Kev Nyab Xeeb Ntawm Dej Extract Ntawm Cistanche Tubulosa Stems Raws li cov khoom noj tshiab raws li kev cai
Mar 23, 2022
Hu rau: Audrey Hu Whatsapp / hp: 0086 13880143964 Email:audrey.hu@wecistanche.com
EFSA NDA Vaj Huam Sib Luag (EFSA Vaj Huam Sib Luag ntawm Kev Noj Qab Haus Huv, Novel Foods thiab Food Allergens), Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Andron Nazik Pearl , Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsab ntawvouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhauser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schnklatter, Gelbmann thiab Helle Katrine Knutsen
Abstract
Ua raws li kev thov los ntawm European Commission, EFSA Vaj Huam Sib Luag ntawm Kev Noj Qab Haus Huv, Novel Foods thiab Food Allergens (NDA) tau thov kom xa cov kev xav txog dej extract ntawmCistanchetubulosastems raws li ib tug tshiab zaub mov (NF) rau nws siv nyob rau hauv cov khoom noj (FS) thiab zaub mov rau tshwj xeeb kho mob hom phiaj (FSMP). Lub hom phiaj ntawm cov pej xeem yog cov neeg laus feem ntau tsis suav nrog cov poj niam cev xeeb tub thiab lactating. Tus neeg thov kev thov thov kom tau txais qhov siab tshaj plaws txhua hnub ntawm 2 g rau FS thiab qib siab tshaj plaws ntawm 10 feem pua hauv FSMP. Cov yam ntxwv ntawm cov extract yogphenylethanoidglycosides(tsawg kawg yog 70 feem pua ntawm NF), tshwj xeeb,echinacoside cov tshuaj(25-45 feem pua ntawm NF). NF tau raug tso cai ua tshuaj kho mob hauv Suav teb xyoo 2005 rau kev kho mob vascular dementia. Lub Vaj Huam Sib Luag sau tseg tias kev txheeb xyuas kev sib koom ua ke ntawm peb txoj kev tshawb fawb suav nrog 1,076 cov neeg mob uas muaj vascular dementia kho nrog cov lus pom zoo NF ntawm ib koob tshuaj txhua hnub ntawm 1,800 mg, qhia tias 12 cov xwm txheej tsis zoo (AEs) tau muab faib ua 'tuaj yeem', 'tej zaum' lossis ' tejzaum nws muaj feem cuam tshuam 'rau qhov raug rau NF. Ob qho ntawm cov AE no tau muab cais ua qhov hnyav (cerebral hemorrhage thiab epilepsy). Pawg Neeg Saib Xyuas tau txiav txim siab tias AEs tau tshaj tawm txog kev txhawj xeeb txog kev nyab xeeb. Lub Vaj Huam Sib Luag kuj tseem sau tseg cov kev txwv ntawm cov kev tshawb fawb toxicological, tshwj xeeb tshaj yog tsis ua raws li EFSA txoj hauv kev ntawm genotoxicity kuaj lub tswv yim thiab tsis ua raws li kev soj ntsuam zoo (GLP) thiab cov ntaub ntawv qhia txog OECD Cov Lus Qhia ntawm kev rov qab tshuaj toxicity. kev kawm. Raws li kev pom ntawm AEs hauv tib neeg kev tshawb fawb, Pawg Neeg Saib Xyuas tau txiav txim siab tias cov kev tshawb fawb toxicological ntxiv, ua raws li cov lus qhia kev sim yuav tsis tuaj yeem kov yeej cov kev txhawj xeeb los ntawm tib neeg kev tshawb fawb. Pawg neeg txiav txim siab tias kev nyab xeeb ntawm NF tsis tau tsim.
