【摘要】 目的测定广州市医药市场上销售的药用明胶硬胶囊壳中重金属元素铅、镉、汞和砷的含量,供监控药用明胶硬胶囊壳中重金属元素铅、镉、汞和砷参考。方法利用石墨炉原子吸收分光光度法和原子荧光光谱法检测药用明胶硬胶囊壳中重金属元素铅、镉、汞和砷的含量。结果本次检测的5家企业生产的药用明胶硬胶囊壳中的铅、镉、汞、砷的含量分别为3.53～11.0、0.13～0.42、0.09～0.18、0.07～0.17mg/kg。依据《明胶空心胶囊》(YBX-2000-2007)标准判断,本次测定的5家企业生产的药用明胶硬胶囊壳中重金属含量符合明胶空心胶囊的要求;若参照《药用植物及制剂进出口绿色行业标准》(WM2-2001),则部份产品铅、镉含量超标;参照欧盟食品卫生标准,则铅含量超过国际标准。结论现行明胶空心胶囊标准已不能满足我国胶囊制剂药品的出口需要,明胶硬胶囊壳的质量标准迫切需要与国际接轨,对现行明胶空心胶囊标准应进行修订。更多还原

【Abstract】 Objective To determine the content of As,Hg,Pb and Cr in medical gelatin hard capsule shells in the medical market of Guangzhou for monitoring the quality of the shells.Methods Graphite furnace atomic absorption spectrophotometry (GF-AAS)and atomic fluorescence spectrometry (AFS)were used.Results The concentration of Pb,Cd,Hg,As was 3.53～11.0,0.13～0.42,0.09～0.18,0.07～0.17 mg/kg,respectively in gelatin hard capsule shell manufactured by 5 pharmaceutical factories.Conclusion The "hollow gelatin capsules" (YBX-2000-2007)standard can not meet the needs of medical gelatin capsules export,and the standard of the medical gelatin hard capsule shell should be improved according to the international standard immediately,the present standard for controlling heavy metal (Pb,Cd,Hg,As)elements should be revised.更多还原