Hauv kev sim siab thiab pawg ntau lawm ntawm nifedipine ruaj khov-tso cov ntsiav tshuaj, berrous fumarate ntsiav tshuaj, buflomedil hydrochloride ntsiav tshuaj, thiab lwm yam, peb sivHydroxyPropyyl methylcellulose (HPMC)Kua, HydroxyPropyf methylulose thiab polyacrylic acid cob ua kua, uas tau ua tiav cov teeb meem ua yeeb yaj kiab ua si, tab sis tau ntsib cov teeb meem zoo nkauj, tab sis tau ntsib cov teeb meem Tom qab qee cov teeb meem txuj ci, peb tam sim no sib txuas lus nrog cov npoj yaig txog cov teeb meem thiab kev daws teeb meem hauv zaj duab xis txheej.
Nyob rau hauv xyoo tsis ntev los no, zaj duab xis txheej thev naus laus zis tau siv dav hauv kev npaj khoom. Cov zaj duab xis txheej tuaj yeem tiv thaiv cov tshuaj los ntawm lub teeb, noo thiab huab cua kom nce qhov ruaj khov ntawm cov tshuaj; Daim npog qhov muag tsis zoo ntawm cov tshuaj thiab pab txhawb tus neeg mob coj nws; Tswj lub xaib tso tawm thiab tso tawm cov tshuaj ceev; tiv thaiv kom haum rau cov tshuaj sib xyaw ntawm cov tshuaj; Txhim kho cov tsos ntawm cov ntsiav tshuaj tos. Nws tseem muaj qhov zoo ntawm cov txheej txheem tsawg dua, lub sijhawm luv dua, kev siv hluav taws xob qis dua, thiab tsawg ntsiav tshuaj hnyav nce. Qhov zoo ntawm cov yeeb yaj kiab-txheej ntsiav tshuaj feem ntau yog nyob ntawm cov khoom siv thiab cov khoom siv ntawm cov khoom siv, thiab lwm yam kev sib xyaw thiab cov khoom lag luam zoo thiab cov khoom siv tau zoo Nyob rau hauv cov khoom xyaw nquag ntawm ntsiav tshuaj, ntau yam excipients thiab cov tsos, hardness, clittic pieces, thiab ntsiav tshuaj ntawm cov ntsiav tshuaj ntawm cov ntsiav tshuaj. Cov qauv ntawm cov txheej ua kua feem ntau muaj cov roj av molecular ntau, cov kuab tshuaj, cov kuab tshuaj, thiab cov khoom siv sib npaug.
1. Noney-sidded puas, zaj duab xis ntug tawg thiab tev
Lub hardness ntawm saum npoo ntawm sab saum toj ntawm cov ntsiav tshuaj me me yog qhov kev sib txhuam me me, thiab kev ntxhov siab thaum lub sijhawm ua kom muaj zog lossis ib leeg poob, ua rau muaj pickmarks lossis pores ntawm lub npoo ntawm Cov qauv ntsiav tshuaj tseem ceeb, uas yog ib tog kev hnav, tshwj xeeb tshaj yog nrog engraved cim zaj duab xis. Qhov kev yooj yim tshaj plaws ntawm zaj duab xis hauv cov ntsiav tshuaj-coated ntsiav tshuaj yog cov fab. Thaum lub adhesion lossis lub zog ntawm zaj duab xis yog tsis txaus, tawg thiab tev ntawm cov yeeb yaj kiab cov npoo yuav tshwm sim. Qhov no yog vim tias qhov loj heev ntawm cov kuab tshuaj ua rau muaj kev ntxhov siab rau sab hauv ntawm zaj duab xis, uas ntau tshaj lub tensile lub zog ntawm txheej zaj duab xis.
