参罗胶囊质量标准研究

Quality Control for Shenluo Capsules

目的建立参罗胶囊的质量标准。方法采用TLC对决明子、苦参进行定性鉴别;采用反相高效液相色谱法(RP-HPLC)对成品中绿原酸、丹参酚酸B的含量进行定量分析。结果定性鉴别方法专属性强、重复性好;绿原酸的检测浓度在0.020 1~0.201 4μg范围内,与峰面积呈良好的线性关系(r=1.000),平均回收率为100.3%,RSD为0.56%(n=9);丹参酚酸B的检测浓度在0.080 6~0.806 0μg范围内,与峰面积呈良好的线性关系(r=1.000),平均回收率为100.4%,RSD为0.79%(n=9)。结论本法专属性强,准确可靠,可作为参罗胶囊的质量控制方法。

OBJECTIVE To establish the quality standard for Shenluo capsules. METHODS TLC was performed to identify semen cassiae torae and radix sophorae flavescentis. RP-HPLC was used to determine the content of chlorogenic acid and salvianolic acid B in the capsules. RESULTS The TLC was specific and duplicate. The linear ranges of chlorogenic acid was 0.020 1 - 0.201 4 μg. Chlorogenic acid possessed a favorable linear relationship with the peak areas. The correlation coefficient was 1. 000. The average recovery was 100.3% with RSD of 0.56% （ n = 9）. With the ranges sample sizes from 0. 080 6 to 0. 806 0 μg, salvianolic acid B possessed a favorable linear relationship with the peak areas. The correlation coefficient was 1.000. The average recovery was 100.4% with RSD of 0.79% （ n = 9）. CONCLUSION This method proves to be sensitive, precise and of strong specificity and high reproducibility and can be used for the quality control of Shenluo Capsules.