丹鹿健腰颗粒质量标准研究

Quality Standard for Danlu Jianyao Granules

目的建立丹鹿健腰颗粒的质量控制标准。方法采用TLC法对丹鹿健腰颗粒中的丹参、夏天无及鹿衔草进行定性鉴别;应用HPLC法对丹鹿健腰颗粒中的丹酚酸B、原阿片碱进行定量测定。结果丹参、夏天无及鹿衔草的TLC鉴别方法专属性强,简单可行。丹酚酸B、原阿片碱分别在0.4~2.0、0.3~1.2μg范围内呈良好的线性关系,r均为0.9999;平均回收率（n=6）分别为99.3%（RSD为0.7%）、98.8%（RSD为1.2%）。结论本研究所建立的质量标准方法稳定、准确、重复性好,可用于丹鹿健腰颗粒的质量控制。

Objective To establish a quality standard for Danlu Jianyao granules. Methods Salvia miltiorrhiza Bge. , Corydalis decumbens （Thunb.） Pers. and Pyrola decorate H. Andres were identified by TLC while salvianolic acid B and protopine were determined by HPLC. Results Salvia miltiorrhiza Bge. , Corydalis decumbens （Thunb.） Pers. and Pyrola decorate H. Andres could be detected by TLC. The linear range of salvianol- ic acid B was good within the range of 0.4 -2.0 μg（ r =0. 9999） and that of protopine was good within the range of 0.3 - 1.2μg （ r = 0. 9999）. The average recovery （ n = 6） of salvianolic acid B and protopine was 99.3% （ RSD = 0.7% ） and 98.8% （ RSD = 1.2% ）, respectively. Conclusion The established method is stable, accurate and reproductible, which can be used for quality control of Danlu Jianyao granules.