动物类中药注射剂的安全性研究进展

Safety of animal traditional Chinese medicine(TCM) injections

动物类中药注射剂是中药注射剂的重要组成部分,其多选取药效显著,副作用少的动物类材料,通过现代工艺制成了包括清热解毒类、补益类、活血化瘀类等多种药效可靠迅速、生物利用度高的中药注射剂。由于中药注射剂的成分复杂,质量标准待完善,及临床存在不合理用药等情况,使得中药注射剂的不良反应发生率明显高于口服中药。动物类中药含有丰富的蛋白和脂肪,而异种蛋白是动物类中药注射剂的主要致敏源。目前关于动物类中药注射剂的不良反应,主要表现为导致皮肤及黏膜和全身各系统的过敏样反应,并且首次用药过程中发生不良反应较常见。动物类注射剂发生过敏样不良反应的具体原因以及诱发过敏或类过敏反应的动物中药注射剂中的相关物质成分目前没有相关明确报道。该文就动物类中药注射剂的不良反应现状,过敏、类过敏研究,血管刺激性检测,热原检测,药代动力学研究及联合用药研究等做一综述,为动物类中药注射剂的质量标准完善,进行深入安全性相关研究提供参考。

Animal medicine injection is an important part of traditional Chinese medicine(TCM) injections. All or part of animals with a significant curative effect and little side reactions as raw materials as well as modern technology are used to produce traditional Chinese medicine injections with a reliable and rapid drug efficacy and high bioavailability. Due to the complex composition of traditional Chinese medicine injections,imperfect quality standards,and unreasonable clinical use,the incidence of adverse reactions of traditional Chinese medicine injections has been significantly higher than that of traditional Chinese medicine for oral use. Animal medicine injections contain rich protein and fat,and heteroproteins are the main sensitization source in animal medicine injections. At present,the adverse reactions of animal medicine injections are mainly manifested in the anaphylaxis-like reactions at skin,mucous membranes and organ systems. The adverse reactions that occur during the first medication are more common. Specific causes for allergiclike adverse reactions in animal injections and related substances in traditional Chinese medicine injections made of animals that induce allergies or anaphylactoid reactions are currently not specifically reported. This article reviews the current adverse reactions of animal TCM injections,allergies and pseudoallergic reactions of animal TCM injections,the pharmacokinetics of animal TCM injections,and the combined use of drugs,in order to improve the quality standards of Chinese medicine injections for animals and provide reference for further safety related research.