二十味沉香丸质量控制标准优化

Optimization of the Quality Control Standard of Ershiwei Chenxiang Pill

本研究通过建立藏药二十味沉香丸的新型质量控制标准体系,为生产企业质量控制与临床安全使用提供参考。用单因素实验优化没食子酸提取工艺,以高效液相色谱法对其进行定量检测并以薄层色谱法对制剂没食子酸成分进行定性分析。结果显示,薄层色谱所得斑点清晰,分离度好;提取工艺和HPLC色谱条件优化后,在0.1~0.5mg/mL浓度区间内,没食子酸浓度与HPLC峰面积值呈现y=5979576x+27982的稳定线性关系,r^2值为0.999;方法学实验误差在允许范围内,没食子酸成分在24h内无明显变化。此方法作为二十味沉香丸质量控制标准,专属性强,定量准确。

This study establishes a new quality control standard system of Ershiwei chenxiang pill. It offers references for quality control in production and application security. Optimize the extraction conditions through the single factor experiments, quantitative test the gallic acid content through high performance liquid chromatography (HPLC) and qualitative identify it by means of thin layer chromatography (TLC). The result shows that the TLC spots are clear and separated well. After the optimization of the extraction technique and HPLC conditions, in the concentration range from 0.1 to 0.5 mg/mL, peak area and gallic acid concentration have a stable linear relationship, which is y=5 979 576x+27 982, r^2=0.999. The measurement biases of methodology experiments are all within the permitted average, gallic acid does not change significantly within 24 h. As the quality control standard of Ershiwei chenxiang pill, established method is reliable and quantitative accurate.