Ntsiab lus:Novel Foods,Cistanche tubulosa, phenylethanoid glycosides,echinacoside, zaub mov ntxiv, zaub mov rau kev kho mob tshwj xeeb
1. Taw qhia
1.1. Keeb kwm thiab cov ntsiab lus ntawm Kev Siv raws li muab los ntawm European Commission
Thaum Lub Kaum Hli 01, 2019, lub tuam txhab Sinphar Tian-Li Pharmaceutical Co., Ltd. tau xa daim ntawv thov mus rau European Commission raws li Tshooj 10 ntawm Txoj Cai (EU) 2015/22831 kom tso cai tso rau hauv Union ua lag luam ntawmCistanche(C.) tubulosaExtract raws li cov khoom noj tshiab (NF). Daim ntawv thov kev tso cai siv C. tubulosa extract hauv cov khoom noj thiab zaub mov rau kev kho mob tshwj xeeb. Tus neeg thov kev pabcuam kuj tau thov kev tiv thaiv cov ntaub ntawv raws li Tshooj 26 ntawm Txoj Cai (EU) 2015/2283. Raws li tsab xov xwm 10(3) ntawm Txoj Cai (EU) 2015/2283, European Commission thov kom European Food Safety Authority muab cov kev xav txog kev tshawb fawb txog C. tubulosa extract raws li NF. Tsis tas li ntawd, European Food Safety Authority tau thov kom suav nrog hauv nws cov kev xav tshawb fawb ib nqe lus hais txog yog tias, thiab yog tias muaj li cas, cov ntaub ntawv ntiag tug uas tus neeg thov kev thov tau thov cov ntaub ntawv tiv thaiv tau siv los piav qhia cov kev xav hauv txoj kab nrog rau Cov cai ntawm Tshooj 26(2)(c) ntawm Txoj Cai (EU) 2015/2283.
2. Cov ntaub ntawv thiab cov txheej txheem
2.1. Cov ntaub ntawv
Kev ntsuas kev nyab xeeb ntawm NF no yog ua raws li cov ntaub ntawv muab hauv daim ntawv thov.
Cov kev cai tswj hwm thiab kev tshawb fawb rau NF cov ntawv thov xa mus rau hauv Tshooj 10 ntawm Txoj Cai (EU) 2015/2283 tau teev nyob rau hauv Commission Implementing Regulation (EU) 2017/24691.
Ib hom qauv thiab cov qauv tsim rau kev nthuav qhia ntawm NF daim ntawv thov tau piav qhia hauv EFSA Cov Lus Qhia ntawm kev npaj thiab nthuav tawm ntawm daim ntawv thov NF (EFSA NDA Vaj Huam Sib Luag, 2016). Raws li tau teev tseg hauv cov lus qhia no, nws yog lub luag haujlwm ntawm tus neeg thov kev pabcuam los muab tag nrho cov ntaub ntawv muaj (muaj, tsis pub lwm tus paub, thiab tshaj tawm) cov ntaub ntawv tshawb fawb (xws li ob qho tib si cov ntaub ntawv pom zoo thiab tsis pom zoo) uas cuam tshuam rau kev nyab xeeb ntawm NF.
Daim ntawv thov NF no suav nrog kev thov rau kev tiv thaiv cov ntaub ntawv ntiag tug raws li Tshooj 26 ntawm Txoj Cai (EU) 2015/2283. Cov ntaub ntawv thov los ntawm tus neeg thov kev tiv thaiv muaj tag nrho cov kev tshawb fawb toxicological thiab tib neeg ntawm daim ntawv thov no.
2.2. Cov txheej txheem
Qhov kev ntsuam xyuas ua raws li cov txheej txheem tau teev tseg hauv EFSA cov lus qhia ntawm NF daim ntawv thov (EFSA NDA Vaj Huam Sib Luag, 2016) thiab cov hauv paus ntsiab lus tau piav qhia hauv cov ntaub ntawv qhia muaj feem cuam tshuam los ntawm EFSA Pawg Neeg Tshawb Fawb. Cov kev cai lij choj rau kev ntsuam xyuas tau muab tso rau hauv Tshooj 11 ntawm Txoj Cai (EU) 2015/2283 thiab hauv Tshooj 7 ntawm Pawg Saib Xyuas Kev Ua Haujlwm (EU) 2017/2469.
Qhov kev ntsuam xyuas no tsuas yog txhawj xeeb txog qhov kev pheej hmoo uas yuav cuam tshuam nrog kev noj NF raws li cov kev xav tau ntawm kev siv thiab tsis yog kev ntsuam xyuas ntawm qhov ua tau zoo ntawm NF hais txog cov txiaj ntsig tau thov.
3. Kev soj ntsuam
3.1. Taw qhia
NF uas yog lub ntsiab lus ntawm daim ntawv thov yog ib tug dej extract ntawm stems ntawm C. tubulosa cultivated nyob rau hauv Tuam Tshoj. Nws muaj tsawg kawg yog 70 feem puaphenylethanoidglycosides. NF yog npaj los siv los ua cov khoom xyaw rau cov khoom noj thiab cov khoom noj rau kev kho mob tshwj xeeb. Lub hom phiaj ntawm cov pej xeem yog cov neeg laus feem ntau tsis suav nrog cov poj niam cev xeeb tub thiab lactating.
