目的 对中药配方颗粒施行国家标准前后多厂家、多批次丹参配方颗粒（Danshen Formula Granules，DFG）进行多成分含量测定和比较分析。方法 收集DFG实行国家标准前4个厂家31批样品和实行国家标准后3个厂家19批样品，采用UPLC法对DFG实行国家标准前、后不同厂家、不同批次样品中丹参素、原儿茶醛、咖啡酸、丹酚酸D、丹酚酸E、迷迭香酸、紫草酸、丹酚酸B、丹酚酸A和丹参酮II_A共10个成分进行含量测定和比较分析。结果 DFG中10种成分线性关系良好（r≥0.999 2），平均加样回收率为92.64%～103.28%，RSD为0.66%～2.60%。DFG施行国家标准前4个厂家样品中10种成分含量均存在显著性差异，而实行国家标准后样品中仅丹参素、丹酚酸A和丹参酮II_A在个别厂家间存在显著性差异。同一厂家DFG中10种成分在实行国家标准后样品中含量普遍高于实行国家标准前样品中成分含量，且有的厂家中成分含量差异倍数在2倍甚至3倍及以上。结论 该方法稳定可行，可用于DFG的质量控制；实行国标后的DFG质量优于实行国标前样品；且不同厂家DFG中丹酚酸B的含量均符合最新国家药品标准。

Objective To determine and compare the multi-component content in Danshen Formula Granules (DFG) from various manufacturers and batches before and after the implementation of national standards for traditional Chinese medicine formula granules. Methods A total of 31 batches of DFG were collected from four manufacturers before implementing the national standards, and 19 batches were collected from three manufacturers after implementing the national standards. The content of 10 components, including danshensu, protocatechualdehyde, caffeic acid, salvianolic acid D, salvianolic acid E, rosmarinic acid, lithospermic acid, salvianolic acid B, salvianolic acid A, and tanshinone II_A, were determined and compared in DFG from different manufacturers and different batches before and after the implementation of national standards using ultra-high performance liquid chromatography method (UPLC). Results The 10 components in DFG had a good linear relationship (r ≥ 0.999 2), with the average sample recovery rate ranging from 92.64% to 103.28% and the RSD range of 0.66%—2.60%. There were significant differences in the content of the 10 components content among DFG samples from four manufacturers before implementing national standards, while only danshensu, danshenolic acid A, and tanshinone II_A in the samples after implementing national standards showed significant differences among individual manufacturers. Within the same manufacturer, the content of 10 components in DFG after the implementation of national standards was generally higher than that in the samples before the implementation of national standards, and some manufacturers showed differences in component content, ranging from two to even three times or more. Conclusion The UPLC method used in this study is stable and feasible, and can be used for the quality control of DFG. The quality of DFG after implementing national standards is better than that of samples before implementing national standards. And the content of salvianolic acid B in DFG from different manufacturers conforms to the latest national drug standard.

R283.6

河南省中医药科学研究专项（20-21ZY2102）；河南省中医药科学研究专项（2023ZY1003）；河南省中医药科学研究专项（20-21ZY1001）；河南省中医药科学研究专项（2022ZY2010）；中医药高质量发展协同创新转化工程自主立项项目（CXZH03）；河南省中医药拔尖人才培养项目（豫中医科教[2018]35号）；河南省高校科技创新团队（23IRTSTHN026）