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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。
Objective: To investigate the molar concentration of osmotic pressure of domestic recombinant human interferon α2b injection, and provide basis for improving the quality standard of osmotic pressure molar concentration. Methods: Sixty-six batches of products from nine enterprises were collected and their osmolality was measured according to the 2010 edition of Chinese Pharmacopoeia (2010 edition). Statistical analysis of the results was carried out. Results: The qualified rate of osmolality was 98.5%. The molar osmolality of more than 90% was between 85% and 115% of the median osmolality of the enterprise. Conclusion: The quality control of osmolality of domestic recombinant human interferon α2b injection has a more comprehensive understanding, which provides data support for the improvement of the quality standard of osmolality.