3.2. Tus kheej ntawm NF
NF yog cov dej extract tau los ntawm cov qia qhuav ntawmCistanchetubulosa(Schenk) Yog.
3.3. Cov txheej txheem ntau lawm
Kev cog qoob loo ntawm C. tubulosa yuav tsum ua ntej kev cog qoob loo ntawm tus tswv cog Tamarix Chinensis uas yog tom qab ntawd inoculated nrog cov cab cab C. tubulosa. Tom qab sau qoob C. tubulosa, stems yog ntxuav, txiav rau hauv slices, thiab qhuav. Cov txheej txheem tsim khoom ntawm NF suav nrog kev rho tawm nrog dej, concentration, nag lossis daus nrog ethanol, thiab cov kauj ruam ua kom qhuav.
3.4. Cov ntaub ntawv sib xyaw
Raws li kev txheeb xyuas ze ntawm ob pawg, NF muaj kwv yees li 93 g carbohydrates uas kwv yees li 1.3 g yog fiber ntau, 1.5 g protein, 1.3 g lipids, 3.2 g noo noo, thiab 0.2 g tshauv ib 100 g. Lub ntsiab tseem ceeb ntawm cov extract yog ib pawg ntawmphenylethanoidglycosides(tsawg kawg 70 feem pua ntawm NF) thiab tshwj xeebechinacoside cov tshuaj(25-45 feem pua ntawm NF). Ntxiv rauechinacoside cov tshuaj, lwm yamphenylethanoid glycosidesKev txheeb xyuas hauv NF yog 20 -acetylacteoside, acteoside, campneoside I, campneoside II, cistantubuloside A, cistantubulosides B1, B2, cistantubulosides C1, C2, crenatoside, decaffeoylacteoside,echinacoside cov tshuaj, isoacteoside, Rhodiola side, syringalide A 30 -aL-rhamnopyranoside thiab tubuloside A.
Tus neeg thov kev pabcuam tau muab cov txiaj ntsig ntawm xya pawg uas pom cov ntsiab lus ntawmphenylethanoidglycosidesthiabechinacoside cov tshuajnyob nruab nrab ntawm 73.5 feem pua thiab 79.8 feem pua thiab 31.9 feem pua thiab 38.9 feem pua, feem.
Cov xya pawg no kuj tau txheeb xyuas cov kuab tshuaj residuals, hnyav hlau, thiab microbiological tsis. Kev sim ntxiv ntawm qee cov khoom siv raw li ntawm NF tau ua rau tshuaj tua kab thiab aflatoxins.
3.4.1. Kev ruaj ntseg
Tus neeg thov tau ua 48- hli (25 degree / RH 60 feem pua ) thiab nrawm 6- hli (40 degree / RH 75 feem pua) kev ntsuas kev ruaj ntseg ntawm rau batch. Thaum kawg ntawm 48 lub hlis, tusphenylethanoidglycosidesthiabechinacoside cov tshuajnyob nruab nrab ntawm 70.1 feem pua thiab 79.1 feem pua thiab 30.1 feem pua thiab 37.1 feem pua, feem. Thaum kawg ntawm 6 lub hlis nyob rau hauv kev ceev ceev cia, qhov ntau yog 71.3–75.3 feem pua thiab 28.0–35.1, feem.
3.5. Specifications
Cov kev qhia tshwj xeeb ntawm NF raws li tus neeg thov kev thov tau qhia hauv Table 1.
Lub Vaj Huam Sib Luag sau cov lus qhia tshwj xeeb 'benzene', uas yog genotoxic thiab carcinogenic.
3.6. Keeb kwm ntawm kev siv NF thiab / lossis ntawm nws qhov chaw
3.6.1. Keeb kwm ntawm kev siv lub hauv paus
Raws li tus neeg thov, cov nroj tsuag muaj keeb kwm ntev ntawm kev siv nyob rau hauv Asia, tshwj xeeb tshaj yog nyob rau hauv cov tshuaj suav tshuaj. Tus neeg thov kev pab kuj tau muab cov ntaub ntawv hais tias lub hauv paus ntawm C. tubulosa yog siv los ua ib qho ntawm 'cov tshuaj thiab cov khoom noj qab haus huv' hauv Canada (Health Canada, 2019).
