Māhele: nā mea uhi;Mea membrane;ʻO nā mea polymer māmā wikiwiki no ka hoʻomākaukau hoʻokuʻu lohi;Mea hoʻokūpaʻa;Kokua hoʻokuʻu ʻia, hoʻopili papa;Mea hoʻopili i hoʻoikaika ʻia.
1. Hoʻolauna huahana
HE NON-IONIC CELLULOSE ETHER keia HUA, i ikeia mawaho ma ke ano he pauda keokeo, he ala ole a me ka ono ole, hiki ke hooheheeia i ka wai a me ka hapa nui o na mea hoohehee polar, e pehu ana i ka wai anuanu e hoomaemae a i ole i ka hooluolu colloidal solution.Loaʻa i ka hoʻonā wai i ka hana ʻili, ke ʻike kiʻekiʻe a me ka hana paʻa.Loaʻa iā HPMC ka waiwai o ka gel wela.Ma hope o ka hoʻomehana ʻana, hoʻoheheʻe ʻia ka wai wai o ka huahana, a laila hoʻoheheʻe ʻia ma hope o ka hoʻoilo.ʻOkoʻa ka mahana gel o nā kikoʻī like ʻole.Solubility hoʻololi me ka viscosity, viscosity zhao haʻahaʻa, ka nui o ka solubility, okoa kiko'ī o HPMC waiwai i kekahi mau okoa, HPMC hoʻoheheʻe 'ia i loko o ka wai,ʻaʻole pili i ka pH waiwai.
He 360 ℃, 0.341g/cm3, 1.326g/cm3 a me 170 ~ 180 ℃ ka wela wela o ka hoʻopau ʻana, ka haʻahaʻa haʻahaʻa, ka mānoanoa maoli a me ke aniani.Ma hope o ka hoʻomehana ʻana, lilo ia i ʻeleʻele ma 190 ~ 200 ° C a wela i 225 ~ 230 ° C.
Ua aneane hiki ole ke hooheheeia ka HPMC i ka chloroform, ethanol (95%), a me diethyl ether, a ua hooheheeia i ka hui ana o ka ethanol a me ka methylene chloride, ka hui ana o ka methanol a me ka methylene chloride, a me ka hui o ka wai a me ka ethanol.Hiki ke hoʻoheheʻe ʻia kekahi mau pae o ka HPMC i loko o nā hui ʻana o ka acetone, methylene chloride, a me 2-propanol, a me nā mea hoʻoheheʻe kūlohelohe ʻē aʻe.
Papa 1: Nā hōʻailona ʻenehana
papahana
ana,
60 gd (2910).
65GD(2906)
75GD(2208)
Methoxy %
28.0-32.0
27.0-30.0
19.0-24.0
Hydroxypropoxy %
7.0-12.0
4.0-7.5
4.0-12.0
ʻO ka mahana gel ℃
56-64.
62.0-68.0
70.0-90.0
Viscosity mpa s.
3,5,6,15,50,4000
50400 0
100400 0150 00100 000
Pohō kaumaha maloʻo %
5.0 a emi mai paha
Ke ahi koena %
1.5 a emi mai paha
pH
4.0-8.0
Metala kaumaha
20 a emi mai paha
arsenic
2.0 a emi mai paha
2. Nā hiʻohiʻona huahana
2.1 Hoʻoheheʻe ʻia ka Hydroxypropyl methylcellulose i loko o ka wai anuanu e hana i kahi hopena colloidal viscous.ʻOiai ka lōʻihi e hoʻohui ʻia i ka wai anuanu a hoʻoulu iki ʻia, hiki ke hoʻoheheʻe ʻia i loko o kahi hopena ʻike.Ma ka ʻokoʻa, ʻaʻole hiki ke hoʻoheheʻe ʻia i ka wai wela ma luna o 60 ℃ a hiki ke pehu wale.I ka hoʻomākaukau ʻana i ka wai wai wai hydroxypropyl methicellulose, ʻoi aku ka maikaʻi o ka hoʻohui ʻana i kahi ʻāpana o ka hydroxypropyl methicellulose i loko o kahi nui o ka wai, hoʻoulu ikaika, wela i 80 ~ 90 ℃, a laila hoʻohui i ke koena hydroxypropyl methicellulose, a hope hoʻohana i ka wai anuanu e hoʻohui. i ka nui i makemakeia.
