摘要
建立普乐安胶囊的质量标准。采用HPLC法对制剂原料油菜花花粉中主要成分槲皮素和山柰素进行定量分析。采用GraceSmart C18色谱柱；以甲醇（A）-0．5%磷酸溶液（B）为流动相，采用梯度洗脱：0min，A-B（50：50）；3min，A-B（40：60）；15min，A-B（50：50）；检测波长：360nm；流速为1．0mL·min^-1；柱温：35℃。对油菜花花粉含的芦丁进行薄层色谱鉴别。槲皮素在0．01248～0．3120μg范围内线性关系良好，平均回收率为99．44％，RSD为0．79％（n=9）。山柰素在0．03197～0．3996μg范围内线性关系良好，平均回收率为98．58％，RSD为1．37％（n=9）。方法准确可靠，专属性强，简便、快捷，可有效控制制剂质量。
To establish the quality standard for Pulean Capsules （Brassica campestris pollen）. The Quercetin and Kaempferol in Pulean Capsules was determined by HPLC. GraceSmart C18 column was used. The mobile phase was methanol （A） -0.5%phosphoric acid （B）, gradient elution （0min , A-B （50 ： 50）; 3min , A-B （40 ： 60）; 15min , A-B （50 ： 50）） and UV detection wavelength was at 360nm. The flow rate was 1.0 mL·min^-1. The temperature of column was at 35℃. Rutin in capsules was identified by TLC. The Quercetin were linear at the range of 0. 01248- 0. 3120μg, respectively. The average recovery was 99.44% and RSD was 0.79% （n= 9）. The kaempferol was linear at the range of 0. 03197-0. 3996μg, respectively. The average recovery was 98.58% and RSD was 1. 37% （n=9）. The established method is accurate, reliable, specific and simple. The quality of the capsules can be controlled by this method.
出处
《中国药事》
CAS
2008年第6期513-515,共3页
Chinese Pharmaceutical Affairs
