M'zaka zana za mbiri ya makapisozi, gelatin yakhala ikukhalabe ndi zida zodziwika bwino za kapisozi chifukwa cha magwero ake ambiri, zokhazikika zakuthupi ndi zamankhwala komanso zida zabwino kwambiri zopangira.Ndi kuchuluka kwa zomwe anthu amakonda makapisozi, makapisozi opanda kanthu amagwiritsidwa ntchito kwambiri pazakudya, zamankhwala ndi zamankhwala.
Komabe, kupezeka ndi kufalikira kwa matenda amisala a ng’ombe ndi matenda a phazi ndi pakamwa kumapangitsa anthu kuyamba kuda nkhawa ndi zinthu zopangidwa ndi nyama.Zinthu zomwe zimagwiritsidwa ntchito kwambiri ndi gelatin ndi mafupa ndi khungu la ng'ombe ndi nkhumba, ndipo ngozi yake yakopa chidwi cha anthu pang'onopang'ono.Pofuna kuchepetsa chiwopsezo cha chitetezo cha zida zopangira kapisozi, akatswiri amakampani akupitilizabe kufufuza ndikupanga zida zoyenera zotengedwa ndi kapisozi.
Kuphatikiza apo, ndi kuchuluka kwa makapisozi osiyanasiyana, kusiyanasiyana kwa zomwe zili mkati mwawo pang'onopang'ono kumapangitsa anthu kuzindikira kuti pali zovuta zolumikizana pakati pa makapisozi a gelatin holo ndi zina zomwe zili ndi zinthu zapadera.Mwachitsanzo, zomwe zili ndi magulu a aldehyde kapena kuchitapo kanthu kuti apange magulu a aldehyde pansi pazifukwa zina zingayambitse kugwirizanitsa kwa gelatin;Zomwe zili ndi kuchepetsa mphamvu zimatha kukhala ndi Maillard reaction ndi gelatin;Zomwe zili ndi hygroscopicity yolimba zipangitsa chipolopolo cha Ming kapisozi kutaya madzi ndikutaya kulimba kwake koyambirira.Kukhazikika kwa kapisozi kakang'ono ka gelatin kumapangitsa kuti kapisozi watsopano akope chidwi kwambiri.
Ndi zinthu ziti zomwe zimachokera ku mbewu zomwe zili zoyenera kupanga makapisozi olimba opanda kanthu?Anthu ayeserapo kwambiri.Chinese patent chikalata ntchito No.: 200810061238 X ntchito pa cellulose sodium sulphate monga waukulu kapisozi zakuthupi;200510013285.3 ntchito kutenga wowuma kapena wowuma zikuchokera monga waukulu kapisozi zakuthupi;Wang GM [1] adanena kuti makapisozi opanda kanthu adapangidwa kuchokera ku makapisozi a chitosan;Zhang Xiaoju et al.[2] adanenanso zazinthu zomwe zili ndi mapuloteni a soya a Konjac ngati chinthu chachikulu cha kapisozi.Zachidziwikire, zida zomwe zimaphunziridwa kwambiri ndi zida za cellulose.Mwa iwo, makapisozi opanda kanthu opangidwa ndi hydroxypropyl methylcellulose (HPMC) apanga kupanga kwakukulu.
HPMC chimagwiritsidwa ntchito m'munda wa chakudya ndi mankhwala.Ndiwothandizira mankhwala omwe amagwiritsidwa ntchito kawirikawiri, omwe amaphatikizidwa mu Pharmacopoeia ya mayiko osiyanasiyana;FDA ndi EU amavomereza HPMC ngati chowonjezera kapena chowonjezera cha chakudya;Gras ndi chinthu chotetezeka, No. GRN 000213;Malinga ndi nkhokwe ya JECFA, INS no.464, palibe malire pa mlingo waukulu wa tsiku ndi tsiku wa HPMC;Mu 1997, idavomerezedwa ndi Unduna wa Zaumoyo ku China ngati chowonjezera chazakudya komanso chowonjezera (No. 20), chomwe chimagwira ntchito pamitundu yonse yazakudya ndikuwonjezera malinga ndi zofunikira zopanga [2-9].Chifukwa cha kusiyana kwa katundu pakati pa HPMC ndi gelatin, mankhwala a HPMC hollow capsule ndi ovuta kwambiri, ndipo ma gelling agents amafunika kuwonjezeredwa, monga Arabic gum, carrageenan (seaweed chingamu), starch, etc.
