益脑复健胶囊的质量标准

Quality Standard for Yinao Fujian Capsules

目的:建立益脑复健胶囊质量标准。方法:采用薄层色谱法鉴别三七、葛根、赤芍、红花、血竭,采用高效液相色谱法对制剂中三七进行定量测定。结果:薄层色谱清晰,分离效果好,阴性无干扰;人参皂苷Rg_1在0.46～13.86μg范围内与峰面积呈良好的线性关系(r=1.000 0)平均回收率为98.1%RSD=2.1%;人参皂苷Rb_1在0.41～12.42μg范围内与峰面积呈良好的线性关系(r=1.000 0)平均回收率为96.1%RSD=1.6%;三七皂苷R_1在0.13～3.78μg范围内与峰面积呈良好的线性关系(r=1.000 0)平均回收率为98.5%RSD=3.2%。结论:本方法可靠,有效、专属性强,可用于该制剂的质量控制。

Objective： To set up the quality standard for yinao fujian capsules. Method： Pseudo-ginseng,root of kudzu vine,root of herbaceous peony, safflower and dragon＇ s blood in preparation were identified by TLC. The content of pseudo-ginseng in the yinao fujian capsules was determined by HPLC. Result： The spot on the thin layer plate was clear. The negative control was not disturbed. The linear range of ginsenoside Rg; was 0.46-13.86μg（r = 1. 000 0）. The average recovery was 98. 1% with RSD of 2. 1% ;The linear range of ginsenoside Rb1 was 0.41-12.42 μg（r = 1. 000 0）. The average recovery was 96. 1% with RSD of 1.6% ;The linear range of notoginsenoside R1 was 0. 13-3.78 μg（ r = 1. 000 0 ）. The average recovery was 98.5 % with RSD of 3.2%. Conclusion： The method is reliable, effective and specific, It can be used for quality control of yinao fujian capsules