基于标准汤剂的姜黄配方颗粒质量评价研究  

Study on quality evaluation of Curcumae Longae Rhizoma formula granules based on standard decoction

作　　者：马智玲 沈建梅 张先梅 王晓亚 万莹莹 张志强 刘艳[1] MA Zhiling;SHEN Jianmei;ZHANG Xianmei;WANG Xiaoya;WAN Yingying;ZHANG Zhiqiang;LIU Yan(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Taiyuan Xiaodian District People′s Hospital,Taiyuan,Shanxi 030032,China;Beijing Tcmages Pharmaceutical Company Limited,Beijing 101301,China;Traditional Chinese Medicine Formula Particles Key Technology National United Engineering Research Center,Beijing 101301,China;Beijing Chinese Medicine Formula Particles Engineering Technology Research Center,Beijing 101301,China;School of Medicine,Qilu Institute of Technology,Ji'nan,Shandong 250200,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]太原市小店区人民医院,山西太原030032 [3]北京康仁堂药业有限公司,北京101301 [4]中药配方颗粒关键技术国家地方联合工程研究中心,北京101301 [5]北京市中药配方颗粒工程技术研究中心,北京101301 [6]齐鲁理工学院医学院,山东济南250200

出　　处：《河北工业科技》2025年第1期12-20,共9页Hebei Journal of Industrial Science and Technology

摘　　要：为实现姜黄配方颗粒生产全过程的质量控制,建立了基于标准汤剂的姜黄配方颗粒质量评价方法。依据含挥发油中药饮片标准汤剂的制备要求,配制了18批姜黄标准汤剂及3批配方颗粒,定量计算挥发油、姜黄素的含量以及双去甲氧基姜黄素、去甲氧基姜黄素和姜黄素的总含量,并采用超高效液相色谱法建立并分析姜黄的特征图谱。结果表明:标准汤剂中姜黄素的质量分数为2.3~4.2 mg/g,双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素的总质量分数为4.0~8.0 mg/g,挥发油的质量分数为0.20%~0.90%;姜黄配方颗粒中,姜黄素的实测质量分数为3.7~4.0 mg/g,双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素的总质量分数为6.6~6.9 mg/g,挥发油的质量分数为0.67%~0.71%;在姜黄特征图谱中标定9个共有峰,指认出4-香豆酸、阿魏酸、环姜黄素、双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素以及芳姜黄酮等7个成分。采用所提质量评价方法能够确定姜黄标准汤剂各指标成分的含量范围,可为姜黄配方颗粒质量标准的制定提供依据,也可为其他含挥发油中药制剂的研究提供参考。In order to achieve quality control throughout the production process of Curcumae Longae Rhizoma granules,a quality evaluation method for Curcumae Longae Rhizoma granules based on standard decoction was established.According to the preparation requirements of the standard decoction of traditional Chinese herbal medicine containing volatile oil,18 batches of standard decoction and three batches of formula granules of Curcumae Longae Rhizoma were prepared.The contents of volatile oil,curcumin and the total contents of dimethoxycurcumin,demethoxycurcumin and curcumin were quantitatively calculated,and the UPLC characteristic chromatograms analysis method was established.The results show that the mass fraction of standard decoction curcumin is 2.34.2 mg/g,the total mass fraction of dimethoxycurcumin,demethoxycurcumin and curcumin is 4.08.0 mg/g,and the mass fraction of volatile oil is 0.20%0.90%;In the Curcumae Longae Rhizoma granules,the measured mass fraction of curcumin is 3.74.0 mg/g,the total mass fraction of dimethoxycurcumin,demethoxycurcumin and total curcumin is 6.66.9 mg/g,and the mass fraction of volatile oil is 0.67%0.71%.The characteristic chromatograms of Curcumae Longae Rhizoma is analyzed,nine common peaks are determined,and seven components including 4-coumaric acid,ferulic acid,cyclocurcumin,dimethoxycurcumin,demethoxycurcumin,curcumin and ar-turmerone are identified.The use of the proposed quality evaluation method can determine the parameter range of Curcumae Longae Rhizoma formula granules and also provide reference for the research of other traditional Chinese medicine preparations containing volatile oil.

关 键 词：中药化学 姜黄 标准汤剂 配方颗粒 姜黄素 挥发油 特征图谱 

分 类 号：R284.1[医药卫生—中药学]