Loratadine Capsulesyog ib qho kev siv dav tshaj -- cov tshuaj tiv thaiv kab mob, uas yog rau tiam thib ob ntawm cov tshuaj tiv thaiv kab mob. Cov khoom xyaw tseem ceeb yog loratadine, thiab nws kuj muaj qee cov khoom ntxiv xws li cov hmoov txhuv nplej siab, lactose, magnesium stearate, thiab lwm yam. Cov khoom siv no pab nrog kev ua kom zoo, ruaj khov, thiab kev tswj hwm ntawm cov tshuaj. Tom qab tib neeg lub cev los rau hauv kev sib cuag nrog allergens, lub cev tiv thaiv kab mob tso tawm tshuaj xws li histamine. Histamine khi rau histamine receptors ntawm lub xovtooj ntawm tes, ua rau muaj cov tsos mob ua xua xws li txham, los ntswg, qhov ntswg congestion, khaus tawv nqaij, ua pob liab liab, thiab lwm yam. txo cov tsos mob ua xua. Piv nrog rau thawj tiam antihistamines, loratadine tsis tshua muaj peev xwm hla cov ntshav- hlwb teeb meem, ua rau muaj kev cuam tshuam hauv nruab nrab tsis muaj zog thiab tsis tshua muaj kev cuam tshuam rau tib neeg kev ua ub no. Cov neeg mob uas muaj lub siab thiab lub raum tsis ua haujlwm yuav tsum kho lawv cov koob tshuaj raws li kev qhia ntawm tus kws kho mob; Cov neeg laus kuj tseem yuav tsum tau ceev faj thaum noj tshuaj thiab ua tib zoo saib xyuas cov tshuaj tsis zoo. Thaum noj tshuaj, ib tus yuav tsum tsis txhob tsav tsheb, kev siv lub tshuab ua haujlwm, lossis ua haujlwm ntawm qhov siab kom tsis txhob muaj xwm txheej tshwm sim los ntawm kev tsis zoo xws li qaug zog; Yog tias koj siv lwm cov tshuaj, thov nrog tus kws kho mob lossis tus kws muag tshuaj ua ntej siv cov khoom no.
Nyob rau tib lub sijhawm, peb lub tuam txhab tsis yog tsuas yog muab cov hmoov ntshiab, tab sis kuj muaj cov ntsiav tshuaj thiab tshuaj txhaj. Yog tias xav tau, thov koj xav tiv tauj peb txhua lub sijhawm.
Cov ntaub ntawv ntxiv ntawm chemical compound:
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Loratadine COA
Loratadine ntsiav tshuajyog ib hom tshuaj siv thib ob - tiam tshuaj antihistamine, feem ntau yog siv los txo cov tsos mob ntawm kev tsis haum tshuaj xws li allergic rhinitis thiab mob urticaria. Nws tuav txoj haujlwm tseem ceeb hauv khw muag tshuaj vim nws cov txiaj ntsig kho mob tseem ceeb thiab cov kev mob tshwm sim me me. Kev nkag siab txog kev tsim cov tshuaj loratadine capsules yog qhov tseem ceeb rau kev ua kom cov tshuaj zoo, ua tau raws li kev xav tau ntawm cov tshuaj kho mob, thiab txhawb kev txhim kho kev lag luam kws tshuaj.
Kev npaj ua ntej ntau lawm
Kev xaiv thiab tshuaj xyuas cov khoom siv raw thiab cov khoom siv pabcuam
Main tshuaj loratadine
Cov txheej txheem zoo: Nws yuav tsum ua raws li cov kev cai ntawm Suav Pharmocopoeia lossis cov chaw muag tshuaj thoob ntiaj teb, thiab qhov purity feem ntau yuav tsum siab dua 98.0%. Cov tsos mob yuav tsum yog dawb los yog tawm dawb crystalline hmoov, tsw tsw thiab tasteless.
