Kev Ruaj Ntseg Tshuaj hauv Kev Npaj Ua Kua
Cov tshuaj kua yog cov tshuaj siv dav dav vim tias lawv yooj yim nqos, hloov pauv tau yooj yim, thiab haum rau cov menyuam yaus thiab cov neeg laus. Piv txwv li, cov kua qab zib, cov tshuaj suspension, cov tshuaj emulsions, cov tshuaj haus, cov tshuaj txhaj, thiab txawm tias cov tshuaj qhov muag. Txawm li cas los xij, txawm tias qhov yooj yim no, cov tshuaj kua ua rau muaj teeb meem loj: kev ruaj khov ntawm cov tshuaj. Kev tsis ruaj khov tuaj yeem txo cov khoom xyaw nquag, hloov pauv cov qauv kev nyab xeeb, ua rau tsis zoo, thiab txawm tias tsim cov khoom puas tsuaj. Yog li ntawd, kev nkag siab txog kev ruaj khov ntawm cov tshuaj hauv cov tshuaj kua yog qhov tseem ceeb rau kev lag luam, cov kws muag tshuaj, thiab cov neeg siv.
Nkag Siab Txog Kev Ruaj Ntseg Hauv Kev Npaj Ua Kua
Kev ruaj khov ntawm cov tshuaj yog lub peev xwm ntawm cov khoom tshuaj kom tswj tau nws tus kheej, lub zog (potency), qhov zoo, thiab kev dawb huv thaum lub sijhawm khaws cia thiab siv. Hauv kev npaj ua kua, kev ruaj khov suav nrog ntau yam tseem ceeb, uas yog:
1. Kev ruaj khov ntawm tshuaj lom neeg: cov tshuaj nquag tsis raug rhuav tshem (piv txwv li hydrolysis lossis oxidation).
2. Kev ruaj khov ntawm lub cev: tsis muaj kev hloov pauv ntawm qhov tsos, xws li cov dej nag uas nyuaj rau tawg, kev sib cais ntawm cov theem emulsion, kev hloov pauv ntawm viscosity, lossis turbidity.
3. Kev ruaj khov ntawm cov kab mob me me: tsis muaj kev loj hlob ntawm cov kab mob me me uas tuaj yeem ua rau cov khoom puas tsuaj thiab ua rau cov neeg mob raug mob.
4. Kev ruaj khov ntawm kev kho mob: cov txiaj ntsig kho mob tseem zoo ib yam thoob plaws lub sijhawm txee.
5. Kev ruaj khov ntawm cov tshuaj lom: cov khoom puas tsuaj tsis nce mus rau qib txaus ntshai.
Cov tshuaj ua kua feem ntau muaj kev phom sij ntau dua li cov tshuaj khov vim tias cov tshuaj nyob hauv ib puag ncig uas ua rau cov tshuaj tiv thaiv kab mob tshwm sim sai dua, nrog rau qhov muaj dej uas tuaj yeem ua qhov chaw rau kev loj hlob ntawm cov kab mob me me.
Cov Yam Cuam Tshuam Rau Kev Ruaj Ntseg Tshuaj
1. Kev sib cais dej
Hydrolysis yog qhov tshuaj tiv thaiv uas cov tshuaj molecule raug dej rhuav tshem. Ntau cov tshuaj uas muaj ester, amide, lossis lactam pawg yooj yim hydrolyzed, tshwj xeeb tshaj yog nyob rau qee qhov pH. Ib qho piv txwv zoo yog beta-lactam tshuaj tua kab mob, uas rhiab heev rau hydrolysis. Vim tias cov kua npaj muaj dej, qhov kev pheej hmoo ntawm hydrolysis nce ntxiv, xav tau cov tswv yim tsim tshuaj xws li kev kho pH, kev siv cov tshuaj sib xyaw, lossis kev khaws cia hauv qhov kub qis.
2. Kev ua kom tawv nqaij puas
Kev oxidation tshwm sim thaum cov tshuaj cuam tshuam nrog cov pa oxygen los ntawm huab cua lossis lwm yam oxidants. Qhov kev cuam tshuam no feem ntau raug ua kom nrawm los ntawm lub teeb, cov hlau ions (catalysts), thiab qhov kub siab. Cov tshuaj uas muaj qee pawg phenol, aldehyde, lossis amine feem ntau yooj yim rau oxidation. Txhawm rau tawm tsam oxidation, cov qauv tuaj yeem siv cov antioxidants (piv txwv li, sodium metabisulfite, BHT, lossis ascorbic acid), ntim khoom airtight, thiab siv nitrogen los hloov qhov chaw cua hauv lub raj mis.