2.2 Hydroxypropyl methylcellulose he non-ionic cellulose ether, ʻaʻole i lawe ka hopena i ka ionic charge, ʻaʻole e launa pū me nā paʻakai metala a i ʻole nā mea ionic organic compound, i mea e hōʻoia ai ʻaʻole e hoʻopili ʻo HPMC me nā mea maka a me nā mea kōkua i ke kaʻina hana. hana ʻana.
2.3 Hydroxypropyl methylcellulose he ikaika anti-sensitivity, a me ka piʻi ʻana o ke degere hoʻololi i ka hoʻolālā mole, ua hoʻonui ʻia ka anti-sensitivity.ʻO nā lāʻau lapaʻau e hoʻohana ana i ka HPMC ma ke ʻano he mea hoʻohui, ʻoi aku ka paʻa o ka maikaʻi i loko o ka manawa kūpono ma mua o nā lāʻau e hoʻohana ana i nā mea kōkua kuʻuna (starch, dextrin, pauda kō).
2.4 ʻO ka hydroxypropyl methylcellulose ka metabolically inert.Ma ke ʻano he mea hoʻohana lāʻau lapaʻau, ʻaʻole ia i metabolized a i hoʻopaʻa ʻia, no laila ʻaʻole ia e hāʻawi i ka wela i nā lāʻau lapaʻau a me nā meaʻai.Loaʻa iā ia ka hoʻohana kūʻokoʻa i ka waiwai calorific haʻahaʻa, paʻakai ʻole, nā lāʻau allergenic ʻole a me nā meaʻai no ka maʻi maʻi.
ʻO 2.5HPMC ka mea paʻa i nā ʻakika a me nā kumu, akā inā ʻoi aku ka pH ma mua o 2 ~ 11 a hoʻopilikia ʻia e ka wela kiʻekiʻe a i ʻole ka lōʻihi o ka mālama ʻana, e hōʻemi ia i ke kiʻekiʻe o ka pala.
2.6 Hiki i ka hydroxypropyl methylcellulose aqueous solution ke hāʻawi i ka hana o ka ʻili, e hōʻike ana i nā kumu kūʻai haʻahaʻa o ka ʻili a me ka ʻāʻī.Loaʻa iā ia kahi emulsification maikaʻi i ka ʻōnaehana ʻelua-phase a hiki ke hoʻohana ʻia ma ke ʻano he stabilizer kūpono a me ka colloid pale.
ʻO 2.7 Hydroxypropyl methylcellulose aqueous solution he mau waiwai hana kiʻiʻoniʻoni maikaʻi loa, a he mea uhi maikaʻi no nā papa a me nā pila.ʻO ka membrane i hana ʻia e ia he kala ʻole a paʻakikī.Inā hoʻohui ʻia ka glycerol, hiki ke hoʻonui ʻia kona plasticity.Ma hope o ka hoʻomaʻamaʻa ʻana i ka ʻili, hoʻopuehu ʻia ka huahana i ka wai anuanu, a hiki ke mālama ʻia ka helu dissolution ma o ka hoʻololi ʻana i ka pH environment.Hoʻohana ʻia ia i nā hoʻomākaukau hoʻokuʻu lohi a me nā hoʻomākaukau ʻana i ka enteric-coated.
3. Ke noi huahana
3.1.Hoʻohana ʻia e like me ka mea hoʻopili a me ka disintegrating agent
Hoʻohana ʻia ʻo HPMC e paipai i ka hoʻoheheʻe ʻana i ka lāʻau lapaʻau a me ke ʻano o ka hoʻokuʻu ʻana i nā noi, hiki ke hoʻoheheʻe pololei ʻia i ka solvent e like me ka adhesive, haʻahaʻa viscosity o HPMC i hoʻoheheʻe ʻia i loko o ka wai e hoʻoheheʻe ʻia i ka ivory sticky colloid solution. ʻoihana, a me ka viscosity kiʻekiʻe no ke kāpili, hoʻohana wale ʻia ma muli o nā ʻano like ʻole a me nā koi ʻē aʻe, ʻo ka laulā he 2% ~ 5%.
