CAJ | 학술논문

目的：：考察国产重组人干扰素α2b注射剂的渗透压摩尔浓度,为该品种渗透压摩尔浓度质量标准的完善提供依据。方法：抽取9家企业的66批产品,根据《中国药典》2010年版三部测定其渗透压摩尔浓度,并对测定结果进行统计分析。结果：渗透压摩尔浓度的合格率为98.5%,90%以上的批次渗透压摩尔浓度在企业规定的渗透压摩尔浓度中间值的85%~115%之间。结论：对国产重组人干扰素α2b注射剂渗透压摩尔浓度的质控状况有了比较全面的了解,为渗透压摩尔浓度质量标准的完善提供了数据支持。
목적：：고찰국산중조인간우소α2b주사제적삼투압마이농도,위해품충삼투압마이농도질량표준적완선제공의거。방법：추취9가기업적66비산품,근거《중국약전》2010년판삼부측정기삼투압마이농도,병대측정결과진행통계분석。결과：삼투압마이농도적합격솔위98.5%,90%이상적비차삼투압마이농도재기업규정적삼투압마이농도중간치적85%~115%지간。결론：대국산중조인간우소α2b주사제삼투압마이농도적질공상황유료비교전면적료해,위삼투압마이농도질량표준적완선제공료수거지지。
Objective:To examine the osmolality of domestic recombinant human interferon α2b injection to provide evidence for the improvement of the national quality standard. Methods:Totally 66 batches of recombinant human interferonα2b injection produced by 9 manufacturers were withdrawn, and the osmolality was determined according to the appendix of Chinese Pharmacopoeia Ⅲ(2010 edition). The results were analyzed with statistical methods. Results:The pass rate of osmolality was 98. 5%. The osmolality of more than 90% of the batches was between 85% and 115% of the intermediate value set by the manufacturers. Conclusion:Comprehensive understanding of the quality control of osmolality of domestic recombinant human interferon α2b injection is obtained, which provides data support for the improvement of quality standard of osmolality.