3.6.2. Keeb kwm ntawm kev siv NF
Raws li tus neeg thov kev pab, cov extract tau tso cai nyob rau hauv Taiwan rau kev siv cov khoom noj uas muaj ntau tshaj ib hnub twg ntawm 450 mg (Taiwan Food and Drug Administration, 2017). Nws tau raug tso cai ua lag luam raws li cov tshuaj noj hauv Suav teb xyoo 2005 rau kev kho mob vascular dementia.
3.7. Kev npaj siv thiab siv qib thiab kev cia siab tias yuav tau txais
3.7.1 ib. Hom neeg
Lub hom phiaj ntawm cov pej xeem uas tau thov los ntawm tus neeg thov kev pab yog cov neeg laus cov neeg laus tsis suav nrog cov poj niam cev xeeb tub thiab lactating poj niam. 'Cov ntaub ntawv tsis txaus' rau cov pab pawg subpopulation no tau raug txiav txim siab rau lawv qhov kev cais tawm.
3.7.2 ib. Cov kev siv thiab kev siv theem
Tus neeg thov kev pom zoo siv NF rau cov khoom noj ntxiv ntawm kev siv 2 g / hnub thiab cov khoom noj rau cov hom phiaj kho mob tshwj xeeb (FSMP) ntawm 100 g / kg zaub mov. Tsis muaj qhov siab tshaj plaws noj txhua hnub ntawm NF tau thov rau FSMP.
3.8. Absorption, tis, metabolism, thiab excretion (ADME)
Kev tshawb nrhiav cov ntaub ntawv los ntawm tus neeg thov tau txheeb xyuas xya qhov kev tshawb fawb luam tawm hauv xya kab lus ntsig txog ADME thiab C. tubulosa qia extracts. Cov kev tshawb fawb no suav nrog cov ntaub ntawv ntawm cov qauv hauv vitro (Li et al., 2016a, 2017) los kawm txog cov metabolites ntawmechinacoside cov tshuaj, cistanoside, acteoside thiab isoacteosideechinacoside cov tshuaj, thiab nas qauv (Jia et al., 2006; Wang et al., 2009; Cui et al., 2016; Li et al., 2016a, b; Qi et al., 2013) los kawm txog bioavailability, tis, metabolism , thiab tshem tawm qee qhovphenylethanoidglycosidesxws liechinacoside cov tshuaj, acteoside, thiab isoacteoside.
3.9. Cov ntaub ntawv noj zaub mov
Xav txog cov kev txheeb xyuas ze ze uas tau muab rau hauv Tshooj 3.4 (Cov ntaub ntawv sib xyaw), Lub Vaj Huam Sib Luag tau txiav txim siab tias kev noj 2 g ntawm NF ib hnub tsis muaj kev noj haus tsis zoo.
3.10. Toxicological ntaub ntawv
Tus neeg thov kev pabcuam tau muab ntau yam kev tshawb fawb toxicological, raws li tus neeg thov kev pabcuam tag nrho lawv tau ua nrog NF, tab sis qhov no tsis muaj pov thawj los ntawm cov ntaub ntawv muaj nyob rau hauv cov ntaub ntawv tshawb fawb.
Genotoxicity tau kawm nyob rau hauv plaub qhov kev kuaj kab mob thim rov qab (Hunan Provincial Chaw Tiv Thaiv Kab Mob thiab Tiv Thaiv, 2005; Development Center for Biotechnology, 2008a; Hubei Provincial Center for Disease Control and Prevention, 2010a; Liao et al., 2018), nyob rau hauv ib qho. vitro chromosomal aberration test (Liao li al., 2018), thiab nyob rau hauv ob qhov kev ntsuam xyuas hauv vivo nas micronucleus (Development Center for Biotechnology, 2008b; Hubei Provincial Center for Disease Control and Prevention, 2010b).
