Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm metformin hydrochloride ntsiav tshuaj hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo siab metformin hydrochloride ntsiav tshuaj muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Metformin Hydrochloride ntsiav tshuaj(Metformin Hydrochloride Tablets), tseem hu ua Metformin, Medecan, Gehuazhi, thiab lwm yam, yog cov tshuaj hypoglycemic ntawm qhov ncauj, koom nrog biguanides. Nws yog thawj zaug - tshuaj kho kab mob rau hom 2 mob ntshav qab zib tau pom zoo los ntawm FDA. Nws yog hom 2 mob ntshav qab zib hom 2 nrog kev tswj kev noj zaub mov tsis zoo, tshwj xeeb tshaj yog rau cov neeg mob rog. Nws tuaj yeem siv ib leeg lossis ua ke nrog lwm cov tshuaj hypoglycemic xws li sulfonylureas thiab insulin. Nws tuaj yeem maj mam nce mus rau qhov siab tshaj plaws txhua hnub ntawm 2 grams (8 ntsiav tshuaj) raws li kev tswj hwm cov ntshav qabzib, thiab kev txhawb nqa - cov ntsiav tshuaj tso tawm tuaj yeem txo qis kev ua pa ntawm plab hnyuv thiab ua kom cov ntshav ua kom muaj zog.
Peb cov khoom
Metformin Hydrochloride Hmoov
Metformin Hydrochloride ntsiav tshuaj
Cov ntaub ntawv ntxiv ntawm chemical compound:
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Metformin Hydrochloride COA
Lub ntsiab technology ntawm Metformin Hydrochloride Pill: hydrophilic gel moj khaum system
Metformin Hydrochloride ntsiav tshuajyog thawj - kab tshuaj rau kev kho mob ntshav qab zib hom 2. Nws txoj kev npaj muaj kev txwv xws li ntau yam kev tswj hwm txhua hnub, qhov tshwm sim ntawm kev mob plab hnyuv loj (txog 30%), thiab lwm yam. Cov kab mob hydrophilic gel skeleton tswj cov tshuaj tso tawm los ntawm kev thaiv lub cev, ua tiav 1-2 koob tshuaj ib hnub thiab txhim kho kev ua raws li tus neeg mob. Cov thev naus laus zis no nyob ntau dua 65% ntawm lub ntiaj teb kev lag luam sib koom rau cov tshuaj metformin sustained-tso formulations thiab tau dhau los ua cov thev naus laus zis thev naus laus zis.
Technical keeb kwm thiab yam ntxwv tshuaj
Pharmacological cov teebmeem thiab kev kho mob ntawm Metformin Hydrochloride
Metformin Hydrochloride ntsiav tshuaj(metformin hydrochloride), raws li tus neeg sawv cev ntawm qhov ncauj hypoglycemic cov neeg ua haujlwm ntawm biguanides, tau dhau los ua thawj - kab tshuaj rau kev kho mob ntshav qab zib hom 2 (T2DM) thoob ntiaj teb txij li thawj zaug siv tshuaj hauv xyoo 1957. Nws cov txheej txheem tseem ceeb ntawm kev ua haujlwm suav nrog:
Inhibition ntawm hepatic qabzib ntau lawm
Los ntawm inhibiting mitochondrial respiratory chain complex I, txo cov hepatic gluconeogenesis thiab glycogen tawg, thiab txo qis cov ntshav qabzib basal.
Txhim khu kev siv peripheral
nce kev noj thiab siv cov piam thaj los ntawm cov leeg nqaij, rog thiab lwm cov ntaub so ntswg, thiab txhim kho cov tshuaj insulin.
Ua kom lub plab hnyuv nqus
Inhibiting nqus cov piam thaj los ntawm cov kab mob hauv plab hnyuv thiab txo cov ntshav qabzib hloov pauv tom qab.
Cov kev tshawb fawb soj ntsuam tau pom tias Metformin tuaj yeem txo glycated hemoglobin (HbA1c) los ntawm 1% -2% yam tsis muaj qhov hnyav, thiab tseem tuaj yeem txo qhov hnyav thaum txo qis kev pheej hmoo ntawm cov kab mob plawv. Nws txoj kev nyab xeeb yog superior rau lwm cov tshuaj biguanide (xws li phenformin), thiab qhov tshwm sim ntawm lactic acidosis yog txo qis.
