调脾抑胰合剂质量标准提升研究  

Research on the Improvement of Quality Standard for Tiaopiyiyi Mixture

作　　者：唐静月 胡敏敏[1] 卞振华 朱洁[1] TANG Jingyue;HU Minmin;BIAN Zhenhua;ZHU Jie(Wuxi Hospital of Traditional Chinese Medicine,Wuxi 214000,China)

机构地区：[1]无锡市中医医院药学部,江苏无锡214000

出　　处：《特产研究》2025年第2期150-154,共5页Special Wild Economic Animal and Plant Research

基　　金：全国中药特色技术传承人才培训项目(T20194828003);无锡市卫健委中青年拔尖人才资助计划项目(HB2020059);无锡市中医医院科研项目(ZYYYB21024、ZYYYB24015);无锡市科学技术协会软科学研究课题项目(KX-24-C166)。

摘　　要：为了提高和完善调脾抑胰合剂的质量标准。本研究采用薄层色谱法对调脾抑胰合剂中的枳实、预知子进行定性鉴别,并考察了不同薄层板、温度及湿度对调脾抑胰合剂薄层鉴别的影响;采用HPLC法测定调脾抑胰合剂中橙皮苷和丹皮酚的含量,色谱柱为Agilent ZORBAX Eclipse XDB C18柱(4.6 mm×250 mm,5μm),以乙腈-0.2%磷酸水溶液为流动相,梯度洗脱(0~5 min,10%A;5~15 min,10%~15%A;15~30 min,15%~25%A;30~35 min,25%~40%A;35~55 min,40%~80%A),流速为1.0 mL/min,柱温为25℃,检测波长为275nm,进样量为10μL。结果表明,枳实、预知子的薄层色谱图斑点清晰,专属性强;橙皮苷和丹皮酚的质量浓度分别在4.04~202.04μg/mL(r=0.999 8,n=6)和0.38~19.16μg/mL(r=0.999 8,n=6)范围内与峰面积线性关系良好,平均加样回收率分别为99.05%和95.71%,RSD分别为2.95%和3.03%(n=6)。该方法操作简便,稳定准确,重复性好,可用于调脾抑胰合剂的质量控制。To optimize and improve the quality standard of Tiaopiyiyi Mixture.TLC was employed for qualitative identification of Aurantii Fructus Immaturus,Akebiae Fructus in Tiaopiyiyi Mixture.The effects of different humidity,temperature and TLC board on TLC identific-ation of Tiaopiyiyi Mixture were investigated.HPLC was employed for the simultaneous determination of hesperidin and paeonol in Tiaop-iyiyi Mixture.Agilent ZORBAX Eclipse XDB C18 column(4.6 mm 250 mm,5 m)was adopted and eluted with acetonitrile and 0.2%phosphoric acid solution as the mobile phase,with gradient elution(0~5 min,10%A;5~15 min,10%~15%A;15~30 min,15%~25%A;30~35 min,25%~40%A;35~55 min,40%~80%A),flow rate of 1.0 mL/min,column temperature of 25℃,detection wavelength of 275 nm.The injection volume was 10 L.TLC spots of Aurantii Fructus Immaturus,Akebiae Fructus were clear,specific.The linear ranges of hesperidin and paeonol were 4.04~202.04 g/mL and 0.38~19.16 g/mL,respectively.The two constituents showed good linear relation-ship in the concentration range(r=0.9998,n=6).The average recoveries of hesperidin and paeonol were 99.05%and 95.71 with RSDs of 2.95%and 3.03%(n=6).The established method is simple,stable,accurate and reproducible,which can be used for the quality control of Tiaopiyiyi Mixture.

关 键 词：调脾抑胰合剂 质量标准 薄层色谱法 高效液相色谱法 橙皮苷 丹皮酚 

分 类 号：R284[医药卫生—中药学]