Hais txog kev kuaj tsiaj, tus neeg thov tau muab ib qho kev kawm mob rau cov nas (Hubei Provincial Center for Disease Control and Prevention, 2010b), ob txoj kev tshawb fawb txog kev mob toxicity hauv nas (Hunan Provincial Center for Disease Control and Prevention, 2005; Liao et al., 2018) , ib txoj kev tshawb fawb txog kev mob toxicity nyob rau hauv nas (Hubei Provincial Center for Disease Control and Prevention, 2010b) thiab 6-hloov kev tshawb fawb hauv nas thiab dev tsom mus kawm txog kev mob toxicity thiab carcinogenicity (Peking University School of Pharmaceutical Sciences, 1998a, b. )
Lub Vaj Huam Sib Luag sau tseg tias qhov kev sim tshuaj genotoxicity tsis ua raws li EFSA Kev Taw Qhia uas thov kom muaj txoj hauv kev los daws genotoxicity hauv thawj kauj ruam nrog cov kab mob rov qab hloov pauv thiab kuaj hauv vitro micronucleus (EFSA Scientific Committee, 2011). Lub Vaj Huam Sib Luag kuj tseem txiav txim siab tias kev tshawb fawb txog kev mob toxicity tsis cuam tshuam rau kev soj ntsuam kev nyab xeeb ntawm NFs. Tsis tas li ntawd, tsis muaj ib qho kev tshawb fawb txog tshuaj toxicity rov qab ua raws li kev soj ntsuam zoo (GLP) thiab cov ntaub ntawv qhia txog OECD. Qhov no kuj tseem siv tau rau txoj kev tshawb fawb txog kev mob toxicity uas tau piav qhia tsis txaus nyob rau hauv yim nplooj ntawv hauv daim ntawv tshaj tawm tsis tau tshaj tawm los ntawm Hubei Provincial Center for Disease Control and Prevention (2010b).
3.10.1. Tib neeg cov ntaub ntawv
Tus neeg thov kev pab tau nthuav tawm plaub qhov kev tshawb fawb tib neeg ua nrog NF cov ntsiab lus hauv Table 2.
Ib tsab xov xwm tau muab rau ntawm qhov tsis muaj kev tswj hwm qhib-label sim nrog 18 tus neeg mob uas muaj mob Alzheimer's Disease Kho nrog ob lub ntsiav tshuaj ntawm 300 mg ntawm NF peb zaug ib hnub (tag nrho cov koob tshuaj txhua hnub ntawm 1,800 mg) rau 48 lub lis piam (Guo et al., 2013). Cov ntsiab lus tseem ceeb ntawm kev nyab xeeb yog cov cim tseem ceeb (ntshav siab, lub plawv dhia, thiab lub cev hnyav); hematological parameters (cov qe ntshav dawb suav tag nrho thiab suav qhov sib txawv, hemoglobin, ntshav liab suav, thiab platelet suav), thiab ntshav chemistry, electrocardiography (ECG); thiab cov xwm txheej tsis zoo (AEs). Thaum lub lis piam 24, 36, thiab 48, diastolic ntshav siab tau tshaj tawm tias qhov ntsuas qis qis dua 6-7 mm Hg piv rau lub lim tiam 0. Ib tus neeg mob qhia xeev siab tom qab 8 lub lis piam thiab ib tus neeg mob tau hnov lus thaum pib ntawm txoj kev tshawb no thiab ib qho rov tshwm sim ntawm lub lim tiam 12. Ib thiab peb tus neeg mob tau pom qhov nce ntxiv (cov duab tsis tau muab) ntawm alanine aminotransferase (ALT) ntawm lub lim tiam 24 thiab lub lim tiam 48, raws li. Tag nrho cov AEs tau tshaj tawm tias mob me me los ntawm cov kws sau ntawv. Lub Vaj Huam Sib Luag sau cov qauv kev tshawb fawb uas tsis muaj kev tswj hwm thiab txiav txim siab tias tsis muaj qhov kev txiav txim siab tuaj yeem txiav txim siab seb cov AEs tau tshaj tawm puas muaj feem cuam tshuam nrog kev kho mob.
Tsis tas li ntawd, tus neeg thov kev pab kuj tau muab ib qho kev ntsuam xyuas ntawm cov ntaub ntawv kev nyab xeeb los ntawm peb qhov kev sim tshuaj (theem II, III, thiab IV) hauv cov neeg mob uas muaj vascular dementia (Sinphar, 2011). Daim ntawv tshaj tawm no tau txheeb xyuas cov AEs tau tshaj tawm hauv peb qhov kev sim no nrog rau 3-hli lub sijhawm. Nws npog cov ntaub ntawv kev nyab xeeb ntawm 1,076 tus neeg mob uas tau txais NF ntawm ib hnub koob tshuaj 1,800 mg hauv peb qhov kev sim no piv rau cov ntaub ntawv kev nyab xeeb ntawm 229 tus neeg mob (piv pawg) kho nrog 6 mg ib hnub ntawm ergoloid mesylates (ib qho sib xyaw ntawm peb. ergot alkaloids) hauv ob qhov kev sim tshuaj (piv txwv li theem II thiab theem III kev sim).
