抗骨增生片的质量标准提高研究 点击下载
论文标题: 抗骨增生片的质量标准提高研究
英文标题:
中文摘要: 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10 μL。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0.018 8~1.88 μg(r=0.999 9)、0.107~2.14 μg(r=0.999 9);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。
英文摘要: 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 0.018 8-1.88 μg for acteoside (r=0.999 9) and 0.107-2.14 μg for icariin (r=0.999 9); 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.
期刊: 2017年第28卷第6期
作者: 陈希,万林春,张文婷
英文作者: CHEN Xi,WAN Linchun,ZHANG Wenting
关键字: 抗骨增生片;柚皮苷;淫羊藿苷;毛蕊花糖苷;鸡血藤;薄层色谱法;高效液相色谱法
KEYWORDS: Kanggu zengsheng tablet; Naringin; Icariin; Acteoside; Spatholobus suberectus; TLC; HPLC
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