首次DNA重组人生长激素(rhGH)国家标准品的研制

Studies on Standardization of the First National Reference Standard for Recombinant DNA-derived Human Growth Hormone(rhGH)

协作标定了首批重组人生长激素（ｒｈＧＨ）国家标准品，以第一次国际标准品为对照，按药典方法：生物测定（去垂体大鼠体重法和胫骨法）及理化测定（ＨＰＳＥＣ）．首次ｒｈＧＨ和Ｍｅｔ－ｒｈＧＨ国家标准品批号为：０６２７－９７０１Ａ和Ｂ；其蛋白含量分别为１．８和２．１ｍｇ／ａｍｐ，生物效价分别为５．０和５．５ＩＵ／ａｍｐ．

An interlaboratory collaborative calibration of the preparations of rhGH had been completed as first national standard.The preparations were assayed against the first international standard for rhGH and for hGH by using pharmacopoeial methods which both were in vivo bioassay and physico-chemical assay.The preparations coded 0627-97001A and B were established as the first national standard for rhGH(Somatropin 191 amino acid) and for Met-rhGH (Somatrem 192 amino acid),with defined content 18mg and 21mg protein per ampoule and defined bioactivity potency of 50 and 55 international units per ampoule respectively.