Ihe ọmụma
Mgbe a bịara n'ịhọrọ ọgwụ ma ọ bụ mgbakwunye kwesịrị ekwesị, ụdị nke ewepụtara ihe na-arụ ọrụ ọgwụ (API) nwere ike ịdị oke mkpa. Ụdị abụọ na-emekarị na mkparịta ụka bụ fluoxetine HCL ntụ ntụ na fluoxetine ntụ ntụ. Ọ bụ ezie na ha nwere ike ịdị ka ndị na-agbanwe agbanwe n'ihi aha ha yiri ya, enwere ọdịiche dị iche n'etiti ha abụọ. Isiokwu a ga-enyocha ma fluoxetine HCL ntụ ntụ bụ n'ezie otu ihe dị ka fluoxetine ntụ ntụ, na-abanye n'ime ihe mejupụtara kemịkal ha, mmetụta na ojiji na ike, na ihe ọ pụtara maka nnọchi na ọgwụ.
Kedu ihe dị iche n'etiti Fluoxetine HCL na Fluoxetine Base?
Fluoxetine HCL, ma ọ bụ fluoxetine hydrochloride, bụ hydrochloride nnu ụdị nke fluoxetine nne na nna. N'ụzọ dị iche, fluoxetine ntụ ntụ na-ezo aka n'ụdị isi nke ọgwụ ahụ, na-enweghị mgbakwunye nke hydrochloride. Ọnụnọ nke hydrochloride na fluoxetine HCL na-emetụta solubility na nkwụsi ike ya, nke n'aka nke ya nwere ike imetụta nnabata ya na ịdị irè n'ime ahụ.
Ọdịdị kemịkal nke fluoxetine nwere mgbanaka phenyl jikọtara na yinye propylamine site na ikuku oxygen. N'ụdị isi ya, fluoxetine dị ka ntọala efu nwere usoro ihe omimi C17H18F3NO. Ụdị nnu HCL, fluoxetine hydrochloride, nwere usoro ihe omimi C17H18F3NO·HCl [1].
Mgbakwunye nke hydrochloride otu na-agbanwe physicochemical Njirimara nke ogige. Fluoxetine HCL bụ mmiri na-agbaze karịa ihe nkesa ya, nke bụ ihe dị mkpa na nhazi ọgwụ. Mmụba solubility nke ụdị HCL nwere ike ime ka mgbaze ka mma na tract gastrointestinal, nwere ike imeziwanye profaịlụ nnabata ya [2].
Ọzọkwa, ụdị nnu nwere ike imetụta nkwụsi ike nke ogige ahụ. Fluoxetine HCL na-eme ka ọ kwụsie ike n'okpuru ọnọdụ nchekwa dị iche iche ma e jiri ya tụnyere ụdị ntọala. Nkwụsi ike a dị oké mkpa maka ịnọgide na-arụ ọrụ nke ọgwụ ahụ n'oge na n'okpuru ọnọdụ gburugburu ebe obibi dị iche iche, nke dị mkpa karịsịa maka mmepụta na nchekwa ọgwụ [3].
Isi ihe ọzọ dị iche bụ isi ihe na-agbaze ha. Isi Fluoxetine nwere ebe mgbaze dị ala ma e jiri ya tụnyere fluoxetine HCL. Ngwongwo a nwere ike imetụta nhazi na nhazi nke ọgwụ, yana omume ya n'ime ahụ [4].
Kedu ka ụdị nnu nke Fluoxetine si emetụta ojiji ya na ike ya?
Ụdị nnu nke ọgwụ nwere ike gbanwee pharmacokinetics ya nke ukwuu, gụnyere solubility ya, ọnụego mgbasa, na bioavailability. Maka fluoxetine, a na-ahọrọkarị ụdị HCL maka nchịkwa ọnụ n'ihi na ọ na-eme ka ọ dịkwuo mma na mmiri, nke nwere ike iduga ngwa ngwa ma dị irè karị.
