赵丽华 应育洁

[摘要]药用辅料是药物制剂中重要组成部分，药用辅料与活性成分一起经历体内的吸收、分布、代谢、排泄过程，因此药用辅料的安全性同样至关重要，辅料相对于活性成分而言，是一种惰性物质。目前较多文献报道显示，很多辅料可引起不良反应，尽管发生率低，但可影响人体很多器官和系统正常功能，如呼吸、血液、消化等系统。因此临床医生及药、护人员应了解与警惕药用辅料相关的不良反应，药品监管部门也应加强辅料的安全性管理措施，保证患者安全用药。

[关键词]药用辅料;不良反应;安全用药

[中图分类号] R978          [文献标识码] A          [文章编号] 1674-4721（2020）6（b）-0025-04

[Abstract] Pharmaceutical excipients are important components of pharmaceutical preparations. The pharmaceutical excipients as well as active pharmaceutical ingredients are involved in the whole process of absorption， distribution， metabolism and excretion in vivo. Therefore， the safety of pharmaceutical excipients is closely related to the that of the pharmaceutical preparations. Pharmaceutical excipients are considered to be inert in contrast to active ingredients. At present， many literature reports have shown that quite a few excipients can cause adverse reactions. Although the incidence is low， it can affect the normal function of many organs and systems of the human body， such as breathing， blood， digestion and other systems. Therefore， clinicians and drug and nursing personnel should be aware of the adverse reactions related to pharmaceutical excipients， and the drug regulatory department should also strengthen the safety management measures of excipients to ensure patients′ safe medication.

[Key words] Pharmaceutical excipients; Adverse reactions; Safety of medication

藥物的不良反应，通常认为是由药物的活性成分造成。但随着各种药用辅料的应用日益广泛，由辅料引起的各种不良反应日益显现，因为部分药用辅料并非惰性，虽然药用辅料不良反应发生率较低，却会对多个器官和系统造成损害，严重危及生命。因此，药用辅料引起的不良反应应引起药品监管、生产部门尤其是临床医生的充分重视。

药用辅料系指生产药品和调配处方时使用的赋形剂和附加剂，是除活性成分或前体以外，在安全性方面已进行了合理的评估，并且包含在药物制剂中的物质[1]，其具有提高药物疗效、降低药物不良反应及提高生物利用度等重要作用[2]。从作用和用途进行分类，常见如：防腐剂、着色剂、助溶剂、矫味剂、吸附剂及增溶剂等[3]。近些年来还研制出具有缓控释、靶向功能的新型辅料。……