生地黄止血海绵剂质量标准研究

Studies on Quality Standard for Hemostatic Sponge of Rehmannia glutinosa Libosch

目的建立生地黄止血海绵剂的质量标准。方法采用薄层色谱法对止血海绵中生地黄进行定性鉴别;采用高效液相色谱法测定了各指纹峰相对于梓醇的含量。色谱柱Akasil-C18柱（250mm×4.6mm,5μm）,乙腈-水梯度洗脱,检测波长为210nm,流速1.0mL/min,柱温30℃。采用紫外分光光度法测定止血海绵中多糖含量。以葡萄糖为对照品采用蒽酮-硫酸法于622nm处测定。结果定性鉴别薄层色谱斑点清晰;梓醇在0.13~2.6μg呈良好的线性关系;平均回收率为103.34%,RSD为2.38%（n=5）。多糖在0.0067～0.067mg呈良好的线性关系;平均回收率为101.81%,RSD为0.79%（n=5）。结论该方法简便、准确、可靠,可作为生地黄止血海绵剂的质量控制方法。

Objective To establish the quality standard for hemostatic sponge of Rehmannia glutinosa Libosch..Methods TLC were used to distinguish Rehmannia glutinosa Libosch..HPLC were used for the deterimination of the summation of the fingerprints peaks relative to the content of catalpol.Akasil-C18（250mm×4.6mm,5μm） column was used and the acetonitrile-water was chosen as the mobile phase in a gradient mode;the flow rate was 1.0mL？min-1,The column temperature was 30℃ and the detection wavelength was 210nm.The content of polysaccharides was determined by UV spectrophotometry.Results The thin-layer chromatography spots were clear and well separated,and catalpol was linear in the range of 0.13～2.60μg,and the average recovery was 103.34% with RSD 2.38%（n = 5）,polysaccharides was linear in the range of 0.006 7～0.067mg,and the average recovery was 101.81% with RSD 0.79%（n = 5）.Conclusion This method was simple,accurate,reliable and could be used as a quality control method for hemostatic sponge of Rehmannia glutinosa Libosch..