ʻO ka hoʻonā wai wai HPMC a me kahi ʻano o ka ethanol e hana i kahi mea hoʻopili hui;Laʻana: 2%HPMC solution wai i hui pū ʻia me 55% ethanol solution i hoʻohana ʻia no ka pelleting o ka amoxicillin capsules, no laila ua hoʻonui ka awelika o ka hemo ʻana o nā capsules amoxicillin mai 38% a 90% me ka HPMC ʻole.
Hiki ke hana ʻia ka HPMC me ka hoʻopili ʻana me ka ʻokoʻa o ka slurry starch ma hope o ka hemo ʻana;Ua hoʻonui ʻia ka hoʻoheheʻe ʻana o nā papa erythromycin enteric-coated mai 38.26% a i 97.38% i ka hui ʻana o 2% HPMC a me 8% starch.
2.2.E hana i ka mea uhi kiʻiʻoniʻoni a me ka mea hana kiʻiʻoniʻoni
ʻO ka HPMC ma ke ʻano he mea hoʻoheheʻe wai e loaʻa i kēia mau hiʻohiʻona: viscosity solution moderate;He mea maʻalahi ke kaʻina hana uhi;He waiwai hana kiʻiʻoniʻoni maikaʻi;Hiki ke mālama i ke ʻano o ka ʻāpana, kākau;Hiki ke hoʻomaʻemaʻe;Hiki ke kala, hoʻoponopono ʻono.Hoʻohana ʻia kēia HUA NO KA WATER-SOLUBLE FILM COATING NO KA PALAPALA A ME PILLS me ka haʻahaʻa haʻahaʻa, A NO KA WATER-BASED FILM COATING ME HIGH VISCOSITY, ʻO ka nui o ka hoʻohana ʻana he 2%-5%.
2.3, e like me ka mānoanoa a me ka colloidal pale kelu
ʻO ka HPMC i hoʻohana ʻia ma ke ʻano he mānoanoa he 0.45% ~ 1.0%, hiki ke hoʻohana ʻia e like me nā kulu maka a me nā mea hoʻonaninani waimaka;Hoʻohana ʻia e hoʻonui i ka paʻa o ka hydrophobic glue, pale i ka coalescence particle, precipitation, ʻo ka dosage maʻamau he 0.5% ~ 1.5%.
2.4, ma ke ʻano he blocker, mea hoʻokuʻu lohi, mea hoʻokuʻu i hoʻomalu ʻia a me ka pore agent
Hoʻohana ʻia ke ʻano hoʻohālike kiʻekiʻe o ka HPMC no ka hoʻomākaukau ʻana i nā mea paʻa a me nā mea hoʻokuʻu hoʻokuʻu ʻia o nā papa hoʻokuʻu hoʻokuʻu ʻia a me nā papa hoʻokuʻu hoʻokuʻu ʻia hydrophilic gel skeleton.ʻO ke ʻano haʻahaʻa viscosity kahi mea hoʻoheheʻe pore no nā papa hoʻokuʻu hoʻomau a hoʻokuʻu ʻia paha i loaʻa koke ka nui o ka lāʻau lapaʻau mua o ia mau papa, a ukali ʻia e ka hoʻokuʻu paʻa a i ʻole ka hoʻokuʻu hoʻokuʻu ʻia e mālama i nā manaʻo kūpono i ke koko.
2.5.Gel a me suppository matrix
Hiki ke hoʻomākaukau ʻia nā suppositories hydrogel a me ka hoʻomākaukau ʻana i ka ʻōpū me ka hoʻohana ʻana i ke ʻano o ka hoʻokumu hydrogel i hoʻohana mau ʻia e HPMC i ka wai.
