1. Ihe ndị bụ isi nke HPMC
Hydroxypropyl methylcellulose, aha Bekee bụ hydroxypropyl methylcellulose, makwaara dị ka HPMC.Usoro ihe omimi ya bụ C8H15O8-(C10Hl8O6)N-C8HL5O8, na ịdị arọ ya dị ihe dịka 86,000.Ngwaahịa a bụ ọkara sịntetik, nke nwere akụkụ methyl na akụkụ cellulose polyhydroxypropyl ether.Enwere ike ime ya site na ụzọ abụọ: otu bụ ịgwọ ọkwa kwesịrị ekwesị nke methyl cellulose na NaOH, wee meghachi omume na propylene oxide n'okpuru nnukwu okpomọkụ na nrụgide dị elu.A ghaghị ịkwado oge mmeghachi omume ahụ ka e wee gbanwee otu methyl na hydroxypropyl ka ọ bụrụ ethers.Ụdị ahụ dị ma jikọta ya na mgbanaka glucose akpọnwụ akpọnwụ nke cellulose ruo n'ókè achọrọ;nke ọzọ bụ iji caustic soda na-emeso owu lint ma ọ bụ osisi pulp fiber iji meghachi omume iji nweta methane chloride na propylene oxide, nke nwere ike nụchaa ma gbadaa.Mee ya ka ọ bụrụ ntụ ntụ ma ọ bụ granules dị mma.HPMC bụ cellulose osisi sitere n'okike yana ezigbo ọgwụ excipient nwere ọtụtụ isi mmalite.A na-eji ya eme ihe ugbu a n'ụlọ na ná mba ọzọ ma bụrụ otu n'ime ọgwụ ndị a na-ejikarị eme ihe na ọgwụ ọnụ.
Ngwaahịa a na-acha ọcha na-acha ọcha na-acha ọcha, anaghị egbu egbu, enweghị isi, granular ma ọ bụ fibrous, ntụ ntụ na-adị mfe.Dịtụ kwụsiri ike n'okpuru ìhè na iru mmiri.Ọ na-agbasa na mmiri oyi na-etolite mmiri ara ehi colloidal ngwọta na ụfọdụ viscosity, na sol-gel interconversion phenomen mere n'ihi na okpomọkụ mgbanwe nke ngwọta na a ụfọdụ itinye uche.Na-agbaze nke ukwuu na 70% ethanol ma ọ bụ dimethyl ketone, mana enweghị ike ime ya na ethanol zuru oke, chloroform ma ọ bụ ethoxyethane.
Uru pH nke hydroxypropyl methylcellulose dị n'etiti 4.0 na 8.0, ma nwee nkwụsi ike dị mma.Uru pH kwụsiri ike n'etiti 3.0 na 11.0.Enwere ike ịchekwa ya na 20 Celsius C na iru mmiri nke 80% maka ụbọchị 10.Ọnụego nnabata mmiri nke HPMC bụ 6.2%.
Hydroxypropyl methylcellulose nwere ụdị ngwaahịa dị iche iche n'ihi ọdịnaya dị iche iche nke methoxy na otu hydroxypropyl dị na nhazi ahụ.N'ebe dị iche iche, ụdị ngwaahịa dị iche iche nwere kpọmkwem viscosity na thermal Njirimara.Gel okpomọkụ ya mere nwere ihe dị iche iche nwere ike iji mee ihe dị iche iche.Mba ọ bụla pharmacopoeia nwere dị iche iche ihe nlereanya chọrọ na okwu: European Pharmacopoeia dabeere na dị iche iche viscosities, dị iche iche degrees nke nnọchi, ojiji ọkwa na ọnụ ọgụgụ nke dị iche iche akara ule nke ngwaahịa na-ere n'ahịa.Ngalaba nke United States Pharmacopoeia bụ mPa·s, na aha ndị a na-akpọkarị bụ ndị a Jiri ọnụọgụ anọ na-anọchi anya ọdịnaya nke hydroxypropyl methylcellulose dị iche iche na ụdị dị iche iche, dị ka hydroxypropyl methylcellulose, 2208. Nkeji abụọ mbụ na-anọchite anya pasent dị nso. nke otu methoxy, na ọnụọgụ abụọ ikpeazụ na-anọchi anya otu hydroxyl.Odika pasenti propyl.
2. HPMC etisasịwo na mmiri usoro
2.1 Usoro mmiri ọkụ
Ebe ọ bụ na hydroxypropyl cellulose bụ ihe a na-adịghị ahụkebe na mmiri ọkụ, ọ nwere ike ịgbasa ya na mmiri ọkụ wee mee ka ọ dị jụụ.A na-ewebata usoro nke abụọ dị ka ndị a:
(1) Tinye mmiri ọkụ achọrọ n'ime akpa wee kpoo ya ihe dịka 70 Celsius.Tinye nke nta nke nta ka ị na-emegharị nwayọọ nwayọọ.Na mbụ, ngwaahịa ahụ na-ese n'elu mmiri wee jiri nwayọọ nwayọọ mepụta slurry.