Cov khoom soj ntsuam: suav nrog cov yam ntxwv, kev txheeb xyuas, cov khoom muaj feem xyuam, kev txiav txim siab cov ntsiab lus, thiab lwm yam. Kev txheeb xyuas tuaj yeem ua tiav los ntawm txoj hauv kev xws li infrared spectroscopy thiab siab - ua kua chromatography; Kev tswj nruj ntawm cov ntsiab lus impurity yuav tsum muaj rau kev tshuaj xyuas cov khoom kom ntseeg tau tias nws tsis pub dhau qhov kev txwv; Kev txiav txim siab tseeb ntawm cov ntsiab lus ntawm loratadine yog qhov yuav tsum tau ua kom ntseeg tau tias nws ua tau raws li qhov xav tau ntawm cov ntawv sau npe.
Cov khoom siv pabcuam
Cov hmoov txhuv nplej siab: feem ntau yog siv los ua cov muab tub lim kom nce ntim thiab qhov hnyav ntawm cov ntsiab lus capsule. Cov hmoov txhuv nplej siab dawb, tsis muaj ntxhiab, thiab impurity tsis muaj hmoov txhuv nplej siab yuav tsum tau xaiv, nrog cov dej noo feem ntau tsis tshaj 12%. Cov khoom soj ntsuam muaj xws li cov yam ntxwv, noo noo, cov ntsiab lus tshauv, thiab lwm yam.
Lactose: Nws kuj yog ib qho khoom siv uas feem ntau siv nrog zoo fluidity thiab compressibility. Nws yuav tsum ua raws li cov qauv zoo uas tau teev tseg hauv cov tshuaj pharmacopoeia, thiab cov khoom kuaj xyuas muaj xws li cov khoom, acidity, sulfate, hnyav hlau, thiab lwm yam.
Magnesium stearate: Raws li lub roj nplua nyeem, nws tuaj yeem tiv thaiv cov khoom los ntawm adhering rau saum npoo ntawm qhov tuag thaum lub ntsiav tshuaj nias txheej txheem, kom ntseeg tau tias du demolding ntawm cov ntsiav tshuaj. Dawb, tsis muaj ntxhiab thiab tsis qab ntsev magnesium stearate yuav tsum tau xaiv, thiab nws cov ntsiab lus yuav tsum ua raws li cov cai. Cov khoom kuaj xyuas muaj xws li cov khoom, cov hlau hnyav, arsenic ntsev, thiab lwm yam.
Kev npaj thiab commissioning ntawm cov cuab yeej thiab cov cuab yeej
Cov khoom siv crushing: xws li universal crusher, siv los tsoo cov ntaub ntawv raw thiab qee cov ntaub ntawv pabcuam ntawm loratadine kom ua tiav qhov loj me me. Ua ntej siv, nws yog ib qho tsim nyog yuav tsum tau kuaj xyuas qhov huv ntawm cov cuab yeej kom paub tseeb tias tsis muaj qhov seem ntawm cov khoom siv yav dhau los; Xyuas seb cov cuab yeej txiav ntawm lub crusher yog ntse thiab ua haujlwm li cas.
Cov cuab yeej tshuaj ntsuam xyuas: Lub vibrating npo yog cov cuab yeej siv tshuaj ntsuam uas siv los tshuaj xyuas cov ntaub ntawv crushed, tshem tawm cov khoom loj los yog qhov tsis zoo, thiab xyuas kom meej qhov loj me ntawm cov ntaub ntawv. Thaum lub sij hawm debugging, nws yog ib qhov tsim nyog los xaiv qhov tsim nyog mesh raws li cov yam ntxwv ntawm cov khoom thiab cov txheej txheem yuav tsum tau, thiab xyuas qhov tseeb thiab nro ntawm lub mesh.
Cov khoom sib xyaw: xws li V- hom khoom sib tov, siv los sib xyaw loratadine thiab ntau yam khoom ntxiv. Ua ntej siv, ntxuav cov khoom siv sab hauv kom ntseeg tau tias tsis muaj impurities; Txheeb xyuas qhov kev ua tau zoo ntawm cov khoom sib tov kom tiv thaiv cov khoom xau; Teem sijhawm sib xyaw kom haum thiab nrawm kom ntseeg tau tias qhov sib xyaw ua haujlwm.