1.1 Kev tsom xam ntawm cov laj thawj tseem ceeb
Raws li deb li cov nti tseem ceeb yog kev txhawj xeeb, lub ntsiab yog vim li cas ntawm lub nti tseem ceeb tsis zoo, thiab lub hardness thiab britleness yog me me. Thaum lub sij hawm txheej txheej txheej txheej, cov ntsiav tshuaj tseem ceeb yog kev sib txhuam muaj zog thaum muaj zog tiv thaiv cov tawv nqaij uas tsis muaj kev nyuaj siab, uas cuam tshuam nrog cov qauv ntawm cov ntsiav tshuaj. Thaum peb ntim nifedipine muaj cov ntsiav tshuaj, vim yog qhov nyuaj ntawm cov ntsiav tshuaj, uas tau tshwm sim rau ntawm ib sab, thiab cov yeeb yaj kiab-co kom du thiab muaj qhov tsis zoo. Tsis tas li ntawd, qhov kev txwv txiav no yog muaj feem xyuam rau cov ntsiav tshuaj hom. Yog tias zaj duab xis tsis xis nyob, tshwj xeeb yog cov yeeb yaj kiab muaj lub logo ntawm cov yas, nws yog ntau dua rau ib sab.
Nyob rau hauv txheej txheej ua haujlwm, qeeb dhau ntawm huab cua kom huv si lossis lub sijhawm ua yeeb yaj kiab heev ntawm cov ntsiav tshuaj cores hauv cov xaim cores Thib ob, lub siab atomization siab yog loj, lub viscosity ntawm txheej ua kua yog qhov tsawg, thiab cov dej khov rau hauv lub sab hauv kev ntxhov siab, ua rau sab hauv kev ntxhov siab loj; Nyob rau tib lub sijhawm, kev sib txhuam ntawm ib sab npoo kuj tseem nce sab hauv kev ntxhov siab ntawm zaj duab xis thiab nrawm zaj duab xis. Tawg sawv ntsug.
Ib qho ntxiv, yog tias kev sib hloov ceev ntawm cov txheej txheej ceev dhau lossis cov txheej txheem kev sib txhuam ntawm cov tshuaj txhuam yuav tsis kis tau zoo, thiab cov yeeb yaj kiab zoo yuav qeeb, uas yuav ua rau ib sab.
Los ntawm txheej ua kua, nws yog feem ntau yog vim kev xaiv cov qauv ntawm cov qauv thiab cov khoom tsis zoo) ntawm cov txheej txheem ua kua thiab cov ntsiav tshuaj.
1.2 Kho
Ib qho yog kho cov tshuaj lossis cov txheej txheem ntau lawm ntawm cov ntsiav tshuaj los txhim kho lub zog ntawm cov ntsiav tshuaj. HPMC yog cov khoom siv txheej siv txheej txheej. Cov nplaum ntawm cov ntsiav tshuaj kom muaj feem xyuam rau cov pab pawg hydroxules, thiab cov pab pawg hydroxen ua nrog cov pab pawg sib piv nrog HPMC los tsim kom muaj advesion siab dua; Cov nplaum tsis muaj zog, thiab ib leeg ib sab thiab cov yeeb yaj kiab txheej feem sib cais. Tus naj npawb ntawm cov pab pawg hydroxyl ntawm cov molecular saw ntawm cov microcrystalline cellulose, thiab nws muaj cov ntsiav tshuaj tau npaj los ntawm lactose thiab lwm cov piam thaj tau muaj qhov sib luag me me. Kev siv cov roj nplua nyeem, tshwj xeeb tshaj hydrophobic lubricants xws li stearic cov tub ntxhais, yuav txo cov tshuaj pleev roj, ua kom zoo nkauj, thiab siv cov dej khov kho, Lub zog nplaum tsis muaj zog zuj zus. Feem ntau, ntau npaum li cas cov roj nplua nyeem, ntau cov adhesion tsis muaj zog. Ib qho ntxiv, hauv kev xaiv ntawm cov ntsiav tshuaj hom, hom biconvx ntsiav tshuaj yuav tsum tau siv kom tau kom deb li sai tau rau cov kev tshwm sim ntawm cov teeb meem tsis xws luag.
