Kāwai: rauemi paninga; Rauemi kiriuhi; Rauemi pūmua e whakahaeretia ana te tere mō ngā whakaritenga tukunga puhoi; Kaihoko whakau; Āwhina whakatārewatanga, piripiri papa; Kaihoko piri whakapakari.
1. Whakataki hua
He HUA CELLULOSE ETHER KĀORE-IONIC tēnei, e kitea ana i waho he paura mā, kāore he kakara, kāore he reka, ka rewa i roto i te wai me te nuinga o ngā whakarewa waro polar, ka pupuhi i roto i te wai matao hei wai mārama, hei wai korori rānei kua paku pōturi. He kaha te mahi o te mata o te wai, he mārama teitei, ā, he pumau te mahi. He āhuatanga tō te HPMC he rite ki te tiēre wera. I muri i te whakamahana, ka hanga te wai hua wai hei waihanga tiēre, kātahi ka rewa i muri i te whakamatao. He rerekē te pāmahana tiēre o ngā whakatakotoranga rerekē. Ka rerekē te wairewatanga me te matotoru, he iti te matotoru, ka nui ake te wairewatanga, he rerekē ngā āhuatanga o ngā whakatakotoranga rerekē o te HPMC, kāore te HPMC i rewa i roto i te wai e pāngia e te uara pH.
Ko te pāmahana mura ohorere, te mātotoru wetewete, te mātotoru pono me te pāmahana whakawhiti karāhe he 360℃, 0.341g/cm3, 1.326g/cm3 me te 170 ~ 180℃. I muri i te whakamahana, ka huri parauri i te 190 ~ 200°C, ā, ka tahuna i te 225 ~ 230°C.
Kāore e tino wairewa te HPMC i roto i te chloroform, te etanoru (95%), me te diethyl ether, ā, ka wairewahia ki roto i te ranunga o te etanoru me te methylene chloride, he ranunga o te methanol me te methylene chloride, me te ranunga o te wai me te etanoru. Ko ētahi taumata o te HPMC ka wairewahia ki roto i ngā ranunga o te acetone, te methylene chloride, me te 2-propanol, tae atu ki ētahi atu whakarewa waro.
Ripanga 1: Ngā tohu hangarau
kaupapa
Ine,
60 karamu (2910).
65GD(2906)
75GD(2208)
% Metoki
28.0-32.0
27.0-30.0
19.0-24.0
% o te hauwaiporoporoki
7.0-12.0
4.0-7.5
4.0-12.0
Te pāmahana o te kirikiri ℃
56-64.
62.0-68.0
70.0-90.0
Te matotoru o te mpa s.
3,5,6,15,50,4000
50400 0
100400 0150 00100 000
% o te whakahekenga taumaha maroke
5.0, iti iho rānei
% toenga tahunga
1.5, iti iho rānei
pH
4.0-8.0
konganuku taumaha
20, iti iho rānei
āheniki
2.0, iti iho rānei
2. Ngā āhuatanga o te hua
2.1 Ka whakarewaina te Hydroxypropyl methylcellulose ki te wai matao hei hanga i tētahi wairewa kōrori matotoru. Mēnā ka tāpirihia ki te wai matao, ka whakaohokia mārire, ka taea te whakarewa hei wairewa mārama. Engari, kāore e rewa i te wai wera i runga ake i te 60℃, ā, ka pupuhi noa iho. I te whakarite i tētahi wairewa wai hydroxypropyl methicellulose, he pai ake te tāpiri i tētahi wāhanga o te hydroxypropyl methicellulose ki tētahi nui o te wai, ka whakaohokia kia kaha, ka whakamahanahia ki te 80 ~ 90℃, kātahi ka tāpirihia te toenga o te hydroxypropyl methicellulose, ā, hei whakamutunga, whakamahia te wai matao hei tāpiri atu ki te nui e hiahiatia ana.
2.2 Ko te Hydroxypropyl methylcellulose he etera cellulose kore-ionic, kāore tōna otinga e kawe i te utu ionic, kāore e taunekeneke ki ngā tote whakarewa, ki ngā pūhui waro ionic rānei, kia kore ai e tauhohe te HPMC ki ētahi atu rauemi mata me ngā mea tāpiri i roto i te tukanga whakaputa.
