药用辅料监管法规、质量标准现状分析及应对措施

Current situation and countermeasures of regulations and quality standards for pharmaceutical excipients

药用辅料是在制剂处方中加入的除主要活性成分外的其他所有物质,是药物制剂的基础材料和重要组成部分,其在药物制剂中具有成型、增溶、助溶、缓控释、充当载体及提高制剂稳定性等功能,也是药物成型发挥治疗、预防和诊断作用的前提和基础。自2017年起,我国的药用辅料在完善制度和加强监管的基础上,借鉴欧美发达国家先进的管理经验,由注册审批改为登记备案,顺应了药用辅料行业的呼声,促进了药用辅料的研发和生产。本文对我国药用辅料监管法规的历史沿革进行了回顾,分析了药用辅料的生产现状和质量标准中存在的常见问题,为加强药用辅料的监管和质量提升提供意见和建议。

Pharmaceutical excipients are all substances that are added into the formulation other than the main active ingredients.They are the basic materials and important components of pharmaceutical preparations.They have the functions of molding,solubility enhancement,sustanined release,acting as the carrier and improving the stability of the preparations.They are also the premise and basis for drug molding in the treatment,prevention and diagnosis.Since 2017,on the basis of improving the system and strengthening the supervision,our pharmaceutical excipients we have learned advanced management experience from developed countries in Europe and America and changed from registration and approval to registration and filing,which has met the needs of the industry and promoted the research and development of pharmaceutical excipients.This paper reviewed the historical evolution of regulations on the supervision of pharmaceutical excipients in China,analyzes the production status and common problems in the quality standards of pharmaceutical excipients,and provided suggestions for strengthening the supervision and quality improvement of pharmaceutical excipients.