Qhov thib ob yog txhawm rau kho cov tshuaj ntawm cov txheej txheej ua kua, thiab txhim kho lub zog ntawm cov kua lossis cov nplaum ntawm txheej yeeb yaj kiab, uas yog cov qauv yooj yim los daws cov teeb meem. Feem ntau, cov ntsiab lus ruaj ruaj nyob hauv cov aqueous system yog 12%, thiab cov ntsiab lus hauv cov kab kuab organic yog 5% rau 8%.
Qhov sib txawv hauv cov kab viscosity ntawm cov kua dej cuam tshuam rau kev nrawm thiab theem kev nkag mus rau hauv cov ntsiav tshuaj ua kua. Thaum muaj tsawg los yog tsis muaj nkag mus, lub adlesion yog tsawg kawg nkaus. Lub viscosity ntawm txheej ua kua thiab cov khoom ntawm txheej txheej zaj duab xis muaj feem cuam tshuam nrog qhov nruab nrab molecular hnyav ntawm lub polymer hauv kev tsim qauv. Qhov siab dua qhov nruab nrab molecular hnyav, ntau dua qhov tawv tawv ntawm txheej zaj duab xis, qhov tsis tshua muaj kev ywj pheej thiab cov hnav tsis kam. Piv txwv, lag luam muaj HPMC muaj cov qib viscosity sib txawv rau kev xaiv vim qhov sib txawv hauv qhov sib txawv ntawm qhov nruab nrab molecular hnyav. Ntxiv nrog rau kev cuam tshuam ntawm cov polymer, ntxiv cov khoom siv lossis nce cov ntsiab lus ntawm cov duab Talc tuaj yeem cuam tshuam txog lub zog ntawm cov yeeb yaj kiab txheej, yog li nws yuav tsum yog siv hauv kev sim.
Thib peb, nyob rau hauv cov txheej txheem ua haujlwm, nws yog qhov tsim nyog yuav nce cov tshuaj tsuag ceev, tshwj xeeb tshaj yog thaum cov tshuaj txau sai dua, yog li cov tshuaj tov ntawm zaj duab xis hauv lub sijhawm luv luv, uas Ua si lub luag haujlwm ntawm kev tiv thaiv cov ntsiav tshuaj. Nce cov tshuaj tsuag tshuaj kuj tseem tuaj yeem txo lub txaj kub, evaporation ntsuas kub, txo qis sab hauv kev ntxhov siab, thiab tseem txo qhov teeb meem ntawm zaj duab xis tawg. Nyob rau tib lub sijhawm, kho qhov kev hloov nrawm ntawm cov txheej yas rau lub xeev zoo tshaj plaws, thiab teeb tsa lub baffle loj los txo kev sib txhuam thiab hnav.
2.adhesion thiab blistering
Nyob rau hauv cov txheej txheem ntawm txheej, thaum cohesion ntawm lub interface ntawm ob lub slices loj dua li cov molecular sib cais ua kom yuam, ob peb slices (ntau ntu) yuav luv luv khi thiab tom qab ntawd cais. Thaum sib npaug ntawm cov tshuaj txau thiab ziab tsis zoo, zaj duab xis yuav lo rau ntawm phab ntsa ntawm lub lauj kaub lossis ua rau cov yeeb yaj kiab tawg rau ntawm qhov chaw adcesion; Nyob rau hauv cov tshuaj tsuag, thaum lub tee dej tsis tau qhuav, cov tee dej unbrots yuav nyob hauv cov txheej txheem npuas, kom cov ntawv txheej npuas tshwm ua npuas.
