1. Basic katundu wa HPMC
Hydroxypropyl methylcellulose, dzina la Chingerezi ndi hydroxypropyl methylcellulose, yomwe imadziwikanso kuti HPMC.Maselo ake ndi C8H15O8-(C10Hl8O6)N-C8HL5O8, ndipo kulemera kwake kwa maselo ndi pafupifupi 86,000.Mankhwalawa ndi opangidwa ndi semi-synthetic, opangidwa ndi gawo la methyl ndi gawo la cellulose polyhydroxypropyl ether.Zitha kupangidwa ndi njira ziwiri: imodzi ndiyo kuchitira kalasi yoyenera ya methyl cellulose ndi NaOH, kenako ndikuchitapo kanthu ndi propylene oxide pansi pa kutentha kwakukulu komanso kuthamanga kwambiri.Nthawi yochitapo iyenera kukhazikika kuti magulu a methyl ndi hydroxypropyl asanduke ma ether.Mawonekedwe alipo ndipo amalumikizidwa ndi mphete ya cellulose yopanda madzi m'thupi kumlingo wofunikira;china ndi kuchitira thonje lint kapena nkhuni zamkati ulusi ndi caustic soda kuti achite kupeza methane kolorayidi ndi propylene oxide, amene angathe kuyengedwa kwambiri ndi pansi.Pangani kukhala ufa wabwino ndi yunifolomu kapena granules.HPMC ndi chilengedwe chomera mapadi ndi wabwino kwambiri excipient mankhwala ndi osiyanasiyana magwero.Pakali pano amagwiritsidwa ntchito kwambiri kunyumba ndi kunja ndipo ndi imodzi mwazinthu zomwe zimagwiritsidwa ntchito kwambiri popanga mankhwala pakamwa.
Izi ndi zoyera mpaka zoyera zamkaka, zopanda poizoni, zopanda fungo, granular kapena fibrous, ufa wosavuta kuyenda.Okhazikika pansi pa kuwala ndi chinyezi.Imafalikira m'madzi ozizira kuti ipange yankho la milky colloidal ndi kukhuthala kwina, ndipo chodabwitsa cha sol-gel interconversion chimachitika chifukwa cha kusintha kwa kutentha kwa yankho ndi ndende inayake.Amasungunuka kwambiri mu 70% ethanol kapena dimethyl ketone, koma osasungunuka mu ethanol, chloroform kapena ethoxyethane.
Mtengo wa pH wa hydroxypropyl methylcellulose uli pakati pa 4.0 ndi 8.0, ndipo uli ndi kukhazikika bwino.Mtengo wa pH ndi wokhazikika pakati pa 3.0 ndi 11.0.Itha kusungidwa pa 20 ° C ndi chinyezi cha 80% kwa masiku 10.Kuchuluka kwa chinyezi kwa HPMC ndi 6.2%.
Hydroxypropyl methylcellulose ili ndi mitundu yosiyanasiyana yazogulitsa chifukwa cha zomwe zili m'magulu a methoxy ndi hydroxypropyl mu kapangidwe kake.Pamalo okhazikika, mitundu yosiyanasiyana yazinthu imakhala ndi viscosity yeniyeni komanso matenthedwe.Kutentha kwa gel osakaniza kotero kumakhala ndi zinthu zosiyanasiyana zomwe zingagwiritsidwe ntchito pazinthu zosiyanasiyana.Pharmacopoeia ya dziko lililonse ili ndi zofunikira ndi mafotokozedwe osiyanasiyana: European Pharmacopoeia imatengera ma viscosities osiyanasiyana, magawo osiyanasiyana olowa m'malo, milingo yogwiritsira ntchito komanso kuchuluka kwazinthu zosiyanasiyana zomwe zimagulitsidwa pamsika.Chigawo cha United States Pharmacopoeia ndi mPa·s, ndipo mayina odziwika ndi awa Gwiritsani ntchito manambala anayi kuyimira zomwe zili mu hydroxypropyl methylcellulose yokhala ndi zolowa m'malo ndi mitundu yosiyanasiyana, monga hydroxypropyl methylcellulose, 2208. Ma manambala awiri oyamba amayimira pafupifupi kuchuluka kwake. ya magulu a methoxy, ndipo manambala awiri omalizira amaimira gulu la hydroxyl.Pafupifupi peresenti ya propyl.
2. HPMC kusungunuka mu madzi njira
2.1 Njira yamadzi otentha
Popeza hydroxypropyl cellulose ndi yosasungunuka m'madzi otentha, imatha kumwazikana m'madzi otentha ndikukhazikika.Njira ziwiri zodziwika bwino zimayambitsidwa motere:
(1) Ikani madzi otentha ofunikira m’chidebe ndi kutentha mpaka pafupifupi 70°C.Onjezani mankhwala pang'onopang'ono ndikuyambitsa pang'onopang'ono.Poyamba, mankhwalawa amayandama pamadzi ndipo pang'onopang'ono amapanga slurry.
