Nkag siab txog tsob nroj kom Extract qhov sib piv hauv Botanical Extracts

Kev noj zaub mov ntxiv tam sim no kev tsim khoom zoo (cGMP) yuav tsum tsim kom muaj qhov tsis zoo rau txhua qhov khoom siv hauv kev tsim cov khoom noj khoom haus kom paub meej tias cov lus qhia tshwj xeeb rau tus kheej, purity, lub zog, muaj pes tsawg leeg, thiab kev txwv ntawm cov kab mob tau ntsib.* Ua raws li botanical extract ingredient specifications yog assured los ntawm kev siv scientifically siv txoj kev ntawm kev tsom xam, cov ntsiab lus ntawm uas yog qhia nyob rau hauv daim ntawv pov thawj ntawm tsom xam (CoAs). Txawm li cas los xij, CoAs niaj hnub suav nrog cov ntaub ntawv ntxiv uas tsis tuaj yeem hloov kho los ntawm kev txheeb xyuas. Cov ntaub ntawv piav qhia no tuaj yeem suav nrog Kev cog qoob loo rau Extract, uas yog qhov sib piv ntawm qhov ntau ntawm botanical tsab xov xwm siv nyob rau hauv kev tsim cov extract rau kom muaj nuj nqis ntawm extract tau. Cog rau Extract piv tuaj yeem ua yuam kev thaum lawv lub ntsiab lus tsis meej meej.

Nyem qhov no kom tau txais Cistanche Extract Nrog 30 feem pua ​​Echinacoside

Cog rau Extract ratiosTsis txhob piav qhia txog botanical extracts vim tias lwm yam tseem ceeb cuam tshuam rau kev pleev xim ntawm cov khoom kawg, xws li qhov zoo ntawm cov khoom siv raw khoom (raws li tau txhais los ntawm cov qauv tshuaj pharmacopeial), cov kuab tshuaj extraction siv, ntev thiab kub ntawm extraction, thiab feem pua. thiab hom excipients tam sim no. Lwm cov lus piav qhia tseem ceeb yuav suav nrog "tus ntiv tes ntiv tes". Txawm hais tias cov teeb meem no, Cog rau Extract feem ntau yog siv los ua ib qho kev ntsuas ntawm lub zog extract rau kev suav ntau npaum li cas. Cov kab lus no txhais thiab qhia meej lub ntsiab lus ntawm tsob nroj rau Extract piv thiab lawv cov kev siv kom zoo hauv kev piav qhia thiab sau cov khoom xyaw botanical extract thiab cov khoom tiav uas muaj lawv.

1 Kev Taw Qhia

Botanical extracts yog tsim los ntawm cov khoom rho tawm tau los ntawm cov khoom pib ntawm botanical keeb kwm [United States Pharmacopeia (USP)]. Lawv tshwm sim los ntawm dissolving soluble nroj tsuag constituent nyob rau hauv extraction solvents thiab cais lawv los ntawm undissolved cog cov ntaub ntawv. Ib qho botanical extract tau raug txhais tias yog "cov complex, multicomponent sib tov tau tom qab siv cov kuab tshuaj los yaj cov khoom ntawm botanical khoom" (Dentali, 2013). Crude botanical extracts (cov uas tsis muaj ntxiv excipients) yog hu ua haiv neeg los yog cov extracts tiag. Excipients feem ntau yog ntxiv rau cov extracts los txhim kho lawv cov khoom tuav cov yam ntxwv, kom standardize constituent concentrations, thiab rau lwm yam functional hom phiaj. Lo lus "botanical extract" ntawm no yog hais txog txhua hom kev rho tawm, ywj siab ntawm kev sib raug zoo ntawm cov neeg muaj npe thiab bioactivity (potency) ntawm cov extract.

