1. Abubuwan asali na HPMC
Hydroxypropyl methylcellulose, sunan Ingilishi shine hydroxypropyl methylcellulose, wanda kuma aka sani da HPMC. Tsarin kwayoyin halittar sa shine C8H15O8-(C10Hl8O6)N-C8HL5O8, kuma nauyinsa na kwayoyin yana kusan 86,000. Samfurin shine Semi-Synthetic, wanda ya ƙunshi ɓangaren methyl da ɓangaren cellulose polyhydroxypropyl ether. Ana iya yin ta ta hanyoyi guda biyu: ɗaya shine a bi da daidaitaccen darajar methyl cellulose tare da NaOH, sa'an nan kuma amsa tare da propylene oxide a ƙarƙashin yanayin zafi da matsa lamba. Dole ne a ci gaba da ɗaukar lokaci ta yadda za a iya canza ƙungiyoyin methyl da hydroxypropyl zuwa ethers. Samfurin yana wanzu kuma an haɗa shi tare da dehydrated glucose zobe na cellulose zuwa iyakar da ake bukata; ɗayan kuma shine a yi amfani da lint ɗin auduga ko itacen ɓawon burodi tare da soda caustic don amsawa don samun methane chloride da propylene oxide, wanda za'a iya ƙarawa da kuma niƙa. Yi shi a cikin lallausan foda ko granules. HPMC shine cellulose shuka na halitta kuma kyakkyawan kayan aikin magunguna ne tare da maɓuɓɓuka da 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 a cikin magungunan baka.
Wannan samfurin fari ne zuwa fari mai madara, mara guba, mara wari, granular ko fibrous, foda mai sauƙi. Ingantacciyar kwanciyar hankali a ƙarƙashin haske da zafi. Yana faɗaɗa cikin ruwan sanyi don samar da maganin colloidal milky tare da wani ɗanɗano mai ɗanɗano, kuma sol-gel interconversion sabon abu yana faruwa ne saboda canjin yanayin zafi na maganin tare da wani taro. Mai narkewa sosai a cikin 70% ethanol ko dimethyl ketone, amma maras narkewa a cikin cikakken ethanol, chloroform ko ethoxyethane.
Ƙimar pH na hydroxypropyl methylcellulose yana tsakanin 4.0 da 8.0, kuma yana da kyakkyawan kwanciyar hankali. Ƙimar pH ta tsaya tsakanin 3.0 da 11.0. Ana iya adana shi a zafin jiki na 20 ° C kuma yanayin zafi na 80% na kwanaki 10. Matsakaicin ɗaukar danshi na HPMC shine 6.2%.
Hydroxypropyl methylcellulose yana da nau'ikan samfura daban-daban saboda abubuwan da ke cikin nau'ikan methoxy da ƙungiyoyin hydroxypropyl a cikin tsarin. A takamaiman taro, nau'ikan samfuran suna da takamaiman danko da kaddarorin thermal. Gel zazzabi sabili da haka suna da kaddarorin daban-daban waɗanda za a iya amfani da su don dalilai daban-daban. Pharmacopoeia na kowace ƙasa yana da buƙatu daban-daban na samfuri da maganganu: Pharmacopoeia na Turai ya dogara ne akan nau'ikan viscosities daban-daban, digiri daban-daban na maye gurbin, matakan amfani da lambobi na nau'ikan samfuran samfuran da aka sayar a kasuwa. Ƙungiyar Pharmacopoeia ta Amurka ita ce mPa·s, kuma sunayen gama gari sune kamar haka Yi amfani da lambobi huɗu don wakiltar abun ciki na hydroxypropyl methylcellulose tare da madogara daban-daban da nau'o'in, irin su hydroxypropyl methylcellulose, 2208. Lambobin farko biyu suna wakiltar kimanin kashi dari. na ƙungiyoyin methoxy, kuma lambobi biyu na ƙarshe suna wakiltar ƙungiyar hydroxyl. Kimanin kashi na propyl.
