中药注射剂受化学成分、生产工艺等因素影响,不良反应发生率也随之增高,越来越受到关注,也打破了中药安全无毒副作用的错误观念。成因:内在因素-中药材来源、产地、采收季节、加工炮制方法;临床因素-不同药物之间配伍不当;患者因素-个体差异、遗传基因、免疫系统、过敏体质、老人、婴儿、经期妇女、孕妇,生理状态不同。特点:发生部位相对集中,以皮肤及附件损害、局部刺激,全身性损害为主;个体差异,可涉及多个器官及系统,免疫系统能力、体质差更容易产生;原材料质量成分密切相关。对策:稳定质量、注意配伍及使用剂量、个体差异及特殊过敏体质、采取监护和应急措施、正确认识不良反应、建立监测机制。并非发生不良反应的药品就是假药劣药,重视中药注射剂不良反应的严重性,同时不能因为出现不良反应就否定中药注射剂疗效,应做到因病施治,合理用药。 Traditional Chinese medicine injection by chemical composition, production processes and other factors, the incidence of adverse reactions also will be more and more attention, but also broke the safe and toxic side effects of traditional Chinese medicine mistaken ideas. Causes: internal factors - the origin of Chinese herbal medicines, the origin of the harvest season, processing methods; clinical factors - improper compatibility between different drugs; patient factors - individual differences, genetic, immune system, allergies, the elderly, infants, women of menstruation Pregnant women, different physiological status. Features: The relative concentration of the site, the skin and accessories damage, local irritation, generalized damage; individual differences may involve multiple organs and systems, immune system ability, physical differences are more likely to occur; raw material quality components are closely related. Countermeasures: Stabilize quality, pay attention to compatibility and use of dose, individual differences and special allergies, take custody and emergency measures, correct understanding of adverse reactions, the establishment of monitoring mechanisms. Drugs that do not cause adverse reactions are counterfeit drugs, pay attention to the seriousness of adverse reactions of traditional Chinese medicine injection, and can not negate the efficacy of traditional Chinese medicine injections because of adverse reactions should be done due to disease treatment, rational drug use.