Bioavailability - yintoni na le nto? Bioavailability amachiza

Bioavailability - sisixa iziyobisi lifikelele kwindawo ephambili amanyathelo emzimbeni womntu okanye isilwanyana. Eli gama libhekisela isixa ezilahlekileyo kugcinwa izondlo eziyingenelo emzimbeni. Ngoko, xa iqondo eliphezulu bioavailability inokubonwa imali encinci elahlekileyo iimpawu zonyango lwaso nasiphi na isiyobisi.

Njani na lo mzobo?

Xa iintlobo Izinga lezifundo iziyobisi bioavailability etyhilwe nokumisela umthamo amayeza egazini, ngamanye imali lifikelele kwegazi. Xa iindlela ezahlukeneyo yokuqalisa iye iziphawuli ezahlukeneyo. Ngoko ke, lo bioavailability emva kokuba inkqubo efakwa ifikelela 100%. Kwaye ukuba kubekho bioavailability ngomlomo, umthamo lifinyele kakhulu ngenxa ukufakwa engaphelelanga kwaye sokonakalisa ichiza kumacandelo ngamnye.

Eli gama lisetyenziswa pharmacokinetics ukubala idosi echanekileyo isigulane emayilandelwe iindlela ezahlukeneyo zolawulo ephilayo.

Bioavailability usebenzisa nezigaba ezibini:

1. Absolute.
2. Relative.

Ingcamango bioavailability ingundoqo

Kukuzibophelela bioavailability - ngomlinganiselo kweziphumo ezivela uhlahlelo athelekisekayo bioavailability iziyobisi ezilawulwa ngayo nayiphi na kwe efakwa, indlela kunye nokufumaneka ichiza, akunike yegazi. Yena njengommandla phantsi kwigophe eziboniswe - ". PPC" "umthamo ixesha", elifinyeziweyo Ukwenza inkqubo enjalo yenzeka kuphela xa iimeko ezifana nokusetyenziswa iidosi ezahlukeneyo iindlela ezahlukeneyo zolawulo ephilayo.

Ukuze ubone inani bioavailability ingundoqo ebambe pharmacokinetic isifundo kuthwalelwa phandle, injongo kukufumana comparative analysis "umthamo kweziyobisi kunye malunga nexesha 'ukuze indlela efakwa kunye athile ukuphunyezwa. Ngoko ke, lo bioavailability ngokupheleleyo kwamachiza - eli AUC ukuba idosi modified ezifunyenwe ngexesha ngokwahlula indlela AUC ethile yolawulo efakwa.

Ingcamango bioavailability isihlobo

bioavailability Relative - oko amayeza PEP, unenzondelelo kuthelekiswa nezinye iintlobo ichiza lo uzisusileyo njengesiseko okanye wangena ngayo nayiphi na enye indlela. Base - efakwa indlela luphawulwa bioavailability epheleleyo.

Ukuze ufumane imali bioavailability kuthelekiswa emzimbeni isicelo izalathiso, nezibonakalisa umthamo ichiza kwinkqubo yokujikeleza kwegazi, okanye xa kukhuthaza umchamo emva ukusetyenziswa esinye okanye ezininzi. Ukuze ufumane ipesenti ephezulu kukuthembeka xa kuhlalutywa isifundo wasebenzisa indlela crossover. Ivumela i ngokupheleleyo ukuphelisa umahluko lweziphumo ezifunyenwe kunye States nokomzimba kwaye zophendlo lwezifo ze eziphilayo.

Ziziphi iindlela ezisetyenziswa ekumiseleni bioavailability?

