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。
OBJECTIVE： To provide reference for the understanding of quality status of Insulin injection and improvement of related standards. METHODS： The statutory methods of Insulin injection were adopted to test 32 batches of samples （including ap- pearance, identification, capacity, visible foreign matter, sterility and potency determination of biological method）. Consulting specification of other similar products, RP-HPLC was conducted to determine the related impurities, content and phenol in sam- ples; HPSEC was conducted to determine the high molecular weight proteins and atomic absorption spectrophotometry was conduct- ed to determine the Zn content. RESULTS： Results of all the 32 batches of samples were qualified by the test of statutory methods. According to the method of other similar products, the determination result of A2, desamido insulin was 15.6%-39.2% and general- ly greater than 5.0% , which was the highest limit of similar products; insulin was 93.2%-102.7% ; protein polymer was 0.5%-0.6%; phenol was 2.34-2.51 mg/ml and Zn was 12.3-14.8 μg/100 U. CONCLUSIONS： The statutory specification of Insulin injection is short of many key specification items such as impurities and content determination; the contents of protein polymer, phenol and Zn were in good control; the contents of A21 desamido insulin are generally high, and stability of insulin main peak is relatively poor.
出处
《中国药房》
CAS
北大核心
2015年第27期3849-3852,共4页
China Pharmacy
关键词
胰岛素注射液
有关物质
含量测定
法定检验标准
Insulin injection
Related impurities
Content determination
Statutory specification
