保元排毒丸中丹参酮ⅡA的含量测定及稳定性研究

Content Determination and Stability Study of TanshinoneⅡA in Baoyuan Paidu Pill

目的：建立保元排毒丸中丹参酮ⅡA的含量测定的方法，并对制剂中丹参酮ⅡA含量的稳定性进行研究。方法：采用高效液相色谱法对保元排毒丸中丹参酮ⅡA的含量进行测定，将制剂分别置温度为（60±2）℃条件下、湿度为（75±5）％条件下3个月，对制剂中丹参酮ⅡA进行稳定性研究。结果：高效液相色谱法测定保元排毒丸中丹参酮ⅡA含量的方法较好，丹参酮ⅡA在0．03～0．30μg范围内线性关系良好（n=5，r=0．9999）；保元排毒丸制剂在（60±20）℃温度条件下、湿度为（75±5）％条件下稳定性良好。结论：高效液相色谱法测定保元排毒丸中丹参酮ⅡA的含量，方法简便、准确，适用于组方丹参中丹参酮ⅡA成分的含量测定；同时稳定性实验表明保元排毒丸制剂中丹参酮ⅡA成分稳定性良好。

Objective ：To establish the content determination method and stability study of tanshinone Ⅱ A in Baoyuan paidu pill. Meth- ods ： detected the content of tanshinone Ⅱ A in Baoyuan Paidu Pill by high performance liquid chromatography （ HPLC ）, and put the pill under the condition of temperature （ 60 ± 2 ） ℃, humidity （ 75± 5 ） % for 3 months, and stability study of tanshinone ⅡA in the pill. Re- sults ：The content of tanshinone Ⅱ A in Baoyuan Paidu Pill detection by HPLC was better, and Tanshinone Ⅱ A had a good linear rela- tionship in the range of 0.03 -0.30 μg（ n = 5, r = 0.999 9 ）. Baoyuan Paidu Pill had good stability under the condition of temperature （ 60 ± 20） ℃, humidity of （ 75 ± 5 ） %. Conclusion ： The method of HPLC determination of tanshinone Ⅱ A in Baoyuan Paidu Pill content is simple and accurate,which can be used for the content determination of tanshinone Ⅱ A in salvia miltiorrhiza of the composition. At the same time, stability test shows that tanshinone Ⅱ A composition in Baoyuan Paidu Pill has good stability.