Shaanxi Bloom Tech Co., Ltd. yog ib qho ntawm cov neeg tsim khoom lag luam thiab cov chaw muag khoom ntawm enalapril malate ntawm Suav teb. Txais tos rau kev lag luam wholesale loj zoo enalapril maleate qhov ncauj daws kev muag ntawm cov muag khoom ntawm no los ntawm peb lub hoobkas. Cov kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Enalapril malate kev dawsyog qhov ncauj npaj uas muaj enalapril malate ua cov khoom siv nquag. Enalapril Malate yog cov txiv neej acid ntsev ua qauv ntawm enalapril, piav qhia txog cov (}}}}} Phenyfpropyl] {{{25} {25} {25} {25} {25} L-Alanyl] - L-proline, (Z) -2-butenioic acid ntsev (1: 1), nrog molecular mis c20h28n2o5 • C4H4O4. Nws yog feem ntau yog cov kua tsis muaj xim thiab pob tshab nrog cov txiv hmab txiv ntoo sib xyaw, uas yooj yim rau cov neeg mob kom lees txais. Txhua 1 Milliliter ntawm kev npaj muaj 1 milligrams ntawm enalapril malate (sib npaug rau 0.764 milligrams ntawm enalapril). Ntxiv nrog rau cov khoom xyaw nquag, nws tseem muaj ntau cov ntaub ntawv citriczoate, xyaws p-hydroxybenzoate, urrife breen entrate, cov khoom siv me me, saj thiab ruaj khov ntawm kev daws. Qhov kev daws teeb meem no feem ntau ntim rau hauv lub raj mis 150ML xim av lub raj mis, nruab nrog 10ml koob txhaj tshuaj thiab lub raj mis tsim kom meej. Qhov kev tsim ntaub ntawv ntim tau ua kom tiav cov photostability ntawm cov tshuaj thiab tswj hwm tus neeg mob siv.
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Enalapril Malate Coa
Evolution ntawm saj cov thev naus laus zis lub cev: los ntawm "Kev Ncaj Ncees Kev Ncaj Ncees" rau "molecular raug kaw"
Enalapril malate kev daws, raws li cov classic angiotensin - kev sib cav ntawm cov neeg mob siab, yog cov neeg laus, yog cov menyuam yaus, cov neeg laus uas muaj kev nyuaj siab. Raws li kev txheeb cais, tshaj 50% ntawm cov neeg mob pediatric uas tsis kam noj cov tshuaj vim tias ua rau kev cuam tshuam rau kev cuam tshuam rau kev cuam tshuam nrog kev cuam tshuam nrog kev tiv thaiv kab mob. Txhawm rau daws cov teeb meem no, saj cov khoom siv tshuab tau hloov zuj zus los ntawm cov qib yooj yim los tswj, thaum kawg ua tiav ib qho leap ntawm "whitewashing" rau "molecular convinement".
Tshuaj ib txwm Kho Lus Txheej Txheem: Kev hloov kho saum npoo ntawm "
Kev thov ua ke ntawm cov khoom qab zib thiab cov neeg sawv cev ntxhiab tsw ntxhiab
Thaum ntxov saj lub ntsej muag siv cov khoom qab zib (xws li sucrose, sacrartics) thiab cov txiv neej ua kom npog ntsej muag los ntawm kev sib xyaw ua ke ntawm cov cim saj. Piv txwv li, ayaned qhov ncauj yog ntxiv nrog sorbitol, sucralose thiab sib xyaw ua ke berry ove-}}} qib saj kev txhawb nqa. Txawm li cas los xij, xws li cov hau kev tau muaj txiaj ntsig zoo rau cov solubility siab thiab cov muaj txiaj ntsig zoo siv yeeb tshuaj. Kev tshawb fawb tau pom tias thaum cov tshuaj ntau tshaj qhov saj ntawm cov qaub ncaug (xws li cov khoom qab zib tseem ceeb ntawm cov qaub ncaug tsis muaj peev xwm 0.1
Cov kev txwv ntawm Ph kev hloov kho thiab salting thev naus laus zis
Nyob rau hauv teb rau pheeb suab ntawm enalapril, cov kws tshawb nrhiav tau sim kom txo cov kev daws teeb meem pH (xws li ntxiv cov citric acid / sodium citrate cov kab ke). Piv txwv li, tswj cov pH nyob rau hauv thaj tsam ntawm 4.0-5.0 tau txo qis cov solubility ntawm enalapril los ntawm kev ua kom txog 30% -40%. Txawm li cas los xij, cov hau kev ntawd yuav tsum muaj kev sib npaug ntawm Bioavailability thiab saj BlaskingShinginal, thaum siab PS tuaj yeem cuam tshuam cov tshuaj ruaj ntseg. Tsis tas li ntawd, txawm hais tias cov txheej txheem ntsev tsim (xws li kev sib sau enalapril saccharin ntsev) tuaj yeem hloov cov tshuaj siv cov tshuaj thiab cuam tshuam rau cov lej.
