感宁颗粒的质量标准提高研究

Study on quality standard improvement of Ganning granules

目的提高感宁颗粒的质量标准。方法采用薄层色谱(TLC)法对感宁颗粒中连翘及黄芩进行定性鉴别并优化栀子的鉴别方法,用高效液相色谱法(HPLC)法同时测定黄芩苷、栀子苷、绿原酸的含量,色谱柱为Agilent Hypersil ODS(4.6 mm×250 mm,5μm),流动相为乙腈(A)-0.1%磷酸溶液(B),进行梯度洗脱,柱温:25℃,检测波长为238 nm;流速:1.0 m L/min。结果 TLC法定性鉴别重复性好,阴性无干扰;黄芩苷、栀子苷、绿原酸分别在12~120μg/m L(r=0.999 9)、9.6~96μg/m L(r=0.999 7)、14.4~144μg/m L(r=0.999 7)浓度范围内线性关系良好,平均回收率分别为99.32%、98.90%、99.14%。结论提高后的质量标准方法简便可行,专属性强,重复性好,能有效地控制感宁颗粒的质量。

Objective To improve the quality standard for Ganning particles. Methods Forsythia suspensa and Scutellaria baicalensis and Georgi were identified by TLC. HPLC was used to determine the contents of Baicalin,Geniposide and Chlorogenic acid. The method employed a column of Agilent Hypersil ODS（ 4. 6 mm × 250 mm,5μm） with the mobile phase of acetonitrile（ A）-0. 1% hydrochloric acid（ B） at a temperature of 25 ℃. The detection wavelength was set at 238 nm; the flowrate was 1. 0 m L/min. Results The TLC statutory identification was repeatable and negative without interference. The calibration curve showed a good linear relationship within the range of 12 ~120 μg/m L for Baicalin（ r = 0. 999 9）,9. 6 ~ 96 μg/m L for Geniposide（ r = 0. 999 7） and 14. 4 ~ 144 μg/m L for Chlorogenic acid（ r = 0. 999 7）,the average recovery was 99. 32%,98. 90% and 99. 14%. Conclusion The improved quality standard is simple,specific and reproducible,and can effectively control the quality of Ganning granules.