2.1 Tsom xam cov laj thawj tseem ceeb
Qhov chaw thiab muaj xwm txheej ntawm cov txheej no feem ntau yog vim txheej txheej ua haujlwm, qhov tsis txaus ntseeg thiab ziab. Cov txau ceev nrawm nrawm dhau los yog lub ntim ntawm atomized roj yog loj heev. Lub ziab nrawm dhau qeeb dhau vim qhov cua tsis muaj cua qis dua lossis cov cua qis hauv lub txaj. Daim ntawv tsis yog qhuav txheej los ntawm txheej hauv lub sijhawm thiab adhesions lossis npuas tshwm sim. Ib qho ntxiv, vim muaj kev sib txig sib luag tsis raug lossis qhov sib dhos, lub khob hliav tshuaj tsim tau me me, thiab cov khoom ntub dej, ua rau muaj cov nplaum. Muaj qeeb qeeb cov lauj kaub, centrifugal zog yog me me dhau, zaj duab xis dov tsis yog qhov zoo tsim adhesion.
Txheej txheej viscosity yog loj heev, kuj yog ib qho ntawm cov laj thawj. Cov khaub ncaws ua kua viscosity yog qhov loj, yooj yim rau cov tsiaj loj dua, nws lub peev xwm nkag mus rau hauv cov yeeb yaj kiab, lub zog ntawm zaj yeeb yaj kiab tsis zoo, ntau lub npuas. Tab sis qhov no tsis muaj cov nyhuv ntau ntawm cov adhesions tradient.
Tsis tas li ntawd, hom yeeb yaj kiab tsis zoo yuav tshwm sim adhesion. Yog tias cov yeeb yaj kiab tiaj tus nyob rau hauv lub lauj kaub txheej dov tsis yog qhov zoo, yuav sib tshooj ua ke, nws yog qhov yooj yim ua rau ob npaug lossis ntau txheej yeeb yaj kiab. Nyob rau hauv peb zus tau ntau lawm Bubfromedil Hydrochloride ntsiav tshuaj, ntau cov sib tshooj tau tshwm nyob rau hauv cov txiv ntseej txheej ntua khoom vim tias ntawm txheej tiaj.
2.2 Cov ntsiab lus
Nws yog feem ntau yog los kho cov tshuaj tsuag thiab ua kom qhuav kom ua tiav cov kev sib npaug tsis sib npaug. Txo cov tshuaj tsuag ceev, nce cov inlet cua ntim thiab cua kub, nce lub qhov taub kub thiab ziab nrawm. Nce cov kev pab them nqi ntawm cov tshuaj tsuag, txo qhov nruab nrab ntawm cov dej phom lossis cov ntawv sib nrug ntawm kev daws teeb meem ntawm rab phom thiab ntawv txaj.
Kho cov txheej txheej tshuaj, nce cov ntsiab lus ntawm cov khoom siv nyob rau hauv cov kuab tshuaj, txo cov kuab tshuaj lossis nce cov kev xav ntawm ethanol tsim nyog nyob rau hauv thaj tsam viscosity; Anti-adhesive tseem tuaj yeem txuas ntxiv, xws li Talcum hmoov, Magnesium stearate, silica gel hmoov lossis oxide peptide. Tuaj yeem txhim kho kev nrawm ntawm cov tais txheej, ua kom muaj zog centrifugal ntawm lub txaj.
Xaiv cov ntawv tsim nyog. Txawm li cas los xij, rau cov ntawv tiaj tus, xws li bebroundedil hydrotside ntsiav tshuaj yias, los ntawm kev txhim kho lub baffle nyob rau hauv lub baquing ban los txhawb nqa lub yob ntawm daim ntawv.
3.one-sider ntxhib thiab tawv nqaij
Nyob rau hauv cov txheej txheem ntawm txheej, vim hais tias txheej txheej ua kua tsis zoo kis, tsis zoo rau saum npoo ntawm zaj duab xis, ua rau cov xim tsis zoo thiab thaj chaw tsis zoo. Wrinkled daim tawv yog ib hom ntawm ntxhib saum npoo, yog kev pom kev ua kom pom tseeb ntau dhau.
