治疗用尿促性腺素的标准化：人绝经期促性腺激素国际标准品的使用与可得性最新情况

Standardization of therapeutic, urinary gonadotrophins: an update on the use and availability of International Standards for Menotrophin.

作者信息

Ferguson Jackie, Hockley Jason, Tiplady Richard, Burns Chris

机构信息

Endocrinology Section, Biotherapeutics Group, National Institute of Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.

出版信息

Biologicals. 2013 Nov;41(6):435-8. doi: 10.1016/j.biologicals.2013.08.004. Epub 2013 Sep 21.

DOI:10.1016/j.biologicals.2013.08.004

PMID:24064050

Abstract

The potencies of therapeutic preparations of gonadotrophins of human, urinary origin, which comprise a heterogenous mix of isoforms with follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivities, are standardized by WHO International Standards (IS). We report here, the evaluation, through an international collaborative study, of a candidate preparation, coded 10/286, to replace the 4th IS, 98/704, for human, urinary FSH and LH (Menotrophin) which has been used for many years for the potency assignment of therapeutic preparations using bioassays. The mean FSH and LH bioactivities of 10/286, determined by in vivo bioassays in terms of 98/704, were 183 IU per ampoule (95% confidence limits 165-202) and 177 IU per ampoule (95% confidence limits 159-197), respectively.

摘要

人尿源促性腺激素治疗制剂含有具有促卵泡生成素（FSH）和促黄体生成素（LH）生物活性的多种异构体的异质混合物，其效价由世界卫生组织国际标准（IS）进行标准化。我们在此报告，通过一项国际合作研究，对一种编码为10/286的候选制剂进行评估，以取代第4个国际标准品98/704，用于人尿FSH和LH（尿促性素），多年来该标准品一直用于通过生物测定法对治疗制剂进行效价测定。根据98/704，通过体内生物测定法测定的10/286的平均FSH和LH生物活性分别为每安瓿183 IU（95%置信限165 - 202）和每安瓿177 IU（95%置信限159 - 197）。