目的 针对配方颗粒质控现状，提出中药配方颗粒标准参考物（traditional Chinese medicine formula granules standard reference，TCMFGSR）的概念，并以丹参配方颗粒（Danshen formula granules，DFG）为研究对象，研究标准参考物同时应用于薄层鉴别、特征/指纹图谱、含量测定项检测的可行性。方法 基于丹参标准汤剂（Danshen standard decoction，DSD）制备3批次丹参配方颗粒标准参考物（Danshen formula granules standard references，DFGSR）。并分别对3批次DFGSR进行薄层鉴别、指纹图谱、含量测定项的质量检测，以及影响因素研究。随后，以DFGSR为对照物质，考察DFGSR在市售DFG产品质量控制中的应用可行性。结果 DFGSR在薄层鉴别中与迷迭香酸、紫草酸、丹酚酸B对照品，及丹参对照药材在相同位置显示相同颜色斑点。且经质谱鉴定，DFGSR的8个特征成分与DFG国家药品标准对照指纹图谱一致。此外，3批次DFGSR之间的相似度均大于0.99、与国标对照图谱相似度均大于0.98、丹酚酸B含量波动范围均在±10%以内。在市售DFG质量控制的实际应用中，DFGSR不仅实现了指纹图谱项的特征峰定位及相似度评价、与对照药材在薄层鉴别项下的鉴别效果一致、与对照品在含量测定项下的测定结果偏差仅为1.08%；而且可以将检测效率提升8倍、检测成本降低90%。结论 DFGSR的研制与应用，实现了对DFG的质量控制，以及一个对照物质同时用于中药配方颗粒薄层鉴别、特征/指纹图谱、含量测定项的检测，对中药配方颗粒的高质量发展具有良好的促进作用。

Objective Be aimed at the current situation of quality control for formula granules, the concept of traditional Chinese medicine formula granules standard reference (TCMFGSR) is proposed. The feasibility of using standard reference for thin layer identification, specific chromatogram/fingerprint, and content determination was studied using Danshen formula granules (DFG) as the research object. Methods Three batches of Danshen formula granules standard references (DFGSR) were prepared based on Danshen standard decoction (DSD). The influence factor studies on three batches of DFGSR, as well as quality evaluation of thin layer identification, fingerprint, and content determination were conducted. Subsequently, using DFGSR as the reference material, the feasibility of applying DFGSR in the quality control of commercially available DFG products was investigated. Results The DFGSR showed the same color spots in the same position as the reference materials for rosmarinic acid, lithospermic acid, salvianolic acid B, and Danshen reference medicinal materials in thin-layer identification. The mass spectrometry identification showed that the eight components of DFGSR were consistent with the national drug standard reference fingerprint of DFG. In addition, the similarity between three batches of DFGSR was greater than 0.99, the similarity with the national standard control spectrum was greater than 0.98, and the fluctuation range of salvianolic acid B content was within ±10%. In practical application of quality control for commercially available DFG, DFGSR not only achieved similarity evaluation and accurately locate the characteristic peaks of the fingerprints, but also had the same identification effect as the reference medicinal materials under the thin-layer identification, and the deviation of determination result of reference material under the content determination was only 1.08%. Moreover, the DFGSR could improve detection efficiency by eight times, reduce detection costs by 10 times. Conclusion The development and application of DFGSR have achieved the quality control of DFG, and simultaneous detection of thin layer identification, specific chromatogram/fingerprints and content determination of traditional Chinese medicine formula granules with one reference material. The standard reference has an excellent promoting effect on the high-quality development of traditional Chinese medicine formula granules.

R283.6

江西省产业链科技创新联合体协同攻关项目“赣食十味——陈皮（樟头红）的关键技术研究”（20224BBG72001）;江西省重大科技研发专项“揭榜挂帅”企业需求类项目：“樟帮”特色中药饮片炮制规范标准研究（20223AAG02021）;江西省重大科技研发专项“揭榜挂帅”企业需求类项目：“赣产药材”中药配方颗粒质量标准化研究（20233AAE02018）