1. Ke ano kumu o HPMC
Hypromellose, inoa Pelekane hydroxypropyl methylcellulose, alias HPMC. ʻO C8H15O8-(C10Hl8O6)n-C8Hl5O8 kona kumu mole, a ʻo ke kaumaha molekala ma kahi o 86,000. ʻO kēia huahana he mea semi-synthetic, ʻo ia kahi ʻāpana o ka hui methyl a me kahi hapa o ka polyhydroxypropyl ether o cellulose. Hiki ke hana ʻia e nā ʻano ʻelua: ʻo ka mālama ʻana i ka methyl cellulose o ka papa kūpono me ka NaOH, a laila e hana me ka propylene oxide ma lalo o ka wela kiʻekiʻe a me ke kaomi kiʻekiʻe. Pono e hoʻomau i ka manawa pane no ka ʻae ʻana i nā hui methyl a me hydroxypropyl e hoʻopaʻa me ka ether. Hoʻopili ʻia ke ʻano o ka anhydroglucose apo o cellulose, a hiki ke hiki i ke degere i makemake ʻia; ʻO ka mea ʻē aʻe e mālama i ka pulupulu linter a i ʻole ka pulupulu lāʻau pulupulu me ka soda caustic, a laila e loaʻa ma ka reacting me ka chlorinated methane a me propylene oxide successively, a laila hoʻomaʻemaʻe hou ʻia, Pulverize, e hana i loko o ka pauka maikaʻi a i ʻole granule. He ʻano like ʻole o ka cellulose mea kanu maoli ʻo HPMC, a he mea hoʻohui lāʻau maikaʻi loa ia, a he kumu ākea kona. I kēia manawa, hoʻohana nui ʻia ia ma ka home a ma waho, a ʻo ia kekahi o nā mea hoʻohana lāʻau lapaʻau me ka helu hoʻohana kiʻekiʻe loa ma waena o nā lāʻau lapaʻau waha.
ʻO ka waihoʻoluʻu o kēia huahana he keʻokeʻo a hiki i ka waiū keʻokeʻo, ʻaʻohe mea ʻawaʻawa a ʻono ʻole, a ʻo ia ka pauka granular a i ʻole fibrous, maʻalahi ke kahe. Ua kūpaʻa ʻo ia ma lalo o ka ʻike māmā a me ka haʻahaʻa. Huhu ia i loko o ka wai anuanu e hana i ka waiu keʻokeʻo colloidal solution me kahi ʻano o ka viscosity. Hiki ke hoʻololi ʻia ka sol-gel interconversion ma muli o ka hoʻololi ʻana o ka mahana o kekahi ʻano hoʻonā. He mea maʻalahi loa ka hoʻoheheʻe ʻana i ka waiʻona 70% a i ʻole dimethyl ketone, a ʻaʻole e hoʻoheheʻe ʻia i loko o ka waiʻona anhydrous, chloroform a i ʻole ethoxyethane.
He kūpaʻa maikaʻi ka Hypromellose inā aia ka pH ma waena o 4.0 a me 8.0, a hiki ke noho paʻa ma waena o 3.0 a me 11.0. Ma hope o ka mālama ʻana i nā lā he 10 ma kahi mahana o 20 ° C a me kahi haʻahaʻa haʻahaʻa o 80%, ʻo ka helu ʻana o ka moisture absorption o HPMC he 6.2%.
Ma muli o ka ʻokoʻa o ka ʻike o nā substituent ʻelua i ke ʻano o hypromellose, methoxy a me hydroxypropyl, ua ʻike ʻia nā ʻano huahana like ʻole. Ma kahi kikoʻī kikoʻī, loaʻa nā ʻano huahana like ʻole i ka viscosity kikoʻī a me ka Thermal gelation temperature, no laila, he mau waiwai like ʻole a hiki ke hoʻohana ʻia no nā kumu like ʻole. ʻO nā lāʻau lapaʻau o nā ʻāina like ʻole he ʻokoʻa nā kikoʻī a me nā hōʻike no ke kumu hoʻohālike: ʻO ka European Pharmacopoeia e pili ana i nā māka like ʻole o nā viscosities like ʻole a me nā pae like ʻole o ka hoʻololi ʻana i nā huahana ma ka mākeke. Hōʻike ʻia e ka papa me kahi helu. ʻO ka ʻāpana he mPa•s. Ma hope o ka hoʻohui ʻana i nā huahelu 4 e hōʻike i ka ʻike a me ke ʻano o kēlā me kēia mea pani o hypromellose, no ka laʻana, hypromellose 2208, ʻo nā huahelu mua ʻelua e hōʻike ana i ka pākēneka kokoke o ka pūʻulu methoxy, ʻo nā huahelu ʻelua hope e hōʻike ana i ka hydroxypropyl Ka pākēneka kokoke o nā hihia.
2. ʻO keʻano o ka hoʻopauʻana i ka HPMC i ka wai
2.1 Ke ano wai wela
No ka mea ʻaʻole i hoʻoheheʻe ʻia ka hypromellose i ka wai wela, hiki ke hoʻopuehu like ʻia i ka wai wela i ka wā mua, a laila i ka wā e hoʻomaha ai, ʻelua mau ʻano maʻamau e wehewehe ʻia penei:
(1) E hoʻokomo i ka nui o ka wai wela i loko o ka pahu a wela iā ia ma kahi o 70 ℃. E hoʻohui mālie i ka huahana ma lalo o ka hoʻoulu lohi. I ka hoʻomaka ʻana, lana ka huahana ma luna o ka ʻili o ka wai, a laila hana mālie i kahi slurry. E hooluolu i ka slurry.
(2) E hoʻohui i ka 1/3 a i ʻole 2/3 o ka nui o ka wai i makemake ʻia i loko o ka pahu a wela iā 70 ° C e hoʻopuehu i ka huahana e hoʻomākaukau i kahi slurry wai wela, a laila hoʻohui i ke koena o ka wai anuanu a i ʻole ka wai hau. i ka slurry wai wela I ka slurry, hooluolu i ka hui ma hope o ka hooulu ana.
2.2 ʻano hui ʻana o ka pauda
Hoʻopuehu piha ʻia nā ʻāpana pauda a me nā mea pauda ʻē aʻe o ka nui like a i ʻole ka nui e ka hui ʻana maloʻo, a laila hoʻohui ʻia ka wai e hoʻoheheʻe. I kēia manawa, hiki ke hoʻoheheʻe ʻia ka hypromellose me ka ʻole o ka agglomeration.
3. Pono o HPMC
3.1 Hiki i ka wai anuanu
Hiki ke hoʻoheheʻe ʻia i ka wai anuanu ma lalo o 40°C a i ʻole 70% ethanol. ʻAʻole hiki ke hoʻoheheʻe ʻia i ka wai wela ma luna o 60 ° C, akā hiki ke hoʻopili ʻia.
3.2 Kemika inertness
ʻO Hypromellose (HPMC) kahi ʻano o ka cellulose ether non-ionic. ʻAʻohe o ka hoʻonā ionic charge a ʻaʻole pili pū me nā paʻakai metala a i ʻole nā pūhui organik ionic. No laila, ʻaʻole i pane aku nā mea ʻē aʻe me ia i ka wā o ka hoʻomākaukau ʻana.
3.3 Paʻa
He mea paʻa ia i ka waika a me ka alkali, a hiki ke mālama ʻia no ka manawa lōʻihi ma waena o ka pH 3 a hiki i ka 1l, a ʻaʻohe loli ʻike o kona viscosity. ʻO ka hopena wai o hypromellose (HPMC) he hopena anti-mold a hiki ke mālama i ka paʻa viscosity maikaʻi i ka wā mālama lōʻihi. ʻOi aku ka maikaʻi o ke kūpaʻa o nā mea hoʻohana lāʻau lapaʻau e hoʻohana ana i ka HPMC ma mua o ka poʻe e hoʻohana ana i nā mea kōkua kuʻuna (e like me dextrin, starch, etc.).
3.4 Hoʻoponopono i ka viscosity
Hiki ke hoʻohui ʻia nā derivatives viscosity like ʻole o HPMC i nā ʻano like ʻole, a hiki ke hoʻololi i kona viscosity e like me kekahi lula, a he pilina laina maikaʻi, no laila hiki ke koho ʻia e like me nā koi.
3.5 Metabolic inertia
ʻAʻole hoʻokomo ʻia ka HPMC i loko o ke kino, a ʻaʻole hāʻawi i nā calorie, no laila he mea palekana no ka hoʻomākaukau ʻana i nā lāʻau lapaʻau.
3.6 Palekana
Manaʻo nui ʻia ʻo HPMC he mea ʻawaʻawa ʻole a hoʻonāukiuki ʻole. He 5g/kg ka nui o ka make make no ka iole, a he 5.2g/kg ka nui o ka make make no ka iole. ʻAʻole pōʻino ka dosage i kēlā me kēia lā i ke kino o ke kanaka.
4. Hoʻohana ʻana i ka HPMC i ka hoʻomākaukau ʻana
4.1 Hoʻohana ʻia ma ke ʻano he mea uhi kiʻiʻoniʻoni a me nā mea hana kiʻiʻoniʻoni
Hoʻohana ʻia ʻo Hypromellose (HPMC) ma ke ʻano he mea papa i uhi ʻia i ke kiʻiʻoniʻoni. Ke hoʻohālikelike ʻia me nā papa kuʻuna i uhi ʻia e like me nā papa i uhi ʻia i ke kō, ʻaʻohe mea maikaʻi o nā papa i uhi ʻia i ka uhi ʻana i ka ʻono a me ke ʻano, akā ʻoi aku ka maikaʻi o ko lākou paʻakikī a me ka friability, Moisture absorption, disintegration, coating weight gain a me nā mea hōʻailona maikaʻi ʻē aʻe. Hoʻohana ʻia ka haʻahaʻa haʻahaʻa haʻahaʻa o kēia huahana ma ke ʻano he mea hoʻoheheʻe kiʻiʻoniʻoni wai no nā papa a me nā pila, a hoʻohana ʻia ka pae kiʻekiʻe-viscosity ma ke ʻano he kiʻi ʻoniʻoni no nā ʻōnaehana solvent organik. ʻO ka nui o ka hoʻohana ʻana he 2.0% -20%.
4.2 ma ke ʻano he mea hoʻopaʻa a hoʻopau
Hiki ke hoʻohana ʻia ka papa haʻahaʻa haʻahaʻa o kēia huahana ma ke ʻano he mea hoʻopaʻa a me ka disintegrant no nā papa, nā pila, a me nā granules, a hiki ke hoʻohana wale ʻia ke kiʻekiʻe-viscosity ma ke ʻano he mea hoʻopili. ʻOkoʻa ka dosage me nā ʻano like ʻole a me nā koi. ʻO ka maʻamau, ʻo ka nui o ka binder i hoʻohana ʻia no nā papa granulation maloʻo he 5%, a ʻo ka nui o ka binder i hoʻohana ʻia no nā papa granulation maloʻo he 2%.
4.3 Ma ke ʻano he luna hoʻomaha
ʻO ka mea hoʻopaneʻe he mea gel viscous me ka hydrophilicity. ʻO ka hoʻohanaʻana i ka mea hoʻolāʻau i ka mea hoʻomaha hiki ke hoʻohaʻahaʻa i ka wikiwiki o ka sedimentation o nā'āpana, a hiki ke hoʻopiliʻia i kaʻili o nā mea e pale ai i ka polymerizing a me ka condensing i loko o ka nuipa. He mea koʻikoʻi ka hana ʻana o nā mea hoʻokuʻu. He ʻano maikaʻi loa ʻo HPMC o nā mea hoʻopaneʻe. Hiki i ka colloidal solution i hoʻoheheʻe ʻia i loko o ia mea ke hoʻemi i ka ʻāʻī o ka wai-paʻa paʻa a me ka ikehu manuahi ma nā ʻāpana paʻa liʻiliʻi, ma laila e hoʻonui ai i ka paʻa o ka ʻōnaehana heterogeneous dispersion. ʻO kēia huahana kahi hoʻomākaukau wai hoʻokuʻu viscosity kiʻekiʻe i hoʻomākaukau ʻia ma ke ʻano he mea hoʻomaha. Loaʻa iā ia ka hopena hoʻokuʻu maikaʻi, maʻalahi e hoʻokaʻawale hou, ʻaʻole pili, a me nā ʻāpana flocculated maikaʻi. ʻO ka nui maʻamau he 0.5% a 1.5%.
4.4 Hoʻohana ʻia ma ke ʻano he blocker, lohi a hoʻokuʻu ʻia a me ka pore-forming agent
Hoʻohana ʻia ka papa kiʻekiʻe-viscosity o kēia huahana no ka hoʻomākaukau ʻana i ka hydrophilic gel matrix sustained-release tablets, retarders a me nā mea hoʻokuʻu hoʻokuʻu ʻia no nā papa hoʻokuʻu hoʻokuʻu ʻia. Loaʻa iā ia ka hopena o ka hoʻopaneʻe ʻana i ka lāʻau lapaʻau. ʻO 10% ~ 80% (W / W) kona hoʻohana ʻana. Hoʻohana ʻia ka papa viscosity haʻahaʻa ma ke ʻano he pore-forming agent no ka hoʻomau ʻana a i ʻole ka hoʻokuʻu ʻia ʻana. Hiki ke kiʻi koke ʻia ka maʻi mua i koi ʻia no ka hopena therapeutic o kēia ʻano papa, a laila hoʻokō ʻia ka hopena hoʻokuʻu ʻia a hoʻopaʻa ʻia, a mālama ʻia ke ʻano o ka lāʻau lapaʻau kūpono i ke kino. Hypromellose hydrates e hana i kahi papa gel i ka wā e hui ai me ka wai. ʻO ke ʻano o ka hoʻokuʻu ʻana i ka lāʻau mai ka papa matrix ʻo ia ka diffusion o ka papa gel a me ka erosion o ka papa gel.
4.5 Hoʻohana ʻia ke kāpili pale e like me ka mānoanoa a me ka colloid
Ke hoʻohana ʻia kēia huahana ma ke ʻano he mānoanoa, ʻo ka ʻike maʻamau ʻo 0.45% ~ 1.0%. Hiki i kēia huahana ke hoʻonui i ka paʻa o ka hydrophobic glue, hana i kahi colloid pale, pale i ka coalescence particle a me ka agglomeration, a laila e pale ai i ka hoʻokumu ʻana o nā sediments. ʻO 0.5% ~ 1.5% ka mea maʻamau.
4.6 Hoʻohana ʻia e like me ka mea capsule
ʻO ka mea maʻamau, ʻo ka gelatin ka mea nui o ka pūpū capsule. He maʻalahi ke kaʻina hana o ka Ming capsule shell, akā aia kekahi mau pilikia a me nā hanana e like me ka pale maikaʻi ʻole o ka wai a me nā lāʻau lapaʻau oxygen, hoʻemi i ka hoʻopau ʻana i ka lāʻau, a me ka lohi o ka wehe ʻana o ka pūpū capsule i ka wā mālama. No laila, hoʻohana ʻia ka hypromellose ma ke ʻano he pani no ka mea capsule i ka hoʻomākaukau ʻana i nā capsules, kahi e hoʻomaikaʻi ai i ka moldability a me ka hoʻohana ʻana i ka hopena o ka capsule, a ua hoʻolaha nui ʻia ma ka home a ma waho.
4.7 Ma ke ʻano he bioadhesive
ʻO ka ʻenehana bioadhesive, ka hoʻohana ʻana i nā mea kōkua me nā polymers bioadhesive, ma ka pili ʻana i ka mucosa biological, e hoʻonui i ka hoʻomau a me ka paʻa o ka pilina ma waena o ka hoʻomākaukau a me ka mucosa, no laila e hoʻokuʻu mālie ʻia ka lāʻau lapaʻau e ka mucosa e hoʻokō i ke kumu o lapaʻau. Hoʻohana nui ʻia i kēia manawa Hoʻohana ʻia ia e mālama i nā maʻi o ka nasal cavity a me ka mucosa waha. ʻO ka ʻenehana bioadhesion gastrointestinal kahi ʻano hou o ka ʻōnaehana lawe lāʻau i hoʻomohala ʻia i nā makahiki i hala. ʻAʻole ia e hoʻolōʻihi i ka manawa noho o ka hoʻomākaukau ʻana i ka lāʻau i loko o ka ʻōpū o ka ʻōpū, akā hoʻomaikaʻi pū i ka hana pili o ka lāʻau me ka membrane cell o ka wahi absorption a hoʻololi i ka wai o ka membrane cell. Hoʻonui ʻia ka mana komo o ka lāʻau i nā epithelial cell o ka ʻōpū liʻiliʻi, e hoʻomaikaʻi ai i ka bioavailability o ka lāʻau.
4.8 Ma ke ʻano he gel topical
Ma ke ʻano he hoʻomākaukau paʻa no ka ʻili, loaʻa i ka gel kahi ʻano o nā pono e like me ka palekana, ka nani, ka hoʻomaʻemaʻe maʻalahi, ke kumu kūʻai haʻahaʻa, ke kaʻina hana hoʻomākaukau maʻalahi, a me ka launa maikaʻi me nā lāʻau lapaʻau. I nā makahiki i hala iho nei, ua loaʻa ka manaʻo nui a ua lilo i ka hoʻomohala ʻana i ka hoʻomākaukau ʻana i waho o ka ʻili. kuhikuhi.
4.9 Ma ke ʻano he mea paʻa i ka ua i loko o ka ʻōnaehana emulsification
Ka manawa hoʻouna: Dec-16-2021