Mmụba solubility nke fluoxetine HCL na-atụgharị gaa na mgbasa ngwa ngwa karịa na mmiri eriri afọ. Mgbasa ngwa ngwa a nwere ike ibute mmịnye ngwa ngwa n'ime ọbara, nwere ike ibute mmalite ngwa ngwa karịa. Otú ọ dị, ọ dị mkpa iburu n'obi na mmetụta ọgwụgwọ n'ozuzu nwere ike ọ gaghị adị ike ma ọ bụ dị ogologo karịa, n'ihi na nke a na-adabere n'ihe dị iche iche gụnyere metabolism na mkpochapụ nke ọgwụ [5].
The bioavailability nke Fluoxetine HCL na-adịkarị elu, yana ihe dịka 72% nke ọnụọgụ ọnụ na-erute mgbasa nke sistem. Nke a dị elu bioavailability na-nwere obere ekenye ya ezi solubility na permeability àgwà. N'ụzọ dị iche, ụdị isi nke fluoxetine nwere ike ịnwe bioavailability dị ala n'ihi mbelata solubility ya, nke nwere ike imetụta ọnụọgụ ọgwụ na-erute mgbasa ozi [6].
Ụdị nnu nwekwara ike imetụta nkesa ọgwụ ahụ n'ime ahụ. Fluoxetine HCL, ozugbo etinyere ya, na-ekewa n'ime ọbara, na-ekwe ka isi fluoxetine gafee akpụkpọ ahụ cell na mgbochi ụbụrụ ọbara nke ọma. Nke a dị oké mkpa maka usoro omume ya dị ka onye na-emechi ihe nchịkwa nke serotonin (SSRI) na usoro nhụjuanya nke etiti [7].
Ọzọkwa, ụdị nnu nwere ike imetụta nkwụsi ike nke ọgwụ na gburugburu pH dị iche iche. Fluoxetine HCL na-ejigide nkwụsi ike ka mma na ọnọdụ acidic, dị ka ndị a na-ahụ na afọ, nke nwere ike ịba uru maka nhazi ọnụ. Nkwụsi ike a na-eme ka ọgwụ ahụ nọgide na-adị mma ruo mgbe ọ ruru ebe a na-aṅụ ya, na-eme ka ike ọgwụgwọ ya dịkwuo elu [8].
Ị nwere ike dochie ntụ ntụ Fluoxetine HCL maka ntụ ntụ Fluoxetine na ọgwụ?
Ndochi anya bụ nchegbu nkịtị maka ndị ọrịa na ndị na-ahụ maka ahụike. Ọ bụ ezie na fluoxetine HCL na fluoxetine base na-ekerịta otu ihe na-arụ ọrụ, ụdị nnu ha dị iche iche nwere ike iduga ọdịiche dị na usoro onunu ogwu, nchịkwa, na mmetụta zuru ezu.
Ajụjụ nke nnọchi dị mgbagwoju anya ma dabere n'ọtụtụ ihe. Site n'usoro iwu, nchịkwa nri na ọgwụ ọjọọ nke US (FDA) na-ewere ụdị nnu dị iche iche nke otu ihe na-arụ ọrụ ka ọ bụrụ otu ihe na-arụ ọrụ. Agbanyeghị, nke a apụtaghị na ha na-agbanwe agbanwe na usoro niile [9].
Mgbe ị na-atụle ngbanwe, ọ dị oke mkpa ịtụle bioequivalence. A na-ewere ngwaahịa ọgwụ abụọ dị ka bioequivalability ma ọ bụrụ na ha nwere otu bioavailability n'okpuru ọnọdụ ndị yiri ya. Mgbe Fluoxetine HCL na isi fluoxetine nwere otu mkpụrụ ndụ na-arụ ọrụ, ụdị nnu ha dị iche iche nwere ike imetụta ọgwụ ọgwụ ha, nwere ike ibute ọdịiche dị na bioavailability [10].
Na omume, ọtụtụ usoro fluoxetine dị n'ahịa na-eji ụdị nnu HCL n'ihi njirimara dị mma ya. Ọ bụrụ na usoro a ga-eji ụdị ntọala ahụ, ọ ga-adị mkpa ka a gbanwee usoro onunu ogwu iji gbakọọ maka ọdịiche dị na ịdị arọ molecular na bioavailability. Dịka ọmụmaatụ, ọgwụ 20 mg nke fluoxetine HCL agaghị adị ka 20 mg nke ntọala fluoxetine n'ihi ibu agbakwunyere nke otu hydrochloride.
