目的 考察国产转移因子注射剂的质量现状及存在问题,对现行质量标准的科学性及检验方法进行研究,完善质量标准。方法 转移因子注射剂为多组分生化药,是2013年国家药品计划抽验品种。通过对3个生产企业57批次转移因子注射剂,依据现行法定质量标准进行标准检验,运用多种统计学方法分析其质量总体水平,比较不同生产企业产品质量;通过探索性研究,建立并完善了多个检测方法,包括微量板-白细胞黏附抑制法、高效液相色谱-氨基酸差值法、酶解-反相离子对色谱法、高效液相色谱特征图谱法等,对该品种的质量状况及现行质量标准的可行性做出总体分析及评价。结果 本次抽验中涉及的57批次样品按现行标准检验,合格率为91.2%。在5批不符合规定样品中,4批为转移因子注射液,均为可见异物不符合规定,1批为注射用转移因子,核糖含量不符合规定。法定检验与探索性研究结果之间存在显著差异,部分项目的检测反映出一些标准上的缺陷和问题;通过本次实验,对国家药品标准地升部十六册中收载的转移因子注射剂标准作了大幅提高和修订。结论 从标准检验和探索研究结果的质量分析情况看,本品总体质量状况一般。探索性研究结果表明法定标准需提高,应采用更专属、准确、灵敏的方法全面控制产品质量。

OBJECTIVE To understand the quality status and problems of domestic transfer factor injections and evaluate the suitability of statutory standard and additional explorative researches. METHODS Fifty-seven batches of transfer factor injections were analyzed according to the legal quality standard and the results were statistically analyzed to assess the overall level of quality. The qualities of the products form different manufacturing enterprises were compared. According to the explorative researches, the overall situation of product quality and standard condition were then comprehensively evaluated. RESULTS The qualified rate of the 57 batches of samples was 91.2%. Four samples failed due to visible foreign substances and one sample failed due to unqualified content of ribose. There were obvious differences between the results of legal test and exploratory research. The results reflected some defects and problems of the legal quality standard which was greatly improved and revised in our research. CONCLUSION The overall quality status of transfer factor injections is not ideal. The results of exploratory research demonstrate that many defects exist in the legal quality standard and a series of exclusive, accurate and sensitive methods should be established to fully control the quality of transfer factor injections.