维生素B2片的一致性评价方法研究

目的 从完善药品质量标准、提升我国仿制药整体水平的角度，提出维生素B2片一致性评价方法的建议。方法 以维生素B2片的关键质量属性为评价出发点，结合生产工艺及国内外药典标准的比较，对本品的评价方法提出建议。结果 本品一致性评价药学研究的关注点应放在有关物质、溶出度及溶出曲线测定方法的建立和验证、产品溶出曲线的考察、晶型、稳定性研究等方面，体内评价是否必须开展有待商榷。结论 对此类无参比制剂的品种，生产企业应结合具体品种的具体情况开展一致性评价。

Discussion on Consistency Evaluation Method of Vitamin B2 Tablets

OBJECTIVE To consummate drug specifications and improve the overall level of generic drugs in our country, the consistency evaluation method of Vitamin B2 tablets is proposed. METHODS With its critical quality attributes(CQA) as the evaluation starting point, as well as combination of production process and specifications described in pharmacopoeias, the evaluation method of Vitamin B2 tablets had been suggested. RESULTS The pharmaceutical research of Vitamin B2 tablets should be focused on related substances, dissolution(including establishment, validation of dissolution profiles method and investigation of dissolution profiles of products under different pH values), polymorphism and stability. The necessity of its in vivo evaluation was open to discuss. CONCLUSION When no reference listed drug(RLD) is available, e.g. Vitamin B2 tablets, the consistency evaluation shall be carried out by pharmaceutical factories case by case.