Hauv kev lag luam tshuaj thiab cov khoom noj khoom haus zoo, cov tshuaj ntsiav softgel tseem yog ib qho ntawm cov qauv tshuaj uas nyiam tshaj plaws rau kev xa cov khoom xyaw tshuaj hydrophobic (APIs), cov vitamins uas yaj hauv roj, thiab cov roj tshwj xeeb. Txawm li cas los xij, cov chaw tsim khoom softgel feem ntau ntsib qhov tsis ua haujlwm ruaj khov thaum lub sijhawm kuaj kev ruaj khov lossis khaws cia rau lub sijhawm ntev:kev sib txuas ntawm gelatin.
Kev sib txuas ua rau lub plhaub tshuaj hloov pauv ntau yam khoom siv lub cev thiab tshuaj, ua rau qeeb qeeb yaj, tsis ua tiav kev sim yaj, thiab ua rau lub cev tsis muaj zog. Phau ntawv qhia no tshawb nrhiav txog kev tshawb fawb txog kev sib txuas thiab muab cov tswv yim siv tau rau cov pab pawg tsim khoom kom txo qhov teeb meem no los ntawm kev xaiv cov khoom siv raw thiab kev tswj hwm ib puag ncig.
Nkag Siab Txog Kev Tshawb Fawb: Dab Tsi Ua Rau Gelatin Cross-Linking?
Kev sib txuas ntawm gelatin yog kev tsim cov tshuaj sib txuas uas tsis tuaj yeem hloov pauv tau (xws li covalent lossis cov hydrogen muaj zog) ntawm cov saw peptide hauv lub plhaub gelatin capsule. Lub network macromolecular no hloov lub plhaub gelatin uas yaj tau zoo heev mus rau hauv daim nyias nyias uas tsis yaj hauv dej, roj hmab, lossis pellicle uas tsis yaj hauv cov kua hauv plab lossis cov hnyuv.
Qhov xwm txheej no feem ntau yog tsav los ntawm peb yam tseem ceeb:
- · Kev Sib Cuam Tshuam ntawm Aldehyde:Qhov muaj cov aldehydes me me lossis cov suab thaj txo qis hauv cov qauv sau encapsulated, cov khoom siv ntxiv, lossis cov ntaub ntawv ntim khoom sai sai reacts nrog cov amino pawg (tshwj xeeb tshaj yog epsilon-amino pawg ntawm lysine residues) hauv cov gelatin molecule ntawm Schiff base reaction.
- · Kev Nyuaj Siab Ib puag ncig:Kev raug rau qhov kub thiab txias ntev thiab cov av noo siab (RH) thaum lub sijhawm ziab lossis khaws cia ua rau cov polymer chain mobility sai dua, txhawb kev sib txuas thermodynamic.
- · Cov khoom tsis huv hauv cov khoom xyaw:Kev ua kom cov polyethylene glycols (PEGs), polysorbates, thiab qee cov roj thauj khoom feem ntau tsim cov tshuaj peroxides thiab aldehydes uas muaj zog dhau sijhawm, ua rau muaj kev sib txuas thaum lub sijhawm khaws cia.
Cov Kev Tshwm Sim: Kev Cuam Tshuam rau Kev Ncaj Ncees thiab Kev Ua Raws Cai ntawm Cov Khoom
Thaum muaj kev sib txuas ua ke, cov teeb meem rau cov hom tshuaj thiab cov koom haum tsim khoom cog lus (CMOs) yog qhov hnyav heev. Thaum lub sijhawm kuaj kev yaj ntawm USP/EP, cov tshuaj mos mos sib txuas ua ib daim "pellicle" uas tsis yaj (ib daim nyias nyias, pob tshab) nyob ib puag ncig daim ntawv qhia tshuaj, ntes cov khoom siv hauv. Qhov no ua rau cov qauv yaj tawm ntawm qhov kev qhia tshwj xeeb (OOS), muaj peev xwm rov qab hu cov khoom, thiab ua rau tus neeg mob tsis muaj txiaj ntsig zoo.
