Albertengo M E, Cinto R O, Araldi H T, Vernengo M J
Departamento de Bioanálisis, Instituto Nacional de Farmacología y Bromatología, Buenos Aires, Argentina.
Sangre (Barc). 1990 Feb;35(1):69-73.
In agreement with the Regional Programme of Reference Materials of the Panamerican Health Organization the Instituto Nacional de Farmacología y Bromatología of Buenos Aires designed a study for the calibration of a Reference Material for Heparin, porcine, mucosal and a Reference Material for Heparin, bovine, mucosal. The assay methods used in this study were those described in the United States Pharmacopeia XXI Ed and British Pharmacopoeia 1980, Addendum 1983. The overall combined potency estimates of both heparin in preparations relative to 4th Int.St. was 1633.83 UI/ampoule (95% confidence limits 1609.70-1657.96 UI/ampoule) for porcine heparin and 1332.31 UI/ampoule (95% confidence limits, 1302.31-1361.77 UI/ampoule) for bovine heparin. The assigned unitage was 1630 UI/ampoule for the porcine Reference Material and 1330 UI/ampoule for the bovine Reference Material.
根据泛美卫生组织的区域参考物质计划,布宜诺斯艾利斯国家药理与食品化学研究所设计了一项研究,用于校准猪黏膜肝素参考物质和牛黏膜肝素参考物质。本研究中使用的测定方法是《美国药典》第21版和《英国药典》1980年版及1983年补编中所述的方法。相对于第4国际标准品,两种肝素制剂的总体合并效价估计值为:猪肝素为1633.83国际单位/安瓿(95%置信限为1609.70 - 1657.96国际单位/安瓿),牛肝素为1332.31国际单位/安瓿(95%置信限为1302.31 - 1361.77国际单位/安瓿)。猪参考物质的指定单位量为1630国际单位/安瓿,牛参考物质的指定单位量为1330国际单位/安瓿。