(2) Tinye 1/3 ma ọ bụ 2/3 nke mmiri achọrọ n'ime akpa ahụ wee kpoo ya na 70 Celsius C iji gbasaa ngwaahịa ahụ, dozie slurry mmiri ọkụ, wee gbakwunye ihe fọdụrụ nke mmiri oyi ma ọ bụ tinye ice. mmiri na mmiri ọkụ slurry.slurry na mmiri, kpalie ngwakọta mgbe obi jụrụ.
2.2 Usoro ngwakọta ntụ ntụ
A na-agbasasị akụkụ ntụ ntụ nke ọma site na ngwakọta akọrọ na nha ma ọ bụ karịa nke ihe ndị ọzọ na-eme ntụ ntụ wee gbazee na mmiri, ebe HMCS na-agbaze na-enweghị coagulation.
3. Uru nke HPMC
3.1 Soluble na mmiri oyi
Ọ bụ soluble na mmiri oyi n'okpuru 40 ℃ ma ọ bụ 70% ethanol, na ihu ọma insoluble na mmiri ọkụ n'elu 60 ℃, ma ike gel.
3.2 Chemical inertness
HPMC bụ ether cellulose na-abụghị ionic.Ngwọta ya enweghị ụgwọ ionic na anaghị emekọ ya na nnu ígwè ma ọ bụ ogige ionic organic.Ya mere, ndị ọzọ excipients adịghị emeghachi omume na ya n'oge nkwadebe mmepụta usoro.
3.3 Nkwụsi ike
Ọ kwụsiri ike na acid na alkali ma nwee ike ịchekwa ya ogologo oge n'etiti pH 3 na 1l na-enweghị mgbanwe dị ukwuu na viscosity.Aqueous ngwọta nke hydroxypropyl methylcellulose (HPMC) bụ antifungal ma na-ejigide ezigbo viscosity nkwụsi ike n'oge nchekwa ogologo oge.Nkwụsi ike dị mma nke HPMC dị mma karịa ihe mgbakwunye ọdịnala (dịka dextrin, starch, wdg).
3.4 viscosity na-agbanwe agbanwe
Ụdị viscosity dị iche iche nke HPMC nwere ike ịdị na nha dị iche iche, na viscosity ha nwere ike gbanwee dị ka mkpa ọ dị ịgbaso iwu ụfọdụ ma nwee mmekọrịta dị mma, ya mere enwere ike ịhọrọ oke dịka mkpa.
3.5 Metabolic inertness
A naghị etinye HPMC ma ọ bụ metabolized n'ime ahụ ma ọ naghị enye okpomọkụ, ya mere ọ bụ ihe nchekwa dị mma maka nkwadebe ọgwụ.
3.6 Nchekwa
A na-ewere HPMC dị ka ihe anaghị egbu egbu, ihe na-adịghị ewe iwe, yana LD50 nke 5g/kg n'ime oke na 5.2g/kg n'ime oke.Usoro onunu ogwu kwa ubochi enweghi ihe ojoo nye mmadu.
4 Ngwa nke HPMC na nkwadebe
4.1 Ihe mkpuchi ihe nkiri na ihe na-emepụta ihe nkiri
A na-eji Hydroxypropyl methylcellulose (HPMC) mee ihe dị ka ihe mkpuchi ihe nkiri.Mbadamba ụrọ ya enweghị uru doro anya karịa mbadamba nkume ndị a na-etinye n'ụdị dị ka mbadamba shuga n'ihe gbasara ikpuchi uto na ọdịdị nke ọgwụ ahụ, mana ike ya, brittleness, na hygroscopicity , adịghị mma nkewa., mkpuchi ibu ibu na ihe ngosi ndị ọzọ dị mma ka mma.A na-eji ọkwa viscosity dị ala nke ngwaahịa a dị ka ihe mkpuchi ihe nkiri na-edozi mmiri maka mbadamba nkume na ọgwụ, na ọkwa viscosity dị elu na-eji ihe mkpuchi ihe nkiri maka usoro ihe mgbaze organic.Ntinye uche na-abụkarị 2.0% ~ 20%.
4.2 Dị ka ihe na-ekekọta na nkewa
Enwere ike iji ọkwa viscosity dị ala nke ngwaahịa a dị ka ihe nkedo na disintegrant maka mbadamba nkume, mkpụrụ ọgwụ, na granules, ebe ọkwa viscosity dị elu nwere ike iji naanị dị ka ihe nkedo.Usoro onunu ogwu dịgasị iche dabere na ihe nlereanya na ihe achọrọ, n'ozuzu 5% maka mbadamba ụrọ granulation na 2% maka mbadamba ụrọ mmiri.
