Cov khoom
Tadalafil ntsiav tshuaj 100 mg
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Tadalafil ntsiav tshuaj 100 mg

Tadalafil ntsiav tshuaj 100 mg

1. General Specification (hauv Tshuag)
(1) API (Ntshiab hmoov)
PE / Al foil hnab / ntawv lub thawv rau Pure hmoov
HPLC Ntau dua lossis sib npaug rau 99.0%
(2) Tablet
Customizable
(3) Ua kua dej
Customizable
(4) Ointment
(5) Cov
2.Customization:
Peb yuav sib tham tus kheej, OEM / ODM, Tsis muaj hom, rau kev tshawb nrhiav kev ruaj ntseg nkaus xwb.
Khoom siv: BM-2-093
Tadalafil CAS 171596-29-5
Kev tshuaj xyuas: HPLC, LC-MS, HNMR
Kev them nyiaj yug Technology: R&D Dept.-4

 

Tadalafil ntsiav tshuaj 100 mg(Tadalafil ntsiav tshuaj) yog ib qho tshuaj siv los kho txiv neej erectile kawg (ED). Nws inhibits PDE5 enzyme, txo cov degradation ntawm cyclic guanosine monophosphate (cGMP), txhim kho nitric oxide (NO) - kho mob vascular du nqaij so, ua rau cov penile corpus cavernosum ntshav txaus, thiab pab cov txiv neej tswj erections raws li kev sib deev stimulation. Nws yuav tsum tau ua haujlwm nyob rau hauv kev sib deev stimulation, thiab cov tshuaj tsis ua hauj lwm yam tsis muaj kev sib deev stimulation. Txawm li cas los xij, nws yog contraindicated rau cov neeg mob noj cov tshuaj nitrate ester (xws li nitroglycerin) raws li lawv yuav ua rau tuag taus hypotension, nrog rau cov tsis haum rau tadalafil los yog excipients, thiab rau cov neeg mob uas muaj caj ces galactose intolerance, lactase deficiency, los yog qabzib galactose malabsorption.

Peb cov khoom
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 Produnct Introduction

Cov ntaub ntawv ntxiv ntawm chemical compound:

Tadalafil | Shaanxi BLOOM Tech Co., Ltd

 

Tadalafil Tablet 100mg | Shaanxi BLOOM Tech Co., Ltd

Tadalafil Tablet 100mg | Shaanxi BLOOM Tech Co., Ltd

Tadalafil COA

Tadalafil COA | Shaanxi BLOOM Tech Co., Ltd

Manufacturing Information

Tadalafil ntsiav tshuaj 100 mgyog qhov ncauj phosphodiesterase hom 5 (PDE5) inhibitor nrog cov qauv molecular C ₂₂ H ₁₉ N ∝ O ₄ thiab molecular hnyav ntawm 389.41. Nws lub npe tshuaj yog (6R, 12aR) -6- (1,3-benzodioxolan-5-yl) -2-methyl-2,3,6,7,12,12-hexahydropyrazino [1 ', 2': 1,6] pyrido [3,4-b] indole-1,4-dione. Raws li PDE5 inhibitor, Tadalafil txhim kho lub vascular du nqaij so cov nyhuv kho los ntawm nitric oxide (NO) los ntawm inhibiting PDE5 enzyme kev ua thiab txo cov degradation ntawm cyclic guanosine monophosphate (cGMP). Nyob rau hauv lub corpus cavernosum ntawm noov, qhov no mechanism yuav ua rau kom ntshav txaus thiab pab cov txiv neej tswj erection nyob rau hauv kev sib deev stimulation; Nyob rau hauv cov hlab ntsha pulmonary, nws tuaj yeem txo cov hlab ntsws tsis zoo thiab txhim kho kev tawm dag zog ntawm cov neeg mob pulmonary arterial hypertension (PAH).

