Kev Tshaj Tawm Txog Kev Tshaj Tawm Txog Kev Tswj Xyuas Cov Khoom Kho Mob Sodium hyaluronate (No. 103, 2022)

Tsis ntev los no, Lub Xeev Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj tau tshaj tawm tsab ntawv tshaj tawm txog Kev Tswj Xyuas Cov Khoom Kho Mob Sodium hyaluronate (No. 103 hauv 2022, tom qab ntawd hu ua No. 103 Tshaj Tawm). Cov keeb kwm yav dhau thiab cov ntsiab lus tseem ceeb ntawm kev hloov kho ntawm Daim Ntawv Ceeb Toom 103 yog raws li hauv qab no:

I. Keeb kwm ntawm kev kho dua tshiab

Xyoo 2009, yav dhau los Lub Xeev Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj tau tshaj tawm Daim Ntawv Ceeb Toom Txog Kev Tswj Xyuas Kev Kho Mob Sodium hyaluronate Cov Khoom (No. 81 ntawm 2009, tom qab ntawd hu ua Daim Ntawv Ceeb Toom No. 81) los qhia thiab tswj kev sau npe thiab saib xyuas kev kho mob sodium hyaluronate ( sodium hyaluronate) hais txog cov khoom. Nrog rau txoj kev loj hlob sai ntawm kev siv tshuab thiab kev lag luam thiab kev tshwm sim ntawm cov khoom tshiab, Kev Tshaj Tawm 81 tsis tuaj yeem ua tiav tag nrho cov kev xav tau ntawm kev lag luam thiab kev tswj hwm. Yog li ntawd, lub Xeev Food and Drug Administration tau teeb tsa kev hloov kho ntawm tsab ntawv tshaj tawm No. 81.

Ii. Kev kho cov ntsiab lus tseem ceeb

(a) Tam sim no, sodium hyaluronate (sodium hyaluronate) cov khoom siv tsis yog siv hauv cov tshuaj thiab cov khoom siv kho mob nkaus xwb, tab sis kuj tseem siv ntau hauv cov tshuaj pleev ib ce, zaub mov thiab lwm yam kev lag luam, thiab qee cov khoom siv rau ntawm ntug ntawm cov tshuaj, khoom siv kho mob thiab tshuaj pleev ib ce. . Txhawm rau ua kom zoo dua rau kev txiav txim siab ntawm kev tswj hwm tus cwj pwm thiab pawg ntawm cov khoom muaj feem xyuam, Daim Ntawv Ceeb Toom No. 103 tau ntxiv cov kev tswj hwm tus cwj pwm txhais lub hauv paus ntsiab lus ntawm ntug cov khoom thiab cov cuab yeej siv tshuaj ua ke nrog cov khoom siv sodium hyaluronate (sodium hyaluronate) thiab cov khoom siv kho mob ntsig txog cov khoom lag luam kev faib tawm. , thiab txhais cov kev tswj hwm tus cwj pwm thiab qeb ntawm cov khoom muaj feem xyuam.

(2) Cov khoom siv kho mob sodium hyaluronate rau kev kho cov zis zais zis epithelial glucosamine tiv thaiv txheej tsis raug tau raug pom zoo rau kev lag luam raws li Class III cov cuab yeej kho mob. Cov khoom lag luam no tsis raug pom zoo raws li qhov xwm txheej ntawm kev lag luam tshuaj, txhawm rau tswj kev tswj hwm txuas ntxiv, txuas ntxiv tswj hwm tus cwj pwm tswj hwm qub.

(3) Thaum cov khoom siv kho mob sodium hyaluronate yog siv rau kev txhaj tshuaj rau hauv dermis thiab hauv qab no, thiab siv los ua cov khoom siv tshuaj ua kom cov ntaub so ntswg ntau ntxiv, yog tias cov khoom tsis muaj cov khoom xyaw tshuaj uas ua rau cov tshuaj pharmacological, metabolic lossis immunological cuam tshuam, nws yuav tsum tau ua raws li cov khoom siv kho mob Class III; Yog tias cov khoom muaj cov tshuaj loog hauv zos thiab lwm yam tshuaj (xws li lidocaine hydrochloride, amino acids, vitamins), nws raug txiav txim los ua cov khoom siv kho mob raws li kev sib xyaw ua ke.

(4) Thaum cov khoom kho mob sodium hyaluronate raug txhaj rau hauv dermis txhawm rau txhim kho cov tawv nqaij mob feem ntau los ntawm cov dej noo thiab dej ntawm sodium hyaluronate, yog tias cov khoom tsis muaj cov khoom xyaw tshuaj uas ua rau cov tshuaj pharmacological, metabolic lossis immunological cuam tshuam, lawv yuav tsum yog tswj raws li hom thib peb ntawm cov cuab yeej kho mob; Yog tias cov khoom muaj tshuaj loog hauv zos thiab lwm yam tshuaj (xws li lidocaine hydrochloride, amino acids, vitamins, thiab lwm yam), nws raug txiav txim tias yog cov khoom siv kho mob ua ke.