2.6 Mea hoʻopili olaola
Ua hui pū ʻia ʻo Metronidazole me HPMC a me polycarboxylethylene 934 i loko o kahi hui hui e hana i nā papa hoʻokuʻu bioadhesive i loaʻa ka 250mg.Ua hōʻike ʻia ka hoʻāʻo ʻana i ka in vitro dissolution ua pehu koke ka hoʻomākaukau ʻana i ka wai, a ua hoʻomalu ʻia ka hoʻokuʻu ʻana i ka lāʻau e ka diffusion a me ka hoʻomaha hoʻomaha kalapona.Ua hōʻike ʻia ka hoʻokō holoholona i ka ʻōnaehana hoʻokuʻu lāʻau hou i nā waiwai adhesion koʻikoʻi i ka mucosa sublingual bovine.
2.7, ma ke ʻano he kōkua hoʻomaha
ʻO ka HIGH viscosity o kēia huahana he kōkua hoʻomaha maikaʻi no ka hoʻomākaukau ʻana i ka wai hoʻomaha, ʻo kāna mea maʻamau ʻo 0.5% ~ 1.5%.
4. Nā laʻana noi
4.1 Hoʻonā ka uhi kiʻiʻoniʻoni: HPMC 2kg, talc 2kg, ʻaila castor 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% ethanol 53000ml, wai 47000ml, puaʻa kūpono nui.ʻElua ala e hana ai.
4.1.1 Ka hoʻomākaukau ʻana i ka wai lole i uhi ʻia i ka puaʻa hiki ke hoʻoheheʻe ʻia: E hoʻohui i ka nui o ka HPMC i ʻōlelo ʻia i loko o ka 95% ethanol, e hoʻomoʻi i ka pō, e hoʻoheheʻe i kahi vector puaʻa ʻē aʻe i loko o ka wai ( kānana inā pono), e hoʻohui i nā haʻina ʻelua a hoʻoulu like e hana i kahi hopena akaka. .Hoʻohui i ka 80% o ka hopena (20% no ka polishing) me ka nui o ka ʻaila castor, Tween-80, a me propylene glycol.
4.1.2 Hoʻomākaukau ʻia ka puaʻa hiki ʻole ke hoʻoheheʻe ʻia (e like me ka iron oxide) i uhi ʻia ka wai HPMC i 95% ethanol i ka pō, a ua hoʻohui ʻia ka wai e hana i ka 2% HPMC transparent solution.Ua lawe ʻia ʻo 20% o kēia hopena no ka polishing, a ua hoʻomākaukau ʻia ke koena 80% solution a me ka hao oxide ma ke ʻano wili wai, a laila hoʻohui ʻia ka nui o nā mea ʻē aʻe a hui pū ʻia no ka hoʻohana.ʻO ke kaʻina hana o ka uhi ʻana i ka wai: e ninini i ka pepa palaoa i loko o ka ipu hao, ma hope o ka hoʻololi ʻana, e hoʻomaʻamaʻa ka ea wela i 45 ℃, hiki iā ʻoe ke pīpī i ka uhi ʻai ʻana, ka mana kahe ma 10 ~ 15ml / min, ma hope o ka pīpī ʻana, hoʻomau i ka maloʻo. me ka ea wela no 5 ~ 10min hiki ke puka i waho o ka ipu hao, e waiho i loko o ka maloʻo maloʻo no ka oi ma mua o 8h.
4.2α-interferon eye membrane 50μg o ka α-interferon i hoʻoheheʻeʻia i ka 10ml0.01ml hydrochloric acid, i hui pūʻia me 90ml ethanol a me 0.5GHPMC, kānana, uhiʻia ma luna o ke koʻokoʻo aniani rotating, sterilized ma 60 ℃ a maloʻo i ka ea.Hana ʻia kēia huahana i mea kiʻiʻoniʻoni.
