Kwanan nan, Hukumar Kula da Abinci da Magunguna ta Jiha ta ba da Sanarwa a kan Gudanar da Category of Medical sodium hyaluronate kayayyakin (No. 103 a 2022, daga nan ake magana a kai a matsayin No. 103 Sanarwa).Asalin da babban abin da ke cikin bitar Sanarwa mai lamba 103 sune kamar haka;
I. Bayanan bita
A cikin 2009, tsohon Jihar Abinci da Drug Administration bayar Sanarwa a kan Management Category of Medical Sodium hyaluronate Products (No. 81 na 2009, daga nan ake magana a kai a matsayin Sanarwa No. 81) don shiryar da kuma tsara rajista da kuma kula da likita sodium hyaluronate (A. sodium hyaluronate) samfurori masu dangantaka.Tare da saurin haɓaka fasahar fasaha da masana'antu da kuma fitowar sabbin kayayyaki, Sanarwa ta 81 ba za ta iya cika cikakkiyar buƙatun masana'antu da ƙa'idodi ba.Don haka, Hukumar Kula da Abinci da Magunguna ta Jiha ta shirya sake fasalin sanarwar mai lamba 81.
Ii.Bita na babban abinda ke ciki
(a) A halin yanzu, ana amfani da kayan sodium hyaluronate (sodium hyaluronate) ba kawai a cikin magunguna da na'urorin likitanci ba, har ma ana amfani da su a cikin kayan shafawa, abinci da sauran fannoni, wasu samfuran ana amfani da su a gefen magunguna, na'urorin likitanci da kayan kwalliya. .Domin ingantacciyar jagorar ƙayyadaddun halayen gudanarwa da nau'ikan samfuran da ke da alaƙa, Sanarwa A'a. 103 ya kara da cewa ka'idodin ma'anar gudanarwa na samfuran gefuna da samfuran haɗin gwiwar na'urar magunguna waɗanda suka haɗa da sodium hyaluronate (sodium hyaluronate) da ƙa'idodin rarraba kayan aikin likitanci masu alaƙa. , da kuma ayyana sifa na gudanarwa da nau'in samfuran da ke da alaƙa.
(2) Samfuran hyaluronate sodium na likitanci don maganin cututtukan mafitsara epithelial glucosamine na lahani na kariya an yarda dasu don talla azaman na'urorin likitanci na Class III.Irin wannan samfurin ba a yarda da shi ba daidai da halin da ake ciki na tallace-tallace na miyagun ƙwayoyi, don ci gaba da ci gaba da gudanarwa, ci gaba da kula da ainihin halayen gudanarwa.
(3) Lokacin da aka yi amfani da samfurin sodium hyaluronate na likita don allura a cikin dermis da ƙasa, kuma ana amfani da shi azaman samfurin cikewar allura don ƙara yawan ƙwayar nama, idan samfurin bai ƙunshi sinadarai na magunguna waɗanda ke kunna tasirin pharmacological, metabolism ko immunological ba, za a gudanar da shi azaman na'urar lafiya ta Class III;Idan samfurin ya ƙunshi maganin sa barci na gida da wasu magunguna (kamar lidocaine hydrochloride, amino acid, bitamin), ana yin hukunci da cewa samfurin haɗin gwiwar na'urar likita ne.
(4) Lokacin da magungunan sodium hyaluronate aka allura a cikin dermis don inganta yanayin fata musamman ta hanyar moisturizing da hydrating effects na sodium hyaluronate, idan kayayyakin ba su ƙunshi pharmaceutical sinadaran da wasa pharmacological, na rayuwa ko immunological effects, za su kasance. ana gudanar da su bisa ga nau'in na'urorin likitanci na uku;Idan samfurin ya ƙunshi magungunan kashe kwayoyin cuta na gida da sauran magunguna (kamar lidocaine hydrochloride, amino acid, bitamin, da sauransu), ana yin hukunci a matsayin samfurin haɗin gwiwa na tushen kayan aikin likita.
