河车壮儿膏质量标准的研究

Studies on the Quality Standard of Heche Zhuang'er Electurary

目的对中药复方制剂河车壮儿膏质量标准进行研究,建立简单易行的质量控制方法。方法利用薄层色谱法鉴别河车壮儿膏中主要中药材黄芪、当归、炙甘草,利用高效液相色谱法(HPLC)测定黄芩中黄芩苷的含量。色谱条件:C18色谱柱;流动相:甲醇-0.1%磷酸(48∶52);流速:1m L/min;检测波长280 nm。结果鉴别试验数据表明阴性对照均无干扰;含量测定结果表明黄芩苷在0.03523~0.5637 g的范围内呈现较好的线性关系(r=0.9998),实验的平均加样回收率为96.7%,符合标准(n=6)。结论本实验所建立的方法简单易行,具有良好的重现性和稳定性,适用于中药复方制剂河车壮儿膏的质量控制。

Objective To establish a method for quality control of Heche Zhuang＇er electuary. Methods Astragalus membranaceus （Fisch.） Bge. vat. mongholicus, Angelica sinensis （Oliv.） Diels and Radix glycyrrhizae preparata were identified by TLC. The content of Baicalin was determined by HPLC. Conditions of HPLC were： Shim-Pack CLS-ODS column （150 ×6.0 mm） with detection wavelength at 280nm. The mobile phase consisting of a mixture of methanol-0, 1%phosphoric acid （48： 52）. The flow rate was lmL/min. Results The spots in TLC were clear and easy to be identified, no interferent in negative control. The linear regression for Baicalin was obtained over the range of 0.03523-0.5637gg. The average revovery was 96.7%, RSD =2.15% （n =6）.Conclusion The method is sensitive, accurate, reproducible and exclusive, which can be used for quality control of Heche Zhuang＇ er electurary.