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Ịghọta Mkpuchi Enteric na Ọgwụ

Mkpuchi enteric bụ ihe mkpuchi pụrụ iche, nke e ji polymer mee, nke a na-etinye n'ụdị ọgwụ ọnụ—nke a na-ejikarị eme ọgwụ na mbadamba, kapsụl, ma ọ bụ mkpụrụ ọgwụ. Ọ na-echebe ọgwụ ahụ pụọ na gburugburu afọ nke nwere nnukwu acidity (pH 1–3), na-ahụ na a na-ewepụta ọgwụ ahụ naanị n'ọnọdụ ndị na-anọpụ iche ma ọ bụ alkaline dị na eriri afọ (pH ≥ 5.5–7). Ihe mgbochi a dị mkpa maka ichebe ọgwụ ndị na-enwe mmetụta acid, ibelata iwe afọ, na iduzi nnyefe ọgwụ gaa na mpaghara eriri afọ ezubere iche.

Gịnị bụ mkpuchi Enteric?

  • NkọwaỌgwụ mkpuchi enteric na-eji ihe nchekwa mmiri nke na-anaghị agbaze nke na-eguzogide acidity afọ mana ọ na-agbaze ngwa ngwa ma ọ bụ na-abanye n'ime eriri afọ na pH.
  • Ihe Ndị A Na-ahụkarịMkpuchi ndị a na-ejikarị methacrylic acid copolymers, hydroxypropyl methylcellulose (HPMC), cellulose acetate, polyvinyl acetate, ma ọ bụ ngwakọta nke polymers eke dịka alginate na pectin.
  • Nchedo site na AcidityỌtụtụ ọgwụ anaghị arụ ọrụ nke ọma n'ọnọdụ acid. Mkpuchi enteric na-ebelata hydrolysis tupu oge eruo, oxidation, ma ọ bụ kristal nke ihe ndị na-arụ ọrụ mgbe ha na-agafe n'afọ.
  • Nnyefe ezubere iche: Site n'ịnọgide na-adị ndụ ruo mgbe ọ ruru duodenum ma ọ bụ karịa n'akụkụ eriri afọ, mbadamba ihe mkpuchi enteric na-eme ka ọgwụ ndị ahụ banye n'ebe kacha mma, na-eme ka arụmọrụ na nnweta bioavailability dịkwuo mma.

Ebumnuche: Ichebe Ezi Omume Ọgwụ na Mwepụ Ezubere Iche

Mbadamba na Kapsụlụ Enteric a kpụchara akpụ maka nnyefe ọgwụ ka mma

Mbadamba na Kapsụlụ Enteric a kpụchara akpụ maka nnyefe ọgwụ ka mma

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Ụdị Ọnụọgụ: Mkpụrụ Ọgwụ Enteric, Mbadamba, na Kapsụlụ

  • Ụdị Monolithic: Ndị a gụnyere sistemụ otu-unit dị ka mkpụrụ ọgwụ, mbadamba, na kapsụl. A na-ejikarị Methacrylic acid copolymers eme ihe ndị a n'ihi na a na-egosi na ha anaghị anabata acid.
  • Sistemụ Ọtụtụ Ihe: A na-etinyekwa mkpuchi enteric n'ahụ pellets, granules, ma ọ bụ microcapsules. Ụzọ a nwere ike ibute mwepụta ọgwụ n'otu ụzọ ahụ ma belata mgbanwe dị iche iche, nke dị mkpa maka ngwaahịa jenerik na ngwaahịa pụrụ iche.
  • Ihe atụ:
    • Mbadamba Pantoprazole: A na-ekpuchi ihe mkpuchi Enteric maka mwepụta oge, na-echebe ihe mgbochi proton pump site na mmebi afọ.
    • Sistemụ Protein Osisi nke nwere obere mkpụrụ: A na-ekpuchi ya maka nchekwa na nnyefe ihe oriri ezubere iche.

Mgbochi nke mwepụta ọgwụ tupu oge eruo na gburugburu ebe nwere asịd

Ihe mkpuchi nke enteric na-adabere na usoro pH na-akpali maka nchekwa ọgwụ:

  • Enweghị ike ịgbaze Polymer na obere pH: A na-emepụta matrix polymer ka ọ nọgide na-adị n'ime acid afọ. Dịka ọmụmaatụ, methacrylic acid copolymers na-agbaze naanị mgbe pH ahụ rịrị elu karịa 5.5—pH nkịtị nke eriri afọ elu.
  • Mkpuchi Anụ Ahụ na Sistemụ SmartNgwaọrụ ndị dị elu na-eji silica mesoporous ma ọ bụ shells ebipụtara na 3D iji gbochie ntọhapụ ruo mgbe a ga-emezu oke pH akọwapụtara.
  • Ihe ndị na-eme ka plastik na ihe mgbakwunye dị: Ngwakọta dịka Polysorbate 80 na-eme ka mgbanwe dịkwuo mma ma na-eme ka profaịlụ ntọhapụ dịkwuo mma, na-eme ka mkpuchi ahụ dị irè ma dịkwa otu n'oge mmepụta na nchekwa.

Nha na Ule Mkpuchi

Ịhazi otu mkpuchi dị oke mkpa. Mmebi iwu nwere ike ibute mgbasa ngwa ngwa, enweghị ike imezi ihe dị na ya, ma ọ bụ mmụba na mmetụta ọjọọ ya. Ụlọ ọrụ mmepụta ihe na-eji usoro nha viscosity azụmaahịa maka ọgwụ iji nọgide na-adị n'otu.viscosity mkpuchi— ihe dị mkpa na-agbanwe agbanwe site na nha viscosity na-aga n'ihu na nlekota viscosity inline maka mkpuchi. Viscosity mkpuchi kacha mma maka mbadamba enteric dị mkpa maka idoanya ihe nkiri, njikọta, na arụmọrụ ọrụ.

Na nchịkọta, mkpuchi enteric na-akwado iguzosi ike n'ezi ihe na mwepụta a na-achịkwa, na-eji ma sayensị ihe onwunwe ma nhazi ziri ezi eme ihe. Uru mkpuchi enteric na-akwado mmezi ọgwụ ka mma, nnabata a pụrụ ịdabere na ya, yana ọgwụgwọ ọnụ dị nchebe.

Ihe Ndị Dị Mkpa Maka Mkpuchi Enteric Dị Irè

Ọnụọgụ Nchedo na Mgbochi Acid

Iji chebe ihe ndị na-arụ ọrụ n'ime ọgwụ site na acid afọ, mbadamba ihe mkpuchi enteric ga-emepụta ihe mgbochi siri ike, nke na-eguzogide acid. Ihe mgbochi a na-egbochi mwepụta ọgwụ tupu oge eruo na mmebi n'ọnọdụ afọ. Polymers na-arụ ọrụ n'ime matrix mkpuchi ahụ anaghị agbaze na pH dị ala (1-3), na-agbaze ma ọ bụ na-agbasa naanị mgbe ekpughere ya na pH dị elu nke eriri afọ (karịsịa pH ≥ 5.5–7). Dịka ọmụmaatụ, egosipụtala na ngwakọta dị ka alginate na pectin - karịsịa mgbe ejikọtara ya na glycerol monostearate (GMS) - na-ejigide iguzosi ike n'ezi ihe ha ma na-egbochi mwepụta ọgwụ ruo awa 2 na mmiri afọ a na-eme ka ọ dị nro, na-aza ngwa ngwa ozugbo erutela pH eriri afọ. Nsonaazụ ndị dị otú ahụ kwekọrọ na ihe achọrọ maka mwepụta ọgwụ United States Pharmacopeia (USP) na-egbu oge, na-ahụ na nnyefe ọgwụ ezubere iche ma na-ebelata mmetụta ọjọọ nke afọ.

