Benny A G, Ockelford P A, Johns A S, Woodfield D G, Berry E W
N Z Med J. 1986 Jun 11;99(803):408-9.
Factor IX concentrates, prepared by standard chromatographic techniques, are used primarily to treat patients with congenital factor IX deficiency. A local factor IX containing concentrate has now been prepared and heat treated. Following heat treatment, and reconstitution, the potency is 280 units per vial. The preparation, HNZFIX, has been compared with the currently available factor IX concentrate Prothrombinex. Following administration into patients with haemophilia B, ex vivo factor IX recovery and half life response have been compared for the two products. The mean recovery values were identical with an average 17 units per litre rise in factor IX activity obtained for each unit of factor IX concentrate administered per kg of body weight. For both products recovery measured as the K ratio was approximately 75% (0.75). The plasma half life responses were 17 and 22.2 h for the HNZFIX and PTX respectively. No unexpected side effects occurred with the HNXFIX which met all the British Pharmacopeia requirements for a therapeutic concentrate.
通过标准色谱技术制备的凝血因子IX浓缩物主要用于治疗先天性凝血因子IX缺乏症患者。现在已经制备并热处理了一种含有局部凝血因子IX的浓缩物。热处理并复溶后，每瓶效力为280单位。该制剂HNZFIX已与目前可用的凝血因子IX浓缩物Prothrombinex进行了比较。在给B型血友病患者给药后，比较了两种产品的体外凝血因子IX回收率和半衰期反应。平均回收率相同，每公斤体重每给予1单位凝血因子IX浓缩物，凝血因子IX活性平均升高17单位/升。两种产品以K比值衡量的回收率约为75%（0.75）。HNZFIX和PTX的血浆半衰期反应分别为17小时和22.2小时。HNXFIX未出现意外副作用，符合英国药典对治疗性浓缩物的所有要求。