(2) Onjezani 1/3 kapena 2/3 ya kuchuluka kwa madzi ofunikira mumtsuko ndikuwotchera mpaka 70 ° C kuti mumwaze mankhwalawo, konzani slurry yamadzi otentha, kenaka yikani madzi ozizira otsalawo kapena kuwonjezera ayezi. madzi ku slurry ya madzi otentha.slurry m'madzi, kusonkhezera osakaniza pambuyo kuzirala.
2.2 Njira yosakaniza ufa
The particles ufa bwinobwino omwazikana ndi youma kusanganikirana ndi ofanana kapena wochuluka kuchuluka kwa zinthu zina ufa kenako kusungunuka ndi madzi, kumene HMCS amasungunuka popanda coagulation.
3. Ubwino wa HPMC
3.1 Kusungunuka m'madzi ozizira
Imasungunuka m'madzi ozizira pansi pa 40 ℃ kapena 70% ethanol, ndipo imakhala yosasungunuka m'madzi otentha kuposa 60 ℃, koma imatha kusungunuka.
3.2 Kusakhazikika kwa Chemical
HPMC ndi non-ionic cellulose ether.Yankho lake lilibe mtengo wa ionic ndipo silimalumikizana ndi mchere wachitsulo kapena ma ionic organic compounds.Choncho, excipients ena sachita nawo pa kukonzekera kupanga ndondomeko.
3.3 Kukhazikika
Ndiwokhazikika ku asidi ndi alkali ndipo akhoza kusungidwa kwa nthawi yaitali pakati pa pH 3 ndi 1l popanda kusintha kwakukulu mu viscosity.Mayankho amadzimadzi a hydroxypropyl methylcellulose (HPMC) ndi antifungal ndipo amakhala okhazikika pakusungidwa kwanthawi yayitali.Kukhazikika kwabwino kwa HPMC ndikwabwinoko kuposa zowonjezera zachikhalidwe (monga dextrin, wowuma, ndi zina).
3.4 Kukhuthala kosinthika
Osiyana mamasukidwe akayendedwe zotumphukira za HPMC akhoza kukhala mosiyanasiyana, ndi mamasukidwe akayendedwe awo akhoza kusinthidwa malinga ndi zofunika kutsatira malamulo ena ndi kukhala ndi ubale wabwino liniya, kotero chiŵerengero akhoza kusankhidwa malinga ndi zosowa.
3.5 Kulephera kwa metabolic
HPMC si odzipereka kapena zimapukusidwa mu thupi ndipo sapereka kutentha, choncho ndi otetezeka excipient kwa mankhwala kukonzekera.
3.6 Chitetezo
HPMC nthawi zambiri imatengedwa kuti ndi yopanda poizoni, yosakwiyitsa, yokhala ndi LD50 ya 5g/kg mu mbewa ndi 5.2g/kg mu makoswe.Mlingo watsiku ndi tsiku ndi wopanda vuto kwa anthu.
4 Kugwiritsa ntchito HPMC pokonzekera
4.1 Zida zokutira mafilimu ndi zida zopangira mafilimu
Hydroxypropyl methylcellulose (HPMC) amagwiritsidwa ntchito ngati filimu yokutira zinthu.Mapiritsi ake okutidwa alibe ubwino wodziwikiratu pamapiritsi ophimbidwa achikhalidwe monga mapiritsi okhala ndi shuga ponena za kubisa kukoma ndi maonekedwe a mankhwala, koma kuuma kwake, brittleness, ndi hygroscopicity , kuwonongeka kosauka., kupaka kulemera kwa kulemera ndi zizindikiro zina zabwinoko.Otsika mamasukidwe akayendedwe kalasi ya mankhwala ntchito ngati madzi sungunuka filimu ❖ kuyanika zakuthupi kwa mapiritsi ndi mapiritsi, ndi mkulu mamasukidwe akayendedwe kalasi ntchito ngati filimu ❖ kuyanika zakuthupi kachitidwe organic zosungunulira.Nthawi zambiri ndende ndi 2.0% ~ 20%.
4.2 Monga chomangira komanso chosokoneza
Otsika mamasukidwe akayendedwe kalasi ya mankhwala angagwiritsidwe ntchito ngati binder ndi disintegrant kwa mapiritsi, mapiritsi, ndi granules, pamene mkulu mamasukidwe akayendedwe kalasi angagwiritsidwe ntchito ngati binder.Mlingo umasiyanasiyana malinga ndi chitsanzo ndi zofunikira, nthawi zambiri 5% pamapiritsi owuma a granulation ndi 2% pamapiritsi a granulation wonyowa.
