商品洋地黄毒甙生物检定中豚鼠法与鸽法测得效价的比较

1、本文用豚鼠法和鸽法比較了6种国产洋地黄粉、2种国产洋地黄毒甙和5种进口洋地黄毒甙的生物效价,用洋地黄粉作标准品。2、洋地黄粉用两种方法測定的結果比較接近。洋地黄毒甙相差达一倍,鸽法的結果较高,此种較大的差异,显然是与样品和标准品在成分上的不同有关。3、本文指出英国副藥典(1954)对洋地黃毒甙的检驗,叫种方法并列,并以洋地黄叶粉为标准品是有問題的。作者考虑到如果用一定純度的洋地黄毒甙作为生物检定的标准品时,各法可以并用,否則应按一种規定的方法进行。本室張淑坤、赵秀文、周海鈞三位同志曾参与本文一部分实驗工作。

A COMPARISON OF RESULTS ESTIMATED BY GUINEA PIG METHOD AND PIGEON METHOD IN THE BIOASSAY OF COMMERCIAL DIGITOXIN

Since 1954 in authors' laboratory, various digitalis preparations, including digitalis leaves, tablets and tinctures and digitoxin and its injections, were assayed by both guineapig method and pigeon (lethal dose) method, using standardized digitalis powder as reference standard. It was found that results of digitalis leaf preparations obtained by guinea pig method and those by pigeon method were reasonably agreeable; while the results of digitoxin preparations obtained by guinea pig method were always significantly lower than those obtained by pigeon method. In this paper, these facts were again shown, when 6 digitalis leaf preparations and 7 commercial digitoxin preparations were investigated. In digitoxin preparations, the potency estimated by pigeon method could be 2.36 times greater than that estimated by guinea pig method. The authors ascribed the difference to the inadequate standard preparation employed in the assay, as digitalis purpurea consisting of chiefly purpurea glycosides A and B being different in the mode of action to digitoxin (commercial) which was chiefly degraded product of purpurea glycoside A. They concluded that in bioassay of digitoxin against a digitalis standard, a suitable authorised method should be strictly followed; and the 4 methods employing different kinds of animals recommended by British Pharmacopeia 1953 and quoted by Bristish Pharmacopeia Codex 1954 for digitoxin would make confusions.