
(10) Ngati zinthu zakuthupi, zamankhwala ndi zachilengedwe za sodium hyaluronate zosinthidwa zikugwirizana ndi za sodium hyaluronate pambuyo potsimikizira, zowongolera ndi magulu oyang'anira zitha kukhazikitsidwa potengera Chilengezo ichi.
(11) Pofuna kufotokozera zofunikira zogwiritsira ntchito, nkhani zolembera zolembera pansi pa zochitika zosiyanasiyana zimatchulidwa.Pazochitika zomwe zikukhudza kusintha kwa kasamalidwe kazinthu kapena magulu, nthawi yosinthira yazaka 2 imaperekedwa kuti zitsimikizike kuti zikuyenda bwino.
UMOYO WABWINOzidzasankhidwa motsatira malamulo a dziko.Mogwirizana ndi mfundo yokhala ndi udindo kwa makasitomala, Hyaluronate idzapitiriza kupanga zatsopano zolimbikitsa thanzi la khungu.
Nthawi yotumiza: Nov-23-2022