4.3 Monga chithandizo choyimitsidwa
The suspending wothandizira ndi viscous gel osakaniza mankhwala kuti ndi hydrophilic ndipo angagwiritsidwe ntchito kuchepetsa yokhazikika liwiro la particles ndi kutsatira pamwamba pa particles kuteteza particles kuti aggregating mu mipira.Zothandizira kuyimitsidwa zimagwira ntchito yofunika kwambiri popanga ma suspension agents.HPMC ndi yabwino kuyimitsidwa zowonjezera.Ake kusungunuka colloidal njira akhoza kuchepetsa madzi-olimba interfacial mavuto ndi ufulu mphamvu yaing'ono olimba particles, potero utithandize bata la sakanikira kubalalitsidwa dongosolo.Izi ndi mkulu-kukhuthala kwamanjenje kuyimitsidwa kukonzekera ndi zabwino kuyimitsidwa tingati, mosavuta kubalalitsidwa, sanali ndodo khoma, ndi zabwino flocculation particles.Mlingo wake wanthawi zonse ndi 0.5% mpaka 1.5%.
4.4 Monga cholepheretsa, chotulutsa nthawi zonse ndi porogen
Mlingo wapamwamba kwambiri wamtunduwu umagwiritsidwa ntchito popanga mapiritsi a hydrophilic gel matrix omasulidwa mosalekeza, mapiritsi osakanikirana amtundu wa retarders ndi othandizira omasulidwa.Zimakhala ndi zotsatira zochedwetsa kutulutsidwa kwa mankhwala.Kugwiritsa ntchito kwake ndi 10% -80% (W / W).Miyezo yocheperako ya viscosity imagwiritsidwa ntchito ngati inducers pore mukupanga kokhazikika kapena koyendetsedwa bwino.Amenewa mapiritsi mwamsanga kukwaniritsa koyamba mlingo chofunika achire tingati kutulutsa zisathe kapena ankalamulira kumasulidwa tingati, ndi kukhala ogwira magazi mankhwala woipa mu thupi.Hydroxypropyl methylcellulose hydrates m'madzi kuti apange gel wosanjikiza.Njira yotulutsira mankhwala a mapiritsi a matrix makamaka imaphatikizapo kufalikira kwa gel osanjikiza ndi kusungunuka kwa gel osanjikiza.
4.5 Thickeners ndi zoteteza colloids
Izi zikagwiritsidwa ntchito ngati thickener, ndende yomwe imagwiritsidwa ntchito kwambiri ndi 0.45% ~ 1.0%.Izi mankhwala akhoza kuonjezera bata wa guluu hydrophobic, kupanga colloid zoteteza, kuteteza particles ku agglomeration ndi agglomeration, potero inhibiting mapangidwe mpweya.Kuphatikizika kwake kofala ndi 0.5% ~ 1.5%.
4.6 Gwiritsani ntchito ngati capsule zakuthupi
Nthawi zambiri chipolopolo cha kapisozi cha makapisozi ndi gelatin.Kapangidwe ka zipolopolo za gelatin capsules ndi zophweka, koma pali mavuto ndi zochitika monga chitetezo chosatetezeka ku mankhwala osokoneza bongo ndi okosijeni, kuchepetsa kusungunuka kwa mankhwala, ndi kuchedwa kutha kwa zipolopolo za capsule panthawi yosungira.Choncho, hydroxypropyl methylcellulose ntchito m'malo zipangizo kapisozi pokonza makapisozi, amene bwino kupanga, akamaumba ndi zotsatira ntchito makapisozi, ndipo wakhala ankalimbikitsa kunyumba ndi kunja.
4.7 Monga bioadhesive
Ukadaulo wa bioadhesion umagwiritsa ntchito ma polima okhala ndi bioadhesive polima kuti agwirizane ndi mucosa wachilengedwe ndikuwonjezera kukhazikika komanso kulimba kwa kukhudzana pakati pa kukonzekera ndi mucous membrane, kulola kuti mankhwalawa atulutsidwe pang'onopang'ono ndikumwedwa ndi mucosa kuti akwaniritse zolinga zachirengedwe.Kuti akwaniritse cholinga cha mankhwala, panopa chimagwiritsidwa ntchito pofuna kuchiza matenda m`mphuno patsekeke, m`kamwa mucosa ndi mbali zina za thupi.Tekinoloje ya m'mimba ya bioadhesion ndi njira yatsopano yoperekera mankhwala yomwe idapangidwa zaka zaposachedwa.Sikuti prolongs okhala nthawi ya mankhwala kukonzekera mu m`mimba thirakiti, komanso bwino kukhudzana ntchito pakati pa mankhwala ndi selo mayamwidwe nembanemba malo ndi kusintha kapangidwe ka selo nembanemba.Kusuntha, ndiko kuti, kupezeka kwa mankhwalawa ku maselo am'mimba a epithelial, potero.
Nthawi yotumiza: Feb-01-2024