Bioavailability - ndi chiyani ichi? Bioavailability wa mankhwala

Bioavailability - ndi kuchuluka kwa mankhwala amene wafika mbuto ikulu ya kanthu mu thupi la munthu kapena nyama. Mawu amenewa amatanthauza kuchuluka otaika ndi kusungidwa zakudya zingatipindulitse thupi. Choncho, pamene digiri yapamwamba ya bioavailability akhoza adzaweruzidwa pang'ono anataya katundu achire mankhwala aliwonse.

Kodi chithunzi ichi?

M'njira muyezo wa maphunziro mankhwala bioavailability kuwululidwa mwa kudziwa voliyumu ya mankhwala mu magazi, i.e. kuchuluka kuti wafika pa mitsempha ya magazi. Mu njira zosiyanasiyana kuyambitsa lili zizindikiro zosiyanasiyana. Choncho, bioavailability pambuyo ndondomeko mtsempha ukufika 100%. Ngati m'kamwa bioavailability zinachitika, voliyumu yafupika kwambiri chifukwa mayamwidwe chosakwanira ndi kuwonongeka kwa mankhwala m'zigawo munthu.

Mawu amenewa amagwiritsidwanso ntchito pharmacokinetics kuwerengera mlingo yolondola kwa wodwala kutsata njira zosiyanasiyana za makonzedwe kuti chamoyo.

Bioavailability ntchito magawo awiri:

1. Mtheradi.
2. Wachibale.

Lingaliro la bioavailability mtheradi

The bioavailability mtheradi - muyezo chifukwa cha kusanthula poyerekeza bioavailability wa mankhwala yake ina kuposa mtsempha, njira ndi kupezeka kwa mankhwala, kuperekedwa kudzera m'mitsempha. Iye analingalira ngati m'dera pansi pa pamapindikira - ". PPC" "buku nthawi", chidule Kugwira njira zinthu zimenezi kokha pamene zinthu monga ntchito Mlingo zosiyanasiyana za njira zosiyanasiyana za makonzedwe kuti chamoyo.

Kuti mudziwe chiwerengero cha bioavailability Mtheradi ukugwira pharmacokinetic kafukufuku ikuchitika, cholinga ndi kupeza poyerekeza kusanthula "mankhwala buku za nthawi" kwa njira mtsempha ndipo makamaka kukhazikitsa. Choncho, bioavailability mtheradi wa mankhwala - AUC izi kwa mlingo kusinthidwa analandira pamene kugawa AUC makamaka njira ya kulamulira ndi mtsempha.

Lingaliro la bioavailability wachibale

Wachibale bioavailability - ndi PEP mankhwala, kakusintha poyerekeza ndi mitundu ina ya mankhwala yemweyo unatenga maziko kapena analowa mu njira ina iliyonse. Base - mtsempha njira wofanana ndi bioavailability mtheradi.

Kuti mupeze kuchuluka kwa bioavailability wachibale m'thupi ntchito akalozera, amakhala voliyumu ya mankhwala m'thupi, kapena pamene excretion wa mkodzo pambuyo ntchito limodzi kapena angapo. Pofuna kupeza amaposa cha kudalirika pamene kupenda phunziro ntchito njira kusinthanitsidwa. Timatha chathunthu kuthetsa kusiyana kwa zotsatira analandira ndi limati thupi ndi pathological wa chamoyo.

Kodi amagwiritsa ntchito kudziŵa bioavailability?

Kudziwa bioavailability otsika lokonzekera, kapena mkulu, asayansi ntchito njira zotsatirazi:

1. Poyerekeza kusanthula kusintha mu buku pakati pa phunziro mankhwala ndi maonekedwe zoyambirira za mankhwala mu madzi kapena mkodzo. Phunziro lino amapereka mokwanira kudziwa kuchuluka kwa bioavailability mtheradi.
2. Muyeso wa mankhwala osiyana anadzetsa thupi m'njira yomweyo. Njira imeneyi zimathandiza kudziwa bioavailability wachibale.
3. Kudziwa bioavailability wachibale wa voliyumu chiyambi cha mankhwala m'njira zosiyanasiyana.
4. Kuphunzira buku mlingo wa zotsatira za mankhwala mu magazi kapena mkodzo. Iwo anachita kudziwa wachibale bioavailability index.

Ubwino wa ntchito HPLC

HPLC - njira ina adziwe bioavailability - koromatogarafe lomwe lili ndi dzuwa mkulu ntchito, ntchito ngati n'koyenera, kulekana kwa zovuta ndi zinthu zophweka. Izo ntchito kaŵirikaŵiri mu kuphunzira bioavailability, ngati ili nkhani zabwino:

1. Chosowa bata zimasokoneza kutentha mu zitsanzo anaphunzira motero.
2. Iwo limachititsa ntchito ndi njira amadzimadzi, amene kwambiri kuchepetsa nthawi ya kusanthula kuwongolera siteji yokonza zitsanzo kwachilengedwenso.
3. Musaphwanye ntchito yokonza ofanana nawo mankhwala kuphunzira.
4. Zipangizo ntchito njira imeneyi kuphunzira ali zokolola kwambiri ndi dzuwa.

