胰岛素注射液质量现状及相关标准研究

发布时间：2018-10-19 07:12

【摘要】：目的:为了解胰岛素注射液的质量现状及提高相关检验标准提供参考。方法:选取32批胰岛素注射液上市产品,根据本品法定检验标准(包括性状、鉴别、装量、可见异物、无菌及生物法测定效价)进行全检。另参照同类产品的法定检验标准,采用反相高效液相色谱法对其有关物质、含量及苯酚的量进行测定;采用高效液相分子排阻色谱法对其高分子蛋白质进行测定;采用原子吸收分光光度法对其锌含量进行测定。结果:按照法定标准进行检验,32批样品检验结果均符合规定。按照同类产品的法定标准进行检验,杂质A21脱氨胰岛素的测定结果为15.6%~39.2%,全部超过同类产品5.0%的限度标准;含量测定结果为93.2%~102.7%;高分子蛋白质含量测定结果为0.5%~0.6%;苯酚的质量浓度测定结果为2.34~2.51 mg/ml;锌含量测定结果为12.3~14.8μg/100 U。结论:胰岛素注射液现行法定检验标准缺少有关物质、含量测定等关键质控项目;相关上市产品高分子蛋白质、苯酚及锌含量控制较好;杂质A21脱氨胰岛素含量普遍偏高,胰岛素主峰的稳定性较差。
[Abstract]:Objective: to provide reference for understanding the quality of insulin injection and improving the related standards. Methods: 32 batches of insulin injection were selected and tested according to the standard of this product (including characters, identification, loading, visible foreign body, aseptic and bioassay). In addition, the related substances, contents and phenol were determined by reversed-phase high performance liquid chromatography (RP-HPLC), and its high molecular protein was determined by high performance liquid chromatography (HPLC). The zinc content was determined by atomic absorption spectrophotometry. Results: 32 batches of samples were tested according to the legal standard. According to the legal standard of the same kind of product, the result of determination of impurity A21 deamination insulin was 15.6% and 39.2%, all exceeding the limit standard of 5.0% of the same product. The results of determination of the content of phenol and phenol were 93.22 ~ 102.7, 0.5 ~ 0.6and 12.314.8 渭 g / 100U, respectively, and the content of zinc in phenol was 2.34 ~ 2.51 mg/ml;. The content of zinc was 12. 3 ~ 14. 8 渭 g / 100 ~ (-1), and the content of zinc in phenol was 12. 3 ~ 14. 8 渭 g / 100. Conclusion: the current standard of insulin injection is short of related substances, content determination and other key quality control items; the contents of macromolecule protein, phenol and zinc are controlled well; the content of impurity A21 deamination insulin is generally high. The stability of the main peak of insulin is poor.
【作者单位】：中国食品药品检定研究院;
【分类号】：R917

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