Oke ọkpụrụkpụ mkpuchi kacha nta dị oke mkpa maka arụmọrụ

Arụmọrụ nke mkpuchi enteric jikọtara kpọmkwem na ọkpụrụkpụ nke ihe nkiri etinyere. Enweghị mkpuchi zuru oke na-enye ohere ịbanye acid, na-emebi nchebe. Usoro onyonyo dị elu dịka optical coherence tomography (OCT) eguzobela oke dị mkpa - ihe dị ka 27.4 µm - maka iguzogide acid a pụrụ ịdabere na ya na mkpụrụ ọgwụ mkpuchi enteric. Polymers azụmaahịa na-achọkarị ọkpụrụkpụ kacha nta: Acryl-Eze® (68 µm), Aquarius™ ENA (69 µm), na Nutratric® (65 µm). N'okpuru ụkpụrụ ndị a, ihe egwu nke ịbanye acid na mwepụta ọgwụ tupu oge eruo dị oke mkpa. OCT na-enye ohere inyocha mkpokọta mkpuchi na-enweghị mbibi, n'oge n'oge usoro usoro mkpuchi enteric, na-akwado mmụba na nrubeisi iwu.

Mkpa nke Mkpuchi Otu na Njupụta

Ịha nhata n'ọkpụrụkpụ mkpuchi, ma n'ime ma n'etiti mbadamba, dị oke mkpa maka arụmọrụ mbadamba na profaịlụ mwepụta ọgwụ a na-atụ anya ya. Ọdịiche dị n'ọkpụrụkpụ nwere ike ime ka ụfọdụ nkeji ghara iguzogide afọ (ọ bụrụ na ekpuchighị ya nke ọma) ma ọ bụ gbuo oge ntọhapụ gabiga ókè (ọ bụrụ na ekpuchi ya nke ukwuu). Njupụta mkpuchi na-emeju ọkpụrụkpụ site na imetụta ọnụego permeability na mgbaze nke ihe nkiri ahụ. Mkpuchi dị arọ—nke na-esitekarị na ihe ndị a họọrọ nke ọma na njikwa viscosity—na-eduga na mbelata porosity na nchebe acid siri ike karị. Ihe ọhụrụ dịkanlekota viscosity inlinemaka mkpuchi na nha viscosity na-aga n'ihu na mmepụta ọgwụ na-eme ka njikwa usoro sie ike ugbu a, na-ebelata mgbanwe dị n'ime na n'etiti otu.

Ihe ndị a na-ejikarị eme ihe na ihe ndị na-emepụta ihe nkiri eji eme ihe na mbadamba mkpuchi Enteric.

Polymers ndị na-akpụ ihe nkiri

Polymer nke na-akpụ ihe nkiri bụ ntọala nke mkpuchi ọ bụla dị n'ime ahụ, nke na-ahụ maka ngwọta pH-nhọrọ nhọrọ:

  • Methacrylate Polymers(dịka ọmụmaatụ, Eudragit® L100, S100): Na-agbaze na pH karịrị 6.0/7.0, a na-ejikarị ya eme ihe n'ihi oke pH ziri ezi na ike iguzogide acid siri ike.
  • Polyvinyl Acetate Phthalate (PVAP):Na-enye nchebe siri ike nke afọ, ọkachasị maka ngwaahịa ndị na-egbu oge.
  • Polymers eke:Alginate, pectin, shellac, na carboxymethyl starch (CMS) bụ ihe ndị ọzọ "na-acha akwụkwọ ndụ akwụkwọ ndụ" nwere ike iguzogide acid. Ọganihu dị na ihe ndị sitere n'okike na-edozi ma nkwado na nchekwa onye ọrịa.

Ihe ndị na-eme ka plastik na ihe mgbakwunye dị

Ihe ndị na-eme ka plastik dị ka glycerol, sorbitol, PEG 3350, na triacetin na-emezi mgbanwe ihe nkiri ahụ, na-egbochi mgbawa, ma na-akwado nhazi ya:

  • PEG 3350:Na-eme ka kemịkalụ kwụsie ike, na-egbochi nsị mmiri, ma na-eme ka ọgwụ ndị na-adịghị mma sie ike.
  • Triacetin:Ọ na-eme ka ihe nkiri ahụ dịkwuo mfe mana ọ nwere ike ịkwaga n'ime isi mbadamba, mgbe ụfọdụ ọ na-emebi ihe ndị na-arụ ọrụ dị nro.
  • Glycerol/Sorbitol:Ọ dị irè karịsịa na sistemụ polymer eke iji melite ike na ịdị irè.
  • Glycerol Monostearate (GMS):Na-eme ka hydrophobicity dịkwuo mma, na-eme ka iguzogide acid dịkwuo mma na mkpuchi sitere n'okike nke dabere na polymer.
  • Ihe mgbakwunye ndị ọzọ:Ihe ndị na-agba agba, ihe ndị na-egbochi ịtachi, na ihe ndị na-eme ka oghere dị n'ime ya dị nro (dịka ọmụmaatụ, talc, titanium dioxide, polysorbates) na-enye uru bara uru na nhazi.

Ihe Ndị Na-eme Ka Acid Na-eguzogide Acid na Ihe Ndị Na-arụ Ọrụ

Ebee ka mbadamba ihe mkpuchi enteric na-agbaze

Ihe ịma aka dị na imezu otu mkpuchi na arụmọrụ kacha mma

Mgbanwe dị n'ime mbadamba na n'etiti mbadamba na ọkpụrụkpụ mkpuchi

Ime ka mkpụrụ mkpuchi ahụ sie ike na mbadamba ihe mkpuchi dị oke mkpa. Mgbanwe dị na mbadamba ihe mkpuchi na-egosi ọdịiche dị n'etiti otu mbadamba, ebe mgbanwe dị n'etiti mbadamba ihe na-atụle ọdịiche dị n'etiti mbadamba ihe mkpuchi na otu ngwugwu. Ha abụọ na-enye aka na arụmọrụ ngwaahịa ikpeazụ.

Mmetụta nke Mkpuchi Na-abụghị Otu na Mwepụ Ọgwụ na Ọrụ Ya

Mkpuchi enteric na-adịghị otu ụdị na-emetụta kpọmkwem profaịlụ mwepụta ọgwụ. Mgbanwe dị iche iche na ọkpụrụkpụ nwere ike imebi iguzogide acid, na-ebute mwepụta ọgwụ tupu oge eruo. Dịka ọmụmaatụ, mkpuchi enteric na abiraterone acetate mụbara mkpughe sistemụ site na okpukpu 2.6 ma e jiri ya tụnyere ụdị ndị na-anaghị ekpuchi, nke jikọtara ya na nchekwa afọ ka mma. N'aka nke ọzọ, mkpuchi na-adịghị otu ụdị na mbadamba pantoprazole kpatara ọrụ na-adịghị agbanwe agbanwe na nnweta bioavailability, karịsịa n'etiti ngwaahịa generic na nke akara.

Mwepụta ọgwụ sitere na pellets a kpụchara akpụ na-emetụta ọkpụrụkpụ na nhazi nke ihe nkiri polymer. Oge mkpuchi ogologo na nrụgide atomizing dị elu nwere ike ibute ihe nkiri buru ibu, mana ojiji na-adịghị mma na-eduga na kinetics ntọhapụ a na-atụghị anya ya.

