HPLC法测定妇炎舒片中丹酚酸B含量.docVIP

HPLC法测定妇炎舒片中丹酚酸B含量[摘要] 目的 建立妇炎舒片中丹酚酸B的含量测定方法。 方法 以丹酚酸B为测定指标，HPLC测定妇炎舒片中丹酚酸B的含量。色谱条件：色谱柱为KromasilC18（250 mm×4.6 mm，5 μm）；流动相：甲醇-乙腈-甲酸-水（30∶10∶1∶59）；检测波长：286 nm；流速：1.0 mL/min。 结果 丹酚酸B对照品在0.508～3.176 μg范围内线性关系良好，r ＝ 0.999 9；平均回收率为97.94%，RSD = 1.14（n = 6）。 结论 本定量方法简便、准确、专属性强，能有效控制妇炎片的质量。 [关键词] 妇炎舒片；高效液相色谱法；丹酚酸B；含量测定 [中图分类号] R286.0 [文献标识码] B [文章编号] 1674-4721（2012）07（c）-0079-02 Determination of salvianolic acid B in Fuyanshu Tablets by HPLC WANG Fen’an1 ZHENG Haibo2 ZHAO Dongling3 1.Ruixin Pharmaceuticals Co.Ltd of Xi’an Jiaotong University in Shannxi Province, Xi’an 710061, China; 2.Medical college of Xi’an Jiaotong University in Shannxi Province, Xi’an 710061, China; 3. Hospital of Xi’an Jiaotong University in Shannxi Province, Xi’an 710061, China [Abstract] Objective To determine of salvianolic acid B in Fuyanshu tablets by HPLC. Methods With salvianolic acid B as the Determination index, HPLC was used to determine the contents of salvianolic acid B in Fuyanshu tablets. The analysis was performed on a Kromasil C18 column(250 mm×4.6 mm, 5 μm); The mobile phase was methanol-acetonitrile- formic acid-water (30∶10∶1∶59) at a flow rate of 1.0 mL/min; The detective wavelength was 286 nm. Results The standard of curves of salvianolic acid B showed a good linearity from 0.508 μg to 3.176 μg, (r = 0.999 9); average recovery was 97.94%，RSD = 1.14(n = 6). Conclusion The quantitative method is simple and convenient, accuracy, and strong specificity which can effective control the quality of Fuyanshu Tablets. [Key words] Fuyanshu tablets; HPLC；Salvianolic acid B; Content determination 妇炎舒胶囊为《国家药品监督管理局国家药品标准中成药地标升国标外科妇科分册》中收载的品种，具有清热凉血，活血止痛的功效[1]。妇炎舒片为改剂型品种，处方由忍冬藤、大血藤、丹参、芍药、甘草等十一味药味组成，文献报道及该制剂质量标准中都采用HPLC法测定芍药中芍药苷的含量[2-3]。处方中丹参具有祛瘀止痛、凉血消痈、清心除烦的功效[4]，本文笔者结合文献采用HPLC法增加丹参中丹酚酸B的含量测定方法[5-6]，有利于制剂中多组分的质量控制，报道如下： 1 仪器与试剂 1.1 仪器 岛津LC-2010CHT 型高效液相色谱仪，LCsolution工作站。 1.2 试剂 丹酚酸B对照品（购自中国药品生物制品检定所，批号：111562-200605）；妇炎舒片（自制，批号：01、02、03）。 2方法与结果 2.1 色谱条件 Kromasil C