The nkịtị excipients nke ọnụ siri ike onunu ogwu ụdị

Nkwadebe siri ike ugbu a bụ ụdị usoro ọgwụgwọ kachasị na-ekesa na nke a na-ejikarị eme ihe n'ahịa, na ha na-enwekarị isi ihe abụọ na ihe mgbakwunye. Excipients, nke a makwaara dị ka excipients, na-ezo aka n'ozuzu okwu maka ihe niile agbakwunyere na nkwadebe siri ike ma e wezụga ọgwụ bụ isi. Dị ka ihe dị iche iche na ọrụ dị iche iche nke ndị na-emepụta ihe si dị, a na-ekewakarị ihe ndị na-emepụta ihe nke nkwadebe siri ike n'ime: fillers, binders, disintegrants, lubricants, ntọhapụ regulators, na mgbe ụfọdụ ndị na-agba agba na ndị na-esi ísì ụtọ nwekwara ike ịgbakwunye dị ka ihe ndị a chọrọ maka nkwadebe ahụ. iji meziwanye Ma ọ bụ gbanwee ọdịdị na uto nke nhazi ahụ.
The excipients nke siri ike nkwadebe kwesịrị izute chọrọ maka ọgwụ ojiji, na nwere ndị na-esonụ àgwà: ①Ọ kwesịrị inwe elu kemịkal kwụsie ike na ọ dịghị ihe ọ bụla anụ ahụ na chemical mmeghachi omume na isi ọgwụ; ② O kwesịghị imetụta mmetụta ọgwụgwọ na mkpebi ọdịnaya nke isi ọgwụ; ③Onweghi ihe ojoo na-aru mmadu Aru, nsi ise, enweghi mmeghachi omume ojoo.
1. Filler (dị mkpa)
N'ihi obere dose nke ọgwụ bụ isi, dose nke ụfọdụ ọgwụ mgbe ụfọdụ bụ nanị ole na ole milligrams ma ọ bụ obere, nke na-adịghị mma na mbadamba akpụ ma ọ bụ nlekọta ụlọ ọgwụ. Ya mere, mgbe isi ihe dị n'ime ọgwụ na-erughị 50mg, ọ dị mkpa ka agbakwunyere ụfọdụ dose nke ndochi, nke a makwaara dị ka diluent.
Ihe ndochi dị mma kwesịrị ịbụ nke physiologically na kemịkalụ inert ma ghara imetụta bioavailability nke ọgwụ na-arụ ọrụ. Ihe ndochi nke a na-ejikarị gụnyere: ① Starch, gụnyere ọka wit, starch ọka, na starch nduku, n'ime nke ọka starch ka a na-ejikarị; kwụsiri ike na okike, dị ala na hygroscopicity, mana ogbenye na mkpakọ; ② Lactose, magburu onwe ya na akụrụngwa na compressible, ezigbo mmiri mmiri; ③ sucrose, nwere hygroscopicity siri ike; ④ pregelatinized starch, nke a makwaara dị ka stachi compressible, nwere ezigbo mkpakọ, fluidity na onwe lubricity; ⑤ microcrystalline cellulose, nke a na-akpọ MCC, nwere ikike njide siri ike na ezigbo mkpakọ; mara dị ka "ihe nkedo akọrọ"; ⑥ Mannitol, ma e jiri ya tụnyere ihe ndị dị n'elu, dị ntakịrị ọnụ karịa, a na-ejikarị ya na mbadamba nkume ndị a na-ata ahụhụ, nke nwekwara uto dị nro; ⑦ Inorganic salts, tumadi gụnyere calcium sulfate, calcium phosphate, calcium carbonate, wdg, na dịtụ kwụsiri ike anụ ahụ na chemical Njirimara.
2. Onye na-edozi mmiri na nrapado
A na-agbakwunye ihe ndị na-eme mmiri mmiri na ihe nkedo n'oge usoro granulation. Onye na-ahụ maka mmiri n'onwe ya abụghị viscous, kama mmiri mmiri nke na-eme ka viscosity nke ihe ahụ na-eme ka ọ bụrụ ihe na-edozi ahụ. Ihe ndị na-eme ka mmiri na-ekpo ọkụ na-agụnyekarị mmiri na-ekpo ọkụ na ethanol, n'ime nke mmiri na-ekpo ọkụ bụ nke mbụ nhọrọ.
