抗骨增生片的质量标准提高研究

摘要

OBJECTIVE:To develop and improve the quality standard for Kanggu zengsheng tablet. METHODS:TLC was used for the qualitative identification of Drynaria fortunei,Epimedii Folium and Spatholobus suberectus;HPLC was used for the contents determination of icariin and acteoside:the column was Diamonsil C18 with mobile phase of acetonitrile-0.1% formic acid solution (gradient elution) at a flow rate of 1.0 mL/min;detection wavelength was 270 nm for icariin and 334 nm for acteoside, Cdumn temperature was 25 ℃,and the injection volume was 10 μL. RESULTS:The TLC spots of D. fortunei,Epimedii Folium and S. suberectus were clear and well separated,negative control without interference. The linear range was 0.0188-1.88 μg for ac-teoside(r=0.9999)and 0.107-2.14 μg for icariin(r=0.9999);RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 100.2%-105.0%(RSD=1.6%,n=9) and 96.2%-99.5%(RSD=1.4%,n=9). CONCLUSIONS:The improved standard can more effectively control the quality of Kanggu zengsheng tablet.%目的:完善和提高抗骨增生片的质量标准.方法:采用薄层色谱法(TLC)对制剂中骨碎补、淫羊藿、鸡血藤进行定性鉴别;采用高效液相色谱法测定制剂中毛蕊花糖苷和淫羊藿苷的含量:色谱柱为Diamonsil C18,流动相为乙腈-0.1%甲酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为270 nm(淫羊藿苷)、334 nm(毛蕊花糖苷),柱温为25℃,进样量为10μL.结果:骨碎补、淫羊藿、鸡血藤的TLC图斑点清晰,分离度好,阴性对照无干扰.毛蕊花糖苷、淫羊藿苷检测进样量线性范围分别为0.0188~1.88μg(r=0.9999)、0.107~2.14μg(r=0.9999);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为100.2%~105.0%(RSD=1.6%,n=9)、96.2%~99.5%(RSD=1.4%,n=9).结论:该标准能更加有效地控制抗骨增生片的质量.