Cov kev txwv ntawm kev npaj zoo tib yam
Cov ntsiav tshuaj Metformin tau muaj cov teeb meem hauv qab no:
Luv ib nrab-lub neej
Lub plasma ib nrab -lub neej yog li 4-6 teev, xav tau 2-3 koob tshuaj ib hnub, thiab ua raws li tus neeg mob tsis zoo.
Gastrointestinal tshuaj
Thaum noj ntawm lub plab khoob, cov tshuaj tau tso tawm sai sai hauv plab, uas tuaj yeem ua rau muaj kev phiv xws li xeev siab, ntuav, thiab raws plab, nrog rau qhov tshwm sim txog li 20% -30%.
Kev hloov pauv hauv cov ntshav tshuaj concentration
Ntau qhov kev tswj hwm tuaj yeem ua rau muaj kev hloov pauv ntawm cov tshuaj ntshav siab siab thiab cov kwj deg, uas tuaj yeem ua rau muaj kev pheej hmoo ntawm hypoglycemia (txawm hais tias Metformin muaj kev pheej hmoo ntawm hypoglycemia thaum siv ib leeg, yuav tsum ceev faj thaum siv nrog lwm cov tshuaj).
Txhawm rau daws cov teeb meem saum toj no, kev txhawb nqa -tso tawm thev naus laus zis tau tshwm sim thaum lub sijhawm keeb kwm. Hydrophilic gel moj khaum system tau dhau los ua cov thev naus laus zis tseem ceeb ntawm Metformin txhawb nqa - tso cov ntsiav tshuaj vim nws txoj kev npaj yooj yim, tus nqi qis, kev tso tshuaj ruaj khov thiab lwm yam zoo.
Technical txoj cai ntawm hydrophilic gel moj khaum system
Lub hauv paus tseem ceeb ntawm cov txheej txheem hydrophilic gel yog hydrophilic polymer, uas hydrates tom qab ntsib dej los tsim ib txheej gel tuab, thiab tswj cov tshuaj tso tawm los ntawm diffusion thiab dissolution mechanisms. Cov khoom siv pob txha pob txha muaj xws li:
Hydroxypropyl methylcellulose (HPMC): Cov khoom siv feem ntau, nws qib viscosity (xws li K4M, K15M, K100M) cuam tshuam rau cov tshuaj tso tawm. HPMC nrog viscosity siab ua ib txheej denser gel thiab tso tshuaj maj mam.
Polyethylene oxide (PEO): nrog rau qhov hnyav molecular ntau yam (100000 txog 7 lab), siab molecular hnyav PEO yog tsim rau ntev - ua qauv.
Sodium alginate: ntuj polysaccharide, nrog zoo biocompatibility, feem ntau hla -txuas nrog calcium ions los txhim kho lub zog ntawm gel.
Carbomer: ntoo khaub lig- txuas acrylic polymer, uas tsim cov viscosity gel tom qab nqus dej, haum rau qis - tshuaj noj.
Tshuaj tso tawm mechanism
Cov tshuaj tso tawm cov txheej txheem ntawm cov ntsiav tshuaj hydrophilic gel matrix tuaj yeem muab faib ua peb theem: Dej theem: tom qab cov ntsiav tshuaj sib cuag nrog cov kua dej hauv plab, cov khoom siv pob txha pob txha absorbs dej los ua ib txheej gel.
Diffusion theem: cov tshuaj diffuses los ntawm cov gel txheej mus rau sab nraud nruab nrab, thiab cov tshuaj tso tawm tus nqi nyob ntawm lub thickness ntawm cov gel txheej thiab diffusion coefficient ntawm cov tshuaj nyob rau hauv lub gel.Dissolution theem: nrog rau tas mus li hydration ntawm lub gel txheej, cov khoom siv pob txha maj mam dissolves, thiab cov tshuaj yog diffused thiab tso tawm los ntawm lub pores. Qhov kev sib cais yog cuam tshuam los ntawm cov khoom siv, pH tus nqi, thiab enzymes.
Cov tshuaj tso tawm tus nqi cuam tshuam los ntawm cov hauv qab no:
Cov khoom ntawm cov pob txha pob txha muaj xws li viscosity, molecular yuag, thiab qib ntawm kev hloov pauv (xws li qhov piv ntawm hydroxypropyl thiab methoxy pawg hauv HPMC). Cov khoom siv tshuaj: solubility, particle loj, cuam tshuam nrog cov khoom siv pob txha. Cov khoom siv tshuaj kho mob: ntau npaum li cas ntawm cov khoom siv pob txha, hom excipients (xws li pore forming agents).