Cov chaw tsis txaus ntseeg ntawm cov cuab yeej siv technologies
Cov kev txhim kho ib txwm muaj yog qhov tseem ceeb "uas tsis hloov pauv ncaj qha rau kev sib cuag ntawm cov tshuaj molecules thiab saj buds. Nws cov kev txwv tau cuam tshuam hauv:
Dougentence Divenence: Cov tshuaj noj ntau dua (xws li 0.07-0.1mg / kg rau pediatric cov neeg mob) muaj kev sib tsoo los ntawm daim npog ntsej muag ntawm cov khoom qab zib;
Tus neeg sib txawv: saj cov rhiab yog cuam tshuam los ntawm lub hnub nyoog thiab caj ces, nrog menyuam yaus lub ntsiab lus pib rau kev iab siab yog 2-3 zaug qis dua li cov neeg laus;
Kev Nyab Xeeb Kev Nyab Xeeb: Kev siv cov khoom qab zib ntau dhau (xws li ASPARAME) yuav ua rau metabolic cuam tshuam, thaum muaj cov kua qab zib (xws li xylitol) tuaj yeem ua rau mob plab.
Lub Tshuab Hluav Taws Xob Lub Tshuab: Tsim Ib Qhov saj "Firewall"
Microencapsatulation Technology: Kev tawg ntawm kev kuaj kom muaj kev lag luam
Microencapsulation cuam tshuam cov tshuaj encapsulating nyob rau hauv micrometer cov khoom sib txawv los ntawm polymer txheej, ua lub cev thaiv. Cov kev tshawb fawb admts tsuag tsuag qhuav txoj kev, thiab eudragit EPO ® npajEnalapril malate kev dawsMicroparticles raws li txheej khoom siv. Qhov kev sim qhia pom tias:
Cov txheej txheem optimization: nyob rau hauv cov xwm txheej ntawm inlete inlete kub ntawm 65℃tawm los ntawm 101.3% -85.4%, thiab cov khoom siv tshuaj yog 7.75% -24.69%;
Kev saj cov phib phuav physching: cov tshuaj tso tawm hauv cov qaub ncaug muaj tsawg dua 5%, thiab cov neeg muaj kev tiv thaiv tsiaj tau pom zoo nyob rau hauv kev xav tau yooj yim;
Bioavailability: piv nrog cov ntsiav tshuaj ib txwm muaj, CMAX thiab AUC ntawm cov kev tsim tawm muaj biotequivalence ntawm 90% -115%.
Muaj Daim Ntawv Thov Txheej Txheej Tshuab
Txheej thev naus laus zis txuas ntxiv cov duab zaj duab xis txuas rau saum npoo ntawm cov tshuaj hais, thaiv kev sib chwv ntawm cov yeeb tshuaj thiab saj cov buds. Piv txwv li, tom qab txheej sib xyaw ua ke chuanxinlian granules nrog Eudragit E100, tau qhab nia tu siab poob qis ntawm 4.2 cov ntsiab lus) rau 1.8 cov ntsiab lus (tom qab txheej). Txawm li cas los xij, txheej thev naus laus zis thev naus laus zis:
Membrane Kev Ncaj Ncees: Enzymatic Hydrolysis hauv cov qaub ncaug yuav ua rau txheej sib tawg;
Txheej txheem ua nyuaj: Zais txheej txheej yuav tsum tau kho kom haum ntawm qhov ntsuas kub, av noo, thiab txau;
Ntu cov khoom siv: tus eudragit series polymer muaj tus nqi ntau dua, uas nce ntau lawm tus nqi.
