1. Abubuwan asali na HPMC
Hypromellose, cikakken suna hydroxypropyl methylcellulose, wanda aka fi sani da HPMC.Tsarin kwayoyinsa shine C8H15O8- (C10Hl8O6) n-C8Hl5O8, kuma nauyin kwayoyinsa shine game da 86000. Wannan samfurin wani abu ne mai mahimmanci, wanda shine ɓangare na methyl kuma wani ɓangare na polyhydroxypropyl ether na cellulose.Ana iya samar da shi ta hanyoyi guda biyu: ɗaya shine cewa ana kula da darajar methyl cellulose mai dacewa tare da NaOH, sa'an nan kuma ya amsa tare da propylene oxide a ƙarƙashin yanayin zafi da matsa lamba.An haɗa fom ɗin zuwa zoben anhydroglucose na cellulose, kuma yana iya kaiwa matakin da ya dace;ɗayan kuma shine a yi maganin linter na auduga ko fiber na itace tare da soda caustic, sannan a mayar da martani da methyl chloride da propylene oxide a jere don samun shi, sannan a ƙara tacewa, a niƙa don yin kyau da uniform foda ko granules.HPMC nau'in cellulose ne na tsire-tsire na halitta iri-iri, kuma yana da kyakkyawan kayan haɓakar magunguna, wanda ke da fa'idodi masu yawa.A halin yanzu, ana amfani da shi sosai a gida da waje, kuma yana ɗaya daga cikin abubuwan da ake amfani da su na magunguna waɗanda aka fi amfani da su a cikin magungunan baka.
Wannan samfurin fari ne zuwa fari mai madara a launi, mara guba kuma maras ɗanɗano, kuma yana cikin nau'in granular ko fibrous foda wanda ke gudana cikin sauƙi.Yana da ɗan kwanciyar hankali a ƙarƙashin hasken haske da zafi.Yana kumbura a cikin ruwan sanyi don samar da maganin colloidal farar madara, wanda ke da ɗanɗano kaɗan, kuma al'amarin na sol-gel interconversion na iya faruwa saboda canjin yanayin zafi na wani taro na maganin.Yana da narkewa sosai a cikin 70% barasa ko dimethyl ketone, kuma ba zai narke cikin cikakken barasa, chloroform ko ethoxyethane ba.
Lokacin da pH na hypromellose ya kasance tsakanin 4.0 da 8.0, yana da kwanciyar hankali mai kyau, kuma zai iya kasancewa a tsaye lokacin da pH ke tsakanin 3.0 da 11.0.Lokacin da zafin jiki ya kai 20 ° C kuma yanayin zafi ya kai 80%, ana adana shi na kwanaki 10.Matsakaicin ɗaukar danshi na HPMC shine 6.2%.
Saboda daban-daban abinda ke ciki na methoxy da hydroxypropyl a cikin tsarin hypromellose, nau'ikan samfurori sun bayyana.A cikin ƙayyadaddun ƙididdiga, nau'ikan samfuran daban-daban suna da takamaiman danko da yanayin zafi na thermal, sabili da haka, suna da kaddarorin daban-daban kuma ana iya amfani da su don dalilai daban-daban.Pharmacopoeias na ƙasashe daban-daban suna da ƙa'idodi daban-daban da wakilci akan samfuran: Turai Pharmacopoeia, bisa ga nau'ikan nau'ikan nau'ikan viscosities daban-daban da digiri na maye gurbin samfuran da aka sayar a kasuwa, ana wakilta ta maki da lambobi, kuma sashin shine mPa. · s;a cikin Pharmacopoeia na Amurka, sunan gama gari Ƙara lambobi 4 a ƙarshen don nuna abun ciki da nau'in kowane madaidaicin hypromellose, irin su hypromellose 2208, lambobi biyu na farko suna wakiltar kimanin kaso na methoxy, kuma lambobi biyu na ƙarshe suna wakiltar hydroxypropyl. Kimanin kashi.
2. Hanyar narkar da HPMC a cikin ruwa
2.1 Hanyar ruwan zafi
Tun da hypromellose ba ya narke a cikin ruwan zafi, ana iya tarwatsa shi daidai a cikin ruwan zafi a farkon, sa'an nan kuma sanyaya.Hanyoyi guda biyu na al'ada an bayyana su kamar haka:
(1) Sanya adadin ruwan zafi da ake buƙata a cikin akwati, sannan a zafi shi zuwa kusan 70 ° C, a hankali ƙara wannan samfurin a hankali a hankali, a farkon, wannan samfurin yana yawo a saman ruwan, sannan a hankali ya samar da slurry, yana motsawa Cool da slurry ƙasa.
