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蒙药乌日格斯图-阿日查(刺柏叶)的质量标准提升                                                      Δ


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        袁小红 ,庞克坚 ,唐 辉 ,张 虹 ,管 辉 ,魏 沣 ,唐 萍(1.石河子大学药学院/新疆植物药资源利用教
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        育部重点实验室,新疆 石河子 832000;2.和田维吾尔药业股份有限公司,新疆 和田 848200;3.博尔塔拉蒙古
        自治州蒙医医院药剂科,新疆 博乐 833400)
        中图分类号 R282;R917          文献标志码 A          文章编号     1001-0408(2021)16-1949-07
        DOI  10.6039/j.issn.1001-0408.2021.16.06
        摘  要   目的:为完善蒙药乌日格斯图-阿日查(刺柏叶)的质量标准提供科学依据。方法:以不同采集地的10批乌日格斯图-阿日
        查药材为样品,对其进行性状观察和显微鉴别;采用薄层色谱法(TLC)对样品中的异槲皮苷、槲皮苷、穗花杉双黄酮、竹柏双黄酮
        A和扁柏双黄酮进行定性鉴别;参照2020年版《中国药典》(四部)通则中的相关方法测定样品中总灰分、酸不溶性灰分、醇溶性浸
        出物、重金属的含量;建立高效液相色谱法(HPLC)测定样品中上述5种成分的含量。结果:乌日格斯图-阿日查粉末呈绿色或黄
        绿色,管胞呈多角形,紧密排列成纵行;气孔为不等式;表皮细胞为近长方形;厚壁细胞呈类长方形,壁连珠状增厚。TLC结果显
        示,供试品在与上述5种成分对照品色谱相应位置上显相同颜色的斑点。10批样品中总灰分、酸不溶性灰分、醇溶性浸出物含量
        分别为 7.37%~11.18%、0.75%~2.98%、16.55%~26.42%,平均值分别为 8.51%、1.27%、22.35%;铅、砷、镉、汞、铜含量分别为
        2.00~5.44、0.65~1.65、0.044~0.100、0.034~0.160、4.59~6.79 mg/kg,平均值分别为 3.73、0.97、0.078、0.061、5.23 mg/kg。异槲皮
        苷、槲皮苷、穗花杉双黄酮、竹柏双黄酮A、扁柏双黄酮检测质量浓度的线性范围分别为4.98~20.02、49.99~199.96、19.94~99.96、
        9.99~40.00、20.20~159.98 μg/mL(r均大于0.999 7);精密度、重复性、稳定性(24 h)试验的RSD均小于3.00%(n=6);平均加样回
        收率为 100.62%~102.96%,RSD 为 1.21%~1.88%(n=6)。10 批样品中上述 5 种成分的平均含量分别为 0.089~0.379、1.379~
        4.250、1.077~2.026、0.162~0.423、0.016 9~0.117 0 mg/g。结论:本研究建立了蒙药乌日格斯图-阿日查药材的定性、定量分析方
        法,暂规定其总灰分不得超过10.22%,酸不溶性灰分不得超过1.53%,醇溶性浸出物不得低于17.88%,重金属铅不得超过5 mg/kg,砷
        不得超过2 mg/kg,镉不得超过0.3 mg/kg,汞不得超过0.2 mg/kg,铜不得超过20 mg/kg。
        关键词 蒙药;乌日格斯图-阿日查;质量标准;薄层色谱法;高效液相色谱法;槲皮苷;穗花杉双黄酮;竹柏双黄酮A

        Improvement of Quality Standard for Mongolian Medicine Juniperus rigida
        YUAN Xiaohong ,PANG Kejian ,TANG Hui ,ZHANG Hong ,GUAN Hui ,WEI Feng ,TANG Ping(1. School
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        of Pharmacy/Key Laboratory of Xinjiang Phytomedicine Resource and Utilization,the Ministry of Education,
        Shihezi University,Xinjiang Shihezi 832000,China;2. Hetian Uygur Pharmaceutical Co.,Ltd.,Xinjiang
        Hetian 848200,China;3. Dept. of Pharmacy,Mongolian Medical Hospital of Bortala Mongolian Autonomous
        Prefecture,Xinjiang Bole 833400,China)
        ABSTRACT    OBJECTIVE:To provide scientific evidence for improving the quality standard of Mongolian medicine Juniperus
        rigida. METHODS:Totally 10 batches of J. rigida from different places were taken as samples to observe their characters and
        identify them by microscope; TLC method was adopted to qualitatively identify isoquercitrin, quercitrin, amentoflavone,
        podocarpusflavone A and hinokiflavone;the contents of total ash,acid-insoluble ash,ethanol-soluble extract and heavy metals
        were determined by related method stated in 2020 edition of Chinese Pharmacopeia(part Ⅳ). The contents of above 5 components
        in samples were determined by HPLC. RESULTS:The powder of J. rigida was green or yellowish green,polygonal tracheids,
        closely arranged in longitudinal with unequal stomatal;epidermal cells were nearly rectangular;sclerenchyma cells were quasi
        rectangular and the wall beadedly thickening. Results of TLC showed that the spots of the same color were found in the
        corresponding positions of chromatogram for test sample and substance control. The contents of total ash,acid-insoluble ash and
        ethanol-soluble extract in 10 batches of samples were 7.37%-11.18%,0.75%-2.98%,16.55%-26.42%,respectively;average
        contents were 8.51%,1.27%,22.35%. The contents of lead,arsenic,cadmium,mercury and copper were 2.00-5.44,0.65-1.65,
        0.044-0.100,0.034-0.160,4.59-6.79 mg/kg,respectively;average contents were 3.73,0.97,0.078,0.061,5.23 mg/kg. The linear
                                                           ranges of isoquercitrin,quercitrin,amentoflavone,podocarpus-
           Δ 项目基金:国家自然科学基金资助项目(No.81860614);新疆维
                                                           flavone A and hinokiflavone were 4.98-20.02,49.99-199.96,
        吾尔自治区重点研发计划项目(No.2017B03013-1)
                                                           19.94-99.96,9.99-40.00,20.20-159.98 μg/mL(all r>0.999 7);
           *硕士。研究方向:民族药质量标准。E-mail:1120448744@qq.
        com                                                RSDs of precision,repeatability and stability (24 h) tests
           # 通信作者:教授,硕士生导师,博士。研究方向:药物分析。电                  were all less than 3.00%(n=6);the average recoveries were
        话:0993-2057878。E-mail:Tanghuishz@qq.com            100.62%-102.96%,RSDs were 1.21%-1.88%(n=6). Average


        中国药房    2021年第32卷第16期                                            China Pharmacy 2021 Vol. 32 No. 16  ·1949 ·
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