2.3 He kaha te ārai-aro o te Hydroxypropyl methylcellulose, ā, i te pikinga ake o te taumata whakakapinga i roto i te hanganga ngota, ka kaha ake hoki te ārai-aro. Ko ngā rongoā e whakamahi ana i te HPMC hei tāpiri he pumau ake te kounga i roto i te wā whai hua i ngā rongoā e whakamahi ana i ētahi atu tāpiri tuku iho (māngaro, dextrin, huka paura).
2.4 Kāore te Hydroxypropyl methylcellulose e pāngia e te mate pāwera. Hei tāpiri rongoā, kāore e pāngia, e mimitia rānei, nō reira kāore e whakarato wera i roto i ngā rongoā me ngā kai. He āhuatanga motuhake tōna mō ngā rongoā iti te uara karori, kāore he tote, kāore e pāwera ki ngā mate pāwera, me ngā kai mō te hunga mate huka.
He tino pumau te 2.5HPMC ki ngā waikawa me ngā kawakore, engari ki te neke atu te pH i te 2 ~ 11, ā, ka pāngia e te pāmahana teitei ake, e te wā rokiroki roa ake rānei, ka whakaitihia te pakari o te hua.
2.6 Ka taea e te wairewa wai Hydroxypropyl methylcellulose te whakarato i te ngohe mata, e whakaatu ana i ngā uara taumahatanga mata me te taumahatanga ā-mata. He whai hua te emulsification i roto i te pūnaha rua-wāhanga, ā, ka taea te whakamahi hei whakaū me te colloid tiaki whai hua.
2.7 He tino pai ngā āhuatanga hanga kiriata o te wairewa wai Hydroxypropyl methylcellulose, ā, he rauemi paninga pai mō ngā papa me ngā pire. Kāore he tae o te kiriuhi i hangaia e ia, ā, he pakari. Mēnā ka tāpirihia he glycerol, ka taea te whakanui ake i tōna kirihou. I muri i te maimoatanga mata, ka whakamararatia te hua ki te wai matao, ā, ka taea te whakahaere i te tere whakarewatanga mā te whakarerekē i te taiao pH. Ka whakamahia i roto i ngā whakaritenga tukunga puhoi me ngā whakaritenga paninga enteric.
3. Te tono hua
3.1. Whakamahia hei piripiri me te kaiwhakarewa
E whakamahia ana te HPMC hei whakatairanga i te whakarewatanga o te rongoā me te tukunga o ngā tono, ka taea te rewa tika ki te whakarewa hei piripiri. He iti te matotoru o te HPMC rewa ki te wai hei hanga i te otinga colloid piri ki te rei, papa, pire, granules i runga i te piripiri me te kaihoko pakaru, ā, he tiketike te matotoru mō te piripiri, he rerekē te momo me ngā whakaritenga rerekē, ko te whānui ko te 2% ~ 5%.
I whakamahia he otinga wai HPMC me tētahi kukū o te etanoru hei hanga i tētahi herenga hiato; Hei tauira: I whakamahia he otinga wai HPMC 2% i konatunatua ki te otinga etanoru 55% hei hanga i ngā pūmua amoxicillin, ā, i piki ake te rewanga toharite o ngā pūmua amoxicillin mai i te 38% ki te 90% me te kore HPMC.
Ka taea te hanga i te HPMC mai i te piripiri hiato me te kukū rerekē o te paru māngaro i muri i te whakarewanga; I piki ake te whakarewanga o ngā papa pania erythromycin enteric mai i te 38.26% ki te 97.38% i te wā i whakakotahihia ai te 2% HPMC me te 8% māngaro.
2.2. Hangaia he rauemi paninga kiriata me he rauemi hanga kiriata
Ko ngā āhuatanga o te HPMC hei rauemi paninga wairewa-wai: he matotoru ngāwari te wairewa; he māmā te tukanga paninga; he pai te āhua hanga kiriata; ka taea te pupuri i te āhua o te wahi, te tuhituhi; ka taea te ātete makuku; ka taea te tae, te whakatika i te reka. KA WHAKAMAHIA TĒNEI HUA HEI PANI KIRIATA WAIWAI MŌ NGĀ PAPA ME NGĀ PIRA HE ITI TE MAKUKU, Ā, MŌ TE PANI KIRIATA KĀORE I TE WAI ME TE MAKUKU TEITEI, KO TE RAHI WHAKAMAHI HE 2%-5%.
