M'makampani opanga mankhwala ndi zakudya, mitundu ya kapisozi ya kapisozi imagwiritsidwa ntchito kwambiri chifukwa chosavuta kunyamula komanso kubisa fungo losasangalatsa. Pakati pawo, makapisozi a enteric-okutidwa, monga othandizira mwapadera amankhwala, amagwira ntchito yofunika kwambiri. Panthawi yogula kapena kupanga R&D, makampani ambiri opanga mankhwala amayang'ana kwambiri chizindikiro: Kodi nthawi yosweka ya makapisozi-okutidwa ndi enteric ndi iti? Nkhaniyi isanthula nkhaniyi mwatsatanetsatane kuti ikuthandizeni kumvetsetsa bwino za kusakhazikika komanso kufunikira kwa makapisozi okhala ndi enteric{4}}.
I. Standard Disintegration Time of Enteric{1}}Coated Capsules
Malinga ndi Chinese Pharmacopoeia ndi zofunikira za dziko, nthawi yosweka ya enteric-makapisozi olimba opaka imafotokozedwa bwino lomwe. Mwachidule, kugawanika kwake kumagawidwa m'magawo awiri, mogwirizana ndi madera osiyanasiyana am'mimba m'thupi la munthu:
M'Gastric Fluid Environment (Acid-Stage Resistant):
Ma capsules a Enteric ayenera kukhala okhazikika m'mimba yamadzimadzi popanda kusweka kapena kutayikira. Muyezo nthawi zambiri umafunika kuti mkati mwa maola a 2 oscillation kapena kumizidwa mumadzimadzi opangira chapamimba (pH 1.2 hydrochloric acid solution), kapisoziyo sayenera kuwonetsa ming'alu, kupasuka, kapena kutayikira kwa zomwe zili mkati. Izi ndikuwonetsetsa kuti mankhwalawa amadutsa m'mimba mosatekeseka, kuteteza asidi am'mimba kuti asawononge zigawo za mankhwala kapena mankhwala kuti asakwiyitse mucosa yapamimba.
Chikhalidwe cha Madzi a M'mimba (Gawo la Disintegration):
Kapisozi akamalowa m'matumbo am'mimba, amayenera kutulutsa mankhwalawa mwachangu. Muyezo umafunika kusamutsa kapisozi woyesedwa m'matumbo am'mimba kukhala madzimadzi opangira matumbo (pH 6.8 phosphate buffer), pomwe nthawi yake yosweka imafunika kukhala mkati mwa mphindi 60 (miyezo ina yayikulu imafuna nthawi yayifupi, monga mkati mwa mphindi 30). Nthawi yeniyeni imasiyana pang'ono kutengera momwe wopanga amapangira komanso mtundu wake, koma mfundo yayikulu ndi "kusweka ukafika m'matumbo".
Chifukwa chake, nthawi ya kupasuka kwa enteric-makapisozi okutidwa si chithunzi chimodzi, koma chithunzithunzi chokwanira cha "palibe kupasuka m'mimba madzimadzi (Kuposa kapena kufanana ndi maola 2)" ndi "kusungunuka msanga m'matumbo amadzimadzi ( Osakwana kapena ofanana ndi mphindi 60)".
II. N'chifukwa Chiyani Nthawi Yogawanika Ili Yofunika Kwambiri?
Cholinga cha ma enteric-coated capsules ndi "site-specific release". Ngati nthawi yopatukana ili yocheperako, ikhoza kukhala ndi zotsatira zoyipa:
Kuwonongeka Kwambiri (M'mimba): Izi zingayambitse kuwonongeka kwa mankhwala ndi chapamimba asidi, kuchepetsa mphamvu; kapena mankhwala akhoza kukhumudwitsa m'mimba, kuchititsa zotsatira zoipa monga nseru ndi kusanza.
Kuchedwa Kutha (M'matumbo): Ngati kapisoziyo imasweka pang'onopang'ono m'matumbo, mankhwalawa sangatulutsidwe pamalo abwino kwambiri omwe amayamwa m'matumbo aang'ono, zomwe zimapangitsa kuti mayamwidwe achepetse kapenanso kutulutsidwa m'thupi asanatuluke.
Chifukwa chake, kuyang'anira mosamalitsa nthawi yakuwonongeka ndikofunikira pakuwonetsetsa kuti mankhwalawa ali ndi bioavailability komanso chithandizo chamankhwala.
III. Zomwe Zimakhudza Nthawi ya Kugawanika
Ngakhale kuti miyezo ya dziko ili ndi malamulo ogwirizana, pakugwiritsa ntchito, nthawi yopatukana imatha kukhudzidwa ndi zinthu zosiyanasiyana:
Mapangidwe Opangira Zinthu: Makapisozi apamwamba-abwino kwambiri a enteric nthawi zambiri amagwiritsa ntchito gelatin yokutidwa ndi zinthu zokutira zamkati (monga Cellulose Acetate Phthalate CAP, Acrylic resin, etc.). Makulidwe ndi kufanana kwa ❖ kuyanika kumatsimikizira mwachindunji nthawi ya kukana kwa asidi ndi liwiro la kupasuka.
Zosungirako Zosungira: Chinyezi ndi kutentha zimakhudza kwambiri chipolopolo cha capsule. Chinyezi chochulukirapo chingapangitse chipolopolo cha kapisozi kuti chifewetse, kusintha mawonekedwe ake komanso kusokoneza nthawi ya kupasuka.
Zomwe Zamkatimu: Ngati mankhwala odzaza ufa kapena ma granules ali ndi hygroscopicity kapena ma pH apadera, amatha kuyanjana ndi zinthu za capsule, kusokoneza njira yowonongeka.
IV. Mapeto
Kuti tifotokoze mwachidule, nthawi ya kupasuka ndi chiyanienteric-makapisozi okutidwa? Yankho ndilo: palibe kupasuka mkati mwa maola a 2 mumadzimadzi opangira m'mimba, ndipo kawirikawiri amawonongeka mkati mwa ola la 1 mumadzimadzi opangira matumbo. Kwa makampani opanga mankhwala, kusankha mankhwala a enteric-makapisozi okutidwa omwe amakwaniritsa miyezo ya pharmacopoeia ndikupereka zokhazikika ndikofunikira kuti muwonetsetse kuti mankhwalawa ndi otetezeka komanso akugwira ntchito. Mukamagula zinthu, onetsetsani kuti mwapempha zitsanzo zoyezetsa nthawi yodzipatula kuti muwonetsetse kuti chinthucho chikukwaniritsa zomwe mukufuna. Ngati pali mafunso okhudza makapisozi opanda kanthu, olandiridwa kuti mulumikizane ndi KornnacCaps.