Txawm hais tias botanical rho tawm tej zaum yuav raug rau kev ua ntxiv los txhawb cov ntsiab lus ntawm cov tshuaj lom neeg hauv chav kawm, thaum lawv tau raug cais tawm raws li ib feem lossis raws li cov khoom siv huv huv, cov khoom no thiab cov kua txiv hmab txiv ntoo tsis suav tias yog cov khoom siv botanical. Tsis tas li ntawd, cov extracts tsis suav nrog cov tshuaj hloov kho cov nroj tsuag tshwj tsis yog qhov khoom cuav tshwm sim los ntawm cov txheej txheem cua sov lossis cov txheej txheem rho tawm. Tsis tas li ntawd, rau lub hom phiaj ntawm tsab xov xwm no, lo lus cog los yog botanical yog siv nyob rau hauv lub dav kev txiav txim siab muaj xws li algae, fungi, thiab lichens, nrog rau cov khoom cog xws li exudates los yog oleo-gum-resins.

Botanical rho tawm tuaj yeem piav qhia, ib feem, los ntawm Cov Tsob Ntoo rau Extract piv ntawm botanical pib cov khoom siv raw (aka biomass) los ntawm lawv tau ua, mus rau qhov tshwm sim, los yog tiav, rho tawm. Lub Chaw Haujlwm Saib Xyuas Tshuaj European (EMA) [European Medicines Agency (EMA), 2010] cov lus qhia xa mus rau qhov piv ntawm cov khoom pib mus rau qhov tseeb / haiv neeg extract piv raws li DER tiag (Drug to Genuine Extract Ratio), † thiab piav qhia yuav ua li cas nthuav tawm cov feem pua ​​​​ntawm cov txiaj ntsig / haiv neeg extract nrog cov feem pua ​​​​excipients rau cov khoom tiav tiav. DER yog siv los ua ib feem ntawm lub zog characterization ntawm ib qho extract, piv txwv li, tus nqi ntawm cov khoom pib siv los ua ib chav tsev ntawm extract. Zej Zog Herbal Monographs los ntawm EMA siv DER, ua ke nrog cov ntaub ntawv tshem tawm cov kuab tshuaj, rau kev txiav txim siab ntawm cov khoom siv cog qoob loo sib npaug hauv kev sib piv cov extracts, thiab rau kev kwv yees cov tshuaj rho tawm raws li kev tsim kho zoo lossis kev siv cog qoob loo.

Kev cog qoob loo rau Extract tuaj yeem ua rau kev txiav txim siab ntawm cov khoom siv raw cov khoom sib npaug, txawm hais tias qhov kawg tshuaj muaj pes tsawg leeg tuaj yeem sib txawv nyob ntawm qhov zoo ntawm cov khoom cog pib thiab cov khoom siv rho tawm. Kev sib piv ze ntawm cov extracts, tseem hu ua lawv cov phytoequivalence (Australian Government. Department of Health, 2011), tsis tuaj yeem txiav txim siab yam tsis muaj kev sib piv cov ntsiab lus ntawm cov kuab tshuaj thiab cov txheej txheem tsim khoom siv, qee zaum ntxiv nrog kev sib piv ntawm cov tshuaj extracts. sau ntawv.

Kab lus no ua ntej muab cov ntsiab lus ntawm botanical extracts, nrog rau lawv cov ntau hom thiab cov ntaub ntawv, standardization, thiab categorization. Cov seem ntxiv piav qhia txog lub tswv yim ntawm Kev cog qoob loo rau Extract thiab cov kev xav tsis zoo. Kuj tseem muaj cov lus qhia txog yuav ua li cas siv tsob nroj rau Extract piv rau hauv daim ntawv lo, thiab nws qhov cuam tshuam rau qhov ntau npaum ntawm cov khoom cog sib npaug.