Kev tsim keeb kwm yav dhau thiab kev tsis sib haum xeeb ntawm 100mg daim ntawv ntau npaum

Cov tshuaj ntau npaum li cas

Cov tshuaj kho cov pa ntawm Tadalafil yog 2.5mg, 5mg, 10mg, thiab 20mg, nrog 20mg yog qhov siab tshaj plaws pom zoo koob tshuaj rau kev kho erectile kawg (ED). Daim ntawv 100mg ntau npaum li cas tsis yog tus qauv tshwj xeeb thiab nws qhov muaj nyob yuav yog vim muaj keeb kwm hauv qab no:

Cov kev xav tau kev tshawb fawb tshwj xeeb: Qee qhov kev sim tshuaj yuav tshawb xyuas cov tshuaj pharmacokinetics lossis kev ua tau zoo ntawm - koob tshuaj Tadalafil, tab sis cov kev tshawb fawb no yuav tsum ua raws li cov qauv kev coj ncaj ncees thiab ua raws li kev saib xyuas ntawm cov koom haum tshaj lij.
Cov khoom lag luam tsis raug cai: Tej zaum yuav tsis pom zoo 100mg cov ntaub ntawv ntau npaum li cas ntawm kev ua lag luam, thiab lawv cov txheej txheem tsim khoom yuav tsis muaj kev tswj hwm zoo, ua rau muaj kev pheej hmoo xws li kev noj tshuaj tsis raug thiab ntau dhau impurities.

Kev pheej hmoo ntawm kev noj ntau dhau

Cov teeb meem kev nyab xeeb: Cov tshuaj ib txwm siv ntawm Tadalafil yog txaus kom ua tau raws li cov kev xav tau ntawm cov neeg mob ED feem ntau, thiab ib koob tshuaj 100mg tuaj yeem ua rau muaj qhov tshwm sim tsis zoo, nrog rau cov kev mob tshwm sim xws li mob taub hau, lub ntsej muag yaug, plab zom mov, mob nqaij, nrog rau cov kev mob tshwm sim loj xws li kev pom kev txawv txav, hnov ​​qhov tsis hnov ​​tsw ntau dua li ntawm 4 lub lis piam, thiab teev).

Kev pheej hmoo ntawm kev siv yeeb tshuaj: koob tshuaj Tadalafil ua ke nrog cov tshuaj nitrate ester (xws li nitroglycerin) tuaj yeem ua rau tuag taus; Kev siv ua ke nrog CYP3A4 inhibitors (xws li ketoconazole) tuaj yeem ua rau cov ntshav ntau ntxiv thiab ua rau muaj kev phom sij ntau ntxiv.

Cov ntsiab lus tseem ceeb ntawm kev tsim khoom thiab kev tswj kom zoo

Txawm hais tias daim ntawv 100mg ntau npaum li cas tsis yog tus qauv tshwj xeeb, nws cov txheej txheem tsim khoom tseem yuav tsum ua raws li Kev Ua Haujlwm Zoo (GMP). Cov hauv qab no yog cov txheej txheem tsim khoom thiab cov ntsiab lus tswj kom zoo rau cov tshuaj Tadalafil cov pa:

Tadalafil Tablet 100mg use | Shaanxi BLOOM Tech Co., Ltd

Cov khoom siv raw

Crushing thiab tshuaj ntsuam: Sib tsoo cov khoom siv Tadalafil rau qhov loj me me, thiab xyuas kom meej qhov sib txawv me me faib los ntawm kev tshuaj ntsuam los txhim kho kev sib xyaw ua ke.
Kev ziab thiab kom tsis muaj menyuam: Qhuav cov ntaub ntawv raw kom tshem tawm cov dej noo thiab tiv thaiv clumping; Yog tias tsim nyog, kev kho kom tsis muaj menyuam yuav tsum tau ua kom ntseeg tau tias qhov kev txwv microbial ua tau raws li qhov yuav tsum tau ua.

