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).
Chakwamba, kusoŵa kwa ma audit gha ŵakupeleka vinthu kukujura nthowa yakuti vinthu vyambura kuzirwa vinjiremo. Mu mafakitale ghakupanga gelatin, ghakulongozgeka na kupenja phindu likuru, ŵanyake awo ŵakupanga vinthu ŵambura kugomezgeka ŵangagwiliskira nchito vyakuvunda vya chikopa, ivyo vikumanyikwa chomene kuti "blue alum skin" kuti ŵaphike gelatin wa mafakitale. Mtengo wa gelatin uyu wakupangika na mafakitale ngwakucepa comene kuluska wa gelatin wakupangika na munkhwala, kweni wakufumira ku mafakitale ghakupangira vikopa. Pakuti kupanga vikumba kukusazgapo kugwiliskira nchito comene vinthu ivyo vili na chromium-, chromium iyo yili mu gelatin wa mafakitale njakukwana comene. Kwambura kufufuza mwakukwana uko vinthu vikufuma na kukhozgera pa malo gha awo ŵakupeleka munkhwala, awo ŵakupanga munkhwala ŵakusuzgika kumanya usange vinthu ivyo vikupangika ni vyambura kuzomerezgeka, ndipo mwambura kumanya ŵakugwiliskira ntchito vinthu vyapasi ivi.
Chachiŵiri, kujumphizga kuyezgeka kwa vyakupangira vinthu kukupangiska kuti vinthu ivyo vikujumpha ivyo vikukhumbikwa vifike ku ŵalwari mwaluŵiro. Kuyana na malango gha buku la Chinese Pharmacopoeia, chromium iyo yili mu makapisozi ghambura kanthu yikwenera yayi kuluska 2ppm. Iyi ni mzere wakufipirwa wakukhora wa chivikiliro. Ndipouli, usange kampani yikujumphizga ndondomeko ya kuwoneseska umo vinthu vikuŵira para yagura vinthu vyakupangira vinthu, nchakusuzga kumanya kuti pali vyakufipiska vya visulo vyakuzirwa ivyo vikuwoneka yayi na maso. Para gelatin iyi ya chromium yikuru-yapangika kuŵa vikumba vya makapisozi na kuzura na munkhwala, yikuŵa "shuga" wakuphakazgika na poizoni.
Kupwetekeka kwa chromium wakujumphizga ku umoyo wa ŵanthu kungaŵa kwambura kuzirwa yayi. Chromium wakuwunjika mu thupi, ndipo chromium wa hexavalent, chomenechomene, ni poizoni chomene. Kumwa kwa nyengo yitali-kungananga viŵaro nga ni chiwindi na impso ndipo kungaŵa na ngozi ya kansa. Nangauli kumwa munkhwala uwu kamoza kungapangiska yayi kuti munthu waŵe na poizoni wakukoma, kweni para munthu wakumwa munkhwala uwu kwa nyengo yitali, mosakayikira wakubisa bomba la nyengo mukati mwa thupi.
Mwakudumura, ŵakupeleka ŵambura kufufuzika panji ŵambura kuyezgeka .vyakupangirandizo zikupangiska kuti chromium yiŵe yinandi mu makapisozi. Ici nchinthu cakutondeka waka yayi kuwoneseska kuti vinthu vikwenda makora, kweni nchakulekaso kucindika umoyo wa ŵakugula. Mabizinesi agho ghakupanga munkhwala ghakwenera kulondezga malango ghawemi, kulinda chomene vipata vyakuwonera na kuyezga, na kuwoneseska kuti kapusulu yiliyose njakuvikilirika ndiposo njakutowa. Usange pali mafumbo ghakukhwaskana na makapisozi ghambura kanthu, Mwapokelereka kuti muyowoye na KornnacCaps.
