摘要
目的:制备和标定第4批人绝经尿促性腺素(HMG)国家标准品。方法:以WHO第5批国际标准品10/286作为标准,选择7个实验室,采用中国药典二部(2010年版)卵泡刺激素(FSH)测定法和黄体生成素(LH)测定法对第4批HMG国家标准品待标品的生物效价进行标定;按照中国药典二部(2010年版)量反应平行线法使用BS 2000对所得数据进行统计计算。结果:第4批HMG国家标准品待标品经协作标定,确定其生物效价为FSH 247 IU·安瓿-1,LH 202 IU·安瓿^(-1)。结论:本批待标品可作为第4批HMG国家标准品,以供HMG及相关制剂的生物效价测定用。
Objective： To establish the 4th national standard for human menopausal gonadotropin （ HMG ） by bioassay. Methods： The biological potency of 4th national standard candidate for HMG was collaboratively calibrated by 7 laboratories using the method collected in Appendix Ⅻ （ FSH bioassay ） and N （ LH bioassay ） in ChP. （ Volume Ⅱ, 2010 edition ） relative to the 5th international standard for human urinary FSH/LH （ IS 10/286 ）,which was provided by National Institute for Biological Standard and Control（ NIBSC ）. The calibration of candidate was combined by using BS 2000, according to Appendix XI V in ChP. （ Volume I1,2010 edition ）quantity response parallel line method.. Results： Relative to the 5th international standard, the biological potency of proposed 4th national standard for HMG was FSH 247 IU per ampoule and LH 202 IU per ampoule. Conclusion： The established candidate can be used as the 4th national standard for HMG for bioassay.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2016年第8期1487-1494,共8页
Chinese Journal of Pharmaceutical Analysis