(5) Daim Ntawv Ceeb Toom No. 81 tau hais tias "rau kev kho mob… Cov khoom lag luam uas muaj cov tshuaj muaj txiaj ntsig zoo xws li daim tawv nqaij rwj yuav tsum raug tswj raws li kev tswj hwm tshuaj". Txawm li cas los xij, nrog kev txhim kho ntawm kev tshawb fawb thiab thev naus laus zis thiab kev nkag siab tob ntawm sodium hyaluronate, nws feem ntau ntseeg hauv zej zog kev tshawb fawb tshawb fawb tias thaum sodium hyaluronate siv rau hauv kev kho mob hnav khaub ncaws, siab molecular hnyav sodium hyaluronate siv rau ntawm daim tawv nqaij qhov txhab tuaj yeem ua raws li qhov chaw. ntawm daim tawv nqaij qhov txhab thiab nqus tau ntau cov dej molecules. Txhawm rau muab qhov chaw ntub dej zoo rau lub qhov txhab ntawm qhov txhab, thiaj li ua kom yooj yim kho qhov txhab ntawm qhov txhab, lub hauv paus ntsiab lus ntawm nws qhov kev txiav txim yog lub cev. Cov khoom no raug tswj raws li cov cuab yeej kho mob hauv Tebchaws Meskas thiab European Union. Yog li ntawd, kev hnav khaub ncaws kho mob tau teev tseg hauv Bulletin 103 uas muaj sodium hyaluronate raug tswj hwm raws li cov khoom siv kho mob yog tias lawv tsis muaj cov khoom xyaw tshuaj uas muaj cov tshuaj pharmacological, metabolic lossis immunological cuam tshuam; Yog tias nws tuaj yeem yog ib feem lossis tag nrho nqus los ntawm lub cev lossis siv rau cov qhov txhab mob ntev, nws yuav tsum tau tswj xyuas raws li peb hom kev kho mob. Yog tias nws tsis tuaj yeem nqus tau los ntawm lub cev thiab siv rau cov qhov txhab tsis zoo, nws yuav tsum tau tswj xyuas raws li hom thib ob ntawm cov cuab yeej kho mob.

(6) Txij li cov ntaub ntawv kho caws pliav uas pab txhim kho thiab tiv thaiv kev tsim cov kab mob dermatologic rational caws pliav tau teev nyob rau hauv "Kev faib cov cuab yeej kho mob" 14-12-02 Cov ntaub ntawv kho pob caws pliav, lawv yuav tsum tau tswj xyuas raws li Qib II cov khoom siv kho mob. Thaum cov khoom zoo li no muaj sodium hyaluronate, lawv cov kev tswj xyuas thiab pawg tswj tsis hloov.

(7) Sodium hyaluronate (sodium hyaluronate) feem ntau yog muab rho tawm los ntawm cov ntaub so ntswg tsiaj los yog tsim los ntawm microbial fermentation, uas muaj qee yam kev pheej hmoo. Kev nyab xeeb thiab kev ua tau zoo ntawm Qeb I cov cuab yeej kho mob tsis tuaj yeem lav tau los ntawm kev tswj hwm kev ntsuas. Yog li ntawd, cov kev tswj xyuas ntawm cov khoom kho mob sodium hyaluronate (sodium hyaluronate) cov khoom nyob rau hauv kev tswj ntawm cov khoom siv kho mob yuav tsum tsis txhob qis dua Qeb II.

(8) Sodium hyaluronate, raws li cov khoom siv moisturizing thiab hydrating, tau siv hauv tshuaj pleev ib ce.Cov khoom uas muaj sodium hyaluronateuas yog siv rau ntawm daim tawv nqaij, plaub hau, rau tes, daim di ncauj thiab lwm qhov chaw ntawm tib neeg los ntawm kev txhuam, tshuaj tsuag los yog lwm yam zoo sib xws rau lub hom phiaj ntawm kev ntxuav, tiv thaiv, hloov kho los yog beautifying, thiab tsis yog siv raws li tshuaj los yog cov cuab yeej kho mob. Cov khoom zoo li no yuav tsum tsis txhob thov rau kev siv kho mob.

(9) tshuaj pleev, tshuaj tua kab mob thiabpaj rwb padsCov tshuaj tua kab mob tsuas yog siv rau kev tua kab mob ntawm daim tawv nqaij puas thiab qhov txhab yuav tsum tsis txhob muab tshuaj ua tshuaj lossis khoom siv kho mob.

(10) Yog tias lub cev, tshuaj lom neeg thiab cov khoom siv roj ntsha ntawm kev hloov kho sodium hyaluronate zoo ib yam nrog cov sodium hyaluronate tom qab kuaj xyuas, cov yam ntxwv ntawm kev tswj hwm thiab kev tswj xyuas yuav raug muab coj los ua raws li tsab ntawv tshaj tawm no.

(11) Txhawm rau kom paub meej txog qhov yuav tsum tau ua, cov teeb meem cuam tshuam ntawm daim ntawv thov kev sau npe nyob rau hauv cov xwm txheej sib txawv tau teev tseg. Rau cov xwm txheej uas cuam tshuam txog kev hloov pauv ntawm cov khoom tswj hwm tus yam ntxwv lossis pawg, kev siv sijhawm hloov pauv ntawm li 2 xyoos yog muab los ua kom muaj kev hloov pauv.

KEV HLUByuav raug cais nruj me ntsis raws li kev cai hauv tebchaws. Raws li txoj cai ntawm kev ua lub luag haujlwm rau cov neeg siv khoom, Hyaluronate yuav txuas ntxiv tsim cov khoom tshiab los txhawb kev noj qab haus huv ntawm daim tawv nqaij.