2.3, hei whakamātotoru me te kāpia tiaki colloidal
Ko te HPMC e whakamahia ana hei whakamaroke he 0.45% ~ 1.0%, ka taea te whakamahi hei pata kanohi me te whakamaroke roimata horihori; Whakamahia hei whakanui ake i te pumau o te kāpia hydrophobic, hei aukati i te whakakotahitanga o te matūriki, te ua, ko te horopeta noa he 0.5% ~ 1.5%.
2.4, hei aukati, hei rauemi tuku puhoi, hei kaihoko tuku whakahaere me te kaihoko pūwero
Ko te tauira matotoru teitei HPMC e whakamahia ana hei whakarite i ngā aukati me ngā kaihoko tukunga whakahaere o ngā papa tukunga pumau angaanga rauemi whakauru me ngā papa tukunga pumau angaanga wai-aroha. Ko te tauira matotoru iti he kaihoko whakapūngao-pūngao mō ngā papa tukunga-tonu, tukunga-whakahaere rānei kia tere ai te whiwhi i te horopeta whakaora tuatahi o aua papa, ā, whai muri ko te tukunga-tonu, tukunga-whakahaere rānei hei pupuri i ngā kukū whai hua i roto i te toto.
2.5. Te hanganga o te kirimi me te pūwero
Ka taea te whakarite i ngā suppositories hydrogel me ngā whakaritenga piripiri puku mā te whakamahi i te āhuatanga o te hanganga hydrogel e whakamahia whānuitia ana e te HPMC i roto i te wai.
2.6 Ngā rauemi piripiri koiora
I konatunatua te Metronidazole ki te HPMC me te polycarboxylethylene 934 i roto i te mīhini whakaranu hei hanga papa tukunga ā-koiora piripono kei roto ko te 250mg. I whakaatuhia e te whakamātautau whakarewatanga in vitro ka tere te pupuhi o te whakaritenga i roto i te wai, ā, i whakahaeretia te tukunga o te rongoā e te horapa me te whakangāwari mekameka waro. I whakaatuhia e te whakatinanatanga kararehe he nui ngā āhuatanga piri koiora o te pūnaha tukunga rongoā hou ki te mucosa sublingual kau.
2.7, hei āwhina whakatārewatanga
He pai te matotoru o tēnei hua hei āwhina i te whakatārewatanga mō ngā wai whakatārewatanga, ko tōna inenga noa ko te 0.5% ~ 1.5%.
4. Ngā tauira tono
4.1 Otinga paninga kiriata: HPMC 2kg, talc 2kg, hinu kātoro 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% etanoru 53000ml, wai 47000ml, tae e tika ana te rahinga. E rua ngā huarahi hei hanga.
4.1.1 Te whakarite i te wai kakahu kua pania ki te tae wairewa: Tāpirihia te nui kua tohua o te HPMC ki roto i te 95% etanoru, rumakina mō te pō, whakarewahia tētahi atu tae ki roto i te wai (tātarihia mēnā e tika ana), whakakotahihia ngā otinga e rua, ka whakaohokia kia ōrite kia puta he otinga mārama. Whakaranua te 80% o te otinga (20% mō te whakakanapa) ki te nui kua tohua o te hinu kātoro, te Tween-80, me te propylene glycol.
4.1.2 Te whakarite i te tae kore-rewa (pērā i te waikura rino) wai paninga HPMC i rumakina ki te 95% etanoru i te pō, ā, i tāpirihia he wai hei hanga i te 2% wai HPMC mārama. I tangohia te 20% o tēnei wai hei whakakanapa, ā, ko te toenga o te 80% wai me te waikura rino i whakaritea mā te tikanga huri wai, kātahi ka tāpirihia te nui o ētahi atu wāhanga, ā, i konatunatua kia ōrite hei whakamahi. Te tukanga paninga o te wai paninga: ringihia te pepa witi ki roto i te kohua paninga huka, i muri i te hurihanga, ka wera te hau wera ki te 45℃, ka taea te rehu i te paninga whāngai, te whakahaere rere i roto i te 10 ~ 15ml/min, i muri i te rehu, whakamaroke tonu ki te hau wera mō te 5 ~ 10min ka taea te tango i te kohua, ka maka ki roto i te whakamaroke kia maroke mō te neke atu i te 8h.
