转移因子注射剂质量评价与研究

发布时间：2018-10-23 09:14

【摘要】：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。
[Abstract]:Objective to investigate the quality status and existing problems of domestic injection of transfer factor, to study the scientific nature and test method of current quality standard, and to perfect the quality standard. Methods transfer factor injection was a multi-component biochemical drug, which was selected by the National Drug Plan in 2013. Through 57 batches of transfer factor injection in 3 production enterprises, according to the current legal quality standard to carry on the standard inspection, using various statistical methods to analyze its overall quality level, to compare the product quality of different production enterprises, through exploratory research, Several detection methods were established and improved, including microplate-leukocyte adhesion inhibition method, high performance liquid chromatography-amino acid difference method, enzymolysis-reverse phase ion pair chromatography, high performance liquid chromatography characteristic chromatogram, etc. The quality of the variety and the feasibility of the current quality standards to make a general analysis and evaluation. Results 57 batches of samples were tested according to the current standard, and the qualified rate was 91.2%. Of the 5 batches of nonconforming samples, 4 batches were transfer factor injection, all were visible foreign bodies, 1 batch was injection transfer factor, and the content of ribose was not in accordance with the regulation. There is a significant difference between the legal test and the findings of the exploratory study, and some of the items' tests reflect some of the defects and problems in the standards. The standard of transfer factor injection contained in 16 volumes of the Ministry of National Drug Standards has been greatly improved and revised. Conclusion from the quality analysis of the standard test and the research results, the overall quality of this product is general. The results of exploratory research show that the legal standard should be improved, and more exclusive, accurate and sensitive methods should be adopted to control the product quality.
【作者单位】：江苏省食品药品监督检验研究院;中国药科大学;淮安市食品药品检验所;
【分类号】：R927;O657.7

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