Hauv peb qhov kev tshawb fawb no, 46 cov kev kawm tau ntsib 49 AEs. Qhov tshwm sim ntawm AEs yog 3.72 feem pua (n=40) rau pawg NF thiab 3.93 feem pua (n=9) rau pawg sib piv. Rau ntawm tag nrho yim AEs tau muab faib ua 'qhov hnyav' tshwm sim hauv pawg NF, uas sawv cev rau qhov tshwm sim zoo sib xws rau ob pawg. Ntawm 40 AEs uas tau tshaj tawm rau NF pab pawg, cov kws tshawb fawb tseem ceeb tshawb fawb tau txiav txim siab tias ib tus tau suav tias yog "muaj feem cuam tshuam" rau NF (gastritis ntawm qib nrab), peb AEs tau suav tias 'tej zaum cuam tshuam' rau NF ( cem quav ntawm qhov nruab nrab. degree, qaug dab peg lossis mob hnyav thiab pw tsaug zog me ntsis) thiab yim AEs tau muab cais ua 'tejzaum muaj feem cuam tshuam' rau NF (cerebral hemorrhage of heavy degree, gastric hemorrhagic ulcer, thiab lethargy of moderate degree, ob zaug cem quav, txhua zaus kiv taub hau, qaug zog thiab tsaug zog. ntawm me ntsis degree). Qhov tshwm sim ntawm AEs uas tau txiav txim siab, tej zaum, lossis tejzaum nws muaj feem cuam tshuam nrog kev kho mob nrog NF yog kwv yees li 1.1 feem pua. Raws li cov kws sau ntawv ntawm qhov kev txheeb xyuas kev sib koom ua ke, C. tubulosa qia extract tau tshwm sim rau 'kev nyab xeeb tsim nyog' rau cov neeg kawm, piv txwv li cov neeg mob uas muaj vascular dementia. Daim ntawv tshaj tawm no kuj tau xa mus rau 5-xyoo Periodic Safety Update Report rau cov khoom tau tso cai raws li cov tshuaj noj hauv Suav teb rau kev kho mob vascular dementia, qhia tias rau 844 tus neeg mob tau kho txij li kev pom zoo ua lag luam hauv xyoo 2005, tsis muaj AE. tau qhia.
4. Kev sib tham
Lub Vaj Huam Sib Luag sau tseg tias kev tshuaj xyuas kev sib koom ua ke ntawm peb txoj kev tshawb fawb tib neeg tau them rau 1,076 tus neeg mob uas muaj vascular dementia kho nrog cov lus pom zoo NF ntawm ib hnub koob tshuaj 1,800 mg. Lub Vaj Huam Sib Luag kuj tseem sau tseg tias txoj hauv kev los ntsuas kev nyab xeeb ntawm tib neeg thiab kev tsim qauv ntawm tib neeg kev tshawb fawb (tshwj xeeb yog siv cov tshuaj pom zoo raws li kev sib piv hauv theem II thiab theem III kev tshawb fawb) tau ua raws li cov kev qhia dav dav rau kev txhim kho kev kho mob ntawm ib qho tshuaj, tsis yog khoom noj tshiab. Kev siv tshuaj raws li kev sib piv es tsis txhob siv cov tshuaj placebo txwv cov lus xaus uas tuaj yeem rub tawm los ntawm cov kev tshawb fawb no rau kev ntsuas kev nyab xeeb ntawm NF. Thaum lub hom phiaj ntawm kev soj ntsuam kev nyab xeeb ntawm cov tshuaj yog los txhawb qhov kev pheej hmoo- txiaj ntsig kev soj ntsuam rau ib pawg neeg mob tshwj xeeb, randomized tswj tib neeg kev sim uas hais txog kev nyab xeeb ntawm NFs yuav tsum tau siv cov placebo tswj thiab qhov zoo rau cov pej xeem.