Nchekwa onye ọrịa bụ ihe kacha mkpa mgbe ị na-atụle nnọchi. Ọ bụ ezie na mmetụta ọgwụgwọ nke ụdị abụọ a na-adịkarị otu, ndị ọrịa n'otu n'otu nwere ike ịzaghachi n'ụzọ dị iche na profaịlụ absorption dị iche iche. Ụfọdụ ndị ọrịa nwere ike ịnwe mgbanwe na mmetụta ma ọ bụ ịdị irè mgbe ha na-agbanwe n'etiti ụdị, karịsịa ma ọ bụrụ na ha na-enwe mmetụta maka obere mgbanwe na ọkwa ọgwụ [5].
Ọ dịkwa mkpa ịtụle ọnọdụ nhazi. Ụdị nnu nwere ike imetụta otú ọgwụ ahụ si emekọrịta ihe na ihe ndị ọzọ na-emepụta ihe. Dịka ọmụmaatụ, ihe ndị e ji mee ihe na mbadamba nkume ma ọ bụ capsule nwere ike ịkachasị ya maka ụdị HCL ma ghara ịrụ ọrụ nke ọma na ụdị ntọala, nwere ike imetụta profaịlụ ntọhapụ ọgwụ ma ọ bụ nkwụsi ike [3].
mmechi
Ịghọta ọdịiche dị n'etiti fluoxetine HCL ntụ ntụ na fluoxetine ntụ ntụ dị mkpa maka iji ọgwụ kwesịrị ekwesị. Ọ bụ ezie na ha na-ekerịta otu ihe na-arụ ọrụ, ụdị kemịkal ha nwere ike imetụta solubility, ike, na dabara adaba nke nnọchi. Ụdị HCL na-enye uru n'ihe gbasara solubility, nkwụsi ike, na bioavailability, nke mere ka ọ bụrụ nhọrọ kachasị mma n'ọtụtụ usoro azụmahịa.
Agbanyeghị, ọ dị mkpa ịghọta na ụdịdị ndị a anaghị agbanwe agbanwe mgbe niile. Ọdịiche dị na njirimara physicochemical ha nwere ike iduga ọdịiche dị na absorption, nkesa, na nke nwere ike ịdị irè na profaịlụ mmetụta. Ọ bụ ezie na ndị na-ahụ maka nhazi nwere ike were ha otu ihe na-arụ ọrụ, a ga-enyocharịrị nke ọma ihe ọ pụtara na nnọchi anya.
Maka ndị ọrịa na ndị na-ahụ maka ahụike, isi ihe a na-ewepụ bụ na ọ bụ ezie na fluoxetine HCL na fluoxetine base nwere njikọ chiri anya, ha abụghị otu n'akụkụ niile nke iji ọgwụ ha eme ihe. Ntụle ọ bụla nke ngbanwe ma ọ bụ mgbanwe n'ụdị ọgwụ kwesịrị ime n'okpuru nduzi nke ọkachamara ahụike nke nwere ike nyochaa mkpa onye ọrịa ahụ yana ihe ndị chọrọ nhazi.
Ka sayensị ọgwụ na-aga n'ihu na-aga n'ihu, ịghọta nuances ndị a na-adịwanye mkpa. Ọ na-enye ohere maka njikwa ọgwụ ziri ezi na ahaziri onwe ya, na-ahụ na ndị ọrịa na-enweta ọgwụgwọ kachasị dị irè na nke kwesịrị ekwesị maka ọnọdụ ha. Gakwuru onye ọkachamara ahụike mgbe niile tupu ịme mgbanwe na usoro ọgwụ iji hụ na nchekwa na ịdị mma.
Ọ bụrụ na ị nwekwara mmasị na ngwaahịa a ma chọọ ịmatakwu nkọwa ngwaahịa, ma ọ bụ chọọ ịmata maka ngwaahịa ndị ọzọ metụtara, biko nweere onwe gị ịkpọtụrụ. iceyqiang@aliyun.com.
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