Kuti akhoza kubweretsa kusintha pa bioavailability okwana?

Muyezo kuchuluka kwa mankhwala, ndi ingested ndi nevnutrivennym, ndi zosakwana 1. Komabe, kungakhale ngakhale zochepa chifukwa cha zina zabwino zina. Choncho, zinthu okhudza bioavailability - ndi:

1. The thupi katundu wa mankhwala.
2. Mtundu wa mankhwala ndi nthawi za kuopsa kwake pa thupi.
3. Maola - asanadye kapena pambuyo.
4. Liwiro yoyeretsera thirakiti m'mimba.
5. Zotsatira za mankhwala ena pa mankhwalawo.
6. Zimene ndalama kwa zakudya zina.

bioequivalence

zosiyanasiyana wina ali ndi bioavailability, bioequivalence ndi. Mfundo imeneyi zayamba mogwirizana ndi pharmacokinetic ndi biofarmatsionnyh zofufuza, imene chinapezeka kuti lochitira mankhwala achire munali chinthu chomwecho ali kugwirizana ndi kusiyana bioavailability.

Choncho, bioequivalence - ndi kuonetsetsa kuti magazi ndi zimakhala za nambalayi zinthu.

zizindikiro Kiyi Wa bioequivalence

Kudziwa bioequivalence la magawo zotsatirazi ntchito formulations ndi:

1. Kuchuluka kapena bioavailability yonse miyala mu m'thupi. Ankafufuza ndi kupanga chiwembu, imene zokhotakhota awiriwa chikuimira kuchuluka kwa mankhwala kutumikiridwa ndi njira zosiyanasiyana, ndi mzere wolunjika akuimira buku osachepera mankhwala wofunikila zotsatira achire.
2. Kutalika kwa okhutira mkulu wa mankhwala. Izi kusonyezedwa chizindikiro ichi suction ndi zotsatira achire pa thupi. Kuti timvetse akamanena za chizindikiro zingakhale chitsanzo cha ogonetsa. A pang'ono achire zotsatira adzakula theka la ora, kapena 2 - malingana ndi maonekedwe a kukonzekera. Zachinyengo achire ntchito adzachita mogwirizana ndi mawonekedwe ofanana maola 5 mpaka 8. Choncho, ngakhale kufanana mu zotsatira zake, mtundu wina ntchito kupewa matenda ndi tulo, ndipo chachiwiri - pa yaing'ono nthawi zina.
3. Kusintha kuchuluka kwa mankhwala magazi patapita nthawi yina.

Launch ya mankhwala mu kukhazikitsa ndi

Musanayambe ntchito yokonza zogulitsa, muyenera kusanthula bioavailability ndi bioequivalence mankhwala, n'kofunika kwambiri. Kuti zimenezi zitheke, ndondomeko izi imagwiridwa:

1. Mlengi adzakhala kugonjera yofunsira ku State Committee pharmacological choti kumasula mankhwala ake kukhazikitsa ndi. Ofesi, nayenso, amatipatsa chilolezo kuchititsa maphunziro bioequivalence ntchito zitsanzo ziwiri: wogwila latsopano.
2. phunziro ikuchitika pa ochiritsira kapena kukhala odzipereka matenda aliwonse mu mlingo chomwecho. Komanso, phunziro lililonse analipira ndi Mlengi.

Ndondomeko ikuchitika mu mabungwe wapadera mankhwala kapena Laboratories ndi thandizo la akatswiri kunja. Kusankha ofuna mayesero ayenera kumwedwa nkhani zofunika zotsatirazi:

1. chiwerengero chawo okwana sangakhale zosakwana 12. pafupipafupi nthawi chiwerengero cha anthu ongodzipereka chinawonjezeka 25. Izi zikachitika makamaka pa nkhani ya mkulu yapakati-munthu mosiyanasiyana magawo pharmacokinetic.
2. Odzipereka ayenera akafika zaka ambiri ndi kukhala zaka kuposa 60.
3. пола, возраста и роста. Kulemera kwa munthu aliyense sikudzakhala zochepa kapena kuposa 20% ya kulemera abwino anapatsidwa jenda, zaka, ndi msinkhu.
4. Sikuloledwa kafukufuku pa anthu akuvutika ndi matenda a mtima kapena aakulu. Nokha ndi gulu la anthu amene kulengeza ntchito mankhwala.

Kodi maphunziro amene anadzipereka?

Musanayambe kulemba chilolezo Fomu kuphunzira kuzindikira bioavailability wa thunthu aliyense mongodzipereka adzilandira kuika zotsatirazi zambiri:

1. Chachikulu kuphunzira cholinga.
2. Kutalika kwa ndondomeko.
3. Waukulu pharmacological deta za mankhwala.
4. oyamba njira ya mankhwala akumwa.
5. The ntchito mlingo.
6. Ndinakumana ndi mankhwala m'thupi.
7. Kuipa mankhwala.
8. Mokoma mphamvu mu ndondomeko kafukufuku.
9. Terms of malipiro a inshuwalansi lapansi.