3. Kev puas tsuaj ntawm daim duab
Kev raug lub teeb, tshwj xeeb tshaj yog lub teeb UV, tuaj yeem ua rau cov khoom xyaw ua haujlwm puas tsuaj. Kev puas tsuaj los ntawm lub teeb tuaj yeem ua rau xim hloov pauv thiab txo qis zog. Yog li ntawd, qee cov kua dej tau ntim rau hauv lub raj mis tsaus (xim av) lossis siv cov ntim khoom uas muaj kev tiv thaiv UV. Ntxiv rau kev ntim khoom, "tiv thaiv kom tsis txhob muaj teeb" kev khaws cia kuj yog cov lus qhia tseem ceeb ntawm daim ntawv lo.
4. Cov nyhuv ntawm pH thiab Buffer
pH yog ib qho tseem ceeb uas ua rau cov tshuaj ua kua ruaj khov. Muaj ntau yam tshuaj tsuas yog ruaj khov hauv ib qho pH xwb. Cov neeg tsim tshuaj feem ntau ntxiv cov buffer systems los tswj pH, tab sis kev siv cov buffers yuav tsum sib npaug vim tias lawv tuaj yeem cuam tshuam rau kev yaj, saj, thiab txawm tias qhov kev puas tsuaj. Ntxiv mus, pH kuj cuam tshuam rau qhov ua tau zoo ntawm cov tshuaj preservatives antimicrobial.
5. Kev Sib Cuam Tshuam Nrog Cov Khoom Pab
Cov khoom xyaw xws li cov khoom qab zib, cov tshuaj preservatives, cosolvents, thiab cov thickening agents tuaj yeem ua rau muaj kev phiv. cuam tshuam nrog cov tshuajPiv txwv li, qee cov tshuaj preservatives tuaj yeem raug adsorbed los ntawm surfactants lossis khi rau polymers, txo lawv cov txiaj ntsig. Cov kev sib cuam tshuam no tsis yog ib txwm pom rau lub qhov muag liab qab tab sis tuaj yeem cuam tshuam loj heev rau qhov zoo ntawm cov khoom thaum lub sijhawm khaws cia.
Kev Ruaj Ntseg Lub Cev: Cov Tshuaj, Cov Khoom Nchuav, thiab Cov Khoom Siv Emulsions
1. Kev daws teeb meem
Hauv cov tshuaj, cov khoom xyaw nquag tau yaj tag, yog li cov teeb meem tseem ceeb feem ntau yog kev puas tsuaj ntawm cov tshuaj lossis kev hloov pauv ntawm kev yaj vim qhov kub thiab txias. Yog tias kev yaj txo qis (piv txwv li, thaum kub qis), kev siv lead ua yuav tshwm sim. Kev siv lead ua tsis yog tsuas yog hloov cov koob tshuaj uas tau muab xwb tab sis kuj cuam tshuam rau qhov tsos thiab kev lees txais ntawm tus neeg mob.
2. Kev ncua
Cov tshuaj uas muaj cov khoom khov uas tawg ua tej daim me me. Cov teeb meem tseem ceeb yog kev ua kom cov khoom khov, kev sib sau ua ke (cov khoom khov uas nyuaj rau co), thiab kev hloov pauv ntawm qhov loj ntawm cov khoom khov (kev sib sau ua ke). Txhawm rau kom txo tau cov teeb meem no, cov tshuaj uas ua rau cov khoom khov (piv txwv li, CMC, HPMC, xanthan gum) thiab cov tshuaj tswj viscosity raug siv. Cov lus qhia "co ua ntej" tsis yog tsuas yog kev ua raws li kev cai xwb, tab sis nws tseem ceeb heev kom ntseeg tau tias cov tshuaj sib npaug.
3. Cov tshuaj pleev xim
Ib qho emulsion yog ib qho system ob-theem (roj-dej) uas tau ruaj khov los ntawm surfactant. Cov emulsions tuaj yeem dhau los ua creaming, coalescence, lossis tawg (kev sib cais mus tas li). Kev ruaj khov ntawm emulsion yog cuam tshuam los ntawm hom surfactant, qhov loj ntawm cov droplet, qhov sib txawv ntawm qhov ceev, thiab qhov kub thiab txias cia. Kev hloov pauv kub heev—xws li khov—tuaj yeem ua rau emulsion puas tsuaj mus tas li.
Kev Ruaj Ntseg ntawm Cov Kab Mob Me Me thiab Lub Luag Haujlwm ntawm Cov Tshuaj Tiv Thaiv
Cov tshuaj ua kua, tshwj xeeb tshaj yog cov uas muaj dej ua, yog cov tshuaj zoo heev rau cov kab mob me me. Kev kis kab mob ntawm cov kab mob me me tuaj yeem tshwm sim thaum lub sijhawm tsim khoom, kev sau, lossis kev siv ntau zaus (piv txwv li, cov tee dej lossis cov kua txiv hmab txiv ntoo siv ntau lub lis piam). Yog li ntawd, ntau cov tshuaj ua kua uas tsis tau ntxuav kom huv muaj cov tshuaj preservatives ntxiv xws li parabens, benzoates, sorbates, lossis benzalkonium chloride (rau qee cov tshuaj preservatives). Txawm li cas los xij, cov tshuaj preservatives yuav tsum tau xaiv los ntawm kev xav txog:
- Cov spectrum ntawm kev ua haujlwm antimicrobial
- pH zoo tshaj plaws rau kev ua haujlwm tiv thaiv
- Tej zaum yuav khaus lossis ua xua
- Kev sib cuam tshuam nrog lwm cov ntaub ntawv
– Cov Cai thiab kev txwv kev nyab xeeb
Rau cov tshuaj uas tsis muaj kab mob xws li qee cov tshuaj txhaj lossis cov tshuaj tee qhov muag, kev tswj hwm cov kab mob me me yuav tsum nruj dua. Kev ua kom tsis muaj kab mob, kev ua kom tsis muaj kab mob, thiab kev ntim khoom tshwj xeeb yog ib feem ntawm lub kaw lus ruaj khov ntawm cov kab mob me me.
