As an indispensable excipient in pharmaceuticals, the safety of empty capsules is directly related to the life and health of patients. However, what are the serious consequences if raw material suppliers are not strictly audited during the production process, or if raw materials are not subjected to incoming inspection? The most direct and fatal consequence is that the heavy metal chromium content in the capsule shells exceeds the safety limit (>2 ppm).
Choyamba, kusowa kwa ma auditor a ma supplier kumatsegula chitseko cha kuchuluka kwa zinthu zotsika mtengo. M'makampani opanga gelatin, motsogozedwa ndi kufunafuna phindu lalikulu, opanga ena osakhulupirika amatha kugwiritsa ntchito zinyalala zachikopa, zomwe zimadziwika kuti "blue alum skin" kuti aphike gelatin yamakampani. Mtengo wa gelatin wamakampaniwa ndi wotsika kwambiri kuposa wa gelatin wamankhwala, koma umachokera kumakampani opanga zikopa. Popeza kutenthetsa khungu kumaphatikizapo kugwiritsa ntchito kwambiri chromium-zokhala ndi chromium, zomwe zili mu chromium mu gelatin ya mafakitale ndizokwera kwambiri. Popanda kuunika kozama kwa gwero komanso{5}}kutsimikizira kwa ogulitsa, opanga mankhwala amavutika kuti azindikire kuti gwero la zopangira silololedwa, motero amangogwiritsa ntchito zinthu zotsika izi mosadziwa.
Kachiwiri, kulumpha kuyezetsa kwazinthu zopangira kumapangitsa kuti zinthu zomwe zimapitilira miyezo zifikire odwala mwachindunji. Malinga ndi malamulo a Chinese Pharmacopoeia, zomwe zili mu chromium mu makapisozi opanda kanthu zisapitirire 2ppm. Uwu ndi mzere wofiira wachitetezo wokhazikika. Komabe, ngati kampani ilumpha sitepe yoyang'anira bwino itagula zinthu zopangira, ndizosatheka kuzindikira kuipitsidwa kwazitsulo zolemera zomwe sizikuwoneka ndi maso. Gelatin yokwera-chromium ikapangidwa kukhala zipolopolo za makapisozi ndikudzazidwa ndi mankhwala, imakhala "shuga" wokutidwa ndi poizoni.
Kuvulaza kwa chromium yochuluka ku thanzi laumunthu sikunganyalanyazidwe. Chromium imadziunjikira m'thupi, ndipo chromium ya hexavalent, makamaka, imakhala yapoizoni kwambiri. Kudya kwa nthawi yayitali-kutha kuwononga ziwalo monga chiwindi ndi impso ndipo zimatha kuyambitsa khansa. Ngakhale kuti kumwa kamodzi kokha sikungabweretse poizoni woopsa, kumwa kwa nthawi yaitali{4}}makapisozi amenewa mosakayikira kumakwirira bomba lomwe lachitika m'thupi.
Mwachidule, ogulitsa osawerengedwa kapena osayesedwazida zogwiritsira ntchitondizomwe zimayambitsa kuchuluka kwa chromium mu makapisozi. Izi sizongolephera kuwongolera khalidwe komanso kunyalanyaza thanzi la ogula. Mabizinesi opanga mankhwala amayenera kutsata zoyambira zabwino, kuteteza mosamalitsa zipata zowunikira ndi kuyesa, ndikuwonetsetsa kuti kapule iliyonse ndi yotetezeka komanso yoyera. Ngati pali mafunso okhudza makapisozi opanda kanthu, Takulandilani kuti mulumikizane ndi KornnacCaps.