Cov khoom siv granulation: Lub tshuab ntub dej granulation tuaj yeem sib xyaw cov khoom sib xyaw nrog cov nplaum ua kom ntub granules. Thaum debugging, nws yog ib qho tsim nyog los xaiv qhov tsim nyog stirring hniav thiab granulation riam ceev raws li cov khoom ntawm cov khoom, tswj tus nqi ntawm cov dej ntxiv thiab granulation lub sij hawm, thiab xyuas kom meej tias cov khoom ntub dej uas tsim los ntawm cov khoom sib xws ntawm qhov loj thiab me me elastic.
Cov cuab yeej ziab khaub ncaws: Cov cua kub cua kub yog siv los ziab cov khoom ntub. Ua ntej siv, xyuas seb qhov ntsuas kub ntawm qhov cub ua haujlwm zoo li cas los xyuas kom meej tias qhov ntsuas kub kom qhuav; Xyuas seb qhov cua tshuab tsis muaj kev cuam tshuam los xyuas kom meej tias cov cua kub tuaj yeem sib npaug ntawm cov khoom txheej.
Cov khoom siv granulation: Lub viav vias granulator tuaj yeem hloov cov khoom qhuav kom ua rau lawv sib txawv hauv qhov loj. Thaum debugging, nws yog ib qho tsim nyog los xaiv qhov tsim nyog mesh loj, tswj qhov ceev thiab quab yuam ntawm tag nrho cov khoom, thiab tsis txhob particle breakage los yog nplua hmoov ntau lawm.
Capsule filling cov cuab yeej: Lub tshuab puv puv tsis siv neeg capsule filling tuaj yeem ua tiav tag nrho cov granules rau hauv lub plhaub capsule. Ntxuav cov cuab yeej thiab teeb tsa cov pwm pwm tsim nyog ua ntej siv; Debug tus nqi filling thiab filling ceev ntawm cov cuab yeej los xyuas kom meej tias qhov sib txawv ntawm kev ntim tshuaj ntsiav ua tau raws li qhov yuav tsum tau ua.
Cov cuab yeej ntim khoom: xws li txhuas- lub tshuab ntim cov hnab yas, siv rau ntim ntim cov tshuaj ntsiav. Thaum kev debugging, cov ntaub ntawv ntim khoom tsim nyog thiab cov pwm yuav tsum raug xaiv raws li cov lus qhia tshwj xeeb ntawm cov tshuaj ntsiav, thiab qhov kub thiab txias sealing yuav tsum tau hloov kho kom ntseeg tau tias sealing thiab zoo nkauj ntawm lub ntim.
Cov txheej txheem ntau lawm
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Kev kho ua ntej ntawm cov khoom siv raw thiab cov khoom pabcuam
Kev sib tsoo thiab kev tshuaj xyuas ntawm loratadine: Cov khoom siv raw ntawm loratadine yog crushed nyob rau hauv ib tug universal crusher, thiab cov khoom crushed yog soj ntsuam los ntawm ib tug vibrating screen los xaiv cov khoom uas yuav tsum tau particle loj (feem ntau yuav tsum tau dhau los ntawm ib tug 80-100 mesh screen) rau tom qab siv.
Ua cov excipients: Starch, lactose thiab lwm yam excipients kuj yuav tsum tau crushed thiab soj ntsuam kom lawv particle loj zoo ib yam li cov loratadine granules. Magnesium stearate feem ntau tsis tas yuav crushed, tab sis nws yuav tsum tau sieved kom tshem tawm clumps.
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sib tov
Kev sib xyaw qhuav: Sib tov cov sieved loratadine granules nrog cov nqi tsim nyog ntawm cov hmoov txhuv nplej siab, lactose, thiab lwm yam excipients nyob rau hauv ib qho kev faib ua feem rau hauv V- hom tov khoom. Tig lub tov khoom thiab sib tov ntawm qhov tsim nyog ceev rau 15-20 feeb kom ua tiav thawj zaug thiab sib xyaw ntawm cov ntaub ntawv.
