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前言生物化学和物理化学特性、固有抗体效应器功能以及涉及到安全问题的各项参数,构成了静脉注射免疫球蛋白的特有的质量标准.一个理想制品的特征,通常包括理论性、临床经验、作用机理并推断出结论.在加工过程中,免疫球蛋白制品不是所有的特性(如蛋白质的化学性质)都保持原样,因此须做某种妥协.另外,由于近年来市场竞争激烈,某些性质似乎陷入过高或过低评估的危险,当然部份原因是由于缺乏临床方面的科学论证;其次,由于各种实验技术没有达到标准化,以致造成已经发表的资料缺乏可比性.本文试图评论当今销售的IVIG质量标准,检测方法以及临床实验,并增加了有关实验借以证实这些推论.
INTRODUCTION Biochemical and physico-chemical properties, intrinsic antibody effector functions, and parameters related to safety issues constitute the unique quality standard for intravenous immunoglobulins. The characteristics of an ideal product typically include theoretical, clinical experience, Mechanism of action and concluded that in the process of processing, immunoglobulin products are not all characteristics (such as the chemical nature of the protein) are kept intact, it is necessary to make some compromise.In addition, due to intense market competition in recent years, certain properties Seems to fall under the risk of being too high or too low, partly because of a lack of scientific justification in the clinic, and secondly because of the lack of standardization of the various experimental techniques that make the published data uncoordinated.This article attempts to comment on the current sales IVIG quality standards, testing methods and clinical trials, and added relevant experiments to confirm these inferences.