人類絨毛性腺激素效價測定法比較

COMPARSION OF ASSAY METHODS OF HUMAN

取市售3廠牌人類絨毛性腺激素製劑各1件（國產品1件，輸入品2件）分別以美國藥典XXI版，英國藥典1980版，日本藥局方XI版的生物測定法及亞培β-HCG15/15試劑的酵素免疫測定法，進行效價測定比較。結果顯示：（1）3件製劑都符合藥典規格，（2）3種生物測定的試驗都呈均質性，而酵素免疫測定法不呈均質性，（3）同一製劑對3種生物測定法的效價差異不顯著，但生物測定法與酵素免疫測定法的效價則部分呈有顯著差異，（4）各製劑間的效價差異對3種生物測定法不顯著，但對酵素免疫測定法則呈極顯著。

To compare the difference in potency of three human chorionic gonadotropin preparations (one from domestic manufatory and two from foreign manufactories) by using the bioassay methods of USP XXI, BP 1980, JP XXI and ABBOTT, β-HCG 15/15 ELISA method respectively, The results showed that (1) all the 3 preparations met specification, (2) three were homogeneous in above 3 bioassay methods, but heterogeneous in ELISA, (3) for each preparation , there was non-significant difference in potency between 3 bioassay methods but significant difference in potency between bioassay method and ELISA method partly, (4) between preparations there was significant difference in potency for each bioassay method but very significant difference in potency for ELSA method and biological method .