Bioavailability - chii ichi? Bioavailability zvinodhaka

Bioavailability - ndiyo chitsama zvinodhaka kuti zvasvika huru nzvimbo chiito womunhu kana mhuka muviri. Izwi rinoreva huwandu akarasika uye zvakachengetwa zvinovaka muviri kuti zvinobatsira kuti muviri. Saka, kana munhu mukuru mwero bioavailability chinogona kuoneka vashomanana kurasika semushonga chero zvinodhaka.

Sei mufananidzo uyu?

Kana mureza siyana kudzidza bioavailability mishonga iri kuona nokuda kuziva uwandu kurapwa muropa, kuti ndiyo mari kwakasvika muropa. In nzira dzakasiyana-siyana kudzidzisa ine zviratidzo zvakasiyana-siyana. Saka bioavailability pashure intravenous muitiro rinosvika 100%. Kana zvokuudzwa nomuromo bioavailability chakaitika, inzwi ipfupi zvikuru nokuda kukwana Absorção de Água uye manyowa zvinodhaka kupinda munhu zvinoriumba.

Izwi iri rinoshandiswawo pharmacokinetics kuverenga yakarurama chipimo chemushonga murwere kuteverwa kuti nzira dzakasiyana-siyana chourongwa kuti muviri.

Bioavailability vachishandisa muzvikamu zviviri:

1. Dzinofanira.
2. Hama.

Pfungwa Mhedziso bioavailability

The Mhedziso bioavailability - chiyero kunokonzerwa kubva kuongorora okufananidza bioavailability zvinodhaka kutarisirwa neimwe pane intravenous, nzira uye Kuwanikwa chinodhaka, vakapiwa nomutsinga. Akafungisisa sezvo nzvimbo pasi munyonga - ". PPC" "vhoriyamu nguva", rakapfupikiswa Kuti aite muitiro kwakadaro kunobvira chete apo mamiriro ezvinhu akadai kushandisa dosages siyana nzira dzakasiyana-siyana chourongwa kuti muviri.

Kuti tizive uwandu kwakakwana bioavailability vakabata pharmacokinetic kudzidza kuitwa, chinangwa ndiko kuwana okufananidza kuongorora "chinodhaka vhoriyamu pakureva nguva 'yokuti intravenous uye zvikuru nzira Implementation. Saka, mhedziso bioavailability mishonga - AUC ichi nokuda dzakachinjwa chipimo chemushonga yakagamuchirwa panguva kupatsanura AUC Kunyanya nzira chourongwa uye intravenous.

Pfungwa hama bioavailability

Hama bioavailability - zviri mishonga Muyambo, kwave kuchiita zvichienzaniswa nemamwe marudzi chete zvinodhaka sokugamuchira hwaro kana akapinda neimwe nzira. Base - intravenous nzira kunoratidzwa Mhedziso bioavailability.

Kuti vawane huwandu hama bioavailability pamuviri kushandisa indices, zvinoratidza Vhoriyamu zvinodhaka munyika kweropa ino, kana apo excretion pamusoro weti pashure kuroorwa kana vakawanda kushandiswa. Kuti vawane yakakwirira chikamu rakavimbika apo ongorora kudzidza akashandisa Crossover nzira. Kunoitawo zvakazara kubvisa musiyano pakati zvabuda vakawana vane vasiri uye pathological inoti zviri muviri.

Nzira dzipi zvinoshandiswa Pakusarudza bioavailability?

Kuona pasi bioavailability rekugadzirira, kana mukuru, masayendisiti vakashandisa zvinotevera unyanzvi:

1. Okufananidza kuongorora kuchinja inzwi pakati kudzidza zvinodhaka uye inokosha chimiro zvinodhaka zviri plasma weti kana. Kudzidza uku anotipa pachinoperera huwandu Mhedziso bioavailability.
2. Kuyerwa mishonga yakasiyana chakaunzwa mumuviri saizvozvo. Nzira iyi inobvumira kuti kuona hama bioavailability.
3. Kuona hama bioavailability bhuku kuburikidza pakatanga zvinodhaka nenzira dzakasiyana-siyana.
4. Kudzidza vhoriyamu pamwero migumisiro zvinodhaka muropa weti kana. It rinoitwa kuona hama bioavailability indekisi.

Zvakanakira kushanda HPLC

HPLC - Imwe nzira dzokuziva bioavailability - chromatography, iro rine yakakwirira kunyatsoshanda ichishanda, kushandiswa kana zvakakodzera, kupatsanurwa kunzwisisa kuti nyore zvinhu. Rinoshandiswa inonyanyoshandiswa kudzidza bioavailability, sezvo ane zvinotevera zvakanaka zviri:

1. Kushaya nokugadzikana ichikutadzisa kuti tembiricha iri kudzidza mimwe saizvozvo.
2. Zvinoita kuti tikwanise kushanda aqueous zvinogadzirisa, izvo yekudyidzana zvinoderedza ya pokuongorora uye kuvandudza padanho kugadzirira zvoutachiona ivhu.
3. No kudikanwa achigadzirira nomukaka kurapwa yokudzidza.
4. The midziyo inoshandiswa nzira iyi kudzidza, ane rakaisvonaka zvibereko uye kunyatsoshanda.

