盐酸林可霉素注射液包装系统中16种元素杂质含量测定及相容性考察

Content Determination of 16 Element Impurities in Lincomycin Hydrochloride Injection Packaging System and its Compatibility Investigation

为建立测定盐酸林可霉素注射液包装系统中16种元素杂质的含量方法,考察在稳定性研究过程中盐酸林可霉素注射液与包装材料的相容性风险,提取液及药液以2%硝酸溶液稀释,分别用钪(Sc)、铟(In)、铋(Bi)和锗(Ge)元素为内标,采用电感耦合等离子体质谱法(ICP-MS)测定16种元素杂质含量。结果表明,2批新生产的盐酸林可霉素注射液(0个月)中16种元素杂质检测结果均符合分析评价阈值要求。在加速条件下存放6个月和长期条件下存放12个月和24个月的同批次样品,硅元素检出量在限度的48%~58%,硼和铝两种元素检出量均小于其限度的30%,钒、镍、铅、镉、铅、砷、汞、钴、锂、锑、铜、铁、锌和钡13种元素检出量均小于其限度的10%。加速实验和长期实验的研究结果表明,包装材料与本品间有相互作用,但该作用未随放置时间的增加有明显的增长趋势,说明本品在全生命周期内与包装系统相容性良好,风险较低。

In order to establish a method for determining the content of 16 elements impurities in the packaging system of lincomycin hydrochloride injection,the study investigates the compatibility risk of lincomycin hydrochloride injection and packaging materials during stability study.After the extract and medicinal solution are diluted with 2%nitric acid solution,scandium(Sc),indium(In),bismuth(Bi)and germanium(Ge)are used as internal standards to determine the impurity content of 16 elements.The test results of 16 element impurities in the 2 batches of newly produced lincomycin hydrochloride injection(0 months)all met the analysis and evaluation threshold requirements.In the same batch of samples stored under accelerated conditions for 6 months and under long-term conditions for 12 months and 24 months,the detection amount of silicon element is within the limit of 48%~58%,the detection amount of boron and aluminum is less than 30%of the corresponding element limit,and the detection amount of vanadium,nickel,lead,cadmium,lead,arsenic,mercury,cobalt,lithium,antimony,copper,iron,zinc and barium is less than 10%of the corresponding element limit.The results of accelerated long-term experiments show that there is an interaction between the packaging material and this product,but this effect does not have a significant growth trend with the increase of storage time,indicating that this product has good compatibility with the packaging system during the entire life cycle,with less risks.