Kiriuhi kanohi 4.2α-interferon I whakarewaina te 50μg o te α-interferon ki roto i te 10ml 0.01ml waikawa hauwaiora, i konatunatua ki te 90ml etanoru me te 0.5GHPMC, i tātarihia, i pania ki runga i te tokotoko karāhe hurihuri, i whakahoromatahia ki te 60℃, ā, i whakamaroketia ki te hau. Ka hangaia tēnei hua hei rauemi kiriata.
4.3 Papa Cotrimoxazole (0.4g±0.08g) SMZ (80 mata) 40kg, māngaro (120 mata) 8kg, otinga wai HPMC 3% 18-20kg, konupora stearate 0.3kg, TMP (80 mata) 8kg, ko te tikanga whakarite ko te whakaranu i te SMZ me te TMP, kātahi ka tāpirihia te māngaro me te whakaranu mō te 5 meneti. Me te otinga wai HPMC 3% kua oti te hanga, he rauemi ngohengohe, me te mata 16 mata, whakamarokehia, kātahi ka tāpirihia te witi katoa o te mata 14 mata, tāpirihia te konupora stearate ranunga, me ngā papa porowhita 12mm me te kupu (SMZco). Ko te nuinga o tēnei hua he mea here. Ko te rewa o ngā papa he 96%/20min.
4.4 Papa piperate (0.25g) piperate 80 mata 25kg, māngaro (120 mata) 2.1kg, konupora stearate te nui e tika ana. Ko tōna tikanga whakaputa he whakaranu i te waikawa pipeoperic, te māngaro, HPMC kia ōrite, me te rauemi ngohengohe 20% etanoru, te kirikiri mata 16 mata, maroke, kātahi ka pania te witi katoa 14 mata, me te konupora stearate vector, me ngā papa tā whitiki porowhita 100mm (PPA0.25). Mā te māngaro hei kaihoko pakaru, ko te tere pakaru o tēnei papa kāore i raro iho i te 80%/2min, he teitei ake i ngā hua rite i Hapani.
4.5 Haehae horihori HPMC-4000, HPMC-4500, HPMC-5000 rānei 0.3g, konutai pūhaumāota 0.45g, pāhare pākawa konutai 0.37g, borax 0.19g, 10% wairewa ammonium chlorbenzylammonium 0.02ml, wai i tāpirihia ki te 100ml. Ko tōna tikanga whakaputa he HPMC, ka whakanohoia ki roto i te 15ml wai, i te 80 ~ 90℃ wai katoa, ka tangohia he wai, ka tāpirihia he 35ml wai, kātahi ka tāpirihia ngā wāhanga e toe ana o te 40ml wairewa kia ōrite te whakaranu, ka tāpirihia te wai kia tino ōrite te nui, kātahi ka whakaranua kia ōrite te nui, ka waiho mō te pō, ka ringihia mārire te tātari, ka tātarihia ki roto i te ipu kua hiritia, ka whakahoromatahia ki te 98 ~ 100℃ mō te 30min, arā, ko te pH kei waenganui i te 8.4°C ki te 8.6°C. HE WHAKAMAHINGA TĒNEI HUA MŌ TE NGĀWARI ROIMEI, HE WHAKAKĪ PAI MŌ TE ROIMEI, INA whakamahia MŌ TE MĀTAOHIROI rūma o mua, ka taea te WHAKAPĀNUI TIKA I TE INENGA O TĒNEI HUA, 0.7% ~ 1.5% te mea TIKA.
4.6 Papa tukunga whakahaere Meththorphan tote kapia meththorphan 187.5mg, lactose 40.0mg, PVP70.0mg, vapor silica 10mg, 40.0 mGHPMC-603, 40.0mg ~ microcrystalline cellulose phthalate-102 me te konupora stearate 2.5mg. Ka whakaritea hei papa mā te tikanga noa. Ka whakamahia tēnei hua hei rauemi tukunga whakahaere.