(2) Ƙara 1/3 ko 2/3 na adadin ruwan da ake buƙata a cikin kwandon kuma zafi shi zuwa 70 ° C don tarwatsa samfurin don shirya slurry na ruwan zafi, sannan ƙara sauran adadin ruwan sanyi ko ruwan kankara har sai silts ruwan zafi A cikin slurry, cakuda yana sanyaya bayan motsawa.
2.2 Hanyar hada foda
An tarwatsa ɓangarorin foda ta hanyar busassun hadawa tare da daidai ko girman adadin sauran sinadaran foda, sannan a narkar da su cikin ruwa.A wannan lokacin, ana iya narkar da hypromellose ba tare da agglomeration ba.
3. Amfanin HPMC
3.1 Ruwa mai sanyi
Mai narkewa a cikin ruwan sanyi da ke ƙasa da 40 ° C ko 70% ethanol, wanda ba zai iya narkewa a cikin ruwan zafi sama da 60 ° C, amma ana iya gelled.
3.2 Rashin rashin kuzari
Hypromellose (HPMC) wani nau'in ether ne maras ionic cellulose.Maganin sa ba shi da cajin ionic kuma baya mu'amala da gishirin ƙarfe ko mahaɗan kwayoyin ionic.Sabili da haka, sauran abubuwan haɓaka ba sa amsawa tare da shi yayin tsarin shirye-shiryen.
3.3 Kwanciyar hankali
Yana da ingantacciyar kwanciyar hankali ga acid da alkali, kuma ana iya adana shi na dogon lokaci tsakanin pH 3 da 1l ba tare da bayyananniyar canji a cikin danko ba.Maganin ruwa mai ruwa na hypromellose (HPMC) yana da tasirin anti-mildew kuma yana iya kula da kwanciyar hankali mai kyau yayin ajiya na dogon lokaci.Magunguna masu amfani da HPMC a matsayin masu haɓakawa suna da ingantacciyar kwanciyar hankali fiye da waɗanda ke amfani da abubuwan haɓaka na gargajiya (kamar dextrin, sitaci, da sauransu).
3.4 Danko daidaitacce
Ana iya haɗa nau'o'in danko daban-daban na HPMC bisa ga ma'auni daban-daban, kuma danko na iya canzawa bisa ga wasu dokoki, kuma yana da dangantaka mai kyau na layi, don haka za'a iya zaɓar rabo bisa ga buƙatu.
3.5 Metabolic inertia
HPMC ba a tunawa ko metabolized a cikin jiki, kuma baya samar da zafi, don haka yana da aminci shirye-shiryen magunguna.
3.6 Tsaro
An yi imani da cewa HPMC abu ne mara guba kuma maras haushi.Matsakaicin kisa ga berayen shine 5g/kg, kuma matsakaicin adadin kisa na berayen shine 5.2g/kg.Magungunan yau da kullun ba su da illa ga mutane.
4. Aikace-aikacen HPMC a cikin shiri
4.1 Kamar yadda kayan shafa fim da kayan aikin fim
Yin amfani da hypromellose (HPMC) a matsayin kayan kwalliyar fim ɗin, idan aka kwatanta da allunan gargajiya na gargajiya kamar allunan da aka yi da sukari, allunan da aka rufe ba su da fa'ida a bayyane a cikin masking ɗanɗanon magani da bayyanar, amma taurinsu da friability , ɗaukar danshi, tarwatsewa, ɗaukar nauyi riba da sauran alamun inganci sun fi kyau.Ana amfani da ƙarancin danko na wannan samfurin azaman kayan shafa na ruwa mai narkewa don allunan da kwaya, kuma ana amfani da madaidaicin madaidaicin a matsayin kayan kwalliyar fim don tsarin narkewar ƙwayoyin cuta.Matsakaicin yawanci shine 2.0% zuwa 20%.
4.2 Kamar yadda mai ɗaure da tarwatsewa
Za'a iya amfani da ƙarancin danko na wannan samfurin azaman mai ɗaure da rarrabuwa don allunan, kwaya, da granules, kuma babban ma'aunin danko kawai za'a iya amfani dashi azaman mai ɗaure.Matsakaicin ya bambanta da samfura da buƙatu daban-daban.Gabaɗaya, adadin abin ɗaure don busassun busassun granulation shine 5%, kuma sashi na ɗaure don allunan granulation shine 2%.