Cov txheej txheem txheej txheem: granulation txoj kev, ntsiav tshuaj siab, ntsiav tshuaj hardness.
Dual tswj qauv rau cov tshuaj tso tawm mechanism
Diffusion tswj theem (0-4h): cov tshuaj diffuses los ntawm qhov pores ntawm gel txheej, uas ua raws li Higuchi kab zauv: Q=√ (D ε/τ) √ (2A - ε) √ (t)
Cov yam ntxwv tsis zoo: diffusion coefficient D=1.2 × 10 ⁻⁶ cm ²/s, porosity ε=0.35
Kev tswj cov txheej txheem tawg (4-12h): Qhov kev sib cais ntawm cov pob txha pob txha yog cuam tshuam nrog kev degradation ntawm polymer, tom qab xoom kev txiav txim kinetics, nrog tus nqi tawg tas li k=0.08 mg / cm ² · h (hauv pH 6.8 tsis tov)
Dual theem tig taw tes tswj: Los ntawm kev kho qhov sib piv ntawm HPMC rau pore forming agents (xws li lactose) (feem ntau 3: 1-5: 1), kev hloov pauv ntawm kev sib kis mus rau kev sib cais yog tiav.
Cov thev naus laus zis tseem ceeb ntawm Metformin Hydrochloride hydrophilic gel matrix sustained - tso cov ntsiav tshuaj
Tshuaj kho kom zoo zoo
Skeleton cov ntaub ntawv xaiv matrix
| Cov khoom siv tshuaj | Cov ntaub ntawv pom zoo | Cov yam ntxwv ntawm cov tshuaj tso tawm nkhaus |
| High solubility (>100 mg/ml) | HPMC K100M + Carbopol | Nruam tso tawm rau 12 teev, ncov rau hav piv<2 |
| Medium solubility (10-100mg / ml) | HPMC K4M + polyvinylpyrrolidone | 8-teev tso tawm tau zoo, tawg tso tawm nyhuv<15% |
| Tsawg solubility (<10mg/mL) | Sodium alginate + calcium carbonate | Yuav tsum tau siv cov surfactants (xws li SLS 2%) |
Functional auxiliary material ratio
Gel enhancer
Thaum CMC Na cov ntsiab lus yog 5%, lub zog gel nce 60%
Floating agent
Thaum qhov piv ntawm HPMC K4M rau acrylic resin IV yog 2: 1, lub sijhawm khaws cia ntab mus txog 8h
Lubricant
Yog hais tias tus nqi ntawm magnesium stearate ntau tshaj 0.8%, gel txheej yuav tawg
txheej txheem npaj
(1) Kev ntub dej granulation thiab compression txoj kev
Qhov no yog txoj kev npaj siv feem ntau, nrog rau cov kauj ruam hauv qab no:
Kev sib xyaw: Sib tov thiab sib xyaw Metformin, cov khoom siv pob txha, pore ua tus neeg sawv cev, thiab lwm yam.
Granulation: Ntxiv tus neeg sawv cev ntub dej (xws li 60% -95% ethanol) ua cov khoom muag, sieve thiab granulate.
Qhuav: Cov khoom ntub dej qhuav ntawm 40-60℃kom txog thaum cov ntsiab lus noo noo tsawg dua lossis sib npaug li 3%.
Tag nrho granule: Qhuav granules yog sieved thiab tov nrog lubricant.
Cov ntsiav tshuaj nias: Tswj lub hardness ntawm cov ntsiav tshuaj (feem ntau 50-100 N) kom ntseeg tau tias cov tshuaj tso tawm stability.
(2) Direct compression txoj kev
Haum rau cov tshuaj los yog excipients uas rhiab heev rau dampness thiab kub thiab muaj fluidity zoo. Xaiv cov khoom siv pob txha uas tuaj yeem ncaj qha mus rau hauv cov ntsiav tshuaj (xws li cov hmoov txhuv nplej siab ua ntej gelatinized, microcrystalline cellulose) thiab tswj cov khoom me me.