Kev sib xyaw ntub dej: Npaj cov nplaum tsim nyog, xws li 10% hmoov txhuv nplej siab slurry. Maj mam ntxiv cov nplaum rau cov khoom sib xyaw qhuav, thaum pib lub tshuab ntub dej granulation rau nplawm thiab granulation. Thaum lub sij hawm pub mis, kev saib xyuas yuav tsum tau them nyiaj rau kev tswj xyuas qhov ceev ceev thiab siv cov nplaum nplaum, yog li cov khoom siv tuaj yeem sib npaug sib npaug thiab tsim cov khoom ntub dej me me. Lub sij hawm ntub dej granulation yog 3-5 feeb.
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Granulation
Tom qab ntub granulation tiav lawm, hloov cov khoom ntub mus rau ib qho cua kub circulating qhov cub kom qhuav. Kev ziab ziab yog feem ntau tswj ntawm 60-70 degree, thiab lub sij hawm ziab yog nyob ntawm cov dej noo ntawm cov khoom ntub thiab kev ua haujlwm ntawm cov khoom ziab, feem ntau 2-3 teev. Tsis tu ncua tig cov khoom thaum lub sij hawm ziab kom paub meej tias txawm tias ziab. Cov dej noo ntawm cov khoom qhuav yuav tsum tau tswj ntawm 3% thiab 5%.
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Tag nrho cov nplej
Qhuav cov khoom thiab siv lub viav vias granulator los puag ncig lawv. Xaiv ib lub sieve haum (feem ntau yog 14-20 mesh) kom tshem tawm cov khoom uas loj dhau los yog me me, ua rau cov khoom me me zoo sib xws. Tag nrho cov khoom yuav tsum xoob thiab tsis muaj pob.
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Tag nrho kev sib xyaw
Ntxiv tag nrho cov granules thiab magnesium stearate mus rau V-hom mixer rau tag nrho cov sib tov, nrog rau lub sij hawm sib tov ntawm 10-15 feeb. Lub hom phiaj ntawm kev sib xyaw yog kom sib npaug faib magnesium stearate rau ntawm qhov chaw ntawm cov khoom, muab lubrication thiab ntxiv kom ntseeg tau tias cov khoom sib xws.
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Capsule filling
Kev xaiv lub plhaub capsule: Xaiv lub plhaub uas tsim nyog raws li cov lus qhia tshwj xeeb thiab kev thauj khoom ntawmLoratadine ntsiav tshuaj. Qhov zoo ntawm lub plhaub capsule yuav tsum ua raws li cov qauv tsim nyog thiab tsis muaj qhov tsis xws luag xws li kev puas tsuaj thiab deformation.
Kev ua haujlwm puv: ntxiv tag nrho cov khoom sib xyaw rau hauv lub hopper ntawm lub tshuab tsis siv neeg capsule filling, kho tus nqi filling thiab filling ceev, thiab pib cov khoom siv tshuaj ntsiav filling. Thaum lub sij hawm sau cov txheej txheem, nws yog ib qho tsim nyog yuav tsum tsis tu ncua xyuas qhov sib txawv ntawm cov tshuaj capsule filling ntim thiab cov tsos zoo kom ua raws li cov kev cai tswj hwm.
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pob
Aluminium yas blister ntim: Muab cov ntim ntim rau hauv cov pwm ntawm lub tshuab ntim yas yas ntim, thiab kaw cov tshuaj ntsiav ntawm aluminium foil thiab yas blister los ntawm cua sov, siab, thiab lwm yam txheej txheem. Thaum lub sij hawm ntim cov txheej txheem, yuav tsum tau them nyiaj mloog mus rau kev tswj lub tshav kub sealing kub thiab siab los xyuas kom meej lub sealing ntawm lub ntim.
Kev ntim khoom sab nraud: Muab cov tshuaj ntsiav ntim rau hauv aluminium- cov hnab yas ntim rau hauv cov thawv ntawv lossis lub raj mis yas, sau cov npe tshuaj, cov lus qhia tshwj xeeb, batch naj npawb, hnub tas sijhawm, thiab lwm yam ntaub ntawv. Lub ntim sab nrauv yuav tsum ruaj khov, zoo nkauj, thiab muaj peev xwm tiv thaiv cov tshuaj los ntawm kev puas tsuaj.