Ihe Ndị Na-akpata Usoro Gburugburu Ebe Obibi: Iru mmiri, Okpomọkụ, Ọnọdụ Ịkpọ nkụ

Ihe ndị dị mkpa gbasara gburugburu ebe obibi n'oge na mgbe usoro mkpuchi enteric gasịrị na-emetụta nke ukwuu n'otú mkpuchi ahụ si dị na ịdị ọcha. Okpomọkụ dị elu na obere iru mmiri na-eme ka nkụ ngwa ngwa mana ọ na-eme ka ihe egwu nke mgbawa na corrugation elu dịkwuo elu. Ịkpọ nkụ ngwa ngwa na-ebutekarị ntụpọ nhazi, gụnyere mgbawa gbawara agbawa ma ọ bụ mbelata, karịsịa na kapsụl osisi na ihe nkiri protein.

Ọnọdụ nchekwa mgbe mkpuchi gasịrị dịkwa mkpa. Ebe iru mmiri dị elu na obere okpomọkụ na-akwalite mgbawa gbawara agbawa, ebe oke iru mmiri na okpomọkụ dị elu nwere ike ibute njikọta na ịrapara nke mkpuchi ahụ. Usoro dịka nyocha elektrọn microscopy (SEM) na X-ray computed tomography (CT) na-egosi na mgbawa ma ọ bụ njikọ microscopic na-agbanwe ozugbo ka ọ bụrụ ọrụ mgbochi mebiri emebi na profaịlụ ntọhapụ ọgwụ gbanwere.

Ọrụ nke Paramita Nhazi (Ụdị Polymer, Plasticizer, Ihe Mgbaze)

Usoro mkpuchi enteric na-ekpebi ma arụmọrụ anụ ahụ na njirimara mwepụta ọgwụ. Nhọrọ nke usoro polymer—ụdị cellulosic, acrylic, ma ọ bụ ụdị sịntetik dị ka PLGA—na-emetụta iguzogide acid na iguzosi ike n'ezi ihe nke igwe. Plasticizers na-eme ka mgbanwe dịkwuo mma ma belata ihe egwu nke mgbawa. Plasticizers hydrophilic (PEG 400, PEG 6000) na-eme ka ikike ịbanye n'ime ahụ dịkwuo elu mana ha nwere ike imebi iguzogide acid site n'ịrụ ọrụ dị ka ihe na-emepụta pore, na-ebelata mwepụta ọgwụ a chọrọ. Plasticizers hydrophobic (dịka ọmụmaatụ, dibutyl sebacate, acetyl tributyl citrate) na-eme ka njikọ ihe nkiri na ihe mgbochi dịkwuo mma.

Ihe mgbaze na-emetụta ojiji na ịkpọ nkụ nke ihe ndị na-eme ka ihe dị n'ime mmiri. Ngwakọta mmanya na mmiri Isopropyl na-akwalite mmepụta ihe nkiri yiri nke ahụ site na sistemụ matrix ethylcellulose-hypromellose. Oke na ụdị ihe mgbaze ga-adaba na nhọrọ polymer na plasticizer iji mee ka otu mkpuchi dịkwuo mma, jikwaa ikike ikuku, ma chekwaa iguzogide acid.

Usoro polima, plastikizer, na solvent dị oke mkpa iji mee ka uru mkpuchi enteric dịkwuo mma. Ụlọ ọrụ ọgwụ na-adabere na usoro nhazi nke ọma iji hụ na arụmọrụ ya dị n'ọtụtụ mbadamba, mkpụrụ ọgwụ, na ụdị ọgwụ ọnụ dị mgbagwoju anya.Nnwale viscosity inline n'oge ana nlekota na-eme ka njikwa ziri ezi nke mkpuchi viscosity dịkwuo mma, na-ahụ na mkpuchi ahụ dị mma maka mbadamba enteric ma na-eme ka nnwale nha anya mkpuchi dị na ọgwụ.

Usoro Mkpuchi Enteric

Nchịkọta nke Usoro Mkpuchi Enteric Nzọụkwụ site na Nzọụkwụ

Nkwadebe nke Ngwọta Mkpuchi

Imepụta mbadamba, mkpụrụ ọgwụ, na usoro ọgwụ dị iche iche na-amalite site na nhọrọ nke polima na ihe ndị na-eme ka ihe dị n'ime mmiri jupụta n'ime mmiri kpụkọrọ akpụkọ. Polima ndị a na-ahụkarị na mmiri kpụkọrọ akpụkọ gụnyere ihe ndị sitere na cellulose na ihe ndị sitere na methacrylate dịka DRUGCOAT® L 100-55. A na-etinye ihe ndị na-eme ka ihe dị n'ime mmiri dị ka triethyl citrate (TEC), polyethylene glycol (PEG 400, 6000), diethyl phthalate, na triacetin iji mee ka ihe nkiri ahụ dịkwuo mma ma nwee ike ime ka ọ dị mfe.ngwọtaNkwadebe gụnyere ịgbari ma ọ bụ ịgbasa polima na plasticizer n'ime mmiri ma ọ bụ ihe mgbaze organic, yana ngwakọta zuru oke iji nweta viscosity mkpuchi zuru oke maka mbadamba enteric, nke na-adịkarị n'etiti 50-100 cP dabere na usoro ịgba na ihe achọrọ maka atomization. Ntụle viscosity na-aga n'ihu na mmepụta ọgwụ - site na iji sistemụ nha viscosity inline azụmaahịa maka ọgwụ - na-ahụ na nhazi otu-site-otu na arụmọrụ kachasị mma nke imepụta fim. Nlekọta viscosity inline maka mkpuchi na-ebelata ihe egwu nke enweghị otu ma na-egbochi nsogbu njikọta.

Usoro Ngwa: Mkpuchi Pan na Mkpuchi Akwa Mmiri

A na-eji ihe mkpuchi pan ma ọ bụ usoro ihe ndina a na-agba mmiri eme ihe, nke a họọrọ dabere na ụdị ngwaahịa na njirimara ihe nkiri achọrọ.

Mkpuchi ite: A na-etinye mbadamba n'ime ite nwere oghere ma ọ bụ nke dị larịị nke na-ada ada mgbe a na-efesa ihe mkpuchi ahụ n'ime pulses. A na-efesa ikuku ọkụ iji mee ka ọ kpọọ nkụ ngwa ngwa. Mkpuchi pan dị mma maka mbadamba na mkpụrụ ọgwụ e ji ekpuchi enteric mana ọ nwere ike ibute ọkpụrụkpụ mkpuchi dị iche iche ma ọ dịghị mma maka sistemụ dị iche iche. Nha nhata dabere na ọsọ pan ahụ, ọnụego ịgbasa, na njikwa okpomọkụ.

Mkpuchi ihe ndina a na-agba mmiri: A na-etinye mbadamba ma ọ bụ pellet n'ime ikuku na-ekpo ọkụ elu ebe a na-efesa ihe ngwọta mkpuchi atomized. Nhazi ya gụnyere ịgba n'elu, ịgba n'okpuru (usoro Wurster), ma ọ bụ ịgba tangential. Mkpuchi akwa fluidized na-enye ohere ijikwa ọkpụrụkpụ ihe nkiri na ịdị n'otu nke ọma, na-eme ka ọ ka mma maka ọgwụ mkpuchi enteric nke chọrọ profaịlụ ntọhapụ ziri ezi. Mmepụta ọhụrụ dị ka sistemụ akwa rotary fluidized (RFB) na-eme ka njikwa nke usoro pellet dị mgbagwoju anya dịkwuo mma. A na-eme nnwale nha nha mkpuchi na ọgwụ mgbe niile n'oge na mgbe etinyere ya iji kwado nkesa nha nha na mkpuchi zuru oke.

