Sakai Shinobu, Adachi Reiko, Miyazaki Tamaki, Aso Yukio, Okuda Haruhiro, Teshima Reiko
Division of Novel Foods and Immunochemistry, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan.
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2012(130):58-65.
Most drugs contain pharmaceutical excipients. These are pharmacologically inactive substances used as vehicles for the active ingredients of a medication. Some of these pharmaceutical excipients are produced from allergenic foods (e.g., milk, egg, peanut, soybean, and sesame) and removing proteins completely from such excipients is difficult. Therefore, if individuals with food allergy consume drugs containing allergenic food-derived excipients, eliminating the risk of developing specific allergic symptoms induced by them may not be possible. We determined the levels of proteins in pharmaceutical excipients and ethical drugs (inhalants and injections) by spectrophotometric analyses. The level of protein in the pharmaceutical excipient lactose in each sample was approximately 1 mg/g. In the case of oils from soybeans, peanuts, and sesame in pharmaceutical excipients, proteins were detected in the range 7-9 microg/g sample. We also determined levels of allergenic proteins in pharmaceutical excipients and ethical drugs using commercial enzyme-linked immunosorbent assay systems. The milk proteins in lactose were detected in the range 1.39-13.07 microg/g. The results of this study suggest that physicians, patients with food allergies, pharmacists, and healthcare providers must pay attention to presence of potential impurities those may cause allergic symptoms in pharmaceutical products.
大多数药物都含有药用辅料。这些是药理上无活性的物质,用作药物活性成分的载体。其中一些药用辅料由致敏性食物(如牛奶、鸡蛋、花生、大豆和芝麻)制成,要将此类辅料中的蛋白质完全去除很困难。因此,如果食物过敏的个体服用含有源自致敏性食物的辅料的药物,就不太可能消除由这些辅料引发特定过敏症状的风险。我们通过分光光度分析测定了药用辅料和处方药(吸入剂和注射剂)中的蛋白质水平。每个样品中乳糖这种药用辅料的蛋白质含量约为1毫克/克。在药用辅料中大豆、花生和芝麻的油类中,检测到的蛋白质含量范围为7 - 9微克/克样品。我们还使用商用酶联免疫吸附测定系统测定了药用辅料和处方药中的致敏蛋白水平。乳糖中的牛奶蛋白检测含量范围为1.39 - 13.07微克/克。这项研究的结果表明,医生、食物过敏患者、药剂师和医疗服务提供者必须关注药品中可能导致过敏症状的潜在杂质的存在。