Rigaldie Yohan, Largeteau Alain, Lemagnen Gilles, Ibalot Fabienne, Pardon Patrick, Demazeau Gérard, Grislain Luc
LPCHP Laboratoire de Physico-Chimie des Hautes Pressions (Interface Hautes Pressions ENSCPB-ICMCB), Ecole Nationale Supérieure de Chimie et de Physique de Bordeaux (ENSCPB), 16 Avenue Pey Berland, 33608 Pessac, France.
Pharm Res. 2003 Dec;20(12):2036-40. doi: 10.1023/b:pham.0000008054.80136.5a.
According to the development in the last decade of industrial processes using high hydrostatic pressure (HHP) for preservation of several commercial food products, novel sterilization or decontamination processes for pharmaceutical products could be conceivable. The aim of this work is to evaluate the effects of HHP on the integrity of insulin and heparin solutions, suspension of monoclonal antibodies and Spherulites.
High performance liquid chromatography, thin layer chromatography, capillary electrophoresis assays, ELISA tests, laser granulometry and spectrophotometry analyses have been performed to compare HHP treated drugs (in a domain of pressure and temperature ranging respectively from 20 up to 500 MPa and from 20 degrees C up to 37 degrees C) vs. untreated ones.
No difference has been detected except for monoclonal antibodies that are altered above 500 MPa.
The structure integrity of sensitive molecule due to the small energy involved by HHP and the development of industrial plants (intended for the decontamination of food products) confer to this technology the potential of a new method for sterilization of fragile drugs and an original alternative to aseptic processes and sterilizing filtration.
鉴于过去十年中使用高静水压（HHP）保存多种商业食品的工业加工过程的发展情况，制药产品的新型灭菌或去污工艺是可以想象的。这项工作的目的是评估高静水压对胰岛素和肝素溶液、单克隆抗体悬浮液以及球晶完整性的影响。
已进行高效液相色谱、薄层色谱、毛细管电泳分析、酶联免疫吸附测定、激光粒度分析和分光光度分析，以比较经过高静水压处理的药物（压力范围为20至500兆帕，温度范围为20摄氏度至37摄氏度）与未处理药物。
除了在500兆帕以上单克隆抗体发生改变外，未检测到差异。
由于高静水压涉及的能量较小，敏感分子的结构完整性以及工业设备（用于食品去污）的发展赋予了该技术成为一种用于易碎药物灭菌的新方法以及无菌工艺和除菌过滤的原始替代方法的潜力。
