蒡芩慢咽滴丸中黄芩苷的含量测定 - 安徽医药杂志社.doc

栀芩合剂质量控制方法的研究 陈晓亮①，汪旭② [摘要] 目的：。方法：采用黄芩苷色谱柱Diamonsil C18 (250 mm ×4.6 mm ,5 μm) ，以甲醇-0.1%磷酸溶液（45：55）为流动相，流速为1.0 mL·min-1，检测波长为280 nm。结果：材（或对照品）相应位置上出现斑点，阴性对照无干扰黄芩苷的线性范围为μg ( r=1)，平均加样回收率为99.08% ( n=9，RSD = 1.17 %)。结论：本方法简单、、可靠。 [关键词] 栀芩合剂；质量标准；TLC；HPLC；黄芩苷Study on quality control of Zhiqin Mixture Chen xiao-liang①,wangxu② ①Haikou people’s hospital , Haikou 570208 , China；Deparement of Pharrmacy,Bayi hospital of Changchun, Changchun 130024 , China [Abstract] Objective:To improve the quality standards of Zhiqin Mixture.Methods: TLC was used to make qualitative determination of gardenia、golden cypress and Scutellaria baicalensis，HPLC was used to determine the content of its main constituents of baicalin. Diamonsil C18 column (250mm×4.6mm ,5μm)was used as the stationary phase,the mixture of methanol-0.1% phosphoric acid (45:55) was served as mobile phase,and its flow rate was 1.0 mL·min-1, The wavelength for detection was 280nm. Results: gardenia、golden cypress and Scutellaria baicalensis were detected by TLC，the content of baicalin in Zhiqin Mixture was determined with HPLC, the linearity range was0.0964～0.8676μg(r=1),The average recovery was 99.08%( n=9,RSD = 1.17 %).Conclusion: The established method is stable、accurate and highly repetitive，which can be used for the quality control of Zhi Mixture． [Key words] Zhi Mixture; quality sttandards;TLC; HPLC; Baicalin 基金项目：军队医疗机构制剂标准提高科研专项课题，No.13ZJZ11-6 作者简介：陈晓亮，硕士，主管药师，研究方向：医院药学，Tel：0898E-mail 作者单位：①570208 海南 海口市人民医院；② 130024 长春 长春八一医院 栀芩合剂为医院院内制剂，处方由栀子、黄芩、黄柏、大黄、天花粉、知母六味中药组成，诸药组合，清热解毒，消痈散结，临床用于治疗中、重度寻常痤疮。本实验对栀芩合剂进行了规范化研究，采用薄层色谱法对栀子、黄柏、黄芩进行定性鉴别，黄芩为方中君药，黄芩苷为黄芩主要有效成分之一，具有广泛的药理活性，有文献报道其具有抗心律失常、降压、缺血性在灌注损伤保护、镇静、护肝利胆、抗肺炎衣原体、抗寄生虫等多种药理活性 [1-3]，本实验查阅相关文献及先前试验研究结果[4-10]采用高效液相色谱法对栀芩合剂中主要成分黄芩苷进行定量测定，通过对黄芩苷的含量控制考察制剂的质量，为其建立该制剂质量控制标准提供了相关依据。 1 仪器与试药 岛津LC-2010AHT高效液相色谱仪（检测器自动进样器，）；KQ-3200E数控超声波处理器(昆山市超声仪器公司)。中国中国中国（中国供含量测定用批号：）黄芩苷（中国供含量测定用批号：-201112），甲醇为色谱纯其它试剂均为分析纯2 方法与结果2.1.1栀子