Kumar A, Rawlings R D, Beaman D C
Dept of Pediatrics and Human Development, Michigan State University, East Lansing 48824-1317.
Pediatrics. 1993 May;91(5):927-33.
Pharmaceutical preparations may contain a variety of excipients ("inert ingredients"). These excipients are generally inactive; however, rare adverse effects caused by excipients have been reported. Information about the excipients in a particular preparation is not readily available.
The information about sweeteners, flavorings, dyes, and preservatives for the chewable and liquid preparations of over-the-counter and prescription products of antidiarrhea, cough and cold, antihistamine/decongestant, analgesic/antipyretic, and liquid theophylline medications was collected.
Information about excipients in 102 chewable and liquid preparations was compiled. An average preparation contained two sweeteners. Saccharin and sucrose were the most common sweeteners found--each was present in 52 preparations--followed by sorbitol, glucose, fructose, and others. For 36 of the 102 preparations, type of flavoring was not specified. In the remaining preparations, cherry was the most common flavoring, followed by vanilla and lemon. Twenty-one different dyes and coloring agents were used. Red dye No. 40 was the most common (42/102), followed by yellow No. 6 (27/102). Of the eight preservatives used, sodium benzoate and methylparabens were present in 42 and 27 of the preparations, respectively. Tables detailing these excipients and adverse effects reported are presented.
The tables should be helpful to physicians in selecting preparations containing different excipients when an adverse reaction occurs. The mandatory labeling of excipients in all pharmaceutical preparations is the only way that physicians and patients can be fully informed.
药物制剂可能含有多种辅料（“惰性成分”）。这些辅料一般无活性；然而，已有辅料引起罕见不良反应的报道。关于特定制剂中辅料的信息不易获取。
收集了抗腹泻、止咳和感冒药、抗组胺/减充血剂、止痛/退烧药以及液体茶碱类药物的非处方药和处方药的咀嚼片和液体制剂中甜味剂、调味剂、染料和防腐剂的信息。
汇编了102种咀嚼片和液体制剂中辅料的信息。一种制剂平均含有两种甜味剂。糖精和蔗糖是最常见的甜味剂——各有52种制剂含有——其次是山梨醇、葡萄糖、果糖及其他。102种制剂中有36种未标明调味剂类型。在其余制剂中，樱桃味是最常见的调味剂，其次是香草味和柠檬味。使用了21种不同的染料和着色剂。40号红色染料最常见（42/102），其次是6号黄色染料（27/102）。在所使用的八种防腐剂中，苯甲酸钠和对羟基苯甲酸甲酯分别存在于42种和27种制剂中。列出了详细说明这些辅料及所报道不良反应的表格。
这些表格应有助于医生在发生不良反应时选择含有不同辅料的制剂。所有药物制剂强制标注辅料是让医生和患者充分知情的唯一途径。
