Na narị afọ akụkọ ihe mere eme nke capsules, gelatin ka nọgidere na-enwe ọnọdụ nke mainstream capsule ihe n'ihi na ya obosara isi mmalite, ike anụ ahụ na kemịkalụ Njirimara na magburu onwe nhazi Njirimara.Site na mmụba nke mmasị ndị mmadụ maka capsules, capsules oghere ka a na-ejikarị n'ubi nri, ọgwụ na ngwaahịa ahụike.
Otú ọ dị, ihe omume na mgbasa nke ọrịa ehi ara na ọrịa ụkwụ na ọnụ na-eme ka ndị mmadụ malite ichegbu onwe ha maka ngwaahịa anụmanụ sitere.Ngwa ngwa gelatin a na-ejikarị bụ ọkpụkpụ na akpụkpọ anụ ehi na ezì, ihe ize ndụ ya ejiriwokwa nke nta nke nta dọta uche ndị mmadụ.Iji belata ihe ize ndụ nchekwa nke akụrụngwa capsule oghere, ndị ọkachamara ụlọ ọrụ na-aga n'ihu na-eme nyocha na imepụta ihe capsule sitere na osisi kwesịrị ekwesị.
Na mgbakwunye, na mmụba nke ụdị capsules dị iche iche, ịdị iche iche nke ọdịnaya ha ji nwayọọ nwayọọ na-eme ka ndị mmadụ ghọta na enwere nsogbu ndakọrịta n'etiti capsules gelatin oghere na ụfọdụ ọdịnaya nwere ihe pụrụ iche.Dịka ọmụmaatụ, ọdịnaya nke nwere otu aldehyde ma ọ bụ imeghachi omume iji mepụta otu aldehyde n'okpuru ọnọdụ ụfọdụ nwere ike iduga na njikọ nke gelatin;Ihe dị n'ime ya nwere mweghachi siri ike nwere ike inwe mmeghachi omume Maillard na gelatin;Ọdịnaya nwere hygroscopicity siri ike ga-eme ka shea nke Ming capsule tụfuo mmiri wee tufuo isi ike mbụ ya.Nkwụsi ike nke capsule nke oghere gelatin na-eme ka mmepe nke ihe capsule ọhụrụ na-adọrọ mmasị karịa.
Kedu ihe ndị sitere na osisi dị mma maka mmepụta nke oghere capsules siri ike?Ndị mmadụ anwalela ọtụtụ ihe.Ngwa akwụkwọ ikike patent nke China Mba: 200810061238 X etinyere maka iwere cellulose sodium sulfate dị ka isi ihe capsule;200510013285.3 etinyere maka iwere starch ma ọ bụ starch mejupụtara dị ka isi ihe capsule;Wang GM [1] kọrọ na e si na capsules chitosan mee capsules oghere;Zhang Xiaoju et al.[2] kọrọ ngwaahịa na Konjac soybean protein dị ka isi capsule ihe.N'ezie, ihe ndị a na-amụkarị bụ ihe cellulose.N'ime ha, capsules oghere nke hydroxypropyl methylcellulose (HPMC) emepụtala nnukwu mmepụta.
A na-eji HPMC eme ihe na ngalaba nri na ọgwụ.Ọ bụ ihe mgbakwunye ọgwụ na-ejikarị eme ihe, nke gụnyere na Pharmacopoeia nke mba dị iche iche;FDA na EU kwadoro HPMC dị ka ihe mgbakwunye nri ozugbo ma ọ bụ na-apụtaghị ìhè;Gras bụ ihe nchekwa, Mba GRN 000213;Dabere na nchekwa data JECFA, INS no.464, enweghị oke na oke kwa ụbọchị nke HPMC;Na 1997, Ministri ahụike nke China kwadoro ya dị ka ihe mgbakwunye nri na ihe na-esi ísì ụtọ (No. 20), nke na-emetụta ụdị nri ọ bụla ma gbakwunye ya dị ka mmepụta chọrọ [2-9].N'ihi ọdịiche nke ihe onwunwe n'etiti HPMC na gelatin, ndenye ọgwụ nke HPMC hollow capsule dị mgbagwoju anya karị, na ọ dị mkpa ka agbakwunye ụfọdụ ihe ndị na-emepụta gelling, dị ka chịngọm Arab, carrageenan (mmiri mmiri), starch, wdg.