Adhesives na-ezo aka na ihe inyeaka na-adabere na viscosity nke ha iji nye ihe na-adịghị viscos ma ọ bụ nke na-ezughị ezu na viscosity kwesịrị ekwesị. Adhesives ndị a na-ejikarị eme ihe na-agụnye: ① Starch slurry, nke bụ otu n'ime ihe ntanye a na-ejikarị eme ihe, dị ọnụ ala , ma nwee arụmọrụ dị mma, na ntinye uche a na-ejikarị bụ 8%-15%; ② Methylcellulose, nke a na-akpọ MC, nwere ezigbo mmiri solubility; ③Hydroxypropylcellulose, nke a na-akpọ HPC, nwere ike iji mee ihe dị ka onye na-ekekọta ntụ ntụ kpọmkwem tableting; ④ Hydroxypropylmethylcellulose, nke a na-akpọ HPMC, ihe a na-agbaze na mmiri oyi; ⑤ Carboxymethylcellulose sodium, nke a na-akpọ CMC-Na, dị mma maka ọgwụ ọjọọ na-adịghị mma; ⑥Ethylcellulose, nke a na-akpọ EC, ihe na-adịghị edozi na mmiri, ma soluble na ethanol; ⑦Povidone, nke a na-akpọ PVP, ihe ahụ dị oke hygroscopic, soluble na mmiri na ethanol; ⑧Na mgbakwunye, enwere polyethylene glycol (nke a na-akpọ PEG), Ihe ndị dị ka gelatin.
3. Na-agbasa
Ndị na-agbasasị na-ezo aka na ihe ndị na-akwalite mgbawa ngwa ngwa nke mbadamba nkume n'ime obere irighiri mmiri dị n'ime eriri afọ. Ewezuga mbadamba ụrọ nwere ihe pụrụ iche dị ka mbadamba ụrọ ewepụtara, mbadamba ihe a na-achịkwa, na mbadamba ụrọ a na-ata ahụhụ, ọ dị mkpa ka etinyekwa ihe ndị na-agbasa. Ihe mgbasa a na-ejikarị eme ihe bụ: ① starch akọrọ, dabara adaba maka ọgwụ na-adịghị ike ma ọ bụ nke na-agbaze ntakịrị; ② carboxymethyl starch sodium, nke a na-akpọ CMS-Na, ihe a bụ ihe na-arụ ọrụ nke ọma; ③ hydroxypropyl cellulose dị ala dochie anya, nke a na-akpọ L-HPC, nke nwere ike ịza ngwa ngwa mgbe ọ gbasasịrị mmiri; ④Cross-njikọ methyl cellulose sodium, zoro aka dị ka CCMC-Na; ihe na-ebu ụzọ zaa n'ime mmiri wee gbazee, na-adịghị edozi na ethanol; Mwepu bụ na ọ nwere hygroscopicity siri ike ma na-ejikarị granulation nke mbadamba nkume ma ọ bụ mbadamba nkume a na-ata ata; ⑥Effervescent disintegrants tumadi gụnyere ngwakọta nke sodium bicarbonate na citric acid, na citric acid, fumaric acid, na sodium carbonate nwekwara ike iji , Potassium Carbonate na Potassium Bicarbonate wdg.
4. Mmanu mmanu
Enwere ike kewaa mmanye n'ụzọ sara mbara ụzọ atọ, gụnyere glidants, ndị na-egbochi ịrapara na mmanu mmanu n'echiche dị warara. ① Glidant: ọrụ ya bụ isi bụ iji belata esemokwu n'etiti ihe ndị dị n'ime, meziwanye mmiri nke ntụ ntụ, ma nyere aka belata ọdịiche dị na arọ mbadamba nkume; ② onye na-egbochi ihe mgbochi: isi ọrụ ya bụ igbochi ịrapara n'oge mkpakọ mbadamba, Iji hụ na arụ ọrụ nke ọma nke mkpakọ mbadamba nkume, ọ nwekwara ike imeziwanye ọdịdị nke mbadamba nkume; ③ mmanu mmanu chivalrous: belata esemokwu n'etiti ihe na mgbidi ebu, iji hụ na arụ ọrụ nke ọma nke mkpakọ mbadamba na ịkwanye. Ihe mmanu a na-ejikarị (n'echiche sara mbara) gụnyere talc ntụ ntụ, magnesium stearate (MS), micronized silica gel, polyethylene glycols, sodium lauryl sulfate, hydrogenated akwukwo nri mmanụ, wdg.