Izvozvo zvinogona kuva nezvahunoita yose bioavailability?

Mureza chitsama chinodhaka, iri anwa nokuda nevnutrivennym, idukusa 1. Zvisinei, zvingava kunyange zvishoma nokuda mamwe nuances. Saka, zvinoita kukanganisa bioavailability - ravapo:

1. The ehupfumi zvokunyama zvinodhaka.
2. Form kurapwa uye ya migumisiro dzayo muviri.
3. Maawa - vasati kudya kana pashure.
4. Speed wokunatswa ari nemudumbu.
5. Igaroziva zvimwe zvinodhaka riri mushonga.
6. Maitiro mari zvimwe zvokudya.

bioequivalence

Imwe siyana ane bioavailability, bioequivalence iri. Izvi pfungwa kwamuka nezvichaitika pharmacokinetic uye biofarmatsionnyh kuferefeta, panguva iyo yakawanikwa kuti kusaruramisira dzokurapwa nezvinodhaka Rine chete fuma ine yakananga noukama musiyano bioavailability.

Saka, bioequivalence - ndiko inonzi ropa uye nyama imwe chete nhamba zvinhu.

zviratidzi kiyi bioequivalence

Kuziva bioequivalence zvinotevera parameters anoshandiswa mune Formulations:

1. Yakawedzerwa kana bioavailability kupfuura rakazara mahwendefa kweropa ino. Kuongororwa ne kuronga, umo makakombama maviri unomirirei uwandu zvinodhaka kutarisirwa nzira dzakasiyana-siyana, uye akarurama mutsetse rinomiririra shoma Vhoriyamu zvinodhaka zvaidiwa kuchirapa kushanda.
2. Ya mukuru zviri zvinodhaka. Izvi chakarurama Matafura makarindira kubvisa uye dzokurapwa migumisiro pamusoro muviri. Kuti tinzwisise musimboti chinoratidza ichi kunogona kuva muenzaniso vakarara mapiritsi. A nezvenyaya dzokurapwa chaizvoizvo zvichataurirana nehafu yeawa, kana 2 - zvichienderana chimiro gadziriro. Hypnotic kuchirapa basa achaita aaisitaura chimiro, 5 kusvika 8 maawa. Saka, pasinei kufanana rawo, mumwe chimiro richashandiswa kudzivisa hope zvirwere, uye yechipiri - panguva zororo nguva diki.
3. Changing huwandu zvinodhaka muropa pashure imwe nguva.

Kanda zviri zvinodhaka ari Implementation

Usati tatanga kugadzirira sale, unofanira kuongorora bioavailability uye bioequivalence zvinodhaka, zvinokosha chaizvo. Kuti izvi zvidaro, zvinotevera nzira rinoitwa:

1. The mugadziri anofanira pasi kushanda kuHurumende Pharmacological Committee of chido kusunungura mushonga yake Implementation. Office, zvinozoita anopa mvumo mufambiro bioequivalence zveBhaibheri Uchishandisa maviri mienzaniso: yaivapo uye itsva.
2. Kudzidza kuitwa musi kwakajairika kana kuva chero chirwere vanozvipira mune imwe chipimo chemushonga. Uyezve, kudzidza mumwe kubhadharwa nokuti mugadziri.

Izvi nzira rinoitwa munguva chaiyo zvokurapa nemasangano kana mumarabhoritari pamwe rubatsiro panze nyanzvi. In kusarudzwa musarudzo nokuti miedzo inofanira kufungwa nyaya inotevera zvinodiwa:

1. nhamba yavo zvachose angasava asingasviki 12 kakawanda nguva nhamba yevazvipiri yakawedzera kusvika 25. Kazhinji, zvinoitika panyaya mukuru interindividual kusiyana pharmacokinetic parameters.
2. Vanozvipira anofanira kusvika makore ruzhinji uye kuva makore kupfuura 60.
3. пола, возраста и роста. Kurema mumwe munhu ngaarege kuva shoma kana anopfuura 20% of yakanaka kurema kuti kupiwa munhurume, zera uye kukwirira.
4. Kutendera tsvakurudzo pamusoro vanhu vachitambura kubva zvemwoyo kana refu. The chete Kunze ndiko kuti boka revanhu vakanga urumbidze kushandisa zvinodhaka ichi.

Sei kurovedza dzevazvipira?

