枳实导滞丸HPLC特征图谱的建立及多指标成分的含量测定  

Establishment of HPLC characteristic chromatogram and determination of multiple ingredients of zhishi daozhi pills

作　　者：王洪明 许学丽 崔俊凤 李守信 孙辉 郝成杰 王辉 WANG Hong-ming;XU Xue-li;CUI Jun-feng;LI Shou-xin;SUN Hui;HAO Cheng-jie;WANG Hui(Binzhou Inspection and Testing Center,Binzhou 25600,China;Shandong Phoenix Pharmaceutical Co.,Ltd,Dongying 257400,China)

机构地区：[1]滨州市检验检测中心,山东滨州256600 [2]山东凤凰制药股份有限公司,山东东营257400

出　　处：《化学研究与应用》2025年第3期616-623,共8页Chemical Research and Application

摘　　要：本研究基于高效液相色谱(HPLC),以乙腈-0.1%磷酸溶液为流动相,进行梯度洗脱,建立枳实导滞丸的HPLC特征图谱及9种指标成分同时定量检测的分析方法。结果显示,枳实导滞丸HPLC特征图谱共确认了12个特征峰,并对其进行了指认及峰归属。9种含量测定指标成分分离度良好,在0.14~435μg·mL^(-1)浓度范围内呈现良好的线性关系(≥0.9997),平均加样回收率为90.91%~99.02%,RSD(n=6)均≤3.3%。本研究建立的HPLC特征图谱及多指标同时定量方法简便准确、专属性高、重复性好,为识别枳实导滞丸的关键质量属性,评价其质量的均一性、稳定性提供参考。A high-performance liquid chromatography(HPLC)was established for determination of the characteristic chromatogram as well as the simultaneous determination of 9 ingredients in Zhishi Daozhi Pills,using acetonitrile and 0.1%phosphoric acid as the mobile phase for gradient elution.The results showed that a total of 12 characteristic peaks had been identified and assigned in the HPLC characteristic chromatogram of Zhishi Daozhi Pills.The 9 ingredients achieved complete separation with good linear relationships in the range of 0.14~435μg·mL^(-1)(r≥0.9997),and the average recovery rates ranged from 90.91%~99.02%with RSD(n=6)≤3.3%.The determination method for the HPLC characteristic chromatogram and multiple ingredients established by this study is simple,accurate,highly specific and have good reproducibility,which provide a reference for identifying the key quality indicators of Zhishi Daozhi Pills and evaluating its uniformity and stability of quality.

关 键 词：枳实导滞丸 高效液相色谱法 特征图谱 多指标同时定量 

分 类 号：O657.7[理学—分析化学]