[关键词]
[摘要]
通过参考《中国药典》2020年版及有关文献,对2021年国家药品监督管理局发布的《中药配方颗粒质量控制与标准制定技术要求》中新增的品种适应性原则进行讨论,并对部分不适宜制成中药配方颗粒的品种进行概括总结,同时提出相关建议,以期更好地完善中药配方颗粒的质量标准要求,促进配方颗粒行业的发展。
[Key word]
[Abstract]
By referring to Chinese Pharmacopoeia of 2020 edition and relevant literatures, the new variety adaptability principle in Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules issued by China Pharmacopoeia Committee in 2021 was discussed in this paper, and some varieties that are not suitable for making traditional Chinese medicine formula granules were summarized, and suggestions were put forward so as to better improve the traditional Chinese medicine formula granules' standard requirements and promote the development of formula granule industry.
[中图分类号]
R282.4
[基金项目]
四川省科学技术厅中药配方颗粒和经典名方技术研发及产业化转移项目(2019YFG0468);四川省科技成果转移转化示范项目(2020ZHCG0073);四川省科学技术厅2020年省级科技计划项目(20YYJC1839);2019年德阳市产学研合作科技研发类项目(2019CK090);四川省大学生创新创业训练计划项目(S202011079042X);成都大学CC国家众创空间2020年度创新创业项目(ccyg202001003)