Tub ntxhais breakrougroughroughs nyob rau hauv lub cev txoj kev siv tshuab
Lub tshuab kev ua kom lub cev ua tiav ua tiav ntawm kev cais ntawm lub cev ntawm cov tshuaj molecules thiab saj cov pa hluav taws "saj cov pa hluav taws". Nws cov txiaj ntsig dag hauv:
UNIVERSITY: Haum rau dej - soluble thiab tsis zoo soluble tshuaj;
Stability: cov txheej txheej txheej khaws cov qauv txheej txheem kev ntseeg thaum lub sijhawm khaws;
Txoj kev tsis muaj peev xwm: los ntawm kev kho cov yeeb yaj kiab thickness thiab polymer hom, cov tshuaj tso tawm yeeb tuaj yeem raug tswj hwm yog qhov tseeb.
Molecular Theem Odking Masking Technology: los ntawm "Kev cais" mus rau "Kev kaw kev kaw"
Ion pauv Resin: Kho kom meej tswj cov kev sib cuam tshuam them nqi
Ion txauv resin immobilizes tshuaj molecules nyob rau hauv lub resin pores los ntawm electrostatic kev sib cuam tshuam, thaiv lawv tso tawm. Txoj kev tshawb no tau siv amberlite irp-69 resin los ua ib qho kev sib xyaw ua tom qab thauj khoom enalapril. Qhov kev sim qhia pom tias:
Thauj khoom muaj peev xwm: Txhua gram ntawm resin tuaj yeem thauj 120-150mg ntawm enalapril;
Kev saj cov ntsej muag cuav: hauv cov qaub ncaug (pH 6.8), cov kua txiv (pH 1.2), 90% ntawm cov tshuaj tawm tsis pub dhau 30 feeb;
Bioavailability: piv nrog cov ntsiav tshuaj ib txwm muaj, TMAX ntawm Resin composites yog txuas ntxiv los ntawm 1 teev, tab sis tsis muaj qhov sib txawv hauv AUC.
Cyclodextrin xam suav nrog: "molecular tawb" ntawm cov qauv sib xws
CyclodExtrin encapsulates tshuaj molecules los ntawm hydrophobic kab noj hniav los tsim supramolecular complexes. Txoj kev tshawb no siv - cyclodextrin rau encapsulate enalapril, sib sau ib 1: 1 inclions complex. Qhov kev sim qhia pom tias:
Encaxulation kev ua tau zoo: the encapsulation clim
Saj cov phib phuav physching: thaum cov tshuaj tso tawm hauv cov qaub ncaug tsawg dua 5%, qhov iab iab kev pom zoo ntawm 4 zaug;
Kev ruaj khov: qhov degradation ntawm kev suav nrog ua ntu zus yog tsawg dua 5% nyob rau hauv 6 lub hlis nyob rau hauv kev ntsuas kom nrawm dua ntawm 40 degree.
Siv thev naus laus zis: chrify hloov kho "iab kev zom"
Kev hloov kho tshuab cov qauv molecular los ntawm kev hloov kho tshuaj lom neeg, txo lawv txoj kev muaj peev xwm saj cov cooks. Kev tshawb fawb tsim ntawm enalapril probug (xws li enalapril valerate ester) qhia tias:
Kev saj tsis tau zoo: Qhov qhab nees ntsim ntawm Prodram tau txo qis los ntawm 4.5 ntsiab lus ntawm cov tshuaj qub rau 1.2 cov ntsiab lus;
BioterSformation: Raws li kev nqis tes ua ntawm esterase hauv lub cev, cov Prodrug hloov dua siab tshiab los ua rau enalapril li 30 feeb;
Pharmacodynamics: There was no significant difference in the antihypertensive effect between the prodrug and the original drug (p>0.05).
Cov ntsiab lus zoo ntawm cov theem molecular thev naus laus zis
Molecular theem lub tshuab ua tiav tau ua tiav kev ua tiav ntawm "Kev cais tawm" rau kev tswj hwm "los tswj hwm tus cwj pwm ntawm cov tshuaj molecules. Nws cov txiaj ntsig dag hauv:
Precision: Kho kom tswj cov tshuaj tso tawm los ntawm kev sib txuam xws li electrostatic, hydrophobic, thiab kev sib haum cua;
Cov nyhuv ntev ntev: lub ntsej muag ua kom cov nyhuv tsis cuam tshuam los ntawm cov qaub ncaug tso tawm;
Biocompatibility: txhua cov ntaub ntawv siv (xws li Cyclodextrin thiab ion sib pauv resin) tau dhau FDA ntawv pov thawj thiab muaj kev nyab xeeb FDA thiab muaj kev nyab xeeb.