Kev npaj cov formulations

ntub granulation: Sib tov Tadalafil nrog excipients (xws li microcrystalline cellulose, lactose, cross- txuas polyvinylpyrrolidone, thiab lwm yam), ntxiv cov nplaum (xws li polyvinylpyrrolidone K30 tov) rau granulation, thiab txhim kho particle flowability thiab compressibility los ntawm ntub granulation.
Qhuav thiab granulation: Qhuav cov khoom ntub dej kom tsim nyog cov ntsiab lus noo noo, tsoo cov khoom loj los ntawm granulator kom ntseeg tau tias qhov loj me me.
Ntsiav tshuaj: Sib tov cov khoom qhuav nrog cov roj nplua nyeem (xws li magnesium stearate) thiab nias rau hauv cov ntsiav tshuaj. Thaum lub sij hawm compression txheej txheem, nws yog ib qho tsim nyog los tswj cov ntsuas xws li cov ntsiav tshuaj qhov hnyav sib txawv, hardness, thiab brittleness.

Tadalafil Tablet 100mg use | Shaanxi BLOOM Tech Co., Ltd
Tadalafil Tablet 100mg use | Shaanxi BLOOM Tech Co., Ltd

Txheej txheej txheej

Zaj duab xis txheej: Dej soluble zaj duab xis txheej cov ntaub ntawv (xws li hydroxypropyl methylcellulose) yog siv los pleev xim rau cov ntsiav tshuaj, txhim kho lawv cov tsos, daim npog qhov ncauj tsis kaj siab, thiab tswj cov tshuaj tso tawm tus nqi.
Txheej txheej txheem tswj: Thaum lub sij hawm txheej txheej txheej, nws yog ib qho tsim nyog los tswj qhov tsis xws li tshuaj tsuag ceev, cua kub inlet, thiab tso cua kub los xyuas kom meej txheej uniformity.

kev tswj kom zoo

Kev txiav txim siab txog cov ntsiab lus: Kev ua haujlwm siab ua kua chromatography (HPLC) yog siv los txiav txim siab cov ntsiab lus ntawm Tadalafil hauv cov ntsiav tshuaj, kom ntseeg tau tias cov ntsiab lus ua tau raws li qhov yuav tsum tau muaj ntawm cov ntawv sau npe.
Kev Ntsuas Kev Soj Ntsuam: Simulate qhov chaw nyob hauv vivo, ntsuas qhov kev sib cais ntawm cov ntsiav tshuaj hauv ib qho nruab nrab, thiab xyuas kom meej tias cov tshuaj tso tawm tus cwj pwm ua tau raws li qhov yuav tsum tau ua.
Microbial limit test: Ua cov tshuaj txwv microbial ntawm cov ntsiav tshuaj kom paub meej tias tsis muaj menyuam lossis cov ntsiab lus microbiological raws li cov qauv tshuaj pharmacopoeia.
Txoj kev tshawb fawb txog kev ruaj ntseg: Los ntawm kev ua qhov ntev - kev ntsuam xyuas kev ruaj ntseg thiab kev ntsuas kev ruaj ntseg nrawm, kev hloov pauv zoo ntawm cov ntsiav tshuaj nyob rau hauv cov xwm txheej sib txawv raug tshuaj xyuas los txiav txim hnub tas sij hawm.

Tadalafil Tablet 100mg use | Shaanxi BLOOM Tech Co., Ltd

Kev txiav txim siab tsim khoom rau cov ntawv tshwj xeeb ntau npaum li cas (xws li 100mg)

Los tsimTadalafil ntsiav tshuaj 100 mgdaim ntawv ntau npaum, cov kev hloov kho thiab kev txiav txim siab hauv qab no yuav tsum tau ua raws li cov txheej txheem ib txwm ua:

koob tshuaj raug

Raw khoom hnyav: Tadalafil raw khoom yog hnyav siv lub siab -paub meej qhov tseeb kom paub meej npaum li cas.
Kev sib xyaw ua ke: Vim muaj ntau npaum li cas, nws yog ib qho tsim nyog los ntxiv dag zog rau kev tswj cov txheej txheem sib tov kom ntseeg tau tias cov khoom siv raw thiab cov khoom siv sib xyaw ua ke sib xyaw ua ke thiab tsis txhob sib txawv ntau npaum li cas.

