Stone B A, Quinn P, Marrs R P
Institute for Reproductive Research, Los Angeles, California.
Acta Endocrinol (Copenh). 1990 Aug;123(2):161-8. doi: 10.1530/acta.0.1230161.
Ten lots of dissociated hMG were characterized by reverse-phase gradient high-performance liquid chromatography. Areas of 12 discrete peaks were directly related to dosages of hMG injected. The lots were further analysed for immunoactive-FSH (41.6-106.2 IU/ampule), immunoactive-LH (11.0-20.4 IU/ampule), bioactive-LH (2.7-17.1 IU/ampule) and bioactive-hMG (149-298 pg E2/mIU immunoactive-FSH/ml). Relationships between integrated areas of the HPLC peaks and biochemical properties of the hMG lots were analysed by stepwise multiple linear regression. Between-lot differences in immunoactive-LH and immunoactive-FSH were related to HPLC peak areas (p less than 0.05); differences in bioactive-LH were not. Areas of 8 peaks were related to differences in bioactive-hMG activity, facilitating close approximation of bioactive-hMG from the derived multi-linear model (p less than 0.001). Rapid characterization of hMG by HPLC is of relevance as recent reports have shown that ovarian responses and pregnancy outcomes of patients are related to the immunoactive and bioactive gonadotropin content of hMG preparations used to induce multiple folliculogenesis before oocyte aspiration, in vitro fertilization, and embryo replacement.
采用反相梯度高效液相色谱法对十批解离的人绝经期促性腺激素（hMG）进行了表征。12个离散峰的面积与注射的hMG剂量直接相关。对这些批次的hMG进一步分析其免疫活性促卵泡生成素（FSH）（41.6 - 106.2 IU/安瓿）、免疫活性促黄体生成素（LH）（11.0 - 20.4 IU/安瓿）、生物活性LH（2.7 - 17.1 IU/安瓿）和生物活性hMG（149 - 298 pg E2/mIU免疫活性FSH/ml）。通过逐步多元线性回归分析了HPLC峰的积分面积与hMG批次生化特性之间的关系。免疫活性LH和免疫活性FSH的批次间差异与HPLC峰面积相关（p小于0.05）；生物活性LH的差异则不然。8个峰的面积与生物活性hMG活性的差异相关，有助于从推导的多线性模型中精确估算生物活性hMG（p小于0.001）。HPLC对hMG的快速表征具有重要意义，因为最近的报告表明，在卵母细胞抽吸、体外受精和胚胎移植前用于诱导多个卵泡发育的hMG制剂的免疫活性和生物活性促性腺激素含量与患者的卵巢反应和妊娠结局相关。
