Cov txheej txheem kev txheeb xyuas rau enteric-coated gelatin npliag capsules muaj xws li: noj 0.25g ntawm cov khoom, ntxiv 50ml dej, cua sov kom yaj, txias, co zoo, noj 5ml ntawm cov tshuaj, ntxiv ob peb tee ntawm poov tshuaj dichromate test tov-dilute hydrochloric acid (4: 1) txiv kab ntxwv nag lossis daus; noj 1ml ntawm cov tshuaj los ntawm kev txheeb xyuas (1), ntxiv 50ml dej, co zoo, ntxiv ob peb tee ntawm tannic acid test tov, uas ua rau turbidity; noj li 0.3g ntawm cov khoom, muab tso rau hauv ib lub raj kuaj, ntxiv ib me me ntawm cov dej qab zib txiv qaub, cov roj generated yuav tig liab litmus daim ntawv xiav.
Cov khoom kuaj muaj xws li lub sij hawm disintegration, friability, poob ntawm ziab, ntom, sulfite, thiab lwm yam. Nyob rau hauv lub sij hawm disintegration xeem, rau ob leeg enteric-coated capsules thiab colonic enteric-coated capsules, noj 6 tsiav tshuaj ntawm cov khoom, sau lawv nrog talc integration hmoov, thiab kuaj raws li txoj kev nyob rau hauv lub sij hawm kuaj cov khoom; nws yuav tsum ua tau raws li qhov yuav tsum tau ua. Txoj kev kuaj friability yog raws li hauv qab no: Siv 50 tsiav tshuaj ntawm cov khoom no, muab tso rau hauv ib lub iav saib, thiab muab tso rau hauv ib tug desiccator uas muaj ib tug saturated magnesium nitrate tov. Khaws qhov kub tsis tu ncua ntawm 25℃± 1℃rau 24 teev. Tshem cov tshuaj ntsiav thiab tam sim ntawd tso txhua lub tshuaj ib leeg rau hauv ib lub khob raj (24 hli puab txoj kab uas hla, 200 hli ntev) sawv ntsug ntawm lub rooj ntoo (2cm tuab). Cia lub cylindrical qhov hnyav (polytetrafluoroethylene, 22mm txoj kab uas hla, 20g ± 0.1g qhov hnyav) kom poob tawm ntawm qhov qhib ntawm lub khob raj. Saib xyuas seb cov tshuaj ntsiav puas tawg. Yog tias muaj kev tawg, tsis pub ntau tshaj 5 ntsiav tshuaj yuav tsum tau tawg. Rau qhov poob ntawm kev ziab kom qhuav, noj 1.0g ntawm cov khoom no, cais lub hau thiab lub cev, thiab qhuav ntawm 105℃rau 6 teev. Qhov hnyav yuav tsum yog 10.0%-16.0%. Cov txheej txheem rau kev soj ntsuam nruj, sulfites, parabens, chloroethanol, ethylene oxide, residue ntawm ignition, chromium, hnyav hlau, thiab microbial txwv nyob rau hauv seem "Light-Gel Empty Capsules" yuav tsum ua raws li cov kev cai.
Cov kev tshawb fawb tsim nyog ntawm gelatin npliag capsules thiab gelatin enteric-coated npliag capsules yuav tsum tsom rau ntawm tus ntoo khaub lig-kev sib txuas uas tshwm sim hauv gelatin molecules, nruab nrab ntawm gelatin molecules, nruab nrab ntawm gelatin thiab tshuaj, thiab ntawm gelatin thiab lwm yam ntaub ntawv dhau sijhawm. Yog tias cross-kev sib txuas tshwm sim thiab qhov kev sib cais ntawm cov qauv tsis ua raws li qhov yuav tsum tau ua, kev ntsuas kev sib cais tuaj yeem ua los ntawm kev ntxiv qee qhov potency ntawm pepsin lossis trypsin rau qhov nruab nrab ntawm kev sib cais (hauv vitro- hauv vivo correlation kev tshawb fawb yuav tsum tau ua).