(3) Txheej txheem parameter tswj
Granulation endpoint: Qhov loj me me ntawm cov khoom ntub dej cuam tshuam rau qhov zoo ntawm cov ntsiav tshuaj compression thiab cov tshuaj tso tawm tus nqi. Coarse granules tuaj yeem ua rau qeeb qeeb ntawm cov ntsiav tshuaj, thaum cov granules zoo tuaj yeem tsim cov hmoov zoo, cuam tshuam rau cov ntsiab lus sib xws.
Kev ziab kom qhuav thiab lub sijhawm: qhov kub thiab txias los ntev ntev tuaj yeem ua rau cov khoom siv pob txha degradation los yog cov tshuaj decomposition, thiab ziab yuav tsum tau kho kom zoo.
Ntsiav tshuaj nias: siab dhau heev lawm yuav ua rau densification ntawm gel txheej thiab maj mam tso tshuaj; Yog tias lub siab qis dhau lawm, lub hardness ntawm cov ntsiav tshuaj yuav tsis txaus thiab nws yuav yooj yim tawg.
Kev Tswj Xyuas Zoo thiab Kev Ntsuam Xyuas
Dissolution yog qhov taw qhia tseem ceeb rau kev ntsuam xyuas qhov zoo ntawm kev txhawb nqa - tso cov ntsiav tshuaj. Feem ntau, txoj kev paddle lossis pob tawb yog siv, nrog 0.1 mol / L hydrochloric acid tov los yog phosphate buffer tov (pH 6.8) raws li qhov nruab nrab, thiab kev sib hloov ceev yog 50-100 rpm. Lub dissolution nkhaus yuav tsum ua raws li cov hauv qab no:
1-teev tso tawm koob tshuaj: Tsawg dua lossis sib npaug li 30% (kom tsis txhob muaj qhov tshwm sim tam sim ntawd).
4-8 teev tso tawm koob tshuaj: 50% -80% (nruam tso tawm).
12-24 teev tso tawm koob tshuaj: Ntau dua lossis sib npaug li 80% (ua tiav tso tawm).
Txheeb xyuas qhov kev txhawb nqa - tso tawm cov txiaj ntsig los ntawm kev sib piv cov tshuaj ntshav siab lub sij hawm curves ntawm sustained - tso cov ntsiav tshuaj thiab cov ntsiav tshuaj tsis tu ncua. Qhov zoo tshaj plaws, kev txhawb nqa - cov ntsiav tshuaj tso tawm yuav tsum muaj qis Cmax (peak concentration), siab dua Tmax (lub sijhawm ncov), thiab smoother AUC (chaw nyob hauv qab nkhaus).
Kev ntsuas nrawm (40℃, 75% RH) thiab ntev - lub sij hawm sim (25℃, 60% RH) tau pom tias cov ntsiav tshuaj hydrophilic gel matrix tuaj yeem hloov pauv cov tshuaj tso tawm vim kev laus ntawm cov ntaub ntawv matrix thaum lub sijhawm khaws cia. Yog li ntawd, nws yog ib qho tsim nyog los xaiv cov khoom siv pob txha ruaj khov thiab ua kom zoo rau cov tshuaj.
Cov lus nug nquag
Dab tsi yog qhov txawv ntawm metformin thiab metformin hydrochloride?
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Metformin vs Metformin Hydrochloride: Zoo sib xws & Qhov sib txawv
Ntau tus neeg xav paub txog qhov sib txawv ntawm metformin vs metformin hydrochloride, thiab nws yog qhov tsis meej pem, tab sis cov lus teb yog tias metformin, metformin hydrochloride, thiab metformin HCl yog cov tshuaj tib yam. Hydrochloride yog ntsev daim ntawv ntawm metformin thiab ntawm ntau lwm yam tshuaj hauv khw.
Metformin SR 500 mg siv rau dab tsi?
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Metformin SR 500 Tablet yog siv los kho mob ntshav qab zib hom 2. Nws muaj Metformin, uas ua haujlwm los ntawm kev txo qis cov piam thaj nqus los ntawm cov zaub mov thiab cov piam thaj uas ua los ntawm lub siab. Nws kuj tseem ua rau lub cev cov lus teb rau insulin, ib yam khoom ntuj uas tswj cov piam thaj hauv cov ntshav.
Leej twg yuav tsum tsis txhob noj metformin hydrochloride?
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puas tau muaj kev fab tshuaj rau metformin lossis lwm yam tshuaj. muaj ntshav qab zib mellitus. muaj kab mob siab lossis raum. muaj mob hnyav.
Cim npe nrov: Metformin hydrochloride ntsiav tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom