补筋片的质量控制研究

Study on Quality Control of Bujin Tablets

关键词:  丹参  制何首乌  士的宁  马钱子碱  高效液相色谱法  补筋片

Key words:  Radix et Rhizoma salviae miltiorrhizae  Radix polygoni multiflori praeparatacum succo glycines sotae  strychnine  brucine  HPLC  Bujin tablets

摘要:

目的建立补筋片质量控制方法。方法采用薄层色谱法鉴别补筋片中丹参、制何首乌；采用高效液相色谱法测定士的宁、马钱子碱含量。结果薄层色谱法可以很好的鉴别丹参、制何首乌；士的宁在0.133 8～2.00 7 μg间线性关系良好(r=0.999 9)，平均回收率为98.98%(RSD=2.61%)；马钱子碱在0.129 6～1.944 μg间线性关系良好(r=0.999 8)，平均回收率为100%(RSD=2.11%)。结论该法操作简便、准确，可用于该制剂的质量控制。

Abstract:

OBJECTIVE To establish a quality control method for Bujin tablets. METHODS The Radix et Rhizoma salviae miltiorrhizae and Radix polygoni multiflori praeparatacum succo glycines sotae in Bujin tablets were identified by TLC. The strychnine and brucine were determined by HPLC. RESULTS The Radix et Rhizoma salviae miltiorrhizae and Radix Polygoni Multiflori Praeparatacum Succo Glycines Sotae could be identified by TLC. Strychnie had a good linear relationship at the range of 0.133 8-2.007 μg (r=0.999 9), and the average recovery was 98.98% (RSD = 2.61%). Brucine had a good linear relationship at the range of 0.129 6-1.994 μg(r=0.999 8), and the average recovery was 100% (RSD= 2.11%). CONCLUSION This method is simple, accurate and suitable for the quality control of Bujin tablets.