杞明眼保胶囊质量标准提升研究

Study on Quality Standara of Qimingyanbao Capsules

目的:提高院内制剂杞明眼保胶囊的质量标准。方法:用薄层色谱法对丹参、墨旱莲进行定性鉴别;采用高效液相色谱法测定处方药材丹参中丹酚酸B的含量。结果:丹参、墨旱莲TLC定性鉴别分离良好、专属性强;丹酚酸B线性范围为37.5~374.0μg/mL(r=0.9999);精密度、重复性、中间精密度、稳定性(8 h)试验的RSD均小于1.5%,平均回收率为98.94(RSD=1.26,n=6)。10批杞明眼保胶囊中丹酚酸B的含量为3.45~5.00 mg/g之间。结论:建立杞明眼保胶囊中丹参、墨旱莲药材的鉴别方法和丹参中丹酚酸B的含量测定方法;根据转移率计算含量限度为1.74 mg/粒。

Objective To improve the quality standard of QimingYanbao to improve the quality standard of QimingYanbao capsule.Methods Radix Salvia miltiorrhiza and Yerbadetajo Herb were identified by TLC;The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC.Results Radix Salvia miltiorrhiza and Yerbadetajo Herb were well identified and separated by TLC;The linear range of salvianolic acid B is 37.5-374.0μg/mL(r=0.9999);The RSD of precision,repeatability,intermediate precision and stability(8 h)tests were less than 1.5%,and the average recovery was 98.94(RSD=1.26,n=6).The content of salvianolic acid B in 10 batches of QimingYanbao capsules was 3.45~5.00 mg/g.Conclusion the identification method of Salvia miltiorrhiza and Yerbadetajo Herb in QimingYanbao capsule and the determination method of salvianolic acid B in Salvia miltiorrhiza were successfully established;According to the transfer rate,the content limit is 1.74mg/capsule.