Saib xyuas cov nyhuv ntawmLoratadine Capsulesntawm acetylcholinesterase kev ua si hauv cov qauv nas, thiab qhia meej txog kev hloov pauv hauv acetylcholinesterase kev ua haujlwm hauv cov nas uas tau kho nrog ntau koob tshuaj Loratadine. Los ntawm txoj kev tshawb no, ntawm ib sab, nws tuaj yeem txhawb kev nkag siab ntawm cov tshuaj pharmacological ntawm Loratadine thiab muab cov ntsiab lus qhia ntau dua rau nws qhov kev thov muaj txiaj ntsig hauv kev kho mob; Ntawm qhov tod tes, nws kuj tseem pab qhia txog kev sib cuam tshuam ntawm cov tshuaj thiab acetylcholinesterase system, muab kev siv rau kev tsim cov tshuaj tshiab lossis kev tshawb pom cov hom phiaj tshuaj tshiab.
Cov ntaub ntawv thiab cov txheej txheem
Cov tsiaj sim: Xaiv cov neeg laus noj qab haus huv SD nas nrog qhov hnyav ntawm 200-250g, ib nrab txiv neej thiab ib nrab poj niam. Cov nas yog khaws cia rau hauv ib chav tsiaj tus qauv nrog qhov ntsuas kub ntawm 22-25℃thiab qhov txheeb ze av noo ntawm 40% -60%. Lawv khaws cia rau hauv lub voj voog ntawm 12 teev ntawm lub teeb thiab 12 teev tsaus ntuj, thiab pub dawb rau noj thiab haus. Cia cov nas hloov mus rau ib puag ncig rau ib lub lis piam ua ntej qhov kev sim pib.
Kev sim tshuaj thiab cov tshuaj reagents: Loratadine raw khoom, yuav los ntawm ib tug zoo -cov neeg muag tshuaj paub, tau raug sim rau purity thiab ua tau raws li qhov kev sim. Loratadine tau npaj rau hauv cov kev daws teeb meem ntawm ntau qhov sib txawv siv qhov tsim nyog ntawm physiological saline, uas yog qis - pawg koob tshuaj (5mg / kg), pawg tshuaj nruab nrab (10mg / kg), thiab siab - pawg koob tshuaj (20mg / kg). Acetylcholinesterase thiab butyrylcholinesterase cov khoom siv tshuaj xyuas kev ua haujlwm tau yuav los ntawm lub tuam txhab kev ua haujlwm lom neeg thiab khaws cia thiab siv raws li cov lus qhia.
Cov cuab yeej sim: feem ntau suav nrog cov khoom siv hluav taws xob (siv rau qhov ntsuas qhov hnyav ntawm cov tshuaj thiab nas lub cev hnyav), siab - nrawm khov centrifuge (siv rau kev sib cais cov khoom hauv cov kua qaub thiab cov ntaub so ntswg), spectrophotometer (siv rau ntsuas cholinesterase kev ua), qhov kub thiab txias da dej (muab qhov ntsuas kub tsim nyog), thiab lwm yam.
Kev sim ua pab pawg thiab kev kho mob: SD nas yoog rau ib puag ncig tau muab faib ua plaub pawg, nrog rau 10 nas nyob rau hauv txhua pab pawg: pawg tswj hwm, pab pawg qis- koob Loratadine, nruab nrab koob tshuaj Loratadine pawg, thiab siab - pawg Loratadine. Cov pab pawg tswj hwm tau muab qhov sib npaug ntawm cov kua qaub ntawm lub cev los ntawm gavage, thaum qhov qis, nruab nrab, thiab siab - cov pab pawg nas tau muab qhov sib npaug ntawm Loratadine tov los ntawm gavage ib hnub ib zaug rau 28 hnub sib law liag.
Kev Sau thiab Ua Qauv: Tom qab 28 hnub ntawm kev tswj hwm, tshuaj loog cov nas thiab sau cov ntshav los ntawm kev sau cov ntshav plawv. Muab cov ntshav tso rau hauv lub raj centrifuge, cia nws sawv ntsug rau 30 feeb, centrifuge ntawm 3000r / min rau 10 feeb, cais cov ntshav, thiab muab tso rau hauv -20℃lub tub yees rau yav tom ntej. Nyob rau tib lub sijhawm, tshem tawm cov ntaub so ntswg ntawm cov nas sai sai, yaug nws nrog cov kua qaub ua ntej txias, nqus cov av noo, hnyav ib qho hnyav ntawm daim siab nqaij, ntxiv tus nqi tsim nyog ntawm physiological saline los ua 10% cov ntaub so ntswg homogenate, ces centrifuge ntawm 3000r / min rau 15 feeb ntawm 4 degree.
