Saevels J, De Braekeleer K, Corthout J
Service de Contrôle des Médicaments, rue Stévin 137, B-1000 Bruxelles.
J Pharm Belg. 2005;60(3):92-6.
Piracetam preparations formulated as capsules, tablets and granules were evaluated with different tests including in vitro dissolution and assay with previously validated methods according to the guideline of the European network of official medicines control laboratories (OMCLs). All examined products complied with the requirements as described here and in the European Pharmacopoeia except for the dissolution test where 3 products did not meet the USP acceptance criteria applied on the established specification.
按照欧洲官方药品控制实验室(OMCLs)网络指南,采用不同测试方法,包括体外溶出度测试和用先前验证的方法进行含量测定,对制成胶囊、片剂和颗粒剂的吡拉西坦制剂进行了评估。除溶出度测试外,所有受试产品均符合此处及《欧洲药典》所述要求,在溶出度测试中有3种产品不符合既定规格所适用的美国药典验收标准。