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Chiyero chemitemo

Muna 1965, European Community yakagadzira Medicines Directive (65/EEC) kuitira kubatanidza mitemo nemirairo ine chekuita nemishonga yezvirimwa pakati penyika.Muna 1988, European Community yakagadzira Guidelines for the Management of Herbal Products, iyo yakataura zvakajeka kuti: “Mushonga wemakwenzi rudzi rwomushonga, uye zvinhu zvinoshanda zviri mauri zvinomera kana kuti gadziriro dzemishonga yemakwenzi.Mishonga yemakwenzi inofanirwa kupihwa rezinesi rekutengesa.Zviyero zvemhando, chengetedzo uye kushanda zvakanaka zvinofanirwa kuzadzikiswa chigadzirwa chisati chatengeswa. "Chikumbiro cherezinesi chinodiwa kupa ruzivo rwunotevera: 1. Ruzivo rwemhando uye huwandu hwezvikamu;2. Tsanangudzo yekugadzira nzira;3. Kudzora kwekutanga zvinhu;4. Kudzora kwemhando uye kuzivikanwa kunofanirwa kuitwa nguva dzose;5. Kudzora kwehutano uye kuongororwa kwezvigadzirwa zvakapedzwa;6. Kuzivikanwa kwekugadzikana.Muna 1990, European Community yakaronga GMP yekugadzirwa kwemishonga yemakwenzi.
Muna December 2005, mishonga yechivanhu KlosterfrauMelisana yakabudirira kunyoreswa muGermany.Ichi chigadzirwa chinonyanya kuumbwa nehuswa hwebharisamu, kunhuhwirira kwevanhu, angelica, ginger, clove, galangal, Eurogentian, kurapa kushushikana kwepfungwa uye kufunganya, kutemwa nemusoro, dysmenorrhea, kurasikirwa kwechido, dyspepsia, kutonhora uye zvichingodaro.MuUK, kune mazana ezvikumbiro zvekunyoreswa kwemishonga yechivanhu, asi kusvika parizvino hapana yemishonga yechivanhu yekuChina.

Pfungwa huru yemishonga muUnited States ndeyokuti kuumbwa kwemakemikari kunofanira kunge kwakajeka, uye munyaya yekugadzirira kwemakemikari, pharmacodynamics yechikamu chimwe nechimwe chemakemikari uye migumisiro yekubatana kwavo pamusoro pekushanda uye chepfu inofanira kuva yakajeka.Pasi pesimba reinonzi orthodox pfungwa yemushonga, iyo US FDA ine kusanzwisisa kwakanyanya kwemushonga wechirimwa, kusanganisira wechinyakare mushonga weChinese, saka haicherechedze mushonga wechirimwa semushonga.Nekudaro, pasi pekumanikidzwa kwekushandiswa kukuru kwekurapa kwekurapa uye maonero akasimba everuzhinji, US Congress yakapasisa dietarysupplement Health Education Act (DSHEA) muna 1994 kuburikidza nekuedza kusingadzoreki uye kukwezva kwemamwe mabhizinesi madiki uye epakati nepakati, ayo akaronga mishonga yechisikigo yemiti inosanganisira. mushonga wechiChinese sechikafu chekuwedzera.Zvinogona kutaurwa kuti chikafu chekuwedzera chigadzirwa chakakosha pakati pekudya nemishonga.Kunyange zvazvo chiratidzo chaicho chisingagoni kuratidzirwa, hutano hwayo hwehutano hunogona kuratidzwa.

Mishonga yemakwenzi inogadzirwa uye inotengeswa muUnited States ine chimiro chepamutemo, ndiko kuti, inozivikanwa kuti ishandiswe mukudzivirira uye kurapwa kwechirwere.Muna 2000, mukupindura zvaidiwa neveruzhinji, Mutungamiriri weUnited States akasarudza kumisa “****** Policy Council on Complementary and Alternative Medicine”, ine nhengo makumi maviri dzakasarudzwa neMutungamiriri zvakanangana kuti vakurukure nezvegwaro remitemo yemubatanidzwa. uye mamwe mishonga uye kuongorora kukosha kwayo.Mugwaro rayo repamutemo kuMutungamiriri neCongress muna 2002, ****** yaisanganisira "mushonga wechinyakare weChinese" muhurongwa hwekuwedzera uye kumwe kurapwa.

Mumakore achangopfuura, iyo FDA yakasimbisa manejimendi ekutonga emishonga yemakwenzi.Muna 2003, yakatanga kushandisa GMP manejimendi ezvekudya uye kuseta zvimiro zvakasimba zvekugadzira uye kunyora mazita ezvekudya.Iyo FDA yakaburitsa Mazano eKukudziridzwa Kwemiti Inodhaka online uye yakakumbira mhinduro pasi rese.The Guiding Principles inonyatso ratidza kuti mishonga yebhotani yakasiyana nemishonga yemakemikari, saka zvavanoda zvehunyanzvi zvinofanirwawo kunge zvakasiyana kubva kune yekupedzisira, uye zvinotsanangudza mamwe maitiro emishonga yebhotani: kemikari yemishonga yebhotani kazhinji musanganiswa wezvikamu zvakawanda, pane kudaro. kupfuura musanganiswa mumwe chete;Haasi makemikari ese ari mumishonga yemakwenzi ****** akajeka;Muzviitiko zvakawanda, zvinoshandiswa zvinoshandiswa zvemishonga yemakwenzi hazvina kutsanangurwa ******;Mune zvimwe zviitiko, basa rehupenyu hwemishonga yemiti haisi ****** chaiyo uye yakajeka;Nzira dzakawanda dzekugadzira nekugadzirisa mishonga yemakwenzi dzine simba guru;Botanicals vane ruzivo rwakakura uye rwenguva refu mukushandiswa kwevanhu.Hapana mhedzisiro yechepfu yehupfu yakawanikwa mukushandiswa kwenguva refu uye kwakawanda kwemishonga yemakwenzi mumuviri wemunhu.Mimwe mishonga yemakwenzi yakatengeswa sezvigadzirwa zvehutano kana zvinovaka muviri.

Zvichienderana nekunzwisisa kweFDA kwemishonga yemiti, zvinodiwa zvehunyanzvi zvemishonga yezvirimwa muMitemo Inotungamira zvakasiyana neayo emishonga yemakemikari, kusanganisira: zvinodiwa zvehunyanzvi zvekutsvagisa preclinical zvakasununguka;Iyo pharmacokinetic bvunzo inogona kubatwa nyore.Kurapa kwakakosha kwekugadzirira kwemishonga yakasanganiswa;Mishonga tekinoroji inoda kuchinjika kugadzirisa;Izvo zvinodiwa zvehunyanzvi zve pharmacology uye toxicology zvakaderedzwa.Iyo nhungamiro inomiririra kusvetuka kwehunhu munzira yeFDA kumishonga yemakwenzi yechisikigo, kusanganisira yechivanhu mishonga yechiChinese.Shanduko huru yemutemo wehurumende yeAmerica pamishonga yemakwenzi yakagadzira mamiriro ekutanga emishonga yemakwenzi kupinda mumusika weAmerica.
Pamusoro peVeregen, iyo yakatotenderwa, inosvika makumi matanhatu kusvika makumi manomwe botanicals iri mupombi kusvika zvino.


Nguva yekutumira: Zvita-09-2022