Izinga lemithethonqubo

Ngo-1965, i-European Community yenza i-Medicines Directive (65/EEC) ukuze ihlanganise imithetho neziqondiso ezihlobene nemithi yezitshalo phakathi kwamazwe.Ngo-1988, i-European Community yakha i- Guidelines for the Management of Herbal Products, eyathi ngokucacile: “Umuthi wamakhambi uwuhlobo oluthile lomuthi, futhi izithako ezisebenzayo eziqukethwe kuwo ziyizitshalo kuphela noma amalungiselelo okwelapha ngamakhambi.Imithi ye-herbal kufanele ibe nelayisensi yokuthengisa.Amazinga ekhwalithi, ukuphepha nokusebenza kahle kufanele kuhlangatshezwane nawo ngaphambi kokuba umkhiqizo udayiswe.”Isicelo selayisensi siyadingeka ukuthi sihlinzeke ngolwazi olulandelayo: 1. Ulwazi lwekhwalithi nobuningi bezingxenye;2. Incazelo yendlela yokukhiqiza;3. Ukulawulwa kwezinto zokuqala;4. Ukulawulwa kwekhwalithi kanye nokuhlonza okufanele kwenziwe njalo;5. Ukulawulwa kwekhwalithi kanye nokuhlolwa kwemikhiqizo eqediwe;6. Ukuhlonza ukuzinza.Ngo-1990, i-European Community yahlongoza i-GMP ukukhiqizwa kwemithi ye-herbal.
Ngo-December 2005, imithi yendabuko i-KlosterfrauMelisana yabhaliswa ngempumelelo eJalimane.Lo mkhiqizo ikakhulukazi uqukethe utshani bebhalsamu, iphunga elimnandi, i-angelica, i-ginger, i-clove, i-galangal, i-Eurogentian, ukwelapha ukungezwani kwengqondo nokukhathazeka, ikhanda elibuhlungu, i-dysmenorrhea, ukungakwazi ukudla, i-dyspepsia, amakhaza nokunye.E-UK, kunamakhulu ezicelo zokubhaliswa kwemithi yesintu, kodwa kuze kube manje azikho ezemithi yendabuko yamaShayina.

Umqondo oyisisekelo wezidakamizwa e-United States ukuthi ukwakheka kwamakhemikhali kufanele kucace, futhi esimweni samalungiselelo ahlanganisiwe, i-pharmacodynamics yengxenye ngayinye yamakhemikhali kanye nemiphumela yokusebenzisana kwabo ekusebenzeni kahle kanye nobuthi kufanele kucace.Ngaphansi kwethonya lalokho okubizwa ngokuthi umqondo we-orthodox wezokwelapha, i-US FDA inokuqonda okuphansi kakhulu kwemithi yezitshalo, kuhlanganise nemithi yendabuko yamaShayina, ngakho-ke ayiboni imithi yezitshalo yemvelo njengomuthi.Kodwa-ke, ngaphansi kwengcindezi yezindleko ezinkulu zokunakekelwa kwezempilo kanye nombono oqinile womphakathi, iCongress yase-US yaphasisa umthetho we-Dietarysupplement Health Education Act (DSHEA) ngo-1994 ngemizamo engapheli kanye nokunxenxa amabhizinisi amancane naphakathi nendawo, abala imithi yezitshalo yemvelo kubandakanya. imithi yendabuko yamaShayina njengesengezo sokudla.Kungashiwo ukuthi isengezo sokudla siwumkhiqizo okhethekile phakathi kokudla nemithi.Nakuba inkomba ethile ayikwazi ukuboniswa, umsebenzi wayo wokunakekelwa kwezempilo ungaboniswa.

Imithi yemvelo yamakhambi ekhiqizwa futhi idayiswe e-United States inesimo esingokomthetho, okungukuthi, iqashelwa ukusetshenziswa ekuvimbeleni nasekwelapheni izifo.Ngo-2000, ngokuphendula isidingo somphakathi, uMongameli wase-United States wanquma ukusungula "****** Policy Council on Complementary and Alternative Medicine", enamalungu angu-20 aqokwe nguMongameli ngokuqondile ukuze axoxe ngeziqondiso zenqubomgomo zokuhambisana. kanye nemithi ehlukile futhi ihlole ukubaluleka kwayo okungaba khona.Embikweni wayo osemthethweni kuMongameli kanye noKhongolose ngo-2002, ****** yayihlanganisa "imithi yendabuko yamaShayina" ohlelweni lokwelapha okuhambisanayo neminye imithi.

Eminyakeni yamuva, i-FDA iqinise ukulawulwa kokulawulwa kwemithi yemvelo yemvelo.Ngo-2003, yaqala ukusebenzisa ukuphathwa kwe-GMP yezithako zokudla futhi yabeka izindinganiso eziqinile zokukhiqiza kanye nokulebula kwezithako zokudla.I-FDA ishicilele Imihlahlandlela Yokuthuthukiswa Kwezidakamizwa Zezitshalo ku-inthanethi futhi yacela ukuphawula emhlabeni wonke.Izimiso Eziqondisayo zikhomba ngokusobala ukuthi imithi yezitshalo ihlukile emithini yamakhemikhali, ngakho izidingo zayo zobuchwepheshe kufanele futhi zehluke kweyakamuva, futhi ichaza izici ezithile zemithi yezitshalo: ukwakheka kwamakhemikhali emithi yezitshalo ngokuvamile kuyingxube yezingxenye eziningi, kunalokho. kunenhlanganisela eyodwa;Akuwona wonke amakhemikhali emithini ye-herbal ****** acacile;Ezimweni eziningi, izithako ezisebenzayo zemithi ye-herbal azinqunywa ******;Kwezinye izimo, umsebenzi webhayoloji wemithi yezitshalo awusho ****** ucacile futhi ucacile;Izindlela eziningi zokulungiselela nokucubungula imithi ye-herbal zinamandla kakhulu;I-Botanicals inokuhlangenwe nakho okubanzi nokwesikhathi eside ekusetshenzisweni komuntu.Ayikho imiphumela emibi esobala enobuthi eyatholwa ekusetshenzisweni kwesikhathi eside nokubanzi komuthi we-herbal emzimbeni womuntu.Eminye imithi yamakhambi idayiswe njengemikhiqizo yezempilo noma izithasiselo zokudla okunomsoco.

Ngokusekelwe ekuqondeni kwe-FDA imithi yezitshalo, izidingo zobuchwepheshe zemithi yezitshalo Ezimisweni Eziqondisayo zihlukile kulezo zemithi yamakhemikhali, okuhlanganisa: izidingo zobuchwepheshe zocwaningo lwangaphambi komtholampilo zixega uma kuqhathaniswa;Ukuhlolwa kwe-pharmacokinetic kungaphathwa ngokuguquguquka.Ukwelashwa okukhethekile kwamalungiselelo e-herbal ahlanganisiwe;Ubuchwepheshe bezemithi budinga ukucubungula okuguquguqukayo;Izidingo zobuchwepheshe ze-pharmacology kanye ne-toxicology zincishisiwe.Imihlahlandlela imele ukweqa kwekhwalithi endleleni ye-FDA emithini yemvelo yemithi, okuhlanganisa nemithi yendabuko yamaShayina.Ushintsho olukhulu lwenqubomgomo kahulumeni waseMelika ngemithi ye-herbal seludale izimo eziyisisekelo zokuthi imithi ye-herbal ingene emakethe yaseMelika.
Ngaphezu kwe-Veregen, osekuvunyelwe kakade, cishe ama-botanicals angaba ngu-60 kuya kwangu-70 asendleleni kuze kube manje.