【摘要】 目的研制重组人干扰素β1b(rhIFNβ1b)生物学活性测定国家标准品。方法按《中国药典》三部(2005版)要求检测rhIFNβ1b标准品原液各项质量指标,以rhIFNβ1b国际标准品为标准进行协作标定,并检测其稳定性。结果rhIFNβ1b国家标准品经检测,外观、无菌试验合格,水分含量为0.8%,分装精度为0.44%。该标准品经3家实验室协作标定24次,几何平均生物学活性为7.18×104IU/支,平均生物学活性的95%可信区间为6.87×104～7.52×104IU/支,单次测定的95%参考值范围为5.76×104～8.68×104IU/支,平均可信限率为4.36%。在温度为-20、4、25和37℃条件下放置12个月,其生物学活性保持稳定。结论该批rhIFNβ1b活性测定国家标准品各项指标均符合要求,可作为国家标准品使用,生物学活性定为7.2×104IU/支,批号为08/01。更多还原

【Abstract】 Objective To prepare the national standard for determination of activity of recombinant human interferonβ1b (rhIFNβ1b). Methods Overall control tests were performed on the bulk of rhIFNβ1b standard according to the requirements in Chinese Pharmacopoeia(2005 edition), with which national standard for rhIFNβ1b was prepared and calibrated collaboratively against international standard for rhIFNβ1b, and evaluated for stability. Results The prepared national standard for rhIFNβ1b was qualified in examination on final container and sterility test, and its moisture content and precision of distribution were 0. 8% and 0. 44% respectively. The standard was calibrated for 24 times by 3 laboratories, and the results showed a geometric mean bioactivity of 7. 18 × 104IU / dose(95% CI 6. 87 × 104 ～ 7. 52 × 104 IU / dose). The 95% CI of geometric mean bioactivity in a single determination was 5. 76 × 104 ～ 8. 68 × 104 IU / dose. The mean confidence limit rate was 4. 36%. The bioactivity of prepared national standard for rhIFNβ1b was stable after storage at -20, 4, 25 and 37℃ for 12 months. Conclusion The prepared standard was qualified in overall control tests and might be used as national standard for determination of activity of rhIFNβ1b. The prepared standard was numbered as Lot 08 / 01, and its bioactivity was defined as 7. 2 × 104 IU / dose.更多还原