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product-1400-1400

Cov khoom lag luam

### Systemic Systems System of Dapoxetine Cov Hmoov Hmoov

Dapoxetine yog xaiv cov serotonin ruptitor inhibitor (SSRI), tsuas yog siv los kho tus txiv neej ejaculate (PE). Raws li cov khoom siv raw (cov hmoov nplej ua purity, cov txheej txheem hluavtaws thiab cov kws muag tshuaj ua haujlwm ncaj qha cuam tshuam qhov zoo thiab ua tau zoo ntawm cov khoom kawg. Kab lus no yuav siv cov ntaub ntawv dapoxetine los ntawm 6 qhov chaw ua haujlwm: Kev faib tshuaj, cov ntaub ntawv ua haujlwm, kev ua lag luam thiab kev tswj hwm kev lag luam.

#### 1. Tshuaj lom neeg thiab kev faib tawm

** 1. Cov ntaub ntawv yooj yim tshuaj **

- ** Lub npe tshuaj ** (s)-n-dimethyl {}}}}} penylpropan {}} amine

- ** tus lej lej **: 119356-77-3

- ** Cov mis molecular ** ** C21H23NO

- ** Molecular hnyav **: 305.41 g / mol

- ** Pom zoo ** ** Dawb rau off-dawb crystalline hmoov

** Solubility **: Soluble me ntsis hauv dej, yooj yim soluble hauv cov kuab tshuaj ethanol (xws li ethanol, c vivfoform).

** 2. Kev faib tawm cov txheej txheem thiab qhov zoo **

Dapoxetine belongs rau ** amphetamine derivatives **, thiab nws lub nplhaib molecular muaj cov peev xwm naphthalal (s configuration), uas muab rau kev hloov pauv (soter) nrog kev xaiv siab.

- ** ** Zoo **:

- ** PURIELY PURIELY **: Lub siab dawb huv **: Lub siab purity ntawm raw khoom yog feem ntau tshaj lossis sib npaug nrog 99.5%, ua kom muaj kev ruaj khov ntawm kev npaj.

- ** Kev ua si ntawm qhov muag thib Ob **: Tsuas yog (s) -Inomer muaj kev ua tshuaj uas muag tshuaj, uas yuav tsum tau ua tiav los ntawm kev ua haujlwm asymmetemes lossis chairal daws teeb meem.

- ** Qhab **: Nws tuaj yeem khaws cia ntev ntev hauv cov khoom siv qhuav thiab lub teeb pom kev zoo, nrog ob peb cov khoom lag luam.

** 3. Kev faib tawm ntawm cov khoom siv hluavtaws?

Qhov synthesis ntawm dapoxetine muaj feem cuam tshuam ntau cov kauj ruam, thiab cov feem tseem ceeb intermediaes suav nrog:

- ** Nruab nruab nrab A **: ((s) {1}} amino {2}} Phenyfropanol (CASE {3}})

- ** Nruab nruab nrab b **: {{{1} aph aphthol (CAS: {2} {2}})

- ** Nruab nruab nrab C **: N, N-Dimethylacrylamide (CAS: {2}})

#### 2. Kev faib tshuaj thiab kev siv tshuab ntawm kev ua

** 1. Cov Khoom Siv Tshuaj **

Dapoxetine inhibits lub 5- hydroxytry thiab txhim kho kev xav tau zoo ntawm synaptic Nws cov nta suav nrog:

- **Rapid onset**: Peak blood drug (Tmax) is reached 1-2 hours after oral administration, suitable for on-demand use.

- ** LUV HEEV-LUB NEEJ **: Tshem tawm ib nrab-lub neej yog txog li 1.5 teev, txo txoj kev pheej hmoo ntawm kev tsub zuj zuj.

** 2. Pharcermotape Qhov Zoo **

- ** Metabolic Pathway **: Feem ntau metabolized los ntawm cyp3A4 thiab CYP2D6 enzymes los tsim cov khoom lag luam tsis muaj zog.

- ** QIB CHAWS NYEEM **: OB TSHWJ XEEB NTAWM 30MG THIAB 60MG, uas tuaj yeem hloov kho raws li tus neeg mob teb.

#### 3. Cov txheej txheem ntau lawm thiab cov txheej txheem kev kawm

** 1. Lub ntsiab tseem ceeb Synthesis txoj kev **

Kev lag luam tsim ntawm Dapoxetine yog tsuas yog raws li ** asymmetric synthesis **, uas tau muab faib ua cov kauj ruam hauv qab no:

1. "Kev tsim kho lub chaw chairal **: Siv Benzaldehyde raws li cov khoom pib, cov (cov (S) -Txoj kev haus dej cawv yog tsim los ntawm kev siv dej cawv.

2. ** Naphthalene Ring Kev Taw Qhia **: {{1} aphthol txuas nrog amino cawv txeej muaj kev xav tsis txaus.

3. ** Amine Methylation **: Qhia txog N, N-Dimethyl pawg los ntawm eschaweriler-clarke cov tshuaj tiv thaiv.