2 Botanical extracts

Botanical extracts, raws li tau hais tseg hauv USP General Tshooj<565>Botanical Extracts [United States Pharmacopeia (USP)], feem ntau yog siv los ua cov khoom xyaw hauv kev noj haus. Botanical extracts uas ua raws li USP monographs rau Botanical Extracts yuav tsum tau txais los ntawm botanical cov khoom uas kuj ua raws li USP monographs sib xws. Extracts tej zaum yuav raug tsim los ua kom pom tseeb cov ntsiab lus xav tau, txo cov ntsiab lus ntawm cov khoom tsis zoo lossis cov impurities, txhim kho txee lub neej, thiab tsim cov khoom zoo sib xws rau kev sim cov txiaj ntsig tau thov. Nyob ntawm seb hom khoom siv botanical thiab extraction technology siv, ua ntej extraction cov khoom siv raw yuav raug rau ntau hom pretreatments, xws li txiav thiab sib tsoo kom txo cov particle loj thiab optimize deg cheeb tsam raug, defatting, thiab lwm yam.

Cov muaj pes tsawg leeg ntawm botanical extracts los ntawm tib tsob nroj yuav txawv heev nyob ntawm seb cov extraction hnyav (s) siv, qhov kub thiab txias ntawm extraction, thiab cov txheej txheem siv los ziab cov extracts. Lwm qhov chaw ntawm kev hloov pauv muaj xws li cov kauj ruam coj los ua kom pom tseeb lossis tshem tawm cov ntsiab lus los yog cov chav kawm ntawm cov khoom sib xyaw, thiab cov khoom sib txuas tsim thaum lub sij hawm rho tawm lossis ua ntxiv. Ntxiv variation nyob rau hauv muaj pes tsawg leeg ntawm botanical extracts ua siv tib hom nroj tsuag thiab cov nroj tsuag ib feem raws li cov ntaub ntawv pib tej zaum yuav tshwm sim los ntawm caj ces yam, ib puag ncig tej yam kev mob, thiab kev ua liaj ua teb. Tswj lub ntuj variations nyob rau hauv cov khoom pib thiab siv cov txheej txheem extraction txheej txheem yuav pab tau los tsim extracts nrog zoo ib yam. Cov khoom tsim nyog inert (excipients) feem ntau ntxiv rau kev rho tawm ntawm granulation lossis lwm cov txheej txheem los ua cov khoom thauj lossis diluent uas txhim kho lub cev tuav cov yam ntxwv xws li flowability thiab mixability. Excipients kuj tuaj yeem pab txhawb kev tsim cov hmoov, txo cov clumping, thiab txhim kho homogeneity, bioavailability, stability, thiab lwm yam ntxwv. Excipients kuj tuaj yeem siv los ua tus qauv ntawm cov extract mus rau cov ntsiab lus ntawm ib lossis ntau qhov sib xyaw.

Raws li USP General Tshooj<565>Botanical Extracts [United States Pharmacopeia (USP)], botanical extracts tuaj yeem raug cais raws li lawv lub cev lub cev raws li cov kua (xws li, fluidextracts thiab tinctures), semisolid (soft), los yog cov ntaub ntawv (qhuav). Cov qauv ntawm lub cev no tau txhais hauv Table 1.

3 Standardization ntawm botanical extracts

Ntau lub koom haum txhais botanical extract standardization txawv

Lub koom haum American Herbal Products Association (AHPA) (American Herbal Products Association, 2003), lub koom haum ua lag luam tshuaj ntsuab hauv Tebchaws Meskas, txhais cov qauv tsim raws li "lub cev tag nrho ntawm cov ntaub ntawv thiab kev tswj hwm uas ua haujlwm kom zoo tshaj qhov sib xws ntawm batch-to-batch. Standardization yog ua tiav los ntawm kev txo qhov kev hloov pauv ntawm cov khoom muaj pes tsawg leeg los ntawm kev ua pov thawj zoo siv rau kev ua liaj ua teb thiab kev tsim khoom. " AHPA (American Herbal Products Association, 2021) taw qhia tias, "[i] qhov tseeb, kev ua qauv zoo-thaum ua tau zoo-ntau ntau tshaj qhov tsuas yog tswj cov ntsiab lus ntawm ib qho kev sib xyaw ua ke ... Nws muaj ntau yam khoom siv raw thiab tswj cov txheej txheem, nrog rau kev siv daim ntawv qhia zoo ib yam. "