Ịkpọcha na Ịgwọta: Mmetụta na Ịdị n'otu, Njupụta, na Mgbochi Acid

Ozugbo etinyere mkpuchi ahụ, mbadamba ndị ahụ na-akpọnwụ ma na-agbaze iji mee ka ihe nkiri ahụ sie ike. Usoro nkụ - okpomọkụ, iru mmiri, ikuku ikuku - dị oke mkpa maka nhazi ihe nkiri ahụ ma a ga-achịkwa ya nke ọma. Ịgwọ ya gụnyere itinye mbadamba ndị a kpuchiri ekpuchi n'ọnọdụ okpomọkụ na/ma ọ bụ iru mmiri dị elu maka oge akọwapụtara (anaghị agbanwe agbanwe: ruo awa 24, nke na-agbanwe agbanwe: awa 3-4). Usoro a na-eme ka njikọ polymer chain dịkwuo mma, na-eme ka ike nrụgide dịkwuo elu, ma na-eme ka iguzogide acid nke oyi akwa enteric dịkwuo mma.

Oge ịkpọ nkụ na ọgwụgwọ na-emetụta njupụta mkpuchi na otu nha. Ọgwụgwọ zuru oke nwere ike ibute nchebe na-adịghị mma megide acid afọ, na-emebi nnyefe ọgwụ. N'aka nke ọzọ, ọgwụgwọ ogologo oge nwere ike ibelata mgbasa mmiri site na fim ahụ, na-eme ka iguzogide acid dịkwuo mma. Na ọkwa mkpuchi dị n'etiti (ọkpụrụkpụ ≈ 7.5%), oge ọgwụgwọ nwere obere mmetụta, ebe ọkwa dị ala ma ọ bụ dị elu chọrọ njikwa ziri ezi. Nlekọta mgbe niile na ọkpụrụkpụ na nhazi nke ihe nkiri ahụ na-eme ka mkpuchi ahụ mezuo nkọwapụta ezubere iche.

Usoro Njikwa Dị Mkpa (CPK)

Njikwa usoro na mkpuchi enteric na-elekwasị anya n'ọtụtụ paramita usoro dị mkpa nke na-emetụta mma ngwaahịa ikpeazụ:

  • Ọsọ ikuku mbata: Na-achịkwa ọsọ ịkpọ nkụ na nhazi ihe nkiri.
  • Ọsọ pan(n'ime mkpuchi pan): Na-emetụta otu ihe mkpuchi ahụ na ikpughe ihe.
  • Okpomọkụ ikuku: Na-emetụta kpọmkwem uzu mmiri mmiri na njikọta polymer.
  • Oge mkpuchi: Na-ekpebi mkpokọta ihe nkiri ahụ na ọkpụrụkpụ ya.
  • Nrụgide atomization: Na-achịkwa nha ntapu mmiri na mgbasa nke mkpuchi ahụ—nke kachasị mkpa maka ịdị n'otu ọdịnaya.
  • Nrụgide onye ofufe: Na-emetụta nkwụsịtụ nke mbadamba na usoro ihe ndina a na-agbaze mmiri.

Ngwaọrụ njikwa usoro ọnụọgụgụ dịka imewe Plackett-Burman na-achọpụta paramita kachasị emetụta. Nhazi akụrụngwa na nha viscosity na-aga n'ihu na-anọgide na-adịgide. Dịka ọmụmaatụ, ịdịgide ibu ọgwụ na mkpụrụ ọgwụ mkpuchi enteric dabere nke ukwuu na ọsọ pan kwụsiri ike na ọnụego ịgbasa nke ọma. Njikwa viscosity mkpuchi site na nha inline na-egbochi mgbanwe n'oge nrụpụta.

Iji hụ na e nwere ike ịkwụsi ike ma chebe ngwaahịa ahụ n'oge nchekwa ya.

Ọgwụ mkpuchi enteric siri ike ruo ogologo oge dị mkpa iji nọgide na-arụ ọrụ na-egbu oge. Njikwa ịdị mma gụnyere ụzọ nyocha dịka:

  • Nnwale mgbaze: Na-eme ka acid ghara iguzogide ma na-akwado mwepụta ọgwụ na pH nke eriri afọ ezubere iche.
  • Nha ọkpụrụkpụ: Na-enyocha ojiji zuru oke na otu nha nke ihe nkiri enteric.
  • Nlekota gburugburu ebe obibi: Na-edobe iru mmiri na okpomọkụ kwesịrị ekwesị n'oge nchekwa na nrụpụta.
  • Nyocha Kalọmetry/Thermogravimetric Nyocha Dị Iche Iche: Na-enyocha mgbanwe nhazi ihe nkiri ka oge na-aga.

Iwusi ike na ntuziaka iwu (GMP, FDA, ICH Q8/Q9) dị mkpa n'oge nkwenye, nrụpụta, na nlekọta mma. Ndekọ nke paramita njikwa usoro dị mkpa na nyocha zuru oke nke ngwaahịa. Ihe atụ: N'ọmụmụ nkwụsi ike tụnyere nke mbadamba ihe mkpuchi enteric, a na-enyocha profaịlụ mgbasa na iguzosi ike n'ezi ihe nke mkpuchi ahụ ruo ọnwa 24 iji hụ na emezuola ihe achọrọ maka ndụ nchekwa.

Nhazi usoro, nhazi akụrụngwa siri ike, na nlekota viscosity inline na-aga n'ihu na-eme ka mmepụta na uru mkpuchi enteric dị mma maka ọgwụ ọnụ.

Mkpa nke mkpuchi Viscosity na Usoro mkpuchi Enteric

Ịgbado ọkụ bụ ihe e ji atụ ihe ngwọta na-eguzogide mmiri, ọ bụkwa ihe dị mkpa na ọgwụ mkpuchi enteric na nchedo ha otu otu. Njikwa viscosity na-eme ka mkpuchi ihe nkiri a na-emegharị emegharị, ọkpụrụkpụ, na iguzogide acid maka mbadamba na mkpụrụ ọgwụ mkpuchi enteric. Ịgbado ọkụ zuru oke maka mbadamba enteric na-enye ohere itinye ya n'otu oge na-enweghị ịda ada, nkesa na-adịghị nhata, ma ọ bụ nkwụsị usoro, na-emetụta kpọmkwem otu mkpuchi na arụmọrụ.

Mmetụta nke Viscosity mkpuchi na mkpuchi otu

Ọbara ọbara dị oke mkpa maka inweta otu nhata n'usoro mkpuchi enteric. Mkpuchi otu nhata na-enye ohere maka mwepụta ọgwụ a na-achịkwa yana nchekwa acid siri ike - uru mkpuchi enteric dị mkpa. Mgbe viscosity dị obere, mmiri mkpuchi ahụ nwere ike ịgba ma ọ bụ daa, na-ebute ntụpọ dị gịrịgịrị ma ọ bụ mkpuchi ezughị ezu; oke elu, ọ nwekwara ike igbochi atomizers ma ọ bụ gbochie ọbụna ịgbasa, na-emepụta ntụpọ mkpuchi ma ọ bụ ihe nkiri siri ike. Usoro dịka terahertz pulsed imaging (TPI) na Raman mapping na-atụle ma na-enyocha otu nhata mkpuchi ahụ, na-achọpụta nsogbu ndị metụtara viscosity na-adịghị mma dịka ọkpụrụkpụ na njupụta dị iche iche n'elu mbadamba. Ọmụmụ ihe na-akwado na ngwọta viscosity dị elu, karịsịa ndị nwere polymers dị arọ molekul dị elu, na-emepụta ihe nkiri nwere nguzozi ọkpụrụkpụ ka ukwuu na ọnụego ntụpọ belatara, na-eme ka iguzogide acid dịkwuo mma na arụmọrụ mwepụta ọgwụ na-egbu oge.