Sib txawv rau cov kev txiav txim siab los ntawm tus neeg thov kev pab hauv kev sib koom ua ke ntawm peb qhov kev sim nrog cov neeg mob uas muaj vascular dementia thiab leej twg tau txiav txim siab tias cov khoom muaj kev nyab xeeb rau cov neeg mob zoo li no, Pawg Neeg Saib Xyuas tau soj ntsuam kev nyab xeeb ntawm NF rau cov neeg laus tsis noj. mus rau hauv tus account tej yam txiaj ntsim. Lub Vaj Huam Sib Luag sau tseg qhov tshwm sim ntawm 12 (1.1 feem pua) AEs thoob plaws peb txoj kev tshawb fawb uas suav nrog 1,076 cov ntsiab lus uas tau txiav txim los ntawm tus thawj xibfwb txoj kev tshawb fawb los ua 'txoj cai', 'tej zaum', lossis 'tej zaum cuam tshuam' rau kev kho mob nrog NF. Ob ntawm AEs no tau muab cais ua qhov hnyav (cerebral hemorrhage thiab epilepsy).
Pawg Neeg Saib Xyuas tau txiav txim siab tias AEs tau tshaj tawm txog kev txhawj xeeb txog kev nyab xeeb. Lub Vaj Huam Sib Luag kuj tseem sau tseg cov kev txwv ntawm cov kev tshawb fawb toxicological, tshwj xeeb tshaj yog tsis ua raws li EFSA Cov Lus Qhia ntawm genotoxicity kuaj lub tswv yim thiab tsis ua raws li GLP thiab cov ntaub ntawv qhia txog OECD Cov ntaub ntawv ntawm cov kev tshawb fawb tshuaj toxicity dua. Raws li kev pom ntawm AEs hauv tib neeg kev tshawb fawb, Pawg Neeg Saib Xyuas tau txiav txim siab tias cov kev tshawb fawb toxicological ntxiv, ua raws li cov lus qhia kev sim yuav tsis tuaj yeem kov yeej cov kev txhawj xeeb los ntawm tib neeg kev tshawb fawb.
5. Cov lus xaus
Pawg neeg txiav txim siab tias kev nyab xeeb ntawm NF tsis tau tsim.
6. Cov kauj ruam tau ua los ntawm EFSA
1) Nyob rau 29/05/2020 EFSA tau txais ib tsab ntawv los ntawm European Commission nrog rau kev thov rau ib tug scientific tswv yim ntawm kev nyab xeeb ntawm dej extract ntawmCistanchetubulosacov, Ref. Ares (2020) 2872765 – 03/06/2020.
2) Hnub tim 29/05/2020, ib daim ntawv thov siv tau ntawm cov dej rho tawm ntawmCistanchetubulosastems, uas tau xa los ntawm lub npe ntawm lub tuam txhab, tau tsim muaj rau EFSA los ntawm European Commission los ntawm Commission e-submission portal (NF2019/1318) thiab cov txheej txheem soj ntsuam kev tshawb fawb tau pib.
3) Thaum lub rooj sib tham thaum Lub Kaum Ib Hlis 24, 2020, NDA Vaj Huam Sib Luag, tau soj ntsuam cov ntaub ntawv, tau txais kev pom zoo txog kev nyab xeeb ntawm dej extract ntawmCistanche tubulosastems raws li NF raws li Txoj Cai (EU) 2015/2283.
Los ntawm: 'Kev nyab xeeb ntawm dej extract ntawmCistanche tubulosastems 'los ntawm Dominique Turck, thiab al
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Cov ntaub ntawv
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Cov ntawv luv
ADME nqus, faib, metabolism, thiab tso tawm
AEs cov xwm txheej tsis zoo
ALT alanine aminotransferase
CFU colony-forming units
ECG electrocardiography
FS Khoom noj khoom haus
FSMP zaub mov rau kev kho mob tshwj xeeb
GC roj chromatography
GLP Kev Xyaum Ua Haujlwm Zoo
HPLC high-performance kua chromatography
NDA Vaj Huam Sib Luag ntawm Nutrition, Novel Foods, thiab Food Allergens
NF cov khoom noj tshiab
OECD Lub Koom Haum rau Kev Lag Luam Kev Lag Luam thiab Kev Txhim Kho
RH txheeb ze humidity
SC Pawg Neeg Saib Xyuas Kev Tshawb Fawb
TID peb zaug ib hnub twg
TLC nyias txheej chromatography
USP Tebchaws Asmeskas Pharmacopeia
