摘要：中药配方颗粒试点工作结束后，为满足中医临床需要，目前国家和各省药品监管部门仍在加紧制定配方颗粒标准。以山东省中药配方颗粒标准复核及审评中遇到的问题为切入点，针对原料合规性、原料基原区分及名称规范性、制法工序、质控指标和方法合理性等问题进行探讨，挖掘其产生的深层次原因，提出关注原料饮片一致性及名称规范性、鼓励和督促企业持续推进生产工艺验证、聚焦检验方法和质量控制指标选择的合理性、构建标准复核及审评标准化体系等建议，以建立科学合理的质量标准，推进中药配方颗粒产业更加健康有序，进而助力我国中药行业高质量发展。

After the completion of pilot work of traditional Chinese medicine formula granules (TCMFGs), national and provincial medical products administrations are still speeding up the standard formulation of TCMFGs to meet the clinical needs. Problems found in the standard re-examine and the review of TCMFGs in Shandong Province are continued to be taken as breakthrough point, such as compliance of raw material standards, distinction and standardization of raw material base and name, preparation process, and rationality of quality control indicators and methods, etc. Specific reasons for the above problems are excavated in this paper, and suggestion on putting forward to pay close attention to standard consistency and name standardization of raw materials, encouraging enterprises to continuously promote the verification of production process, focusing on rationality of inspection methods and quality control indicators, establishing scientific and reasonable formula particle inspection standards and building a standardized system for standard re-examine and review are put forward, in order to promote healthy and orderly development of the TCMFGs industry, and then help high-quality development of TCM industry.

R288

山东省重点研发计划重大科技创新工程项目(2021CXGC010511);山东省重点研发计划项目(2020RKB24001);山东省人文社会科学课题(2021-YYGL-44);山东省食品药品检验研究院平台课题(SDIFDC-KY-1-2021023,SDIFDC-KY-1-2021026)