Ukuze ubone bioavailability ephantsi kwaleyo yokulungiselela, okanye phezulu, izazinzulu kusetyenziswa obu buchule bulandelayo:

1. Uhlalutyo lokuthelekisa utshintsho umthamo phakathi ichiza zokufunda kunye uhlobo olusisiseko ichiza plasma okanye yokuchama. Olu phando lunika ngokupheleleyo ukuqinisekisa ukuba isixa bioavailability epheleleyo.
2. Ukulinganiswa amachiza ezahlukeneyo eyaziswa umzimba ngendlela efanayo. Le ndlela ivumela ukugqiba bioavailability isalamane.
3. Ukuze ubone bioavailability relative umthamo sijonge ukusungulwa iziyobisi ngeendlela ezahlukahlukeneyo.
4. Ukufunda umthamo nomgangatho neziphumo beziyobisi egazini okanye yokuchama. Oku kwenziwa ukujonga isalamane index bioavailability.

Izinto eziluncedo nesicelo solibalo

Solibalo - Enye indlela yokufumanisa bioavailability - chromatography, iba ukusebenza aphezulu ukusebenza, isetyenziswe xa kuyimfuneko, esekungcoleni lunzima izinto ezilula. Oku kusetyenziswa kakhulu ekufundeni bioavailability, njengoko unawo iimpawu ezintle zilandelayo:

1. Ukungabikho uzinzo enqamla kwiqondo lobushushu kwi iisampuli befundela wenjenje.
2. Oku kwenza kube lula ukusebenza kunye nezisombululo zolwelo, leyo kunciphisa kakhulu ixesha kokuhlalutya nokuphucula nqanaba ukulungiselela iisampuli eziphilayo.
3. Akukho mfuneko yokuba lokulungiselela avela yesifundo amayeza.
4. Izixhobo ezisetyenziswa kule ndlela yokufunda, uye umsebenzi omhle kunye nokusebenza.

Onokuba nefuthe kwi bioavailability lilonke?

Imali eqhelekileyo beziyobisi, le tapeworm nevnutrivennym, lingaphantsi kwe 1. Nangona kunjalo, mhlawumbi ibe ngaphantsi ngenxa ezithile bokuqonda ezongezelelweyo. Ngoko ke, izinto ezichaphazela bioavailability - is:

1. Iimpawu ezibonakalayo ze ichiza.
2. Ifomu amayeza kunye nobude nemiphumela yayo emzimbeni.
3. Iiyure - ngaphambi kokutya okanye emva.
4. Isantya yokuhlambulula phecana zesisu.
5. Ifuthe nezinye iziyobisi iyeza.
6. Abasabela ngayo imali ukutya okuthile.

bioequivalence

Olunye uhlobo has a bioavailability, bioequivalence liselikho. Le nto iye inzondo ngokunxulumene kuphando pharmacokinetic kunye biofarmatsionnyh, ngexesha apho kwafunyaniswa ukuba ukungalingani iziyobisi zonyango equlathe into efanayo ubudlelwane ngqo kunye umahluko bioavailability.

Ngenxa yoko, bioequivalence - kukuqinisekisa igazi kunye nezihlunu inani elifanayo kwezinto.

Iimpawu eziphambili bioequivalence

Ukuze ubone bioequivalence kwe parameters alandelayo asetyenziswa kwi ngezakhiwo:

1. Ukwanda okanye bioavailability kakhulu epheleleyo amacwecwe kwegazi. Iphandwe ugobe, apho ezigoso ezimbini zimele isixa iziyobisi ezilawulwa ngeendlela ezahlukahlukeneyo, kwaye umgca othe ngqo imele umthamo ubuncinane ichiza olufunekayo ukusebenza therapeutic.
2. Ixesha eziphakamileyo umxholo beziyobisi. Esi ubonisa Isalathisi kukhawulezisa sokufunxa kunye neziphumo zonyango kwi emzimbeni. Ukuze uqonde umongo esi salathisi kunokuba umzekelo ipilisi zokulala. A isiphumo okuncinane zonyango iza kuba nesiqingatha seyure, okanye 2 - kuxhomekeka kuhlobo zamalungiselelo. umsebenzi thile therapeutic uya kwenza ngokuvumelana imilo enye, iiyure ezi-5 ukuya kwi-8. Ngaloo ndlela, nangona ukufana ukusebenza kwayo, olunye uhlobo uya kuziphanzisa ukuthintela zokulala, kwaye eyesibini - ixesha elincinane lokuphumla.
3. Ukutshintsha isixa kweziyobisi egazini emva kwexesha elithile.

