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特木仁-5味散的指纹图谱建立及4种成分的含量测定                                                          Δ


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        孙灿灿 ,周 婧,苏比依努尔·吐尔洪,马桂芝(新疆医科大学药学院,乌鲁木齐 830054)
                                                  #
        中图分类号 R917          文献标志码 A           文章编号 1001-0408(2022)04-0452-06
        DOI   10.6039/j.issn.1001-0408.2022.04.12

        摘   要   目的 建立特木仁-5味散的指纹图谱并进行化学模式识别分析,同时测定其中4种成分的含量。方法 采用高效液相色谱
        法结合《中药色谱指纹图谱相似度评价系统(2012版)》建立10批特木仁-5味散(编号S1~S10)的指纹图谱并进行相似度评价,与
        混合对照品比对指认共有峰。采用SPSS 26.0软件对共有峰进行系统聚类分析、主成分分析。采用高效液相色谱法测定10批样
        品中没食子酸、栀子苷、绿原酸、鞣花酸的含量。结果 从10批特木仁-5味散的指纹图谱中共标定15个共有峰,相似度为0.997~
        0.999;指认峰1为没食子酸、峰3为栀子苷、峰5为绿原酸、峰12为鞣花酸。10批样品中,S4、S9聚为一类,S6~S8聚为一类,其余
        批次样品聚为一类;前3个主成分的累计方差贡献率为89.245%。没食子酸、栀子苷、绿原酸、鞣花酸检测质量浓度的线性范围分
        别为 5.55~177.5、15.98~511.5、2.56~82.0、13.48~431.5 μg/mL;精密度、稳定性(24 h)、重复性试验的 RSD 均小于 2%(n=6 或
        n=7);平均加样回收率分别为101.56%、102.21%、98.60%、96.62%,RSD分别为1.90%、1.61%、1.58%、1.73%(n=6)。10批特木
        仁-5味散中,上述成分的平均含量分别为5.03~5.64、10.38~12.16、1.40~1.69、6.47~7.11 mg/g。结论 所建指纹图谱稳定、可行,
        含量测定方法符合相关规定,结合化学模式识别分析可用于特木仁-5味散的质量控制。
        关键词 特木仁-5味散;指纹图谱;系统聚类分析;主成分分析;含量测定

        Establishment of the fingerprint of Temurin-5 powder and content determination of 4 components
        SUN Cancan,ZHOU Jing,Subiyinuer·Tuerhong,MA Guizhi(College of Pharmacy,Xinjiang Medical University,
        Urumqi 830054,China)

        ABSTRACT    OBJECTIVE To establish the fingerprint of Temurin-5 powder,conduct chemical pattern recognition analysis,and
        determine the contents of 4 components simultaneously. METHODS The fingerprints of 10 batches of Temurin-5 powder were
        established and similarity evaluation was performed by using high performance liquid chromatography(HPLC)combined with the
        Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine (2012 edition);common peaks
        were identified by comparing with mixed substance control. The common peaks were analyzed by systematic cluster analysis and
        principal component analysis with SPSS 26.0 software. The HPLC method was used to determine the contents of gallic acid,
        geniposide,chlorogenic acid and ellagic acid in 10 batches of samples. RESULTS A total of 15 common peaks were identified
        from the fingerprints of 10 batches of Temurin-5 powder,and the similarity was 0.997-0.999. It was identified that peak 1 was
        gallic acid,peak 3 was geniposide,peak 5 was chlorogenic acid and peak 12 was ellagic acid. Among the 10 batches of samples,
        S4 and S9 were grouped into one category,S6-S8 were grouped into one category,and the other batches of samples were grouped
        into one category. The accumulative variance contribution rate of first three principal components was 89.245%. The linear ranges
        of gallic acid,geniposide,chlorogenic acid and ellagic acid were 5.55-177.5,15.98-511.5,2.56-82.0 and 13.48-431.5 μ g/mL,
        respectively. RSDs of precision,stability (24 h) and repeatability tests were all less than 2% (n=6 or n=7). The average
        recoveries were 101.56%,102.21%,98.60% and 96.62%,respectively,RSDs were 1.90%,1.61%,1.58% and 1.73%(n=6).
        Average contents of above components were 5.03-5.64,10.38-12.16,1.40-1.69,6.47-7.11 mg/g,respectively. CONCLUSIONS The
        established fingerprint is stable and feasible,and the content determination method meets the relevant regulations. Combined with
        chemical pattern recognition analysis,it can be used for the quality control of Temurin-5 powder.
        KEYWORDS Temurin-5 powders;fingerprint;systematic cluster analysis;principal component analysis;content determination


            特木仁-5 味散出自藏医经典《四部医典·后序本》,                       热、明目的铁面为主。研究指出,铁面有消肿、清肝热、
        也称扎格切-5汤散,是由铁面、诃子、栀子、黄柏、川楝子                         明目、解毒的功效;诃子有祛“三弊”所致诸疾、调理体素
                                  [1]
        5味药材组成的传统蒙药制剂 。本方性凉,方中以清肝                           及解毒的功效;栀子有清血热、明目、祛巴达干希拉、滋
            Δ 基金项目:新疆维吾尔自治区重点研发计划项目(No.2017B03-             养强壮及调节体素的功效;黄柏有清热、明目的功效;川
        013-2)                                              楝子有祛巴达干希拉、燥黄水、止痛、杀虫、明目的功效;
            *硕士研究生。研究方向:药品质量控制。E-mail:1597165545@                                  [1]
                                                            诸药共奏清肝热、明目之功 。蒙医理论认为,眼睛系靠
        qq.com
                                                            火元素之特性构成的感形器,故其属性为火,且眼为肝
            # 通信作者:副教授,硕士生导师,博士。研究方向:药品质量控
                                                                                                         [2]
        制。E-mail:maguizhi000@126.com                        之华,为司视希拉存在之处,也是病变希拉窜行之道 。

        ·452 ·  China Pharmacy 2022 Vol. 33 No. 4                                    中国药房    2022年第33卷第4期
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