药用辅料的不良反应及其安全性管理

Adverse reactions of pharmaceutical excipients and their safety management

药用辅料系药物制剂中除活性成分以外所有物料的统称,其功能除赋形外,还能保持或增加活性成分的稳定性和生物利用度。据估计,现有40余类上千种药用辅料,如溶剂、吸附剂、防腐剂、着色剂、矫味剂、增稠剂、抗氧剂等;另外,近年还出现一些新型辅料。辅料相对于活性成分而言,是一种惰性物质。然而,现有资料证明,许多辅料可引起不良反应,如丙二醇致溶血、苯甲醇致喘息综合征等。药用辅料的安全性涉及其毒性、质量和不正确使用。临床医师应了解与辅料相关的不良反应,药品管理部门也应加强辅料的安全性管理以利于维护患者安全。

Pharmaceutical excipients refer to any substances other than the active principal in the pharmaceutical preparation.Their functions are to protect,support or enhance the stability and bioavaila bility of the active ingredient besides formulating a dosage form.It is reckoned that 40 kinds and more of pharmaceutical excipients including over one thousan d different materials are now used in the manufacturing of pharmaceutical products,such as solvents,absorbents,preservations,colouring agents,flavouring agents,thickening agents,antioxidants,and so on.In addition,new classes of exc ipients have been available in recent years.Pharmaceutical excipients are consi dered to be inert in contrast to active drug.However,adverse reactions to a wide range of excipients are now documented,such as hemolysis to propylene glycol,gasping syndrome to benzyl alcohol,etc.The safety of pharmaceutical excipients involves their toxicity,quality,and improper use.The clinicians should be aware of the adverse reactions associated with pharmaceutical excipients,and drug regulatory authority should strengthen the management of the safety of pharma ceutical excipients in order to safeguard the patient safety.