Paclitaxel chinhu chakaomarara chigadzirwa chine yakasimba antitumor chiitiko.Nekuda kwekunyanya uye kuomarara kwechimiro chayo.zvakakosha kunyatso gadzirisa kutonga kwemhando uye zviyero zve.paclitaxel.Kudzora kwemhando uye zviyero zvepaclitaxel zvinotsanangurwa zvakadzama pazasi.
Kudzora kwemhando ye paclitaxel
1.raw material control: the raw material ye paclitaxel inofanira kutengwa kubva kune vanokwanisa vatengesi.uye iva nechokwadi chekuchena uye hutano hwezvinhu zvakasvibirira.Raw materials inofanira kuiswa pasi pekuongororwa kwehutano hwakaoma.kusanganisira kuongororwa kwemakemikari.microbial discovery.impurity discover.etc. .kuti vaone kuti vanosangana nezvinodiwa zvekugadzira.
2.production process control: Mukugadzirwa kwepaclitaxel.strict quality control matanho anofanirwa kutorwa.kusanganisira process verification.critical control point monitoring.intermediate testing.etc..kuvimbisa kugadzikana kwemaitiro ekugadzira uye kuenderana kwechigadzirwa.
3.finished chigadzirwa chekuongorora:paclitaxelzvigadzirwa zvinofanirwa kuve zvakanangana zvemhando yekuongorora.including traits.purity.content.related substances.solvent residues nezvimwe zvinhu kuti zvive nechokwadi chekuchengetedzwa kwechigadzirwa uye kubudirira.
4.stability inspection: zvigadzirwa zvepaclitaxel zvinofanira kuva zvekugara kwenguva refu kuongorora kuti vaone kuchinja kwehutano hwavo pasi pemamiriro akasiyana-siyana ekuchengetedza.kupa chikonzero chechokwadi chechigadzirwa.
Paclitaxel standard
1.content determination:paclitaxel content determination procedures kunyanya dzinosanganisira high performance liquid chromatography.ultraviolet inooneka spectrophotometry zvichingodaro.Maitiro akasimba ekutonga mukati anofanira kugadzwa kuti ave nechokwadi chekuti zviri mubatch rimwe nerimwe rezvigadzirwa zvinosangana nemitemo.
2.Kuongororwa kwezvinhu zvine hukama:zvinhu zvine hukama zvepaclitaxel zvinonyanya zvinosanganisira mametabolites ayo uye zvigadzirwa zvekuora.Nzira uye zviyero zvekuongororwa kwezvinhu zvakakosha zvinofanirwa kuumbwa kuti ive nechokwadi chekuti zviri mukati mezvinhu zvakakosha muchigadzirwa chakapedzwa zviri mukati meiyo yakatarwa.
3.solvent residue check:Organic solvents inogona kushandiswa mukugadzirwa kwepaclitaxel.saka chigadzirwa chakapedzwa chinofanira kuongororwa kune zvakasara zvinogadziriswa kuti zvive nechokwadi chekuteerera mitemo.
4.zvimwe zvinhu zvekuongorora: Pamusoro pezvinhu zvekuongorora zviri pamusoro.zvimwe zvinhu zvinofanirawo kuongororwa maererano nezvinodiwa zvehutano hwechigadzirwa.sezvakaita particle size distribution.pH value.moisture.etc.
Summary
Semushonga unokosha unorwisa bundu.kudzorwa kwemhando uye mwero wepaclitaxelzvakakosha zvikuru pakuchengetedza uye kushanda kwechigadzirwa.Matanho akasimba ekugadzirisa hutano anofanirwa kutorwa mukugadzirwa kwekugadzira kugadza mitemo yesainzi uye inonzwisisika yehutano kuitira kuti hutano hwebatch imwe neimwe yezvigadzirwa huve hwakagadzikana uye hwakavimbika.Panguva imwe chete. .kutarisira kunofanira kusimbiswa kuti kuve nechokwadi chekuchengetedzwa uye kutevedza panguva yekugadzirwa nekushandiswa.Kuburikidza nekuvandudzwa kunoramba kuripo uye kuvandudzwa kwehutano hwehutano hwehutano.hutano hwekugadzira uye kushandiswa kwemurwere kwepaclitaxel kunogona kuwedzera kuvandudzwa.
Ongorora: Mabhenefiti angangodaro uye mashandisirwo anoratidzwa muchinyorwa chino anobva mumabhuku akaburitswa.
Nguva yekutumira: Nov-16-2023