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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 study the quality standard of Hechuangzhuanggao, a traditional Chinese medicine preparation, and establish a simple and easy quality control method. Methods The main traditional Chinese medicines Astragalus, Angelica and Zhigancao were identified by TLC. The contents of baicalin in Radix Scutellariae were determined by high performance liquid chromatography (HPLC). Chromatographic conditions: C18 column; mobile phase: methanol -0.1% phosphoric acid (48:52); flow rate: 1m L / min; detection wavelength 280 nm. The results of identification test data showed no negative control; content determination results show that baicalin in the range of 0.03523 ~ 0.5637 g showed a good linear relationship (r = 0.9998), the average recovery of the experiment was 96.7%, in line with the standard (n = 6). Conclusion The method established in this experiment is simple and easy to operate with good reproducibility and stability and is suitable for the quality control of HCHZH cream.