Mmekọrịta dị n'etiti Viscosity mkpuchi na Njirimara Ihe nkiri

Mkpuchi viscosity na-akpụzi ihe ndị dị na fim dịka njupụta, ọkpụrụkpụ, otu nha, ike nrụgide, na ikike ịbanye n'ime ha. Ihe nkiri ndị dị oke nkọ, ndị a kpụrụ nke ọma na-esi na usoro viscous kacha mma apụta, nke na-egbochi mbufụt tupu oge eruo, mbuze, ma ọ bụ ọdịda na mmiri afọ e mere ka ọ dị ka ihe e ji eme ihe. Oke viscosity nwere ike ibute ihe ndị dị n'ime igwe na-adịghị mma na iguzogide acid adịghị ike, ebe ihe nkiri ndị a na-eme na viscosity dị elu na-egosi mmezi nhazi na ọrụ mgbochi. Ọdịnaya plasticizer na ọkwa polymer na-achịkwa rheology nke mkpuchi ahụ—nguzozi ha na-emetụta iguzosi ike n'ezi ihe nkiri ikpeazụ. Dịka ọmụmaatụ:

  • Mbadamba Pantoprazole:Viscosity na-emetụta ọkpụrụkpụ na njupụta, si otú a na-emetụta àgwà mwepụta na-egbu oge na profaịlụ mgbasa.
  • Ihe nkiri Chitosan/zein:Mmụba nke plastik na-ebelata viscosity na modulus, na-eme ka mgbanwe dịkwuo mma mana na-ebelata ihe mgbochi.

Nnwale otu ihe na ọgwụ na-ejikarị onyonyo (TPI, SEM) na Raman mapping eme ihe iji chọpụta njikọ dị n'etiti viscosity, ihe nkiri, na arụmọrụ enteric a pụrụ ịtụkwasị obi.

Ihe Ndị Na-emetụta Viscosity Mkpuchi

Nhazi

Nhazi bụ ihe kacha ekpebi viscosity. Ọnụọgụ polima dị elu na-eme ka viscosity ngwọta dịkwuo elu, na-emepụta ihe nkiri siri ike ma dị otu. Ihe ndị na-eme ka plastik dị nro—dịka glycerol, PEG-400, na sorbitol—na-agbanwe viscosity site n'ịbawanye molekul na ime ka mgbanwe dịkwuo mma, ọ bụ ezie na oke ọnụọgụ nwere ike imebi ọrụ mgbochi.

  • Ihe atụ: Na mkpuchi sodium alginate, pasentị nke glycerol ma ọ bụ PEG-400 na-agbanwe viscosity, si otú a na-agbanwe ike mmiri, nkwụsi ike, na ọkpụrụkpụ ikpeazụ nke mkpuchi ahụ.

Okpomọkụ

Okpomọkụ na-achịkwa viscosity nke ọma. Ọkụkọ okpomọkụ na-ebelata viscosity, na-eme ka mmiri na atomization dịkwuo mma na ngwa mkpuchi. Ụdị viscosity agbaze (equation Carreau na Arrhenius) na-akọwa otu ngwakọta mkpuchi ọgwụ si emeghachi omume na mgbanwe okpomọkụ, na-emetụta ọnọdụ nhazi ihe nkiri ahụ. Agbanyeghị, oke okpomọkụ nwere ike ime ka nkwadebe ahụ dị nro, na-akpata nsogbu mkpuchi ma ọ bụ na-emebi ọgwụ ndị nwere mmetụta.

  • Ihe atụ: Mkpuchi Eudragit L 100-55 na-egosi obere viscosity na nhazi ihe nkiri ka mma na okpomọkụ dị elu, ma ọ bụrụhaala na a na-achịkwa ọkwa plasticizer nke ọma.

Ụdị dị iche iche nke otu

Mgbanwe nke otu-otu na-emetụta viscosity, ya mere nha nha nke mkpuchi enteric. Ọdịiche ihe ndị dị n'ime (nha nke ihe, ọkwa polymer) na ọnọdụ usoro nwere ike ịgbanwe ngwọta ma ọ bụ gbazee viscosity n'etiti ọsọ mmepụta, na-eyi egwu imegharị ihe. Nlekọta viscosity n'ime usoro maka mkpuchi - site na iji teknụzụ nyocha usoro (PAT) - na-enyere aka ịchọpụta ma gbanwee mgbanwe usoro n'oge, na-akwado nha viscosity na-aga n'ihu na mmepụta ọgwụ.

  • Ihe atụ: Mbadamba sodium alginate sitere na otu dị iche iche nwere ike ịdị iche na ọzịza na mbuze n'ihi mgbanwe ọkwa viscosity, na-emetụta mwepụta ọgwụ zuru oke.

Njikwa mkpuchi viscosity—gụnyere nhazi, okpomọkụ, na njikwa ogbe—dị oke mkpa maka mbadamba mkpuchi enteric a na-emegharị emegharị, na usoro mkpuchi enteric dị irè.

Sistemụ Ntụle Viscosity Azụmaahịa na Sistemụ Ntụle Viscosity Na-aga n'ihu maka Mkpuchi Enteric

Mkpa maka Nlekota Viscosity Oge Dị Anya

Ịnọgide na-enwe ike ịdịgide n'otu oge n'oge usoro mkpuchi enteric dị mkpa maka mkpuchi otu na ngwaahịa ọgwụ dịka mbadamba na mkpụrụ ọgwụ mkpuchi enteric. Mgbanwe na viscosity na-ebutekarị ntụpọ dị ka ọkpụrụkpụ mkpuchi na-adịghị mma, ịfụfụ, na oke elu, na-emetụta kpọmkwem arụmọrụ na ọdịdị ngwaahịa.

Nlekota viscosity n'oge na-enye nzaghachi ozugbo, na-enye ndị ọrụ ohere ịnọgide na-enwe viscosity mkpuchi zuru oke maka mbadamba enteric mgbe otu gasịrị. Nke a na-ebelata ihe egwu nke nnwale nha nha mkpuchi dara ada na ọgwụ, ebe ọ na-akwado mmezi usoro na-aga n'ihu ma na-ebelata ihe mkpofu dị oke ọnụ ma ọ bụ nhazi ngwaahịa. Ebe ọ bụ na ngwọta mkpuchi nwere ike ịgbanwe na viscosity n'ihi mgbanwe okpomọkụ, evaporation nke ihe mgbaze, ma ọ bụ mgbanwe ihe eji emepụta ihe, nlekota viscosity inline maka mkpuchi na-enye ohere mgbanwe dị iche iche, na-egbochi mgbanwe dị mkpa na otu ọ bụla ma na-akwado ihe achọrọ maka iwu maka ọgwụ mkpuchi enteric emechara.

Sistemụ Nha Viscosity Azụmaahịa Dị E Nwere

Usoro mkpuchi ọgwụ ọgbara ọhụrụ emeela ka usoro nha viscosity azụmaahịa dị n'ime ụlọ ọrụ dị iche iche. Sistemụ ndị a na-eji ụkpụrụ ọrụ dị iche iche ma na-enye atụmatụ pụrụ iche emere maka imepụta ọgwụ siri ike.

