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作者中文名	作者英文名	单位中文名	单位英文名	E-Mail
李宁新	LI Ning-xin	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China
卢志标	LU Zhi-biao	桂林三金药业有限公司，广西桂林541000	Guilin Sanjin Pharmaceutical Co.，Ltd.，Guilin 541000，China
马潇	MA Xiao	甘肃省药品检验研究院，甘肃兰州730000	Gansu Institute for Drug Control，Lanzhou 730000，China
李明华	LI Ming-hua	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China
郭晓晗	GUO Xiao-han	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China
程显隆	CHENG Xian-long	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China	程显隆，研究员，研究方向：中药质量控制；Tel：（010）67095432，E-mail：cxl@nifdc.org.cn
魏锋	WEI Feng	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China	魏锋，研究员，研究方向：中药质量评价；Tel：（010）67095432，E-mail：weifeng@nifdc.org.cn
马双成	MA Shuang-cheng	中国食品药品检定研究院，北京100050	National Institute for Food and Drug Control，Beijing 100050，China

基金项目:国家重点研发计划“中药材净切制关键技术与智能设备研究及应用”（2019YFC1711500）

中文摘要:目的：拟根据淡豆豉的质量问题，选择适合的质量控制指标，采用生药鉴定学、薄层鉴别、含量测定等方法，开展淡豆豉质量标准研究工作，为淡豆豉药材质量标准的提升和完善提供参考。方法：采用传统生药鉴定方法，对淡豆豉及其伪品的性状特征进行比较，找出具有鉴别专属性的性状特征，修订淡豆豉的性状鉴别项；对淡豆豉标准薄层鉴别中的展开剂进行优化，建立专属性强的薄层鉴别方法；根据淡豆豉发酵前后的成分差异，以能体现发酵程度的大豆苷元、染料木素为指标，建立含量测定方法，以Agilent SB C18（250 mm×4.6 mm，5 μm）色谱柱为固定相，以乙腈-1%冰醋酸（25∶75）为流动相，流速为1 mL·min-1，柱温为40 ℃，检测波长为260 nm。结果：建立的性状鉴别项，能从种脐特征区分伪品黑芸豆；建立的薄层鉴别方法也能有效地区分伪品；选择的大豆苷元、染料木素作为含量测定指标，可以有效地区分正伪品及未发酵品，考虑到不同发酵工艺的差异造成的含量差异，建议淡豆豉中染料木素、大豆苷元的总量不得少于0.040%。结论：建立的性状鉴别项、薄层鉴别项和含量测定方法能够更好地控制淡豆豉质量，可为2020年版《中华人民共和国药典》关于淡豆豉药材质量标准的修订提供参考。

中文关键词:中药材淡豆豉指标成分标准修订

Definition of Key Components for Quality Control on Revision of Standards of Sojae Semen Praeparatum

Abstract:Objective：To improve the standard of Sojae Semen Praeparatum，the key index components were selected to revise the standard of Sojae Semen Praeparatum，due to its quality problem. Methods：The morphologic characteristics were found to modify the description of the standard by pharmacognosic methods，the TCL method was established by option of development solvent and replacement of the TLC plate，daidzein and genistein were selected to establish the assay method. The determination was carried out by means of an Agilent SB-C18 （250 mm×4.6 mm，5 μm） column. The mobile phase was composed of acetonitrile and water solvent containing 1% glacial acetic acid （25∶75）. The flow rate was 1.0 mL·min-1 and the detection wavelength was 260 nm. The column temperature was set at 40 ℃. Results：The description，TLC method were able to distinguish Sojae Semen Praeparatum from its adulterants. The assay method can used not only to distinguish Sojae Semen Praeparatum and its adulterants，but also to distinguish whether Sojae Semen Praeparatum was fermented or not. The proposed content limit of sum of daidzein and genistein was not less than 0.040%. Conclusion：The description，TLC method，assay method can be used to control the quality of Sojae Semen Praeparatum，which can be the reference for standard revision of it.

keywords:traditional Chinese medicine Sojae Semen Praeparatum index components standard revision

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