4.3 Nā papa Cotrimoxazole (0.4g±0.08g) SMZ (80 mesh) 40kg, starch (120 mesh) 8kg, 3%HPMC aqueous solution 18-20kg, magnesium stearate 0.3kg, TMP (80 mesh) 8kg, ke ʻano o ka hoʻomākaukau. hui SMZ a me TMP, a laila e hoʻohui i ka starch a hui no 5min.Me ka 3% HPMC wai hoʻonā prefabricated, mea palupalu, me 16 mesh pale granulation, maloʻo, a laila me 14 mesh pale palaoa a pau, hoʻohui i ka magnesium stearate hui, me 12mm poepoe me ka hua'ōlelo (SMZco) stamping papa.Hoʻohana nui ʻia kēia huahana ma ke ʻano he binder.ʻO ka hoʻoheheʻe ʻana o nā papa he 96% / 20min.
4.4 Piperate papa (0.25g) piperate 80 mesh 25kg, starch (120 mesh) 2.1kg, magnesium stearate ka nui kupono.ʻO kāna hana hana ʻo ka hui ʻana i ka pipeoperic acid, starch, HPMC me ka 20% ethanol soft material, 16 mesh screen granulate, maloʻo, a laila 14 mesh screen whole grain, a me vector magnesium stearate, me 100mm circular belt word (PPA0.25). ) nā papa heʻi.Me ka starch ma ke ʻano he mea hoʻoheheʻe, ʻaʻole emi ka helu dissolution o kēia papa ma lalo o 80%/2min, ʻoi aku ka kiʻekiʻe ma mua o nā huahana like ma Iapana.
4.5 Haehae hana HPMC-4000, HPMC-4500 a i ole HPMC-5000 0.3g, sodium chloride 0.45g, potassium chloride 0.37g, borax 0.19g, 10% ammonium chlorbenzylammonium solution 0.02ml, wai i hoohuiia i 10ml.ʻO kāna hana hana ʻo HPMC i hoʻokomo ʻia i loko o ka wai 15ml, ma 80 ~ 90 ℃ wai piha e lawe i kahi, hoʻohui i ka wai 35ml, a laila loaʻa nā ʻāpana i koe o 40ml aqueous solution i hui pū ʻia, hoʻohui i ka wai i ka nui piha, a laila hui like, kū i ka pō. , E ninini mālie i ka kānana, e kānana i loko o ka pahu i hoʻopaʻa ʻia, sterilized ma 98 ~ 100 ℃ no 30min, ʻo ia hoʻi, ʻO ka pH mai ka 8.4 ° C a hiki i 8.6 ° C. HOʻohana ʻia kēia mea waiwai no ka waimaka ʻole, he pani maikaʻi no ka waimaka, Ke hoʻohana ʻia no ka microscopy o ke keʻena mua, hiki ke hoʻonui ʻia i ka nui o kēia huahana, 0.7% ~ 1.5% kūpono.
4.6 Meththorphan hoʻokuʻu ʻia nā papa meththorphan resin paʻakai 187.5mg, lactose 40.0mg, PVP70.0mg, vapor silica 10mg, 40.0 mGHPMC-603, 40.0mg ~ microcrystalline cellulose phthalate-102.5mgarate a me ka magnesium stearate.Hoʻomākaukau ʻia e like me nā papa ma ke ʻano maʻamau.Hoʻohana ʻia kēia huahana ma ke ʻano he mea hoʻokuʻu ʻia.
4.7 No nā papa avantomycin ⅳ, 2149g avantomycin ⅳ monohydrate a me 1000ml isopropyl wai hui ʻia o 15% (mass concentration) eudragitL-100 (9:1) i hoʻoulu ʻia, hui ʻia, granulated, a maloʻo ma 35 ℃.ʻO nā granules maloʻo 575g a me 62.5g hydroxypropylocellulose E-50 i hui maikaʻi ʻia, a laila 7.5g stearic acid a me 3.25g magnesium stearate i hoʻohui ʻia i nā papa e loaʻa ai ka hoʻokuʻu mau ʻana o nā papa vanguard mycin ⅳ.Hoʻohana ʻia kēia huahana ma ke ʻano he mea hoʻokuʻu lohi.