Launch beziyobisi ekuphunyezweni

Phambi kokuba uqalise ukulungiselela intengiso, kufuneka uhlole i bioavailability kunye bioequivalence kwamachiza, kubalulekile kakhulu. Ukuza kuthi ga ngoku, le nkqubo ilandelayo yenzelwa:

1. Umenzi uya kungenisa isicelo kwiKomiti imithi State of umnqweno ukukhulula amayeza yakhe ukuphunyezwa. Office, ke, unika imvume yokuqhuba izifundo bioequivalence usebenzisa iisampulu ezimbini: akhoyo namatsha.
2. Uphononongo olwenziwe kumavolontiya nasiphi na isifo eqhelekileyo okanye kwi idosi enye. Ukongezelela, isifundo ngasinye kuhlawulwa umenzi.

Le nkqubo yenziwa kumaziko ezizodwa zonyango okanye neelabhoratri ngoncedo ziingcali ngaphandle. Xa ukhetho labaviwa mvavanyo kufuneka ithathelwe ingqalelo ezi mfuno zilandelayo:

1. Inani labo ogcweleyo akufunekanga ibe ngaphantsi kwe-12 amaxesha rhoqo xa inani amavolontiya kwandisa ukuya 25 Xa oku kwenzeka ubukhulu becala kwimeko ukwahluka ophezulu inter-ngamnye kwi parameters pharmacokinetic.
2. Amavolontiya kufuneka zifike yobudala emntaneni kwaye ube neminyaka ngaphezulu kwama-60.
3. пола, возраста и роста. akayi kuba ngaphantsi okanye ngaphezulu kwe-20% ye-ubunzima efanelekileyo ukuba isini elinikiweyo, ubudala kunye nobude Ubunzima lomntu ngamnye.
4. Akuvumelekile uphando abantu abaphethwe zizifo sentliziyo okanye ezondeleyo. Le ngaphandle kuphela kukuba kukho iqela labantu abathe bacebisa ukusetyenziswa kweli chiza.

Njani na uqeqesho lwamavolontiya?

Phambi kokuba utyikitye ifomu yemvume isifundo, kujongwa bioavailability ukwimo, ivolontiya ngalinye kufuneka kufumana iseti zilandelayo ulwazi:

1. Eyona yokuqala ukufunda njongo.
2. Ixesha le nkqubo.
3. Eyona data amayeza malunga ichiza.
4. Intshayelelo indlela amayeza ngomlomo.
5. Oyidlayo isicelo.
6. Ifuthe iziyobisi emzimbeni.
7. Ezingeloncedo eli chiza.
8. Le bokuqonda kwamandla kwinkqubo yophando.
9. Imigaqo intlawulo nepolisi ye-inshorensi.

Xa ivolontiya utyikitya isivumelwano kunye nesivumelwano sokuba yimfihlo, abaphengululi wenziwe axilongwe ngokupheleleyo. Oku kuquka:

1. oogqirha zohlolo jikelele.
2. Uhlalutyo igazi nomchamo.
3. Blood ngamachiza ezinto eziphilayo.
4. Uvavanyo igazi HIV, ngegcushuwa kunye hepatitis.
5. Ukukhulelwa kwabasetyhini.

egumbini ngalinye lixhotyiswe yonke into efunekayo ukuze ukufunda kube lula. Ngapha koko, nayiphi na i-inshorensi inkampani isivumelwano malunga nendlela yokufumana inshorensi xa kuthe a angasiphumelelanga lokulinga. Ukongezelela, thethwana iimeko kunye nemali kwentlawulo.

Ngubani ovumelekileyo ukuba bafunde?