Qhov Cuam Tshuam ntawm Kub , Av noo, thiab Kev Thauj Mus Los
Qhov kub siab feem ntau ua rau cov tshuaj puas tsuaj sai dua (Arrhenius principle). Cov khoom khaws cia rau hauv lub tsheb kub lossis raug tshav ntuj ntev tuaj yeem puas tsuaj sai dua li qhov xav tau. Ntawm qhov tod tes, qhov kub qis dhau tuaj yeem ua rau muaj nag lossis ua rau cov emulsions puas tsuaj. Yog vim li cas qee cov khoom muaj cov lus qhia kom "khaws cia ntawm 2–8 ° C" lossis "tsis txhob khov."
Kev thauj mus los kuj tseem ceeb heev: kev poob siab tuaj yeem cuam tshuam rau cov khoom ncua thiab cov emulsions, thaum lub siab thiab qhov kub hloov pauv thaum lub sijhawm faib tawm tuaj yeem ua rau muaj kev hloov pauv zoo. Feem ntau, kev lag luam ua qhov kev sim ruaj khov uas ua piv txwv cov xwm txheej faib tawm kom ntseeg tau tias cov khoom tseem nyob hauv cov lus qhia tshwj xeeb.
Cov Txheej Txheem Ntim Khoom thiab Kaw Thawv
Kev ntim khoom tsis yog tsuas yog ib lub thawv xwb; nws yog ib feem ntawm lub kaw lus ruaj khov. Qee cov yas tuaj yeem nqus cov tshuaj lipophilic, thaum iav tuaj yeem cuam tshuam nrog cov tshuaj alkaline heev. Ntxiv mus, cov pa oxygen thiab cov dej permeability ntawm cov ntaub ntawv ntim khoom tuaj yeem cuam tshuam rau kev oxidation thiab concentration ntawm cov tshuaj (vim yog evaporation). Cov kaw lus kaw yuav tsum nruj kom tiv thaiv kev ua qias tuaj thiab kev poob cov kuab tshuaj. Lub raj mis tsaus nti, cov blisters tshwj xeeb, cov sterile droppers, thiab cov kaus mom tiv thaiv menyuam yaus yog cov piv txwv ntawm cov qauv tsim uas tuaj yeem txhim kho kev ruaj khov thiab kev nyab xeeb.
Kev Ntsuas Kev Ruaj Ntseg thiab Kev Txiav Txim Siab Txog Lub Neej Txee
Lub sijhawm khaws cia yog txiav txim siab los ntawm kev sim ua kom ruaj khov mus sij hawm ntev thiab ua kom nrawm dua. Cov kev ntsuas uas tau sim feem ntau suav nrog cov khoom xyaw nquag, cov khoom puas tsuaj, pH, viscosity, tsos, homogeneity, thiab kev sim microbiological. Cov ntaub ntawv no yog siv los tsim hnub tas sij hawm thiab cov xwm txheej khaws cia. Rau cov khoom sib xyaw, lo lus beyond-use-by-date (BUD) feem ntau yog siv, uas feem ntau luv dua vim yog cov ntaub ntawv ruaj khov tsawg.
Xaus
Kev ruaj khov ntawm cov tshuaj hauv cov ntawv tshuaj kua yog cuam tshuam los ntawm ntau yam sib txuas, xws li kev puas tsuaj ntawm cov tshuaj (hydrolysis, oxidation, photodegradation), kev hloov pauv lub cev (sedimentation, phase separation), thiab kev ua qias tuaj ntawm cov kab mob me me. Kev tswj hwm pH, kev siv cov khoom siv kom raug, kev xaiv cov ntim khoom, kev tswj cov txheej txheem tsim khoom , thiab kev khaws cia pom zoo yog qhov tseem ceeb rau kev tswj hwm qhov zoo thiab kev nyab xeeb. Los ntawm kev nkag siab txog cov ntsiab cai ruaj khov no, cov kws tshaj lij tshuaj thiab kev lag luam tuaj yeem ua kom cov neeg mob tau txais cov ntawv tshuaj kua zoo, muaj kev nyab xeeb, thiab sib xws kom txog thaum kawg ntawm lawv lub txee.