2. HPMC narke cikin hanyar ruwa
2.1 Hanyar ruwan zafi
Tunda hydroxypropyl cellulose ba ya narkewa a cikin ruwan zafi, ana iya tarwatsa shi daidai a cikin ruwan zafi sannan a sanyaya. Ana gabatar da hanyoyi guda biyu na al'ada kamar haka:
(1) Sanya adadin ruwan zafi da ake buƙata a cikin kwandon kuma zafi shi zuwa kusan 70 ° C. Ƙara samfur a hankali yayin motsawa a hankali. Da farko, samfurin yana iyo akan ruwa sannan a hankali ya samar da slurry.
(2) Ƙara 1/3 ko 2/3 na adadin ruwan da ake buƙata a cikin akwati kuma a zafi shi zuwa 70 ° C don tarwatsa samfurin, shirya slurry na ruwan zafi, sa'an nan kuma ƙara sauran adadin ruwan sanyi ko ƙara kankara. ruwa zuwa ruwan zafi slurry. slurry a cikin ruwa, motsa cakuda bayan sanyaya.
2.2 Hanyar hada foda
Ana tarwatsa ɓangarorin foda da kyau ta hanyar haɗakar bushewa tare da daidai ko mafi girma na sauran abubuwan foda sannan a narkar da su da ruwa, inda HMCS ta narke ba tare da coagulation ba.
3. Amfanin HPMC
3.1 Mai narkewa a cikin ruwan sanyi
Yana da narkewa a cikin ruwan sanyi ƙasa 40 ℃ ko 70% ethanol, kuma m insoluble a cikin ruwan zafi sama da 60 ℃, amma zai iya gel.
3.2 Rashin rashin kuzari
HPMC shine ether cellulose maras ionic. 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 aikin samar da shirye-shiryen.
3.3 Kwanciyar hankali
Yana da kwanciyar hankali ga acid da alkali kuma ana iya adana shi na dogon lokaci tsakanin pH 3 da 1l ba tare da wani canji mai mahimmanci a cikin danko ba. Maganin ruwa mai ruwa na hydroxypropyl methylcellulose (HPMC) antifungal ne kuma suna kula da kwanciyar hankali mai kyau yayin ajiya na dogon lokaci. Ingancin kwanciyar hankali na HPMC ya fi abubuwan da ake amfani da su na gargajiya (kamar dextrin, sitaci, da sauransu).
3.4 Daidaitaccen danko
Dabbobin danko daban-daban na HPMC na iya zama cikin ma'auni daban-daban, kuma ana iya canza dankon su bisa ga buƙatun bin wasu ƙa'idodi kuma suna da kyakkyawar alaƙar layi, don haka za'a iya zaɓar rabo gwargwadon buƙatu.
3.5 Rashin rashin kuzari
HPMC ba a tsotse ko metabolized a cikin jiki kuma baya samar da zafi, don haka yana da aminci ga shirye-shiryen magunguna.
3.6 Tsaro
Ana ɗaukar HPMC gabaɗaya a matsayin mara guba, abu mara ban haushi, tare da LD50 na 5g/kg a cikin beraye da 5.2g/kg a cikin berayen. Magungunan yau da kullun ba su da illa ga mutane.
4 Aikace-aikacen HPMC a cikin shiri
4.1 Kayan aikin fim da kayan aikin fim
Hydroxypropyl methylcellulose (HPMC) ana amfani dashi azaman kayan shafa na fim. Allunan sa masu rufi ba su da fa'ida a bayyane akan allunan masu rufi na gargajiya irin su allunan da aka rufe da sukari dangane da masking dandano da bayyanar da miyagun ƙwayoyi, amma taurin sa, brittleness, da hygroscopicity, rarrabuwa mara kyau. , Rufe nauyi riba da sauran ingancin Manuniya ne mafi alhẽri. Ana amfani da ƙananan danko sa na wannan samfurin azaman kayan shafa na ruwa mai narkewa don allunan da kwaya, kuma ana amfani da babban danko mai mahimmanci azaman kayan shafa na fim don tsarin narkewar ƙwayoyin cuta. Matsakaicin yawanci shine 2.0% ~ 20%.
4.2 A matsayin mai ɗaure da tarwatsewa
Za'a iya amfani da ƙaramin ɗanƙoƙi na wannan samfur azaman ɗaure da rarrabuwa don allunan, kwaya, da granules, yayin da babban ma'aunin ɗanƙoƙi kawai za'a iya amfani dashi azaman ɗaure. Matsakaicin ya bambanta bisa ga samfurin da buƙatun, gabaɗaya 5% don busassun allunan granulation da 2% don allunan granulation rigar.