Kev txiav txim siab txog kev ua acetylcholinesterase: Cov kev ua ub no ntawm acetylcholinesterase thiab butyrylcholinesterase hauv cov ntshav thiab daim siab cov ntaub so ntswg tau ntsuas los ntawm cov txheej txheem muab los ntawm cov khoom siv reagent. Cov kauj ruam ua haujlwm tshwj xeeb yog nruj me ntsis raws li cov lus qhia ntawm cov khoom siv reagent. Tus nqi absorbance yog ntsuas ntawm ib lub wavelength tshwj xeeb uas siv lub spectrophotometer, thiab chav ua haujlwm enzyme yog xam raws li tus qauv nkhaus.
Kev txheeb xyuas kev txheeb xyuas: Siv cov software tshaj lij kev txheeb cais los ua cov ntaub ntawv sim. Cov ntaub ntawv ntau yog qhia raws li qhov txhais tau tias ± tus qauv sib txawv, thiab ib qho - txoj kev ANOVA yog siv rau kev sib piv ntawm ntau pawg. Yog tias muaj qhov sib txawv ntawm qhov sib txawv, LSD txoj kev siv ntxiv rau kev sib piv ua ke; Yog tias qhov sib txawv tsis sib xws, Dunnett's T3 txoj kev siv rau kev sib piv ua ke. Qhov sib txawv yog suav tias yog qhov tseem ceeb nrog P<0.05.
tshwm sim
Cov nyhuv ntawm Loratadine ntawm cov tshuaj acetylcholinesterase hauv cov nas
Compared with the control group, the low-dose Loratadine group showed a slight decrease in serum acetylcholinesterase activity in rats, but the difference was not statistically significant (P>0.05); Kev ua haujlwm ntawm cov ntshav acetylcholinesterase hauv cov koob tshuaj nruab nrab Loratadine tau txo qis, thiab qhov sib txawv yog qhov tseem ceeb (P<0.05); The high-dose Loratadine group showed a more significant decrease in serum acetylcholinesterase activity compared to the control group, with a highly significant difference (P<0.01).
Cov nyhuv ntawm Loratadine ntawm kev ua haujlwm ntawm serum butyrylcholinesterase hauv cov nas
There was no significant change in serum butyrylcholinesterase activity in the low-dose Loratadine group compared to the control group (P>0.05); Kev ua haujlwm ntawm serum butyrylcholinesterase hauv pawg koob tshuaj nruab nrab txo qis, thiab qhov sib txawv yog qhov tseem ceeb (P<0.05); The high-dose group showed a more significant decrease in serum butyrylcholinesterase activity compared to the control group, with a highly significant difference (P<0.01).
Cov txiaj ntsig ntawm Loratadine ntawm Acetylcholinesterase Kev Ua Haujlwm hauv nas Liver
In liver tissue, there was no significant difference in acetylcholinesterase activity between the low-dose Loratadine group and the control group (P>0.05); Kev ua haujlwm ntawm acetylcholinesterase hauv daim siab ntawm pawg tshuaj nruab nrab tau txo qis (P<0.05); The high-dose group showed a greater decrease in liver acetylcholinesterase activity compared to the control group, with a highly significant difference (P<0.01).
Cov nyhuv ntawm Loratadine ntawm kev ua haujlwm ntawm butyrylcholinesterase hauv nas daim siab
Low dose Loratadine had little effect on the activity of butyrylcholinesterase in rat liver, and there was no significant difference compared with the control group (P>0.05); Kev ua haujlwm ntawm daim siab butyrylcholinesterase tau txo qis me ntsis hauv pawg tshuaj nruab nrab (P<0.05); The high-dose group showed a significant decrease in liver butyrylcholinesterase activity, with a highly significant difference compared to the control group (P<0.01).
Cim npe nrov: Loratadine capsules, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom