1. Nā waiwai kumu o HPMC
ʻO Hydroxypropyl methylcellulose, ʻo ka inoa Pelekane ʻo hydroxypropyl methylcellulose, ʻike ʻia ʻo HPMC. ʻO C8H15O8-(C10Hl8O6) N-C8HL5O8 kāna kumu molekala, a ʻo kona kaumaha molekala ma kahi o 86,000. ʻO ka huahana he semi-synthetic, nona ka hapa methyl a me ka cellulose polyhydroxypropyl ether. Hiki ke hana ʻia ma nā ʻano ʻelua: ʻo ka mālama ʻana i ka pae kūpono o ka methyl cellulose me 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 i hiki ke hoʻololi i nā pūʻulu methyl a me hydroxypropyl i ethers. Aia ke ʻano a hoʻopaʻa ʻia me ke apo glucose dehydrated o cellulose i ka nui e pono ai; ʻO ka mea ʻē aʻe, ʻo ia ka mālama ʻana i ka pulupulu lint a i ʻole ka pulupulu lāʻau pulupulu me ka soda caustic e hana i ka loaʻa ʻana o ka methane chloride a me propylene oxide, hiki ke hoʻomaʻemaʻe hou ʻia a lepo. E hana i loko o ka pauka a i ʻole granules. ʻO ka HPMC kahi mea kanu cellulose maoli a me kahi mea hoʻohana lāʻau lapaʻau maikaʻi loa me ka nui o nā kumu. Hoʻohana nui ʻia i kēia manawa ma ka home a ma waho a ʻo ia kekahi o nā mea hoʻohana lāʻau lapaʻau maʻamau i nā lāʻau lapaʻau waha.
He keʻokeʻo kēia huahana a hiki i ka waiu keʻokeʻo, ʻaʻohe mea ʻawaʻawa, ʻaʻala ʻole, granular a fibrous paha, ka pauka maʻalahi. Paʻa paʻa ma lalo o ka mālamalama a me ka haʻahaʻa. Hoʻonui ia i loko o ka wai anuanu e hana i kahi hopena colloidal milky me kahi viscosity, a ʻo ka sol-gel interconversion hanana ma muli o ka hoʻololi ʻana o ka mahana o ka hopena me kahi ʻano koʻikoʻi. Hiki ke hoʻoheheʻe ʻia i loko o 70% ethanol a i ʻole dimethyl ketone, akā ʻaʻole hiki ke hoʻoheheʻe ʻia i ka ethanol piha, chloroform a i ʻole ethoxyethane.
Aia ka pH waiwai o ka hydroxypropyl methylcellulose ma waena o 4.0 a me 8.0, a he kūpaʻa maikaʻi kona. Paʻa ka pH ma waena o 3.0 a me 11.0. Hiki ke mālama ʻia ma 20 ° C a me ka haʻahaʻa haʻahaʻa o 80% no 10 mau lā. He 6.2% ka nui o ka hoʻoheheʻe ʻana o ka wai o HPMC.
Loaʻa i ka Hydroxypropyl methylcellulose nā ʻano huahana like ʻole ma muli o nā mea like ʻole o nā pūʻulu methoxy a me hydroxypropyl i loko o ka hale. Ma nā kikoʻī kikoʻī, loaʻa nā ʻano huahana like ʻole i ka viscosity a me nā waiwai wela. ʻO ka mahana gel a no laila he mau waiwai like ʻole e hiki ke hoʻohana ʻia no nā kumu like ʻole. He ʻokoʻa nā koi a me nā ʻōlelo hoʻohālike o kēlā me kēia ʻāina: ʻo ka European Pharmacopoeia e pili ana i nā viscosities like ʻole, nā pae like ʻole o ka hoʻololi ʻana, nā pae hoʻohana a me nā helu o nā māka like ʻole o nā huahana i kūʻai ʻia ma ka mākeke. ʻO ka ʻāpana o ka United States Pharmacopoeia he mPa·s, a penei nā inoa maʻamau. o nā pūʻulu methoxy, a ʻo nā huahelu ʻelua hope e hōʻike ana i ka pūʻulu hydroxyl. Ka pākēneka o ka propyl.
2. Hoʻoheheʻe ʻia ka HPMC i ke ʻano wai
2.1 Ke ano wai wela
No ka hiki ʻole ke hoʻoheheʻe ʻia ka hydroxypropyl cellulose i ka wai wela, hiki ke hoʻopuehu ʻia i loko o ka wai wela a laila hoʻomaha. Hoʻokomo ʻia nā ʻano hana maʻamau ʻelua e like me kēia:
(1) E hoʻokomo i ka nui o ka wai wela i makemake ʻia i loko o ka pahu a wela iā ia ma kahi o 70 ° C. E hoʻonui mālie i ka huahana me ka hoʻoulu mālie. I ka wā mua, lana ka huahana ma luna o ka wai a laila hana mālie i kahi 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 e hoʻohui i ka hau. wai i ka slurry wai wela. slurry i ka wai, e hoʻoulu i ka hui ma hope o ka hoʻoluʻu.
2.2 ʻano hui ʻana o ka pauda
Hoʻopuehu maikaʻi ʻia nā ʻāpana pauka ma ka hui ʻana maloʻo me ka like a i ʻole ka nui o nā mea pauka ʻē aʻe a laila hoʻoheheʻe ʻia me ka wai, kahi e hemo ai ka HMCS me ka ʻole o ka coagulation.
3. Pono o HPMC
3.1 Hiki ke hoʻoheheʻe ʻia i ka wai anuanu
Hiki ke hoʻoheheʻe ʻia i ka wai anuanu ma lalo o 40 ℃ a i ʻole 70% ethanol, a ʻaʻole hiki ke hoʻoheheʻe ʻia i ka wai wela ma luna o 60 ℃, akā hiki ke gel.
3.2 Kemika inertness
ʻO ka HPMC kahi ether cellulose 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 ke kaʻina hana hoʻomākaukau.
3.3 Paʻa
Paʻa ia i ka waikawa a me ka alkali a hiki ke mālama ʻia no ka manawa lōʻihi ma waena o ka pH 3 a me 1l me ka ʻole o ka loli nui o ka viscosity. ʻO nā hāʻina wai o ka hydroxypropyl methylcellulose (HPMC) he antifungal a mālama i ka paʻa viscosity maikaʻi i ka wā mālama lōʻihi. ʻOi aku ka maikaʻi o ka paʻa o ka HPMC ma mua o nā excipients kahiko (e like me dextrin, starch, etc.).
3.4 Hiki ke hoʻololi i ka viscosity
Okoa viscosity derivatives o HPMC hiki ke i loko o ka like 'ole, a me ko lakou viscosity hiki ke hoʻololi 'ia e like me ka pono e hoʻokō i kekahi mau rula a me ka maikaʻi laina laina, no laila, hiki ke koho i ka lākiō e like me ka pono.
3.5 Metabolic inertness
ʻAʻole hoʻokomo ʻia ʻo HPMC i loko o ke kino a ʻaʻole hāʻawi i ka wela, no laila he mea palekana palekana no ka hoʻomākaukau lāʻau.
3.6 Palekana
Manaʻo ʻia ʻo HPMC he mea ʻawaʻawa ʻole, ʻaʻole hoʻonāukiuki, me ka LD50 o 5g/kg i nā ʻiole a me 5.2g/kg i nā ʻiole. ʻAʻole pōʻino i nā kānaka ka nui o kēlā me kēia lā.
4 Hoʻohana ʻana i ka HPMC i ka hoʻomākaukau ʻana
4.1 Nā mea hoʻopili kiʻiʻoniʻoni a me nā mea hana kiʻiʻoniʻoni
Hoʻohana ʻia ʻo Hydroxypropyl methylcellulose (HPMC) ma ke ʻano he mea uhi kiʻiʻoniʻoni. ʻAʻohe mea maikaʻi o kāna mau papa i uhi ʻia ma mua o nā papa i uhi ʻia e like me nā papa i uhi ʻia i ke kō ma ke ʻano o ka uhi ʻana i ka ʻono a me ke ʻano o ka lāʻau lapaʻau, akā ʻo kona paʻakikī, brittleness, a me ka hygroscopicity, ʻilihune disintegration. , ʻoi aku ka maikaʻi o ka loaʻa ʻana o ke kaumaha a me nā hōʻailona maikaʻi ʻē aʻe. Hoʻohana ʻia ka haʻahaʻa haʻahaʻa viscosity o kēia huahana e like me ka wai-soluble film coating material no nā papa a me nā pila, a hoʻohana ʻia ke kiʻekiʻe viscosity ma ke ʻano he kiʻi ʻoniʻoni no nā ʻōnaehana solvent organik. ʻO ka maʻamau ka 2.0% ~ 20%.
4.2 Ma ke ʻano he mea hoʻopaʻa a hoʻopau
Hiki ke hoʻohana ʻia ka pae viscosity haʻahaʻa o kēia huahana ma ke ʻano he mea hoʻopaʻa a me ka disintegrant no nā papa, nā pila, a me nā granules, ʻoiai ke kiʻekiʻe viscosity grade hiki ke hoʻohana wale ʻia ma ke ʻano he binder. ʻOkoʻa ka dosage e like me ke kumu hoʻohālike a me nā koi, maʻamau 5% no nā papa granulation maloʻo a me 2% no nā papa granulation pulu.
4.3 Ma ke ʻano he kōkua hoʻomaha
ʻO ka mea hoʻopaneʻe he mea gel viscous i hydrophilic a hiki ke hoʻohana ʻia e hoʻolōʻihi i ka wikiwiki o ka hoʻonohonoho ʻana o nā ʻāpana a pili i ka ʻili o nā ʻāpana e pale ai i ka hui ʻana o nā ʻāpana i loko o nā pōpō. He kuleana koʻikoʻi nā mea kōkua hoʻokuʻu i ka hana ʻana i nā mea hoʻokuʻu. He mea hoʻohui maikaʻi loa ka HPMC. Hiki i kāna mea hoʻoheheʻe colloidal hoʻoheheʻe ke hoʻohaʻahaʻa i ka wai-solid interfacial tension a me ka ikehu manuahi o nā ʻāpana paʻa liʻiliʻi, a laila e hoʻonui ai i ka paʻa o ka ʻōnaehana heterogeneous dispersion. ʻO kēia huahana kahi hoʻomākaukau hoʻomaha viscosity kiʻekiʻe me ka hopena hoʻokuʻu maikaʻi, maʻalahi ka hoʻopuehu ʻana, ka paia non-stick, a me nā ʻāpana flocculation maikaʻi. ʻO kāna dosage maʻamau he 0.5% a 1.5%.
4.4 Ma ke ʻano he retardant, hoʻokuʻu hoʻomau a me ka porogen
Hoʻohana ʻia ka papa viscosity kiʻekiʻe o kēia huahana no ka hoʻomākaukau ʻana i nā papa hoʻokuʻu hoʻokuʻu ʻia hydrophilic gel matrix, nā papa hoʻokuʻu hoʻokuʻu hoʻokuʻu ʻia o nā mea hoʻokuʻu a me nā mea hoʻokuʻu hoʻokuʻu. Loaʻa iā ia ka hopena o ka hoʻopaneʻe ʻana i ka lāʻau lapaʻau. ʻO 10% -80% (W/W) kona hoʻohana ʻana. Hoʻohana ʻia nā pae viscosity haʻahaʻa ma ke ʻano he pore inducers i nā ʻano hoʻokuʻu hoʻokuʻu hoʻomau a hoʻomalu ʻia. Hiki i ia mau papa ke hoʻokō koke i ka nui mua e pono ai no ka hopena therapeutic, a laila hana i kahi hopena hoʻokuʻu hoʻomau a hoʻomalu ʻia, a mālama i nā ʻano lāʻau lapaʻau kūpono i ke kino. Hydroxypropyl methylcellulose hydrates i ka wai e hana i kahi papa gel. ʻO ka mīkini hoʻokuʻu lāʻau lapaʻau o nā papa matrix ka nui o ka diffusion o ka papa gel a me ka hemo ʻana o ka papa gel.
4.5 Nā mea mānoanoa a me nā colloids pale
Ke hoʻohana ʻia kēia huahana e like me ka mānoanoa, ʻo ka hoʻohana 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 nā ʻāpana mai ka agglomeration a me ka agglomeration, a laila e pale ai i ka hoʻokumu ʻana o ka ua. ʻO 0.5% ~ 1.5% kona manaʻo maʻamau.
4.6 Hoʻohana e like me ka mea capsule
ʻO ka mea maʻamau, ʻo ka gelatin ka mea o ka pūpū capsule. He mea maʻalahi ke kaʻina hana o nā pūpū capsule gelatin, akā aia nā pilikia a me nā hanana e like me ka pale maikaʻi ʻole i ka wai a me ka oxygen-sensitive lāʻau, hoʻemi i ka hoʻopau ʻana i ka lāʻau, a me ka hoʻokaʻulua ʻana o nā pūpū capsule i ka wā mālama. No laila, hoʻohana ʻia ka hydroxypropyl methylcellulose i mea pani no nā mea capsule i ka hoʻomākaukau ʻana i nā capsules, kahi e hoʻomaikaʻi ai i ka hana ʻana, hoʻoheheʻe a hoʻohana i nā hopena o nā capsules, a ua hoʻolaha nui ʻia ma ka home a ma waho.
4.7 Ma ke ʻano he bioadhesive
Hoʻohana ka ʻenehana Bioadhesion i nā excipients me nā polymers bioadhesive e pili i ka mucosa biological a hoʻonui i ke kūpaʻa a me ka paʻa o ka pilina ma waena o ka hoʻomākaukau ʻana a me ka mucosa, e ʻae i ka lāʻau e hoʻokuʻu mālie a hoʻomoʻa ʻia e ka mucosa e hoʻokō i nā kumu therapeutic. No ka hoʻokō ʻana i ke kumu o ka lāʻau lapaʻau, hoʻohana nui ʻia i kēia manawa e mālama i nā maʻi i loko o ka lua ihu, mucosa waha a me nā ʻāpana ʻē aʻe o ke kino. 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 lapaʻau i ka ʻōpū o ka ʻōpū, akā hoʻomaikaʻi pū i ka hana pili ma waena o ka lāʻau lapaʻau a me ka pūnaewele absorption membrane cell a hoʻololi i ke ʻano o ka membrane cell. ʻO ka Mobility, ʻo ia hoʻi, ka permeability o ka lāʻau i nā ʻāpana epithelial intestinal, no laila
Ka manawa hoʻouna: Feb-01-2024