3.1 Tsom xam ntawm cov laj thawj tseem ceeb
Thawj feem yog cuam tshuam nrog lub nti txuj ci. Qhov loj dua thawj qhov chaw ntawm qhov tseem ceeb ntawm cov tub ntxhais yog, qhov loj dua ntawm cov khoom ntawm cov coated yuav yog.
Thib ob, nws muaj kev sib raug zoo nrog cov txheej txheej tshuaj. Nws yog feem ntau ntseeg hais tias lub cev molecular, conctration thiab ntxiv ntawm cov polymer hauv kev daws teeb meem muaj feem xyuam rau cov npoo sib dhos ntawm zaj duab xis. Lawv coj los ntawm kev cuam tshuam ntawm cov viscosity ntawm txheej viscosity, thiab kev ntxhib ntawm zaj duab xis txheej yog yuav luag linear nrog cov viscosity, nce nrog kev nce ntawm viscosity. Ntau dhau cov ntsiab lus muaj cov ntsiab lus hauv cov tshuaj txheej tuaj yeem yooj yim ua rau muaj coarsening.
Thaum kawg, nws muaj feem xyuam rau cov kev ua haujlwm txheej. Lub atomization ceev yog tsawg dhau los yog siab dhau (cov nyhuv atomization tsis zoo rau cov pos huab tee dej thiab ua ib qho ib-tog tawv nqaij. Thiab cov cua qhuav heev ntawm cov cua qhuav (pa cua sov dhau heev, tsim cov huab cua ntws dhau lawm, ua rau muaj huab cua ntws dhau lawm, tseem ua rau cov dej ntws tam sim no, kuj ua rau cov tee dej tsis zoo yog tsis zoo.
3.2 cov ntsiab lus
Thawj yog los txhim kho qhov zoo ntawm cov tub ntxhais. Nyob rau hauv lub premise ntawm ensuring qhov tseem ceeb ntawm cov tseem ceeb, kho cov txheej txheej tshuaj thiab txo cov viscosity (concentration) lossis cov ntsiab lus ntawm cov kev daws teeb meem. Cawv-soluble lossis dej cawv-2-dej coating daws tau xaiv tau. Tom qab ntawd kho cov haujlwm ua haujlwm, tsim nyog txhim kho kev nrawm ntawm cov txheej txheej yob tusyees, nce kev sib txhuam, txhawb nqa kev sib txhuam ntawm cov kua txheej. Yog tias lub txaj kub yog siab, txo cov pa roj av thiab nqus tau cua sov. Yog tias muaj tshuaj tua kab, atomization siab siab yuav tsum tau txhim kho kom cov pos huab ua kom cov pos huab tawm mus rau saum npoo ntawm daim ntawv, thiaj li ua kom pos huab nrog me dua Qhov nruab nrab ntawm lub taub thiab tiv thaiv qhov tshwm sim ntawm cov huab loj poob, tshwj xeeb yog rau txheej ua kua nrog cov viscosity loj. Qhov kev ncua deb ntawm rab phom txau thiab cov ntawv txaj kuj tseem tuaj yeem hloov kho. Phom txau diav nrog metheye lub taub hau dhau (015 hli ~ 1.2 mm) thiab siab ntws tus nqi ntawm atomizing roj yog xaiv. Cov tshuaj txau tau kho kom haum rau ntau lub khob hliav qab ntxig huab
4. LWM YAM POJ
4.1 Tsom xam cov laj thawj tseem ceeb
Qhov no tshwm sim thaum cov duab ntawm zaj duab xis yog cim lossis cim. Vim tias cov khaub ncaws hnav khaub ncaws tsim nyog rau cov khoom siv hluav taws xob, xws li cov khaub ncaws ua kom qhuav, thiab lwm yam. Ib leeg ob tog notch ploj lossis lub logo tsis meej, cov laj thawj rau qhov tshwm sim no nyob rau cov khoom noj ua kua dej.