4.7 Mō ngā papa avantomycin ⅳ, i whakaohokia, i konatunatua, i whakapūpūhia, ā, i whakamaroketia ki te 35℃ te 2149g avantomycin ⅳ monohydrate me te 1000ml wai isopropyl o te 15% (kukū papatipu) eudragitL-100 (9:1). I konatunatua paitia ngā pūpū maroke 575g me te 62.5g hydroxypropylocellulose E-50, kātahi ka tāpirihia te 7.5g waikawa stearic me te 3.25g konupora stearate ki ngā papa hei whiwhi i te tukunga tonu o ngā papa vanguard mycin ⅳ. Ka whakamahia tēnei hua hei rauemi tukunga puhoi.
4.8 Ngā paura tuku-pūmau o te Nifedipine I konatunatua te 1 wāhanga o te nifedipine, te 3 wāhanga o te hydroxypropyl methyl cellulose me te 3 wāhanga o te ethyl cellulose ki te whakarewa whakauru (ethanol: methylene chloride = 1:1), ā, i tāpirihia te 8 wāhanga o te māngaro kānga hei hanga paura mā te tikanga wairewa-waenga. Kāore i pāngia te tere tukunga rongoā o ngā paura e te huringa o te pH taiao, ā, he puhoi ake i tērā o ngā paura e wātea ana i te hokohoko. I muri i te 12 hāora o te horomia, ko te kukū toto tangata he 12mg/ml, ā, kāore he rerekētanga takitahi.
4.9 Pūmua tukunga pumau Propranhaol hydrochloride 60kg, cellulose maikorokiriata 40kg, tāpirihia he 50L wai hei hanga i ngā kirikiri. I konatunatua te HPMC1kg me te EC 9kg ki roto i te whakarewa whakauru (methylene chloride: methanol =1:1) 200L hei hanga i te otinga paninga, me te tere rere o te 750ml/min i runga i ngā matūriki porowhita hurihuri, ka pania ngā matūriki mā roto i te rahi o te pore o te mata 1.4mm ngā matūriki katoa, kātahi ka whakakīia ki roto i te pūmua kōhatu me te mīhini whakakī pūmua noa. Kei roto i ia pūmua he 160mg o ngā matūriki porowhita propranolol hydrochloride.
4.10 I whakaritea ngā papa angaanga Naprolol HCL mā te whakaranu i te naprolol HCL :HPMC: CMC-NA i te ōwehenga o te 1:0.25:2.25. Tata ki te kore te tere tukunga o te rongoā i roto i ngā haora 12.
Ka taea hoki te hanga i ētahi atu rongoā mai i ngā rauemi angaanga whakaranu, pērā i te metoprolol: HPMC: CMC-NA e ai ki: 1:1.25:1.25; Allylprolol:HPMC e ai ki te ōwehenga 1:2.8:2.92. Tata ki te kore te tere tukunga o te rongoā i roto i ngā haora 12.
4.11 I whakaritea ngā papa angaanga o ngā rauemi whakaranu o ngā matū ethylaminosine mā te tikanga noa mā te whakamahi i te ranunga o te paura moroiti silica gel: CMC-NA :HPMC 1:0.7:4.4. Ka taea te tuku i te rongoā mō te 12 hāora i roto i te vitro me te in vivo, ā, he pai te hononga o te tauira tukunga raina. E ai ki ngā ture a te FDA, ko te roa o te rokiroki o tēnei hua he 2 tau te roa.
4.12 HPMC (50mPa·s) (5 wāhanga), HPMC (4000 mPa·s) (3 wāhanga) me te HPC1 i whakarewaina ki roto i te 1000 wāhanga wai, i tāpirihia te 60 wāhanga acetaminophen me te 6 wāhanga silica gel, i whakaohokia ki te homogenizer, ā, i whakamarokehia ki te rehu. Kei roto i tēnei hua te 80% o te rongoā matua.
4.13 I tatauhia ngā papa angaanga tiēre wai-whakaaro Theophylline i runga i te taumaha katoa o te papa, 18%-35% theophylline, 7.5%-22.5% HPMC, 0.5% lactose, me te nui tika o te hinu whakangawari wai-whakaaro i whakaritea hei papa tukunga whakahaere, ka taea te pupuri i te kukū toto whai hua o te tinana tangata mō te 12 hāora i muri i te horomia.
Te wā tuku: Hui-tanguru-05-2024