Marker compounds yog cov ntsiab lus uas tej zaum yuav los yog tsis cuam tshuam nrog kev kho mob thiab feem ntau yog siv los ua kev tswj hwm hauv kev ua haujlwm. Lawv kuj tuaj yeem pab qhia txog tus kheej thaum tshwj xeeb rau botanical raw khoom raws li kev xav. Ntawm qhov tod tes, cov qib sib xyaw ua ke yuav tsis sib txawv nrog rau lwm cov ntsiab lus tseem ceeb dua piv rau kev kho mob, vim qhov sib txawv ntawm cov noob caj noob ces, kev loj hlob, lossis kev ruaj ntseg thaum ua thiab khaws cia.

EMA categorizes "standardised extracts" raws li cov neeg uas tau txheeb xyuas cov neeg tuaj koom tau nkag siab kom tag nrho cov nyiaj tau los ntawm kev ua pov thawj kho mob [European Medicines Agency (EMA), 2010]. Txoj kev sib raug zoo ntawm cov khoom pov thawj rau ib qho kev ua haujlwm lom neeg tuaj yeem tsis meej. Awang (2004) tau sau tseg tias tus kheej ntawm cov neeg muaj lub luag haujlwm rau kev ua haujlwm lom neeg ntawm cov nroj tsuag rho tawm tsis tshua pom meej meej, txawm tias muaj bioassays thiab kev tshawb fawb soj ntsuam, thiab ntau tus neeg tuaj yeem tuaj yeem ua haujlwm rau ntau qib thiab ntau yam. Ob peb piv txwv ntawm bioactive constituents nyob rau hauv "standardised extracts" muaj xws li laxative sennosides ntawm senna nplooj, lub hepatoprotective silymarin flavonolignans ntawm mis nyuj thistle txiv hmab txiv ntoo, thiab cov anti-nauseant gingerols ntawm qhiav rhizome.

Kev tshem tawm cov khoom tsis zoo, uas yog hu ua cov cim tsis zoo, los ntawm kev rho tawm kuj suav tias yog ib daim ntawv ntawm kev tsim qauv. Piv txwv ntawm cov cim tsis zoo suav nrog cov neurotoxic thujones pom hauv tansy, thiab hepatotoxic pyrrolizidine alkaloids pom hauv comfrey thiab lwm yam tshuaj ntsuab. Marker compounds suav nrog cov khoom siv uas yog cov yam ntxwv ntawm ib hom lossis ntau yam ntawm cov nroj tsuag, thiab yog li muaj txiaj ntsig zoo rau kev tsim qauv tab sis yuav tsis muaj lub luag haujlwm tag nrho rau kev npaj kho mob. Piv txwv suav nrog parthenolide hauv feverfew thiab echinacoside hauv Echinacea angustifolia thiab E. pallida.

Bioassays ntawm cov extracts tuaj yeem muab qee qhov kev ntsuas ntawm kev kho mob, txawm tias lawv tsis tshua siv rau kev tsim qauv. Ib qho piv txwv classic yog kev siv hauv vivo bioassays nrog Qav, miv, thiab nquab los ua qauv kev rho tawm ntawm digitalis (Dieuaide li al., 1935; Lehman, 1936). Hauv lwm qhov piv txwv, bioassay raug pom zoo los ua ib txoj hauv kev los xyuas kom muaj kev ua lag luam tshuaj (potency) ntawm zaj ntshav (Croton lechleri) latex botanical tshuaj (US Department of Health thiab Human Services, 2012). Txawm hais tias lawv yuav muaj txiaj ntsig zoo rau kev tsim cov khoom lag luam rau kev ntsuas qhov muaj zog, cov teeb meem nrog bioassay-based standardization suav nrog tus nqi, qhov nyuaj, thiab ua kom pom kev sib raug zoo rau kev kho mob cuam tshuam rau tib neeg.