Usati kusaina matenderana fomu chidzidzo, kuziva bioavailability ari fuma, mumwe nomumwe anozvipira anofanira kugamuchira zvinotevera seti mashoko:

1. The chikuru yokudzidza chinangwa.
2. Ya nzira.
3. Huru pharmacological mashoko pamusoro zvinodhaka.
4. Sumo nzira mishonga dzinogamuchidzanwa.
5. The rikashandiswa chipimo chemushonga.
6. Kusangana zvinodhaka mumuviri.
7. Zvazvakashatira zvinodhaka ichi.
8. The nuances simba iri pakutsvakurudza kwacho.
9. Terms zviri kuripwa inishuwarenzi itsika.

Kamwe rokuzvipira anosaina chibvumirano uye zvakavanzika chibvumirano, vatsvakurudzi pavaiita kuchipatara kuongorora zvizere. Zvinosanganisira:

1. General rokuongorora vanachiremba.
2. Analysis ropa uye weti.
3. Blood nemakemikari omuviri.
4. A bvunzo ropa HIV, njovhera uye kuzvimba chiropa.
5. Pregnancy vakadzi.

Kamuri imwe neimwe akashongedzerwa zvose zvaidikanwa nyore kudzidza. Uyezve, kambani inishuwarenzi chero chiri chibvumirano sei kuwana inishuwarenzi iri chiitiko munhu akatadza chiedzwa. Uyezve, nekambani zvinhu uye huwandu remuneration.

Ndiani anobvumirwa kudzidza?

Basa nevazvipiri anotakura mutsvakurudzi. Anofanira kusangana zvinotevera ezvinhu:

1. The mutsvakurudzi iri kodzero dzidziso uye kuita zvose makemikari uye pharmacological minda.
2. On ake anofanira kunge gwaro kosi kupera.
3. The mutsvakurudzi anofanira kuva kunzwisisa chii bioavailability zvinodhaka kwakakwana (ichi zvinokosha) uye worudzii mushonga zvaanazvo kudzidza.

Mukuwedzera mutsvakurudzi muboka unofanira zvinosanganisira mukoti. Mabasa avo anosanganisira:

1. Monitoring utano varwere.
2. Achiita utongi nguva.
3. Kugadzwa catheters.
4. The kurega imwe mari ropa ongororo pavarwere.

Uyezve, vari boka zvinosanganisira:

1. Analytics uye wevanamakanika.
2. Pharmacokinetics.
3. Masvomhu.

Vaigadzirira mushumo basa

Panopera zvose tsvakurudzo mabasa zvikurukuru chiremba akaita kubva papepa, izvo zvinofanira kuratidza zvinotevera pfungwa:

1. The vakawanda urongwa pharmacological zvidzidzo. Zvinofanira hako mvumo neDare Pharmacological State Committee.
2. All date pamusoro nevazvipiri. wevanotungamirira, anthropometric uye kurapwa Data zvinofanira kutaurwa. Yokupedzisira inoratidza kana nezvokupindira wevarwere.
3. Serial nhamba uye mazita mukugadzira makambani, uyewo nguva yavo kuchirapa migumisiro.
4. Musiyano zvinodhaka Kutarisirwa uye inoshanda chipimo chemushonga.
5. Nzira yaakasarudza zvoutachiona zvokunyama uye pre-kugadzira.
6. Kutevedzana kwezviitiko vanoongorora pakatanga metrological kuita uye kuratidzira chromatogram.
7. Full mashoko ose afambe pharmacokinetic kudzidza uye kunyatsoongorora bioequivalence. Rinotaurawo rinodonongodza zvirongwa zvose zvaishandiswa kudzidza.
8. Migumisiro kuonekwa uwandu zvinodhaka mune zvoutachiona ivhu.
9. Medical vanozvipira mepu uye munhu profiles.
10. Results of pharmacokinetic pakudzidza yokupararira tsika kudirwa tinyatsonzwisisa bioequivalence.

Nzira kuti bioequivalence

A kudzidza pamusoro bioavailability zvinodhaka riri kuitwa chete chipimo chemushonga pa Formulations vaviri mumichero uye yepakutanga. Kana kushanda kuti kudzidza zvinodhaka zvakawanda tsvakurudzo kuitwa yoga chimwe.

Nguva penguva pakati negashiro chepakutanga Generic uye yakajeka nguva misha zvinodhaka mumuviri, kukwana kurega nguva. Zvinofanira kuva akaenzana paavhareji 6 nguva kukwana kurega. Zvakashandiswa kudzidza anogona kuva plasma, serum kana ropa. It hunobviswa imwe tsinga iri ano pakati kugokora kuburikidza anobudisa mushonga zvishoma nezvishoma. Zvakabudiswa ngazviitwe katatu:

1. Panguva kukura chezvinhu zviri gadziriro. Zvinofanira kuva 3 pfungwa pamusoro munyonga "wevasungwa - nguva".
2. Panguva soro Absorção de Água. It aishanda vanenge 5 points.
3. Panguva malabsorption. Inoshandisa anenge 3 points.

Kudzidza kunogona kunzi chinogamuchirika, kana kukosha nzvimbo pasi munyonga "wevasungwa - nguva" chinhambwe kubva pasi kusvikira wokupedzisira mharidzo anenge 80%.