Optimization ntawm cov ntsiav tshuaj nias txheej txheem

Cov ntsiav tshuaj tswj qhov hnyav: 100mg ntsiav tshuaj muaj cov ntsiav tshuaj hnyav hnyav, thiab cov ntsiav tshuaj nias txheej txheem yuav tsum tau ua kom zoo kom ntseeg tau tias qhov sib txawv ntawm cov ntsiav tshuaj hnyav raws li qhov xav tau.
Hardness thiab Fragility: Cov ntsiav tshuaj ntau npaum yuav ntsib teeb meem xws li tsis txaus hardness thiab fragility ntau dhau, uas yuav tsum tau ua kom zoo dua los ntawm kev kho qhov tsis xws li compression siab thiab lubricant ntau npaum.

Kev xaiv cov khoom siv txheej txheej

Txheej thickness: Cov txheej thickness ntawm siab - cov ntsiav tshuaj koob tshuaj tuaj yeem nce ntxiv, thiab cov khoom siv txheej txheej tsim nyog yuav tsum raug xaiv los ua kom cov txheej txheem sib xws.
Kev tso tshuaj: Txhawm rau tswj cov tshuaj tso tawm tus nqi, nws yog ib qho tsim nyog yuav tsum xaiv cov khoom tsim tawm - tso tawm lossis tswj cov txheej txheem tso tawm thiab ua kom zoo dua cov txheej txheem txheej txheej.

kev soj ntsuam kev nyab xeeb

Cov kev tshawb fawb hauv tsev kho mob: Ua ntej tsim cov 100mg ntau npaum daim ntawv, cov kev tshawb fawb ua ntej txaus yuav tsum tau ntsuas nws txoj kev nyab xeeb thiab kev ua tau zoo.
Kev sim tshuaj kho mob: Yog tias daim ntawv 100mg tau npaj rau kev siv tshuaj kho mob, kev sim tshuaj xyuas nruj yuav tsum tau kuaj xyuas nws cov txiaj ntsig thiab kev nyab xeeb.

Kev ua raws cai thiab kev xav txog kev coj ncaj ncees

Kev cai ua raws cai

Kev sau npe tshuaj: Txhawm rau tsim cov ntawv 100mg ntau npaum li cas, daim ntawv thov kev sau npe yuav tsum xa mus rau lub tuam tsev tswj hwm tshuaj, muab cov ntaub ntawv tshawb fawb txaus los txhawb nws txoj kev nyab xeeb thiab kev ua tau zoo.
GMP daim ntawv pov thawj: Cov txheej txheem tsim khoom yuav tsum ua raws li GMP cov cai kom ntseeg tau tias cov tshuaj tswj tau zoo.

Kev xav txog kev ncaj ncees

Kev nyab xeeb ntawm tus neeg mob: Kev siv ntau ntawm Tadalafil tuaj yeem ua rau muaj kev pheej hmoo ntawm tus neeg mob, thiab kev txiav txim siab siv nws yuav tsum tau ua tom qab ntsuas tag nrho cov neeg mob cov txiaj ntsig thiab kev pheej hmoo.
Tus kws kho mob cov lus qhia: Daim ntawv 100mg ntau npaum yuav tsum tsuas yog siv raws li kev qhia nruj los ntawm kws kho mob, thiab cov neeg mob tsis raug tso cai los kho cov tshuaj ntawm lawv tus kheej.

kev phiv tshuaj

Tadalafil ntsiav tshuaj 100 mg, raws li cov khoom siv tshuaj nquag (API) ntawm phosphodiesterase 5 (PDE5) inhibitor cov tshuaj, tsis tsuas yog coj cov teebmeem tseem ceeb, tab sis kuj tseem ua rau muaj kev cuam tshuam ntawm lub cev, uas yog cov tshuaj tiv thaiv tsis zoo (ADRs). Tsis zoo li cov qauv tshuaj, kev siv ncaj qha ntawm cov khoom siv hmoov hmoov zoo ua rau cov kev pheej hmoo no.