Ụkpụrụ Ọrụ:

  • Viscometa ndị na-agbagharị agbagharị:Tụọ ike dị mkpa iji tụgharịa ihe n'ime mmiri mkpuchi ahụ, na-agbanwe ike iguzogide igwe ka ọ bụrụ uru viscosity. Ọ bụ ezie na ọ siri ike, nhọrọ ọhụrụ nwere ike inye njikọta ịdị ọcha na akpaaka ka mma.
  • Ihe mmetụta nke ịma jijiji:Ngwaọrụ dịkaViscometer Ọgwụ Lonnmeterjiri nyocha ịma jijiji chọpụta oke mmiri na njupụta ya n'otu oge. Ndị a na-enye ọgụgụ oge, ha anaghị echekwa nke ọma, e mekwara ha maka ịrụ ọrụ na-aga n'ihu na sistemụ mechiri emechi, dị ọcha.
  • Viscometers Ultrasonic na Solid-State:Sistemụ dịka viscometers steeti siri ike nke BioODE na-eji ebili mmiri ultrasonic ma ọ bụ ihe ndị dị ndụ siri ike, na-eme ka ha ghara iguzogide ọnọdụ gburugburu ebe obibi siri ike ma dịkwa mma maka nha viscosity na-aga n'ihu na mmepụta ọgwụ.
  • Ọkpụkpụ Capillary na Microfluidic:Viscometers kinematic capillary na sistemụ microfluidic rheology dabara adaba maka nnwale viscosity obere olu yana izi ezi dị elu, bara uru mgbe ị na-arụ ọrụ na mmiri mkpuchi ọgwụ dị oke ọnụ ma ọ bụ nke pere mpe.
  • Usoro Spectroscopy:Enwere ike iji usoro inline vibration (dịka ọmụmaatụ, Raman, IR) na fluorescence spectroscopic mee ihe, a na-ejikarị ihe nlereanya kemometric eme ihe maka nyocha usoro dị elu.

Sistemụ Azụmaahịa Dị Mkpa:

  • Nta LonnmeterViscometers dị n'ịntanetị:E mere ya maka nrụpụta ọgwụ na-aga n'ihu, na-enye oke viscosity sara mbara, obere mmezi, na ijikọ ya na ahịrị mkpuchi akpaka.

Usoro nhọrọ maka ojiji ọgwụ:
Mgbe ị na-ahọrọ sistemụ nha viscosity inline azụmaahịa maka mkpuchi enteric ọgwụ, lekwasị anya na njirisi ndị a:

  • Izi ezi n'oge a:Ihe dị mkpa maka njikwa usoro na ịdị mma ngwaahịa.
  • Ndakọrịta:Ngwa ahụ ga-adabara ụdị usoro mkpuchi a kapịrị ọnụ (gelatin, dabere na polymer, mmiri mmiri, ntọhapụ na-adịgide adịgide).
  • Mgbanwe na Njikọta:Nhazi modular na ndakọrịta na sistemụ njikwa akpaaka na usoro Industry 4.0.
  • Mmezi na Nhazi:Mkpọtụrụ maka ngwaọrụ ndị na-anaghị arụzi nke ọma, ndị na-agbanwe onwe ha nke nwere ike iguzogide gburugburu mmepụta ọgwụ.
  • Ike Gburugburu Ebe Obibi:Ike ịnọgide na-enwe ezi uche n'okpuru ọnọdụ okpomọkụ dị iche iche, iru mmiri, na usoro mmiri mmiri.

Uru nke Ntụle Viscosity Na-aga n'ihu maka Njikwa Usoro Mkpuchi Enteric

Ntụle viscosity na-aga n'ihu na-agbanwe usoro mkpuchi enteric na ọtụtụ uru a na-atụ anya:

  • Mgbochi Ịhazi Mkpuchi na Mmerụ Ahụ:Nzaghachi ozugbo na-eme ka e jiri mkpuchi enteric mee ihe n'otu ụzọ ahụ. Nke a na-ebelata ntụpọ dịka mmebi, ịfụfụ, na arụmọrụ ihe mgbochi dị ala, na-akwado atụmanya iwu na ahịa maka mkpụrụ ọgwụ na mbadamba mkpuchi enteric.
  • Ịrụ ọrụ nke usoro:Njikwa akpaaka na-ebelata oge ọrụ maka nlele na nhazi aka, na-eme ka mmepụta ya dịkwuo elu ma na-eji ngwa ahịa ngwọta mkpuchi eme ihe nke ọma.
  • Nchekwa Ihe na Mmetụta Gburugburu Ebe Obibi:Site n'ịgbanwe viscosity nke ọma, sistemụ na-ebelata ihe ndị e mefuru ma zere ojiji ihe mgbaze na-enweghị isi. Nke a na-akwado nkwado gburugburu ebe obibi na imeziwanye akụrụngwa.
  • Nkwa na Nrubeisi Ogo:Data na-aga n'ihu, nke e dekọrọ na-enye akwụkwọ maka otu mkpuchi enteric ọ bụla, na-eme ka njikwa mma na akụkọ iwu dị mfe.
  • Nlaghachi na itinye ego:Ndị nrụpụta na-ahụ mmụba nke mmepụta, ịdị mma nke otu na-agbanwe agbanwe, na mbelata ọrụ ma ọ bụ ịjụ mgbe emechara nlekota inline viscosity maka mkpuchi. A na-edekọ uru ndị a na ọmụmụ ihe ikpe na nyocha ndị ọgbọ nyochachara.

Na nchịkọta, sistemụ nha viscosity dị n'ime ụlọ ahịa—na-agbagharị agbagharị, na-ama jijiji, na-eme ka ihe dị n'ime ya dị ka ihe na-agbanwe agbanwe, na-eme ka ọ dị mfe ijikwa viscosity nke oge a. Nhọpụta na njikọta ha nke ọma na-eme ka ụkpụrụ kachasị elu nke njikwa usoro, ịdị mma, na arụmọrụ maka ojiji mkpuchi enteric ọgwụ.

Atụmatụ Njikwa Ogo maka Mkpuchi Otu na Mmepụta Ọgwụ

Mkpuchi otu dị oke mkpa n'ịmepụta mbadamba mkpuchi enteric, mkpụrụ ọgwụ mkpuchi enteric, na ụdị ọgwụ ndị ọzọ a na-aṅụ. Njikwa mma dị irè na-elekwasị anya n'ịnọgide na-enwe nguzozi mkpuchi site na ijikọta nlekota usoro oge, nnwale siri ike, na nchọpụta nsogbu ngwa ngwa - nke ọ bụla site na akpaaka na teknụzụ dijitalụ na-eme ka ọ sie ike.

Nlekota N'ime Ahịrị Na-emekarị: Viscosity, Okpukpu, na Otu

Nlekọta n'usoro na-aga n'ihu na-abụ isi ihe na-eme ka mkpuchi ahụ dịrị n'otu.

  • Viscositi:Sistemụ nha viscosity inline azụmaahịa, dị ka viscometers in-line akpaghị aka, na-enye nzaghachi oge na-aga n'ihu na viscosity mkpuchi. Nke a dị oke mkpa maka ọgwụ mkpuchi enteric, ebe viscosity na-ezighi ezi na-emetụta nhazi ihe nkiri, na-ebute ntụpọ ma ọ bụ mkpuchi mkpuchi na-adịghị mma. Viscometers akpaghị aka na-enye izi ezi na obere mmezi, na-ahụ na ngwọta mkpuchi ahụ ka dị n'ime oke viscosity zuru oke maka mbadamba enteric ma na-ebelata ntinye aka nke onye ọrụ.
  • Ọkpụrụkpụ:Tomography nke Optic Coherence (OCT) na-enye ohere ka a tụọ ọkpụrụkpụ mkpuchi ahụ n'enweghị mbibi, n'ime ahịrị. Ọ na-emepụta data n'oge na-adịghị anya na ọkpụrụkpụ ihe nkiri ahụ, otu ihe ahụ, na ọbụna oke elu. Teknụzụ OCT na-ejikọta nke ọma na porosity na ule siri ike na-anọghị n'ịntanetị, na-akwado njikwa usoro na mmepe ngwa ngwa nke usoro mkpuchi ọhụrụ.
  • Ịdị n'otu:Nyocha onyonyo elu akpaaka na nyocha spectrophotometric na-enye nlekota ọzọ maka agba, mma, na ịdị n'otu, ihe ngosi niile bụ isi nke usoro mkpuchi enteric ọgwụ na-aga nke ọma.

