两面针药材、饮片、标准汤剂与配方颗粒量值传递的研究  

Study on the transfer of the quantity value of the medicinal materials,decoction pieces,standard decoction and formula granule of Zanthoxylum nitidum(Roxb.)DC.

作　　者：赵伟志 游庭活 魏家保 刘华明 尚华 刘洋洋 ZHAO Weizhi;YOU Tinghuo;WEI Jiabao;LIU Huaming;SHANG Hua;LIU Yangyang(China Resources Sanjiu Pharmaceutical Co.,LTD.,Shenzhen 518000,China;China Resources Sanjiu Modern ChineseMedicine Pharmaceutical Co.,LTD.,Huizhou 516000,China;Anhui Provincial Key Laboratory of Chinese MedicineFormulation Granules,Huaibei 235000,China)

机构地区：[1]华润三九医药股份有限公司,广东深圳518000 [2]华润三九现代中药制药有限公司,广东惠州516000 [3]中药配方颗粒安徽省重点实验室,安徽淮北235000

出　　处：《广东药科大学学报》2024年第5期51-59,共9页Journal of Guangdong Pharmaceutical University

基　　金：深圳市科技计划项目(JSGG20191129093418578);淮北市科技计划项目(HK2022AB007)。

摘　　要：目的采用HPLC法对两面针药材、饮片、标准汤剂与配方颗粒的特征图谱和氯化两面针碱质量分数进行相关性研究,并考察化学成分的传递与差异。方法采用Agilent 5 TC C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.1%甲酸为流动相进行梯度洗脱,检测波长为271 nm,流速为1 mL/min,进样体积为10μL,柱温为25℃。结果以两面针对照药材和木兰花碱、氯化两面针碱、白屈菜红碱为参照,建立了15批两面针药材、饮片、标准汤剂冻干粉与3批配方颗粒的多成分HPLC特征图谱,确定了7个共有特征峰。两面针药材、饮片、标准汤剂冻干粉、配方颗粒HPLC对照指纹图谱之间相似度计算结果均大于0.90。饮片到标准汤剂冻干粉的氯化两面针碱含量转移率为9.2%~19.0%,均值为13.8%,SD为3.51%,均值±2SD范围为6.8%~20.8%,未出现离散值,传递性较好。结论两面针药材、饮片、标准汤剂与配方颗粒的主要化学成分基本相同;HPLC特征图谱各主要特征峰相关性良好。所建立的质量评价模式能够反映两面针从饮片到配方颗粒多成分的整体面貌,为两面针配方颗粒的质量控制提供了依据。Objective To study the correlation between the characteristics and the content of Nitidine chloride of Nitidine and its medicinal materials,decoction pieces,standard decoction and formula granules by HPLC,and to investigate the transfer and difference of chemical components.Methods The chromatography was performed on Agilent 5 TC C18(250 mm×4.6 mm,5μm)column with acetonitrile-0.1%formic acid as mobile phase by gradient elution.The detection wavelength was set at 271 nm,the flow rate was 1 mL/min,the sample volume was 10μL,and the column temperature was 25℃.Results The multicomponent HPLC characteristic maps of 15 batches of Nianduloides,decoction pieces,freeze-dried powder of standard decoction and 3 batches of formula granules were established with reference to Nianduloides and magnanimine,Niandulosine chloride and chelidonine,and 7 common characteristic peaks were identified.The similarity calculation results of HPLC fingerprints of Niandrix medicinal materials,decoction pieces,standard decoction lyophilized powder and formula granules were all greater than 0.90.The transfer rate of nitidnine chloride content from decoction pieces to standard decoction freeze-dried powder was 9.2%-19.0%,with an average of 13.8%,SD 3.51%,and mean±2SD 6.8%-20.8%.No discrete value was found,indicating good transfer.Conclusion The main chemical components of the herbs,decoction pieces,standard decoction and formula granules are basically the same.There is good correlation between the main characteristic peaks of HPLC characteristic spectrum.The established quality evaluation model can reflect the overall appearance of the multi-components from decoction pieces to formula particles,which can provide a basis for the quality control of formula particles.

关 键 词：两面针 标准汤剂 配方颗粒 特征图谱 氯化两面针碱 

分 类 号：R284.1[医药卫生—中药学] R283[医药卫生—中医学]