Sebenza ntliziyo uthwala uphando. Umele ukuhlangabezana le miqathango ilandelayo:

1. Le umphandi unelungelo kwithiyori nokuqhele ukwenziwa onke amasimi yemichiza imithi.
2. On izandla zakhe kufuneka isiqinisekiso ikhosi sokugqitywa.
3. I umphandi kufuneka baziqonde ngokupheleleyo iyini na bioavailability beziyobisi (oku kubaluleke) yaye yintoni uhlobo amayeza anayo ukufunda.

Ukongeza ngumphandi kwi qela kufuneka ibandakanye ngumongikazi. imisebenzi yabo ziquka:

1. Ukubeka iliso impilo kwizigulane.
2. Yenza mathuba umbuso.
3. Ifaka catheters.
4. Ukurhoxiswa isixa esithile igazi uhlalutyo kwizigulane.

Ngaphezu koko, kwi qela ziquka:

1. Ukuhlaziywa kunye namagcisa.
2. Pharmacokinetics.
3. Mathematics.

Ukuzoba up ingxelo kumsebenzi

Ekugqityweni yonke imisebenzi yophando nkalo ugqirha ezenziwe ngephepha, ekufuneka zibonise ngongoma zilandelayo:

1. Isicwangciso jikelele izifundo imithi. Kufuneka unegunya luvunywe ziinqobo ezisesikweni zeKomiti State imithi.
2. Yonke idatha malunga amavolontiya. yabantu, anthropometric kwaye lwezonyango kufuneka zicaciswe. Le yokugqibela ibonisa ukuba ukubandakanyeka yezigulane.
3. amanani Uthotho kunye namagama eenkampani mveliso, kwakunye ixesha yeziphumo zabo zonyango.
4. ulawulo iziyobisi umehluko kunye balawule kakuhle.
5. Indlela yokukhetha izinto eziphilayo kunye pre-processing.
6. Ukulandelelanisa labahlalutyi kunye nokuqaliswa kokusebenza metrological kunye nomboniso chromatogram.
7. Iinkcukacha ezizeleyo zonke ukuhamba ukufunda pharmacokinetic kunye nokuvavanywa bioequivalence. Kwakhona lidwelisa zonke i iinkqubo ezisetyenziswa kwi sifundo.
8. Iziphumo ekufumanekeni isixa iziyobisi iisampuli eziphilayo.
9. iimaphu amavolontiya zonyango kunye profiles ngamnye.
10. Iziphumo zophononongo pharmacokinetic lwamaxabiso nokusasazeka eziza kusetyenziswa kuvavanyo lwe bioequivalence.

Inkqubo ye bioequivalence

Uphando malunga bioavailability kwamachiza oluqhutywa idosi enye nemixube ezimbini: i efunyenwe kunye yokuqala. Kwimeko isicelo kwi sifundo sophando iziyobisi eziliqela kwenziwa ngokwahlukeneyo ngalinye.

Ixesha lekhefu phakathi ulwamkelo ozingenelayo nabangenamandla ixesha ukubana iziyobisi original emzimbeni, ixesha ukurhoxiswa buso. Kufuneka ube kulingana-avareji ngamaxesha 6 ukususwa buso. Materials zisetyenziswe kwisifundo isenokuba plasma, serum okanye igazi. is he taken ukusuka apho iphuma kwi egoso ye engqinibeni ngokusebenzisa catheter. Komculo kufuneka kwenziwe kathathu:

1. Ngelo xesha lokukhula isiqulatho iphambili yokulungiselela. Kufuneka sibe malunga ne-3 amanqaku kwigophe "xi - time".
2. Ngexesha ukufunxeka ophezulu. Oku isicelo malunga 5 amanqaku.
3. Ngexesha malabsorption. It usebenzisa malunga nama-3 amanqaku.

ixesha study ingqalelo elamkelekileyo, ukuba ixabiso le ndawo phantsi kwigophe "xi - ixesha" kumgama ukusuka emhlabeni ukuya kwisampula yokugqibela yi malunga ne-80%.