Kev kuaj mob tus nqi ntawm kev siv thev naus laus zis: los ntawm "Kev Kho Mob Ua Raws" rau "Kev Tswj Xyuas Kev Noj Qab Haus Huv"
Kev tawm tsam kev sib tw hauv kev siv tshuaj rau pediatric
Kev pom zoo ntawm kev hloov kho lub qhov ncauj yog qhov tseem ceeb theem tshiab hauv kev kho mob ntawm cov kev kub siab. Cov kev tshawb fawb soj ntsuam tau pom tias:
Kev Ua Raws Txoj Kev Raug Cai: Qhov cuam tshuam ntawm kev kho mob rau cov neeg mob uas siv cov kev daws teeb meem ntawm 32% rau 8%;
Ntshav siab tswj: Tom qab 12 lub lis piam ntawm kev kho mob, systolic ntshav siab poob qis los ntawm 12-15mmHG, thiab kev ua raws li 25%;
Safety: There was no significant difference in the incidence of adverse reactions between tablets and tablets (p>0.05).
Kev noj tshuaj kom ua tau zoo rau cov neeg mob laus
Cov neeg laus muaj cov neeg mob sib nkag siab zoo dua rau saj ntawm cov tshuaj vim muaj teeb meem nqos thiab saj tsis tau. Kev tshawb fawb qhia tau tias:
Nqos yooj yim: txoj kev vam meej ntawm kev nqos cov kev daws qhov ncauj yog 40% siab tshaj cov ntsiav tshuaj;
Saj lees txais: 85% ntawm cov neeg mob laus xav txog qhov saj ntawm kev daws teeb meem yog "lees txais" lossis "zoo";
Kev sib cuam tshuam yeeb tshuaj: Thaum txoj kev daws teeb meem yog noj nrog zaub mov, cma, tab sis AUC tsis pom tias lub sijhawm tswj hwm tau hloov kho tau.
Cov txiaj ntsig ntev ntawm cov txiaj ntsig ntawm cov kab mob kis
Kev nce qib ntawm saj cov khaub noom masking technology tsis tsuas yog txhim kho ib qho tshuaj adherence, tab sis kuj txhawb nqa ntev {{ruam kev tswj hwm ntawm cov kab mob ntev. Piv txwv li:
Cov neeg mob plawv tsis ua hauj lwm: Cov tshuaj tov ntsej muag tau txo cov tshuaj noj txhua hnub los ntawm 2 zaug rau 1 xyoos txo qis hauv tsev kho mob;
Asymptomatic sab laug ventricular kawg cov neeg mob: ua raws cai thaum ntxov tau nce ntxiv ntawm 45% mus rau 72%, thiab kev pheej hmoo ntawm cov xwm txheej plawv poob qis ntawm 30%.
Kev xam pom yav tom ntej: los ntawm "ib Technology" rau "cov tshuab txawj ntse"
- Tus Kheej Kev Customization ntawm 3D Printing Tshuab
3D luam ntawv tshuab tuaj yeem ua tiav tus kheej customization ntawm cov ntaub ntawv tshuaj noj, koob tshuaj, thiab tso curves. Piv txwv li, los ntawm luam ntawv txheej txheem ntawm cov qauv, txheej txheej sab nraud yog cov khoom qab zib thiab txheej txheej sab hauv), thiab cov tso tawm txheej txheej ntawm ".
- Kev xa cov khoom ntawm Nanotechnology
Nanocarriet, xws li Liposomes thiab Polymer nanoparticles, tuaj yeem encapsulate cov tshuaj molecules thiab ua tiav cov phiaj xwm kev xa tawm los ntawm kev tshaj tawm mucosal. Kev tshawb fawb tau pom tias lub sijhawm khaws cia ntawmEnalapril malate kev dawsNanoparticles hauv qhov ncauj mucosa yog peb zaug ntev dua thiab iab kev pom yog txo los ntawm 80%.
- Saj twv ua ntej siv dag ntxias
Cov kev twv ua ntej ua qauv raws li tshuab kev kawm tuaj yeem tshuaj xyuas qhov zoo tshaj plaws saj daim npog ntsej muag. Piv txwv li, los ntawm kev txheeb xyuas cov qauv molecular, cov khoom ntawm kev siv tshuaj, kwv yees kev tshawb fawb, kwv yees thiab kev txhim kho lub voj voog tuaj yeem ua kom luv ntawm 18 lub hlis mus rau 6 lub hlis.
Cim npe nrov: Enalapril Malate ntawm qhov ncauj daws, cov chaw muag khoom, chaw tsim khoom, Hoobkas, lag luam wholesale, yuav, nqe, loj, loj, rau muag