凝血质的生物检定

凝血貭(thromboplastinum)为自新鮮酵母、牛脑或其他动植物組織中提出的一种磷脂类化合物,已收載于1959年版中国药学会上海分会編的《药品規范》中。其制剂的合理使用在于使出血局部施药时能发揮加速血凝作用,要求效果愈高愈好,因而关于它的生物检定是属于限度試驗性貭。用去鈣血浆測凝法的試驗,是比較簡便的方法。上海市1956年版《药品規范》卽采用此法,但几年来国內各地試驗結果,表明存在很多問題,实驗結果的差异很大。1951年《美国新药和非法定药集》規定用本法时在对照管20-30分钟不

STUDIES ON THE BIOLOGICAL ASSAY OF THROMBOPLASTIN

A series of studies were made on factors influencing the coagulation time of rabbit's oxalated plasma in the biological assay of thtomboplastin. It was found that the anticoagulanting action of sodium Chloride as reported by Jaques and Dunlop (1945) could be greatly reduced in the presence of thromboplastin and the Change of the concentration of calcium chloride exerted least effect on the coagulation time, while the concentration of thtomboplastin in the plasma mixture adopted was 0.045%. It was shown that a low concentration of calcium chloride such as 0.003—0.009%in the mixture and a temperature of 25℃ adopted during the assay gave favourable results with greater accuray.It was suggested that while the assay proceeded under the above-mentioned conditions,the coagulation time of the plasma in the blank tube should be within the range of 17—23 minutes and that in the specimen tube should not be more than 6 minutes. Following the modified procedure, over thirty commercial samples of thromboplastin were tested. An analysis of the results proves that the improved method is able to detect samples of poor quality or samples deteriorated during storage.