创伤1号合剂质量标准研究

目的建立创伤1号合剂的质量控制标准。方法采用薄层色谱法定性鉴别创伤1号合剂中的当归、川芎、西红花、赤芍,采用高效液相色谱法测定制剂中阿魏酸的含量。结果供试品溶液薄层色谱中,在与对照药材溶液或对照品溶液色谱相应位置上出现相同颜色的斑点或荧光斑点,阴性对照品溶液无干扰;高效液相色谱中,阿魏酸质量浓度在1.51～24.2μg/mL范围内与峰面积线性关系良好(r=0.996 4),平均回收率为99.30%,RSD为1.20%(n=6)。结论薄层色谱法斑点清晰、特异性强,可用于创伤1号合剂的定性鉴别;高效液相色谱法简便快速,精密度高,准确度好,可用于创伤1号合剂的质量控制。

Study on Quality Standard of Chuangshang 1 Mixture

Objective To establish the quality standard for Chuangshang 1 Mixture.Methods Radix Angelicae sinensis,Rhizoma Chuanxiong,Radix paeoniae rubra and Crocus sativus L were identified using TLC.The content of ferulic acid in Chuangshang 1 Mixture was determined by HPLC.Results Spots obtained form the test solutions had the same color in reference solution and medicalmateial in the same location,and the bland solution had no interference.The linear range of ferulic acid was from 1.51 to 24.2 μg/mL（r=0.996 4）,the average recovery was 99.30%.Conclusion In TLC,the spots are very clear and specific to identify the herbal medicine in Chuangshang 1 Mixture.HPLC is simple,quick,high precise and accurate for the quality control of Chuangshang 1 Heji.