制半夏配方颗粒质量评价  

Quality evaluation for Zhibanxia Formula Granules

作　　者：白婧 石燕红[2,3] 杨莉[3,4] 王峥涛 王瑞 BAI Jing;SHI Yan-hong;YANG Li;WANG Zheng-tao;WANG Rui(College of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Institute of TCM International Standardization,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Ministry of Education Key Laboratory for Standardization of Chinese Medicines,Institute of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Institute of Interdisciplinary Integrative Medicine Research,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药学院,上海201203 [2]上海中医药大学中医药国际标准化研究所,上海201203 [3]上海中医药大学中药研究所,中药标准化教育部重点实验室,上海201203 [4]上海中医药大学交叉科学研究院,上海201203

出　　处：《中成药》2023年第3期729-733,共5页Chinese Traditional Patent Medicine

基　　金：上海市中医药三年行动计划[ZY(2021-2023)-0215]。

摘　　要：目的评价制半夏配方颗粒质量。方法建立HPLC特征图谱,进行相似度分析。以腺嘌呤为内标,计算鸟嘌呤、尿苷、鸟苷相对校正因子,一测多评法测定这4种核苷含量。结果10批样品特征图谱中有6个共有峰(鸟嘌呤、尿苷、腺嘌呤、鸟苷、5-羟甲基糠醛、6-姜辣素),相似度均大于0.990。4种核苷在各自范围内线性关系良好(r≥0.9990),平均加样回收率96.67%~101.8%,RSD 1.04%~1.72%,一测多评法所得结果与外标法接近。结论该方法快速准确,稳定可控,可用于制半夏配方颗粒的质量控制。AIM To evaluate the quality of Zhibanxia Formula Granules.METHODS The characteristic HPLC chromatograms were established,after which similarity analysis was performed.Adenine was taken as an internal standard to calculate the relative correction factors of guanine,uridine and guanosine,then quantitative analysis of multi-components by single-marker(QAMS)was adopted in the content determination of these four nucleosides.RESULTS There were six common peaks(guanine,uridine,adenine,guanosine,5-hydroxymethylfurfural,6-gingerol)in the characteristic chromatograms of ten batches of samples with the similarities of more than 0.990.Four nucleosides showed good linear relationships within their own ranges(r≥0.9990),whose average recoveries were 96.67%-101.8%with the RSDs of 1.04%-1.72%.The results obtained by QAMS approximated those obtained by external standard method.CONCLUSION This rapid,accurate,stable and controllable method can be used for the quality control of Zhibanxia Formula Granules.

关 键 词：制半夏配方颗粒 HPLC特征图谱 腺嘌呤 鸟嘌呤 尿苷 鸟苷 一测多评 

分 类 号：R927.2[医药卫生—药学]