Kev tsim qauv rau cov neeg ua haujlwm lossis cov cim cim thiab bioassays uas cuam tshuam txog cov txheej txheem ntawm kev ua haujlwm tau piav qhia los ntawm van Breemen li al. (2007). Hubbard et al. (2019) tau tshaj tawm tias kev txhim kho tsis ntev los no hauv bioinformatics thiab bioassay thev naus laus zis tau ua rau nws muaj peev xwm hais txog ntau tus neeg muaj phytochemical hauv cov nroj tsuag extract thiab muaj peev xwm ntau yam ntawm lawv cov teebmeem lom. Qhov no tso cai rau ntau qib ntawm kev nthuav dav rau cov yam ntxwv ntawm cov yam ntxwv uas tuaj yeem siv rau cov nroj tsuag extract standardization.

4 Categorization ntawm botanical extracts

Ntxiv rau qhov kev faib tawm ntawm cov extracts seb lawv puas yog kua, muag, lossis qhuav, cov lus hais saum toj no EMA qeb ntawm "tus qauv rho tawm" tau koom nrog ob pawg ntawm cov extracts, uas yog "quantified extracts," thiab "lwm cov extracts," nyob ntawm ntawm kev sib raug zoo ntawm cov neeg muaj npe paub thiab cov extract cov khoom lom neeg [European Medicines Agency (EMA), 2010]. Tsis zoo li EMA-txhim kho cov qauv tsim tawm, nyob rau hauv ntau cov khoom rho tawm cov khoom pov thawj ib feem, tab sis tsis tag nrho, suav rau ib qho kev rho tawm ntawm bioactivity. Nyob rau hauv cov ntaub ntawv no, thiab rau "lwm cov extracts" uas tsis muaj kev sib raug zoo ntawm cov neeg txheeb cais thiab extract bioactivity, tag nrho cov extract yog suav tias yog cov khoom siv.

Crude extracts tej zaum yuav ua tiav ntxiv, los yog ib tug xaiv extraction yuav tau ua nyob rau hauv lub xub ntiag los mloog zoo rau tej chav kawm ntawm phytochemicals los yog kom txo tau cov ntsiab lus ntawm pliaj constituents, los yog ob qho tib si. Gymnema nplooj extract muaj NLT ntau dua 5.0 feem pua ​​​​ntawm gymnemic acids li USP Purified Gymnema Extract, thiab USP Powdered Ginkgo Extract uas muaj NLT 22.0 feem pua ​​thiab NMT 27.0 feem pua ​​flavonol glycosides, thiab NLT 5.4 feem pua ​​thiab NMT 12. Licorice cag deglycyrrhizinated extract thiab ntsuab tshuaj yej nplooj decaffeinated extract nrog ib tug concentrated cov ntsiab lus ntawm catechins li USP Powdered Decaffeinated Green Tea Extract sawv cev rau cov extracts nyob rau hauv uas tshwj xeeb constituents tau raug tshem tawm.

Cov khoom tshwj xeeb no poob rau hauv cov tshuaj complexity txuas ntxiv los ntawm kev xaiv thiab ib nrab purified botanical rho tawm los yog rho tawm cov feem uas mloog zoo rau hauv chav kawm phytochemical, mus rau ib chav cais ntawm cov phytochemical constituents, mus rau ib qho chaw (Daim duab 1). Raws li qhov ntsuas ntawm cov tshuaj purification, ob qho piv txwv tom kawg no yuav tsis raug txiav txim siab tsim nyog ntxiv lawm. Piv txwv ntawm cov ntsiab lus tseem ceeb ntawm cov ntsiab lus suav nrog sennosides muab rho tawm los ntawm senna nplooj ntawv lossis senna pods (USP Sennosides) thiab curcuminoids muab rho tawm los ntawm turmeric rhizome (USP Curcuminoids).

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