甲伤药胶囊质量标准研究

Study on Quality Standard for Jiashangyao Capsules

目的:建立甲伤药胶囊的质量标准。方法:采用显微法对甲伤药胶囊中的三七、红花、当归进行定性鉴别;采用高效液相色谱法对三七中人参皂苷Rg_1、人参皂苷Rb_1、三七皂苷R_1的含量进行测定。结果:三七、红花、当归的显微图谱清晰。人参皂苷Rg_1、人参皂苷Rb_1、三七皂苷R_1的进样量在0.316~10μg范围内呈现良好的线性关系(r=0.998 7),精密度、稳定性、重复性试验的RSD<2%,平均加样回收率为99.58%,RSD=0.84%(n=6)。结论:所建标准可有效控制甲伤药胶囊的质量。

Objective： To establish the quality standard of Jiashangyao Capsules. Methods： Microscopic identification was used to perform qualitative identification for notoginseng, safflower and angelica sinensis in Jiashangyao Capsules. HPLC was employed to determine the content of ginsenoside Rg1, ginsenoside RbL, and notoginsenoside R1. Results： The icroscopic spectrum of notoginseng, safflower and angelica sinensis were clear. The amount of ginsenoside Rgl, gin- senoside Rb1 and angelica sinensis R1 in the range of 0. 316 to 10 μg showed a good linear relationship （r = 0. 998 7）. RSDs of precision, stability and reproducibility tests were lower than 2%. The average recovery was 99.58% （ RSD = 0.84%, n = 6）. Conclusion： The established standard can effectively control the quality of Jiashangyao Capsules.