4.3 Dị ka enyemaka nkwusioru
Onye na-ahụ maka nkwụsịtụ bụ ihe gel viscous nke bụ hydrophilic na enwere ike iji mee ka ọ kwụsịlata ngwa ngwa nke irighiri ihe ma na-arapara n'elu ihe ndị ahụ iji gbochie ihe ndị ahụ na-agbakọta na bọọlụ.Ihe enyemaka nkwusioru na-arụ ọrụ dị mkpa n'imepụta ihe nkwusioru.HPMC bụ ihe mgbakwunye nkwusioru dị mma.Ngwọta colloidal gbazere ya nwere ike belata esemokwu interfacial siri ike nke mmiri mmiri na ike efu nke obere ihe siri ike, si otú a na-eme ka nkwụsi ike nke sistemu mgbasa ozi dị iche iche.Ngwaahịa a bụ nkwadebe nkwusioru dị elu nke nwere mmetụta nkwusioru dị mma, mgbasa ozi dị mfe, mgbidi na-adịghị mma, yana ezigbo flocculation ahụ.Usoro ọgwụgwọ ya bụ 0.5% ruo 1.5%.
4.4 Dị ka onye nkwụghachi azụ, onye na-ahapụ ya na porogen
A na-eji ọkwa viscosity dị elu nke ngwaahịa a iji dozie mbadamba nkume na-ahapụ hydrophilic gel matrix, mbadamba ihe agwakọta ihe na-akwado-mwepụta nke ndị na-azụ ahịa na ndị ọrụ na-achịkwa.Ọ nwere mmetụta nke igbu oge ntọhapụ ọgwụ.Nleba ojiji ya bụ 10%-80% (W/W).A na-eji ọkwa viscosity dị ala dị ka ndị na-akpali akpali n'ụdị ntọhapụ akwadoro ma ọ bụ na-achịkwa.Mbadamba ụrọ dị otú ahụ nwere ike nweta ngwa ngwa mbụ achọrọ maka mmetụta ọgwụgwọ, wee mepụta mmetụta ntọhapụ na-adịgide adịgide ma ọ bụ na-achịkwa, ma na-ejigide mkpokọta ọgwụ ọbara dị irè n'ime ahụ.Hydroxypropyl methylcellulose hydrates n'ime mmiri iji mepụta akwa gel.Usoro ntọhapụ ọgwụ nke mbadamba matriks na-agụnyekarị mgbasa nke oyi akwa gel na mgbasa nke oyi akwa gel.
4.5 Thickers na nchebe colloid
Mgbe ngwaahịa a na-eji dị ka a thickener, a na-ejikarị ịta bụ 0.45% ~ 1.0%.Ngwaahịa a nwekwara ike ime ka nkwụsi ike nke gluu hydrophobic dịkwuo elu, na-emepụta colloid nchebe, na-egbochi ihe ndị sitere na agglomeration na agglomeration, si otú ahụ na-egbochi nhazi nke mmiri ozuzo.Ọnụ ọgụgụ ya na-emekarị bụ 0.5% ~ 1.5%.
4.6 Jiri dị ka ihe capsule
Ọtụtụ mgbe, ihe mkpuchi capsule nke capsules bụ gelatin.Usoro mmepụta nke shells capsule gelatin dị mfe, ma enwere nsogbu na ihe ndị dị ka nchebe na-adịghị mma megide mmiri mmiri na ọgwụ ndị na-emetụta ikuku oxygen, mbelata mgbasa ọgwụ ọgwụ, na nkwụsịtụ nke shells capsule n'oge nchekwa.Ya mere, a na-eji hydroxypropyl methylcellulose dochie ihe capsule na nkwadebe nke capsules, nke na-eme ka mmepụta, ịkpụzi na ojiji nke capsules dịkwuo mma, ma kwalitere ya n'ụlọ na ná mba ọzọ.
4.7 Dị ka bioadhesive
Teknụzụ bioadhesion na-eji ihe mgbakwunye nwere polymers bioadhesive iji rube isi na mucosa dị ndụ ma kwalite ngbanwe na nchichi nke kọntaktị n'etiti nkwadebe na mucosa, na-enye ohere iji nwayọ wepụta ọgwụ ahụ ma tinye ya na mucosa iji nweta ebumnuche ọgwụgwọ.Iji mezuo ebumnuche ọgwụgwọ, a na-eji ya ugbu a na-agwọ ọrịa na oghere imi, mucosa ọnụ na akụkụ ahụ ndị ọzọ.Teknụzụ bioadhesion nke eriri afọ bụ ụdị usoro nnyefe ọgwụ ọhụrụ emepụtara n'afọ ndị na-adịbeghị anya.Ọ bụghị naanị na ọ na-agbatị oge obibi nke nkwadebe ọgwụ na tract gastrointestinal, kamakwa na-eme ka ọrụ kọntaktị dị n'etiti ọgwụ ahụ na saịtị absorption cell membrane ma gbanwee nhazi nke akpụkpọ ahụ.Mobility, ya bụ, permeability nke ọgwụ na cell epithelial intestinal, si otú ahụ.
Oge nzipu: Feb-01-2024