Kamodzi mongodzipereka walembapo mgwirizano ndi pangano chinsinsi ofufuza anagwira zachipatala Kupenda zonse. Pamafunikanso:

1. General anayendera madokotala.
2. Analysis magazi ndi mkodzo.
3. Magazi sayansi.
4. A magazi kuti HIV, chindoko ndi chiwindi.
5. Mimba akazi.

Aliyense chipinda ali okonzeka ndi zonse zofunika kuphunzira mosavuta. Komanso, gulu lirilonse inshuwalansi ndi pangano bwanji kupeza inshuwalansi likhoza koyesera analephera. Komanso, negotiated zikhalidwe ndi kuchuluka kwa Malipilo.

Amene amaloledwa kuphunzira?

Ntchito pamodzi ndi anthu odzipereka amanyamula kafukufuku. Iye ayenera kukumana zinthu zotsatirazi:

1. kafukufuku The kulandira chiphunzitso ndi machitidwe a minda yonse mankhwala ndi pharmacological.
2. Pa manja ake ayenera kukhala ndi satifiketi kumene chokwanira.
3. kafukufuku ayenera kukhala ankamvetsa bwino zimene ndi bioavailability wa mankhwala (izi ndi zofunika), ndi wotani mankhwala iye ayenera kuphunzira.

Kuwonjezera wofufuza gulu monga namwino. ntchito yawo ikuphatikiza:

1. Kuunikira umoyo wa odwala.
2. Kuchita mphindi boma.
3. Khazikitsa catheters.
4. Kusiya kwa wina kuchuluka kwa magazi kwa kusanthula odwala.

Komanso, gulu monga:

1. Analytics ndipo amaphunzitsidwa.
2. Pharmacokinetics.
3. Masamu.

Kukafola lipoti pa ntchito

Akamaliza wa zinthu zonse kafukufuku kwenikweni dokotala opangidwa kuchokera pepala, zomwe tiyenera kuonetsera mfundo zotsatirazi:

1. Dongosolo ambiri a maphunziro pharmacological. Iwo ayenera kuvomereza pharmacological State Komiti.
2. deta zonse za odzipereka. zaziwerengero, anthropometric ndi matenda deta iyenera mwasankha. Yotsirizira limasonyeza ngati nkhani ya odwala.
3. manambala siriyo ndi mayina a makampani popanga, komanso nthawi ya zotsatira zawo achire.
4. Dongosolo zosinthika mankhwala ndi mlingo ogwira.
5. The njira yosankha zinthu zamoyo ndi chisanadze processing.
6. Zinayendera akatswiri ndi kukhazikitsa ntchito metrological ndi kuwonetsera chromatogram.
7. mfundo zonse amayenda kuphunzira pharmacokinetic ndi kufufuza bioequivalence. Komanso imalemba mapulogalamu onse ntchito pa phunziroli.
8. Zotsatira za kudziwika kuchuluka kwa mankhwala zitsanzo kwachilengedwenso.
9. Medical odzipereka mapu ndi mbiri payekha.
10. Zotsatira za kafukufuku pharmacokinetic amatsogoza kupezeka kwa ntchito ziyenera a bioequivalence.

Ndondomeko bioequivalence

Kafukufuku pa bioavailability wa mankhwala ikuchitika mu mlingo amodzi formulations ziwiri: anachokera ndi choyambirira. Pankhani ya ofunsira kuphunzira kufufuza mankhwala angapo ikuchitika padera kwa aliyense.

Nthawi imeneyi pakati pa phwando la apachiyambi generic ndi kumatanthauza nthawi kusamutsidwa mankhwala mu thupi, tsankho achire nthawi. Iwo ayenera kukhala wolingana avareji nthawi 6 tsankho kuchotsa. Zipangizo ntchito kuphunzira angakhale plasma, seramu kapena magazi. Amatengedwa kuchokera mtsempha mu wakuba wa chigongono kudzera catheter a. Zitsanzo zosankhidwazi ayenera chidachitika katatu;

1. Pa nthawi ya kukula kwa okhutira chachikulu lokonzekera. Ziyenera kukhala pafupi 3 mfundo pa pamapindikira "ndende - nthawi".
2. Pa nthawi ya mayamwidwe mkulu. Kugwiritsidwa ntchito za 5 mfundo.
3. Pa nthawi ya malabsorption. Iwo amagwiritsa pafupifupi 3 mfundo.

nthawi chophunzira akhoza kovomerezedwa, ngati mtengo wa m'dera pansi pa pamapindikira "ndende - nthawi" chapatali kuchokera pansi mpaka chitsanzo otsiriza pafupifupi 80%.