HPMC dzenje kapisozi ndi mankhwala ndi maganizo achilengedwe.Ukadaulo wake wakuthupi ndi wopanga umadziwika ndi mabungwe achiyuda, achisilamu komanso okonda zamasamba.Ikhoza kukwaniritsa zosowa za anthu a zipembedzo zosiyanasiyana ndi zizolowezi zodyera, ndipo imavomerezedwa kwambiri.Kuphatikiza apo, makapisozi opanda kanthu a HPMC ali ndi zotsatirazi:
1.Madzi otsika - pafupifupi 60% otsika kuposa gelatin hollow capsule
Madzi omwe ali mu makapisozi a gelatin opanda kanthu nthawi zambiri amakhala 12.5% - 17.5% [10].Kutentha ndi chinyezi cha chilengedwe kuyenera kuyendetsedwa molingana ndi nthawi yopangira, kuyendetsa, kugwiritsa ntchito ndi kusunga makapisozi opanda kanthu.Kutentha koyenera ndi 15-25 ℃ ndi chinyezi chachibale ndi 35% - 65%, kotero kuti ntchito ya mankhwalawa ikhoza kusungidwa kwa nthawi yayitali.Madzi a HPMC nembanemba ndi otsika kwambiri, nthawi zambiri 4% - 5%, omwe ali pafupifupi 60% m'munsi kuposa gelatin dzenje kapisozi (mkuyu. 1).Kusinthanitsa madzi ndi chilengedwe pakasungidwe kwa nthawi yayitali kumawonjezera madzi omwe ali mu kapisozi wa HPMC pamapaketi omwe atchulidwa, koma osapitilira 9% mkati mwa zaka 5.
Chithunzi 1.Kuyerekeza kwa LOD kwa HMPC ndi zipolopolo za Gelatin pansi pa RH yosiyana
Maonekedwe amadzi otsika amapangitsa HPMC kapisozi yopanda kanthu kukhala yoyenera kudzaza zinthu za hygroscopic kapena zomwe zimakhudzidwa ndi madzi kuti zitalikitse moyo wa alumali wazinthu.
2.Kulimba kwakukulu, palibe brittleness
Monga tanena kale, filimu ya gelatin imakhala ndi chinyezi chodziwika bwino.Ngati ndi otsika kuposa malire awa, gelatin filimu adzakhala kwambiri Chimaona.Makapisozi wamba a gelatin opanda zowonjezera amakhala ndi chiopsezo cha brittleness yopitilira 10% pomwe chinyezi chili 10%;Pamene madzi akupitirirabe kuchepa mpaka 5%, 100% brittleness idzachitika.Mosiyana ndi zimenezi, kulimba kwa makapisozi a HPMC opanda kanthu ndi abwino kwambiri, ndipo amakhalabe ndi ntchito yabwino ngakhale chinyezi cha chilengedwe ndi chochepa (mkuyu 3).Zachidziwikire, kuchuluka kwa ma ebrittlement a makapisozi opanda kanthu a HPMC okhala ndi malamulo osiyanasiyana pansi pa chinyezi chochepa kudzawonetsa kusiyana kwakukulu.
