Bassett R, Ceccarelli D, Crisci C, di Tria A M, Mancinelli M, Martelli F, Mendola D, Pezzotti A
Serono International SA, Geneva, Switzerland.
Curr Med Res Opin. 2005 Jun;21(6):899-905. doi: 10.1185/030079905X48410.
Pharmaceutical preparations of human menopausal gonadotrophin (hMG), urine-derived follicle-stimulating hormone (u-FSH) and highly purified u-FSH (u-FSH-HP) have been available since the early 1960s and the mid 1980s and 1990s, respectively. Another commercial preparation of u-FSH-HP, Folyrmon P, was launched in Japan in 1999. The aim of this study is to assess the purity of Folyrmon P and to compare it with Fertinorm-P, another commercial preparation of u-FSH-HP that has been available since 1993.
Folyrmon P and Fertinorm-P were assessed for total protein content, biological activity, immunological activity, specific activity, purity and levels of protein contamination.
Folyrmon P, which is extracted from the urine of post-menopausal women, has a specific activity of between 4000 and 5000 IU/mg, while Fertinorm-P, which is also manufactured from the urine of post-menopausal women, has a specific activity of at least 10,000 IU/mg. It has been well documented that commercially available hMG and u-FSH preparations can contain a number of urine-derived protein contaminants. This also proves to be the case for Folyrmon P, in which contaminant proteins other than FSH were shown to be present. It was also demonstrated that both preparations, Folyrmon P and Fertinorm-P, contained high levels of oxidized FSH.
The low specific activity and high level of contaminants in Folyrmon P indicate that this u-FSH is not highly purified. Overall, Fertinorm-P, with higher specific activity and lower levels of contaminant proteins, appears to be of higher quality compared with Folyrmon P.
人绝经期促性腺激素（hMG）、尿源性促卵泡激素（u-FSH）及高纯度u-FSH（u-FSH-HP）的药物制剂分别自20世纪60年代初、80年代中期和90年代开始可得。另一种u-FSH-HP的商业制剂Folyrmon P于1999年在日本推出。本研究的目的是评估Folyrmon P的纯度，并将其与自1993年起可得的另一种u-FSH-HP商业制剂Fertinorm-P进行比较。
对Folyrmon P和Fertinorm-P进行总蛋白含量、生物活性、免疫活性、比活性、纯度及蛋白质污染水平的评估。
从绝经后妇女尿液中提取的Folyrmon P的比活性在4000至5000 IU/mg之间，而同样由绝经后妇女尿液制成的Fertinorm-P的比活性至少为10000 IU/mg。已有充分文献记载，市售的hMG和u-FSH制剂可能含有多种尿源性蛋白质污染物。Folyrmon P也被证明是这种情况，其中除FSH外还存在其他污染蛋白。还证明了Folyrmon P和Fertinorm-P这两种制剂都含有高水平的氧化型FSH。
Folyrmon P的低比活性和高污染水平表明这种u-FSH没有高度纯化。总体而言，Fertinorm-P比活性更高且污染蛋白水平更低，与Folyrmon P相比似乎质量更高。
