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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 are generic names for all materials in pharmaceutical preparations other than the active ingredient, and their function is to maintain or increase the stability and bioavailability of the active ingredient in addition to the excipients. It is estimated that the existing more than 40 kinds of thousands of kinds of pharmaceutical excipients, such as solvents, adsorbents, preservatives, coloring agents, flavoring agents, thickeners, antioxidants, etc .; In addition, in recent years there are also some new accessories. The excipient is an inert substance relative to the active ingredient. However, the available data show that many excipients can cause adverse reactions, such as propylene glycol hemolysis, benzyl alcohol-induced wheeze syndrome. The safety of pharmaceutical excipients relates to their toxicity, quality and incorrect use. Clinicians should be aware of the adverse reactions associated with excipients, and drug administrations should also strengthen the safety management of excipients in order to maintain patient safety.