盐酸多奈哌齐片质量评价

Quality analysis of donepezil hydrochloride tablet

目的评价盐酸多奈哌齐片的质量现状,为其生产质控和有效监管提供参考。方法按照国家药品抽检计划要求,采用各执行标准检验结合探索性研究的方式,对包括原研企业在内的7家生产企业的140批次样品进行质量考察。结果按执行标准检验全部合格,普通国产制剂与参比制剂及通过仿制药一致性评价的产品,在有关物质和含量等方面仍存在一定的质量差异。现行片剂各执行标准中,检验项目不同,检验方法和标准限度不统一。结论国内盐酸多奈哌齐片的总体质量趋好,仿制制剂质量水平与参比制剂仍存在差距。现行标准基本可行,但仍需完善和提高,以控制生产过程,提升药品质量。

Objective To evaluate the quality status of donepezil hydrochloride for providing reference for its production,quality control and supervision.Methods According to the general requirements of inspection program,the statutory methods combined with the exploratory studies were used to evaluate the quality condition of 140 batches of donepezil hydrochloride produced by 7 manufactures.Results All samples were inspected according to the executive standards,and the qualified rate was 100%.But there were some quality differences in related substances and assay among generic drugs,RLD(reference listed drug),and products passing the consistency evaluation.The legal standards were various with different test items and the methods and limits of standards were not uniformed.Conclusion The overall quality of donepezil hydrochloride was good,but there was still a gap between the quality level of the generic drug and the RLD.The current standard is basically feasible,but it still needs to be perfected to control the production process and improve the quality of preparations.