4.3 A matsayin wakili mai dakatarwa
Wakilin da aka dakatar shine wani abu mai danko mai danko tare da hydrophilicity, wanda zai iya rage saurin sedimentation na barbashi lokacin da aka yi amfani da shi a cikin wakili mai dakatarwa, kuma ana iya haɗa shi zuwa saman sassan don hana barbashi daga haɗuwa da raguwa a cikin ball. .Wakilan da aka dakatar suna taka muhimmiyar rawa wajen yin dakatarwa.HPMC ne mai kyau iri-iri na dakatar jamiái, da kuma ta narkar da colloidal bayani iya rage tashin hankali na ruwa-m dubawa da kuma free makamashi a kan kananan m barbashi, game da shi inganta kwanciyar hankali na iri-iri watsawa tsarin.Ana amfani da babban darajar wannan samfur azaman shiri-nau'in ruwa wanda aka shirya azaman wakili mai dakatarwa.Yana da tasiri mai kyau na dakatarwa, yana da sauƙin sakewa, baya tsayawa a bango, kuma yana da ƙananan ƙwayoyin cuta.Matsakaicin adadin yau da kullun shine 0.5% zuwa 1.5%.
4.4 A matsayin mai toshewa, wakili mai ɗorewa da wakili mai haifar da pore
Ana amfani da babban ma'aunin danko na wannan samfurin don shirya allunan ci gaba na hydrophilic gel matrix, masu katsewa da wakilai-saki don allunan abubuwan da aka haɗa-saki matrix, kuma yana da tasirin jinkirta sakin miyagun ƙwayoyi.Yawan amfani da shi shine 10% ~ 80% (W / W).Ana amfani da ma'auni mai ƙarancin danko azaman wakilai masu haifar da pore don ci gaba-saki ko shirye-shiryen sakin sarrafawa.Matsakaicin farko da ake buƙata don tasirin warkewa na wannan nau'in kwamfutar hannu za a iya samu da sauri, sannan kuma aiwatar da ci gaba-saki-saki-saki-saki, kuma ana kiyaye tasirin magungunan jini mai inganci a cikin jiki.Lokacin da hypromellose ya hadu da ruwa, yana yin ruwa don samar da gel Layer.Tsarin sakin miyagun ƙwayoyi daga kwamfutar hannu na matrix ya haɗa da yaduwa na gel Layer da yashwar gel Layer.
4.5 Manne mai kariya azaman thickener da colloid
Lokacin da aka yi amfani da wannan samfurin azaman thickener, yawan amfani da taro shine 0.45% ~ 1.0%.Wannan samfurin kuma zai iya ƙara kwanciyar hankali na manne hydrophobic, samar da colloid mai karewa, hana barbashi daga agglomerating da agglomerating, ta haka ne ya hana samuwar laka, kuma taro na yau da kullun shine 0.5% ~ 1.5%.
4.6 Capsule abu don capsules
Yawancin lokaci capsule harsashi capsule abu na capsule yana dogara ne akan gelatin.Tsarin samar da harsashi na capsule gelatin abu ne mai sauƙi, amma akwai wasu matsaloli da al'amura kamar rashin kariya daga danshi da magungunan oxygen, ƙarancin narkewar ƙwayoyi, da jinkirta tarwatsewar harsashin capsule yayin ajiya.Sabili da haka, ana amfani da hypromellose, a matsayin maye gurbin gelatin capsules, a cikin shirye-shiryen capsules, wanda ke inganta haɓakawa da amfani da tasirin capsules, kuma an inganta shi sosai a gida da waje.
4.7 a matsayin bioadhesive
Fasahar bioadhesion, yin amfani da abubuwan haɓakawa tare da polymers na bioadhesive, ta hanyar mannewa ga mucosa na ilimin halitta, yana haɓaka ci gaba da ƙulla hulɗar da ke tsakanin shirye-shiryen da mucosa, don haka an saki miyagun ƙwayoyi a hankali kuma a shayar da mucosa don cimma manufar warkewa.A halin yanzu ana amfani da shi sosai Ana amfani da shi don magance cututtuka na kogon hanci, mucosa na baki da sauran sassa.Fasahar bioadhesion na hanji wani sabon tsarin isar da magunguna ne da aka haɓaka a cikin 'yan shekarun nan.Ba wai kawai yana tsawaita lokacin zama na shirye-shiryen magunguna a cikin ƙwayar gastrointestinal ba, amma kuma yana inganta aikin hulɗar tsakanin miyagun ƙwayoyi da membrane tantanin halitta a wurin sha, yana canza launin ruwan kwayar halitta, Inganta shigar da miyagun ƙwayoyi zuwa cikin hanji. Kwayoyin epithelial, don haka inganta bioavailability na miyagun ƙwayoyi.
4.8 Kamar yadda gel
A matsayin shirye-shiryen m don fata, gel yana da jerin fa'idodi irin su aminci, kyakkyawa, tsaftacewa mai sauƙi, ƙananan farashi, tsari mai sauƙi na shirye-shirye, da kuma dacewa mai kyau tare da kwayoyi.hanya.
Lokacin aikawa: Dec-15-2022