4.8 Nifedipine hoʻokuʻu paʻa mau granules 1 ʻāpana nifedipine, 3 ʻāpana hydroxypropyl methyl cellulose a me 3 ʻāpana ethyl cellulose i hui pū ʻia me ka solvent hui ʻia (ethanol: methylene chloride = 1:1), a ua hoʻohui ʻia he 8 ʻāpana kānana starch no ka hana ʻana i nā granule e ka medium-soluble. ʻano hana.ʻAʻole i hoʻopilikia ʻia ka hoʻokuʻu ʻana o ka lāʻau lapaʻau e ka hoʻololi ʻana o ka pH kaiapuni a ʻoi aku ka lohi ma mua o nā granules i kūʻai ʻia.Ma hope o 12 mau hola o ka hoʻoponopono waha, ʻo 12mg / ml ke koko kanaka, ʻaʻohe ʻokoʻa hoʻokahi.
4.9 Propranhaol hydrochloride hoʻokuʻu ʻia ka capsule Propranhaol hydrochloride 60kg, microcrystalline cellulose 40kg, hoʻohui i 50L wai e hana i nā granules.Ua hui pū ʻia ʻo HPMC1kg a me EC 9kg i ka solvent hui ʻia (methylene chloride: methanol = 1: 1) 200L e hana i ka hoʻonā uhi, me kahi kahe kahe o 750ml / min spray ma nā ʻāpana spherical rolling, nā mea i uhi ʻia ma o ka nui pore o 1.4 mm nā ʻāpana holoʻokoʻa, a laila hoʻopiha ʻia i loko o ka pahu pōhaku me ka mīkini hoʻopiha capsule maʻamau.Loaʻa i kēlā me kēia capsule he 160mg o propranolol hydrochloride spherical particles.
4.10 Ua hoʻomākaukau ʻia nā papa iwi iwi Naprolol HCL ma ka hui ʻana i ka naprolol HCL :HPMC: CMC-NA ma ka ratio o 1:0.25:2.25.Ua kokoke ka helu o ka hoʻokuʻu ʻana i ka lāʻau i ke kauoha ʻole i loko o 12 mau hola.
Hiki ke hana ʻia nā lāʻau ʻē aʻe me nā mea iwi iwi hui pū, e like me metoprolol: HPMC: CMC-NA e like me: 1:1.25:1.25;Allylprolol: HPMC e like me ka ratio 1:2.8:2.92.Ua kokoke ka helu o ka hoʻokuʻu ʻana i ka lāʻau i ke kauoha ʻole i loko o 12 mau hola.
4.11 Ua hoʻomākaukau ʻia nā papa iwi o nā mea i hui pū ʻia o nā derivatives ethylaminosine ma ke ʻano maʻamau me ka hoʻohana ʻana i ka hui ʻana o ka pauda micro silica gel: CMC-NA: HPMC 1:0.7:4.4.Hiki ke hoʻokuʻu ʻia ka lāʻau lapaʻau no 12h ma in vitro a me in vivo, a he pilina maikaʻi ke kumu hoʻokuʻu laina.ʻO nā hopena o ka hōʻike kūpaʻa wikiwiki e like me nā lula FDA e wānana i ka mālama ʻana o kēia huahana a hiki i 2 mau makahiki.
4.12 HPMC (50mPa·s) (5 ʻāpana), HPMC (4000 mPa·s) (3 ʻāpana) a me HPC1 i hoʻoheheʻe ʻia i 1000 mau ʻāpana wai, 60 mau ʻāpana acetaminophen a me 6 mau ʻāpana silica gel i hoʻohui ʻia, hoʻoulu ʻia me ka homogenizer, a hoʻomaloʻo ʻia.Aia kēia huahana i ka 80% o ka lāʻau lapaʻau nui.
4.13 Ua helu ʻia nā papa ʻiʻo Theophylline hydrophilic gel e like me ka nui o ke kaumaha o ka papa, 18% -35% theophylline, 7.5% -22.5% HPMC, 0.5% lactose, a me ka nui kūpono o ka hydrophobic lubricant i hoʻomākaukau maʻamau i loko o nā papa hoʻokuʻu hoʻokuʻu ʻia. e mālama i ke koko kūpono o ke kino o ke kanaka no 12h ma hope o ka lawelawe waha.
Ka manawa hoʻouna: Feb-05-2024