(5) Sanarwa A'a. 81 ya nuna cewa "don kula da ... Kayayyakin da ke da takamaiman tasirin magunguna irin su ulcers na fata za a sarrafa su bisa ga kulawar miyagun ƙwayoyi ".Duk da haka, tare da ci gaban kimiyya da fasaha da kuma zurfin fahimtar sodium hyaluronate, an yi imani da shi a cikin al'ummar bincike na kimiyya cewa lokacin da ake amfani da sodium hyaluronate a cikin tufafi na likita, nauyin nauyin sodium hyaluronate mai nauyin kwayoyin halitta wanda aka yi amfani da shi ga raunukan fata zai iya mannewa a saman. na raunukan fata da kuma sha babban adadin kwayoyin ruwa.Don samar da yanayin warkar da rigar don raunin rauni, don sauƙaƙe warkar da raunin rauni, ka'idar aikinta galibi ta jiki ne.Ana sarrafa waɗannan samfuran azaman na'urorin likitanci a cikin Amurka da Tarayyar Turai.Don haka, suturar likitanci da aka ƙayyade a cikin Bulletin 103 waɗanda ke ɗauke da sodium hyaluronate ana tsara su azaman na'urorin likitanci idan ba su ƙunshi sinadarai na magunguna waɗanda ke da tasirin magunguna, na rayuwa ko rigakafi;Idan jiki zai iya shafe shi gaba ɗaya ko gaba ɗaya ko kuma ya yi amfani da shi don raunuka na yau da kullun, yakamata a sarrafa shi bisa ga nau'in na'urar lafiya ta uku.Idan jiki ba zai iya shanye shi ba kuma ana amfani dashi don raunukan da ba na yau da kullun ba, yakamata a sarrafa shi gwargwadon nau'in na'urar likita ta biyu.
(6) Tun da kayan gyaran tabo waɗanda ke taimakawa wajen haɓakawa da hana samuwar tabo masu ma'ana na dermatologic an jera su a cikin "Rarraba Na'urorin Likita" 14-12-02 Kayan gyaran tabo, za a sarrafa su bisa ga na'urorin likitanci na II.Lokacin da irin waɗannan samfuran suka ƙunshi sodium hyaluronate, kayan sarrafa su da nau'ikan gudanarwa ba sa canzawa.
(7) Sodium hyaluronate (sodium hyaluronate) gabaɗaya ana fitar da shi daga kyallen dabbobi ko kuma samar da su ta hanyar fermentation na ƙwayoyin cuta, wanda ke da wasu haɗarin haɗari.Ba za a iya tabbatar da aminci da ingancin na'urorin likitanci na Rukunin I ta hanyar matakan tsari ba.Don haka, nau'in gudanarwa na samfuran likitancin sodium hyaluronate (sodium hyaluronate) a ƙarƙashin sarrafa na'urorin likitanci bai kamata ya zama ƙasa da Category II ba.
(8) Sodium hyaluronate, a matsayin sinadari mai damshi da ruwa, an yi amfani da shi a cikin kayan kwalliya.Kayayyakin da ke ɗauke da sodium hyaluronatewanda ake shafa wa fata, gashi, farce, lebe da sauran sassan jikin mutum ta hanyar shafa, feshi ko sauran makamantansu don manufar tsaftacewa, kariya, gyara ko kawata, kuma ba a sarrafa su azaman magunguna ko na'urorin likitanci.Irin waɗannan samfuran bai kamata a yi da'awar amfani da magani ba.
(9) magarya, maganin kashe kwayoyin cuta daauduga padsBa za a yi amfani da magungunan kashe qwari da aka yi amfani da su kawai don lalata fata da raunuka a matsayin magunguna ko na'urorin likita ba.
(10) Idan abubuwan da ke cikin jiki, sinadarai da halittu na sodium hyaluronate da aka gyara sun dace da na sodium hyaluronate bayan tabbatarwa, ana iya aiwatar da halayen gudanarwa da nau'ikan gudanarwa ta hanyar komawa zuwa wannan Sanarwa.
(11) Don bayyana abubuwan da ake buƙata na aiwatarwa, an tsara abubuwan da suka dace na aikace-aikacen rajista a ƙarƙashin yanayi daban-daban.Don yanayin da ke tattare da canjin halayen sarrafa samfur ko nau'ikan, ana ba da lokacin aiwatar da canjin kusan shekaru 2 don tabbatar da sauyi mai sauƙi.
LAFIYAza a rarraba su sosai daidai da dokokin ƙasa.Dangane da ka'idar kasancewa da alhakin abokan ciniki, Hyaluronate zai ci gaba da samar da sababbin samfurori don inganta lafiyar fata.
Lokacin aikawa: Nuwamba-23-2022