5. Ntọhapụ modulator
Ndị na-ahazi mwepụta na mbadamba ọnụ dị mma maka ịchịkwa ọsọ na ogo ntọhapụ ọgwụ n'ime nkwadebe ntọhapụ ọnụ, iji hụ na a na-ebuga ọgwụ ahụ na saịtị onye ọrịa n'otu ọsọ ma na-edobe ụfọdụ ntinye n'ime anụ ahụ ma ọ bụ mmiri ara. , si otú ahụ nweta mmetụta ọgwụgwọ a na-atụ anya ya ma belata nsí na mmetụta. A na-ekewa ndị na-ahazi ntọhapụ ndị a na-ejikarị n'ụdị matriks, polymer na-ewepụta ngwa ngwa nke mkpuchi ihe nkiri na thickener.
(1) Ụdị ntọhapụ modulator
①Hydrophilic gel skeleton skeleton: ọ na-aza mgbe ekpughere ya na mmiri na-etolite ihe mgbochi gel iji chịkwaa ntọhapụ ọgwụ, nke a na-ejikarị bụ methyl cellulose, carboxymethyl cellulose, hydroxypropyl cellulose, povidone, carbomer, alginic acid Salt, chitosan, wdg.
② Ihe ọkpụkpụ na-adịghị edozi: Ihe ọkpụkpụ na-adịghị edozi na-ezo aka na polymer molecular dị elu nke na-adịghị edozi n'ime mmiri ma ọ bụ nwere ntakịrị mmiri solubility. A na-ejikarị ethyl cellulose, polyethylene, polyethylene na-egbu egbu, polymethacrylic acid, ethylene-vinyl acetate copolymer, silicone roba, wdg.
③ Bioerodible framework material: Ihe eji eme ihe nke a na-ejikarị eme ihe na-agụnye abụba anụmanụ, mmanụ ihe oriri hydrogenated, beeswax, mmanya stearyl, carnauba wax, glyceryl monostearate, wdg. Ọ nwere ike igbu oge mgbasa na ntọhapụ nke ọgwụ na-agbaze mmiri.
(2) Mgbanwe ntọhapụ mkpuchi mkpuchi
① Ihe ndị na-adịghị ike polymer: ihe ọkpụkpụ na-adịghị edozi dị ka EC.
②Enteric polymer ihe: nkịtị enteric polymer ihe tumadi na-agụnye acrylic resin, L-ụdị na S-ụdị, hydroxypropylmethylcellulose acetate succinate (HPMCAS), cellulose acetate phthalate (CAP), hydroxypropylmethylcellulose phthalate (HPMCP), wdg Ọ na-eji disoluzes nke disoluses n'elu ihe na eriri afọ ihe ọṅụṅụ, na dissolves na kpọmkwem akụkụ na-egwu a ọrụ.
6. Ngwa ndị ọzọ
Na mgbakwunye na ihe ndị a na-ejikarị eme ihe n'elu, a na-agbakwunye ihe ndị ọzọ mgbe ụfọdụ iji gboo mkpa nchịkwa ọgwụ nke ọma, melite njirimara ọgwụ ma ọ bụ melite nnabata. Dịka ọmụmaatụ, agba agba, ihe ụtọ na ihe na-atọ ụtọ.
① Onye na-agba agba: Ebumnuche bụ isi nke ịgbakwunye ihe a bụ iji melite ọdịdị nke mbadamba nkume ma mee ka ọ dịkwuo mfe ịmata na ịmata ọdịiche. Pigmenti ndị a na-ejikarị eme ihe kwesịrị izute nkọwapụta ọgwụ, na ego agbakwunyere ekwesịghị ịfe 0.05%.
②Aromatics and sweeteners: Isi nzube nke aromatics na sweeteners bụ imeziwanye ụtọ ọgwụ, dị ka mbadamba nkume ndị a na-ata ahụhụ na mbadamba ọnụ na-etisa. Ihe na-esi ísì ụtọ a na-ejikarị eme ihe na-agụnye essences, mmanụ ísì ụtọ dị iche iche, wdg; Ihe ụtọ a na-ejikarị gụnyere sucrose, aspartame, wdg.