HPMC oghere capsule bụ ngwaahịa nwere echiche eke.Ndị otu ndị Juu, Alakụba na ndị anaghị eri anụ ghọtara ihe ya na teknụzụ mmepụta ya.Ọ nwere ike gboo mkpa nke ndị nwere okpukpe dị iche iche na omume iri nri, ma nwee nnabata dị elu.Na mgbakwunye, HPMC oghere capsules nwere ihe ndị a pụrụ iche:
1.Low mmiri ọdịnaya - banyere 60% ala karịa gelatin oghere capsule
Ọdịnaya mmiri nke capsules oghere gelatin na-abụkarị 12.5% - 17.5% [10].Ekwesịrị ịchịkwa okpomọkụ na iru mmiri nke gburugburu ebe obibi n'ime oke kwesịrị ekwesị n'oge mmepụta, njem, ojiji na ichekwa capsules oghere.Okpomọkụ kwesịrị ekwesị bụ 15-25 ℃ na iru mmiri dị n'etiti 35% - 65%, nke mere na enwere ike ịnọgide na-arụ ọrụ nke ngwaahịa ahụ ogologo oge.Ọdịnaya mmiri nke akpụkpọ ahụ HPMC dị obere, n'ozuzu 4% - 5%, nke dị ihe dịka 60% dị ala karịa nke capsule oghere gelatin (Fig 1).Mgbanwe mmiri na gburugburu ebe obibi n'oge nchekwa ogologo oge ga-abawanye ọdịnaya mmiri nke HPMC oghere capsule na nkwakọ ngwaahịa akọwapụtara, mana ọ gaghị agafe 9% n'ime afọ ise.
Fig1.Ntụle LOD nke HMPC na shei Gelatin n'okpuru RH dị iche iche
Njirimara nke ọdịnaya mmiri dị ala na-eme ka capsule oghere HPMC dabara adaba maka imeju ihe dị n'ime hygroscopic ma ọ bụ mmiri dị ogologo iji gbatịa ndụ shelf nke ngwaahịa ahụ.
2.High siri ike, ọ dịghị brittleness
Dị ka e kwuru n'elu, ihe nkiri gelatin nwere kpọmkwem mmiri ọdịnaya.Ọ bụrụ na ọ dị ala karịa oke a, ihe nkiri gelatin ga-abụ nke ukwuu.Nkịtị gelatin oghere capsules na-enweghị ihe mgbakwunye ọ bụla nwere ihe ize ndụ nke brittleness karịa 10% mgbe mmiri ọdịnaya bụ 10%;Mgbe ọdịnaya mmiri ahụ na-aga n'ihu na-ebelata ruo 5%, 100% brittleness ga-eme.N'ụzọ dị iche, ndị siri ike nke HPMC oghere capsules dị nnọọ mma, na ha na-anọgide na-arụ ọrụ ọma ọbụna ma ọ bụrụ na gburugburu ebe obibi iru mmiri bụ ala (Fig. 3).N'ezie, embrittlement ọnụego nke HPMC oghere capsules na dị iche iche ndenye n'okpuru ala iru mmiri ga-egosi oké iche.
N'ụzọ megidere nke ahụ, capsules gelatin oghere etinyere na gburugburu oke iru mmiri ga-adị nro, gbanwee ma ọ bụ ọbụna daa mgbe ọ gbasasịrị mmiri.HPMC oghere capsule nwere ike ịnọgide na-enwe ezigbo udi na arụmọrụ ọbụna n'okpuru ọnọdụ nke elu iru mmiri.Ya mere, HPMC oghere capsule nwere ike ime mgbanwe na gburugburu ebe obibi.Mgbe mpaghara ahịa nke ngwaahịa ahụ na-ekpuchi mpaghara ihu igwe dị iche iche ma ọ bụ ọnọdụ nchekwa adịghị mma, uru a nke HMPC oghere capsule dị oke mkpa.