Sistemụ ndị ejikọtara ọnụ na-ejikọtakarị ihe mmetụta ndị a n'ime gburugburu nzaghachi dị njikere maka IoT, nke mechiri emechi, na-akwado atụmatụ Quality-by-Design (QbD) na nrubeisi iwu.

Usoro Nlele maka Nyocha Intra- na Inter-Batch

Nlele ọnụọgụgụ na-eme ka mkpuchi dịrị n'otu n'ime na n'etiti otu:

  • Nnwale n'ime otu:See ma ọ dịkarịa ala ihe atụ atọ site na ebe iri pụrụ iche n'ime drum ma ọ bụ blender n'oge mmepụta otu. Nke a na-eme ka a hụ na nsonaazụ ya na-apụta n'ọtụtụ mgbanwe usoro nwere ike ime.
  • Nlele n'etiti ogbe:Ntuziaka iwu na-atụ aro ka a nyochaa opekata mpe otu atọ nọọrọ onwe ha, yana opekata mpe ihe nlele isii kwa otu mgbe mgbanwe microstructural dị ala. Ụzọ a na-akwado mmụba nke otu otu na nnwale nha nha na ọgwụ.
  • Nnyocha na-ejikarị nha ọkpụrụkpụ, nlele anya, na ụzọ spectroscopic iji gosi na ha bụ otu. Usoro nnabata na-elekwasị anya na mgbanwe ọkọlọtọ na ọnụọgụ nke mgbanwe, yana usoro a na-enyocha ka oge na-aga iji chọpụta nsogbu ndị na-adịgide adịgide ma ọ bụ mgbanwe usoro.

Nchọpụta nsogbu na ihe ndị ọzọ gbasara mgbazi maka ihe mkpuchi ahụ

Nsogbu mkpuchi—dị ka ijiji, ịkpụcha akpụkpọ ahụ, na ịkpụcha akpụkpọ ahụ—nwere ike imebi ọrụ na ọdịdị nke mbadamba mkpuchi enteric. Nchọpụta nsogbu chọrọ ihe ndị a kapịrị ọnụ:

  • Ejima:Ọ na-abụkarị site na ọdịdị mbadamba ma ọ bụ ọsọ pan. Ọgwụgwọ gụnyere ịgbanwe ntụgharị pan, imeziwanye usoro isi mbadamba, na ijikwa ibu nke otu.
  • Mkpụmkpụ:Ihe na-esi na ngwakọta ma ọ bụ nkewa agba ezughi oke pụta. Meziwanye site na imeziwanye usoro ngwakọta, ịhazi ọnụego mmiri dị mma, ma ọ bụ ịgbanwe mgbasa nke agba.
  • Ịkpụcha:Ejikọtara ya na mkpuchi gbawara agbawa ma ọ bụ nrụgide igwe. Mezi ya site na ịgbanwe usoro mkpuchi ahụ - ịbawanye ọkwa plastik ma ọ bụ ịgbanwe ọnụego nkụ - iji melite iguzosi ike n'ezi ihe na mgbanwe nke ihe nkiri ahụ.

Ojiji nke usoro Ndozi na Mgbochi (CAPA) na-eme ka mkpebi ntụpọ dị mfe. Nyocha ihe kpatara ya na-ewepụ usoro ma ọ bụ ihe ndị na-adịghị mma, ebe ihe mgbochi na-eme ka ntụziaka na ntọala dịkwuo mma iji zere nlọghachi.

Nzaghachi na akpaaka n'oge na usoro mkpuchi

Mmeghachi omume akpaaka na nzaghachi oge na-akwalite arụmọrụ na ịdị mma na usoro mkpuchi enteric:

  • Sistemụ Njikwa Dị Elu:Nyiwe na teknụzụ nyocha usoro (PAT) nke IoT na-enyere aka na-achịkọta data usoro na-aga n'ihu. Sistemụ dị ka ndị na-emepụta ihe dijitalụ na gburugburu DataFactory nke AI na-enyocha usoro, na-eme ka mmeghachi omume mgbanwe na ọnụego ịgbasa, okpomọkụ ịkpọ nkụ, na viscosity mkpuchi.
  • Mgbanwe Mmezi Ozugbo:Sistemụ akpaaka na-aza ajụjụ gbasara nha dị n'ime site na ịgbanwe paramita dị mkpa ozugbo, na-ebelata oke ntụpọ na ihe mkpofu ihe.
  • Nkwenye Na-aga n'ihu:Ikpo okwu ndị a na-akwado ihe achọrọ maka nkwenye usoro na-aga n'ihu (CPV) dịka e depụtara na ntuziaka iwu, na-enyere ndị nrụpụta aka ịnọgide na-enwe otu mkpuchi na ịdị mma n'ofe usoro mmepụta.

Site na ijikọta nlekota viscosity azụmaahịa maka mkpuchi, nyocha ọkpụrụkpụ na-adịghị emebi emebi, na njikwa mmezi akpaaka, ndị na-emepụta ọgwụ na-enweta uru mkpuchi enteric na-adịgide adịgide ebe ha na-emezu ihe siri ike nke nrubeisi na arụmọrụ nke oge a.

Isi Ihe Ndị Dị Mkpa Maka Ịhazi Mkpuchi na Arụmọrụ Ọgwụ

Oke Mkpuchi Dị Mkpa: Maka nchekwa siri ike nke acid, debe obere ọkpụrụkpụ mkpuchi enteric nke 27.4 µm. Ọkpụrụkpụ nkezi nke ≥ 63.4 µm na-eme ka mkpụrụ ọgwụ niile a kpuchiri enteric mezuo ihe achọrọ maka ịgbaze ma nye nsonaazụ ọgwụgwọ na-aga n'ihu. Ekwesịrị iji usoro mkpebi dị elu dị ka optical coherence tomography (OCT) kwado ọkpụrụkpụ mkpuchi ahụ, nke na-eme ka a mata nha nha mkpuchi ahụ n'oge mmepụta ya.

Nnyocha Otu: Jiri ọrụ nkesa nyocha na paramita ọnụọgụgụ dịka ntụgharị ọkọlọtọ (RSD) iji tụọ nha nha mkpuchi n'ofe otu. Sistemụ OCT n'ịntanetị egosipụtala ike azụmaahịa, dakọtara ma na-agafekarị izi ezi nke usoro ọdịnala na-anọghị n'ịntanetị site n'inye SD dị n'etiti mbadamba dị ala dị ka 9 µm (ihe dị ka 13% RSD).

Nhazi Usoro Nhazi: Nyochaa ma melite paramita usoro dị mkpa—ọsọ ite, ọnụego ịgbasa, ikuku mbata, okpomọkụ ikuku anwụrụ ọkụ, anya egbe ruo n'ihe ndina, na nrụgide ikuku atomization.

