乙肝灵胶囊质量标准改进研究

Study on Improvement of Quality Standard of Yiganling Capsules

目的改进乙肝灵胶囊的质量标准。方法采用薄层色谱(TLC)法对大黄、人参、甘草进行定性鉴别,并在检查项下增加土大黄苷的鉴别;采用高效液相色谱(HPLC)法测定君药大黄中大黄素、大黄酚的含量。结果定性鉴别方法斑点清晰,专属性强。大黄素进样量在0. 023 4～0. 292 5μg范围内与峰面积积分值线性关系良好,r=1. 000 0,平均回收率为100. 17%,RSD为1. 98%(n=6);大黄酚进样量在0. 039 16～0. 489 60μg范围内与峰面积积分值线性关系良好,r=1. 000 0,平均回收率为96. 38%,RSD为1. 52%(n=6)。结论改进后的质量标准可行,可用于乙肝灵胶囊的质量控制。

Objective To improve the quality standard of Yiganling Capsules. Methods TLC method was adopted for qualitative identifi- cation of Rheum palmatum, Panax ginseng, Glycyrrhiza uralensis and the identification method of rhaponticin was added in the examina- tion. HPLC method was used to determine the content of emodin and chrysophanol. Results The qualitative identification methods had clear spots and good specificity. There was a good linear correlation in the range of 0. 023 4-0. 292 5 μg（r = 1. 000 0） for emodin, the average recovery was 100. 17%, the RSD was 1.98% （n=6）, and there was a good linear correlation in the range of 0.039 16- 0.489 60 μg（ r = 1. 000 0） for chrysophanol, the average recovery was 96. 38%, the RSD was 1.52% （ n = 6）. Conclusion The improved quality standard is feasible, it can be used for quality control for Yiganling Capsules.