4.3 A matsayin taimakon dakatarwa
Wakilin dakatarwa wani abu ne na gel mai danko wanda yake hydrophilic kuma ana iya amfani dashi don rage saurin daidaitawar barbashi da mannewa saman ɓangarorin don hana ɓarna daga haɗuwa cikin ƙwallaye. Kayan taimako na dakatarwa suna taka muhimmiyar rawa wajen samar da wakilai na dakatarwa. HPMC kyakkyawan ƙari ne na dakatarwa. Narkar da shi colloidal bayani zai iya rage ruwa-m interfacial tashin hankali da kuma free makamashi na kananan m barbashi, game da shi inganta kwanciyar hankali na iri-iri watsawa tsarin. Wannan samfurin babban shiri ne na dakatarwa tare da sakamako mai kyau na dakatarwa, tarwatsawa mai sauƙi, bango mara sanda, da ƙananan ɓangarorin flocculation. Matsakaicin sa na yau da kullun shine 0.5% zuwa 1.5%.
4.4 A matsayin mai ɗorewa, wakili mai dorewa da porogen
Ana amfani da babban ma'aunin danko na wannan samfurin don shirya allunan ɗorewa na matrix hydrophilic, matrix ɗin kayan hade-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe-haɗe da wakilai-saki. Yana da tasirin jinkirta sakin miyagun ƙwayoyi. Matsakaicin amfaninsa shine 10% -80% (W/W). Ana amfani da ƙananan matakan danko azaman masu haifar da pore a cikin abubuwan da aka ɗora ko sarrafawa. Irin waɗannan allunan na iya da sauri cimma kashi na farko da ake buƙata don tasirin warkewa, sannan su samar da sakamako mai dorewa ko sarrafawa, da kuma kula da ingantaccen adadin magungunan jini a cikin jiki. Hydroxypropyl methylcellulose hydrates a cikin ruwa don samar da gel Layer. Hanyar sakin miyagun ƙwayoyi na allunan matrix sun haɗa da yaduwa na gel Layer da rushewar gel Layer.
4.5 Masu kauri da masu karewa
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 kariya, hana barbashi daga agglomeration da agglomeration, don haka hana samuwar hazo. Matsayinta na kowa shine 0.5% ~ 1.5%.
4.6 Yi amfani da azaman kayan capsule
Yawancin lokaci capsule harsashi abu na capsules shine gelatin. Tsarin samar da harsashi na capsule gelatin abu ne mai sauƙi, amma akwai matsaloli da al'amura kamar rashin kariya daga danshi- da magungunan iskar oxygen, rage narkewar ƙwayoyi, da jinkirta wargajewar harsashi na capsule yayin ajiya. Saboda haka, ana amfani da hydroxypropyl methylcellulose a matsayin madadin kayan kwalliya a cikin shirye-shiryen capsules, wanda ke inganta masana'antu, gyare-gyare da amfani da tasirin capsules, kuma an inganta shi sosai a gida da waje.
4.7 A matsayin bioadhesive
Fasahar Bioadhesion tana amfani da abubuwan haɓakawa tare da polymers masu haɓakawa don manne da mucosa na halitta da haɓaka daidaito da ƙima na lamba tsakanin shirye-shiryen da mucosa, ƙyale ƙwayar cuta ta saki sannu a hankali kuma ta shayar da mucosa don cimma dalilai na warkewa. Don cimma manufar magani, a halin yanzu ana amfani da shi don magance cututtuka a cikin kogon hanci, mucosa na baki da sauran sassan jiki. Fasahar bioadhesion na hanji sabon nau'in tsarin isar da magunguna ne wanda aka haɓaka a cikin 'yan shekarun nan. Ba wai kawai yana tsawaita lokacin zama na shirye-shiryen miyagun ƙwayoyi a cikin ƙwayar gastrointestinal ba, amma har ma yana inganta aikin hulɗar tsakanin miyagun ƙwayoyi da wurin shayar da ƙwayar sel kuma yana canza tsarin tsarin kwayar halitta. Motsi, wato, permeability na miyagun ƙwayoyi zuwa ƙwayoyin epithelial na hanji, don haka.
Lokacin aikawa: Fabrairu-01-2024