Nhọrọ Polymer na Plasticizer: Họrọ polima dị elu maka ihe nkiri na-agbanwe agbanwe, dị gịrịgịrị na obere oge nhazi. Tụlee nhọrọ ndị dabere na nkwụsi ike dịka PVAP, methacrylic acid copolymers (Eudragit L/S), polyethylene glycol (PEG) dị ka plasticizer, ma ọ bụ shellac eke maka ngwa ọhụrụ. Nhọrọ ziri ezi na-emetụta nhazi ihe nkiri, mwepụta ọgwụ, ma nwee ike ime ka njikwa usoro dị mfe.

Ijikọta Sistemụ Ntụle Viscosity Na-aga n'ihu maka Njikwa Usoro Siri Ike

Nlekota Viscosity Inline: Tinye usoro nha viscosity dị n'ime ụlọ ahịa maka ọgwụ iji nọgide na-enwe viscosity mkpuchi zuru oke maka mbadamba enteric. Nha na njikwa oge dị mkpa maka njikwa viscosity mkpuchi, na-egbochi ntụpọ sitere na usoro viscosity dị n'okpuru ma ọ bụ karịa.

Uru Usoro:

  • Na-ahụ na a na-enyocha nha viscosity na-aga n'ihu n'imepụta ọgwụ, na-enye nzaghachi ozugbo na nhazi usoro mkpuchi enteric.
  • Na-ebelata mgbanwe dị iche iche n'otu otu ebe ọ na-akwado nnwale otu esi eji mkpuchi eme ihe na ọgwụ.
  • Na-eme ka mmeghachi omume dị mma nye nsogbu dịka mgbanwe nhazi ma ọ bụ mgbanwe akụrụngwa, na-eduga n'oge okirikiri ngwa ngwa na mbelata ihe mkpofu.

Usoro kacha mma ndị a, nke ngwaọrụ nyocha ọgbara ọhụrụ na njikwa usoro kwadoro, na-akọwapụta ụzọ kachasị mma isi mepụta mbadamba na mkpụrụ ọgwụ ndị a kpuchiri ekpuchi nke dị elu ma na-agbanwe agbanwe.

Ajụjụ Ndị A Na-ajụkarị

1. Gịnị bụ mkpuchi enteric, gịnịkwa mere o ji dị mkpa maka ọgwụ ọnụ?

Mkpuchi Enteric bụ ihe mkpuchi pụrụ iche nke a na-etinye n'ụdị ọgwụ ọnụ dịka mbadamba na kapsụl. Isi ihe kpatara ya bụ ichebe ọgwụ ahụ ka ọ ghara ịgbasa n'ime gburugburu acidic nke afọ, na-enye ohere ka ihe dị n'ime ya agbapụ naanị ozugbo ọ ruru ebe dị mma ma ọ bụ alkaline nke eriri afọ. Nke a na-egbochi ọgwụ acid-labile, dị ka ụfọdụ enzymes ma ọ bụ proton pump inhibitors, ka ọ ghara imebi tupu a na-amịnye ya. Ọ na-echebekwa mkpuchi afọ site na iwe site na ọgwụ ndị nwere ike ibute mmerụ ahụ, dị ka ọgwụ mgbochi mkpali na-abụghị steroidal (NSAIDs). Dịka ọmụmaatụ, abiraterone acetate nke a na-ekpuchi enteric na-anọgide na-adị ọcha n'oge njem afọ, na-eme ka a na-amịnye ya ebe ọ kacha dị irè. Usoro mkpuchi enteric dị mkpa na usoro mkpuchi enteric ọgwụ ma na-enye aka na bioavailability ọgwụ kacha mma, na-eme ka ọ bụrụ uru dị mkpa na nnyefe ọgwụ ọnụ.

2. Kedu ka viscosity mkpuchi si emetụta àgwà nke mbadamba mkpuchi enteric?

Ịdị ọcha nke mkpuchi ahụ—otú ihe ngwọta mkpuchi ahụ si dị oke ma ọ bụ mmiri mmiri—na-arụ ọrụ dị mkpa na usoro usoro mkpuchi enteric. viscosity nke ngwọta ahụ na-achịkwa mmiri, mgbasa, na njikọta nke ihe nkiri polymer na mbadamba ọ bụla. Ọ bụrụ na viscosity mkpuchi ahụ dị obere, ihe nkiri ahụ nwere ike ịghọ nke na-adịghị nhata, yana mpaghara dị gịrịgịrị nke na-anaghị echebe ọgwụ ahụ n'afọ. Ọ bụrụ na ọ dị oke elu, mmụba na ntụpọ dị ka mgbawa ma ọ bụ elu "peel oroma" nwere ike ime. Ịnọgide na-enwe viscosity mkpuchi zuru oke maka mbadamba enteric dị mkpa iji nweta ihe mgbochi yiri nke ahụ, nke na-enye iguzogide acid na mwepụta ọgwụ a na-achịkwa. Njikwa viscosity kwesịrị ekwesị na-egbochikwa ntụpọ nrụpụta dị ka delamination ma na-ahụ na arụmọrụ a pụrụ ịdabere na ya na otu ọ bụla.

3. Kedu usoro nha viscosity inline azụmaahịa na gịnị mere eji eji ha eme ihe mkpuchi enteric?

Sistemụ nha viscosity inline azụmaahịa maka ọgwụ bụ ihe mmetụta ma ọ bụ ngwaọrụ arụnyere ozugbo na ahịrị mkpuchi. Sistemụ ndị a na-enyocha ma na-achịkwa viscosity nke ngwọta mkpuchi n'oge mmepụta. Nlekọta viscosity inline maka mkpuchi na-enyere aka idobe viscosity ebumnuche, belata nnwale aka, ma chọpụta ngwa ngwa mgbanwe usoro. Viscometers in-line akpaghị aka na sistemụ dị elu dị ka kinematic capillary ma ọ bụ microfluidic viscometers na-akwado njikwa viscosity mkpuchi site na inye mkpuchi kwụsiri ike, nke a na-emegharị emegharị. Nke a na-ebelata mgbanwe na ọdịdị na ọrụ mbadamba, na-echekwa ịdị mma nke ogbe, ma na-enyere aka iru ụkpụrụ omume nrụpụta dị mma (GMP). Nha viscosity na-aga n'ihu na mmepụta ọgwụ, karịsịa maka ọgwụ mkpuchi enteric, na-eme ka obere ntụpọ mkpuchi, obere ọnụego ịjụ, na arụmọrụ ngwaahịa na-aga n'ihu.

4. Gịnị mere otu ihe mkpuchi ji dị oke mkpa maka mkpụrụ ọgwụ mkpuchi enteric?

Nha nhata nke mkpuchi enteric pụtara ọkpụrụkpụ na mkpuchi na-adịgide adịgide na mbadamba ọ bụla n'otu ngwugwu. Mkpuchi na-adịghị agbanwe agbanwe nwere ike ibute nchebe nke ọma, na-eme ka ọgwụ ahụ na-apụta n'oge afọ ma ọ bụ ghara ịrụ ọrụ dịka e zubere ya n'ime eriri afọ. Nke a nwere ike imebi arụmọrụ, nchekwa, na nrubeisi iwu, ma nwee ike ịbawanye ohere nke mmebi ọgwụ ma ọ bụ mmetụta ọjọọ nke onye ọrịa. Obere ọdịiche dị na ọkpụrụkpụ mkpuchi na-emetụta kpọmkwem ọnụego mwepụta ọgwụ na nsonaazụ ọgwụgwọ. Nnwale nha nha mkpuchi na ọgwụ na-adaberekarị na usoro nyocha na-adịghị emebi emebi iji hụ na mkpụrụ ọgwụ ọ bụla a kpuchiri enteric na-enye nchebe na mwepụta a na-achịkwa mgbe niile.

Ngwa Ndị Ọzọ


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