** 2. Txheej txheem kev coj ua kom zoo dua **

- ** Muab cov tshuaj ntsuab ntsuab **: Txo cov kev siv tshuaj lom (xws li cyanide hydrogenation es tsis txhob muaj cov txheej txheem txo qis.

- ** NTXIV NWS CUA TIV Tawb **: Txhim kho cov tshuaj tiv thaiv kev ua tau zoo thiab txo cov pob-to-batch sib txawv.

#### 4. Daim ntawv thov cov cheeb tsam thiab kev tsim kho qauv

** 1. Kev taw qhia nthuav tawm **

Ntxiv rau kev ua kom ntxov ntxov, Dapoxetine tau kawm hauv cov chaw hauv qab no:

- ** Kev sib daj sib deev poj niam **: Kev tshawb fawb ua ntej tau pom nws cov peev xwm ua tau zoo rau kev sib deev tsis sib deev.

- ** Kev kho ncua kev kho mob rau Kev Nyuaj Siab **: Siv nws cov kev nrawm nrawm {1}} i} ht cov teeb meem.

** 2. Ntsej Muag Dosage Daim Ntawv Tsim Tawm **

- ** OFALL MISCENT RQUEATE **: Nrhiav kev ua raws li tus neeg mob ua raws thiab ua kom luv rau lub sijhawm ntev mus txog 30 feeb.

- ** Kev txhaj tshuaj kom ntev ntev **: Rau cov neeg mob ntev uas xav tau kev kho mob ntev, txuas lub sijhawm ntawm kev nqis tes ua li cas 72 teev.

### 5. Kev ua lag luam cov xwm txheej thiab kev sib tw toj roob hauv pes

** 1. Kev Lag Luam Thoob Ntiaj Teb Loj **

- ** Muaj 2023 tseem ceeb?

- ** Kev faib tawm hauv cheeb tsam **: North America cov nyiaj rau 45%, Europe 30%, thiab A Asia-Pacific Xeev tau txais kev loj hlob tshaj plaws (Cagram 12%).

** 2. Chaw Tsim Tshuaj Loj **

- ** Cov tuam txhab tshawb fawb thawj zaug **: Johnson & Johnson (Janssen Kws Tshuaj) tuav cov ntaub ntawv patent kom txog rau 2022.

- ** API cov neeg muab khoom **:

- ** Is Nrias teb **: Chaw Sun Lub cev, Dr. Reddy's (nqi nqi kom zoo dua li 60% ntawm cov khoom siv thoob ntiaj teb).

- ** Tuam Tshoj **: HuaaHiha Kws Tshuaj, Shijiazhuang Care Group (FDA Cov ntawv pov thawj, tsom mus rau lub lag luam siab).

### 6. Cov cai tswjfwm thiab kev tswjhwm zoo

** 1. Cov Tshuaj Tiv Thaiv Thoob Ntiaj Teb **

- ** USP-NF **: stipulates hais tias tag nrho cov impurities ntawm cov tshuaj uas cuam tshuam yog tsawg dua lossis sib npaug}. 1%. 1%. 1%.

- ** EP **: Chiral Purity (s-isomer) ntau dua lossis sib npaug rau 99. {{%.

** 2. Cov khoom tseem ceeb "

- ** HPLC Txuj Ci **: Txiav txim siab cov ntsiab lus ntawm lub ntsiab tivthaiv thiab impurity spectrum.

- ** Maiv Chiral Chrataphy **: Xyuas kom muaj kev ua kom zoo nkauj.

- ** RESDALLE KANTH **: Ua raws li Ich Q3C cov lus qhia (xws li Methanol tsawg dua lossis sib npaug rau 3000ppM).

#### 7. Yav Tom Ntej Kev Loj Hlob

1. ** Kev sib tw hauv paus tom qab cov khoom tiav patent **: Tom qab 2022, cov tuam txhab cov tshuaj muaj txiaj ntsig nrawm, thiab qhov xav tau APIIS yuav nce.

2. ** Kev xa khoom tshiab **: Kev loj hlob ntawm cov neeg uas tsis yog-thawj cov khoom siv tshuaj xws li kev ua kom muaj qhov sib hloov pauv thiab qhov ntswg.

3. ** Kev kho kom haum rau kev kho **: Ua ke nrog PDE5 inhibitors (xws li Sildenafil) los kho cov neeg mob nrog cov neeg ua haujlwm nrog cov neeg mob siab thiab PE.

#### xaus

Dapoxetine API yog cov khoom siv tseem ceeb rau PIB kev kho, thiab nws cov kev pab cuam tshuam yog cov khoom sib txhawb chiral thiab tswj tsis ncaj ncees. Nrog rau kev tsim kho tshiab ntawm cov thev naus laus zis thiab cov khoom lag luam no tseem yuav ua rau cov txiv neej kev noj qab haus huv thiab coj cov nplua nuj rov qab los rau API tuam txhab. Yav tom ntej, ntsuab synthesis thiab meej zoo tswj yuav yog tus yuam sij ntawm kev sib tw.