M'malo mwake, makapisozi opanda kanthu a gelatin omwe amaikidwa m'malo onyowa kwambiri amafewetsa, kufota kapena kugwa atamwa madzi.HPMC dzenje kapisozi akhoza kukhalabe mawonekedwe abwino ndi ntchito ngakhale pansi pa chikhalidwe cha chinyezi mkulu.Choncho, HPMC dzenje kapisozi ali amphamvu kusinthasintha kwa chilengedwe.Malo ogulitsa malonda akamakhudza madera osiyanasiyana a nyengo kapena malo osungirako ndi osauka, mwayi uwu wa HMPC hollow capsule ndiwofunika kwambiri.
3.Kukhazikika kwamankhwala kwamphamvu
Kuphatikizika kwa makapisozi a gelatin ndi vuto laminga lomwe limakumana ndi kukonzekera kapisozi.Chifukwa gulu la aldehyde la okhutira limakhudzidwa ndi gulu la amino la amino acid mu gelatin kuti lipange maukonde, chipolopolo cha kapisozi chimakhala chovuta kusungunuka pansi pa kusungunuka kwa m'galasi, zomwe zimakhudza kutulutsidwa kwa mankhwala.Hydroxypropyl methylcellulose ndi chochokera ku cellulose, chomwe chimakhala chopanda mankhwala ndipo chimagwirizana kwambiri ndi zinthu zambiri.Choncho, HPMC dzenje kapisozi alibe chiopsezo mtanda zolumikizira anachita ndi mkulu mankhwala bata
4.Good zokutira ntchito
Enteric TACHIMATA makapisozi ntchito mankhwala amene mosavuta kuonongeka ndi asidi chapamimba, zokwiyitsa kwa chapamimba mucosa kapena amafuna chandamale makonzedwe.Ukadaulo wovomerezeka padziko lonse lapansi wa makapisozi okhala ndi enteric ndi zokutira zonse za ma pellets ndi makapisozi okhala ndi enteric.HPMC kapisozi dzenje limasonyeza ubwino wapadera mu zokutira chonse cha kapisozi.
Kafukufukuyu akuwonetsa kuti chifukwa chazovuta za HPMC kapisozi yopanda kanthu, kuyanjana ndi zida zambiri zokutira zamkati ndizokwera kwambiri kuposa gelatin, komanso kuthamanga kwa zomatira ndi kufanana kwa zida zokutira ndizabwinoko kuposa gelatin, makamaka kudalirika kwa zokutira kwa kapu ya thupi. ndi bwino kwambiri.Mayeso a in vitro dissolution adawonetsa kuti kutsekemera kwa kapisozi wa HPMC m'mimba kunali kotsika ndipo kunali kumasulidwa kwabwino m'matumbo[
Mapeto
Makhalidwe a HPMC hollow capsule akulitsa ntchito yake.Kuchokera kuzinthu zonse zachilengedwe kupita kuzinthu zowonongeka kapena za hygroscopic, zimakhalanso ndi ntchito zapadera m'munda wa inhalants youma ufa ndi kupaka enteric.Zindikirani kuti makapisozi opanda kanthu a HPMC omwe ali pamsika pano ndi kunja ali ndi mpweya wokwanira komanso kupasuka pang'onopang'ono kuposa makapisozi a gelatin, koma bioavailability yawo mu vivo ndi yofanana [11], yomwe iyenera kuganiziridwa pakufufuza ndi chitukuko.
Monga tonse tikudziwa, pali njira yotalikirapo yochokera ku kafukufuku wa labotale, kuyesa kwakukulu, kupanga mafakitale kupita kukulimbikitsa msika.Ichi ndichifukwa chake, patapita zaka zafukufuku ndi chitukuko, zida zochepa chabe za kapisozi zopanda kanthu zopangidwa ndi zomera zochokera ku zomera zalembedwa bwino.Mu 1997, capsugel adatsogolera pakulemba HPMC hollow capsule vcapstm ku United States, ndikupereka chisankho chatsopano cha kapisozi wapakamwa.Pakalipano, malonda a pachaka a makapisozi a HPMC padziko lonse lapansi aposa 20 biliyoni, ndipo akukula pa mlingo wa 25% pachaka.
Nthawi yotumiza: May-06-2022