Kev txheeb xyuas thiab kev kho mob ntawm qhov tsis zoo tshwm sim

1. Cov tshuaj tiv thaiv tsis zoo hauv cov hlab plawv

Tadalafil tuaj yeem ua rau mob plawv tsis zoo, nrog rau mob hauv siab, angina, myocardial infarction, thiab arrhythmia, tshwj xeeb tshaj yog rau cov neeg mob uas muaj keeb kwm ntawm cov kab mob plawv, qhov kev pheej hmoo siab dua. Cov txheej txheem ntawm nws qhov tshwm sim yog cuam tshuam nrog kev siv tshuaj vasodilation ua rau muaj kev siv cov pa oxygen ntau ntxiv hauv myocardial thiab tsis txaus cov hlab ntsha ntawm cov hlab ntsha. Cov tswv yim tswj xyuas muaj xws li:

  • Tso tshuaj tam sim ntawd: Yog tias cov tsos mob xws li mob hauv siab, palpitations, los yog ua tsis taus pa nyuaj, nres tshuaj tam sim ntawd thiab nrhiav kev kho mob.
  • Kev tshuaj xyuas electrocardiogram: Ua ib qho kev ntsuam xyuas electrocardiogram txhawm rau ntsuas qhov muaj myocardial ischemia lossis arrhythmia.
  • Kev ntsuam xyuas kab mob plawv: Rau cov neeg mob uas muaj keeb kwm ntawm cov kab mob plawv, kev ntsuam xyuas kab mob plawv, suav nrog kev ntsuas kev ntxhov siab lossis kev mob plawv, yuav tsum tau ua ua ntej siv.
  • Contraindications: Nws yog contraindicated rau cov neeg mob uas nyuam qhuav ntsib myocardial infarction, tsis ruaj khov angina, refractory arrhythmia, hypotension, los yog refractory hypertension.
2. Kev tsis zoo rau lub qhov muag pom

Tadalafil tuaj yeem ua rau pom kev tsis pom kev tsis zoo, suav nrog qhov muag tsis pom kev, xim tsis pom kev txawv txav, thiab tsis yog arterial anterior ischemic optic neuropathy (NAION), uas tuaj yeem ua rau tsis pom kev mus tas li. Cov txheej txheem ntawm nws qhov tshwm sim yog cuam tshuam nrog kev siv tshuaj dilation ntawm cov hlab ntsha ntawm cov hlab ntsha uas ua rau cov retina ischemia. Cov tswv yim tswj xyuas muaj xws li:

  • Kev txiav tshuaj tam sim ntawd: Thaum cov tsos mob xws li qhov muag tsis pom kev lossis pom xim txawv txav tshwm sim, cov tshuaj yuav tsum tau nres tam sim ntawd thiab yuav tsum tau nrhiav kev kho mob.
  • Kev ntsuam xyuas Ophthalmic: Ua qhov kev ntsuam xyuas nyiaj txiag thiab kev kuaj pom qhov muag txhawm rau txheeb xyuas qhov pom ntawm qhov muag pom lossis NAION.
  • Contraindications: Cov neeg mob uas muaj keeb kwm ntawm NAION los yog kab mob ntawm cov kab mob retinal (xws li retinitis pigmentosa) yog contraindicated.
3. Cov tshuaj tiv thaiv tsis zoo rau lub auditory system

Tadalafil tuaj yeem ua rau muaj kev hnov ​​​​lus tsis zoo, nrog rau kev hnov ​​​​mob sai sai thiab tinnitus. Cov txheej txheem ntawm nws qhov tshwm sim tseem tsis tau meej meej, tab sis nws yuav cuam tshuam rau cov ntshav tsis txaus los ntawm lub pob ntseg sab hauv vascular spasm. Cov tswv yim tswj xyuas muaj xws li:

  • Tso tshuaj tam sim: Thaum cov tsos mob xws li hnov ​​​​lus tsis hnov ​​​​lus lossis tinnitus tshwm sim, nres tshuaj tam sim ntawd thiab nrhiav kev kho mob.
  • Kev Xeem Mloog: Ua cov suab nrov ntshiab audiometry thiab acoustic impedance kuaj los ntsuas qhov tsis hnov ​​​​lus.
  • Tsis txhob muaj suab nrov: Txo cov suab nrov thiab zam kev siv tshuaj ototoxic (xws li cov tshuaj tua kab mob aminoglycoside).

 

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