3.Strong chemical kwụsie ike
Mmeghachi omume na-ejikọta ọnụ nke capsules gelatin bụ nsogbu ogwu na-ezute site na nkwadebe capsule.N'ihi na otu aldehyde nke ọdịnaya na-emeghachi omume na amino acid nke amino acid na gelatin iji mepụta usoro netwọkụ, shei capsule siri ike igbari n'okpuru ọnọdụ mgbasa na vitro, nke na-emetụta ntọhapụ nke ọgwụ.Hydroxypropyl methylcellulose bụ ihe sitere na cellulose, bụ nke na-adịghị arụ ọrụ nke kemịkalụ ma nwee ezigbo ndakọrịta na ọtụtụ ihe.Ya mere, HPMC oghere capsule enweghị ihe ize ndụ nke cross-njikọ mmeghachi omume na elu kemịkal kwụsie ike
4.Good mkpuchi arụmọrụ
A na-eji capsules mkpuchi nke enteric mee ihe maka ọgwụ ndị dị mfe nke gastric acid mebie, na-akpasu mucosa afọ ma ọ bụ mkpa nlekọta ezubere iche.Nkà na ụzụ nke mba ụwa nabatara nke capsules mkpuchi ime bụ mkpuchi n'ozuzu nke pellets na capsules nwere mkpuchi.HPMC oghere capsule na-egosi uru pụrụ iche na mkpuchi n'ozuzu nke capsule.
The nnyocha na-egosi na n'ihi ike ike elu nke HPMC oghere capsule, mmekọrịta na ọtụtụ enteric mkpuchi ihe bụ budata elu karịa gelatin, na adhesion ọsọ na uniformity nke mkpuchi ihe bụ budata mma karịa gelatin, karịsịa mkpuchi ntụkwasị obi nke okpu okpu junction. na-emeziwanye nke ọma.Nnwale mgbasa nke in vitro gosiri na ikike nke capsule HPMC dị n'ime afọ dị ala ma enwere ntọhapụ dị mma n'ime eriri afọ.
Mmechi
Njirimara nke capsule oghere HPMC agbasawanyela mpaghara ngwa ya.Site na ngwaahịa niile sitere n'okike ruo na mmiri dị nro ma ọ bụ ọdịnaya hygroscopic, ọ nwekwara ngwa pụrụ iche n'ọhịa nke inhalants ntụ ntụ na mkpuchi enteric.Ekwesiri iburu n'uche na HPMC oghere capsules ugbu a n'ahịa n'ụlọ na ná mba ọzọ nwere ikuku oxygen dị elu na nkwụsịtụ nwayọọ karịa gelatin oghere capsules, mana bioavailability ha na vivo yiri [11], nke kwesịrị ịtụle na nyocha na mmepe.
Dị ka anyị niile maara, e nwere ụzọ dị anya isi na nyocha ụlọ nyocha, nnwale buru ibu, mmepụta ụlọ ọrụ na nkwalite ahịa.Nke a bụ ya mere, mgbe nyocha na mmepe nke ọtụtụ afọ gasịrị, ọ bụ naanị ngwaahịa capsule ole na ole nwere oghere nke sitere na ihe ndị sitere na osisi ka e depụtara nke ọma.Na 1997, capsugel butere ụzọ n'ịdepụta HPMC oghere capsule vcapstm na United States, na-enye nhọrọ ọhụrụ maka capsule ọnụ.Ka ọ dị ugbu a, ọnụ ahịa ahịa kwa afọ nke HPMC oghere capsules n'ụwa karịrị ijeri 20, ma na-eto eto na ọnụego 25% kwa afọ.
Oge nzipu: Mee-06-2022