Embrapa Agroindústria Tropical, Fortaleza, CE, 60020-181, Brazil.
Instituto de Química, Universidade Federal de Goiás, Goiânia, GO, 74690-900, Brazil.
J Pharm Biomed Anal. 2018 May 10;153:29-36. doi: 10.1016/j.jpba.2018.02.013. Epub 2018 Feb 11.
Several flavoring and sweetening agents added to excipient of pediatric syrups are not declared in the package leaflet. Therefore, the aim of this study was to develop a non-target, simple, and precise method for qualitative and quantitative evaluation of pediatric syrups using NMR spectroscopy combined with chemometrics. This approach allowed the identification of several added compounds as citric acid, cyclamate, ethanol, glycerol, propylene glycol, saccharin, sorbitol, fructose, glucose, and sucrose. Among the sugared syrups, sucrose was the main carbohydrate with approximately 59.1%, and for sweetened syrups, glycerol with 25.5%. The ethanol was found with highest concentration of 4.0%, approximately. In addition, some syrups presented both sugar and sweetener, which is inconsistent according to the purpose of the addition. Consequently, institutional structures of countries as Brazil that are in charge of public health should put additional compliance pressure on pharmaceutical companies to clearly declare in package leaflet the presence and exact amount of the main compounds (at least) existent in the pediatric excipients.
几种添加到儿科糖浆赋形剂中的调味剂和甜味剂未在包装说明书中声明。因此，本研究的目的是开发一种非靶向、简单、精确的方法，使用 NMR 光谱结合化学计量学对儿科糖浆进行定性和定量评估。该方法能够识别出几种添加的化合物，如柠檬酸、环己胺、乙醇、甘油、丙二醇、糖精、山梨糖醇、果糖、葡萄糖和蔗糖。在含糖糖浆中，蔗糖是主要的碳水化合物，约占 59.1%，而在加糖糖浆中，甘油占 25.5%。发现乙醇的浓度最高，约为 4.0%。此外，一些糖浆既含糖又含甜味剂，这与添加的目的不一致。因此，负责公共卫生的巴西等国家的机构应向制药公司施加额外的合规压力，要求其在包装说明书中明确声明（至少）存在于儿科赋形剂中的主要化合物的存在和确切含量。