4.2 Kho
Kho cov tshuaj ntawm txheej daws teeb meem. Siv cov roj tsawg polmers lossis siab adhesion zaj duab xis ua cov ntaub ntawv; Nce tus nqi ntawm cov kuab tshuaj, txo cov viscosity ntawm txheej daws teeb meem; Ua kom muaj cov tshuaj yas, txo cov kev ntxhov siab sab hauv. Txawv plhaw plhaw cov nyhuv txawv yog qhov sib txawv, polyethylene glycol 200 yog qhov zoo dua li propylene glycol, glycerin. Kuj tseem tuaj yeem txo cov tshuaj tsuag ceev. Ua kom cov cua kub ntxiv, nce qhov kub ntawm cov ntawv txaj, yog li ntawd cov txheej tsim yog muaj zog, tab sis kom tiv thaiv ntug kev tawg. Ib qho ntxiv, hauv kev tsim ntawm kev cim tuag, peb yuav tsum them sai sai rau qhov kev txiav lub kaum thiab lwm yam khoom zoo, kom tiv thaiv qhov tshwm sim ntawm Choj tshwm sim.
5.Clothing membrane cov qauv
5.1 Kev tsom xam ntawm cov laj thawj tseem ceeb
Nyob rau hauv ntau cov kev daws teeb meem muaj cov pigments lossis tuag uas tsis muaj teeb meem thiab kev faib tawm cov xim tsis sib xws, cov xim sib txawv yog tsim ntawm cov nplais. Qhov laj thawj tseem ceeb yog qhov nrawm ntawm cov txheej txheej dhau los yog cov kev sib xyaw ua haujlwm tsis zoo, thiab cov khoom siv sib xyaw ua tsis tau zoo ntawm cov ntawv nyob rau lub sijhawm qub; Cov concentration ntawm cov xim xim lossis zas xim cov kua yog qhov siab dhau lawm, lossis cov khoom kub heev dhau lawm, yog li cov xim txheej ua kua tsis yog dov tawm hauv lub sijhawm; Cov nplaum ntawm zaj duab xis kuj tseem tuaj yeem tshwm sim los; Cov duab ntawm daim yog tsis haum, xws li ntev daim, vim tias dov li daim, tseem yuav ua rau xim sib txawv.
5.2 Tshuaj
Ua kom cov ceev nrawm ntawm cov txheej txheej yas lossis tus naj npawb ntawm baffle, kho rau lub xeev tsim nyog, yog li ntawd cov ntawv hauv lub lauj kaub dawb yob. Txo cov txheej txheej ua kua tshuaj tsuag ceev, txo qhov kub kub. Nyob rau hauv kev tshuaj tsim qauv ntawm cov xim txheej daws, cov tshuaj pleev ib ce lossis cov ntsiab lus yuav tsum raug txo kom tsawg, thiab xim xim yuav tsum raug xaiv. Cov xim lossis zas yuav tsum yog qhov muag heev thiab cov lus yuav tsum yog qhov me me. Cov dej tsis muaj zog yog qhov zoo dua li cov dej soluble de tsis migrate dyes, oxidation ntawm lub preatability ntawm zaj duab xis kuj zoo dua li cov dej soluble dyes. Kuj xaiv cov hom uas tsim nyog. Nyob rau hauv cov txheej txheem ntawm zaj duab xis txheej, muaj ntau yam teeb meem, tab sis tsis hais dab tsi los ntawm kev txhim kho cov khoom siv txheej thiab ua haujlwm, yog li kom ua tiav daim ntawv thov daws tau thiab kev ua haujlwm tsis zoo. Nrog rau cov qauv ntawm txheej thev naus laus zis, kev txhim kho thiab kev siv tshuab tshiab, kev ua yeeb yam zoo kuj tseem yuav tau txais kev loj hlob sai sai.
Lub Sijhawm Post: Apr-25-2024