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 (>2ppm).
Okokuqala, ukunqongophala kophicotho lwababoneleli kuvula ucango lokungena kwezinto ezikumgangatho ophantsi. Kwishishini lemveliso yegelatin, eqhutywa kukufuna inzuzo enkulu, abanye abavelisi abanganyanisekanga banokusebenzisa inkunkuma yesikhumba, eyaziwa ngokuba yi "blue alum skin" ukubilisa igelatin yeshishini. Ixabiso lale gelatin yoshishino lisezantsi kakhulu kunelo legelatin yamayeza, kodwa lisuka kwishishini lokusukwa kwesikhumba. Kuba ukwenza ulusu kubandakanya ukusetyenziswa kakhulu kwechromium-equlethe iiarhente, umxholo wechromium kwigelatin yeshishini uphezulu kakhulu. Ngaphandle kophicotho olungqongqo lwemithombo kunye -noqinisekiso lwesiza lwababoneleli, abavelisi bamayeza bakufumana kunzima ukuchonga ukungabikho semthethweni komthombo wemathiriyeli ekrwada, ngokwenza njalo besebenzisa ezi mathiriyeli zingaphantsi ngokungazi.
Okwesibini, ukutsiba uvavanyo lwezinto eziluhlaza kuvumela iimveliso ezidlula imigangatho ukufikelela kwizigulana ngokuthe ngqo. Ngokwemigaqo ye-Pharmacopoeia yaseTshayina, umxholo we-chromium kwii-capsules ezingenanto akufanele zidlule i-2ppm. Lo ngumgca obomvu wokhuseleko olungqongqo. Nangona kunjalo, ukuba inkampani idlula inyathelo lokuhlola umgangatho emva kokuthenga izinto eziluhlaza, akunakwenzeka ukuchonga ukungcola kwentsimbi enzima engabonakaliyo ngeso lenyama. Xa le gelatin -phezulu yechromium yenziwe amaqokobhe ecapsule kwaye izaliswe ngamayeza, iba "yiswekile" eqatywe yityhefu.
Umonakalo wechromium egqithisileyo kwimpilo yabantu awunakujongelwa phantsi. I-Chromium iqokelelana emzimbeni, kwaye i-chromium ene-hexavalent, ngakumbi, inetyhefu kakhulu. Ukutya ixesha elide{2}kungonakalisa amalungu afana nesibindi kunye nezintso kwaye kunokubangela umngcipheko we-carcinogenic. Nangona ukutya nje okukodwa kusenokungabangeli ityhefu ebukhali, ukusetyenziswa ixesha elide{4}}kweziyobisi ze-capsule ngaphandle kwamathandabuzo kungcwaba ibhombu yexesha ngaphakathi emzimbeni.
Isishwankathelo, ababoneleli abangaphicothwanga okanye abangavavanywangaiimpahla ezingekasilwazezona zizathu zechromium egqithisileyo kwiicapsules. Oku akukona nje ukungaphumeleli kulawulo lomgangatho kodwa nokungakhathaleli impilo yabathengi. Amashishini okuvelisa amayeza kufuneka abambelele kwiziseko ezisemgangathweni, agade ngokungqongqo amasango ophicotho-zincwadi novavanyo, kwaye aqinisekise ukuba yonke i-capsule enye ikhuselekile kwaye inyulu. Ukuba kukho nayiphi na imibuzo malunga nee-capsules ezingenanto, Wamkelekile ukuba uqhagamshelane ne-KornnacCaps.