Cov Tswv Yim Txuj Ci Kom Tiv Thaiv Kev Sib Txuas Lus Softgel
1. Kev Tswj Xyuas Cov Khoom Siv Gelatin Raw Zoo
Cov tshuaj lom neeg sib xyaw thiab kev huv ntawm cov tshuaj gelatin uas tuaj txog yog koj thawj kab kev tiv thaiv. Cov lus qhia txog gelatin txheem (xws li Bloom lub zog thiab viscosity) tsis txaus los kwv yees tus cwj pwm sib txuas. Cov chaw tsim khoom yuav tsum yuam kom cov neeg muag khoom tswj hwm thiab txheeb xyuas cov khoom xyaw me me.
| Tseem ceeb heevTus cwj pwm zoo (CQA) | Kev Txwv ntawm Cov Khoom Siv | Kev cuam tshuam rau kev ua haujlwm ntawm Softgel |
| Lub zog tawg paj | 150 – 240 g (± 5g sib xyaw ua ke) | Xyuas kom muaj zog zoo tshaj plaws thiab elasticity ntawm daim kab xev. |
| Viscosity (6.67% ntawm 60 ° C) | 2.5 – 4.5 mPa·s | Tswj cov zaj duab xis thickness, kev ruaj ntseg ntawm kev sib khi, thiab yooj yim ntawm encapsulation. |
| Cov Hlau (Fe) Cov Ntsiab Lus | < 15 ppm | Txo qhov oxidation ntawm cov roj sau thiab tom qab ntawd aldehyde tiam. |
| Tus nqi ntawm Peroxide | < 20 ppm | Tiv thaiv kev pib ntawm cov tes hauj lwm sib txuas dawb-radical. |
2. Kev Txhim Kho Cov Qauv Sau thiab Kev Tshuaj Xyuas Cov Khoom Siv
Yuav kom tiv thaiv lub plhaub gelatin ntawm cov khoom ua haujlwm, cov kws tshawb fawb txog kev tsim khoom yuav tsum muaj cov tshuaj aldehyde scavengers lossis cov tshuaj tiv thaiv kev sib tw rau hauv lub matrix sau. Ntxiv me me ntawm cov amino acids, xws li glycine lossis lysine, rau hauv lub fill lossis lub gelatin mass tuaj yeem sib tw nrog cov aldehydes me me, ua kom zoo khaws cia qhov kev ua tiav ntawm lub plhaub matrix.
3. Kev Siv Cov Tshuab Ziab Khaub Ncaws Zoo Tshaj Plaws
Lub sijhawm ziab yog ib kauj ruam tseem ceeb uas cov softgels yooj yim raug kev kub ntxhov los ntawm cua sov. Kev siv ntau theem, kev ziab tas mus li nrog rau kev tshem cov dej noo kom raug ua rau cov dej noo maj mam tshem tawm yam tsis muaj cua sov ntau dhau rau cov gelatin ribbons. Kev tswj cov dej noo tsawg (20% -25% RH) ntawm qhov kub tswj tau ntawm 20 ° C - 22 ° C txo qhov kev hloov pauv ntawm cov saw hlau macromolecular.
Kev Nkag Siab Txog Kev Siv Tshuab: Kev xaiv ib lub chaw tsim khoom uas siv cov khoom siv raw khoom uas taug qab tau tag nrho, ua kom ntseeg tau tias qhov sib txawv ntawm cov khoom me me raug khaws cia ze rau xoom, txo qhov kev pheej hmoo mus sij hawm ntev ntawm kev tsim cov khoom me me.
Vim Li Cas Kev Pom Tseeb Txog Kev Muab Khoom Thiab Kev Ua Raws Cai ntawm SOP Tseem Ceeb
Kev tiv thaiv kev sib txuas lus yuav tsum muaj ntau tshaj li cov khoom xyaw zoo xwb; nws xav tau kev tsim khoom kom sib xws. Cov tuam txhab tsim khoom gelatin thoob ntiaj teb ua tiav qhov no los ntawm kev siv cov txheej txheem ua haujlwm Standard Operating Procedures (SOPs) thoob plaws lawv cov kab ntau lawm. Txij li cov khoom siv raw ncaj qha mus rau kev ua haujlwm hauv chav huv, kev ua kom tsis muaj kev phom sij rau cov hlau hnyav thiab cov neeg sawv cev oxidative yog qhov tseem ceeb rau kev tsim cov softgels uas ruaj khov thiab ruaj khov.
Tiv tauj nrog Eric
Lub sijhawm tshaj tawm: Lub Rau Hli-16-2026
